Table 2

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

Severity levelDefinitionInterventionExamples
1—minimalNo harm; no change in condition.
  • Resolves with proper counselling.

  • Does not require any change in dose or generic.

Mild nausea with DFP or DFX.
  • 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.

  • 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—majorToxic 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—catastrophicDeath 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.