ID

42301

Description

Study ID: 111406 Clinical Study ID: 111406 Study Title: A First-Time-in-Human Study to Evaluate the Safety, Tolerability and Pharmacokinetics of GSK1399686 After Single and Repeated Oral Dosing in Healthy Volunteers using a Dose- Escalating, Randomized, Placebo-Controlled Study Design Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00721812 Sponsor: GlaxoSmithKline Phase: Phase 1 Study Recruitment Status: Completed Generic Name: Placebo, locally-acting anti-inflammatory compound GSK1399686 Study Indication: Inflammatory Bowel Diseases

Keywords

  1. 5/17/21 5/17/21 -
  2. 5/18/21 5/18/21 -
Copyright Holder

GlaxoSmithKline

Uploaded on

May 18, 2021

DOI

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License

Creative Commons BY 4.0

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Safety, Tolerability and Pharmacokinetics of GSK1399686 After Single and Repeated Oral Dosing NCT00721812

Non-Serious Adverse Events; Serious Adverse Events; SAE Follow-up

Administrative
Description

Administrative

Alias
UMLS CUI-1
C1320722
Subject Identifier
Description

Subject Identifier

Data type

text

Alias
UMLS CUI [1]
C2348585
Centre Number
Description

Centre Number

Data type

text

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

Randomisation Number

Data type

text

Alias
UMLS CUI [1,1]
C0034656
UMLS CUI [1,2]
C0237753
Non-Serious Adverse Event
Description

Non-Serious Adverse Event

Alias
UMLS CUI-1
C1518404
Did the subject experience any non-serious adverse events during the study?
Description

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

Data type

boolean

Alias
UMLS CUI [1]
C1518404
Non-Serious Adverse Event
Description

Non-Serious Adverse Event

Alias
UMLS CUI-1
C1518404
Event
Description

Diagnosis Only (if known) Otherwise Sign/Symptom

Data type

text

Alias
UMLS CUI [1]
C0877248
Non-Serious Adverse Event Start Date
Description

Non-Serious Adverse Event Start Date

Data type

date

Alias
UMLS CUI [1,1]
C1518404
UMLS CUI [1,2]
C0808070
Non-Serious Adverse Event Start Time
Description

Non-Serious Adverse Event Start Time

Data type

time

Alias
UMLS CUI [1,1]
C1518404
UMLS CUI [1,2]
C1301880
Non-Serious Adverse Event Outcome
Description

Non-Serious Adverse Event Outcome

Data type

integer

Alias
UMLS CUI [1,1]
C1518404
UMLS CUI [1,2]
C1705586
Non-Serious Adverse Event End Date
Description

Non-Serious Adverse Event End Date

Data type

date

Alias
UMLS CUI [1,1]
C1518404
UMLS CUI [1,2]
C0806020
Non-Serious Adverse Event End Time
Description

Non-Serious Adverse Event End Time

Data type

time

Alias
UMLS CUI [1,1]
C1518404
UMLS CUI [1,2]
C1522314
Non-Serious Adverse Event Frequency
Description

Non-Serious Adverse Event Frequency

Data type

integer

Alias
UMLS CUI [1,1]
C1518404
UMLS CUI [1,2]
C0439603
Non-Serious Adverse Event Maximum Intensity
Description

Non-Serious Adverse Event Maximum Intensity

Data type

text

Alias
UMLS CUI [1]
C1518404
UMLS CUI [2,1]
C0518690
UMLS CUI [2,2]
C0806909
Action Taken with Investigational Product(s) as a Result of the Non-Serious AE
Description

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

Data type

text

Alias
UMLS CUI [1,1]
C1704758
UMLS CUI [1,2]
C1518404
Did the subject withdraw from study as a result of this AE?
Description

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

Data type

boolean

Alias
UMLS CUI [1]
C1518404
UMLS CUI [2]
C2349954
Is there a reasonable possibility that the AE may have been caused by the investigational product?
Description

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

Data type

boolean

Alias
UMLS CUI [1]
C1518404
UMLS CUI [2,1]
C0013230
UMLS CUI [2,2]
C0439849
Serious Adverse Event (Section 1)
Description

Serious Adverse Event (Section 1)

Alias
UMLS CUI-1
C1519255
Did the subject experience a serious adverse event during the study?
Description

Did the subject experience a serious adverse event during the study?

Data type

boolean

Alias
UMLS CUI [1]
C1519255
If fatal, was a post-mortem/autopsy performed
Description

If Yes, summarise findings in Section 11 Narrative Remarks of this SAE form.

Data type

boolean

Alias
UMLS CUI [1]
C0004398
UMLS CUI [2]
C1519255
Serious Adverse Event (Section 1)
Description

Serious Adverse Event (Section 1)

Alias
UMLS CUI-1
C1519255
Serious Adverse Event
Description

Diagnosis Only (if known) Otherwise Sign/Symptom

Data type

text

Alias
UMLS CUI [1]
C1519255
Serious Adverse Event Start Date
Description

Serious Adverse Event Start Date

Data type

date

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0808070
Serious Adverse Event Start Time
Description

Serious Adverse Event Start Time

Data type

time

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C1301880
Serious Adverse Event Outcome
Description

Serious Adverse Event Outcome

Data type

integer

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C1705586
Serious Adverse Event End date
Description

Serious Adverse Event End date

Data type

date

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0806020
Serious Adverse Event End Time
Description

Serious Adverse Event End Time

Data type

time

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C1522314
Serious Adverse Event Maximum Intensity
Description

Serious Adverse Event Maximum Intensity

Data type

text

Alias
UMLS CUI [1]
C1519255
UMLS CUI [2,1]
C0518690
UMLS CUI [2,2]
C0806909
Action Taken with Investigational Product(s) as a Result of the SAE
Description

Action Taken with Investigational Product(s) as a Result of the SAE

Data type

text

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

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

Data type

boolean

Alias
UMLS CUI [1,1]
C1710677
UMLS CUI [1,2]
C1519255
Is there a reasonable possibility the SAE may have been caused by the investigational product?
Description

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

Data type

boolean

Alias
UMLS CUI [1]
C1519255
UMLS CUI [2,1]
C0013230
UMLS CUI [2,2]
C0439849
Serious Adverse Event - Seriousness (Section 2)
Description

Serious Adverse Event - Seriousness (Section 2)

Alias
UMLS CUI-1
C1519255
UMLS CUI-2
C1710056
Specify reason(s) for considering this a SAE
Description

Check all that apply.

Data type

text

Alias
UMLS CUI [1,1]
C1710056
UMLS CUI [1,2]
C0392360
Specify other reason considering this an SAE
Description

Specify other reason considering this an SAE

Data type

text

Alias
UMLS CUI [1]
C1519255
UMLS CUI [2,1]
C0392360
UMLS CUI [2,2]
C0205394
UMLS CUI [3]
C2348235
Serious Adverse Event - Demography Data (Section 3)
Description

Serious Adverse Event - Demography Data (Section 3)

Alias
UMLS CUI-1
C1519255
UMLS CUI-3
C0011298
Date of birth
Description

Date of birth

Data type

date

Alias
UMLS CUI [1]
C0421451
Sex
Description

Sex

Data type

text

Alias
UMLS CUI [1]
C0079399
Weight
Description

Weight

Data type

float

Measurement units
  • kg
Alias
UMLS CUI [1]
C0005910
kg
Serious Adverse Event - Investigational Product
Description

Serious Adverse Event - Investigational Product

Alias
UMLS CUI-1
C1519255
UMLS CUI-3
C0304229
If deliberate or inadvertent administration of further dose(s) of investigational product(s) to the subject occurred, did the reported adverse event recur?
Description

If deliberate or inadvertent administration of further dose(s) of investigational product(s) to the subject occurred, did the reported adverse event recur?

Data type

text

Alias
UMLS CUI [1]
C0304229
UMLS CUI [2]
C1519255
UMLS CUI [3]
C0034897
Serious Adverse Event - Causes (Section 5)
Description

Serious Adverse Event - Causes (Section 5)

Alias
UMLS CUI-1
C1519255
UMLS CUI-2
C0085978
Possible Causes of SAE Other Than Investigational Product(s)
Description

Check all that apply

Data type

integer

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0085978
UMLS CUI [2]
C0205394
Specify other cause of SAE
Description

Specify other cause of SAE

Data type

text

Alias
UMLS CUI [1]
C0085978
UMLS CUI [2]
C1519255
UMLS CUI [3]
C0205394
UMLS CUI [4]
C2348235
Serious Adverse Event - RELEVANT Medical Conditions (Section 6)
Description

Serious Adverse Event - RELEVANT Medical Conditions (Section 6)

Alias
UMLS CUI-1
C1519255
UMLS CUI-2
C0262926
Specify any RELEVANT past or current medical disorders, allergies, surgeries, etc. that can help explain the SAE
Description

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

Data type

text

Alias
UMLS CUI [1]
C0012634
UMLS CUI [2]
C0020517
UMLS CUI [3]
C0543467
UMLS CUI [4]
C1519255
Medical condition - Date of Onset
Description

Medical condition - Date of Onset

Data type

date

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C0574845
Condition Present at Time of the SAE?
Description

Condition Present at Time of the SAE?

Data type

boolean

Alias
UMLS CUI [1]
C0012634
UMLS CUI [2]
C1519255
If condition not present at time of SAE, enter Date of Last Occurrence
Description

If condition not present at time of SAE, enter Date of Last Occurrence

Data type

date

Alias
UMLS CUI [1]
C0012634
UMLS CUI [2]
C1519255
UMLS CUI [3,1]
C2745955
UMLS CUI [3,2]
C1517741
UMLS CUI [3,3]
C0011008
Serious Adverse Event - Other RELEVANT Risk Factors (Section 7)
Description

Serious Adverse Event - Other RELEVANT Risk Factors (Section 7)

Alias
UMLS CUI-1
C1519255
UMLS CUI-3
C0035648
UMLS CUI-4
C0205394
Other RELEVANT Risk Factors
Description

(provide any family or social history (e.g., smoking, alcohol, diet, drug abuse, occupational hazard) relevant to the SAE)

Data type

text

Alias
UMLS CUI [1]
C0035648
UMLS CUI [2]
C1519255
Serious Adverse Event - Concomitant Medications (Section 8)
Description

Serious Adverse Event - Concomitant Medications (Section 8)

Alias
UMLS CUI-1
C1519255
UMLS CUI-3
C2347852
Drug Name
Description

(Trade Name preferred)

Data type

text

Alias
UMLS CUI [1]
C2360065
Drug Dose
Description

Drug Dose

Data type

float

Alias
UMLS CUI [1]
C0678766
Unit
Description

Unit

Data type

text

Alias
UMLS CUI [1]
C1519795
Medication Frequency
Description

Medication Frequency

Data type

text

Alias
UMLS CUI [1]
C3476109
Medication Route
Description

Medication Route

Data type

text

Alias
UMLS CUI [1]
C0013153
Medication taken prior to study?
Description

Medication taken prior to study?

Data type

boolean

Alias
UMLS CUI [1]
C2826667
Medication Start Date
Description

Medication Start Date

Data type

date

Alias
UMLS CUI [1]
C2826734
Medication Stop Date
Description

Medication Stop Date

Data type

date

Alias
UMLS CUI [1]
C2826744
Ongoing Medication?
Description

Ongoing Medication?

Data type

boolean

Alias
UMLS CUI [1]
C2826666
Reason for Medication
Description

Reason for Medication

Data type

text

Alias
UMLS CUI [1]
C2826696
Serious Adverse Event - Details of Investigational Product(s) (Section 9)
Description

Serious Adverse Event - Details of Investigational Product(s) (Section 9)

Alias
UMLS CUI-1
C1519255
UMLS CUI-3
C0304229
UMLS CUI-5
C1522508
Details of Investigational Product(s)
Description

Details of Investigational Product(s)

Data type

text

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

Was treatment blind broken at investigational Site?

Data type

text

Alias
UMLS CUI [1]
C3897431
Serious Adverse Event - Details of RELEVANT Assessments (Section 10)
Description

Serious Adverse Event - Details of RELEVANT Assessments (Section 10)

Alias
UMLS CUI-1
C1519255
UMLS CUI-3
C0220825
UMLS CUI-4
C1522508
Details of RELEVANT Assessments
Description

(provide details of any other tests/procedures which were carried out to diagnose or confirm the SAE e.g., laboratory data with units and normal range)

Data type

text

Alias
UMLS CUI [1,1]
C0220825
UMLS CUI [1,2]
C1522508
Serious Adverse Event - Narrative Remarks (Section 11)
Description

Serious Adverse Event - Narrative Remarks (Section 11)

Alias
UMLS CUI-1
C1519255
UMLS CUI-3
C0947611
Narrative Remarks
Description

(provide a brief narrative description of the SAE and details of treatment given)

Data type

text

Alias
UMLS CUI [1]
C0947611
SAE - Investigator's signature
Description

SAE - Investigator's signature

Alias
UMLS CUI-1
C1519255
UMLS CUI-2
C2346576
Investigator's signature
Description

(confirming that the data on the SAE pages are accurate and complete)

Data type

text

Alias
UMLS CUI [1]
C2346576
Investigator's signature Date
Description

Investigator's signature Date

Data type

date

Alias
UMLS CUI [1,1]
C2346576
UMLS CUI [1,2]
C0011008
Investigator's name
Description

Investigator's name

Data type

text

Alias
UMLS CUI [1]
C2826892
Serious Adverse Event (SAE) - Additional/ Follow-up Information
Description

Serious Adverse Event (SAE) - Additional/ Follow-up Information

Alias
UMLS CUI-1
C1519255
UMLS CUI-3
C1522577
UMLS CUI-5
C1524062
UMLS CUI-7
C1533716
Serious Adverse Event (SAE) - Additional/ Follow-up Information
Description

(use this page to provide any additional details on the SAE not already captured on the previous pages)

Data type

text

Alias
UMLS CUI [1]
C1519255
UMLS CUI [2]
C1522577
UMLS CUI [3]
C1524062
UMLS CUI [4]
C1533716
Investigator's Signature (SAE Follow-up)
Description

Investigator's Signature (SAE Follow-up)

Alias
UMLS CUI-1
C2346576
UMLS CUI-3
C1519255
UMLS CUI-4
C1522577
Investigator's Signature
Description

(confirming that the data on this page is accurate and complete)

Data type

text

Alias
UMLS CUI [1]
C2346576
Investigator's Signature Date
Description

Investigator's Signature Date

Data type

date

Alias
UMLS CUI [1,1]
C2346576
UMLS CUI [1,2]
C0011008
Investigator's name
Description

Investigator's name

Data type

text

Alias
UMLS CUI [1]
C2826892

Similar models

Non-Serious Adverse Events; Serious Adverse Events; SAE Follow-up

Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Administrative
C1320722 (UMLS CUI-1)
Subject Identifier
Item
Subject Identifier
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
Non-Serious Adverse Event
C1518404 (UMLS CUI-1)
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
C1518404 (UMLS CUI [1])
Item Group
Non-Serious Adverse Event
C1518404 (UMLS CUI-1)
Event
Item
Event
text
C0877248 (UMLS CUI [1])
Non-Serious Adverse Event Start Date
Item
Non-Serious Adverse Event Start Date
date
C1518404 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])
Non-Serious Adverse Event Start Time
Item
Non-Serious Adverse Event Start Time
time
C1518404 (UMLS CUI [1,1])
C1301880 (UMLS CUI [1,2])
Item
Non-Serious Adverse Event Outcome
integer
C1518404 (UMLS CUI [1,1])
C1705586 (UMLS CUI [1,2])
Code List
Non-Serious Adverse Event Outcome
CL Item
Recovered/Resolved (1)
CL Item
Recovering/Resolving (2)
CL Item
Not recovered/Not resolved (3)
CL Item
Recovered/Resolvedwith sequelae (4)
Non-Serious Adverse Event End Date
Item
Non-Serious Adverse Event End Date
date
C1518404 (UMLS CUI [1,1])
C0806020 (UMLS CUI [1,2])
Non-Serious Adverse Event End Time
Item
Non-Serious Adverse Event End Time
time
C1518404 (UMLS CUI [1,1])
C1522314 (UMLS CUI [1,2])
Item
Non-Serious Adverse Event Frequency
integer
C1518404 (UMLS CUI [1,1])
C0439603 (UMLS CUI [1,2])
Code List
Non-Serious Adverse Event Frequency
CL Item
Single episode (1)
CL Item
Intermittent (2)
Item
Non-Serious Adverse Event Maximum Intensity
text
C1518404 (UMLS CUI [1])
C0518690 (UMLS CUI [2,1])
C0806909 (UMLS CUI [2,2])
Code List
Non-Serious Adverse Event 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 Non-Serious AE
text
C1704758 (UMLS CUI [1,1])
C1518404 (UMLS CUI [1,2])
Code List
Action Taken with Investigational Product(s) as a Result of the Non-Serious AE
CL Item
Investigational product(s) withdrawn (1)
CL Item
Dose reduced (2)
CL Item
Dose increased (3)
CL Item
Dose not changed (4)
CL Item
Dose interrupted (5)
CL Item
Not applicable (X)
Did the subject withdraw from study as a result of this AE?
Item
Did the subject withdraw from study as a result of this AE?
boolean
C1518404 (UMLS CUI [1])
C2349954 (UMLS CUI [2])
Is there a reasonable possibility that the AE may have been caused by the investigational product?
Item
Is there a reasonable possibility that the AE may have been caused by the investigational product?
boolean
C1518404 (UMLS CUI [1])
C0013230 (UMLS CUI [2,1])
C0439849 (UMLS CUI [2,2])
Item Group
Serious Adverse Event (Section 1)
C1519255 (UMLS CUI-1)
Did the subject experience a serious adverse event during the study?
Item
Did the subject experience a serious adverse event during the study?
boolean
C1519255 (UMLS CUI [1])
If fatal, was a post-mortem/autopsy performed
Item
If fatal, was a post-mortem/autopsy performed
boolean
C0004398 (UMLS CUI [1])
C1519255 (UMLS CUI [2])
Item Group
Serious Adverse Event (Section 1)
C1519255 (UMLS CUI-1)
Serious Adverse Event
Item
Serious Adverse Event
text
C1519255 (UMLS CUI [1])
Serious Adverse Event Start Date
Item
Serious Adverse Event Start Date
date
C1519255 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])
Serious Adverse Event Start Time
Item
Serious Adverse Event Start Time
time
C1519255 (UMLS CUI [1,1])
C1301880 (UMLS CUI [1,2])
Item
Serious Adverse Event Outcome
integer
C1519255 (UMLS CUI [1,1])
C1705586 (UMLS CUI [1,2])
Code List
Serious Adverse Event Outcome
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)
Serious Adverse Event End date
Item
Serious Adverse Event End date
date
C1519255 (UMLS CUI [1,1])
C0806020 (UMLS CUI [1,2])
Serious Adverse Event End Time
Item
Serious Adverse Event End Time
time
C1519255 (UMLS CUI [1,1])
C1522314 (UMLS CUI [1,2])
Item
Serious Adverse Event Maximum Intensity
text
C1519255 (UMLS CUI [1])
C0518690 (UMLS CUI [2,1])
C0806909 (UMLS CUI [2,2])
Code List
Serious Adverse Event 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])
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
Dose not changed (4)
CL Item
Dose interrupted (5)
CL Item
Not applicable (X)
Did the subject withdraw from study as a result of this SAE?
Item
Did the subject withdraw from study as a result of this SAE?
boolean
C1710677 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
Is there a reasonable possibility the SAE may have been caused by the investigational product?
Item
Is there a reasonable possibility the SAE may have been caused by the investigational product?
boolean
C1519255 (UMLS CUI [1])
C0013230 (UMLS CUI [2,1])
C0439849 (UMLS CUI [2,2])
Item Group
Serious Adverse Event - Seriousness (Section 2)
C1519255 (UMLS CUI-1)
C1710056 (UMLS CUI-2)
Item
Specify reason(s) for considering this a SAE
text
C1710056 (UMLS CUI [1,1])
C0392360 (UMLS CUI [1,2])
Code List
Specify reason(s) for considering this a SAE
CL Item
Results in death  (A)
CL Item
Is life-threatening (B)
CL Item
Requires hospitalisation or prolongation of existing hospitalisation (C)
CL Item
Results in disability/incapacity (D)
CL Item
Congenital anomaly/birth defect (E)
CL Item
Other, specify (F)
Specify other reason considering this an SAE
Item
Specify other reason considering this an SAE
text
C1519255 (UMLS CUI [1])
C0392360 (UMLS CUI [2,1])
C0205394 (UMLS CUI [2,2])
C2348235 (UMLS CUI [3])
Item Group
Serious Adverse Event - Demography Data (Section 3)
C1519255 (UMLS CUI-1)
C0011298 (UMLS CUI-3)
Date of birth
Item
Date of birth
date
C0421451 (UMLS CUI [1])
Item
Sex
text
C0079399 (UMLS CUI [1])
Code List
Sex
CL Item
Male (M)
CL Item
Female (F)
Weight
Item
Weight
float
C0005910 (UMLS CUI [1])
Item Group
Serious Adverse Event - Investigational Product
C1519255 (UMLS CUI-1)
C0304229 (UMLS CUI-3)
Item
If deliberate or inadvertent administration of further dose(s) of investigational product(s) to the subject occurred, did the reported adverse event recur?
text
C0304229 (UMLS CUI [1])
C1519255 (UMLS CUI [2])
C0034897 (UMLS CUI [3])
Code List
If deliberate or inadvertent administration of further dose(s) of investigational product(s) to the subject occurred, did the reported adverse event recur?
CL Item
Yes (Y)
CL Item
No (N)
CL Item
Unknown at this time (U)
CL Item
Not applicable (X)
Item Group
Serious Adverse Event - Causes (Section 5)
C1519255 (UMLS CUI-1)
C0085978 (UMLS CUI-2)
Item
Possible Causes of SAE Other Than Investigational Product(s)
integer
C1519255 (UMLS CUI [1,1])
C0085978 (UMLS CUI [1,2])
C0205394 (UMLS CUI [2])
Code List
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)
Specify other cause of SAE
Item
Specify other cause of SAE
text
C0085978 (UMLS CUI [1])
C1519255 (UMLS CUI [2])
C0205394 (UMLS CUI [3])
C2348235 (UMLS CUI [4])
Item Group
Serious Adverse Event - RELEVANT Medical Conditions (Section 6)
C1519255 (UMLS CUI-1)
C0262926 (UMLS CUI-2)
Specify any RELEVANT past or current medical disorders, allergies surgeries, etc. that can help explain the SAE
Item
Specify any RELEVANT past or current medical disorders, allergies, surgeries, etc. that can help explain the SAE
text
C0012634 (UMLS CUI [1])
C0020517 (UMLS CUI [2])
C0543467 (UMLS CUI [3])
C1519255 (UMLS CUI [4])
Medical condition - Date of Onset
Item
Medical condition - Date of Onset
date
C0012634 (UMLS CUI [1,1])
C0574845 (UMLS CUI [1,2])
Condition Present at Time of the SAE?
Item
Condition Present at Time of the SAE?
boolean
C0012634 (UMLS CUI [1])
C1519255 (UMLS CUI [2])
If condition not present at time of SAE, enter Date of Last Occurrence
Item
If condition not present at time of SAE, enter Date of Last Occurrence
date
C0012634 (UMLS CUI [1])
C1519255 (UMLS CUI [2])
C2745955 (UMLS CUI [3,1])
C1517741 (UMLS CUI [3,2])
C0011008 (UMLS CUI [3,3])
Item Group
Serious Adverse Event - Other RELEVANT Risk Factors (Section 7)
C1519255 (UMLS CUI-1)
C0035648 (UMLS CUI-3)
C0205394 (UMLS CUI-4)
Other RELEVANT Risk Factors
Item
Other RELEVANT Risk Factors
text
C0035648 (UMLS CUI [1])
C1519255 (UMLS CUI [2])
Item Group
Serious Adverse Event - Concomitant Medications (Section 8)
C1519255 (UMLS CUI-1)
C2347852 (UMLS CUI-3)
Drug Name
Item
Drug Name
text
C2360065 (UMLS CUI [1])
Drug Dose
Item
Drug Dose
float
C0678766 (UMLS CUI [1])
Unit
Item
Unit
text
C1519795 (UMLS CUI [1])
Medication Frequency
Item
Medication Frequency
text
C3476109 (UMLS CUI [1])
Medication Route
Item
Medication Route
text
C0013153 (UMLS CUI [1])
Medication taken prior to study?
Item
Medication taken prior to study?
boolean
C2826667 (UMLS CUI [1])
Medication Start Date
Item
Medication Start Date
date
C2826734 (UMLS CUI [1])
Medication Stop Date
Item
Medication Stop Date
date
C2826744 (UMLS CUI [1])
Ongoing Medication?
Item
Ongoing Medication?
boolean
C2826666 (UMLS CUI [1])
Reason for Medication
Item
Reason for Medication
text
C2826696 (UMLS CUI [1])
Item Group
Serious Adverse Event - Details of Investigational Product(s) (Section 9)
C1519255 (UMLS CUI-1)
C0304229 (UMLS CUI-3)
C1522508 (UMLS CUI-5)
Details of Investigational Product(s)
Item
Details of Investigational Product(s)
text
C0304229 (UMLS CUI [1,1])
C1522508 (UMLS CUI [1,2])
Item
Was treatment blind broken at investigational Site?
text
C3897431 (UMLS CUI [1])
Code List
Was treatment blind broken at investigational Site?
CL Item
Yes (Y)
CL Item
No (N)
CL Item
Not applicable (X)
Item Group
Serious Adverse Event - Details of RELEVANT Assessments (Section 10)
C1519255 (UMLS CUI-1)
C0220825 (UMLS CUI-3)
C1522508 (UMLS CUI-4)
Details of RELEVANT Assessments
Item
Details of RELEVANT Assessments
text
C0220825 (UMLS CUI [1,1])
C1522508 (UMLS CUI [1,2])
Item Group
Serious Adverse Event - Narrative Remarks (Section 11)
C1519255 (UMLS CUI-1)
C0947611 (UMLS CUI-3)
Narrative Remarks
Item
Narrative Remarks
text
C0947611 (UMLS CUI [1])
Item Group
SAE - Investigator's signature
C1519255 (UMLS CUI-1)
C2346576 (UMLS CUI-2)
Investigator's signature
Item
Investigator's signature
text
C2346576 (UMLS CUI [1])
Investigator's signature Date
Item
Investigator's signature Date
date
C2346576 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Investigator's name
Item
Investigator's name
text
C2826892 (UMLS CUI [1])
Item Group
Serious Adverse Event (SAE) - Additional/ Follow-up Information
C1519255 (UMLS CUI-1)
C1522577 (UMLS CUI-3)
C1524062 (UMLS CUI-5)
C1533716 (UMLS CUI-7)
Serious Adverse Event (SAE) - Additional/ Follow-up Information
Item
Serious Adverse Event (SAE) - Additional/ Follow-up Information
text
C1519255 (UMLS CUI [1])
C1522577 (UMLS CUI [2])
C1524062 (UMLS CUI [3])
C1533716 (UMLS CUI [4])
Item Group
Investigator's Signature (SAE Follow-up)
C2346576 (UMLS CUI-1)
C1519255 (UMLS CUI-3)
C1522577 (UMLS CUI-4)
Investigator's Signature
Item
Investigator's Signature
text
C2346576 (UMLS CUI [1])
Investigator's Signature Date
Item
Investigator's Signature Date
date
C2346576 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Investigator's name
Item
Investigator's name
text
C2826892 (UMLS CUI [1])

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