Table 4.
Summary of more frequent treatment-emergent adverse events occurring in at least 10 % of the patients in the safety population
| PT n (%) | PTX (n = 46) | PWI (n = 46) | PTI (n = 48) | |||
|---|---|---|---|---|---|---|
| All grades | Grade 3–4 | All grades | Grade 3–4 | All grades | Grade 3–4 | |
| Any TEAE | 43 (94 %) | 5 (11 %) | 45 (98 %) | 5 (11 %) | 47 (98 %) | 16 (33 %) |
| Nasopharyngitis | 8 (17 %) | 0 | 7 (15 %) | 0 | 6 (13 %) | 0 |
| Neutropenia | 2 (4 %) | 2 (4 %) | 3 (7 %) | 0 | 5 (10 %) | 5 (10 %) |
| Peripheral sensory neuropathy | 13 (28 %) | 0 | 10 (22 %) | 0 | 14 (29 %) | 0 |
| Paresthesia | 8 (17 %) | 0 | 5 (11 %) | 0 | 4 (8 %) | 0 |
| Conjunctivitis | 3 (7 %) | 0 | 2 (4 %) | 0 | 5 (10 %) | |
| Vertigo | 1 (2 %) | 0 | 0 | 0 | 5 (10 %) | 0 |
| Diarrhea | 8 (17 %) | 0 | 18 (39 %) | 1 (2 %) | 14 (29 %) | 0 |
| Nausea | 4 (9 %) | 0 | 7 (15 %) | 0 | 11 (23 %) | 0 |
| Stomatitis | 4 (9 %) | 0 | 6 (13 %) | 0 | 8 (17 %) | 0 |
| Constipation | 5 (11 %) | 0 | 7 (15 %) | 0 | 5 (10 %) | 0 |
| Alopecia | 34 (74 %) | NA | 28 (61 %) | NA | 33 (69 %) | NA |
| Rash | 7 (15 %) | 0 | 3 (7 %) | 0 | 6 (13 %) | 0 |
| Myalgia | 6 (13 %) | 0 | 5 (11 %) | 0 | 3 (6 %) | 0 |
| Arthralgia | 6 (13 %) | 0 | 5 (11 %) | 0 | 1 (2.1 %) | 0 |
| Asthenia | 26 (57 %) | 0 | 21 (46 %) | 0 | 24 (50 %) | 0 |
| Fatigue | 8 (17 %) | 0 | 6 (13 %) | 0 | 6 (13 %) | 0 |
| Peripheral edema | 4 (9 %) | 0 | 1 (2 %) | 0 | 5 (10 %) | 0 |
Only rows with frequency of at least 5 % in at least one column are shown