Table 4.
Frequency of the most common adverse events during the multiple dose study
System organ class | Preferred term | Multiple Dose Study | ||||
---|---|---|---|---|---|---|
Placebo | Ferroquine | |||||
(N = 7) | 400 mg (N = 6) | 600 mg (N = 6) | 800 mg (N = 6) | 1000 mg (N = 1) | ||
Any class | Any TEAE | 6 (86) | 6 (100) | 6 (100) | 6 (100) | 1 (100) |
Gastrointestinal disorders | Any TEAE | 4 (57) | 3 (50) | 4 (67) | 5 (83) | 1 (100) |
Abdominal pain | 3 (43) | 1 (17) | 1 (17) | 2 (33) | 1 (100) | |
Diarrhoea | 0 | 0 | 0 | 2 (33) | 0 | |
Nausea | 1 (14) | 2 (33) | 2 (33) | 3 (50) | 0 | |
Toothache | 1 (14) | 1 (17) | 0 | 2 (33) | 0 | |
Vomiting | 0 | 1 (17) | 2 (33) | 1 (17) | 1 (100) | |
system disorders | Any TEAE | 1 (14) | 1 (17) | 3 (50) | 1 (17) | 0 |
Dizziness | 0 | 0 | 1 (17) | 0 | 0 | |
Headache | 1 (14) | 1 (17) | 2 (33) | 1 (17) | 0 |
NOTE: N (%): count of patients (percentage per group); TEAE: treatment emergent adverse event