Table 3 Incidence of treatment emergent adverse events (TEAEs) and adverse events (AEs) patients treated with ASAQ
Sign or symptom | Total number of patients | Prevalence at enrolment | TEAE | AE | AE vs TEAE | |||
|---|---|---|---|---|---|---|---|---|
n | Incidence | n | Incidence | Relative difference | ||||
Gastro-intestinal | Anorexia | 1279 | 47% | 217 | 17% | 551 | 43% | 154% |
Abdominal | 740 | 46% | 66 | 9% | 202 | 27% | 206% | |
Vomiting | 1277 | 34% | 188 | 15% | 392 | 31% | 108% | |
Diarrhoea | 1278 | 20% | 214 | 17% | 315 | 25% | 47% | |
Nausea | 726 | 18% | 22 | 3% | 107 | 15% | 386% | |
Neurological | Headache | 736 | 46% | 27 | 4% | 132 | 18% | 388% |
Dizziness | 519 | 2% | 3 | 1% | 15 | 3% | 399% | |
Tinnitus | 200 | 1% | 1 | 1% | 1 | 1% | 0% | |
Dermatological | Pruritus | 756 | 26% | 141 | 19% | 192 | 25% | 36% |
Skin symptom | 759 | 24% | 97 | 13% | 118 | 16% | 22% | |
Other | Cough | 759 | 69% | 248 | 33% | 371 | 49% | 50% |
Weakness | 1119 | 59% | 176 | 16% | 470 | 42% | 167% | |
Myalgia | 216 | 32% | 17 | 8% | 21 | 10% | 24% | |
Jaundice | 759 | 2% | 4 | 1% | 4 | 1% | 0% | |