ID

41259

Beskrivning

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)

Nyckelord

Versioner (1)
  1. 2020-07-29 2020-07-29 -
Rättsinnehavare

GlaxoSmithKline

Uppladdad den

29 juli 2020

DOI

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Licens

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

Engelsk

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

1 Formulär  
Administrative
Beskrivning

Administrative

Alias
UMLS CUI-1
C1320722
Subject Identifier
Beskrivning

Subject Identifier

Datatyp

text

Alias
UMLS CUI [1]
C2348585
Centre Number
Beskrivning

Centre Number

Datatyp

text

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

Randomisation Number

Datatyp

text

Alias
UMLS CUI [1,1]
C0034656
UMLS CUI [1,2]
C0237753
Non-serious Adverse Events (AE)
Beskrivning

Non-serious Adverse Events (AE)

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

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

Datatyp

boolean

Alias
UMLS CUI [1]
C1518404
Non-serious Adverse Events (AE)
Beskrivning

Non-serious Adverse Events (AE)

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

Diagnosis only (if known), otherwise sign/ symptom

Datatyp

text

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

Non-serious Adverse Events (AE) - Start Date

Datatyp

date

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

Non-serious Adverse Events (AE) - Start Time

Datatyp

time

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

Non-serious Adverse Events (AE) - Outcome

Datatyp

integer

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

Non-serious Adverse Events (AE) - End Date

Datatyp

date

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

Non-serious Adverse Events (AE) - End Time

Datatyp

time

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

Non-serious Adverse Events (AE) - Frequency

Datatyp

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
Beskrivning

Action taken with investigational product(s) as a result of the non-serious AE

Datatyp

text

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

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

Datatyp

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?
Beskrivning

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

Datatyp

boolean

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

Serious Adverse Event (SAE)

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

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

Datatyp

boolean

Alias
UMLS CUI [1]
C1519255
Serious Adverse Event (SAE) - Section 1
Beskrivning

Serious Adverse Event (SAE) - Section 1

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

Diagnosis only (if known), otherwise sign/ symptom

Datatyp

text

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

Serious Adverse Event (SAE) - Start Date

Datatyp

date

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

Serious Adverse Event (SAE) - Start Time

Datatyp

time

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

Serious Adverse Event (SAE) - Outcome

Datatyp

integer

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

Serious Adverse Event (SAE) - End Date

Datatyp

date

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

Serious Adverse Event (SAE) - End Time

Datatyp

time

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

Serious Adverse Event (SAE) - Maximum Intensity

Datatyp

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
Beskrivning

Action taken with investigational product(s) as a result of the SAE

Datatyp

text

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

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

Datatyp

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?
Beskrivning

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

Datatyp

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?
Beskrivning

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

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0004398
UMLS CUI [1,2]
C1519255
Serious Adverse Event (SAE) - Section 2 Seriousness
Beskrivning

Serious Adverse Event (SAE) - Section 2 Seriousness

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

Check all that apply

Datatyp

text

Alias
UMLS CUI [1,1]
C1710056
UMLS CUI [1,2]
C0392360
If other reason(s) for considering this a SAE ,specify
Beskrivning

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

Datatyp

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
Beskrivning

Serious Adverse Event (SAE) - Section 3 Demography Data

Alias
UMLS CUI-1
C1519255
UMLS CUI-2
C0011298
Date of birth
Beskrivning

Date of birth

Datatyp

date

Alias
UMLS CUI [1]
C0421451
Sex
Beskrivning

Sex

Datatyp

text

Alias
UMLS CUI [1]
C0079399
Weight
Beskrivning

Weight

Datatyp

float

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

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?
Beskrivning

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

Datatyp

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
Beskrivning

Serious Adverse Event (SAE) - Section 5

Alias
UMLS CUI-1
C1519255
Possible causes of SAE other than investigational product(s)
Beskrivning

Check all that apply

Datatyp

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)
Beskrivning

Specify medical condition(s)

Datatyp

text

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

Specify concomitant medication(s)

Datatyp

text

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

Specify other cause of SAE

Datatyp

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
Beskrivning

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
Beskrivning

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

Datatyp

text

Alias
UMLS CUI [1]
C0012634
UMLS CUI [2]
C0020517
UMLS CUI [3]
C0543467
UMLS CUI [4]
C1519255
Date of onset of medical condition
Beskrivning

Date of onset of medical condition

Datatyp

date

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C0574845
Condition present at time of the SAE?
Beskrivning

Condition present at time of the SAE?

Datatyp

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
Beskrivning

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

Datatyp

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
Beskrivning

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
Beskrivning

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

Datatyp

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
Beskrivning

Serious Adverse Event (SAE) - Section 8 Concomitant medications

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

Trade name preferred

Datatyp

text

Alias
UMLS CUI [1]
C0013227
Medication dose
Beskrivning

Medication dose

Datatyp

float

Alias
UMLS CUI [1]
C3174092
Medication unit
Beskrivning

Medication unit

Datatyp

text

Alias
UMLS CUI [1,1]
C2347852
UMLS CUI [1,2]
C1519795
Medication Frequency
Beskrivning

Medication Frequency

Datatyp

text

Alias
UMLS CUI [1]
C3476109
Medication Route
Beskrivning

Medication Route

Datatyp

text

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

Medication taken prior to study?

Datatyp

boolean

Alias
UMLS CUI [1]
C2826667
Medication start date
Beskrivning

Medication start date

Datatyp

date

Alias
UMLS CUI [1]
C2826734
Medication stop date
Beskrivning

Medication stop date

Datatyp

date

Alias
UMLS CUI [1]
C2826744
Ongoing medication?
Beskrivning

Ongoing medication?

Datatyp

boolean

Alias
UMLS CUI [1]
C2826666
Reason for medication?
Beskrivning

Reason for medication?

Datatyp

text

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

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
Beskrivning

Visit

Datatyp

integer

Alias
UMLS CUI [1]
C0545082
Date of dose
Beskrivning

Date of dose

Datatyp

date

Alias
UMLS CUI [1,1]
C0178602
UMLS CUI [1,2]
C0011008
Was treatment blind broken at investigational site?
Beskrivning

Was treatment blind broken at investigational site?

Datatyp

text

Alias
UMLS CUI [1]
C3897431
Serious Adverse Event (SAE) - Section 10
Beskrivning

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
Beskrivning

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

Datatyp

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
Beskrivning

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
Beskrivning

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

Datatyp

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
Beskrivning

Investigator's signature

Alias
UMLS CUI-1
C2346576
Investigator's signature
Beskrivning

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

Datatyp

text

Alias
UMLS CUI [1]
C2346576
Investigator's name (print)
Beskrivning

Investigator's name (print)

Datatyp

text

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

Investigator's signature date

Datatyp

date

Alias
UMLS CUI [1,1]
C2346576
UMLS CUI [1,2]
C0011008
Tillbaka till toppen

Similar models

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

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
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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