Table 2.
Detected differences between the percentage of treated patients expected to experience adverse drug reactions (ADRs) as reported in the Summary of Product Characteristics (SPC) and the observed cumulative incidence of ADRs among 154 patients on Target-Vig
| Follow up (months) | Expected % | Observed | ||
|---|---|---|---|---|
| Median (IQR) | N | % (95% CI) | ||
| Bevacizumab (n = 49) | 6.7 (3.9–7.8) | |||
| Myalgia | [1–10] | 21 | 42.9 (29.0–56.7) | |
| Arthralgia | [1–10] | 21 | 42.9 (29.0–56.7) | |
| Headache | [1–10] | 14 | 28.6 (15.9–41.2) | |
| Cetuximab (n = 12) | 3.4 (2.6–5.2) | |||
| Nausea | [1–10] | 5 | 41.7 (13.8–69.6) | |
| Asthenia | [1–10] | 5 | 41.7 (13.8–69.6) | |
| Mucositis | [1–10] | 7 | 58.3 (30.4–86.2) | |
| Imatinib (n = 12) | 16.2 (14.6–18.4) | |||
| Eyelids oedema | [1–10] | 8 | 66.7 (40.0–93.3) | |
| Lacrimation increased | [1–10] | 5 | 41.7 (13.8–69.6) | |
| Joint swelling | [1–10] | 6 | 50.0 (21.7–78.3) | |
| Sorafenib (n = 20) | 4.9 (2.9–11.5) | |||
| Neuropathy | [1–10] | 8 | 40.0 (18.5–61.5) | |
| Skin desquamation | [1–10] | 7 | 35.0 (14.1–55.9) | |
| Myalgia | [1–10] | 9 | 45.0 (23.2–66.8) | |
| Arthralgia | [1–10] | 9 | 45.0 (23.2–66.8) | |
| Sunitinib (n = 27) | 9.9 (3.9–14.2) | |||
| Hypothyroidism | [1–10] | 26 | 96.3 (89.2–100) | |
| Musculoskeletal pain | [1–10] | 15 | 55.6 (36.8–74.3) | |
| Blood creatinine increase | [1–10] | 12 | 44.4 (25.7–63.2) | |
| Abdominal discomfort | [1–10] | 12 | 44.4 (25.7–63.2) | |
| Hypertriglyceridemia | [1–10] | 10 | 37.0 (18.8–55.3) | |
| Flatulence | [1–10] | 8 | 29.6 (12.4–46.9) | |
| Oral pain | [1–10] | 8 | 29.6 (12.4–46.9) | |
| Hypercholesterolaemia | [0.1–1] | 10 | 37.0 (18.8–55.3) | |
| Hyperglycaemia | [0.1–1] | 7 | 25.9 (9.4–42.5) | |
| Dental abscess | [0.1–1] | 5 | 18.5 (3.9–33.2) | |
CI Confidence Interval, IQR Interquartile Range