AEs occurring in >10% of patients by dose level (part 1 and part 2)
| AE (preferred term) . | 25 mg (n = 2) . | 75 mg (n = 2) . | 100 mg (n = 8) . | 125 mg (n = 55) . | 150 mg (n = 6) . | Overall (n = 73) . | Related . | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall (N = 73) . | MM (n = 34) . | |||||||||||||||
| No. . | % . | No. . | % . | No. . | % . | No. . | % . | No. . | % . | No. . | % . | No. . | % . | No. . | % . | |
| Nausea | 0 | 1 | 50 | 3 | 37.5 | 18 | 32.7 | 4 | 66.7 | 26 | 35.6 | 17 | 23.3 | 7 | 20.6 | |
| Diarrhea | 1 | 50 | 0 | 2 | 25 | 17 | 30.9 | 4 | 66.7 | 24 | 32.9 | 15 | 20.5 | 9 | 26.5 | |
| Dyspepsia | 1 | 50 | 0 | 3 | 37.5 | 14 | 25.5 | 0 | 18 | 24.7 | 14 | 19.2 | 7 | 20.6 | ||
| Fatigue | 1 | 50 | 1 | 50 | 0 | 12 | 21.8 | 1 | 16.7 | 15 | 20.5 | 12 | 16.4 | 7 | 20.6 | |
| Anorexia | 0 | 0 | 1 | 12.5 | 12 | 21.8 | 1 | 16.7 | 14 | 19.2 | 10 | 13.7 | 5 | 14.7 | ||
| Gastrointestinal reflux | 0 | 1 | 50 | 2 | 25 | 10 | 18.2 | 1 | 16.7 | 14 | 19.2 | 11 | 15.1 | 3 | 8.8 | |
| Vomiting | 1 | 50 | 1 | 50 | 4 | 50 | 6 | 10.9 | 2 | 33.3 | 14 | 19.2 | 7 | 9.6 | 2 | 5.9 |
| Anemia | 0 | 1 | 50 | 3 | 37.5 | 7 | 12.7 | 0 | 11 | 15.1 | 2 | 2.7 | 2 | 5.9 | ||
| Asthenia | 0 | 0 | 1 | 12.5 | 8 | 14.5 | 1 | 16.7 | 10 | 13.7 | 2 | 2.7 | 0 | |||
| Upper respiratory tract infection | 0 | 0 | 2 | 25 | 7 | 12.7 | 1 | 16.7 | 10 | 13.7 | 0 | 0 | ||||
| Back pain | 1 | 50 | 0 | 2 | 25 | 5 | 9.1 | 1 | 16.7 | 9 | 12.3 | 0 | 0 | |||
| Insomnia | 2 | 100 | 0 | 0 | 7 | 12.7 | 0 | 9 | 12.3 | 3 | 4.1 | 1 | 2.9 | |||
| Rash | 0 | 0 | 0 | 7 | 12.7 | 2 | 33.3 | 9 | 12.3 | 5 | 6.8 | 2 | 5.9 | |||
| Constipation | 0 | 0 | 1 | 12.5 | 7 | 12.7 | 0 | 8 | 11 | 0 | 0 | |||||
| Cough | 0 | 0 | 3 | 37.5 | 5 | 9.1 | 0 | 8 | 11 | 1 | 1.4 | 0 | ||||
| Odynophagia | 0 | 0 | 0 | 7 | 12.7 | 1 | 16.7 | 8 | 11 | 6 | 8.2 | 0 | ||||
| Headache | 0 | 1 | 50 | 0 | 6 | 10.9 | 0 | 7 | 9.6 | 4 | 5.5 | 2 | 5.9 | |||
| Neutropenia | 1 | 50 | 0 | 2 | 25 | 3 | 5.5 | 1 | 16.7 | 7 | 9.6 | 5 | 6.8 | 2 | 5.9 | |
| Pyrexia | 0 | 0 | 2 | 25 | 5 | 9.1 | 0 | 7 | 9.6 | 0 | 0 | |||||
| AE (preferred term) . | 25 mg (n = 2) . | 75 mg (n = 2) . | 100 mg (n = 8) . | 125 mg (n = 55) . | 150 mg (n = 6) . | Overall (n = 73) . | Related . | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall (N = 73) . | MM (n = 34) . | |||||||||||||||
| No. . | % . | No. . | % . | No. . | % . | No. . | % . | No. . | % . | No. . | % . | No. . | % . | No. . | % . | |
| Nausea | 0 | 1 | 50 | 3 | 37.5 | 18 | 32.7 | 4 | 66.7 | 26 | 35.6 | 17 | 23.3 | 7 | 20.6 | |
| Diarrhea | 1 | 50 | 0 | 2 | 25 | 17 | 30.9 | 4 | 66.7 | 24 | 32.9 | 15 | 20.5 | 9 | 26.5 | |
| Dyspepsia | 1 | 50 | 0 | 3 | 37.5 | 14 | 25.5 | 0 | 18 | 24.7 | 14 | 19.2 | 7 | 20.6 | ||
| Fatigue | 1 | 50 | 1 | 50 | 0 | 12 | 21.8 | 1 | 16.7 | 15 | 20.5 | 12 | 16.4 | 7 | 20.6 | |
| Anorexia | 0 | 0 | 1 | 12.5 | 12 | 21.8 | 1 | 16.7 | 14 | 19.2 | 10 | 13.7 | 5 | 14.7 | ||
| Gastrointestinal reflux | 0 | 1 | 50 | 2 | 25 | 10 | 18.2 | 1 | 16.7 | 14 | 19.2 | 11 | 15.1 | 3 | 8.8 | |
| Vomiting | 1 | 50 | 1 | 50 | 4 | 50 | 6 | 10.9 | 2 | 33.3 | 14 | 19.2 | 7 | 9.6 | 2 | 5.9 |
| Anemia | 0 | 1 | 50 | 3 | 37.5 | 7 | 12.7 | 0 | 11 | 15.1 | 2 | 2.7 | 2 | 5.9 | ||
| Asthenia | 0 | 0 | 1 | 12.5 | 8 | 14.5 | 1 | 16.7 | 10 | 13.7 | 2 | 2.7 | 0 | |||
| Upper respiratory tract infection | 0 | 0 | 2 | 25 | 7 | 12.7 | 1 | 16.7 | 10 | 13.7 | 0 | 0 | ||||
| Back pain | 1 | 50 | 0 | 2 | 25 | 5 | 9.1 | 1 | 16.7 | 9 | 12.3 | 0 | 0 | |||
| Insomnia | 2 | 100 | 0 | 0 | 7 | 12.7 | 0 | 9 | 12.3 | 3 | 4.1 | 1 | 2.9 | |||
| Rash | 0 | 0 | 0 | 7 | 12.7 | 2 | 33.3 | 9 | 12.3 | 5 | 6.8 | 2 | 5.9 | |||
| Constipation | 0 | 0 | 1 | 12.5 | 7 | 12.7 | 0 | 8 | 11 | 0 | 0 | |||||
| Cough | 0 | 0 | 3 | 37.5 | 5 | 9.1 | 0 | 8 | 11 | 1 | 1.4 | 0 | ||||
| Odynophagia | 0 | 0 | 0 | 7 | 12.7 | 1 | 16.7 | 8 | 11 | 6 | 8.2 | 0 | ||||
| Headache | 0 | 1 | 50 | 0 | 6 | 10.9 | 0 | 7 | 9.6 | 4 | 5.5 | 2 | 5.9 | |||
| Neutropenia | 1 | 50 | 0 | 2 | 25 | 3 | 5.5 | 1 | 16.7 | 7 | 9.6 | 5 | 6.8 | 2 | 5.9 | |
| Pyrexia | 0 | 0 | 2 | 25 | 5 | 9.1 | 0 | 7 | 9.6 | 0 | 0 | |||||