Table 4 Adverse events reported in 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 |