A Study of Docetaxel Monotherapy or DOXIL and Docetaxel in Patients With Advanced Breast Cancer

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
ClinicalTrials.gov Identifier:
NCT00091442
First received: September 8, 2004
Last updated: April 2, 2014
Last verified: April 2014
Results First Received: December 15, 2009  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Breast Cancer
Interventions: Drug: Docetaxel
Drug: DOXIL

  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
A total of 751 participants were enrolled and randomized at 143 sites in 19 countries.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
751 participants were randomly assigned to 2 treatment groups (Docetaxel: 373 ; DOXIL+docetaxel: 378). 750 participants received treatment (Docetaxel: 373; DOXIL+docetaxel: 377). 1 participant in DOXIL+docetaxel treatment group did not receive treatment.

Reporting Groups
  Description
Docetaxel Docetaxel monotherapy: Docetaxel 75 mg/m2 solution administered by intravenous infusion over 1 hour on Day 1 of every 21-day cycle.
DOXIL+Docetaxel DOXIL and docetaxel combination: DOXIL 30 mg/m2 solution administered by intravenous infusion, followed by docetaxel 60 mg/m2 administration by intravenous infusion over 1 hour on Day 1 of every 21-day cycle.

Participant Flow:   Overall Study
    Docetaxel     DOXIL+Docetaxel  
STARTED     373     378  
COMPLETED     4 [1]   5 [1]
NOT COMPLETED     369     373  
Progressive Disease                 220                 189  
Physician Decision                 61                 58  
Withdrawal by Subject                 38                 46  
Adverse Event                 29                 48  
2cycles therapy beyond Complete response                 9                 16  
Death                 9                 7  
Lost to Follow-up                 1                 3  
Not Specified                 2                 6  
[1] Indicates number of participants on study treatment at time of the primary objective



  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
Docetaxel Docetaxel monotherapy: Docetaxel 75 mg/m2 solution administered by intravenous infusion over 1 hour on Day 1 of every 21-day cycle.
DOXIL+Docetaxel DOXIL and docetaxel combination: DOXIL 30 mg/m2 solution administered by intravenous infusion, followed by docetaxel 60 mg/m2 administration by intravenous infusion over 1 hour on Day 1 of every 21-day cycle.
Total Total of all reporting groups

Baseline Measures
    Docetaxel     DOXIL+Docetaxel     Total  
Number of Participants  
[units: participants]
  373     378     751  
Age  
[units: years]
Mean ± Standard Deviation
  52.0  ± 9.23     52.8  ± 9.17     52.4  ± 9.20  
Gender  
[units: Participants]
     
Female     373     378     751  
Male     0     0     0  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Time to Progression   [ Time Frame: From date of randomization until date of disease progression or death, whichever occurred first, until approximately 485 events of disease progression or death were observed, as assessed approximately 15 months after the last patient was enrolled ]

2.  Secondary:   Overall Survival   [ Time Frame: From the date of randomization until the participant's death from any cause, as assessed until approximately 485 death events were observed which is assessed approximately 25 months after the last patient was enrolled ]

3.  Secondary:   Response Rate: Number of Participants in the Evaluable Population Who Achieved a Complete Response (CR) or Partial Response (PR)   [ Time Frame: Up to 30 to 42 days after last dose of study medication ]


  Serious Adverse Events
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Time Frame From first dose of study medication until 30 days after the last dose of study medication.
Additional Description 751 participants were randomly assigned to 2 treatment groups (Docetaxel: 373 ; DOXIL+docetaxel: 378). 750 participants received treatment (Docetaxel: 373; DOXIL+docetaxel: 377). 1 participant in DOXIL+docetaxel treatment group did not receive treatment.

Reporting Groups
  Description
Docetaxel Docetaxel monotherapy: Docetaxel 75 mg/m2 solution administered by intravenous infusion over 1 hour on Day 1 of every 21-day cycle.
DOXIL+Docetaxel DOXIL and docetaxel combination: DOXIL 30 mg/m2 solution administered by intravenous infusion, followed by docetaxel 60 mg/m2 administration by intravenous infusion over 1 hour on Day 1 of every 21-day cycle.

Serious Adverse Events
    Docetaxel     DOXIL+Docetaxel  
Total, serious adverse events      
# participants affected / at risk     59/373 (15.82%)     69/377 (18.30%)  
Blood and lymphatic system disorders      
Neutropenia † 1    
# participants affected / at risk     14/373 (3.75%)     17/377 (4.51%)  
Febrile neutropenia † 1    
# participants affected / at risk     10/373 (2.68%)     10/377 (2.65%)  
Leukopenia † 1    
# participants affected / at risk     1/373 (0.27%)     4/377 (1.06%)  
Anaemia † 1    
# participants affected / at risk     2/373 (0.54%)     2/377 (0.53%)  
Lymphadenopathy † 1    
# participants affected / at risk     0/373 (0.00%)     1/377 (0.27%)  
Neutropenia † 1    
# participants affected / at risk     14/373 (3.75%)     17/377 (4.51%)  
Febrile neutropenia † 1    
# participants affected / at risk     10/373 (2.68%)     10/377 (2.65%)  
Leukopenia † 1    
# participants affected / at risk     1/373 (0.27%)     4/377 (1.06%)  
Anaemia † 1    
# participants affected / at risk     2/373 (0.54%)     2/377 (0.53%)  
Lymphadenopathy † 1    
# participants affected / at risk     0/373 (0.00%)     1/377 (0.27%)  
Cardiac disorders      
cardiac failure † 1    
# participants affected / at risk     2/373 (0.54%)     1/377 (0.27%)  
Atrial fibrillation † 1    
# participants affected / at risk     1/373 (0.27%)     1/377 (0.27%)  
Pericardial effusion † 1    
# participants affected / at risk     2/373 (0.54%)     0/377 (0.00%)  
Cardiac failure congestive † 1    
# participants affected / at risk     1/373 (0.27%)     0/377 (0.00%)  
Cardiomyopathy † 1    
# participants affected / at risk     0/373 (0.00%)     1/377 (0.27%)  
Supraventricular tachycardia † 1    
# participants affected / at risk     0/373 (0.00%)     1/377 (0.27%)  
Tachycardia † 1    
# participants affected / at risk     0/373 (0.00%)     1/377 (0.27%)  
Diabetic ketoacidosis † 1    
# participants affected / at risk     1/373 (0.27%)     0/377 (0.00%)  
cardiac failure † 1    
# participants affected / at risk     2/373 (0.54%)     1/377 (0.27%)  
Atrial fibrillation † 1    
# participants affected / at risk     1/373 (0.27%)     1/377 (0.27%)  
Pericardial effusion † 1    
# participants affected / at risk     2/373 (0.54%)     0/377 (0.00%)  
Cardiac failure congestive † 1    
# participants affected / at risk     1/373 (0.27%)     0/377 (0.00%)  
Cardiomyopathy † 1    
# participants affected / at risk     0/373 (0.00%)     1/377 (0.27%)  
Supraventricular tachycardia † 1    
# participants affected / at risk     0/373 (0.00%)     1/377 (0.27%)  
Tachycardia † 1    
# participants affected / at risk     0/373 (0.00%)     1/377 (0.27%)  
Diabetic ketoacidosis † 1    
# participants affected / at risk     1/373 (0.27%)     0/377 (0.00%)  
Gastrointestinal disorders      
Vomiting † 1    
# participants affected / at risk     3/373 (0.80%)     4/377 (1.06%)  
Diarrhoea † 1    
# participants affected / at risk     2/373 (0.54%)     3/377 (0.80%)  
Nausea † 1    
# participants affected / at risk     3/373 (0.80%)     2/377 (0.53%)  
Stomatitis † 1    
# participants affected / at risk     1/373 (0.27%)     4/377 (1.06%)  
Abdominal pain † 1    
# participants affected / at risk     2/373 (0.54%)     0/377 (0.00%)  
Abdominal mass † 1    
# participants affected / at risk     1/373 (0.27%)     0/377 (0.00%)  
Dysphagia † 1    
# participants affected / at risk     0/373 (0.00%)     1/377 (0.27%)  
Gastric haemorrhage † 1    
# participants affected / at risk     0/373 (0.00%)     1/377 (0.27%)  
Gastrointestinal ulcer † 1    
# participants affected / at risk     0/373 (0.00%)     1/377 (0.27%)  
Ileus † 1    
# participants affected / at risk     1/373 (0.27%)     0/377 (0.00%)  
Intestinal ischaemia † 1    
# participants affected / at risk     0/373 (0.00%)     1/377 (0.27%)  
Peritonitis † 1    
# participants affected / at risk     0/373 (0.00%)     1/377 (0.27%)  
Vomiting † 1    
# participants affected / at risk     3/373 (0.80%)     4/377 (1.06%)  
Diarrhoea † 1    
# participants affected / at risk     2/373 (0.54%)     3/377 (0.80%)  
Nausea † 1    
# participants affected / at risk     3/373 (0.80%)     2/377 (0.53%)  
Stomatitis † 1    
# participants affected / at risk     1/373 (0.27%)     4/377 (1.06%)  
Abdominal pain † 1    
# participants affected / at risk     2/373 (0.54%)     0/377 (0.00%)  
Abdominal mass † 1    
# participants affected / at risk     1/373 (0.27%)     0/377 (0.00%)  
Dysphagia † 1    
# participants affected / at risk     0/373 (0.00%)     1/377 (0.27%)  
Gastric haemorrhage † 1    
# participants affected / at risk     0/373 (0.00%)     1/377 (0.27%)  
Gastrointestinal ulcer † 1    
# participants affected / at risk     0/373 (0.00%)     1/377 (0.27%)  
Ileus † 1    
# participants affected / at risk     1/373 (0.27%)     0/377 (0.00%)  
Intestinal ischaemia † 1    
# participants affected / at risk     0/373 (0.00%)     1/377 (0.27%)  
Peritonitis † 1    
# participants affected / at risk     0/373 (0.00%)     1/377 (0.27%)  
General disorders      
Pyrexia † 1    
# participants affected / at risk     3/373 (0.80%)     6/377 (1.59%)  
Asthenia † 1    
# participants affected / at risk     1/373 (0.27%)     3/377 (0.80%)  
Infusion related reaction † 1    
# participants affected / at risk     0/373 (0.00%)     2/377 (0.53%)  
Death † 1    
# participants affected / at risk     1/373 (0.27%)     0/377 (0.00%)  
Multi-organ failure † 1    
# participants affected / at risk     0/373 (0.00%)     1/377 (0.27%)  
Pyrexia † 1    
# participants affected / at risk     3/373 (0.80%)     6/377 (1.59%)  
Asthenia † 1    
# participants affected / at risk     1/373 (0.27%)     3/377 (0.80%)  
Infusion related reaction † 1    
# participants affected / at risk     0/373 (0.00%)     2/377 (0.53%)  
Death † 1    
# participants affected / at risk     1/373 (0.27%)     0/377 (0.00%)  
Multi-organ failure † 1    
# participants affected / at risk     0/373 (0.00%)     1/377 (0.27%)  
Hepatobiliary disorders      
Biliary colic † 1    
# participants affected / at risk     1/373 (0.27%)     0/377 (0.00%)  
Cholecystitis acute † 1    
# participants affected / at risk     1/373 (0.27%)     0/377 (0.00%)  
Cholelithiasis † 1    
# participants affected / at risk     0/373 (0.00%)     1/377 (0.27%)  
Hyperbilirubinaemia † 1    
# participants affected / at risk     1/373 (0.27%)     0/377 (0.00%)  
Biliary colic † 1    
# participants affected / at risk     1/373 (0.27%)     0/377 (0.00%)  
Cholecystitis acute † 1    
# participants affected / at risk     1/373 (0.27%)     0/377 (0.00%)  
Cholelithiasis † 1    
# participants affected / at risk     0/373 (0.00%)     1/377 (0.27%)  
Hyperbilirubinaemia † 1    
# participants affected / at risk     1/373 (0.27%)     0/377 (0.00%)  
Immune system disorders      
Anaphylactic reaction † 1    
# participants affected / at risk     0/373 (0.00%)     1/377 (0.27%)  
Anaphylactic reaction † 1    
# participants affected / at risk     0/373 (0.00%)     1/377 (0.27%)  
Infections and infestations      
Pneumonia † 1    
# participants affected / at risk     0/373 (0.00%)     12/377 (3.18%)  
Neutropenic sepsis † 1    
# participants affected / at risk     4/373 (1.07%)     0/377 (0.00%)  
Cellulitis † 1    
# participants affected / at risk     1/373 (0.27%)     2/377 (0.53%)  
Urinary tract infection † 1    
# participants affected / at risk     1/373 (0.27%)     1/377 (0.27%)  
Appendicitis † 1    
# participants affected / at risk     0/373 (0.00%)     1/377 (0.27%)  
Breast abscess † 1    
# participants affected / at risk     1/373 (0.27%)     0/377 (0.00%)  
Catheter related infection † 1    
# participants affected / at risk     1/373 (0.27%)     0/377 (0.00%)  
Catheter site cellulitis † 1    
# participants affected / at risk     1/373 (0.27%)     0/377 (0.00%)  
Cystitis † 1    
# participants affected / at risk     0/373 (0.00%)     1/377 (0.27%)  
Erysipelas † 1    
# participants affected / at risk     1/373 (0.27%)     0/377 (0.00%)  
Folliculitis † 1    
# participants affected / at risk     0/373 (0.00%)     1/377 (0.27%)  
Groin abscess † 1    
# participants affected / at risk     1/373 (0.27%)     0/377 (0.00%)  
Infection † 1    
# participants affected / at risk     0/373 (0.00%)     1/377 (0.27%)  
Lung infection † 1    
# participants affected / at risk     1/373 (0.27%)     0/377 (0.00%)  
Pulpitis dental † 1    
# participants affected / at risk     1/373 (0.27%)     0/377 (0.00%)  
Pyelonephritis † 1    
# participants affected / at risk     1/373 (0.27%)     0/377 (0.00%)  
Skin infection † 1    
# participants affected / at risk     0/373 (0.00%)     1/377 (0.27%)  
Staphylococcal infection † 1    
# participants affected / at risk     1/373 (0.27%)     0/377 (0.00%)  
Subcutaneous abscess † 1    
# participants affected / at risk     0/373 (0.00%)     1/377 (0.27%)  
Tooth abscess † 1    
# participants affected / at risk     0/373 (0.00%)     1/377 (0.27%)  
Vaginal infection † 1    
# participants affected / at risk     0/373 (0.00%)     1/377 (0.27%)  
Viral infection † 1    
# participants affected / at risk     0/373 (0.00%)     1/377 (0.27%)  
Vulvitis † 1    
# participants affected / at risk     0/373 (0.00%)     1/377 (0.27%)  
Pneumonia † 1    
# participants affected / at risk     0/373 (0.00%)     12/377 (3.18%)  
Neutropenic sepsis † 1    
# participants affected / at risk     4/373 (1.07%)     0/377 (0.00%)  
Cellulitis † 1    
# participants affected / at risk     1/373 (0.27%)     2/377 (0.53%)  
Urinary tract infection † 1    
# participants affected / at risk     1/373 (0.27%)     1/377 (0.27%)  
Appendicitis † 1    
# participants affected / at risk     0/373 (0.00%)     1/377 (0.27%)  
Breast abscess † 1    
# participants affected / at risk     1/373 (0.27%)     0/377 (0.00%)  
Catheter related infection † 1    
# participants affected / at risk     1/373 (0.27%)     0/377 (0.00%)  
Catheter site cellulitis † 1    
# participants affected / at risk     1/373 (0.27%)     0/377 (0.00%)  
Cystitis † 1    
# participants affected / at risk     0/373 (0.00%)     1/377 (0.27%)  
Erysipelas † 1    
# participants affected / at risk     1/373 (0.27%)     0/377 (0.00%)  
Folliculitis † 1    
# participants affected / at risk     0/373 (0.00%)     1/377 (0.27%)  
Groin abscess † 1    
# participants affected / at risk     1/373 (0.27%)     0/377 (0.00%)  
Infection † 1    
# participants affected / at risk     0/373 (0.00%)     1/377 (0.27%)  
Lung infection † 1    
# participants affected / at risk     1/373 (0.27%)     0/377 (0.00%)  
Pulpitis dental † 1    
# participants affected / at risk     1/373 (0.27%)     0/377 (0.00%)  
Pyelonephritis † 1    
# participants affected / at risk     1/373 (0.27%)     0/377 (0.00%)  
Skin infection † 1    
# participants affected / at risk     0/373 (0.00%)     1/377 (0.27%)  
Staphylococcal infection † 1    
# participants affected / at risk     1/373 (0.27%)     0/377 (0.00%)  
Subcutaneous abscess † 1    
# participants affected / at risk     0/373 (0.00%)     1/377 (0.27%)  
Tooth abscess † 1    
# participants affected / at risk     0/373 (0.00%)     1/377 (0.27%)  
Vaginal infection † 1    
# participants affected / at risk     0/373 (0.00%)     1/377 (0.27%)  
Viral infection † 1    
# participants affected / at risk     0/373 (0.00%)     1/377 (0.27%)  
Vulvitis † 1    
# participants affected / at risk     0/373 (0.00%)     1/377 (0.27%)  
Injury, poisoning and procedural complications      
Fall † 1    
# participants affected / at risk     1/373 (0.27%)     1/377 (0.27%)  
Alcohol poisoning † 1    
# participants affected / at risk     0/373 (0.00%)     1/377 (0.27%)  
Humerus fracture † 1    
# participants affected / at risk     1/373 (0.27%)     0/377 (0.00%)  
Upper limb fracture † 1    
# participants affected / at risk     1/373 (0.27%)     0/377 (0.00%)  
Fall † 1    
# participants affected / at risk     1/373 (0.27%)     1/377 (0.27%)  
Alcohol poisoning † 1    
# participants affected / at risk     0/373 (0.00%)     1/377 (0.27%)  
Humerus fracture † 1    
# participants affected / at risk     1/373 (0.27%)     0/377 (0.00%)  
Upper limb fracture † 1    
# participants affected / at risk     1/373 (0.27%)     0/377 (0.00%)  
Investigations      
Alanine aminotransferease increased † 1    
# participants affected / at risk     1/373 (0.27%)     0/377 (0.00%)  
Aspartate aminotransferase increased † 1    
# participants affected / at risk     1/373 (0.27%)     0/377 (0.00%)  
Blood creatinine increased † 1    
# participants affected / at risk     1/373 (0.27%)     0/377 (0.00%)  
Blood urea increased † 1    
# participants affected / at risk     1/373 (0.27%)     0/377 (0.00%)  
Ejection fraction decreased † 1    
# participants affected / at risk     0/373 (0.00%)     1/377 (0.27%)  
Alanine aminotransferease increased † 1    
# participants affected / at risk     1/373 (0.27%)     0/377 (0.00%)  
Aspartate aminotransferase increased † 1    
# participants affected / at risk     1/373 (0.27%)     0/377 (0.00%)  
Blood creatinine increased † 1    
# participants affected / at risk     1/373 (0.27%)     0/377 (0.00%)  
Blood urea increased † 1    
# participants affected / at risk     1/373 (0.27%)     0/377 (0.00%)  
Ejection fraction decreased † 1    
# participants affected / at risk     0/373 (0.00%)     1/377 (0.27%)  
Metabolism and nutrition disorders      
Dehydration † 1    
# participants affected / at risk     3/373 (0.80%)     2/377 (0.53%)  
Hypocalcaemia † 1    
# participants affected / at risk     0/373 (0.00%)     2/377 (0.53%)  
Hypokalaemia † 1    
# participants affected / at risk     1/373 (0.27%)     1/377 (0.27%)  
Hypercalcaemia † 1    
# participants affected / at risk     0/373 (0.00%)     1/377 (0.27%)  
Hyperglycaemia † 1    
# participants affected / at risk     0/373 (0.00%)     1/377 (0.27%)  
Hypomagnesaemia † 1    
# participants affected / at risk     1/373 (0.27%)     0/377 (0.00%)  
Dehydration † 1    
# participants affected / at risk     3/373 (0.80%)     2/377 (0.53%)  
Hypocalcaemia † 1    
# participants affected / at risk     0/373 (0.00%)     2/377 (0.53%)  
Hypokalaemia † 1    
# participants affected / at risk     1/373 (0.27%)     1/377 (0.27%)  
Hypercalcaemia † 1    
# participants affected / at risk     0/373 (0.00%)     1/377 (0.27%)  
Hyperglycaemia † 1    
# participants affected / at risk     0/373 (0.00%)     1/377 (0.27%)  
Hypomagnesaemia † 1    
# participants affected / at risk     1/373 (0.27%)     0/377 (0.00%)  
Musculoskeletal and connective tissue disorders      
Back pain † 1    
# participants affected / at risk     0/373 (0.00%)     1/377 (0.27%)  
Bone pain † 1    
# participants affected / at risk     1/373 (0.27%)     0/377 (0.00%)  
Pathological fracture † 1    
# participants affected / at risk     1/373 (0.27%)     0/377 (0.00%)  
Back pain † 1    
# participants affected / at risk     0/373 (0.00%)     1/377 (0.27%)  
Bone pain † 1    
# participants affected / at risk     1/373 (0.27%)     0/377 (0.00%)  
Pathological fracture † 1    
# participants affected / at risk     1/373 (0.27%)     0/377 (0.00%)  
Neoplasms benign, malignant and unspecified (incl cysts and polyps)      
Adenocarcinoma † 1    
# participants affected / at risk     1/373 (0.27%)     0/377 (0.00%)  
Metastasis † 1    
# participants affected / at risk     0/373 (0.00%)     1/377 (0.27%)  
Neoplasm malignant † 1    
# participants affected / at risk     0/373 (0.00%)     1/377 (0.27%)  
Adenocarcinoma † 1    
# participants affected / at risk     1/373 (0.27%)     0/377 (0.00%)  
Metastasis † 1    
# participants affected / at risk     0/373 (0.00%)     1/377 (0.27%)  
Neoplasm malignant † 1    
# participants affected / at risk     0/373 (0.00%)     1/377 (0.27%)  
Nervous system disorders      
Convulsion † 1    
# participants affected / at risk     1/373 (0.27%)     1/377 (0.27%)  
Heachache † 1    
# participants affected / at risk     1/373 (0.27%)     1/377 (0.27%)  
Loss of consciousness † 1    
# participants affected / at risk     0/373 (0.00%)     2/377 (0.53%)  
Brain stem syndrome † 1    
# participants affected / at risk     0/373 (0.00%)     1/377 (0.27%)  
Cerebrovascular accident † 1    
# participants affected / at risk     0/373 (0.00%)     1/377 (0.27%)  
Dizziness † 1    
# participants affected / at risk     0/373 (0.00%)     1/377 (0.27%)  
Grand mal convulsion † 1    
# participants affected / at risk     0/373 (0.00%)     1/377 (0.27%)  
Hemiplegia † 1    
# participants affected / at risk     1/373 (0.27%)     0/377 (0.00%)  
Speech disorder † 1    
# participants affected / at risk     0/373 (0.00%)     1/377 (0.27%)  
Syncope † 1    
# participants affected / at risk     0/373 (0.00%)     1/377 (0.27%)  
Convulsion † 1    
# participants affected / at risk     1/373 (0.27%)     1/377 (0.27%)  
Heachache † 1    
# participants affected / at risk     1/373 (0.27%)     1/377 (0.27%)  
Loss of consciousness † 1    
# participants affected / at risk     0/373 (0.00%)     2/377 (0.53%)  
Brain stem syndrome † 1    
# participants affected / at risk     0/373 (0.00%)     1/377 (0.27%)  
Cerebrovascular accident † 1    
# participants affected / at risk     0/373 (0.00%)     1/377 (0.27%)  
Dizziness † 1    
# participants affected / at risk     0/373 (0.00%)     1/377 (0.27%)  
Grand mal convulsion † 1    
# participants affected / at risk     0/373 (0.00%)     1/377 (0.27%)  
Hemiplegia † 1    
# participants affected / at risk     1/373 (0.27%)     0/377 (0.00%)  
Speech disorder † 1    
# participants affected / at risk     0/373 (0.00%)     1/377 (0.27%)  
Syncope † 1    
# participants affected / at risk     0/373 (0.00%)     1/377 (0.27%)  
Psychiatric disorders      
Anxiety † 1    
# participants affected / at risk     1/373 (0.27%)     0/377 (0.00%)  
Mental status changes † 1    
# participants affected / at risk     0/373 (0.00%)     1/377 (0.27%)  
Anxiety † 1    
# participants affected / at risk     1/373 (0.27%)     0/377 (0.00%)  
Mental status changes † 1    
# participants affected / at risk     0/373 (0.00%)     1/377 (0.27%)  
Reproductive system and breast disorders      
Metrorrhagia † 1    
# participants affected / at risk     1/373 (0.27%)     0/377 (0.00%)  
Uterine polyp † 1    
# participants affected / at risk     1/373 (0.27%)     0/377 (0.00%)  
Metrorrhagia † 1    
# participants affected / at risk     1/373 (0.27%)     0/377 (0.00%)  
Uterine polyp † 1    
# participants affected / at risk     1/373 (0.27%)     0/377 (0.00%)  
Respiratory, thoracic and mediastinal disorders      
Pleural effusion † 1    
# participants affected / at risk     4/373 (1.07%)     0/377 (0.00%)  
Pulmonary embolism † 1    
# participants affected / at risk     2/373 (0.54%)     2/377 (0.53%)  
Dyspnoea † 1    
# participants affected / at risk     2/373 (0.54%)     1/377 (0.27%)  
Acute respiratory failure † 1    
# participants affected / at risk     1/373 (0.27%)     1/377 (0.27%)  
Respiratory arrest † 1    
# participants affected / at risk     0/373 (0.00%)     2/377 (0.53%)  
Respiratory failure † 1    
# participants affected / at risk     0/373 (0.00%)     2/377 (0.53%)  
Asthma † 1    
# participants affected / at risk     0/373 (0.00%)     1/377 (0.27%)  
Asthmatic crisis † 1    
# participants affected / at risk     1/373 (0.27%)     0/377 (0.00%)  
Bronchial haemorrhage † 1    
# participants affected / at risk     0/373 (0.00%)     1/377 (0.27%)  
Bronchospasm † 1    
# participants affected / at risk     0/373 (0.00%)     1/377 (0.27%)  
Hydrothorax † 1    
# participants affected / at risk     1/373 (0.27%)     0/377 (0.00%)  
Hypoxia † 1    
# participants affected / at risk     0/373 (0.00%)     1/377 (0.27%)  
Pneumothorax † 1    
# participants affected / at risk     1/373 (0.27%)     0/377 (0.00%)  
Pulmonary oedema † 1    
# participants affected / at risk     0/373 (0.00%)     1/377 (0.27%)  
Pleural effusion † 1    
# participants affected / at risk     4/373 (1.07%)     0/377 (0.00%)  
Pulmonary embolism † 1    
# participants affected / at risk     2/373 (0.54%)     2/377 (0.53%)  
Dyspnoea † 1    
# participants affected / at risk     2/373 (0.54%)     1/377 (0.27%)  
Acute respiratory failure † 1    
# participants affected / at risk     1/373 (0.27%)     1/377 (0.27%)  
Respiratory arrest † 1    
# participants affected / at risk     0/373 (0.00%)     2/377 (0.53%)  
Respiratory failure † 1    
# participants affected / at risk     0/373 (0.00%)     2/377 (0.53%)  
Asthma † 1    
# participants affected / at risk     0/373 (0.00%)     1/377 (0.27%)  
Asthmatic crisis † 1    
# participants affected / at risk     1/373 (0.27%)     0/377 (0.00%)  
Bronchial haemorrhage † 1    
# participants affected / at risk     0/373 (0.00%)     1/377 (0.27%)  
Bronchospasm † 1    
# participants affected / at risk     0/373 (0.00%)     1/377 (0.27%)  
Hydrothorax † 1    
# participants affected / at risk     1/373 (0.27%)     0/377 (0.00%)  
Hypoxia † 1    
# participants affected / at risk     0/373 (0.00%)     1/377 (0.27%)  
Pneumothorax † 1    
# participants affected / at risk     1/373 (0.27%)     0/377 (0.00%)  
Pulmonary oedema † 1    
# participants affected / at risk     0/373 (0.00%)     1/377 (0.27%)  
Skin and subcutaneous tissue disorders      
Palmar-plantar erythrodysaesthesia syndrome † 1    
# participants affected / at risk     0/373 (0.00%)     7/377 (1.86%)  
Intertrigo † 1    
# participants affected / at risk     0/373 (0.00%)     1/377 (0.27%)  
Palmar-plantar erythrodysaesthesia syndrome † 1    
# participants affected / at risk     0/373 (0.00%)     7/377 (1.86%)  
Intertrigo † 1    
# participants affected / at risk     0/373 (0.00%)     1/377 (0.27%)  
Surgical and medical procedures      
Surgery † 1    
# participants affected / at risk     0/373 (0.00%)     1/377 (0.27%)  
Uterine dilation and curettage † 1    
# participants affected / at risk     1/373 (0.27%)     0/377 (0.00%)  
Surgery † 1    
# participants affected / at risk     0/373 (0.00%)     1/377 (0.27%)  
Uterine dilation and curettage † 1    
# participants affected / at risk     1/373 (0.27%)     0/377 (0.00%)  
Vascular disorders      
Deep vein thrombosis † 1    
# participants affected / at risk     1/373 (0.27%)     0/377 (0.00%)  
Embolism † 1    
# participants affected / at risk     1/373 (0.27%)     0/377 (0.00%)  
Hypertension † 1    
# participants affected / at risk     0/373 (0.00%)     1/377 (0.27%)  
Jugular vein thrombosis † 1    
# participants affected / at risk     1/373 (0.27%)     0/377 (0.00%)  
Phlebitis † 1    
# participants affected / at risk     0/373 (0.00%)     1/377 (0.27%)  
Subclavian vein thrombosis † 1    
# participants affected / at risk     1/373 (0.27%)     0/377 (0.00%)  
Superior vena caval occlusion † 1    
# participants affected / at risk     0/373 (0.00%)     1/377 (0.27%)  
Deep vein thrombosis † 1    
# participants affected / at risk     1/373 (0.27%)     0/377 (0.00%)  
Embolism † 1    
# participants affected / at risk     1/373 (0.27%)     0/377 (0.00%)  
Hypertension † 1    
# participants affected / at risk     0/373 (0.00%)     1/377 (0.27%)  
Jugular vein thrombosis † 1    
# participants affected / at risk     1/373 (0.27%)     0/377 (0.00%)  
Phlebitis † 1    
# participants affected / at risk     0/373 (0.00%)     1/377 (0.27%)  
Subclavian vein thrombosis † 1    
# participants affected / at risk     1/373 (0.27%)     0/377 (0.00%)  
Superior vena caval occlusion † 1    
# participants affected / at risk     0/373 (0.00%)     1/377 (0.27%)  
Events were collected by systematic assessment
1 Term from vocabulary, MedDRA 10.0




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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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