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Phase II Study of AZD2281 in Patients With Known BRCA Mutation Status or Recurrent High Grade Ovarian Cancer or Patients With Known BRCA Mutation Status/ Triple Neg Breast Cancer

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
British Columbia Cancer Agency
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00679783
First received: May 15, 2008
Last updated: September 2, 2014
Last verified: September 2014
Results First Received: July 19, 2011  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Ovarian Carcinoma
Breast Cancer
Intervention: Drug: AZD2281

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
The first patient was enrolled on July 8, 2008 and efficacy and safety data were collected up to the data cut-off of March 26, 2010. Patients were enrolled at 6 centres in Canada. Of the 112 patients who gave informed consent 21 patients failed eligibility criteria or withdrew their consent and were not allocated to treatment.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
The study enrolled both known BRCA mutation carriers and patients with unknown BRCA status. Those with unknown status at entry had to provide a DNA sample for BRCA. One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis. Study data are summarised by confirmed mutation status.

Reporting Groups
  Description
BRCA Positive Non-serous Ovarian Patients with non-serous ovarian cancer who have a harmful mutation in the "breast cancer genes" BRCA1 or BRCA2. (Serous tumors are the most common subtype of ovarian cancer; other subtypes are grouped together as "non-serous" in this study).
BRCA Positive Serous Ovarian Patients with serous ovarian cancer who have a harmful mutation in the "breast cancer genes" BRCA1 or BRCA2. (Serous tumors are the most common subtype of ovarian cancer).
BRCA Negative Non-serous Ovarian Patients with non-serous ovarian cancer who do not have a harmful mutation in the "breast cancer genes" BRCA1 or BRCA2
BRCA Negative Serous Ovarian Patients with serous ovarian cancer who do not have a harmful mutation in the "breast cancer genes" BRCA1 or BRCA2
BRCA Positive Non-triple Negative Breast Patients with non-Triple negative breast cancer (non-TNBC) who have a harmful mutation in the "breast cancer genes" BRCA1 or BRCA2. Non-TNBC are cancers that have receptors for oestrogen, progesterone or Her2
BRCA Positive Triple Negative Breast Patients with Triple negative breast cancer (TNBC) who have a harmful mutation in the "breast cancer genes" BRCA1 or BRCA2. TNBC are cancers that don’t have receptors for oestrogen, progesterone or Her2 (Some commonly used breast cancer treatments don’t work for TNBC)
BRCA Negative Triple Negative Breast Patients with Triple negative breast cancer (TNBC) who do not have a harmful mutation in the "breast cancer genes" BRCA1 or BRCA2.

Participant Flow:   Overall Study
    BRCA Positive Non-serous Ovarian     BRCA Positive Serous Ovarian     BRCA Negative Non-serous Ovarian     BRCA Negative Serous Ovarian     BRCA Positive Non-triple Negative Breast     BRCA Positive Triple Negative Breast     BRCA Negative Triple Negative Breast  
STARTED     4 [1]   13 [1]   3 [1]   45 [1]   5 [1]   5 [1]   16 [1]
COMPLETED     2 [2]   10 [2]   2 [2]   25 [2]   4 [2]   5 [2]   15 [2]
NOT COMPLETED     2     3     1     20     1     0     1  
Adverse Event                 0                 0                 0                 3                 0                 0                 1  
Lack of Efficacy                 0                 1                 0                 2                 0                 0                 0  
Withdrawal by Subject                 0                 0                 1                 1                 0                 0                 0  
Not Captured                 0                 0                 0                 5                 0                 0                 0  
Ongoing at data cut-off                 2                 2                 0                 9                 1                 0                 0  
[1] Gave Informed consent and passed screening
[2] Patients who discontinued treatment following disease progression.



  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
BRCA Positive Non-serous Ovarian Patients with non-serous ovarian cancer who have a harmful mutation in the "breast cancer genes" BRCA1 or BRCA2. (Serous tumors are the most common subtype of ovarian cancer; other subtypes are grouped together as "non-serous" in this study).
BRCA Positive Serous Ovarian Patients with serous ovarian cancer who have a harmful mutation in the "breast cancer genes" BRCA1 or BRCA2. (Serous tumors are the most common subtype of ovarian cancer).
BRCA Negative Non-serous Ovarian Patients with non-serous ovarian cancer who do not have a harmful mutation in the "breast cancer genes" BRCA1 or BRCA2
BRCA Negative Serous Ovarian Patients with serous ovarian cancer who do not have a harmful mutation in the "breast cancer genes" BRCA1 or BRCA2
BRCA Positive Non-triple Negative Breast Patients with non-Triple negative breast cancer (non-TNBC) who have a harmful mutation in the "breast cancer genes" BRCA1 or BRCA2. Non-TNBC are cancers that have receptors for oestrogen, progesterone or Her2
BRCA Positive Triple Negative Breast Patients with Triple negative breast cancer (TNBC) who have a harmful mutation in the "breast cancer genes" BRCA1 or BRCA2. TNBC are cancers that don’t have receptors for oestrogen, progesterone or Her2 (Some commonly used breast cancer treatments don’t work for TNBC)
BRCA Negative Triple Negative Breast Patients with Triple negative breast cancer (TNBC) who do not have a harmful mutation in the "breast cancer genes" BRCA1 or BRCA2.
Total Total of all reporting groups

Baseline Measures
    BRCA Positive Non-serous Ovarian     BRCA Positive Serous Ovarian     BRCA Negative Non-serous Ovarian     BRCA Negative Serous Ovarian     BRCA Positive Non-triple Negative Breast     BRCA Positive Triple Negative Breast     BRCA Negative Triple Negative Breast     Total  
Number of Participants  
[units: participants]
  4     13     3     44     5     5     16     90  
Age  
[units: Year]
Mean ± Standard Deviation
  60  ± 18.7     53.7  ± 7.3     60.3  ± 12.9     61  ± 9.5     49.4  ± 20.5     44.8  ± 15.5     48.8  ± 5.5     52.9  ± 13  
Gender  
[units: Participants]
               
Female     4     13     3     44     5     5     16     90  
Male     0     0     0     0     0     0     0     0  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Objective Response Rate (ORR) Evaluated According to Response Evaluation Criteria In Solid Tumors (RECIST) Guidelines   [ Time Frame: Each patient with measurable disease at baseline was assessed for Objective Response from the sequence of RECIST scan data up to data cut-off, 26 March 2010. RECIST scans were performed every 8 weeks (+/- 2 weeks) from randomization. ]

2.  Secondary:   Disease Control Rate (DCR)   [ Time Frame: 16 Weeks ]

3.  Secondary:   Duration of Response   [ Time Frame: RECIST tumour assessments carried out every 8 weeks from randomization (+/- 2 weeks) until data cut-off on 26 March 2010. ]

4.  Secondary:   Best Percentage Change From Baseline in Tumour Size   [ Time Frame: Each patient with measurable disease at baseline was assessed for best percentage change in tumour size from the sequence of RECIST scan data up to data cut-off, 26 March 2010. RECIST scans were performed every 8 weeks (+/- 2 weeks) from randomization. ]

5.  Secondary:   CA-125 Levels (Ovarian Cancer Patients Only)   [ Time Frame: 24 weeks ]

6.  Secondary:   Progression Free Survival (PFS)   [ Time Frame: RECIST tumour assessments carried out every 8 weeks from randomization (+/- 2 weeks) until data cut-off on 26 March 2010. ]


  Serious Adverse Events


  Other Adverse Events
  Hide Other Adverse Events

Time Frame No text entered.
Additional Description One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis

Frequency Threshold
Threshold above which other adverse events are reported   5%  

Reporting Groups
  Description
BRCA Positive Non-serous Ovarian Patients with non-serous ovarian cancer who have a harmful mutation in the "breast cancer genes" BRCA1 or BRCA2. (Serous tumors are the most common subtype of ovarian cancer; other subtypes are grouped together as "non-serous" in this study).
BRCA Positive Serous Ovarian Patients with serous ovarian cancer who have a harmful mutation in the "breast cancer genes" BRCA1 or BRCA2. (Serous tumors are the most common subtype of ovarian cancer).
BRCA Negative Non-serous Ovarian Patients with non-serous ovarian cancer who do not have a harmful mutation in the "breast cancer genes" BRCA1 or BRCA2
BRCA Negative Serous Ovarian Patients with serous ovarian cancer who do not have a harmful mutation in the "breast cancer genes" BRCA1 or BRCA2
BRCA Positive Non-triple Negative Breast Patients with non-Triple negative breast cancer (non-TNBC) who have a harmful mutation in the "breast cancer genes" BRCA1 or BRCA2. Non-TNBC are cancers that have receptors for oestrogen, progesterone or Her2
BRCA Positive Triple Negative Breast Patients with Triple negative breast cancer (TNBC) who have a harmful mutation in the "breast cancer genes" BRCA1 or BRCA2. TNBC are cancers that don’t have receptors for oestrogen, progesterone or Her2 (Some commonly used breast cancer treatments don’t work for TNBC)
BRCA Negative Triple Negative Breast Patients with Triple negative breast cancer (TNBC) who do not have a harmful mutation in the "breast cancer genes" BRCA1 or BRCA2.

Other Adverse Events
    BRCA Positive Non-serous Ovarian     BRCA Positive Serous Ovarian     BRCA Negative Non-serous Ovarian     BRCA Negative Serous Ovarian     BRCA Positive Non-triple Negative Breast     BRCA Positive Triple Negative Breast     BRCA Negative Triple Negative Breast  
Total, other (not including serious) adverse events                
# participants affected / at risk     4/4     13/13     3/3     44/44     5/5     5/5     15/16  
Blood and lymphatic system disorders                
Anaemia † 1              
# participants affected / at risk     0/4 (0.00%)     0/13 (0.00%)     0/3 (0.00%)     2/44 (4.55%)     1/5 (20.00%)     1/5 (20.00%)     2/16 (12.50%)  
Neutropenia † 1              
# participants affected / at risk     0/4 (0.00%)     1/13 (7.69%)     0/3 (0.00%)     1/44 (2.27%)     0/5 (0.00%)     0/5 (0.00%)     0/16 (0.00%)  
Thrombocytopenia † 1              
# participants affected / at risk     0/4 (0.00%)     0/13 (0.00%)     0/3 (0.00%)     0/44 (0.00%)     1/5 (20.00%)     0/5 (0.00%)     0/16 (0.00%)  
Cardiac disorders                
Palpitations † 1              
# participants affected / at risk     1/4 (25.00%)     0/13 (0.00%)     0/3 (0.00%)     1/44 (2.27%)     0/5 (0.00%)     0/5 (0.00%)     0/16 (0.00%)  
Sinus Tachycardia † 1              
# participants affected / at risk     0/4 (0.00%)     1/13 (7.69%)     0/3 (0.00%)     0/44 (0.00%)     0/5 (0.00%)     0/5 (0.00%)     0/16 (0.00%)  
Tachycardia † 1              
# participants affected / at risk     0/4 (0.00%)     1/13 (7.69%)     0/3 (0.00%)     0/44 (0.00%)     0/5 (0.00%)     1/5 (20.00%)     0/16 (0.00%)  
Ear and labyrinth disorders                
Ear Pain † 1              
# participants affected / at risk     0/4 (0.00%)     0/13 (0.00%)     0/3 (0.00%)     0/44 (0.00%)     1/5 (20.00%)     0/5 (0.00%)     0/16 (0.00%)  
Tinnitus † 1              
# participants affected / at risk     1/4 (25.00%)     1/13 (7.69%)     0/3 (0.00%)     0/44 (0.00%)     0/5 (0.00%)     0/5 (0.00%)     1/16 (6.25%)  
Vertigo † 1              
# participants affected / at risk     0/4 (0.00%)     0/13 (0.00%)     0/3 (0.00%)     0/44 (0.00%)     0/5 (0.00%)     0/5 (0.00%)     1/16 (6.25%)  
Eye disorders                
Visual Impairment † 1              
# participants affected / at risk     0/4 (0.00%)     0/13 (0.00%)     1/3 (33.33%)     0/44 (0.00%)     0/5 (0.00%)     0/5 (0.00%)     0/16 (0.00%)  
Gastrointestinal disorders                
Nausea † 1              
# participants affected / at risk     3/4 (75.00%)     9/13 (69.23%)     2/3 (66.67%)     28/44 (63.64%)     3/5 (60.00%)     5/5 (100.00%)     8/16 (50.00%)  
Vomiting † 1              
# participants affected / at risk     2/4 (50.00%)     4/13 (30.77%)     1/3 (33.33%)     18/44 (40.91%)     2/5 (40.00%)     3/5 (60.00%)     4/16 (25.00%)  
Abdominal Distension † 1              
# participants affected / at risk     2/4 (50.00%)     3/13 (23.08%)     0/3 (0.00%)     11/44 (25.00%)     0/5 (0.00%)     0/5 (0.00%)     1/16 (6.25%)  
Abdominal Pain † 1              
# participants affected / at risk     0/4 (0.00%)     2/13 (15.38%)     0/3 (0.00%)     11/44 (25.00%)     2/5 (40.00%)     1/5 (20.00%)     1/16 (6.25%)  
Diarrhoea † 1              
# participants affected / at risk     2/4 (50.00%)     2/13 (15.38%)     0/3 (0.00%)     11/44 (25.00%)     0/5 (0.00%)     0/5 (0.00%)     0/16 (0.00%)  
Abdominal Pain Lower † 1              
# participants affected / at risk     0/4 (0.00%)     1/13 (7.69%)     0/3 (0.00%)     6/44 (13.64%)     0/5 (0.00%)     0/5 (0.00%)     0/16 (0.00%)  
Abdominal Pain Upper † 1              
# participants affected / at risk     2/4 (50.00%)     2/13 (15.38%)     0/3 (0.00%)     5/44 (11.36%)     1/5 (20.00%)     0/5 (0.00%)     0/16 (0.00%)  
Constipation † 1              
# participants affected / at risk     1/4 (25.00%)     5/13 (38.46%)     0/3 (0.00%)     5/44 (11.36%)     1/5 (20.00%)     2/5 (40.00%)     1/16 (6.25%)  
Dyspepsia † 1              
# participants affected / at risk     1/4 (25.00%)     4/13 (30.77%)     0/3 (0.00%)     5/44 (11.36%)     0/5 (0.00%)     1/5 (20.00%)     1/16 (6.25%)  
Rectal Haemorrhage † 1              
# participants affected / at risk     0/4 (0.00%)     0/13 (0.00%)     0/3 (0.00%)     3/44 (6.82%)     0/5 (0.00%)     0/5 (0.00%)     0/16 (0.00%)  
Dry Mouth † 1              
# participants affected / at risk     0/4 (0.00%)     2/13 (15.38%)     0/3 (0.00%)     2/44 (4.55%)     0/5 (0.00%)     0/5 (0.00%)     0/16 (0.00%)  
Gingival Pain † 1              
# participants affected / at risk     0/4 (0.00%)     1/13 (7.69%)     0/3 (0.00%)     2/44 (4.55%)     0/5 (0.00%)     0/5 (0.00%)     0/16 (0.00%)  
Stomatitis † 1              
# participants affected / at risk     2/4 (50.00%)     2/13 (15.38%)     0/3 (0.00%)     1/44 (2.27%)     1/5 (20.00%)     0/5 (0.00%)     1/16 (6.25%)  
Abdominal Discomfort † 1              
# participants affected / at risk     0/4 (0.00%)     1/13 (7.69%)     0/3 (0.00%)     0/44 (0.00%)     1/5 (20.00%)     0/5 (0.00%)     0/16 (0.00%)  
Anal Haemorrhage † 1              
# participants affected / at risk     0/4 (0.00%)     1/13 (7.69%)     0/3 (0.00%)     0/44 (0.00%)     0/5 (0.00%)     0/5 (0.00%)     0/16 (0.00%)  
Gastrooesophageal Reflux Disease † 1              
# participants affected / at risk     0/4 (0.00%)     1/13 (7.69%)     0/3 (0.00%)     0/44 (0.00%)     0/5 (0.00%)     0/5 (0.00%)     0/16 (0.00%)  
Haemorrhoids † 1              
# participants affected / at risk     0/4 (0.00%)     0/13 (0.00%)     0/3 (0.00%)     0/44 (0.00%)     0/5 (0.00%)     1/5 (20.00%)     0/16 (0.00%)  
Hypoaesthesia Oral † 1              
# participants affected / at risk     0/4 (0.00%)     1/13 (7.69%)     0/3 (0.00%)     0/44 (0.00%)     0/5 (0.00%)     0/5 (0.00%)     0/16 (0.00%)  
Mouth Haemorrhage † 1              
# participants affected / at risk     0/4 (0.00%)     1/13 (7.69%)     0/3 (0.00%)     0/44 (0.00%)     0/5 (0.00%)     0/5 (0.00%)     0/16 (0.00%)  
Oesophageal Pain † 1              
# participants affected / at risk     0/4 (0.00%)     1/13 (7.69%)     0/3 (0.00%)     0/44 (0.00%)     0/5 (0.00%)     0/5 (0.00%)     0/16 (0.00%)  
Oral Discomfort † 1              
# participants affected / at risk     0/4 (0.00%)     0/13 (0.00%)     0/3 (0.00%)     0/44 (0.00%)     0/5 (0.00%)     1/5 (20.00%)     0/16 (0.00%)  
Toothache † 1              
# participants affected / at risk     0/4 (0.00%)     1/13 (7.69%)     0/3 (0.00%)     0/44 (0.00%)     0/5 (0.00%)     0/5 (0.00%)     0/16 (0.00%)  
General disorders                
Fatigue † 1              
# participants affected / at risk     4/4 (100.00%)     12/13 (92.31%)     1/3 (33.33%)     28/44 (63.64%)     3/5 (60.00%)     3/5 (60.00%)     7/16 (43.75%)  
Oedema Peripheral † 1              
# participants affected / at risk     2/4 (50.00%)     3/13 (23.08%)     0/3 (0.00%)     8/44 (18.18%)     0/5 (0.00%)     0/5 (0.00%)     2/16 (12.50%)  
Chills † 1              
# participants affected / at risk     2/4 (50.00%)     1/13 (7.69%)     1/3 (33.33%)     0/44 (0.00%)     0/5 (0.00%)     1/5 (20.00%)     1/16 (6.25%)  
Asthenia † 1              
# participants affected / at risk     0/4 (0.00%)     0/13 (0.00%)     0/3 (0.00%)     0/44 (0.00%)     0/5 (0.00%)     1/5 (20.00%)     0/16 (0.00%)  
Axillary Pain † 1              
# participants affected / at risk     1/4 (25.00%)     0/13 (0.00%)     0/3 (0.00%)     0/44 (0.00%)     0/5 (0.00%)     0/5 (0.00%)     0/16 (0.00%)  
Face Oedema † 1              
# participants affected / at risk     1/4 (25.00%)     0/13 (0.00%)     0/3 (0.00%)     0/44 (0.00%)     0/5 (0.00%)     0/5 (0.00%)     0/16 (0.00%)  
Feeling Hot † 1              
# participants affected / at risk     0/4 (0.00%)     0/13 (0.00%)     0/3 (0.00%)     0/44 (0.00%)     1/5 (20.00%)     0/5 (0.00%)     0/16 (0.00%)  
Influenza Like Illness † 1              
# participants affected / at risk     0/4 (0.00%)     1/13 (7.69%)     0/3 (0.00%)     1/44 (2.27%)     0/5 (0.00%)     0/5 (0.00%)     0/16 (0.00%)  
Injection Site Reaction † 1              
# participants affected / at risk     0/4 (0.00%)     1/13 (7.69%)     0/3 (0.00%)     0/44 (0.00%)     0/5 (0.00%)     0/5 (0.00%)     0/16 (0.00%)  
Localised Oedema † 1              
# participants affected / at risk     0/4 (0.00%)     1/13 (7.69%)     0/3 (0.00%)     0/44 (0.00%)     0/5 (0.00%)     0/5 (0.00%)     0/16 (0.00%)  
Mucosal Inflammation † 1              
# participants affected / at risk     1/4 (25.00%)     1/13 (7.69%)     0/3 (0.00%)     0/44 (0.00%)     0/5 (0.00%)     0/5 (0.00%)     0/16 (0.00%)  
Non-Cardiac Chest Pain † 1              
# participants affected / at risk     0/4 (0.00%)     1/13 (7.69%)     0/3 (0.00%)     1/44 (2.27%)     1/5 (20.00%)     0/5 (0.00%)     0/16 (0.00%)  
Pyrexia † 1              
# participants affected / at risk     0/4 (0.00%)     1/13 (7.69%)     1/3 (33.33%)     1/44 (2.27%)     1/5 (20.00%)     0/5 (0.00%)     1/16 (6.25%)  
Secretion Discharge † 1              
# participants affected / at risk     0/4 (0.00%)     0/13 (0.00%)     0/3 (0.00%)     0/44 (0.00%)     0/5 (0.00%)     0/5 (0.00%)     1/16 (6.25%)  
Thirst † 1              
# participants affected / at risk     0/4 (0.00%)     0/13 (0.00%)     0/3 (0.00%)     0/44 (0.00%)     0/5 (0.00%)     0/5 (0.00%)     1/16 (6.25%)  
Hepatobiliary disorders                
Hepatic Haemorrhage † 1              
# participants affected / at risk     0/4 (0.00%)     1/13 (7.69%)     0/3 (0.00%)     0/44 (0.00%)     0/5 (0.00%)     0/5 (0.00%)     0/16 (0.00%)  
Hyperbilirubinaemia † 1              
# participants affected / at risk     0/4 (0.00%)     1/13 (7.69%)     0/3 (0.00%)     0/44 (0.00%)     0/5 (0.00%)     0/5 (0.00%)     0/16 (0.00%)  
Infections and infestations                
Upper Respiratory Tract Infection † 1              
# participants affected / at risk     0/4 (0.00%)     0/13 (0.00%)     0/3 (0.00%)     7/44 (15.91%)     0/5 (0.00%)     0/5 (0.00%)     0/16 (0.00%)  
Rhinitis † 1              
# participants affected / at risk     0/4 (0.00%)     1/13 (7.69%)     0/3 (0.00%)     2/44 (4.55%)     0/5 (0.00%)     0/5 (0.00%)     0/16 (0.00%)  
Urinary Tract Infection † 1              
# participants affected / at risk     0/4 (0.00%)     2/13 (15.38%)     0/3 (0.00%)     1/44 (2.27%)     0/5 (0.00%)     0/5 (0.00%)     0/16 (0.00%)  
Breast Cellulitis † 1              
# participants affected / at risk     0/4 (0.00%)     0/13 (0.00%)     0/3 (0.00%)     0/44 (0.00%)     0/5 (0.00%)     0/5 (0.00%)     1/16 (6.25%)  
Candidiasis † 1              
# participants affected / at risk     0/4 (0.00%)     1/13 (7.69%)     0/3 (0.00%)     0/44 (0.00%)     0/5 (0.00%)     0/5 (0.00%)     0/16 (0.00%)  
Infection † 1              
# participants affected / at risk     0/4 (0.00%)     0/13 (0.00%)     0/3 (0.00%)     0/44 (0.00%)     0/5 (0.00%)     0/5 (0.00%)     1/16 (6.25%)  
Oral Infection † 1              
# participants affected / at risk     0/4 (0.00%)     0/13 (0.00%)     0/3 (0.00%)     0/44 (0.00%)     0/5 (0.00%)     0/5 (0.00%)     1/16 (6.25%)  
Sepsis † 1              
# participants affected / at risk     0/4 (0.00%)     0/13 (0.00%)     1/3 (33.33%)     0/44 (0.00%)     0/5 (0.00%)     0/5 (0.00%)     0/16 (0.00%)  
Skin Infection † 1              
# participants affected / at risk     0/4 (0.00%)     1/13 (7.69%)     0/3 (0.00%)     1/44 (2.27%)     0/5 (0.00%)     0/5 (0.00%)     0/16 (0.00%)  
Vaginal Infection † 1              
# participants affected / at risk     0/4 (0.00%)     0/13 (0.00%)     0/3 (0.00%)     0/44 (0.00%)     0/5 (0.00%)     0/5 (0.00%)     1/16 (6.25%)  
Viral Infection † 1              
# participants affected / at risk     0/4 (0.00%)     0/13 (0.00%)     0/3 (0.00%)     1/44 (2.27%)     1/5 (20.00%)     0/5 (0.00%)     0/16 (0.00%)  
Vulvovaginitis Streptococcal † 1              
# participants affected / at risk     0/4 (0.00%)     1/13 (7.69%)     0/3 (0.00%)     0/44 (0.00%)     0/5 (0.00%)     0/5 (0.00%)     0/16 (0.00%)  
Injury, poisoning and procedural complications                
Procedural Pain † 1              
# participants affected / at risk     0/4 (0.00%)     0/13 (0.00%)     0/3 (0.00%)     3/44 (6.82%)     0/5 (0.00%)     1/5 (20.00%)     0/16 (0.00%)  
Tooth Injury † 1              
# participants affected / at risk     0/4 (0.00%)     0/13 (0.00%)     0/3 (0.00%)     0/44 (0.00%)     0/5 (0.00%)     1/5 (20.00%)     0/16 (0.00%)  
Weight Decreased † 1              
# participants affected / at risk     1/4 (25.00%)     0/13 (0.00%)     0/3 (0.00%)     4/44 (9.09%)     0/5 (0.00%)     0/5 (0.00%)     0/16 (0.00%)  
Alanine Aminotransferase Increased † 1              
# participants affected / at risk     0/4 (0.00%)     1/13 (7.69%)     0/3 (0.00%)     0/44 (0.00%)     0/5 (0.00%)     0/5 (0.00%)     0/16 (0.00%)  
Aspartate Aminotransferase Increased † 1              
# participants affected / at risk     0/4 (0.00%)     1/13 (7.69%)     0/3 (0.00%)     0/44 (0.00%)     0/5 (0.00%)     0/5 (0.00%)     0/16 (0.00%)  
Blood Alkaline Phosphatase Increased † 1              
# participants affected / at risk     0/4 (0.00%)     1/13 (7.69%)     0/3 (0.00%)     0/44 (0.00%)     0/5 (0.00%)     0/5 (0.00%)     0/16 (0.00%)  
Blood Glucose Increased † 1              
# participants affected / at risk     0/4 (0.00%)     1/13 (7.69%)     0/3 (0.00%)     0/44 (0.00%)     0/5 (0.00%)     0/5 (0.00%)     0/16 (0.00%)  
Blood Iron Decreased † 1              
# participants affected / at risk     0/4 (0.00%)     0/13 (0.00%)     0/3 (0.00%)     0/44 (0.00%)     0/5 (0.00%)     1/5 (20.00%)     0/16 (0.00%)  
Cardiac Murmur † 1              
# participants affected / at risk     0/4 (0.00%)     1/13 (7.69%)     0/3 (0.00%)     0/44 (0.00%)     0/5 (0.00%)     0/5 (0.00%)     0/16 (0.00%)  
Electrocardiogram Qt Prolonged † 1              
# participants affected / at risk     0/4 (0.00%)     0/13 (0.00%)     0/3 (0.00%)     0/44 (0.00%)     0/5 (0.00%)     0/5 (0.00%)     1/16 (6.25%)  
Gamma-Glutamyltransferase Increased † 1              
# participants affected / at risk     0/4 (0.00%)     1/13 (7.69%)     0/3 (0.00%)     0/44 (0.00%)     0/5 (0.00%)     1/5 (20.00%)     1/16 (6.25%)  
Haemoglobin Decreased † 1              
# participants affected / at risk     1/4 (25.00%)     1/13 (7.69%)     0/3 (0.00%)     1/44 (2.27%)     0/5 (0.00%)     0/5 (0.00%)     0/16 (0.00%)  
Metabolism and nutrition disorders                
Decreased Appetite † 1              
# participants affected / at risk     2/4 (50.00%)     7/13 (53.85%)     1/3 (33.33%)     13/44 (29.55%)     2/5 (40.00%)     1/5 (20.00%)     4/16 (25.00%)  
Hypercalcaemia † 1              
# participants affected / at risk     0/4 (0.00%)     1/13 (7.69%)     0/3 (0.00%)     0/44 (0.00%)     0/5 (0.00%)     0/5 (0.00%)     0/16 (0.00%)  
Hypokalaemia † 1              
# participants affected / at risk     0/4 (0.00%)     0/13 (0.00%)     0/3 (0.00%)     1/44 (2.27%)     0/5 (0.00%)     0/5 (0.00%)     1/16 (6.25%)  
Hyponatraemia † 1              
# participants affected / at risk     0/4 (0.00%)     1/13 (7.69%)     0/3 (0.00%)     0/44 (0.00%)     0/5 (0.00%)     0/5 (0.00%)     0/16 (0.00%)  
Musculoskeletal and connective tissue disorders                
Arthralgia † 1              
# participants affected / at risk     2/4 (50.00%)     2/13 (15.38%)     0/3 (0.00%)     6/44 (13.64%)     0/5 (0.00%)     0/5 (0.00%)     2/16 (12.50%)  
Back Pain † 1              
# participants affected / at risk     0/4 (0.00%)     2/13 (15.38%)     1/3 (33.33%)     4/44 (9.09%)     0/5 (0.00%)     0/5 (0.00%)     4/16 (25.00%)  
Myalgia † 1              
# participants affected / at risk     1/4 (25.00%)     4/13 (30.77%)     0/3 (0.00%)     2/44 (4.55%)     1/5 (20.00%)     1/5 (20.00%)     3/16 (18.75%)  
Groin Pain † 1              
# participants affected / at risk     1/4 (25.00%)     0/13 (0.00%)     0/3 (0.00%)     3/44 (6.82%)     0/5 (0.00%)     0/5 (0.00%)     1/16 (6.25%)  
Pain In Extremity † 1              
# participants affected / at risk     1/4 (25.00%)     2/13 (15.38%)     0/3 (0.00%)     3/44 (6.82%)     1/5 (20.00%)     1/5 (20.00%)     0/16 (0.00%)  
Musculoskeletal Pain † 1              
# participants affected / at risk     0/4 (0.00%)     2/13 (15.38%)     0/3 (0.00%)     1/44 (2.27%)     0/5 (0.00%)     0/5 (0.00%)     1/16 (6.25%)  
Neck Pain † 1              
# participants affected / at risk     0/4 (0.00%)     0/13 (0.00%)     0/3 (0.00%)     2/44 (4.55%)     0/5 (0.00%)     0/5 (0.00%)     2/16 (12.50%)  
Costochondritis † 1              
# participants affected / at risk     0/4 (0.00%)     0/13 (0.00%)     0/3 (0.00%)     0/44 (0.00%)     0/5 (0.00%)     0/5 (0.00%)     1/16 (6.25%)  
Flank Pain † 1              
# participants affected / at risk     0/4 (0.00%)     1/13 (7.69%)     0/3 (0.00%)     0/44 (0.00%)     0/5 (0.00%)     0/5 (0.00%)     0/16 (0.00%)  
Muscular Weakness † 1              
# participants affected / at risk     0/4 (0.00%)     0/13 (0.00%)     1/3 (33.33%)     0/44 (0.00%)     0/5 (0.00%)     0/5 (0.00%)     1/16 (6.25%)  
Musculoskeletal Chest Pain † 1              
# participants affected / at risk     0/4 (0.00%)     0/13 (0.00%)     0/3 (0.00%)     0/44 (0.00%)     1/5 (20.00%)     0/5 (0.00%)     0/16 (0.00%)  
Musculoskeletal Stiffness † 1              
# participants affected / at risk     0/4 (0.00%)     0/13 (0.00%)     0/3 (0.00%)     0/44 (0.00%)     0/5 (0.00%)     0/5 (0.00%)     1/16 (6.25%)  
Neoplasms benign, malignant and unspecified (incl cysts and polyps)                
Cancer Pain † 1              
# participants affected / at risk     0/4 (0.00%)     0/13 (0.00%)     0/3 (0.00%)     0/44 (0.00%)     1/5 (20.00%)     0/5 (0.00%)     0/16 (0.00%)  
Nervous system disorders                
Dysgeusia † 1              
# participants affected / at risk     0/4 (0.00%)     5/13 (38.46%)     1/3 (33.33%)     9/44 (20.45%)     2/5 (40.00%)     2/5 (40.00%)     0/16 (0.00%)  
Headache † 1              
# participants affected / at risk     3/4 (75.00%)     2/13 (15.38%)     0/3 (0.00%)     7/44 (15.91%)     3/5 (60.00%)     0/5 (0.00%)     2/16 (12.50%)  
Dizziness † 1              
# participants affected / at risk     2/4 (50.00%)     6/13 (46.15%)     1/3 (33.33%)     5/44 (11.36%)     1/5 (20.00%)     1/5 (20.00%)     2/16 (12.50%)  
Peripheral Sensory Neuropathy † 1              
# participants affected / at risk     0/4 (0.00%)     0/13 (0.00%)     1/3 (33.33%)     2/44 (4.55%)     0/5 (0.00%)     0/5 (0.00%)     0/16 (0.00%)  
Ataxia † 1              
# participants affected / at risk     0/4 (0.00%)     0/13 (0.00%)     0/3 (0.00%)     0/44 (0.00%)     0/5 (0.00%)     0/5 (0.00%)     1/16 (6.25%)  
Dysarthria † 1              
# participants affected / at risk     1/4 (25.00%)     0/13 (0.00%)     0/3 (0.00%)     0/44 (0.00%)     0/5 (0.00%)     0/5 (0.00%)     0/16 (0.00%)  
Hyperaesthesia † 1              
# participants affected / at risk     0/4 (0.00%)     0/13 (0.00%)     0/3 (0.00%)     0/44 (0.00%)     0/5 (0.00%)     0/5 (0.00%)     1/16 (6.25%)  
Memory Impairment † 1              
# participants affected / at risk     1/4 (25.00%)     0/13 (0.00%)     0/3 (0.00%)     0/44 (0.00%)     0/5 (0.00%)     0/5 (0.00%)     0/16 (0.00%)  
Mental Impairment † 1              
# participants affected / at risk     0/4 (0.00%)     1/13 (7.69%)     0/3 (0.00%)     0/44 (0.00%)     0/5 (0.00%)     0/5 (0.00%)     0/16 (0.00%)  
Neuropathy Peripheral † 1              
# participants affected / at risk     0/4 (0.00%)     0/13 (0.00%)     0/3 (0.00%)     0/44 (0.00%)     0/5 (0.00%)     0/5 (0.00%)     1/16 (6.25%)  
Parosmia † 1              
# participants affected / at risk     0/4 (0.00%)     0/13 (0.00%)     0/3 (0.00%)     1/44 (2.27%)     0/5 (0.00%)     0/5 (0.00%)     1/16 (6.25%)  
Psychomotor Hyperactivity † 1              
# participants affected / at risk     1/4 (25.00%)     0/13 (0.00%)     0/3 (0.00%)     0/44 (0.00%)     0/5 (0.00%)     0/5 (0.00%)     0/16 (0.00%)  
Sinus Headache † 1              
# participants affected / at risk     0/4 (0.00%)     1/13 (7.69%)     0/3 (0.00%)     0/44 (0.00%)     0/5 (0.00%)     0/5 (0.00%)     0/16 (0.00%)  
Syncope † 1              
# participants affected / at risk     1/4 (25.00%)     0/13 (0.00%)     0/3 (0.00%)     0/44 (0.00%)     0/5 (0.00%)     0/5 (0.00%)     0/16 (0.00%)  
Psychiatric disorders                
Insomnia † 1              
# participants affected / at risk     0/4 (0.00%)     2/13 (15.38%)     0/3 (0.00%)     7/44 (15.91%)     0/5 (0.00%)     1/5 (20.00%)     1/16 (6.25%)  
Anxiety † 1              
# participants affected / at risk     0/4 (0.00%)     2/13 (15.38%)     0/3 (0.00%)     2/44 (4.55%)     0/5 (0.00%)     0/5 (0.00%)     0/16 (0.00%)  
Depression † 1              
# participants affected / at risk     1/4 (25.00%)     1/13 (7.69%)     0/3 (0.00%)     0/44 (0.00%)     0/5 (0.00%)     0/5 (0.00%)     0/16 (0.00%)  
Mood Altered † 1              
# participants affected / at risk     0/4 (0.00%)     0/13 (0.00%)     0/3 (0.00%)     0/44 (0.00%)     0/5 (0.00%)     0/5 (0.00%)     1/16 (6.25%)  
Renal and urinary disorders                
Dysuria † 1              
# participants affected / at risk     0/4 (0.00%)     2/13 (15.38%)     0/3 (0.00%)     2/44 (4.55%)     0/5 (0.00%)     0/5 (0.00%)     0/16 (0.00%)  
Hydronephrosis † 1              
# participants affected / at risk     0/4 (0.00%)     1/13 (7.69%)     0/3 (0.00%)     0/44 (0.00%)     0/5 (0.00%)     0/5 (0.00%)     0/16 (0.00%)  
Proteinuria † 1              
# participants affected / at risk     0/4 (0.00%)     1/13 (7.69%)     0/3 (0.00%)     0/44 (0.00%)     0/5 (0.00%)     0/5 (0.00%)     0/16 (0.00%)  
Urinary Incontinence † 1              
# participants affected / at risk     0/4 (0.00%)     0/13 (0.00%)     1/3 (33.33%)     0/44 (0.00%)     0/5 (0.00%)     0/5 (0.00%)     0/16 (0.00%)  
Reproductive system and breast disorders                
Breast Pain † 1              
# participants affected / at risk     1/4 (25.00%)     1/13 (7.69%)     0/3 (0.00%)     0/44 (0.00%)     0/5 (0.00%)     0/5 (0.00%)     0/16 (0.00%)  
Genital Rash † 1              
# participants affected / at risk     1/4 (25.00%)     0/13 (0.00%)     0/3 (0.00%)     0/44 (0.00%)     0/5 (0.00%)     0/5 (0.00%)     0/16 (0.00%)  
Oedema Genital † 1              
# participants affected / at risk     0/4 (0.00%)     1/13 (7.69%)     0/3 (0.00%)     0/44 (0.00%)     0/5 (0.00%)     0/5 (0.00%)     0/16 (0.00%)  
Pelvic Discomfort † 1              
# participants affected / at risk     0/4 (0.00%)     1/13 (7.69%)     0/3 (0.00%)     0/44 (0.00%)     0/5 (0.00%)     0/5 (0.00%)     0/16 (0.00%)  
Pelvic Pain † 1              
# participants affected / at risk     1/4 (25.00%)     0/13 (0.00%)     0/3 (0.00%)     0/44 (0.00%)     0/5 (0.00%)     0/5 (0.00%)     0/16 (0.00%)  
Vaginal Haemorrhage † 1              
# participants affected / at risk     0/4 (0.00%)     1/13 (7.69%)     0/3 (0.00%)     0/44 (0.00%)     0/5 (0.00%)     0/5 (0.00%)     0/16 (0.00%)  
Respiratory, thoracic and mediastinal disorders                
Cough † 1              
# participants affected / at risk     2/4 (50.00%)     5/13 (38.46%)     0/3 (0.00%)     5/44 (11.36%)     1/5 (20.00%)     0/5 (0.00%)     1/16 (6.25%)  
Dyspnoea † 1              
# participants affected / at risk     2/4 (50.00%)     2/13 (15.38%)     0/3 (0.00%)     5/44 (11.36%)     2/5 (40.00%)     0/5 (0.00%)     3/16 (18.75%)  
Oropharyngeal Pain † 1              
# participants affected / at risk     0/4 (0.00%)     2/13 (15.38%)     0/3 (0.00%)     1/44 (2.27%)     1/5 (20.00%)     0/5 (0.00%)     0/16 (0.00%)  
Rhinorrhoea † 1              
# participants affected / at risk     1/4 (25.00%)     1/13 (7.69%)     0/3 (0.00%)     2/44 (4.55%)     0/5 (0.00%)     0/5 (0.00%)     0/16 (0.00%)  
Dysphonia † 1              
# participants affected / at risk     0/4 (0.00%)     0/13 (0.00%)     0/3 (0.00%)     1/44 (2.27%)     0/5 (0.00%)     1/5 (20.00%)     0/16 (0.00%)  
Epistaxis † 1              
# participants affected / at risk     0/4 (0.00%)     1/13 (7.69%)     0/3 (0.00%)     1/44 (2.27%)     0/5 (0.00%)     0/5 (0.00%)     0/16 (0.00%)  
Haemoptysis † 1              
# participants affected / at risk     0/4 (0.00%)     0/13 (0.00%)     0/3 (0.00%)     0/44 (0.00%)     1/5 (20.00%)     0/5 (0.00%)     0/16 (0.00%)  
Nasal Congestion † 1              
# participants affected / at risk     0/4 (0.00%)     0/13 (0.00%)     0/3 (0.00%)     1/44 (2.27%)     1/5 (20.00%)     0/5 (0.00%)     1/16 (6.25%)  
Nasal Dryness † 1              
# participants affected / at risk     0/4 (0.00%)     0/13 (0.00%)     0/3 (0.00%)     0/44 (0.00%)     0/5 (0.00%)     0/5 (0.00%)     1/16 (6.25%)  
Pleural Effusion † 1              
# participants affected / at risk     0/4 (0.00%)     1/13 (7.69%)     0/3 (0.00%)     1/44 (2.27%)     0/5 (0.00%)     0/5 (0.00%)     0/16 (0.00%)  
Pulmonary Fibrosis † 1              
# participants affected / at risk     0/4 (0.00%)     1/13 (7.69%)     0/3 (0.00%)     0/44 (0.00%)     0/5 (0.00%)     0/5 (0.00%)     0/16 (0.00%)  
Rales † 1              
# participants affected / at risk     0/4 (0.00%)     0/13 (0.00%)     0/3 (0.00%)     0/44 (0.00%)     0/5 (0.00%)     0/5 (0.00%)     1/16 (6.25%)  
Respiratory Tract Congestion † 1              
# participants affected / at risk     1/4 (25.00%)     0/13 (0.00%)     0/3 (0.00%)     0/44 (0.00%)     0/5 (0.00%)     0/5 (0.00%)     0/16 (0.00%)  
Rhinalgia † 1              
# participants affected / at risk     0/4 (0.00%)     1/13 (7.69%)     0/3 (0.00%)     0/44 (0.00%)     0/5 (0.00%)     0/5 (0.00%)     0/16 (0.00%)  
Rhinitis Allergic † 1              
# participants affected / at risk     0/4 (0.00%)     1/13 (7.69%)     0/3 (0.00%)     0/44 (0.00%)     0/5 (0.00%)     0/5 (0.00%)     0/16 (0.00%)  
Upper Respiratory Tract Congestion † 1              
# participants affected / at risk     0/4 (0.00%)     1/13 (7.69%)     0/3 (0.00%)     0/44 (0.00%)     0/5 (0.00%)     0/5 (0.00%)     0/16 (0.00%)  
Skin and subcutaneous tissue disorders                
Rash † 1              
# participants affected / at risk     0/4 (0.00%)     3/13 (23.08%)     0/3 (0.00%)     6/44 (13.64%)     1/5 (20.00%)     0/5 (0.00%)     0/16 (0.00%)  
Pruritus † 1              
# participants affected / at risk     0/4 (0.00%)     0/13 (0.00%)     0/3 (0.00%)     4/44 (9.09%)     0/5 (0.00%)     0/5 (0.00%)     3/16 (18.75%)  
Alopecia † 1              
# participants affected / at risk     0/4 (0.00%)     0/13 (0.00%)     0/3 (0.00%)     3/44 (6.82%)     0/5 (0.00%)     1/5 (20.00%)     0/16 (0.00%)  
Dermatitis Acneiform † 1              
# participants affected / at risk     0/4 (0.00%)     0/13 (0.00%)     0/3 (0.00%)     0/44 (0.00%)     0/5 (0.00%)     0/5 (0.00%)     1/16 (6.25%)  
Dry Skin † 1              
# participants affected / at risk     0/4 (0.00%)     1/13 (7.69%)     0/3 (0.00%)     0/44 (0.00%)     0/5 (0.00%)     1/5 (20.00%)     0/16 (0.00%)  
Erythema † 1              
# participants affected / at risk     1/4 (25.00%)     0/13 (0.00%)     0/3 (0.00%)     1/44 (2.27%)     1/5 (20.00%)     0/5 (0.00%)     0/16 (0.00%)  
Hyperhidrosis † 1              
# participants affected / at risk     1/4 (25.00%)     0/13 (0.00%)     0/3 (0.00%)     0/44 (0.00%)     0/5 (0.00%)     0/5 (0.00%)     1/16 (6.25%)  
Nail Disorder † 1              
# participants affected / at risk     0/4 (0.00%)     0/13 (0.00%)     0/3 (0.00%)     0/44 (0.00%)     0/5 (0.00%)     1/5 (20.00%)     0/16 (0.00%)  
Pain Of Skin † 1              
# participants affected / at risk     0/4 (0.00%)     0/13 (0.00%)     0/3 (0.00%)     0/44 (0.00%)     0/5 (0.00%)     0/5 (0.00%)     1/16 (6.25%)  
Skin Hypopigmentation † 1              
# participants affected / at risk     0/4 (0.00%)     1/13 (7.69%)     0/3 (0.00%)     0/44 (0.00%)     0/5 (0.00%)     0/5 (0.00%)     0/16 (0.00%)  
Skin Nodule † 1              
# participants affected / at risk     0/4 (0.00%)     0/13 (0.00%)     0/3 (0.00%)     0/44 (0.00%)     0/5 (0.00%)     1/5 (20.00%)     0/16 (0.00%)  
Urticaria † 1              
# participants affected / at risk     0/4 (0.00%)     1/13 (7.69%)     0/3 (0.00%)     0/44 (0.00%)     0/5 (0.00%)     0/5 (0.00%)     0/16 (0.00%)  
Vascular disorders                
Deep Vein Thrombosis † 1              
# participants affected / at risk     0/4 (0.00%)     0/13 (0.00%)     1/3 (33.33%)     0/44 (0.00%)     0/5 (0.00%)     1/5 (20.00%)     0/16 (0.00%)  
Lymphoedema † 1              
# participants affected / at risk     0/4 (0.00%)     0/13 (0.00%)     0/3 (0.00%)     0/44 (0.00%)     0/5 (0.00%)     0/5 (0.00%)     1/16 (6.25%)  
Events were collected by systematic assessment
1 Term from vocabulary, MedDRA 13.1



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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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