Life-Threatening | PharmaBharat Tools

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Life-Threatening | PharmaBharat Tools

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PV Seriousness & Causality AssessmentLife-Threatening

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Fatal Case Hospitalization Prolonged

Life-Threatening

Seriousness & Causality Assessment

Definition

Seriousness criterion: event that placed the patient at immediate risk of death.

Example

Acute anaphylaxis with hypotension—life-threatening.

Regulatory source

ICH E2D

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