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Table 4 Adverse events reported in efficacy trials in Tanzania

From: Monitoring of efficacy and safety of artemisinin-based anti-malarials for treatment of uncomplicated malaria: a review of evidence of implementation of anti-malarial therapeutic efficacy trials in Tanzania

Study ID Adverse events reported Comments
TZ001_AS + AQ Severe malaria (3.4%) Not attributed to the treatment
TZ001_AL Severe malaria (1.0%) Not attributed to the treatment
TZ002_ AL Death (0.2%) Not attributed to the treatment
TZ004_ AL Gastrointestinal complaints (5.3%), vomiting (1.5%), dermatological (including itching) (3.0%), respiratory (including respiratory infection) (15.9%), dizziness (0.8%), convulsions (2.3%) Gastrointestinal complaints were likely to be attributed to the drugs
TZ004_ AZ + AS Gastrointestinal complaints (2%), vomiting (7.6%), dermatological (including itching) (5.4%), respiratory tract respiratory infections (11.6%), dizziness (1.6%), convulsions (0.8%) Gastrointestinal complaints were likely to be attributed to the drugs
TZ005_ AL Severe malaria (4%), vomiting (1%), cough (10%), abdominal pain (1%), diarrhoea (3%), weakness (1%), upper respiratory tract infections (22%), skin infections (9%), urinary tract infection (5%), otitis media (4%), tonsillitis (2%), conjunctivitis (4%), worm infestation (1%), periodontitis (1%), asthma (0.3%) Severe malaria was recorded as severe adverse event. The rest were mild or moderate in severity
TZ006_ AL Severe malaria (1%), fever (34%), cough (34%), diarrhoea (12%) Severe malaria was recorded as severe adverse event. The rest were mild or moderate in severity. None was considered related to AL treatment
TZ009_ AL Cough (49.4%), fever (20.2%), abdominal pain (10.1%), diarrhoea (1.3%), Headache (1.3%), skin rashes (1.3%) No serious adverse events. All the AEs were not related to the treatment