Descrizione

If Yes, record details in the other items of this itemgroup/form. Non-serious adverse event terms should be reviewed for potential SAEs per protocol (if serious, fill out Serious Adverse Event form instead). 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.

Tipo di dati

text

Alias

UMLS CUI [1]

C1518404

Descrizione

No medical or investigational procedure. If a diagnosis subsequently becomes available, then this should be entered and the sign or symptom crossed out, initialled and dated by the investigator.

Tipo di dati

text

Alias

UMLS CUI [1,1]

C1518404

UMLS CUI [1,2]

C0011900

Descrizione

Start Date

Tipo di dati

date

Alias

UMLS CUI [1]

C2697888

Descrizione

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.

Tipo di dati

integer

Alias

UMLS CUI [1]

C1705586

Descrizione

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’.

Tipo di dati

date

Alias

UMLS CUI [1]

C2697886

Descrizione

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).

Tipo di dati

text

Alias

UMLS CUI [1,1]

C0518690

UMLS CUI [1,2]

C0877248

Descrizione

Investigational product(s) withdrawn = Administration of investigational product(s) was permanently discontinued. Dose reduced = Dose is reduced for one or more investigational product(s). Dose increased = Dose increased for one or more investigational product(s). Dose not changed = Investigational 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).

Tipo di dati

text

Alias

UMLS CUI [1,1]

C1704758

UMLS CUI [1,2]

C1518404

Descrizione

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 pick Adverse event as reason for withdrawal.

Tipo di dati

text

Alias

UMLS CUI [1,1]

C1710677

UMLS CUI [1,2]

C1518404

Descrizione

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.

Tipo di dati

text

Alias

UMLS CUI [1,1]

C0304229

UMLS CUI [1,2]

C0085978

UMLS CUI [1,3]

C1518404