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Table 2 Treatment-Related Toxicities (Patient Number)

From: A randomized phase II trial of mitoxantrone, estramustine and vinorelbine or bcl-2 modulation with 13-cis retinoic acid, interferon and paclitaxel in patients with metastatic castrate-resistant prostate cancer: ECOG 3899

  Arm A (n = 35) Arm B (n = 35)   Arm A (n = 35) Arm B (n = 35)
  Grade Grade   Grade Grade
Toxicity Type 1, 2 3 4 1, 2 3 4 Toxicity Type 1, 2 3 4 1, 2 3 4
Allergic reaction - - - - 2 - Stomatitis 5 - - 6 1 -
Allergic rhinitis 1 - - 1 - - Taste disturbance 6 - - 4 - -
Hemoglobin 31 3 1 28 5 - Vomiting 10 - - 9 1 -
Leukocytes 9 18 8 22 4 2 Diarrhea 5 2 - 11 - -
Neutrophils 4 11 18 16 7 2 GI-other 2 - - - - -
Platelets 20 5 - 13 1 - Hematuria - 1 - 1 - -
Transfusion: - 1 - - 4 - Rectal bleeding - - - - 1 -
Sinus tachycardia - 1 - - 1 - Alkaline phos 13 2 - 15 3 -
Supraventricular - - - - 1 - Bilirubin 1 1 1 5 - -
Cardiac-ischemia - - - 1 - - Hypoalbuminemia - - - 1 - -
Cardiac-left vent - 1 - - - - SGOT 7 - - 10 1 -
Edema 9 - - 4 - - SGPT 6 - - 7 1 -
Hypertension 2 - - 1 - - Febrile neutropenia - 4 - - 1 -
Hypotension 1 - - 3 - - Infection w/neutro - 1 1 - - -
Phlebitis 1 - - - - - Infectionw/oneutro 2   - 1 1 -
Thrombosis/emb - 6 1 - 1 - Hypercalcemia 1 - - 1 - -
Fatigue 21 7 1 23 7 1 Hyperglycemia 2 1 - 3 1 -
Fever - - - 7 1 - Hyperkalemia 1 - - 1 - -
Rigors/chills 1 - - 10 - - Hypertrig 6 - - 22 1 -
Sweating - - - 2 - - Hyponatremia 1 - - 1 - -
Weight gain 1 - - - - - Metabolic-other 1 - - - - -
Weight loss 14 - - 7 2 - Muscle weakness 1 - - - 1 -
PTT - 1 - - - - Ataxia - - - 1 - -
PT 1 1 - - - - Dizziness 3 - - 3 - -
Alopecia 8 - - 11 - - Hallucinations - - - - 1 -
Bruising 2 - - - - - Insomnia 2 - - 7 - -
Dry skin 1 - - 3 - - Depression 4 1 - 2 - -
Flushing - - - 3 - - Euphoria 1 - - - - -
Injection site 2 - - - - - Neuropathy-motor 2 - - 1 - -
Pruritus 2 - - - - - Neuro-sensory 6 - - 9 - -
Rash 4 - - 2 - - Vertigo 1 - - - - -
Skin-other 2 - - - - - Neurologic-other 1 - - - - -
Gynecomastia 3 - - - - - Tearing 1 - - - - -
Hot flashes 3 - - 1 - - Blurred vision 1 - - 3 - -
Endocrine-other - - - 1 - - Abdominal pain 2 - - - - -
Anorexia 16 1 - 14 2 - Arthralgia 2 - - 3 - -
Constipation 12 1 - 8 - - Bone pain 1 - - 5 - -
Dehydration - 1 - 2 1 - Chest pain 1 - - - - -
Dyspepsia 3 - - - - - Headache 2 - - 8 - -
Dysphagia 1 - - 1 - - Myalgia 4 - - 11 - -
Flatulence 1 - - 1 - - Pain-other 2 - - - - -
Mouth dryness - - - 3 - - Cough 5 - - - - -
Nausea 21 - - 18 1 - Dyspnea 7 - 1 11 1 -
Sense of smell 1 - - - - - Hypoxia - - - - 1 -
Creatinine/GU 8 - 1 3 - 2 Pulmonary-other - - - 3 1 -