Table 2.
Numbers of GEMINI LTS study patients with malignancy events by indication, previous immunomodulator exposure and disease duration
| Malignancy site, n | Crohn’s disease (3196 PY) | Ulcerative colitis (2474 PY) | Previous exposure to immunomodulators (4377 PY) | No previous exposure to immunomodulators (1293 PY) | Duration of diseases ≤5 y (2196 PY) | Duration of disease >5 y (3474 PY) |
|---|---|---|---|---|---|---|
| Breast | 1 | 1 | 2 | 0 | 0 | 2 |
| Central nervous system | 0 | 2 | 2 | 0 | 0 | 2 |
| Gynaecologic | 1 | 0 | 1 | 0 | 0 | 1 |
| Hepatic | 2 | 0 | 2 | 0 | 1 | 1 |
| Lower gastrointestinal | 2 | 3a | 5a | 0 | 0 | 5a |
| Lymphoma | 1 | 0 | 1 | 0 | 1 | 0 |
| Mouth and throat | 1 | 0 | 1 | 0 | 1 | 0 |
| Multiple myeloma | 1 | 0 | 1 | 0 | 1 | 0 |
| Prostate | 1 | 1 | 1 | 1 | 1 | 1 |
| Renal and bladder | 3 | 3 | 4 | 2 | 2 | 4 |
| Respiratory | 1 | 3 | 4 | 0 | 1 | 3 |
| Soft-tissue sarcomas | 1 | 0 | 1 | 0 | 0 | 1 |
| Thyroid | 2 | 1 | 3 | 0 | 0 | 3 |
| All cancers | 17 | 14 | 28 | 3 | 8 | 23 |
Abbreviations: LTS, long-term safety; PY, patient-years.
a
Including one patient who experienced two events.