ID

27457

Beschreibung

Study ID: 103094 Clinical Study ID: ARI103094 Study Title: ARI103094-Follow-Up Study for REDUCE Study Subjects Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00883909 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 3 Study Recruitment Status: Completed Generic Name: dutasteride Trade Name: Zytefor,Zyfetor,Duagen,Avolve,Avodart,Avidart Study Indication: Neoplasms, Prostate

Stichworte

Versionen (2)
  1. 15.11.17 15.11.17 -
  2. 26.11.17 26.11.17 -
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GlaxoSmithKline

Hochgeladen am

15. November 2017

DOI

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Serious adverse events GSK study Prostatic neoplasms NCT00883909

Englisch

Serious adverse events GSK study Prostatic neoplasms NCT00883909

1 Formulare  
Administrative Data
Beschreibung

Administrative Data

Alias
UMLS CUI-1
C1320722
Subject Identifier
Beschreibung

Subject Identifier

Datentyp

integer

Alias
UMLS CUI [1]
C2348585
Centre Number
Beschreibung

Centre Number

Datentyp

text

SERIOUS ADVERSE EVENT (SAE)
Beschreibung

SERIOUS ADVERSE EVENT (SAE)

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

If Yes, record details below.

Datentyp

text

If fatal, was a post-mortem/autopsy performed?
Beschreibung

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

Datentyp

text

SECTION 1: Serious adverse event
Beschreibung

SECTION 1: Serious adverse event

Event
Beschreibung

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.

Datentyp

text

Start Date
Beschreibung

Record the start date of the first occurrence of the SAE.

Datentyp

date

Alias
UMLS CUI [1]
C0808070
Outcome
Beschreibung

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.

Datentyp

integer

End Date
Beschreibung

Record the end date. This is the date the SAE Recovered/Resolved, or if the outcome was fatal, record the date the subject died. 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’.

Datentyp

date

Alias
UMLS CUI [1]
C0806020
Maximum Intensity
Beschreibung

Record the maximum intensity that occurred over the duration of the event. Amend the intensity if it increases. 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).

Datentyp

text

Action Taken with IP in REDUCE Study or Prescription Dutasteride as a Result of the SAE
Beschreibung

IP in REDUCE study or prescription dutasteride withdrawn = Administration of IP in REDUCE study or prescription dutasteride was permanently discontinued. Dose reduced = Dose is reduced for IP in REDUCE study or prescription dutasteride. Dose increased = Dose increased for IP in REDUCE study or prescription dutasteride. Dose not changed = IP in REDUCE study or prescription dutasteride continues even though an adverse event has occurred. Dose interrupted = Administration of IP in REDUCE study or prescription dutasteride was temporarily interrupted but then restarted. Not applicable =Subject was not receiving IP in REDUCE study or prescription dutasteride when the event occurred (e.g., pre-or post-dosing) or the subject died and there was no prior decision to discontinue IP(s).

Datentyp

text

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

Indicate ’Yes’ if the event(s) were directly responsible for the subject’s withdrawal as indicated on the Study Conclusion page, otherwise indicate ’No’.

Datentyp

text

Is there a reasonable possibility the SAE may have been caused by IP in REDUCE study or prescription dutasteride?
Beschreibung

It is a regulatory requirement for investigators to assess relationship to investigational product in REDUCE study or prescription dutasteride 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.

Datentyp

text

If Yes, specify reason
Beschreibung

Relationship to IP in REDUCE specification

Datentyp

integer

SECTION 2: Seriousness (specify reason(s) for considering this a SAE, select all that apply)
Beschreibung

SECTION 2: Seriousness (specify reason(s) for considering this a SAE, select all that apply)

[A] Results in death
Beschreibung

SAE results in death

Datentyp

boolean

Alias
UMLS CUI [1]
C0011065
[B] Is life-threatening
Beschreibung

Note: 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.

Datentyp

boolean

Alias
UMLS CUI [1]
C2826244
[C] Requires hospitalisation or prolongation of existing hospitalisation
Beschreibung

Note: 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.

Datentyp

boolean

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

Note: 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.

Datentyp

boolean

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

Congenital anomaly/birth defect

Datentyp

boolean

Alias
UMLS CUI [1]
C0000768
[F] Other
Beschreibung

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.

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C1880177
[F] Other, specify
Beschreibung

See definition of SAE

Datentyp

text

Alias
UMLS CUI [1]
C3845569
SECTION 3: Demography data
Beschreibung

SECTION 3: Demography data

Date of birth
Beschreibung

Date of birth

Datentyp

date

Alias
UMLS CUI [1]
C0421451
Sex
Beschreibung

Sex

Datentyp

text

Alias
UMLS CUI [1]
C0079399
Weight
Beschreibung

Weight

Datentyp

float

Maßeinheiten
  • kg
Alias
UMLS CUI [1]
C0005910
kg
SECTION 4: Recurrence of SAE
Beschreibung

SECTION 4: Recurrence of SAE

If Investigational Product in REDUCE Study or Prescription Dutasteride was Stopped, Did the Reported Event(s) Recur After Further Investigational Product in REDUCE Study or Prescription Dutasteride was Administered?
Beschreibung

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

Datentyp

text

SECTION 5: Possible Causes of SAE Other Than Investigational Product in REDUCE Study or Prescription Dutasteride
Beschreibung

SECTION 5: Possible Causes of SAE Other Than Investigational Product in REDUCE Study or Prescription Dutasteride

Disease under study
Beschreibung

Disease under study

Datentyp

boolean

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

Medical condition

Datentyp

boolean

Alias
UMLS CUI [1]
C1699700
Specify medical condition(s)
Beschreibung

Medical condition specification

Datentyp

text

Lack of efficacy
Beschreibung

Lack of efficacy

Datentyp

boolean

Alias
UMLS CUI [1]
C0235828
Withdrawal of investigational product in REDUCE study or prescription dutasteride
Beschreibung

Withdrawal of investigational product

Datentyp

boolean

Alias
UMLS CUI [1,1]
C2349954
UMLS CUI [1,2]
C0013227
Concomitant Medication(s)
Beschreibung

Concomitant Medication

Datentyp

boolean

Alias
UMLS CUI [1]
C2347852
Specify concomitant medication(s)
Beschreibung

Concomitant Medication specification

Datentyp

text

Alias
UMLS CUI [1]
C2347852
Activity related to study participation (e.g. procedures)
Beschreibung

Activity related to study participation

Datentyp

boolean

Alias
UMLS CUI [1]
C2348568
Other
Beschreibung

Other possible Cause of SAE

Datentyp

boolean

Other, specify
Beschreibung

Other possible Cause of SAE specification

Datentyp

text

SECTION 6: RELEVANT Medical Conditions
Beschreibung

SECTION 6: RELEVANT Medical Conditions

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

Relevant Medical Conditions

Datentyp

text

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C0262926
UMLS CUI [1,3]
C1519255
Date of onset
Beschreibung

Date of onset

Datentyp

date

Alias
UMLS CUI [1]
C0574845
Condition Present at Time of the SAE?
Beschreibung

Condition Present at Time of the SAE

Datentyp

text

If No, Date of Last Occurrence
Beschreibung

Date of Last Occurrence

Datentyp

date

SECTION 7: Other RELEVANT Risk Factors
Beschreibung

SECTION 7: Other RELEVANT Risk Factors

Other relevant risk factors
Beschreibung

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

Datentyp

text

SECTION 8: RELEVANT Concomitant Medications
Beschreibung

SECTION 8: RELEVANT Concomitant Medications

Drug name
Beschreibung

(Trade name preferred)

Datentyp

text

Alias
UMLS CUI [1]
C0013227
Dose
Beschreibung

Dose

Datentyp

float

Alias
UMLS CUI [1]
C3174092
Unit
Beschreibung

Unit

Datentyp

text

Frequency
Beschreibung

Frequency

Datentyp

text

Route
Beschreibung

Route

Datentyp

text

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

administration prior to study

Datentyp

text

Start Date
Beschreibung

Start Date

Datentyp

date

Alias
UMLS CUI [1]
C0808070
Stop Date
Beschreibung

Stop Date

Datentyp

date

Alias
UMLS CUI [1]
C0806020
Ongoing Medication?
Beschreibung

Ongoing Medication

Datentyp

text

Alias
UMLS CUI [1]
C2826666
Reason for Medication
Beschreibung

Reason for Medication

Datentyp

text

Alias
UMLS CUI [1,1]
C0392360
UMLS CUI [1,2]
C0013227
SECTION 9: Drug Details
Beschreibung

SECTION 9: Drug Details

Start Date Investigational Product (from REDUCE study)
Beschreibung

Start Date Investigational Product

Datentyp

date

Stop Date Investigational Product (from REDUCE study)
Beschreibung

Stop Date Investigational Product

Datentyp

date

Start Date Prescription Dutasteride
Beschreibung

Start Date Prescription Dutasteride

Datentyp

date

Stop Date Prescription Dutasteride
Beschreibung

Stop Date Prescription Dutasteride

Datentyp

date

SECTION 10: Details of RELEVANT Assessments
Beschreibung

SECTION 10: Details of RELEVANT Assessments

Details of Relevant Assessments
Beschreibung

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.

Datentyp

text

Alias
UMLS CUI [1,1]
C1261322
UMLS CUI [1,2]
C1519255
SECTION 11: Narrative Remarks
Beschreibung

SECTION 11: Narrative Remarks

Narrative Remarks
Beschreibung

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

Datentyp

text

Investigator information
Beschreibung

Investigator information

Investigator’s signature
Beschreibung

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

Datentyp

text

Alias
UMLS CUI [1]
C2346576
Investigator’s name (print)
Beschreibung

Investigator name

Datentyp

text

Alias
UMLS CUI [1]
C2826892
Date
Beschreibung

Investigator Signature Date

Datentyp

date

Alias
UMLS CUI [1,1]
C2346576
UMLS CUI [1,2]
C0011008
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Ähnliche Modelle

Serious adverse events GSK study Prostatic neoplasms NCT00883909

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
Administrative Data
C1320722 (UMLS CUI-1)
Subject Identifier
Item
Subject Identifier
integer
C2348585 (UMLS CUI [1])
Centre Number
Item
Centre Number
text
Item Group
SERIOUS ADVERSE EVENT (SAE)
Item
Did the subject experience a serious adverse event during the study?
text
non-serious adverse events
Code List
Did the subject experience a serious adverse event during the study?
CL Item
Yes (Y)
CL Item
No (N)
Item
If fatal, was a post-mortem/autopsy performed?
text
fatal SAE
Code List
If fatal, was a post-mortem/autopsy performed?
CL Item
Yes (Y)
CL Item
No (N)
Item Group
SECTION 1: Serious adverse event
Event
Item
Event
text
Start Date
Item
Start Date
date
C0808070 (UMLS CUI [1])
Item
Outcome
integer
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])
Item
Maximum Intensity
text
Maximum Intensity
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 IP in REDUCE Study or Prescription Dutasteride as a Result of the SAE
text
Action Taken with IP
Code List
Action Taken with IP in REDUCE Study or Prescription Dutasteride as a Result of the SAE
CL Item
IP in REDUCE study or prescription dutasteride 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
Withdrawal
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 the SAE may have been caused by IP in REDUCE study or prescription dutasteride?
text
Cause of Adverse event
Code List
Is there a reasonable possibility the SAE may have been caused by IP in REDUCE study or prescription dutasteride?
CL Item
Yes (Y)
CL Item
No (N)
Item
If Yes, specify reason
integer
Relationship to IP in REDUCE specification
Code List
If Yes, specify reason
CL Item
Prior use of IP in REDUCE study (1)
CL Item
Prescription dutasteride (2)
CL Item
Unable to distinguish (3)
Item Group
SECTION 2: Seriousness (specify reason(s) for considering this a SAE, select all that apply)
SAE results in death
Item
[A] Results in death
boolean
C0011065 (UMLS CUI [1])
SAE is life-threatening
Item
[B] Is life-threatening
boolean
C2826244 (UMLS CUI [1])
SAE requires hospitalisation
Item
[C] Requires hospitalisation or prolongation of existing hospitalisation
boolean
C0019993 (UMLS CUI [1])
SAE results in disability/incapacity
Item
[D] Results in disability/incapacity
boolean
C0231170 (UMLS CUI [1])
Congenital anomaly/birth defect
Item
[E] Congenital anomaly/birth defect
boolean
C0000768 (UMLS CUI [1])
Other SAE
Item
[F] Other
boolean
C1519255 (UMLS CUI [1,1])
C1880177 (UMLS CUI [1,2])
Other SAE specification
Item
[F] Other, specify
text
C3845569 (UMLS CUI [1])
Item Group
SECTION 3: Demography data
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 (Male)
CL Item
Female (Female)
Weight
Item
Weight
float
C0005910 (UMLS CUI [1])
Item Group
SECTION 4: Recurrence of SAE
Item
If Investigational Product in REDUCE Study or Prescription Dutasteride was Stopped, Did the Reported Event(s) Recur After Further Investigational Product in REDUCE Study or Prescription Dutasteride was Administered?
text
Recurrence of SAE
Code List
If Investigational Product in REDUCE Study or Prescription Dutasteride was Stopped, Did the Reported Event(s) Recur After Further Investigational Product in REDUCE Study or Prescription Dutasteride was 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
SECTION 5: Possible Causes of SAE Other Than Investigational Product in REDUCE Study or Prescription Dutasteride
Disease under study
Item
Disease under study
boolean
C0012634 (UMLS CUI [1])
Medical condition
Item
Medical condition(s)
boolean
C1699700 (UMLS CUI [1])
Medical condition specification
Item
Specify medical condition(s)
text
Lack of efficacy
Item
Lack of efficacy
boolean
C0235828 (UMLS CUI [1])
Withdrawal of investigational product
Item
Withdrawal of investigational product in REDUCE study or prescription dutasteride
boolean
C2349954 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
Concomitant Medication
Item
Concomitant Medication(s)
boolean
C2347852 (UMLS CUI [1])
Concomitant Medication specification
Item
Specify concomitant medication(s)
text
C2347852 (UMLS CUI [1])
Activity related to study participation
Item
Activity related to study participation (e.g. procedures)
boolean
C2348568 (UMLS CUI [1])
Other possible Cause of SAE
Item
Other
boolean
Other possible Cause of SAE specification
Item
Other, specify
text
Item Group
SECTION 6: RELEVANT Medical Conditions
Relevant Medical Conditions
Item
Specify any relevant past or current medical disorders, allergies, surgeries, etc. that can help explain the SAE.
text
C0012634 (UMLS CUI [1,1])
C0262926 (UMLS CUI [1,2])
C1519255 (UMLS CUI [1,3])
Date of onset
Item
Date of onset
date
C0574845 (UMLS CUI [1])
Item
Condition Present at Time of the SAE?
text
Condition Present at Time of the SAE
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
Item Group
SECTION 7: Other RELEVANT Risk Factors
Other relevant risk factors
Item
Other relevant risk factors
text
Item Group
SECTION 8: RELEVANT Concomitant Medications
Drug name
Item
Drug name
text
C0013227 (UMLS CUI [1])
Dose
Item
Dose
float
C3174092 (UMLS CUI [1])
Unit
Item
Unit
text
Frequency
Item
Frequency
text
Route
Item
Route
text
C0013153 (UMLS CUI [1])
Item
Taken Prior to Study?
text
administration prior to study
Code List
Taken Prior to Study?
CL Item
Yes (Y)
CL Item
No (N)
Start Date
Item
Start Date
date
C0808070 (UMLS CUI [1])
Stop Date
Item
Stop Date
date
C0806020 (UMLS CUI [1])
Item
Ongoing Medication?
text
C2826666 (UMLS CUI [1])
Ongoing Medication
Code List
Ongoing Medication?
CL Item
Yes (Y)
CL Item
No (N)
Reason for Medication
Item
Reason for Medication
text
C0392360 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
Item Group
SECTION 9: Drug Details
Start Date Investigational Product
Item
Start Date Investigational Product (from REDUCE study)
date
Stop Date Investigational Product
Item
Stop Date Investigational Product (from REDUCE study)
date
Start Date Prescription Dutasteride
Item
Start Date Prescription Dutasteride
date
Stop Date Prescription Dutasteride
Item
Stop Date Prescription Dutasteride
date
Item Group
SECTION 10: Details of RELEVANT Assessments
Details of Relevant Assessments
Item
Details of Relevant Assessments
text
C1261322 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
Item Group
SECTION 11: Narrative Remarks
Narrative Remarks
Item
Narrative Remarks
text
Item Group
Investigator information
Investigator Signature
Item
Investigator’s signature
text
C2346576 (UMLS CUI [1])
Investigator name
Item
Investigator’s name (print)
text
C2826892 (UMLS CUI [1])
Investigator Signature Date
Item
Date
date
C2346576 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
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