Ropinirole Case Report Form GSK RRL100013

Beschrijving

Any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. For marketed medicinal products, this also includes failure to produce expected benefits (i.e .. lack of efficacy), abuse or misuse. Examples of an AE includes Significant or unexpected worsening or exacerbation of the condition/ indication under study. Exacerbation of a chronic or intermittent pre-existing condition including either an increase in frequency and/or intensity of the condition. New condition(s) detected or diagnosed after investigational product administration even though it may have been present prior to the start of the study. Signs, symptoms, or the clinical sequelae of a suspected interaction. Signs, symptoms, or the clinical sequelae of a suspected overdose of either investigational product or a concomitant medication (overdose per se should not be reported as an AE/SAE). Examples of an AE does NOT include a/an Medical or surgical procedure (e.g., endoscopy, appendectomy); the condition that leads to the procedure is an AE. Situations where an untoward medical occurrence did not occur (social and/or convenience admission to a hospital). • Anticipated day-to-day fluctuations of pre-existing disease(s) or condition(s) present or detected at the start of the study that do not worsen. The disease/disorder being studied, or expected progression, signs. or symptoms of the disease/disorder being studied, unless more severe than expected for the subject's condition. For GSK clinical studies, AEs may include pre- or post-treatment events that occur as a result of protocol-mandated procedures (i.e., invasive procedures, modification of subject's previous therapeutic regimen). See protocol for clarification. Add in any other project- or protocol-specific clarifications about untoward medical occurrences that do (or do not) need to be collected as AEs. These must be consistent with those outlined in the protocol and agreed with Global Clinical Safety & Pharmacovigilance

Datatype

text

Alias

UMLS CUI [1]

C1518404

Beschrijving

Diagnosis Enter only the diagnosis (if known); otherwise enter sign or symptom. If a diagnosis subsequently becomes available, then this should be entered and the sign or symptom crossed out, initialled and dated by the investigator. Start Date Record the start date of the first occurrence of the AE. Start Time Record the start time of the AE. Outcome All AEs 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 AE 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 AE was ongoing at the time of death, but was not the cause of death. End Date Record the end date. This is the date the AE Recovered/Resolved. If the event Recovered/Resolved with sequelae, enter the date the subject's medical End Time condition resolved or stabilised. Leave blank if the AE is 'Not recovered/Not resolved' or 'Recovering/Resolving'. Record the end time of the AE. 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 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). 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 Dose increased = Dose increased for one or more investigational product(s). Non-Serious AE 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 stopped temporarily but then restarted. Not applicable = Subject was not receiving investigational product(s) when the event occurred (e.g., pre-or post-dosing). Withdrawal Indicate 'Yes' if the event(s) were directly responsible 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 poss bility' 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.

Datatype

text

Beschrijving

NON-SERIOUS ADVERSE EVENTS

Datatype

text

Alias

UMLS CUI [1]

C1518404

Beschrijving

Start Date

Datatype

date

Alias

UMLS CUI [1]

C0808070

Beschrijving

Start Time

Datatype

time

Alias

UMLS CUI [1]

C1301880

Beschrijving

Outcome

Datatype

text

Alias

UMLS CUI [1]

C1705586

Beschrijving

End Date

Datatype

text

Alias

UMLS CUI [1]

C0806020

Beschrijving

End time

Datatype

time

Alias

UMLS CUI [1]

C1522314

Beschrijving

Maximum Intensity

Datatype

text

Alias

UMLS CUI [1]

C1710066

Beschrijving

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

Datatype

text

Alias

UMLS CUI [1,1]

C1704758

UMLS CUI [1,2]

C1518404

Beschrijving

Withdrawal

Datatype

text

Alias

UMLS CUI [1,1]

C2349954

UMLS CUI [1,2]

C1519255

Beschrijving

Relationship to lnvestigational Product(s)

Datatype

text

Alias

UMLS CUI [1,1]

C0304229

UMLS CUI [1,2]

C1522508

Beschrijving

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

Datatype

boolean

Alias

UMLS CUI [1]

C1518404