Table 2.
Summary of adverse events
| Overall |
KRAS wild-type |
|||||
|---|---|---|---|---|---|---|
| AE category, n (%) | SEL + DOC 60 (n = 84) | SEL + DOC 75 (n = 84) | PBO + DOC 75 (n = 43) | SEL + DOC 60 (n = 61) | SEL + DOC 75 (n = 54) | PBO + DOC 75 (n = 30) |
| Any AE | 81 (96) | 83 (99) | 39 (91) | 59 (97) | 53 (98) | 27 (90) |
| Any AE ≥CTCAE grade 3 | 50 (60) | 53 (63) | 23 (54) | 37 (61) | 30 (56) | 14 (47) |
| Any SAEa | 40 (48) | 38 (45) | 16 (37) | 27 (44) | 23 (43) | 10 (33) |
| Any SAE causally related to SEL/PBOa | 19 (23) | 18 (21) | 7 (16) | 12 (20) | 14 (26) | 3 (10) |
| Any SAE causally related to DOCa | 15 (18) | 19 (23) | 9 (21) | 11 (18) | 13 (24) | 4 (13) |
| Any AE leading to hospitalization | 36 (43) | 36 (43) | 14 (33) | 23 (38) | 23 (43) | 10 (33) |
| Any AE with outcome of death | 5 (6) | 7 (8) | 1 (2) | 5 (8) | 5 (9) | 1 (3) |
| Any AE leading to discontinuation of SEL/PBO | 16 (19) | 21 (25) | 3 (7) | 12 (20) | 14 (26) | 2 (7) |
| Causally related to SEL/PBOa | 12 (14) | 15 (18) | 2 (5) | 8 (13) | 12 (22) | 1 (3) |
| Any AE leading to dose interruption of SEL/PBO | 29 (35) | 24 (29) | 8 (19) | 16 (26) | 11 (20) | 7 (23) |
| Any AE leading to dose reduction of SEL/PBO | 16 (19) | 19 (23) | 2 (5) | 11 (18) | 11 (20) | 1 (3) |
| Any AE leading to discontinuation of DOC | 14 (17) | 19 (23) | 6 (14) | 10 (16) | 11 (20) | 5 (17) |
| Causally related to DOC | 10 (12) | 16 (19) | 5 (12) | 6 (10) | 9 (17) | 4 (13) |
| Any AE leading to dose delay of DOC | 15 (18) | 10 (12) | 5 (12) | 10 (16) | 6 (11) | 5 (17) |
| Any AE leading to dose reduction of DOC | 7 (8) | 6 (7) | 3 (7) | 4 (7) | 3 (6) | 3 (10) |
a
Assessed by investigator.
AE, adverse event; CTCAE, Common Terminology Criteria for Adverse Events; DOC, docetaxel; PBO, placebo; SAE, serious adverse event; SEL, selumetinib.