Table 2.
Adverse events per generic form and the reference group
| Events | Accord (n = 107) | Amarox (n = 81) | Sandoz (n = 13) | Reference (n = 150) |
|---|---|---|---|---|
| Any new or worsened AE (%)a | 32 (29.9) | 28 (34.6) | 4 (30.8) | 32 (21.3) |
| Odds ratio (95% CIb) | 1.7 (0.9–3.2) | 2.3 (1.2–4.5) | 1.4 (0.4–5.7) | N/A |
| Individual AEs (%) | ||||
| Fatigue | 12 (11.2) | 4 (4.9) | 0 | 6 (4.0) |
| Skin toxicity | 8 (7.5) | 3 (3.7) | 1 (7.7) | 1 (0.7) |
| Muscle spasms | 8 (7.5) | 4 (4.9) | 0 | 5 (3.3) |
| Diarrhoea | 6 (5.6) | 7 (8.6) | 1 (7.7) | 5 (3.3) |
| Flushing | 5 (4.7) | 0 | 1 (7.7) | 0 |
| Nausea | 3 (2.8) | 8 (9.9) | 0 | 6 (4.0) |
| Swollen eyes | 0 | 0 | 2 (15.4) | 0 |
| Other | 18 (16.8) | 23 (28.4) | 2 (15.4) | 18 (12.0) |
| Other events (%) | ||||
| Painful ingestion | 0 | 1 (1.2) | 0 | 0 |
| Unpleasant taste | 0 | 23 (28.4) | 0 | 0 |
| AEs and other events combined (%) | 32 (29.9) | 42 (51.9) | 4 (30.8) | 32 (21.3) |
| Switch to second generic (%) | 13 (12.1) | 26 (32.1) | 2 (15.4) | N/A |
aRepresents the amount of patients that experienced at least one AE. Some patients had multiple individual AEs
bThe odds ratio was calculated paired, relative to the reference group; “log(Duration)” was used as a mixed effect in the model
AE(s) adverse event(s), CI confidence interval, N/A not available