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BEATRICE Study: A Study of Bevacizumab (Avastin) Adjuvant Therapy in Triple Negative Breast Cancer

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT00528567
First received: September 11, 2007
Last updated: August 5, 2015
Last verified: August 2015
Results First Received: February 28, 2013  
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: Bevacizumab
Drug: Standard adjuvant chemotherapy

  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
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Bevacizumab and Chemotherapy

Participants randomized to receive bevacizumab and chemotherapy.

For these patients, bevacizumab was given in combination with chemotherapy at a dose of 5 mg/kg/week equivalent using 1 of 3 different scheduling options depending on the schedule of the adjuvant chemotherapy selected. After completing chemotherapy + bevacizumab (treatment period 1), patients in this arm received bevacizumab monotherapy up to a total duration of 1 year (treatment period 2).

At the end of treatment (i.e., after approximately 55 weeks), patients were followed up until the end of the study.

Chemotherapy

Participants randomized to receive chemotherapy alone.

For patients randomized to the chemotherapy alone arm, investigators could select from one of three chemotherapy regimens. After completing chemotherapy (treatment period 1) patients entered a post-treatment surveillance period for the remainder of the first year after randomization (treatment period 2).

At the end of treatment (i.e., after approximately 55 weeks), patients were followed up until the end of the study.


Participant Flow:   Overall Study
    Bevacizumab and Chemotherapy     Chemotherapy  
STARTED     1301     1290  
Intention to Treat     1301     1290  
Safety Population     1288     1271  
COMPLETED     870     982  
NOT COMPLETED     431     308  
Death                 4                 5  
Breast Cancer Recurrence/2nd Primary                 30                 60  
Adverse Event/Intermittent Illness                 255                 29  
Violation Criteria at Entry                 3                 17  
Withdrew Consent                 59                 55  
Refused Treatment/Did Not Cooperate                 52                 42  
Failure to Return                 1                 4  
Other Protocol Violation                 5                 21  
Administrative/Other                 22                 75  



  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.
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Reporting Groups
  Description
Bevacizumab and Chemotherapy Participants randomized to receive bevacizumab and chemotherapy
Chemotherapy Participants randomized to receive chemotherapy alone
Total Total of all reporting groups

Baseline Measures
    Bevacizumab and Chemotherapy     Chemotherapy     Total  
Number of Participants  
[units: participants]
  1301     1290     2591  
Age, Customized  
[units: participants]
     
< 40 years     231     253     484  
>= 40 to < 65 years     952     916     1868  
>= 65 years     118     121     239  
Gender  
[units: participants]
     
Female     1301     1290     2591  
Male     0     0     0  



  Outcome Measures
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1.  Primary:   Time to Invasive Disease-free Survival (IDFS) Event   [ Time Frame: Event driven (until data cutoff: 29 February 2012: up to 49 months) ]

2.  Primary:   Percentage of Participants With Invasive Disease-free Survival (IDFS) Events   [ Time Frame: Event driven (until data cutoff: 29 February 2012 up to 49 months) ]

3.  Primary:   Time to Invasive Disease-free Survival (IDFS) Event Excluding Second Primary Non-Breast Invasive Cancer   [ Time Frame: Event driven (until data cutoff: 29 February 2012: up to 49 months) ]

4.  Primary:   Percentage of Participants With Invasive Disease-free Survival (IDFS) Events Excluding Second Primary Non-Breast Invasive Cancer   [ Time Frame: Event driven (until data cutoff: 29 February 2012: up to 49 months) ]

5.  Secondary:   Time to Overall Survival (OS) Event   [ Time Frame: Event driven (until data cutoff: 29 February 2012: up to 49 months) ]

6.  Secondary:   Time to Overall Survival (OS) Event   [ Time Frame: Event driven (until data cutoff: 30 June 2014: up to 77 months) ]

7.  Secondary:   Percentage of Participants With Overall Survival (OS) Event   [ Time Frame: Event driven (until data cut off: 29 February 2012: up to 49 months) ]

8.  Secondary:   Percentage of Participants With Overall Survival (OS) Event   [ Time Frame: Event driven (until data cut off: 30 June 2014: up to 77 months) ]

9.  Secondary:   Time to Breast Cancer-Free Interval (BCFI) Event   [ Time Frame: Event driven (until data cutoff: 29 February 2012: up to 49 months) ]

10.  Secondary:   Percentage of Participants With Breast Cancer-Free Interval (BCFI) Events   [ Time Frame: Event driven (until data cutoff: 29 February 2012: up to 49 months) ]

11.  Secondary:   Time to Disease-Free Survival (DFS) Event   [ Time Frame: Event driven (until data cutoff: 29 February 2012: up to 49 months) ]

12.  Secondary:   Percentage of Participants With Disease-Free Survival (DFS) Events   [ Time Frame: Event driven (until data cutoff: 29 February 2012: up to 49 months) ]

13.  Secondary:   Time to Distant Disease-Free Survival (DDFS) Event   [ Time Frame: Event driven (until data cutoff: 29 February 2012: up to 49 months) ]

14.  Secondary:   Percentage of Participants With Distant Disease-Free Survival (DDFS) Events   [ Time Frame: Event driven (until data cutoff: 29 February 2012: up to 49 months) ]

15.  Secondary:   Number of Participants With Serious Adverse Events (SAEs), Adverse Events (AEs) and Deaths   [ Time Frame: Through end of study: 30 June 2014: up to 77 months ]


  Serious Adverse Events
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Time Frame Through end of study, 30 June 2014
Additional Description The analysis set was the safety population, defined as all randomized participants who received at least one dose of study drug. Participants who received at least one full or partial dose of bevacizumab were included in the bevacizumab and chemotherapy arm; all others, in the chemotherapy arm. MedDRA (15.0) and MedDRA (17.0) were used.

Reporting Groups
  Description
Bevacizumab and Chemotherapy (0-18 Months) Occurring in participants who received bevacizumab and chemotherapy, during treatment period (0-18 months) after first dose
Chemotherapy (0-18 Months) Occurring in participants who received chemotherapy alone, during treatment period (0-18 months) after first dose
Bevacizumab and Chemotherapy (>18 Months) Occurring in participants who received bevacizumab and chemotherapy, during follow-up period (>18 months) after first dose
Chemotherapy (>18 Months) Occurring in participants who received chemotherapy alone, during follow-up period (>18 months) after first dose

Serious Adverse Events
    Bevacizumab and Chemotherapy (0-18 Months)     Chemotherapy (0-18 Months)     Bevacizumab and Chemotherapy (>18 Months)     Chemotherapy (>18 Months)  
Total, serious adverse events          
# participants affected / at risk     379/1288 (29.43%)     250/1271 (19.67%)     45/1288 (3.49%)     48/1271 (3.78%)  
Blood and lymphatic system disorders          
Febrile neutropenia        
# participants affected / at risk     84/1288 (6.52%)     59/1271 (4.64%)     0/1288 (0.00%)     0/1271 (0.00%)  
Neutropenia        
# participants affected / at risk     69/1288 (5.36%)     38/1271 (2.99%)     0/1288 (0.00%)     0/1271 (0.00%)  
Leukopenia        
# participants affected / at risk     8/1288 (0.62%)     1/1271 (0.08%)     0/1288 (0.00%)     0/1271 (0.00%)  
Anaemia        
# participants affected / at risk     1/1288 (0.08%)     3/1271 (0.24%)     0/1288 (0.00%)     0/1271 (0.00%)  
Thrombocytopenia        
# participants affected / at risk     4/1288 (0.31%)     0/1271 (0.00%)     0/1288 (0.00%)     1/1271 (0.08%)  
Pancytopenia        
# participants affected / at risk     1/1288 (0.08%)     1/1271 (0.08%)     0/1288 (0.00%)     0/1271 (0.00%)  
Febrile bone marrow aplasia        
# participants affected / at risk     1/1288 (0.08%)     0/1271 (0.00%)     0/1288 (0.00%)     0/1271 (0.00%)  
Cardiac disorders          
Atrial fibrillation        
# participants affected / at risk     4/1288 (0.31%)     2/1271 (0.16%)     0/1288 (0.00%)     0/1271 (0.00%)  
Cardiac failure congestive        
# participants affected / at risk     6/1288 (0.47%)     0/1271 (0.00%)     0/1288 (0.00%)     0/1271 (0.00%)  
Acute myocardial infarction        
# participants affected / at risk     4/1288 (0.31%)     0/1271 (0.00%)     1/1288 (0.08%)     0/1271 (0.00%)  
Left ventricular dysfunction        
# participants affected / at risk     4/1288 (0.31%)     0/1271 (0.00%)     0/1288 (0.00%)     0/1271 (0.00%)  
Myocardial infarction        
# participants affected / at risk     4/1288 (0.31%)     0/1271 (0.00%)     2/1288 (0.16%)     1/1271 (0.08%)  
Supraventricular tachycardia        
# participants affected / at risk     0/1288 (0.00%)     2/1271 (0.16%)     0/1288 (0.00%)     0/1271 (0.00%)  
Tachycardia        
# participants affected / at risk     0/1288 (0.00%)     2/1271 (0.16%)     0/1288 (0.00%)     0/1271 (0.00%)  
Ventricular fibrillation        
# participants affected / at risk     1/1288 (0.08%)     1/1271 (0.08%)     0/1288 (0.00%)     1/1271 (0.08%)  
Angina pectoris        
# participants affected / at risk     1/1288 (0.08%)     0/1271 (0.00%)     2/1288 (0.16%)     0/1271 (0.00%)  
Arrhythmia        
# participants affected / at risk     0/1288 (0.00%)     1/1271 (0.08%)     0/1288 (0.00%)     0/1271 (0.00%)  
Arteriosclerosis coronary artery        
# participants affected / at risk     1/1288 (0.08%)     0/1271 (0.00%)     0/1288 (0.00%)     0/1271 (0.00%)  
Atrial thrombosis        
# participants affected / at risk     0/1288 (0.00%)     1/1271 (0.08%)     0/1288 (0.00%)     0/1271 (0.00%)  
Cardiac failure        
# participants affected / at risk     1/1288 (0.08%)     0/1271 (0.00%)     0/1288 (0.00%)     0/1271 (0.00%)  
Cardio-respiratory arrest        
# participants affected / at risk     1/1288 (0.08%)     0/1271 (0.00%)     0/1288 (0.00%)     0/1271 (0.00%)  
Cardiogenic shock        
# participants affected / at risk     1/1288 (0.08%)     0/1271 (0.00%)     0/1288 (0.00%)     0/1271 (0.00%)  
Congestive cardiomyopathy        
# participants affected / at risk     1/1288 (0.08%)     0/1271 (0.00%)     0/1288 (0.00%)     0/1271 (0.00%)  
Coronary artery disease        
# participants affected / at risk     1/1288 (0.08%)     0/1271 (0.00%)     0/1288 (0.00%)     0/1271 (0.00%)  
Coronary artery stenosis        
# participants affected / at risk     1/1288 (0.08%)     0/1271 (0.00%)     0/1288 (0.00%)     0/1271 (0.00%)  
Left ventricular failure        
# participants affected / at risk     1/1288 (0.08%)     0/1271 (0.00%)     0/1288 (0.00%)     0/1271 (0.00%)  
Mitral valve disease        
# participants affected / at risk     1/1288 (0.08%)     0/1271 (0.00%)     0/1288 (0.00%)     0/1271 (0.00%)  
Cardiac arrest † 1        
# participants affected / at risk     0/1288 (0.00%)     0/1271 (0.00%)     1/1288 (0.08%)     0/1271 (0.00%)  
Acute coronary syndrome        
# participants affected / at risk     0/1288 (0.00%)     0/1271 (0.00%)     1/1288 (0.08%)     0/1271 (0.00%)  
Angina unstable † 1        
# participants affected / at risk     0/1288 (0.00%)     0/1271 (0.00%)     1/1288 (0.08%)     0/1271 (0.00%)  
Ear and labyrinth disorders          
Sudden hearing loss        
# participants affected / at risk     0/1288 (0.00%)     1/1271 (0.08%)     0/1288 (0.00%)     0/1271 (0.00%)  
Endocrine disorders          
Basedow's disease        
# participants affected / at risk     1/1288 (0.08%)     0/1271 (0.00%)     0/1288 (0.00%)     0/1271 (0.00%)  
Goitre        
# participants affected / at risk     0/1288 (0.00%)     1/1271 (0.08%)     2/1288 (0.16%)     1/1271 (0.08%)  
Hyperparathyroidism primary † 1        
# participants affected / at risk     0/1288 (0.00%)     0/1271 (0.00%)     1/1288 (0.08%)     0/1271 (0.00%)  
Eye disorders          
Cataract † 1        
# participants affected / at risk     0/1288 (0.00%)     0/1271 (0.00%)     1/1288 (0.08%)     0/1271 (0.00%)  
Diplopia        
# participants affected / at risk     0/1288 (0.00%)     0/1271 (0.00%)     1/1288 (0.08%)     0/1271 (0.00%)  
Gaze palsy        
# participants affected / at risk     0/1288 (0.00%)     0/1271 (0.00%)     0/1288 (0.00%)     1/1271 (0.08%)  
Gastrointestinal disorders          
Vomiting        
# participants affected / at risk     7/1288 (0.54%)     9/1271 (0.71%)     0/1288 (0.00%)     0/1271 (0.00%)  
Stomatitis        
# participants affected / at risk     12/1288 (0.93%)     2/1271 (0.16%)     0/1288 (0.00%)     0/1271 (0.00%)  
Nausea        
# participants affected / at risk     8/1288 (0.62%)     4/1271 (0.31%)     0/1288 (0.00%)     0/1271 (0.00%)  
Abdominal pain        
# participants affected / at risk     3/1288 (0.23%)     5/1271 (0.39%)     0/1288 (0.00%)     0/1271 (0.00%)  
Diarrhoea        
# participants affected / at risk     4/1288 (0.31%)     3/1271 (0.24%)     0/1288 (0.00%)     0/1271 (0.00%)  
Colitis        
# participants affected / at risk     1/1288 (0.08%)     2/1271 (0.16%)     0/1288 (0.00%)     0/1271 (0.00%)  
Pancreatitis        
# participants affected / at risk     3/1288 (0.23%)     0/1271 (0.00%)     0/1288 (0.00%)     0/1271 (0.00%)  
Anal fistula        
# participants affected / at risk     1/1288 (0.08%)     1/1271 (0.08%)     0/1288 (0.00%)     0/1271 (0.00%)  
Abdominal pain lower        
# participants affected / at risk     1/1288 (0.08%)     0/1271 (0.00%)     0/1288 (0.00%)     0/1271 (0.00%)  
Abdominal pain upper        
# participants affected / at risk     1/1288 (0.08%)     0/1271 (0.00%)     0/1288 (0.00%)     0/1271 (0.00%)  
Anal fissure        
# participants affected / at risk     1/1288 (0.08%)     0/1271 (0.00%)     0/1288 (0.00%)     0/1271 (0.00%)  
Caecitis        
# participants affected / at risk     0/1288 (0.00%)     1/1271 (0.08%)     0/1288 (0.00%)     0/1271 (0.00%)  
Constipation        
# participants affected / at risk     1/1288 (0.08%)     0/1271 (0.00%)     0/1288 (0.00%)     0/1271 (0.00%)  
Diverticular perforation        
# participants affected / at risk     1/1288 (0.08%)     0/1271 (0.00%)     0/1288 (0.00%)     0/1271 (0.00%)  
Diverticulitis intestinal haemorrhagic        
# participants affected / at risk     1/1288 (0.08%)     0/1271 (0.00%)     1/1288 (0.08%)     0/1271 (0.00%)  
Enterocolonic fistula        
# participants affected / at risk     1/1288 (0.08%)     0/1271 (0.00%)     0/1288 (0.00%)     0/1271 (0.00%)  
Gastric ulcer haemorrhage        
# participants affected / at risk     1/1288 (0.08%)     0/1271 (0.00%)     0/1288 (0.00%)     0/1271 (0.00%)  
Gastritis        
# participants affected / at risk     1/1288 (0.08%)     0/1271 (0.00%)     0/1288 (0.00%)     1/1271 (0.08%)  
Gastrointestinal haemorrhage        
# participants affected / at risk     1/1288 (0.08%)     0/1271 (0.00%)     0/1288 (0.00%)     0/1271 (0.00%)  
Gastrointestinal inflammation        
# participants affected / at risk     1/1288 (0.08%)     0/1271 (0.00%)     0/1288 (0.00%)     0/1271 (0.00%)  
Gingival ulceration        
# participants affected / at risk     1/1288 (0.08%)     0/1271 (0.00%)     0/1288 (0.00%)     0/1271 (0.00%)  
Gingivitis        
# participants affected / at risk     1/1288 (0.08%)     0/1271 (0.00%)     0/1288 (0.00%)     0/1271 (0.00%)  
Haematochezia        
# participants affected / at risk     1/1288 (0.08%)     0/1271 (0.00%)     0/1288 (0.00%)     0/1271 (0.00%)  
Haemorrhoids        
# participants affected / at risk     0/1288 (0.00%)     1/1271 (0.08%)     0/1288 (0.00%)     0/1271 (0.00%)  
Inguinal hernia        
# participants affected / at risk     0/1288 (0.00%)     1/1271 (0.08%)     0/1288 (0.00%)     0/1271 (0.00%)  
Intestinal obstruction        
# participants affected / at risk     1/1288 (0.08%)     0/1271 (0.00%)     0/1288 (0.00%)     0/1271 (0.00%)  
Neutropenic colitis        
# participants affected / at risk     0/1288 (0.00%)     1/1271 (0.08%)     0/1288 (0.00%)     0/1271 (0.00%)  
Periodontitis        
# participants affected / at risk     1/1288 (0.08%)     0/1271 (0.00%)     0/1288 (0.00%)     0/1271 (0.00%)  
Proctitis        
# participants affected / at risk     1/1288 (0.08%)     0/1271 (0.00%)     0/1288 (0.00%)     0/1271 (0.00%)  
Rectal haemorrhage        
# participants affected / at risk     1/1288 (0.08%)     0/1271 (0.00%)     0/1288 (0.00%)     0/1271 (0.00%)  
Rectal polyp        
# participants affected / at risk     0/1288 (0.00%)     1/1271 (0.08%)     0/1288 (0.00%)     0/1271 (0.00%)  
Subileus        
# participants affected / at risk     1/1288 (0.08%)     0/1271 (0.00%)     0/1288 (0.00%)     0/1271 (0.00%)  
Toothache        
# participants affected / at risk     1/1288 (0.08%)     0/1271 (0.00%)     0/1288 (0.00%)     0/1271 (0.00%)  
Umbilical hernia        
# participants affected / at risk     1/1288 (0.08%)     0/1271 (0.00%)     0/1288 (0.00%)     0/1271 (0.00%)  
Crohn’s Disease        
# participants affected / at risk     0/1288 (0.00%)     0/1271 (0.00%)     1/1288 (0.08%)     0/1271 (0.00%)  
Gastrooesophageal reflux disease        
# participants affected / at risk     0/1288 (0.00%)     0/1271 (0.00%)     1/1288 (0.08%)     0/1271 (0.00%)  
Ileus        
# participants affected / at risk     0/1288 (0.00%)     0/1271 (0.00%)     1/1288 (0.08%)     0/1271 (0.00%)  
Oesophagitis        
# participants affected / at risk     0/1288 (0.00%)     0/1271 (0.00%)     0/1288 (0.00%)     1/1271 (0.08%)  
General disorders          
Pyrexia        
# participants affected / at risk     21/1288 (1.63%)     19/1271 (1.49%)     0/1288 (0.00%)     0/1271 (0.00%)  
General physical health deterioration        
# participants affected / at risk     5/1288 (0.39%)     2/1271 (0.16%)     0/1288 (0.00%)     0/1271 (0.00%)  
Chest pain        
# participants affected / at risk     3/1288 (0.23%)     3/1271 (0.24%)     1/1288 (0.08%)     0/1271 (0.00%)  
Non-cardiac chest pain        
# participants affected / at risk     3/1288 (0.23%)     1/1271 (0.08%)     0/1288 (0.00%)     1/1271 (0.08%)  
Chest discomfort        
# participants affected / at risk     1/1288 (0.08%)     2/1271 (0.16%)     0/1288 (0.00%)     0/1271 (0.00%)  
Thrombosis in device        
# participants affected / at risk     2/1288 (0.16%)     1/1271 (0.08%)     0/1288 (0.00%)     0/1271 (0.00%)  
Device damage        
# participants affected / at risk     1/1288 (0.08%)     1/1271 (0.08%)     0/1288 (0.00%)     0/1271 (0.00%)  
Malaise        
# participants affected / at risk     2/1288 (0.16%)     0/1271 (0.00%)     1/1288 (0.08%)     0/1271 (0.00%)  
Pain        
# participants affected / at risk     1/1288 (0.08%)     1/1271 (0.08%)     0/1288 (0.00%)     0/1271 (0.00%)  
Patient-device incompatibility        
# participants affected / at risk     2/1288 (0.16%)     0/1271 (0.00%)     0/1288 (0.00%)     0/1271 (0.00%)  
Adverse drug reaction        
# participants affected / at risk     0/1288 (0.00%)     1/1271 (0.08%)     0/1288 (0.00%)     0/1271 (0.00%)  
Asthenia        
# participants affected / at risk     0/1288 (0.00%)     1/1271 (0.08%)     0/1288 (0.00%)     0/1271 (0.00%)  
Catheter site haematoma        
# participants affected / at risk     1/1288 (0.08%)     0/1271 (0.00%)     0/1288 (0.00%)     0/1271 (0.00%)  
Catheter site inflammation        
# participants affected / at risk     1/1288 (0.08%)     0/1271 (0.00%)     0/1288 (0.00%)     0/1271 (0.00%)  
Catheter site pain        
# participants affected / at risk     1/1288 (0.08%)     0/1271 (0.00%)     0/1288 (0.00%)     0/1271 (0.00%)  
Chills        
# participants affected / at risk     1/1288 (0.08%)     0/1271 (0.00%)     0/1288 (0.00%)     0/1271 (0.00%)  
Device deployment issue        
# participants affected / at risk     1/1288 (0.08%)     0/1271 (0.00%)     0/1288 (0.00%)     0/1271 (0.00%)  
Device dislocation        
# participants affected / at risk     1/1288 (0.08%)     0/1271 (0.00%)     0/1288 (0.00%)     0/1271 (0.00%)  
Device extrusion        
# participants affected / at risk     0/1288 (0.00%)     1/1271 (0.08%)     0/1288 (0.00%)     0/1271 (0.00%)  
Device malfunction        
# participants affected / at risk     0/1288 (0.00%)     1/1271 (0.08%)     0/1288 (0.00%)     0/1271 (0.00%)  
Extravasation        
# participants affected / at risk     1/1288 (0.08%)     0/1271 (0.00%)     0/1288 (0.00%)     0/1271 (0.00%)  
Fatigue        
# participants affected / at risk     1/1288 (0.08%)     0/1271 (0.00%)     0/1288 (0.00%)     0/1271 (0.00%)  
Multi-organ failure        
# participants affected / at risk     1/1288 (0.08%)     0/1271 (0.00%)     0/1288 (0.00%)     0/1271 (0.00%)  
Lipogranuloma † 1        
# participants affected / at risk     0/1288 (0.00%)     0/1271 (0.00%)     0/1288 (0.00%)     1/1271 (0.08%)  
Oedema peripheral † 1        
# participants affected / at risk     0/1288 (0.00%)     0/1271 (0.00%)     1/1288 (0.08%)     0/1271 (0.00%)  
Hepatobiliary disorders          
Cholecystitis        
# participants affected / at risk     1/1288 (0.08%)     2/1271 (0.16%)     2/1288 (0.16%)     0/1271 (0.00%)  
Bile duct stone        
# participants affected / at risk     0/1288 (0.00%)     1/1271 (0.08%)     0/1288 (0.00%)     0/1271 (0.00%)  
Cholecystitis acute        
# participants affected / at risk     1/1288 (0.08%)     0/1271 (0.00%)     0/1288 (0.00%)     0/1271 (0.00%)  
Hepatic lesion        
# participants affected / at risk     0/1288 (0.00%)     1/1271 (0.08%)     0/1288 (0.00%)     0/1271 (0.00%)  
Hepatitis        
# participants affected / at risk     0/1288 (0.00%)     1/1271 (0.08%)     0/1288 (0.00%)     0/1271 (0.00%)  
Hepatitis acute        
# participants affected / at risk     0/1288 (0.00%)     1/1271 (0.08%)     0/1288 (0.00%)     0/1271 (0.00%)  
Immune system disorders          
Hypersensitivity        
# participants affected / at risk     0/1288 (0.00%)     1/1271 (0.08%)     0/1288 (0.00%)     0/1271 (0.00%)  
Infections and infestations          
Neutropenic sepsis        
# participants affected / at risk     13/1288 (1.01%)     11/1271 (0.87%)     0/1288 (0.00%)     0/1271 (0.00%)  
Infection        
# participants affected / at risk     14/1288 (1.09%)     3/1271 (0.24%)     0/1288 (0.00%)     1/1271 (0.08%)  
Device related infection        
# participants affected / at risk     9/1288 (0.70%)     4/1271 (0.31%)     0/1288 (0.00%)     0/1271 (0.00%)  
Pneumonia        
# participants affected / at risk     7/1288 (0.54%)     6/1271 (0.47%)     0/1288 (0.00%)     0/1271 (0.00%)  
Neutropenic infection        
# participants affected / at risk     8/1288 (0.62%)     2/1271 (0.16%)     0/1288 (0.00%)     0/1271 (0.00%)  
Diverticulitis        
# participants affected / at risk     4/1288 (0.31%)     5/1271 (0.39%)     0/1288 (0.00%)     1/1271 (0.08%)  
Cellulitis        
# participants affected / at risk     5/1288 (0.39%)     3/1271 (0.24%)     0/1288 (0.00%)     2/1271 (0.16%)  
Urinary tract infection        
# participants affected / at risk     4/1288 (0.31%)     2/1271 (0.16%)     0/1288 (0.00%)     1/1271 (0.08%)  
Anal abscess        
# participants affected / at risk     5/1288 (0.39%)     0/1271 (0.00%)     0/1288 (0.00%)     0/1271 (0.00%)  
Sepsis        
# participants affected / at risk     4/1288 (0.31%)     1/1271 (0.08%)     0/1288 (0.00%)     0/1271 (0.00%)  
H1N1 influenza        
# participants affected / at risk     3/1288 (0.23%)     1/1271 (0.08%)     0/1288 (0.00%)     0/1271 (0.00%)  
Herpes zoster        
# participants affected / at risk     1/1288 (0.08%)     3/1271 (0.24%)     0/1288 (0.00%)     0/1271 (0.00%)  
Mastitis        
# participants affected / at risk     2/1288 (0.16%)     2/1271 (0.16%)     2/1288 (0.16%)     1/1271 (0.08%)  
Wound infection        
# participants affected / at risk     3/1288 (0.23%)     1/1271 (0.08%)     0/1288 (0.00%)     0/1271 (0.00%)  
Bronchitis        
# participants affected / at risk     1/1288 (0.08%)     2/1271 (0.16%)     0/1288 (0.00%)     0/1271 (0.00%)  
Gastroenteritis        
# participants affected / at risk     1/1288 (0.08%)     2/1271 (0.16%)     0/1288 (0.00%)     1/1271 (0.08%)  
Pharyngitis        
# participants affected / at risk     3/1288 (0.23%)     0/1271 (0.00%)     0/1288 (0.00%)     0/1271 (0.00%)  
Upper respiratory tract infection        
# participants affected / at risk     0/1288 (0.00%)     3/1271 (0.24%)     0/1288 (0.00%)     0/1271 (0.00%)  
Breast abscess        
# participants affected / at risk     0/1288 (0.00%)     2/1271 (0.16%)     0/1288 (0.00%)     0/1271 (0.00%)  
Breast cellulitis        
# participants affected / at risk     1/1288 (0.08%)     1/1271 (0.08%)     1/1288 (0.08%)     2/1271 (0.16%)  
Febrile infection        
# participants affected / at risk     2/1288 (0.16%)     0/1271 (0.00%)     0/1288 (0.00%)     0/1271 (0.00%)  
Gastrointestinal infection        
# participants affected / at risk     2/1288 (0.16%)     0/1271 (0.00%)     0/1288 (0.00%)     0/1271 (0.00%)  
Lower respiratory tract infection        
# participants affected / at risk     1/1288 (0.08%)     1/1271 (0.08%)     0/1288 (0.00%)     0/1271 (0.00%)  
Respiratory tract infection        
# participants affected / at risk     1/1288 (0.08%)     1/1271 (0.08%)     0/1288 (0.00%)     0/1271 (0.00%)  
Sinusitis        
# participants affected / at risk     1/1288 (0.08%)     1/1271 (0.08%)     0/1288 (0.00%)     0/1271 (0.00%)  
Tooth infection        
# participants affected / at risk     1/1288 (0.08%)     1/1271 (0.08%)     0/1288 (0.00%)     0/1271 (0.00%)  
Abscess limb        
# participants affected / at risk     1/1288 (0.08%)     0/1271 (0.00%)     0/1288 (0.00%)     0/1271 (0.00%)  
Abscess oral        
# participants affected / at risk     0/1288 (0.00%)     1/1271 (0.08%)     0/1288 (0.00%)     0/1271 (0.00%)  
Appendicitis        
# participants affected / at risk     1/1288 (0.08%)     0/1271 (0.00%)     1/1288 (0.08%)     1/1271 (0.08%)  
Bartholin's abscess        
# participants affected / at risk     1/1288 (0.08%)     0/1271 (0.00%)     0/1288 (0.00%)     0/1271 (0.00%)  
Breast infection        
# participants affected / at risk     1/1288 (0.08%)     0/1271 (0.00%)     0/1288 (0.00%)     0/1271 (0.00%)  
Bronchopneumonia        
# participants affected / at risk     1/1288 (0.08%)     0/1271 (0.00%)     0/1288 (0.00%)     1/1271 (0.08%)  
Catheter site cellulitis        
# participants affected / at risk     1/1288 (0.08%)     0/1271 (0.00%)     0/1288 (0.00%)     0/1271 (0.00%)  
Catheter site infection        
# participants affected / at risk     0/1288 (0.00%)     1/1271 (0.08%)     0/1288 (0.00%)     0/1271 (0.00%)  
Chronic sinusitis        
# participants affected / at risk     1/1288 (0.08%)     0/1271 (0.00%)     0/1288 (0.00%)     0/1271 (0.00%)  
Clostridium difficile colitis        
# participants affected / at risk     1/1288 (0.08%)     0/1271 (0.00%)     0/1288 (0.00%)     0/1271 (0.00%)  
Cystitis        
# participants affected / at risk     0/1288 (0.00%)     1/1271 (0.08%)     0/1288 (0.00%)     0/1271 (0.00%)  
Enterocolitis infectious        
# participants affected / at risk     1/1288 (0.08%)     0/1271 (0.00%)     0/1288 (0.00%)     0/1271 (0.00%)  
Erysipelas        
# participants affected / at risk     1/1288 (0.08%)     0/1271 (0.00%)     0/1288 (0.00%)     0/1271 (0.00%)  
Escherichia sepsis        
# participants affected / at risk     0/1288 (0.00%)     1/1271 (0.08%)     0/1288 (0.00%)     0/1271 (0.00%)  
Gastroenteritis norovirus        
# participants affected / at risk     1/1288 (0.08%)     0/1271 (0.00%)     0/1288 (0.00%)     0/1271 (0.00%)  
Groin abscess        
# participants affected / at risk     1/1288 (0.08%)     0/1271 (0.00%)     0/1288 (0.00%)     0/1271 (0.00%)  
Herpes zoster disseminated        
# participants affected / at risk     0/1288 (0.00%)     1/1271 (0.08%)     0/1288 (0.00%)     0/1271 (0.00%)  
Lymph node abscess        
# participants affected / at risk     0/1288 (0.00%)     1/1271 (0.08%)     0/1288 (0.00%)     0/1271 (0.00%)  
Meningitis        
# participants affected / at risk     0/1288 (0.00%)     1/1271 (0.08%)     0/1288 (0.00%)     0/1271 (0.00%)  
Nasopharyngitis        
# participants affected / at risk     1/1288 (0.08%)     0/1271 (0.00%)     0/1288 (0.00%)     0/1271 (0.00%)  
Oesophageal candidiasis        
# participants affected / at risk     1/1288 (0.08%)     0/1271 (0.00%)     0/1288 (0.00%)     0/1271 (0.00%)  
Osteomyelitis        
# participants affected / at risk     0/1288 (0.00%)     1/1271 (0.08%)     0/1288 (0.00%)     0/1271 (0.00%)  
Otitis externa        
# participants affected / at risk     0/1288 (0.00%)     1/1271 (0.08%)     0/1288 (0.00%)     0/1271 (0.00%)  
Peritonsillitis        
# participants affected / at risk     1/1288 (0.08%)     0/1271 (0.00%)     0/1288 (0.00%)     0/1271 (0.00%)  
Pilonidal cyst        
# participants affected / at risk     1/1288 (0.08%)     0/1271 (0.00%)     0/1288 (0.00%)     0/1271 (0.00%)  
Pneumocystis jiroveci pneumonia        
# participants affected / at risk     1/1288 (0.08%)     0/1271 (0.00%)     0/1288 (0.00%)     0/1271 (0.00%)  
Pneumonia bacterial        
# participants affected / at risk     1/1288 (0.08%)     0/1271 (0.00%)     0/1288 (0.00%)     0/1271 (0.00%)  
Post procedural infection        
# participants affected / at risk     0/1288 (0.00%)     1/1271 (0.08%)     0/1288 (0.00%)     0/1271 (0.00%)  
Postoperative wound infection        
# participants affected / at risk     0/1288 (0.00%)     1/1271 (0.08%)     0/1288 (0.00%)     0/1271 (0.00%)  
Pseudomonal sepsis        
# participants affected / at risk     0/1288 (0.00%)     1/1271 (0.08%)     0/1288 (0.00%)     0/1271 (0.00%)  
Rectal abscess        
# participants affected / at risk     1/1288 (0.08%)     0/1271 (0.00%)     0/1288 (0.00%)     0/1271 (0.00%)  
Skin infection        
# participants affected / at risk     1/1288 (0.08%)     0/1271 (0.00%)     0/1288 (0.00%)     0/1271 (0.00%)  
Staphylococcal infection        
# participants affected / at risk     0/1288 (0.00%)     1/1271 (0.08%)     0/1288 (0.00%)     0/1271 (0.00%)  
Tuberculosis        
# participants affected / at risk     0/1288 (0.00%)     1/1271 (0.08%)     0/1288 (0.00%)     0/1271 (0.00%)  
Salpingo-oophoritis † 1        
# participants affected / at risk     0/1288 (0.00%)     0/1271 (0.00%)     1/1288 (0.08%)     0/1271 (0.00%)  
Wound abscess        
# participants affected / at risk     0/1288 (0.00%)     0/1271 (0.00%)     1/1288 (0.08%)     0/1271 (0.00%)  
Tonsillitis † 1        
# participants affected / at risk     0/1288 (0.00%)     0/1271 (0.00%)     0/1288 (0.00%)     1/1271 (0.08%)  
Atypical pneumonia † 1        
# participants affected / at risk     0/1288 (0.00%)     0/1271 (0.00%)     0/1288 (0.00%)     1/1271 (0.08%)  
Injury, poisoning and procedural complications          
Humerus fracture        
# participants affected / at risk     1/1288 (0.08%)     1/1271 (0.08%)     0/1288 (0.00%)     0/1271 (0.00%)  
Ligament rupture        
# participants affected / at risk     0/1288 (0.00%)     2/1271 (0.16%)     0/1288 (0.00%)     0/1271 (0.00%)  
Wound complication        
# participants affected / at risk     2/1288 (0.16%)     0/1271 (0.00%)     0/1288 (0.00%)     0/1271 (0.00%)  
Wound dehiscence        
# participants affected / at risk     1/1288 (0.08%)     1/1271 (0.08%)     0/1288 (0.00%)     0/1271 (0.00%)  
Ankle fracture        
# participants affected / at risk     0/1288 (0.00%)     1/1271 (0.08%)     0/1288 (0.00%)     1/1271 (0.08%)  
Cervical vertebral fracture        
# participants affected / at risk     1/1288 (0.08%)     0/1271 (0.00%)     0/1288 (0.00%)     0/1271 (0.00%)  
Coronary artery restenosis        
# participants affected / at risk     1/1288 (0.08%)     0/1271 (0.00%)     0/1288 (0.00%)     0/1271 (0.00%)  
Femoral neck fracture        
# participants affected / at risk     0/1288 (0.00%)     1/1271 (0.08%)     0/1288 (0.00%)     1/1271 (0.08%)  
Forearm fracture        
# participants affected / at risk     1/1288 (0.08%)     0/1271 (0.00%)     0/1288 (0.00%)     0/1271 (0.00%)  
Head injury        
# participants affected / at risk     1/1288 (0.08%)     0/1271 (0.00%)     0/1288 (0.00%)     0/1271 (0.00%)  
Hip fracture        
# participants affected / at risk     1/1288 (0.08%)     0/1271 (0.00%)     0/1288 (0.00%)     0/1271 (0.00%)  
In-stent coronary artery restenosis        
# participants affected / at risk     1/1288 (0.08%)     0/1271 (0.00%)     0/1288 (0.00%)     0/1271 (0.00%)  
Radiation skin injury        
# participants affected / at risk     1/1288 (0.08%)     0/1271 (0.00%)     0/1288 (0.00%)     0/1271 (0.00%)  
Radius fracture        
# participants affected / at risk     1/1288 (0.08%)     0/1271 (0.00%)     1/1288 (0.08%)     0/1271 (0.00%)  
Rib fracture        
# participants affected / at risk     1/1288 (0.08%)     0/1271 (0.00%)     0/1288 (0.00%)     1/1271 (0.08%)  
Road traffic accident        
# participants affected / at risk     1/1288 (0.08%)     0/1271 (0.00%)     0/1288 (0.00%)     0/1271 (0.00%)  
Procedural complication † 1        
# participants affected / at risk     0/1288 (0.00%)     0/1271 (0.00%)     0/1288 (0.00%)     1/1271 (0.08%)  
Contusion † 1        
# participants affected / at risk     0/1288 (0.00%)     0/1271 (0.00%)     0/1288 (0.00%)     1/1271 (0.08%)  
Fall † 1        
# participants affected / at risk     0/1288 (0.00%)     0/1271 (0.00%)     0/1288 (0.00%)     1/1271 (0.08%)  
Fracture † 1        
# participants affected / at risk     0/1288 (0.00%)     0/1271 (0.00%)     0/1288 (0.00%)     1/1271 (0.08%)  
Injury † 1        
# participants affected / at risk     0/1288 (0.00%)     0/1271 (0.00%)     1/1288 (0.08%)     0/1271 (0.00%)  
Multiple injuries † 1        
# participants affected / at risk     0/1288 (0.00%)     0/1271 (0.00%)     0/1288 (0.00%)     1/1271 (0.08%)  
Periprosthetic fracture        
# participants affected / at risk     0/1288 (0.00%)     0/1271 (0.00%)     1/1288 (0.08%)     0/1271 (0.00%)  
Pubis fracture        
# participants affected / at risk     0/1288 (0.00%)     0/1271 (0.00%)     1/1288 (0.08%)     0/1271 (0.00%)  
Radiation pneumonitis        
# participants affected / at risk     0/1288 (0.00%)     0/1271 (0.00%)     1/1288 (0.08%)     0/1271 (0.00%)  
Tibia fracture        
# participants affected / at risk     0/1288 (0.00%)     0/1271 (0.00%)     0/1288 (0.00%)     1/1271 (0.08%)  
Wound        
# participants affected / at risk     0/1288 (0.00%)     0/1271 (0.00%)     1/1288 (0.08%)     0/1271 (0.00%)  
Investigations          
Haemoglobin decreased        
# participants affected / at risk     1/1288 (0.08%)     1/1271 (0.08%)     0/1288 (0.00%)     0/1271 (0.00%)  
Blood pressure decreased        
# participants affected / at risk     1/1288 (0.08%)     0/1271 (0.00%)     0/1288 (0.00%)     0/1271 (0.00%)  
Cytology abnormal        
# participants affected / at risk     1/1288 (0.08%)     0/1271 (0.00%)     0/1288 (0.00%)     0/1271 (0.00%)  
Ejection fraction decreased        
# participants affected / at risk     1/1288 (0.08%)     0/1271 (0.00%)     0/1288 (0.00%)     0/1271 (0.00%)  
Electrocardiogram QT prolonged        
# participants affected / at risk     1/1288 (0.08%)     0/1271 (0.00%)     0/1288 (0.00%)     0/1271 (0.00%)  
Gamma-glutamyltransferase increased        
# participants affected / at risk     1/1288 (0.08%)     0/1271 (0.00%)     0/1288 (0.00%)     0/1271 (0.00%)  
Influenza A virus test positive        
# participants affected / at risk     1/1288 (0.08%)     0/1271 (0.00%)     0/1288 (0.00%)     0/1271 (0.00%)  
Liver function test abnormal        
# participants affected / at risk     1/1288 (0.08%)     0/1271 (0.00%)     0/1288 (0.00%)     0/1271 (0.00%)  
Metabolism and nutrition disorders          
Dehydration        
# participants affected / at risk     5/1288 (0.39%)     7/1271 (0.55%)     0/1288 (0.00%)     0/1271 (0.00%)  
Hypokalaemia        
# participants affected / at risk     1/1288 (0.08%)     1/1271 (0.08%)     0/1288 (0.00%)     0/1271 (0.00%)  
Decreased appetite        
# participants affected / at risk     0/1288 (0.00%)     1/1271 (0.08%)     0/1288 (0.00%)     0/1271 (0.00%)  
Hyperglycaemia        
# participants affected / at risk     0/1288 (0.00%)     1/1271 (0.08%)     0/1288 (0.00%)     0/1271 (0.00%)  
Hyponatraemia        
# participants affected / at risk     1/1288 (0.08%)     0/1271 (0.00%)     0/1288 (0.00%)     0/1271 (0.00%)  
Musculoskeletal and connective tissue disorders          
Intervertebral disc protrusion        
# participants affected / at risk     2/1288 (0.16%)     1/1271 (0.08%)     0/1288 (0.00%)     0/1271 (0.00%)  
Arthralgia        
# participants affected / at risk     2/1288 (0.16%)     0/1271 (0.00%)     3/1288 (0.23%)     0/1271 (0.00%)  
Arthritis        
# participants affected / at risk     2/1288 (0.16%)     0/1271 (0.00%)     0/1288 (0.00%)     0/1271 (0.00%)  
Back pain        
# participants affected / at risk     1/1288 (0.08%)     1/1271 (0.08%)     0/1288 (0.00%)     0/1271 (0.00%)  
Musculoskeletal pain        
# participants affected / at risk     1/1288 (0.08%)     1/1271 (0.08%)     0/1288 (0.00%)     0/1271 (0.00%)  
Myalgia        
# participants affected / at risk     1/1288 (0.08%)     1/1271 (0.08%)     0/1288 (0.00%)     0/1271 (0.00%)  
Pain in extremity        
# participants affected / at risk     1/1288 (0.08%)     1/1271 (0.08%)     0/1288 (0.00%)     0/1271 (0.00%)  
Bone pain        
# participants affected / at risk     1/1288 (0.08%)     0/1271 (0.00%)     0/1288 (0.00%)     0/1271 (0.00%)  
Neck pain        
# participants affected / at risk     1/1288 (0.08%)     0/1271 (0.00%)     0/1288 (0.00%)     0/1271 (0.00%)  
Osteonecrosis        
# participants affected / at risk     0/1288 (0.00%)     1/1271 (0.08%)     0/1288 (0.00%)     1/1271 (0.08%)  
Intervertebral disc disorder † 1        
# participants affected / at risk     0/1288 (0.00%)     0/1271 (0.00%)     0/1288 (0.00%)     1/1271 (0.08%)  
Neoplasms benign, malignant and unspecified (incl cysts and polyps)          
Meningioma        
# participants affected / at risk     1/1288 (0.08%)     1/1271 (0.08%)     0/1288 (0.00%)     0/1271 (0.00%)  
Benign breast neoplasm        
# participants affected / at risk     0/1288 (0.00%)     1/1271 (0.08%)     0/1288 (0.00%)     0/1271 (0.00%)  
Squamous cell carcinoma of skin        
# participants affected / at risk     0/1288 (0.00%)     1/1271 (0.08%)     0/1288 (0.00%)     0/1271 (0.00%)  
Antiomyolipoma        
# participants affected / at risk     0/1288 (0.00%)     0/1271 (0.00%)     1/1288 (0.08%)     0/1271 (0.00%)  
Basal cell carcinoma        
# participants affected / at risk     0/1288 (0.00%)     0/1271 (0.00%)     1/1288 (0.08%)     0/1271 (0.00%)  
Bowen’s disease        
# participants affected / at risk     0/1288 (0.00%)     0/1271 (0.00%)     1/1288 (0.08%)     0/1271 (0.00%)  
Haemangioma        
# participants affected / at risk     0/1288 (0.00%)     0/1271 (0.00%)     1/1288 (0.08%)     0/1271 (0.00%)  
Leiomyoma        
# participants affected / at risk     0/1288 (0.00%)     0/1271 (0.00%)     1/1288 (0.08%)     0/1271 (0.00%)  
Oesophageal neoplasm        
# participants affected / at risk     0/1288 (0.00%)     0/1271 (0.00%)     1/1288 (0.08%)     0/1271 (0.00%)  
Ovarian fibroma        
# participants affected / at risk     0/1288 (0.00%)     0/1271 (0.00%)     0/1288 (0.00%)     1/1271 (0.08%)  
Uterine Leiomyoma        
# participants affected / at risk     0/1288 (0.00%)     0/1271 (0.00%)     0/1288 (0.00%)     1/1271 (0.08%)  
Nervous system disorders          
Syncope        
# participants affected / at risk     5/1288 (0.39%)     2/1271 (0.16%)     0/1288 (0.00%)     1/1271 (0.08%)  
Headache        
# participants affected / at risk     3/1288 (0.23%)     0/1271 (0.00%)     1/1288 (0.08%)     0/1271 (0.00%)  
Transient ischaemic attack        
# participants affected / at risk     3/1288 (0.23%)     0/1271 (0.00%)     0/1288 (0.00%)     0/1271 (0.00%)  
Convulsion        
# participants affected / at risk     1/1288 (0.08%)     1/1271 (0.08%)     0/1288 (0.00%)     0/1271 (0.00%)  
Dizziness        
# participants affected / at risk     1/1288 (0.08%)     1/1271 (0.08%)     1/1288 (0.08%)     0/1271 (0.00%)  
Posterior reversible encephalopathy syndrome        
# participants affected / at risk     2/1288 (0.16%)     0/1271 (0.00%)     0/1288 (0.00%)     0/1271 (0.00%)  
Cerebral ischaemia        
# participants affected / at risk     1/1288 (0.08%)     0/1271 (0.00%)     0/1288 (0.00%)     0/1271 (0.00%)  
Cerebrovascular accident        
# participants affected / at risk     0/1288 (0.00%)     1/1271 (0.08%)     1/1288 (0.08%)     0/1271 (0.00%)  
Neuropathy peripheral        
# participants affected / at risk     0/1288 (0.00%)     1/1271 (0.08%)     0/1288 (0.00%)     0/1271 (0.00%)  
Sciatica        
# participants affected / at risk     1/1288 (0.08%)     0/1271 (0.00%)     0/1288 (0.00%)     0/1271 (0.00%)  
Presyncope † 1        
# participants affected / at risk     0/1288 (0.00%)     0/1271 (0.00%)     1/1288 (0.08%)     0/1271 (0.00%)  
Loss of consciousness        
# participants affected / at risk     0/1288 (0.00%)     0/1271 (0.00%)     1/1288 (0.08%)     1/1271 (0.08%)  
Carpal tunnel syndrome        
# participants affected / at risk     0/1288 (0.00%)     0/1271 (0.00%)     1/1288 (0.08%)     0/1271 (0.00%)  
Hypoaesthesia † 1        
# participants affected / at risk     0/1288 (0.00%)     0/1271 (0.00%)     1/1288 (0.08%)     0/1271 (0.00%)  
Hypoxic-ischaemic encephalopathy        
# participants affected / at risk     0/1288 (0.00%)     0/1271 (0.00%)     0/1288 (0.00%)     1/1271 (0.08%)  
Pregnancy, puerperium and perinatal conditions          
Abortion spontaneous † 1        
# participants affected / at risk     0/1288 (0.00%)     0/1271 (0.00%)     0/1288 (0.00%)     1/1271 (0.08%)  
Hyperemesis gravidarum        
# participants affected / at risk     0/1288 (0.00%)     0/1271 (0.00%)     0/1288 (0.00%)     1/1271 (0.08%)  
Premature delivery        
# participants affected / at risk     0/1288 (0.00%)     0/1271 (0.00%)     1/1288 (0.08%)     0/1271 (0.00%)  
Psychiatric disorders          
Suicide attempt        
# participants affected / at risk     2/1288 (0.16%)     1/1271 (0.08%)     0/1288 (0.00%)     0/1271 (0.00%)  
Depression        
# participants affected / at risk     1/1288 (0.08%)     1/1271 (0.08%)     1/1288 (0.08%)     1/1271 (0.08%)  
Agitation        
# participants affected / at risk     0/1288 (0.00%)     1/1271 (0.08%)     0/1288 (0.00%)     0/1271 (0.00%)  
Anxiety        
# participants affected / at risk     0/1288 (0.00%)     1/1271 (0.08%)     0/1288 (0.00%)     0/1271 (0.00%)  
Disorientation        
# participants affected / at risk     0/1288 (0.00%)     1/1271 (0.08%)     0/1288 (0.00%)     0/1271 (0.00%)  
Conversion disorder † 1        
# participants affected / at risk     0/1288 (0.00%)     0/1271 (0.00%)     1/1288 (0.08%)     1/1271 (0.08%)  
Panic attack        
# participants affected / at risk     0/1288 (0.00%)     0/1271 (0.00%)     0/1288 (0.00%)     1/1271 (0.08%)  
Psychotic disorder        
# participants affected / at risk     0/1288 (0.00%)     0/1271 (0.00%)     0/1288 (0.00%)     1/1271 (0.08%)  
Renal and urinary disorders          
Renal failure acute        
# participants affected / at risk     1/1288 (0.08%)     1/1271 (0.08%)     0/1288 (0.00%)     0/1271 (0.00%)  
IGA nephropathy        
# participants affected / at risk     1/1288 (0.08%)     0/1271 (0.00%)     0/1288 (0.00%)     0/1271 (0.00%)  
Stress urinary incontinence        
# participants affected / at risk     0/1288 (0.00%)     1/1271 (0.08%)     0/1288 (0.00%)     0/1271 (0.00%)  
Calculus ureteric        
# participants affected / at risk     0/1288 (0.00%)     0/1271 (0.00%)     0/1288 (0.00%)     1/1271 (0.08%)  
Reproductive system and breast disorders          
Menorrhagia        
# participants affected / at risk     1/1288 (0.08%)     2/1271 (0.16%)     0/1288 (0.00%)     0/1271 (0.00%)  
Vaginal haemorrhage        
# participants affected / at risk     2/1288 (0.16%)     1/1271 (0.08%)     0/1288 (0.00%)     0/1271 (0.00%)  
Ovarian cyst        
# participants affected / at risk     1/1288 (0.08%)     1/1271 (0.08%)     0/1288 (0.00%)     0/1271 (0.00%)  
Bartholin's cyst        
# participants affected / at risk     0/1288 (0.00%)     1/1271 (0.08%)     0/1288 (0.00%)     0/1271 (0.00%)  
Breast cyst        
# participants affected / at risk     1/1288 (0.08%)     0/1271 (0.00%)     0/1288 (0.00%)     0/1271 (0.00%)  
Breast haematoma        
# participants affected / at risk     1/1288 (0.08%)     0/1271 (0.00%)     0/1288 (0.00%)     0/1271 (0.00%)  
Endometrial hyperplasia        
# participants affected / at risk     1/1288 (0.08%)     0/1271 (0.00%)     0/1288 (0.00%)     0/1271 (0.00%)  
Metrorrhagia        
# participants affected / at risk     0/1288 (0.00%)     1/1271 (0.08%)     0/1288 (0.00%)     0/1271 (0.00%)  
Uterine prolapse        
# participants affected / at risk     0/1288 (0.00%)     1/1271 (0.08%)     0/1288 (0.00%)     0/1271 (0.00%)  
Vaginal ulceration        
# participants affected / at risk     1/1288 (0.08%)     0/1271 (0.00%)     0/1288 (0.00%)     0/1271 (0.00%)  
Endometriosis        
# participants affected / at risk     0/1288 (0.00%)     0/1271 (0.00%)     1/1288 (0.08%)     1/1271 (0.08%)  
Adenomyosis        
# participants affected / at risk     0/1288 (0.00%)     0/1271 (0.00%)     1/1288 (0.08%)     0/1271 (0.00%)  
Breast calcifications        
# participants affected / at risk     0/1288 (0.00%)     0/1271 (0.00%)     0/1288 (0.00%)     1/1271 (0.08%)  
Breast mass        
# participants affected / at risk     0/1288 (0.00%)     0/1271 (0.00%)     1/1288 (0.08%)     0/1271 (0.00%)  
Dysfunctional uterine bleeding        
# participants affected / at risk     0/1288 (0.00%)     0/1271 (0.00%)     0/1288 (0.00%)     1/1271 (0.08%)  
Vaginal prolapse        
# participants affected / at risk     0/1288 (0.00%)     0/1271 (0.00%)     0/1288 (0.00%)     1/1271 (0.08%)  
Respiratory, thoracic and mediastinal disorders          
Pulmonary embolism        
# participants affected / at risk     3/1288 (0.23%)     7/1271 (0.55%)     0/1288 (0.00%)     0/1271 (0.00%)  
Dyspnoea        
# participants affected / at risk     6/1288 (0.47%)     2/1271 (0.16%)     0/1288 (0.00%)     0/1271 (0.00%)  
Pneumothorax        
# participants affected / at risk     5/1288 (0.39%)     0/1271 (0.00%)     0/1288 (0.00%)     0/1271 (0.00%)  
Bronchospasm        
# participants affected / at risk     2/1288 (0.16%)     0/1271 (0.00%)     0/1288 (0.00%)     0/1271 (0.00%)  
Nasal septum perforation        
# participants affected / at risk     2/1288 (0.16%)     0/1271 (0.00%)     0/1288 (0.00%)     0/1271 (0.00%)  
Acute respiratory failure        
# participants affected / at risk     1/1288 (0.08%)     0/1271 (0.00%)     0/1288 (0.00%)     0/1271 (0.00%)  
Asthma        
# participants affected / at risk     1/1288 (0.08%)     0/1271 (0.00%)     0/1288 (0.00%)     0/1271 (0.00%)  
Atelectasis        
# participants affected / at risk     0/1288 (0.00%)     1/1271 (0.08%)     0/1288 (0.00%)     0/1271 (0.00%)  
Dyspnoea exertional        
# participants affected / at risk     0/1288 (0.00%)     1/1271 (0.08%)     0/1288 (0.00%)     0/1271 (0.00%)  
Epistaxis        
# participants affected / at risk     1/1288 (0.08%)     0/1271 (0.00%)     0/1288 (0.00%)     0/1271 (0.00%)  
Haemoptysis        
# participants affected / at risk     1/1288 (0.08%)     0/1271 (0.00%)     0/1288 (0.00%)     0/1271 (0.00%)  
Hyperventilation        
# participants affected / at risk     0/1288 (0.00%)     1/1271 (0.08%)     0/1288 (0.00%)     1/1271 (0.08%)  
Interstitial lung disease        
# participants affected / at risk     1/1288 (0.08%)     0/1271 (0.00%)     0/1288 (0.00%)     0/1271 (0.00%)  
Lung disorder        
# participants affected / at risk     0/1288 (0.00%)     1/1271 (0.08%)     0/1288 (0.00%)     0/1271 (0.00%)  
Pharyngeal inflammation        
# participants affected / at risk     1/1288 (0.08%)     0/1271 (0.00%)     0/1288 (0.00%)     0/1271 (0.00%)  
Pleural effusion        
# participants affected / at risk     1/1288 (0.08%)     0/1271 (0.00%)     0/1288 (0.00%)     0/1271 (0.00%)  
Pneumonitis        
# participants affected / at risk     1/1288 (0.08%)     0/1271 (0.00%)     0/1288 (0.00%)     0/1271 (0.00%)  
Pulmonary artery thrombosis        
# participants affected / at risk     0/1288 (0.00%)     1/1271 (0.08%)     0/1288 (0.00%)     0/1271 (0.00%)  
Vocal cord polyp        
# participants affected / at risk     1/1288 (0.08%)     0/1271 (0.00%)     0/1288 (0.00%)     0/1271 (0.00%)  
Skin and subcutaneous tissue disorders          
Dermatitis        
# participants affected / at risk     1/1288 (0.08%)     0/1271 (0.00%)     0/1288 (0.00%)     0/1271 (0.00%)  
Palmar-plantar erythrodysaesthesia syndrome        
# participants affected / at risk     1/1288 (0.08%)     0/1271 (0.00%)     0/1288 (0.00%)     0/1271 (0.00%)  
Pruritus generalised        
# participants affected / at risk     1/1288 (0.08%)     0/1271 (0.00%)     0/1288 (0.00%)     0/1271 (0.00%)  
Rash        
# participants affected / at risk     1/1288 (0.08%)     0/1271 (0.00%)     0/1288 (0.00%)     0/1271 (0.00%)  
Rash pruritic        
# participants affected / at risk     1/1288 (0.08%)     0/1271 (0.00%)     0/1288 (0.00%)     0/1271 (0.00%)  
Skin lesion        
# participants affected / at risk     1/1288 (0.08%)     0/1271 (0.00%)     0/1288 (0.00%)     0/1271 (0.00%)  
Skin necrosis        
# participants affected / at risk     1/1288 (0.08%)     0/1271 (0.00%)     0/1288 (0.00%)     0/1271 (0.00%)  
Hypertrophic scar † 1        
# participants affected / at risk     0/1288 (0.00%)     0/1271 (0.00%)     0/1288 (0.00%)     1/1271 (0.08%)  
Surgical and medical procedures          
Breast prosthesis implantation        
# participants affected / at risk     0/1288 (0.00%)     0/1271 (0.00%)     0/1288 (0.00%)     1/1271 (0.08%)  
Hysterectomy        
# participants affected / at risk     0/1288 (0.00%)     0/1271 (0.00%)     0/1288 (0.00%)     1/1271 (0.08%)  
Rehabilitation therapy        
# participants affected / at risk     0/1288 (0.00%)     0/1271 (0.00%)     1/1288 (0.08%)     0/1271 (0.00%)  
Vascular disorders          
Deep vein thrombosis        
# participants affected / at risk     6/1288 (0.47%)     5/1271 (0.39%)     0/1288 (0.00%)     1/1271 (0.08%)  
Hypertension        
# participants affected / at risk     7/1288 (0.54%)     1/1271 (0.08%)     0/1288 (0.00%)     0/1271 (0.00%)  
Venous thrombosis        
# participants affected / at risk     0/1288 (0.00%)     3/1271 (0.24%)     0/1288 (0.00%)     0/1271 (0.00%)  
Hypotension        
# participants affected / at risk     0/1288 (0.00%)     2/1271 (0.16%)     0/1288 (0.00%)     0/1271 (0.00%)  
Thrombophlebitis superficial        
# participants affected / at risk     1/1288 (0.08%)     1/1271 (0.08%)     0/1288 (0.00%)     0/1271 (0.00%)  
Arterial thrombosis        
# participants affected / at risk     0/1288 (0.00%)     1/1271 (0.08%)     0/1288 (0.00%)     0/1271 (0.00%)  
Hypertensive crisis        
# participants affected / at risk     1/1288 (0.08%)     0/1271 (0.00%)     0/1288 (0.00%)     0/1271 (0.00%)  
Shock        
# participants affected / at risk     0/1288 (0.00%)     1/1271 (0.08%)     0/1288 (0.00%)     0/1271 (0.00%)  
Venous thrombosis limb        
# participants affected / at risk     0/1288 (0.00%)     1/1271 (0.08%)     0/1288 (0.00%)     0/1271 (0.00%)  
Haematoma † 1        
# participants affected / at risk     0/1288 (0.00%)     0/1271 (0.00%)     2/1288 (0.16%)     0/1271 (0.00%)  
Events were collected by systematic assessment
1 Term from vocabulary, MedDRA (16.0)




  Other Adverse Events


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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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