ID

29055

Descripción

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

Palabras clave

  1. 5/10/17 5/10/17 -
  2. 22/2/18 22/2/18 -
  3. 22/2/18 22/2/18 -
  4. 22/2/18 22/2/18 -
  5. 17/9/21 17/9/21 -
Titular de derechos de autor

gsk

Subido en

22 de febrero de 2018

DOI

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Licencia

Creative Commons BY-NC 3.0

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Ropinirole Case Report Form GSK RRL100013

NON-SERIOUS ADVERSE EVENT

NON-SERIOUS ADVERSE EVENT
Descripción

NON-SERIOUS ADVERSE EVENT

DEFINITION OF A NON-SERIOUS ADVERSE EVENT
Descripción

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

Tipo de datos

text

Alias
UMLS CUI [1]
C1518404
INSTRUCTIONS FOR COMPLETING NON-SERIOUS ADVERSE EVENTS
Descripción

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.

Tipo de datos

text

NON-SERIOUS ADVERSE EVENTS
Descripción

NON-SERIOUS ADVERSE EVENTS

NON-SERIOUS ADVERSE EVENTS
Descripción

NON-SERIOUS ADVERSE EVENTS

Tipo de datos

text

Alias
UMLS CUI [1]
C1518404
Start Date
Descripción

Start Date

Tipo de datos

date

Alias
UMLS CUI [1]
C0808070
Start Time
Descripción

Start Time

Tipo de datos

time

Alias
UMLS CUI [1]
C1301880
Outcome
Descripción

Outcome

Tipo de datos

text

Alias
UMLS CUI [1]
C1705586
End Date
Descripción

End Date

Tipo de datos

text

Alias
UMLS CUI [1]
C0806020
End time
Descripción

End time

Tipo de datos

time

Alias
UMLS CUI [1]
C1522314
Maximum Intensity
Descripción

Maximum Intensity

Tipo de datos

text

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

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

Tipo de datos

text

Alias
UMLS CUI [1,1]
C1704758
UMLS CUI [1,2]
C1518404
Withdrawal
Descripción

Withdrawal

Tipo de datos

text

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

Relationship to lnvestigational Product(s)

Tipo de datos

text

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

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

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1518404

Similar models

NON-SERIOUS ADVERSE EVENT

Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
NON-SERIOUS ADVERSE EVENT
DEFINITION OF A NON-SERIOUS ADVERSE EVENT
Item
DEFINITION OF A NON-SERIOUS ADVERSE EVENT
text
C1518404 (UMLS CUI [1])
Item
INSTRUCTIONS FOR COMPLETING NON-SERIOUS ADVERSE EVENTS
text
Code List
INSTRUCTIONS FOR COMPLETING NON-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
NON-SERIOUS ADVERSE EVENTS
NON-SERIOUS ADVERSE EVENTS
Item
NON-SERIOUS ADVERSE EVENTS
text
C1518404 (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 Non-Serious AE
Item
Action Taken with Investigational Product(s) as a Result of the Non-Serious AE
text
C1704758 (UMLS CUI [1,1])
C1518404 (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 non-serious adverse events during the study?
Item
Did the subject experience any non-serious adverse events during the study?
boolean
C1518404 (UMLS CUI [1])

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