Adverse events
| Adverse Event . | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| R (n = 76), n (%) . | RL (n = 77), n (%) . | |||||||||
| Any . | Grade 1 . | Grade 2 . | Grade 3 . | Grade 4 . | Any . | Grade 1 . | Grade 2 . | Grade 3 . | Grade 4 . | |
| Hematological | ||||||||||
| Neutropenia | 4 (5) | 3 (4) | 1 (1) | 18 (23) | 14 (18) | 4 (5) | ||||
| Lymphopenia | 1 (1) | 1 (1) | ||||||||
| Anemia | 2 (3) | 2 (3) | 3 (4) | 1 (1) | 1 (1) | 1 (1) | ||||
| Thrombocytopenia | 4 (5) | 1 (1) | 2 (3) | 1 (1) | ||||||
| Febrile neutropenia | 1 (1) | 1 (1) | ||||||||
| Nonhematological | ||||||||||
| IR symptoms | 11 (14) | 2 (3) | 8 (11) | 1 (1) | 5 (6) | 1 (1) | 4 (5) | |||
| Fatigue | 26 (34) | 17 (22) | 8 (11) | 1 (1) | 40 (52) | 29 (38) | 9 (12) | 2 (3) | ||
| Fever | 11 (14) | 7 (9) | 4 (5) | 12 (16) | 11 (14) | 1 (1) | ||||
| Diarrhea | 9 (12) | 6 (8) | 3 (4) | 19 (25) | 18 (23) | 1 (1) | ||||
| Nausea/vomiting | 12 (16) | 8 (11) | 4 (5) | 17 (22) | 14 (18) | 2 (3) | 1 (1) | |||
| Mucositis | 5 (7) | 4 (5) | 1 (1) | 3 (4) | 2 (3) | 1 (1) | ||||
| Skin rash | 5 (7) | 2 (3) | 2 (3) | 1 (1) | 21 (27) | 11 (14) | 6 (8) | 4 (5) | ||
| Cough | 10 (13) | 9 (12) | 1 (1) | 19 (25) | 14 (18) | 5 (6) | ||||
| Transaminase increase | 2 (3) | 1 (1) | 1 (1) | 2 (3) | 1 (1) | 1 (1) | ||||
| Headache | 7 (9) | 5 (7) | 2 (3) | 12 (16) | 12 (16) | |||||
| Infections | 14 (18) | 6 (8) | 6 (8) | 2 (3) | 23 (30) | 6 (8) | 14 (18) | 3 (4) | ||
| Skin infection | 2 (3) | 1 (1) | 1 (1) | 4 (5) | 2 (3) | 2 (3) | ||||
| Upper respiratory infection | 8 (11) | 6 (8) | 2 (3) | 13 (17) | 4 (5) | 8 (10) | 1 (1) | |||
| Urinary tract infection | 3 (4) | 3 (4) | 4 (5) | 2 (3) | 2 (3) | |||||
| Other* | 1 (1) | 1 (1) | 4 (5) | 1 (1) | 3 (4) | |||||
| Adverse Event . | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| R (n = 76), n (%) . | RL (n = 77), n (%) . | |||||||||
| Any . | Grade 1 . | Grade 2 . | Grade 3 . | Grade 4 . | Any . | Grade 1 . | Grade 2 . | Grade 3 . | Grade 4 . | |
| Hematological | ||||||||||
| Neutropenia | 4 (5) | 3 (4) | 1 (1) | 18 (23) | 14 (18) | 4 (5) | ||||
| Lymphopenia | 1 (1) | 1 (1) | ||||||||
| Anemia | 2 (3) | 2 (3) | 3 (4) | 1 (1) | 1 (1) | 1 (1) | ||||
| Thrombocytopenia | 4 (5) | 1 (1) | 2 (3) | 1 (1) | ||||||
| Febrile neutropenia | 1 (1) | 1 (1) | ||||||||
| Nonhematological | ||||||||||
| IR symptoms | 11 (14) | 2 (3) | 8 (11) | 1 (1) | 5 (6) | 1 (1) | 4 (5) | |||
| Fatigue | 26 (34) | 17 (22) | 8 (11) | 1 (1) | 40 (52) | 29 (38) | 9 (12) | 2 (3) | ||
| Fever | 11 (14) | 7 (9) | 4 (5) | 12 (16) | 11 (14) | 1 (1) | ||||
| Diarrhea | 9 (12) | 6 (8) | 3 (4) | 19 (25) | 18 (23) | 1 (1) | ||||
| Nausea/vomiting | 12 (16) | 8 (11) | 4 (5) | 17 (22) | 14 (18) | 2 (3) | 1 (1) | |||
| Mucositis | 5 (7) | 4 (5) | 1 (1) | 3 (4) | 2 (3) | 1 (1) | ||||
| Skin rash | 5 (7) | 2 (3) | 2 (3) | 1 (1) | 21 (27) | 11 (14) | 6 (8) | 4 (5) | ||
| Cough | 10 (13) | 9 (12) | 1 (1) | 19 (25) | 14 (18) | 5 (6) | ||||
| Transaminase increase | 2 (3) | 1 (1) | 1 (1) | 2 (3) | 1 (1) | 1 (1) | ||||
| Headache | 7 (9) | 5 (7) | 2 (3) | 12 (16) | 12 (16) | |||||
| Infections | 14 (18) | 6 (8) | 6 (8) | 2 (3) | 23 (30) | 6 (8) | 14 (18) | 3 (4) | ||
| Skin infection | 2 (3) | 1 (1) | 1 (1) | 4 (5) | 2 (3) | 2 (3) | ||||
| Upper respiratory infection | 8 (11) | 6 (8) | 2 (3) | 13 (17) | 4 (5) | 8 (10) | 1 (1) | |||
| Urinary tract infection | 3 (4) | 3 (4) | 4 (5) | 2 (3) | 2 (3) | |||||
| Other* | 1 (1) | 1 (1) | 4 (5) | 1 (1) | 3 (4) | |||||
Adverse events were reported from study entry to last tumor assessment at week 23 or 30 d after treatment discontinuation or immediately before any off-trial treatment, whichever occurred first. Serious adverse events possibly related to late toxicity of the study treatment and second malignancies occurring during the follow-up had to be reported according to the protocol.
Including 1 venous catheter infection in R arm and 1 grade 1 viral infection, 2 grade 2 dental abscesses, and 1 grade 2 infection of unclear origin in RL arm.