Table 3.
Overall AE profile of all enrolled clinical studies
| AEs | Statistics from individual study (incidence, %) | TOTAL | ||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1* | 2 | 3 | 4 | 5 | 6 | 7 | 8 | 9 | 10 | 11 | 12 | 13 | 14 | 15 | AEs | Reporting studies | Incidence (%) | |
| Fatigue | 8.6 | 41.5 | 33.3 | 6.5 | 40.0 | 10.3 | 72.2 | 85.7 | 10.6 | 37.4 | 67.5 | 4.7 | 12.8 | 223 | 13 | 28.9 | ||
| Skin reaction | 5.7 | 24.5 | 40.5 | 13.7 | 1.3 | 55.6 | 52.4 | 2.1 | 7.0 | 72.8 | 4.3 | 152 | 11 | 19.7 | ||||
| Diarrhoea | 2.9 | 7.5 | 40.0 | 6.9 | 50.0 | 28.6 | 47.4 | 2.1 | 20.9 | 59.6 | 1.6 | 8.5 | 142 | 12 | 18.4 | |||
| Nausea and vomiting | 2.9 | 17.0 | 26.2 | 6.5 | 6.9 | 1.3 | 27.8 | 66.6 | 26.3 | 6.4 | 31.3 | 31.6 | 6.3 | 8.5 | 134 | 14 | 17.4 | |
| Hyperglycaemia | 2.9 | 9.4 | 71.4 | 4.3 | 4.8 | 17.2 | 18.8 | 16.7 | 61.9 | 5.3 | 10.6 | 19.1 | 5.3 | 4.7 | 6.4 | 116 | 15 | 15.0 |
| Decreased appetite | 5.7 | 13.2 | 33.3 | 6.9 | 1.3 | 27.8 | 42.9 | 73.7 | 6.4 | 20.9 | 11.4 | 1.6 | 95 | 12 | 12.3 | |||
| Muco/stomatitis | 5.7 | 45.2 | 1.3 | 44.4 | 100 | 2.1 | 35.1 | 93 | 7 | 12.0 | ||||||||
| Thrombocytopenia | 8.6 | 24.5 | 47.6 | 2.4 | 52.4 | 84.2 | 8.5 | 10.4 | 1.6 | 8.5 | 85 | 10 | 11.0 | |||||
| Anaemia | 2.9 | 11.3 | 6.9 | 52.4 | 68.4 | 21.3 | 15.7 | 6.1 | 1.6 | 14.9 | 76 | 10 | 9.8 | |||||
| Pain | 2.9 | 6.9 | 1.3 | 2.1 | 48.7 | 6.1 | 68 | 6 | 8.8 | |||||||||
| Elevated AST/ALT | 8.6 | 16.7 | 10.9 | 6.9 | 61.9 | 17.0 | 12.2 | 14.9 | 59 | 8 | 7.6 | |||||||
| Musculoskeletal pain | 2.9 | 15.1 | 9.5 | 6.9 | 2.5 | 52.4 | 25.2 | 1.6 | 58 | 8 | 7.5 | |||||||
| Hypertriglyceridaemia | 71.4 | 52.4 | 2.1% | 42 | 3 | 5.4 | ||||||||||||
| Neutropenia | 21.4 | 28.6 | 94.7 | 8.5 | 6.1 | 40 | 5 | 5.2 | ||||||||||
| Constipation | 11.1 | 18.3 | 13.2 | 3.1 | 40 | 4 | 5.2 | |||||||||||
| Headache | 2.9 | 10.3 | 19.0 | 2.1 | 22.6 | 4.7 | 38 | 6 | 4.9 | |||||||||
| Cough | 13.0 | 15.8 | 33 | 2 | 4.3 | |||||||||||||
| Pyrexia | 15.1 | 1.3 | 2.1 | 18.3 | 1.6 | 31 | 4 | 4.0 | ||||||||||
| Hypercholesterolaemia | 59.5 | 19.0 | 29 | 2 | 3.8 | |||||||||||||
| Dyspnoea | 15.7 | 7.9 | 27 | 2 | 3.5 | |||||||||||||
| Leukopenia | 28.6 | 94.7 | 4.3 | 26 | 3 | 3.4 | ||||||||||||
| Weight decreased | 2.9 | 6.9 | 23.8 | 6.4 | 11.3 | 24 | 5 | 3.1 | ||||||||||
| Muscle spasm | 6.5 | 6.9 | 11.1 | 13.2 | 4.3 | 24 | 5 | 3.1 | ||||||||||
| Dehydration | 2.9 | 11.1 | 4.3 | 10.5 | 17 | 4 | 2.2 | |||||||||||
| Creatinine elevation | 16.7 | 6.1 | 4.3 | 16 | 3 | 2.1 | ||||||||||||
| Neuropathy | 84.2 | 16 | 1 | 2.1 | ||||||||||||||
| Hypophosphataemia | 2.9 | 14.3 | 4.3 | 7.0 | 14 | 4 | 1.8 | |||||||||||
| Elevated ALK phosphatase | 2.9 | 2.1 | 9.6 | 14 | 3 | 1.8 | ||||||||||||
| Muscular weakness | 2.9 | 7.5 | 5.2 | 13 | 3 | 1.7 | ||||||||||||
| Dyspepsia | 2.9 | 9.6 | 12 | 2 | 1.6 | |||||||||||||
| Paronychia | 10.5 | 12 | 1 | 1.6 | ||||||||||||||
*
Study number.