Treatment‐emergent adverse events reported in ≥10% of treated patients in any arm
| System organ class/preferred term . | RAM + CAP (n = 52) . | ICR + CAP (n = 49) . | CAP (n = 49) . | |||
|---|---|---|---|---|---|---|
| All grades . | Grade ≥3 . | All grades . | Grade ≥3 . | All grades . | Grade ≥3 . | |
| Blood and lymphatic system disorders | 21 (40.4) | 8 (15.4) | 20 (40.8) | 8 (16.3) | 18 (36.7) | 2 (4.1) |
| Thrombocytopenia | 9 (17.3) | 1 (1.9) | 1 (2.0) | 0 | 9 (18.4) | 0 |
| Neutropenia | 8 (15.4) | 3 (5.8) | 6 (12.2) | 3 (6.1) | 6 (12.2) | 0 |
| Anemia | 7 (13.5) | 1 (1.9) | 15 (30.6) | 5 (10.2) | 12 (24.5) | 2 (4.1) |
| Leukopenia | 4 (7.7) | 0 | 0 | 0 | 7 (14.3) | 0 |
| Cardiac disorders | 6 (11.5) | 2 (3.8) | 16 (32.7) | 6 (12.2) | 4 (8.2) | 0 |
| Ear and labyrinth disorder | 1 (1.9) | 0 | 1 (2.0) | 0 | 2 (4.1) | 0 |
| Eye disorders | 12 (23.1) | 0 | 15 (30.6) | 0 | 5 (10.2) | 0 |
| Lacrimation increased | 4 (7.7) | 0 | 6 (12.2) | 0 | 2 (4.1) | 0 |
| Gastrointestinal disorders | 43 (82.7) | 5 (9.6) | 47 (95.9) | 8 (16.3) | 44 (89.8) | 6 (12.2) |
| Nausea | 27 (51.9) | 0 | 38 (77.6) | 2 (4.1) | 26 (53.1) | 3 (6.1) |
| Diarrhea | 22 (42.3) | 1 (1.9) | 21 (42.9) | 2 (4.1) | 28 (57.1) | 3 (6.1) |
| Constipation | 19 (36.5) | 0 | 14 (28.6) | 0 | 17 (34.7) | 0 |
| Vomiting | 18 (34.6) | 1 (1.9) | 26 (53.1) | 2 (4.1) | 14 (28.6) | 3 (6.1) |
| Stomatitis | 14 (26.9) | 0 | 4 (8.2) | 1 (2.0) | 7 (14.3) | 0 |
| Abdominal pain | 9 (17.3) | 1 (1.9) | 6 (12.2) | 0 | 5 (10.2) | 1 (2.0) |
| Dyspepsia | 6 (11.5) | 0 | 5 (10.2) | 0 | 3 (6.1) | 0 |
| General disorders and administration site conditions | 38 (73.1) | 5 (9.6) | 42 (85.7) | 5 (10.2) | 37 (75.5) | 4 (8.2) |
| Fatigue | 27 (51.9) | 3 (5.8) | 28 (57.1) | 1 (2.0) | 26 (53.1) | 1 (2.0) |
| Pyrexia | 14 (26.9) | 0 | 8 (16.3) | 1 (2.0) | 4 (8.2) | 0 |
| Edema peripheral | 13 (25.0) | 0 | 19 (38.8) | 1 (2.0) | 6 (12.2) | 0 |
| Mucosal inflammation | 9 (17.3) | 2 (3.8) | 4 (8.2) | 0 | 9 (18.4) | 0 |
| Influenza‐like illness | 6 (11.5) | 0 | 2 (4.1) | 0 | 1 (2.0) | 1 (2.0) |
| Hepatobiliary disorders | 6 (11.5) | 2 (3.8) | 0 | 0 | 4 (8.2) | 0 |
| Infections and infestations | 22 (42.3) | 0 | 19 (38.8) | 4 (8.2) | 18 (36.7) | 3 (6.1) |
| Sinusitis | 7 (13.5) | 0 | 0 | 0 | 3 (6.1) | 0 |
| Injury, poisoning, and procedural complications | 12 (23.1) | 1 (1.9) | 9 (18.4) | 2 (4.1) | 8 (16.3) | 1 (2.0) |
| Investigations | 24 (46.2) | 3 (5.8) | 14 (28.6) | 0 | 18 (36.7) | 0 |
| Aspartate aminotransferase increased | 9 (17.3) | 0 | 2 (4.1) | 0 | 7 (14.3) | 0 |
| Alanine aminotransferase increased | 5 (9.6) | 0 | 1 (2.0) | 0 | 5 (10.2) | 0 |
| Metabolism and nutrition disorders | 30 (57.7) | 3 (5.8) | 25 (51.0) | 7 (14.3) | 24 (49.0) | 7 (14.3) |
| Decreased appetite | 17 (32.7) | 0 | 11 (22.4) | 2 (4.1) | 10 (20.4) | 1 (2.0) |
| Hypokalemia | 12 (23.1) | 2 (3.8) | 7 (14.3) | 2 (4.1) | 12 (24.5) | 5 (10.2) |
| Hyperglycemia | 9 (17.3) | 0 | 4 (8.2) | 0 | 2 (4.1) | 0 |
| Dehydration | 6 (11.5) | 2 (3.8) | 11 (22.4) | 4 (8.2) | 3 (6.1) | 2 (4.1) |
| Hypocalcemia | 5 (9.6) | 0 | 4 (8.2) | 3 (6.1) | 6 (12.2) | 0 |
| Musculoskeletal and connective tissue disorders | 31 (59.6) | 5 (9.6) | 17 (34.7) | 2 (4.1) | 32 (65.3) | 2 (4.1) |
| Pain in extremity | 15 (28.8) | 2 (3.8) | 3 (6.1) | 0 | 6 (12.2) | 1 (2.0) |
| Arthralgia | 11 (21.2) | 0 | 2 (4.1) | 0 | 8 (16.3) | 0 |
| Back pain | 11 (21.2) | 3 (5.8) | 7 (14.3) | 1 (2.0) | 8 (16.3) | 0 |
| Myalgia | 9 (17.3) | 0 | 4 (8.2) | 0 | 3 (6.1) | 0 |
| Musculoskeletal chest pain | 8 (15.4) | 1 (1.9) | 3 (6.1) | 1 (2.0) | 7 (14.3) | 0 |
| Musculoskeletal pain | 6 (11.5) | 1 (1.9) | 1 (2.0) | 0 | 3 (6.1) | 0 |
| Neck pain | 6 (11.5) | 0 | 3 (6.1) | 0 | 0 | 0 |
| Muscle spasms | 5 (9.6) | 0 | 0 | 0 | 5 (10.2) | 0 |
| Neoplasms benign, malignant, and unspecified | 2 (3.8) | 0 | 6 (1.2) | 4 (8.2) | 1 (2.0) | 1 (2.0) |
| Nervous system disorders | 37 (71.2) | 1 (1.9) | 28 (57.1) | 5 (10.2) | 22 (44.9) | 2 (4.1) |
| Headache | 26 (50.0) | 0 | 9 (18.4) | 1 (2.0) | 11 (22.4) | 1 (2.0) |
| Neuropathy peripheral | 10 (19.2) | 0 | 6 (12.2) | 0 | 4 (8.2) | 0 |
| Dysgeusia | 6 (11.5) | 0 | 6 (12.2) | 0 | 3 (6.1) | 0 |
| Peripheral sensory neuropathy | 6 (11.5) | 0 | 5 (10.2) | 0 | 2 (4.1) | 0 |
| Dizziness | 5 (9.6) | 0 | 6 (12.2) | 0 | 3 (6.1) | 0 |
| Psychiatric disorders | 17 (32.7) | 0 | 17 (34.7) | 0 | 17 (34.7) | 1 (2.0) |
| Insomnia | 7 (13.5) | 0 | 9 (18.4) | 0 | 12 (24.5) | 0 |
| Anxiety | 6 (11.5) | 0 | 7 (14.3) | 0 | 5 (10.2) | 0 |
| Depression | 6 (11.5) | 0 | 6 (12.2) | 0 | 4 (8.2) | 0 |
| Renal and urinary disorders | 6 (11.5) | 0 | 6 (12.2) | 2 (4.1) | 6 (12.2) | 1 (2.0) |
| Respiratory, thoracic, and mediastinal disorders | 38 (73.1) | 7 (13.5) | 34 (69.4) | 11 (22.4) | 20 (40.8) | 0 |
| Cough | 21 (40.4) | 0 | 10 (20.4) | 0 | 9 (18.4) | 0 |
| Dyspnea | 20 (38.5) | 4 (7.7) | 18 (36.7) | 4 (8.2) | 9 (18.4) | 0 |
| Epistaxis | 9 (17.3) | 0 | 0 | 0 | 3 (6.1) | 0 |
| Rhinorrhea | 6 (11.5) | 0 | 2 (4.1) | 0 | 1 (2.0) | 0 |
| Oropharyngeal pain | 5 (9.6) | 0 | 3 (6.1) | 0 | 5 (10.2) | 0 |
| Pleural effusion | 5 (9.6) | 2 (3.8) | 16 (32.7) | 6 (12.2) | 0 | 0 |
| Skin and subcutaneous tissue disorders | 43 (82.7) | 9 (17.3) | 24 (49.0) | 3 (6.1) | 42 (85.7) | 7 (14.3) |
| Palmar‐plantar erythrodysesthesia syndrome | 38 (73.1) | 9 (17.3) | 15 (30.6) | 3 (6.1) | 35 (71.4) | 6 (12.2) |
| Skin hyperpigmentation | 7 (13.5) | 0 | 2 (4.1) | 0 | 4 (8.2) | 0 |
| Dry skin | 3 (5.8) | 0 | 0 | 0 | 5 (10.2) | 0 |
| Erythema | 3 (5.8) | 0 | 3 (6.1) | 0 | 7 (14.3) | 0 |
| Vascular disorders | 22 (42.3) | 7 (13.5) | 17 (34.7) | 3 (6.1) | 11 (22.4) | 2 (4.1) |
| Hypertension | 16 (30.8) | 4 (7.7) | 1 (2.0) | 0 | 1 (2.0) | 1 (2.0) |
| System organ class/preferred term . | RAM + CAP (n = 52) . | ICR + CAP (n = 49) . | CAP (n = 49) . | |||
|---|---|---|---|---|---|---|
| All grades . | Grade ≥3 . | All grades . | Grade ≥3 . | All grades . | Grade ≥3 . | |
| Blood and lymphatic system disorders | 21 (40.4) | 8 (15.4) | 20 (40.8) | 8 (16.3) | 18 (36.7) | 2 (4.1) |
| Thrombocytopenia | 9 (17.3) | 1 (1.9) | 1 (2.0) | 0 | 9 (18.4) | 0 |
| Neutropenia | 8 (15.4) | 3 (5.8) | 6 (12.2) | 3 (6.1) | 6 (12.2) | 0 |
| Anemia | 7 (13.5) | 1 (1.9) | 15 (30.6) | 5 (10.2) | 12 (24.5) | 2 (4.1) |
| Leukopenia | 4 (7.7) | 0 | 0 | 0 | 7 (14.3) | 0 |
| Cardiac disorders | 6 (11.5) | 2 (3.8) | 16 (32.7) | 6 (12.2) | 4 (8.2) | 0 |
| Ear and labyrinth disorder | 1 (1.9) | 0 | 1 (2.0) | 0 | 2 (4.1) | 0 |
| Eye disorders | 12 (23.1) | 0 | 15 (30.6) | 0 | 5 (10.2) | 0 |
| Lacrimation increased | 4 (7.7) | 0 | 6 (12.2) | 0 | 2 (4.1) | 0 |
| Gastrointestinal disorders | 43 (82.7) | 5 (9.6) | 47 (95.9) | 8 (16.3) | 44 (89.8) | 6 (12.2) |
| Nausea | 27 (51.9) | 0 | 38 (77.6) | 2 (4.1) | 26 (53.1) | 3 (6.1) |
| Diarrhea | 22 (42.3) | 1 (1.9) | 21 (42.9) | 2 (4.1) | 28 (57.1) | 3 (6.1) |
| Constipation | 19 (36.5) | 0 | 14 (28.6) | 0 | 17 (34.7) | 0 |
| Vomiting | 18 (34.6) | 1 (1.9) | 26 (53.1) | 2 (4.1) | 14 (28.6) | 3 (6.1) |
| Stomatitis | 14 (26.9) | 0 | 4 (8.2) | 1 (2.0) | 7 (14.3) | 0 |
| Abdominal pain | 9 (17.3) | 1 (1.9) | 6 (12.2) | 0 | 5 (10.2) | 1 (2.0) |
| Dyspepsia | 6 (11.5) | 0 | 5 (10.2) | 0 | 3 (6.1) | 0 |
| General disorders and administration site conditions | 38 (73.1) | 5 (9.6) | 42 (85.7) | 5 (10.2) | 37 (75.5) | 4 (8.2) |
| Fatigue | 27 (51.9) | 3 (5.8) | 28 (57.1) | 1 (2.0) | 26 (53.1) | 1 (2.0) |
| Pyrexia | 14 (26.9) | 0 | 8 (16.3) | 1 (2.0) | 4 (8.2) | 0 |
| Edema peripheral | 13 (25.0) | 0 | 19 (38.8) | 1 (2.0) | 6 (12.2) | 0 |
| Mucosal inflammation | 9 (17.3) | 2 (3.8) | 4 (8.2) | 0 | 9 (18.4) | 0 |
| Influenza‐like illness | 6 (11.5) | 0 | 2 (4.1) | 0 | 1 (2.0) | 1 (2.0) |
| Hepatobiliary disorders | 6 (11.5) | 2 (3.8) | 0 | 0 | 4 (8.2) | 0 |
| Infections and infestations | 22 (42.3) | 0 | 19 (38.8) | 4 (8.2) | 18 (36.7) | 3 (6.1) |
| Sinusitis | 7 (13.5) | 0 | 0 | 0 | 3 (6.1) | 0 |
| Injury, poisoning, and procedural complications | 12 (23.1) | 1 (1.9) | 9 (18.4) | 2 (4.1) | 8 (16.3) | 1 (2.0) |
| Investigations | 24 (46.2) | 3 (5.8) | 14 (28.6) | 0 | 18 (36.7) | 0 |
| Aspartate aminotransferase increased | 9 (17.3) | 0 | 2 (4.1) | 0 | 7 (14.3) | 0 |
| Alanine aminotransferase increased | 5 (9.6) | 0 | 1 (2.0) | 0 | 5 (10.2) | 0 |
| Metabolism and nutrition disorders | 30 (57.7) | 3 (5.8) | 25 (51.0) | 7 (14.3) | 24 (49.0) | 7 (14.3) |
| Decreased appetite | 17 (32.7) | 0 | 11 (22.4) | 2 (4.1) | 10 (20.4) | 1 (2.0) |
| Hypokalemia | 12 (23.1) | 2 (3.8) | 7 (14.3) | 2 (4.1) | 12 (24.5) | 5 (10.2) |
| Hyperglycemia | 9 (17.3) | 0 | 4 (8.2) | 0 | 2 (4.1) | 0 |
| Dehydration | 6 (11.5) | 2 (3.8) | 11 (22.4) | 4 (8.2) | 3 (6.1) | 2 (4.1) |
| Hypocalcemia | 5 (9.6) | 0 | 4 (8.2) | 3 (6.1) | 6 (12.2) | 0 |
| Musculoskeletal and connective tissue disorders | 31 (59.6) | 5 (9.6) | 17 (34.7) | 2 (4.1) | 32 (65.3) | 2 (4.1) |
| Pain in extremity | 15 (28.8) | 2 (3.8) | 3 (6.1) | 0 | 6 (12.2) | 1 (2.0) |
| Arthralgia | 11 (21.2) | 0 | 2 (4.1) | 0 | 8 (16.3) | 0 |
| Back pain | 11 (21.2) | 3 (5.8) | 7 (14.3) | 1 (2.0) | 8 (16.3) | 0 |
| Myalgia | 9 (17.3) | 0 | 4 (8.2) | 0 | 3 (6.1) | 0 |
| Musculoskeletal chest pain | 8 (15.4) | 1 (1.9) | 3 (6.1) | 1 (2.0) | 7 (14.3) | 0 |
| Musculoskeletal pain | 6 (11.5) | 1 (1.9) | 1 (2.0) | 0 | 3 (6.1) | 0 |
| Neck pain | 6 (11.5) | 0 | 3 (6.1) | 0 | 0 | 0 |
| Muscle spasms | 5 (9.6) | 0 | 0 | 0 | 5 (10.2) | 0 |
| Neoplasms benign, malignant, and unspecified | 2 (3.8) | 0 | 6 (1.2) | 4 (8.2) | 1 (2.0) | 1 (2.0) |
| Nervous system disorders | 37 (71.2) | 1 (1.9) | 28 (57.1) | 5 (10.2) | 22 (44.9) | 2 (4.1) |
| Headache | 26 (50.0) | 0 | 9 (18.4) | 1 (2.0) | 11 (22.4) | 1 (2.0) |
| Neuropathy peripheral | 10 (19.2) | 0 | 6 (12.2) | 0 | 4 (8.2) | 0 |
| Dysgeusia | 6 (11.5) | 0 | 6 (12.2) | 0 | 3 (6.1) | 0 |
| Peripheral sensory neuropathy | 6 (11.5) | 0 | 5 (10.2) | 0 | 2 (4.1) | 0 |
| Dizziness | 5 (9.6) | 0 | 6 (12.2) | 0 | 3 (6.1) | 0 |
| Psychiatric disorders | 17 (32.7) | 0 | 17 (34.7) | 0 | 17 (34.7) | 1 (2.0) |
| Insomnia | 7 (13.5) | 0 | 9 (18.4) | 0 | 12 (24.5) | 0 |
| Anxiety | 6 (11.5) | 0 | 7 (14.3) | 0 | 5 (10.2) | 0 |
| Depression | 6 (11.5) | 0 | 6 (12.2) | 0 | 4 (8.2) | 0 |
| Renal and urinary disorders | 6 (11.5) | 0 | 6 (12.2) | 2 (4.1) | 6 (12.2) | 1 (2.0) |
| Respiratory, thoracic, and mediastinal disorders | 38 (73.1) | 7 (13.5) | 34 (69.4) | 11 (22.4) | 20 (40.8) | 0 |
| Cough | 21 (40.4) | 0 | 10 (20.4) | 0 | 9 (18.4) | 0 |
| Dyspnea | 20 (38.5) | 4 (7.7) | 18 (36.7) | 4 (8.2) | 9 (18.4) | 0 |
| Epistaxis | 9 (17.3) | 0 | 0 | 0 | 3 (6.1) | 0 |
| Rhinorrhea | 6 (11.5) | 0 | 2 (4.1) | 0 | 1 (2.0) | 0 |
| Oropharyngeal pain | 5 (9.6) | 0 | 3 (6.1) | 0 | 5 (10.2) | 0 |
| Pleural effusion | 5 (9.6) | 2 (3.8) | 16 (32.7) | 6 (12.2) | 0 | 0 |
| Skin and subcutaneous tissue disorders | 43 (82.7) | 9 (17.3) | 24 (49.0) | 3 (6.1) | 42 (85.7) | 7 (14.3) |
| Palmar‐plantar erythrodysesthesia syndrome | 38 (73.1) | 9 (17.3) | 15 (30.6) | 3 (6.1) | 35 (71.4) | 6 (12.2) |
| Skin hyperpigmentation | 7 (13.5) | 0 | 2 (4.1) | 0 | 4 (8.2) | 0 |
| Dry skin | 3 (5.8) | 0 | 0 | 0 | 5 (10.2) | 0 |
| Erythema | 3 (5.8) | 0 | 3 (6.1) | 0 | 7 (14.3) | 0 |
| Vascular disorders | 22 (42.3) | 7 (13.5) | 17 (34.7) | 3 (6.1) | 11 (22.4) | 2 (4.1) |
| Hypertension | 16 (30.8) | 4 (7.7) | 1 (2.0) | 0 | 1 (2.0) | 1 (2.0) |
Treatment‐emergent adverse events reported in ≥10% of treated patients in any arm
| System organ class/preferred term . | RAM + CAP (n = 52) . | ICR + CAP (n = 49) . | CAP (n = 49) . | |||
|---|---|---|---|---|---|---|
| All grades . | Grade ≥3 . | All grades . | Grade ≥3 . | All grades . | Grade ≥3 . | |
| Blood and lymphatic system disorders | 21 (40.4) | 8 (15.4) | 20 (40.8) | 8 (16.3) | 18 (36.7) | 2 (4.1) |
| Thrombocytopenia | 9 (17.3) | 1 (1.9) | 1 (2.0) | 0 | 9 (18.4) | 0 |
| Neutropenia | 8 (15.4) | 3 (5.8) | 6 (12.2) | 3 (6.1) | 6 (12.2) | 0 |
| Anemia | 7 (13.5) | 1 (1.9) | 15 (30.6) | 5 (10.2) | 12 (24.5) | 2 (4.1) |
| Leukopenia | 4 (7.7) | 0 | 0 | 0 | 7 (14.3) | 0 |
| Cardiac disorders | 6 (11.5) | 2 (3.8) | 16 (32.7) | 6 (12.2) | 4 (8.2) | 0 |
| Ear and labyrinth disorder | 1 (1.9) | 0 | 1 (2.0) | 0 | 2 (4.1) | 0 |
| Eye disorders | 12 (23.1) | 0 | 15 (30.6) | 0 | 5 (10.2) | 0 |
| Lacrimation increased | 4 (7.7) | 0 | 6 (12.2) | 0 | 2 (4.1) | 0 |
| Gastrointestinal disorders | 43 (82.7) | 5 (9.6) | 47 (95.9) | 8 (16.3) | 44 (89.8) | 6 (12.2) |
| Nausea | 27 (51.9) | 0 | 38 (77.6) | 2 (4.1) | 26 (53.1) | 3 (6.1) |
| Diarrhea | 22 (42.3) | 1 (1.9) | 21 (42.9) | 2 (4.1) | 28 (57.1) | 3 (6.1) |
| Constipation | 19 (36.5) | 0 | 14 (28.6) | 0 | 17 (34.7) | 0 |
| Vomiting | 18 (34.6) | 1 (1.9) | 26 (53.1) | 2 (4.1) | 14 (28.6) | 3 (6.1) |
| Stomatitis | 14 (26.9) | 0 | 4 (8.2) | 1 (2.0) | 7 (14.3) | 0 |
| Abdominal pain | 9 (17.3) | 1 (1.9) | 6 (12.2) | 0 | 5 (10.2) | 1 (2.0) |
| Dyspepsia | 6 (11.5) | 0 | 5 (10.2) | 0 | 3 (6.1) | 0 |
| General disorders and administration site conditions | 38 (73.1) | 5 (9.6) | 42 (85.7) | 5 (10.2) | 37 (75.5) | 4 (8.2) |
| Fatigue | 27 (51.9) | 3 (5.8) | 28 (57.1) | 1 (2.0) | 26 (53.1) | 1 (2.0) |
| Pyrexia | 14 (26.9) | 0 | 8 (16.3) | 1 (2.0) | 4 (8.2) | 0 |
| Edema peripheral | 13 (25.0) | 0 | 19 (38.8) | 1 (2.0) | 6 (12.2) | 0 |
| Mucosal inflammation | 9 (17.3) | 2 (3.8) | 4 (8.2) | 0 | 9 (18.4) | 0 |
| Influenza‐like illness | 6 (11.5) | 0 | 2 (4.1) | 0 | 1 (2.0) | 1 (2.0) |
| Hepatobiliary disorders | 6 (11.5) | 2 (3.8) | 0 | 0 | 4 (8.2) | 0 |
| Infections and infestations | 22 (42.3) | 0 | 19 (38.8) | 4 (8.2) | 18 (36.7) | 3 (6.1) |
| Sinusitis | 7 (13.5) | 0 | 0 | 0 | 3 (6.1) | 0 |
| Injury, poisoning, and procedural complications | 12 (23.1) | 1 (1.9) | 9 (18.4) | 2 (4.1) | 8 (16.3) | 1 (2.0) |
| Investigations | 24 (46.2) | 3 (5.8) | 14 (28.6) | 0 | 18 (36.7) | 0 |
| Aspartate aminotransferase increased | 9 (17.3) | 0 | 2 (4.1) | 0 | 7 (14.3) | 0 |
| Alanine aminotransferase increased | 5 (9.6) | 0 | 1 (2.0) | 0 | 5 (10.2) | 0 |
| Metabolism and nutrition disorders | 30 (57.7) | 3 (5.8) | 25 (51.0) | 7 (14.3) | 24 (49.0) | 7 (14.3) |
| Decreased appetite | 17 (32.7) | 0 | 11 (22.4) | 2 (4.1) | 10 (20.4) | 1 (2.0) |
| Hypokalemia | 12 (23.1) | 2 (3.8) | 7 (14.3) | 2 (4.1) | 12 (24.5) | 5 (10.2) |
| Hyperglycemia | 9 (17.3) | 0 | 4 (8.2) | 0 | 2 (4.1) | 0 |
| Dehydration | 6 (11.5) | 2 (3.8) | 11 (22.4) | 4 (8.2) | 3 (6.1) | 2 (4.1) |
| Hypocalcemia | 5 (9.6) | 0 | 4 (8.2) | 3 (6.1) | 6 (12.2) | 0 |
| Musculoskeletal and connective tissue disorders | 31 (59.6) | 5 (9.6) | 17 (34.7) | 2 (4.1) | 32 (65.3) | 2 (4.1) |
| Pain in extremity | 15 (28.8) | 2 (3.8) | 3 (6.1) | 0 | 6 (12.2) | 1 (2.0) |
| Arthralgia | 11 (21.2) | 0 | 2 (4.1) | 0 | 8 (16.3) | 0 |
| Back pain | 11 (21.2) | 3 (5.8) | 7 (14.3) | 1 (2.0) | 8 (16.3) | 0 |
| Myalgia | 9 (17.3) | 0 | 4 (8.2) | 0 | 3 (6.1) | 0 |
| Musculoskeletal chest pain | 8 (15.4) | 1 (1.9) | 3 (6.1) | 1 (2.0) | 7 (14.3) | 0 |
| Musculoskeletal pain | 6 (11.5) | 1 (1.9) | 1 (2.0) | 0 | 3 (6.1) | 0 |
| Neck pain | 6 (11.5) | 0 | 3 (6.1) | 0 | 0 | 0 |
| Muscle spasms | 5 (9.6) | 0 | 0 | 0 | 5 (10.2) | 0 |
| Neoplasms benign, malignant, and unspecified | 2 (3.8) | 0 | 6 (1.2) | 4 (8.2) | 1 (2.0) | 1 (2.0) |
| Nervous system disorders | 37 (71.2) | 1 (1.9) | 28 (57.1) | 5 (10.2) | 22 (44.9) | 2 (4.1) |
| Headache | 26 (50.0) | 0 | 9 (18.4) | 1 (2.0) | 11 (22.4) | 1 (2.0) |
| Neuropathy peripheral | 10 (19.2) | 0 | 6 (12.2) | 0 | 4 (8.2) | 0 |
| Dysgeusia | 6 (11.5) | 0 | 6 (12.2) | 0 | 3 (6.1) | 0 |
| Peripheral sensory neuropathy | 6 (11.5) | 0 | 5 (10.2) | 0 | 2 (4.1) | 0 |
| Dizziness | 5 (9.6) | 0 | 6 (12.2) | 0 | 3 (6.1) | 0 |
| Psychiatric disorders | 17 (32.7) | 0 | 17 (34.7) | 0 | 17 (34.7) | 1 (2.0) |
| Insomnia | 7 (13.5) | 0 | 9 (18.4) | 0 | 12 (24.5) | 0 |
| Anxiety | 6 (11.5) | 0 | 7 (14.3) | 0 | 5 (10.2) | 0 |
| Depression | 6 (11.5) | 0 | 6 (12.2) | 0 | 4 (8.2) | 0 |
| Renal and urinary disorders | 6 (11.5) | 0 | 6 (12.2) | 2 (4.1) | 6 (12.2) | 1 (2.0) |
| Respiratory, thoracic, and mediastinal disorders | 38 (73.1) | 7 (13.5) | 34 (69.4) | 11 (22.4) | 20 (40.8) | 0 |
| Cough | 21 (40.4) | 0 | 10 (20.4) | 0 | 9 (18.4) | 0 |
| Dyspnea | 20 (38.5) | 4 (7.7) | 18 (36.7) | 4 (8.2) | 9 (18.4) | 0 |
| Epistaxis | 9 (17.3) | 0 | 0 | 0 | 3 (6.1) | 0 |
| Rhinorrhea | 6 (11.5) | 0 | 2 (4.1) | 0 | 1 (2.0) | 0 |
| Oropharyngeal pain | 5 (9.6) | 0 | 3 (6.1) | 0 | 5 (10.2) | 0 |
| Pleural effusion | 5 (9.6) | 2 (3.8) | 16 (32.7) | 6 (12.2) | 0 | 0 |
| Skin and subcutaneous tissue disorders | 43 (82.7) | 9 (17.3) | 24 (49.0) | 3 (6.1) | 42 (85.7) | 7 (14.3) |
| Palmar‐plantar erythrodysesthesia syndrome | 38 (73.1) | 9 (17.3) | 15 (30.6) | 3 (6.1) | 35 (71.4) | 6 (12.2) |
| Skin hyperpigmentation | 7 (13.5) | 0 | 2 (4.1) | 0 | 4 (8.2) | 0 |
| Dry skin | 3 (5.8) | 0 | 0 | 0 | 5 (10.2) | 0 |
| Erythema | 3 (5.8) | 0 | 3 (6.1) | 0 | 7 (14.3) | 0 |
| Vascular disorders | 22 (42.3) | 7 (13.5) | 17 (34.7) | 3 (6.1) | 11 (22.4) | 2 (4.1) |
| Hypertension | 16 (30.8) | 4 (7.7) | 1 (2.0) | 0 | 1 (2.0) | 1 (2.0) |
| System organ class/preferred term . | RAM + CAP (n = 52) . | ICR + CAP (n = 49) . | CAP (n = 49) . | |||
|---|---|---|---|---|---|---|
| All grades . | Grade ≥3 . | All grades . | Grade ≥3 . | All grades . | Grade ≥3 . | |
| Blood and lymphatic system disorders | 21 (40.4) | 8 (15.4) | 20 (40.8) | 8 (16.3) | 18 (36.7) | 2 (4.1) |
| Thrombocytopenia | 9 (17.3) | 1 (1.9) | 1 (2.0) | 0 | 9 (18.4) | 0 |
| Neutropenia | 8 (15.4) | 3 (5.8) | 6 (12.2) | 3 (6.1) | 6 (12.2) | 0 |
| Anemia | 7 (13.5) | 1 (1.9) | 15 (30.6) | 5 (10.2) | 12 (24.5) | 2 (4.1) |
| Leukopenia | 4 (7.7) | 0 | 0 | 0 | 7 (14.3) | 0 |
| Cardiac disorders | 6 (11.5) | 2 (3.8) | 16 (32.7) | 6 (12.2) | 4 (8.2) | 0 |
| Ear and labyrinth disorder | 1 (1.9) | 0 | 1 (2.0) | 0 | 2 (4.1) | 0 |
| Eye disorders | 12 (23.1) | 0 | 15 (30.6) | 0 | 5 (10.2) | 0 |
| Lacrimation increased | 4 (7.7) | 0 | 6 (12.2) | 0 | 2 (4.1) | 0 |
| Gastrointestinal disorders | 43 (82.7) | 5 (9.6) | 47 (95.9) | 8 (16.3) | 44 (89.8) | 6 (12.2) |
| Nausea | 27 (51.9) | 0 | 38 (77.6) | 2 (4.1) | 26 (53.1) | 3 (6.1) |
| Diarrhea | 22 (42.3) | 1 (1.9) | 21 (42.9) | 2 (4.1) | 28 (57.1) | 3 (6.1) |
| Constipation | 19 (36.5) | 0 | 14 (28.6) | 0 | 17 (34.7) | 0 |
| Vomiting | 18 (34.6) | 1 (1.9) | 26 (53.1) | 2 (4.1) | 14 (28.6) | 3 (6.1) |
| Stomatitis | 14 (26.9) | 0 | 4 (8.2) | 1 (2.0) | 7 (14.3) | 0 |
| Abdominal pain | 9 (17.3) | 1 (1.9) | 6 (12.2) | 0 | 5 (10.2) | 1 (2.0) |
| Dyspepsia | 6 (11.5) | 0 | 5 (10.2) | 0 | 3 (6.1) | 0 |
| General disorders and administration site conditions | 38 (73.1) | 5 (9.6) | 42 (85.7) | 5 (10.2) | 37 (75.5) | 4 (8.2) |
| Fatigue | 27 (51.9) | 3 (5.8) | 28 (57.1) | 1 (2.0) | 26 (53.1) | 1 (2.0) |
| Pyrexia | 14 (26.9) | 0 | 8 (16.3) | 1 (2.0) | 4 (8.2) | 0 |
| Edema peripheral | 13 (25.0) | 0 | 19 (38.8) | 1 (2.0) | 6 (12.2) | 0 |
| Mucosal inflammation | 9 (17.3) | 2 (3.8) | 4 (8.2) | 0 | 9 (18.4) | 0 |
| Influenza‐like illness | 6 (11.5) | 0 | 2 (4.1) | 0 | 1 (2.0) | 1 (2.0) |
| Hepatobiliary disorders | 6 (11.5) | 2 (3.8) | 0 | 0 | 4 (8.2) | 0 |
| Infections and infestations | 22 (42.3) | 0 | 19 (38.8) | 4 (8.2) | 18 (36.7) | 3 (6.1) |
| Sinusitis | 7 (13.5) | 0 | 0 | 0 | 3 (6.1) | 0 |
| Injury, poisoning, and procedural complications | 12 (23.1) | 1 (1.9) | 9 (18.4) | 2 (4.1) | 8 (16.3) | 1 (2.0) |
| Investigations | 24 (46.2) | 3 (5.8) | 14 (28.6) | 0 | 18 (36.7) | 0 |
| Aspartate aminotransferase increased | 9 (17.3) | 0 | 2 (4.1) | 0 | 7 (14.3) | 0 |
| Alanine aminotransferase increased | 5 (9.6) | 0 | 1 (2.0) | 0 | 5 (10.2) | 0 |
| Metabolism and nutrition disorders | 30 (57.7) | 3 (5.8) | 25 (51.0) | 7 (14.3) | 24 (49.0) | 7 (14.3) |
| Decreased appetite | 17 (32.7) | 0 | 11 (22.4) | 2 (4.1) | 10 (20.4) | 1 (2.0) |
| Hypokalemia | 12 (23.1) | 2 (3.8) | 7 (14.3) | 2 (4.1) | 12 (24.5) | 5 (10.2) |
| Hyperglycemia | 9 (17.3) | 0 | 4 (8.2) | 0 | 2 (4.1) | 0 |
| Dehydration | 6 (11.5) | 2 (3.8) | 11 (22.4) | 4 (8.2) | 3 (6.1) | 2 (4.1) |
| Hypocalcemia | 5 (9.6) | 0 | 4 (8.2) | 3 (6.1) | 6 (12.2) | 0 |
| Musculoskeletal and connective tissue disorders | 31 (59.6) | 5 (9.6) | 17 (34.7) | 2 (4.1) | 32 (65.3) | 2 (4.1) |
| Pain in extremity | 15 (28.8) | 2 (3.8) | 3 (6.1) | 0 | 6 (12.2) | 1 (2.0) |
| Arthralgia | 11 (21.2) | 0 | 2 (4.1) | 0 | 8 (16.3) | 0 |
| Back pain | 11 (21.2) | 3 (5.8) | 7 (14.3) | 1 (2.0) | 8 (16.3) | 0 |
| Myalgia | 9 (17.3) | 0 | 4 (8.2) | 0 | 3 (6.1) | 0 |
| Musculoskeletal chest pain | 8 (15.4) | 1 (1.9) | 3 (6.1) | 1 (2.0) | 7 (14.3) | 0 |
| Musculoskeletal pain | 6 (11.5) | 1 (1.9) | 1 (2.0) | 0 | 3 (6.1) | 0 |
| Neck pain | 6 (11.5) | 0 | 3 (6.1) | 0 | 0 | 0 |
| Muscle spasms | 5 (9.6) | 0 | 0 | 0 | 5 (10.2) | 0 |
| Neoplasms benign, malignant, and unspecified | 2 (3.8) | 0 | 6 (1.2) | 4 (8.2) | 1 (2.0) | 1 (2.0) |
| Nervous system disorders | 37 (71.2) | 1 (1.9) | 28 (57.1) | 5 (10.2) | 22 (44.9) | 2 (4.1) |
| Headache | 26 (50.0) | 0 | 9 (18.4) | 1 (2.0) | 11 (22.4) | 1 (2.0) |
| Neuropathy peripheral | 10 (19.2) | 0 | 6 (12.2) | 0 | 4 (8.2) | 0 |
| Dysgeusia | 6 (11.5) | 0 | 6 (12.2) | 0 | 3 (6.1) | 0 |
| Peripheral sensory neuropathy | 6 (11.5) | 0 | 5 (10.2) | 0 | 2 (4.1) | 0 |
| Dizziness | 5 (9.6) | 0 | 6 (12.2) | 0 | 3 (6.1) | 0 |
| Psychiatric disorders | 17 (32.7) | 0 | 17 (34.7) | 0 | 17 (34.7) | 1 (2.0) |
| Insomnia | 7 (13.5) | 0 | 9 (18.4) | 0 | 12 (24.5) | 0 |
| Anxiety | 6 (11.5) | 0 | 7 (14.3) | 0 | 5 (10.2) | 0 |
| Depression | 6 (11.5) | 0 | 6 (12.2) | 0 | 4 (8.2) | 0 |
| Renal and urinary disorders | 6 (11.5) | 0 | 6 (12.2) | 2 (4.1) | 6 (12.2) | 1 (2.0) |
| Respiratory, thoracic, and mediastinal disorders | 38 (73.1) | 7 (13.5) | 34 (69.4) | 11 (22.4) | 20 (40.8) | 0 |
| Cough | 21 (40.4) | 0 | 10 (20.4) | 0 | 9 (18.4) | 0 |
| Dyspnea | 20 (38.5) | 4 (7.7) | 18 (36.7) | 4 (8.2) | 9 (18.4) | 0 |
| Epistaxis | 9 (17.3) | 0 | 0 | 0 | 3 (6.1) | 0 |
| Rhinorrhea | 6 (11.5) | 0 | 2 (4.1) | 0 | 1 (2.0) | 0 |
| Oropharyngeal pain | 5 (9.6) | 0 | 3 (6.1) | 0 | 5 (10.2) | 0 |
| Pleural effusion | 5 (9.6) | 2 (3.8) | 16 (32.7) | 6 (12.2) | 0 | 0 |
| Skin and subcutaneous tissue disorders | 43 (82.7) | 9 (17.3) | 24 (49.0) | 3 (6.1) | 42 (85.7) | 7 (14.3) |
| Palmar‐plantar erythrodysesthesia syndrome | 38 (73.1) | 9 (17.3) | 15 (30.6) | 3 (6.1) | 35 (71.4) | 6 (12.2) |
| Skin hyperpigmentation | 7 (13.5) | 0 | 2 (4.1) | 0 | 4 (8.2) | 0 |
| Dry skin | 3 (5.8) | 0 | 0 | 0 | 5 (10.2) | 0 |
| Erythema | 3 (5.8) | 0 | 3 (6.1) | 0 | 7 (14.3) | 0 |
| Vascular disorders | 22 (42.3) | 7 (13.5) | 17 (34.7) | 3 (6.1) | 11 (22.4) | 2 (4.1) |
| Hypertension | 16 (30.8) | 4 (7.7) | 1 (2.0) | 0 | 1 (2.0) | 1 (2.0) |
This PDF is available to Subscribers Only
View Article Abstract & Purchase OptionsFor full access to this pdf, sign in to an existing account, or purchase an annual subscription.
