Table 2A.
| irAE | N (%) in Each Group | p-value with Fisher’s exact test (comparing CR/PR vs. SD/PD#) | ||
|---|---|---|---|---|
| CR/PR | SD | PD | ||
| Any irAE | 87 | 21 | 84 | 0.0082 |
| Dermatologic | ||||
| • Rash | 26 (29.9%) | 4 (19.0%) | 20 (23.8%) | 0.0006 |
| • Vitiligo | 9 (10.3%) | 1 (4.8%) | 5 (6.0%) | |
| • Bullous dermatoses | 1 (1.1%) | 0 (0%) | 1 (1.2%) | |
| • Dry skin | 0 (0%) | 0 (0%) | 1 (1.2%) | |
| Endocrine | ||||
| • Hypothyroidism | 9 (10.3%) | 4 (19.0%) | 13 (15.5%) | 0.8440 |
| • Hyperthyroidism | 1 (1.1%) | 2 (9.5%) | 6 (7.1%) | |
| • Hypophysitis | 1 (1.1%) | 0 (0%) | 0 (0%) | |
| • Adrenal insufficiency | 1 (1.1%) | 2 (9.5%) | 1 (1.2%) | |
| • Type I DM | 0 (0%) | 1 (4.8%) | 0 (0%) | |
| Rheumatologic | ||||
| • Myalgia | 12 (13.8%) | 0 (0%) | 7 (8.3%) | 0.0197 |
| • Xerostomia | 2 (2.3%) | 0 (0%) | 1 (1.2%) | |
| • Temporal arteritis | 0 (0%) | 0 (0%) | 1 (1.2%) | |
| • Myositis | 1 (1.1%) | 0 (0%) | 2 (2.4%) | |
| • Arthritis | 9 (10.3%) | 1 (4.8%) | 5 (6.0%) | |
| Gastrointestinal | ||||
| • Colitis | 5 (5.7%) | 0 (0%) | 5 (6.0%) | 0.1888 |
| • Hepatitis | 1 (1.1%) | 5 (23.8%) | 11 (13.1%) | |
| • Pancreatitis | 0 (0%) | 0 (0%) | 0 (0%) | |
| Pneumonitis | 5 (5.7%) | 0 (0%) | 3 (3.6%) | 0.1327 |
| Nephritis | 1 (1.1%) | 1 (4.8%) | 1 (1.2%) | 1.0000 |
| Neurologic | ||||
| • Aseptic meningitis | 1 (1.1%) | 0 (0%) | 1 (1.2%) | 1.0000 |
| Hematologic | ||||
| • Hemolytic anemia | 0 (0%) | 0 (0%) | 0 (0%) | 0.1231 |
| • Immune thrombocytopenia | 2 (2.3%) | 0 (0%) | 0 (0%) | |
#Based on investigator-assessed best response to anti-PD-1 therapy based on RECIST v1.1.