Table. Targeted Adverse Events Reported Until the Time-to-Treatment Failure Event, According to Treatment Assignmenta.
| Adverse event | Maximum AE grade, No. (%) | |||||||
|---|---|---|---|---|---|---|---|---|
| Patients receiving paclitaxel (n = 63) | Patients receiving VEX (n = 70) | |||||||
| 1 | 2 | 3 | 4 | 1 | 2 | 3 | 4 | |
| Anemia | 20 (31.7) | 21 (33.3) | 2 (3.2) | NR | 19 (27.1) | 6 (8.6) | 4 (5.7) | NR |
| Alopecia | 2 (3.2) | 19 (30.2) | NR | NR | NR | 2 (2.9) | NR | NR |
| Palmar-plantar erythrodysesthesia syndrome | 3 (4.8) | 2 (3.2) | NR | NR | 4 (5.7) | 1 (1.4) | 4 (5.7) | NR |
| Anaphylaxis | NR | NR | 1 (1.6) | NR | NR | NR | NR | NR |
| Allergic reaction | 2 (3.2) | 4 (6.3) | 1 (1.6) | NR | 1 (1.4) | 1 (1.4) | NR | NR |
| Anorexia | NR | 1 (1.6) | NR | NR | 1 (1.4) | 4 (5.7) | 1 (1.4) | NR |
| Diarrhea | 8 (12.7) | 4 (6.3) | NR | NR | 15 (21.4) | 7 (10.0) | 1 (1.4) | NR |
| Constipation | 9 (14.3) | 4 (6.3) | NR | NR | 4 (5.7) | 2 (2.9) | NR | NR |
| Mucositis oral | 5 (7.9) | 2 (3.2) | NR | NR | 4 (5.7) | 1 (1.4) | NR | NR |
| Nausea | 12 (19.0) | 5 (7.9) | NR | NR | 19 (27.1) | 9 (12.9) | 2 (2.9) | NR |
| Vomiting | 3 (4.8) | 6 (9.5) | NR | NR | 7 (10.0) | 1 (1.4) | 1 (1.4) | NR |
| Peripheral sensory neuropathy | 16 (25.4) | 14 (22.2) | 5 (7.9) | NR | 4 (5.7) | NR | NR | NR |
| Infection | 5 (7.9) | 14 (22.2) | 1 (1.6) | NR | 2 (2.9) | 9 (12.9) | 2 (2.9) | NR |
| Arthralgia and/or myalgia | 13 (20.6) | 7 (11.1) | 1 (1.6) | NR | 13 (18.6) | 4 (5.7) | NR | NR |
| Injection site reaction | NR | 1 (1.6) | NR | NR | NR | NR | NR | NR |
| Fatigue | 17 (27.0) | 17 (27.0) | 1 (1.6) | NR | 17 (24.3) | 12 (17.1) | 5 (7.1) | NR |
| Acute coronary syndrome | NR | 1 (1.6) | NR | NR | NR | NR | NR | NR |
| Supraventricular tachycardia | 1 (1.6) | 1 (1.6) | 1 (1.6) | NR | 2 (2.9) | 1 (1.4) | 1 (1.4) | NR |
| Ventricular arrhythmia | 1 (1.6) | NR | NR | NR | NR | NR | NR | NR |
| Optic nerve disorder | 1 (1.6) | NR | NR | NR | 1 (1.4) | NR | NR | NR |
| Thrombocytopenia | 1 (1.6) | NR | NR | NR | 8 (11.4) | NR | NR | NR |
| Neutrophil count decreased | 2 (3.2) | 10 (15.9) | 8 (12.7) | 1 (1.6) | 2 (2.9) | 7 (10.0) | 11 (15.7) | 9 (12.9) |
| Aspartate aminotransferase increased | 16 (25.4) | 3 (4.8) | NR | NR | 12 (17.1) | 1 (1.4) | 3 (4.3) | NR |
| Any targetedb AE | 4 (6.3) | 40 (63.5) | 17 (27.0) | 1 (1.6) | 14 (20.0) | 21 (30.0) | 21 (30.0) | 9 (12.9) |
| Other grade 3 or 4 AE | NR | NR | 7 (11.1) | 1 (1.6) | NR | NR | 18 (25.7) | 5 (7.1) |
Abbreviations: AE, adverse event; NR, none reported.
a
Data on AEs were collected without regard to trial medication, and AEs were assessed according to the terminology and grading of severity used the Common Terminology Criteria for Adverse Events dictionary, version 4. NR indicates that no AEs of that grade were reported. There were 3 deaths during study treatment, 1 in the paclitaxel group and 2 in the VEX group (see eAppendix 2 in Supplement 2).
b
Two targeted AEs, heart failure and sinus bradycardia, were not reported for any patients and are not included here.