Golimumab | ||||
---|---|---|---|---|
50 mg only | 50 and 100 mg | 100 mg only | All patients | |
Treated patients in the study | 98 | 195 | 138 | 431 |
All malignancies | ||||
Observed number of patients | 3 | 11 | 6 | 20 |
Incidence (95% CI)/100 pt-yrsa | 1.23 (0.25, 3.59) | 1.59 (0.79, 2.85) | 1.42 (0.52, 3.10) | 1.47 (0.90, 2.28) |
SIRb | 1.36 | 1.20 | 0.81 | 1.11 |
(95% CI)c | (0.28, 3.98) | (0.48, 2.47) | (0.17, 2.36) | (0.59, 1.89) |
Type of malignancy | ||||
Lymphoma | ||||
Observed number of patients | 0 | 2 | 2 | 4 |
Incidence (95% CI)/100 pt-yrsa | 0.00 (0.00, 1.22) | 0.28 (0.03, 1.03) | 0.47 (0.06, 1.68) | 0.29 (0.08, 0.74) |
SIRb | 0.00 | 8.13 | 12.32 | 7.96 |
(95% CI)c | (0.00, 31.87) | (0.99, 29.38) | (1.49, 44.49) | (2.17, 20.39) |
Other malignancies | ||||
Observed number of patients | 3 | 5 | 1 | 9 |
Incidence (95% CI)/100 pt-yrsa | 1.23 (0.25, 3.59) | 0.71 (0.23, 1.66) | 0.23 (0.01, 1.30) | 0.65 (0.30, 1.24) |
SIRb | 1.42 | 0.89 | 0.28 | 0.80 |
(95% CI)c | (0.29, 4.15) | (0.29, 2.07) | (0.01, 1.56) | (0.36, 1.51) |
Nonmelanoma skin cancer | ||||
Observed number of patients | 0 | 5 | 3 | 8 |
Incidence (95% CI)/100 pt-yrsa | 0.00 (0.00, 1.22) | 0.72 (0.23, 1.69) | 0.71 (0.15, 2.08) | 0.59 (0.25, 1.16) |