Table 2.
Adverse event | RO7297089 First assigned dose | |||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|
60 mg (n = 3) |
180 mg (n = 5) |
360 mg (n = 4) |
1080 mg (n = 12) |
1850 mg (n = 3) |
All patients (N = 27) |
|||||||
Any grade | Grade 3–4 | Any grade | Grade 3–4 | Any grade | Grade 3–4 | Any grade | Grade 3–4 | Any grade | Grade 3–4 | Any grade | Grade 3–4 | |
Hematologic AE | ||||||||||||
Anemia | 1 (33%) | 1 (33%) | 3 (60%) | 3 (60%) | 3 (75%) | 1 (25%) | 3 (25%) | 3 (25%) | 0 | 0 | 10 (37%) | 8 (30%) |
Platelet count decreased* | 1 (33%) | 1 (33%) | 3 (60%) | 2 (40%) | 2 (50%) | 2 (50%) | 2 (17%) | 1 (8%) | 0 | 0 | 8 (30%) | 6 (22%) |
Non-hematologic AE | ||||||||||||
Infusion-related reaction | 1 (33%) | 0 | 3 (60%) | 0 | 3 (75%) | 0 | 3 (25%) | 0 | 0 | 0 | 10 (37%) | 0 |
Back pain | 1 (33%) | 0 | 1 (20%) | 0 | 0 | 0 | 4 (33%) | 1 (8%) | 1 (33%) | 0 | 7 (26%) | 1 (4%) |
ALT increased | 0 | 0 | 3 (60%) | 1 (20%) | 0 | 0 | 2 (17%) | 0 | 0 | 0 | 5 (19%) | 1 (4%) |
AST increased | 0 | 0 | 2 (40%) | 1 (20%) | 0 | 0 | 2 (17%) | 0 | 0 | 0 | 4 (15%) | 1 (4%) |
Diarrhea | 1 (33%) | 0 | 1 (20%) | 0 | 0 | 0 | 2 (17%) | 0 | 0 | 0 | 4 (15%) | 0 |
Fatigue | 1 (33%) | 0 | 0 | 0 | 1 (25%) | 1 (25%) | 2 (17%) | 0 | 0 | 0 | 4 (15%) | 1 (4%) |
Arthralgia | 0 | 0 | 0 | 0 | 0 | 0 | 3 (25%) | 0 | 0 | 0 | 3 (11%) | 0 |
CRP increased | 1 (33%) | 0 | 1 (20%) | 0 | 0 | 0 | 1 (8%) | 0 | 0 | 0 | 3 (11%) | 0 |
Dyspnea | 0 | 0 | 2 (40%) | 0 | 0 | 0 | 1 (8%) | 0 | 0 | 0 | 3 (11%) | 0 |
Headache | 0 | 0 | 0 | 0 | 0 | 0 | 2 (17%) | 0 | 1 (33%) | 0 | 3 (11%) | 0 |
Nausea | 0 | 0 | 0 | 0 | 0 | 0 | 2 (17%) | 0 | 1 (33%) | 0 | 3 (11%) | 0 |
Pyrexia | 1 (33%) | 0 | 1 (20%) | 0 | 0 | 0 | 1 (8%) | 0 | 0 | 0 | 4 (15%) | 0 |
AE adverse event, ALT alanine transaminase, AST aspartate transaminase, CRP C-reactive protein
*Platelet count decreased includes the terms thrombocytopenia and platelet count decreased