Hospitalization Prolonged | PharmaBharat Tools

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Hospitalization Prolonged | PharmaBharat Tools

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Causality Assessment Company Seriousness Criteria Important Medical Event(IME)Rechallenge Positive Dechallenge Positive Drug Interaction Congenital Anomaly Fatal Case Life-Threatening Hospitalization Prolonged Disability Significant Temporal Relationship Alternative Etiology Biological Plausibility Adverse Event Outcome Alternative Etiology Biological Plausibility Causality Assessment Company Causality Assessment Common Terminology Criteria for Adverse Events(CTCAE)Persistent or Significant Disability Expectedness Hospitalization Important Medical Event(IME)Life-Threatening Listed (Expectedness)Naranjo Algorithm Related (Causality)Serious Adverse Event(SAE)Seriousness Criteria Severity Unexpected Adverse Event Unrelated (Causality)WHO-UMC Causality Assessment

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PV Seriousness & Causality AssessmentHospitalization Prolonged

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Life-Threatening Disability Significant

Hospitalization Prolonged

Seriousness & Causality Assessment

Definition

Seriousness: initial or prolonged hospitalization; includes admission for observation.

Example

Admitted for 24h observation after syncope—serious.

Regulatory source

ICH E2D

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