Table 4.
Treatment-related select adverse event and their management with immunomodulatory medication (IMM) by organ category
| Select Adverse Event Organ Category | Nivolumab + Ipilimumab (N=94)
|
Ipilimumab (N=46)
|
||||||
|---|---|---|---|---|---|---|---|---|
| Patients reporting select adverse event, n (A) | Patients managed with IMM, n (% of A) (B) | Patients with resolutiona of select adverse event after treatment with IMM, n (% of B) | Median time to resolutiona, weeks (95% CI) | Patients reporting select adverse event, n (A) | Patients managed with IMM, n (% of A) (B) | Patients with resolutiona of select adverse event after treatment with IMM, n (% of B) | Median time to resolutiona, weeks (95% CI) | |
|
| ||||||||
| Skin | 67 | 41 (61.2) | 24 (68.6) | 18.6 (9.3, 35.1) | 26 | 13 (50.0) | 11 (84.6) | 8.6 (3.3, 22.0) |
| Grade 3–4 | 9 | 9 (100.0) | 8 (88.9) | 6.1 (0.9, 24.1) | 0 | 0 | 0 | NE |
|
| ||||||||
| Gastrointestinal | 48 | 31 (64.6) | 26 (92.9) | 4.7 (3.0, 6.7) | 17 | 11 (64.7) | 7 (77.8) | 5.0 (1.4, 12.1) |
| Grade 3–4 | 20 | 16 (80.0) | 15 (88.2) | 4.3 (1.4, 10.7) | 5 | 5 (100.0) | 4 (80.0) | 3.6 (0.7, 5.0) |
|
| ||||||||
| Endocrineb | 32 | 14 (43.8) | 2 (14.3) | NE (NE, NE) | 8 | 3 (37.5) | 1 (33.3) | NE (0.9, NE) |
| Grade 3–4 | 5 | 4 (80.0) | 1 (25.0) | NE (5.6, NE) | 2 | 2 (100) | 1 (50.0) | NE (0.9, NE) |
|
| ||||||||
| Hepatic | 26 | 13 (50.0) | 11 (84.6) | 14.1 (3.1, 19.6) | 2 | 0 | 0 | NE |
| Grade 3–4 | 14 | 12 (85.7) | 10 (83.3) | 8.3 (2.1, 14.1) | 0 | 0 | 0 | NE |
|
| ||||||||
| Pulmonary | 11 | 8 (72.7) | 6 (75.0) | 6.1 (0.3, 9.0) | 2 | 2 (100.0) | 2 (100.0) | 3.2 (2.9, 3.6) |
| Grade 3–4 | 3 | 3 (100.0) | 2 (66.7) | 9.0 (0.3, 9.0) | 1 | 1 (100.0) | 1 (100.0) | 3.6 (NE, NE) |
|
| ||||||||
| Renal | 3 | 2 (66.7) | 2 (100.0) | 0.4 (0.3, 0.6) | 1 | 0 | 0 | NE |
| Grade 3–4 | 1 | 1 (100.0) | 1 (100.0) | 0.6 (NE, NE) | 0 | 0 | 0 | NE |
Table includes events reported after the first dose and within 100 days of the last dose of study treatment.
a
Resolution of an event was defined as complete resolution or improvement to the baseline level among all clustered events in a given category experienced by the patient.
b
Endocrine events were managed with hormone replacement therapy. Patients requiring long term hormone replacement therapy were not counted as resolved.
NE, not estimable