Table 2.
BAY1436032-related treatment-emergent adverse events occurring in ≥5% of treated subjects.
| TEAE | CTCAE grade | Cohort 1: 300 mg BID | Cohort 2: 600 mg BID | Cohort 3: 1200 mg BID | Cohort 4: 1500 mg BID | Total |
|---|---|---|---|---|---|---|
| n = 7 | n = 4 | n = 7 | n = 9 | n = 27 (%) | ||
| Sinus tachycardia | Grade 1 | 1 | 0 | 0 | 1 | 2 (7) |
| Diarrhea | Grade 2 | 0 | 0 | 2 | 0 | 2 (7) |
| Nausea | Grade 1 | 1 | 1 | 1 | 1 | 4 (15) |
| Grade 2 | 1 | 0 | 0 | 0 | 1 (4) | |
| Vomiting | Grade 1 | 2 | 1 | 0 | 1 | 4 (15) |
| Fatigue | Grade 1 | 0 | 1 | 0 | 0 | 1 (4) |
| Grade 2 | 1 | 0 | 1 | 0 | 2 (7) | |
| Grade 3 | 0 | 0 | 0 | 1 | 1 (4) | |
| Decreased appetite | Grade 1 | 1 | 0 | 0 | 0 | 1 (4) |
| Grade 2 | 1 | 0 | 0 | 0 | 1 (4) | |
| Hypomagnesaemia | Grade 1 | 1 | 0 | 0 | 1 | 2 (7) |
| Differentiation syndromea | Grade 2 | 0 | 0 | 0 | 1 | 1 (4) |
| Grade 3 | 0 | 0 | 1 | 0 | 1 (4) | |
| Dyspnea | Grade 1 | 1 | 0 | 1 | 0 | 2 (7) |
| Grade 2 | 1 | 0 | 0 | 0 | 1 (4) |
BID twice-daily, CTCAE common terminology criteria for adverse events, n number of subjects, TEAE treatment-emergent adverse events (as per MedDRA PT).
aSymptoms were not reported, only the term differentiation syndrome (DS). Three additional subjects presented with symptoms associated with DS and are not listed in the table since the individual symptoms occurred in <5% of treated subjects.