Adverse events graded according to National Cancer Institute toxicity criteria
| Toxicity . | Patients, n (%) . | P . | |
|---|---|---|---|
| TD (n = 134) . | MP (n = 134) . | ||
| Hematologic | |||
| Anemia | 6 (4) | 15 (11) | .067 |
| Leukopenia | 4 (3) | 20 (15) | < .001 |
| Thrombopenia | 2 (1) | 16 (12) | < .001 |
| Infection | 18 (13) | 11 (8) | .237 |
| Thromboembolic | |||
| DVT | 13 (10) | 5 (4) | .085 |
| Pulmonary embolism | 4 (3) | 4 (3) | 1.0 |
| Fatigue | 15 (11) | 8 (6) | .190 |
| Neuropathy | 10 (7) | 2 (1) | < .001* |
| Neuropathy G1+2) | 87 (65) | 43 (32) | |
| Constipation | 10 (7) | 4 (3) | < .001* |
| Constipation G1+2) | 35 (26) | 13 (10) | |
| Nausea or vomiting | 8 (6) | 4 (3) | .377 |
| Renal creatinine increase) | 6 (4) | 1 (1) | .120 |
| Pulmonary | |||
| Dyspnea | 4 (3) | 2 (1) | .684 |
| Pulmonary edema | 4 (3) | 0 (0) | .122 |
| Cardiac | |||
| Cardiotoxicity | 4 (3) | 4 (3) | 1.0 |
| Hypertension | 1 (1) | 1 (1) | 1.0 |
| Edema | 1 (1) | 0 (0) | .999 |
| Skin | |||
| Exanthema or rash | 2 (1) | 2 (1) | 1.0 |
| Alopecia | 2 (1) | 0 (0) | .498 |
| Glaucoma | 2 (1) | 0 (0) | .498 |
| Psychological disturbance | 2 (1) | 1 (1) | < .001* |
| Psychological disturbance (G1+2) | 48 (36) | 24 (18) | |
| Bleeding | 1 (1) | 1 (1) | 1.0 |
| Diarrhea | 1 (1) | 1 (1) | 1.0 |
| Hyperglycemia | 1 (1) | 1 (1) | 1.0 |
| Reported grade 3 to 4 events ≥1) | 121 | 104 | |
| Toxicity . | Patients, n (%) . | P . | |
|---|---|---|---|
| TD (n = 134) . | MP (n = 134) . | ||
| Hematologic | |||
| Anemia | 6 (4) | 15 (11) | .067 |
| Leukopenia | 4 (3) | 20 (15) | < .001 |
| Thrombopenia | 2 (1) | 16 (12) | < .001 |
| Infection | 18 (13) | 11 (8) | .237 |
| Thromboembolic | |||
| DVT | 13 (10) | 5 (4) | .085 |
| Pulmonary embolism | 4 (3) | 4 (3) | 1.0 |
| Fatigue | 15 (11) | 8 (6) | .190 |
| Neuropathy | 10 (7) | 2 (1) | < .001* |
| Neuropathy G1+2) | 87 (65) | 43 (32) | |
| Constipation | 10 (7) | 4 (3) | < .001* |
| Constipation G1+2) | 35 (26) | 13 (10) | |
| Nausea or vomiting | 8 (6) | 4 (3) | .377 |
| Renal creatinine increase) | 6 (4) | 1 (1) | .120 |
| Pulmonary | |||
| Dyspnea | 4 (3) | 2 (1) | .684 |
| Pulmonary edema | 4 (3) | 0 (0) | .122 |
| Cardiac | |||
| Cardiotoxicity | 4 (3) | 4 (3) | 1.0 |
| Hypertension | 1 (1) | 1 (1) | 1.0 |
| Edema | 1 (1) | 0 (0) | .999 |
| Skin | |||
| Exanthema or rash | 2 (1) | 2 (1) | 1.0 |
| Alopecia | 2 (1) | 0 (0) | .498 |
| Glaucoma | 2 (1) | 0 (0) | .498 |
| Psychological disturbance | 2 (1) | 1 (1) | < .001* |
| Psychological disturbance (G1+2) | 48 (36) | 24 (18) | |
| Bleeding | 1 (1) | 1 (1) | 1.0 |
| Diarrhea | 1 (1) | 1 (1) | 1.0 |
| Hyperglycemia | 1 (1) | 1 (1) | 1.0 |
| Reported grade 3 to 4 events ≥1) | 121 | 104 | |
Grade 3 to 4 (unless otherwise specified) adverse events during induction therapy are assumed.
DVT indicates deep vein thrombosis.
Cochrane-Armitage trend test.