TABLE 3.
Adverse events occurring in >5% of subjects on tafenoquine or mefloquine (prophylactic phase)a
| Adverse event | No. (%) of subjects by AE severity and treatment group |
|||||||
|---|---|---|---|---|---|---|---|---|
| Mild |
Moderate |
Severe |
Total |
|||||
| Tafenoquine | Mefloquine | Tafenoquine | Mefloquine | Tafenoquine | Mefloquine | Tafenoquine | Mefloquine | |
| At least one AE | 431 (88) | 140 (86) | 194 (39) | 46 (28) | 18 (4) | 3 (2) | 454 (92) | 143 (88) |
| Gastrointestinal | ||||||||
| Gastroenteritis | 109 (22) | 36 (22) | 80 (16) | 17 (11) | 6 (1) | 0 | 182 (37) | 51 (32) |
| Diarrhea | 77 (16) | 28 (17) | 0 | 2 (1) | 1 (<1) | 0 | 77 (16) | 30 (19) |
| Nausea | 27 (6) | 13 (8) | 1 (<1) | 0 | 0 | 0 | 28 (6) | 13 (8) |
| Abdominal pain | 19 (4) | 11 (7) | 5 (1) | 3 (2) | 1 (<1) | 0 | 24 (5) | 13 (8) |
| Vomiting | 19 (4) | 8 (5) | 2 (<1) | 1 (<1) | 0 | 0 | 21 (4) | 8 (5) |
| Musculoskeletal | ||||||||
| Injury | 149 (30) | 46 (28) | 45 (9) | 4 (3) | 3 (<1) | 2 (1) | 178 (36) | 49 (30) |
| Back pain | 65 (13) | 24 (15) | 12 (2) | 2 (1) | 0 | 0 | 74 (15) | 26 (16) |
| Arthralgia | 52 (11) | 17 (11) | 9 (2) | 1 (<1) | 0 | 0 | 55 (11) | 18 (11) |
| Respiratory | ||||||||
| URTI | 97 (20) | 30 (19) | 6 (1) | 2 (1) | 0 | 0 | 101 (21) | 32 (20) |
| Pharyngitis | 24 (5) | 2 (1) | 2 (<1) | 1 (<1) | 0 | 0 | 25 (5) | 3 (2) |
| Dermatological | ||||||||
| Rash | 70 (14) | 20 (12) | 1 (<1) | 1 (<1) | 0 | 0 | 70 (14) | 21 (13) |
| Fungal dermatitis | 43 (9) | 8 (5) | 1 (<1) | 0 | 0 | 0 | 44 (9) | 8 (5) |
| Headache (constitutional AE) | 59 (12) | 18 (11) | 2 (<1) | 2 (1) | 0 | 0 | 61 (12) | 20 (12) |
| Viral infection | 23 (5) | 7 (4) | 16 (3) | 6 (4) | 1 (<1) | 0 | 39 (8) | 13 (8) |
a
In total, there were 492 tafenoquine subjects and 162 mefloquine subjects. AE, adverse event; URTI, upper respiratory tract infection.