Treatment discontinuations due to adverse drug reactions occurred in 18% of patients who received JEVTANA and 8% of patients who received mitoxantrone. The most common adverse reactions leading to treatment discontinuation in the JEVTANA group were neutropenia and renal failure. Dose reductions were reported in 12% of JEVTANA-treated patients and 4% of mitoxantrone-treated patients. Dose delays were reported in 28% of JEVTANA-treated patients and 15% of mitoxantrone-treated patients.

Table 2 – Incidence of Reported Adverse ReactionsGraded using NCI CTCAE version 3 and Hematologic Abnormalities in ≥ 5% of Patients Receiving JEVTANA in Combination with Prednisone or Mitoxantrone in Combination with Prednisone  JEVTANA 25 mg/m2 every 3 weeks with prednisone 10 mg daily
n=371 Mitoxantrone 12 mg/m2 every 3 weeks with prednisone 10 mg daily
n=371
 Grade 1–4
n (%) Grade 3–4
n (%) Grade 1–4
n (%) Grade 3–4
n (%)
Any Adverse Reaction     
Blood and Lymphatic System Disorders 
  NeutropeniaBased on laboratory values, cabazitaxel: n =369, mitoxantrone: n = 370.  347 (94%) 303 (82%) 325 (87%) 215 (58%)
  Febrile Neutropenia 27 (7%) 27 (7%) 5 (1%) 5 (1%)
  Anemia  361 (98%) 39 (11%) 302 (82%) 18 (5%)
  Leukopenia  355 (96%) 253 (69%) 343 (93%) 157 (42%)
  Thrombocytopenia  176 (48%) 15 (4%) 160 (43%) 6 (2%)
Cardiac Disorders 
  ArrhythmiaIncludes atrial fibrillation, atrial flutter, atrial tachycardia, atrioventricular block complete, bradycardia, palpitations, supraventricular tachycardia, tachyarrhythmia, and tachycardia.  18 (5%) 4 (1%) 6 (2%) 1 (< 1%)
Gastrointestinal Disorders 
  Diarrhea 173 (47%) 23 (6%) 39 (11%) 1 (< 1%)
  Nausea 127 (34%) 7 (2%) 85 (23%) 1 (< 1%)
  Vomiting 83 (22%) 6 (2%) 38 (10%) 0
  Constipation 76 (20%) 4 (1%) 57 (15%) 2 (< 1%)
  Abdominal PainIncludes abdominal discomfort, abdominal pain lower, abdominal pain upper, abdominal tenderness, and GI pain.  64 (17%) 7 (2%) 23 (6%) 0
  DyspepsiaIncludes gastroesophageal reflux disease and reflux gastritis.  36 (10%) 0 9 (2%) 0
General Disorders and Administration Site Conditions 
  Fatigue 136 (37%) 18 (5%) 102 (27%) 11 (3%)
  Asthenia 76 (20%) 17 (5%) 46 (12%) 9 (2%)
  Pyrexia 45 (12%) 4 (1%) 23 (6%) 1 (< 1%)
  Peripheral Edema 34 (9%) 2 (< 1%) 34 (9%) 2 (< 1%)
  Mucosal Inflammation 22 (6%) 1 (< 1%) 10 (3%) 1 (< 1%)
  Pain 20 (5%) 4 (1%) 18 (5%) 7 (2%)
Infections and Infestations 
  Urinary Tract InfectionIncludes urinary tract infection enterococcal and urinary tract infection fungal.  29 (8%) 6 (2%) 12 (3%) 4 (1%)
Investigations 
  Weight Decreased 32 (9%) 0 28 (8%) 1 (< 1%)
Metabolism and Nutrition Disorders 
  Anorexia 59 (16%) 3 (< 1%) 39 (11%) 3 (< 1%)
  Dehydration 18 (5%) 8 (2%) 10 (3%) 3 (< 1%)
Musculoskeletal and Connective Tissue Disorders 
  Back Pain 60 (16%) 14 (4%) 45 (12%) 11 (3%)
  Arthralgia 39 (11%) 4 (1%) 31 (8%) 4 (1%)
  Muscle Spasms 27 (7%) 0 10 (3%) 0
Nervous System Disorders 
  Periphera