Table 2

Details of adverse event (AE) severity level and its management*

Severity level	Definition	Intervention	Examples
1—minimal	No harm; no change in condition.	Resolves with proper counselling. Does not require any change in dose or generic.	Mild nausea with DFP or DFX.
2—minor	Transient change in condition. Not life-threatening. Condition returns to baseline with interventions. Not directly related to the drug.	Requires temporarily holding the medication.	Viral fever on DFO. Thrombocytopenia due to infection while on DFP. Raised serum transaminases due to viral hepatitis. Mild rash while on DFX.
3—moderate	Change in condition not life threatening. Condition returns to baseline once drug is stopped.	Requires intervention such as stopping or switching the drug.	Infusion related local reactions on DFO. Drug related neutropenia while on DFP. Persistent nausea and vomiting with DFP or DFO. Persistent rash with DFX.
4—major	Toxic adverse effects on higher doses which may lead to permanent disability or severe illness that is, sepsis.	Permanent discontinuation of drug.	Renal failure with DFX. Ototoxicity or retinotoxity with DFO. Febrile neutropenia and/or bleeding due to DFP. Significant DFP related arthropathy leading to severe disability.
5—catastrophic	Death or severe life altering disability (ie, becoming bed ridden) due to drug related AE.		Sepsis related to drug induced neutropenia leading to mortality or significant morbidity like stroke, permanent end organ damage, severe and permanent functional restriction. Significant life-threatening bleeding due to drug related thrombocytopenia. Severe life-threatening acute liver failure.

*Patients who already had an AE for a specific drug prior to the study period were not considered for AE classification.
DFO, deferoxamine; DFP, deferiprone; DFX, deferasirox.