Table 3.
Frequency of NPAEs in P. vivax malaria patients given tafenoquine/chloroquine, primaquine/chloroquine or placebo/chloroquine [9]
| Adverse event, n (%) | TQ + CQ | PQ + CQ (N = 50) | Placebo + CQ (N = 54) | |||
|---|---|---|---|---|---|---|
| 50 mg (N = 55) | 100 mg (N = 57) | 300 mg (N = 57) | 600 mg (N = 56) | |||
| Any nervous system disorder | 17 (31) | 17 (30) | 13 (23) | 16 (29) | 17 (34) | 21 (39) |
| Headache | 14 (25) | 17 (30) | 10 (18) | 16 (29) | 14 (28) | 20 (37) |
| Dizziness | 7 (13) | 2 (4) | 5 (9) | 4 (7) | 5 (10) | 5 (9) |
| Migraine | 0 | 0 | 0 | 0 | 0 | 1 (2) |
| Tremor | 0 | 0 | 1 (2) | 1 (2) | 0 | 0 |
| Paraesthesia | 0 | 0 | 0 | 1 (2) | 0 | 0 |
| Sciatica | 0 | 1 (2) | 0 | 0 | 0 | 0 |
| Burning sensation | 1 (2) | 0 | 0 | 0 | 0 | 0 |
| Syncope | 0 | 0 | 0 | 0 | 1 (2) | 0 |
| Dysaesthesia | 0 | 0 | 0 | 0 | 1 (2) | 0 |
| Any psychiatric disorder | 2 (4) | 3 (5) | 5 (9) | 3 (5) | 1 (2) | 1 (2) |
| Insomnia | 2 (4) | 3 (5) | 5 (9) | 3 (5) | 3 (6) | 1 (2) |
| Tic | 0 | 0 | 0 | 1 (2) | 0 | 0 |
| Expanded termsa | ||||||
| Asthenia | 5 (9) | 4 (7) | 1 (2) | 5 (9) | 0 | 0 |
| Fatigue | 0 | 1 (2) | 1 (2) | 0 | 0 | 0 |
CQ chloroquine, PQ primaquine, TQ tafenoquine
aExpanded terms: labyrinthitis, vertigo, vestibular disorder, asthenia, fatigue, and alcohol intolerance were also considered with possible reference to vestibulocochlear function