Table 2.
Treatment-related AEs during MOVIE phase I
Preferred term | Dose level 1 (N = 4) |
Dose level 2 (N = 10) |
Overall (N = 14) |
||||
---|---|---|---|---|---|---|---|
Grade 2 | Grade 2 | Grade 3 | Grade 4 | Grade 2 | Grade 3 | Grade 4 | |
Anemia | 3 (30.0%) | 3 (21.4%) | |||||
Asthenia | 8 (80.0%) | 3 (30.0%) | 8 (57.1%) | 3 (21.4%) | |||
ALP increase | 3 (30.0%) | 3 (21.4%) | |||||
Colitis | 1 (10.0%) | 1 (10.0%) | 1 (7.1%) | 1 (7.1%) | |||
Constipation | 1 (25.0%) | 1 (7.1%) | |||||
Decreased appetite | 1 (10.0%) | 1 (7.1%) | |||||
Dermatitis exfoliative | 1 (10.0%) | 1 (7.1%) | |||||
Diarrhea | 1 (10.0%) | 1 (7.1%) | |||||
Dry skin | 2 (20.0%) | 2 (14.3%) | |||||
GGT increase | 3 (30.0%) | 3 (21.4%) | |||||
Hyperthyroidism | 3 (30.0%) | 3 (21.4%) | |||||
Hypothyroidism | 1 (25.0%) | 1 (1.7%) | |||||
Lymphocyte count increase | 1 (10.0%) | 1 (7.1%) | |||||
Musculoskeletal pain | 1 (10.0%) | 1 (7.1%) | |||||
Nausea | 2 (20.0%) | 2 (14.3%) | |||||
Neutropenia | 1 (10.0%) | 1 (7.1%) | |||||
Pruritus | 2 (20.0%) | 2 (14%) | |||||
Rash maculopapular | 1 (10.0%) | 1 (7.1%) |
AE, adverse event; ALP, alkaline phosphatase; GGT, γ-glutamyltransferase.