Summary of TEAEs reported for >10% patients in either treatment group (safety population)
| Period: Preferred term . | CT-P10 . | Rituximab . | ||||
|---|---|---|---|---|---|---|
| Grade 1 or 2 . | Grade 3 . | Grade 4 . | Grade 1 or 2 . | Grade 3 . | Grade 4 . | |
| Overall study period | n = 70 | n = 70 | ||||
| Abdominal pain | 7 (10) | 1 (1) | 0 | 11 (16) | 0 | 0 |
| Alopecia | 10 (14) | 0 | 0 | 5 (7) | 0 | 0 |
| Asthenia | 5 (7) | 0 | 0 | 8 (11) | 0 | 0 |
| Back pain | 2 (3) | 0 | 0 | 12 (17) | 0 | 0 |
| Constipation | 12 (17) | 0 | 0 | 10 (14) | 0 | 0 |
| Diarrhea | 6 (9) | 0 | 0 | 7 (10) | 1 (1) | 0 |
| Fatigue | 6 (9) | 0 | 0 | 7 (10) | 1 (1) | 0 |
| Infusion-related reaction | 14 (20) | 2 (3) | 0 | 19 (27) | 0 | 0 |
| Nausea | 9 (13) | 0 | 0 | 7 (10) | 0 | 0 |
| Neuropathy peripheral | 10 (14) | 0 | 0 | 11 (16) | 1 (1) | 0 |
| Neutropenia | 6 (9) | 14 (20) | 8 (11) | 8 (11) | 7 (10) | 5 (7) |
| Paresthesia | 2 (3) | 1 (1) | 0 | 8 (11) | 0 | 0 |
| Upper respiratory tract infection | 14 (20) | 0 | 0 | 15 (21) | 3 (4) | 0 |
| Maintenance study period | n = 62 | n = 60 | ||||
| Neutropenia | 2 (3) | 1 (2) | 3 (5) | 3 (5) | 3 (5) | 1 (2) |
| Upper respiratory tract infection | 11 (18) | 0 | 0 | 7 (12) | 3 (5) | 0 |
| Period: Preferred term . | CT-P10 . | Rituximab . | ||||
|---|---|---|---|---|---|---|
| Grade 1 or 2 . | Grade 3 . | Grade 4 . | Grade 1 or 2 . | Grade 3 . | Grade 4 . | |
| Overall study period | n = 70 | n = 70 | ||||
| Abdominal pain | 7 (10) | 1 (1) | 0 | 11 (16) | 0 | 0 |
| Alopecia | 10 (14) | 0 | 0 | 5 (7) | 0 | 0 |
| Asthenia | 5 (7) | 0 | 0 | 8 (11) | 0 | 0 |
| Back pain | 2 (3) | 0 | 0 | 12 (17) | 0 | 0 |
| Constipation | 12 (17) | 0 | 0 | 10 (14) | 0 | 0 |
| Diarrhea | 6 (9) | 0 | 0 | 7 (10) | 1 (1) | 0 |
| Fatigue | 6 (9) | 0 | 0 | 7 (10) | 1 (1) | 0 |
| Infusion-related reaction | 14 (20) | 2 (3) | 0 | 19 (27) | 0 | 0 |
| Nausea | 9 (13) | 0 | 0 | 7 (10) | 0 | 0 |
| Neuropathy peripheral | 10 (14) | 0 | 0 | 11 (16) | 1 (1) | 0 |
| Neutropenia | 6 (9) | 14 (20) | 8 (11) | 8 (11) | 7 (10) | 5 (7) |
| Paresthesia | 2 (3) | 1 (1) | 0 | 8 (11) | 0 | 0 |
| Upper respiratory tract infection | 14 (20) | 0 | 0 | 15 (21) | 3 (4) | 0 |
| Maintenance study period | n = 62 | n = 60 | ||||
| Neutropenia | 2 (3) | 1 (2) | 3 (5) | 3 (5) | 3 (5) | 1 (2) |
| Upper respiratory tract infection | 11 (18) | 0 | 0 | 7 (12) | 3 (5) | 0 |
Data are n (%) of patients.