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Sanofi H1N1 Influenza Vaccine Administered at Different Dose Levels With and Without AS03 Adjuvant in Healthy Adult and Elderly Populations

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier:
NCT00963157
First received: August 20, 2009
Last updated: December 4, 2014
Last verified: January 2011
Results First Received: November 10, 2011  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator, Outcomes Assessor);   Primary Purpose: Prevention
Condition: Influenza
Interventions: Drug: AS03
Biological: Influenza Virus Vaccine, Monovalent A/H1N1 A/California/7/2009 NYMC X-179A

  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
Participants were healthy adults age 18 and older recruited from existing volunteer populations and from the communities at large around the clinical sites. Participants were enrolled between 24Sep2009 and 16Nov2009.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
3.75 mcg H1N1 Vaccine + AS03 Adjuvant Participants received 3.75 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.
7.5 mcg H1N1 Vaccine + AS03 Adjuvant Participants received 7.5 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.
7.5 mcg H1N1 Vaccine Unadjuvanted Participants received 7.5 mcg H1N1 vaccine unadjuvanted on Day 0 and Day 21.
15 mcg H1N1 Vaccine + AS03 Adjuvant Participants received 15 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.
15 mcg H1N1 Vaccine Unadjuvanted Participants received 15 mcg H1N1 vaccine unadjuvanted on Day 0 and Day 21.

Participant Flow:   Overall Study
    3.75 mcg H1N1 Vaccine + AS03 Adjuvant   7.5 mcg H1N1 Vaccine + AS03 Adjuvant   7.5 mcg H1N1 Vaccine Unadjuvanted   15 mcg H1N1 Vaccine + AS03 Adjuvant   15 mcg H1N1 Vaccine Unadjuvanted
STARTED   156   163   160   157   153 
COMPLETED   151   159   155   150   151 
NOT COMPLETED   5   4   5   7   2 



  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
3.75 mcg H1N1 Vaccine + AS03 Adjuvant Participants received 3.75 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.
7.5 mcg H1N1 Vaccine + AS03 Adjuvant Participants received 7.5 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.
7.5 mcg H1N1 Vaccine Unadjuvanted Participants received 7.5 mcg H1N1 vaccine unadjuvanted on Day 0 and Day 21.
15 mcg H1N1 Vaccine + AS03 Adjuvant Participants received 15 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.
15 mcg H1N1 Vaccine Unadjuvanted Participants received 15 mcg H1N1 vaccine unadjuvanted on Day 0 and Day 21.
Total Total of all reporting groups

Baseline Measures
   3.75 mcg H1N1 Vaccine + AS03 Adjuvant   7.5 mcg H1N1 Vaccine + AS03 Adjuvant   7.5 mcg H1N1 Vaccine Unadjuvanted   15 mcg H1N1 Vaccine + AS03 Adjuvant   15 mcg H1N1 Vaccine Unadjuvanted   Total 
Overall Participants Analyzed 
[Units: Participants]
 156   163   160   157   153   789 
Age 
[Units: Participants]
           
<=18 years   0   0   0   0   0   0 
Between 18 and 65 years   107   111   110   109   107   544 
>=65 years   49   52   50   48   46   245 
Age 
[Units: Years]
Mean (Standard Deviation)
 51.3  (17.6)   51.7  (18.0)   51.6  (17.8)   50.1  (18.3)   52.1  (18.6)   51.4  (18.0) 
Gender 
[Units: Participants]
           
Female   89   84   93   85   72   423 
Male   67   79   67   72   81   366 
Region of Enrollment 
[Units: Participants]
           
United States   156   163   160   157   153   789 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Number of Participants Age 18 to 64 Years With 4-fold or Greater Hemagglutination Inhibition Assay (HAI) Antibody Titer Increases Against the Influenza H1N1 2009 Virus 8 Days Following the First Dose of H1N1 Vaccine   [ Time Frame: Day 0 prior to vaccination and 8 days after the first H1N1 vaccination ]

2.  Primary:   Number of Participants Age 18 to 64 Years With 4-fold or Greater Hemagglutination Inhibition Assay (HAI) Antibody Titer Increases Against the Influenza H1N1 2009 Virus 21 Days Following the First Dose of H1N1 Vaccine   [ Time Frame: Day 0 prior to vaccination and 21 days after the first H1N1 vaccination ]

3.  Primary:   Number of Participants Age 65 Years and Older With 4-fold or Greater Hemagglutination Inhibition Assay (HAI) Antibody Titer Increases Against the Influenza H1N1 2009 Virus 8 Days Following the First Dose of H1N1 Vaccine   [ Time Frame: Day 0 prior to vaccination and 8 days after the first H1N1 vaccination ]

4.  Primary:   Number of Participants Age 65 Years and Older With 4-fold or Greater Hemagglutination Inhibition Assay (HAI) Antibody Titer Increases Against the Influenza H1N1 2009 Virus 21 Days Following the First Dose of H1N1 Vaccine   [ Time Frame: Day 0 prior to vaccination and 21 days after the first H1N1 vaccination ]

5.  Primary:   Number of Participants Reporting Vaccine-associated Serious Adverse Events (SAEs)   [ Time Frame: Day 0 through Day 365 after the last vaccination ]

6.  Primary:   Number of Participants With Hematology Laboratory Adverse Events After the First Vaccination   [ Time Frame: 8-10 days after first vaccination ]

7.  Primary:   Number of Participants With Hematology Laboratory Adverse Events After the Second Vaccination   [ Time Frame: 8-10 days after second vaccination ]

8.  Primary:   Number of Participants With Chemistry Laboratory Adverse Events After the First Vaccination   [ Time Frame: 8-10 days after first vaccination ]

9.  Primary:   Number of Participants With Chemistry Laboratory Adverse Events After the Second Vaccination   [ Time Frame: 8-10 days after second vaccination ]

10.  Primary:   Number of Participants Reporting Solicited Subjective Systemic Reactions After the First Vaccination   [ Time Frame: Within 8 days (Day 0-7) post first vaccination ]

11.  Primary:   Number of Participants Reporting Solicited Subjective Systemic Reactions After the Second Vaccination   [ Time Frame: Within 8 days (Day 0-7) post second vaccination ]

12.  Primary:   Number of Participants Reporting Fever After the First Vaccination   [ Time Frame: Within 8 days (Day 0-7) post first vaccination ]

13.  Primary:   Number of Participants Reporting Fever After the Second Vaccination   [ Time Frame: Within 8 days (Day 0-7) post second vaccination ]

14.  Primary:   Number of Participants Reporting Solicited Subjective Local Reactions After the First Vaccination   [ Time Frame: Within 8 days (Day 0-7) post first vaccination ]

15.  Primary:   Number of Participants Reporting Solicited Subjective Local Reactions After the Second Vaccination   [ Time Frame: Within 8 days (Day 0-7) post second vaccination ]

16.  Primary:   Number of Participants Reporting Solicited Quantitative Local Reactions After the First Vaccination   [ Time Frame: Within 8 days (Day 0-7) post first vaccination ]

17.  Primary:   Number of Participants Reporting Solicited Quantitative Local Reactions After the Second Vaccination   [ Time Frame: Within 8 days (Day 0-7) post second vaccination ]

18.  Primary:   Number of Participants Age 18 to 64 Years With a Serum Hemagglutination Inhibition Assay (HAI) Antibody Titer of 1:40 or Greater Against the H1N1 2009 Virus 8 Days Following the First Dose of H1N1 Vaccine   [ Time Frame: Day 8 after the first vaccination ]

19.  Primary:   Number of Participants Age 18 to 64 Years With a Serum Hemagglutination Inhibition Assay (HAI) Antibody Titer of 1:40 or Greater Against the H1N1 2009 Virus 21 Days Following the First Dose of H1N1 Vaccine   [ Time Frame: Day 21 after the first vaccination ]

20.  Primary:   Number of Participants Age 65 Years and Older With a Serum Hemagglutination Inhibition Assay (HAI) Antibody Titer of 1:40 or Greater Against the H1N1 2009 Virus 8 Days Following the First Dose of H1N1 Vaccine   [ Time Frame: Day 8 after the first vaccination ]

21.  Primary:   Number of Participants Age 65 Years and Older With a Serum Hemagglutination Inhibition Assay (HAI) Antibody Titer of 1:40 or Greater Against the H1N1 2009 Virus 21 Days Following the First Dose of H1N1 Vaccine   [ Time Frame: Day 21 after the first vaccination ]

22.  Secondary:   Number of Participants Age 18 to 64 Years With a Serum Hemagglutination Inhibition Assay (HAI) Antibody Titer of 1:40 or Greater Against the H1N1 2009 Virus 8 Days Following the Second Dose of H1N1 Vaccine   [ Time Frame: Day 8 after the second vaccination ]

23.  Secondary:   Number of Participants Age 18 to 64 Years With a Serum Hemagglutination Inhibition Assay (HAI) Antibody Titer of 1:40 or Greater Against the H1N1 2009 Virus 21 Days Following the Second Dose of H1N1 Vaccine   [ Time Frame: Day 21 after the second vaccination ]

24.  Secondary:   Number of Participants Age 18 to 64 Years With a Serum Hemagglutination Inhibition Assay (HAI) Antibody Titer of 1:40 or Greater Against the H1N1 2009 Virus 180 Days Following the Second Dose of H1N1 Vaccine   [ Time Frame: Day 180 after the second vaccination ]

25.  Secondary:   Number of Participants Age 18 to 64 Years With a Serum Hemagglutination Inhibition Assay (HAI) Antibody Titer of 1:40 or Greater Against the H1N1 2009 Virus 270 Days Following the Second Dose of H1N1 Vaccine   [ Time Frame: Day 270 after the second vaccination ]

26.  Secondary:   Number of Participants Age 65 Years and Older With a Serum Hemagglutination Inhibition Assay (HAI) Antibody Titer of 1:40 or Greater Against the H1N1 2009 Virus 8 Days Following the Second Dose of H1N1 Vaccine   [ Time Frame: Day 8 after the second vaccination ]

27.  Secondary:   Number of Participants Age 65 Years and Older With a Serum Hemagglutination Inhibition Assay (HAI) Antibody Titer of 1:40 or Greater Against the H1N1 2009 Virus 21 Days Following the Second Dose of H1N1 Vaccine   [ Time Frame: Day 21 after the second vaccination ]

28.  Secondary:   Number of Participants Age 65 Years and Older With a Serum Hemagglutination Inhibition Assay (HAI) Antibody Titer of 1:40 or Greater Against the H1N1 2009 Virus 180 Days Following the Second Dose of H1N1 Vaccine   [ Time Frame: Day 180 after the second vaccination ]

29.  Secondary:   Number of Participants Age 65 Years and Older With a Serum Hemagglutination Inhibition Assay (HAI) Antibody Titer of 1:40 or Greater Against the H1N1 2009 Virus 270 Days Following the Second Dose of H1N1 Vaccine   [ Time Frame: Day 270 after the second vaccination ]

30.  Secondary:   Number of Participants Age 18 to 64 Years With 4-fold or Greater Hemagglutination Inhibition Assay (HAI) Antibody Titer Increases Against the Influenza H1N1 2009 Virus 8 Days Following the Second Dose of H1N1 Vaccine   [ Time Frame: Day 0 prior to vaccination and 8 days after the second H1N1 vaccination ]

31.  Secondary:   Number of Participants Age 18 to 64 Years With 4-fold or Greater Hemagglutination Inhibition Assay (HAI) Antibody Titer Increases Against the Influenza H1N1 2009 Virus 21 Days Following the Second Dose of H1N1 Vaccine   [ Time Frame: Day 0 prior to vaccination and 21 days after the second H1N1 vaccination ]

32.  Secondary:   Number of Participants Age 18 to 64 Years With 4-fold or Greater Hemagglutination Inhibition Assay (HAI) Antibody Titer Increases Against the Influenza H1N1 2009 Virus 180 Days Following the Second Dose of H1N1 Vaccine   [ Time Frame: Day 0 prior to vaccination and 180 days after the second H1N1 vaccination ]

33.  Secondary:   Number of Participants Age 18 to 64 Years With 4-fold or Greater Hemagglutination Inhibition Assay (HAI) Antibody Titer Increases Against the Influenza H1N1 2009 Virus 270 Days Following the Second Dose of H1N1 Vaccine   [ Time Frame: Day 0 prior to vaccination and 270 days after the second H1N1 vaccination ]

34.  Secondary:   Number of Participants Age 65 Years and Older With 4-fold or Greater Hemagglutination Inhibition Assay (HAI) Antibody Titer Increases Against the Influenza H1N1 2009 Virus 8 Days Following the Second Dose of H1N1 Vaccine   [ Time Frame: Day 0 prior to vaccination and 8 days after the second H1N1 vaccination ]

35.  Secondary:   Number of Participants Age 65 Years and Older With 4-fold or Greater Hemagglutination Inhibition Assay (HAI) Antibody Titer Increases Against the Influenza H1N1 2009 Virus 21 Days Following the Second Dose of H1N1 Vaccine   [ Time Frame: Day 0 prior to vaccination and 21 days after the second H1N1 vaccination ]

36.  Secondary:   Number of Participants Age 65 Years and Older With 4-fold or Greater Hemagglutination Inhibition Assay (HAI) Antibody Titer Increases Against the Influenza H1N1 2009 Virus 180 Days Following the Second Dose of H1N1 Vaccine   [ Time Frame: Day 0 prior to vaccination and 180 days after the second H1N1 vaccination ]

37.  Secondary:   Number of Participants Age 65 Years and Older With 4-fold or Greater Hemagglutination Inhibition Assay (HAI) Antibody Titer Increases Against the Influenza H1N1 2009 Virus 270 Days Following the Second Dose of H1N1 Vaccine   [ Time Frame: Day 0 prior to vaccination and 270 days after the second H1N1 vaccination ]


  Serious Adverse Events
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Time Frame Solicited events were collected for 8 days after each vaccination, unsolicited events through 21 days after last vaccination, and serious adverse events and new onset chronic medical conditions through 365 days after last vaccination.
Additional Description For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.

Reporting Groups
  Description
3.75 mcg H1N1 Vaccine + AS03 Adjuvant Participants received 3.75 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.
7.5 mcg H1N1 Vaccine + AS03 Adjuvant Participants received 7.5 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.
7.5 mcg H1N1 Vaccine Unadjuvanted Participants received 7.5 mcg H1N1 vaccine unadjuvanted on Day 0 and Day 21.
15 mcg H1N1 Vaccine + AS03 Adjuvant Participants received 15 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.
15 mcg H1N1 Vaccine Unadjuvanted Participants received 15 mcg H1N1 vaccine unadjuvanted on Day 0 and Day 21.

Serious Adverse Events
    3.75 mcg H1N1 Vaccine + AS03 Adjuvant   7.5 mcg H1N1 Vaccine + AS03 Adjuvant   7.5 mcg H1N1 Vaccine Unadjuvanted   15 mcg H1N1 Vaccine + AS03 Adjuvant   15 mcg H1N1 Vaccine Unadjuvanted
Total, serious adverse events           
# participants affected / at risk   6/156 (3.85%)   7/163 (4.29%)   12/160 (7.50%)   8/157 (5.10%)   8/153 (5.23%) 
Blood and lymphatic system disorders           
Thrombocytopenia * 1           
# participants affected / at risk   1/156 (0.64%)   0/163 (0.00%)   0/160 (0.00%)   0/157 (0.00%)   0/153 (0.00%) 
# events   1   0   0   0   0 
Anaemia * 1           
# participants affected / at risk   0/156 (0.00%)   1/163 (0.61%)   0/160 (0.00%)   0/157 (0.00%)   0/153 (0.00%) 
# events   0   1   0   0   0 
Cardiac disorders           
Sick sinus syndrome * 1           
# participants affected / at risk   0/156 (0.00%)   1/163 (0.61%)   0/160 (0.00%)   0/157 (0.00%)   0/153 (0.00%) 
# events   0   1   0   0   0 
Atrial fibrillation * 1           
# participants affected / at risk   0/156 (0.00%)   0/163 (0.00%)   1/160 (0.63%)   0/157 (0.00%)   0/153 (0.00%) 
# events   0   0   1   0   0 
Supraventricular tachycardia * 1           
# participants affected / at risk   0/156 (0.00%)   0/163 (0.00%)   0/160 (0.00%)   1/157 (0.64%)   0/153 (0.00%) 
# events   0   0   0   1   0 
Aortic valve incompetence * 1           
# participants affected / at risk   0/156 (0.00%)   0/163 (0.00%)   0/160 (0.00%)   0/157 (0.00%)   1/153 (0.65%) 
# events   0   0   0   0   1 
Arrhythmia * 1           
# participants affected / at risk   0/156 (0.00%)   0/163 (0.00%)   0/160 (0.00%)   0/157 (0.00%)   1/153 (0.65%) 
# events   0   0   0   0   1 
Gastrointestinal disorders           
Abdominal pain lower * 1           
# participants affected / at risk   0/156 (0.00%)   0/163 (0.00%)   0/160 (0.00%)   1/157 (0.64%)   0/153 (0.00%) 
# events   0   0   0   1   0 
Colitis * 1           
# participants affected / at risk   0/156 (0.00%)   0/163 (0.00%)   0/160 (0.00%)   1/157 (0.64%)   0/153 (0.00%) 
# events   0   0   0   1   0 
Small intestinal obstruction * 1           
# participants affected / at risk   0/156 (0.00%)   0/163 (0.00%)   0/160 (0.00%)   0/157 (0.00%)   1/153 (0.65%) 
# events   0   0   0   0   1 
General disorders           
Chest pain * 1           
# participants affected / at risk   0/156 (0.00%)   0/163 (0.00%)   0/160 (0.00%)   0/157 (0.00%)   1/153 (0.65%) 
# events   0   0   0   0   1 
Infections and infestations           
Appendicitis * 1           
# participants affected / at risk   1/156 (0.64%)   0/163 (0.00%)   0/160 (0.00%)   0/157 (0.00%)   0/153 (0.00%) 
# events   1   0   0   0   0 
Urinary tract infection * 1           
# participants affected / at risk   0/156 (0.00%)   1/163 (0.61%)   0/160 (0.00%)   0/157 (0.00%)   0/153 (0.00%) 
# events   0   1   0   0   0 
Pneumonia * 1           
# participants affected / at risk   0/156 (0.00%)   1/163 (0.61%)   0/160 (0.00%)   0/157 (0.00%)   0/153 (0.00%) 
# events   0   1   0   0   0 
Pulmonary tuberculosis * 1           
# participants affected / at risk   0/156 (0.00%)   0/163 (0.00%)   1/160 (0.63%)   0/157 (0.00%)   0/153 (0.00%) 
# events   0   0   1   0   0 
Cellulitis * 1           
# participants affected / at risk   0/156 (0.00%)   0/163 (0.00%)   1/160 (0.63%)   0/157 (0.00%)   0/153 (0.00%) 
# events   0   0   1   0   0 
Haemophilus sepsis * 1           
# participants affected / at risk   0/156 (0.00%)   0/163 (0.00%)   0/160 (0.00%)   0/157 (0.00%)   1/153 (0.65%) 
# events   0   0   0   0   1 
Injury, poisoning and procedural complications           
Post procedural complication * 1           
# participants affected / at risk   1/156 (0.64%)   0/163 (0.00%)   0/160 (0.00%)   0/157 (0.00%)   0/153 (0.00%) 
# events   1   0   0   0   0 
Respiratory fume inhalation disorder * 1           
# participants affected / at risk   0/156 (0.00%)   0/163 (0.00%)   0/160 (0.00%)   1/157 (0.64%)   0/153 (0.00%) 
# events   0   0   0   1   0 
Hip fracture * 1           
# participants affected / at risk   0/156 (0.00%)   0/163 (0.00%)   0/160 (0.00%)   0/157 (0.00%)   1/153 (0.65%) 
# events   0   0   0   0   1 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)           
Endometrial cancer * 1           
# participants affected / at risk   1/156 (0.64%)   0/163 (0.00%)   0/160 (0.00%)   0/157 (0.00%)   0/153 (0.00%) 
# events   1   0   0   0   0 
Breast cancer * 1           
# participants affected / at risk   1/156 (0.64%)   0/163 (0.00%)   0/160 (0.00%)   1/157 (0.64%)   0/153 (0.00%) 
# events   1   0   0   1   0 
Bladder cancer * 1           
# participants affected / at risk   1/156 (0.64%)   0/163 (0.00%)   0/160 (0.00%)   0/157 (0.00%)   0/153 (0.00%) 
# events   1   0   0   0   0 
Non-small cell lung cancer metastatic * 1           
# participants affected / at risk   0/156 (0.00%)   1/163 (0.61%)   0/160 (0.00%)   0/157 (0.00%)   0/153 (0.00%) 
# events   0   1   0   0   0 
Prostate cancer * 1           
# participants affected / at risk   0/156 (0.00%)   1/163 (0.61%)   1/160 (0.63%)   0/157 (0.00%)   0/153 (0.00%) 
# events   0   1   1   0   0 
Colon cancer * 1           
# participants affected / at risk   0/156 (0.00%)   0/163 (0.00%)   1/160 (0.63%)   0/157 (0.00%)   0/153 (0.00%) 
# events   0   0   1   0   0 
Lymphoma * 1           
# participants affected / at risk   0/156 (0.00%)   0/163 (0.00%)   1/160 (0.63%)   0/157 (0.00%)   0/153 (0.00%) 
# events   0   0   1   0   0 
Chronic lymphocytic leukaemia * 1           
# participants affected / at risk   0/156 (0.00%)   0/163 (0.00%)   0/160 (0.00%)   1/157 (0.64%)   0/153 (0.00%) 
# events   0   0   0   1   0 
Hepatic cancer metastatic * 1           
# participants affected / at risk   0/156 (0.00%)   0/163 (0.00%)   0/160 (0.00%)   0/157 (0.00%)   1/153 (0.65%) 
# events   0   0   0   0   1 
Nervous system disorders           
Ischaemic stroke * 1           
# participants affected / at risk   0/156 (0.00%)   1/163 (0.61%)   0/160 (0.00%)   0/157 (0.00%)   0/153 (0.00%) 
# events   0   1   0   0   0 
Grand mal convulsion * 1           
# participants affected / at risk   0/156 (0.00%)   0/163 (0.00%)   1/160 (0.63%)   0/157 (0.00%)   0/153 (0.00%) 
# events   0   0   1   0   0 
Aqueductal stenosis * 1           
# participants affected / at risk   0/156 (0.00%)   0/163 (0.00%)   1/160 (0.63%)   0/157 (0.00%)   0/153 (0.00%) 
# events   0   0   1   0   0 
Cervical myelopathy * 1           
# participants affected / at risk   0/156 (0.00%)   0/163 (0.00%)   1/160 (0.63%)   0/157 (0.00%)   0/153 (0.00%) 
# events   0   0   1   0   0 
Presyncope * 1           
# participants affected / at risk   0/156 (0.00%)   0/163 (0.00%)   0/160 (0.00%)   1/157 (0.64%)   0/153 (0.00%) 
# events   0   0   0   1   0 
Dementia * 1           
# participants affected / at risk   0/156 (0.00%)   0/163 (0.00%)   0/160 (0.00%)   0/157 (0.00%)   1/153 (0.65%) 
# events   0   0   0   0   1 
Psychiatric disorders           
Major depression * 1           
# participants affected / at risk   1/156 (0.64%)   0/163 (0.00%)   0/160 (0.00%)   0/157 (0.00%)   0/153 (0.00%) 
# events   1   0   0   0   0 
Mental status changes * 1           
# participants affected / at risk   0/156 (0.00%)   1/163 (0.61%)   0/160 (0.00%)   0/157 (0.00%)   0/153 (0.00%) 
# events   0   1   0   0   0 
Renal and urinary disorders           
Bladder prolapse * 1           
# participants affected / at risk   0/156 (0.00%)   0/163 (0.00%)   1/160 (0.63%)   0/157 (0.00%)   0/153 (0.00%) 
# events   0   0   1   0   0 
Respiratory, thoracic and mediastinal disorders           
Pneumothorax * 1           
# participants affected / at risk   1/156 (0.64%)   0/163 (0.00%)   0/160 (0.00%)   0/157 (0.00%)   0/153 (0.00%) 
# events   1   0   0   0   0 
Pulmonary fibrosis * 1           
# participants affected / at risk   0/156 (0.00%)   0/163 (0.00%)   1/160 (0.63%)   0/157 (0.00%)   0/153 (0.00%) 
# events   0   0   1   0   0 
Pneumonia aspiration * 1           
# participants affected / at risk   0/156 (0.00%)   0/163 (0.00%)   1/160 (0.63%)   0/157 (0.00%)   0/153 (0.00%) 
# events   0   0   1   0   0 
Pharyngeal oedema * 1           
# participants affected / at risk   0/156 (0.00%)   0/163 (0.00%)   0/160 (0.00%)   1/157 (0.64%)   0/153 (0.00%) 
# events   0   0   0   1   0 
Surgical and medical procedures           
Hysterectomy * 1           
# participants affected / at risk   0/156 (0.00%)   1/163 (0.61%)   0/160 (0.00%)   0/157 (0.00%)   0/153 (0.00%) 
# events   0   1   0   0   0 
Gastric bypass * 1           
# participants affected / at risk   0/156 (0.00%)   0/163 (0.00%)   1/160 (0.63%)   0/157 (0.00%)   0/153 (0.00%) 
# events   0   0   1   0   0 
Spinal laminectomy * 1           
# participants affected / at risk   0/156 (0.00%)   0/163 (0.00%)   0/160 (0.00%)   1/157 (0.64%)   0/153 (0.00%) 
# events   0   0   0   1   0 
Atrial septal defect repair * 1           
# participants affected / at risk   0/156 (0.00%)   0/163 (0.00%)   0/160 (0.00%)   0/157 (0.00%)   1/153 (0.65%) 
# events   0   0   0   0   1 
Implantable defibrillator insertion * 1           
# participants affected / at risk   0/156 (0.00%)   0/163 (0.00%)   0/160 (0.00%)   0/157 (0.00%)   1/153 (0.65%) 
# events   0   0   0   0   1 
* Events were collected by non-systematic assessment
1 Term from vocabulary, MedDRA (14.0)




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