ID

24747

Beskrivning

Study ID: 100470 Clinical Study ID: SCO100470 Study Title: A multicentre, randomised, double-blind, parallel group, 24 week study to compare the effect of salmeterol/fluticasone propionate combination product 50/250mcg, with salmeterol 50mcg both delivered twice daily via DISKUS®/ACCUHALER® inhaler on lung function and dyspnoea in subjects with Chronic Obstructive Pulmonary Disease (COPD). Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: N/A Sponsor:GlaxoSmithKline Collaborators: N/A Phase: Phase 3 Study Recruitment Status: Completed Generic Name: fluticasone propionate/salmeterol Trade Name: Serevent Study Indication: Pulmonary Disease, Chronic Obstructive

Nyckelord

Versioner (4)
  1. 2017-08-08 2017-08-08 -
  2. 2017-08-08 2017-08-08 -
  3. 2017-08-08 2017-08-08 -
  4. 2017-08-16 2017-08-16 -
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16 augusti 2017

DOI

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Creative Commons BY-NC 3.0
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serious adverse events salmeterol/fluticasone propionate combination compared to salmeterol on COPD 100470

Engelsk

serious adverse events salmeterol/fluticasone propionate combination compared to salmeterol on COPD 100470

1 Formulär  
Administrative Data
Beskrivning

Administrative Data

Alias
UMLS CUI-1
C1320722
Subject Identifier
Beskrivning

subject identifier

Datatyp

integer

Alias
UMLS CUI [1]
C2348585
Centre Number
Beskrivning

centre number

Datatyp

integer

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

randomisation number

Datatyp

integer

Alias
UMLS CUI [1,1]
C0034656
UMLS CUI [1,2]
C0237753
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

serious adverse event

Datatyp

text

Alias
UMLS CUI [1]
C1519255
SAE: SECTION 1
Beskrivning

SAE: SECTION 1

Alias
UMLS CUI-1
C1519255
Event
Beskrivning

Diagnosis Only (if known) Otherwise Sign/Symptom

Datatyp

text

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0011900
Start Date
Beskrivning

start date of serius adverse event

Datatyp

date

Alias
UMLS CUI [1,1]
C0808070
UMLS CUI [1,2]
C1519255
Outcome
Beskrivning

outcome of serious adverse event

Datatyp

integer

Alias
UMLS CUI [1]
C1705586
End date
Beskrivning

end date of serious adverse event

Datatyp

date

Alias
UMLS CUI [1,1]
C0806020
UMLS CUI [1,2]
C1519255
Maximum Intensity
Beskrivning

maximum intensity of serious adverse event

Datatyp

text

Alias
UMLS CUI [1,1]
C1710056
UMLS CUI [1,2]
C1519255
Action Taken with Investigational Product(s) as a Result of the SAE
Beskrivning

change in investigational product dose due to serious adverse event

Datatyp

text

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0304229
UMLS CUI [1,3]
C1707811
Withdrawal
Beskrivning

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

Datatyp

text

Alias
UMLS CUI [1,1]
C0422727
UMLS CUI [1,2]
C1519255
Relationship to Investigational Product(s)
Beskrivning

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

Datatyp

text

Alias
UMLS CUI [1,1]
C0013230
UMLS CUI [1,2]
C1519255
SAE: SECTION 2 Seriousness
Beskrivning

SAE: SECTION 2 Seriousness

Alias
UMLS CUI-1
C1710056
Results in death
Beskrivning

results in death

Datatyp

boolean

Alias
UMLS CUI [1]
C0011065
Is life-threatening
Beskrivning

life-threatening SAE

Datatyp

boolean

Alias
UMLS CUI [1]
C1517874
Requires hospitalisation or prolongation of existing hospitalisation
Beskrivning

requires hospitalization

Datatyp

boolean

Alias
UMLS CUI [1]
C0019993
Results in disability/incapacity
Beskrivning

results in disability

Datatyp

boolean

Alias
UMLS CUI [1]
C0231170
Congenital anomaly/birth defect
Beskrivning

congenital abnormality

Datatyp

boolean

Alias
UMLS CUI [1]
C0000768
Other, specify
Beskrivning

specify other diseases below.

Datatyp

text

Alias
UMLS CUI [1]
C2359476
SAE: SECTION 3 Demography Data
Beskrivning

SAE: SECTION 3 Demography Data

Alias
UMLS CUI-1
C0011298
Date of birth
Beskrivning

date of birth

Datatyp

date

Alias
UMLS CUI [1]
C0421451
Sex
Beskrivning

gender

Datatyp

text

Alias
UMLS CUI [1]
C0079399
Weight
Beskrivning

body weight

Datatyp

float

Måttenheter
  • kg
Alias
UMLS CUI [1]
C0005910
kg
SAE: SECTION 4 Investigational Products
Beskrivning

SAE: SECTION 4 Investigational Products

Alias
UMLS CUI-1
C0304229
If Investigational Product(s) was Stopped, Did the Reported Event(s) Recur After Further Investigational Product(s) were Administered?
Beskrivning

adverse recur after further investigational products

Datatyp

text

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C1519255
SAE: Section 5 Possible Causes of SAE Other Than Investigational Product(s
Beskrivning

SAE: Section 5 Possible Causes of SAE Other Than Investigational Product(s

Alias
UMLS CUI-1
C3828190
Disease under study
Beskrivning

disease under study

Datatyp

boolean

Alias
UMLS CUI [1]
C0012634
Medical condition(s)
Beskrivning

medical conditions

Datatyp

boolean

Alias
UMLS CUI [1]
C0012634
Lack of efficacy
Beskrivning

lack of efficacy

Datatyp

boolean

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

withdrawal of investigational products

Datatyp

boolean

Alias
UMLS CUI [1,1]
C2349954
UMLS CUI [1,2]
C0013227
Concomitant medication
Beskrivning

concomitant medication

Datatyp

boolean

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

study subject participation status

Datatyp

boolean

Alias
UMLS CUI [1]
C2348568
Other, specify
Beskrivning

specify other reasons below.

Datatyp

text

Alias
UMLS CUI [1]
C3840932
SAE: SECTION 6 RELEVANT Medical Conditions
Beskrivning

SAE: SECTION 6 RELEVANT Medical Conditions

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

medical conditions

Datatyp

text

Alias
UMLS CUI [1]
C0012634
Date of Onset
Beskrivning

date of onset of serious adverse event

Datatyp

date

Alias
UMLS CUI [1]
C2985916
Condition Present at Time of the SAE?
Beskrivning

medical condition present at time of serious adverse event

Datatyp

text

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C1519255
If No, Date of Last Occurrence.
Beskrivning

If "no" to medical condition present at time of SAE.

Datatyp

date

Alias
UMLS CUI [1,1]
C2745955
UMLS CUI [1,2]
C0012634
UMLS CUI [1,3]
C0011008
SAE: SECTION 7 Other RELEVANT Risk Factors
Beskrivning

SAE: SECTION 7 Other RELEVANT Risk Factors

Alias
UMLS CUI-1
C0035648
UMLS CUI-2
C1519255
Record other risk factors for serious adverse events.
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 [1,1]
C0035648
UMLS CUI [1,2]
C1519255
SAE: SECTION 8 RELEVANT Concomitant Medications
Beskrivning

SAE: SECTION 8 RELEVANT Concomitant Medications

Alias
UMLS CUI-1
C2347852
Drug Name
Beskrivning

Trade Name preferred

Datatyp

text

Alias
UMLS CUI [1]
C0013227
Dose
Beskrivning

medication dose

Datatyp

integer

Alias
UMLS CUI [1]
C3174092
Unit
Beskrivning

medication unit

Datatyp

text

Alias
UMLS CUI [1]
C1519795
Frequency
Beskrivning

medication frequency

Datatyp

text

Alias
UMLS CUI [1]
C3476109
Route
Beskrivning

medication route

Datatyp

text

Alias
UMLS CUI [1]
C0013153
Taken Prior to Study?
Beskrivning

medication taken prior to study

Datatyp

text

Alias
UMLS CUI [1]
C2826667
Start Date
Beskrivning

start date of medication

Datatyp

date

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0808070
Stop Date
Beskrivning

stop date of medication

Datatyp

date

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0806020
Ongoing medication?
Beskrivning

concomitant medication ongoing

Datatyp

text

Alias
UMLS CUI [1]
C2826666
Reason for Medication
Beskrivning

indication of medication

Datatyp

text

Alias
UMLS CUI [1,1]
C0392360
UMLS CUI [1,2]
C0013227
SAE: SECTION 9 Details of Investigational Product(s) Run -in period
Beskrivning

SAE: SECTION 9 Details of Investigational Product(s) Run -in period

Alias
UMLS CUI-1
C0304229
Start Date
Beskrivning

start date of investigational products

Datatyp

date

Alias
UMLS CUI [1,1]
C0808070
UMLS CUI [1,2]
C0304229
Stop Date
Beskrivning

stop date of investigational products

Datatyp

date

Alias
UMLS CUI [1,1]
C0806020
UMLS CUI [1,2]
C0304229
SAE: SECTION 9 Details of Investigational Product(s): Investigational product
Beskrivning

SAE: SECTION 9 Details of Investigational Product(s): Investigational product

Alias
UMLS CUI-1
C0304229
Start Date
Beskrivning

start date of investigational products

Datatyp

date

Alias
UMLS CUI [1,1]
C0808070
UMLS CUI [1,2]
C0304229
Stop Date
Beskrivning

stop date of investigational products

Datatyp

date

Alias
UMLS CUI [1,1]
C0806020
UMLS CUI [1,2]
C0304229
Start Date of Interruption
Beskrivning

start date of interruption of investigational products

Datatyp

date

Alias
UMLS CUI [1,1]
C0808070
UMLS CUI [1,2]
C1512900
Stop Date of Interruption
Beskrivning

stop date of interruption of investigational products

Datatyp

date

Alias
UMLS CUI [1,1]
C0806020
UMLS CUI [1,2]
C1512900
SAE: SECTION 9 Details of Investigational Product(s)
Beskrivning

SAE: SECTION 9 Details of Investigational Product(s)

Alias
UMLS CUI-1
C0304229
Was randomisation code broken at investigational site?
Beskrivning

randomisation

Datatyp

text

Alias
UMLS CUI [1]
C0034656
SAE: SECTION 10 Details of RELEVANT Assessments
Beskrivning

SAE: SECTION 10 Details of RELEVANT Assessments

Alias
UMLS CUI-1
C1516048
UMLS CUI-2
C1519255
Provide details of any other tests/procedures which were carried out to diagnose or confirm the SAE.
Beskrivning

e.g., laboratory data with units and normal range

Datatyp

text

Alias
UMLS CUI [1,1]
C0011900
UMLS CUI [1,2]
C1519255
SAE: SECTION 11 Narrative Remarks
Beskrivning

SAE: SECTION 11 Narrative Remarks

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

narrative description of the serious adverse event

Datatyp

text

Alias
UMLS CUI [1,1]
C0947611
UMLS CUI [1,2]
C1519255
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
Beskrivning

print

Datatyp

text

Alias
UMLS CUI [1]
C2826892
Date
Beskrivning

date

Datatyp

date

Alias
UMLS CUI [1]
C0011008
Tillbaka till toppen

Similar models

serious adverse events salmeterol/fluticasone propionate combination compared to salmeterol on COPD 100470

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
Administrative Data
C1320722 (UMLS CUI-1)
subject identifier
Item
Subject Identifier
integer
C2348585 (UMLS CUI [1])
centre number
Item
Centre Number
integer
C0600091 (UMLS CUI [1,1])
C0019994 (UMLS CUI [1,2])
randomisation number
Item
Randomisation Number
integer
C0034656 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
Item Group
SERIOUS ADVERSE EVENT (SAE)
C1519255 (UMLS CUI-1)
Item
Did the subject experience a serious adverse event during the study?
text
C1519255 (UMLS CUI [1])
serious adverse event
Code List
Did the subject experience a serious adverse event during the study?
CL Item
Yes (Y)
CL Item
No (N)
Item Group
SAE: SECTION 1
C1519255 (UMLS CUI-1)
diagnosis of serious adverse event
Item
Event
text
C1519255 (UMLS CUI [1,1])
C0011900 (UMLS CUI [1,2])
start date of serius adverse event
Item
Start Date
date
C0808070 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
Item
Outcome
integer
C1705586 (UMLS CUI [1])
outcome of serious adverse event
Code List
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)
end date of serious adverse event
Item
End date
date
C0806020 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
Item
Maximum Intensity
text
C1710056 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
maximum intensity of serious adverse event
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
C1519255 (UMLS CUI [1,1])
C0304229 (UMLS CUI [1,2])
C1707811 (UMLS CUI [1,3])
change in investigational product dose due to serious adverse event
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)
Item
Withdrawal
text
C0422727 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
subject withdrawal due to serious AE
Code List
Withdrawal
CL Item
Yes (Y)
CL Item
No (N)
Item
Relationship to Investigational Product(s)
text
C0013230 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
serious AE caused by investigational product
Code List
Relationship to Investigational Product(s)
CL Item
Yes (Y)
CL Item
No (N)
Item Group
SAE: SECTION 2 Seriousness
C1710056 (UMLS CUI-1)
results in death
Item
Results in death
boolean
C0011065 (UMLS CUI [1])
life-threatening SAE
Item
Is life-threatening
boolean
C1517874 (UMLS CUI [1])
requires hospitalization
Item
Requires hospitalisation or prolongation of existing hospitalisation
boolean
C0019993 (UMLS CUI [1])
results in disability
Item
Results in disability/incapacity
boolean
C0231170 (UMLS CUI [1])
congenital abnormality
Item
Congenital anomaly/birth defect
boolean
C0000768 (UMLS CUI [1])
other diseases
Item
Other, specify
text
C2359476 (UMLS CUI [1])
Item Group
SAE: 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])
gender
Code List
Sex
CL Item
Male (Male)
CL Item
Female (Female)
body weight
Item
Weight
float
C0005910 (UMLS CUI [1])
Item Group
SAE: SECTION 4 Investigational Products
C0304229 (UMLS CUI-1)
Item
If Investigational Product(s) was Stopped, Did the Reported Event(s) Recur After Further Investigational Product(s) were Administered?
text
C0304229 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
adverse recur after further investigational products
Code List
If Investigational Product(s) was Stopped, Did the Reported Event(s) Recur After Further Investigational Product(s) were Administered?
CL Item
Yes (Yes)
CL Item
No (No)
CL Item
Unknown at this time (Unknown at this time)
CL Item
Not applicable (Not applicable)
Item Group
SAE: Section 5 Possible Causes of SAE Other Than Investigational Product(s
C3828190 (UMLS CUI-1)
disease under study
Item
Disease under study
boolean
C0012634 (UMLS CUI [1])
medical conditions
Item
Medical condition(s)
boolean
C0012634 (UMLS CUI [1])
lack of efficacy
Item
Lack of efficacy
boolean
C0235828 (UMLS CUI [1])
withdrawal of investigational products
Item
Withdrawal of investigational product(s
boolean
C2349954 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
concomitant medication
Item
Concomitant medication
boolean
C2347852 (UMLS CUI [1])
study subject participation status
Item
Activity related to study participation
boolean
C2348568 (UMLS CUI [1])
other reasons
Item
Other, specify
text
C3840932 (UMLS CUI [1])
Item Group
SAE: SECTION 6 RELEVANT Medical Conditions
C0012634 (UMLS CUI-1)
medical conditions
Item
Specify any RELEVANT past or current medical disorders, allergies, surgeries, etc. that can help explain the SAE.
text
C0012634 (UMLS CUI [1])
date of onset of serious adverse event
Item
Date of Onset
date
C2985916 (UMLS CUI [1])
Item
Condition Present at Time of the SAE?
text
C0012634 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
medical condition present at time of serious adverse event
Code List
Condition Present at Time of the SAE?
CL Item
Yes (Y)
CL Item
No (N)
date of last occurrence of medical condition
Item
If No, Date of Last Occurrence.
date
C2745955 (UMLS CUI [1,1])
C0012634 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
Item Group
SAE: SECTION 7 Other RELEVANT Risk Factors
C0035648 (UMLS CUI-1)
C1519255 (UMLS CUI-2)
risk factors for serious adverse events
Item
Record other risk factors for serious adverse events.
text
C0035648 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
Item Group
SAE: SECTION 8 RELEVANT Concomitant Medications
C2347852 (UMLS CUI-1)
drug name
Item
Drug Name
text
C0013227 (UMLS CUI [1])
medication dose
Item
Dose
integer
C3174092 (UMLS CUI [1])
Item
Unit
text
C1519795 (UMLS CUI [1])
medication unit
Code List
Unit
CL Item
Actuation (ACTU)
CL Item
Ampoule  (AMP)
CL Item
Application  (APP)
CL Item
Bottle  (BOT)
CL Item
Cubic centimeter (CC)
CL Item
Capsule (CAP)
CL Item
Gram (G)
CL Item
Drops  (GTT)
CL Item
International Units (IU)
CL Item
Litre (L)
CL Item
Litres per minute (L/MIN)
CL Item
Lozenge (LOZ)
CL Item
Microgram (MCG)
CL Item
Microgram per kilogram per minute (MCG/KG/MIN)
CL Item
Microlitre (MCL)
CL Item
Millimole (MMOL)
CL Item
Nebule (NEB)
CL Item
Puff (PUFF)
CL Item
Spray (SPR)
CL Item
Tablet (TAB)
CL Item
Tablespoon (TBLSP)
CL Item
Teaspoon (TSP)
CL Item
Percent (%)
CL Item
Unknown (UNK)
Item
Frequency
text
C3476109 (UMLS CUI [1])
medication frequency
Code List
Frequency
CL Item
1 X daily (OD/QD)
CL Item
2 X daily (BID)
CL Item
3 X daily (TID)
CL Item
4 X daily  (QID)
CL Item
Continuous (CONT)
CL Item
Cumulative dose (CUM)
CL Item
Daily (D)
CL Item
Intermittent (INT)
CL Item
Not available (NA)
CL Item
At night (NOCT)
CL Item
Other (OTH)
CL Item
As required (PRN)
CL Item
Every hour (quaque hora) (QH)
CL Item
Every other day (QOD)
CL Item
Every night (quaque nocte) (QN)
CL Item
Single dose (SD)
CL Item
Immediately (STAT)
CL Item
Taper (TAP)
CL Item
Unknown (UNK)
Item
Route
text
C0013153 (UMLS CUI [1])
medication route
Code List
Route
CL Item
Intramuscular (IM)
CL Item
Inhalation (IH)
CL Item
Intranasal (IN)
CL Item
Injection (INJ)
CL Item
Intravenous (IV)
CL Item
Nasal (NS)
CL Item
Other (OTH)
CL Item
Oral (PO)
CL Item
Subcutaneous (SC)
CL Item
Topical (TP)
CL Item
Unknown (UNK)
Item
Taken Prior to Study?
text
C2826667 (UMLS CUI [1])
medication taken prior to study
Code List
Taken Prior to Study?
CL Item
Yes (Y)
CL Item
No (N)
start date of medication
Item
Start Date
date
C0013227 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])
stop date of medication
Item
Stop Date
date
C0013227 (UMLS CUI [1,1])
C0806020 (UMLS CUI [1,2])
Item
Ongoing medication?
text
C2826666 (UMLS CUI [1])
concomitant medication ongoing
Code List
Ongoing medication?
CL Item
Yes (Y)
CL Item
No (N)
indication of medication
Item
Reason for Medication
text
C0392360 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
Item Group
SAE: SECTION 9 Details of Investigational Product(s) Run -in period
C0304229 (UMLS CUI-1)
start date of investigational products
Item
Start Date
date
C0808070 (UMLS CUI [1,1])
C0304229 (UMLS CUI [1,2])
stop date of investigational products
Item
Stop Date
date
C0806020 (UMLS CUI [1,1])
C0304229 (UMLS CUI [1,2])
Item Group
SAE: SECTION 9 Details of Investigational Product(s): Investigational product
C0304229 (UMLS CUI-1)
start date of investigational products
Item
Start Date
date
C0808070 (UMLS CUI [1,1])
C0304229 (UMLS CUI [1,2])
stop date of investigational products
Item
Stop Date
date
C0806020 (UMLS CUI [1,1])
C0304229 (UMLS CUI [1,2])
start date of interruption of investigational products
Item
Start Date of Interruption
date
C0808070 (UMLS CUI [1,1])
C1512900 (UMLS CUI [1,2])
stop date of interruption of investigational products
Item
Stop Date of Interruption
date
C0806020 (UMLS CUI [1,1])
C1512900 (UMLS CUI [1,2])
Item Group
SAE: SECTION 9 Details of Investigational Product(s)
C0304229 (UMLS CUI-1)
Item
Was randomisation code broken at investigational site?
text
C0034656 (UMLS CUI [1])
randomisation
Code List
Was randomisation code broken at investigational site?
CL Item
Yes (Yes)
CL Item
No (No)
CL Item
Not applicable (Not applicable)
Item Group
SAE: SECTION 10 Details of RELEVANT Assessments
C1516048 (UMLS CUI-1)
C1519255 (UMLS CUI-2)
diagnosis of serious adverse events
Item
Provide details of any other tests/procedures which were carried out to diagnose or confirm the SAE.
text
C0011900 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
Item Group
SAE: SECTION 11 Narrative Remarks
C0947611 (UMLS CUI-1)
C1519255 (UMLS CUI-2)
narrative description of the serious adverse event
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])
Item Group
Investigator's signature
C2346576 (UMLS CUI-1)
investigator's signature
Item
Investigator’s signature
text
C2346576 (UMLS CUI [1])
investigator's name
Item
Investigator’s name
text
C2826892 (UMLS CUI [1])
date
Item
Date
date
C0011008 (UMLS CUI [1])
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