Table 2

Adverse events graded according to National Cancer Institute toxicity criteria

ToxicityPatients, n (%)P
TD (n = 134)MP (n = 134)
Hematologic
    Anemia6 (4)15 (11).067
    Leukopenia4 (3)20 (15)< .001
    Thrombopenia2 (1)16 (12)< .001
Infection18 (13)11 (8).237
Thromboembolic
    DVT13 (10)5 (4).085
    Pulmonary embolism4 (3)4 (3)1.0
Fatigue15 (11)8 (6).190
Neuropathy10 (7)2 (1)< .001*
    Neuropathy G1+2)87 (65)43 (32)
Constipation10 (7)4 (3)< .001*
    Constipation G1+2)35 (26)13 (10)
Nausea or vomiting8 (6)4 (3).377
Renal creatinine increase)6 (4)1 (1).120
Pulmonary
    Dyspnea4 (3)2 (1).684
    Pulmonary edema4 (3)0 (0).122
Cardiac
    Cardiotoxicity4 (3)4 (3)1.0
    Hypertension1 (1)1 (1)1.0
    Edema1 (1)0 (0).999
Skin
    Exanthema or rash2 (1)2 (1)1.0
    Alopecia2 (1)0 (0).498
Glaucoma2 (1)0 (0).498
Psychological disturbance2 (1)1 (1)< .001*
    Psychological disturbance (G1+2)48 (36)24 (18)
Bleeding1 (1)1 (1)1.0
Diarrhea1 (1)1 (1)1.0
Hyperglycemia1 (1)1 (1)1.0
Reported grade 3 to 4 events ≥1)121104
  • Grade 3 to 4 (unless otherwise specified) adverse events during induction therapy are assumed.

  • DVT indicates deep vein thrombosis.

  • * Cochrane-Armitage trend test.