ID

41259

Description

Study ID: 103471 Clinical Study ID: 103471 Study Title: A randomised, double blind, placebo-controlled, double dummy, five-way cross over dose-escalation study to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of single inhaled doses of GSK233705 (20-500µg via DPI), and, tiotropium bromide (18µg via DPI) in healthy male subjects. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Sponsor: GlaxoSmithKline Phase: Phase 1 Study Recruitment Status: Completed Generic Name: Darotropium Bromide Trade Name: Darotropium Bromide Study Indication: Chronic Obstructive Pulmonary Disease (COPD)

Keywords

Versions (1)
  1. 7/29/20 7/29/20 -
Copyright Holder

GlaxoSmithKline

Uploaded on

July 29, 2020

DOI

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License

Creative Commons BY 4.0
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Safety, tolerability, pharmacokinetics and pharmacodynamics of GSK233705 and tiotropium bromide (103471)

English

Non-serious Adverse Events (AE); Serious Adverse Events (SAE)

1 forms  
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 Events (AE)
Description

Non-serious Adverse Events (AE)

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 Events (AE)
Description

Non-serious Adverse Events (AE)

Alias
UMLS CUI-1
C1518404
Non-serious Adverse Event (AE)
Description

Diagnosis only (if known), otherwise sign/ symptom

Data type

text

Alias
UMLS CUI [1]
C1518404
Non-serious Adverse Events (AE) - Start Date
Description

Non-serious Adverse Events (AE) - Start Date

Data type

date

Alias
UMLS CUI [1,1]
C1518404
UMLS CUI [1,2]
C0808070
Non-serious Adverse Events (AE) - Start Time
Description

Non-serious Adverse Events (AE) - Start Time

Data type

time

Alias
UMLS CUI [1,1]
C1518404
UMLS CUI [1,2]
C1301880
Non-serious Adverse Events (AE) - Outcome
Description

Non-serious Adverse Events (AE) - Outcome

Data type

integer

Alias
UMLS CUI [1,1]
C1518404
UMLS CUI [1,2]
C1705586
Non-serious Adverse Events (AE) - End Date
Description

Non-serious Adverse Events (AE) - End Date

Data type

date

Alias
UMLS CUI [1,1]
C1518404
UMLS CUI [1,2]
C0806020
Non-serious Adverse Events (AE) - End Time
Description

Non-serious Adverse Events (AE) - End Time

Data type

time

Alias
UMLS CUI [1,1]
C1518404
UMLS CUI [1,2]
C1522314
Non-serious Adverse Events (AE) - Frequency
Description

Non-serious Adverse Events (AE) - Frequency

Data type

integer

Alias
UMLS CUI [1,1]
C1518404
UMLS CUI [1,2]
C0439603
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 [1,1]
C1710677
UMLS CUI [1,2]
C1518404
Is there a reasonable possibility that the AE may have been caused by the investigationhal product?
Description

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

Data type

boolean

Alias
UMLS CUI [1,1]
C1518404
UMLS CUI [1,2]
C0013230
UMLS CUI [1,3]
C0439849
Serious Adverse Event (SAE)
Description

Serious Adverse Event (SAE)

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
Serious Adverse Event (SAE) - Section 1
Description

Serious Adverse Event (SAE) - Section 1

Alias
UMLS CUI-1
C1519255
Serious Adverse Event (SAE)
Description

Diagnosis only (if known), otherwise sign/ symptom

Data type

text

Alias
UMLS CUI [1]
C1519255
Serious Adverse Event (SAE) - Start Date
Description

Serious Adverse Event (SAE) - Start Date

Data type

date

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

Serious Adverse Event (SAE) - Start Time

Data type

time

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C1301880
Serious Adverse Event (SAE) - Outcome
Description

Serious Adverse Event (SAE) - Outcome

Data type

integer

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C1705586
Serious Adverse Event (SAE) - End Date
Description

Serious Adverse Event (SAE) - End Date

Data type

date

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

Serious Adverse Event (SAE) - End Time

Data type

time

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

Serious Adverse Event (SAE) - Maximum Intensity

Data type

text

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0518690
UMLS CUI [1,3]
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 [1,1]
C1519255
UMLS CUI [1,2]
C0013230
UMLS CUI [1,3]
C0439849
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 [1,1]
C0004398
UMLS CUI [1,2]
C1519255
Serious Adverse Event (SAE) - Section 2 Seriousness
Description

Serious Adverse Event (SAE) - Section 2 Seriousness

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
If other reason(s) for considering this a SAE ,specify
Description

If other reason(s) for considering this a SAE ,specify

Data type

text

Alias
UMLS CUI [1,1]
C1710056
UMLS CUI [1,2]
C0392360
UMLS CUI [2]
C0205394
UMLS CUI [3]
C2348235
Serious Adverse Event (SAE) - Section 3 Demography Data
Description

Serious Adverse Event (SAE) - Section 3 Demography Data

Alias
UMLS CUI-1
C1519255
UMLS CUI-2
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

Alias
UMLS CUI [1]
C0005910
Serious Adverse Event (SAE) - Section 4
Description

Serious Adverse Event (SAE) - Section 4

Alias
UMLS CUI-1
C1519255
If investigational product(s) was stopped, did the reported event(s) recur after further investigational product(s) were administered?
Description

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

Data type

text

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0034897
UMLS CUI [2,1]
C0304229
UMLS CUI [2,2]
C0457454
Serious Adverse Event (SAE) - Section 5
Description

Serious Adverse Event (SAE) - Section 5

Alias
UMLS CUI-1
C1519255
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 [1,3]
C0304229
UMLS CUI [1,4]
C0205394
Specify medical condition(s)
Description

Specify medical condition(s)

Data type

text

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C2348235
Specify concomitant medication(s)
Description

Specify concomitant medication(s)

Data type

text

Alias
UMLS CUI [1,1]
C2347852
UMLS CUI [1,2]
C2348235
Specify other cause of SAE
Description

Specify other cause of SAE

Data type

text

Alias
UMLS CUI [1,1]
C0085978
UMLS CUI [1,2]
C1519255
UMLS CUI [2,1]
C0205394
UMLS CUI [2,2]
C2348235
Serious Adverse Event (SAE) - Section 6 Relevant Medical Conditions
Description

Serious Adverse Event (SAE) - Section 6 Relevant Medical Conditions

Alias
UMLS CUI-1
C1519255
UMLS CUI-2
C0012634
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
Date of onset of medical condition
Description

Date of onset of medical condition

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 [1,1]
C0012634
UMLS CUI [1,2]
C0150312
UMLS CUI [1,3]
C1519255
If condition not present at time of the SAE, enter date of last occurence
Description

If condition not present at time of the SAE, enter date of last occurence

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 (SAE) - Section 7 Other relevant risk factors
Description

Serious Adverse Event (SAE) - Section 7 Other relevant risk factors

Alias
UMLS CUI-1
C1519255
UMLS CUI-2
C0035648
UMLS CUI-3
C0205394
Provide any family or social history (e.g. smoking, alcohol, diet, drug abuse, occupational hazard) relevant to the SAE
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]
C0241889
UMLS CUI [2]
C3714536
UMLS CUI [3]
C1519384
UMLS CUI [4]
C0001948
UMLS CUI [5]
C0012155
UMLS CUI [6]
C0013146
UMLS CUI [7]
C0337074
UMLS CUI [8]
C1519255
Serious Adverse Event (SAE) - Section 8 Concomitant medications
Description

Serious Adverse Event (SAE) - Section 8 Concomitant medications

Alias
UMLS CUI-1
C1519255
UMLS CUI-2
C2347852
Drug name
Description

Trade name preferred

Data type

text

Alias
UMLS CUI [1]
C0013227
Medication dose
Description

Medication dose

Data type

float

Alias
UMLS CUI [1]
C3174092
Medication unit
Description

Medication unit

Data type

text

Alias
UMLS CUI [1,1]
C2347852
UMLS CUI [1,2]
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 [1,1]
C0392360
UMLS CUI [1,2]
C0013227
Serious Adverse Event (SAE) - Section 9 Details of investigational product(s)
Description

Serious Adverse Event (SAE) - Section 9 Details of investigational product(s)

Alias
UMLS CUI-1
C1519255
UMLS CUI-2
C0304229
UMLS CUI-3
C1522508
Visit
Description

Visit

Data type

integer

Alias
UMLS CUI [1]
C0545082
Date of dose
Description

Date of dose

Data type

date

Alias
UMLS CUI [1,1]
C0178602
UMLS CUI [1,2]
C0011008
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 (SAE) - Section 10
Description

Serious Adverse Event (SAE) - Section 10

Alias
UMLS CUI-1
C1519255
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
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]
C1519255
UMLS CUI [1,2]
C0431080
UMLS CUI [2]
C0022885
UMLS CUI [3]
C1519795
UMLS CUI [4]
C0086715
Serious Adverse Event (SAE) - Section 11 Narrative remarks
Description

Serious Adverse Event (SAE) - Section 11 Narrative remarks

Alias
UMLS CUI-1
C1519255
UMLS CUI-2
C0947611
Provide a brief narrative description of the SAE and details of treatment given
Description

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

Data type

text

Alias
UMLS CUI [1,1]
C0947611
UMLS CUI [1,2]
C1519255
UMLS CUI [2,1]
C0087111
UMLS CUI [2,2]
C1522508
Investigator's signature
Description

Investigator's signature

Alias
UMLS CUI-1
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 name (print)
Description

Investigator's name (print)

Data type

text

Alias
UMLS CUI [1]
C2826892
Investigator's signature date
Description

Investigator's signature date

Data type

date

Alias
UMLS CUI [1,1]
C2346576
UMLS CUI [1,2]
C0011008
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Similar models

Non-serious Adverse Events (AE); Serious Adverse Events (SAE)

1 forms
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 Events (AE)
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 Events (AE)
C1518404 (UMLS CUI-1)
Non-serious Adverse Event (AE)
Item
Non-serious Adverse Event (AE)
text
C1518404 (UMLS CUI [1])
Non-serious Adverse Events (AE) - Start Date
Item
Non-serious Adverse Events (AE) - Start Date
date
C1518404 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])
Non-serious Adverse Events (AE) - Start Time
Item
Non-serious Adverse Events (AE) - Start Time
time
C1518404 (UMLS CUI [1,1])
C1301880 (UMLS CUI [1,2])
Item
Non-serious Adverse Events (AE) - Outcome
integer
C1518404 (UMLS CUI [1,1])
C1705586 (UMLS CUI [1,2])
Non-serious Adverse Events (AE) - Outcome
Code List
Non-serious Adverse Events (AE) - 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)
Non-serious Adverse Events (AE) - End Date
Item
Non-serious Adverse Events (AE) - End Date
date
C1518404 (UMLS CUI [1,1])
C0806020 (UMLS CUI [1,2])
Non-serious Adverse Events (AE) - End Time
Item
Non-serious Adverse Events (AE) - End Time
time
C1518404 (UMLS CUI [1,1])
C1522314 (UMLS CUI [1,2])
Item
Non-serious Adverse Events (AE) - Frequency
integer
C1518404 (UMLS CUI [1,1])
C0439603 (UMLS CUI [1,2])
Non-serious Adverse Events (AE) - Frequency
Code List
Non-serious Adverse Events (AE) - Frequency
CL Item
Single episode (1)
CL Item
Intermittent (2)
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])
Action taken with investigational product(s) as a result of the non-serious AE
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
C1710677 (UMLS CUI [1,1])
C1518404 (UMLS CUI [1,2])
Is there a reasonable possibility that the AE may have been caused by the investigationhal product?
Item
Is there a reasonable possibility that the AE may have been caused by the investigationhal product?
boolean
C1518404 (UMLS CUI [1,1])
C0013230 (UMLS CUI [1,2])
C0439849 (UMLS CUI [1,3])
Item Group
Serious Adverse Event (SAE)
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])
Item Group
Serious Adverse Event (SAE) - Section 1
C1519255 (UMLS CUI-1)
Serious Adverse Event (SAE)
Item
Serious Adverse Event (SAE)
text
C1519255 (UMLS CUI [1])
Serious Adverse Event (SAE) - Start Date
Item
Serious Adverse Event (SAE) - Start Date
date
C1519255 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])
Serious Adverse Event (SAE) - Start Time
Item
Serious Adverse Event (SAE) - Start Time
time
C1519255 (UMLS CUI [1,1])
C1301880 (UMLS CUI [1,2])
Item
Serious Adverse Event (SAE) - Outcome
integer
C1519255 (UMLS CUI [1,1])
C1705586 (UMLS CUI [1,2])
Serious Adverse Event (SAE) - Outcome
Code List
Serious Adverse Event (SAE) - Outcome
CL Item
Recovered/ Resolved (1)
CL Item
Recovering/ Resolving (2)
CL Item
Not recovered/ Not resolved (3)
CL Item
Recovered/ Resolved with seqelae (4)
CL Item
Fatal (5)
Serious Adverse Event (SAE) - End Date
Item
Serious Adverse Event (SAE) - End Date
date
C1519255 (UMLS CUI [1,1])
C0806020 (UMLS CUI [1,2])
Serious Adverse Event (SAE) - End Time
Item
Serious Adverse Event (SAE) - End Time
time
C1519255 (UMLS CUI [1,1])
C1522314 (UMLS CUI [1,2])
Item
Serious Adverse Event (SAE) - Maximum Intensity
text
C1519255 (UMLS CUI [1,1])
C0518690 (UMLS CUI [1,2])
C0806909 (UMLS CUI [1,3])
Serious Adverse Event (SAE) - Maximum Intensity
Code List
Serious Adverse Event (SAE) - 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])
Action taken with 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
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 [1,1])
C0013230 (UMLS CUI [1,2])
C0439849 (UMLS CUI [1,3])
If fatal, was a post-mortem/ autopsy performed?
Item
If fatal, was a post-mortem/ autopsy performed?
boolean
C0004398 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
Item Group
Serious Adverse Event (SAE) - Section 2 Seriousness
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])
Specify reason(s) for considering this a SAE
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)
If other reason(s) for considering this a SAE ,specify
Item
If other reason(s) for considering this a SAE ,specify
text
C1710056 (UMLS CUI [1,1])
C0392360 (UMLS CUI [1,2])
C0205394 (UMLS CUI [2])
C2348235 (UMLS CUI [3])
Item Group
Serious Adverse Event (SAE) - Section 3 Demography Data
C1519255 (UMLS CUI-1)
C0011298 (UMLS CUI-2)
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
Serious Adverse Event (SAE) - Section 4
C1519255 (UMLS CUI-1)
Item
If investigational product(s) was stopped, did the reported event(s) recur after further investigational product(s) were administered?
text
C1519255 (UMLS CUI [1,1])
C0034897 (UMLS CUI [1,2])
C0304229 (UMLS CUI [2,1])
C0457454 (UMLS CUI [2,2])
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 (Y)
CL Item
No (N)
CL Item
Unknown at this time (U)
CL Item
Not applicable (X)
Item Group
Serious Adverse Event (SAE) - Section 5
C1519255 (UMLS CUI-1)
Item
Possible causes of SAE other than investigational product(s)
integer
C1519255 (UMLS CUI [1,1])
C0085978 (UMLS CUI [1,2])
C0304229 (UMLS CUI [1,3])
C0205394 (UMLS CUI [1,4])
Possible causes of SAE other than investigational product(s)
Code List
Possible causes of SAE other than investigational product(s)
CL Item
Disease under study (1)
CL Item
Medical condition(s), specify (record in Section 6) (2)
CL Item
Lack of efficacy (3)
CL Item
Withdrawal of investigational product(s) (4)
CL Item
Concomitant medication(s) specify (record in Section 8) (5)
CL Item
Activity related to study participation (e.g. procedures) (6)
CL Item
Other, specify (7)
Specify medical condition(s)
Item
Specify medical condition(s)
text
C0012634 (UMLS CUI [1,1])
C2348235 (UMLS CUI [1,2])
Specify concomitant medication(s)
Item
Specify concomitant medication(s)
text
C2347852 (UMLS CUI [1,1])
C2348235 (UMLS CUI [1,2])
Specify other cause of SAE
Item
Specify other cause of SAE
text
C0085978 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
C0205394 (UMLS CUI [2,1])
C2348235 (UMLS CUI [2,2])
Item Group
Serious Adverse Event (SAE) - Section 6 Relevant Medical Conditions
C1519255 (UMLS CUI-1)
C0012634 (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])
Date of onset of medical condition
Item
Date of onset of medical condition
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 [1,1])
C0150312 (UMLS CUI [1,2])
C1519255 (UMLS CUI [1,3])
If condition not present at time of the SAE, enter date of last occurence
Item
If condition not present at time of the SAE, enter date of last occurence
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 (SAE) - Section 7 Other relevant risk factors
C1519255 (UMLS CUI-1)
C0035648 (UMLS CUI-2)
C0205394 (UMLS CUI-3)
Provide any family or social history (e.g. smoking, alcohol, diet, drug abuse, occupational hazard) relevant to the SAE
Item
Provide any family or social history (e.g. smoking, alcohol, diet, drug abuse, occupational hazard) relevant to the SAE
text
C0241889 (UMLS CUI [1])
C3714536 (UMLS CUI [2])
C1519384 (UMLS CUI [3])
C0001948 (UMLS CUI [4])
C0012155 (UMLS CUI [5])
C0013146 (UMLS CUI [6])
C0337074 (UMLS CUI [7])
C1519255 (UMLS CUI [8])
Item Group
Serious Adverse Event (SAE) - Section 8 Concomitant medications
C1519255 (UMLS CUI-1)
C2347852 (UMLS CUI-2)
Drug name
Item
Drug name
text
C0013227 (UMLS CUI [1])
Medication dose
Item
Medication dose
float
C3174092 (UMLS CUI [1])
Medication unit
Item
Medication unit
text
C2347852 (UMLS CUI [1,1])
C1519795 (UMLS CUI [1,2])
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
C0392360 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
Item Group
Serious Adverse Event (SAE) - Section 9 Details of investigational product(s)
C1519255 (UMLS CUI-1)
C0304229 (UMLS CUI-2)
C1522508 (UMLS CUI-3)
Item
Visit
integer
C0545082 (UMLS CUI [1])
Visit
Code List
Visit
CL Item
Screening visit (1)
CL Item
Treatment period 1 (2)
CL Item
Treatment period 2 (3)
CL Item
Treatment period 3 (4)
CL Item
Treatment period 4 (5)
CL Item
Treatment period 5 (6)
Date of dose
Item
Date of dose
date
C0178602 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Item
Was treatment blind broken at investigational site?
text
C3897431 (UMLS CUI [1])
Was treatment blind broken at investigational site?
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 (SAE) - Section 10
C1519255 (UMLS CUI-1)
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
Item
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
text
C1519255 (UMLS CUI [1,1])
C0431080 (UMLS CUI [1,2])
C0022885 (UMLS CUI [2])
C1519795 (UMLS CUI [3])
C0086715 (UMLS CUI [4])
Item Group
Serious Adverse Event (SAE) - Section 11 Narrative remarks
C1519255 (UMLS CUI-1)
C0947611 (UMLS CUI-2)
Provide a brief narrative description of the SAE and details of treatment given
Item
Provide a brief narrative description of the SAE and details of treatment given
text
C0947611 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
C0087111 (UMLS CUI [2,1])
C1522508 (UMLS CUI [2,2])
Item Group
Investigator's signature
C2346576 (UMLS CUI-1)
Investigator's signature
Item
Investigator's signature
text
C2346576 (UMLS CUI [1])
Investigator's name (print)
Item
Investigator's name (print)
text
C2826892 (UMLS CUI [1])
Investigator's signature date
Item
Investigator's signature date
date
C2346576 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
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