ID

31975

Beschreibung

Study ID: 106181 Clinical Study ID: B2C106181 Study Title: An open-label, single-arm study to determine the excretion balance and metabolic disposition of [14C]GW642444 administered as a single dose of an oral solution to healthy male volunteers Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT01286831 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: vilanterol Trade Name: Study Indication: Pulmonary Disease, Chronic Obstructive

Stichworte

Versionen (5)
  1. 09.10.18 09.10.18 -
  2. 09.10.18 09.10.18 - Julian Varghese
  3. 10.10.18 10.10.18 -
  4. 10.10.18 10.10.18 -
  5. 14.12.18 14.12.18 -
Rechteinhaber

GSK group of companies

Hochgeladen am

10. Oktober 2018

DOI

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Extension balance and metabolic disposition of vilanterol as a single oral dose. 106181

Englisch

Follow-Up Forms

1 Formulare  
  1. StudyEvent: ODM
    1. Follow-Up Forms
Physical examination data
Beschreibung

Physical examination data

Concomitant medications
Beschreibung

Record any changes to the subject's concomitant medications or any new medications taken since the last visit in the appropriate Concomitant Medications section

Datentyp

text

Adverse Events
Beschreibung

Record details of any new Adverse Events obseved or reported by the subject or any changes to ongoing adverse events in the appropriate NON-Serious Adverse Events/Serious Adverse Events section.

Datentyp

text

Physical Examination
Beschreibung

Indicate current physical findings by choosing the appropriate box(es) below and if YES, describe concisely: [different findings should be separated by either a (;) or a (/)]

Datentyp

text

Date of Assessment
Beschreibung

Date of Assessment

Datentyp

date

Skin
Beschreibung

Change from Baseline?

Datentyp

boolean

Lungs
Beschreibung

Change from Baseline?

Datentyp

boolean

Cardiovascular
Beschreibung

Change from Baseline?

Datentyp

boolean

Abdomen (Liver and Spleen)
Beschreibung

Change from Baseline?

Datentyp

boolean

Vital Signs Follow-Up
Beschreibung

Vital Signs Follow-Up

Date
Beschreibung

e.g., 01 JAN 10

Datentyp

date

Planned Relative Time
Beschreibung

e.g., 15 min

Datentyp

integer

Actual Time
Beschreibung

e.g., 13:02

Datentyp

time

Blood Pressure Systolic
Beschreibung

Supine

Datentyp

integer

Maßeinheiten
  • mmHg
mmHg
Blood Pressure Diastolic
Beschreibung

Supine

Datentyp

integer

Maßeinheiten
  • mmHg
mmHg
Heart rate
Beschreibung

Heart rate

Datentyp

integer

Maßeinheiten
  • bpm
bpm
Temperature
Beschreibung

oral

Datentyp

float

Maßeinheiten
  • °C
°C
12 LEAD ECG Follow-Up
Beschreibung

12 LEAD ECG Follow-Up

Start date of ECG
Beschreibung

Start date of ECG

Datentyp

date

Planned Relative Time
Beschreibung

Planned Relative Time

Datentyp

text

Start Time of ECG
Beschreibung

Start Time of ECG

Datentyp

time

Ventricular Rate
Beschreibung

Ventricular Rate

Datentyp

integer

Maßeinheiten
  • bpm
bpm
PR Interval
Beschreibung

PR Interval

Datentyp

integer

Maßeinheiten
  • msec
msec
QRS Duration
Beschreibung

QRS Duration

Datentyp

integer

Maßeinheiten
  • msec
msec
Uncorrected QT Interval
Beschreibung

Uncorrected QT Interval

Datentyp

integer

Maßeinheiten
  • msec
msec
QTc Invertal
Beschreibung

QTc Invertal

Datentyp

integer

Maßeinheiten
  • msec
msec
Result of the ECG
Beschreibung

Enter code for result from the following list: 1=Normal 2=Abnormal - not clinically significant 3=Abnormal - clinically significant 4=No result (not available)

Datentyp

integer

12 LEAD ECG Abnormalities Follow-Up
Beschreibung

12 LEAD ECG Abnormalities Follow-Up

Date of ECG
Beschreibung

Date of ECG

Datentyp

date

Time of ECG
Beschreibung

Time of ECG

Datentyp

time

Rhythm
Beschreibung

Rhythm

Datentyp

integer

P-Wave and QRS Morphology
Beschreibung

P-Wave and QRS Morphology

Datentyp

integer

Conduction
Beschreibung

Conduction

Datentyp

integer

Myocardial Infraction
Beschreibung

Myocardial Infraction

Datentyp

integer

Depolarisation/Repolarisation (QRS-T)
Beschreibung

Depolarisation/Repolarisation (QRS-T)

Datentyp

integer

Other abnormalities
Beschreibung

Other abnormalities

Datentyp

integer

Electronically transferred laboratory data Follow-Up
Beschreibung

Electronically transferred laboratory data Follow-Up

Clinical chemistry
Beschreibung

Clinical chemistry

Datentyp

datetime

Haematology
Beschreibung

Haematology

Datentyp

datetime

Urinalisys
Beschreibung

Urinalisys

Datentyp

datetime

Pharmacogenetic (PGx) Research
Beschreibung

Pharmacogenetic (PGx) Research

Consent for PGx Research
Beschreibung

Consent for PGx Research

Datentyp

text

Has consent been obtained for PGx Research?
Beschreibung

Has consent been obtained for PGx Research?

Datentyp

boolean

If YES, record the date informed consent obtained for PGx Research
Beschreibung

If YES, record the date informed consent obtained for PGx Research

Datentyp

date

If NO, choose ONE reason:
Beschreibung

If NO, choose ONE reason:

Datentyp

text

Sample collection
Beschreibung

Sample collection

Datentyp

text

Has a Sample been collected for PGx Research?
Beschreibung

Has a Sample been collected for PGx Research?

Datentyp

boolean

If YES, record a date sample taken
Beschreibung

If YES, record a date sample taken

Datentyp

date

Withdrawal of consent
Beschreibung

Has subject withdrawn consent for PGx Research?

Datentyp

boolean

If YES, record the date informed consentwithdrawn for PGx research
Beschreibung

If YES, record the date informed consentwithdrawn for PGx research

Datentyp

date

Sample destruction
Beschreibung

Has a request been made for sample destruction?

Datentyp

boolean

If YES, choose one reason:
Beschreibung

If YES, choose one reason:

Datentyp

text

Concomitant medications Follow-Up
Beschreibung

Concomitant medications Follow-Up

Were any concomitant medications taken by the subject during the study?
Beschreibung

Were any concomitant medications taken by the subject during the study?

Datentyp

boolean

if YES, record each medication on a separate line using Trade Names where possible
Beschreibung

if YES, record each medication on a separate line using Trade Names where possible

Datentyp

text

Drug name
Beschreibung

Trade Name preferred e.g, Aspirin

Datentyp

integer

Unit dose
Beschreibung

e.g., 200

Datentyp

integer

Units
Beschreibung

e.g., mg

Datentyp

integer

Frequency
Beschreibung

e.g., BID

Datentyp

integer

Route
Beschreibung

e.g., PO

Datentyp

integer

Reason for Medication
Beschreibung

e.g., Headache

Datentyp

text

Start Date
Beschreibung

e.g., 31 MAY 08

Datentyp

date

Start Time
Beschreibung

e.g., 14:10

Datentyp

time

Taken prior to Study?
Beschreibung

Taken prior to Study?

Datentyp

boolean

Stop Date
Beschreibung

e.g., 30 MAY 08

Datentyp

date

Stop Time
Beschreibung

e.g.,23:00

Datentyp

time

Ongoing Medication
Beschreibung

Ongoing Medication

Datentyp

boolean

Non-Serious Adverse Events
Beschreibung

Non-Serious Adverse Events

Did the subject experience any non-serious adverse events during the study?
Beschreibung

If this is a Serious Adverse Event (SAE), do not complete this form, go to the SAE section and complete the SAE form. If YES record details below

Datentyp

boolean

Event
Beschreibung

Diagnosis only (if known)Otherwise Sign/Symptom e.g., Headache

Datentyp

text

Start Date
Beschreibung

e.g., 25 JAN 09

Datentyp

date

Start Time
Beschreibung

e.g., 13:25

Datentyp

time

Outcome
Beschreibung

1=Recovered/Resolved 2=Recovering/Resolving 3=Not recovered/not resolved 4=Recovered/Resolved with sequelae e.g., 1

Datentyp

integer

End Date
Beschreibung

e.g., 27 JAN 09

Datentyp

date

End Time
Beschreibung

e.g., 10:20

Datentyp

time

Frequency
Beschreibung

1=Single episode 2=Intermittent e.g., 1

Datentyp

integer

Maximum Intensity
Beschreibung

1=Mild 2=Moderate 3=Severe X=Not applicable e.g., 1

Datentyp

integer

Action taken with Investigational Product(s) as a Result of the Non-Serious AE
Beschreibung

1=Investigational product(s) withdrawn 2=Dose reduced 3=Dose increased 4=Dose not changed 5=Dos interrupted X=not applicable e.g., 4

Datentyp

integer

Withdrawal
Beschreibung

Did the subject withdraw from study as a result of this AE?

Datentyp

boolean

Relationship to Investigational Product(s)
Beschreibung

Is there a reasonable possibility that the AE may have been caused by the investigational product?

Datentyp

boolean

Serious Adverse Events (SAE)
Beschreibung

Serious Adverse Events (SAE)

Did the subject experience a SAE during the study?
Beschreibung

if YES record details below

Datentyp

boolean

SECTION 1
Beschreibung

SECTION 1

Datentyp

text

Event
Beschreibung

Diagnosis only (if known) Otherwise Sign/Symptom e.g., Anaphylaxis

Datentyp

text

Start Date
Beschreibung

e.g., 25 JAN 09

Datentyp

date

Start Time
Beschreibung

e.g., 13:25

Datentyp

time

Outcome
Beschreibung

1=Recovered/Resolved 2=Recovering/Resolving 3=Not recovered/Not resolved 4=Recovered/Resolved with sequelae 5=Fatal e.g., 1

Datentyp

integer

End Date
Beschreibung

e.g., 27 JAN 09

Datentyp

date

End Time
Beschreibung

e.g, 10:20

Datentyp

time

Maximum Intensity
Beschreibung

1=Mild 2=Moderate 3=Severe X=Not applicable

Datentyp

integer

Action taken with Investigational Product(s) as a result of the SAE
Beschreibung

1=Investigational product(s) withdrawn 2=Dose reduced 3=Dose increased 4=Dose not changed 5=Dose interrupted X=Not applicable

Datentyp

integer

Withdrawal
Beschreibung

Did the subject withdraw from study as a result of this SAE?

Datentyp

boolean

Relationship to Investigational Product(s)
Beschreibung

Is there a reasonable possibility that the AE may have been caused by the investigational product?

Datentyp

boolean

if FATAL, was a post-mortem/autopsy performed
Beschreibung

if YES, summarise findings

Datentyp

boolean

SECTION 2
Beschreibung

SECTION 2

Datentyp

text

Seriousness
Beschreibung

specify reason(s) for considering this a SAE, and tick all that apply:

Datentyp

text

SECTION 3 Demography Data
Beschreibung

SECTION 3 Demography Data

Datentyp

text

Date of Birth
Beschreibung

Date of Birth

Datentyp

date

Sex
Beschreibung

Sex

Datentyp

text

Weight
Beschreibung

Weight

Datentyp

float

Maßeinheiten
  • kg
kg
SECTION 4
Beschreibung

SECTION 4

Datentyp

text

If investigational product(s) was stopped, did the reported event(s) recur after further investigational product(s) were administered?
Beschreibung

If investigational product(s) was stopped, did the reported event(s) recur after further investigational product(s) were administered?

Datentyp

text

SECTION 5 Possible causes of SAE other than Investigational Product(s)
Beschreibung

mark all that apply:

Datentyp

text

SECTION 6 RELEVANT Medical Conditions
Beschreibung

SECTION 6 RELEVANT Medical Conditions

Datentyp

text

Specify any RELEVANT past or present medical disorders, allergies, surgeries that can help explain the SAE.
Beschreibung

Ensure each medical condition recorded in this section is also recorded in the appropriate Medical Condition form

Datentyp

text

Date of onset
Beschreibung

Date of onset

Datentyp

date

Condition Present at Time of the SAE?
Beschreibung

Condition Present at Time of the SAE?

Datentyp

boolean

If NO, Date of Last Occurrence
Beschreibung

If NO, Date of Last Occurrence

Datentyp

date

SECTION 7 Other relevant risk factors
Beschreibung

Provide any family history or social history (e.g., smoking, alcohol, diet, drug abuse, occupational hazard) relevant to the SAE. Ensure each risk factor recorded in this section is also recorded in the appropriate Medical Conditions form

Datentyp

text

SECTION 8 RELEVANT concomitant medications
Beschreibung

Include details of any concomitant medication(s) that may help explain the SAE, may have caused the SAE or was used to treat the SAE. Ensure each risk factor recorded in this section is also recorded in the appropriate Medical Conditions form

Datentyp

text

Drug Name
Beschreibung

Trade Name preferred e.g., Zantac

Datentyp

text

Dose
Beschreibung

e.g., 150

Datentyp

text

Unit
Beschreibung

e.g., mg

Datentyp

float

Frequency
Beschreibung

e.g., BID

Datentyp

float

Route
Beschreibung

Route

Datentyp

text

Taken prior to study?
Beschreibung

Taken prior to study?

Datentyp

boolean

Start Date
Beschreibung

e.g., 25 JAN 09

Datentyp

date

Stop Date
Beschreibung

27 JAN 09

Datentyp

date

Ongoing Medication?
Beschreibung

Ongoing Medication?

Datentyp

boolean

Reason for Medication
Beschreibung

e.g., Gastric ulcer

Datentyp

text

SECTION 9 Details of Investigational Product(s)
Beschreibung

SECTION 9 Details of Investigational Product(s)

Datentyp

text

SECTION 10 Details of RELEVANT assessments
Beschreibung

Provide detailsn of any tests or procedures carried out to diagnose or confirm the SAE (e.g., laboratory data with units and normal range) of data for this SAE have not been previously entered, and the CRF includes a page for the test, ensure the data is also entered on the page

Datentyp

text

SECTION 11 Narrative Remarks
Beschreibung

Provide a brief narrative description of the SAE and details of treatment given

Datentyp

text

Investigator's signature
Beschreibung

Confirming that the data on the SAE pages are accurate and complete

Datentyp

text

Investigator's name (print)
Beschreibung

Investigator's name (print)

Datentyp

text

Date
Beschreibung

Date

Datentyp

date

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Ähnliche Modelle

Follow-Up Forms

1 Formulare
  1. StudyEvent: ODM
    1. Follow-Up Forms
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
Physical examination data
Concomitant medications
Item
Concomitant medications
text
Adverse Events
Item
Adverse Events
text
Physical Examination
Item
Physical Examination
text
Date of Assessment
Item
Date of Assessment
date
Skin
Item
Skin
boolean
Lungs
Item
Lungs
boolean
Cardiovascular
Item
Cardiovascular
boolean
Abdomen (Liver and Spleen)
Item
Abdomen (Liver and Spleen)
boolean
Item Group
Vital Signs Follow-Up
Date
Item
Date
date
Item
Planned Relative Time
integer
Planned Relative Time
Code List
Planned Relative Time
CL Item
Follow-Up (1)
Actual Time
Item
Actual Time
time
Blood Pressure Systolic
Item
Blood Pressure Systolic
integer
Blood Pressure Diastolic
Item
Blood Pressure Diastolic
integer
Heart rate
Item
Heart rate
integer
Temperature
Item
Temperature
float
Item Group
12 LEAD ECG Follow-Up
Start date of ECG
Item
Start date of ECG
date
Item
Planned Relative Time
text
Planned Relative Time
Code List
Planned Relative Time
CL Item
ECG 1 Follow UP (1)
CL Item
ECG 2 Unscheduled (2)
CL Item
ECG 3 Unscheduled (3)
Start Time of ECG
Item
Start Time of ECG
time
Ventricular Rate
Item
Ventricular Rate
integer
PR Interval
Item
PR Interval
integer
QRS Duration
Item
QRS Duration
integer
Uncorrected QT Interval
Item
Uncorrected QT Interval
integer
QTc Invertal
Item
QTc Invertal
integer
Result of the ECG
Item
Result of the ECG
integer
Item Group
12 LEAD ECG Abnormalities Follow-Up
Date of ECG
Item
Date of ECG
date
Time of ECG
Item
Time of ECG
time
Item
Rhythm
integer
Rhythm
Code List
Rhythm
CL Item
[A 1] Sinus bradycardia (1)
CL Item
[A21] Sinus bradycardia (heart rate 40-50 beats/min) (2)
CL Item
[A22] Sinus bradycardia (heart rate 30-39 beats/min) (3)
CL Item
[A23] Sinus bradycardia (heart rate < 30 beats/min) (4)
CL Item
[A 3] Sinus pause (5)
CL Item
[A 2] Sinus tachycardia (6)
CL Item
[A 4] Ectropic supraventricular beats (7)
CL Item
[A20] Ectropic supraventricular rythm (8)
CL Item
[A17] Wandering atrial pacemaker (9)
CL Item
[A26] Multifocal atrial tachycardia (Wandering atrial pacemaker with heart rate > 100 beats/min) (10)
CL Item
[A 6] Supraventricular tachycardia (Heart rate > 100 beats/min) (11)
CL Item
[A 7] Atrial flutter (12)
CL Item
[A 8] Atrial fibrillation (13)
CL Item
[A 5] Junctional rhythm (heart rate <100 beats/min) (14)
CL Item
[A25] Junctional rhythm (15)
CL Item
[A24] Junctional tachycardia (heart rate > 100 beats/min) (16)
CL Item
[A 9] Ectopic ventricular beats (17)
Item
P-Wave and QRS Morphology
integer
P-Wave and QRS Morphology
Code List
P-Wave and QRS Morphology
CL Item
[B 3] right ventricular hypertrophy (1)
CL Item
[B 5] Intraatrial conduction delay (2)
CL Item
[B 7] Poor R wave progression (3)
CL Item
[B 9] Left atrial abnormality (4)
CL Item
[B10] Right atrial abnormality (5)
CL Item
[A12] Ventricular couplets (6)
CL Item
[A13] Bigeminy (7)
CL Item
[A28] Trigeminy (8)
CL Item
[A14] Electrical alternans (9)
CL Item
[A29] R on T phenomenon (10)
CL Item
[A18] Ventricular vebrilation (11)
CL Item
[A19] Indioventricular rhythm (heart rate < 100 bpm) (12)
CL Item
[A10] Sustained ventricular tachycardia (13)
CL Item
[A11] Non-sustained ventricular tachycardia  (14)
CL Item
[A33] Sinus arrhythmia  (15)
CL Item
[A33] Sinus arrhythmia  (15)
CL Item
[A27] Ventricular tachycardia  (16)
CL Item
[A30] Monomorphic ventricular tachycardia  (17)
CL Item
[A15] Torsades de Pointes (Polymorphic ventricular tachycardia with prolonged QT) (18)
CL Item
[A31] Polymorphic (sustained and non-sustained) ventricular tachycardia (19)
CL Item
[A16] Artificial pacemaker  (20)
CL Item
[A35] Atrial premature complex (21)
CL Item
[A99]Other abnormal rhythm  (22)
CL Item
[B16] Late R wave transition (23)
CL Item
[D14] Increased voltage consistent with left ventricular hypertrophy (24)
CL Item
[B99] Other morphology (25)
Item
Conduction
integer
Conduction
Code List
Conduction
CL Item
[C 1] First degree AV block (PR interval > 200 msec) (1)
CL Item
[C20] Short PR interval (2)
CL Item
[C 2] Second degree AV block (Mobitz type 1) (3)
CL Item
[C 3] Second degree AV block (Mobitz type 2) (4)
CL Item
[C16] 2:1 AV block  (5)
CL Item
[C 4] Third degree AV block (6)
CL Item
[C 5] Left axis deviation (QRS axis more negative than -30°) (7)
CL Item
[C 6] Right axis deviation (QRS axis more positive than +110°) (8)
CL Item
[C 7] Incomplete right bundle branch block (9)
CL Item
[C13] Incomplete left bundle branch block (10)
CL Item
[C 8] Right bundle branch block  (11)
CL Item
[C 14] Left anterior hemiblock (synonymous to left anterior fascicular block) (12)
Item
Myocardial Infraction
integer
Myocardial Infraction
Code List
Myocardial Infraction
CL Item
[D 1] Myocardial infraction, old (1)
CL Item
[D 2] Myocardial infraction, anterior (2)
CL Item
[D 3] Myocardial infraction, lateral (3)
CL Item
[D 4] Myocardial infraction, posterior (4)
CL Item
[D 5] Myocardial infraction, inferior (5)
Item
Depolarisation/Repolarisation (QRS-T)
integer
Depolarisation/Repolarisation (QRS-T)
Code List
Depolarisation/Repolarisation (QRS-T)
CL Item
[D 7] Non-specific ST-T changes (1)
CL Item
[D19] J point elevation (2)
CL Item
[D 8] ST elevation (3)
CL Item
[D21] ST elevation-pericarditis (4)
CL Item
[D 9] ST depression (5)
CL Item
[D96] ST segment abnormality, not specified (6)
CL Item
[D10] U waves abnormal (7)
CL Item
[D11] T wave inversion (8)
CL Item
[D12] T wave peaked (9)
Item
Other abnormalities
integer
Other abnormalities
Code List
Other abnormalities
CL Item
[E99] Other abnormalities (1)
CL Item
[C15] Left posterior hemiblock (synonymous to left posterior fascicular block) (2)
CL Item
[C 9] Left bundle branch block  (3)
CL Item
[C17] Bifascicular block (4)
CL Item
[C10] Non-specific intraventricular conduction delay (QRS>120msec) (5)
CL Item
[C11] Accessory pathway (Wolff-Parkinson White, Lown-Ganong-Levine) (6)
CL Item
[C18] AV dissociation  (7)
CL Item
[C28] Prolonged QT 450-500 (8)
CL Item
[C29] Prolonged QT >500 (9)
CL Item
[C30] Prolonged QTc Interval 450-500 (10)
CL Item
[C31] Prolonged QTc Interval >500 (11)
CL Item
[C99] Other conduction (12)
CL Item
[D 6] Myocardial infraction, septal (13)
CL Item
[D20] Myocardial infraction, Non-Q wave (14)
CL Item
[D08] Other myocardial infraction (15)
CL Item
[D15] T waves flat (16)
CL Item
[D16] T waves biphasic (17)
CL Item
[D18] Notched T-waves (18)
CL Item
[D13] Low QRS voltage (19)
CL Item
[D17] T-wave flattening/inversion (20)
CL Item
[D22] Juvenile T wave pattern, early repolarization (21)
CL Item
[D97] T wave abnormality, not specified (22)
CL Item
[D99] Other depolarization/repolarization (23)
Item Group
Electronically transferred laboratory data Follow-Up
Clinical chemistry
Item
Clinical chemistry
datetime
Haematology
Item
Haematology
datetime
Urinalisys
Item
Urinalisys
datetime
Item Group
Pharmacogenetic (PGx) Research
Consent for PGx Research
Item
Consent for PGx Research
text
Has consent been obtained for PGx Research?
Item
Has consent been obtained for PGx Research?
boolean
If YES, record the date informed consent obtained for PGx Research
Item
If YES, record the date informed consent obtained for PGx Research
date
Item
If NO, choose ONE reason:
text
If NO, choose ONE reason:
Code List
If NO, choose ONE reason:
CL Item
Subject declined (1)
CL Item
Subject not asked by Investigator (2)
CL Item
Other, specify_______________ (3)
Sample collection
Item
Sample collection
text
Has a Sample been collected for PGx Research?
Item
Has a Sample been collected for PGx Research?
boolean
If YES, record a date sample taken
Item
If YES, record a date sample taken
date
Withdrawal of consent
Item
Withdrawal of consent
boolean
If YES, record the date informed consentwithdrawn for PGx research
Item
If YES, record the date informed consentwithdrawn for PGx research
date
Sample destruction
Item
Sample destruction
boolean
Item
If YES, choose one reason:
text
If YES, choose one reason:
Code List
If YES, choose one reason:
CL Item
[1] Subject requested (1)
CL Item
[z] Other, specify_____________ (2)
Item Group
Concomitant medications Follow-Up
Were any concomitant medications taken by the subject during the study?
Item
Were any concomitant medications taken by the subject during the study?
boolean
if YES, record each medication on a separate line using Trade Names where possible
Item
if YES, record each medication on a separate line using Trade Names where possible
text
Drug name
Item
Drug name
integer
Unit dose
Item
Unit dose
integer
Units
Item
Units
integer
Frequency
Item
Frequency
integer
Route
Item
Route
integer
Reason for Medication
Item
Reason for Medication
text
Start Date
Item
Start Date
date
Start Time
Item
Start Time
time
Taken prior to Study?
Item
Taken prior to Study?
boolean
Stop Date
Item
Stop Date
date
Stop Time
Item
Stop Time
time
Ongoing Medication
Item
Ongoing Medication
boolean
Item Group
Non-Serious Adverse Events
Did the subject experience any non-serious adverse events during the study?
Item
Did the subject experience any non-serious adverse events during the study?
boolean
Event
Item
Event
text
Start Date
Item
Start Date
date
Start Time
Item
Start Time
time
Outcome
Item
Outcome
integer
End Date
Item
End Date
date
End Time
Item
End Time
time
Frequency
Item
Frequency
integer
Maximum Intensity
Item
Maximum Intensity
integer
Action taken with Investigational Product(s) as a Result of the Non-Serious AE
Item
Action taken with Investigational Product(s) as a Result of the Non-Serious AE
integer
Withdrawal
Item
Withdrawal
boolean
Relationship to Investigational Product(s)
Item
Relationship to Investigational Product(s)
boolean
Item Group
Serious Adverse Events (SAE)
Did the subject experience a SAE during the study?
Item
Did the subject experience a SAE during the study?
boolean
SECTION 1
Item
SECTION 1
text
Event
Item
Event
text
Start Date
Item
Start Date
date
Start Time
Item
Start Time
time
Outcome
Item
Outcome
integer
End Date
Item
End Date
date
End Time
Item
End Time
time
Maximum Intensity
Item
Maximum Intensity
integer
Action taken with Investigational Product(s) as a result of the SAE
Item
Action taken with Investigational Product(s) as a result of the SAE
integer
Withdrawal
Item
Withdrawal
boolean
Relationship to Investigational Product(s)
Item
Relationship to Investigational Product(s)
boolean
if FATAL, was a post-mortem/autopsy performed
Item
if FATAL, was a post-mortem/autopsy performed
boolean
SECTION 2
Item
SECTION 2
text
Item
Seriousness
text
Seriousness
Code List
Seriousness
CL Item
Results in death (1)
CL Item
Is life-threatening (2)
CL Item
Requires hospitalisation or prolongation of existing hospitalisation (3)
CL Item
Results in disability/incapacity (4)
CL Item
Congenital anomaly/birth defect (5)
CL Item
Other, specify______________________________ (6)
CL Item
Liver injury and impaired liver function (7)
SECTION 3 Demography Data
Item
SECTION 3 Demography Data
text
Date of Birth
Item
Date of Birth
date
Item
Sex
text
Sex
Code List
Sex
CL Item
Male (1)
CL Item
Female (2)
Weight
Item
Weight
float
SECTION 4
Item
SECTION 4
text
Item
If investigational product(s) was stopped, did the reported event(s) recur after further investigational product(s) were administered?
text
If investigational product(s) was stopped, did the reported event(s) recur after further investigational product(s) were administered?
Code List
If investigational product(s) was stopped, did the reported event(s) recur after further investigational product(s) were administered?
CL Item
Yes (1)
CL Item
No (2)
CL Item
Unknown at this time (3)
CL Item
Not applicable (4)
Item
SECTION 5 Possible causes of SAE other than Investigational Product(s)
text
Section 5 Possible causes of SAE other than Investigational Product(s)
Code List
SECTION 5 Possible causes of SAE other than Investigational Product(s)
CL Item
Disease under study (1)
CL Item
Medical condition(s) specify______________________ (2)
CL Item
Lack of efficacy (3)
CL Item
Withdrawal of investigational product(s) (4)
CL Item
Concomitant medication(s) specify________________ (5)
CL Item
Activity related to study participation (e.g., procedures) (6)
CL Item
Other, specify ________________________________ (7)
SECTION 6 RELEVANT Medical Conditions
Item
SECTION 6 RELEVANT Medical Conditions
text
Specify any RELEVANT past or present medical disorders, allergies, surgeries that can help explain the SAE.
Item
Specify any RELEVANT past or present medical disorders, allergies, surgeries that can help explain the SAE.
text
Date of onset
Item
Date of onset
date
Condition Present at Time of the SAE?
Item
Condition Present at Time of the SAE?
boolean
If NO, Date of Last Occurrence
Item
If NO, Date of Last Occurrence
date
SECTION 7 Other relevant risk factors
Item
SECTION 7 Other relevant risk factors
text
SECTION 8 RELEVANT concomitant medications
Item
SECTION 8 RELEVANT concomitant medications
text
Drug Name
Item
Drug Name
text
Dose
Item
Dose
text
Unit
Item
Unit
float
Frequency
Item
Frequency
float
Route
Item
Route
text
Taken prior to study?
Item
Taken prior to study?
boolean
Start Date
Item
Start Date
date
Stop Date
Item
Stop Date
date
Ongoing Medication?
Item
Ongoing Medication?
boolean
Reason for Medication
Item
Reason for Medication
text
SECTION 9 Details of Investigational Product(s)
Item
SECTION 9 Details of Investigational Product(s)
text
SECTION 10 Details of RELEVANT assessments
Item
SECTION 10 Details of RELEVANT assessments
text
SECTION 11 Narrative Remarks
Item
SECTION 11 Narrative Remarks
text
Investigator's signature
Item
Investigator's signature
text
Investigator's name (print)
Item
Investigator's name (print)
text
Date
Item
Date
date
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