Ropinirole Case Report Form GSK RRL100013

Beschreibung

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 Action Taken with lnvestigational product(s) withdrawn = Administration of investigational product(s) was permanently discontinued.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

Datentyp

text

Alias

UMLS CUI [1]

C1519255

Beschreibung

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

Datentyp

text

Beschreibung

SERIOUS ADVERSE EVENTS

Datentyp

text

Alias

UMLS CUI [1]

C1519255

Beschreibung

Start Date

Datentyp

date

Alias

UMLS CUI [1]

C0808070

Beschreibung

Start Time

Datentyp

time

Alias

UMLS CUI [1]

C1301880

Beschreibung

Outcome

Datentyp

text

Alias

UMLS CUI [1]

C1705586

Beschreibung

End Date

Datentyp

text

Alias

UMLS CUI [1]

C0806020

Beschreibung

End time

Datentyp

time

Alias

UMLS CUI [1]

C1522314

Beschreibung

Maximum Intensity

Datentyp

text

Alias

UMLS CUI [1]

C1710066

Beschreibung

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

Datentyp

text

Alias

UMLS CUI [1,1]

C1704758

UMLS CUI [1,2]

C1519255

Beschreibung

Withdrawal

Datentyp

text

Alias

UMLS CUI [1,1]

C2349954

UMLS CUI [1,2]

C1519255

Beschreibung

Relationship to lnvestigational Product(s)

Datentyp

text

Alias

UMLS CUI [1,1]

C0304229

UMLS CUI [1,2]

C1522508

Beschreibung

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

Datentyp

boolean

Alias

UMLS CUI [1]

C1519255