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–

Page 1 Data Coordination Unit– MUSC ESETT Study Book v3 05Jan2016

ESETT

____ ____ ____

Subject ID

___ ___ - ___ ___ ___ - ___ ___ ___ ___ (dd-mmm-yyyy)

Date of assessment

Data Collected?

O No O Yes

General Comments:

Name of person who collected data: If this worksheet is a source document, sign/date here:

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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


ESETT

____ ____ ____

Subject ID

___ ___ - ___ ___ ___ - ___ ___ ___ ___ (dd-mmm-yyyy)

Date of assessment

Data Collected?

O No O Yes

General Comments:


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Form 102: Randomization (version 1)

Q01 Study Drug ID administered: (the 4-digit code of the study drug administered)

Visit: Baseline


ESETT

____ ____ ____

Subject ID

___ ___ - ___ ___ ___ - ___ ___ ___ ___ (dd-mmm-yyyy)

Date of assessment

Data Collected?

O No O Yes

General Comments:


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Form 504: Study Drug Infusion (version 1)

Q01 Start date/time of infusion: ___ ___ - ___ ___ ___ - ___ ___ ___ ___ / ___ ___ : ___ ___ O AM O PM

dd-mmm-yyyy hh:mm

Q02 Stop date/time of infusion: ___ ___ - ___ ___ ___ - ___ ___ ___ ___ / ___ ___ : ___ ___ O AM O PM

dd-mmm-yyyy hh:mm

Q03 Infusion volume: ___ ___ mL

Q04 Initial infusion rate: ___ . ___ mL/min

Q05 Estimated weight at time of study drug infusion: ___ ___ ___ . ___

Q06 Estimated weight units: O lbs

O kg

Q07 Actual weight: ___ ___ ___ . ___

Q08 Actual weight units: O lbs

O kg

Q09 Describe any problems that occurred with study drug administration:

Visit: Baseline


ESETT

____ ____ ____

Subject ID

___ ___ - ___ ___ ___ - ___ ___ ___ ___ (dd-mmm-yyyy)

Date of assessment

Data Collected?

O No O Yes

General Comments:


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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?


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?


Assessment at 60 minutes (Primary Outcome)

Q05 Was the 60 minute assessment for seizures/responsiveness done?


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?


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?


Visit: Baseline


ESETT

____ ____ ____

Subject ID

___ ___ - ___ ___ ___ - ___ ___ ___ ___ (dd-mmm-yyyy)

Date of assessment

Data Collected?

O No O Yes

General Comments:


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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)


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


ESETT

____ ____ ____

Subject ID

___ ___ - ___ ___ ___ - ___ ___ ___ ___ (dd-mmm-yyyy)

Date of assessment

Data Collected?

O No O Yes

General Comments:


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Q12 Was this form completed at the subject’s bedside at the time of assessment?

O No O Yes

Q13 If Q12 = ‘No’

How was the information for questions 7, 8, and 10 on this form determined? Check all that apply

Discussion with the treating team within 3 hours of the 60 minute

assessment

Discussion with the treating team more than 3 hours after the 60 minute

assessment

Medical Record

Visit: Baseline


ESETT

____ ____ ____

Subject ID

___ ___ - ___ ___ ___ - ___ ___ ___ ___ (dd-mmm-yyyy)

Date of assessment

Data Collected?

O No O Yes

General Comments:


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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?


Q02

Did the subject experience life-threatening cardiac arrhythmia within 60 minutes of the start of study drug infusion?


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?


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


ESETT

____ ____ ____

Subject ID

___ ___ - ___ ___ ___ - ___ ___ ___ ___ (dd-mmm-yyyy)

Date of assessment

Data Collected?

O No O Yes

General Comments:


Form 211: Informed Consent Log (version 2)

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Q01 Is this subject known to have been previously randomized into the ESETT Trial at any participating site? O No O Yes

Q02 If Q01 = ‘Yes’ Previous Subject ID for this subject:

___ ___ ___ ___

Document all attempts made to obtain informed consent (in the order that they occurred)

A. Date/time of consent attempt

B. Contact person

C. Description of consent attempt

D. Outcome

Q03-1

___ ___ - ___ ___ ___ - ___ ___ ___ ___

dd-mmm-yyyy

___ ___ : ___ ___ O AM O PM

O Subject

O LAR

O Other

O Consent obtained

O Consent declined

O Notification only

O Notification only - subject deceased

O No determination of consent or notification

Q03-2

___ ___ - ___ ___ ___ - ___ ___ ___ ___

dd-mmm-yyyy

___ ___ : ___ ___ O AM O PM

O Subject

O LAR

O Other

O Consent obtained

O Consent declined

O Notification only



Visit: Baseline


ESETT

____ ____ ____

Subject ID

___ ___ - ___ ___ ___ - ___ ___ ___ ___ (dd-mmm-yyyy)

Date of assessment

Data Collected?

O No O Yes

General Comments:



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Document all attempts made to obtain informed consent (in the order that they occurred)

A. Date/time of consent attempt

B. Contact person

C. Description of consent attempt

D. Outcome

Q03-3

___ ___ - ___ ___ ___ - ___ ___ ___ ___

dd-mmm-yyyy

___ ___ : ___ ___ O AM O PM

O Subject

O LAR

O Other

O Consent obtained

O Consent declined

O Notification only



Q03-4

___ ___ - ___ ___ ___ - ___ ___ ___ ___

dd-mmm-yyyy

___ ___ : ___ ___ O AM O PM

O Subject

O LAR

O Other

O Consent obtained

O Consent declined

O Notification only



Q03-5

___ ___ - ___ ___ ___ - ___ ___ ___ ___

dd-mmm-yyyy

___ ___ : ___ ___ O AM O PM

O Subject

O LAR

O Other

O Consent obtained

O Consent declined

O Notification only



Visit: Baseline


ESETT

____ ____ ____

Subject ID

___ ___ - ___ ___ ___ - ___ ___ ___ ___ (dd-mmm-yyyy)

Date of assessment

Data Collected?

O No O Yes

General Comments:



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Q04 Identify any informed consent errors of which the study team

becomes aware:

Check all that apply.

Lost original IC

Missing documentation of IC process

Incorrect IC version signed

IC missing subject/LAR signature

IC missing/incorrect subject/LAR signature date

IC missing investigator signature

IC missing/incorrect investigator signature date

Other

Q05 If Q04 = ‘Other’ Please specify ‘other’

errors:

Q06

O Completed

O Not given

O Refused

O Other

LAR/Subject post-enrollment survey:

Visit: Baseline


ESETT

____ ____ ____

Subject ID

___ ___ - ___ ___ ___ - ___ ___ ___ ___ (dd-mmm-yyyy)

Date of assessment

Data Collected?

O No O Yes

General Comments:


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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


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:


Visit: Baseline


ESETT

____ ____ ____

Subject ID

___ ___ - ___ ___ ___ - ___ ___ ___ ___ (dd-mmm-yyyy)

Date of assessment

Data Collected?

O No O Yes

General Comments:


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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):


Q09 Treatment with sedatives with anticonvulsant properties other than benzodiazepines prior to start of study drug infusion (propofol, etomidate, ketamine or other similar agents):


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:


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


ESETT

____ ____ ____

Subject ID

___ ___ - ___ ___ ___ - ___ ___ ___ ___ (dd-mmm-yyyy)

Date of assessment

Data Collected?

O No O Yes

General Comments:


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Form 506: ED Arrival Form (version 1)

Q01 Date/time of ED arrival: ___ ___ - ___ ___ ___ - ___ ___ ___ ___ / ___ ___ : ___ ___ O AM O PM

dd-mmm-yyyy hh:mm

Document all benzodiazepines administered for the enrolling seizure event prior to study drug infusion

Date/time of benzodiazepine administration Medication Dose in milligrams Route Setting

Q02-1

___ ___ - ___ ___ ___ - ___ ___ ___ ___

dd-mmm-yyyy

___ ___ : ___ ___ O AM O PM

O Diazepam

O Midazolam

O Lorazepam

O IV

O IM

O PR

O IN/PB

O Prior to EMS

O EMS

O ED

Q02-2

___ ___ - ___ ___ ___ - ___ ___ ___ ___

dd-mmm-yyyy

___ ___ : ___ ___ O AM O PM

O Diazepam

O Midazolam

O Lorazepam

O IV

O IM

O PR

O IN/PB

O Prior to EMS

O EMS

O ED

Q02-3

___ ___ - ___ ___ ___ - ___ ___ ___ ___

dd-mmm-yyyy

___ ___ : ___ ___ O AM O PM

O Diazepam

O Midazolam

O Lorazepam

O IV

O IM

O PR

O IN/PB

O Prior to EMS

O EMS

O ED

Q02-4

___ ___ - ___ ___ ___ - ___ ___ ___ ___

dd-mmm-yyyy

___ ___ : ___ ___ O AM O PM

O Diazepam

O Midazolam

O Lorazepam

O IV

O IM

O PR

O IN/PB

O Prior to EMS

O EMS

O ED

Visit: Baseline


ESETT

____ ____ ____

Subject ID

___ ___ - ___ ___ ___ - ___ ___ ___ ___ (dd-mmm-yyyy)

Date of assessment

Data Collected?

O No O Yes

General Comments:


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Form 117: Baseline Vital Signs (version 1)

Baseline vital signs are the vital signs collected closest and prior to the start of study drug infusion

Q01 Date/time of vital signs assessment: ___ ___ - ___ ___ ___ - ___ ___ ___ ___ / ___ ___ : ___ ___ O AM O PM

dd-mmm-yyyy hh:mm

Q02 Blood pressure (systolic): ___ ___ ___ mm Hg

Q03 Blood pressure (diastolic): ___ ___ ___ mm Hg

Q04 Heart rate/pulse: ___ ___ ___ beats/min

Q05 Respiratory rate: ___ ___ breaths/min

Q06 Temperature: ___ ___ ___

Q07 Temperature units: O °C O °F

Q08 Oxygen saturation (%):

___ ___ ___ %

Visit: Baseline


ESETT

____ ____ ____

Subject ID

___ ___ - ___ ___ ___ - ___ ___ ___ ___ (dd-mmm-yyyy)

Date of assessment

Data Collected?

O No O Yes

General Comments:


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Form 505: Demographics (version 1)

Q01 Ethnicity:

O Hispanic or Latino

O Not Hispanic or Latino

O Unknown

Q02 Race: (Check all that apply)

American Indian or Alaska Native

Asian

Black or African American

Native Hawaiian or Other Pacific Islander

White

Unknown

Q03 Number of years of education: ___ ___ years

Visit: Baseline


ESETT

____ ____ ____

Subject ID

___ ___ - ___ ___ ___ - ___ ___ ___ ___ (dd-mmm-yyyy)

Date of assessment

Data Collected?

O No O Yes

General Comments:


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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:

Aspirin Carbamazepine Clobazam Diazepam Ethosuximide Etomidate Ezogabine Felbamate Fosphenytoin Gabapentin Heparin Ibuprofen

Ketamine Lacosamide Lamotrigine Levetiracetam Naproxen Oxcarbamazepine Parampanel Pentobarbital Phenobarbital Phenytoin Pregabalin Primidone

Rufinamide Salicylate Sulphonylureas Tiagabine Tolmetin Topiramate Valproate Valproic acid Vigabatrin Zonisamide

Visit: Baseline


ESETT

____ ____ ____

Subject ID

___ ___ - ___ ___ ___ - ___ ___ ___ ___ (dd-mmm-yyyy)

Date of assessment

Data Collected?

O No O Yes

General Comments:


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Form 508: Affirmation of Adverse Event Assessment (version 1)

Q01 Affirmation of adverse event assessment at 24-36 hours post randomization:

O This subject was re-evaluated for adverse events at 24-36 hours post

randomization.

O This subject was not re-evaluated for adverse events at 24-36 hours post

randomization due to staff error.

O This subject was not re-evaluated for adverse events at 24-36 hours post

randomization due to ‘end of study’ occurring prior to that time.

Visit: Baseline


ESETT

____ ____ ____

Subject ID

___ ___ - ___ ___ ___ - ___ ___ ___ ___ (dd-mmm-yyyy)

Date of assessment

Data Collected?

O No O Yes

General Comments:


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.

Grade 4 - Life-threatening consequences; urgent intervention indicated.

Grade 5 - Death related to AE.

Q02 Grade:

O Grade 1

O Grade 2

O Grade 3

O Grade 4

O Grade 5

Q03 Serious? O No O Yes

Q04 Relatedness to study intervention:

O Unrelated

O Unlikely

O Reasonable possibility

O Definite

Q05 Date of onset: ___ ___ - ___ ___ ___ - ___ ___ ___ ___

dd-mmm-yyyy

Q40 Time of onset: ___ ___ : ___ ___ O AM O PM

hh:mm

Q06 Outcome:

O Resolved

O Resolved with sequelae

O Continuing (Follow up is required)

O Continuing at end of study (No follow up is required)

O Continuing at time of death

O Unknown

Q07

If Q06 is ‘Resolved’ or ‘Resolved with sequelae’

Date of resolution:

___ ___ - ___ ___ ___ - ___ ___ ___ ___ (dd-mmm-yyyy)


ESETT

____ ____ ____

Subject ID

___ ___ - ___ ___ ___ - ___ ___ ___ ___ (dd-mmm-yyyy)

Date of assessment

Data Collected?

O No O Yes

General Comments:


Visit: Baseline

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Q08 Actions taken with study intervention: (Check all that apply)

None

Study intervention interrupted

Study intervention discontinued

Study intervention modified

Q30 Which of the following protocol/MOP specific definition was met by this adverse event?

O Life-threatening hypotension

O Life-threatening cardiac arrhythmia

O Acute seizure recurrence

O Acute anaphylaxis

O Acute respiratory depression requiring intubation

O Hepatic transaminase or ammonia elevations

O Purple glove syndrome

O None of the above

Q31

If Q30 = ‘Acute seizure recurrence’

Is this the first recurrent seizure onset?

O No

O Yes

Q32


Date of recurrent seizure onset:

___ ___ - ___ ___ ___ - ___ ___ ___ ___ dd-mmm-yyyy

Q41


Time of recurrent seizure onset:

___ ___ : ___ ___ O AM O PM

hh:mm

Q33


Did patient receive anticonvulsant?

O No

O Yes

Q34 Was endotracheal intubation performed or attempted as a result of this adverse event?

O No

O Yes

Q35 If Q34 = ‘Yes’

Has this intubation been reported in a prior AE?

O No

O Yes

Q36 If Q35 = ‘Yes’

AE CRF ID number: ___ ___ ___ ___ ___ ___ ___

Q37 If Q34 = ‘Yes’

Indication for intubation:

O Seizure activity

O Respiratory depression

O Decreased level of consciousness

O Other Specify _______________________


ESETT

____ ____ ____

Subject ID

___ ___ - ___ ___ ___ - ___ ___ ___ ___ (dd-mmm-yyyy)

Date of assessment

Data Collected?

O No O Yes

General Comments:


Visit: Baseline

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Complete the remainder of the form for SAEs only.

Q38 If Q35 = ‘No’ Date of intubation (or attempt):

___ ___ - ___ ___ ___ - ___ ___ ___ ___ dd-mmm-yyyy

Q42 If Q35 = ‘No’ Time of intubation (or attempt):

___ ___ : ___ ___ O AM O PM

hh:mm

Q39 If Q35 = ‘No’ Was the attempted intubation successful?

O No

O Yes

Q09 If Q03 is ‘Yes’

Describe event or

problem: DO NOT identify any subject, physician, or institution by name.

Q10 If Q03 is ‘Yes’ Relevant Tests/Laboratory Data, including dates:

Q11 If Q03 is ‘Yes’ Other Relevant History, Including Preexisting Medical Conditions:

Q12 If Q03 is ‘Yes’ Last name of reporting site investigator:

Q13 If Q03 is ‘Yes’ Date of reporting site investigator signature:

___ ___ - ___ ___ ___ - ___ ___ ___ ___ (dd-mmm-yyyy)


ESETT

____ ____ ____

Subject ID

___ ___ - ___ ___ ___ - ___ ___ ___ ___ (dd-mmm-yyyy)

Date of assessment

Data Collected?

O No O Yes

General Comments:


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Form 123: Hospital Discharge (version 1)

Q01 Was the subject discharged within 30 days of randomization?

O No

O Yes

O Unknown (e.g. if consent withdrawn)

Q02 If Q01 = ‘Yes’ Discharge date: ___ ___ - ___ ___ ___ - ___ ___ ___ ___ (dd-mmm-yyyy)

Q03

Number of days in the ICU: For partial days, round up. For subjects in ICU for >30 days, enter 30.

___ ___ days

Q04 Diagnosis at time of discharge (or subject’s end of study, whichever comes first):

O Seizure / Status epilepticus

O Non-epileptic spell

O Unable to determine from the medical record

Q05 If Q04 = ‘Non-epileptic spell’

Type of non-epileptic spell: O Psychogenic non-epileptic seizures

O Other seizure mimic or non-epileptic coma Specify _____________

Visit: End of Study


ESETT

____ ____ ____

Subject ID

___ ___ - ___ ___ ___ - ___ ___ ___ ___ (dd-mmm-yyyy)

Date of assessment

Data Collected?

O No O Yes

General Comments:


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Form 123: Hospital Discharge (version 1)

Q06 Is there a prior history of epilepsy? O No

O Yes

Q07 If Q06 = ‘Yes’ Was enrolling episode provoked or unprovoked?

O Provoked

O Unprovoked

Q08

If Q06 = ‘No’ or if Q07 = ‘Provoked’

Precipitant of the enrolling episode:

O Anti-epileptic drug withdrawal/non compliance

O Toxic (alcohol / drug withdrawal-not AEDs, poisoning, etc.)

O Febrile illness

O CNS infection

O CNS tumor

O Acute stroke/Hemorrhage

O Hypoxic ischemic encephalopathy

O Metabolic (hypoglycemia, hyponatremia, etc.)

O Acute trauma

O Insufficient information to determine/idiopathic/cryptogenic

O Other Specify _______________________

Q09 Emergency room disposition:

O Discharged from the ED

O Admitted directly to ICU

O Admitted directly to another (non-ICU) unit of hospital

O Transferred to a non-study hospital

Visit: End of Study


ESETT

____ ____ ____

Subject ID

___ ___ - ___ ___ ___ - ___ ___ ___ ___ (dd-mmm-yyyy)

Date of assessment

Data Collected?

O No O Yes

General Comments:


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Form 507: EEG Interpretation form (version 1)

Visit: End of Study

Q01 Was an EEG conducted for standard of care within 24 hours of seizure onset?

O No

O Yes

Q02 If Q01 = ‘Yes’ Date/time EEG was started: ___ ___ - ___ ___ ___ - ___ ___ ___ ___ / ___ ___ : ___ ___ O AM O PM

dd-mmm-yyyy hh:mm

Q03 If Q01 = ‘Yes’ Type of EEG conducted: O Routine

O Prolonged/continuous

Q04 If Q03 = ‘Prolonged/continuous’

Specify duration: O Less than 24 hours

O Greater than or equal to 24 hours

Q05 If Q03 = ‘Routine’

Specify duration:

O 1 hour or less

O Greater than 1 hour but less than 2 hours

O 2 hours

O Greater than 2 hours

Q06 If Q01 = ‘Yes’ Seizures recorded on EEG: O No

O Yes

Q07 If Q06= ‘Yes’ Was clinical correlate noted on report?

O No

O Yes

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Subject ID

___ ___ - ___ ___ ___ - ___ ___ ___ ___ (dd-mmm-yyyy)

Date of assessment

Data Collected?

O No O Yes

General Comments:


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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.

Grade 4 - Life-threatening consequences; urgent intervention indicated.

Grade 5 - Death related to AE.

Q02 Grade:

O Grade 1

O Grade 2

O Grade 3

O Grade 4

O Grade 5

Q03 Serious? O No O Yes

Q04 Relatedness to study intervention:

O Unrelated

O Unlikely

O Reasonable possibility

O Definite

Q05 Date of onset: ___ ___ - ___ ___ ___ - ___ ___ ___ ___

dd-mmm-yyyy

Q40 Time of onset: ___ ___ : ___ ___ O AM O PM

hh:mm

Q06 Outcome:

O Resolved

O Resolved with sequelae

O Continuing (Follow up is required)

O Continuing at end of study (No follow up is required)

O Continuing at time of death

O Unknown

Q07

If Q06 is ‘Resolved’ or ‘Resolved with sequelae’

Date of resolution:

___ ___ - ___ ___ ___ - ___ ___ ___ ___ (dd-mmm-yyyy)


ESETT

____ ____ ____

Subject ID

___ ___ - ___ ___ ___ - ___ ___ ___ ___ (dd-mmm-yyyy)

Date of assessment

Data Collected?

O No O Yes

General Comments:


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Q08 Actions taken with study intervention: (Check all that apply)

None

Study intervention interrupted

Study intervention discontinued

Study intervention modified

Q30 Which of the following protocol/MOP specific definition was met by this adverse event?

O Life-threatening hypotension

O Life-threatening cardiac arrhythmia

O Acute seizure recurrence

O Acute anaphylaxis

O Acute respiratory depression requiring intubation

O Hepatic transaminase or ammonia elevations

O Purple glove syndrome

O None of the above

Q31


Is this the first recurrent seizure onset?

O No

O Yes

Q32


Date of recurrent seizure onset:

___ ___ - ___ ___ ___ - ___ ___ ___ ___ dd-mmm-yyyy

Q41


Time of recurrent seizure onset:

___ ___ : ___ ___ O AM O PM

hh:mm

Q33


Did patient receive anticonvulsant?

O No

O Yes

Q34 Was endotracheal intubation performed or attempted as a result of this adverse event?

O No

O Yes

Q35 If Q34 = ‘Yes’

Has this intubation been reported in a prior AE?

O No

O Yes

Q36 If Q35 = ‘Yes’

AE CRF ID number: ___ ___ ___ ___ ___ ___ ___

Q37 If Q34 = ‘Yes’

Indication for intubation:

O Seizure activity

O Respiratory depression

O Decreased level of consciousness

O Other Specify _______________________

Visit: End of Study


ESETT

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Subject ID

___ ___ - ___ ___ ___ - ___ ___ ___ ___ (dd-mmm-yyyy)

Date of assessment

Data Collected?

O No O Yes

General Comments:


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Complete the remainder of the form for SAEs only.

Q38 If Q35 = ‘No’ Date of intubation (or attempt):

___ ___ - ___ ___ ___ - ___ ___ ___ ___ dd-mmm-yyyy

Q42 If Q35 = ‘No’ Time of intubation (or attempt):

___ ___ : ___ ___ O AM O PM

hh:mm

Q39 If Q35 = ‘No’ Was the attempted intubation successful?

O No

O Yes

Q09 If Q03 is ‘Yes’

Describe event or

problem: DO NOT identify any subject, physician, or institution by name.

Q10 If Q03 is ‘Yes’ Relevant Tests/Laboratory Data, including dates:

Q11 If Q03 is ‘Yes’ Other Relevant History, Including Preexisting Medical Conditions:

Q12 If Q03 is ‘Yes’ Last name of reporting site investigator:

Q13 If Q03 is ‘Yes’ Date of reporting site investigator signature:

___ ___ - ___ ___ ___ - ___ ___ ___ ___ (dd-mmm-yyyy)

Visit: End of Study


ESETT

____ ____ ____

Subject ID

___ ___ - ___ ___ ___ - ___ ___ ___ ___ (dd-mmm-yyyy)

Date of assessment

Data Collected?

O No O Yes

General Comments:


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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: ___ ___ - ___ ___ ___ - ___ ___ ___ ___

(dd-mmm-yyyy)

Q09 Clinical summary packet file (attach file):

Documents

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–