| Arm A | Arm B |
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First-line (Cap+Bev) N = 37 | | Second-line (Eve+Exe) N = 17 | | First-line (Eve+Exe) N = 37 | | Second-line (Cap+Bev) N = 19 | |
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Any grade | Grade 3/4 | Any grade | Grade 3/4 | Any grade | Grade 3/4 | Any grade | Grade 3/4 |
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Adverse event, n (%) |
Anemia | 1 (2.7%) | | 4 (23.5%) | | 5 (13.5%) | | | |
Arthralgia | 5 (13.5%) | | | | 4 (10.8%) | | 1 (5.3%) | |
Bone pain | 3 (8.1%) | | | | 6 (16.2%) | | | |
Cough | 5 (13.5%) | | 3 (17.6%) | | 6 (16.2%) | | 2 (10.5%) | |
Decreased appetite | 6 (16.2%) | | 1 (5.9%) | | 5 (13.5%) | | | |
Diarrhea | 12 (32.4%) | | 2 (11.8%) | | 11 (29.7%) | | 5 (26.3%) | |
Dyspnea | 6 (16.2%) | | 3 (17.6%) | | 4 (10.8%) | | 4 (21.1%) | |
Fatigue | 13 (35.1%) | | 3 (17.6%) | | 6 (16.2%) | | 2 (10.5%) | |
Hand-Foot Syndrome | 21 (56.8%) | 7 (18.9%) | | | 1 (2.7%) | | 6 (31.6%) | 2 (10.5%) |
Headache | 6 (16.2%) | | | | 6 (16.2%) | | | |
Hypertension | 11 (29.7%) | 5 (13.5%) | | | 2 (5.4%) | | 3 (15.8%) | |
Mucosal inflammation | 4 (10.8%) | | 2 (11.8%) | | 7 (18.9%) | | | |
Nausea | 15 (40.5%) | | 1 (5.9%) | | 9 (24.3%) | | 5 (26.3%) | |
Edema peripheral | 2 (5.4%) | | | | 6 (16.2%) | | 2 (10.5%) | |
Pain | 2 (5.4%) | | 2 (11.8%) | 2 (11.8%) | 1 (2.7%) | | | |
Pleural effusion | 2 (5.4%) | | | | 2 (5.4%) | | 3 (15.8%) | |
Pneumonia | | | | 2 (11.8%) | 3 (8.1%) | | | |
PSN | 6 (16.2%) | | | | 1 (2.7%) | | 2 (10.5%) | |
Stomatitis | 9 (24.3%) | | 1 (5.9%) | | 5 (13.5%) | | 1 (5.3%) | |
- Percentages in second-line therapy refer to the number of patients, who started second-line therapy. Time range: from first administration of study treatment until 30 days after end of treatment in each treatment line. Unrelated TEAEs starting within 30 days of end of first-line therapy and after start of second-line therapy were considered treatment-emergent in both treatment lines in case second-line therapy had started within 30 days of end of first-line therapy. MedDRA v20.0. PSN = Peripheral sensory neuropathy