Adverse Events Reported During the Trial Period Possibly or Probably Related to Rituximab or With Unknown Relationship
. | Arm A (375 mg/m2) . | Arm B (500 mg/m2) . | ||||||
---|---|---|---|---|---|---|---|---|
Grade 1 . | Grade 2 . | Grade 3 . | Grade 4 . | Grade 1 . | Grade 2 . | Grade 3 . | Grade 4 . | |
Any adverse event | 35 | 23 | 4 | 1 | 32 | 41 | 12 | 0 |
General disorders | 13 | 13 | 3 | 1 | 8 | 8 | 4 | 0 |
Fever | 4 | 8 | — | — | 4 | 5 | 1 | — |
Rigors | 3 | 4 | 3 | — | — | 4 | 1 | — |
Hypothermia | 4 | — | — | — | 4 | — | — | — |
Any pain | 1 | 1 | — | — | — | 1 | 1 | — |
Oedema | — | — | — | — | — | — | — | — |
Anaphylactic shock | — | — | — | 1 | — | — | — | — |
Cardiovascular, mainly hypotension | 5 | 3 | — | — | 1 | 5 | 1 | — |
Nervous disorders | 3 | 2 | — | — | 2 | 1 | 1 | — |
Gastrointestinal disorders | 4 | 1 | — | — | 8 | 8 | — | — |
Respiratory disorders | 6 | 3 | 1 | — | 6 | 3 | — | — |
Skin (pruritus) | 2 | — | — | — | 3 | 5 | 1 | — |
Urinary disorders | 1 | 1 | — | — | — | 1 | — | — |
Thrombocytopenia | — | — | — | — | — | — | 1 | — |
Anemia | — | — | — | — | — | 1 | 1 | — |
Neutropenia | — | — | — | — | — | — | 1 | — |
. | Arm A (375 mg/m2) . | Arm B (500 mg/m2) . | ||||||
---|---|---|---|---|---|---|---|---|
Grade 1 . | Grade 2 . | Grade 3 . | Grade 4 . | Grade 1 . | Grade 2 . | Grade 3 . | Grade 4 . | |
Any adverse event | 35 | 23 | 4 | 1 | 32 | 41 | 12 | 0 |
General disorders | 13 | 13 | 3 | 1 | 8 | 8 | 4 | 0 |
Fever | 4 | 8 | — | — | 4 | 5 | 1 | — |
Rigors | 3 | 4 | 3 | — | — | 4 | 1 | — |
Hypothermia | 4 | — | — | — | 4 | — | — | — |
Any pain | 1 | 1 | — | — | — | 1 | 1 | — |
Oedema | — | — | — | — | — | — | — | — |
Anaphylactic shock | — | — | — | 1 | — | — | — | — |
Cardiovascular, mainly hypotension | 5 | 3 | — | — | 1 | 5 | 1 | — |
Nervous disorders | 3 | 2 | — | — | 2 | 1 | 1 | — |
Gastrointestinal disorders | 4 | 1 | — | — | 8 | 8 | — | — |
Respiratory disorders | 6 | 3 | 1 | — | 6 | 3 | — | — |
Skin (pruritus) | 2 | — | — | — | 3 | 5 | 1 | — |
Urinary disorders | 1 | 1 | — | — | — | 1 | — | — |
Thrombocytopenia | — | — | — | — | — | — | 1 | — |
Anemia | — | — | — | — | — | 1 | 1 | — |
Neutropenia | — | — | — | — | — | — | 1 | — |