ID

42817

Description

Ropinirole Case Report Form GSK RRL100013 GSK Study ID: 100013 Clinical Study ID: RRL100013 A 12-Week, Double-Blind, Placebo-Controlled, Twice-Daily Dosing Study to Assess the Efficacy and Safety of Ropinirole in Patients Suffering from Restless Legs Syndrome (RLS) Requiring Extended Treatment Coverage

Keywords

Versions (4)
  1. 2/22/18 2/22/18 -
  2. 2/24/18 2/24/18 -
  3. 2/25/18 2/25/18 -
  4. 9/17/21 9/17/21 -
Copyright Holder

gsk

Uploaded on

September 17, 2021

DOI

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Creative Commons BY-NC 3.0
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Ropinirole Case Report Form GSK RRL100013

English

SERIOUS ADVERSE EVENT

4 forms  
SERIOUS ADVERSE EVENT
Description

SERIOUS ADVERSE EVENT

DEFINITION OF A SERIOUS ADVERSE EVENT
Description

Diagnosis 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. Start Date Record the start date of the first occurrence of the SAE. Start Time Record the start time of the SAE. Outc o m e All SAEs must b e followed until the events are resolved, t h e condition stabilises, the events are otherwise explained, or the subject i s 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. End Date 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/ End Time 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'. Record the end time of the SAE. Maximum Record the maximum intensity that occurred over the duration of the event. Amend the intensity if it increases. Intensity 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 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). Action Taken with lnvestigational product(s) withdrawn = Administration of investigational product(s) was permanently discontinued. lnvestigational Dose reduced = Dose is reduced for one or more investigational product(s). Product(s) as a Result of the SAE Dose increased = Dose increased for one or more investigational product(s). Dose not changed = lnvestigational product(s) continues even though an adverse event has occurred. Dose interrupted = Administration of one or more investigational product(s) was temporarily interrupted but then restarted. Not applicable = Subject was not receiving investigational product(s) when the event occurred (e.g., pre-or post-dosing) or the subject died and there was no prior decision to discontinue IP(s). Withdrawal Indicate 'Yes' if the event(s) were directly respons ble for the subject's withdrawal as indicated on the Study Conclusion page, otherwise indicate 'No'. Relationship to It is a regulatory requirement for investigators to assess relationship to investigational product(s) based on information available. The assessment should be lnvestigational reviewed on receipt of any new information and amended if necessary. 'A reasonable poss bility' is meant to convey that there are facts/evidence or arguments Product(s) 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 dechallen

Data type

text

Alias
UMLS CUI [1]
C1519255
INSTRUCTIONS FOR COMPLETING SERIOUS ADVERSE EVENTS
Description

Diagnosis 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. Start Date Record the start date of the first occurrence of the SAE. Start Time Record the start time of the SAE. Outc o m e All SAEs must b e followed until the events are resolved, t h e condition stabilises, the events are otherwise explained, or the subject i s 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. End Date 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/ End Time 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'. Record the end time of the SAE. Maximum Record the maximum intensity that occurred over the duration of the event. Amend the intensity if it increases. Intensity 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 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). Action Taken with lnvestigational product(s) withdrawn = Administration of investigational product(s) was permanently discontinued. lnvestigational Dose reduced = Dose is reduced for one or more investigational product(s). Product(s) as a Result of the SAE Dose increased = Dose increased for one or more investigational product(s). Dose not changed = lnvestigational product(s) continues even though an adverse event has occurred. Dose interrupted = Administration of one or more investigational product(s) was temporarily interrupted but then restarted. Not applicable = Subject was not receiving investigational product(s) when the event occurred (e.g., pre-or post-dosing) or the subject died and there was no prior decision to discontinue IP(s). Withdrawal Indicate 'Yes' if the event(s) were directly respons ble for the subject's withdrawal as indicated on the Study Conclusion page, otherwise indicate 'No'. Relationship to It is a regulatory requirement for investigators to assess relationship to investigational product(s) based on information available. The assessment should be lnvestigational reviewed on receipt of any new information and amended if necessary. 'A reasonable poss bility' is meant to convey that there are facts/evidence or arguments Product(s) 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 dechallen

Data type

text

SERIOUS ADVERSE EVENTS
Description

SERIOUS ADVERSE EVENTS

SERIOUS ADVERSE EVENTS
Description

SERIOUS ADVERSE EVENTS

Data type

text

Alias
UMLS CUI [1]
C1519255
Start Date
Description

Start Date

Data type

date

Alias
UMLS CUI [1]
C0808070
Start Time
Description

Start Time

Data type

time

Alias
UMLS CUI [1]
C1301880
Outcome
Description

Outcome

Data type

text

Alias
UMLS CUI [1]
C1705586
End Date
Description

End Date

Data type

text

Alias
UMLS CUI [1]
C0806020
End time
Description

End time

Data type

time

Alias
UMLS CUI [1]
C1522314
Maximum Intensity
Description

Maximum Intensity

Data type

text

Alias
UMLS CUI [1]
C1710066
Action Taken with Investigational Product(s) as a Result of the Serious AE
Description

Action Taken with Investigational Product(s) as a Result of the Serious AE

Data type

text

Alias
UMLS CUI [1,1]
C1704758
UMLS CUI [1,2]
C1519255
Withdrawal
Description

Withdrawal

Data type

text

Alias
UMLS CUI [1,1]
C2349954
UMLS CUI [1,2]
C1519255
Relationship to lnvestigational Product(s)
Description

Relationship to lnvestigational Product(s)

Data type

text

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C1522508
Did the subject experience any serious adverse events during the study?
Description

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

Data type

boolean

Alias
UMLS CUI [1]
C1519255
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Similar models

SERIOUS ADVERSE EVENT

4 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
SERIOUS ADVERSE EVENT
DEFINITION OF A SERIOUS ADVERSE EVENT
Item
DEFINITION OF A SERIOUS ADVERSE EVENT
text
C1519255 (UMLS CUI [1])
Item
INSTRUCTIONS FOR COMPLETING SERIOUS ADVERSE EVENTS
text
INSTRUCTIONS FOR COMPLETING NON-SERIOUS ADVERSE EVENTS
Code List
INSTRUCTIONS FOR COMPLETING SERIOUS ADVERSE EVENTS
CL Item
Diagnosis (Diagnosis)
C0011900 (UMLS CUI-1)
(Comment:en)
CL Item
Start Date (Start Date)
C0808070 (UMLS CUI-1)
(Comment:en)
CL Item
Start Time (Start Time)
C1301880 (UMLS CUI-1)
(Comment:en)
CL Item
Outcome (Outcome)
C1705586 (UMLS CUI-1)
(Comment:en)
CL Item
End Date (End Date)
C0806020 (UMLS CUI-1)
(Comment:en)
CL Item
End Time (End Time)
C1522314 (UMLS CUI-1)
(Comment:en)
CL Item
Maximum Intensity (Maximum Intensity)
C1710066 (UMLS CUI-1)
(Comment:en)
CL Item
Withdrawal (Withdrawal)
C2349954 (UMLS CUI-1)
C1519255 (UMLS CUI-2)
(Comment:en)
Item Group
SERIOUS ADVERSE EVENTS
SERIOUS ADVERSE EVENTS
Item
SERIOUS ADVERSE EVENTS
text
C1519255 (UMLS CUI [1])
Start Date
Item
Start Date
date
C0808070 (UMLS CUI [1])
Start Time
Item
Start Time
time
C1301880 (UMLS CUI [1])
Outcome
Item
Outcome
text
C1705586 (UMLS CUI [1])
End Date
Item
End Date
text
C0806020 (UMLS CUI [1])
End time
Item
End time
time
C1522314 (UMLS CUI [1])
Maximum Intensity
Item
Maximum Intensity
text
C1710066 (UMLS CUI [1])
Action Taken with Investigational Product(s) as a Result of the Serious AE
Item
Action Taken with Investigational Product(s) as a Result of the Serious AE
text
C1704758 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
Withdrawal
Item
Withdrawal
text
C2349954 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
Relationship to lnvestigational Product(s)
Item
Relationship to lnvestigational Product(s)
text
C0304229 (UMLS CUI [1,1])
C1522508 (UMLS CUI [1,2])
Did the subject experience any serious adverse events during the study?
Item
Did the subject experience any serious adverse events during the study?
boolean
C1519255 (UMLS CUI [1])
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