Table 2.
Summary of all-grade and G3/G4 irAEs rates between the PROVIDENCE cohort 1 and the control cohort. In between cohorts comparisons were presented with univariable Chi-squared test. Separate multivariable logistic regressions including the interaction between exposure to treatment (i.e., TTF) and vitamin D systematic supplementation (i.e., the cohort) were performed to compute the OR with 95%CIs for the risk of adverse events. irAEs: immune-related adverse events; aOR: adjusted odd ratio, 95%CI: 95% confidence interval; TTF: time to treatment failure; TTF*cohort: interaction between TTF and the cohort
| irAEs of any grade | G3/G4 irAEs | |||||||
|---|---|---|---|---|---|---|---|---|
| N°(%) | aOR(95%CI)–TTF*cohort INTERACTION p value | N°(%) | aOR(95%CI)–TTF*cohort INTERACTION p value | |||||
| Cohort 1 | Control | p value | Cohort 1 | Control | p value | |||
| Patients | 101 | 238 | 101 | 238 | ||||
| Overall | 60(59.4) | 91(38.2) | 0.001 | 1.16(0.60–2.25)–0.005 | 13(12.9) | 15(6.3) | 0.045 | 3.21(1.21–8.56)–0.2670 |
| Thyroid irAEs | 4(4.0) | 33(13.9) | 0.008 | 0.16(0.03–0.85)–0.426 | 2(2.0) | – | 0.029 | – |
| Other endocrine irAEs | 2(1.9) | 1(0.4) | 0.161 | 9.48(0.59–152.43)–0.481 | 2(1.9) | 1(0.4) | 0.158 | 9.62(0.60–154.13)–0.477 |
| Colitis | 23(22.8) | 27(11.3) | 0.007 | 1.29(0.55–3.03)–0.032 | 4(4.0) | 4(1.7) | 0.206 | 3.69(0.66–20.54)–0.482 |
| Cutaneous irAEs | 19(18.8) | 30(12.6) | 0.138 | 0.53(0.19–1.43)–0.001 | 1(1.0) | 1(0.4) | 0.531 | 3.26(0.11–97.32)–0.781 |
| Pneumological irAEs | 6(5.9) | 6(2.5) | 0.119 | 1.48(0.31–7.13)–0.285 | 2(1.9) | 5(2.1) | 0.943 | 1.77(0.21–15.16)–0.503 |
| Hepatic irAEs | 5(5.0) | 5(2.1) | 0.157 | 0.78(0.11–5.48)–0.050 | 1(1.0) | 2(0.8) | 0.893 | 0.85(0.02–25.40)–0.763 |
| Rheumatologic irAEs | 4(4.0) | 9(3.8) | 0.937 | 0.52(0.08–3.31)–0.234 | – | – | – | – |
| Neuro-muscular irAEs | 2(1.9) | 4(1.7) | 0.848 | 0.72(0.06–8.74)–0.531 | – | – | – | – |