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Safety and Efficacy Study of MDV3100 in Patients With Castration-Resistant Prostate Cancer Who Have Been Previously Treated With Docetaxel-based Chemotherapy (AFFIRM)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Astellas Pharma Inc
Information provided by (Responsible Party):
Medivation, Inc.
ClinicalTrials.gov Identifier:
NCT00974311
First received: September 9, 2009
Last updated: February 22, 2014
Last verified: February 2014
Results First Received: September 28, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Castration-Resistant Prostate Cancer
Interventions: Drug: Enzalutamide
Drug: Placebo

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Multicenter, global clinical trial

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Patients were randomized 2:1 to receive either Enzalutamide or placebo

Reporting Groups
  Description
Enzalutamide Participants received 160 mg Enzalutamide orally per day. Treatment continued until unacceptable toxicity, confirmed disease progression and the patient was scheduled to initiate a new systemic antineoplastic therapy, death, or withdrawal.
Placebo Participants received placebo tablets orally once a day. Treatment continued until unacceptable toxicity, confirmed disease progression and the patient was scheduled to initiate a new systemic antineoplastic therapy, death, or withdrawal.

Participant Flow:   Overall Study
    Enzalutamide   Placebo
STARTED   800   399 
COMPLETED   254 [1]   163 [1] 
NOT COMPLETED   546   236 
Lost to Follow-up                1                1 
Death                305                211 
Withdrawal of consent                9                5 
Continuing Treatment                231                19 
[1] Indicates participants continuing long-term follow-up as of 25 September 2011.



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Enzalutamide Participants received 160 mg Enzalutamide orally per day. Treatment continued until unacceptable toxicity, confirmed disease progression and the patient was scheduled to initiate a new systemic antineoplastic therapy, death, or withdrawal.
Placebo Participants received placebo tablets orally once a day. Treatment continued until unacceptable toxicity, confirmed disease progression and the patient was scheduled to initiate a new systemic antineoplastic therapy, death, or withdrawal.
Total Total of all reporting groups

Baseline Measures
   Enzalutamide   Placebo   Total 
Overall Participants Analyzed 
[Units: Participants]
 800   399   1199 
Age 
[Units: Participants]
     
<=18 years   0   0   0 
Between 18 and 65 years   232   130   362 
>=65 years   568   269   837 
Age 
[Units: Years]
Mean (Standard Deviation)
 68.8  (7.96)   68.6  (8.39)   68.7  (8.11) 
Gender 
[Units: Participants]
     
Female   0   0   0 
Male   800   399   1199 
Region of Enrollment 
[Units: Participants]
     
United States   181   107   288 
Spain   23   13   36 
Austria   15   10   25 
Chile   6   5   11 
United Kingdom   82   50   132 
Italy   20   10   30 
France   193   80   273 
Canada   82   25   107 
Argentina   7   3   10 
Belgium   27   18   45 
Poland   7   4   11 
Australia   60   33   93 
South Africa   3   3   6 
Germany   62   24   86 
Netherlands   32   14   46 


  Outcome Measures
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1.  Primary:   Overall Survival   [ Time Frame: During study period (up to 3 years) ]

2.  Secondary:   Radiographic Progression-free Survival   [ Time Frame: During study period (up to 3 years) ]

3.  Secondary:   Time to First Skeletal-related Event   [ Time Frame: During study period (up to 3 years) ]

4.  Secondary:   Functional Assessment of Cancer Therapy - Prostate (FACT-P)   [ Time Frame: During study period (up to 3 years) ]

5.  Secondary:   Time to Prostate-specific Antigen (PSA) Progression   [ Time Frame: Baseline and at every study visit from week 13 while on study drug (up to 3 years) ]

6.  Secondary:   Percentage of Patients With Pain Palliation   [ Time Frame: During study period (up to 3 years) ]

7.  Secondary:   Percentage of Patients With Prostate Specific Antigen (PSA) Response   [ Time Frame: During study period (up to 3 years) ]

8.  Secondary:   Percentage of Patients With Soft-tissue Objective Response   [ Time Frame: During study period (up to 3 years) ]

9.  Secondary:   European Quality of Life Five-Domain Scale (EQ-5D)   [ Time Frame: At Week 13 visit ]
Results not yet reported.   Anticipated Reporting Date:   12/2013   Safety Issue:   No

10.  Secondary:   Circulating Tumor Cell (CTC) Conversion Rate   [ Time Frame: During study period (up to 3 years) ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No


  Serious Adverse Events
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Time Frame No text entered.
Additional Description No text entered.

Reporting Groups
  Description
Enzalutamide Participants received 160 mg Enzalutamide orally per day. Treatment continued until unacceptable toxicity, confirmed disease progression and the patient was scheduled to initiate a new systemic antineoplastic therapy, death, or withdrawal.
Placebo Participants received placebo tablets orally once a day. Treatment continued until unacceptable toxicity, confirmed disease progression and the patient was scheduled to initiate a new systemic antineoplastic therapy, death, or withdrawal.

Serious Adverse Events
    Enzalutamide   Placebo
Total, serious adverse events     
# participants affected / at risk   268/800 (33.50%)   154/399 (38.60%) 
Blood and lymphatic system disorders     
Anaemia † 1     
# participants affected / at risk   21/800 (2.63%)   12/399 (3.01%) 
Anaemia of malignant disease † 1     
# participants affected / at risk   2/800 (0.25%)   1/399 (0.25%) 
Disseminated intravascular coagulation † 1     
# participants affected / at risk   1/800 (0.13%)   0/399 (0.00%) 
Pancytopenia † 1     
# participants affected / at risk   0/800 (0.00%)   1/399 (0.25%) 
Thrombocytopenia † 1     
# participants affected / at risk   1/800 (0.13%)   0/399 (0.00%) 
Leukocytosis † 1     
# participants affected / at risk   0/800 (0.00%)   1/399 (0.25%) 
Cardiac disorders     
Cardiac failure † 1     
# participants affected / at risk   2/800 (0.25%)   2/399 (0.50%) 
Angina pectoris † 1     
# participants affected / at risk   2/800 (0.25%)   1/399 (0.25%) 
Acute myocardial infarction † 1     
# participants affected / at risk   2/800 (0.25%)   0/399 (0.00%) 
Cardiac failure congestive † 1     
# participants affected / at risk   2/800 (0.25%)   0/399 (0.00%) 
Atrial flutter † 1     
# participants affected / at risk   1/800 (0.13%)   1/399 (0.25%) 
Bradycardia † 1     
# participants affected / at risk   0/800 (0.00%)   1/399 (0.25%) 
Cardiogenic shock † 1     
# participants affected / at risk   0/800 (0.00%)   1/399 (0.25%) 
Left ventricular failure † 1     
# participants affected / at risk   1/800 (0.13%)   0/399 (0.00%) 
Mitral valve incompetance † 1     
# participants affected / at risk   0/800 (0.00%)   1/399 (0.25%) 
Ventricular fibrillation † 1     
# participants affected / at risk   0/800 (0.00%)   1/399 (0.25%) 
Arrhythmia supraventricular † 1     
# participants affected / at risk   1/800 (0.13%)   0/399 (0.00%) 
Atrial fibrillation † 1     
# participants affected / at risk   1/800 (0.13%)   0/399 (0.00%) 
Atrioventricular block complete † 1     
# participants affected / at risk   1/800 (0.13%)   0/399 (0.00%) 
Myocardial ischaemia † 1     
# participants affected / at risk   1/800 (0.13%)   0/399 (0.00%) 
Myocardial infarction † 1     
# participants affected / at risk   0/800 (0.00%)   2/399 (0.50%) 
Congenital, familial and genetic disorders     
Adenomatous polyposis coli † 1     
# participants affected / at risk   0/800 (0.00%)   1/399 (0.25%) 
Ear and labyrinth disorders     
Ear pain † 1     
# participants affected / at risk   0/800 (0.00%)   1/399 (0.25%) 
Vertigo † 1     
# participants affected / at risk   0/800 (0.00%)   1/399 (0.25%) 
Endocrine disorders     
Adrenal insufficiency † 1     
# participants affected / at risk   0/800 (0.00%)   1/399 (0.25%) 
Eye disorders     
Retinal detachment † 1     
# participants affected / at risk   0/800 (0.00%)   1/399 (0.25%) 
Papilloedema † 1     
# participants affected / at risk   0/800 (0.00%)   1/399 (0.25%) 
Visual acuity reduced † 1     
# participants affected / at risk   1/800 (0.13%)   0/399 (0.00%) 
Visual impairment † 1     
# participants affected / at risk   1/800 (0.13%)   0/399 (0.00%) 
Gastrointestinal disorders     
Vomiting † 1     
# participants affected / at risk   2/800 (0.25%)   8/399 (2.01%) 
Nausea † 1     
# participants affected / at risk   5/800 (0.63%)   3/399 (0.75%) 
Constipation † 1     
# participants affected / at risk   5/800 (0.63%)   3/399 (0.75%) 
Rectal haemorrhage † 1     
# participants affected / at risk   2/800 (0.25%)   3/399 (0.75%) 
Abdominal pain † 1     
# participants affected / at risk   1/800 (0.13%)   2/399 (0.50%) 
Diarrhoea † 1     
# participants affected / at risk   3/800 (0.38%)   0/399 (0.00%) 
Small intestinal obstruction † 1     
# participants affected / at risk   3/800 (0.38%)   0/399 (0.00%) 
Colonic obstruction † 1     
# participants affected / at risk   2/800 (0.25%)   0/399 (0.00%) 
Faecaloma † 1     
# participants affected / at risk   0/800 (0.00%)   2/399 (0.50%) 
Gastrointestinal haemorrhage † 1     
# participants affected / at risk   1/800 (0.13%)   1/399 (0.25%) 
Intestinal obstruction † 1     
# participants affected / at risk   1/800 (0.13%)   1/399 (0.25%) 
Abdominal pain lower † 1     
# participants affected / at risk   1/800 (0.13%)   0/399 (0.00%) 
Colitis † 1     
# participants affected / at risk   1/800 (0.13%)   0/399 (0.00%) 
Gastric ulcer haemorrhage † 1     
# participants affected / at risk   1/800 (0.13%)   0/399 (0.00%) 
Gastrointestinal obstruction † 1     
# participants affected / at risk   0/800 (0.00%)   1/399 (0.25%) 
Haematochezia † 1     
# participants affected / at risk   0/800 (0.00%)   1/399 (0.25%) 
Intestinal perforation † 1     
# participants affected / at risk   1/800 (0.13%)   0/399 (0.00%) 
Large intestine perforation † 1     
# participants affected / at risk   0/800 (0.00%)   1/399 (0.25%) 
Pancreatitis † 1     
# participants affected / at risk   1/800 (0.13%)   0/399 (0.00%) 
Proctalgia † 1     
# participants affected / at risk   1/800 (0.13%)   0/399 (0.00%) 
Retroperitoneal haemorrhage † 1     
# participants affected / at risk   1/800 (0.13%)   0/399 (0.00%) 
Intestinal mass † 1     
# participants affected / at risk   0/800 (0.00%)   1/399 (0.25%) 
Pancreatitis acute † 1     
# participants affected / at risk   0/800 (0.00%)   1/399 (0.25%) 
Peptic ulcer † 1     
# participants affected / at risk   1/800 (0.13%)   0/399 (0.00%) 
General disorders     
General physical health deterioration † 1     
# participants affected / at risk   17/800 (2.13%)   8/399 (2.01%) 
Asthenia † 1     
# participants affected / at risk   3/800 (0.38%)   3/399 (0.75%) 
Pain † 1     
# participants affected / at risk   5/800 (0.63%)   1/399 (0.25%) 
Fatigue † 1     
# participants affected / at risk   2/800 (0.25%)   3/399 (0.75%) 
Pyrexia † 1     
# participants affected / at risk   2/800 (0.25%)   5/399 (1.25%) 
Oedema peripheral † 1     
# participants affected / at risk   1/800 (0.13%)   3/399 (0.75%) 
Malaise † 1     
# participants affected / at risk   2/800 (0.25%)   2/399 (0.50%) 
Chest pain † 1     
# participants affected / at risk   1/800 (0.13%)   1/399 (0.25%) 
Death † 1     
# participants affected / at risk   1/800 (0.13%)   0/399 (0.00%) 
Euthanasia † 1     
# participants affected / at risk   0/800 (0.00%)   1/399 (0.25%) 
General symptom † 1     
# participants affected / at risk   1/800 (0.13%)   0/399 (0.00%) 
Immune system disorders     
Anaphylactic reaction † 1     
# participants affected / at risk   1/800 (0.13%)   0/399 (0.00%) 
Infections and infestations     
Pneumonia † 1     
# participants affected / at risk   12/800 (1.50%)   5/399 (1.25%) 
Urinary tract infection † 1     
# participants affected / at risk   7/800 (0.88%)   5/399 (1.25%) 
Urosepsis † 1     
# participants affected / at risk   4/800 (0.50%)   1/399 (0.25%) 
Sepsis † 1     
# participants affected / at risk   3/800 (0.38%)   1/399 (0.25%) 
Gastroenteritis † 1     
# participants affected / at risk   1/800 (0.13%)   2/399 (0.50%) 
Bronchitis † 1     
# participants affected / at risk   1/800 (0.13%)   1/399 (0.25%) 
Device related infection † 1     
# participants affected / at risk   2/800 (0.25%)   0/399 (0.00%) 
Escherichia sepsis † 1     
# participants affected / at risk   2/800 (0.25%)   0/399 (0.00%) 
Lobar pneumonia † 1     
# participants affected / at risk   1/800 (0.13%)   1/399 (0.25%) 
Staphylococcal sepsis † 1     
# participants affected / at risk   1/800 (0.13%)   1/399 (0.25%) 
Cellulitis † 1     
# participants affected / at risk   1/800 (0.13%)   1/399 (0.25%) 
Erysipelas † 1     
# participants affected / at risk   1/800 (0.13%)   1/399 (0.25%) 
Lower respiratory tract infection † 1     
# participants affected / at risk   2/800 (0.25%)   0/399 (0.00%) 
Abdominal abscess † 1     
# participants affected / at risk   0/800 (0.00%)   1/399 (0.25%) 
Catheter bacteraemia † 1     
# participants affected / at risk   1/800 (0.13%)   0/399 (0.00%) 
Chest wall abscess † 1     
# participants affected / at risk   1/800 (0.13%)   0/399 (0.00%) 
Clostridium difficile colitis † 1     
# participants affected / at risk   1/800 (0.13%)   0/399 (0.00%) 
Cystitis † 1     
# participants affected / at risk   1/800 (0.13%)   0/399 (0.00%) 
Extradural abscess † 1     
# participants affected / at risk   1/800 (0.13%)   0/399 (0.00%) 
Infection † 1     
# participants affected / at risk   1/800 (0.13%)   0/399 (0.00%) 
Infective exacerbation of chronic obstructive airways disease † 1     
# participants affected / at risk   1/800 (0.13%)   0/399 (0.00%) 
Kidney infection † 1     
# participants affected / at risk   1/800 (0.13%)   0/399 (0.00%) 
Klebsiella bacteraemia † 1     
# participants affected / at risk   1/800 (0.13%)   0/399 (0.00%) 
Parotitis † 1     
# participants affected / at risk   0/800 (0.00%)   1/399 (0.25%) 
Pneumonia bacterial † 1     
# participants affected / at risk   1/800 (0.13%)   0/399 (0.00%) 
Rectal abscess † 1     
# participants affected / at risk   0/800 (0.00%)   1/399 (0.25%) 
Respiratory tract infection † 1     
# participants affected / at risk   0/800 (0.00%)   1/399 (0.25%) 
Septic Shock † 1     
# participants affected / at risk   0/800 (0.00%)   1/399 (0.25%) 
Tooth Infection † 1     
# participants affected / at risk   0/800 (0.00%)   1/399 (0.25%) 
Upper respiratory tract infection † 1     
# participants affected / at risk   0/800 (0.00%)   1/399 (0.25%) 
Herpes zoster † 1     
# participants affected / at risk   1/800 (0.13%)   0/399 (0.00%) 
Viral pericarditis † 1     
# participants affected / at risk   1/800 (0.13%)   0/399 (0.00%) 
Injury, poisoning and procedural complications     
Subdural haematoma † 1     
# participants affected / at risk   2/800 (0.25%)   1/399 (0.25%) 
Femur fracture † 1     
# participants affected / at risk   2/800 (0.25%)   0/399 (0.00%) 
Fall † 1     
# participants affected / at risk   1/800 (0.13%)   0/399 (0.00%) 
Femoral neck fracture † 1     
# participants affected / at risk   1/800 (0.13%)   0/399 (0.00%) 
Fracture † 1     
# participants affected / at risk   1/800 (0.13%)   0/399 (0.00%) 
Hip fracture † 1     
# participants affected / at risk   1/800 (0.13%)   0/399 (0.00%) 
Lumbar vertebral fracture † 1     
# participants affected / at risk   1/800 (0.13%)   0/399 (0.00%) 
Medical device complication † 1     
# participants affected / at risk   0/800 (0.00%)   1/399 (0.25%) 
Patella fracture † 1     
# participants affected / at risk   1/800 (0.13%)   0/399 (0.00%) 
Post procedural haematuria † 1     
# participants affected / at risk   1/800 (0.13%)   0/399 (0.00%) 
Post-traumatic pain † 1     
# participants affected / at risk   0/800 (0.00%)   1/399 (0.25%) 
Radiation oesophagitis † 1     
# participants affected / at risk   0/800 (0.00%)   1/399 (0.25%) 
Soft tissue injury † 1     
# participants affected / at risk   0/800 (0.00%)   1/399 (0.25%) 
Spinal compression fracture † 1     
# participants affected / at risk   0/800 (0.00%)   1/399 (0.25%) 
Hand fracture † 1     
# participants affected / at risk   1/800 (0.13%)   0/399 (0.00%) 
Thoracic vertebral fracture † 1     
# participants affected / at risk   1/800 (0.13%)   0/399 (0.00%) 
Investigations     
Liver function test abnormal † 1     
# participants affected / at risk   0/800 (0.00%)   1/399 (0.25%) 
Weight decreased † 1     
# participants affected / at risk   1/800 (0.13%)   0/399 (0.00%) 
Metabolism and nutrition disorders     
Dehydration † 1     
# participants affected / at risk   3/800 (0.38%)   3/399 (0.75%) 
Hyponatraemia † 1     
# participants affected / at risk   2/800 (0.25%)   3/399 (0.75%) 
Hypoglycaemia † 1     
# participants affected / at risk   1/800 (0.13%)   2/399 (0.50%) 
Hypercalcaemia † 1     
# participants affected / at risk   2/800 (0.25%)   0/399 (0.00%) 
Anorexia † 1     
# participants affected / at risk   1/800 (0.13%)   1/399 (0.25%) 
Hyperuricaemia † 1     
# participants affected / at risk   1/800 (0.13%)   0/399 (0.00%) 
Hypocalcaemia † 1     
# participants affected / at risk   1/800 (0.13%)   0/399 (0.00%) 
Hypokalaemia † 1     
# participants affected / at risk   1/800 (0.13%)   0/399 (0.00%) 
Hypophosphataemia † 1     
# participants affected / at risk   1/800 (0.13%)   0/399 (0.00%) 
Hypovolaemia † 1     
# participants affected / at risk   1/800 (0.13%)   0/399 (0.00%) 
Cachexia † 1     
# participants affected / at risk   0/800 (0.00%)   1/399 (0.25%) 
Musculoskeletal and connective tissue disorders     
Back pain † 1     
# participants affected / at risk   11/800 (1.38%)   7/399 (1.75%) 
Bone pain † 1     
# participants affected / at risk   12/800 (1.50%)   4/399 (1.00%) 
Pathological fracture † 1     
# participants affected / at risk   12/800 (1.50%)   2/399 (0.50%) 
Pain in extremity † 1     
# participants affected / at risk   3/800 (0.38%)   2/399 (0.50%) 
Arthralgia † 1     
# participants affected / at risk   3/800 (0.38%)   1/399 (0.25%) 
Muscular weakness † 1     
# participants affected / at risk   2/800 (0.25%)   0/399 (0.00%) 
Myalgia † 1     
# participants affected / at risk   2/800 (0.25%)   0/399 (0.00%) 
Osteonecrosis † 1     
# participants affected / at risk   2/800 (0.25%)   0/399 (0.00%) 
Musculoskeletal chest pain † 1     
# participants affected / at risk   2/800 (0.25%)   0/399 (0.00%) 
Chondrocalcinosis pyrophosphate † 1     
# participants affected / at risk   1/800 (0.13%)   0/399 (0.00%) 
Flank pain † 1     
# participants affected / at risk   1/800 (0.13%)   0/399 (0.00%) 
Intervertebral disc protrusion † 1     
# participants affected / at risk   0/800 (0.00%)   1/399 (0.25%) 
Muscle haemorrhage † 1     
# participants affected / at risk   1/800 (0.13%)   0/399 (0.00%) 
Osteoarthritis † 1     
# participants affected / at risk   1/800 (0.13%)   0/399 (0.00%) 
Rhabdomyolysis † 1     
# participants affected / at risk   1/800 (0.13%)   0/399 (0.00%) 
Spinal column stenosis † 1     
# participants affected / at risk   1/800 (0.13%)   0/399 (0.00%) 
Osteitis † 1     
# participants affected / at risk   1/800 (0.13%)   0/399 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Metastatic pain † 1     
# participants affected / at risk   12/800 (1.50%)   3/399 (0.75%) 
Cancer pain † 1     
# participants affected / at risk   8/800 (1.00%)   5/399 (1.25%) 
Metastases to central nervous system † 1     
# participants affected / at risk   4/800 (0.50%)   1/399 (0.25%) 
Metastases to Bone † 1     
# participants affected / at risk   1/800 (0.13%)   5/399 (1.25%) 
Malignant pleural effusion † 1     
# participants affected / at risk   2/800 (0.25%)   1/399 (0.25%) 
Tumour pain † 1     
# participants affected / at risk   0/800 (0.00%)   3/399 (0.75%) 
Acute leukaemia † 1     
# participants affected / at risk   1/800 (0.13%)   0/399 (0.00%) 
Acute monocytic leukaemia † 1     
# participants affected / at risk   1/800 (0.13%)   0/399 (0.00%) 
Bone marrow tumour cell infiltration † 1     
# participants affected / at risk   1/800 (0.13%)   0/399 (0.00%) 
Metastases to liver † 1     
# participants affected / at risk   0/800 (0.00%)   1/399 (0.25%) 
Metastases to meninges † 1     
# participants affected / at risk   1/800 (0.13%)   0/399 (0.00%) 
Neoplasm progression † 1     
# participants affected / at risk   0/800 (0.00%)   1/399 (0.25%) 
Small cell lung cancer stage unspecified † 1     
# participants affected / at risk   1/800 (0.13%)   0/399 (0.00%) 
Transitional cell carcinoma † 1     
# participants affected / at risk   0/800 (0.00%)   1/399 (0.25%) 
Bronchial carcinoma † 1     
# participants affected / at risk   1/800 (0.13%)   0/399 (0.00%) 
Gastrointestinal tract adenoma † 1     
# participants affected / at risk   0/800 (0.00%)   1/399 (0.25%) 
Metastases to lung † 1     
# participants affected / at risk   1/800 (0.13%)   0/399 (0.00%) 
Nervous system disorders     
Spinal cord compression † 1     
# participants affected / at risk   48/800 (6.00%)   15/399 (3.76%) 
Cauda equina syndrome † 1     
# participants affected / at risk   6/800 (0.75%)   0/399 (0.00%) 
Nerve root compression † 1     
# participants affected / at risk   1/800 (0.13%)   4/399 (1.00%) 
Syncope † 1     
# participants affected / at risk   3/800 (0.38%)   2/399 (0.50%) 
Cerebrovascular accident † 1     
# participants affected / at risk   3/800 (0.38%)   1/399 (0.25%) 
Hepatic encephalopathy † 1     
# participants affected / at risk   1/800 (0.13%)   2/399 (0.50%) 
Dizziness † 1     
# participants affected / at risk   2/800 (0.25%)   1/399 (0.25%) 
Transient ischemic attack † 1     
# participants affected / at risk   3/800 (0.38%)   1/399 (0.25%) 
Cerebral haemorrhage † 1     
# participants affected / at risk   1/800 (0.13%)   1/399 (0.25%) 
Convulsion † 1     
# participants affected / at risk   2/800 (0.25%)   0/399 (0.00%) 
Cranial neuropathy † 1     
# participants affected / at risk   2/800 (0.25%)   0/399 (0.00%) 
Epiduritis † 1     
# participants affected / at risk   2/800 (0.25%)   0/399 (0.00%) 
Nerve compression † 1     
# participants affected / at risk   1/800 (0.13%)   1/399 (0.25%) 
Partial seizures † 1     
# participants affected / at risk   2/800 (0.25%)   0/399 (0.00%) 
Lethargy † 1     
# participants affected / at risk   3/800 (0.38%)   0/399 (0.00%) 
Headache † 1     
# participants affected / at risk   1/800 (0.13%)   1/399 (0.25%) 
Akathisia † 1     
# participants affected / at risk   1/800 (0.13%)   0/399 (0.00%) 
Central nervous system lesion † 1     
# participants affected / at risk   1/800 (0.13%)   0/399 (0.00%) 
Cranial nerve palsies multiple † 1     
# participants affected / at risk   1/800 (0.13%)   0/399 (0.00%) 
Embolic stroke † 1     
# participants affected / at risk   0/800 (0.00%)   1/399 (0.25%) 
Facial palsy † 1     
# participants affected / at risk   0/800 (0.00%)   1/399 (0.25%) 
Haemorrhage intracranial † 1     
# participants affected / at risk   1/800 (0.13%)   0/399 (0.00%) 
Haemorrhagic stroke † 1     
# participants affected / at risk   1/800 (0.13%)   0/399 (0.00%) 
Ischaemic stroke † 1     
# participants affected / at risk   0/800 (0.00%)   1/399 (0.25%) 
Lacunar infarction † 1     
# participants affected / at risk   1/800 (0.13%)   0/399 (0.00%) 
Loss of consciousness † 1     
# participants affected / at risk   0/800 (0.00%)   1/399 (0.25%) 
Lumbar radiculopathy † 1     
# participants affected / at risk   1/800 (0.13%)   0/399 (0.00%) 
Motor dysfunction † 1     
# participants affected / at risk   0/800 (0.00%)   1/399 (0.25%) 
Pachymeningitis † 1     
# participants affected / at risk   1/800 (0.13%)   0/399 (0.00%) 
Presyncope † 1     
# participants affected / at risk   1/800 (0.13%)   0/399 (0.00%) 
Status epilepticus † 1     
# participants affected / at risk   1/800 (0.13%)   0/399 (0.00%) 
Hypoglossal nerve paresis † 1     
# participants affected / at risk   1/800 (0.13%)   0/399 (0.00%) 
Normal pressure hydrocephalus † 1     
# participants affected / at risk   1/800 (0.13%)   0/399 (0.00%) 
Tremor † 1     
# participants affected / at risk   1/800 (0.13%)   0/399 (0.00%) 
Trigeminal neuralgia † 1     
# participants affected / at risk   1/800 (0.13%)   0/399 (0.00%) 
Visual field defect † 1     
# participants affected / at risk   1/800 (0.13%)   0/399 (0.00%) 
Psychiatric disorders     
Confusional state † 1     
# participants affected / at risk   2/800 (0.25%)   2/399 (0.50%) 
Depressed mood † 1     
# participants affected / at risk   1/800 (0.13%)   0/399 (0.00%) 
Hallucination † 1     
# participants affected / at risk   1/800 (0.13%)   0/399 (0.00%) 
Mental status changes † 1     
# participants affected / at risk   1/800 (0.13%)   0/399 (0.00%) 
Depression † 1     
# participants affected / at risk   1/800 (0.13%)   0/399 (0.00%) 
Disorientation † 1     
# participants affected / at risk   0/800 (0.00%)   1/399 (0.25%) 
Renal and urinary disorders     
Haematuria † 1     
# participants affected / at risk   12/800 (1.50%)   5/399 (1.25%) 
Urinary retention † 1     
# participants affected / at risk   3/800 (0.38%)   8/399 (2.01%) 
Urinary tract obstruction † 1     
# participants affected / at risk   7/800 (0.88%)   1/399 (0.25%) 
Post renal failure † 1     
# participants affected / at risk   3/800 (0.38%)   3/399 (0.75%) 
Renal failure † 1     
# participants affected / at risk   3/800 (0.38%)   3/399 (0.75%) 
Renal failure acute † 1     
# participants affected / at risk   2/800 (0.25%)   3/399 (0.75%) 
Bladder perforation † 1     
# participants affected / at risk   1/800 (0.13%)   1/399 (0.25%) 
Hydronephrosis † 1     
# participants affected / at risk   1/800 (0.13%)   1/399 (0.25%) 
Nephrolithiasis † 1     
# participants affected / at risk   2/800 (0.25%)   0/399 (0.00%) 
Cystitis haemorrhagic † 1     
# participants affected / at risk   2/800 (0.25%)   0/399 (0.00%) 
Renal colic † 1     
# participants affected / at risk   2/800 (0.25%)   0/399 (0.00%) 
Bladder obstruction † 1     
# participants affected / at risk   1/800 (0.13%)   0/399 (0.00%) 
Dysuria † 1     
# participants affected / at risk   1/800 (0.13%)   0/399 (0.00%) 
Obstructive uropathy † 1     
# participants affected / at risk   1/800 (0.13%)   0/399 (0.00%) 
Ureteric obstruction † 1     
# participants affected / at risk   1/800 (0.13%)   0/399 (0.00%) 
Urethral obstruction † 1     
# participants affected / at risk   1/800 (0.13%)   0/399 (0.00%) 
Urethral stenosis † 1     
# participants affected / at risk   0/800 (0.00%)   1/399 (0.25%) 
Reproductive system and breast disorders     
Pelvic pain † 1     
# participants affected / at risk   1/800 (0.13%)   1/399 (0.25%) 
Respiratory, thoracic and mediastinal disorders     
Pulmonary embolism † 1     
# participants affected / at risk   3/800 (0.38%)   4/399 (1.00%) 
Pleural effusion † 1     
# participants affected / at risk   2/800 (0.25%)   3/399 (0.75%) 
Chronic obstructive pulmonary disease † 1     
# participants affected / at risk   3/800 (0.38%)   0/399 (0.00%) 
Pneumothorax † 1     
# participants affected / at risk   2/800 (0.25%)   1/399 (0.25%) 
Epistaxis † 1     
# participants affected / at risk   1/800 (0.13%)   1/399 (0.25%) 
Pulmonary oedema † 1     
# participants affected / at risk   2/800 (0.25%)   0/399 (0.00%) 
Dyspnoea † 1     
# participants affected / at risk   1/800 (0.13%)   1/399 (0.25%) 
Acute pulmonary oedema † 1     
# participants affected / at risk   1/800 (0.13%)   0/399 (0.00%) 
Haemoptysis † 1     
# participants affected / at risk   1/800 (0.13%)   0/399 (0.00%) 
Respiratory arrest † 1     
# participants affected / at risk   0/800 (0.00%)   1/399 (0.25%) 
Hydropneumothorax † 1     
# participants affected / at risk   1/800 (0.13%)   0/399 (0.00%) 
Pleuritic pain † 1     
# participants affected / at risk   1/800 (0.13%)   0/399 (0.00%) 
Skin and subcutaneous tissue disorders     
Hyperhidrosis † 1     
# participants affected / at risk   0/800 (0.00%)   1/399 (0.25%) 
Vascular purpura † 1     
# participants affected / at risk   0/800 (0.00%)   1/399 (0.25%) 
Surgical and medical procedures     
Bladder catheter removal † 1     
# participants affected / at risk   1/800 (0.13%)   0/399 (0.00%) 
Limb operation † 1     
# participants affected / at risk   1/800 (0.13%)   0/399 (0.00%) 
Pain management † 1     
# participants affected / at risk   1/800 (0.13%)   0/399 (0.00%) 
Cataract operation † 1     
# participants affected / at risk   0/800 (0.00%)   1/399 (0.25%) 
Colon polypectomy † 1     
# participants affected / at risk   1/800 (0.13%)   0/399 (0.00%) 
Oesophageal dilation procedure † 1     
# participants affected / at risk   1/800 (0.13%)   0/399 (0.00%) 
Pleurodesis † 1     
# participants affected / at risk   1/800 (0.13%)   0/399 (0.00%) 
Ureteral stent insertion † 1     
# participants affected / at risk   1/800 (0.13%)   0/399 (0.00%) 
Vascular disorders     
Deep vein thrombosis † 1     
# participants affected / at risk   3/800 (0.38%)   3/399 (0.75%) 
Haematoma † 1     
# participants affected / at risk   2/800 (0.25%)   0/399 (0.00%) 
Lymphoedema † 1     
# participants affected / at risk   2/800 (0.25%)   0/399 (0.00%) 
Hypertensive crisis † 1     
# participants affected / at risk   0/800 (0.00%)   1/399 (0.25%) 
Hypotension † 1     
# participants affected / at risk   0/800 (0.00%)   1/399 (0.25%) 
Peripheral ischaemia † 1     
# participants affected / at risk   1/800 (0.13%)   0/399 (0.00%) 
Orthostatic hypotension † 1     
# participants affected / at risk   0/800 (0.00%)   1/399 (0.25%) 
Events were collected by systematic assessment
1 Term from vocabulary, MedDRA (12.0)




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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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