Trial Outcomes & Findings for Efficacy Study of Two Influenza Vaccines and Placebo in Healthy Adult Subjects (NCT NCT00630331)

NCT ID: NCT00630331

Last Updated: 2024-05-24

Results Overview

The vaccine efficacy of CCI and IVV vaccines was estimated relative to Placebo group as the number of subjects prevented against virus-confirmed symptomatic influenza illness caused by each of three vaccine-like virus strains.

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 11404 participants
• Primary outcome timeframe: 6 Months
• Results posted on: 2024-05-24

Participant Flow

Participants were enrolled at multiple centres in the US, Poland and Finland.

All enrolled subjects were included in the trial.

Participant milestones

Measure	CCI Vaccine One dose of cell culture-derived influenza vaccine.	IVV Vaccine One dose of the trivalent egg-derived influenza virus vaccine.	Placebo One dose of phosphate buffered solution (PBS).
Overall Study STARTED	3828	3676	3900
Overall Study COMPLETED	3622	3510	3712
Overall Study NOT COMPLETED	206	166	188

Reasons for withdrawal

Measure	CCI Vaccine One dose of cell culture-derived influenza vaccine.	IVV Vaccine One dose of the trivalent egg-derived influenza virus vaccine.	Placebo One dose of phosphate buffered solution (PBS).
Overall Study Death	2	1	1
Overall Study Adverse Event	1	0	0
Overall Study Withdrawal by Subject	12	7	5
Overall Study Lost to Follow-up	175	143	170
Overall Study Inappropriate enrollment	3	6	3
Overall Study Unable to classify	9	4	3
Overall Study Protocol Violation	4	5	6

Baseline Characteristics

Efficacy Study of Two Influenza Vaccines and Placebo in Healthy Adult Subjects

Baseline characteristics by cohort

Measure	CCI Vaccine n=3828 Participants One dose of cell culture-derived influenza vaccine.	IVV Vaccine n=3676 Participants One dose of the trivalent egg-derived influenza virus vaccine.	Placebo n=3900 Participants One dose of phosphate buffered solution (PBS).	Total n=11404 Participants Total of all reporting groups
Age, Continuous	32.7 years STANDARD_DEVIATION 10.1 • n=93 Participants	33.0 years STANDARD_DEVIATION 10.2 • n=4 Participants	32.7 years STANDARD_DEVIATION 10.2 • n=27 Participants	32.8 years STANDARD_DEVIATION 10.2 • n=483 Participants
Sex/Gender, Customized Female	2088 Subjects n=93 Participants	2026 Subjects n=4 Participants	2176 Subjects n=27 Participants	6290 Subjects n=483 Participants
Sex/Gender, Customized Male	1740 Subjects n=93 Participants	1649 Subjects n=4 Participants	1722 Subjects n=27 Participants	5111 Subjects n=483 Participants
Sex/Gender, Customized Not Available	0 Subjects n=93 Participants	1 Subjects n=4 Participants	2 Subjects n=27 Participants	3 Subjects n=483 Participants

PRIMARY outcome

Timeframe: 6 Months

Population: Analysis was performed on per protocol (PP) efficacy population i.e. the subjects in the exposed efficacy population who correctly received the vaccine and provided evaluable swab samples at the relevant time points.

The vaccine efficacy of CCI and IVV vaccines was estimated relative to Placebo group as the number of subjects prevented against virus-confirmed symptomatic influenza illness caused by each of three vaccine-like virus strains.

Outcome measures

Measure	CCI Vaccine n=3776 Participants One dose of cell culture-derived influenza vaccine.	IVV Vaccine n=3638 Participants One dose of the trivalent egg-derived influenza virus vaccine.	Placebo n=3843 Participants One dose of phosphate buffered solution (PBS).
Number of Subjects With Culture-Confirmed Influenza Illness Caused by Vaccine-like Strains Overall	7 Subjects	9 Subjects	44 Subjects
Number of Subjects With Culture-Confirmed Influenza Illness Caused by Vaccine-like Strains A/Wisconsin/67/2005 (H3N2)-like	2 Subjects	1 Subjects	0 Subjects
Number of Subjects With Culture-Confirmed Influenza Illness Caused by Vaccine-like Strains A/Solomon Islands/3/2006 (H1N1)-like	5 Subjects	8 Subjects	43 Subjects
Number of Subjects With Culture-Confirmed Influenza Illness Caused by Vaccine-like Strains B/Malaysia/2506/2004-like	0 Subjects	0 Subjects	1 Subjects

SECONDARY outcome

Timeframe: 6 Months

Population: Analysis was done on PP efficacy population.

The vaccine efficacy of CCI and IVV vaccines was estimated relative to placebo group as the number of subjects prevented against virus-confirmed symptomatic influenza A or B illness caused by non-vaccine-like strains.

Outcome measures

Measure	CCI Vaccine n=3776 Participants One dose of cell culture-derived influenza vaccine.	IVV Vaccine n=3638 Participants One dose of the trivalent egg-derived influenza virus vaccine.	Placebo n=3843 Participants One dose of phosphate buffered solution (PBS).
Number of Subjects With Culture-confirmed Influenza Illness Caused by Non-Vaccine Like Strains Overall	30 Subjects	29 Subjects	74 Subjects
Number of Subjects With Culture-confirmed Influenza Illness Caused by Non-Vaccine Like Strains A/H3N2	0 Subjects	2 Subjects	8 Subjects
Number of Subjects With Culture-confirmed Influenza Illness Caused by Non-Vaccine Like Strains A/H1N1	1 Subjects	0 Subjects	8 Subjects
Number of Subjects With Culture-confirmed Influenza Illness Caused by Non-Vaccine Like Strains B	29 Subjects	27 Subjects	59 Subjects

SECONDARY outcome

Timeframe: 6 Months

Population: Analysis was done on PP efficacy population.

The vaccine efficacy of CCI and IVV vaccines was estimated relative to placebo as the number of subjected prevented against virus-confirmed symptomatic influenza A or B illness caused by vaccine-like and non-vaccine-like strains.

Outcome measures

Measure	CCI Vaccine n=3776 Participants One dose of cell culture-derived influenza vaccine.	IVV Vaccine n=3638 Participants One dose of the trivalent egg-derived influenza virus vaccine.	Placebo n=3843 Participants One dose of phosphate buffered solution (PBS).
Number of Subjects With Influenza Caused by Vaccine-like and Non-vaccine-like Strains Overall	42 Subjects	49 Subjects	140 Subjects
Number of Subjects With Influenza Caused by Vaccine-like and Non-vaccine-like Strains A/H3N2	6 Subjects	12 Subjects	25 Subjects
Number of Subjects With Influenza Caused by Vaccine-like and Non-vaccine-like Strains A/H1N1	6 Subjects	10 Subjects	57 Subjects
Number of Subjects With Influenza Caused by Vaccine-like and Non-vaccine-like Strains B	30 Subjects	27 Subjects	61 Subjects

SECONDARY outcome

Timeframe: 6 Months

Population: Analysis was done on the PP efficacy population.

The number of subjects in this analysis included all subjects in the per protocol efficacy population.

Outcome measures

Measure	CCI Vaccine n=3775 Participants One dose of cell culture-derived influenza vaccine.	IVV Vaccine n=3638 Participants One dose of the trivalent egg-derived influenza virus vaccine.	Placebo n=3837 Participants One dose of phosphate buffered solution (PBS).
Influenza-Associated Days in Bed, All Subjects	0.04 Number of Days Standard Deviation 0.496	0.04 Number of Days Standard Deviation 0.404	0.12 Number of Days Standard Deviation 0.777

SECONDARY outcome

Timeframe: 6 Months

Population: Analysis was done on PP efficacy population.

The analysis was done among the subset of subjects in the per protocol efficacy population who had culture-confirmed influenza.

Outcome measures

Measure	CCI Vaccine n=180 Participants One dose of cell culture-derived influenza vaccine.	IVV Vaccine n=230 Participants One dose of the trivalent egg-derived influenza virus vaccine.	Placebo n=332 Participants One dose of phosphate buffered solution (PBS).
Influenza-Associated Days in Bed, Subset of Subjects With Virus-Confirmed- Influenza	3.9 Number of Days Standard Deviation 2.62	2.9 Number of Days Standard Deviation 1.98	3.4 Number of Days Standard Deviation 2.4

SECONDARY outcome

Timeframe: 6 Months

Population: Analysis was done of PP efficacy population.

The number of subjects in this analysis included all subjects in the per protocol efficacy population.

Outcome measures

Measure	CCI Vaccine n=3775 Participants One dose of cell culture-derived influenza vaccine.	IVV Vaccine n=3638 Participants One dose of the trivalent egg-derived influenza virus vaccine.	Placebo n=3838 Participants One dose of phosphate buffered solution (PBS).
Number Of Medical Visits (Inpatient and Outpatient) Due to Influenza Illness or Symptoms of Influenza, All Subjects	0.01 Number of Medical Visits Standard Deviation 0.138	0.01 Number of Medical Visits Standard Deviation 0.134	0.03 Number of Medical Visits Standard Deviation 0.262

SECONDARY outcome

Timeframe: 6 Months

Population: Analysis was done of PP efficacy population.

The analysis was done among the subset of subjects in the per protocol efficacy population who had culture-confirmed influenza.

Outcome measures

Measure	CCI Vaccine n=180 Participants One dose of cell culture-derived influenza vaccine.	IVV Vaccine n=230 Participants One dose of the trivalent egg-derived influenza virus vaccine.	Placebo n=332 Participants One dose of phosphate buffered solution (PBS).
Number of Medical Visits (Inpatient and Outpatient), Subset of Subjects With Virus-Confirmed-Influenza	0.8 Number of Medical Visits Standard Deviation 0.92	0.6 Number of Medical Visits Standard Deviation 1.0	0.8 Number of Medical Visits Standard Deviation 1.16

SECONDARY outcome

Timeframe: 6 Months

Population: Analysis was done on PP efficacy population.

The number of subjects in this analysis included all subjects in the per protocol efficacy population.

Outcome measures

Measure	CCI Vaccine n=3775 Participants One dose of cell culture-derived influenza vaccine.	IVV Vaccine n=3638 Participants One dose of the trivalent egg-derived influenza virus vaccine.	Placebo n=3837 Participants One dose of phosphate buffered solution (PBS).
Number of Days of Usual Activity (i.e. Job, School,Household/Family/Community Activities) Lost Due to Influenza Disease, All Subjects	0.06 Numebr of Days of Usual Activity Lost Standard Deviation 0.635	0.05 Numebr of Days of Usual Activity Lost Standard Deviation 0.605	0.16 Numebr of Days of Usual Activity Lost Standard Deviation 1.006

SECONDARY outcome

Timeframe: 6 Months

Population: Analysis was done on PP efficacy population.

The analysis was done among the subset of subjects in the per protocol efficacy population who had culture-confirmed influenza.

Outcome measures

Measure	CCI Vaccine n=180 Participants One dose of cell culture-derived influenza vaccine.	IVV Vaccine n=230 Participants One dose of the trivalent egg-derived influenza virus vaccine.	Placebo n=332 Participants One dose of phosphate buffered solution (PBS).
Number of Days of Usual Activity (i.e. Job, School,Household/Family/Community Activities) Lost, Subset of Subjects With Virus-Confirmed-Influenza	5.1 Numebr of Days of Usual Activity Lost Standard Deviation 3.41	4.0 Numebr of Days of Usual Activity Lost Standard Deviation 3.4	4.6 Numebr of Days of Usual Activity Lost Standard Deviation 3.45

SECONDARY outcome

Timeframe: Before vaccination (day 1) and three weeks after vaccination (day 22)

Population: Analysis was done on a subset of subjects who constituted the PP immunogenicity population.

Immunogenicity was measured as the percentage of subjects achieving HI titers ≥40 at baseline (day 1) and three weeks after (day 22) one vaccination of either cell-culture or egg-derived vaccine or placebo for each of the three influenza vaccine strains (A/H1N1, A/H3N2 and B), evaluated using hemagglutination inhibition (HI) egg-derived antigen assay. This criterion is met according to US (CBER) guideline if the lower limit of the two-sided 95% CI for the percentage of subjects achieving HI titers ≥40 is ≥70%.

Outcome measures

Measure	CCI Vaccine n=228 Participants One dose of cell culture-derived influenza vaccine.	IVV Vaccine n=695 Participants One dose of the trivalent egg-derived influenza virus vaccine.	Placebo n=55 Participants One dose of phosphate buffered solution (PBS).
Percentages of Subjects Who Achieved HI Titers ≥40 After One Vaccination of Either Cell-culture Derived or Egg-derived Influenza Vaccine or Placebo A/H3N2 - Day 22	99 Percentages of subjects Interval 97.0 to 100.0	99 Percentages of subjects Interval 98.0 to 100.0	65 Percentages of subjects Interval 51.0 to 78.0
Percentages of Subjects Who Achieved HI Titers ≥40 After One Vaccination of Either Cell-culture Derived or Egg-derived Influenza Vaccine or Placebo A/H1N1 - Day 1	48 Percentages of subjects Interval 42.0 to 55.0	53 Percentages of subjects Interval 49.0 to 57.0	60 Percentages of subjects Interval 46.0 to 73.0
Percentages of Subjects Who Achieved HI Titers ≥40 After One Vaccination of Either Cell-culture Derived or Egg-derived Influenza Vaccine or Placebo A/H1N1 - Day 22	99 Percentages of subjects Interval 97.0 to 100.0	98 Percentages of subjects Interval 97.0 to 99.0	60 Percentages of subjects Interval 46.0 to 73.0
Percentages of Subjects Who Achieved HI Titers ≥40 After One Vaccination of Either Cell-culture Derived or Egg-derived Influenza Vaccine or Placebo A/H3N2 - Day 1	63 Percentages of subjects Interval 57.0 to 69.0	58 Percentages of subjects Interval 54.0 to 61.0	71 Percentages of subjects Interval 57.0 to 82.0
Percentages of Subjects Who Achieved HI Titers ≥40 After One Vaccination of Either Cell-culture Derived or Egg-derived Influenza Vaccine or Placebo B - Day 1	25 Percentages of subjects Interval 20.0 to 31.0	23 Percentages of subjects Interval 20.0 to 27.0	22 Percentages of subjects Interval 12.0 to 35.0
Percentages of Subjects Who Achieved HI Titers ≥40 After One Vaccination of Either Cell-culture Derived or Egg-derived Influenza Vaccine or Placebo B - Day 22	78 Percentages of subjects Interval 72.0 to 83.0	92 Percentages of subjects Interval 90.0 to 94.0	22 Percentages of subjects Interval 12.0 to 35.0

SECONDARY outcome

Timeframe: Three weeks after vaccination (day 22)

Population: Analysis was done on a subset of subjects who constituted the PP immunogenicity population.

As per the CBER guideline, seroconversion is defined as the percentage of subjects with a prevaccination HI titer <10, a postvaccination titer ≥40; or in subjects with prevaccination HI titer ≥10, a ≥4-fold increase in postvaccination HI antibody titer. According to CBER criteria, the lower limit of the two-sided 95% CI for the percentage of subjects achieving seroconversion for HI antibody titer at day 22 met exceeded 40%.

Outcome measures

Measure	CCI Vaccine n=228 Participants One dose of cell culture-derived influenza vaccine.	IVV Vaccine n=695 Participants One dose of the trivalent egg-derived influenza virus vaccine.	Placebo n=55 Participants One dose of phosphate buffered solution (PBS).
Percentages of Subjects Achieving Seroconversion After One Vaccination of Either Cell-culture Derived or Egg-derived Influenza Vaccine or Placebo A/H1N1	78 Percentages of subjects Interval 72.0 to 83.0	75 Percentages of subjects Interval 71.0 to 78.0	0 Percentages of subjects Interval 0.0 to 6.0
Percentages of Subjects Achieving Seroconversion After One Vaccination of Either Cell-culture Derived or Egg-derived Influenza Vaccine or Placebo A/H3N2	59 Percentages of subjects Interval 53.0 to 66.0	68 Percentages of subjects Interval 64.0 to 71.0	0 Percentages of subjects Interval 0.0 to 6.0
Percentages of Subjects Achieving Seroconversion After One Vaccination of Either Cell-culture Derived or Egg-derived Influenza Vaccine or Placebo B	51 Percentages of subjects Interval 45.0 to 58.0	68 Percentages of subjects Interval 65.0 to 72.0	0 Percentages of subjects Interval 0.0 to 6.0

SECONDARY outcome

Timeframe: Up to 7 days post vaccination

Population: Analysis was done on Safety population i.e. all subjects in the exposed population who provide post vaccination safety data.

The solicited local and systemic reactogenicity were collected up to 7 days after vaccination for all three vaccine groups.

Outcome measures

Measure	CCI Vaccine n=3813 Participants One dose of cell culture-derived influenza vaccine.	IVV Vaccine n=3669 Participants One dose of the trivalent egg-derived influenza virus vaccine.	Placebo n=3894 Participants One dose of phosphate buffered solution (PBS).
Number of Subjects Reported Solicited Local and Systemic Reactions up to 7 Days After Vaccination Injection site Pain	1158 Subjects	893 Subjects	375 Subjects
Number of Subjects Reported Solicited Local and Systemic Reactions up to 7 Days After Vaccination Injection site Erythema	510 Subjects	492 Subjects	391 Subjects
Number of Subjects Reported Solicited Local and Systemic Reactions up to 7 Days After Vaccination Injection site Induration	239 Subjects	207 Subjects	101 Subjects
Number of Subjects Reported Solicited Local and Systemic Reactions up to 7 Days After Vaccination Injection site Ecchymosis	143 Subjects	110 Subjects	147 Subjects
Number of Subjects Reported Solicited Local and Systemic Reactions up to 7 Days After Vaccination Injection site Swelling	218 Subjects	181 Subjects	103 Subjects
Number of Subjects Reported Solicited Local and Systemic Reactions up to 7 Days After Vaccination Chills	210 Subjects	211 Subjects	223 Subjects
Number of Subjects Reported Solicited Local and Systemic Reactions up to 7 Days After Vaccination Malaise	290 Subjects	259 Subjects	237 Subjects
Number of Subjects Reported Solicited Local and Systemic Reactions up to 7 Days After Vaccination Myalgia	450 Subjects	364 Subjects	275 Subjects
Number of Subjects Reported Solicited Local and Systemic Reactions up to 7 Days After Vaccination Arthralgia	108 Subjects	111 Subjects	125 Subjects
Number of Subjects Reported Solicited Local and Systemic Reactions up to 7 Days After Vaccination Headache	564 Subjects	551 Subjects	592 Subjects
Number of Subjects Reported Solicited Local and Systemic Reactions up to 7 Days After Vaccination Sweating	124 Subjects	122 Subjects	120 Subjects
Number of Subjects Reported Solicited Local and Systemic Reactions up to 7 Days After Vaccination Fatigue	390 Subjects	404 Subjects	384 Subjects
Number of Subjects Reported Solicited Local and Systemic Reactions up to 7 Days After Vaccination Fever (>= 38 C)	27 Subjects	21 Subjects	15 Subjects
Number of Subjects Reported Solicited Local and Systemic Reactions up to 7 Days After Vaccination Oral Temp. (< 38 C)	3786 Subjects	3648 Subjects	3879 Subjects
Number of Subjects Reported Solicited Local and Systemic Reactions up to 7 Days After Vaccination Stayed home due to Reactions (N=3781, 3651, 3867)	42 Subjects	62 Subjects	42 Subjects
Number of Subjects Reported Solicited Local and Systemic Reactions up to 7 Days After Vaccination Analgesic medicines used	394 Subjects	397 Subjects	386 Subjects

Adverse Events

CCI Vaccine

Serious events: 42 serious events

Other events: 1949 other events

Deaths: 0 deaths

IVV Vaccine

Serious events: 35 serious events

Other events: 1703 other events

Deaths: 0 deaths

Placebo

Serious events: 38 serious events

Other events: 1387 other events

Deaths: 0 deaths

Serious adverse events

Measure	CCI Vaccine n=3813 participants at risk One dose of cell culture-derived influenza vaccine.	IVV Vaccine n=3669 participants at risk One dose of the trivalent egg-derived influenza virus vaccine.	Placebo n=3894 participants at risk One dose of phosphate buffered solution (PBS).
Cardiac disorders Cardiac Failure Congestive	0.03% 1/3813 • Number of events 1 • Serious Adverse Events were collected throughout the study period (i.e., 6 months). The analysis was done on the safety population.	0.00% 0/3669 • Serious Adverse Events were collected throughout the study period (i.e., 6 months). The analysis was done on the safety population.	0.00% 0/3894 • Serious Adverse Events were collected throughout the study period (i.e., 6 months). The analysis was done on the safety population.
Cardiac disorders Coronary Artery disease	0.00% 0/3813 • Serious Adverse Events were collected throughout the study period (i.e., 6 months). The analysis was done on the safety population.	0.00% 0/3669 • Serious Adverse Events were collected throughout the study period (i.e., 6 months). The analysis was done on the safety population.	0.03% 1/3894 • Number of events 1 • Serious Adverse Events were collected throughout the study period (i.e., 6 months). The analysis was done on the safety population.
Ear and labyrinth disorders Vertigo Positional	0.00% 0/3813 • Serious Adverse Events were collected throughout the study period (i.e., 6 months). The analysis was done on the safety population.	0.03% 1/3669 • Number of events 1 • Serious Adverse Events were collected throughout the study period (i.e., 6 months). The analysis was done on the safety population.	0.00% 0/3894 • Serious Adverse Events were collected throughout the study period (i.e., 6 months). The analysis was done on the safety population.
Endocrine disorders Hyperthyroidism	0.03% 1/3813 • Number of events 1 • Serious Adverse Events were collected throughout the study period (i.e., 6 months). The analysis was done on the safety population.	0.00% 0/3669 • Serious Adverse Events were collected throughout the study period (i.e., 6 months). The analysis was done on the safety population.	0.00% 0/3894 • Serious Adverse Events were collected throughout the study period (i.e., 6 months). The analysis was done on the safety population.
Eye disorders Mydriasis	0.00% 0/3813 • Serious Adverse Events were collected throughout the study period (i.e., 6 months). The analysis was done on the safety population.	0.00% 0/3669 • Serious Adverse Events were collected throughout the study period (i.e., 6 months). The analysis was done on the safety population.	0.03% 1/3894 • Number of events 1 • Serious Adverse Events were collected throughout the study period (i.e., 6 months). The analysis was done on the safety population.
Gastrointestinal disorders Abdominal Pain	0.03% 1/3813 • Number of events 1 • Serious Adverse Events were collected throughout the study period (i.e., 6 months). The analysis was done on the safety population.	0.03% 1/3669 • Number of events 1 • Serious Adverse Events were collected throughout the study period (i.e., 6 months). The analysis was done on the safety population.	0.00% 0/3894 • Serious Adverse Events were collected throughout the study period (i.e., 6 months). The analysis was done on the safety population.
Gastrointestinal disorders Abdominal Pain Upper	0.00% 0/3813 • Serious Adverse Events were collected throughout the study period (i.e., 6 months). The analysis was done on the safety population.	0.03% 1/3669 • Number of events 1 • Serious Adverse Events were collected throughout the study period (i.e., 6 months). The analysis was done on the safety population.	0.03% 1/3894 • Number of events 1 • Serious Adverse Events were collected throughout the study period (i.e., 6 months). The analysis was done on the safety population.
Gastrointestinal disorders Anal Fistula	0.00% 0/3813 • Serious Adverse Events were collected throughout the study period (i.e., 6 months). The analysis was done on the safety population.	0.03% 1/3669 • Number of events 1 • Serious Adverse Events were collected throughout the study period (i.e., 6 months). The analysis was done on the safety population.	0.00% 0/3894 • Serious Adverse Events were collected throughout the study period (i.e., 6 months). The analysis was done on the safety population.
Gastrointestinal disorders Colitis Ischaemic	0.00% 0/3813 • Serious Adverse Events were collected throughout the study period (i.e., 6 months). The analysis was done on the safety population.	0.03% 1/3669 • Number of events 1 • Serious Adverse Events were collected throughout the study period (i.e., 6 months). The analysis was done on the safety population.	0.00% 0/3894 • Serious Adverse Events were collected throughout the study period (i.e., 6 months). The analysis was done on the safety population.
Gastrointestinal disorders Crohn's Disease	0.03% 1/3813 • Number of events 1 • Serious Adverse Events were collected throughout the study period (i.e., 6 months). The analysis was done on the safety population.	0.00% 0/3669 • Serious Adverse Events were collected throughout the study period (i.e., 6 months). The analysis was done on the safety population.	0.00% 0/3894 • Serious Adverse Events were collected throughout the study period (i.e., 6 months). The analysis was done on the safety population.
Gastrointestinal disorders Gastrooesophageal Reflux Disease	0.03% 1/3813 • Number of events 1 • Serious Adverse Events were collected throughout the study period (i.e., 6 months). The analysis was done on the safety population.	0.00% 0/3669 • Serious Adverse Events were collected throughout the study period (i.e., 6 months). The analysis was done on the safety population.	0.00% 0/3894 • Serious Adverse Events were collected throughout the study period (i.e., 6 months). The analysis was done on the safety population.
Gastrointestinal disorders Haemorrhoids	0.00% 0/3813 • Serious Adverse Events were collected throughout the study period (i.e., 6 months). The analysis was done on the safety population.	0.00% 0/3669 • Serious Adverse Events were collected throughout the study period (i.e., 6 months). The analysis was done on the safety population.	0.03% 1/3894 • Number of events 1 • Serious Adverse Events were collected throughout the study period (i.e., 6 months). The analysis was done on the safety population.
Gastrointestinal disorders Inguinal Hernia	0.00% 0/3813 • Serious Adverse Events were collected throughout the study period (i.e., 6 months). The analysis was done on the safety population.	0.03% 1/3669 • Number of events 1 • Serious Adverse Events were collected throughout the study period (i.e., 6 months). The analysis was done on the safety population.	0.03% 1/3894 • Number of events 1 • Serious Adverse Events were collected throughout the study period (i.e., 6 months). The analysis was done on the safety population.
Gastrointestinal disorders Intestinal Obstructon	0.00% 0/3813 • Serious Adverse Events were collected throughout the study period (i.e., 6 months). The analysis was done on the safety population.	0.03% 1/3669 • Number of events 1 • Serious Adverse Events were collected throughout the study period (i.e., 6 months). The analysis was done on the safety population.	0.00% 0/3894 • Serious Adverse Events were collected throughout the study period (i.e., 6 months). The analysis was done on the safety population.
Gastrointestinal disorders Pancreatitis Acute	0.03% 1/3813 • Number of events 1 • Serious Adverse Events were collected throughout the study period (i.e., 6 months). The analysis was done on the safety population.	0.00% 0/3669 • Serious Adverse Events were collected throughout the study period (i.e., 6 months). The analysis was done on the safety population.	0.00% 0/3894 • Serious Adverse Events were collected throughout the study period (i.e., 6 months). The analysis was done on the safety population.
Gastrointestinal disorders Peritoneal Cyst	0.03% 1/3813 • Number of events 1 • Serious Adverse Events were collected throughout the study period (i.e., 6 months). The analysis was done on the safety population.	0.00% 0/3669 • Serious Adverse Events were collected throughout the study period (i.e., 6 months). The analysis was done on the safety population.	0.00% 0/3894 • Serious Adverse Events were collected throughout the study period (i.e., 6 months). The analysis was done on the safety population.
Gastrointestinal disorders Salivary Duct Inflammation	0.00% 0/3813 • Serious Adverse Events were collected throughout the study period (i.e., 6 months). The analysis was done on the safety population.	0.00% 0/3669 • Serious Adverse Events were collected throughout the study period (i.e., 6 months). The analysis was done on the safety population.	0.03% 1/3894 • Number of events 1 • Serious Adverse Events were collected throughout the study period (i.e., 6 months). The analysis was done on the safety population.
Gastrointestinal disorders Salivary Gland Calculus	0.00% 0/3813 • Serious Adverse Events were collected throughout the study period (i.e., 6 months). The analysis was done on the safety population.	0.00% 0/3669 • Serious Adverse Events were collected throughout the study period (i.e., 6 months). The analysis was done on the safety population.	0.03% 1/3894 • Number of events 1 • Serious Adverse Events were collected throughout the study period (i.e., 6 months). The analysis was done on the safety population.
Gastrointestinal disorders Small Intestinal Obstruction	0.00% 0/3813 • Serious Adverse Events were collected throughout the study period (i.e., 6 months). The analysis was done on the safety population.	0.00% 0/3669 • Serious Adverse Events were collected throughout the study period (i.e., 6 months). The analysis was done on the safety population.	0.03% 1/3894 • Number of events 1 • Serious Adverse Events were collected throughout the study period (i.e., 6 months). The analysis was done on the safety population.
Gastrointestinal disorders Vomiting in Pregnancy	0.00% 0/3813 • Serious Adverse Events were collected throughout the study period (i.e., 6 months). The analysis was done on the safety population.	0.03% 1/3669 • Number of events 1 • Serious Adverse Events were collected throughout the study period (i.e., 6 months). The analysis was done on the safety population.	0.00% 0/3894 • Serious Adverse Events were collected throughout the study period (i.e., 6 months). The analysis was done on the safety population.
General disorders Chest Pain	0.00% 0/3813 • Serious Adverse Events were collected throughout the study period (i.e., 6 months). The analysis was done on the safety population.	0.00% 0/3669 • Serious Adverse Events were collected throughout the study period (i.e., 6 months). The analysis was done on the safety population.	0.03% 1/3894 • Number of events 1 • Serious Adverse Events were collected throughout the study period (i.e., 6 months). The analysis was done on the safety population.
General disorders Death	0.03% 1/3813 • Number of events 1 • Serious Adverse Events were collected throughout the study period (i.e., 6 months). The analysis was done on the safety population.	0.00% 0/3669 • Serious Adverse Events were collected throughout the study period (i.e., 6 months). The analysis was done on the safety population.	0.00% 0/3894 • Serious Adverse Events were collected throughout the study period (i.e., 6 months). The analysis was done on the safety population.
General disorders Non-Cardiac Chest Pain	0.00% 0/3813 • Serious Adverse Events were collected throughout the study period (i.e., 6 months). The analysis was done on the safety population.	0.00% 0/3669 • Serious Adverse Events were collected throughout the study period (i.e., 6 months). The analysis was done on the safety population.	0.03% 1/3894 • Number of events 1 • Serious Adverse Events were collected throughout the study period (i.e., 6 months). The analysis was done on the safety population.
Hepatobiliary disorders Cholangitis Sclerosing	0.03% 1/3813 • Number of events 1 • Serious Adverse Events were collected throughout the study period (i.e., 6 months). The analysis was done on the safety population.	0.00% 0/3669 • Serious Adverse Events were collected throughout the study period (i.e., 6 months). The analysis was done on the safety population.	0.00% 0/3894 • Serious Adverse Events were collected throughout the study period (i.e., 6 months). The analysis was done on the safety population.
Hepatobiliary disorders Cholecystitis	0.03% 1/3813 • Number of events 1 • Serious Adverse Events were collected throughout the study period (i.e., 6 months). The analysis was done on the safety population.	0.00% 0/3669 • Serious Adverse Events were collected throughout the study period (i.e., 6 months). The analysis was done on the safety population.	0.00% 0/3894 • Serious Adverse Events were collected throughout the study period (i.e., 6 months). The analysis was done on the safety population.
Hepatobiliary disorders Cholecystitis Acute	0.00% 0/3813 • Serious Adverse Events were collected throughout the study period (i.e., 6 months). The analysis was done on the safety population.	0.03% 1/3669 • Number of events 1 • Serious Adverse Events were collected throughout the study period (i.e., 6 months). The analysis was done on the safety population.	0.00% 0/3894 • Serious Adverse Events were collected throughout the study period (i.e., 6 months). The analysis was done on the safety population.
Hepatobiliary disorders Cholelithiasis	0.03% 1/3813 • Number of events 1 • Serious Adverse Events were collected throughout the study period (i.e., 6 months). The analysis was done on the safety population.	0.00% 0/3669 • Serious Adverse Events were collected throughout the study period (i.e., 6 months). The analysis was done on the safety population.	0.03% 1/3894 • Number of events 1 • Serious Adverse Events were collected throughout the study period (i.e., 6 months). The analysis was done on the safety population.
Hepatobiliary disorders Hepatitis Acute	0.03% 1/3813 • Number of events 1 • Serious Adverse Events were collected throughout the study period (i.e., 6 months). The analysis was done on the safety population.	0.00% 0/3669 • Serious Adverse Events were collected throughout the study period (i.e., 6 months). The analysis was done on the safety population.	0.00% 0/3894 • Serious Adverse Events were collected throughout the study period (i.e., 6 months). The analysis was done on the safety population.
Hepatobiliary disorders Jaundice	0.03% 1/3813 • Number of events 1 • Serious Adverse Events were collected throughout the study period (i.e., 6 months). The analysis was done on the safety population.	0.00% 0/3669 • Serious Adverse Events were collected throughout the study period (i.e., 6 months). The analysis was done on the safety population.	0.00% 0/3894 • Serious Adverse Events were collected throughout the study period (i.e., 6 months). The analysis was done on the safety population.
Infections and infestations Acute Sinusitis	0.03% 1/3813 • Number of events 1 • Serious Adverse Events were collected throughout the study period (i.e., 6 months). The analysis was done on the safety population.	0.00% 0/3669 • Serious Adverse Events were collected throughout the study period (i.e., 6 months). The analysis was done on the safety population.	0.00% 0/3894 • Serious Adverse Events were collected throughout the study period (i.e., 6 months). The analysis was done on the safety population.
Infections and infestations Acute Tonsillitis	0.03% 1/3813 • Number of events 1 • Serious Adverse Events were collected throughout the study period (i.e., 6 months). The analysis was done on the safety population.	0.00% 0/3669 • Serious Adverse Events were collected throughout the study period (i.e., 6 months). The analysis was done on the safety population.	0.00% 0/3894 • Serious Adverse Events were collected throughout the study period (i.e., 6 months). The analysis was done on the safety population.
Infections and infestations Appendicitis	0.03% 1/3813 • Number of events 1 • Serious Adverse Events were collected throughout the study period (i.e., 6 months). The analysis was done on the safety population.	0.03% 1/3669 • Number of events 1 • Serious Adverse Events were collected throughout the study period (i.e., 6 months). The analysis was done on the safety population.	0.08% 3/3894 • Number of events 3 • Serious Adverse Events were collected throughout the study period (i.e., 6 months). The analysis was done on the safety population.
Infections and infestations Breast Cellulitis	0.00% 0/3813 • Serious Adverse Events were collected throughout the study period (i.e., 6 months). The analysis was done on the safety population.	0.00% 0/3669 • Serious Adverse Events were collected throughout the study period (i.e., 6 months). The analysis was done on the safety population.	0.03% 1/3894 • Number of events 1 • Serious Adverse Events were collected throughout the study period (i.e., 6 months). The analysis was done on the safety population.
Infections and infestations Cellulitis	0.03% 1/3813 • Number of events 1 • Serious Adverse Events were collected throughout the study period (i.e., 6 months). The analysis was done on the safety population.	0.00% 0/3669 • Serious Adverse Events were collected throughout the study period (i.e., 6 months). The analysis was done on the safety population.	0.00% 0/3894 • Serious Adverse Events were collected throughout the study period (i.e., 6 months). The analysis was done on the safety population.
Infections and infestations Diverticulitis	0.03% 1/3813 • Number of events 1 • Serious Adverse Events were collected throughout the study period (i.e., 6 months). The analysis was done on the safety population.	0.00% 0/3669 • Serious Adverse Events were collected throughout the study period (i.e., 6 months). The analysis was done on the safety population.	0.00% 0/3894 • Serious Adverse Events were collected throughout the study period (i.e., 6 months). The analysis was done on the safety population.
Infections and infestations Gastroenteritis Viral	0.00% 0/3813 • Serious Adverse Events were collected throughout the study period (i.e., 6 months). The analysis was done on the safety population.	0.03% 1/3669 • Number of events 1 • Serious Adverse Events were collected throughout the study period (i.e., 6 months). The analysis was done on the safety population.	0.00% 0/3894 • Serious Adverse Events were collected throughout the study period (i.e., 6 months). The analysis was done on the safety population.
Infections and infestations Infection	0.03% 1/3813 • Number of events 1 • Serious Adverse Events were collected throughout the study period (i.e., 6 months). The analysis was done on the safety population.	0.00% 0/3669 • Serious Adverse Events were collected throughout the study period (i.e., 6 months). The analysis was done on the safety population.	0.00% 0/3894 • Serious Adverse Events were collected throughout the study period (i.e., 6 months). The analysis was done on the safety population.
Infections and infestations Lung Abscess	0.03% 1/3813 • Number of events 1 • Serious Adverse Events were collected throughout the study period (i.e., 6 months). The analysis was done on the safety population.	0.00% 0/3669 • Serious Adverse Events were collected throughout the study period (i.e., 6 months). The analysis was done on the safety population.	0.00% 0/3894 • Serious Adverse Events were collected throughout the study period (i.e., 6 months). The analysis was done on the safety population.
Infections and infestations Mastitis Bacterial	0.00% 0/3813 • Serious Adverse Events were collected throughout the study period (i.e., 6 months). The analysis was done on the safety population.	0.00% 0/3669 • Serious Adverse Events were collected throughout the study period (i.e., 6 months). The analysis was done on the safety population.	0.03% 1/3894 • Number of events 1 • Serious Adverse Events were collected throughout the study period (i.e., 6 months). The analysis was done on the safety population.
Infections and infestations Perirectal Abscess	0.00% 0/3813 • Serious Adverse Events were collected throughout the study period (i.e., 6 months). The analysis was done on the safety population.	0.03% 1/3669 • Number of events 1 • Serious Adverse Events were collected throughout the study period (i.e., 6 months). The analysis was done on the safety population.	0.00% 0/3894 • Serious Adverse Events were collected throughout the study period (i.e., 6 months). The analysis was done on the safety population.
Infections and infestations Peritonsillar Abscess	0.00% 0/3813 • Serious Adverse Events were collected throughout the study period (i.e., 6 months). The analysis was done on the safety population.	0.03% 1/3669 • Number of events 1 • Serious Adverse Events were collected throughout the study period (i.e., 6 months). The analysis was done on the safety population.	0.00% 0/3894 • Serious Adverse Events were collected throughout the study period (i.e., 6 months). The analysis was done on the safety population.
Infections and infestations Pharyngitis	0.00% 0/3813 • Serious Adverse Events were collected throughout the study period (i.e., 6 months). The analysis was done on the safety population.	0.00% 0/3669 • Serious Adverse Events were collected throughout the study period (i.e., 6 months). The analysis was done on the safety population.	0.05% 2/3894 • Number of events 2 • Serious Adverse Events were collected throughout the study period (i.e., 6 months). The analysis was done on the safety population.
Infections and infestations Pneumonia	0.00% 0/3813 • Serious Adverse Events were collected throughout the study period (i.e., 6 months). The analysis was done on the safety population.	0.03% 1/3669 • Number of events 1 • Serious Adverse Events were collected throughout the study period (i.e., 6 months). The analysis was done on the safety population.	0.05% 2/3894 • Number of events 2 • Serious Adverse Events were collected throughout the study period (i.e., 6 months). The analysis was done on the safety population.
Infections and infestations Pyelonephritis Acute	0.03% 1/3813 • Number of events 1 • Serious Adverse Events were collected throughout the study period (i.e., 6 months). The analysis was done on the safety population.	0.00% 0/3669 • Serious Adverse Events were collected throughout the study period (i.e., 6 months). The analysis was done on the safety population.	0.00% 0/3894 • Serious Adverse Events were collected throughout the study period (i.e., 6 months). The analysis was done on the safety population.
Infections and infestations Urinary Tract Infection	0.03% 1/3813 • Number of events 1 • Serious Adverse Events were collected throughout the study period (i.e., 6 months). The analysis was done on the safety population.	0.03% 1/3669 • Number of events 1 • Serious Adverse Events were collected throughout the study period (i.e., 6 months). The analysis was done on the safety population.	0.00% 0/3894 • Serious Adverse Events were collected throughout the study period (i.e., 6 months). The analysis was done on the safety population.
Infections and infestations Wound Infection	0.03% 1/3813 • Number of events 1 • Serious Adverse Events were collected throughout the study period (i.e., 6 months). The analysis was done on the safety population.	0.00% 0/3669 • Serious Adverse Events were collected throughout the study period (i.e., 6 months). The analysis was done on the safety population.	0.00% 0/3894 • Serious Adverse Events were collected throughout the study period (i.e., 6 months). The analysis was done on the safety population.
Injury, poisoning and procedural complications Abdominal Injury	0.00% 0/3813 • Serious Adverse Events were collected throughout the study period (i.e., 6 months). The analysis was done on the safety population.	0.03% 1/3669 • Number of events 1 • Serious Adverse Events were collected throughout the study period (i.e., 6 months). The analysis was done on the safety population.	0.00% 0/3894 • Serious Adverse Events were collected throughout the study period (i.e., 6 months). The analysis was done on the safety population.
Injury, poisoning and procedural complications Alcohol Poisoning	0.03% 1/3813 • Number of events 1 • Serious Adverse Events were collected throughout the study period (i.e., 6 months). The analysis was done on the safety population.	0.00% 0/3669 • Serious Adverse Events were collected throughout the study period (i.e., 6 months). The analysis was done on the safety population.	0.00% 0/3894 • Serious Adverse Events were collected throughout the study period (i.e., 6 months). The analysis was done on the safety population.
Injury, poisoning and procedural complications Ankle Fracture	0.05% 2/3813 • Number of events 2 • Serious Adverse Events were collected throughout the study period (i.e., 6 months). The analysis was done on the safety population.	0.00% 0/3669 • Serious Adverse Events were collected throughout the study period (i.e., 6 months). The analysis was done on the safety population.	0.03% 1/3894 • Number of events 1 • Serious Adverse Events were collected throughout the study period (i.e., 6 months). The analysis was done on the safety population.
Injury, poisoning and procedural complications Chest Injury	0.00% 0/3813 • Serious Adverse Events were collected throughout the study period (i.e., 6 months). The analysis was done on the safety population.	0.00% 0/3669 • Serious Adverse Events were collected throughout the study period (i.e., 6 months). The analysis was done on the safety population.	0.03% 1/3894 • Number of events 1 • Serious Adverse Events were collected throughout the study period (i.e., 6 months). The analysis was done on the safety population.
Injury, poisoning and procedural complications Extradural Haematoma	0.03% 1/3813 • Number of events 1 • Serious Adverse Events were collected throughout the study period (i.e., 6 months). The analysis was done on the safety population.	0.00% 0/3669 • Serious Adverse Events were collected throughout the study period (i.e., 6 months). The analysis was done on the safety population.	0.00% 0/3894 • Serious Adverse Events were collected throughout the study period (i.e., 6 months). The analysis was done on the safety population.
Injury, poisoning and procedural complications Foot Fracture	0.00% 0/3813 • Serious Adverse Events were collected throughout the study period (i.e., 6 months). The analysis was done on the safety population.	0.03% 1/3669 • Number of events 1 • Serious Adverse Events were collected throughout the study period (i.e., 6 months). The analysis was done on the safety population.	0.00% 0/3894 • Serious Adverse Events were collected throughout the study period (i.e., 6 months). The analysis was done on the safety population.
Injury, poisoning and procedural complications Joint Injury	0.00% 0/3813 • Serious Adverse Events were collected throughout the study period (i.e., 6 months). The analysis was done on the safety population.	0.03% 1/3669 • Number of events 1 • Serious Adverse Events were collected throughout the study period (i.e., 6 months). The analysis was done on the safety population.	0.00% 0/3894 • Serious Adverse Events were collected throughout the study period (i.e., 6 months). The analysis was done on the safety population.
Injury, poisoning and procedural complications Road Traffic Accident	0.00% 0/3813 • Serious Adverse Events were collected throughout the study period (i.e., 6 months). The analysis was done on the safety population.	0.03% 1/3669 • Number of events 1 • Serious Adverse Events were collected throughout the study period (i.e., 6 months). The analysis was done on the safety population.	0.00% 0/3894 • Serious Adverse Events were collected throughout the study period (i.e., 6 months). The analysis was done on the safety population.
Injury, poisoning and procedural complications Skull Fracture	0.03% 1/3813 • Number of events 1 • Serious Adverse Events were collected throughout the study period (i.e., 6 months). The analysis was done on the safety population.	0.00% 0/3669 • Serious Adverse Events were collected throughout the study period (i.e., 6 months). The analysis was done on the safety population.	0.00% 0/3894 • Serious Adverse Events were collected throughout the study period (i.e., 6 months). The analysis was done on the safety population.
Injury, poisoning and procedural complications Subdural Haematoma	0.03% 1/3813 • Number of events 1 • Serious Adverse Events were collected throughout the study period (i.e., 6 months). The analysis was done on the safety population.	0.03% 1/3669 • Number of events 1 • Serious Adverse Events were collected throughout the study period (i.e., 6 months). The analysis was done on the safety population.	0.00% 0/3894 • Serious Adverse Events were collected throughout the study period (i.e., 6 months). The analysis was done on the safety population.
Injury, poisoning and procedural complications Tendon Rupture	0.03% 1/3813 • Number of events 1 • Serious Adverse Events were collected throughout the study period (i.e., 6 months). The analysis was done on the safety population.	0.00% 0/3669 • Serious Adverse Events were collected throughout the study period (i.e., 6 months). The analysis was done on the safety population.	0.00% 0/3894 • Serious Adverse Events were collected throughout the study period (i.e., 6 months). The analysis was done on the safety population.
Injury, poisoning and procedural complications Upper Limb Fracture	0.00% 0/3813 • Serious Adverse Events were collected throughout the study period (i.e., 6 months). The analysis was done on the safety population.	0.03% 1/3669 • Number of events 1 • Serious Adverse Events were collected throughout the study period (i.e., 6 months). The analysis was done on the safety population.	0.00% 0/3894 • Serious Adverse Events were collected throughout the study period (i.e., 6 months). The analysis was done on the safety population.
Injury, poisoning and procedural complications Wound	0.00% 0/3813 • Serious Adverse Events were collected throughout the study period (i.e., 6 months). The analysis was done on the safety population.	0.03% 1/3669 • Number of events 1 • Serious Adverse Events were collected throughout the study period (i.e., 6 months). The analysis was done on the safety population.	0.00% 0/3894 • Serious Adverse Events were collected throughout the study period (i.e., 6 months). The analysis was done on the safety population.
Metabolism and nutrition disorders Obesity	0.03% 1/3813 • Number of events 1 • Serious Adverse Events were collected throughout the study period (i.e., 6 months). The analysis was done on the safety population.	0.00% 0/3669 • Serious Adverse Events were collected throughout the study period (i.e., 6 months). The analysis was done on the safety population.	0.00% 0/3894 • Serious Adverse Events were collected throughout the study period (i.e., 6 months). The analysis was done on the safety population.
Musculoskeletal and connective tissue disorders Back Pain	0.00% 0/3813 • Serious Adverse Events were collected throughout the study period (i.e., 6 months). The analysis was done on the safety population.	0.00% 0/3669 • Serious Adverse Events were collected throughout the study period (i.e., 6 months). The analysis was done on the safety population.	0.05% 2/3894 • Number of events 2 • Serious Adverse Events were collected throughout the study period (i.e., 6 months). The analysis was done on the safety population.
Musculoskeletal and connective tissue disorders Intervertebral Disc Protrusion	0.05% 2/3813 • Number of events 2 • Serious Adverse Events were collected throughout the study period (i.e., 6 months). The analysis was done on the safety population.	0.00% 0/3669 • Serious Adverse Events were collected throughout the study period (i.e., 6 months). The analysis was done on the safety population.	0.05% 2/3894 • Number of events 2 • Serious Adverse Events were collected throughout the study period (i.e., 6 months). The analysis was done on the safety population.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Adenocarcinoma of the Cervix	0.00% 0/3813 • Serious Adverse Events were collected throughout the study period (i.e., 6 months). The analysis was done on the safety population.	0.00% 0/3669 • Serious Adverse Events were collected throughout the study period (i.e., 6 months). The analysis was done on the safety population.	0.03% 1/3894 • Number of events 1 • Serious Adverse Events were collected throughout the study period (i.e., 6 months). The analysis was done on the safety population.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bone Neoplasm	0.03% 1/3813 • Number of events 1 • Serious Adverse Events were collected throughout the study period (i.e., 6 months). The analysis was done on the safety population.	0.00% 0/3669 • Serious Adverse Events were collected throughout the study period (i.e., 6 months). The analysis was done on the safety population.	0.00% 0/3894 • Serious Adverse Events were collected throughout the study period (i.e., 6 months). The analysis was done on the safety population.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Breast Cancer	0.00% 0/3813 • Serious Adverse Events were collected throughout the study period (i.e., 6 months). The analysis was done on the safety population.	0.00% 0/3669 • Serious Adverse Events were collected throughout the study period (i.e., 6 months). The analysis was done on the safety population.	0.03% 1/3894 • Number of events 1 • Serious Adverse Events were collected throughout the study period (i.e., 6 months). The analysis was done on the safety population.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Carcinoid Tumour	0.00% 0/3813 • Serious Adverse Events were collected throughout the study period (i.e., 6 months). The analysis was done on the safety population.	0.00% 0/3669 • Serious Adverse Events were collected throughout the study period (i.e., 6 months). The analysis was done on the safety population.	0.03% 1/3894 • Number of events 1 • Serious Adverse Events were collected throughout the study period (i.e., 6 months). The analysis was done on the safety population.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Leiomyosarcoma	0.00% 0/3813 • Serious Adverse Events were collected throughout the study period (i.e., 6 months). The analysis was done on the safety population.	0.00% 0/3669 • Serious Adverse Events were collected throughout the study period (i.e., 6 months). The analysis was done on the safety population.	0.03% 1/3894 • Number of events 1 • Serious Adverse Events were collected throughout the study period (i.e., 6 months). The analysis was done on the safety population.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Ovarian Cancer	0.00% 0/3813 • Serious Adverse Events were collected throughout the study period (i.e., 6 months). The analysis was done on the safety population.	0.03% 1/3669 • Number of events 1 • Serious Adverse Events were collected throughout the study period (i.e., 6 months). The analysis was done on the safety population.	0.00% 0/3894 • Serious Adverse Events were collected throughout the study period (i.e., 6 months). The analysis was done on the safety population.
Nervous system disorders Cerebral Haemorrhage	0.00% 0/3813 • Serious Adverse Events were collected throughout the study period (i.e., 6 months). The analysis was done on the safety population.	0.00% 0/3669 • Serious Adverse Events were collected throughout the study period (i.e., 6 months). The analysis was done on the safety population.	0.03% 1/3894 • Number of events 1 • Serious Adverse Events were collected throughout the study period (i.e., 6 months). The analysis was done on the safety population.
Nervous system disorders Epilepsy	0.00% 0/3813 • Serious Adverse Events were collected throughout the study period (i.e., 6 months). The analysis was done on the safety population.	0.03% 1/3669 • Number of events 1 • Serious Adverse Events were collected throughout the study period (i.e., 6 months). The analysis was done on the safety population.	0.00% 0/3894 • Serious Adverse Events were collected throughout the study period (i.e., 6 months). The analysis was done on the safety population.
Nervous system disorders Headache	0.00% 0/3813 • Serious Adverse Events were collected throughout the study period (i.e., 6 months). The analysis was done on the safety population.	0.00% 0/3669 • Serious Adverse Events were collected throughout the study period (i.e., 6 months). The analysis was done on the safety population.	0.03% 1/3894 • Number of events 1 • Serious Adverse Events were collected throughout the study period (i.e., 6 months). The analysis was done on the safety population.
Nervous system disorders Loss of Consciousness	0.03% 1/3813 • Number of events 1 • Serious Adverse Events were collected throughout the study period (i.e., 6 months). The analysis was done on the safety population.	0.00% 0/3669 • Serious Adverse Events were collected throughout the study period (i.e., 6 months). The analysis was done on the safety population.	0.00% 0/3894 • Serious Adverse Events were collected throughout the study period (i.e., 6 months). The analysis was done on the safety population.
Nervous system disorders Migraine	0.03% 1/3813 • Number of events 1 • Serious Adverse Events were collected throughout the study period (i.e., 6 months). The analysis was done on the safety population.	0.00% 0/3669 • Serious Adverse Events were collected throughout the study period (i.e., 6 months). The analysis was done on the safety population.	0.03% 1/3894 • Number of events 1 • Serious Adverse Events were collected throughout the study period (i.e., 6 months). The analysis was done on the safety population.
Nervous system disorders Syncope	0.03% 1/3813 • Number of events 1 • Serious Adverse Events were collected throughout the study period (i.e., 6 months). The analysis was done on the safety population.	0.00% 0/3669 • Serious Adverse Events were collected throughout the study period (i.e., 6 months). The analysis was done on the safety population.	0.00% 0/3894 • Serious Adverse Events were collected throughout the study period (i.e., 6 months). The analysis was done on the safety population.
Nervous system disorders Tethered Cord Syndrome	0.00% 0/3813 • Serious Adverse Events were collected throughout the study period (i.e., 6 months). The analysis was done on the safety population.	0.00% 0/3669 • Serious Adverse Events were collected throughout the study period (i.e., 6 months). The analysis was done on the safety population.	0.03% 1/3894 • Number of events 1 • Serious Adverse Events were collected throughout the study period (i.e., 6 months). The analysis was done on the safety population.
Pregnancy, puerperium and perinatal conditions Abortion Spontaneous	0.03% 1/3813 • Number of events 1 • Serious Adverse Events were collected throughout the study period (i.e., 6 months). The analysis was done on the safety population.	0.03% 1/3669 • Number of events 1 • Serious Adverse Events were collected throughout the study period (i.e., 6 months). The analysis was done on the safety population.	0.00% 0/3894 • Serious Adverse Events were collected throughout the study period (i.e., 6 months). The analysis was done on the safety population.
Pregnancy, puerperium and perinatal conditions Delivery	0.03% 1/3813 • Number of events 1 • Serious Adverse Events were collected throughout the study period (i.e., 6 months). The analysis was done on the safety population.	0.00% 0/3669 • Serious Adverse Events were collected throughout the study period (i.e., 6 months). The analysis was done on the safety population.	0.00% 0/3894 • Serious Adverse Events were collected throughout the study period (i.e., 6 months). The analysis was done on the safety population.
Pregnancy, puerperium and perinatal conditions Ectopic Pregnancy	0.03% 1/3813 • Number of events 1 • Serious Adverse Events were collected throughout the study period (i.e., 6 months). The analysis was done on the safety population.	0.03% 1/3669 • Number of events 1 • Serious Adverse Events were collected throughout the study period (i.e., 6 months). The analysis was done on the safety population.	0.00% 0/3894 • Serious Adverse Events were collected throughout the study period (i.e., 6 months). The analysis was done on the safety population.
Psychiatric disorders Acute Stress Disorder	0.00% 0/3813 • Serious Adverse Events were collected throughout the study period (i.e., 6 months). The analysis was done on the safety population.	0.03% 1/3669 • Number of events 1 • Serious Adverse Events were collected throughout the study period (i.e., 6 months). The analysis was done on the safety population.	0.00% 0/3894 • Serious Adverse Events were collected throughout the study period (i.e., 6 months). The analysis was done on the safety population.
Psychiatric disorders Anxiety	0.00% 0/3813 • Serious Adverse Events were collected throughout the study period (i.e., 6 months). The analysis was done on the safety population.	0.00% 0/3669 • Serious Adverse Events were collected throughout the study period (i.e., 6 months). The analysis was done on the safety population.	0.03% 1/3894 • Number of events 1 • Serious Adverse Events were collected throughout the study period (i.e., 6 months). The analysis was done on the safety population.
Psychiatric disorders Bipolar Disorder	0.03% 1/3813 • Number of events 1 • Serious Adverse Events were collected throughout the study period (i.e., 6 months). The analysis was done on the safety population.	0.00% 0/3669 • Serious Adverse Events were collected throughout the study period (i.e., 6 months). The analysis was done on the safety population.	0.00% 0/3894 • Serious Adverse Events were collected throughout the study period (i.e., 6 months). The analysis was done on the safety population.
Psychiatric disorders Borderline Personality Disorder	0.00% 0/3813 • Serious Adverse Events were collected throughout the study period (i.e., 6 months). The analysis was done on the safety population.	0.00% 0/3669 • Serious Adverse Events were collected throughout the study period (i.e., 6 months). The analysis was done on the safety population.	0.03% 1/3894 • Number of events 1 • Serious Adverse Events were collected throughout the study period (i.e., 6 months). The analysis was done on the safety population.
Psychiatric disorders Major Depression	0.00% 0/3813 • Serious Adverse Events were collected throughout the study period (i.e., 6 months). The analysis was done on the safety population.	0.03% 1/3669 • Number of events 1 • Serious Adverse Events were collected throughout the study period (i.e., 6 months). The analysis was done on the safety population.	0.00% 0/3894 • Serious Adverse Events were collected throughout the study period (i.e., 6 months). The analysis was done on the safety population.
Psychiatric disorders Psychotic Disorder	0.00% 0/3813 • Serious Adverse Events were collected throughout the study period (i.e., 6 months). The analysis was done on the safety population.	0.03% 1/3669 • Number of events 1 • Serious Adverse Events were collected throughout the study period (i.e., 6 months). The analysis was done on the safety population.	0.00% 0/3894 • Serious Adverse Events were collected throughout the study period (i.e., 6 months). The analysis was done on the safety population.
Renal and urinary disorders Bladder Prolapse	0.00% 0/3813 • Serious Adverse Events were collected throughout the study period (i.e., 6 months). The analysis was done on the safety population.	0.00% 0/3669 • Serious Adverse Events were collected throughout the study period (i.e., 6 months). The analysis was done on the safety population.	0.03% 1/3894 • Number of events 1 • Serious Adverse Events were collected throughout the study period (i.e., 6 months). The analysis was done on the safety population.
Renal and urinary disorders Dysuria	0.00% 0/3813 • Serious Adverse Events were collected throughout the study period (i.e., 6 months). The analysis was done on the safety population.	0.03% 1/3669 • Number of events 1 • Serious Adverse Events were collected throughout the study period (i.e., 6 months). The analysis was done on the safety population.	0.00% 0/3894 • Serious Adverse Events were collected throughout the study period (i.e., 6 months). The analysis was done on the safety population.
Renal and urinary disorders Renal Failure Acute	0.03% 1/3813 • Number of events 1 • Serious Adverse Events were collected throughout the study period (i.e., 6 months). The analysis was done on the safety population.	0.00% 0/3669 • Serious Adverse Events were collected throughout the study period (i.e., 6 months). The analysis was done on the safety population.	0.00% 0/3894 • Serious Adverse Events were collected throughout the study period (i.e., 6 months). The analysis was done on the safety population.
Reproductive system and breast disorders Breast Hyperplasia	0.00% 0/3813 • Serious Adverse Events were collected throughout the study period (i.e., 6 months). The analysis was done on the safety population.	0.00% 0/3669 • Serious Adverse Events were collected throughout the study period (i.e., 6 months). The analysis was done on the safety population.	0.03% 1/3894 • Number of events 1 • Serious Adverse Events were collected throughout the study period (i.e., 6 months). The analysis was done on the safety population.
Reproductive system and breast disorders Dysmenorrhoea	0.00% 0/3813 • Serious Adverse Events were collected throughout the study period (i.e., 6 months). The analysis was done on the safety population.	0.00% 0/3669 • Serious Adverse Events were collected throughout the study period (i.e., 6 months). The analysis was done on the safety population.	0.03% 1/3894 • Number of events 1 • Serious Adverse Events were collected throughout the study period (i.e., 6 months). The analysis was done on the safety population.
Reproductive system and breast disorders Haemorrhagic Ovarian Cyst	0.00% 0/3813 • Serious Adverse Events were collected throughout the study period (i.e., 6 months). The analysis was done on the safety population.	0.05% 2/3669 • Number of events 2 • Serious Adverse Events were collected throughout the study period (i.e., 6 months). The analysis was done on the safety population.	0.00% 0/3894 • Serious Adverse Events were collected throughout the study period (i.e., 6 months). The analysis was done on the safety population.
Reproductive system and breast disorders Menometrorrhagia	0.00% 0/3813 • Serious Adverse Events were collected throughout the study period (i.e., 6 months). The analysis was done on the safety population.	0.00% 0/3669 • Serious Adverse Events were collected throughout the study period (i.e., 6 months). The analysis was done on the safety population.	0.03% 1/3894 • Number of events 1 • Serious Adverse Events were collected throughout the study period (i.e., 6 months). The analysis was done on the safety population.
Reproductive system and breast disorders Pelvic Pain	0.00% 0/3813 • Serious Adverse Events were collected throughout the study period (i.e., 6 months). The analysis was done on the safety population.	0.00% 0/3669 • Serious Adverse Events were collected throughout the study period (i.e., 6 months). The analysis was done on the safety population.	0.03% 1/3894 • Number of events 1 • Serious Adverse Events were collected throughout the study period (i.e., 6 months). The analysis was done on the safety population.
Reproductive system and breast disorders Polycystic Ovaries	0.03% 1/3813 • Number of events 1 • Serious Adverse Events were collected throughout the study period (i.e., 6 months). The analysis was done on the safety population.	0.00% 0/3669 • Serious Adverse Events were collected throughout the study period (i.e., 6 months). The analysis was done on the safety population.	0.00% 0/3894 • Serious Adverse Events were collected throughout the study period (i.e., 6 months). The analysis was done on the safety population.
Reproductive system and breast disorders Uterine Haemorrhage	0.03% 1/3813 • Number of events 1 • Serious Adverse Events were collected throughout the study period (i.e., 6 months). The analysis was done on the safety population.	0.00% 0/3669 • Serious Adverse Events were collected throughout the study period (i.e., 6 months). The analysis was done on the safety population.	0.00% 0/3894 • Serious Adverse Events were collected throughout the study period (i.e., 6 months). The analysis was done on the safety population.
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.03% 1/3813 • Number of events 1 • Serious Adverse Events were collected throughout the study period (i.e., 6 months). The analysis was done on the safety population.	0.00% 0/3669 • Serious Adverse Events were collected throughout the study period (i.e., 6 months). The analysis was done on the safety population.	0.00% 0/3894 • Serious Adverse Events were collected throughout the study period (i.e., 6 months). The analysis was done on the safety population.
Respiratory, thoracic and mediastinal disorders Nasal Septum Deviation	0.03% 1/3813 • Number of events 1 • Serious Adverse Events were collected throughout the study period (i.e., 6 months). The analysis was done on the safety population.	0.05% 2/3669 • Number of events 2 • Serious Adverse Events were collected throughout the study period (i.e., 6 months). The analysis was done on the safety population.	0.00% 0/3894 • Serious Adverse Events were collected throughout the study period (i.e., 6 months). The analysis was done on the safety population.
Respiratory, thoracic and mediastinal disorders Pulmonary Embolism	0.03% 1/3813 • Number of events 1 • Serious Adverse Events were collected throughout the study period (i.e., 6 months). The analysis was done on the safety population.	0.00% 0/3669 • Serious Adverse Events were collected throughout the study period (i.e., 6 months). The analysis was done on the safety population.	0.00% 0/3894 • Serious Adverse Events were collected throughout the study period (i.e., 6 months). The analysis was done on the safety population.
Respiratory, thoracic and mediastinal disorders Tonsillar Hypertrophy	0.03% 1/3813 • Number of events 1 • Serious Adverse Events were collected throughout the study period (i.e., 6 months). The analysis was done on the safety population.	0.00% 0/3669 • Serious Adverse Events were collected throughout the study period (i.e., 6 months). The analysis was done on the safety population.	0.00% 0/3894 • Serious Adverse Events were collected throughout the study period (i.e., 6 months). The analysis was done on the safety population.
Skin and subcutaneous tissue disorders Dermatitis Atopic	0.00% 0/3813 • Serious Adverse Events were collected throughout the study period (i.e., 6 months). The analysis was done on the safety population.	0.00% 0/3669 • Serious Adverse Events were collected throughout the study period (i.e., 6 months). The analysis was done on the safety population.	0.03% 1/3894 • Number of events 1 • Serious Adverse Events were collected throughout the study period (i.e., 6 months). The analysis was done on the safety population.
Social circumstances Homicide	0.00% 0/3813 • Serious Adverse Events were collected throughout the study period (i.e., 6 months). The analysis was done on the safety population.	0.03% 1/3669 • Number of events 1 • Serious Adverse Events were collected throughout the study period (i.e., 6 months). The analysis was done on the safety population.	0.00% 0/3894 • Serious Adverse Events were collected throughout the study period (i.e., 6 months). The analysis was done on the safety population.
Surgical and medical procedures Aortic Valve Replacement	0.03% 1/3813 • Number of events 1 • Serious Adverse Events were collected throughout the study period (i.e., 6 months). The analysis was done on the safety population.	0.00% 0/3669 • Serious Adverse Events were collected throughout the study period (i.e., 6 months). The analysis was done on the safety population.	0.00% 0/3894 • Serious Adverse Events were collected throughout the study period (i.e., 6 months). The analysis was done on the safety population.
Surgical and medical procedures Appendicetomy	0.03% 1/3813 • Number of events 1 • Serious Adverse Events were collected throughout the study period (i.e., 6 months). The analysis was done on the safety population.	0.00% 0/3669 • Serious Adverse Events were collected throughout the study period (i.e., 6 months). The analysis was done on the safety population.	0.03% 1/3894 • Number of events 1 • Serious Adverse Events were collected throughout the study period (i.e., 6 months). The analysis was done on the safety population.
Surgical and medical procedures Knee Operation	0.03% 1/3813 • Number of events 1 • Serious Adverse Events were collected throughout the study period (i.e., 6 months). The analysis was done on the safety population.	0.00% 0/3669 • Serious Adverse Events were collected throughout the study period (i.e., 6 months). The analysis was done on the safety population.	0.00% 0/3894 • Serious Adverse Events were collected throughout the study period (i.e., 6 months). The analysis was done on the safety population.
Surgical and medical procedures Medical Device Removal	0.00% 0/3813 • Serious Adverse Events were collected throughout the study period (i.e., 6 months). The analysis was done on the safety population.	0.03% 1/3669 • Number of events 1 • Serious Adverse Events were collected throughout the study period (i.e., 6 months). The analysis was done on the safety population.	0.00% 0/3894 • Serious Adverse Events were collected throughout the study period (i.e., 6 months). The analysis was done on the safety population.
Surgical and medical procedures Nasal Septal Operation	0.00% 0/3813 • Serious Adverse Events were collected throughout the study period (i.e., 6 months). The analysis was done on the safety population.	0.03% 1/3669 • Number of events 1 • Serious Adverse Events were collected throughout the study period (i.e., 6 months). The analysis was done on the safety population.	0.00% 0/3894 • Serious Adverse Events were collected throughout the study period (i.e., 6 months). The analysis was done on the safety population.
Surgical and medical procedures Rhinoplasty	0.00% 0/3813 • Serious Adverse Events were collected throughout the study period (i.e., 6 months). The analysis was done on the safety population.	0.03% 1/3669 • Number of events 1 • Serious Adverse Events were collected throughout the study period (i.e., 6 months). The analysis was done on the safety population.	0.00% 0/3894 • Serious Adverse Events were collected throughout the study period (i.e., 6 months). The analysis was done on the safety population.
Surgical and medical procedures Tendon Operation	0.03% 1/3813 • Number of events 1 • Serious Adverse Events were collected throughout the study period (i.e., 6 months). The analysis was done on the safety population.	0.00% 0/3669 • Serious Adverse Events were collected throughout the study period (i.e., 6 months). The analysis was done on the safety population.	0.00% 0/3894 • Serious Adverse Events were collected throughout the study period (i.e., 6 months). The analysis was done on the safety population.
Vascular disorders Deep Vein Thrombosis	0.03% 1/3813 • Number of events 1 • Serious Adverse Events were collected throughout the study period (i.e., 6 months). The analysis was done on the safety population.	0.00% 0/3669 • Serious Adverse Events were collected throughout the study period (i.e., 6 months). The analysis was done on the safety population.	0.00% 0/3894 • Serious Adverse Events were collected throughout the study period (i.e., 6 months). The analysis was done on the safety population.
Vascular disorders Hypertension	0.03% 1/3813 • Number of events 1 • Serious Adverse Events were collected throughout the study period (i.e., 6 months). The analysis was done on the safety population.	0.00% 0/3669 • Serious Adverse Events were collected throughout the study period (i.e., 6 months). The analysis was done on the safety population.	0.00% 0/3894 • Serious Adverse Events were collected throughout the study period (i.e., 6 months). The analysis was done on the safety population.
Vascular disorders Thrombophlebitis	0.00% 0/3813 • Serious Adverse Events were collected throughout the study period (i.e., 6 months). The analysis was done on the safety population.	0.03% 1/3669 • Number of events 1 • Serious Adverse Events were collected throughout the study period (i.e., 6 months). The analysis was done on the safety population.	0.00% 0/3894 • Serious Adverse Events were collected throughout the study period (i.e., 6 months). The analysis was done on the safety population.
Vascular disorders Varicose Vein	0.00% 0/3813 • Serious Adverse Events were collected throughout the study period (i.e., 6 months). The analysis was done on the safety population.	0.00% 0/3669 • Serious Adverse Events were collected throughout the study period (i.e., 6 months). The analysis was done on the safety population.	0.03% 1/3894 • Number of events 1 • Serious Adverse Events were collected throughout the study period (i.e., 6 months). The analysis was done on the safety population.

Other adverse events

Measure	CCI Vaccine n=3813 participants at risk One dose of cell culture-derived influenza vaccine.	IVV Vaccine n=3669 participants at risk One dose of the trivalent egg-derived influenza virus vaccine.	Placebo n=3894 participants at risk One dose of phosphate buffered solution (PBS).
General disorders Chills	5.6% 212/3813 • Serious Adverse Events were collected throughout the study period (i.e., 6 months). The analysis was done on the safety population.	5.8% 212/3669 • Serious Adverse Events were collected throughout the study period (i.e., 6 months). The analysis was done on the safety population.	5.8% 225/3894 • Serious Adverse Events were collected throughout the study period (i.e., 6 months). The analysis was done on the safety population.
General disorders Fatigue	10.2% 390/3813 • Serious Adverse Events were collected throughout the study period (i.e., 6 months). The analysis was done on the safety population.	11.0% 404/3669 • Serious Adverse Events were collected throughout the study period (i.e., 6 months). The analysis was done on the safety population.	9.9% 386/3894 • Serious Adverse Events were collected throughout the study period (i.e., 6 months). The analysis was done on the safety population.
General disorders Injection Site Erythema	13.4% 510/3813 • Serious Adverse Events were collected throughout the study period (i.e., 6 months). The analysis was done on the safety population.	13.4% 492/3669 • Serious Adverse Events were collected throughout the study period (i.e., 6 months). The analysis was done on the safety population.	10.0% 391/3894 • Serious Adverse Events were collected throughout the study period (i.e., 6 months). The analysis was done on the safety population.
General disorders Injection Site Induration	6.3% 239/3813 • Serious Adverse Events were collected throughout the study period (i.e., 6 months). The analysis was done on the safety population.	5.6% 207/3669 • Serious Adverse Events were collected throughout the study period (i.e., 6 months). The analysis was done on the safety population.	2.6% 101/3894 • Serious Adverse Events were collected throughout the study period (i.e., 6 months). The analysis was done on the safety population.
General disorders Injection Site Pain	30.4% 1158/3813 • Serious Adverse Events were collected throughout the study period (i.e., 6 months). The analysis was done on the safety population.	24.3% 893/3669 • Serious Adverse Events were collected throughout the study period (i.e., 6 months). The analysis was done on the safety population.	9.6% 375/3894 • Serious Adverse Events were collected throughout the study period (i.e., 6 months). The analysis was done on the safety population.
General disorders Injection Site Swelling	5.7% 218/3813 • Serious Adverse Events were collected throughout the study period (i.e., 6 months). The analysis was done on the safety population.	4.9% 181/3669 • Serious Adverse Events were collected throughout the study period (i.e., 6 months). The analysis was done on the safety population.	2.6% 103/3894 • Serious Adverse Events were collected throughout the study period (i.e., 6 months). The analysis was done on the safety population.
General disorders Malaise	7.6% 290/3813 • Serious Adverse Events were collected throughout the study period (i.e., 6 months). The analysis was done on the safety population.	7.1% 260/3669 • Serious Adverse Events were collected throughout the study period (i.e., 6 months). The analysis was done on the safety population.	6.1% 238/3894 • Serious Adverse Events were collected throughout the study period (i.e., 6 months). The analysis was done on the safety population.
Musculoskeletal and connective tissue disorders Myalgia	11.8% 451/3813 • Serious Adverse Events were collected throughout the study period (i.e., 6 months). The analysis was done on the safety population.	10.1% 369/3669 • Serious Adverse Events were collected throughout the study period (i.e., 6 months). The analysis was done on the safety population.	7.1% 278/3894 • Serious Adverse Events were collected throughout the study period (i.e., 6 months). The analysis was done on the safety population.
Nervous system disorders Headache	15.0% 571/3813 • Serious Adverse Events were collected throughout the study period (i.e., 6 months). The analysis was done on the safety population.	15.1% 554/3669 • Serious Adverse Events were collected throughout the study period (i.e., 6 months). The analysis was done on the safety population.	15.3% 597/3894 • Serious Adverse Events were collected throughout the study period (i.e., 6 months). The analysis was done on the safety population.

Additional Information

Posting Director

Novartis Vaccines and Diagnostics

Email: RegistryContactVaccinesUS@novartis.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place