Evaluating malaria subjects may include the collection of medical history, as well as recording symptoms of the disease, and characteristics of the subject based on physical examination and special investigations, such as laboratory tests and electrocardiograms (ECGs). Medical history helps to confirm the diagnosis, exclude severe malaria, and identify underlying risk factors that may also be exclusion criteria (e.g., pregnancy, co-morbidities such as HIV, malnutrition). Data regarding recent antimalarial treatment, as well as any concomitant medication use (including traditional, alternative and complementary medicines) and previous medical history may be exclusion criteria and, if not, are necessary for the interpretation of possible adverse events (AEs). Physical characteristics of the subject can include age, body weight, and pregnancy status for women of child-bearing age, as well as whether or not any abnormalities were detected on physical examination and special investigations. 

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