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Table 3 Presumptive diagnostic categories assigned to reported SAE cases following Mectizan® treatment*

From: Serious adverse events following treatment with ivermectin for onchocerciasis control: a review of reported cases

Diagnostic Category Symptoms & Signs
Anaphylactic Reaction Generalized immediate hypersensitivity response (urticaria, pruritis, angioedema, vascular collapse, life-threatening respiratory distress) after the administration of Mectizan®
Mild Mazzotti Reaction† Manifestation of 2 or more of the following symptoms within 7 days of the administration of Mectizan®: pruritis, fever, headache, edema, lymphadenopathy, myalgia, generalized body aches
Severe Mazzotti Reaction† Manifestation of 1 or both of the following symptoms within 7 days of the administration of Mectizan®: hypotension, asthma attacks in known patients; or manifestation of bullous skin lesions after 1–2 weeks of administration of Mectizan®
Functional Impairment with Normal Mental Status‡ Manifestation of symptoms typical of Mild Mazzotti Reaction at a severity such that patient required assistance with Activities of Daily Living (ADLs) (eating, bathing, walking) but maintained normal mental status within 7 days of the administration of Mecizan
Neurologic Encephalopathy, meningitis, or other neurologic sequelae within 7 days of the administration of Mectizan®
Cardiovascular Cardiovascular symptoms and signs, excluding hypotension, within 7 days of the administration of Mectizan®
Pulmonary Respiratory symptoms and signs, excluding Mazzotti-type bronchoconstriction, within 7 days of the administration of Mectizan®
Gastrointestinal Gastrointestinal symptoms including dehydration within 7 days of the administration of Mectizan®
Other Any other symptoms and signs within 7 days of the administration of Mectizan®
  1. *All cases met the definition of an SAE (See note 1) before being assigned one of these presumptive diagnoses; †adapted from McGavin DDM (1998). Opthalmology in the Tropics and Subtropics. In Manson's Tropical Diseases. 20th edn. (ed. GC Cook GC) W. B. Saunders Co. Ltd, London, p. 248; ‡adapted from Gardon J et al. [6].