SAS Sytstem. The results include data from the following ... · AST increased KEYNOTE-006 Ipilimumab 3 mg/kg Q3W 256 median 2022 6 2 3 [1;5] 1 [0;2] AST increased _ALL Ipilimumab

SUPPLEMENTARY INFORMATION In format provided by Boutros et al. (SEPTEMBER 2016)

NATURE REVIEWS | CLINICAL ONCOLOGY www.nature.com/reviews/nrclinonc

Supplementary Table 1: Incidence per 1000 person-months of all grade and grade 3 to 5 adverse events under immunotherapy using the

SAS Sytstem. The results include data from the following studies: CA-184-002, KEYNOTE-001, KEYNOTE-001 (randomized cohorts),

KEYNOTE-002, KEYNOTE-006, CheckMate-037, CheckMate-066, CheckMate-067, and CheckMate-069.

Adverse event Study Regimen

N patients

Follow-up duration statistic

N patients_months

N of AEs

N of grade

3-5 AEs

AE incidence per 1000 person-

months [95%CI]

Grade 3-5 AE incidence per 1000 person-

months [95%CI]

ALT increased CheckMate-067 Ipilimumab 3 mg/Kg + Nivolumab 1 mg/kg

313 minimum 3819 55 26 14 [11;18] 7 [4;9]

ALT increased CheckMate-069 Ipilimumab 3 mg/Kg + Nivolumab 1 mg/kg

94 minimum 1034 21 10 20 [12;29] 10 [4;16]

ALT increased _ALL Ipilimumab 3 mg/Kg + Nivolumab 1 mg/kg

407 4853 76 36 16 [12;19] 7 [5;10]

ALT increased CA-184-002 Ipilimumab 3 mg/kg Q3W 131 median 3642 2 0 1 [0;1] 0 [0;0]

ALT increased CheckMate-067 Ipilimumab 3 mg/kg Q3W 311 minimum 3794 12 5 3 [1;5] 1 [0;2]

ALT increased CheckMate-069 Ipilimumab 3 mg/kg Q3W 46 minimum 506 2 0 4 [0;9] 0 [0;0]

ALT increased KEYNOTE-006 Ipilimumab 3 mg/kg Q3W 256 median 2022 9 2 4 [2;7] 1 [0;2]

ALT increased _ALL Ipilimumab 3 mg/kg Q3W 744 9964 25 7 3 [2;3] 1 [0;1]

ALT increased CheckMate-037 Nivolumab 3mg/kg Q2W 268 median 2251 7 2 3 [1;5] 1 [0;2]



ALT increased _ALL Nivolumab 3mg/kg Q2W 787 9604 22 8 2 [1;3] 1 [0;1]




N patients


N patients_months

N of AEs

N of grade

3-5 AEs


months [95%CI]


months [95%CI]

ALT increased KEYNOTE-001 Pembrolizumab 10 mg/kg Q2W

57 median 627 6 0 10 [2;17] 0 [0;0]


278 median 2196 12 0 5 [2;9] 0 [0;0]

ALT increased _ALL Pembrolizumab 10 mg/kg Q2W

335 2823 18 0 6 [3;9] 0 [0;0]


56 median 616 5 0 8 [1;15] 0 [0;0]

ALT increased KEYNOTE-001 (randomized cohorts)

Pembrolizumab 10 mg/kg Q3W

84 median 672 2 0 3 [0;7] 0 [0;0]


140 1288 7 0 5 [1;9] 0 [0;0]


22 median 242 0 0 0 [0;0] 0 [0;0]

ALT increased KEYNOTE-001 (randomized cohorts)


89 median 712 4 0 6 [0;11] 0 [0;0]


111 954 4 0 4 [0;8] 0 [0;0]

AST increased CheckMate-067 Ipilimumab 3 mg/Kg + Nivolumab 1 mg/kg

313 minimum 3819 48 19 13 [9;16] 5 [3;7]

AST increased CheckMate-069 Ipilimumab 3 mg/Kg + Nivolumab 1 mg/kg

94 minimum 1034 20 7 19 [11;28] 7 [2;12]

AST increased _ALL Ipilimumab 3 mg/Kg + Nivolumab 1 mg/kg

407 4853 68 26 14 [11;17] 5 [3;7]




N patients


N patients_months

N of AEs

N of grade

3-5 AEs


months [95%CI]


months [95%CI]

AST increased CA-184-002 Ipilimumab 3 mg/kg Q3W 131 median 3642 1 0 0 [0;1] 0 [0;0]

AST increased CheckMate-067 Ipilimumab 3 mg/kg Q3W 311 minimum 3794 11 2 3 [1;5] 1 [0;1]

AST increased CheckMate-069 Ipilimumab 3 mg/kg Q3W 46 minimum 506 2 0 4 [0;9] 0 [0;0]

AST increased KEYNOTE-006 Ipilimumab 3 mg/kg Q3W 256 median 2022 6 2 3 [1;5] 1 [0;2]

AST increased _ALL Ipilimumab 3 mg/kg Q3W 744 9964 20 4 2 [1;3] 0 [0;1]

AST increased CheckMate-037 Nivolumab 3mg/kg Q2W 268 median 2251 11 1 5 [2;8] 0 [0;1]



AST increased _ALL Nivolumab 3mg/kg Q2W 787 9604 25 5 3 [2;4] 1 [0;1]

AST increased KEYNOTE-001 Pembrolizumab 10 mg/kg Q2W

57 median 627 7 0 11 [3;19] 0 [0;0]


278 median 2196 14 0 6 [3;10] 0 [0;0]

AST increased _ALL Pembrolizumab 10 mg/kg Q2W

335 2823 21 0 7 [4;11] 0 [0;0]


56 median 616 5 2 8 [1;15] 3 [0;8]

AST increased KEYNOTE-001 (randomized cohorts)


84 median 672 2 0 3 [0;7] 0 [0;0]


140 1288 7 2 5 [1;9] 2 [0;4]




N patients


N patients_months

N of AEs

N of grade

3-5 AEs


months [95%CI]


months [95%CI]


22 median 242 1 0 4 [0;12] 0 [0;0]

AST increased KEYNOTE-001 (randomized cohorts)


89 median 712 3 0 4 [0;9] 0 [0;0]


111 954 4 0 4 [0;8] 0 [0;0]

Abdominal discomfort KEYNOTE-001 Pembrolizumab 10 mg/kg Q2W

57 median 627 2 0 3 [0;8] 0 [0;0]

Abdominal discomfort _ALL Pembrolizumab 10 mg/kg Q2W

57 627 2 0 3 [0;8] 0 [0;0]


56 median 616 0 0 0 [0;0] 0 [0;0]

Abdominal discomfort KEYNOTE-001 (randomized cohorts)


84 median 672 2 2 3 [0;7] 3 [0;7]


140 1288 2 2 2 [0;4] 2 [0;4]


22 median 242 0 0 0 [0;0] 0 [0;0]

Abdominal discomfort KEYNOTE-001 (randomized cohorts)


89 median 712 2 2 3 [0;7] 3 [0;7]


111 954 2 2 2 [0;5] 2 [0;5]

Abdominal distension KEYNOTE-001 Pembrolizumab 10 mg/kg Q2W

57 median 627 3 1 5 [0;10] 2 [0;5]




N patients


N patients_months

N of AEs

N of grade

3-5 AEs


months [95%CI]


months [95%CI]

Abdominal distension _ALL Pembrolizumab 10 mg/kg Q2W

57 627 3 1 5 [0;10] 2 [0;5]


56 median 616 0 0 0 [0;0] 0 [0;0]


56 616 0 0 0 [0;0] 0 [0;0]


22 median 242 0 0 0 [0;0] 0 [0;0]


22 242 0 0 0 [0;0] 0 [0;0]

Abdominal pain CheckMate-069 Ipilimumab 3 mg/Kg + Nivolumab 1 mg/kg

94 minimum 1034 10 0 10 [4;16] 0 [0;0]

Abdominal pain _ALL Ipilimumab 3 mg/Kg + Nivolumab 1 mg/kg

94 1034 10 0 10 [4;16] 0 [0;0]

Abdominal pain CA-184-002 Ipilimumab 3 mg/kg Q3W 131 median 3642 20 2 5 [3;8] 1 [0;1]

Abdominal pain CheckMate-069 Ipilimumab 3 mg/kg Q3W 46 minimum 506 4 1 8 [0;16] 2 [0;6]

Abdominal pain KEYNOTE-006 Ipilimumab 3 mg/kg Q3W 256 median 2022 15 0 7 [4;11] 0 [0;0]

Abdominal pain _ALL Ipilimumab 3 mg/kg Q3W 433 6170 39 3 6 [4;8] 0 [0;1]

Abdominal pain CheckMate-066 Nivolumab 3mg/kg Q2W 206 median 3440 8 0 2 [1;4] 0 [0;0]

Abdominal pain _ALL Nivolumab 3mg/kg Q2W 206 3440 8 0 2 [1;4] 0 [0;0]

Abdominal pain KEYNOTE-001 Pembrolizumab 10 mg/kg Q2W

57 median 627 6 1 10 [2;17] 2 [0;5]




N patients


N patients_months

N of AEs

N of grade

3-5 AEs


months [95%CI]


months [95%CI]


278 median 2196 10 0 5 [2;7] 0 [0;0]

Abdominal pain _ALL Pembrolizumab 10 mg/kg Q2W

335 2823 16 1 6 [3;8] 0 [0;1]


56 median 616 0 0 0 [0;0] 0 [0;0]

Abdominal pain KEYNOTE-001 (randomized cohorts)


84 median 672 0 0 0 [0;0] 0 [0;0]


140 1288 0 0 0 [0;0] 0 [0;0]


22 median 242 1 0 4 [0;12] 0 [0;0]

Abdominal pain KEYNOTE-001 (randomized cohorts)


89 median 712 3 0 4 [0;9] 0 [0;0]


111 954 4 0 4 [0;8] 0 [0;0]

Abdominal pain upper KEYNOTE-006 Ipilimumab 3 mg/kg Q3W 256 median 2022 1 0 0 [0;1] 0 [0;0]

Abdominal pain upper _ALL Ipilimumab 3 mg/kg Q3W 256 2022 1 0 0 [0;1] 0 [0;0]

Abdominal pain upper KEYNOTE-006 Pembrolizumab 10 mg/kg Q2W

278 median 2196 4 0 2 [0;4] 0 [0;0]

Abdominal pain upper _ALL Pembrolizumab 10 mg/kg Q2W

278 2196 4 0 2 [0;4] 0 [0;0]

Adrenal insufficiency CheckMate-069 Ipilimumab 3 mg/Kg + Nivolumab 1 mg/kg

94 minimum 1034 6 1 6 [1;10] 1 [0;3]




N patients


N patients_months

N of AEs

N of grade

3-5 AEs


months [95%CI]


months [95%CI]

Adrenal insufficiency _ALL Ipilimumab 3 mg/Kg + Nivolumab 1 mg/kg

94 1034 6 1 6 [1;10] 1 [0;3]

Adrenal insufficiency CA-184-002 Ipilimumab 3 mg/kg Q3W 131 median 3642 2 0 1 [0;1] 0 [0;0]

Adrenal insufficiency CheckMate-069 Ipilimumab 3 mg/kg Q3W 46 minimum 506 2 1 4 [0;9] 2 [0;6]

Adrenal insufficiency _ALL Ipilimumab 3 mg/kg Q3W 177 4148 4 1 1 [0;2] 0 [0;1]

Alopecia KEYNOTE-006 Ipilimumab 3 mg/kg Q3W 256 median 2022 2 0 1 [0;2] 0 [0;0]

Alopecia _ALL Ipilimumab 3 mg/kg Q3W 256 2022 2 0 1 [0;2] 0 [0;0]

Alopecia CheckMate-037 Nivolumab 3mg/kg Q2W 268 median 2251 1 0 0 [0;1] 0 [0;0]

Alopecia CheckMate-066 Nivolumab 3mg/kg Q2W 206 median 3440 7 0 2 [1;4] 0 [0;0]

Alopecia _ALL Nivolumab 3mg/kg Q2W 474 5691 8 0 1 [0;2] 0 [0;0]

Alopecia KEYNOTE-006 Pembrolizumab 10 mg/kg Q2W

278 median 2196 4 0 2 [0;4] 0 [0;0]

Alopecia _ALL Pembrolizumab 10 mg/kg Q2W

278 2196 4 0 2 [0;4] 0 [0;0]


179 median 1790 1 0 1 [0;2] 0 [0;0]


179 1790 1 0 1 [0;2] 0 [0;0]


178 median 1780 5 0 3 [0;5] 0 [0;0]


178 1780 5 0 3 [0;5] 0 [0;0]




N patients


N patients_months

N of AEs

N of grade

3-5 AEs


months [95%CI]


months [95%CI]

Anemia CA-184-002 Ipilimumab 3 mg/kg Q3W 131 median 3642 15 4 4 [2;6] 1 [0;2]

Anemia KEYNOTE-006 Ipilimumab 3 mg/kg Q3W 256 median 2022 1 1 0 [0;1] 0 [0;1]

Anemia _ALL Ipilimumab 3 mg/kg Q3W 387 5664 16 5 3 [1;4] 1 [0;2]

Anemia CheckMate-037 Nivolumab 3mg/kg Q2W 268 median 2251 10 2 4 [2;7] 1 [0;2]

Anemia CheckMate-066 Nivolumab 3mg/kg Q2W 206 median 3440 9 0 3 [1;4] 0 [0;0]

Anemia _ALL Nivolumab 3mg/kg Q2W 474 5691 19 2 3 [2;5] 0 [0;1]

Anemia KEYNOTE-001 Pembrolizumab 10 mg/kg Q2W

57 median 627 4 0 6 [0;13] 0 [0;0]


278 median 2196 3 2 1 [0;3] 1 [0;2]

Anemia _ALL Pembrolizumab 10 mg/kg Q2W

335 2823 7 2 2 [1;4] 1 [0;2]


56 median 616 0 0 0 [0;0] 0 [0;0]

Anemia KEYNOTE-001 (randomized cohorts)


84 median 672 1 0 1 [0;4] 0 [0;0]


179 median 1790 7 0 4 [1;7] 0 [0;0]


319 3078 8 0 3 [1;4] 0 [0;0]


22 median 242 0 0 0 [0;0] 0 [0;0]




N patients


N patients_months

N of AEs

N of grade

3-5 AEs


months [95%CI]


months [95%CI]

Anemia KEYNOTE-001 (randomized cohorts)


89 median 712 3 1 4 [0;9] 1 [0;4]


178 median 1780 5 1 3 [0;5] 1 [0;2]


289 2734 8 2 3 [1;5] 1 [0;2]

Arthralgia CheckMate-067 Ipilimumab 3 mg/Kg + Nivolumab 1 mg/kg

313 minimum 3819 33 1 9 [6;12] 0 [0;1]

Arthralgia CheckMate-069 Ipilimumab 3 mg/Kg + Nivolumab 1 mg/kg

94 minimum 1034 10 0 10 [4;16] 0 [0;0]

Arthralgia _ALL Ipilimumab 3 mg/Kg + Nivolumab 1 mg/kg

407 4853 43 1 9 [6;12] 0 [0;1]

Arthralgia CheckMate-067 Ipilimumab 3 mg/kg Q3W 311 minimum 3794 19 0 5 [3;7] 0 [0;0]

Arthralgia CheckMate-069 Ipilimumab 3 mg/kg Q3W 46 minimum 506 4 0 8 [0;16] 0 [0;0]

Arthralgia KEYNOTE-006 Ipilimumab 3 mg/kg Q3W 256 median 2022 13 2 6 [3;10] 1 [0;2]

Arthralgia _ALL Ipilimumab 3 mg/kg Q3W 613 6323 36 2 6 [4;8] 0 [0;1]

Arthralgia CheckMate-037 Nivolumab 3mg/kg Q2W 268 median 2251 14 0 6 [3;9] 0 [0;0]



Arthralgia _ALL Nivolumab 3mg/kg Q2W 787 9604 50 0 5 [4;7] 0 [0;0]

Arthralgia KEYNOTE-001 Pembrolizumab 10 mg/kg Q2W

57 median 627 12 0 19 [8;30] 0 [0;0]




N patients


N patients_months

N of AEs

N of grade

3-5 AEs


months [95%CI]


months [95%CI]


278 median 2196 26 0 12 [7;16] 0 [0;0]

Arthralgia _ALL Pembrolizumab 10 mg/kg Q2W

335 2823 38 0 13 [9;18] 0 [0;0]


56 median 616 7 0 11 [3;20] 0 [0;0]

Arthralgia KEYNOTE-001 (randomized cohorts)


84 median 672 10 0 15 [6;24] 0 [0;0]


179 median 1790 11 1 6 [3;10] 1 [0;2]


319 3078 28 1 9 [6;12] 0 [0;1]


22 median 242 1 0 4 [0;12] 0 [0;0]

Arthralgia KEYNOTE-001 (randomized cohorts)


89 median 712 11 0 15 [6;25] 0 [0;0]


178 median 1780 13 1 7 [3;11] 1 [0;2]


289 2734 25 1 9 [6;13] 0 [0;1]

Arthritis KEYNOTE-006 Ipilimumab 3 mg/kg Q3W 256 median 2022 0 0 0 [0;0] 0 [0;0]

Arthritis _ALL Ipilimumab 3 mg/kg Q3W 256 2022 0 0 0 [0;0] 0 [0;0]

Arthritis KEYNOTE-001 Pembrolizumab 10 mg/kg Q2W

57 median 627 2 0 3 [0;8] 0 [0;0]




N patients


N patients_months

N of AEs

N of grade

3-5 AEs


months [95%CI]


months [95%CI]


278 median 2196 5 0 2 [0;4] 0 [0;0]

Arthritis _ALL Pembrolizumab 10 mg/kg Q2W

335 2823 7 0 2 [1;4] 0 [0;0]


56 median 616 0 0 0 [0;0] 0 [0;0]


56 616 0 0 0 [0;0] 0 [0;0]


22 median 242 0 0 0 [0;0] 0 [0;0]


22 242 0 0 0 [0;0] 0 [0;0]

Asthenia CheckMate-069 Ipilimumab 3 mg/Kg + Nivolumab 1 mg/kg

94 minimum 1034 8 0 8 [2;13] 0 [0;0]

Asthenia _ALL Ipilimumab 3 mg/Kg + Nivolumab 1 mg/kg

94 1034 8 0 8 [2;13] 0 [0;0]

Asthenia CheckMate-069 Ipilimumab 3 mg/kg Q3W 46 minimum 506 5 0 10 [1;19] 0 [0;0]

Asthenia KEYNOTE-006 Ipilimumab 3 mg/kg Q3W 256 median 2022 16 2 8 [4;12] 1 [0;2]

Asthenia _ALL Ipilimumab 3 mg/kg Q3W 302 2528 21 2 8 [5;12] 1 [0;2]

Asthenia CheckMate-066 Nivolumab 3mg/kg Q2W 206 median 3440 21 0 6 [3;9] 0 [0;0]

Asthenia _ALL Nivolumab 3mg/kg Q2W 206 3440 21 0 6 [3;9] 0 [0;0]

Asthenia KEYNOTE-001 Pembrolizumab 10 mg/kg Q2W

57 median 627 11 0 18 [7;28] 0 [0;0]




N patients


N patients_months

N of AEs

N of grade

3-5 AEs


months [95%CI]


months [95%CI]


278 median 2196 32 1 15 [10;20] 0 [0;1]

Asthenia _ALL Pembrolizumab 10 mg/kg Q2W

335 2823 43 1 15 [11;20] 0 [0;1]


56 median 616 2 0 3 [0;8] 0 [0;0]

Asthenia KEYNOTE-001 (randomized cohorts)


84 median 672 6 0 9 [2;16] 0 [0;0]


179 median 1790 8 1 4 [1;8] 1 [0;2]


319 3078 16 1 5 [3;8] 0 [0;1]


22 median 242 0 0 0 [0;0] 0 [0;0]

Asthenia KEYNOTE-001 (randomized cohorts)


89 median 712 5 0 7 [1;13] 0 [0;0]

Asthenia KEYNOTE-002 Pembrolizumab Pembrolizumab 2 mg/kg Q3W

178 median 1780 6 1 3 [1;6] 1 [0;2]


289 2734 11 1 4 [2;6] 0 [0;1]

Back pain KEYNOTE-006 Ipilimumab 3 mg/kg Q3W 256 median 2022 0 0 0 [0;0] 0 [0;0]

Back pain _ALL Ipilimumab 3 mg/kg Q3W 256 2022 0 0 0 [0;0] 0 [0;0]




N patients


N patients_months

N of AEs

N of grade

3-5 AEs


months [95%CI]


months [95%CI]

Back pain KEYNOTE-001 Pembrolizumab 10 mg/kg Q2W

57 median 627 2 0 3 [0;8] 0 [0;0]


278 median 2196 7 0 3 [1;6] 0 [0;0]

Back pain _ALL Pembrolizumab 10 mg/kg Q2W

335 2823 9 0 3 [1;5] 0 [0;0]


56 median 616 0 0 0 [0;0] 0 [0;0]

Back pain KEYNOTE-001 (randomized cohorts)


84 median 672 2 0 3 [0;7] 0 [0;0]


140 1288 2 0 2 [0;4] 0 [0;0]


22 median 242 0 0 0 [0;0] 0 [0;0]

Back pain KEYNOTE-001 (randomized cohorts)


89 median 712 3 0 4 [0;9] 0 [0;0]


111 954 3 0 3 [0;7] 0 [0;0]

Balance disorder KEYNOTE-001 Pembrolizumab 10 mg/kg Q2W

57 median 627 2 0 3 [0;8] 0 [0;0]

Balance disorder _ALL Pembrolizumab 10 mg/kg Q2W

57 627 2 0 3 [0;8] 0 [0;0]


56 median 616 0 0 0 [0;0] 0 [0;0]




N patients


N patients_months

N of AEs

N of grade

3-5 AEs


months [95%CI]


months [95%CI]


56 616 0 0 0 [0;0] 0 [0;0]


22 median 242 0 0 0 [0;0] 0 [0;0]


22 242 0 0 0 [0;0] 0 [0;0]

Blood TSH decreased CheckMate-069 Ipilimumab 3 mg/Kg + Nivolumab 1 mg/kg

94 minimum 1034 5 0 5 [1;9] 0 [0;0]

Blood TSH decreased _ALL Ipilimumab 3 mg/Kg + Nivolumab 1 mg/kg

94 1034 5 0 5 [1;9] 0 [0;0]

Blood TSH decreased CheckMate-069 Ipilimumab 3 mg/kg Q3W 46 minimum 506 0 0 0 [0;0] 0 [0;0]

Blood TSH decreased KEYNOTE-006 Ipilimumab 3 mg/kg Q3W 256 median 2022 2 1 1 [0;2] 0 [0;1]

Blood TSH decreased _ALL Ipilimumab 3 mg/kg Q3W 302 2528 2 1 1 [0;2] 0 [0;1]

Blood TSH decreased CheckMate-037 Nivolumab 3mg/kg Q2W 268 median 2251 3 0 1 [0;3] 0 [0;0]

Blood TSH decreased _ALL Nivolumab 3mg/kg Q2W 268 2251 3 0 1 [0;3] 0 [0;0]

Blood TSH decreased KEYNOTE-006 Pembrolizumab 10 mg/kg Q2W

278 median 2196 3 0 1 [0;3] 0 [0;0]

Blood TSH decreased _ALL Pembrolizumab 10 mg/kg Q2W

278 2196 3 0 1 [0;3] 0 [0;0]

Blood TSH decreased KEYNOTE-001 (randomized cohorts)


84 median 672 2 0 3 [0;7] 0 [0;0]


84 672 2 0 3 [0;7] 0 [0;0]




N patients


N patients_months

N of AEs

N of grade

3-5 AEs


months [95%CI]


months [95%CI]

Blood TSH decreased KEYNOTE-001 (randomized cohorts)


89 median 712 0 0 0 [0;0] 0 [0;0]


89 712 0 0 0 [0;0] 0 [0;0]

Blood TSH increased CA-184-002 Ipilimumab 3 mg/kg Q3W 131 median 3642 1 0 0 [0;1] 0 [0;0]

Blood TSH increased KEYNOTE-006 Ipilimumab 3 mg/kg Q3W 256 median 2022 1 0 0 [0;1] 0 [0;0]

Blood TSH increased _ALL Ipilimumab 3 mg/kg Q3W 387 5664 2 0 0 [0;1] 0 [0;0]

Blood TSH increased KEYNOTE-006 Pembrolizumab 10 mg/kg Q2W

278 median 2196 2 0 1 [0;2] 0 [0;0]

Blood TSH increased _ALL Pembrolizumab 10 mg/kg Q2W

278 2196 2 0 1 [0;2] 0 [0;0]

Blood TSH increased KEYNOTE-001 (randomized cohorts)


84 median 672 3 0 4 [0;10] 0 [0;0]


84 672 3 0 4 [0;10] 0 [0;0]

Blood TSH increased KEYNOTE-001 (randomized cohorts)


89 median 712 1 0 1 [0;4] 0 [0;0]


89 712 1 0 1 [0;4] 0 [0;0]

Blood alkaline phosphatase increased

KEYNOTE-006 Ipilimumab 3 mg/kg Q3W 256 median 2022 4 0 2 [0;4] 0 [0;0]


_ALL Ipilimumab 3 mg/kg Q3W 256 2022 4 0 2 [0;4] 0 [0;0]




N patients


N patients_months

N of AEs

N of grade

3-5 AEs


months [95%CI]


months [95%CI]


KEYNOTE-001 Pembrolizumab 10 mg/kg Q2W

57 median 627 2 0 3 [0;8] 0 [0;0]



278 median 2196 2 0 1 [0;2] 0 [0;0]


_ALL Pembrolizumab 10 mg/kg Q2W

335 2823 4 0 1 [0;3] 0 [0;0]



56 median 616 0 0 0 [0;0] 0 [0;0]



56 616 0 0 0 [0;0] 0 [0;0]



22 median 242 0 0 0 [0;0] 0 [0;0]



22 242 0 0 0 [0;0] 0 [0;0]

Blood bilirubin increased CheckMate-069 Ipilimumab 3 mg/Kg + Nivolumab 1 mg/kg

94 minimum 1034 5 0 5 [1;9] 0 [0;0]

Blood bilirubin increased _ALL Ipilimumab 3 mg/Kg + Nivolumab 1 mg/kg

94 1034 5 0 5 [1;9] 0 [0;0]

Blood bilirubin increased CheckMate-069 Ipilimumab 3 mg/kg Q3W 46 minimum 506 0 0 0 [0;0] 0 [0;0]

Blood bilirubin increased KEYNOTE-006 Ipilimumab 3 mg/kg Q3W 256 median 2022 0 0 0 [0;0] 0 [0;0]

Blood bilirubin increased _ALL Ipilimumab 3 mg/kg Q3W 302 2528 0 0 0 [0;0] 0 [0;0]

Blood bilirubin increased CheckMate-066 Nivolumab 3mg/kg Q2W 206 median 3440 2 0 1 [0;1] 0 [0;0]

Blood bilirubin increased _ALL Nivolumab 3mg/kg Q2W 206 3440 2 0 1 [0;1] 0 [0;0]




N patients


N patients_months

N of AEs

N of grade

3-5 AEs


months [95%CI]


months [95%CI]

Blood bilirubin increased KEYNOTE-006 Pembrolizumab 10 mg/kg Q2W

278 median 2196 6 0 3 [1;5] 0 [0;0]

Blood bilirubin increased _ALL Pembrolizumab 10 mg/kg Q2W

278 2196 6 0 3 [1;5] 0 [0;0]

Blood cholesterol increased


57 median 627 2 0 3 [0;8] 0 [0;0]



57 627 2 0 3 [0;8] 0 [0;0]



56 median 616 0 0 0 [0;0] 0 [0;0]



56 616 0 0 0 [0;0] 0 [0;0]



22 median 242 0 0 0 [0;0] 0 [0;0]



22 242 0 0 0 [0;0] 0 [0;0]

Blood creatinine increased CheckMate-069 Ipilimumab 3 mg/Kg + Nivolumab 1 mg/kg

94 minimum 1034 2 1 2 [0;5] 1 [0;3]

Blood creatinine increased _ALL Ipilimumab 3 mg/Kg + Nivolumab 1 mg/kg

94 1034 2 1 2 [0;5] 1 [0;3]

Blood creatinine increased CheckMate-069 Ipilimumab 3 mg/kg Q3W 46 minimum 506 0 0 0 [0;0] 0 [0;0]

Blood creatinine increased KEYNOTE-006 Ipilimumab 3 mg/kg Q3W 256 median 2022 1 0 0 [0;1] 0 [0;0]

Blood creatinine increased _ALL Ipilimumab 3 mg/kg Q3W 302 2528 1 0 0 [0;1] 0 [0;0]




N patients


N patients_months

N of AEs

N of grade

3-5 AEs


months [95%CI]


months [95%CI]

Blood creatinine increased CheckMate-037 Nivolumab 3mg/kg Q2W 268 median 2251 2 0 1 [0;2] 0 [0;0]

Blood creatinine increased CheckMate-066 Nivolumab 3mg/kg Q2W 206 median 3440 1 0 0 [0;1] 0 [0;0]

Blood creatinine increased _ALL Nivolumab 3mg/kg Q2W 474 5691 3 0 1 [0;1] 0 [0;0]

Blood creatinine increased KEYNOTE-001 Pembrolizumab 10 mg/kg Q2W

57 median 627 3 0 5 [0;10] 0 [0;0]


278 median 2196 4 0 2 [0;4] 0 [0;0]

Blood creatinine increased _ALL Pembrolizumab 10 mg/kg Q2W

335 2823 7 0 2 [1;4] 0 [0;0]


56 median 616 0 0 0 [0;0] 0 [0;0]


56 616 0 0 0 [0;0] 0 [0;0]


22 median 242 0 0 0 [0;0] 0 [0;0]


22 242 0 0 0 [0;0] 0 [0;0]

Blood lactate dehydrogenase increased






278 median 2196 5 1 2 [0;4] 0 [0;1]




N patients


N patients_months

N of AEs

N of grade

3-5 AEs


months [95%CI]


months [95%CI]



278 2196 5 1 2 [0;4] 0 [0;1]

Bone pain KEYNOTE-006 Ipilimumab 3 mg/kg Q3W 256 median 2022 0 0 0 [0;0] 0 [0;0]

Bone pain _ALL Ipilimumab 3 mg/kg Q3W 256 2022 0 0 0 [0;0] 0 [0;0]

Bone pain KEYNOTE-006 Pembrolizumab 10 mg/kg Q2W

278 median 2196 3 0 1 [0;3] 0 [0;0]

Bone pain _ALL Pembrolizumab 10 mg/kg Q2W

278 2196 3 0 1 [0;3] 0 [0;0]

Chest pain KEYNOTE-001 (randomized cohorts)


84 median 672 2 0 3 [0;7] 0 [0;0]

Chest pain _ALL Pembrolizumab 10 mg/kg Q3W

84 672 2 0 3 [0;7] 0 [0;0]

Chest pain KEYNOTE-001 (randomized cohorts)


89 median 712 0 0 0 [0;0] 0 [0;0]

Chest pain _ALL Pembrolizumab 2 mg/kg Q3W

89 712 0 0 0 [0;0] 0 [0;0]

Chills CheckMate-069 Ipilimumab 3 mg/Kg + Nivolumab 1 mg/kg

94 minimum 1034 10 0 10 [4;16] 0 [0;0]

Chills _ALL Ipilimumab 3 mg/Kg + Nivolumab 1 mg/kg

94 1034 10 0 10 [4;16] 0 [0;0]

Chills CheckMate-069 Ipilimumab 3 mg/kg Q3W 46 minimum 506 3 0 6 [0;13] 0 [0;0]

Chills KEYNOTE-006 Ipilimumab 3 mg/kg Q3W 256 median 2022 2 0 1 [0;2] 0 [0;0]

Chills _ALL Ipilimumab 3 mg/kg Q3W 302 2528 5 0 2 [0;4] 0 [0;0]




N patients


N patients_months

N of AEs

N of grade

3-5 AEs


months [95%CI]


months [95%CI]

Chills KEYNOTE-001 Pembrolizumab 10 mg/kg Q2W

57 median 627 6 0 10 [2;17] 0 [0;0]


278 median 2196 3 0 1 [0;3] 0 [0;0]

Chills _ALL Pembrolizumab 10 mg/kg Q2W

335 2823 9 0 3 [1;5] 0 [0;0]


56 median 616 2 0 3 [0;8] 0 [0;0]

Chills KEYNOTE-001 (randomized cohorts)


84 median 672 3 0 4 [0;10] 0 [0;0]


140 1288 5 0 4 [0;7] 0 [0;0]


22 median 242 1 0 4 [0;12] 0 [0;0]

Chills KEYNOTE-001 (randomized cohorts)


89 median 712 7 0 10 [3;17] 0 [0;0]


111 954 8 0 8 [3;14] 0 [0;0]

Colitis CheckMate-067 Ipilimumab 3 mg/Kg + Nivolumab 1 mg/kg

313 minimum 3819 37 24 10 [7;13] 6 [4;9]

Colitis CheckMate-069 Ipilimumab 3 mg/Kg + Nivolumab 1 mg/kg

94 minimum 1034 22 16 21 [12;30] 15 [8;23]

Colitis _ALL Ipilimumab 3 mg/Kg + Nivolumab 1 mg/kg

407 4853 59 40 12 [9;15] 8 [6;11]




N patients


N patients_months

N of AEs

N of grade

3-5 AEs


months [95%CI]


months [95%CI]

Colitis CA-184-002 Ipilimumab 3 mg/kg Q3W 131 median 3642 10 7 3 [1;4] 2 [0;3]

Colitis CheckMate-067 Ipilimumab 3 mg/kg Q3W 311 minimum 3794 36 27 9 [6;13] 7 [4;10]

Colitis CheckMate-069 Ipilimumab 3 mg/kg Q3W 46 minimum 506 6 3 12 [2;21] 6 [0;13]

Colitis KEYNOTE-006 Ipilimumab 3 mg/kg Q3W 256 median 2022 19 16 9 [5;14] 8 [4;12]

Colitis _ALL Ipilimumab 3 mg/kg Q3W 744 9964 71 53 7 [5;9] 5 [4;7]

Colitis CheckMate-037 Nivolumab 3mg/kg Q2W 268 median 2251 3 2 1 [0;3] 1 [0;2]



Colitis _ALL Nivolumab 3mg/kg Q2W 787 9604 9 5 1 [0;2] 1 [0;1]

Colitis KEYNOTE-006 Pembrolizumab 10 mg/kg Q2W

278 median 2196 4 4 2 [0;4] 2 [0;4]

Colitis _ALL Pembrolizumab 10 mg/kg Q2W

278 2196 4 4 2 [0;4] 2 [0;4]

Confusion KEYNOTE-001 Pembrolizumab 10 mg/kg Q2W

57 median 627 1 0 2 [0;5] 0 [0;0]

Confusion _ALL Pembrolizumab 10 mg/kg Q2W

57 627 1 0 2 [0;5] 0 [0;0]


56 median 616 1 0 2 [0;5] 0 [0;0]


56 616 1 0 2 [0;5] 0 [0;0]




N patients


N patients_months

N of AEs

N of grade

3-5 AEs


months [95%CI]


months [95%CI]


22 median 242 0 0 0 [0;0] 0 [0;0]


22 242 0 0 0 [0;0] 0 [0;0]

Conjunctivitis KEYNOTE-006 Ipilimumab 3 mg/kg Q3W 256 median 2022 1 0 0 [0;1] 0 [0;0]

Conjunctivitis _ALL Ipilimumab 3 mg/kg Q3W 256 2022 1 0 0 [0;1] 0 [0;0]

Conjunctivitis KEYNOTE-006 Pembrolizumab 10 mg/kg Q2W

278 median 2196 4 0 2 [0;4] 0 [0;0]

Conjunctivitis _ALL Pembrolizumab 10 mg/kg Q2W

278 2196 4 0 2 [0;4] 0 [0;0]

Constipation CheckMate-069 Ipilimumab 3 mg/Kg + Nivolumab 1 mg/kg

94 minimum 1034 10 1 10 [4;16] 1 [0;3]

Constipation _ALL Ipilimumab 3 mg/Kg + Nivolumab 1 mg/kg

94 1034 10 1 10 [4;16] 1 [0;3]

Constipation CA-184-002 Ipilimumab 3 mg/kg Q3W 131 median 3642 27 3 7 [5;10] 1 [0;2]

Constipation CheckMate-069 Ipilimumab 3 mg/kg Q3W 46 minimum 506 4 0 8 [0;16] 0 [0;0]

Constipation KEYNOTE-006 Ipilimumab 3 mg/kg Q3W 256 median 2022 5 0 2 [0;5] 0 [0;0]

Constipation _ALL Ipilimumab 3 mg/kg Q3W 433 6170 36 3 6 [4;8] 0 [0;1]

Constipation CheckMate-037 Nivolumab 3mg/kg Q2W 268 median 2251 6 0 3 [1;5] 0 [0;0]

Constipation CheckMate-066 Nivolumab 3mg/kg Q2W 206 median 3440 22 0 6 [4;9] 0 [0;0]

Constipation _ALL Nivolumab 3mg/kg Q2W 474 5691 28 0 5 [3;7] 0 [0;0]




N patients


N patients_months

N of AEs

N of grade

3-5 AEs


months [95%CI]


months [95%CI]

Constipation KEYNOTE-001 Pembrolizumab 10 mg/kg Q2W

57 median 627 2 0 3 [0;8] 0 [0;0]


278 median 2196 7 0 3 [1;6] 0 [0;0]

Constipation _ALL Pembrolizumab 10 mg/kg Q2W

335 2823 9 0 3 [1;5] 0 [0;0]


56 median 616 2 0 3 [0;8] 0 [0;0]

Constipation KEYNOTE-001 (randomized cohorts)


84 median 672 4 0 6 [0;12] 0 [0;0]


179 median 1790 9 0 5 [2;8] 0 [0;0]


319 3078 15 0 5 [2;7] 0 [0;0]


22 median 242 0 0 0 [0;0] 0 [0;0]

Constipation KEYNOTE-001 (randomized cohorts)


89 median 712 4 0 6 [0;11] 0 [0;0]


178 median 1780 5 0 3 [0;5] 0 [0;0]


289 2734 9 0 3 [1;5] 0 [0;0]

Cough CA-184-002 Ipilimumab 3 mg/kg Q3W 131 median 3642 21 0 6 [3;8] 0 [0;0]

Cough KEYNOTE-006 Ipilimumab 3 mg/kg Q3W 256 median 2022 0 0 0 [0;0] 0 [0;0]




N patients


N patients_months

N of AEs

N of grade

3-5 AEs


months [95%CI]


months [95%CI]

Cough _ALL Ipilimumab 3 mg/kg Q3W 387 5664 21 0 4 [2;5] 0 [0;0]

Cough CheckMate-066 Nivolumab 3mg/kg Q2W 206 median 3440 6 0 2 [0;3] 0 [0;0]

Cough _ALL Nivolumab 3mg/kg Q2W 206 3440 6 0 2 [0;3] 0 [0;0]

Cough KEYNOTE-001 Pembrolizumab 10 mg/kg Q2W

57 median 627 6 0 10 [2;17] 0 [0;0]


278 median 2196 10 0 5 [2;7] 0 [0;0]

Cough _ALL Pembrolizumab 10 mg/kg Q2W

335 2823 16 0 6 [3;8] 0 [0;0]


56 median 616 3 0 5 [0;10] 0 [0;0]

Cough KEYNOTE-001 (randomized cohorts)


84 median 672 6 0 9 [2;16] 0 [0;0]


140 1288 9 0 7 [2;12] 0 [0;0]


22 median 242 2 0 8 [0;20] 0 [0;0]

Cough KEYNOTE-001 (randomized cohorts)


89 median 712 8 0 11 [3;19] 0 [0;0]


111 954 10 0 10 [4;17] 0 [0;0]

Decrease in serum corticotropin

CA-184-002 Ipilimumab 3 mg/kg Q3W 131 median 3642 2 0 1 [0;1] 0 [0;0]




N patients


N patients_months

N of AEs

N of grade

3-5 AEs


months [95%CI]


months [95%CI]

Decrease in serum corticotropin


Decreased appetite CheckMate-067 Ipilimumab 3 mg/Kg + Nivolumab 1 mg/kg

313 minimum 3819 56 4 15 [11;19] 1 [0;2]

Decreased appetite CheckMate-069 Ipilimumab 3 mg/Kg + Nivolumab 1 mg/kg

94 minimum 1034 14 0 14 [6;21] 0 [0;0]

Decreased appetite _ALL Ipilimumab 3 mg/Kg + Nivolumab 1 mg/kg

407 4853 70 4 14 [11;18] 1 [0;2]

Decreased appetite CA-184-002 Ipilimumab 3 mg/kg Q3W 131 median 3642 35 2 10 [6;13] 1 [0;1]

Decreased appetite CheckMate-067 Ipilimumab 3 mg/kg Q3W 311 minimum 3794 39 1 10 [7;14] 0 [0;1]

Decreased appetite CheckMate-069 Ipilimumab 3 mg/kg Q3W 46 minimum 506 4 0 8 [0;16] 0 [0;0]

Decreased appetite KEYNOTE-006 Ipilimumab 3 mg/kg Q3W 256 median 2022 20 0 10 [6;14] 0 [0;0]

Decreased appetite _ALL Ipilimumab 3 mg/kg Q3W 744 9964 98 3 10 [8;12] 0 [0;1]

Decreased appetite CheckMate-037 Nivolumab 3mg/kg Q2W 268 median 2251 14 0 6 [3;9] 0 [0;0]



Decreased appetite _ALL Nivolumab 3mg/kg Q2W 787 9604 59 0 6 [5;8] 0 [0;0]

Decreased appetite KEYNOTE-001 Pembrolizumab 10 mg/kg Q2W

57 median 627 5 1 8 [1;15] 2 [0;5]


278 median 2196 17 0 8 [4;11] 0 [0;0]




N patients


N patients_months

N of AEs

N of grade

3-5 AEs


months [95%CI]


months [95%CI]

Decreased appetite _ALL Pembrolizumab 10 mg/kg Q2W

335 2823 22 1 8 [5;11] 0 [0;1]


56 median 616 0 0 0 [0;0] 0 [0;0]

Decreased appetite KEYNOTE-001 (randomized cohorts)


84 median 672 5 0 7 [1;14] 0 [0;0]


179 median 1790 17 2 9 [5;14] 1 [0;3]


319 3078 22 2 7 [4;10] 1 [0;2]


22 median 242 1 0 4 [0;12] 0 [0;0]

Decreased appetite KEYNOTE-001 (randomized cohorts)


89 median 712 8 0 11 [3;19] 0 [0;0]


178 median 1780 8 0 4 [1;8] 0 [0;0]


289 2734 17 0 6 [3;9] 0 [0;0]

Dehydration KEYNOTE-001 Pembrolizumab 10 mg/kg Q2W

57 median 627 2 0 3 [0;8] 0 [0;0]

Dehydration _ALL Pembrolizumab 10 mg/kg Q2W

57 627 2 0 3 [0;8] 0 [0;0]


56 median 616 0 0 0 [0;0] 0 [0;0]




N patients


N patients_months

N of AEs

N of grade

3-5 AEs


months [95%CI]


months [95%CI]

Dehydration KEYNOTE-001 (randomized cohorts)


84 median 672 1 0 1 [0;4] 0 [0;0]


140 1288 1 0 1 [0;2] 0 [0;0]


22 median 242 0 0 0 [0;0] 0 [0;0]

Dehydration KEYNOTE-001 (randomized cohorts)


89 median 712 1 0 1 [0;4] 0 [0;0]


111 954 1 0 1 [0;3] 0 [0;0]

Dermatitis KEYNOTE-006 Ipilimumab 3 mg/kg Q3W 256 median 2022 1 0 0 [0;1] 0 [0;0]

Dermatitis _ALL Ipilimumab 3 mg/kg Q3W 256 2022 1 0 0 [0;1] 0 [0;0]

Dermatitis CheckMate-037 Nivolumab 3mg/kg Q2W 268 median 2251 5 0 2 [0;4] 0 [0;0]

Dermatitis _ALL Nivolumab 3mg/kg Q2W 268 2251 5 0 2 [0;4] 0 [0;0]

Dermatitis KEYNOTE-006 Pembrolizumab 10 mg/kg Q2W

278 median 2196 3 0 1 [0;3] 0 [0;0]

Dermatitis _ALL Pembrolizumab 10 mg/kg Q2W

278 2196 3 0 1 [0;3] 0 [0;0]

Diabetes mellitus CheckMate-066 Nivolumab 3mg/kg Q2W 206 median 3440 1 0 0 [0;1] 0 [0;0]

Diabetes mellitus _ALL Nivolumab 3mg/kg Q2W 206 3440 1 0 0 [0;1] 0 [0;0]

Diarrhea CheckMate-067 Ipilimumab 3 mg/Kg + Nivolumab 1 mg/kg

313 minimum 3819 138 29 36 [30;42] 8 [5;10]




N patients


N patients_months

N of AEs

N of grade

3-5 AEs


months [95%CI]


months [95%CI]

Diarrhea CheckMate-069 Ipilimumab 3 mg/Kg + Nivolumab 1 mg/kg

94 minimum 1034 42 10 41 [28;53] 10 [4;16]

Diarrhea _ALL Ipilimumab 3 mg/Kg + Nivolumab 1 mg/kg

407 4853 180 39 37 [32;43] 8 [6;11]

Diarrhea CA-184-002 Ipilimumab 3 mg/kg Q3W 131 median 3642 43 7 12 [8;15] 2 [0;3]

Diarrhea CheckMate-067 Ipilimumab 3 mg/kg Q3W 311 minimum 3794 103 19 27 [22;32] 5 [3;7]

Diarrhea CheckMate-069 Ipilimumab 3 mg/kg Q3W 46 minimum 506 17 5 34 [18;50] 10 [1;19]

Diarrhea KEYNOTE-006 Ipilimumab 3 mg/kg Q3W 256 median 2022 58 8 29 [21;36] 4 [1;7]

Diarrhea _ALL Ipilimumab 3 mg/kg Q3W 744 9964 221 39 22 [19;25] 4 [3;5]

Diarrhea CheckMate-037 Nivolumab 3mg/kg Q2W 268 median 2251 30 1 13 [9;18] 0 [0;1]



Diarrhea _ALL Nivolumab 3mg/kg Q2W 787 9604 123 10 13 [11;15] 1 [0;2]

Diarrhea KEYNOTE-001 Pembrolizumab 10 mg/kg Q2W

57 median 627 12 1 19 [8;30] 2 [0;5]


278 median 2196 47 7 21 [15;28] 3 [1;6]

Diarrhea _ALL Pembrolizumab 10 mg/kg Q2W

335 2823 59 8 21 [16;26] 3 [1;5]


56 median 616 9 0 15 [5;24] 0 [0;0]




N patients


N patients_months

N of AEs

N of grade

3-5 AEs


months [95%CI]


months [95%CI]

Diarrhea KEYNOTE-001 (randomized cohorts)


84 median 672 12 1 18 [8;28] 1 [0;4]


179 median 1790 19 2 11 [6;15] 1 [0;3]


319 3078 40 3 13 [9;17] 1 [0;2]


22 median 242 6 0 25 [5;45] 0 [0;0]

Diarrhea KEYNOTE-001 (randomized cohorts)


89 median 712 10 0 14 [5;23] 0 [0;0]


178 median 1780 15 0 8 [4;13] 0 [0;0]


289 2734 31 0 11 [7;15] 0 [0;0]

Diverticulitis KEYNOTE-001 Pembrolizumab 10 mg/kg Q2W

57 median 627 1 0 2 [0;5] 0 [0;0]

Diverticulitis _ALL Pembrolizumab 10 mg/kg Q2W

57 627 1 0 2 [0;5] 0 [0;0]


56 median 616 1 0 2 [0;5] 0 [0;0]


56 616 1 0 2 [0;5] 0 [0;0]


22 median 242 0 0 0 [0;0] 0 [0;0]




N patients


N patients_months

N of AEs

N of grade

3-5 AEs


months [95%CI]


months [95%CI]


22 242 0 0 0 [0;0] 0 [0;0]

Dizziness KEYNOTE-006 Ipilimumab 3 mg/kg Q3W 256 median 2022 2 0 1 [0;2] 0 [0;0]

Dizziness _ALL Ipilimumab 3 mg/kg Q3W 256 2022 2 0 1 [0;2] 0 [0;0]

Dizziness KEYNOTE-001 Pembrolizumab 10 mg/kg Q2W

57 median 627 2 0 3 [0;8] 0 [0;0]


278 median 2196 8 0 4 [1;6] 0 [0;0]

Dizziness _ALL Pembrolizumab 10 mg/kg Q2W

335 2823 10 0 4 [1;6] 0 [0;0]


56 median 616 1 0 2 [0;5] 0 [0;0]

Dizziness KEYNOTE-001 (randomized cohorts)


84 median 672 0 0 0 [0;0] 0 [0;0]


140 1288 1 0 1 [0;2] 0 [0;0]


22 median 242 0 0 0 [0;0] 0 [0;0]

Dizziness KEYNOTE-001 (randomized cohorts)


89 median 712 2 0 3 [0;7] 0 [0;0]


111 954 2 0 2 [0;5] 0 [0;0]

Dry eye KEYNOTE-001 Pembrolizumab 10 mg/kg Q2W

57 median 627 4 0 6 [0;13] 0 [0;0]




N patients


N patients_months

N of AEs

N of grade

3-5 AEs


months [95%CI]


months [95%CI]

Dry eye _ALL Pembrolizumab 10 mg/kg Q2W

57 627 4 0 6 [0;13] 0 [0;0]


56 median 616 0 0 0 [0;0] 0 [0;0]

Dry eye KEYNOTE-001 (randomized cohorts)


84 median 672 0 0 0 [0;0] 0 [0;0]


140 1288 0 0 0 [0;0] 0 [0;0]


22 median 242 0 0 0 [0;0] 0 [0;0]

Dry eye KEYNOTE-001 (randomized cohorts)


89 median 712 2 0 3 [0;7] 0 [0;0]


111 954 2 0 2 [0;5] 0 [0;0]

Dry mouth KEYNOTE-006 Ipilimumab 3 mg/kg Q3W 256 median 2022 1 0 0 [0;1] 0 [0;0]

Dry mouth _ALL Ipilimumab 3 mg/kg Q3W 256 2022 1 0 0 [0;1] 0 [0;0]

Dry mouth KEYNOTE-001 Pembrolizumab 10 mg/kg Q2W

57 median 627 3 0 5 [0;10] 0 [0;0]


278 median 2196 20 0 9 [5;13] 0 [0;0]

Dry mouth _ALL Pembrolizumab 10 mg/kg Q2W

335 2823 23 0 8 [5;11] 0 [0;0]


56 median 616 1 0 2 [0;5] 0 [0;0]




N patients


N patients_months

N of AEs

N of grade

3-5 AEs


months [95%CI]


months [95%CI]

Dry mouth KEYNOTE-001 (randomized cohorts)


84 median 672 2 0 3 [0;7] 0 [0;0]


140 1288 3 0 2 [0;5] 0 [0;0]


22 median 242 0 0 0 [0;0] 0 [0;0]

Dry mouth KEYNOTE-001 (randomized cohorts)


89 median 712 0 0 0 [0;0] 0 [0;0]


111 954 0 0 0 [0;0] 0 [0;0]

Dry skin KEYNOTE-006 Ipilimumab 3 mg/kg Q3W 256 median 2022 3 0 1 [0;3] 0 [0;0]

Dry skin _ALL Ipilimumab 3 mg/kg Q3W 256 2022 3 0 1 [0;3] 0 [0;0]

Dry skin CheckMate-066 Nivolumab 3mg/kg Q2W 206 median 3440 9 0 3 [1;4] 0 [0;0]

Dry skin _ALL Nivolumab 3mg/kg Q2W 206 3440 9 0 3 [1;4] 0 [0;0]

Dry skin KEYNOTE-006 Pembrolizumab 10 mg/kg Q2W

278 median 2196 6 0 3 [1;5] 0 [0;0]

Dry skin _ALL Pembrolizumab 10 mg/kg Q2W

278 2196 6 0 3 [1;5] 0 [0;0]

Dry skin KEYNOTE-001 (randomized cohorts)


84 median 672 0 0 0 [0;0] 0 [0;0]


179 median 1790 9 0 5 [2;8] 0 [0;0]




N patients


N patients_months

N of AEs

N of grade

3-5 AEs


months [95%CI]


months [95%CI]


263 2462 9 0 4 [1;6] 0 [0;0]

Dry skin KEYNOTE-001 (randomized cohorts)


89 median 712 2 0 3 [0;7] 0 [0;0]


178 median 1780 9 0 5 [2;8] 0 [0;0]


267 2492 11 0 4 [2;7] 0 [0;0]

Dysgueusia KEYNOTE-006 Ipilimumab 3 mg/kg Q3W 256 median 2022 3 0 1 [0;3] 0 [0;0]

Dysgueusia _ALL Ipilimumab 3 mg/kg Q3W 256 2022 3 0 1 [0;3] 0 [0;0]

Dysgueusia CheckMate-066 Nivolumab 3mg/kg Q2W 206 median 3440 6 0 2 [0;3] 0 [0;0]

Dysgueusia _ALL Nivolumab 3mg/kg Q2W 206 3440 6 0 2 [0;3] 0 [0;0]

Dysgueusia KEYNOTE-001 Pembrolizumab 10 mg/kg Q2W

57 median 627 0 0 0 [0;0] 0 [0;0]


278 median 2196 10 0 5 [2;7] 0 [0;0]

Dysgueusia _ALL Pembrolizumab 10 mg/kg Q2W

335 2823 10 0 4 [1;6] 0 [0;0]


56 median 616 1 0 2 [0;5] 0 [0;0]


56 616 1 0 2 [0;5] 0 [0;0]




N patients


N patients_months

N of AEs

N of grade

3-5 AEs


months [95%CI]


months [95%CI]


22 median 242 1 0 4 [0;12] 0 [0;0]


22 242 1 0 4 [0;12] 0 [0;0]

Dyspepsia KEYNOTE-006 Ipilimumab 3 mg/kg Q3W 256 median 2022 1 0 0 [0;1] 0 [0;0]

Dyspepsia _ALL Ipilimumab 3 mg/kg Q3W 256 2022 1 0 0 [0;1] 0 [0;0]

Dyspepsia KEYNOTE-006 Pembrolizumab 10 mg/kg Q2W

278 median 2196 4 0 2 [0;4] 0 [0;0]

Dyspepsia _ALL Pembrolizumab 10 mg/kg Q2W

278 2196 4 0 2 [0;4] 0 [0;0]

Dyspnea CheckMate-067 Ipilimumab 3 mg/Kg + Nivolumab 1 mg/kg

313 minimum 3819 32 2 8 [5;11] 1 [0;1]

Dyspnea CheckMate-069 Ipilimumab 3 mg/Kg + Nivolumab 1 mg/kg

94 minimum 1034 9 3 9 [3;14] 3 [0;6]

Dyspnea _ALL Ipilimumab 3 mg/Kg + Nivolumab 1 mg/kg

407 4853 41 5 8 [6;11] 1 [0;2]

Dyspnea CA-184-002 Ipilimumab 3 mg/kg Q3W 131 median 3642 19 5 5 [3;8] 1 [0;3]

Dyspnea CheckMate-067 Ipilimumab 3 mg/kg Q3W 311 minimum 3794 13 0 3 [2;5] 0 [0;0]

Dyspnea CheckMate-069 Ipilimumab 3 mg/kg Q3W 46 minimum 506 5 0 10 [1;19] 0 [0;0]

Dyspnea KEYNOTE-006 Ipilimumab 3 mg/kg Q3W 256 median 2022 3 1 1 [0;3] 0 [0;1]

Dyspnea _ALL Ipilimumab 3 mg/kg Q3W 744 9964 40 6 4 [3;5] 1 [0;1]

Dyspnea CheckMate-067 Nivolumab 3mg/kg Q2W 313 median 3913 14 1 4 [2;5] 0 [0;1]




N patients


N patients_months

N of AEs

N of grade

3-5 AEs


months [95%CI]


months [95%CI]

Dyspnea _ALL Nivolumab 3mg/kg Q2W 313 3913 14 1 4 [2;5] 0 [0;1]

Dyspnea KEYNOTE-001 Pembrolizumab 10 mg/kg Q2W

57 median 627 5 0 8 [1;15] 0 [0;0]


278 median 2196 4 0 2 [0;4] 0 [0;0]

Dyspnea _ALL Pembrolizumab 10 mg/kg Q2W

335 2823 9 0 3 [1;5] 0 [0;0]


56 median 616 0 0 0 [0;0] 0 [0;0]

Dyspnea KEYNOTE-001 (randomized cohorts)


84 median 672 7 1 10 [3;18] 1 [0;4]


140 1288 7 1 5 [1;9] 1 [0;2]


22 median 242 1 0 4 [0;12] 0 [0;0]

Dyspnea KEYNOTE-001 (randomized cohorts)


89 median 712 7 0 10 [3;17] 0 [0;0]


111 954 8 0 8 [3;14] 0 [0;0]

Dyspnea exertional KEYNOTE-001 (randomized cohorts)


84 median 672 1 0 1 [0;4] 0 [0;0]

Dyspnea exertional _ALL Pembrolizumab 10 mg/kg Q3W

84 672 1 0 1 [0;4] 0 [0;0]




N patients


N patients_months

N of AEs

N of grade

3-5 AEs


months [95%CI]


months [95%CI]

Dyspnea exertional KEYNOTE-001 (randomized cohorts)


89 median 712 1 0 1 [0;4] 0 [0;0]

Dyspnea exertional _ALL Pembrolizumab 2 mg/kg Q3W

89 712 1 0 1 [0;4] 0 [0;0]

Eczema KEYNOTE-006 Ipilimumab 3 mg/kg Q3W 256 median 2022 1 0 0 [0;1] 0 [0;0]

Eczema _ALL Ipilimumab 3 mg/kg Q3W 256 2022 1 0 0 [0;1] 0 [0;0]

Eczema CheckMate-066 Nivolumab 3mg/kg Q2W 206 median 3440 5 0 1 [0;3] 0 [0;0]

Eczema _ALL Nivolumab 3mg/kg Q2W 206 3440 5 0 1 [0;3] 0 [0;0]

Eczema KEYNOTE-001 Pembrolizumab 10 mg/kg Q2W

57 median 627 3 0 5 [0;10] 0 [0;0]


278 median 2196 4 0 2 [0;4] 0 [0;0]

Eczema _ALL Pembrolizumab 10 mg/kg Q2W

335 2823 7 0 2 [1;4] 0 [0;0]


56 median 616 0 0 0 [0;0] 0 [0;0]


56 616 0 0 0 [0;0] 0 [0;0]


22 median 242 0 0 0 [0;0] 0 [0;0]


22 242 0 0 0 [0;0] 0 [0;0]

Eosinophilia KEYNOTE-006 Ipilimumab 3 mg/kg Q3W 256 median 2022 2 0 1 [0;2] 0 [0;0]




N patients


N patients_months

N of AEs

N of grade

3-5 AEs


months [95%CI]


months [95%CI]

Eosinophilia _ALL Ipilimumab 3 mg/kg Q3W 256 2022 2 0 1 [0;2] 0 [0;0]

Eosinophilia KEYNOTE-006 Pembrolizumab 10 mg/kg Q2W

278 median 2196 0 0 0 [0;0] 0 [0;0]

Eosinophilia _ALL Pembrolizumab 10 mg/kg Q2W

278 2196 0 0 0 [0;0] 0 [0;0]

Erythema CheckMate-069 Ipilimumab 3 mg/Kg + Nivolumab 1 mg/kg

94 minimum 1034 6 0 6 [1;10] 0 [0;0]

Erythema _ALL Ipilimumab 3 mg/Kg + Nivolumab 1 mg/kg

94 1034 6 0 6 [1;10] 0 [0;0]

Erythema CheckMate-069 Ipilimumab 3 mg/kg Q3W 46 minimum 506 0 0 0 [0;0] 0 [0;0]

Erythema KEYNOTE-006 Ipilimumab 3 mg/kg Q3W 256 median 2022 5 0 2 [0;5] 0 [0;0]

Erythema _ALL Ipilimumab 3 mg/kg Q3W 302 2528 5 0 2 [0;4] 0 [0;0]

Erythema CheckMate-066 Nivolumab 3mg/kg Q2W 206 median 3440 13 0 4 [2;6] 0 [0;0]

Erythema _ALL Nivolumab 3mg/kg Q2W 206 3440 13 0 4 [2;6] 0 [0;0]

Erythema KEYNOTE-001 Pembrolizumab 10 mg/kg Q2W

57 median 627 1 0 2 [0;5] 0 [0;0]


278 median 2196 8 0 4 [1;6] 0 [0;0]

Erythema _ALL Pembrolizumab 10 mg/kg Q2W

335 2823 9 0 3 [1;5] 0 [0;0]


56 median 616 0 0 0 [0;0] 0 [0;0]




N patients


N patients_months

N of AEs

N of grade

3-5 AEs


months [95%CI]


months [95%CI]

Erythema KEYNOTE-001 (randomized cohorts)


84 median 672 2 0 3 [0;7] 0 [0;0]


140 1288 2 0 2 [0;4] 0 [0;0]


22 median 242 1 0 4 [0;12] 0 [0;0]

Erythema KEYNOTE-001 (randomized cohorts)


89 median 712 4 0 6 [0;11] 0 [0;0]


111 954 5 0 5 [1;10] 0 [0;0]

Face oedema KEYNOTE-001 (randomized cohorts)


84 median 672 1 0 1 [0;4] 0 [0;0]

Face oedema _ALL Pembrolizumab 10 mg/kg Q3W

84 672 1 0 1 [0;4] 0 [0;0]

Face oedema KEYNOTE-001 (randomized cohorts)


89 median 712 2 0 3 [0;7] 0 [0;0]

Face oedema _ALL Pembrolizumab 2 mg/kg Q3W

89 712 2 0 3 [0;7] 0 [0;0]

Fatigue CheckMate-067 Ipilimumab 3 mg/Kg + Nivolumab 1 mg/kg

313 minimum 3819 110 13 29 [23;34] 3 [2;5]

Fatigue CheckMate-069 Ipilimumab 3 mg/Kg + Nivolumab 1 mg/kg

94 minimum 1034 37 5 36 [24;47] 5 [1;9]

Fatigue _ALL Ipilimumab 3 mg/Kg + Nivolumab 1 mg/kg

407 4853 147 18 30 [25;35] 4 [2;5]




N patients


N patients_months

N of AEs

N of grade

3-5 AEs


months [95%CI]


months [95%CI]

Fatigue CA-184-002 Ipilimumab 3 mg/kg Q3W 131 median 3642 55 9 15 [11;19] 2 [1;4]

Fatigue CheckMate-067 Ipilimumab 3 mg/kg Q3W 311 minimum 3794 87 3 23 [18;28] 1 [0;2]

Fatigue CheckMate-069 Ipilimumab 3 mg/kg Q3W 46 minimum 506 20 0 40 [22;57] 0 [0;0]

Fatigue KEYNOTE-006 Ipilimumab 3 mg/kg Q3W 256 median 2022 39 3 19 [13;25] 1 [0;3]

Fatigue _ALL Ipilimumab 3 mg/kg Q3W 744 9964 201 15 20 [17;23] 2 [1;2]

Fatigue CheckMate-037 Nivolumab 3mg/kg Q2W 268 median 2251 65 2 29 [22;36] 1 [0;2]



Fatigue _ALL Nivolumab 3mg/kg Q2W 787 9604 213 6 22 [19;25] 1 [0;1]

Fatigue KEYNOTE-001 Pembrolizumab 10 mg/kg Q2W

57 median 627 26 2 41 [26;57] 3 [0;8]


278 median 2196 58 0 26 [20;33] 0 [0;0]

Fatigue _ALL Pembrolizumab 10 mg/kg Q2W

335 2823 84 2 30 [23;36] 1 [0;2]


56 median 616 13 0 21 [10;33] 0 [0;0]

Fatigue KEYNOTE-001 (randomized cohorts)


84 median 672 31 0 46 [30;62] 0 [0;0]


179 median 1790 52 1 29 [21;37] 1 [0;2]




N patients


N patients_months

N of AEs

N of grade

3-5 AEs


months [95%CI]


months [95%CI]


319 3078 96 1 31 [25;37] 0 [0;1]


22 median 242 2 0 8 [0;20] 0 [0;0]

Fatigue KEYNOTE-001 (randomized cohorts)


89 median 712 29 5 41 [26;56] 7 [1;13]


178 median 1780 40 2 22 [16;29] 1 [0;3]


289 2734 71 7 26 [20;32] 3 [1;4]

Flatulence KEYNOTE-006 Ipilimumab 3 mg/kg Q3W 256 median 2022 4 0 2 [0;4] 0 [0;0]

Flatulence _ALL Ipilimumab 3 mg/kg Q3W 256 2022 4 0 2 [0;4] 0 [0;0]

Flatulence KEYNOTE-006 Pembrolizumab 10 mg/kg Q2W

278 median 2196 1 0 0 [0;1] 0 [0;0]

Flatulence _ALL Pembrolizumab 10 mg/kg Q2W

278 2196 1 0 0 [0;1] 0 [0;0]

Flushing KEYNOTE-006 Ipilimumab 3 mg/kg Q3W 256 median 2022 2 0 1 [0;2] 0 [0;0]

Flushing _ALL Ipilimumab 3 mg/kg Q3W 256 2022 2 0 1 [0;2] 0 [0;0]

Flushing CheckMate-066 Nivolumab 3mg/kg Q2W 206 median 3440 1 0 0 [0;1] 0 [0;0]

Flushing _ALL Nivolumab 3mg/kg Q2W 206 3440 1 0 0 [0;1] 0 [0;0]

Flushing KEYNOTE-006 Pembrolizumab 10 mg/kg Q2W

278 median 2196 3 0 1 [0;3] 0 [0;0]




N patients


N patients_months

N of AEs

N of grade

3-5 AEs


months [95%CI]


months [95%CI]

Flushing _ALL Pembrolizumab 10 mg/kg Q2W

278 2196 3 0 1 [0;3] 0 [0;0]

Frequent bowel movements





CheckMate-066 Nivolumab 3mg/kg Q2W 206 median 3440 2 0 1 [0;1] 0 [0;0]


_ALL Nivolumab 3mg/kg Q2W 206 3440 2 0 1 [0;1] 0 [0;0]



278 median 2196 0 0 0 [0;0] 0 [0;0]



278 2196 0 0 0 [0;0] 0 [0;0]

Gastro-oesophageal reflux KEYNOTE-001 (randomized cohorts)


84 median 672 0 0 0 [0;0] 0 [0;0]

Gastro-oesophageal reflux _ALL Pembrolizumab 10 mg/kg Q3W

84 672 0 0 0 [0;0] 0 [0;0]

Gastro-oesophageal reflux KEYNOTE-001 (randomized cohorts)


89 median 712 3 0 4 [0;9] 0 [0;0]

Gastro-oesophageal reflux _ALL Pembrolizumab 2 mg/kg Q3W

89 712 3 0 4 [0;9] 0 [0;0]

Hair color changes KEYNOTE-006 Ipilimumab 3 mg/kg Q3W 256 median 2022 0 0 0 [0;0] 0 [0;0]

Hair color changes _ALL Ipilimumab 3 mg/kg Q3W 256 2022 0 0 0 [0;0] 0 [0;0]




N patients


N patients_months

N of AEs

N of grade

3-5 AEs


months [95%CI]


months [95%CI]

Hair color changes KEYNOTE-001 Pembrolizumab 10 mg/kg Q2W

57 median 627 2 0 3 [0;8] 0 [0;0]


278 median 2196 4 0 2 [0;4] 0 [0;0]

Hair color changes _ALL Pembrolizumab 10 mg/kg Q2W

335 2823 6 0 2 [0;4] 0 [0;0]


56 median 616 0 0 0 [0;0] 0 [0;0]


56 616 0 0 0 [0;0] 0 [0;0]


22 median 242 0 0 0 [0;0] 0 [0;0]


22 242 0 0 0 [0;0] 0 [0;0]

Headache CheckMate-067 Ipilimumab 3 mg/Kg + Nivolumab 1 mg/kg

313 minimum 3819 32 1 8 [5;11] 0 [0;1]

Headache CheckMate-069 Ipilimumab 3 mg/Kg + Nivolumab 1 mg/kg

94 minimum 1034 13 2 13 [6;19] 2 [0;5]

Headache _ALL Ipilimumab 3 mg/Kg + Nivolumab 1 mg/kg

407 4853 45 3 9 [7;12] 1 [0;1]

Headache CA-184-002 Ipilimumab 3 mg/kg Q3W 131 median 3642 19 3 5 [3;8] 1 [0;2]

Headache CheckMate-067 Ipilimumab 3 mg/kg Q3W 311 minimum 3794 13 0 3 [2;5] 0 [0;0]

Headache CheckMate-069 Ipilimumab 3 mg/kg Q3W 46 minimum 506 5 0 10 [1;19] 0 [0;0]




N patients


N patients_months

N of AEs

N of grade

3-5 AEs


months [95%CI]


months [95%CI]

Headache KEYNOTE-006 Ipilimumab 3 mg/kg Q3W 256 median 2022 9 0 4 [2;7] 0 [0;0]

Headache _ALL Ipilimumab 3 mg/kg Q3W 744 9964 46 3 5 [3;6] 0 [0;1]

Headache CheckMate-066 Nivolumab 3mg/kg Q2W 206 median 3440 9 0 3 [1;4] 0 [0;0]

Headache CheckMate-067 Nivolumab 3mg/kg Q2W 313 median 3913 23 0 6 [3;8] 0 [0;0]

Headache _ALL Nivolumab 3mg/kg Q2W 519 7353 32 0 4 [3;6] 0 [0;0]

Headache KEYNOTE-001 Pembrolizumab 10 mg/kg Q2W

57 median 627 10 0 16 [6;26] 0 [0;0]


278 median 2196 9 0 4 [1;7] 0 [0;0]

Headache _ALL Pembrolizumab 10 mg/kg Q2W

335 2823 19 0 7 [4;10] 0 [0;0]


56 median 616 3 0 5 [0;10] 0 [0;0]

Headache KEYNOTE-001 (randomized cohorts)


84 median 672 3 0 4 [0;10] 0 [0;0]


140 1288 6 0 5 [1;8] 0 [0;0]


22 median 242 1 0 4 [0;12] 0 [0;0]

Headache KEYNOTE-001 (randomized cohorts)


89 median 712 4 0 6 [0;11] 0 [0;0]


111 954 5 0 5 [1;10] 0 [0;0]




N patients


N patients_months

N of AEs

N of grade

3-5 AEs


months [95%CI]


months [95%CI]

Hepatitis CheckMate-069 Ipilimumab 3 mg/Kg + Nivolumab 1 mg/kg

94 minimum 1034 3 3 3 [0;6] 3 [0;6]

Hepatitis _ALL Ipilimumab 3 mg/Kg + Nivolumab 1 mg/kg

94 1034 3 3 3 [0;6] 3 [0;6]

Hepatitis CA-184-002 Ipilimumab 3 mg/kg Q3W 131 median 3642 1 0 0 [0;1] 0 [0;0]

Hepatitis CheckMate-069 Ipilimumab 3 mg/kg Q3W 46 minimum 506 0 0 0 [0;0] 0 [0;0]

Hepatitis _ALL Ipilimumab 3 mg/kg Q3W 177 4148 1 0 0 [0;1] 0 [0;0]

Hepatocellular injury KEYNOTE-006 Ipilimumab 3 mg/kg Q3W 256 median 2022 3 2 1 [0;3] 1 [0;2]

Hepatocellular injury _ALL Ipilimumab 3 mg/kg Q3W 256 2022 3 2 1 [0;3] 1 [0;2]

Hepatocellular injury KEYNOTE-006 Pembrolizumab 10 mg/kg Q2W

278 median 2196 0 0 0 [0;0] 0 [0;0]

Hepatocellular injury _ALL Pembrolizumab 10 mg/kg Q2W

278 2196 0 0 0 [0;0] 0 [0;0]

Hot flush KEYNOTE-006 Ipilimumab 3 mg/kg Q3W 256 median 2022 1 0 0 [0;1] 0 [0;0]

Hot flush _ALL Ipilimumab 3 mg/kg Q3W 256 2022 1 0 0 [0;1] 0 [0;0]

Hot flush CheckMate-066 Nivolumab 3mg/kg Q2W 206 median 3440 3 0 1 [0;2] 0 [0;0]

Hot flush _ALL Nivolumab 3mg/kg Q2W 206 3440 3 0 1 [0;2] 0 [0;0]

Hot flush KEYNOTE-001 Pembrolizumab 10 mg/kg Q2W

57 median 627 2 0 3 [0;8] 0 [0;0]


278 median 2196 3 0 1 [0;3] 0 [0;0]




N patients


N patients_months

N of AEs

N of grade

3-5 AEs


months [95%CI]


months [95%CI]

Hot flush _ALL Pembrolizumab 10 mg/kg Q2W

335 2823 5 0 2 [0;3] 0 [0;0]


56 median 616 1 0 2 [0;5] 0 [0;0]


56 616 1 0 2 [0;5] 0 [0;0]


22 median 242 0 0 0 [0;0] 0 [0;0]


22 242 0 0 0 [0;0] 0 [0;0]

Hyperglycemia KEYNOTE-001 Pembrolizumab 10 mg/kg Q2W

57 median 627 1 0 2 [0;5] 0 [0;0]

Hyperglycemia _ALL Pembrolizumab 10 mg/kg Q2W

57 627 1 0 2 [0;5] 0 [0;0]


56 median 616 0 0 0 [0;0] 0 [0;0]


56 616 0 0 0 [0;0] 0 [0;0]


22 median 242 1 0 4 [0;12] 0 [0;0]


22 242 1 0 4 [0;12] 0 [0;0]

Hyperhidrosis CheckMate-066 Nivolumab 3mg/kg Q2W 206 median 3440 2 0 1 [0;1] 0 [0;0]

Hyperhidrosis _ALL Nivolumab 3mg/kg Q2W 206 3440 2 0 1 [0;1] 0 [0;0]




N patients


N patients_months

N of AEs

N of grade

3-5 AEs


months [95%CI]


months [95%CI]

Hypersensitivity KEYNOTE-006 Ipilimumab 3 mg/kg Q3W 256 median 2022 2 0 1 [0;2] 0 [0;0]

Hypersensitivity _ALL Ipilimumab 3 mg/kg Q3W 256 2022 2 0 1 [0;2] 0 [0;0]

Hypersensitivity CheckMate-037 Nivolumab 3mg/kg Q2W 268 median 2251 2 0 1 [0;2] 0 [0;0]

Hypersensitivity CheckMate-066 Nivolumab 3mg/kg Q2W 206 median 3440 6 0 2 [0;3] 0 [0;0]

Hypersensitivity _ALL Nivolumab 3mg/kg Q2W 474 5691 8 0 1 [0;2] 0 [0;0]

Hypersensitivity KEYNOTE-006 Pembrolizumab 10 mg/kg Q2W

278 median 2196 2 0 1 [0;2] 0 [0;0]

Hypersensitivity _ALL Pembrolizumab 10 mg/kg Q2W

278 2196 2 0 1 [0;2] 0 [0;0]

Hypertension KEYNOTE-006 Ipilimumab 3 mg/kg Q3W 256 median 2022 0 0 0 [0;0] 0 [0;0]

Hypertension _ALL Ipilimumab 3 mg/kg Q3W 256 2022 0 0 0 [0;0] 0 [0;0]

Hypertension KEYNOTE-006 Pembrolizumab 10 mg/kg Q2W

278 median 2196 3 2 1 [0;3] 1 [0;2]

Hypertension _ALL Pembrolizumab 10 mg/kg Q2W

278 2196 3 2 1 [0;3] 1 [0;2]

Hyperthyroidism CheckMate-067 Ipilimumab 3 mg/Kg + Nivolumab 1 mg/kg

313 minimum 3819 31 3 8 [5;11] 1 [0;2]

Hyperthyroidism CheckMate-069 Ipilimumab 3 mg/Kg + Nivolumab 1 mg/kg

94 minimum 1034 4 0 4 [0;8] 0 [0;0]

Hyperthyroidism _ALL Ipilimumab 3 mg/Kg + Nivolumab 1 mg/kg

407 4853 35 3 7 [5;10] 1 [0;1]

Hyperthyroidism CheckMate-067 Ipilimumab 3 mg/kg Q3W 311 minimum 3794 3 0 1 [0;2] 0 [0;0]




N patients


N patients_months

N of AEs

N of grade

3-5 AEs


months [95%CI]


months [95%CI]

Hyperthyroidism CheckMate-069 Ipilimumab 3 mg/kg Q3W 46 minimum 506 0 0 0 [0;0] 0 [0;0]

Hyperthyroidism KEYNOTE-006 Ipilimumab 3 mg/kg Q3W 256 median 2022 6 1 3 [1;5] 0 [0;1]

Hyperthyroidism _ALL Ipilimumab 3 mg/kg Q3W 613 6323 9 1 1 [0;2] 0 [0;0]

Hyperthyroidism CheckMate-037 Nivolumab 3mg/kg Q2W 268 median 2251 5 0 2 [0;4] 0 [0;0]

Hyperthyroidism CheckMate-066 Nivolumab 3mg/kg Q2W 206 median 3440 7 1 2 [1;4] 0 [0;1]

Hyperthyroidism CheckMate-067 Nivolumab 3mg/kg Q2W 313 median 3913 13 . 3 [2;5] . [0;.]

Hyperthyroidism _ALL Nivolumab 3mg/kg Q2W 787 9604 25 1 3 [2;4] 0 [0;0]

Hyperthyroidism KEYNOTE-006 Pembrolizumab 10 mg/kg Q2W

278 median 2196 17 0 8 [4;11] 0 [0;0]

Hyperthyroidism _ALL Pembrolizumab 10 mg/kg Q2W

278 2196 17 0 8 [4;11] 0 [0;0]

Hyperthyroidism KEYNOTE-001 (randomized cohorts)


84 median 672 2 0 3 [0;7] 0 [0;0]


84 672 2 0 3 [0;7] 0 [0;0]

Hyperthyroidism KEYNOTE-001 (randomized cohorts)


89 median 712 1 0 1 [0;4] 0 [0;0]


89 712 1 0 1 [0;4] 0 [0;0]

Hypertriglyceridemia KEYNOTE-006 Ipilimumab 3 mg/kg Q3W 256 median 2022 0 0 0 [0;0] 0 [0;0]

Hypertriglyceridemia _ALL Ipilimumab 3 mg/kg Q3W 256 2022 0 0 0 [0;0] 0 [0;0]




N patients


N patients_months

N of AEs

N of grade

3-5 AEs


months [95%CI]


months [95%CI]

Hypertriglyceridemia KEYNOTE-006 Pembrolizumab 10 mg/kg Q2W

278 median 2196 1 0 0 [0;1] 0 [0;0]

Hypertriglyceridemia _ALL Pembrolizumab 10 mg/kg Q2W

278 2196 1 0 0 [0;1] 0 [0;0]

Hypocalcemia KEYNOTE-006 Ipilimumab 3 mg/kg Q3W 256 median 2022 0 0 0 [0;0] 0 [0;0]

Hypocalcemia _ALL Ipilimumab 3 mg/kg Q3W 256 2022 0 0 0 [0;0] 0 [0;0]

Hypocalcemia KEYNOTE-006 Pembrolizumab 10 mg/kg Q2W

278 median 2196 6 0 3 [1;5] 0 [0;0]

Hypocalcemia _ALL Pembrolizumab 10 mg/kg Q2W

278 2196 6 0 3 [1;5] 0 [0;0]

Hypoesthesia KEYNOTE-001 (randomized cohorts)


84 median 672 0 0 0 [0;0] 0 [0;0]

Hypoesthesia _ALL Pembrolizumab 10 mg/kg Q3W

84 672 0 0 0 [0;0] 0 [0;0]

Hypoesthesia KEYNOTE-001 (randomized cohorts)


89 median 712 3 0 4 [0;9] 0 [0;0]

Hypoesthesia _ALL Pembrolizumab 2 mg/kg Q3W

89 712 3 0 4 [0;9] 0 [0;0]

Hypomagnesemia KEYNOTE-006 Ipilimumab 3 mg/kg Q3W 256 median 2022 1 0 0 [0;1] 0 [0;0]

Hypomagnesemia _ALL Ipilimumab 3 mg/kg Q3W 256 2022 1 0 0 [0;1] 0 [0;0]

Hypomagnesemia KEYNOTE-006 Pembrolizumab 10 mg/kg Q2W

278 median 2196 2 0 1 [0;2] 0 [0;0]




N patients


N patients_months

N of AEs

N of grade

3-5 AEs


months [95%CI]


months [95%CI]

Hypomagnesemia _ALL Pembrolizumab 10 mg/kg Q2W

278 2196 2 0 1 [0;2] 0 [0;0]

Hypophysitis CheckMate-067 Ipilimumab 3 mg/Kg + Nivolumab 1 mg/kg

313 minimum 3819 24 5 6 [4;9] 1 [0;2]

Hypophysitis _ALL Ipilimumab 3 mg/Kg + Nivolumab 1 mg/kg

313 3819 24 5 6 [4;9] 1 [0;2]

Hypophysitis CA-184-002 Ipilimumab 3 mg/kg Q3W 131 median 3642 2 2 1 [0;1] 1 [0;1]

Hypophysitis CheckMate-067 Ipilimumab 3 mg/kg Q3W 311 minimum 3794 12 6 3 [1;5] 2 [0;3]

Hypophysitis CheckMate-069 Ipilimumab 3 mg/kg Q3W 46 minimum 506 3 2 6 [0;13] 4 [0;9]

Hypophysitis KEYNOTE-006 Ipilimumab 3 mg/kg Q3W 256 median 2022 4 2 2 [0;4] 1 [0;2]

Hypophysitis _ALL Ipilimumab 3 mg/kg Q3W 744 9964 21 12 2 [1;3] 1 [1;2]

Hypophysitis CheckMate-066 Nivolumab 3mg/kg Q2W 206 median 3440 1 1 0 [0;1] 0 [0;1]

Hypophysitis CheckMate-067 Nivolumab 3mg/kg Q2W 313 median 3913 2 1 1 [0;1] 0 [0;1]

Hypophysitis _ALL Nivolumab 3mg/kg Q2W 519 7353 3 2 0 [0;1] 0 [0;1]

Hypophysitis KEYNOTE-006 Pembrolizumab 10 mg/kg Q2W

278 median 2196 0 0 0 [0;0] 0 [0;0]

Hypophysitis _ALL Pembrolizumab 10 mg/kg Q2W

278 2196 0 0 0 [0;0] 0 [0;0]

Hypophysitis KEYNOTE-001 (randomized cohorts)


84 median 672 0 0 0 [0;0] 0 [0;0]


84 672 0 0 0 [0;0] 0 [0;0]




N patients


N patients_months

N of AEs

N of grade

3-5 AEs


months [95%CI]


months [95%CI]

Hypophysitis KEYNOTE-001 (randomized cohorts)


89 median 712 2 1 3 [0;7] 1 [0;4]


89 712 2 1 3 [0;7] 1 [0;4]

Hypopituitarism CA-184-002 Ipilimumab 3 mg/kg Q3W 131 median 3642 3 2 1 [0;2] 1 [0;1]

Hypopituitarism _ALL Ipilimumab 3 mg/kg Q3W 131 3642 3 2 1 [0;2] 1 [0;1]

Hypotension CheckMate-066 Nivolumab 3mg/kg Q2W 206 median 3440 1 0 0 [0;1] 0 [0;0]

Hypotension _ALL Nivolumab 3mg/kg Q2W 206 3440 1 0 0 [0;1] 0 [0;0]

Hypothyroidism CheckMate-067 Ipilimumab 3 mg/Kg + Nivolumab 1 mg/kg

313 minimum 3819 47 1 12 [9;16] 0 [0;1]

Hypothyroidism CheckMate-069 Ipilimumab 3 mg/Kg + Nivolumab 1 mg/kg

94 minimum 1034 15 0 15 [7;22] 0 [0;0]

Hypothyroidism _ALL Ipilimumab 3 mg/Kg + Nivolumab 1 mg/kg

407 4853 62 1 13 [10;16] 0 [0;1]

Hypothyroidism CA-184-002 Ipilimumab 3 mg/kg Q3W 131 median 3642 2 0 1 [0;1] 0 [0;0]

Hypothyroidism CheckMate-067 Ipilimumab 3 mg/kg Q3W 311 minimum 3794 13 0 3 [2;5] 0 [0;0]

Hypothyroidism CheckMate-069 Ipilimumab 3 mg/kg Q3W 46 minimum 506 7 0 14 [4;24] 0 [0;0]

Hypothyroidism KEYNOTE-006 Ipilimumab 3 mg/kg Q3W 256 median 2022 2 0 1 [0;2] 0 [0;0]

Hypothyroidism _ALL Ipilimumab 3 mg/kg Q3W 744 9964 24 0 2 [1;3] 0 [0;0]

Hypothyroidism CheckMate-037 Nivolumab 3mg/kg Q2W 268 median 2251 15 0 7 [3;10] 0 [0;0]






N patients


N patients_months

N of AEs

N of grade

3-5 AEs


months [95%CI]


months [95%CI]

Hypothyroidism _ALL Nivolumab 3mg/kg Q2W 787 9604 51 0 5 [4;7] 0 [0;0]

Hypothyroidism KEYNOTE-001 Pembrolizumab 10 mg/kg Q2W

57 median 627 9 1 14 [5;24] 2 [0;5]


278 median 2196 25 1 11 [7;16] 0 [0;1]

Hypothyroidism _ALL Pembrolizumab 10 mg/kg Q2W

335 2823 34 2 12 [8;16] 1 [0;2]


56 median 616 1 0 2 [0;5] 0 [0;0]

Hypothyroidism KEYNOTE-001 (randomized cohorts)


84 median 672 2 0 3 [0;7] 0 [0;0]


179 median 1790 13 0 7 [3;11] 0 [0;0]


319 3078 16 0 5 [3;8] 0 [0;0]


22 median 242 1 0 4 [0;12] 0 [0;0]

Hypothyroidism KEYNOTE-001 (randomized cohorts)


89 median 712 5 0 7 [1;13] 0 [0;0]


178 median 1780 9 0 5 [2;8] 0 [0;0]


289 2734 15 0 5 [3;8] 0 [0;0]




N patients


N patients_months

N of AEs

N of grade

3-5 AEs


months [95%CI]


months [95%CI]

Increased lipase CheckMate-069 Ipilimumab 3 mg/Kg + Nivolumab 1 mg/kg

94 minimum 1034 12 8 12 [5;18] 8 [2;13]

Increased lipase _ALL Ipilimumab 3 mg/Kg + Nivolumab 1 mg/kg

94 1034 12 8 12 [5;18] 8 [2;13]

Increased lipase CheckMate-069 Ipilimumab 3 mg/kg Q3W 46 minimum 506 2 1 4 [0;9] 2 [0;6]

Increased lipase _ALL Ipilimumab 3 mg/kg Q3W 46 506 2 1 4 [0;9] 2 [0;6]

Influenza-like illness KEYNOTE-006 Ipilimumab 3 mg/kg Q3W 256 median 2022 4 1 2 [0;4] 0 [0;1]

Influenza-like illness _ALL Ipilimumab 3 mg/kg Q3W 256 2022 4 1 2 [0;4] 0 [0;1]

Influenza-like illness KEYNOTE-001 Pembrolizumab 10 mg/kg Q2W

57 median 627 3 0 5 [0;10] 0 [0;0]


278 median 2196 2 0 1 [0;2] 0 [0;0]

Influenza-like illness _ALL Pembrolizumab 10 mg/kg Q2W

335 2823 5 0 2 [0;3] 0 [0;0]


56 median 616 0 0 0 [0;0] 0 [0;0]

Influenza-like illness KEYNOTE-001 (randomized cohorts)


84 median 672 1 0 1 [0;4] 0 [0;0]


224 1960 2 0 1 [0;2] 0 [0;0]


22 median 242 0 0 0 [0;0] 0 [0;0]




N patients


N patients_months

N of AEs

N of grade

3-5 AEs


months [95%CI]


months [95%CI]

Influenza-like illness KEYNOTE-001 (randomized cohorts)


89 median 712 1 0 1 [0;4] 0 [0;0]


200 1666 2 0 1 [0;3] 0 [0;0]

Infusion Related reaction CheckMate-037 Nivolumab 3mg/kg Q2W 268 median 2251 3 1 1 [0;3] 0 [0;1]

Infusion Related reaction CheckMate-066 Nivolumab 3mg/kg Q2W 206 median 3440 9 0 3 [1;4] 0 [0;0]

Infusion Related reaction _ALL Nivolumab 3mg/kg Q2W 474 5691 12 1 2 [1;3] 0 [0;1]

Insomnia KEYNOTE-006 Ipilimumab 3 mg/kg Q3W 256 median 2022 0 0 0 [0;0] 0 [0;0]

Insomnia _ALL Ipilimumab 3 mg/kg Q3W 256 2022 0 0 0 [0;0] 0 [0;0]

Insomnia KEYNOTE-006 Pembrolizumab 10 mg/kg Q2W

278 median 2196 6 0 3 [1;5] 0 [0;0]

Insomnia _ALL Pembrolizumab 10 mg/kg Q2W

278 2196 6 0 3 [1;5] 0 [0;0]

Interstitial lung disease CheckMate-069 Ipilimumab 3 mg/Kg + Nivolumab 1 mg/kg

94 minimum 1034 1 0 1 [0;3] 0 [0;0]

Interstitial lung disease _ALL Ipilimumab 3 mg/Kg + Nivolumab 1 mg/kg

94 1034 1 0 1 [0;3] 0 [0;0]

Interstitial lung disease CheckMate-069 Ipilimumab 3 mg/kg Q3W 46 minimum 506 0 0 0 [0;0] 0 [0;0]

Interstitial lung disease _ALL Ipilimumab 3 mg/kg Q3W 46 506 0 0 0 [0;0] 0 [0;0]

Joint swelling KEYNOTE-001 (randomized cohorts)


84 median 672 2 0 3 [0;7] 0 [0;0]

Joint swelling _ALL Pembrolizumab 10 mg/kg Q3W

84 672 2 0 3 [0;7] 0 [0;0]




N patients


N patients_months

N of AEs

N of grade

3-5 AEs


months [95%CI]


months [95%CI]

Joint swelling KEYNOTE-001 (randomized cohorts)


89 median 712 0 0 0 [0;0] 0 [0;0]

Joint swelling _ALL Pembrolizumab 2 mg/kg Q3W

89 712 0 0 0 [0;0] 0 [0;0]

Lethargy KEYNOTE-006 Ipilimumab 3 mg/kg Q3W 256 median 2022 3 0 1 [0;3] 0 [0;0]

Lethargy _ALL Ipilimumab 3 mg/kg Q3W 256 2022 3 0 1 [0;3] 0 [0;0]

Lethargy KEYNOTE-006 Pembrolizumab 10 mg/kg Q2W

278 median 2196 2 0 1 [0;2] 0 [0;0]

Lethargy _ALL Pembrolizumab 10 mg/kg Q2W

278 2196 2 0 1 [0;2] 0 [0;0]

Lethargy KEYNOTE-001 (randomized cohorts)


84 median 672 0 0 0 [0;0] 0 [0;0]


84 672 0 0 0 [0;0] 0 [0;0]

Lethargy KEYNOTE-001 (randomized cohorts)


89 median 712 4 0 6 [0;11] 0 [0;0]


89 712 4 0 6 [0;11] 0 [0;0]

Lymphopenia CheckMate-066 Nivolumab 3mg/kg Q2W 206 median 3440 5 0 1 [0;3] 0 [0;0]

Lymphopenia _ALL Nivolumab 3mg/kg Q2W 206 3440 5 0 1 [0;3] 0 [0;0]

Malaise CheckMate-066 Nivolumab 3mg/kg Q2W 206 median 3440 1 0 0 [0;1] 0 [0;0]

Malaise _ALL Nivolumab 3mg/kg Q2W 206 3440 1 0 0 [0;1] 0 [0;0]

Memory impairment KEYNOTE-006 Ipilimumab 3 mg/kg Q3W 256 median 2022 0 0 0 [0;0] 0 [0;0]




N patients


N patients_months

N of AEs

N of grade

3-5 AEs


months [95%CI]


months [95%CI]

Memory impairment _ALL Ipilimumab 3 mg/kg Q3W 256 2022 0 0 0 [0;0] 0 [0;0]

Memory impairment KEYNOTE-006 Pembrolizumab 10 mg/kg Q2W

278 median 2196 3 0 1 [0;3] 0 [0;0]

Memory impairment _ALL Pembrolizumab 10 mg/kg Q2W

278 2196 3 0 1 [0;3] 0 [0;0]

Mucosal inflammation KEYNOTE-006 Ipilimumab 3 mg/kg Q3W 256 median 2022 3 0 1 [0;3] 0 [0;0]

Mucosal inflammation _ALL Ipilimumab 3 mg/kg Q3W 256 2022 3 0 1 [0;3] 0 [0;0]

Mucosal inflammation KEYNOTE-006 Pembrolizumab 10 mg/kg Q2W

278 median 2196 1 0 0 [0;1] 0 [0;0]

Mucosal inflammation _ALL Pembrolizumab 10 mg/kg Q2W

278 2196 1 0 0 [0;1] 0 [0;0]

Mucosal inflammation KEYNOTE-001 (randomized cohorts)


84 median 672 1 0 1 [0;4] 0 [0;0]


84 672 1 0 1 [0;4] 0 [0;0]

Mucosal inflammation KEYNOTE-001 (randomized cohorts)


89 median 712 1 0 1 [0;4] 0 [0;0]


89 712 1 0 1 [0;4] 0 [0;0]

Muscle spasms KEYNOTE-006 Ipilimumab 3 mg/kg Q3W 256 median 2022 1 0 0 [0;1] 0 [0;0]

Muscle spasms _ALL Ipilimumab 3 mg/kg Q3W 256 2022 1 0 0 [0;1] 0 [0;0]

Muscle spasms KEYNOTE-001 Pembrolizumab 10 mg/kg Q2W

57 median 627 0 0 0 [0;0] 0 [0;0]




N patients


N patients_months

N of AEs

N of grade

3-5 AEs


months [95%CI]


months [95%CI]


278 median 2196 4 0 2 [0;4] 0 [0;0]

Muscle spasms _ALL Pembrolizumab 10 mg/kg Q2W

335 2823 4 0 1 [0;3] 0 [0;0]


56 median 616 1 0 2 [0;5] 0 [0;0]

Muscle spasms KEYNOTE-001 (randomized cohorts)


84 median 672 2 0 3 [0;7] 0 [0;0]


140 1288 3 0 2 [0;5] 0 [0;0]


22 median 242 1 0 4 [0;12] 0 [0;0]

Muscle spasms KEYNOTE-001 (randomized cohorts)


89 median 712 2 0 3 [0;7] 0 [0;0]


111 954 3 0 3 [0;7] 0 [0;0]

Muscular weakness KEYNOTE-001 Pembrolizumab 10 mg/kg Q2W

57 median 627 1 0 2 [0;5] 0 [0;0]

Muscular weakness _ALL Pembrolizumab Pembrolizumab 10 mg/kg Q2W

57 627 1 0 2 [0;5] 0 [0;0]


56 median 616 1 0 2 [0;5] 0 [0;0]




N patients


N patients_months

N of AEs

N of grade

3-5 AEs


months [95%CI]


months [95%CI]

Muscular weakness KEYNOTE-001 (randomized cohorts)


84 median 672 3 0 4 [0;10] 0 [0;0]

Muscular weakness _ALL Pembrolizumab 10 mg/kg Q3W

140 1288 4 0 3 [0;6] 0 [0;0]


22 median 242 0 0 0 [0;0] 0 [0;0]

Muscular weakness KEYNOTE-001 (randomized cohorts)


89 median 712 3 1 4 [0;9] 1 [0;4]

Muscular weakness _ALL Pembrolizumab 2 mg/kg Q3W

111 954 3 1 3 [0;7] 1 [0;3]

Muskuloskeletal stiffness KEYNOTE-006 Ipilimumab 3 mg/kg Q3W 256 median 2022 0 0 0 [0;0] 0 [0;0]

Muskuloskeletal stiffness _ALL Ipilimumab 3 mg/kg Q3W 256 2022 0 0 0 [0;0] 0 [0;0]

Muskuloskeletal stiffness KEYNOTE-006 Pembrolizumab 10 mg/kg Q2W

278 median 2196 3 0 1 [0;3] 0 [0;0]

Muskuloskeletal stiffness _ALL Pembrolizumab 10 mg/kg Q2W

278 2196 3 0 1 [0;3] 0 [0;0]

Myalgia CheckMate-069 Ipilimumab 3 mg/Kg + Nivolumab 1 mg/kg

94 minimum 1034 9 0 9 [3;14] 0 [0;0]

Myalgia _ALL Ipilimumab 3 mg/Kg + Nivolumab 1 mg/kg

94 1034 9 0 9 [3;14] 0 [0;0]

Myalgia CheckMate-069 Ipilimumab 3 mg/kg Q3W 46 minimum 506 6 0 12 [2;21] 0 [0;0]

Myalgia KEYNOTE-006 Ipilimumab 3 mg/kg Q3W 256 median 2022 5 1 2 [0;5] 0 [0;1]

Myalgia _ALL Ipilimumab 3 mg/kg Q3W 302 2528 11 1 4 [2;7] 0 [0;1]




N patients


N patients_months

N of AEs

N of grade

3-5 AEs


months [95%CI]


months [95%CI]

Myalgia CheckMate-066 Nivolumab 3mg/kg Q2W 206 median 3440 9 0 3 [1;4] 0 [0;0]

Myalgia _ALL Nivolumab 3mg/kg Q2W 206 3440 9 0 3 [1;4] 0 [0;0]

Myalgia KEYNOTE-006 Pembrolizumab 10 mg/kg Q2W

278 median 2196 19 1 9 [5;13] 0 [0;1]

Myalgia _ALL Pembrolizumab 10 mg/kg Q2W

278 2196 19 1 9 [5;13] 0 [0;1]

Myalgia KEYNOTE-001 (randomized cohorts)


84 median 672 4 0 6 [0;12] 0 [0;0]


179 median 1790 7 0 4 [1;7] 0 [0;0]


263 2462 11 0 4 [2;7] 0 [0;0]

Myalgia KEYNOTE-001 (randomized cohorts)


89 median 712 5 0 7 [1;13] 0 [0;0]


178 median 1780 9 2 5 [2;8] 1 [0;3]


267 2492 14 2 6 [3;9] 1 [0;2]

Nasal congestion KEYNOTE-001 Pembrolizumab 10 mg/kg Q2W

57 median 627 0 0 0 [0;0] 0 [0;0]

Nasal congestion _ALL Pembrolizumab 10 mg/kg Q2W

57 627 0 0 0 [0;0] 0 [0;0]


56 median 616 2 0 3 [0;8] 0 [0;0]




N patients


N patients_months

N of AEs

N of grade

3-5 AEs


months [95%CI]


months [95%CI]


56 616 2 0 3 [0;8] 0 [0;0]


22 median 242 0 0 0 [0;0] 0 [0;0]


22 242 0 0 0 [0;0] 0 [0;0]

Nausea CheckMate-067 Ipilimumab 3 mg/Kg + Nivolumab 1 mg/kg

313 minimum 3819 81 7 21 [17;26] 2 [0;3]

Nausea CheckMate-069 Ipilimumab 3 mg/Kg + Nivolumab 1 mg/kg

94 minimum 1034 21 1 20 [12;29] 1 [0;3]

Nausea _ALL Ipilimumab 3 mg/Kg + Nivolumab 1 mg/kg

407 4853 102 8 21 [17;25] 2 [1;3]

Nausea CA-184-002 Ipilimumab 3 mg/kg Q3W 131 median 3642 46 3 13 [9;16] 1 [0;2]

Nausea CheckMate-067 Ipilimumab 3 mg/kg Q3W 311 minimum 3794 50 2 13 [10;17] 1 [0;1]

Nausea CheckMate-069 Ipilimumab 3 mg/kg Q3W 46 minimum 506 11 1 22 [9;35] 2 [0;6]

Nausea KEYNOTE-006 Ipilimumab 3 mg/kg Q3W 256 median 2022 22 1 11 [6;15] 0 [0;1]

Nausea _ALL Ipilimumab 3 mg/kg Q3W 744 9964 129 7 13 [11;15] 1 [0;1]

Nausea CheckMate-037 Nivolumab 3mg/kg Q2W 268 median 2251 25 0 11 [7;15] 0 [0;0]



Nausea _ALL Nivolumab 3mg/kg Q2W 787 9604 100 0 10 [8;12] 0 [0;0]




N patients


N patients_months

N of AEs

N of grade

3-5 AEs


months [95%CI]


months [95%CI]

Nausea KEYNOTE-001 Pembrolizumab 10 mg/kg Q2W

57 median 627 7 0 11 [3;19] 0 [0;0]


278 median 2196 28 0 13 [8;17] 0 [0;0]

Nausea _ALL Pembrolizumab 10 mg/kg Q2W

335 2823 35 0 12 [8;17] 0 [0;0]


56 median 616 4 0 6 [0;13] 0 [0;0]

Nausea KEYNOTE-001 (randomized cohorts)


84 median 672 11 0 16 [7;26] 0 [0;0]


179 median 1790 15 1 8 [4;13] 1 [0;2]


319 3078 30 1 10 [6;13] 0 [0;1]


22 median 242 2 0 8 [0;20] 0 [0;0]

Nausea KEYNOTE-001 (randomized cohorts)


89 median 712 7 0 10 [3;17] 0 [0;0]


178 median 1780 8 0 4 [1;8] 0 [0;0]


289 2734 17 0 6 [3;9] 0 [0;0]

Neck pain KEYNOTE-001 Pembrolizumab 10 mg/kg Q2W

57 median 627 1 0 2 [0;5] 0 [0;0]




N patients


N patients_months

N of AEs

N of grade

3-5 AEs


months [95%CI]


months [95%CI]

Neck pain _ALL Pembrolizumab 10 mg/kg Q2W

57 627 1 0 2 [0;5] 0 [0;0]


56 median 616 1 0 2 [0;5] 0 [0;0]


56 616 1 0 2 [0;5] 0 [0;0]


22 median 242 0 0 0 [0;0] 0 [0;0]


22 242 0 0 0 [0;0] 0 [0;0]

Neutropenia KEYNOTE-006 Ipilimumab 3 mg/kg Q3W 256 median 2022 0 0 0 [0;0] 0 [0;0]

Neutropenia _ALL Ipilimumab 3 mg/kg Q3W 256 2022 0 0 0 [0;0] 0 [0;0]

Neutropenia CheckMate-037 Nivolumab 3mg/kg Q2W 268 median 2251 0 0 0 [0;0] 0 [0;0]

Neutropenia CheckMate-066 Nivolumab 3mg/kg Q2W 206 median 3440 0 0 0 [0;0] 0 [0;0]

Neutropenia _ALL Nivolumab 3mg/kg Q2W 474 5691 0 0 0 [0;0] 0 [0;0]

Neutropenia KEYNOTE-006 Pembrolizumab 10 mg/kg Q2W

278 median 2196 3 0 1 [0;3] 0 [0;0]

Neutropenia _ALL Pembrolizumab 10 mg/kg Q2W

278 2196 3 0 1 [0;3] 0 [0;0]


179 median 1790 1 0 1 [0;2] 0 [0;0]


179 1790 1 0 1 [0;2] 0 [0;0]




N patients


N patients_months

N of AEs

N of grade

3-5 AEs


months [95%CI]


months [95%CI]


178 median 1780 1 0 1 [0;2] 0 [0;0]


178 1780 1 0 1 [0;2] 0 [0;0]

Night sweats KEYNOTE-001 Pembrolizumab 10 mg/kg Q2W

57 median 627 3 0 5 [0;10] 0 [0;0]

Night sweats _ALL Pembrolizumab 10 mg/kg Q2W

57 627 3 0 5 [0;10] 0 [0;0]


56 median 616 0 0 0 [0;0] 0 [0;0]

Night sweats KEYNOTE-001 (randomized cohorts)


84 median 672 1 0 1 [0;4] 0 [0;0]


140 1288 1 0 1 [0;2] 0 [0;0]


22 median 242 0 0 0 [0;0] 0 [0;0]

Night sweats KEYNOTE-001 (randomized cohorts)


89 median 712 4 0 6 [0;11] 0 [0;0]


111 954 4 0 4 [0;8] 0 [0;0]

Oropharyngeal pain KEYNOTE-006 Ipilimumab 3 mg/kg Q3W 256 median 2022 0 0 0 [0;0] 0 [0;0]

Oropharyngeal pain _ALL Ipilimumab 3 mg/kg Q3W 256 2022 0 0 0 [0;0] 0 [0;0]

Oropharyngeal pain KEYNOTE-006 Pembrolizumab 10 mg/kg Q2W

278 median 2196 3 0 1 [0;3] 0 [0;0]




N patients


N patients_months

N of AEs

N of grade

3-5 AEs


months [95%CI]


months [95%CI]

Oropharyngeal pain _ALL Pembrolizumab 10 mg/kg Q2W

278 2196 3 0 1 [0;3] 0 [0;0]

Pain KEYNOTE-001 (randomized cohorts)


84 median 672 0 0 0 [0;0] 0 [0;0]

Pain _ALL Pembrolizumab 10 mg/kg Q3W

84 672 0 0 0 [0;0] 0 [0;0]

Pain KEYNOTE-001 (randomized cohorts)


89 median 712 2 0 3 [0;7] 0 [0;0]

Pain _ALL Pembrolizumab 2 mg/kg Q3W

89 712 2 0 3 [0;7] 0 [0;0]

Pain in extermity KEYNOTE-006 Ipilimumab 3 mg/kg Q3W 256 median 2022 1 0 0 [0;1] 0 [0;0]

Pain in extermity _ALL Ipilimumab 3 mg/kg Q3W 256 2022 1 0 0 [0;1] 0 [0;0]

Pain in extermity CheckMate-066 Nivolumab 3mg/kg Q2W 206 median 3440 6 0 2 [0;3] 0 [0;0]

Pain in extermity _ALL Nivolumab 3mg/kg Q2W 206 3440 6 0 2 [0;3] 0 [0;0]

Pain in extermity KEYNOTE-001 Pembrolizumab 10 mg/kg Q2W

57 median 627 1 0 2 [0;5] 0 [0;0]


278 median 2196 6 1 3 [1;5] 0 [0;1]

Pain in extermity _ALL Pembrolizumab 10 mg/kg Q2W

335 2823 7 1 2 [1;4] 0 [0;1]


56 median 616 1 0 2 [0;5] 0 [0;0]




N patients


N patients_months

N of AEs

N of grade

3-5 AEs


months [95%CI]


months [95%CI]


56 616 1 0 2 [0;5] 0 [0;0]


22 median 242 1 0 4 [0;12] 0 [0;0]


22 242 1 0 4 [0;12] 0 [0;0]

Pain in jaw KEYNOTE-001 (randomized cohorts)


84 median 672 1 0 1 [0;4] 0 [0;0]

Pain in jaw _ALL Pembrolizumab 10 mg/kg Q3W

84 672 1 0 1 [0;4] 0 [0;0]

Pain in jaw KEYNOTE-001 (randomized cohorts)


89 median 712 1 0 1 [0;4] 0 [0;0]

Pain in jaw _ALL Pembrolizumab 2 mg/kg Q3W

89 712 1 0 1 [0;4] 0 [0;0]

Palpitations CheckMate-066 Nivolumab 3mg/kg Q2W 206 median 3440 1 0 0 [0;1] 0 [0;0]

Palpitations _ALL Nivolumab 3mg/kg Q2W 206 3440 1 0 0 [0;1] 0 [0;0]

Papule KEYNOTE-006 Ipilimumab 3 mg/kg Q3W 256 median 2022 0 0 0 [0;0] 0 [0;0]

Papule _ALL Ipilimumab 3 mg/kg Q3W 256 2022 0 0 0 [0;0] 0 [0;0]

Papule KEYNOTE-006 Pembrolizumab 10 mg/kg Q2W

278 median 2196 3 0 1 [0;3] 0 [0;0]

Papule _ALL Pembrolizumab 10 mg/kg Q2W

278 2196 3 0 1 [0;3] 0 [0;0]

Paresthesia KEYNOTE-006 Ipilimumab 3 mg/kg Q3W 256 median 2022 3 1 1 [0;3] 0 [0;1]




N patients


N patients_months

N of AEs

N of grade

3-5 AEs


months [95%CI]


months [95%CI]

Paresthesia _ALL Ipilimumab 3 mg/kg Q3W 256 2022 3 1 1 [0;3] 0 [0;1]

Paresthesia CheckMate-066 Nivolumab 3mg/kg Q2W 206 median 3440 2 0 1 [0;1] 0 [0;0]

Paresthesia _ALL Nivolumab 3mg/kg Q2W 206 3440 2 0 1 [0;1] 0 [0;0]

Paresthesia KEYNOTE-006 Pembrolizumab 10 mg/kg Q2W

278 median 2196 0 0 0 [0;0] 0 [0;0]

Paresthesia _ALL Pembrolizumab 10 mg/kg Q2W

278 2196 0 0 0 [0;0] 0 [0;0]

Paresthesia KEYNOTE-001 (randomized cohorts)


84 median 672 2 0 3 [0;7] 0 [0;0]


179 median 1790 2 0 1 [0;3] 0 [0;0]


263 2462 4 0 2 [0;3] 0 [0;0]

Paresthesia KEYNOTE-001 (randomized cohorts)


89 median 712 0 0 0 [0;0] 0 [0;0]


178 median 1780 1 0 1 [0;2] 0 [0;0]


267 2492 1 0 0 [0;1] 0 [0;0]

Peripheral edema KEYNOTE-006 Ipilimumab 3 mg/kg Q3W 256 median 2022 1 0 0 [0;1] 0 [0;0]

Peripheral edema _ALL Ipilimumab 3 mg/kg Q3W 256 2022 1 0 0 [0;1] 0 [0;0]

Peripheral edema KEYNOTE-006 Pembrolizumab 10 mg/kg Q2W

278 median 2196 3 0 1 [0;3] 0 [0;0]




N patients


N patients_months

N of AEs

N of grade

3-5 AEs


months [95%CI]


months [95%CI]

Peripheral edema _ALL Pembrolizumab 10 mg/kg Q2W

278 2196 3 0 1 [0;3] 0 [0;0]

Peripheral neuropathy KEYNOTE-001 Pembrolizumab 10 mg/kg Q2W

57 median 627 3 0 5 [0;10] 0 [0;0]

Peripheral neuropathy _ALL Pembrolizumab 10 mg/kg Q2W

57 627 3 0 5 [0;10] 0 [0;0]


56 median 616 0 0 0 [0;0] 0 [0;0]

Peripheral neuropathy KEYNOTE-001 (randomized cohorts)


84 median 672 2 0 3 [0;7] 0 [0;0]


179 median 1790 0 0 0 [0;0] 0 [0;0]


319 3078 2 0 1 [0;2] 0 [0;0]


22 median 242 0 0 0 [0;0] 0 [0;0]

Peripheral neuropathy KEYNOTE-001 (randomized cohorts)


89 median 712 1 0 1 [0;4] 0 [0;0]


178 median 1780 2 0 1 [0;3] 0 [0;0]


289 2734 3 0 1 [0;2] 0 [0;0]

Peripheral oedema KEYNOTE-001 Pembrolizumab 10 mg/kg Q2W

57 median 627 3 0 5 [0;10] 0 [0;0]




N patients


N patients_months

N of AEs

N of grade

3-5 AEs


months [95%CI]


months [95%CI]

Peripheral oedema _ALL Pembrolizumab 10 mg/kg Q2W

57 627 3 0 5 [0;10] 0 [0;0]


56 median 616 1 0 2 [0;5] 0 [0;0]

Peripheral oedema KEYNOTE-001 (randomized cohorts)


84 median 672 3 0 4 [0;10] 0 [0;0]


140 1288 4 0 3 [0;6] 0 [0;0]


22 median 242 0 0 0 [0;0] 0 [0;0]

Peripheral oedema KEYNOTE-001 (randomized cohorts)


89 median 712 4 0 6 [0;11] 0 [0;0]


111 954 4 0 4 [0;8] 0 [0;0]

Photosensitivity reaction CheckMate-066 Nivolumab 3mg/kg Q2W 206 median 3440 3 0 1 [0;2] 0 [0;0]

Photosensitivity reaction _ALL Nivolumab 3mg/kg Q2W 206 3440 3 0 1 [0;2] 0 [0;0]

Pigmentation disorder KEYNOTE-001 (randomized cohorts)


84 median 672 0 0 0 [0;0] 0 [0;0]

Pigmentation disorder _ALL Pembrolizumab 10 mg/kg Q3W

84 672 0 0 0 [0;0] 0 [0;0]

Pigmentation disorder KEYNOTE-001 (randomized cohorts)


89 median 712 2 0 3 [0;7] 0 [0;0]

Pigmentation disorder _ALL Pembrolizumab 2 mg/kg Q3W

89 712 2 0 3 [0;7] 0 [0;0]




N patients


N patients_months

N of AEs

N of grade

3-5 AEs


months [95%CI]


months [95%CI]

Pneumonitis CheckMate-067 Ipilimumab 3 mg/Kg + Nivolumab 1 mg/kg

313 minimum 3819 20 3 5 [3;8] 1 [0;2]

Pneumonitis CheckMate-069 Ipilimumab 3 mg/Kg + Nivolumab 1 mg/kg

94 minimum 1034 10 2 10 [4;16] 2 [0;5]

Pneumonitis _ALL Ipilimumab 3 mg/Kg + Nivolumab 1 mg/kg

407 4853 30 5 6 [4;8] 1 [0;2]

Pneumonitis CheckMate-067 Ipilimumab 3 mg/kg Q3W 311 minimum 3794 5 1 1 [0;2] 0 [0;1]

Pneumonitis CheckMate-069 Ipilimumab 3 mg/kg Q3W 46 minimum 506 2 1 4 [0;9] 2 [0;6]

Pneumonitis _ALL Ipilimumab 3 mg/kg Q3W 357 4300 7 2 2 [0;3] 0 [0;1]

Pneumonitis CheckMate-037 Nivolumab 3mg/kg Q2W 268 median 2251 5 0 2 [0;4] 0 [0;0]



Pneumonitis _ALL Nivolumab 3mg/kg Q2W 787 9604 12 1 1 [1;2] 0 [0;0]

Pneumonitis KEYNOTE-001 Pembrolizumab 10 mg/kg Q2W

57 median 627 4 0 6 [0;13] 0 [0;0]

Pneumonitis _ALL Pembrolizumab 10 mg/kg Q2W

57 627 4 0 6 [0;13] 0 [0;0]


56 median 616 2 0 3 [0;8] 0 [0;0]

Pneumonitis KEYNOTE-001 (randomized cohorts)


84 median 672 1 0 1 [0;4] 0 [0;0]


140 1288 3 0 2 [0;5] 0 [0;0]




N patients


N patients_months

N of AEs

N of grade

3-5 AEs


months [95%CI]


months [95%CI]


22 median 242 0 0 0 [0;0] 0 [0;0]

Pneumonitis KEYNOTE-001 (randomized cohorts)


89 median 712 2 1 3 [0;7] 1 [0;4]


111 954 2 1 2 [0;5] 1 [0;3]

Productive cough KEYNOTE-001 Pembrolizumab 10 mg/kg Q2W

57 median 627 2 0 3 [0;8] 0 [0;0]

Productive cough _ALL Pembrolizumab 10 mg/kg Q2W

57 627 2 0 3 [0;8] 0 [0;0]


56 median 616 0 0 0 [0;0] 0 [0;0]


56 616 0 0 0 [0;0] 0 [0;0]


22 median 242 0 0 0 [0;0] 0 [0;0]


22 242 0 0 0 [0;0] 0 [0;0]

Pruritus CheckMate-067 Ipilimumab 3 mg/Kg + Nivolumab 1 mg/kg

313 minimum 3819 104 6 27 [22;32] 2 [0;3]

Pruritus CheckMate-069 Ipilimumab 3 mg/Kg + Nivolumab 1 mg/kg

94 minimum 1034 33 1 32 [21;43] 1 [0;3]

Pruritus _ALL Ipilimumab 3 mg/Kg + Nivolumab 1 mg/kg

407 4853 137 7 28 [24;33] 1 [0;3]




N patients


N patients_months

N of AEs

N of grade

3-5 AEs


months [95%CI]


months [95%CI]

Pruritus CA-184-002 Ipilimumab 3 mg/kg Q3W 131 median 3642 32 0 9 [6;12] 0 [0;0]

Pruritus CheckMate-067 Ipilimumab 3 mg/kg Q3W 311 minimum 3794 110 1 29 [24;34] 0 [0;1]

Pruritus CheckMate-069 Ipilimumab 3 mg/kg Q3W 46 minimum 506 13 0 26 [12;40] 0 [0;0]

Pruritus KEYNOTE-006 Ipilimumab 3 mg/kg Q3W 256 median 2022 65 1 32 [24;40] 0 [0;1]

Pruritus _ALL Ipilimumab 3 mg/kg Q3W 744 9964 220 2 22 [19;25] 0 [0;0]

Pruritus CheckMate-037 Nivolumab 3mg/kg Q2W 268 median 2251 43 0 19 [13;25] 0 [0;0]

Pruritus CheckMate-066 Nivolumab 3mg/kg Q2W 206 median 3440 35 1 10 [7;14] 0 [0;1]

Pruritus _ALL Nivolumab 3mg/kg Q2W 474 5691 78 1 14 [11;17] 0 [0;1]

Pruritus KEYNOTE-001 Pembrolizumab 10 mg/kg Q2W

57 median 627 15 0 24 [12;36] 0 [0;0]


278 median 2196 40 0 18 [13;24] 0 [0;0]

Pruritus _ALL Pembrolizumab 10 mg/kg Q2W

335 2823 55 0 19 [14;25] 0 [0;0]


56 median 616 9 0 15 [5;24] 0 [0;0]

Pruritus KEYNOTE-001 (randomized cohorts)


84 median 672 16 0 24 [12;35] 0 [0;0]


179 median 1790 42 0 23 [16;31] 0 [0;0]


319 3078 67 0 22 [17;27] 0 [0;0]




N patients


N patients_months

N of AEs

N of grade

3-5 AEs


months [95%CI]


months [95%CI]


22 median 242 4 1 17 [0;33] 4 [0;12]

Pruritus KEYNOTE-001 (randomized cohorts)


89 median 712 23 0 32 [19;46] 0 [0;0]


178 median 1780 37 0 21 [14;27] 0 [0;0]


289 2734 64 1 23 [18;29] 0 [0;1]

Pyrexia CheckMate-067 Ipilimumab 3 mg/Kg + Nivolumab 1 mg/kg

313 minimum 3819 58 2 15 [11;19] 1 [0;1]

Pyrexia CheckMate-069 Ipilimumab 3 mg/Kg + Nivolumab 1 mg/kg

94 minimum 1034 19 3 18 [10;27] 3 [0;6]

Pyrexia _ALL Ipilimumab 3 mg/Kg + Nivolumab 1 mg/kg

407 4853 77 5 16 [12;19] 1 [0;2]

Pyrexia CA-184-002 Ipilimumab 3 mg/kg Q3W 131 median 3642 16 0 4 [2;7] 0 [0;0]

Pyrexia CheckMate-067 Ipilimumab 3 mg/kg Q3W 311 minimum 3794 21 1 6 [3;8] 0 [0;1]

Pyrexia CheckMate-069 Ipilimumab 3 mg/kg Q3W 46 minimum 506 7 0 14 [4;24] 0 [0;0]

Pyrexia KEYNOTE-006 Ipilimumab 3 mg/kg Q3W 256 median 2022 6 0 3 [1;5] 0 [0;0]

Pyrexia _ALL Ipilimumab 3 mg/kg Q3W 744 9964 50 1 5 [4;6] 0 [0;0]

Pyrexia CheckMate-066 Nivolumab 3mg/kg Q2W 206 median 3440 15 0 4 [2;7] 0 [0;0]

Pyrexia CheckMate-067 Nivolumab 3mg/kg Q2W 313 median 3913 18 0 5 [2;7] 0 [0;0]

Pyrexia _ALL Nivolumab 3mg/kg Q2W 519 7353 33 0 4 [3;6] 0 [0;0]




N patients


N patients_months

N of AEs

N of grade

3-5 AEs


months [95%CI]


months [95%CI]

Pyrexia KEYNOTE-001 Pembrolizumab 10 mg/kg Q2W

57 median 627 7 0 11 [3;19] 0 [0;0]


278 median 2196 11 0 5 [2;8] 0 [0;0]

Pyrexia _ALL Pembrolizumab 10 mg/kg Q2W

335 2823 18 0 6 [3;9] 0 [0;0]


56 median 616 3 0 5 [0;10] 0 [0;0]

Pyrexia KEYNOTE-001 (randomized cohorts)


84 median 672 5 0 7 [1;14] 0 [0;0]


140 1288 8 0 6 [2;11] 0 [0;0]


22 median 242 0 0 0 [0;0] 0 [0;0]

Pyrexia KEYNOTE-001 (randomized cohorts)


89 median 712 3 0 4 [0;9] 0 [0;0]


111 954 3 0 3 [0;7] 0 [0;0]

Rash CheckMate-067 Ipilimumab 3 mg/Kg + Nivolumab 1 mg/kg

313 minimum 3819 89 9 23 [18;28] 2 [1;4]

Rash CheckMate-069 Ipilimumab 3 mg/Kg + Nivolumab 1 mg/kg

94 minimum 1034 39 5 38 [26;50] 5 [1;9]

Rash _ALL Ipilimumab 3 mg/Kg + Nivolumab 1 mg/kg

407 4853 128 14 26 [22;31] 3 [1;4]




N patients


N patients_months

N of AEs

N of grade

3-5 AEs


months [95%CI]


months [95%CI]

Rash CA-184-002 Ipilimumab 3 mg/kg Q3W 131 median 3642 25 1 7 [4;10] 0 [0;1]

Rash CheckMate-067 Ipilimumab 3 mg/kg Q3W 311 minimum 3794 102 6 27 [22;32] 2 [0;3]

Rash CheckMate-069 Ipilimumab 3 mg/kg Q3W 46 minimum 506 12 0 24 [10;37] 0 [0;0]

Rash KEYNOTE-006 Ipilimumab 3 mg/kg Q3W 256 median 2022 37 2 18 [12;24] 1 [0;2]

Rash _ALL Ipilimumab 3 mg/kg Q3W 744 9964 176 9 18 [15;20] 1 [0;1]

Rash CheckMate-037 Nivolumab 3mg/kg Q2W 268 median 2251 25 1 11 [7;15] 0 [0;1]



Rash _ALL Nivolumab 3mg/kg Q2W 787 9604 137 4 14 [12;17] 0 [0;1]

Rash KEYNOTE-001 Pembrolizumab 10 mg/kg Q2W

57 median 627 15 2 24 [12;36] 3 [0;8]


278 median 2196 41 0 19 [13;24] 0 [0;0]

Rash _ALL Pembrolizumab 10 mg/kg Q2W

335 2823 56 2 20 [15;25] 1 [0;2]


56 median 616 10 0 16 [6;26] 0 [0;0]

Rash KEYNOTE-001 (randomized cohorts)


84 median 672 15 1 22 [11;34] 1 [0;4]


179 median 1790 18 0 10 [5;15] 0 [0;0]




N patients


N patients_months

N of AEs

N of grade

3-5 AEs


months [95%CI]


months [95%CI]


319 3078 43 1 14 [10;18] 0 [0;1]


22 median 242 3 1 12 [0;26] 4 [0;12]

Rash KEYNOTE-001 (randomized cohorts)


89 median 712 16 0 22 [11;33] 0 [0;0]


178 median 1780 21 0 12 [7;17] 0 [0;0]


289 2734 40 1 15 [10;19] 0 [0;1]

Rash erythematous KEYNOTE-006 Ipilimumab 3 mg/kg Q3W 256 median 2022 1 0 0 [0;1] 0 [0;0]

Rash erythematous _ALL Ipilimumab 3 mg/kg Q3W 256 2022 1 0 0 [0;1] 0 [0;0]

Rash erythematous CheckMate-037 Nivolumab 3mg/kg Q2W 268 median 2251 3 0 1 [0;3] 0 [0;0]

Rash erythematous _ALL Nivolumab 3mg/kg Q2W 268 2251 3 0 1 [0;3] 0 [0;0]

Rash erythematous KEYNOTE-006 Pembrolizumab 10 mg/kg Q2W

278 median 2196 3 0 1 [0;3] 0 [0;0]

Rash erythematous _ALL Pembrolizumab 10 mg/kg Q2W

278 2196 3 0 1 [0;3] 0 [0;0]

Rash generalised KEYNOTE-001 (randomized cohorts)


84 median 672 2 0 3 [0;7] 0 [0;0]

Rash generalised _ALL Pembrolizumab 10 mg/kg Q3W

84 672 2 0 3 [0;7] 0 [0;0]




N patients


N patients_months

N of AEs

N of grade

3-5 AEs


months [95%CI]


months [95%CI]

Rash generalised KEYNOTE-001 (randomized cohorts)


89 median 712 1 0 1 [0;4] 0 [0;0]

Rash generalised _ALL Pembrolizumab 2 mg/kg Q3W

89 712 1 0 1 [0;4] 0 [0;0]

Rash maculopapular CheckMate-067 Ipilimumab 3 mg/Kg + Nivolumab 1 mg/kg

313 minimum 3819 37 6 10 [7;13] 2 [0;3]

Rash maculopapular CheckMate-069 Ipilimumab 3 mg/Kg + Nivolumab 1 mg/kg

94 minimum 1034 15 3 15 [7;22] 3 [0;6]

Rash maculopapular _ALL Ipilimumab 3 mg/Kg + Nivolumab 1 mg/kg

407 4853 52 9 11 [8;14] 2 [1;3]

Rash maculopapular CheckMate-067 Ipilimumab 3 mg/kg Q3W 311 minimum 3794 37 1 10 [7;13] 0 [0;1]

Rash maculopapular CheckMate-069 Ipilimumab 3 mg/kg Q3W 46 minimum 506 8 0 16 [5;27] 0 [0;0]

Rash maculopapular KEYNOTE-006 Ipilimumab 3 mg/kg Q3W 256 median 2022 7 1 3 [1;6] 0 [0;1]

Rash maculopapular _ALL Ipilimumab 3 mg/kg Q3W 613 6323 52 2 8 [6;10] 0 [0;1]

Rash maculopapular CheckMate-037 Nivolumab 3mg/kg Q2W 268 median 2251 14 0 6 [3;9] 0 [0;0]

Rash maculopapular CheckMate-066 Nivolumab 3mg/kg Q2W 206 median 3440 6 1 2 [0;3] 0 [0;1]

Rash maculopapular _ALL Nivolumab 3mg/kg Q2W 474 5691 20 1 4 [2;5] 0 [0;1]

Rash maculopapular KEYNOTE-001 Pembrolizumab 10 mg/kg Q2W

57 median 627 1 0 2 [0;5] 0 [0;0]


278 median 2196 10 0 5 [2;7] 0 [0;0]

Rash maculopapular _ALL Pembrolizumab 10 mg/kg Q2W

335 2823 11 0 4 [2;6] 0 [0;0]




N patients


N patients_months

N of AEs

N of grade

3-5 AEs


months [95%CI]


months [95%CI]


56 median 616 1 0 2 [0;5] 0 [0;0]

Rash maculopapular KEYNOTE-001 (randomized cohorts)


84 median 672 2 1 3 [0;7] 1 [0;4]


179 median 1790 10 1 6 [2;9] 1 [0;2]


319 3078 13 2 4 [2;7] 1 [0;2]


22 median 242 0 0 0 [0;0] 0 [0;0]

Rash maculopapular KEYNOTE-001 (randomized cohorts)


89 median 712 2 0 3 [0;7] 0 [0;0]


178 median 1780 5 1 3 [0;5] 1 [0;2]


289 2734 7 1 3 [1;4] 0 [0;1]

Rash papular KEYNOTE-006 Ipilimumab 3 mg/kg Q3W 256 median 2022 3 0 1 [0;3] 0 [0;0]

Rash papular _ALL Ipilimumab 3 mg/kg Q3W 256 2022 3 0 1 [0;3] 0 [0;0]

Rash papular CheckMate-066 Nivolumab 3mg/kg Q2W 206 median 3440 5 0 1 [0;3] 0 [0;0]

Rash papular _ALL Nivolumab 3mg/kg Q2W 206 3440 5 0 1 [0;3] 0 [0;0]

Rash papular KEYNOTE-006 Pembrolizumab 10 mg/kg Q2W

278 median 2196 0 0 0 [0;0] 0 [0;0]




N patients


N patients_months

N of AEs

N of grade

3-5 AEs


months [95%CI]


months [95%CI]

Rash papular _ALL Pembrolizumab 10 mg/kg Q2W

278 2196 0 0 0 [0;0] 0 [0;0]

Rash pruritic CheckMate-069 Ipilimumab 3 mg/Kg + Nivolumab 1 mg/kg

94 minimum 1034 3 0 3 [0;6] 0 [0;0]

Rash pruritic _ALL Ipilimumab 3 mg/Kg + Nivolumab 1 mg/kg

94 1034 3 0 3 [0;6] 0 [0;0]

Rash pruritic CheckMate-069 Ipilimumab 3 mg/kg Q3W 46 minimum 506 5 0 10 [1;19] 0 [0;0]

Rash pruritic KEYNOTE-006 Ipilimumab 3 mg/kg Q3W 256 median 2022 4 0 2 [0;4] 0 [0;0]

Rash pruritic _ALL Ipilimumab 3 mg/kg Q3W 302 2528 9 0 4 [1;6] 0 [0;0]

Rash pruritic KEYNOTE-006 Pembrolizumab 10 mg/kg Q2W

278 median 2196 4 0 2 [0;4] 0 [0;0]

Rash pruritic _ALL Pembrolizumab 10 mg/kg Q2W

278 2196 4 0 2 [0;4] 0 [0;0]

Renal failure CheckMate-069 Ipilimumab 3 mg/Kg + Nivolumab 1 mg/kg

94 minimum 1034 1 0 1 [0;3] 0 [0;0]

Renal failure _ALL Ipilimumab 3 mg/Kg + Nivolumab 1 mg/kg

94 1034 1 0 1 [0;3] 0 [0;0]

Renal failure CheckMate-069 Ipilimumab 3 mg/kg Q3W 46 minimum 506 0 0 0 [0;0] 0 [0;0]

Renal failure _ALL Ipilimumab 3 mg/kg Q3W 46 506 0 0 0 [0;0] 0 [0;0]

Renal failure CheckMate-066 Nivolumab 3mg/kg Q2W 206 median 3440 2 0 1 [0;1] 0 [0;0]

Renal failure _ALL Nivolumab 3mg/kg Q2W 206 3440 2 0 1 [0;1] 0 [0;0]

Renal failure KEYNOTE-001 Pembrolizumab 10 mg/kg Q2W

57 median 627 2 2 3 [0;8] 3 [0;8]




N patients


N patients_months

N of AEs

N of grade

3-5 AEs


months [95%CI]


months [95%CI]

Renal failure _ALL Pembrolizumab 10 mg/kg Q2W

57 627 2 2 3 [0;8] 3 [0;8]


56 median 616 1 0 2 [0;5] 0 [0;0]


56 616 1 0 2 [0;5] 0 [0;0]


22 median 242 0 0 0 [0;0] 0 [0;0]


22 242 0 0 0 [0;0] 0 [0;0]

Skin hypopigmentation KEYNOTE-006 Ipilimumab 3 mg/kg Q3W 256 median 2022 0 0 0 [0;0] 0 [0;0]

Skin hypopigmentation _ALL Ipilimumab 3 mg/kg Q3W 256 2022 0 0 0 [0;0] 0 [0;0]

Skin hypopigmentation KEYNOTE-006 Pembrolizumab 10 mg/kg Q2W

278 median 2196 5 0 2 [0;4] 0 [0;0]

Skin hypopigmentation _ALL Pembrolizumab 10 mg/kg Q2W

278 2196 5 0 2 [0;4] 0 [0;0]

Skin hypopigmentation KEYNOTE-001 (randomized cohorts)


84 median 672 2 0 3 [0;7] 0 [0;0]


84 672 2 0 3 [0;7] 0 [0;0]

Skin hypopigmentation KEYNOTE-001 (randomized cohorts)


89 median 712 0 0 0 [0;0] 0 [0;0]


89 712 0 0 0 [0;0] 0 [0;0]




N patients


N patients_months

N of AEs

N of grade

3-5 AEs


months [95%CI]


months [95%CI]

Skin lesion KEYNOTE-006 Ipilimumab 3 mg/kg Q3W 256 median 2022 0 0 0 [0;0] 0 [0;0]

Skin lesion _ALL Ipilimumab 3 mg/kg Q3W 256 2022 0 0 0 [0;0] 0 [0;0]

Skin lesion KEYNOTE-006 Pembrolizumab 10 mg/kg Q2W

278 median 2196 1 0 0 [0;1] 0 [0;0]

Skin lesion _ALL Pembrolizumab 10 mg/kg Q2W

278 2196 1 0 0 [0;1] 0 [0;0]

Soft feces KEYNOTE-006 Ipilimumab 3 mg/kg Q3W 256 median 2022 3 0 1 [0;3] 0 [0;0]

Soft feces _ALL Ipilimumab 3 mg/kg Q3W 256 2022 3 0 1 [0;3] 0 [0;0]

Soft feces KEYNOTE-006 Pembrolizumab 10 mg/kg Q2W

278 median 2196 1 0 0 [0;1] 0 [0;0]

Soft feces _ALL Pembrolizumab 10 mg/kg Q2W

278 2196 1 0 0 [0;1] 0 [0;0]

Thrombocytopenia CheckMate-066 Nivolumab 3mg/kg Q2W 206 median 3440 0 0 0 [0;0] 0 [0;0]

Thrombocytopenia _ALL Nivolumab 3mg/kg Q2W 206 3440 0 0 0 [0;0] 0 [0;0]

Thrombocytopenia KEYNOTE-001 Pembrolizumab 10 mg/kg Q2W

57 median 627 1 0 2 [0;5] 0 [0;0]

Thrombocytopenia _ALL Pembrolizumab 10 mg/kg Q2W

57 627 1 0 2 [0;5] 0 [0;0]


56 median 616 1 0 2 [0;5] 0 [0;0]

Thrombocytopenia KEYNOTE-001 (randomized cohorts)


84 median 672 2 0 3 [0;7] 0 [0;0]




N patients


N patients_months

N of AEs

N of grade

3-5 AEs


months [95%CI]


months [95%CI]


179 median 1790 2 1 1 [0;3] 1 [0;2]


319 3078 5 1 2 [0;3] 0 [0;1]


22 median 242 2 0 8 [0;20] 0 [0;0]

Thrombocytopenia KEYNOTE-001 (randomized cohorts)


89 median 712 0 0 0 [0;0] 0 [0;0]


178 median 1780 2 0 1 [0;3] 0 [0;0]


289 2734 4 0 1 [0;3] 0 [0;0]

Thyroxine decreased KEYNOTE-001 (randomized cohorts)


84 median 672 3 0 4 [0;10] 0 [0;0]

Thyroxine decreased _ALL Pembrolizumab 10 mg/kg Q3W

84 672 3 0 4 [0;10] 0 [0;0]

Thyroxine decreased KEYNOTE-001 (randomized cohorts)


89 median 712 1 0 1 [0;4] 0 [0;0]

Thyroxine decreased _ALL Pembrolizumab 2 mg/kg Q3W

89 712 1 0 1 [0;4] 0 [0;0]

Tumour pain KEYNOTE-001 (randomized cohorts)


84 median 672 2 0 3 [0;7] 0 [0;0]

Tumour pain _ALL Pembrolizumab 10 mg/kg Q3W

84 672 2 0 3 [0;7] 0 [0;0]




N patients


N patients_months

N of AEs

N of grade

3-5 AEs


months [95%CI]


months [95%CI]

Tumour pain KEYNOTE-001 (randomized cohorts)


89 median 712 1 0 1 [0;4] 0 [0;0]

Tumour pain _ALL Pembrolizumab 2 mg/kg Q3W

89 712 1 0 1 [0;4] 0 [0;0]

Upper respiratory tract infection






278 median 2196 3 0 1 [0;3] 0 [0;0]



278 2196 3 0 1 [0;3] 0 [0;0]

Uveitis KEYNOTE-001 Pembrolizumab 10 mg/kg Q2W

57 median 627 0 0 0 [0;0] 0 [0;0]

Uveitis _ALL Pembrolizumab 10 mg/kg Q2W

57 627 0 0 0 [0;0] 0 [0;0]


56 median 616 2 0 3 [0;8] 0 [0;0]


56 616 2 0 3 [0;8] 0 [0;0]


22 median 242 0 0 0 [0;0] 0 [0;0]


22 242 0 0 0 [0;0] 0 [0;0]




N patients


N patients_months

N of AEs

N of grade

3-5 AEs


months [95%CI]


months [95%CI]

Vertigo CheckMate-066 Nivolumab 3mg/kg Q2W 206 median 3440 2 0 1 [0;1] 0 [0;0]

Vertigo _ALL Nivolumab 3mg/kg Q2W 206 3440 2 0 1 [0;1] 0 [0;0]

Vertigo KEYNOTE-001 (randomized cohorts)


84 median 672 2 0 3 [0;7] 0 [0;0]

Vertigo _ALL Pembrolizumab 10 mg/kg Q3W

84 672 2 0 3 [0;7] 0 [0;0]

Vertigo KEYNOTE-001 (randomized cohorts)


89 median 712 0 0 0 [0;0] 0 [0;0]

Vertigo _ALL Pembrolizumab 2 mg/kg Q3W

89 712 0 0 0 [0;0] 0 [0;0]

Vision blurred KEYNOTE-006 Ipilimumab 3 mg/kg Q3W 256 median 2022 3 0 1 [0;3] 0 [0;0]

Vision blurred _ALL Ipilimumab 3 mg/kg Q3W 256 2022 3 0 1 [0;3] 0 [0;0]

Vision blurred KEYNOTE-006 Pembrolizumab 10 mg/kg Q2W

278 median 2196 1 0 0 [0;1] 0 [0;0]

Vision blurred _ALL Pembrolizumab 10 mg/kg Q2W

278 2196 1 0 0 [0;1] 0 [0;0]

Visual impairment KEYNOTE-001 Pembrolizumab 10 mg/kg Q2W

57 median 627 1 0 2 [0;5] 0 [0;0]

Visual impairment _ALL Pembrolizumab 10 mg/kg Q2W

57 627 1 0 2 [0;5] 0 [0;0]


56 median 616 0 0 0 [0;0] 0 [0;0]




N patients


N patients_months

N of AEs

N of grade

3-5 AEs


months [95%CI]


months [95%CI]

Visual impairment KEYNOTE-001 (randomized cohorts)


84 median 672 0 0 0 [0;0] 0 [0;0]


140 1288 0 0 0 [0;0] 0 [0;0]


22 median 242 1 0 4 [0;12] 0 [0;0]

Visual impairment KEYNOTE-001 (randomized cohorts)


89 median 712 2 0 3 [0;7] 0 [0;0]


111 954 3 0 3 [0;7] 0 [0;0]

Vitiligo CheckMate-067 Ipilimumab 3 mg/Kg + Nivolumab 1 mg/kg

313 minimum 3819 21 0 5 [3;8] 0 [0;0]

Vitiligo CheckMate-069 Ipilimumab 3 mg/Kg + Nivolumab 1 mg/kg

94 minimum 1034 10 0 10 [4;16] 0 [0;0]

Vitiligo _ALL Ipilimumab 3 mg/Kg + Nivolumab 1 mg/kg

407 4853 31 0 6 [4;9] 0 [0;0]

Vitiligo CA-184-002 Ipilimumab 3 mg/kg Q3W 131 median 3642 3 0 1 [0;2] 0 [0;0]

Vitiligo CheckMate-067 Ipilimumab 3 mg/kg Q3W 311 minimum 3794 12 0 3 [1;5] 0 [0;0]

Vitiligo CheckMate-069 Ipilimumab 3 mg/kg Q3W 46 minimum 506 4 0 8 [0;16] 0 [0;0]

Vitiligo KEYNOTE-006 Ipilimumab 3 mg/kg Q3W 256 median 2022 4 0 2 [0;4] 0 [0;0]

Vitiligo _ALL Ipilimumab 3 mg/kg Q3W 744 9964 23 0 2 [1;3] 0 [0;0]

Vitiligo CheckMate-037 Nivolumab 3mg/kg Q2W 268 median 2251 14 0 6 [3;9] 0 [0;0]

Vitiligo CheckMate-066 Nivolumab 3mg/kg Q2W 206 median 3440 22 0 6 [4;9] 0 [0;0]




N patients


N patients_months

N of AEs

N of grade

3-5 AEs


months [95%CI]


months [95%CI]

Vitiligo _ALL Nivolumab 3mg/kg Q2W 474 5691 36 0 6 [4;8] 0 [0;0]

Vitiligo KEYNOTE-001 Pembrolizumab 10 mg/kg Q2W

57 median 627 7 0 11 [3;19] 0 [0;0]


278 median 2196 25 0 11 [7;16] 0 [0;0]

Vitiligo _ALL Pembrolizumab 10 mg/kg Q2W

335 2823 32 0 11 [7;15] 0 [0;0]


56 median 616 4 0 6 [0;13] 0 [0;0]

Vitiligo KEYNOTE-001 (randomized cohorts)


84 median 672 5 0 7 [1;14] 0 [0;0]


179 median 1790 9 0 5 [2;8] 0 [0;0]


319 3078 18 0 6 [3;9] 0 [0;0]


22 median 242 1 0 4 [0;12] 0 [0;0]

Vitiligo KEYNOTE-001 (randomized cohorts)


89 median 712 8 0 11 [3;19] 0 [0;0]


178 median 1780 10 0 6 [2;9] 0 [0;0]


289 2734 19 0 7 [4;10] 0 [0;0]




N patients


N patients_months

N of AEs

N of grade

3-5 AEs


months [95%CI]


months [95%CI]

Vomiting CheckMate-067 Ipilimumab 3 mg/Kg + Nivolumab 1 mg/kg

313 minimum 3819 48 8 13 [9;16] 2 [1;4]

Vomiting CheckMate-069 Ipilimumab 3 mg/Kg + Nivolumab 1 mg/kg

94 minimum 1034 13 1 13 [6;19] 1 [0;3]

Vomiting _ALL Ipilimumab 3 mg/Kg + Nivolumab 1 mg/kg

407 4853 61 9 13 [9;16] 2 [1;3]

Vomiting CA-184-002 Ipilimumab 3 mg/kg Q3W 131 median 3642 31 3 9 [6;12] 1 [0;2]

Vomiting CheckMate-067 Ipilimumab 3 mg/kg Q3W 311 minimum 3794 23 1 6 [4;9] 0 [0;1]

Vomiting CheckMate-069 Ipilimumab 3 mg/kg Q3W 46 minimum 506 5 0 10 [1;19] 0 [0;0]

Vomiting KEYNOTE-006 Ipilimumab 3 mg/kg Q3W 256 median 2022 14 0 7 [3;11] 0 [0;0]

Vomiting _ALL Ipilimumab 3 mg/kg Q3W 744 9964 73 4 7 [6;9] 0 [0;1]

Vomiting CheckMate-037 Nivolumab 3mg/kg Q2W 268 median 2251 8 1 4 [1;6] 0 [0;1]



Vomiting _ALL Nivolumab 3mg/kg Q2W 787 9604 41 3 4 [3;6] 0 [0;1]

Vomiting KEYNOTE-001 Pembrolizumab 10 mg/kg Q2W

57 median 627 3 1 5 [0;10] 2 [0;5]


278 median 2196 10 1 5 [2;7] 0 [0;1]

Vomiting _ALL Pembrolizumab 10 mg/kg Q2W

335 2823 13 2 5 [2;7] 1 [0;2]




N patients


N patients_months

N of AEs

N of grade

3-5 AEs


months [95%CI]


months [95%CI]


56 median 616 1 0 2 [0;5] 0 [0;0]

Vomiting KEYNOTE-001 (randomized cohorts)


84 median 672 3 0 4 [0;10] 0 [0;0]


179 median 1790 10 1 6 [2;9] 1 [0;2]


319 3078 14 1 5 [2;7] 0 [0;1]


22 median 242 0 0 0 [0;0] 0 [0;0]

Vomiting KEYNOTE-001 (randomized cohorts)


89 median 712 2 0 3 [0;7] 0 [0;0]


178 median 1780 2 1 1 [0;3] 1 [0;2]


289 2734 4 1 1 [0;3] 0 [0;1]

Weight decreased KEYNOTE-006 Ipilimumab 3 mg/kg Q3W 256 median 2022 5 1 2 [0;5] 0 [0;1]

Weight decreased _ALL Ipilimumab 3 mg/kg Q3W 256 2022 5 1 2 [0;5] 0 [0;1]

Weight decreased KEYNOTE-001 Pembrolizumab 10 mg/kg Q2W

57 median 627 2 0 3 [0;8] 0 [0;0]


278 median 2196 3 0 1 [0;3] 0 [0;0]

Weight decreased _ALL Pembrolizumab 10 mg/kg Q2W

335 2823 5 0 2 [0;3] 0 [0;0]




N patients


N patients_months

N of AEs

N of grade

3-5 AEs


months [95%CI]


months [95%CI]


56 median 616 0 0 0 [0;0] 0 [0;0]

Weight decreased KEYNOTE-001 (randomized cohorts)


84 median 672 2 0 3 [0;7] 0 [0;0]


140 1288 2 0 2 [0;4] 0 [0;0]


22 median 242 0 0 0 [0;0] 0 [0;0]

Weight decreased KEYNOTE-001 (randomized cohorts)


89 median 712 3 0 4 [0;9] 0 [0;0]


111 954 3 0 3 [0;7] 0 [0;0]

Wheezing KEYNOTE-001 (randomized cohorts)


84 median 672 2 0 3 [0;7] 0 [0;0]

Wheezing _ALL Pembrolizumab 10 mg/kg Q3W

84 672 2 0 3 [0;7] 0 [0;0]

Wheezing KEYNOTE-001 (randomized cohorts)


89 median 712 0 0 0 [0;0] 0 [0;0]

Wheezing _ALL Pembrolizumab 2 mg/kg Q3W

89 712 0 0 0 [0;0] 0 [0;0]

leukopenia CheckMate-066 Nivolumab 3mg/kg Q2W 206 median 3440 1 0 0 [0;1] 0 [0;0]

leukopenia _ALL Nivolumab 3mg/kg Q2W 206 3440 1 0 0 [0;1] 0 [0;0]

leukopenia KEYNOTE-001 Pembrolizumab 10 mg/kg Q2W

57 median 627 1 0 2 [0;5] 0 [0;0]




N patients


N patients_months

N of AEs

N of grade

3-5 AEs


months [95%CI]


months [95%CI]

leukopenia _ALL Pembrolizumab 10 mg/kg Q2W

57 627 1 0 2 [0;5] 0 [0;0]


56 median 616 1 0 2 [0;5] 0 [0;0]


56 616 1 0 2 [0;5] 0 [0;0]


22 median 242 1 0 4 [0;12] 0 [0;0]


22 242 1 0 4 [0;12] 0 [0;0]

renal failure acute CheckMate-069 Ipilimumab 3 mg/Kg + Nivolumab 1 mg/kg

94 minimum 1034 0 0 0 [0;0] 0 [0;0]

renal failure acute _ALL Ipilimumab 3 mg/Kg + Nivolumab 1 mg/kg

94 1034 0 0 0 [0;0] 0 [0;0]

renal failure acute CheckMate-069 Ipilimumab 3 mg/kg Q3W 46 minimum 506 1 0 2 [0;6] 0 [0;0]

renal failure acute _ALL Ipilimumab 3 mg/kg Q3W 46 506 1 0 2 [0;6] 0 [0;0]

renal failure acute CheckMate-066 Nivolumab 3mg/kg Q2W 206 median 3440 1 1 0 [0;1] 0 [0;1]

renal failure acute _ALL Nivolumab 3mg/kg Q2W 206 3440 1 1 0 [0;1] 0 [0;1]

SAS Sytstem. The results include data from the following ... · AST increased KEYNOTE-006 Ipilimumab 3 mg/kg Q3W 256 median 2022 6 2 3 [1;5] 1 [0;2] AST increased _ALL Ipilimumab

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