Table 2.
Adverse Events (Safety Population).*
| Variable | Rucaparib (N = 270) | Control Medication | ||||||
|---|---|---|---|---|---|---|---|---|
| Docetaxel (N = 71) | Second-Generation ARPI (N = 59) | Total Control (N = 130) | ||||||
| Any Grade | Grade ≥3 | Any Grade | Grade ≥3 | Any Grade | Grade ≥3 | Any Grade | Grade ≥3 | |
| number of patients (percent) | ||||||||
| Any adverse event | 270 (100) | 161 (60) | 71 (100) | 43 (61) | 58 (98) | 26 (44) | 129 (99) | 69 (53) |
| Fatigue | 165 (61) | 19 (7) | 48 (68) | 7 (10) | 34 (58) | 5 (8) | 82 (63) | 12 (9) |
| Nausea | 134 (50) | 7 (3) | 11 (15) | 1 (1) | 14 (24) | 0 | 25 (19) | 1 (1) |
| Anemia or decreased hemoglobin | 126 (47) | 64 (24) | 10 (14) | 1 (1) | 13 (22) | 0 | 23 (18) | 1 (1) |
| Decreased appetite | 96 (36) | 1 (<1) | 15 (21) | 0 | 14 (24) | 2 (3) | 29 (22) | 2 (2) |
| Diarrhea | 83 (31) | 4 (1) | 28 (39) | 2 (3) | 8 (14) | 0 | 36 (28) | 2 (2) |
| Rash† | 78 (29) | 4 (1) | 13 (18) | 1 (1) | 6 (10) | 0 | 19 (15) | 1 (1) |
| Constipation | 74 (27) | 3 (1) | 13 (18) | 1 (1) | 6 (10) | 0 | 19 (15) | 1 (1) |
| Increased ALT or AST | 72 (27) | 14 (5) | 3 (4) | 1 (1) | 3 (5) | 0 | 6 (5) | 1 (1) |
| Vomiting | 65 (24) | 2 (1) | 6 (8) | 1 (1) | 5 (8) | 0 | 11 (8) | 1 (1) |
| Back pain | 60 (22) | 9 (3) | 11 (15) | 3 (4) | 14 (24) | 2 (3) | 25 (19) | 5 (4) |
| Peripheral edema | 54 (20) | 0 | 15 (21) | 0 | 6 (10) | 0 | 21 (16) | 0 |
| Increased creatinine | 51 (19) | 0 | 3 (4) | 0 | 3 (5) | 0 | 6 (5) | 0 |
| Thrombocytopenia or decreased platelet count | 50 (19) | 16 (6) | 0 | 0 | 0 | 0 | 0 | 0 |
| Arthralgia | 49 (18) | 0 | 17 (24) | 4 (6) | 13 (22) | 0 | 30 (23) | 4 (3) |
| Dysgeusia | 45 (17) | 1 (<1) | 15 (21) | 0 | 3 (5) | 0 | 18 (14) | 0 |
| Dyspnea | 44 (16) | 1 (<1) | 12 (17) | 2 (3) | 3 (5) | 0 | 15 (12) | 2 (2) |
| Decreased weight | 40 (15) | 2 (1) | 9 (13) | 0 | 7 (12) | 0 | 16 (12) | 0 |
| Neutropenia or decreased neutrophil count | 37 (14) | 20 (7) | 11 (15) | 10 (14) | 0 | 0 | 11 (8) | 10 (8) |
| Dizziness | 36 (13) | 1 (<1) | 3 (4) | 0 | 8 (14) | 0 | 11 (8) | 0 |
| Headache | 31 (11) | 1 (<1) | 4 (6) | 0 | 5 (8) | 0 | 9 (7) | 0 |
| Limb pain | 30 (11) | 2 (1) | 6 (8) | 0 | 8 (14) | 1 (2) | 14 (11) | 1 (1) |
| Neuropathy‡ | 25 (9) | 0 | 34 (48) | 4 (6) | 2 (3) | 0 | 36 (28) | 4 (3) |
| Cough | 24 (9) | 2 (1) | 11 (15) | 0 | 5 (8) | 0 | 16 (12) | 0 |
| Insomnia | 20 (7) | 0 | 8 (11) | 0 | 6 (10) | 0 | 14 (11) | 0 |
| Hypertension | 16 (6) | 6 (2) | 2 (3) | 1 (1) | 9 (15) | 6 (10) | 11 (8) | 7 (5) |
| Stomatitis | 13 (5) | 2 (1) | 10 (14) | 2 (3) | 0 | 0 | 10 (8) | 1 (1) |
| Hypokalemia | 12 (4) | 3 (1) | 4 (6) | 1 (1) | 6 (10) | 2 (3) | 10 (8) | 3 (2) |
| Alopecia | 5 (2) | 0 | 25 (35) | 1 (1) | 1 (2) | 0 | 26 (20) | 1 (1) |
| Febrile neutropenia | 2 (1) | 2 (1) | 9 (13) | 8 (11) | 0 | 0 | 9 (7) | 8 (6) |
| Serious adverse event or dose adjustment | ||||||||
| Serious adverse event | 78 (29) | NA | 23 (32) | NA | 13 (22) | NA | 36 (28) | NA |
| Interruption of intervention owing to adverse event | 142 (53) | NA | 19 (27) | NA | 12 (20) | NA | 31 (24) | NA |
| Dose reduction owing to adverse event | 104 (39) | NA | 21 (30) | NA | 11 (19) | NA | 32 (25) | NA |
| Discontinuation owing to adverse event | 40 (15) | NA | 23 (32) | NA | 5 (8) | NA | 28 (22) | NA |
| Death from adverse event | 5 (2) | NA | 0 | NA | 3 (5) | NA | 3 (2) | NA |
Listed are adverse events of any grade that were reported in at least 10% of the patients in either group and corresponding adverse events of grade 3 or higher, according to the Common Terminology Criteria for Adverse Events. ALT denotes alanine aminotransferase, and AST aspartate aminotransferase.
Rash includes acneiform dermatitis, blister, blood blister, bullous dermatitis, contact dermatitis, eczema, erythematous rash, maculopapular rash, palmar–plantar erythrodysesthesia syndrome, papular rash, photosensitivity reaction, pruritic rash, pruritis, psoriasis, skin discoloration, skin exfoliation, skin hyperpigmentation, skin induration, skin lesion, skin toxicity, skin ulcer, and solar dermatitis.
Neuropathy includes neurotoxicity, paresthesia, peripheral motor neuropathy, peripheral neuropathy, peripheral sensory neuropathy, and polyneuropathy.