Table 3.
Frequencies of toxicity endpoints corrected for pre-existence
| Number of patients (n = 161; exploration cohort) | Number of patients (n = 161; validation cohort) | |
|---|---|---|
| Any grade toxicity | ||
| Diarrhea | 6 (4%) | 7 (4%) |
| Skin toxicity | 23 (14%) | 23 (14%) |
| Elevated transaminases | 50 (31%) | 56 (35%) |
| Elevated bilirubin | 7 (4%) | 7 (4%) |
| Hepatitis | 6 (4%) | 2 (1%) |
| Hypothyroidism or hyperthyroidism | 64 (40%) | 65 (40%) |
| Pneumonitis/Interstitial lung disease | 8 (5%) | 8 (5%) |
| Colitis | 2 (1%) | 4 (3%) |
| Rheumatological toxicity | 10 (6%) | 13 (8%) |
| Hypophysitis | 1 (1%) | 1 (1%) |
| Treatment-related toxicity | 96 (60%) | 85 (53%) |
| Other outcomes | ||
| Decreased renal clearance grade ≥2 | 28 (17%) | 41 (26%) |
| Any grade 3 or higher toxicity | 24 (15%) | 26 (16%) |
| Any grade 3 or higher treatment-related toxicity | 14 (9%) | 9 (6%) |
| Steroid use | 42 (26%) | 38 (24%) |
| Treatment stop caused by toxicity | ||
| Temporary interruption | 15 (9%) | 15 (9%) |
| Definitive discontinuation | 6 (4%) | 5 (3%) |