Table 2. Treatment-emergent adverse events by severity and preferred term* occurring in ⩾15% of phase 1 patients.
| |
PX-866 dose |
|||
|---|---|---|---|---|
| 4 mg (N=10) | 6 mg (N=10) | 8 mg (N=23) | Total (N=43) | |
|
Frequency by severity,
N
(%) | ||||
| Grade 1 | 32 (56) | 36 (49) | 84 (50) | 152 (51) |
| Grade 2 | 10 (18) | 30 (41) | 62 (37) | 102 (34) |
| Grade 3 | 8 (14) | 5 (7) | 15 (9) | 28 (9) |
| Grade 4 | 7 (12) | 3 (4) | 8 (5) | 18 (6) |
| Grade 5 |
0 (0) |
0 (0) |
0 (0) |
0 (0) |
|
Frequency by preferred term,
N
(%) | ||||
| Diarrhoea | 7 (70) | 8 (80) | 18 (78) | 33 (77) |
| Fatigue | 6 (60) | 7 (70) | 13 (57) | 26 (61) |
| Nausea | 5 (50) | 4 (40) | 16 (70) | 25 (58) |
| Vomiting | 3 (30) | 5 (50) | 14 (61) | 22 (51) |
| Neutropenia | 6 (60) | 5 (50) | 6 (26) | 17 (40) |
| Oedema peripheral | 4 (40) | 6 (60) | 7 (30) | 17 (40) |
| Decreased appetite | 1 (10) | 4 (40) | 10 (44) | 15 (35) |
| Dehydration | 3 (30) | 1 (10) | 11 (48) | 15 (35) |
| Anaemia | 2 (20) | 2 (20) | 9 (39) | 13 (30) |
| Constipation | 2 (30) | 3 (30) | 8 (35) | 13 (30) |
| Alopecia | 2 (20) | 6 (60) | 4 (17) | 12 (28) |
| Asthenia | 1 (10) | 4 (40) | 6 (26) | 11 (26) |
| Pyrexia | 1 (10) | 4 (40) | 6 (26) | 11 (26) |
| Cough | 2 (20) | 5 (50) | 3 (13) | 10 (23) |
| Bone pain | 0 (0) | 4 (40) | 5 (22) | 9 (21) |
| Hypokalemia | 2 (20) | 1 (10) | 6 (26) | 9 (21) |
| Stomatitis | 1 (10) | 4 (40) | 4 (17) | 9 (21) |
| Dysgeusia | 2 (20) | 3 (30) | 3 (13) | 8 (19) |
| Arthralgia | 0 (0) | 2 (20) | 5 (22) | 7 (16) |
| Dizziness | 1 (10) | 2 (20) | 4 (17) | 7 (16) |
| Epistaxis | 1 (10) | 2 (20) | 4 (17) | 7 (16) |
| Oropharyngeal pain | 1 (10) | 1 (10) | 5 (22) | 7 (16) |
*Preferred terms were coded using Medical Dictionary for Regulatory Activities version 13.0.