| Incidence (% patients) | ITC results | ||||||
---|---|---|---|---|---|---|---|---|
COMBI-v | coBRIM | |||||||
AE type | D + T (n = 350) | V (n = 349) | V (n = 239) | V + T (n = 254) | RR | LCI | UCI | p value |
Alopecia | 0(0) | 1(<1) | 1(<1) | 1(<1) | 0.35 | 0.01 | 24.22 | 0.6295 |
Anemia | 7(2.0) | 4(1.2) | 6(2.4) | 4(1.6) | 2.63 | 0.46 | 15.10 | 0.2787 |
Arthralgia | 3(<1) | 15(4.3) | 12(4.9) | 6(2.4) | 0.40 | 0.08 | 1.91 | 0.2513 |
Asthenia | 5(1.4) | 4(1.2) | 3(1.2) | 5(2.0) | 0.75 | 0.11 | 5.17 | 0.7711 |
Cutaneous squamous cell carcinoma | 5(1.4) | 62(17.8) | 27(11.3) | 6(2.4) | 0.38 | 0.11 | 1.34 | 0.1337 |
Dermatitis acneiform | 0(0) | 4(1.2) | 3(1.2) | 6(2.4) | 0.06 | 0.00 | 1.40 | 0.0792 |
Diarrhea | 4(1.1) | 2(<1) | 2(<1) | 16(6.5) | 0.25 | 0.03 | 2.34 | 0.2242 |
Fatigue | 4(1.1) | 7(2.0) | 7(2.9) | 10(4.1) | 0.40 | 0.09 | 1.88 | 0.2459 |
Hyperkeratosis | 0(0) | 2(<1) | 6(2.4) | 0(0) | 2.60 | 0.04 | 169.50 | 0.6534 |
Hypertension | 54(15.4) | 33(9.5) | 6(2.4) | 11(4.5) | 0.89 | 0.31 | 2.58 | 0.8353 |
Increased ALT | 9(2.6) | 15(4.3) | 15(6.1) | 28(11.3) | 0.32 | 0.12 | 0.88 | 0.0280 |
Increased AST | 5(1.4) | 9(2.6) | 5(2.0) | 21(8.5) | 0.13 | 0.03 | 0.56 | 0.0062 |
Increased blood ALP | 7(2.0) | 5(1.4) | 4(1.6) | 10(4.1) | 0.56 | 0.11 | 2.82 | 0.4826 |
Increased blood CPK | 6(1.7) | 1(<1) | 0(0) | 28(11.3) | 0.11 | 0.00 | 3.49 | 0.2076 |
Increased GGT | 19(5.4) | 17(4.9) | 25(10.2) | 32(13.0) | 0.87 | 0.39 | 1.96 | 0.7436 |
Keratocanthoma | 2(<1) | 35(10.0) | 20(8.1) | 3(1.2) | 0.38 | 0.06 | 2.44 | 0.3091 |
Maculopapular rash | 2(<1) | 13(3.7) | 13(5.3) | 17(6.9) | 0.12 | 0.02 | 0.61 | 0.0105 |
Myalgia | 0(0) | 4(1.2) | 6(2.4) | 1(<1) | 0.67 | 0.02 | 24.45 | 0.8258 |
Nausea | 1(<1) | 1(<1) | 2(<1) | 2(<1) | 0.53 | 0.02 | 11.65 | 0.6871 |
Pain in extremity | 4(1.1) | 2(<1) | 6(2.4) | 3(1.2) | 4.00 | 0.45 | 35.40 | 0.2121 |
Photosensitivity reaction | 0(0) | 1(<1) | 0(0) | 7(2.8) | 0.02 | 0.00 | 1.62 | 0.0820 |
Pyrexia | 16(4.6) | 2(<1) | 0(0) | 4(1.6) | 0.94 | 0.04 | 24.60 | 0.9712 |
Rash | 3(<1) | 30(8.6) | 14(5.7) | 13(5.3) | 0.11 | 0.03 | 0.43 | 0.0017 |
SCC of skin | 2(<1) | 20(5.7) | 31(12.6) | 7(2.8) | 0.44 | 0.08 | 2.32 | 0.3349 |
Vomiting | 4(1.1) | 3(<1) | 3(1.3) | 3(1.2) | 0.94 | 0.09 | 9.60 | 0.9598 |