ID

33547

Beschrijving

Study ID: 107806 Clinical Study ID: RA3107806 Study Title: An open label study to determine the safety, tolerability, excretion balance and pharmacokinetics of Losmapimod, administered as a single dose of an oral solution to healthy adult male subjects Patient Level Data: Clinicaltrials.gov Identifier: NCT00599612 https://clinicaltrials.gov/ct2/show/NCT00599612 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: losmapimod Trade Name: losmapimod Study Indication: Pulmonary Disease, Chronic Obstructive The study consists of a screening, study visit and follow-up. The protocol identifier for all: RA3107806 This document contains the form of SAE. It has to be filled in if the subject has experienced an SAE.

Link

https://clinicaltrials.gov/ct2/show/NCT00599612

Trefwoorden

Versies (1)
  1. 12-12-18 12-12-18 -
Houder van rechten

GlaxoSmithKline

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12 december 2018

DOI

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Licentie

Creative Commons BY-NC 3.0
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Safety, tolerability, excretion balance and pharmacokinetics of Losmapimod in healthy males, NCT00599612

Engels

Serious Adverse Event (SAE)

1 Formulieren  
Administrative data
Beschrijving

Administrative data

Alias
UMLS CUI-1
C1320722
Subject Number
Beschrijving

Subject Number

Datatype

text

Alias
UMLS CUI [1]
C2348585
Centre Number
Beschrijving

Centre Number

Datatype

text

Alias
UMLS CUI [1,1]
C0600091
UMLS CUI [1,2]
C0019994
Randomisation Number
Beschrijving

Randomisation Number

Datatype

text

Alias
UMLS CUI [1,1]
C0034656
UMLS CUI [1,2]
C0237753
Serious Adverse Events, Section 1
Beschrijving

Serious Adverse Events, Section 1

Alias
UMLS CUI-1
C1519255
Did the subject experience any serious adverse events during the study?
Beschrijving

If YES, record following items. A serious adverse event is any untoward medical occurrence that, at any dose: a) results in death b) is life-threatening c) requires hospitalization or prolongation of existing hospitalization d) results in disability/incapacity e) a congenital anomaly/birth defect f) other

Datatype

text

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0347984
UMLS CUI [1,3]
C2347804
Serious adverse events, Diagnosis
Beschrijving

Diagnosis only (if known) OR Serious signs / symptoms (list one per line). Record one SAE diagnosis per line, or a sign/symptom if the diagnosis is not available. lf a diagnosis subsequently becomes available, this then should be entered and the sign/symptom crossed out, initialled and dated by the investigator. A separate form should be used for each SAE. However, if multiple SAEs which are temporally or c inically related are apparent at the time of initial reporting then these may be reported on the same page. If this was recorded previously as a non-serious event but has progressed to serious, put a line through the Non-Serious AE record and transcribe the details onto the SAE form.

Datatype

text

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0011900
Date of onset
Beschrijving

day month year. Record the date of onset of the first occurrence of the event or signs/symptoms of the serious event, not the date the event became serious.

Datatype

date

Alias
UMLS CUI [1,1]
C0574845
UMLS CUI [1,2]
C1519255
Time of onset
Beschrijving

00:00-23:59. Record the time of onset of the first occurrence of the event or signs/symptoms of the serious event, not the time the event became serious.

Datatype

time

Alias
UMLS CUI [1,1]
C0449244
UMLS CUI [1,2]
C1519255
Outcome of SAE
Beschrijving

All SAEs must be followed until the events are resolved, the condition stabilizes, the events are otherwise explained, or the subject is lost to follow-up. Indicate if the event was "Recovered/Resolved", "Recovered/Resolved with sequelae". If the SAE is ongoing at the time the subject completes the study or becomes lost to follow-up, the outcome must be recorded as "Not recovered/not resolved" or "Recovering/Resolving". Also enter "Not recovered/not resolved" if the SAE was ongoing at the time of death, but was not the cause of death, enter fatal for the SAE which was the direct cause of death.

Datatype

integer

Alias
UMLS CUI [1]
C1705586
End date
Beschrijving

day month year. Record the end date. This is the date the SAE Recovered/Resolved, or if the outcome was fatal, record the date the subject died. If the event Recovered/Resolved with sequelae, enter the date the subject's medical condition resolved or stabilised. Leave blank if the SAE is 'Not recovered/Not resolved' or 'Recovering/Resolving'.

Datatype

date

Alias
UMLS CUI [1,1]
C0806020
UMLS CUI [1,2]
C1519255
End time
Beschrijving

00:00-23:59. Record the end time of the SAE.

Datatype

time

Alias
UMLS CUI [1,1]
C1522314
UMLS CUI [1,2]
C1519255
Maximum intensity
Beschrijving

Record the maximum intensity that occurred over the duration of the SAE. Amend the intensity if it increases. Mild = An event that is easily tolerated by the subject, causing minimal discomfort and not interfering with everyday activities. Moderate = An event that is sufficientlydiscomforitng to interfere with everyday activities. Severe = An event that prevents normal everyday activities. Not applicable = Those event(s) where intensity is meaningless or impossible to determine (i.e., blindness and coma).

Datatype

text

Alias
UMLS CUI [1]
C1710066
Action taken with investigational product(s) as a result of the SAE
Beschrijving

lnvestigationalproduct(s) withdrawn = Admin istration of investigational product(s) was permanently discontinued. Dose reduced = Dose is reduced for one or more investigational product(s). Dose increased = Dose increased for one or more investigational product(s). Dose not changed = lnvestigational product(s) continues even though an adverse event has occurred. Dose interrupted = Administration of one or more investigational product(s) was temporarily interrupted but then restarted. Not applicable = Subject was not receiving nvestigational product(s) when the event occurred (e.g., pre-or post-dosing) or the subject died and there was no prior decision to discontinue IP(s).

Datatype

text

Alias
UMLS CUI [1,1]
C1704758
UMLS CUI [1,2]
C1519255
Did the subject withdraw from study as a result of this SAE?
Beschrijving

Indicate ' Yes' if the event(s) were directly responsible for the subject's withdrawal as indicated on the Study Conclusion page, otherwise indicate 'No'.

Datatype

text

Alias
UMLS CUI [1,1]
C2349954
UMLS CUI [1,2]
C1519255
Is there a reasonable possibility the SAE may have been caused by the investigational product(s)?
Beschrijving

It is a regulatory requirement for investigators to assess relationship to investigational product(s) based on information available. The assessment should be reviewed on receipt of any new information and amended if necessary. "A reasonable possibility" is meant to convey that there are facts/evidence or arguments to suggest a causal relationship. Facts/evidence/arguments that may support "A reasonable possibility'' include, for example, a temporal relationship, a pharmacologically-predicted event, or positive dechallenge or rechallenge. Confounding factors, such as concomitant medication, a concomitant illness, or relevant medical history, should also be considered.

Datatype

text

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C0085978
UMLS CUI [1,3]
C1519255
If fatal, was a post-mortem/autopsy performed?
Beschrijving

If yes, summarise findings in Section 11 Narrative Remarks of thes SAE form.

Datatype

text

Alias
UMLS CUI [1,1]
C0004398
UMLS CUI [1,2]
C1519255
Section 2 Seriousness
Beschrijving

Section 2 Seriousness

Alias
UMLS CUI-1
C1710056
Results in death
Beschrijving

Results in death

Datatype

boolean

Alias
UMLS CUI [1,1]
C0011065
UMLS CUI [1,2]
C1519255
Is life-threatening
Beschrijving

Life-threatening

Datatype

boolean

Alias
UMLS CUI [1]
C1517874
Requires hospitalization or prolongation of existing hospitalization
Beschrijving

Hospitalization/ prolongation of existing hospitalization

Datatype

boolean

Alias
UMLS CUI [1,1]
C0019993
UMLS CUI [1,2]
C1519255
UMLS CUI [2,1]
C0745041
UMLS CUI [2,2]
C1519255
Results in disability/incapacity
Beschrijving

Results in disability/incapacity

Datatype

boolean

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0231170
Congenital anomaly/birth defect
Beschrijving

Congenital anomaly/birth defect

Datatype

boolean

Alias
UMLS CUI [1,1]
C0000768
UMLS CUI [1,2]
C1519255
Other seriousness
Beschrijving

Other seriousness

Datatype

boolean

Alias
UMLS CUI [1,1]
C1710056
UMLS CUI [1,2]
C0205394
If other seriousness, please specify
Beschrijving

Other seriousness, specification

Datatype

text

Alias
UMLS CUI [1,1]
C1710056
UMLS CUI [1,2]
C0205394
Section 3 Demography Data
Beschrijving

Section 3 Demography Data

Alias
UMLS CUI-1
C0011298
Date of birth
Beschrijving

day month year

Datatype

date

Alias
UMLS CUI [1]
C0421451
Sex
Beschrijving

Sex

Datatype

text

Alias
UMLS CUI [1]
C0079399
Weight
Beschrijving

Weight

Datatype

float

Maateenheden
  • kg
Alias
UMLS CUI [1]
C0005910
kg
Section 4 Recurrence of Adverse event after further investigational product
Beschrijving

Section 4 Recurrence of Adverse event after further investigational product

Alias
UMLS CUI-1
C0034897
UMLS CUI-2
C0877248
UMLS CUI-3
C1517331
UMLS CUI-4
C0304229
If the Investigational Product(s) was stopped, did the reported event(s) recur after further investigational product(s) were administered?
Beschrijving

Recurrence of Adverse event after further investigational product

Datatype

text

Alias
UMLS CUI [1,1]
C0034897
UMLS CUI [1,2]
C0877248
UMLS CUI [1,3]
C1517331
UMLS CUI [1,4]
C0304229
SECTION 5 Possible Causes of SAE other than Investigational Product(s)
Beschrijving

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

Alias
UMLS CUI-1
C0015127
UMLS CUI-2
C1519255
Disease under study
Beschrijving

Disease

Datatype

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C1519255
UMLS CUI [1,3]
C0347984
UMLS CUI [1,4]
C0008976
Medical condition(s)
Beschrijving

Medical condition(s)

Datatype

boolean

Alias
UMLS CUI [1]
C0012634
If Medical condition(s), please specify
Beschrijving

Medical condition(s), specification

Datatype

text

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C0348080
Lack of efficacy
Beschrijving

Lack of efficacy

Datatype

boolean

Alias
UMLS CUI [1]
C0235828
Withdrawal of investigational product(s)
Beschrijving

Withdrawal of investigational product(s)

Datatype

boolean

Alias
UMLS CUI [1,1]
C2349954
UMLS CUI [1,2]
C0304229
UMLS CUI [1,3]
C1519255
Concomitant medication
Beschrijving

Concomitant medication

Datatype

boolean

Alias
UMLS CUI [1,1]
C2347852
UMLS CUI [1,2]
C1519255
If Concomitant medication, please specify
Beschrijving

Concomitant medication, specify

Datatype

text

Alias
UMLS CUI [1]
C2347852
Activity related to study participation
Beschrijving

(e.g., procedures)

Datatype

boolean

Alias
UMLS CUI [1]
C2348568
Other causation
Beschrijving

Other causation

Datatype

boolean

Alias
UMLS CUI [1,1]
C0205394
UMLS CUI [1,2]
C0015127
UMLS CUI [1,3]
C1519255
If Other, please specify
Beschrijving

Other, specify

Datatype

text

Alias
UMLS CUI [1,1]
C0205394
UMLS CUI [1,2]
C0015127
Section 6 Relevant Medical Conditions
Beschrijving

Section 6 Relevant Medical Conditions

Alias
UMLS CUI-1
C0012634
UMLS CUI-2
C0262926
Specify any relevant past or current medical disorders, allergies, surgeries, etc. that can help explain the SAE
Beschrijving

Past or current medical disorders, allergies, surgeries

Datatype

text

Alias
UMLS CUI [1,1]
C1444637
UMLS CUI [1,2]
C0012634
UMLS CUI [2,1]
C0521116
UMLS CUI [2,2]
C0012634
UMLS CUI [3]
C0020517
UMLS CUI [4]
C0543467
Date of onset
Beschrijving

day month year

Datatype

date

Alias
UMLS CUI [1]
C0574845
Condition present at time of the SAE?
Beschrijving

Condition present at time of SAE

Datatype

text

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C0150312
UMLS CUI [1,3]
C1519255
If you ticked no in "condition present...", please date the last occurrence
Beschrijving

day month year

Datatype

date

Alias
UMLS CUI [1,1]
C2745955
UMLS CUI [1,2]
C0012634
UMLS CUI [1,3]
C0011008
UMLS CUI [1,4]
C1519255
SECTION 7 Other Relevant Risk Factors
Beschrijving

SECTION 7 Other Relevant Risk Factors

Alias
UMLS CUI-1
C0205394
UMLS CUI-2
C0035648
UMLS CUI-3
C1519255
Specify any family history or any social history relevant to the SAE.
Beschrijving

(e.g., smoking, alcohol, diet, drug abuse, occupational hazard)

Datatype

text

Alias
UMLS CUI [1,1]
C0241889
UMLS CUI [1,2]
C3714536
SECTION 8 Relevant Concomitant Medications
Beschrijving

SECTION 8 Relevant Concomitant Medications

Alias
UMLS CUI-1
C2347852
Drug name
Beschrijving

(Trade name preferred)

Datatype

text

Alias
UMLS CUI [1]
C0013227
Drug Dose
Beschrijving

Drug Dose

Datatype

integer

Alias
UMLS CUI [1]
C0678766
Dose unit
Beschrijving

Dose unit

Datatype

text

Alias
UMLS CUI [1]
C0869039
Frequency
Beschrijving

Frequency

Datatype

text

Alias
UMLS CUI [1]
C3476109
Route
Beschrijving

Route

Datatype

text

Alias
UMLS CUI [1]
C0013153
Started pre-study
Beschrijving

Started pre-study

Datatype

boolean

Alias
UMLS CUI [1,1]
C0808070
UMLS CUI [1,2]
C0332152
UMLS CUI [1,3]
C2347804
Date started
Beschrijving

day month year

Datatype

date

Alias
UMLS CUI [1]
C0808070
Date stopped
Beschrijving

day month year

Datatype

date

Alias
UMLS CUI [1]
C0806020
Ongoing medication
Beschrijving

Ongoing medication

Datatype

text

Alias
UMLS CUI [1]
C2826666
Reason for medication
Beschrijving

Reason for medication

Datatype

text

Alias
UMLS CUI [1]
C2826696
SECTION 9 Details of Investigational Product(s)
Beschrijving

SECTION 9 Details of Investigational Product(s)

Alias
UMLS CUI-1
C0013230
UMLS CUI-2
C1522508
lnvestigational product
Beschrijving

lnvestigational product

Datatype

text

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C1522508
Was treatment blind broken at investigational site?
Beschrijving

Treatment blind broken

Datatype

text

Alias
UMLS CUI [1]
C3897431
SECTION 10 Details of Relevant Assessments
Beschrijving

SECTION 10 Details of Relevant Assessments

Alias
UMLS CUI-1
C1261322
UMLS CUI-2
C1519255
Details of assessment
Beschrijving

Provide details of any other assessments or supplementary investigations/examinations that were conducted as part of the subject’s care and/or based on clinical judgment of the likely causative factors of the SAE. This may include, but not be limited to: • Laboratory data. Always provide the reference range and baseline values (fax or mail pages if extensive supporting data) • Findings of ECGs, X-rays, etc. • Results of other diagnostic tests or assays • Key findings from hospital discharge or pathology reports

Datatype

text

Alias
UMLS CUI [1,1]
C1522508
UMLS CUI [1,2]
C0220825
SECTION 11 Narrative Remarks
Beschrijving

SECTION 11 Narrative Remarks

Alias
UMLS CUI-1
C0947611
UMLS CUI-2
C1519255
Description of SAE
Beschrijving

This should include but not be limited to the following: • Any previous occurrences of this type of event • Any relevant non-serious adverse events that occurred prior to the SAE • The full clinical presentation and sequelae/evolution of the SAE • Any associated signs and symptoms of the SAE • Explain any possible causes of the SAE • Treatment for the SAE (including any specific medications administered or non-drug treatment) • Any other action taken for the management of the SAE or the subject • Duration and outcome of the SAE • If the SAE is associated with an overdose of investigational product(s), details of the amount of overdose and whether it was intentional or accidental.

Datatype

text

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0678257
Reporting investigator - Name (print)
Beschrijving

Confirm that the data on the SAE pages are accurate and complete.

Datatype

text

Alias
UMLS CUI [1]
C2826892
Invetigator Signature
Beschrijving

Invetigator Signature

Datatype

text

Alias
UMLS CUI [1]
C2346576
Date
Beschrijving

day month year

Datatype

date

Alias
UMLS CUI [1]
C0011008
Section 12 Additional/Follow-up information
Beschrijving

Section 12 Additional/Follow-up information

Alias
UMLS CUI-1
C1524062
UMLS CUI-2
C1533716
UMLS CUI-3
C1519255
UMLS CUI-4
C1522577
Additional/Follow-up information
Beschrijving

use this itemg to provide any additional details on the SAE not already captured on the previous items

Datatype

text

Alias
UMLS CUI [1,1]
C1524062
UMLS CUI [1,2]
C1533716
UMLS CUI [1,3]
C1519255
UMLS CUI [1,4]
C1522577
Invetigator Signature
Beschrijving

Invetigator Signature

Datatype

text

Alias
UMLS CUI [1]
C2346576
Reporting investigator - Name (print)
Beschrijving

Reporting investigator - Name

Datatype

text

Alias
UMLS CUI [1]
C2826892
Date
Beschrijving

day month year

Datatype

date

Alias
UMLS CUI [1]
C0011008
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Similar models

Serious Adverse Event (SAE)

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
Administrative data
C1320722 (UMLS CUI-1)
Subject Number
Item
Subject Number
text
C2348585 (UMLS CUI [1])
Centre Number
Item
Centre Number
text
C0600091 (UMLS CUI [1,1])
C0019994 (UMLS CUI [1,2])
Randomisation Number
Item
Randomisation Number
text
C0034656 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
Item Group
Serious Adverse Events, Section 1
C1519255 (UMLS CUI-1)
Item
Did the subject experience any serious adverse events during the study?
text
C1519255 (UMLS CUI [1,1])
C0347984 (UMLS CUI [1,2])
C2347804 (UMLS CUI [1,3])
SAE during study
Code List
Did the subject experience any serious adverse events during the study?
CL Item
Yes (Y)
CL Item
No (N)
Serious adverse events, Diagnosis
Item
Serious adverse events, Diagnosis
text
C1519255 (UMLS CUI [1,1])
C0011900 (UMLS CUI [1,2])
Date of onset
Item
Date of onset
date
C0574845 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
Time of onset
Item
Time of onset
time
C0449244 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
Item
Outcome of SAE
integer
C1705586 (UMLS CUI [1])
Outcome of SAE
Code List
Outcome of SAE
CL Item
Recovered/Resolved (1)
CL Item
recovering/Resolving (2)
CL Item
Not recovered/Not Resolved (3)
CL Item
Recovered/Resolved with Sequelae (4)
CL Item
Fatal (5)
End date
Item
End date
date
C0806020 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
End time
Item
End time
time
C1522314 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
Item
Maximum intensity
text
C1710066 (UMLS CUI [1])
Maximum intensity
Code List
Maximum intensity
CL Item
Mild (1)
CL Item
Moderate (2)
CL Item
Severe (3)
CL Item
Not applicable (X)
Item
Action taken with investigational product(s) as a result of the SAE
text
C1704758 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
Investigational product(s) as a result of the SAE
Code List
Action taken with investigational product(s) as a result of the SAE
CL Item
Investigational product(s) withdrawn (1)
CL Item
Dose reduced (2)
CL Item
Dose increased (3)
CL Item
Not applicable (X)
CL Item
Dose not changed (4)
CL Item
Dose interrupted (5)
Item
Did the subject withdraw from study as a result of this SAE?
text
C2349954 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
Withdrawal
Code List
Did the subject withdraw from study as a result of this SAE?
CL Item
Yes (Y)
CL Item
No (N)
Item
Is there a reasonable possibility the SAE may have been caused by the investigational product(s)?
text
C0304229 (UMLS CUI [1,1])
C0085978 (UMLS CUI [1,2])
C1519255 (UMLS CUI [1,3])
Relationship to investigational product(s)
Code List
Is there a reasonable possibility the SAE may have been caused by the investigational product(s)?
CL Item
Yes (Y)
CL Item
No (N)
Item
If fatal, was a post-mortem/autopsy performed?
text
C0004398 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
post-mortem/autopsy performance
Code List
If fatal, was a post-mortem/autopsy performed?
CL Item
Yes (Y)
CL Item
No (N)
Item Group
Section 2 Seriousness
C1710056 (UMLS CUI-1)
Results in death
Item
Results in death
boolean
C0011065 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
Life-threatening
Item
Is life-threatening
boolean
C1517874 (UMLS CUI [1])
Hospitalization/ prolongation of existing hospitalization
Item
Requires hospitalization or prolongation of existing hospitalization
boolean
C0019993 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
C0745041 (UMLS CUI [2,1])
C1519255 (UMLS CUI [2,2])
Results in disability/incapacity
Item
Results in disability/incapacity
boolean
C1519255 (UMLS CUI [1,1])
C0231170 (UMLS CUI [1,2])
Congenital anomaly/birth defect
Item
Congenital anomaly/birth defect
boolean
C0000768 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
Other seriousness
Item
Other seriousness
boolean
C1710056 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
Other seriousness, specification
Item
If other seriousness, please specify
text
C1710056 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
Item Group
Section 3 Demography Data
C0011298 (UMLS CUI-1)
Date of birth
Item
Date of birth
date
C0421451 (UMLS CUI [1])
Item
Sex
text
C0079399 (UMLS CUI [1])
Sex
Code List
Sex
CL Item
Male (M)
CL Item
Female (F)
Weight
Item
Weight
float
C0005910 (UMLS CUI [1])
Item Group
Section 4 Recurrence of Adverse event after further investigational product
C0034897 (UMLS CUI-1)
C0877248 (UMLS CUI-2)
C1517331 (UMLS CUI-3)
C0304229 (UMLS CUI-4)
Item
If the Investigational Product(s) was stopped, did the reported event(s) recur after further investigational product(s) were administered?
text
C0034897 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
C1517331 (UMLS CUI [1,3])
C0304229 (UMLS CUI [1,4])
Administration of reported event(s) recur after further investigational product(s)
Code List
If the Investigational Product(s) was stopped, did the reported event(s) recur after further investigational product(s) were administered?
CL Item
Yes (Y)
CL Item
No (N)
CL Item
Unknown at this time (UN)
CL Item
Not applicable (NA)
Item Group
SECTION 5 Possible Causes of SAE other than Investigational Product(s)
C0015127 (UMLS CUI-1)
C1519255 (UMLS CUI-2)
Disease
Item
Disease under study
boolean
C0012634 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
C0347984 (UMLS CUI [1,3])
C0008976 (UMLS CUI [1,4])
Medical condition(s)
Item
Medical condition(s)
boolean
C0012634 (UMLS CUI [1])
Medical condition(s), specification
Item
If Medical condition(s), please specify
text
C0012634 (UMLS CUI [1,1])
C0348080 (UMLS CUI [1,2])
Lack of efficacy
Item
Lack of efficacy
boolean
C0235828 (UMLS CUI [1])
Withdrawal of investigational product(s)
Item
Withdrawal of investigational product(s)
boolean
C2349954 (UMLS CUI [1,1])
C0304229 (UMLS CUI [1,2])
C1519255 (UMLS CUI [1,3])
Concomitant medication
Item
Concomitant medication
boolean
C2347852 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
Concomitant medication, specify
Item
If Concomitant medication, please specify
text
C2347852 (UMLS CUI [1])
Activity related to study participation
Item
Activity related to study participation
boolean
C2348568 (UMLS CUI [1])
Other causation
Item
Other causation
boolean
C0205394 (UMLS CUI [1,1])
C0015127 (UMLS CUI [1,2])
C1519255 (UMLS CUI [1,3])
Other, specify
Item
If Other, please specify
text
C0205394 (UMLS CUI [1,1])
C0015127 (UMLS CUI [1,2])
Item Group
Section 6 Relevant Medical Conditions
C0012634 (UMLS CUI-1)
C0262926 (UMLS CUI-2)
Past or current medical disorders, allergies, surgeries
Item
Specify any relevant past or current medical disorders, allergies, surgeries, etc. that can help explain the SAE
text
C1444637 (UMLS CUI [1,1])
C0012634 (UMLS CUI [1,2])
C0521116 (UMLS CUI [2,1])
C0012634 (UMLS CUI [2,2])
C0020517 (UMLS CUI [3])
C0543467 (UMLS CUI [4])
Date of onset
Item
Date of onset
date
C0574845 (UMLS CUI [1])
Item
Condition present at time of the SAE?
text
C0012634 (UMLS CUI [1,1])
C0150312 (UMLS CUI [1,2])
C1519255 (UMLS CUI [1,3])
Condition present at time of SAE
Code List
Condition present at time of the SAE?
CL Item
Yes (Y)
CL Item
No (N)
No presence, date of last occurrence
Item
If you ticked no in "condition present...", please date the last occurrence
date
C2745955 (UMLS CUI [1,1])
C0012634 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
C1519255 (UMLS CUI [1,4])
Item Group
SECTION 7 Other Relevant Risk Factors
C0205394 (UMLS CUI-1)
C0035648 (UMLS CUI-2)
C1519255 (UMLS CUI-3)
Any family history/any social history relevant to the SAE.
Item
Specify any family history or any social history relevant to the SAE.
text
C0241889 (UMLS CUI [1,1])
C3714536 (UMLS CUI [1,2])
Item Group
SECTION 8 Relevant Concomitant Medications
C2347852 (UMLS CUI-1)
Drug name
Item
Drug name
text
C0013227 (UMLS CUI [1])
Drug Dose
Item
Drug Dose
integer
C0678766 (UMLS CUI [1])
Dose unit
Item
Dose unit
text
C0869039 (UMLS CUI [1])
Frequency
Item
Frequency
text
C3476109 (UMLS CUI [1])
Route
Item
Route
text
C0013153 (UMLS CUI [1])
Started pre-study
Item
Started pre-study
boolean
C0808070 (UMLS CUI [1,1])
C0332152 (UMLS CUI [1,2])
C2347804 (UMLS CUI [1,3])
Date started
Item
Date started
date
C0808070 (UMLS CUI [1])
Date stopped
Item
Date stopped
date
C0806020 (UMLS CUI [1])
Item
Ongoing medication
text
C2826666 (UMLS CUI [1])
Ongoing medication
Code List
Ongoing medication
CL Item
Yes (Y)
CL Item
No (N)
Reason for medication
Item
Reason for medication
text
C2826696 (UMLS CUI [1])
Item Group
SECTION 9 Details of Investigational Product(s)
C0013230 (UMLS CUI-1)
C1522508 (UMLS CUI-2)
lnvestigational product
Item
lnvestigational product
text
C0304229 (UMLS CUI [1,1])
C1522508 (UMLS CUI [1,2])
Item
Was treatment blind broken at investigational site?
text
C3897431 (UMLS CUI [1])
Blind broken treatment
Code List
Was treatment blind broken at investigational site?
CL Item
Yes (Y)
CL Item
No (N)
CL Item
Not applicable (NA)
Item Group
SECTION 10 Details of Relevant Assessments
C1261322 (UMLS CUI-1)
C1519255 (UMLS CUI-2)
Details of assessment
Item
Details of assessment
text
C1522508 (UMLS CUI [1,1])
C0220825 (UMLS CUI [1,2])
Item Group
SECTION 11 Narrative Remarks
C0947611 (UMLS CUI-1)
C1519255 (UMLS CUI-2)
Description of SAE
Item
Description of SAE
text
C1519255 (UMLS CUI [1,1])
C0678257 (UMLS CUI [1,2])
Reporting investigator - Name
Item
Reporting investigator - Name (print)
text
C2826892 (UMLS CUI [1])
Invetigator Signature
Item
Invetigator Signature
text
C2346576 (UMLS CUI [1])
Date
Item
Date
date
C0011008 (UMLS CUI [1])
Item Group
Section 12 Additional/Follow-up information
C1524062 (UMLS CUI-1)
C1533716 (UMLS CUI-2)
C1519255 (UMLS CUI-3)
C1522577 (UMLS CUI-4)
Additional/Follow-up information
Item
Additional/Follow-up information
text
C1524062 (UMLS CUI [1,1])
C1533716 (UMLS CUI [1,2])
C1519255 (UMLS CUI [1,3])
C1522577 (UMLS CUI [1,4])
Invetigator Signature
Item
Invetigator Signature
text
C2346576 (UMLS CUI [1])
Reporting investigator - Name
Item
Reporting investigator - Name (print)
text
C2826892 (UMLS CUI [1])
Date
Item
Date
date
C0011008 (UMLS CUI [1])
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