TEAEs occurring in >15% of patients
. | Total (n = 48) (%) . | |||||
---|---|---|---|---|---|---|
All grades . | Grade 1 . | Grade 2 . | Grade 3 . | Grade 4 . | Grade 5 . | |
Subjects with at least 1 TEAE | 48 (100.0) | 6 (12.5) | 19 (39.6) | 17 (35.4) | 4 (8.3) | 2 (4.2) |
Headache | 33 (68.8) | 25 (52.1) | 8 (16.7) | 0 | 0 | 0 |
Contusion | 27 (56.3) | 27 (56.3) | 0 | 0 | 0 | 0 |
Diarrhea | 21 (43.8) | 20 (41.7) | 1 (2.1) | 0 | 0 | 0 |
Upper respiratory tract infection | 20 (41.7) | 2 (4.2) | 18 (37.5) | 0 | 0 | 0 |
Influenza-like illness | 18 (37.5) | 15 (31.3) | 3 (6.3) | 0 | 0 | 0 |
Myalgia | 18 (37.5) | 16 (33.3) | 2 (4.2) | 0 | 0 | 0 |
Arthralgia | 16 (33.3) | 9 (18.8) | 7 (14.6) | 0 | 0 | 0 |
Maculopapular rash | 16 (33.3) | 15 (31.3) | 0 | 1 (2.1) | 0 | 0 |
Petechiae | 14 (29.2) | 14 (29.2) | 0 | 0 | 0 | 0 |
Nausea | 13 (27.1) | 13 (27.1) | 0 | 0 | 0 | 0 |
Cough | 11 (22.9) | 11 (22.9) | 0 | 0 | 0 | 0 |
Dizziness | 11 (22.9) | 11 (22.9) | 0 | 0 | 0 | 0 |
Nasal congestion | 11 (22.9) | 9 (18.8) | 2 (4.2) | 0 | 0 | 0 |
Dyspnea | 10 (20.8) | 9 (18.8) | 1 (2.1) | 0 | 0 | 0 |
Fatigue | 10 (20.8) | 9 (18.8) | 1 (2.1) | 0 | 0 | 0 |
Pyrexia | 10 (20.8) | 9 (18.8) | 1 (2.1) | 0 | 0 | 0 |
Neutropenia* | 9 (18.8) | 1 (2.1) | 2 (4.2) | 3 (6.3) | 3 (6.3) | 0 |
Peripheral edema | 9 (18.8) | 9 (18.8) | 0 | 0 | 0 | 0 |
Thrombocytopenia | 9 (18.8) | 3 (6.3) | 3 (6.3) | 2 (4.2) | 1 (2.1) | 0 |
Lung infection | 8 (16.7) | 0 | 4 (8.3) | 4 (8.3) | 0 | 0 |
Sinusitis | 8 (16.7) | 0 | 8 (16.7) | 0 | 0 | 0 |
Urinary tract infection | 8 (16.7) | 0 | 7 (14.6) | 1 (2.1) | 0 | 0 |
. | Total (n = 48) (%) . | |||||
---|---|---|---|---|---|---|
All grades . | Grade 1 . | Grade 2 . | Grade 3 . | Grade 4 . | Grade 5 . | |
Subjects with at least 1 TEAE | 48 (100.0) | 6 (12.5) | 19 (39.6) | 17 (35.4) | 4 (8.3) | 2 (4.2) |
Headache | 33 (68.8) | 25 (52.1) | 8 (16.7) | 0 | 0 | 0 |
Contusion | 27 (56.3) | 27 (56.3) | 0 | 0 | 0 | 0 |
Diarrhea | 21 (43.8) | 20 (41.7) | 1 (2.1) | 0 | 0 | 0 |
Upper respiratory tract infection | 20 (41.7) | 2 (4.2) | 18 (37.5) | 0 | 0 | 0 |
Influenza-like illness | 18 (37.5) | 15 (31.3) | 3 (6.3) | 0 | 0 | 0 |
Myalgia | 18 (37.5) | 16 (33.3) | 2 (4.2) | 0 | 0 | 0 |
Arthralgia | 16 (33.3) | 9 (18.8) | 7 (14.6) | 0 | 0 | 0 |
Maculopapular rash | 16 (33.3) | 15 (31.3) | 0 | 1 (2.1) | 0 | 0 |
Petechiae | 14 (29.2) | 14 (29.2) | 0 | 0 | 0 | 0 |
Nausea | 13 (27.1) | 13 (27.1) | 0 | 0 | 0 | 0 |
Cough | 11 (22.9) | 11 (22.9) | 0 | 0 | 0 | 0 |
Dizziness | 11 (22.9) | 11 (22.9) | 0 | 0 | 0 | 0 |
Nasal congestion | 11 (22.9) | 9 (18.8) | 2 (4.2) | 0 | 0 | 0 |
Dyspnea | 10 (20.8) | 9 (18.8) | 1 (2.1) | 0 | 0 | 0 |
Fatigue | 10 (20.8) | 9 (18.8) | 1 (2.1) | 0 | 0 | 0 |
Pyrexia | 10 (20.8) | 9 (18.8) | 1 (2.1) | 0 | 0 | 0 |
Neutropenia* | 9 (18.8) | 1 (2.1) | 2 (4.2) | 3 (6.3) | 3 (6.3) | 0 |
Peripheral edema | 9 (18.8) | 9 (18.8) | 0 | 0 | 0 | 0 |
Thrombocytopenia | 9 (18.8) | 3 (6.3) | 3 (6.3) | 2 (4.2) | 1 (2.1) | 0 |
Lung infection | 8 (16.7) | 0 | 4 (8.3) | 4 (8.3) | 0 | 0 |
Sinusitis | 8 (16.7) | 0 | 8 (16.7) | 0 | 0 | 0 |
Urinary tract infection | 8 (16.7) | 0 | 7 (14.6) | 1 (2.1) | 0 | 0 |
Included neutropenia and neutrophil count decrease.