Efficacy and Tolerability of TREXIMA™ (sumatriptan 85mg/naproxen sodium 500mg) ID 101999

Beskrivning

Subject Identifier

Datatyp

text

Alias

UMLS CUI [1]

C2348585 (Clinical Trial Subject Unique Identifier)

Beskrivning

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. IF THIS EVENT MEETS THE DEFINITION OF SERIOUS, COMPLETE THE SERIOUS ADVERSE EVENT SECTION

Datatyp

text

Alias

UMLS CUI [1]

C1518404 (Non-serious Adverse Event)

Beskrivning

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.

Datatyp

text

Alias

UMLS CUI [1]

C0011900 (Diagnosis)

SNOMED

439401001

LOINC

LP30831-9

Beskrivning

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

Datatyp

date

Alias

UMLS CUI [1]

C2697888 (Adverse Event Start Date)

Beskrivning

Record the start time of the AE.

Datatyp

time

Alias

UMLS CUI [1]

C2826806 (Adverse Event Start Date Time)

Beskrivning

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.

Datatyp

integer

Alias

UMLS CUI [1]

C1705586 (Adverse Event Outcome)

Beskrivning

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 condition resolved or stabilised. Leave blank if the AE is ’Not recovered/Not resolved’ or ’Recovering/Resolving’.

Datatyp

date

Alias

UMLS CUI [1]

C2697886 (Adverse Event End Date)

Beskrivning

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).

Datatyp

text

Alias

UMLS CUI [1]

C1710066 (Severity of Adverse Event)

Beskrivning

Investigational product(s) withdrawn = Dose reduced = Dose increased = Dose not changed = Dose interrupted = Not applicable = Administration of investigational product(s) was permanently discontinued. Dose is reduced for one or more investigational product(s). Dose increased for one or more investigational product(s). Investigational product(s) continues even though an adverse event has occurred. Administration of one or more investigational product(s) was stopped temporarily but then restarted. Subject was not receiving investigational product(s) when the event occurred (e.g., pre-or post-dosing).

Datatyp

text

Alias

UMLS CUI [1,1]

C1704758 (Action Taken with Study Treatment)

UMLS CUI [1,2]

C1518404 (Non-serious Adverse Event)

Beskrivning

Indicate ’Yes’ if the event(s) were directly responsible for the subject’s withdrawal as indicated on the Study Conclusion page, otherwise indicate ’No’. If yes: Complete Study Conclusion page and tick Adverse event as reason for withdrawal.

Datatyp

text

Alias

UMLS CUI [1,1]

C1710677 (Withdrawal by Subject)

UMLS CUI [1,2]

C1518404 (Non-serious Adverse Event)

Beskrivning

It is a regulatory requirement for investigators to assess relationship to investigational product(s) 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.

Datatyp

text

Alias

UMLS CUI [1,1]

C0304229 (Experimental drug)

UMLS CUI [1,2]

C0085978 (Causations)

UMLS CUI [1,3]

C1518404 (Non-serious Adverse Event)