ID

29574

Descrição

Study ID: 104385 Clinical Study ID: RES104385 Study Title: A randomised double-blind two-period crossover study to investigate the effect of treatment with repeat doses of a PPAR gamma agonist on the allergen-induced late asthmatic response in subjects with mild asthma compared with repeat doses of placebo Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00318630 https://clinicaltrials.gov/ct2/show/NCT00318630 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: rosiglitazone Trade Name: Avandia XR,Avandia; Rosiglitazone XR,Avandia XR,Avandia Study Indication: Asthma This ODM-file contains Adverse Events: Serious Adverse Events (Part of "End of Study").

Link

https://clinicaltrials.gov/ct2/show/NCT00318630

Palavras-chave

Versões (1)
  1. 06/04/2018 06/04/2018 - Sarah Riepenhausen
Titular dos direitos

GlaxoSmithKline

Transferido a

6 de abril de 2018

DOI

Para um pedido faça login.

Licença

Creative Commons BY-NC 3.0
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GSK Influence of PPAR gamma agonist vs. Placebo on allergen-induced late asthmatic response NCT00318630

Inglês

Adverse Events: Serious Adverse Events

1 Formulários  
Administrative Data
Descrição

Administrative Data

Alias
UMLS CUI-1
C1320722
UMLS CUI-2
C0877248
Subject identifier
Descrição

Subject identifier

Tipo de dados

text

Alias
UMLS CUI [1]
C2348585
Center number
Descrição

Center number

Tipo de dados

text

Alias
UMLS CUI [1,1]
C1301943
UMLS CUI [1,2]
C0600091
Randomisation number
Descrição

Randomisation number

Tipo de dados

text

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

Serious Adverse Events - Section 1

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

DEFINITION A serious adverse event is any untoward medical occurrence that, at any dose: a) results in death. b) is life-threatening. The term ‘life-threatening’ in the definition of ‘serious’ refers to an event in which the subject was at risk of death at the time of the event. It does not refer to an event, which hypothetically might have caused death, if it were more severe. c) requires hospitalisation or prolongation of existing hospitalisation. In general, hospitalisation signifies that the subject has been detained (usually involving at least an overnight stay) at the hospital or emergency ward for observation and/or treatment that would not have been appropriate in the physician’s office or out-patient setting. Complications that occur during hospitalisation are AEs. If a complication prolongs hospitalisation or fulfils any other serious criteria, the event is ’serious’. When in doubt as to whether ’hospitalisation’ occurred or was necessary, the AE should be considered ’serious’. Hospitalisation for elective treatment of a pre-existing condition that did not worsen from baseline is not considered an AE. d) results in disability/incapacity. The term disability means a substantial disruption of a person’s ability to conduct normal life functions. This definition is not intended to include experiences of relatively minor medical significance such as uncomplicated headache, nausea, vomiting, diarrhoea, influenza, and accidental trauma (e.g., sprained ankle) which may interfere or prevent everyday life functions but do not constitute a substantial disruption. e) is a congenital anomaly/birth defect. f) other: Medical or scientific judgement should be exercised in deciding whether reporting is appropriate in other situations, such as important medical events that may not be immediately life-threatening or result in death or hospitalisation but may jeopardise the subject or may require medical or surgical intervention to prevent one of the other outcomes listed in the above definition. These should also be considered serious. Examples of such events are invasive or malignant cancers, intensive treatment in an emergency room or at home for allergic bronchospasm, blood dyscrasias or convulsions that do not result in hospitalisation, or development of drug dependency or drug abuse. If yes, record the details in the other items of this itemgroup and the other Serious Adverse Events itemgroups.

Tipo de dados

text

Alias
UMLS CUI [1]
C1519255
Diagnosis only if known, otherwise sign/symptom
Descrição

Record one SAE diagnosis per line, or a sign/symptom if the diagnosis is not available. If a diagnosis subsequently becomes available, this then should be entered and the sign/symptom crossed out, initialled and dated by the investigator. A separate form should be used for each SAE however if multiple SAEs which are temporally or clinically related are apparent at the time of initial reporting then these may be reported on the same page. Ensure that no medical or investigational procedures are captured in the Serious Adverse Event Sections. Death should not be recorded as an SAE but should be recorded as the outcome of an SAE. The condition that resulted in the death should be recorded as the SAE.

Tipo de dados

text

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C0011900
UMLS CUI [2,1]
C0877248
UMLS CUI [2,2]
C0037088
Start Date
Descrição

Record the start date of the first occurrence of the SAE. Start dates must be provided for the reporting of adverse event data. If the exact date is not known, liaise with the investigator to ensure that a best estimate is provided.

Tipo de dados

date

Alias
UMLS CUI [1]
C2697888
Start Time
Descrição

Record the start time of the SAE.

Tipo de dados

time

Alias
UMLS CUI [1,1]
C1301880
UMLS CUI [1,2]
C0877248
Outcome
Descrição

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

Tipo de dados

integer

Alias
UMLS CUI [1]
C1705586
End date
Descrição

Record the end date. This is the date the SAE Recovered/Resolved, or if the outcome was fatal, record the date the subject died (Date of Death). If the event Recovered/Resolved with sequelae, enter the date the subject’s medical condition resolved or stabilised. Leave blank if the SAE is ’Not recovered/Not resolved’ or ’Recovering/Resolving’.

Tipo de dados

date

Alias
UMLS CUI [1,1]
C0806020
UMLS CUI [1,2]
C1518404
Record the end time of the SAE.
Descrição

End Time

Tipo de dados

time

Alias
UMLS CUI [1]
C2826658
Record the maximum intensity that occurred over the duration of the event. Amend the intensity if it increases.
Descrição

Mild = An event that is easily tolerated by the subject, causing minimal discomfort and not interfering with everyday activities. Moderate = An event that is sufficiently discomforting to interfere with normal everyday activities. Severe = An event that prevents normal everyday activities. Not applicable = those event(s) where intensity is meaningless or impossible to determine (i.e., blindness and coma).

Tipo de dados

text

Alias
UMLS CUI [1]
C1710066
Action taken with investigational products as a result of the SAE
Descrição

Investigational product(s) withdrawn = Administration of investigational product(s) was permanently discontinued. Dose reduced = Dose is reduced for one or more investigational product(s). Dose increased = Dose increased for one or more investigational product(s). Dose not changed = Investigational product(s) continues even though an adverse event has occurred. Dose interrupted = Administration of one or more investigational product(s) was stopped temporarily but then restarted. Not applicable = Subject was not receiving investigational product(s) when the event occurred (e.g., pre-or post-dosing).

Tipo de dados

text

Alias
UMLS CUI [1]
C2826626
Did the subject withdraw from study as a result of this SAE?
Descrição

Indicate ’Yes’ if the event(s) were directly responsible for the subject’s withdrawal as indicated on the Study Conclusion page, otherwise indicate ’No’. If yes, complete Study Conclusion form and pick Adverse event as reason for withdrawal.

Tipo de dados

text

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

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

Tipo de dados

text

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0013230
UMLS CUI [1,3]
C0439849
If fatal, was a post-mortem/autopsy performed?
Descrição

If Yes, summarise findings in Section 11 Narrative Remarks of the SAE itemgroups.

Tipo de dados

text

Alias
UMLS CUI [1,1]
C0004398
UMLS CUI [1,2]
C1519255
Serious Adverse Events - Section 2: Seriousness
Descrição

Serious Adverse Events - Section 2: Seriousness

Alias
UMLS CUI-1
C1519255
UMLS CUI-2
C0439793
SAE results in death.
Descrição

A

Tipo de dados

boolean

Alias
UMLS CUI [1]
C1705232
SAE Is life-threatening.
Descrição

B

Tipo de dados

boolean

Alias
UMLS CUI [1]
C1517874
SAE requires hospitalisation or prolongation of existing hospitalisation.
Descrição

C

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0019993
UMLS CUI [2,1]
C1519255
UMLS CUI [2,2]
C0745041
SAE results in disability/incapacity
Descrição

D

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C3176592
UMLS CUI [1,2]
C1274040
UMLS CUI [1,3]
C1519255
Congenital anomaly/birth defect
Descrição

E

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0000768
UMLS CUI [1,2]
C1519255
Other
Descrição

F Medical or scientific judgement should be exercised in deciding whether reporting is appropriate in other situations, such as important medical events that may not be immediately life-threatening or result in death or hospitalisation but may jeopardise the subject or may require medical or surgical intervention to prevent one of the other outcomes listed in the above definition. These should also be considered serious. Examples of such events are invasive or malignant cancers, intensive treatment in an emergency room or at home for allergic bronchospasm, blood dyscrasias or convulsions that do not result in hospitalisation, or development of drug dependency or drug abuse. If yes, specify in the item "Other, specify".

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0205394
UMLS CUI [1,2]
C1519255
Other, specify.
Descrição

If yes in item "other" of itemgroup SAE - Section 2: Seriousness

Tipo de dados

text

Alias
UMLS CUI [1,1]
C0205394
UMLS CUI [1,2]
C1519255
Serious Adverse Events - Section 3: Demography Data
Descrição

Serious Adverse Events - Section 3: Demography Data

Alias
UMLS CUI-1
C1828479
UMLS CUI-2
C0011298
UMLS CUI-3
C1519255
Date of birth
Descrição

Date of birth

Tipo de dados

date

Alias
UMLS CUI [1]
C0421451
Sex
Descrição

Gender

Tipo de dados

text

Alias
UMLS CUI [1]
C0079399
Weight
Descrição

Weight

Tipo de dados

float

Unidades de medida
  • kg
Alias
UMLS CUI [1]
C0005910
kg
Serious Adverse Events - Section 4
Descrição

Serious Adverse Events - Section 4

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

If Investigational Product was Stopped, Did the Reported Event(s) Recur After Further Investigational Product(s) Were Administered?

Tipo de dados

text

Alias
UMLS CUI [1,1]
C2945760
UMLS CUI [1,2]
C1519255
Serious Adverse Events - Section 5: Possible Causes of SAE Other Than Investigational Products
Descrição

Serious Adverse Events - Section 5: Possible Causes of SAE Other Than Investigational Products

Alias
UMLS CUI-1
C0085978
UMLS CUI-2
C1519255
UMLS CUI-3
C0304229
UMLS CUI-4
C3845511
Disease under study
Descrição

Disease under study

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C1547657
UMLS CUI [1,2]
C0877248
UMLS CUI [1,3]
C0012634
Medical condition(s)
Descrição

If yes, record in Section 6.

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C1547657
UMLS CUI [1,2]
C0877248
UMLS CUI [1,3]
C0009488
Lack of efficacy
Descrição

Lack of efficacy

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C1547657
UMLS CUI [1,2]
C0877248
UMLS CUI [1,3]
C0235828
Withdrawal of investigational product(s)
Descrição

Withdrawal of investigational product(s)

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C1547657
UMLS CUI [1,2]
C0877248
UMLS CUI [1,3]
C0304229
UMLS CUI [1,4]
C2349954
Concomitant medication
Descrição

If yes, record in Section 8.

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C2347852
UMLS CUI [1,2]
C1519255
UMLS CUI [1,3]
C0085978
Activity related to study participation
Descrição

e.g., procedures

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C2348568
UMLS CUI [1,2]
C0085978
UMLS CUI [1,3]
C1519255
Other
Descrição

If yes, specify in "other, specify" item.

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C3840932
UMLS CUI [1,2]
C1519255
Other, specify
Descrição

If yes in item "other" of this itemgroup, specify.

Tipo de dados

text

Alias
UMLS CUI [1,1]
C3840932
UMLS CUI [1,2]
C1519255
Serious Adverse Events - Section 6: Relevant medical conditions
Descrição

Serious Adverse Events - Section 6: Relevant medical conditions

Alias
UMLS CUI-1
C1828479
UMLS CUI-2
C0012634
UMLS CUI-3
C1519255
Specify any RELEVANT past or current medical disorders, allergies, surgeries, etc. that can help explain the SAE.
Descrição

Relevant past or current medical conditions

Tipo de dados

text

Alias
UMLS CUI [1,1]
C0262926
UMLS CUI [1,2]
C1519255
UMLS CUI [2,1]
C3899485
UMLS CUI [2,2]
C1519255
Date of onset
Descrição

Date of onset

Tipo de dados

date

Alias
UMLS CUI [1,1]
C0574845
UMLS CUI [1,2]
C0009488
Condition Present at Time of the SAE?
Descrição

Condition Present at Time of the SAE?

Tipo de dados

text

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C0150312
UMLS CUI [1,3]
C1519255
If No, Date of Last Occurrence
Descrição

Fill in if condition was not present at time of SAE.

Tipo de dados

date

Alias
UMLS CUI [1,1]
C2745955
UMLS CUI [1,2]
C0012634
UMLS CUI [1,3]
C0011008
Serious Adverse Events - Section 7: Other relevant risk factors
Descrição

Serious Adverse Events - Section 7: Other relevant risk factors

Alias
UMLS CUI-1
C0035648
UMLS CUI-2
C1519255
Other RELEVANT Risk Factors
Descrição

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

Tipo de dados

text

Alias
UMLS CUI [1,1]
C0035648
UMLS CUI [1,2]
C1519255
Serious Adverse Events - Section 8: Relevant concomitant medication
Descrição

Serious Adverse Events - Section 8: Relevant concomitant medication

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

Include details of any concomitant medication(s) which may have contributed to the event. Trade name preferred.

Tipo de dados

text

Alias
UMLS CUI [1,1]
C2360065
UMLS CUI [1,2]
C2347852
Dose
Descrição

Dose

Tipo de dados

float

Alias
UMLS CUI [1,1]
C3174092
UMLS CUI [1,2]
C2347852
Unit
Descrição

Unit

Tipo de dados

text

Alias
UMLS CUI [1,1]
C1519795
UMLS CUI [1,2]
C2347852
UMLS CUI [1,3]
C1519255
Frequency
Descrição

Frequency

Tipo de dados

text

Alias
UMLS CUI [1,1]
C3476109
UMLS CUI [1,2]
C2347852
UMLS CUI [1,3]
C1519255
Route
Descrição

Route

Tipo de dados

text

Alias
UMLS CUI [1]
C2826730
Taken prior to study?
Descrição

Taken prior to study?

Tipo de dados

text

Alias
UMLS CUI [1]
C2826667
Start Date
Descrição

Start Date

Tipo de dados

date

Alias
UMLS CUI [1]
C2826734
Stop Date
Descrição

Stop Date

Tipo de dados

date

Alias
UMLS CUI [1,1]
C0806020
UMLS CUI [1,2]
C2347852
Ongoing medication?
Descrição

Ongoing medication?

Tipo de dados

text

Alias
UMLS CUI [1]
C2826666
Reason for medication
Descrição

Reason for medication

Tipo de dados

text

Alias
UMLS CUI [1]
C2826696
Serious Adverse Events - Section 9: Details of investigational Products
Descrição

Serious Adverse Events - Section 9: Details of investigational Products

Alias
UMLS CUI-1
C1519255
UMLS CUI-2
C0304229
Start Date Treatment period 1
Descrição

Start Date Treatment period 1

Tipo de dados

date

Alias
UMLS CUI [1,1]
C3173309
UMLS CUI [1,2]
C0304229
Start Date Treatment period 2
Descrição

Start Date Treatment period 2

Tipo de dados

date

Alias
UMLS CUI [1,1]
C3173309
UMLS CUI [1,2]
C0304229
Stop Date Treatment period 1
Descrição

Stop Date Treatment period 1

Tipo de dados

date

Alias
UMLS CUI [1,1]
C0806020
UMLS CUI [1,2]
C0304229
Stop Date Treatment period 2
Descrição

Stop Date Treatment period 2

Tipo de dados

date

Alias
UMLS CUI [1,1]
C0806020
UMLS CUI [1,2]
C0304229
Was treatment blind broken at investigational site?
Descrição

Treatment blind

Tipo de dados

text

Alias
UMLS CUI [1,1]
C2347038
UMLS CUI [1,2]
C0449438
Serious Adverse Events - Section 10: Details of relevant assessments
Descrição

Serious Adverse Events - Section 10: Details of relevant assessments

Alias
UMLS CUI-1
C2700391
UMLS CUI-2
C0011900
UMLS CUI-3
C1519255
Details of relevant assessments
Descrição

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

Tipo de dados

text

Alias
UMLS CUI [1,1]
C2700391
UMLS CUI [1,2]
C0011900
UMLS CUI [1,3]
C1519255
Serious Adverse Events - Section 11: Narrative Remarks
Descrição

Serious Adverse Events - 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
Descrição

Narrative Remarks

Tipo de dados

text

Alias
UMLS CUI [1,1]
C0947611
UMLS CUI [1,2]
C1519255
Investigator's signature
Descrição

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

Tipo de dados

text

Alias
UMLS CUI [1]
C2346576
Date of Investigator signature
Descrição

Date of Investigator signature

Tipo de dados

date

Alias
UMLS CUI [1,1]
C2346576
UMLS CUI [1,2]
C0011008
Investigator's Name (print)
Descrição

Investigator's Name

Tipo de dados

text

Alias
UMLS CUI [1]
C2826892
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Similar models

Adverse Events: Serious Adverse Events

1 Formulários
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Item Group
Administrative Data
C1320722 (UMLS CUI-1)
C0877248 (UMLS CUI-2)
Subject identifier
Item
Subject identifier
text
C2348585 (UMLS CUI [1])
Center number
Item
Center number
text
C1301943 (UMLS CUI [1,1])
C0600091 (UMLS CUI [1,2])
Randomisation number
Item
Randomisation number
text
C0034656 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
Item Group
Serious Adverse Events - Section 1
C1519255 (UMLS CUI-1)
Item
Did the subject experience a serious adverse event during the study?
text
C1519255 (UMLS CUI [1])
Non-Serious Adverse Event
Code List
Did the subject experience a serious adverse event during the study?
CL Item
yes (Y)
CL Item
no (N)
Event: Diagnosis, Signs, Symptoms
Item
Diagnosis only if known, otherwise sign/symptom
text
C0877248 (UMLS CUI [1,1])
C0011900 (UMLS CUI [1,2])
C0877248 (UMLS CUI [2,1])
C0037088 (UMLS CUI [2,2])
Start Date
Item
Start Date
date
C2697888 (UMLS CUI [1])
Start Time
Item
Start Time
time
C1301880 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
Item
Outcome
integer
C1705586 (UMLS CUI [1])
Outcome
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)
CL Item
Fatal (5)
End Date
Item
End date
date
C0806020 (UMLS CUI [1,1])
C1518404 (UMLS CUI [1,2])
End Time
Item
Record the end time of the SAE.
time
C2826658 (UMLS CUI [1])
Item
Record the maximum intensity that occurred over the duration of the event. Amend the intensity if it increases.
text
C1710066 (UMLS CUI [1])
Maximum intensity
Code List
Record the maximum intensity that occurred over the duration of the event. Amend the intensity if it increases.
CL Item
Mild (1)
CL Item
Moderate (2)
CL Item
Severe (3)
CL Item
not applicable (X)
Item
Action taken with investigational products as a result of the SAE
text
C2826626 (UMLS CUI [1])
Action taken with investigational products
Code List
Action taken with investigational products as a result of the SAE
CL Item
investigational products 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
Did the subject withdraw from study as a result of this SAE?
text
C1710677 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
Non-Serious Adverse Event
Code List
Did the subject withdraw from study as a result of this SAE?
CL Item
yes (Y)
CL Item
no (N)
Item
Is there a reasonable possibility that the SAE may have been caused by the investigational product?
text
C1519255 (UMLS CUI [1,1])
C0013230 (UMLS CUI [1,2])
C0439849 (UMLS CUI [1,3])
Non-Serious Adverse Event
Code List
Is there a reasonable possibility that the SAE may have been caused by the investigational product?
CL Item
yes (Y)
CL Item
no (N)
Item
If fatal, was a post-mortem/autopsy performed?
text
C0004398 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
Non-Serious Adverse Event
Code List
If fatal, was a post-mortem/autopsy performed?
CL Item
yes (Y)
CL Item
no (N)
Item Group
Serious Adverse Events - Section 2: Seriousness
C1519255 (UMLS CUI-1)
C0439793 (UMLS CUI-2)
Death
Item
SAE results in death.
boolean
C1705232 (UMLS CUI [1])
Life-threatening
Item
SAE Is life-threatening.
boolean
C1517874 (UMLS CUI [1])
(Prolongation of) Hospitalisation
Item
SAE requires hospitalisation or prolongation of existing hospitalisation.
boolean
C1519255 (UMLS CUI [1,1])
C0019993 (UMLS CUI [1,2])
C1519255 (UMLS CUI [2,1])
C0745041 (UMLS CUI [2,2])
Disability, Incapacity
Item
SAE results in disability/incapacity
boolean
C3176592 (UMLS CUI [1,1])
C1274040 (UMLS CUI [1,2])
C1519255 (UMLS CUI [1,3])
Congenital anomaly/birth defect
Item
Congenital anomaly/birth defect
boolean
C0000768 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
Other
Item
Other
boolean
C0205394 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
Other
Item
Other, specify.
text
C0205394 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
Item Group
Serious Adverse Events - Section 3: Demography Data
C1828479 (UMLS CUI-1)
C0011298 (UMLS CUI-2)
C1519255 (UMLS CUI-3)
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)
Weight
Item
Weight
float
C0005910 (UMLS CUI [1])
Item Group
Serious Adverse Events - Section 4
C1519255 (UMLS CUI-1)
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
C2945760 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
Recurrent SAE after further administration
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 (Yes)
CL Item
No (No)
CL Item
Unknown at this time (Unknown at this time)
CL Item
Not applicable (Not applicable)
Item Group
Serious Adverse Events - Section 5: Possible Causes of SAE Other Than Investigational Products
C0085978 (UMLS CUI-1)
C1519255 (UMLS CUI-2)
C0304229 (UMLS CUI-3)
C3845511 (UMLS CUI-4)
Disease under study
Item
Disease under study
boolean
C1547657 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
C0012634 (UMLS CUI [1,3])
Medical condition(s)
Item
Medical condition(s)
boolean
C1547657 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
C0009488 (UMLS CUI [1,3])
Lack of efficacy
Item
Lack of efficacy
boolean
C1547657 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
C0235828 (UMLS CUI [1,3])
Withdrawal of investigational product(s)
Item
Withdrawal of investigational product(s)
boolean
C1547657 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
C0304229 (UMLS CUI [1,3])
C2349954 (UMLS CUI [1,4])
Concomitant medication
Item
Concomitant medication
boolean
C2347852 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
C0085978 (UMLS CUI [1,3])
Activity related to study participation
Item
Activity related to study participation
boolean
C2348568 (UMLS CUI [1,1])
C0085978 (UMLS CUI [1,2])
C1519255 (UMLS CUI [1,3])
Other
Item
Other
boolean
C3840932 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
Other
Item
Other, specify
text
C3840932 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
Item Group
Serious Adverse Events - Section 6: Relevant medical conditions
C1828479 (UMLS CUI-1)
C0012634 (UMLS CUI-2)
C1519255 (UMLS CUI-3)
Relevant past or current medical conditions
Item
Specify any RELEVANT past or current medical disorders, allergies, surgeries, etc. that can help explain the SAE.
text
C0262926 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
C3899485 (UMLS CUI [2,1])
C1519255 (UMLS CUI [2,2])
Date of onset
Item
Date of onset
date
C0574845 (UMLS CUI [1,1])
C0009488 (UMLS CUI [1,2])
Item
Condition Present at Time of the SAE?
text
C0012634 (UMLS CUI [1,1])
C0150312 (UMLS CUI [1,2])
C1519255 (UMLS CUI [1,3])
Non-Serious Adverse Event
Code List
Condition Present at Time of the SAE?
CL Item
yes (Y)
CL Item
no (N)
Date of Last Occurrence
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
Serious Adverse Events - Section 7: Other relevant risk factors
C0035648 (UMLS CUI-1)
C1519255 (UMLS CUI-2)
Other RELEVANT Risk Factors
Item
Other RELEVANT Risk Factors
text
C0035648 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
Item Group
Serious Adverse Events - Section 8: Relevant concomitant medication
C1519255 (UMLS CUI-1)
C2347852 (UMLS CUI-2)
Drug name
Item
Drug name
text
C2360065 (UMLS CUI [1,1])
C2347852 (UMLS CUI [1,2])
Dose
Item
Dose
float
C3174092 (UMLS CUI [1,1])
C2347852 (UMLS CUI [1,2])
Unit
Item
Unit
text
C1519795 (UMLS CUI [1,1])
C2347852 (UMLS CUI [1,2])
C1519255 (UMLS CUI [1,3])
Frequency
Item
Frequency
text
C3476109 (UMLS CUI [1,1])
C2347852 (UMLS CUI [1,2])
C1519255 (UMLS CUI [1,3])
Route
Item
Route
text
C2826730 (UMLS CUI [1])
Item
Taken prior to study?
text
C2826667 (UMLS CUI [1])
Non-Serious Adverse Event
Code List
Taken prior to study?
CL Item
yes (Y)
CL Item
no (N)
Start Date
Item
Start Date
date
C2826734 (UMLS CUI [1])
Stop Date
Item
Stop Date
date
C0806020 (UMLS CUI [1,1])
C2347852 (UMLS CUI [1,2])
Item
Ongoing medication?
text
C2826666 (UMLS CUI [1])
Non-Serious Adverse Event
Code List
Ongoing medication?
CL Item
yes (Y)
CL Item
no (N)
Reason for medication
Item
Reason for medication
text
C2826696 (UMLS CUI [1])
Item Group
Serious Adverse Events - Section 9: Details of investigational Products
C1519255 (UMLS CUI-1)
C0304229 (UMLS CUI-2)
Start Date Treatment period 1
Item
Start Date Treatment period 1
date
C3173309 (UMLS CUI [1,1])
C0304229 (UMLS CUI [1,2])
Start Date Treatment period 2
Item
Start Date Treatment period 2
date
C3173309 (UMLS CUI [1,1])
C0304229 (UMLS CUI [1,2])
Stop Date Treatment period 1
Item
Stop Date Treatment period 1
date
C0806020 (UMLS CUI [1,1])
C0304229 (UMLS CUI [1,2])
Stop Date Treatment period 2
Item
Stop Date Treatment period 2
date
C0806020 (UMLS CUI [1,1])
C0304229 (UMLS CUI [1,2])
Item
Was treatment blind broken at investigational site?
text
C2347038 (UMLS CUI [1,1])
C0449438 (UMLS CUI [1,2])
Treatment blind
Code List
Was treatment blind broken at investigational site?
CL Item
Yes (Yes)
CL Item
No (No)
CL Item
Not Applicable (Not Applicable)
Item Group
Serious Adverse Events - Section 10: Details of relevant assessments
C2700391 (UMLS CUI-1)
C0011900 (UMLS CUI-2)
C1519255 (UMLS CUI-3)
Details of relevant assessments
Item
Details of relevant assessments
text
C2700391 (UMLS CUI [1,1])
C0011900 (UMLS CUI [1,2])
C1519255 (UMLS CUI [1,3])
Item Group
Serious Adverse Events - Section 11: Narrative Remarks
C0947611 (UMLS CUI-1)
C1519255 (UMLS CUI-2)
Narrative Remarks
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])
Investigator's signature
Item
Investigator's signature
text
C2346576 (UMLS CUI [1])
Date of Investigator signature
Item
Date of Investigator signature
date
C2346576 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Investigator's Name
Item
Investigator's Name (print)
text
C2826892 (UMLS CUI [1])
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