Page 1 Data Coordination Unit– MUSC ESETT Study Book v3 05Jan2016 ESETT ____ ____ ____ Subject ID General Comments: Name of person who collected data: If this worksheet is a source document, sign/date here: Page 1 of 1 ESETT version 1 24Jun2015 Subject Enrollment Form (version 1) Q03 Gender: O Male O Female Q04 Estimated age group: O Child (2-17) O Adult (18-65) O Elder (66 or older) Q05 Enrollment Date: (i.e. the date of study drug infusion.) ___ ___ - ___ ___ ___ - ___ ___ ___ ___ dd-mmm-yyyy Visit: Baseline
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ESETT Visit: Baseline Data Collected? O O No Yes · Data Collected? O O Yes General Comments: ... O No O Yes O Unknown Q05 O No O Yes O Visit: Baseline. Data Coordination Unit–
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Page 1 Data Coordination Unit– MUSC ESETT Study Book v3 05Jan2016
Name of person who collected data: If this worksheet is a source document, sign/date here:
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Form 501: Treatment Effect (version 1)
Assessment at 20 minutes
Q01 Was the 20 minute assessment for seizures/responsiveness done?
O No O Yes O Unknown
Q02 If Q01 = ‘Yes’
Date/time of 20 minute assessment: ___ ___ - ___ ___ ___ - ___ ___ ___ ___ / ___ ___ : ___ ___ O AM O PM
dd-mmm-yyyy hh:mm
Q03 If Q01 = ‘Yes’
Were there clinically apparent seizures at 20 minutes after the start of the study drug infusion?
O No O Yes O Unknown
Q04 If Q01 = ‘Yes’
Was responsiveness to verbal commands or noxious stimuli improved at 20 minutes after the start of study drug infusion compared to responsiveness at the time the study drug infusion began?
O No O Yes O Unknown
Assessment at 60 minutes (Primary Outcome)
Q05 Was the 60 minute assessment for seizures/responsiveness done?
O No O Yes O Unknown
Q06 If Q05 = ‘Yes’
Date/time of 60 minute assessment: ___ ___ - ___ ___ ___ - ___ ___ ___ ___ / ___ ___ : ___ ___ O AM O PM
dd-mmm-yyyy hh:mm
Q07 If Q05 = ‘Yes’
Were there clinically apparent seizures at 60 minutes after the start of the study drug infusion?
O No O Yes O Unknown
Q08 If Q05 = ‘Yes’
Was responsiveness to verbal commands or noxious stimuli improved at 60 minutes after the start of study drug infusion compared to responsiveness at the time the study drug infusion began?
O No O Yes O Unknown
Visit: Baseline
Page 5 Data Coordination Unit– MUSC ESETT Study Book v3 05Jan2016
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Form 501: Treatment Effect (version 1)
Q09 If Q05 = ‘Yes’
Richmond Agitation Sedation Scale (RASS) at 60 minute assessment:
O +4 Combative (Overtly combative, violent, immediate danger to staff)
O +3 Very agitated (Pulls or removes tube(s) or catheter(s); aggressive)
O +2 Agitated (Frequent non-purposeful movement, fights ventilator)
O +1 Restless (Anxious but movements not aggressive vigorous)
O 0 Alert and calm
O -1 Drowsy (Not fully alert, but has sustained awakening (eye-opening/
eye contact) to voice (>10 seconds))
O -2 Light sedation (Briefly awakens with eye contact to voice (<10
seconds))
O -3 Moderate sedation (Movement or eye opening to voice (but no eye
contact))
O -4 Deep sedation (No response to voice, but movement or eye
opening to physical stimulation)
O -5 Unarousable (No response to voice or physical stimulation)
Other anti-seizure medications
Q10
Aside from the study drug, were any other anti-seizure medications administered within 60 minutes after the study drug infusion began? (see MOP for a list of anti-seizure medications)
O No O Yes O Unknown
If Q10 = ‘Yes’
A. Date/time other anti-seizure medications
administered within 60 minutes after study drug infusion
C. Dose in milligrams
B. Medication name
Q11-1 If Q10 = ‘Yes’
___ ___ - ___ ___ ___ - ___ ___ ___ ___
dd-mmm-yyyy
___ ___ : ___ ___ O AM O PM
Q11-2 If Q10 = ‘Yes’
___ ___ - ___ ___ ___ - ___ ___ ___ ___
dd-mmm-yyyy
___ ___ : ___ ___ O AM O PM
Visit: Baseline
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Name of person who collected data: If this worksheet is a source document, sign/date here:
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Form 503: Secondary Outcomes (version 1)
If ‘yes’ for any question below, complete a corresponding AE form.
Life-threatening hypotension is defined as systolic blood pressure remaining below the age-specified thresholds on two consecutive readings at least 10 minutes apart and remaining below the age-specified thresholds for more than 10 minutes after reduction of the rate of study drug infusion
rate (or its termination) and a fluid challenge. The “age-specified thresholds” for systolic blood pressure are 90 mmHg in adults and children 13 years and older, 80 mmHg in children 7 to 12 years old, and 70 mmHg in children through 6 years of age.
Q01
Did the subject experience life-threatening hypotension within 60 minutes of the start of study drug infusion?
O No O Yes O Unknown
Q02
Did the subject experience life-threatening cardiac arrhythmia within 60 minutes of the start of study drug infusion?
O No O Yes O Unknown
Q03 Was endotracheal intubation performed or attempted within 60 minutes of the start of study drug infusion? O No O Yes O Unknown
Q04 Did the subject experience acute seizure recurrence between 60 minutes and 12 hours after the start of study drug infusion?
O No O Yes O Unknown
Q05 Did the subject experience acute anaphylaxis within 6 hours of the start of study drug infusion? O No O Yes O Unknown
Visit: Baseline
Page 8 Data Coordination Unit– MUSC ESETT Study Book v3 05Jan2016
Name of person who collected data: If this worksheet is a source document, sign/date here:
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Form 101: Eligibility (version 1)
All eligibility criteria must be met prior to study drug administration/randomization
Q01 Subject’s date of birth: (must be > 2 years of age to be eligible)
___ ___ - ___ ___ ___ - ___ ___ ___ ___
dd-mmm-yyyy
Inclusion Criteria
Q02 Subject experiencing generalized convulsive seizure greater than 5 minutes in duration: O No O Yes O Unknown
Q03
Subject received adequate cumulative dose(s) of benzodiazepines (may be administered in two or more divided doses):
For all adults, and children ≥ 40 kg, adequate doses are at least: diazepam 10 mg IV or PR or lorazepam 4 mg IV or midazolam 10 mg IV or IM
For children < 40 kg, adequate doses are at least: diazepam 0.3 mg/kg IV or PR or lorazepam 0.1 mg/kg IV or midazolam 0.3mg/kg IM - or 0.2 mg/kg IV
O No O Yes O Unknown
Q04 At least one dose of benzodiazepine was received ≥ 5 minutes and < 30 minutes prior to start of study drug infusion: O No O Yes O Unknown
Q05 Subject continued to have persistent or recurrent convulsions in the emergency department after receiving benzodiazepine and prior to start of study drug infusion:
O No O Yes O Unknown
Visit: Baseline
Page 12 Data Coordination Unit– MUSC ESETT Study Book v3 05Jan2016
Name of person who collected data: If this worksheet is a source document, sign/date here:
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Form 101: Eligibility (version 1)
Exclusion Criteria
Q06 Known pregnancy: O No O Yes O Unknown
Q07 Prisoner: O No O Yes O Unknown
Q08 Treatment with a second line anticonvulsant prior to start of study drug infusion for this episode of status epilepticus (Fosphenytoin (FOS), Phenytoin (PHT), Valproic Acid (VPA), Levetiracetam (LEV), phenobarbital or other similar agents):
O No O Yes O Unknown
Q09 Treatment with sedatives with anticonvulsant properties other than benzodiazepines prior to start of study drug infusion (propofol, etomidate, ketamine or other similar agents):
O No O Yes O Unknown
Q10 Endotracheal intubation prior to start of study drug infusion: O No O Yes O Unknown
Q11 Acute traumatic brain injury: O No O Yes O Unknown
Q12 Known metabolic disorder: O No O Yes O Unknown
Q13 Known liver disease: O No O Yes O Unknown
Q14 Known severe renal impairment: O No O Yes O Unknown
Q15 Known contraindication to Fosphenytoin (FOS), Phenytoin (PHT), Valproic Acid (VPA), or Levetiracetam (LEV), including allergy to any study drug or sustained hypotension:
O No O Yes O Unknown
Q16 Hypoglycemia < 50 mg/dL: O No O Yes O Unknown
Q17 Hyperglycemia > 400 mg/dL: O No O Yes O Unknown
Q18 Cardiac arrest / post-anoxic seizures: O No O Yes O Unknown
Q19 The patient is wearing an opt-out bracelet or other opt-out identifier: O No O Yes O Unknown
Q20 The patient is known to have been previously enrolled in ESETT: O No O Yes O Unknown
Visit: Baseline
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Form 108: Prior Relevant Home Medications (version 1)
Document currently prescribed anticonvulsant medications and medications that may affect protein binding of study drug taken by the subject (see CRF guidelines). Medications are listed below.
A.
Name of Medication
B. Dose (mg) If A = ‘Phenytoin,’ ‘Levetiracetam,’ or
‘Valproic Acid/Valproate’
C. Frequency If A = ‘Phenytoin,’ ‘Levetiracetam,’ or
‘Valproic Acid/Valproate’
D. Indication
E. Taken in the 24 hours
prior to ED arrival?
Q01-1 __ __ __ __
O 1x per day
O 2x per day
O 3x per day
O Epilepsy
O Other
O Unknown
O No
O Yes
Q01-2 __ __ __ __
O 1x per day
O 2x per day
O 3x per day
O Epilepsy
O Other
O Unknown
O No
O Yes
Q01-3 __ __ __ __
O 1x per day
O 2x per day
O 3x per day
O Epilepsy
O Other
O Unknown
O No
O Yes
Q01-4 __ __ __ __
O 1x per day
O 2x per day
O 3x per day
O Epilepsy
O Other
O Unknown
O No
O Yes
Q01-5 __ __ __ __
O 1x per day
O 2x per day
O 3x per day
O Epilepsy
O Other
O Unknown
O No
O Yes
Q01-6 __ __ __ __
O 1x per day
O 2x per day
O 3x per day
O Epilepsy
O Other
O Unknown
O No
O Yes
Anticonvulsants/AEDs (anti-epilepsy drugs) and medications that affect protein binding:
Name of person who collected data: If this worksheet is a source document, sign/date here:
Visit: Baseline
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Form 104: Adverse Events (version 2)
This CRF is optional and should only be completed if the subject experiences an Adverse Event.
All adverse events (AEs) occurring within 24 hours of treatment and all serious adverse events (SAEs) occurring during study participation should
be documented on an AE case report form.
Q01 Adverse Event Name:
Grade: Please refer to Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0.
Grade refers to the severity of the AE. The CTCAE displays Grades 1 through 5 with unique clinical descriptions of severity for each AE based on this general guideline:
Grade 1 - Mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated.
Grade 2 - Moderate; minimal, local or noninvasive intervention indicated; limiting age-appropriate instrumental Activities of Daily Living.
Grade 3 - Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self care Activities of Daily Living.
Name of person who collected data: If this worksheet is a source document, sign/date here:
Visit: End of Study
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Form 104: Adverse Events (version 2)
This CRF is optional and should only be completed if the subject experiences an Adverse Event.
All adverse events (AEs) occurring within 24 hours of treatment and all serious adverse events (SAEs) occurring during study participation should
be documented on an AE case report form.
Q01 Adverse Event Name:
Grade: Please refer to Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0.
Grade refers to the severity of the AE. The CTCAE displays Grades 1 through 5 with unique clinical descriptions of severity for each AE based on this general guideline:
Grade 1 - Mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated.
Grade 2 - Moderate; minimal, local or noninvasive intervention indicated; limiting age-appropriate instrumental Activities of Daily Living.
Grade 3 - Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self care Activities of Daily Living.
Name of person who collected data: If this worksheet is a source document, sign/date here:
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Form 126: End of Study (version 2)
Visit: End of Study
Q01 Primary reason for study termination:
O Study Completed
O Consent withdrawn/declined Specify: ______________________
O Lost to follow-up
O Death
O Other Specify: ____________________________
Q02
If Q01 = ‘Consent Withdrawn/Declined’
Date consent was withdrawn/declined: ___ ___ - ___ ___ ___ - ___ ___ ___ ___
(dd-mmm-yyyy)
Q03
If Q01 = ‘Consent Withdrawn/Declined’
Was study termination due to an adverse event? O No O Yes
Q04 If Q01 = ‘Lost to follow-up’
Date subject was last known to be alive: ___ ___ - ___ ___ ___ - ___ ___ ___ ___
(dd-mmm-yyyy)
Q05 If Q01 = ‘Death’
Date of death: ___ ___ - ___ ___ ___ - ___ ___ ___ ___
(dd-mmm-yyyy)
The site PI must review and affirm the accuracy of the information reflected in all of the case report forms for this study participant. Please complete the section below after this review and affirmation is complete.
Q06 First/given name of reviewing site PI: (50 character max)
Q07 Last/family name of reviewing site PI: (50 character max)
Q08 Date of site PI review and affirmation: ___ ___ - ___ ___ ___ - ___ ___ ___ ___