Field

Description

Seriousness Criteria

Death? (A.1.5.2)

To indicate if the reaction resulted in death, select one of the following options:

• Yes

• No

• No Information

Life threatening? (A.1.5.2)

Indicates if the patient was at risk of death at the time of the adverse event or continued use of the device might have resulted in the death of the patient.

Select one of the following options:

• Yes

• No

• No Information

Hospitalization  New? (A.1.5.2)

Indicates if the patient requires inpatient hospitalization or prolongation of existing hospitalization.

select one of the following options:

• Yes

• No

• No Information

Disability? (A.1.5.2)

Indicates if the adverse event resulted in a substantial disruption of a person’s ability to conduct normal life functions.

Select one of the following options:

• Yes

• No

• No Information

Congenital anomaly? (A.1.5.2)

Indicates, if the patient is exposed to a medical product prior to conception or during pregnancy may have resulted in an adverse outcome in the new born. Select one of the following options:

• Yes

• No

• No Information

Require intervention (devices)? (A.1.5.2)

To indicate if the reaction requires medical or surgical intervention from the doctor. Example: Allergic brochospasm requires emergency treatment.

Select one of the following options:

• Yes

• No

Other Serious (Important Medical Events) (A.1.5.2)

Indicates if patient experienced any other important medical events that may not be immediately life-threatening or result in death hospitalization but may jeopardise the patient or may require intervention prevent one of the other outcomes. These should also usually be considered serious.

Examples of such events are intensive treatment in an emergency room or home for allergic bronchospasm; blood dyscrasias or convulsions that do not result in hospitalisation; or development of drug dependency or drug abuse.

Select one of the following options:

• Yes

• No

Seriousness Decision By

Indicates who made the seriousness decision in a case.

Select one of the following options:

• Local HCP

• Patient

• HPO

Temporary or permanent functional incapacity

Indicates if the adverse event has resulted in permanent or temporary disability.

This criteria is available in Event and Case level. The value from Event level gets displayed  in Case level criteria.

Select one of the following options.

• Yes

• No

Hospitalization prolonged? (A.1.5.2)

Indicates if hospitalization was prolonged.

Other Medically Serious Info?

Enter medically serious information associated with the adverse reaction.

Reporter assessment and Company assessment

Seriousness(A.1.5.1/E.i.3.1)

   The seriousness of the event as described by the reporter or company or Both.

Severity

The severity of the reaction evaluated by the reporter or company.

Outcome (B.2.i.8/E.i.7)

The outcome of the adverse drug reaction as reported by the Reporter or Company.

Date of outcome

The date of knowing the outcome.

Date of assessment

The date on which the assessment of reaction was made.

Manual

when user selects the seriousness criteria at event    level and upon saving the case, the seriousness criteria is rolled up from Event level to Case level.

If the manual check box is selected,the case level seriousness criteria remains unchanged even if the event level serious criteria is changed.

Note: This works only when validations 5020 is set to ON.

Other AE Characteristics

Cancer?

Indicate if the outcome of the reaction was attributed to 'cancer'.

RX therapy required?

Indicate if the patient required any treatment therapy on experiencing the adverse event.

Overdose?

Indicate if the adverse event was a case of overdose.

Lack of effect?

Indicate if the outcome of the reaction was a case due to lack of effect with a medicinal product.

Dependence?

Indicate if the outcome of the reaction was a case of dependence.

Drug interaction?

Indicate if the outcome of the reaction was a case of drug interaction.

Req. therapeutic measures?

Indicate if the patient required therapeutic measures on experiencing the AE.

Serious injury?

Indicate if the outcome of the reaction was a serious injury.

Malfunction?

Indicate if the outcome of the reaction was a case of malfunction.

Case level Seriousness criteria is cleared when event level Seriousness criteria is not selected

Positive gram?

Indicate if the outcome of the reaction was a positive gram.

Purulent discharge?

Indicate if there was any evidence of a purulent discharge.

Extending past nearest joints?

Indicate if the adverse event extended past nearest joints.

Drainage of lymph nodes?

Indicate if the result of the reaction resulted in the drainage of lymph nodes or not.  Normally used for vaccine related cases.  

Hospitalization required? - Historic

Indicate if the patient required hospitalization earlier.

Medication errors?

Indicate if the outcome of the reaction was any medication errors.

Off-Label

The cases where the drug consumed by the patient not according to the current label are considered as Off-Label. This field is set manually.

Death Caused By

The reason or cause of death.