Descrição

Subject Identifier

Tipo de dados

integer

Alias

UMLS CUI [1]

C2348585

Descrição

If this is a Serious Adverse Event (SAE), do not complete this form, go to the SAE section and complete the SAE form. If Yes, record details below.

Tipo de dados

text

Alias

UMLS CUI [1]

C1518404

Descrição

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.

Tipo de dados

text

Alias

UMLS CUI [1]

C1518404

Descrição

Day onth Year Record the start date of the first occurrence of the AE.

Tipo de dados

text

Alias

UMLS CUI [1,1]

C0808070

UMLS CUI [1,2]

C0877248

Descrição

Hr : Min 00:00-23:59 Record the start time of the AE.

Tipo de dados

time

Alias

UMLS CUI [1,1]

C1301880

UMLS CUI [1,2]

C1518404

Descrição

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 de dados

integer

Alias

UMLS CUI [1]

C1705586

Descrição

Day Month Year 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’.

Tipo de dados

text

Alias

UMLS CUI [1,1]

C0806020

UMLS CUI [1,2]

C0877248

Descrição

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).

Tipo de dados

integer

Alias

UMLS CUI [1,1]

C0518690

UMLS CUI [1,2]

C0877248

Descrição

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 occured. 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 de dados

integer

Alias

UMLS CUI [1,1]

C1704758

UMLS CUI [1,2]

C1518404

Descrição

Indicate ’Yes’ if the event(s) were directly responsible for the subject’s withdrawal as indicated on the Study Conclusion page, otherwise indicate ’No’.

Tipo de dados

text

Alias

UMLS CUI [1,1]

C0877248

UMLS CUI [1,2]

C2349954

Descrição

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 de dados

text

Alias

UMLS CUI [1,1]

C1518404

UMLS CUI [1,2]

C0013230

UMLS CUI [1,3]

C0439849