Table 2. Treatment-related adverse events of interest and those that occurred in ⩾10% of the modified intent-to-treat population (N=4543).
| Adverse event | Grade 1/2, n (%) | Grade 3/4, n (%) | Total, N (%)a |
|---|---|---|---|
|
Non-haematologic | |||
| Diarrhoea | 1885 (41) | 237 (5) | 2122 (47) |
| Fatigue | 1406 (31) | 403 (9) | 1809 (40) |
| Nausea | 1517 (33) | 111 (2) | 1629 (36)b |
| Decreased appetite | 1295 (29) | 102 (2) | 1398 (31)b |
| Mucosal inflammation | 1195 (26) | 137 (3) | 1332 (29) |
| Stomatitis | 1144 (25) | 133 (3) | 1277 (28) |
| Vomiting | 1107 (24) | 143 (3) | 1250 (28) |
| Hand–foot syndrome | 909 (20) | 311 (7) | 1221 (27)b |
| Dysgeusia | 1124 (25) | 28 (1) | 1152 (25) |
| Hypertension | 837 (18) | 267 (6) | 1104 (24) |
| Asthenia | 713 (16) | 306 (7) | 1021 (22)b,c |
| Dyspepsia | 828 (18) | 16 (<1) | 844 (19) |
| Rash | 734 (16) | 38 (1) | 772 (17) |
| Constipation | 628 (14) | 12 (<1) | 641 (14)b |
| Epistaxis | 585 (13) | 31 (1) | 616 (14) |
| Yellow skin | 588 (13) | 5 (<1) | 593 (13) |
| Headache | 495 (11) | 26 (1) | 521 (11) |
| Hypothyroidism | 489 (11) | 27 (1) | 516 (11) |
| Skin discolouration | 487 (11) | 4 (<1) | 491 (11) |
| Hair colour changes | 481 (11) | 9 (<1) | 490 (11) |
| Dry skin | 458 (10) | 3 (<1) | 461 (10) |
| Pain in extremity | 413 (9) | 42 (1) | 455 (10) |
| ALT increased | 94 (2) | 23 (1) | 117 (3) |
| Cardiac failure | 0 | 13 (<1) | 17 (<1) |
| Congestive cardiac failure | 1 (<1) | 13 (<1) | 14 (<1) |
|
Haematologicd | |||
| Thrombocytopenia | 741 (16) | 440 (10) | 1182 (26) |
| Neutropenia | 486 (11) | 315 (7) | 801 (18) |
| Anaemia | 594 (13) | 203 (4) | 798 (18)b |
| Leukopenia | 414 (9) | 97 (2) | 511 (11) |
Abbreviation: ALT=alanine aminotransferase.
Eighty patients (2%) died from treatment-related adverse events (data not shown, except for cardiac failure (n=4) and asthenia and thrombocytopenia (both n=1)).
Grade missing for one patient.
Includes one patient with grade 5 asthenia, a 55-year-old female with a medical history of hypertension and Hodgkin's disease, who had baseline Eastern Cooperative Oncology Group performance status of 2, and massive liver metastases, and pulmonary and mediastinal metastases before the start of the study; in addition to asthenia, other treatment-related serious adverse events experienced by the patient included dyspnoea, thrombopenia, hypotension, and hypothermia.
Related haematological adverse events with different preferred terms were collected and pooled.