Table 3 |
|
|
Presumptive diagnostic categories assigned to reported SAE cases following Mectizan® treatment* |
|
| 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® |
|
|
|
|
*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]. |
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Twum-Danso Filaria Journal 2003 2(Suppl 1):S3 doi:10.1186/1475-2883-2-S1-S3 |
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