TEAEs in ≥15% of patients
TEAE . | Total (N = 35) . | ||
---|---|---|---|
All grades, n (%) . | Grade 3, n (%) . | Grade 4, n (%) . | |
Any AE | 34 (97) | 16 (46) | 8 (23) |
Hematologic | |||
Neutropenia | 7 (20) | 3 (9) | 3 (9) |
Investigations | |||
ALT/AST increased | 20 (57) | 11 (31) | 3 (9) |
Blood alkaline phosphatase increased | 6 (17) | 0 | 0 |
Blood creatinine increased | 6 (17) | 0 | 0 |
Nonhematologic | |||
Pyrexia | 13 (37) | 0 | 0 |
Cough | 12 (34) | 0 | 0 |
Diarrhea | 11 (31) | 0 | 0 |
Fatigue | 11 (31) | 3 (9) | 0 |
Nausea | 9 (26) | 0 | 0 |
Weight decrease | 9 (26) | 0 | 0 |
Headache | 8 (23) | 0 | 0 |
Maculopapular rash | 8 (23) | 6 (17) | 0 |
Chills | 6 (17) | 0 | 0 |
Constipation | 6 (17) | 0 | 0 |
Dyspnea | 6 (17) | 3 (9) | 1 (3) |
Pneumonia* | 8 (23) | 5 (14) | 1 (3) |
Wheezing | 6 (17) | 0 | 0 |
TEAE . | Total (N = 35) . | ||
---|---|---|---|
All grades, n (%) . | Grade 3, n (%) . | Grade 4, n (%) . | |
Any AE | 34 (97) | 16 (46) | 8 (23) |
Hematologic | |||
Neutropenia | 7 (20) | 3 (9) | 3 (9) |
Investigations | |||
ALT/AST increased | 20 (57) | 11 (31) | 3 (9) |
Blood alkaline phosphatase increased | 6 (17) | 0 | 0 |
Blood creatinine increased | 6 (17) | 0 | 0 |
Nonhematologic | |||
Pyrexia | 13 (37) | 0 | 0 |
Cough | 12 (34) | 0 | 0 |
Diarrhea | 11 (31) | 0 | 0 |
Fatigue | 11 (31) | 3 (9) | 0 |
Nausea | 9 (26) | 0 | 0 |
Weight decrease | 9 (26) | 0 | 0 |
Headache | 8 (23) | 0 | 0 |
Maculopapular rash | 8 (23) | 6 (17) | 0 |
Chills | 6 (17) | 0 | 0 |
Constipation | 6 (17) | 0 | 0 |
Dyspnea | 6 (17) | 3 (9) | 1 (3) |
Pneumonia* | 8 (23) | 5 (14) | 1 (3) |
Wheezing | 6 (17) | 0 | 0 |
Includes all events of lung infections, viral and bacterial pneumonia, including 1 event of HSV pneumonia (grade 5).