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Causality Assessment
I. Temporal Relationship
1. Did the ADR or laboratory parameter abnormality appear after the start of the drug?
Yes
No
I.1 Date of the start of the drug
I.2 Date of the appearance of the adverse drug reaction/lab abnormality
2. Did the ADR or laboratory parameter abnormality resolve after discontinuation of the drug(dechallenge)? or Administration of specific antagonist?
Yes
No
Not applicable
2.1 Date of the discontinuation of the drug / Administration of specific antagonist
2.2 Date of the resolution of the adverse drug reaction/lab abnormality
3. Did the ADR or laboratory parameter abnormality reappear upon reintroduction of the drug(rechallenge)?
Yes
No
Not applicable
3.1 Date of the reintroduction of the drug
3.2 Date of the reappearance of the adverse drug reaction/lab abnormality
II. Alternative Explanations
4. Are there any other possible causes for the ADR (e.g., other medications, diseases, environmental factors)?
Yes
No
4.1 What are the causes that attribute to the ADR other than the suspected drug?
5. Is there known pharmacological evidence that supports a causal link between the drug and the ADR?
Yes
No
5.1 State the evidence that supports as a causal link between the suspected drug and the ADR
III. Clinical Pharmacology
6. Whether additional information about the ADR or laboratory abnormality is needed/available and is under examination?
Yes
No
6.1 What is the information that requires further investigation or examination
