Trial Outcomes & Findings for A Study to Evaluate the Safety and Immunogenicity of IVX-A12 in Participants of 60 to 85 Years of Age (NCT NCT05903183)
NCT ID: NCT05903183
Last Updated: 2025-12-05
Results Overview
Solicited local ARs include pain, tenderness, erythema, and swelling. Solicited systemic ARs include headache, chills, fatigue, myalgia, arthralgia, vomiting, diarrhea, and fever.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
264 participants
Primary outcome timeframe
From Day 0 to Day 6
Results posted on
2025-12-05
Participant Flow
Participants were recruited at 10 investigative sites in the United States.
A total 264 participants were enrolled and randomized to receive vaccinations in this study. The study has a Main Trial part and Observation Extension Trial part.
Participant milestones
| Measure |
Main Trial Part: IVX-A12 150 mcg
Participants received a single dose of 150 mcg IVX-A12, IM injection on Day 1.
|
Main Trial Part: IVX-A12 150 mcg With MF59
Participants received a single dose of 150 mcg IVX-A12 adjuvanted with MF59, IM injection on Day 1.
|
Main Trial Part: Placebo
Participants received matching placebo on Day 1.
|
Observational Extension Part: IVX-A12 150 mcg
Participants who received a single dose of 150 mcg IVX-A12, IM injection on Day 1 in Main Trial part were enrolled and observed in Extension part.
|
Observational Extension Part: Placebo
Participants who received matching placebo on Day 1 in Main Trial part were enrolled and observed in Extension part.
|
|---|---|---|---|---|---|
|
Main Trial Part (365 Days)
STARTED
|
102
|
109
|
53
|
0
|
0
|
|
Main Trial Part (365 Days)
Safety Set
|
103
|
108
|
53
|
0
|
0
|
|
Main Trial Part (365 Days)
COMPLETED
|
99
|
107
|
51
|
0
|
0
|
|
Main Trial Part (365 Days)
NOT COMPLETED
|
3
|
2
|
2
|
0
|
0
|
|
Observation Extension Part (144 Days)
STARTED
|
0
|
0
|
0
|
35
|
20
|
|
Observation Extension Part (144 Days)
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
|
Observation Extension Part (144 Days)
NOT COMPLETED
|
0
|
0
|
0
|
35
|
20
|
Reasons for withdrawal
| Measure |
Main Trial Part: IVX-A12 150 mcg
Participants received a single dose of 150 mcg IVX-A12, IM injection on Day 1.
|
Main Trial Part: IVX-A12 150 mcg With MF59
Participants received a single dose of 150 mcg IVX-A12 adjuvanted with MF59, IM injection on Day 1.
|
Main Trial Part: Placebo
Participants received matching placebo on Day 1.
|
Observational Extension Part: IVX-A12 150 mcg
Participants who received a single dose of 150 mcg IVX-A12, IM injection on Day 1 in Main Trial part were enrolled and observed in Extension part.
|
Observational Extension Part: Placebo
Participants who received matching placebo on Day 1 in Main Trial part were enrolled and observed in Extension part.
|
|---|---|---|---|---|---|
|
Main Trial Part (365 Days)
Death
|
1
|
0
|
0
|
0
|
0
|
|
Main Trial Part (365 Days)
Other
|
1
|
2
|
1
|
0
|
0
|
|
Main Trial Part (365 Days)
Lost to Follow-up
|
0
|
0
|
1
|
0
|
0
|
|
Main Trial Part (365 Days)
Withdrawal by Subject
|
1
|
0
|
0
|
0
|
0
|
|
Observation Extension Part (144 Days)
Sponsor's decision
|
0
|
0
|
0
|
35
|
20
|
Baseline Characteristics
A Study to Evaluate the Safety and Immunogenicity of IVX-A12 in Participants of 60 to 85 Years of Age
Baseline characteristics by cohort
| Measure |
Main Trial Part: IVX-A12 150 mcg
n=102 Participants
Participants received a single dose of 150 mcg IVX-A12, IM injection on Day 1.
|
Main Trial Part: IVX-A12 150 mcg With MF59
n=109 Participants
Participants received a single dose of 150 mcg IVX-A12 adjuvanted with MF59, IM injection on Day 1.
|
Main Trial Part: Placebo
n=53 Participants
Participants received matching placebo on Day 1.
|
Total
n=264 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
69.2 years
STANDARD_DEVIATION 6.05 • n=37 Participants
|
69.3 years
STANDARD_DEVIATION 5.83 • n=37 Participants
|
68.8 years
STANDARD_DEVIATION 5.79 • n=74 Participants
|
69.2 years
STANDARD_DEVIATION 5.89 • n=267 Participants
|
|
Sex: Female, Male
Female
|
55 Participants
n=37 Participants
|
65 Participants
n=37 Participants
|
32 Participants
n=74 Participants
|
152 Participants
n=267 Participants
|
|
Sex: Female, Male
Male
|
47 Participants
n=37 Participants
|
44 Participants
n=37 Participants
|
21 Participants
n=74 Participants
|
112 Participants
n=267 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
19 Participants
n=37 Participants
|
23 Participants
n=37 Participants
|
7 Participants
n=74 Participants
|
49 Participants
n=267 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
82 Participants
n=37 Participants
|
84 Participants
n=37 Participants
|
46 Participants
n=74 Participants
|
212 Participants
n=267 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=37 Participants
|
2 Participants
n=37 Participants
|
0 Participants
n=74 Participants
|
3 Participants
n=267 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=37 Participants
|
0 Participants
n=37 Participants
|
0 Participants
n=74 Participants
|
0 Participants
n=267 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=37 Participants
|
0 Participants
n=37 Participants
|
0 Participants
n=74 Participants
|
0 Participants
n=267 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=37 Participants
|
1 Participants
n=37 Participants
|
0 Participants
n=74 Participants
|
1 Participants
n=267 Participants
|
|
Race (NIH/OMB)
Black or African American
|
12 Participants
n=37 Participants
|
14 Participants
n=37 Participants
|
5 Participants
n=74 Participants
|
31 Participants
n=267 Participants
|
|
Race (NIH/OMB)
White
|
88 Participants
n=37 Participants
|
94 Participants
n=37 Participants
|
48 Participants
n=74 Participants
|
230 Participants
n=267 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=37 Participants
|
0 Participants
n=37 Participants
|
0 Participants
n=74 Participants
|
0 Participants
n=267 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=37 Participants
|
0 Participants
n=37 Participants
|
0 Participants
n=74 Participants
|
2 Participants
n=267 Participants
|
PRIMARY outcome
Timeframe: From Day 0 to Day 6Population: The Safety Set includes all participants who received any amount of IVX-A12 or placebo.
Solicited local ARs include pain, tenderness, erythema, and swelling. Solicited systemic ARs include headache, chills, fatigue, myalgia, arthralgia, vomiting, diarrhea, and fever.
Outcome measures
| Measure |
Main Trial Part: IVX-A12 150 mcg With MF59
n=108 Participants
Participants received a single dose of 150 mcg IVX-A12 adjuvanted with MF59, IM injection on Day 1.
|
Main Trial Part: Placebo
n=53 Participants
Participants received matching placebo on Day 1.
|
Main Trial Part: IVX-A12 150 mcg
n=103 Participants
Participants received a single dose of 150 mcg IVX-A12, IM injection on Day 1.
|
|---|---|---|---|
|
Number of Participants With Solicited Local Adverse Reactions (ARs) and Systemic ARs
Solicited Local Adverse Reactions
|
68 Participants
|
5 Participants
|
46 Participants
|
|
Number of Participants With Solicited Local Adverse Reactions (ARs) and Systemic ARs
Solicited Systemic Adverse Reactions
|
56 Participants
|
19 Participants
|
34 Participants
|
PRIMARY outcome
Timeframe: From Day 0 to Day 28Population: The Safety Set includes all participants who received any amount of IVX-A12 or placebo.
An unsolicited AE is an AE that was not solicited using the post-vaccination diary and that was spontaneously communicated by a participant.
Outcome measures
| Measure |
Main Trial Part: IVX-A12 150 mcg With MF59
n=108 Participants
Participants received a single dose of 150 mcg IVX-A12 adjuvanted with MF59, IM injection on Day 1.
|
Main Trial Part: Placebo
n=53 Participants
Participants received matching placebo on Day 1.
|
Main Trial Part: IVX-A12 150 mcg
n=103 Participants
Participants received a single dose of 150 mcg IVX-A12, IM injection on Day 1.
|
|---|---|---|---|
|
Number of Participants With Unsolicited Adverse Events
|
38 Participants
|
13 Participants
|
33 Participants
|
PRIMARY outcome
Timeframe: At Day 28Population: The PPS includes all participants in the FAS who received a dose of IVX-A12 or placebo and have no major protocol deviations, which may exclude participants from PPS.
Model-adjusted GMT and corresponding 95% CI were derived from an analysis of covariance (ANCOVA) model of log2 titer at Day 28 with independent variables of log2 baseline titer, age group, and treatment group.
Outcome measures
| Measure |
Main Trial Part: IVX-A12 150 mcg With MF59
n=98 Participants
Participants received a single dose of 150 mcg IVX-A12 adjuvanted with MF59, IM injection on Day 1.
|
Main Trial Part: Placebo
n=47 Participants
Participants received matching placebo on Day 1.
|
Main Trial Part: IVX-A12 150 mcg
n=96 Participants
Participants received a single dose of 150 mcg IVX-A12, IM injection on Day 1.
|
|---|---|---|---|
|
Model-adjusted Geometric Mean Titers (GMT) for RSV-A, RSV-B, hMPV-A, and hMPV-B-specific Neutralizing Antibodies (NAb)
RSV-A
|
11167.48 MN50 titer
Interval 9101.24 to 13702.82
|
1944.00 MN50 titer
Interval 1449.07 to 2607.97
|
11980.96 MN50 titer
Interval 9760.34 to 14706.8
|
|
Model-adjusted Geometric Mean Titers (GMT) for RSV-A, RSV-B, hMPV-A, and hMPV-B-specific Neutralizing Antibodies (NAb)
RSV-B
|
6560.64 MN50 titer
Interval 5493.69 to 7834.81
|
2205.65 MN50 titer
Interval 1708.45 to 2847.55
|
7787.22 MN50 titer
Interval 6516.69 to 9305.46
|
|
Model-adjusted Geometric Mean Titers (GMT) for RSV-A, RSV-B, hMPV-A, and hMPV-B-specific Neutralizing Antibodies (NAb)
hMPV-A
|
1416.79 MN50 titer
Interval 1187.96 to 1689.69
|
465.09 MN50 titer
Interval 361.26 to 598.76
|
1643.58 MN50 titer
Interval 1378.03 to 1960.31
|
|
Model-adjusted Geometric Mean Titers (GMT) for RSV-A, RSV-B, hMPV-A, and hMPV-B-specific Neutralizing Antibodies (NAb)
hMPV-B
|
17317.65 MN50 titer
Interval 15103.86 to 19855.92
|
6370.00 MN50 titer
Interval 5230.31 to 7758.03
|
15503.09 MN50 titer
Interval 13515.07 to 17783.54
|
PRIMARY outcome
Timeframe: At Day 28Population: The PPS includes all participants in the FAS who received a dose of IVX-A12 or placebo and have no major protocol deviations, which may exclude participants from PPS.
Model-adjusted GMC and corresponding 95% CI were derived from an analysis of covariance (ANCOVA) model of log2 concentration at Day 28 with independent variables of log2 baseline concentration, age group, and treatment group.
Outcome measures
| Measure |
Main Trial Part: IVX-A12 150 mcg With MF59
n=98 Participants
Participants received a single dose of 150 mcg IVX-A12 adjuvanted with MF59, IM injection on Day 1.
|
Main Trial Part: Placebo
n=47 Participants
Participants received matching placebo on Day 1.
|
Main Trial Part: IVX-A12 150 mcg
n=96 Participants
Participants received a single dose of 150 mcg IVX-A12, IM injection on Day 1.
|
|---|---|---|---|
|
Model-adjusted Geometric Mean Concentrations (GMC) for RSV and hMPV Prefusion F Protein-specific IgG Antibodies (Ab)
RSV
|
1556.06 ELISA units per milliliter (EU/mL)
Interval 1375.49 to 1760.33
|
393.03 ELISA units per milliliter (EU/mL)
Interval 329.37 to 468.99
|
1549.06 ELISA units per milliliter (EU/mL)
Interval 1369.32 to 1752.38
|
|
Model-adjusted Geometric Mean Concentrations (GMC) for RSV and hMPV Prefusion F Protein-specific IgG Antibodies (Ab)
hMPV
|
1856.88 ELISA units per milliliter (EU/mL)
Interval 1614.14 to 2136.12
|
444.74 ELISA units per milliliter (EU/mL)
Interval 363.06 to 544.79
|
1707.15 ELISA units per milliliter (EU/mL)
Interval 1482.99 to 1965.19
|
PRIMARY outcome
Timeframe: From Day 0 (pre-vaccination) up to Day 28 post-vaccinationPopulation: The PPS includes all participants in the FAS who received a dose of IVX-A12 or placebo and have no major protocol deviations, which may exclude participants from PPS.
Proportion of participants with non-missing results at the specified visit achieving a 4-fold or greater increase in NAb titer versus baseline (Day 0).
Outcome measures
| Measure |
Main Trial Part: IVX-A12 150 mcg With MF59
n=98 Participants
Participants received a single dose of 150 mcg IVX-A12 adjuvanted with MF59, IM injection on Day 1.
|
Main Trial Part: Placebo
n=47 Participants
Participants received matching placebo on Day 1.
|
Main Trial Part: IVX-A12 150 mcg
n=96 Participants
Participants received a single dose of 150 mcg IVX-A12, IM injection on Day 1.
|
|---|---|---|---|
|
Percentage of Participants With a >=4-fold Increase in Serum RSV-A, RSV-B, hMPV-A, and hMPV-B-specific NAb Titers
RSV-A: Day 28
|
55.1 percentage of participants
|
0 percentage of participants
|
57.3 percentage of participants
|
|
Percentage of Participants With a >=4-fold Increase in Serum RSV-A, RSV-B, hMPV-A, and hMPV-B-specific NAb Titers
RSV-B: Day 28
|
36.7 percentage of participants
|
2.1 percentage of participants
|
43.8 percentage of participants
|
|
Percentage of Participants With a >=4-fold Increase in Serum RSV-A, RSV-B, hMPV-A, and hMPV-B-specific NAb Titers
hMPV-B: Day 28
|
35.7 percentage of participants
|
0 percentage of participants
|
25.0 percentage of participants
|
|
Percentage of Participants With a >=4-fold Increase in Serum RSV-A, RSV-B, hMPV-A, and hMPV-B-specific NAb Titers
hMPV-A: Day 28
|
28.6 percentage of participants
|
0.0 percentage of participants
|
38.5 percentage of participants
|
PRIMARY outcome
Timeframe: From Day 0 (pre-vaccination) up to Day 28 post-vaccinationPopulation: The PPS includes all participants in the FAS who received a dose of IVX-A12 or placebo and have no major protocol deviations, which may exclude participants from PPS.
Proportion of participants with non-missing results at the specified visit achieving a 4-fold or greater increase in Ab concentration versus baseline (Day 0).
Outcome measures
| Measure |
Main Trial Part: IVX-A12 150 mcg With MF59
n=98 Participants
Participants received a single dose of 150 mcg IVX-A12 adjuvanted with MF59, IM injection on Day 1.
|
Main Trial Part: Placebo
n=47 Participants
Participants received matching placebo on Day 1.
|
Main Trial Part: IVX-A12 150 mcg
n=96 Participants
Participants received a single dose of 150 mcg IVX-A12, IM injection on Day 1.
|
|---|---|---|---|
|
Percentage of Participants With >=4-fold Increase in RSV and hMPV-specific IgG Ab Concentration
RSV: Day 28
|
42.9 percentage of participants
|
0.0 percentage of participants
|
45.8 percentage of participants
|
|
Percentage of Participants With >=4-fold Increase in RSV and hMPV-specific IgG Ab Concentration
hMPV: Day 28
|
52.0 percentage of participants
|
0.0 percentage of participants
|
47.9 percentage of participants
|
PRIMARY outcome
Timeframe: From Day 0 (pre-vaccination) up to Day 28 post-vaccinationPopulation: The PPS includes all participants in the FAS who received a dose of IVX-A12 or placebo and have no major protocol deviations, which may exclude participants from PPS.
GMFR is defined as the geometric mean of the ratio of NAb titer at specified timepoints after vaccination divided by baseline (Day 0) titer.
Outcome measures
| Measure |
Main Trial Part: IVX-A12 150 mcg With MF59
n=98 Participants
Participants received a single dose of 150 mcg IVX-A12 adjuvanted with MF59, IM injection on Day 1.
|
Main Trial Part: Placebo
n=47 Participants
Participants received matching placebo on Day 1.
|
Main Trial Part: IVX-A12 150 mcg
n=96 Participants
Participants received a single dose of 150 mcg IVX-A12, IM injection on Day 1.
|
|---|---|---|---|
|
Geometric Mean Fold Rise (GMFR) in Serum for RSV-A, RSV-B, hMPV-A, and hMPV-B-Specific NAb Titers
RSV-A: Day 28
|
5.07 fold rise
Interval 3.92 to 6.57
|
0.95 fold rise
Interval 0.85 to 1.06
|
5.86 fold rise
Interval 4.59 to 7.48
|
|
Geometric Mean Fold Rise (GMFR) in Serum for RSV-A, RSV-B, hMPV-A, and hMPV-B-Specific NAb Titers
RSV-B: Day 28
|
3.11 fold rise
Interval 2.54 to 3.8
|
1.08 fold rise
Interval 0.87 to 1.34
|
3.67 fold rise
Interval 2.99 to 4.5
|
|
Geometric Mean Fold Rise (GMFR) in Serum for RSV-A, RSV-B, hMPV-A, and hMPV-B-Specific NAb Titers
hMPV-A: Day 28
|
2.486 fold rise
Interval 2.022 to 3.058
|
0.910 fold rise
Interval 0.764 to 1.083
|
3.150 fold rise
Interval 2.544 to 3.9
|
|
Geometric Mean Fold Rise (GMFR) in Serum for RSV-A, RSV-B, hMPV-A, and hMPV-B-Specific NAb Titers
hMPV-B: Day 28
|
2.746 fold rise
Interval 2.254 to 3.346
|
0.936 fold rise
Interval 0.806 to 1.087
|
2.426 fold rise
Interval 2.016 to 2.919
|
PRIMARY outcome
Timeframe: From Day 0 (pre-vaccination) up to Day 28 post-vaccinationPopulation: The PPS includes all participants in the FAS who received a dose of IVX-A12 or placebo and have no major protocol deviations, which may exclude participants from PPS.
GMFR is defined as the geometric mean of the ratio of Ab concentration at specified timepoints after vaccination divided by baseline (Day 0) concentration.
Outcome measures
| Measure |
Main Trial Part: IVX-A12 150 mcg With MF59
n=98 Participants
Participants received a single dose of 150 mcg IVX-A12 adjuvanted with MF59, IM injection on Day 1.
|
Main Trial Part: Placebo
n=47 Participants
Participants received matching placebo on Day 1.
|
Main Trial Part: IVX-A12 150 mcg
n=96 Participants
Participants received a single dose of 150 mcg IVX-A12, IM injection on Day 1.
|
|---|---|---|---|
|
Geometric Mean Fold Rise (GMFR) in Serum for RSV and hMPV Prefusion F Protein-specific IgG Ab Concentrations
RSV: Day 28
|
3.465 fold rise
Interval 2.896 to 4.146
|
0.987 fold rise
Interval 0.917 to 1.063
|
3.858 fold rise
Interval 3.253 to 4.575
|
|
Geometric Mean Fold Rise (GMFR) in Serum for RSV and hMPV Prefusion F Protein-specific IgG Ab Concentrations
hMPV: Day 28
|
4.266 fold rise
Interval 3.561 to 5.111
|
0.896 fold rise
Interval 0.775 to 1.037
|
4.008 fold rise
Interval 3.321 to 4.838
|
SECONDARY outcome
Timeframe: From Day 0 up to the end of study (up to Day 365)Population: The Safety Set includes all participants who received any amount of IVX-A12 or placebo.
An SAE is defined as any untoward medical occurrence that met one or more of the following: resulted in death; was immediately life-threatening; required in-patient hospitalization or prolongation of existing hospitalization; resulted in persistent or significant disability/incapacity; was a congenital anomaly or birth defect in the offspring of a subject; was an important and significant medical event that might have jeopardized the participant or required medical intervention to prevent one of the aforementioned outcomes. Any AESI occurring during the trial will be categorized and reported as an SAE. These AESIs include anaphylaxis, thrombocytopenia, and other potential immune-mediate conditions (including Guillain Barre syndrome). MAAEs are defined as AEs leading to an unscheduled visit to or by a healthcare professional, including visits to an emergency department, but not fulfilling seriousness criteria.
Outcome measures
| Measure |
Main Trial Part: IVX-A12 150 mcg With MF59
n=108 Participants
Participants received a single dose of 150 mcg IVX-A12 adjuvanted with MF59, IM injection on Day 1.
|
Main Trial Part: Placebo
n=53 Participants
Participants received matching placebo on Day 1.
|
Main Trial Part: IVX-A12 150 mcg
n=103 Participants
Participants received a single dose of 150 mcg IVX-A12, IM injection on Day 1.
|
|---|---|---|---|
|
Number of Participants With Serious Adverse Event (SAE), Medically-attended Adverse Events (MAAEs), and AEs Leading to Trial Withdrawal
SAEs
|
3 Participants
|
1 Participants
|
5 Participants
|
|
Number of Participants With Serious Adverse Event (SAE), Medically-attended Adverse Events (MAAEs), and AEs Leading to Trial Withdrawal
MAAEs
|
60 Participants
|
21 Participants
|
54 Participants
|
|
Number of Participants With Serious Adverse Event (SAE), Medically-attended Adverse Events (MAAEs), and AEs Leading to Trial Withdrawal
AE Leading to Study Discontinuation
|
0 Participants
|
0 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: From Day 0 up to Day 365 (end of study)Population: The Safety Set includes all participants who received any amount of IVX-A12 or placebo.
Data is summarized as the number of subjects with at least one LRTI event (mild, moderate, or severe) by treatment group.
Outcome measures
| Measure |
Main Trial Part: IVX-A12 150 mcg With MF59
n=108 Participants
Participants received a single dose of 150 mcg IVX-A12 adjuvanted with MF59, IM injection on Day 1.
|
Main Trial Part: Placebo
n=53 Participants
Participants received matching placebo on Day 1.
|
Main Trial Part: IVX-A12 150 mcg
n=103 Participants
Participants received a single dose of 150 mcg IVX-A12, IM injection on Day 1.
|
|---|---|---|---|
|
Number of Participants With Mild, Moderate, or Severe Lower Respiratory Tract Illness (LRTI) Caused by RSV and/or hMPV
|
2 Participants
|
0 Participants
|
4 Participants
|
SECONDARY outcome
Timeframe: From Day 0 up to Day 365 (end of study)Population: The Safety Set includes all participants who received any amount of IVX-A12 or placebo.
Data is summarized as the number of subjects with at least one LRTI event (mild, moderate, or severe) by treatment group.
Outcome measures
| Measure |
Main Trial Part: IVX-A12 150 mcg With MF59
n=108 Participants
Participants received a single dose of 150 mcg IVX-A12 adjuvanted with MF59, IM injection on Day 1.
|
Main Trial Part: Placebo
n=53 Participants
Participants received matching placebo on Day 1.
|
Main Trial Part: IVX-A12 150 mcg
n=103 Participants
Participants received a single dose of 150 mcg IVX-A12, IM injection on Day 1.
|
|---|---|---|---|
|
Number of Participants With Mild, Moderate, or Severe LRTI Cases Not Caused by RSV or hMPV
|
11 Participants
|
4 Participants
|
14 Participants
|
SECONDARY outcome
Timeframe: At Screening, Days 0, 7 and 28Population: The Safety Set includes all participants who received any amount of IVX-A12 or placebo.
Outcome measures
| Measure |
Main Trial Part: IVX-A12 150 mcg With MF59
n=108 Participants
Participants received a single dose of 150 mcg IVX-A12 adjuvanted with MF59, IM injection on Day 1.
|
Main Trial Part: Placebo
n=53 Participants
Participants received matching placebo on Day 1.
|
Main Trial Part: IVX-A12 150 mcg
n=103 Participants
Participants received a single dose of 150 mcg IVX-A12, IM injection on Day 1.
|
|---|---|---|---|
|
Number of Participants With Clinically Significant Safety Laboratory Parameters
|
0 participants
|
0 participants
|
0 participants
|
SECONDARY outcome
Timeframe: At Days 180 and 365Population: The PPS includes all participants in the FAS who received a dose of IVX-A12 or placebo and have no major protocol deviations, which may exclude participants from PPS. Here 'n' refers to number of participants analyzed at given timepoints.
Model-adjusted GMT and corresponding 95% CI were derived from an analysis of covariance (ANCOVA) model of log2 titer at each post-baseline timepoint with independent variables of log2 baseline titer, age group, and treatment group.
Outcome measures
| Measure |
Main Trial Part: IVX-A12 150 mcg With MF59
n=98 Participants
Participants received a single dose of 150 mcg IVX-A12 adjuvanted with MF59, IM injection on Day 1.
|
Main Trial Part: Placebo
n=47 Participants
Participants received matching placebo on Day 1.
|
Main Trial Part: IVX-A12 150 mcg
n=96 Participants
Participants received a single dose of 150 mcg IVX-A12, IM injection on Day 1.
|
|---|---|---|---|
|
Model-Adjusted GMTs for RSV-A, RSV-B, hMPV-A, and hMPV-B-specific NAb
RSV-A: Day 365
|
3793.79 MN50 titer
Interval 3164.62 to 4548.04
|
1933.12 MN50 titer
Interval 1500.23 to 2490.9
|
4142.06 MN50 titer
Interval 3464.8 to 4951.71
|
|
Model-Adjusted GMTs for RSV-A, RSV-B, hMPV-A, and hMPV-B-specific NAb
RSV-B: Day 180
|
4152.76 MN50 titer
Interval 3516.39 to 4904.29
|
2205.81 MN50 titer
Interval 1744.68 to 2788.83
|
4536.59 MN50 titer
Interval 3856.59 to 5336.5
|
|
Model-Adjusted GMTs for RSV-A, RSV-B, hMPV-A, and hMPV-B-specific NAb
RSV-B: Day 365
|
2640.17 MN50 titer
Interval 2124.78 to 3085.15
|
1640.56 MN50 titer
Interval 1318.92 to 2040.65
|
2690.13 MN50 titer
Interval 2306.79 to 3137.18
|
|
Model-Adjusted GMTs for RSV-A, RSV-B, hMPV-A, and hMPV-B-specific NAb
hMPV-A: Day 180
|
690.94 MN50 titer
Interval 601.39 to 793.83
|
383.31 MN50 titer
Interval 315.11 to 466.27
|
667.67 MN50 titer
Interval 582.87 to 764.8
|
|
Model-Adjusted GMTs for RSV-A, RSV-B, hMPV-A, and hMPV-B-specific NAb
hMPV-A: Day 365
|
535.25 MN50 titer
Interval 460.94 to 621.53
|
421.28 MN50 titer
Interval 341.91 to 519.08
|
589.68 MN50 titer
Interval 508.98 to 683.17
|
|
Model-Adjusted GMTs for RSV-A, RSV-B, hMPV-A, and hMPV-B-specific NAb
hMPV-B: Day 180
|
9482.90 MN50 titer
Interval 8175.75 to 10999.05
|
4243.59 MN50 titer
Interval 3437.19 to 5239.18
|
9709.73 MN50 titer
Interval 8393.5 to 11232.35
|
|
Model-Adjusted GMTs for RSV-A, RSV-B, hMPV-A, and hMPV-B-specific NAb
hMPV-B: Day 365
|
7699.03 MN50 titer
Interval 6574.9 to 9015.36
|
4743.25 MN50 titer
Interval 3800.77 to 5919.44
|
8519.18 MN50 titer
Interval 7290.09 to 9955.49
|
|
Model-Adjusted GMTs for RSV-A, RSV-B, hMPV-A, and hMPV-B-specific NAb
RSV-A: Day 180
|
7145.43 MN50 titer
Interval 5857.89 to 8715.98
|
2741.63 MN50 titer
Interval 2068.75 to 3633.36
|
6864.00 MN50 titer
Interval 5643.98 to 8347.73
|
SECONDARY outcome
Timeframe: At Days 180, and 365Population: The PPS includes all participants in the FAS who received a dose of IVX-A12 or placebo and have no major protocol deviations, which may exclude participants from PPS. Here 'n' refers to number of participants analyzed at given timepoints.
Model-adjusted GMC and corresponding 95% CI were derived from an analysis of covariance (ANCOVA) model of log2 concentration at each post-baseline timepoint with independent variables of log2 baseline concentration, age group, and treatment group.
Outcome measures
| Measure |
Main Trial Part: IVX-A12 150 mcg With MF59
n=98 Participants
Participants received a single dose of 150 mcg IVX-A12 adjuvanted with MF59, IM injection on Day 1.
|
Main Trial Part: Placebo
n=47 Participants
Participants received matching placebo on Day 1.
|
Main Trial Part: IVX-A12 150 mcg
n=96 Participants
Participants received a single dose of 150 mcg IVX-A12, IM injection on Day 1.
|
|---|---|---|---|
|
Model-Adjusted GMCs for RSV and hMPV Prefusion F Protein-specific IgG Ab Concentrations
RSV: Day 180
|
739.32 ELISA units per milliliter (EU/mL)
Interval 646.32 to 845.7
|
313.74 ELISA units per milliliter (EU/mL)
Interval 259.41 to 379.45
|
730.14 ELISA units per milliliter (EU/mL)
Interval 640.2 to 832.72
|
|
Model-Adjusted GMCs for RSV and hMPV Prefusion F Protein-specific IgG Ab Concentrations
RSV: Day 365
|
772.83 ELISA units per milliliter (EU/mL)
Interval 695.2 to 859.12
|
406.42 ELISA units per milliliter (EU/mL)
Interval 350.62 to 471.11
|
781.54 ELISA units per milliliter (EU/mL)
Interval 704.3 to 867.24
|
|
Model-Adjusted GMCs for RSV and hMPV Prefusion F Protein-specific IgG Ab Concentrations
hMPV: Day 365
|
994.03 ELISA units per milliliter (EU/mL)
Interval 886.24 to 1114.94
|
560.77 ELISA units per milliliter (EU/mL)
Interval 476.93 to 659.35
|
1018.26 ELISA units per milliliter (EU/mL)
Interval 909.04 to 1140.59
|
|
Model-Adjusted GMCs for RSV and hMPV Prefusion F Protein-specific IgG Ab Concentrations
hMPV: Day 180
|
937.01 ELISA units per milliliter (EU/mL)
Interval 819.77 to 1071.02
|
386.81 ELISA units per milliliter (EU/mL)
Interval 319.62 to 468.12
|
925.81 ELISA units per milliliter (EU/mL)
Interval 811.73 to 1055.92
|
SECONDARY outcome
Timeframe: From Day 0 (pre-vaccination) up to Day 180 and Day 365 post-vaccinationPopulation: The PPS includes all participants in the FAS who received a dose of IVX-A12 or placebo and have no major protocol deviations, which may exclude participants from PPS. Here 'n' refers to number of participants analyzed at given timepoints.
Proportion of participants with non-missing results at the specified visit achieving a 4-fold or greater increase in NAb titer versus baseline (Day 0).
Outcome measures
| Measure |
Main Trial Part: IVX-A12 150 mcg With MF59
n=98 Participants
Participants received a single dose of 150 mcg IVX-A12 adjuvanted with MF59, IM injection on Day 1.
|
Main Trial Part: Placebo
n=47 Participants
Participants received matching placebo on Day 1.
|
Main Trial Part: IVX-A12 150 mcg
n=96 Participants
Participants received a single dose of 150 mcg IVX-A12, IM injection on Day 1.
|
|---|---|---|---|
|
Percentage of Participants With a >=4-fold Increase in Serum RSV-A, RSV-B, hMPV-A, and hMPV-B-specific NAb Titers
hMPV-B: Day 365
|
3.4 percentage of participants
|
0.0 percentage of participants
|
9.1 percentage of participants
|
|
Percentage of Participants With a >=4-fold Increase in Serum RSV-A, RSV-B, hMPV-A, and hMPV-B-specific NAb Titers
RSV-A: Day 180
|
35.9 percentage of participants
|
6.7 percentage of participants
|
35.9 percentage of participants
|
|
Percentage of Participants With a >=4-fold Increase in Serum RSV-A, RSV-B, hMPV-A, and hMPV-B-specific NAb Titers
RSV-A: Day 365
|
21.6 percentage of participants
|
2.3 percentage of participants
|
18.2 percentage of participants
|
|
Percentage of Participants With a >=4-fold Increase in Serum RSV-A, RSV-B, hMPV-A, and hMPV-B-specific NAb Titers
RSV-B: Day 180
|
18.7 percentage of participants
|
4.4 percentage of participants
|
23.7 percentage of participants
|
|
Percentage of Participants With a >=4-fold Increase in Serum RSV-A, RSV-B, hMPV-A, and hMPV-B-specific NAb Titers
RSV-B: Day 365
|
9.1 percentage of participants
|
2.3 percentage of participants
|
6.8 percentage of participants
|
|
Percentage of Participants With a >=4-fold Increase in Serum RSV-A, RSV-B, hMPV-A, and hMPV-B-specific NAb Titers
hMPV-B: Day 180
|
14.1 percentage of participants
|
0.0 percentage of participants
|
12.9 percentage of participants
|
|
Percentage of Participants With a >=4-fold Increase in Serum RSV-A, RSV-B, hMPV-A, and hMPV-B-specific NAb Titers
hMPV-A: Day 180
|
6.5 percentage of participants
|
0.0 percentage of participants
|
7.5 percentage of participants
|
|
Percentage of Participants With a >=4-fold Increase in Serum RSV-A, RSV-B, hMPV-A, and hMPV-B-specific NAb Titers
hMPV-A: Day 365
|
4.5 percentage of participants
|
2.3 percentage of participants
|
6.8 percentage of participants
|
SECONDARY outcome
Timeframe: From Day 0 (pre-vaccination) up to Days 180, and 365 post-vaccinationPopulation: The PPS includes all participants in the FAS who received a dose of IVX-A12 or placebo and have no major protocol deviations, which may exclude participants from PPS. Here 'n' refers to number of participants analyzed at given timepoints.
Proportion of participants with non-missing results at the specified visit achieving a 4-fold or greater increase in Ab concentration versus baseline (Day 0).
Outcome measures
| Measure |
Main Trial Part: IVX-A12 150 mcg With MF59
n=98 Participants
Participants received a single dose of 150 mcg IVX-A12 adjuvanted with MF59, IM injection on Day 1.
|
Main Trial Part: Placebo
n=47 Participants
Participants received matching placebo on Day 1.
|
Main Trial Part: IVX-A12 150 mcg
n=96 Participants
Participants received a single dose of 150 mcg IVX-A12, IM injection on Day 1.
|
|---|---|---|---|
|
Percentage of Participants With >=4-fold Increase in RSV and hMPV Prefusion F Protein-specific IgG Ab Concentrations
RSV: Day 180
|
12.0 percentage of participants
|
0.0 percentage of participants
|
12.9 percentage of participants
|
|
Percentage of Participants With >=4-fold Increase in RSV and hMPV Prefusion F Protein-specific IgG Ab Concentrations
RSV: Day 365
|
10.2 percentage of participants
|
0.0 percentage of participants
|
8.0 percentage of participants
|
|
Percentage of Participants With >=4-fold Increase in RSV and hMPV Prefusion F Protein-specific IgG Ab Concentrations
hMPV: Day 180
|
19.6 percentage of participants
|
0.0 percentage of participants
|
21.5 percentage of participants
|
|
Percentage of Participants With >=4-fold Increase in RSV and hMPV Prefusion F Protein-specific IgG Ab Concentrations
hMPV: Day 365
|
20.5 percentage of participants
|
0.0 percentage of participants
|
27.3 percentage of participants
|
SECONDARY outcome
Timeframe: From Day 0 (pre-vaccination) up to Days 28, 180, and 365 post-vaccinationPopulation: The PPS includes all participants in the FAS who received a dose of IVX-A12 or placebo and have no major protocol deviations, which may exclude participants from PPS. Here 'n' refers to number of participants analyzed at given timepoints.
Proportion of participants with non-missing results at the specified visit achieving a 8-fold or greater increase in NAb titer versus baseline (Day 0).
Outcome measures
| Measure |
Main Trial Part: IVX-A12 150 mcg With MF59
n=98 Participants
Participants received a single dose of 150 mcg IVX-A12 adjuvanted with MF59, IM injection on Day 1.
|
Main Trial Part: Placebo
n=47 Participants
Participants received matching placebo on Day 1.
|
Main Trial Part: IVX-A12 150 mcg
n=96 Participants
Participants received a single dose of 150 mcg IVX-A12, IM injection on Day 1.
|
|---|---|---|---|
|
Percentage of Participants With a >=8-fold Increase in Serum RSV-A, RSV-B, hMPV-A, and hMPV-B-specific NAb Titers
RSV-A: Day 28
|
38.8 percentage of participants
|
0.0 percentage of participants
|
39.6 percentage of participants
|
|
Percentage of Participants With a >=8-fold Increase in Serum RSV-A, RSV-B, hMPV-A, and hMPV-B-specific NAb Titers
RSV-B: Day 28
|
16.3 percentage of participants
|
2.1 percentage of participants
|
21.9 percentage of participants
|
|
Percentage of Participants With a >=8-fold Increase in Serum RSV-A, RSV-B, hMPV-A, and hMPV-B-specific NAb Titers
RSV-B: Day 180
|
4.4 percentage of participants
|
0.0 percentage of participants
|
7.5 percentage of participants
|
|
Percentage of Participants With a >=8-fold Increase in Serum RSV-A, RSV-B, hMPV-A, and hMPV-B-specific NAb Titers
RSV-B: Day 365
|
3.4 percentage of participants
|
0.0 percentage of participants
|
2.3 percentage of participants
|
|
Percentage of Participants With a >=8-fold Increase in Serum RSV-A, RSV-B, hMPV-A, and hMPV-B-specific NAb Titers
hMPV-A: Day 28
|
15.3 percentage of participants
|
0 percentage of participants
|
13.5 percentage of participants
|
|
Percentage of Participants With a >=8-fold Increase in Serum RSV-A, RSV-B, hMPV-A, and hMPV-B-specific NAb Titers
hMPV-A: Day 180
|
2.2 percentage of participants
|
0 percentage of participants
|
2.2 percentage of participants
|
|
Percentage of Participants With a >=8-fold Increase in Serum RSV-A, RSV-B, hMPV-A, and hMPV-B-specific NAb Titers
hMPV-A: Day 365
|
0 percentage of participants
|
0 percentage of participants
|
1.1 percentage of participants
|
|
Percentage of Participants With a >=8-fold Increase in Serum RSV-A, RSV-B, hMPV-A, and hMPV-B-specific NAb Titers
hMPV-B: Day 28
|
19.4 percentage of participants
|
0 percentage of participants
|
11.5 percentage of participants
|
|
Percentage of Participants With a >=8-fold Increase in Serum RSV-A, RSV-B, hMPV-A, and hMPV-B-specific NAb Titers
hMPV-B: Day 180
|
4.3 percentage of participants
|
0 percentage of participants
|
4.3 percentage of participants
|
|
Percentage of Participants With a >=8-fold Increase in Serum RSV-A, RSV-B, hMPV-A, and hMPV-B-specific NAb Titers
hMPV-B: Day 365
|
2.3 percentage of participants
|
0 percentage of participants
|
1.1 percentage of participants
|
|
Percentage of Participants With a >=8-fold Increase in Serum RSV-A, RSV-B, hMPV-A, and hMPV-B-specific NAb Titers
RSV-A: Day 180
|
20.7 percentage of participants
|
2.2 percentage of participants
|
16.3 percentage of participants
|
|
Percentage of Participants With a >=8-fold Increase in Serum RSV-A, RSV-B, hMPV-A, and hMPV-B-specific NAb Titers
RSV-A: Day 365
|
9.1 percentage of participants
|
0.0 percentage of participants
|
8.0 percentage of participants
|
SECONDARY outcome
Timeframe: From Day 0 (pre-vaccination) up to Day 180 and Day 365 post-vaccinationPopulation: The PPS includes all participants in the FAS who received a dose of IVX-A12 or placebo and have no major protocol deviations, which may exclude participants from PPS. Here 'n' refers to number of participants analyzed at given timepoints.
GMFR is defined as the geometric mean of the ratio of Ab concentration at specified timepoints after vaccination divided by baseline (Day 0) concentration.
Outcome measures
| Measure |
Main Trial Part: IVX-A12 150 mcg With MF59
n=98 Participants
Participants received a single dose of 150 mcg IVX-A12 adjuvanted with MF59, IM injection on Day 1.
|
Main Trial Part: Placebo
n=47 Participants
Participants received matching placebo on Day 1.
|
Main Trial Part: IVX-A12 150 mcg
n=96 Participants
Participants received a single dose of 150 mcg IVX-A12, IM injection on Day 1.
|
|---|---|---|---|
|
GMFR in Serum for RSV-A, RSV-B, hMPV-A, and hMPV-B-specific NAb Titers and RSV and hMPV Prefusion F Protein-specific IgG Ab Concentrations
RSV-A: Day 180
|
3.18 fold rise
Interval 2.44 to 4.15
|
1.34 fold rise
Interval 1.09 to 1.65
|
3.21 fold rise
Interval 2.66 to 3.88
|
|
GMFR in Serum for RSV-A, RSV-B, hMPV-A, and hMPV-B-specific NAb Titers and RSV and hMPV Prefusion F Protein-specific IgG Ab Concentrations
RSV-A: Day 365
|
1.68 fold rise
Interval 1.33 to 2.13
|
0.94 fold rise
Interval 0.78 to 1.13
|
1.97 fold rise
Interval 1.63 to 2.39
|
|
GMFR in Serum for RSV-A, RSV-B, hMPV-A, and hMPV-B-specific NAb Titers and RSV and hMPV Prefusion F Protein-specific IgG Ab Concentrations
RSV-B: Day 180
|
1.88 fold rise
Interval 1.55 to 2.29
|
1.02 fold rise
Interval 0.8 to 1.29
|
2.02 fold rise
Interval 1.67 to 2.45
|
|
GMFR in Serum for RSV-A, RSV-B, hMPV-A, and hMPV-B-specific NAb Titers and RSV and hMPV Prefusion F Protein-specific IgG Ab Concentrations
RSV-B: Day 365
|
1.20 fold rise
Interval 0.99 to 1.45
|
0.76 fold rise
Interval 0.61 to 0.94
|
1.23 fold rise
Interval 1.02 to 1.47
|
|
GMFR in Serum for RSV-A, RSV-B, hMPV-A, and hMPV-B-specific NAb Titers and RSV and hMPV Prefusion F Protein-specific IgG Ab Concentrations
hMPV-A: Day 180
|
1.115 fold rise
Interval 0.909 to 1.367
|
0.736 fold rise
Interval 0.562 to 0.962
|
1.285 fold rise
Interval 1.079 to 1.53
|
|
GMFR in Serum for RSV-A, RSV-B, hMPV-A, and hMPV-B-specific NAb Titers and RSV and hMPV Prefusion F Protein-specific IgG Ab Concentrations
hMPV-A: Day 365
|
0.866 fold rise
Interval 0.706 to 1.063
|
0.793 fold rise
Interval 0.606 to 1.037
|
1.094 fold rise
Interval 0.914 to 1.31
|
|
GMFR in Serum for RSV-A, RSV-B, hMPV-A, and hMPV-B-specific NAb Titers and RSV and hMPV Prefusion F Protein-specific IgG Ab Concentrations
hMPV-B: Day 180
|
1.456 fold rise
Interval 1.21 to 1.753
|
0.622 fold rise
Interval 0.5 to 0.773
|
1.482 fold rise
Interval 1.258 to 1.747
|
|
GMFR in Serum for RSV-A, RSV-B, hMPV-A, and hMPV-B-specific NAb Titers and RSV and hMPV Prefusion F Protein-specific IgG Ab Concentrations
hMPV-B: Day 365
|
1.153 fold rise
Interval 0.961 to 1.384
|
0.681 fold rise
Interval 0.551 to 0.841
|
1.262 fold rise
Interval 1.056 to 1.509
|
|
GMFR in Serum for RSV-A, RSV-B, hMPV-A, and hMPV-B-specific NAb Titers and RSV and hMPV Prefusion F Protein-specific IgG Ab Concentrations
RSV Pre-F: Day 180
|
1.638 fold rise
Interval 1.38 to 1.945
|
0.774 fold rise
Interval 0.665 to 0.901
|
1.728 fold rise
Interval 1.487 to 2.007
|
|
GMFR in Serum for RSV-A, RSV-B, hMPV-A, and hMPV-B-specific NAb Titers and RSV and hMPV Prefusion F Protein-specific IgG Ab Concentrations
RSV Pre-F: Day 365
|
1.687 fold rise
Interval 1.457 to 1.952
|
0.973 fold rise
Interval 0.874 to 1.084
|
1.844 fold rise
Interval 1.631 to 2.084
|
|
GMFR in Serum for RSV-A, RSV-B, hMPV-A, and hMPV-B-specific NAb Titers and RSV and hMPV Prefusion F Protein-specific IgG Ab Concentrations
hMPV Pre-F: Day 180
|
2.118 fold rise
Interval 1.786 to 2.512
|
0.794 fold rise
Interval 0.691 to 0.912
|
2.157 fold rise
Interval 1.822 to 2.553
|
|
GMFR in Serum for RSV-A, RSV-B, hMPV-A, and hMPV-B-specific NAb Titers and RSV and hMPV Prefusion F Protein-specific IgG Ab Concentrations
hMPV Pre-F: Day 365
|
2.293 fold rise
Interval 1.989 to 2.644
|
1.149 fold rise
Interval 0.986 to 1.339
|
2.380 fold rise
Interval 2.029 to 2.792
|
SECONDARY outcome
Timeframe: At Days 28, 180, and 365 post-vaccinationPopulation: The PPS includes all participants in the FAS who received a dose of IVX-A12 or placebo and have no major protocol deviations, which may exclude participants from PPS. Here 'n' refers to number of participants analyzed at given timepoints.
The median, as well as 25th and 75th percentiles of serum NAb titers and IgG Ab concentrations are summarized at specified timepoints.
Outcome measures
| Measure |
Main Trial Part: IVX-A12 150 mcg With MF59
n=98 Participants
Participants received a single dose of 150 mcg IVX-A12 adjuvanted with MF59, IM injection on Day 1.
|
Main Trial Part: Placebo
n=47 Participants
Participants received matching placebo on Day 1.
|
Main Trial Part: IVX-A12 150 mcg
n=96 Participants
Participants received a single dose of 150 mcg IVX-A12, IM injection on Day 1.
|
|---|---|---|---|
|
Reverse Cumulative Distribution (RCD) Curve of Serum NAb Titers and IgG Ab Concentrations
RSV-A: Day 0
|
2068.22 MN50 titer
Interval 984.3 to 4601.8
|
1764.10 MN50 titer
Interval 765.6 to 4136.5
|
1779.18 MN50 titer
Interval 894.07 to 3661.52
|
|
Reverse Cumulative Distribution (RCD) Curve of Serum NAb Titers and IgG Ab Concentrations
RSV-A: Day 28
|
10806.21 MN50 titer
Interval 4939.5 to 25893.8
|
1943.00 MN50 titer
Interval 772.8 to 3576.8
|
12010.69 MN50 titer
Interval 4870.35 to 23207.12
|
|
Reverse Cumulative Distribution (RCD) Curve of Serum NAb Titers and IgG Ab Concentrations
RSV-A: Day 180
|
6244.78 MN50 titer
Interval 3200.74 to 14601.61
|
2601.00 MN50 titer
Interval 861.1 to 5542.7
|
6393.44 MN50 titer
Interval 3098.72 to 11645.52
|
|
Reverse Cumulative Distribution (RCD) Curve of Serum NAb Titers and IgG Ab Concentrations
RSV-A: Day 365
|
3630.01 MN50 titer
Interval 1828.4 to 8923.32
|
1769.58 MN50 titer
Interval 852.51 to 3427.73
|
3793.15 MN50 titer
Interval 1869.68 to 6393.49
|
|
Reverse Cumulative Distribution (RCD) Curve of Serum NAb Titers and IgG Ab Concentrations
RSV-B: Day 0
|
2046.80 MN50 titer
Interval 1068.3 to 4611.8
|
1722.20 MN50 titer
Interval 814.4 to 4421.9
|
1965.30 MN50 titer
Interval 974.83 to 4937.85
|
|
Reverse Cumulative Distribution (RCD) Curve of Serum NAb Titers and IgG Ab Concentrations
RSV-B: Day 28
|
6491.77 MN50 titer
Interval 2957.7 to 13097.1
|
1757.20 MN50 titer
Interval 888.6 to 4941.8
|
6945.86 MN50 titer
Interval 3691.86 to 17581.86
|
|
Reverse Cumulative Distribution (RCD) Curve of Serum NAb Titers and IgG Ab Concentrations
RSV-B: Day 180
|
3427.10 MN50 titer
Interval 1924.6 to 7152.4
|
2192.40 MN50 titer
Interval 971.1 to 4308.0
|
4226.30 MN50 titer
Interval 2123.4 to 10341.4
|
|
Reverse Cumulative Distribution (RCD) Curve of Serum NAb Titers and IgG Ab Concentrations
RSV-B: Day 365
|
2191.31 MN50 titer
Interval 1365.43 to 5447.75
|
1416.93 MN50 titer
Interval 641.92 to 2867.91
|
2606.69 MN50 titer
Interval 1451.24 to 5158.12
|
|
Reverse Cumulative Distribution (RCD) Curve of Serum NAb Titers and IgG Ab Concentrations
hMPV-A: Day 0
|
538.90 MN50 titer
Interval 313.3 to 1068.7
|
360.50 MN50 titer
Interval 221.4 to 842.0
|
415.73 MN50 titer
Interval 264.05 to 816.11
|
|
Reverse Cumulative Distribution (RCD) Curve of Serum NAb Titers and IgG Ab Concentrations
hMPV-A: Day 28
|
2.223 MN50 titer
Interval 1.303 to 4.294
|
0.999 MN50 titer
Interval 0.643 to 1.306
|
3.145 MN50 titer
Interval 1.479 to 5.837
|
|
Reverse Cumulative Distribution (RCD) Curve of Serum NAb Titers and IgG Ab Concentrations
hMPV-A: Day 180
|
716.65 MN50 titer
Interval 450.9 to 1159.94
|
320.50 MN50 titer
Interval 220.7 to 677.8
|
636.90 MN50 titer
Interval 360.3 to 995.4
|
|
Reverse Cumulative Distribution (RCD) Curve of Serum NAb Titers and IgG Ab Concentrations
hMPV-A: Day 365
|
514.09 MN50 titer
Interval 299.03 to 919.9
|
313.65 MN50 titer
Interval 225.71 to 736.6
|
518.85 MN50 titer
Interval 312.16 to 810.61
|
|
Reverse Cumulative Distribution (RCD) Curve of Serum NAb Titers and IgG Ab Concentrations
RSV Pre F: Day 0
|
432.69 MN50 titer
Interval 257.7 to 802.6
|
489.60 MN50 titer
Interval 184.5 to 662.6
|
359.94 MN50 titer
Interval 222.96 to 694.54
|
|
Reverse Cumulative Distribution (RCD) Curve of Serum NAb Titers and IgG Ab Concentrations
RSV Pre F: Day 28
|
1574.69 MN50 titer
Interval 1095.8 to 2313.4
|
439.00 MN50 titer
Interval 191.8 to 675.9
|
1544.51 MN50 titer
Interval 1008.49 to 2328.19
|
|
Reverse Cumulative Distribution (RCD) Curve of Serum NAb Titers and IgG Ab Concentrations
RSV Pre F: Day 180
|
774.70 MN50 titer
Interval 499.56 to 1176.65
|
308.60 MN50 titer
Interval 133.0 to 628.5
|
653.30 MN50 titer
Interval 437.5 to 1142.2
|
|
Reverse Cumulative Distribution (RCD) Curve of Serum NAb Titers and IgG Ab Concentrations
RSV Pre F: Day 365
|
879.79 MN50 titer
Interval 521.74 to 1355.85
|
483.45 MN50 titer
Interval 210.38 to 730.11
|
691.49 MN50 titer
Interval 499.49 to 1105.17
|
|
Reverse Cumulative Distribution (RCD) Curve of Serum NAb Titers and IgG Ab Concentrations
hMPV Pre F: Day 0
|
524.42 MN50 titer
Interval 246.2 to 757.9
|
531.20 MN50 titer
Interval 273.2 to 855.4
|
410.74 MN50 titer
Interval 226.27 to 726.27
|
|
Reverse Cumulative Distribution (RCD) Curve of Serum NAb Titers and IgG Ab Concentrations
hMPV Pre F: Day 28
|
1757.83 MN50 titer
Interval 1275.9 to 2744.1
|
444.00 MN50 titer
Interval 254.4 to 851.9
|
1857.88 MN50 titer
Interval 986.18 to 2815.41
|
|
Reverse Cumulative Distribution (RCD) Curve of Serum NAb Titers and IgG Ab Concentrations
hMPV Pre F: Day 180
|
920.64 MN50 titer
Interval 520.62 to 1585.77
|
383.20 MN50 titer
Interval 251.4 to 672.3
|
959.30 MN50 titer
Interval 585.4 to 1548.4
|
|
Reverse Cumulative Distribution (RCD) Curve of Serum NAb Titers and IgG Ab Concentrations
hMPV Pre F: Day 365
|
989.21 MN50 titer
Interval 684.24 to 1632.1
|
621.84 MN50 titer
Interval 363.65 to 950.72
|
967.80 MN50 titer
Interval 664.7 to 1543.22
|
Adverse Events
Main Trial Part: IVX-A12 150 mcg
Serious events: 5 serious events
Other events: 75 other events
Deaths: 1 deaths
Main Trial Part: IVX-A12 150 mcg With MF59
Serious events: 3 serious events
Other events: 81 other events
Deaths: 0 deaths
Main Trial Part: Placebo
Serious events: 1 serious events
Other events: 42 other events
Deaths: 0 deaths
Observational Extension Part: IVX-A12 150 mcg
Serious events: 1 serious events
Other events: 3 other events
Deaths: 0 deaths
Observational Extension Part: Placebo
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Main Trial Part: IVX-A12 150 mcg
n=103 participants at risk
Participants received a single dose of 150 mcg IVX-A12, IM injection on Day 1.
|
Main Trial Part: IVX-A12 150 mcg With MF59
n=108 participants at risk
Participants received a single dose of 150 mcg IVX-A12 adjuvanted with MF59, IM injection on Day 1.
|
Main Trial Part: Placebo
n=53 participants at risk
Participants received matching placebo on Day 1.
|
Observational Extension Part: IVX-A12 150 mcg
n=35 participants at risk
Participants who received a single dose of 150 mcg IVX-A12, IM injection on Day 1 in Main Trial part were enrolled and observed in Extension part.
|
Observational Extension Part: Placebo
n=20 participants at risk
Participants who received matching placebo on Day 1 in Main Trial part were enrolled and observed in Extension part.
|
|---|---|---|---|---|---|
|
Infections and infestations
Abscess limb
|
0.00%
0/103 • From study start to end of observational extension part (up to Day 509)
|
0.93%
1/108 • From study start to end of observational extension part (up to Day 509)
|
0.00%
0/53 • From study start to end of observational extension part (up to Day 509)
|
0.00%
0/35 • From study start to end of observational extension part (up to Day 509)
|
0.00%
0/20 • From study start to end of observational extension part (up to Day 509)
|
|
Infections and infestations
Pneumonia
|
0.00%
0/103 • From study start to end of observational extension part (up to Day 509)
|
0.93%
1/108 • From study start to end of observational extension part (up to Day 509)
|
0.00%
0/53 • From study start to end of observational extension part (up to Day 509)
|
0.00%
0/35 • From study start to end of observational extension part (up to Day 509)
|
0.00%
0/20 • From study start to end of observational extension part (up to Day 509)
|
|
Infections and infestations
Pneumonia staphylococcal
|
0.00%
0/103 • From study start to end of observational extension part (up to Day 509)
|
0.93%
1/108 • From study start to end of observational extension part (up to Day 509)
|
0.00%
0/53 • From study start to end of observational extension part (up to Day 509)
|
0.00%
0/35 • From study start to end of observational extension part (up to Day 509)
|
0.00%
0/20 • From study start to end of observational extension part (up to Day 509)
|
|
Infections and infestations
Pneumonia viral
|
0.97%
1/103 • From study start to end of observational extension part (up to Day 509)
|
0.00%
0/108 • From study start to end of observational extension part (up to Day 509)
|
0.00%
0/53 • From study start to end of observational extension part (up to Day 509)
|
0.00%
0/35 • From study start to end of observational extension part (up to Day 509)
|
0.00%
0/20 • From study start to end of observational extension part (up to Day 509)
|
|
Infections and infestations
Pyelonephritis
|
0.97%
1/103 • From study start to end of observational extension part (up to Day 509)
|
0.00%
0/108 • From study start to end of observational extension part (up to Day 509)
|
0.00%
0/53 • From study start to end of observational extension part (up to Day 509)
|
0.00%
0/35 • From study start to end of observational extension part (up to Day 509)
|
0.00%
0/20 • From study start to end of observational extension part (up to Day 509)
|
|
Nervous system disorders
Cerebellar stroke
|
0.00%
0/103 • From study start to end of observational extension part (up to Day 509)
|
0.93%
1/108 • From study start to end of observational extension part (up to Day 509)
|
0.00%
0/53 • From study start to end of observational extension part (up to Day 509)
|
0.00%
0/35 • From study start to end of observational extension part (up to Day 509)
|
0.00%
0/20 • From study start to end of observational extension part (up to Day 509)
|
|
Nervous system disorders
Seizure
|
0.00%
0/103 • From study start to end of observational extension part (up to Day 509)
|
0.00%
0/108 • From study start to end of observational extension part (up to Day 509)
|
1.9%
1/53 • From study start to end of observational extension part (up to Day 509)
|
0.00%
0/35 • From study start to end of observational extension part (up to Day 509)
|
0.00%
0/20 • From study start to end of observational extension part (up to Day 509)
|
|
Vascular disorders
Deep vein thrombosis
|
1.9%
2/103 • From study start to end of observational extension part (up to Day 509)
|
0.00%
0/108 • From study start to end of observational extension part (up to Day 509)
|
0.00%
0/53 • From study start to end of observational extension part (up to Day 509)
|
2.9%
1/35 • From study start to end of observational extension part (up to Day 509)
|
0.00%
0/20 • From study start to end of observational extension part (up to Day 509)
|
|
General disorders
Sudden death
|
0.97%
1/103 • From study start to end of observational extension part (up to Day 509)
|
0.00%
0/108 • From study start to end of observational extension part (up to Day 509)
|
0.00%
0/53 • From study start to end of observational extension part (up to Day 509)
|
0.00%
0/35 • From study start to end of observational extension part (up to Day 509)
|
0.00%
0/20 • From study start to end of observational extension part (up to Day 509)
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
0.97%
1/103 • From study start to end of observational extension part (up to Day 509)
|
0.00%
0/108 • From study start to end of observational extension part (up to Day 509)
|
0.00%
0/53 • From study start to end of observational extension part (up to Day 509)
|
0.00%
0/35 • From study start to end of observational extension part (up to Day 509)
|
0.00%
0/20 • From study start to end of observational extension part (up to Day 509)
|
|
Renal and urinary disorders
Stag horn calculus
|
0.97%
1/103 • From study start to end of observational extension part (up to Day 509)
|
0.00%
0/108 • From study start to end of observational extension part (up to Day 509)
|
0.00%
0/53 • From study start to end of observational extension part (up to Day 509)
|
0.00%
0/35 • From study start to end of observational extension part (up to Day 509)
|
0.00%
0/20 • From study start to end of observational extension part (up to Day 509)
|
Other adverse events
| Measure |
Main Trial Part: IVX-A12 150 mcg
n=103 participants at risk
Participants received a single dose of 150 mcg IVX-A12, IM injection on Day 1.
|
Main Trial Part: IVX-A12 150 mcg With MF59
n=108 participants at risk
Participants received a single dose of 150 mcg IVX-A12 adjuvanted with MF59, IM injection on Day 1.
|
Main Trial Part: Placebo
n=53 participants at risk
Participants received matching placebo on Day 1.
|
Observational Extension Part: IVX-A12 150 mcg
n=35 participants at risk
Participants who received a single dose of 150 mcg IVX-A12, IM injection on Day 1 in Main Trial part were enrolled and observed in Extension part.
|
Observational Extension Part: Placebo
n=20 participants at risk
Participants who received matching placebo on Day 1 in Main Trial part were enrolled and observed in Extension part.
|
|---|---|---|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
10.7%
11/103 • From study start to end of observational extension part (up to Day 509)
|
16.7%
18/108 • From study start to end of observational extension part (up to Day 509)
|
13.2%
7/53 • From study start to end of observational extension part (up to Day 509)
|
0.00%
0/35 • From study start to end of observational extension part (up to Day 509)
|
0.00%
0/20 • From study start to end of observational extension part (up to Day 509)
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
3.9%
4/103 • From study start to end of observational extension part (up to Day 509)
|
4.6%
5/108 • From study start to end of observational extension part (up to Day 509)
|
1.9%
1/53 • From study start to end of observational extension part (up to Day 509)
|
0.00%
0/35 • From study start to end of observational extension part (up to Day 509)
|
0.00%
0/20 • From study start to end of observational extension part (up to Day 509)
|
|
Nervous system disorders
Headache
|
7.8%
8/103 • From study start to end of observational extension part (up to Day 509)
|
8.3%
9/108 • From study start to end of observational extension part (up to Day 509)
|
15.1%
8/53 • From study start to end of observational extension part (up to Day 509)
|
0.00%
0/35 • From study start to end of observational extension part (up to Day 509)
|
0.00%
0/20 • From study start to end of observational extension part (up to Day 509)
|
|
General disorders
Fatigue
|
7.8%
8/103 • From study start to end of observational extension part (up to Day 509)
|
12.0%
13/108 • From study start to end of observational extension part (up to Day 509)
|
13.2%
7/53 • From study start to end of observational extension part (up to Day 509)
|
0.00%
0/35 • From study start to end of observational extension part (up to Day 509)
|
0.00%
0/20 • From study start to end of observational extension part (up to Day 509)
|
|
Gastrointestinal disorders
Diarrhea
|
0.00%
0/103 • From study start to end of observational extension part (up to Day 509)
|
5.6%
6/108 • From study start to end of observational extension part (up to Day 509)
|
0.00%
0/53 • From study start to end of observational extension part (up to Day 509)
|
0.00%
0/35 • From study start to end of observational extension part (up to Day 509)
|
0.00%
0/20 • From study start to end of observational extension part (up to Day 509)
|
|
Investigations
Blood pressure increased
|
1.9%
2/103 • From study start to end of observational extension part (up to Day 509)
|
0.93%
1/108 • From study start to end of observational extension part (up to Day 509)
|
0.00%
0/53 • From study start to end of observational extension part (up to Day 509)
|
0.00%
0/35 • From study start to end of observational extension part (up to Day 509)
|
0.00%
0/20 • From study start to end of observational extension part (up to Day 509)
|
|
Ear and labyrinth disorders
Ear pain
|
0.97%
1/103 • From study start to end of observational extension part (up to Day 509)
|
4.6%
5/108 • From study start to end of observational extension part (up to Day 509)
|
3.8%
2/53 • From study start to end of observational extension part (up to Day 509)
|
0.00%
0/35 • From study start to end of observational extension part (up to Day 509)
|
0.00%
0/20 • From study start to end of observational extension part (up to Day 509)
|
|
Vascular disorders
Hypertension
|
7.8%
8/103 • From study start to end of observational extension part (up to Day 509)
|
8.3%
9/108 • From study start to end of observational extension part (up to Day 509)
|
0.00%
0/53 • From study start to end of observational extension part (up to Day 509)
|
0.00%
0/35 • From study start to end of observational extension part (up to Day 509)
|
0.00%
0/20 • From study start to end of observational extension part (up to Day 509)
|
|
Infections and infestations
COVID-19
|
12.6%
13/103 • From study start to end of observational extension part (up to Day 509)
|
13.9%
15/108 • From study start to end of observational extension part (up to Day 509)
|
17.0%
9/53 • From study start to end of observational extension part (up to Day 509)
|
0.00%
0/35 • From study start to end of observational extension part (up to Day 509)
|
0.00%
0/20 • From study start to end of observational extension part (up to Day 509)
|
|
Infections and infestations
Respiratory tract infection
|
6.8%
7/103 • From study start to end of observational extension part (up to Day 509)
|
11.1%
12/108 • From study start to end of observational extension part (up to Day 509)
|
9.4%
5/53 • From study start to end of observational extension part (up to Day 509)
|
0.00%
0/35 • From study start to end of observational extension part (up to Day 509)
|
0.00%
0/20 • From study start to end of observational extension part (up to Day 509)
|
|
Infections and infestations
Urinary tract infection
|
5.8%
6/103 • From study start to end of observational extension part (up to Day 509)
|
1.9%
2/108 • From study start to end of observational extension part (up to Day 509)
|
3.8%
2/53 • From study start to end of observational extension part (up to Day 509)
|
0.00%
0/35 • From study start to end of observational extension part (up to Day 509)
|
0.00%
0/20 • From study start to end of observational extension part (up to Day 509)
|
|
Infections and infestations
Sinusitis
|
3.9%
4/103 • From study start to end of observational extension part (up to Day 509)
|
2.8%
3/108 • From study start to end of observational extension part (up to Day 509)
|
1.9%
1/53 • From study start to end of observational extension part (up to Day 509)
|
0.00%
0/35 • From study start to end of observational extension part (up to Day 509)
|
0.00%
0/20 • From study start to end of observational extension part (up to Day 509)
|
|
Infections and infestations
Cellulitis
|
2.9%
3/103 • From study start to end of observational extension part (up to Day 509)
|
2.8%
3/108 • From study start to end of observational extension part (up to Day 509)
|
0.00%
0/53 • From study start to end of observational extension part (up to Day 509)
|
0.00%
0/35 • From study start to end of observational extension part (up to Day 509)
|
0.00%
0/20 • From study start to end of observational extension part (up to Day 509)
|
|
Infections and infestations
Tooth infection
|
0.97%
1/103 • From study start to end of observational extension part (up to Day 509)
|
1.9%
2/108 • From study start to end of observational extension part (up to Day 509)
|
0.00%
0/53 • From study start to end of observational extension part (up to Day 509)
|
0.00%
0/35 • From study start to end of observational extension part (up to Day 509)
|
0.00%
0/20 • From study start to end of observational extension part (up to Day 509)
|
|
Infections and infestations
Acute sinusitis
|
0.97%
1/103 • From study start to end of observational extension part (up to Day 509)
|
0.00%
0/108 • From study start to end of observational extension part (up to Day 509)
|
1.9%
1/53 • From study start to end of observational extension part (up to Day 509)
|
0.00%
0/35 • From study start to end of observational extension part (up to Day 509)
|
0.00%
0/20 • From study start to end of observational extension part (up to Day 509)
|
|
Infections and infestations
Conjunctivitis
|
1.9%
2/103 • From study start to end of observational extension part (up to Day 509)
|
0.00%
0/108 • From study start to end of observational extension part (up to Day 509)
|
0.00%
0/53 • From study start to end of observational extension part (up to Day 509)
|
0.00%
0/35 • From study start to end of observational extension part (up to Day 509)
|
0.00%
0/20 • From study start to end of observational extension part (up to Day 509)
|
|
Infections and infestations
Conjunctivitis bacterial
|
0.97%
1/103 • From study start to end of observational extension part (up to Day 509)
|
0.93%
1/108 • From study start to end of observational extension part (up to Day 509)
|
0.00%
0/53 • From study start to end of observational extension part (up to Day 509)
|
0.00%
0/35 • From study start to end of observational extension part (up to Day 509)
|
0.00%
0/20 • From study start to end of observational extension part (up to Day 509)
|
|
Infections and infestations
Ear infection
|
1.9%
2/103 • From study start to end of observational extension part (up to Day 509)
|
0.00%
0/108 • From study start to end of observational extension part (up to Day 509)
|
0.00%
0/53 • From study start to end of observational extension part (up to Day 509)
|
0.00%
0/35 • From study start to end of observational extension part (up to Day 509)
|
0.00%
0/20 • From study start to end of observational extension part (up to Day 509)
|
|
Infections and infestations
Fungal infection
|
0.97%
1/103 • From study start to end of observational extension part (up to Day 509)
|
0.93%
1/108 • From study start to end of observational extension part (up to Day 509)
|
0.00%
0/53 • From study start to end of observational extension part (up to Day 509)
|
0.00%
0/35 • From study start to end of observational extension part (up to Day 509)
|
0.00%
0/20 • From study start to end of observational extension part (up to Day 509)
|
|
Infections and infestations
Gingivitis
|
0.97%
1/103 • From study start to end of observational extension part (up to Day 509)
|
0.93%
1/108 • From study start to end of observational extension part (up to Day 509)
|
0.00%
0/53 • From study start to end of observational extension part (up to Day 509)
|
0.00%
0/35 • From study start to end of observational extension part (up to Day 509)
|
0.00%
0/20 • From study start to end of observational extension part (up to Day 509)
|
|
Infections and infestations
HCoV-OC43 infection
|
0.97%
1/103 • From study start to end of observational extension part (up to Day 509)
|
0.00%
0/108 • From study start to end of observational extension part (up to Day 509)
|
1.9%
1/53 • From study start to end of observational extension part (up to Day 509)
|
0.00%
0/35 • From study start to end of observational extension part (up to Day 509)
|
0.00%
0/20 • From study start to end of observational extension part (up to Day 509)
|
|
Infections and infestations
Pharyngitis
|
1.9%
2/103 • From study start to end of observational extension part (up to Day 509)
|
0.00%
0/108 • From study start to end of observational extension part (up to Day 509)
|
0.00%
0/53 • From study start to end of observational extension part (up to Day 509)
|
0.00%
0/35 • From study start to end of observational extension part (up to Day 509)
|
0.00%
0/20 • From study start to end of observational extension part (up to Day 509)
|
|
Infections and infestations
Abdominal abscess
|
0.00%
0/103 • From study start to end of observational extension part (up to Day 509)
|
0.93%
1/108 • From study start to end of observational extension part (up to Day 509)
|
0.00%
0/53 • From study start to end of observational extension part (up to Day 509)
|
0.00%
0/35 • From study start to end of observational extension part (up to Day 509)
|
0.00%
0/20 • From study start to end of observational extension part (up to Day 509)
|
|
Infections and infestations
Abscess limb
|
0.00%
0/103 • From study start to end of observational extension part (up to Day 509)
|
0.93%
1/108 • From study start to end of observational extension part (up to Day 509)
|
0.00%
0/53 • From study start to end of observational extension part (up to Day 509)
|
0.00%
0/35 • From study start to end of observational extension part (up to Day 509)
|
0.00%
0/20 • From study start to end of observational extension part (up to Day 509)
|
|
Infections and infestations
Acarodermatitis
|
0.00%
0/103 • From study start to end of observational extension part (up to Day 509)
|
0.93%
1/108 • From study start to end of observational extension part (up to Day 509)
|
0.00%
0/53 • From study start to end of observational extension part (up to Day 509)
|
0.00%
0/35 • From study start to end of observational extension part (up to Day 509)
|
0.00%
0/20 • From study start to end of observational extension part (up to Day 509)
|
|
Infections and infestations
Bronchitis viral
|
0.00%
0/103 • From study start to end of observational extension part (up to Day 509)
|
0.93%
1/108 • From study start to end of observational extension part (up to Day 509)
|
0.00%
0/53 • From study start to end of observational extension part (up to Day 509)
|
0.00%
0/35 • From study start to end of observational extension part (up to Day 509)
|
0.00%
0/20 • From study start to end of observational extension part (up to Day 509)
|
|
Infections and infestations
COVID-19 pneumonia
|
0.00%
0/103 • From study start to end of observational extension part (up to Day 509)
|
0.93%
1/108 • From study start to end of observational extension part (up to Day 509)
|
0.00%
0/53 • From study start to end of observational extension part (up to Day 509)
|
0.00%
0/35 • From study start to end of observational extension part (up to Day 509)
|
0.00%
0/20 • From study start to end of observational extension part (up to Day 509)
|
|
Infections and infestations
Coronavirus infection
|
0.00%
0/103 • From study start to end of observational extension part (up to Day 509)
|
0.93%
1/108 • From study start to end of observational extension part (up to Day 509)
|
0.00%
0/53 • From study start to end of observational extension part (up to Day 509)
|
0.00%
0/35 • From study start to end of observational extension part (up to Day 509)
|
0.00%
0/20 • From study start to end of observational extension part (up to Day 509)
|
|
Infections and infestations
Enterocolitis bacterial
|
0.00%
0/103 • From study start to end of observational extension part (up to Day 509)
|
0.00%
0/108 • From study start to end of observational extension part (up to Day 509)
|
1.9%
1/53 • From study start to end of observational extension part (up to Day 509)
|
0.00%
0/35 • From study start to end of observational extension part (up to Day 509)
|
0.00%
0/20 • From study start to end of observational extension part (up to Day 509)
|
|
Infections and infestations
Eye infection
|
0.00%
0/103 • From study start to end of observational extension part (up to Day 509)
|
0.93%
1/108 • From study start to end of observational extension part (up to Day 509)
|
0.00%
0/53 • From study start to end of observational extension part (up to Day 509)
|
0.00%
0/35 • From study start to end of observational extension part (up to Day 509)
|
0.00%
0/20 • From study start to end of observational extension part (up to Day 509)
|
|
Infections and infestations
Folliculitis
|
0.97%
1/103 • From study start to end of observational extension part (up to Day 509)
|
0.00%
0/108 • From study start to end of observational extension part (up to Day 509)
|
0.00%
0/53 • From study start to end of observational extension part (up to Day 509)
|
0.00%
0/35 • From study start to end of observational extension part (up to Day 509)
|
0.00%
0/20 • From study start to end of observational extension part (up to Day 509)
|
|
Infections and infestations
Gingival abscess
|
0.00%
0/103 • From study start to end of observational extension part (up to Day 509)
|
0.00%
0/108 • From study start to end of observational extension part (up to Day 509)
|
1.9%
1/53 • From study start to end of observational extension part (up to Day 509)
|
0.00%
0/35 • From study start to end of observational extension part (up to Day 509)
|
0.00%
0/20 • From study start to end of observational extension part (up to Day 509)
|
|
Infections and infestations
Herpes zoster
|
0.00%
0/103 • From study start to end of observational extension part (up to Day 509)
|
0.93%
1/108 • From study start to end of observational extension part (up to Day 509)
|
0.00%
0/53 • From study start to end of observational extension part (up to Day 509)
|
0.00%
0/35 • From study start to end of observational extension part (up to Day 509)
|
0.00%
0/20 • From study start to end of observational extension part (up to Day 509)
|
|
Infections and infestations
Hordeolum
|
0.97%
1/103 • From study start to end of observational extension part (up to Day 509)
|
0.00%
0/108 • From study start to end of observational extension part (up to Day 509)
|
0.00%
0/53 • From study start to end of observational extension part (up to Day 509)
|
0.00%
0/35 • From study start to end of observational extension part (up to Day 509)
|
0.00%
0/20 • From study start to end of observational extension part (up to Day 509)
|
|
Infections and infestations
Laryngitis
|
0.00%
0/103 • From study start to end of observational extension part (up to Day 509)
|
0.93%
1/108 • From study start to end of observational extension part (up to Day 509)
|
0.00%
0/53 • From study start to end of observational extension part (up to Day 509)
|
0.00%
0/35 • From study start to end of observational extension part (up to Day 509)
|
0.00%
0/20 • From study start to end of observational extension part (up to Day 509)
|
|
Infections and infestations
Metapneumovirus infection
|
0.00%
0/103 • From study start to end of observational extension part (up to Day 509)
|
0.93%
1/108 • From study start to end of observational extension part (up to Day 509)
|
0.00%
0/53 • From study start to end of observational extension part (up to Day 509)
|
0.00%
0/35 • From study start to end of observational extension part (up to Day 509)
|
0.00%
0/20 • From study start to end of observational extension part (up to Day 509)
|
|
Infections and infestations
Oesophageal candidiasis
|
0.00%
0/103 • From study start to end of observational extension part (up to Day 509)
|
0.93%
1/108 • From study start to end of observational extension part (up to Day 509)
|
0.00%
0/53 • From study start to end of observational extension part (up to Day 509)
|
0.00%
0/35 • From study start to end of observational extension part (up to Day 509)
|
0.00%
0/20 • From study start to end of observational extension part (up to Day 509)
|
|
Infections and infestations
Periodontitis
|
0.00%
0/103 • From study start to end of observational extension part (up to Day 509)
|
0.93%
1/108 • From study start to end of observational extension part (up to Day 509)
|
0.00%
0/53 • From study start to end of observational extension part (up to Day 509)
|
0.00%
0/35 • From study start to end of observational extension part (up to Day 509)
|
0.00%
0/20 • From study start to end of observational extension part (up to Day 509)
|
|
Infections and infestations
Pneumonia viral
|
0.97%
1/103 • From study start to end of observational extension part (up to Day 509)
|
0.00%
0/108 • From study start to end of observational extension part (up to Day 509)
|
0.00%
0/53 • From study start to end of observational extension part (up to Day 509)
|
0.00%
0/35 • From study start to end of observational extension part (up to Day 509)
|
0.00%
0/20 • From study start to end of observational extension part (up to Day 509)
|
|
Infections and infestations
Post procedural infection
|
0.00%
0/103 • From study start to end of observational extension part (up to Day 509)
|
0.00%
0/108 • From study start to end of observational extension part (up to Day 509)
|
1.9%
1/53 • From study start to end of observational extension part (up to Day 509)
|
0.00%
0/35 • From study start to end of observational extension part (up to Day 509)
|
0.00%
0/20 • From study start to end of observational extension part (up to Day 509)
|
|
Infections and infestations
Salmonellosis
|
0.97%
1/103 • From study start to end of observational extension part (up to Day 509)
|
0.00%
0/108 • From study start to end of observational extension part (up to Day 509)
|
0.00%
0/53 • From study start to end of observational extension part (up to Day 509)
|
0.00%
0/35 • From study start to end of observational extension part (up to Day 509)
|
0.00%
0/20 • From study start to end of observational extension part (up to Day 509)
|
|
Infections and infestations
Vulvovaginal mycotic infection
|
0.00%
0/103 • From study start to end of observational extension part (up to Day 509)
|
0.93%
1/108 • From study start to end of observational extension part (up to Day 509)
|
0.00%
0/53 • From study start to end of observational extension part (up to Day 509)
|
0.00%
0/35 • From study start to end of observational extension part (up to Day 509)
|
0.00%
0/20 • From study start to end of observational extension part (up to Day 509)
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
4.9%
5/103 • From study start to end of observational extension part (up to Day 509)
|
2.8%
3/108 • From study start to end of observational extension part (up to Day 509)
|
5.7%
3/53 • From study start to end of observational extension part (up to Day 509)
|
0.00%
0/35 • From study start to end of observational extension part (up to Day 509)
|
0.00%
0/20 • From study start to end of observational extension part (up to Day 509)
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
1.9%
2/103 • From study start to end of observational extension part (up to Day 509)
|
0.93%
1/108 • From study start to end of observational extension part (up to Day 509)
|
1.9%
1/53 • From study start to end of observational extension part (up to Day 509)
|
0.00%
0/35 • From study start to end of observational extension part (up to Day 509)
|
0.00%
0/20 • From study start to end of observational extension part (up to Day 509)
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
1.9%
2/103 • From study start to end of observational extension part (up to Day 509)
|
0.93%
1/108 • From study start to end of observational extension part (up to Day 509)
|
0.00%
0/53 • From study start to end of observational extension part (up to Day 509)
|
0.00%
0/35 • From study start to end of observational extension part (up to Day 509)
|
0.00%
0/20 • From study start to end of observational extension part (up to Day 509)
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.00%
0/103 • From study start to end of observational extension part (up to Day 509)
|
0.93%
1/108 • From study start to end of observational extension part (up to Day 509)
|
1.9%
1/53 • From study start to end of observational extension part (up to Day 509)
|
0.00%
0/35 • From study start to end of observational extension part (up to Day 509)
|
0.00%
0/20 • From study start to end of observational extension part (up to Day 509)
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.97%
1/103 • From study start to end of observational extension part (up to Day 509)
|
0.00%
0/108 • From study start to end of observational extension part (up to Day 509)
|
0.00%
0/53 • From study start to end of observational extension part (up to Day 509)
|
0.00%
0/35 • From study start to end of observational extension part (up to Day 509)
|
0.00%
0/20 • From study start to end of observational extension part (up to Day 509)
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal cobble stone mucosa
|
0.00%
0/103 • From study start to end of observational extension part (up to Day 509)
|
0.93%
1/108 • From study start to end of observational extension part (up to Day 509)
|
0.00%
0/53 • From study start to end of observational extension part (up to Day 509)
|
0.00%
0/35 • From study start to end of observational extension part (up to Day 509)
|
0.00%
0/20 • From study start to end of observational extension part (up to Day 509)
|
|
Infections and infestations
Lyme disease
|
0.97%
1/103 • From study start to end of observational extension part (up to Day 509)
|
0.00%
0/108 • From study start to end of observational extension part (up to Day 509)
|
0.00%
0/53 • From study start to end of observational extension part (up to Day 509)
|
0.00%
0/35 • From study start to end of observational extension part (up to Day 509)
|
0.00%
0/20 • From study start to end of observational extension part (up to Day 509)
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/103 • From study start to end of observational extension part (up to Day 509)
|
0.93%
1/108 • From study start to end of observational extension part (up to Day 509)
|
0.00%
0/53 • From study start to end of observational extension part (up to Day 509)
|
0.00%
0/35 • From study start to end of observational extension part (up to Day 509)
|
0.00%
0/20 • From study start to end of observational extension part (up to Day 509)
|
|
Infections and infestations
Oral candidiasis
|
0.00%
0/103 • From study start to end of observational extension part (up to Day 509)
|
0.00%
0/108 • From study start to end of observational extension part (up to Day 509)
|
1.9%
1/53 • From study start to end of observational extension part (up to Day 509)
|
0.00%
0/35 • From study start to end of observational extension part (up to Day 509)
|
0.00%
0/20 • From study start to end of observational extension part (up to Day 509)
|
|
Infections and infestations
Otitis externa
|
0.97%
1/103 • From study start to end of observational extension part (up to Day 509)
|
0.00%
0/108 • From study start to end of observational extension part (up to Day 509)
|
0.00%
0/53 • From study start to end of observational extension part (up to Day 509)
|
0.00%
0/35 • From study start to end of observational extension part (up to Day 509)
|
0.00%
0/20 • From study start to end of observational extension part (up to Day 509)
|
|
Infections and infestations
Sialoadenitis
|
0.00%
0/103 • From study start to end of observational extension part (up to Day 509)
|
0.93%
1/108 • From study start to end of observational extension part (up to Day 509)
|
0.00%
0/53 • From study start to end of observational extension part (up to Day 509)
|
0.00%
0/35 • From study start to end of observational extension part (up to Day 509)
|
0.00%
0/20 • From study start to end of observational extension part (up to Day 509)
|
|
Infections and infestations
Pharyngitis streptococcal
|
0.00%
0/103 • From study start to end of observational extension part (up to Day 509)
|
2.8%
3/108 • From study start to end of observational extension part (up to Day 509)
|
0.00%
0/53 • From study start to end of observational extension part (up to Day 509)
|
0.00%
0/35 • From study start to end of observational extension part (up to Day 509)
|
0.00%
0/20 • From study start to end of observational extension part (up to Day 509)
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
1.9%
2/103 • From study start to end of observational extension part (up to Day 509)
|
3.7%
4/108 • From study start to end of observational extension part (up to Day 509)
|
0.00%
0/53 • From study start to end of observational extension part (up to Day 509)
|
0.00%
0/35 • From study start to end of observational extension part (up to Day 509)
|
0.00%
0/20 • From study start to end of observational extension part (up to Day 509)
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
3.9%
4/103 • From study start to end of observational extension part (up to Day 509)
|
0.93%
1/108 • From study start to end of observational extension part (up to Day 509)
|
0.00%
0/53 • From study start to end of observational extension part (up to Day 509)
|
0.00%
0/35 • From study start to end of observational extension part (up to Day 509)
|
0.00%
0/20 • From study start to end of observational extension part (up to Day 509)
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/103 • From study start to end of observational extension part (up to Day 509)
|
0.93%
1/108 • From study start to end of observational extension part (up to Day 509)
|
1.9%
1/53 • From study start to end of observational extension part (up to Day 509)
|
0.00%
0/35 • From study start to end of observational extension part (up to Day 509)
|
0.00%
0/20 • From study start to end of observational extension part (up to Day 509)
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.97%
1/103 • From study start to end of observational extension part (up to Day 509)
|
0.00%
0/108 • From study start to end of observational extension part (up to Day 509)
|
0.00%
0/53 • From study start to end of observational extension part (up to Day 509)
|
0.00%
0/35 • From study start to end of observational extension part (up to Day 509)
|
0.00%
0/20 • From study start to end of observational extension part (up to Day 509)
|
|
Musculoskeletal and connective tissue disorders
Foot deformity
|
0.97%
1/103 • From study start to end of observational extension part (up to Day 509)
|
0.00%
0/108 • From study start to end of observational extension part (up to Day 509)
|
0.00%
0/53 • From study start to end of observational extension part (up to Day 509)
|
0.00%
0/35 • From study start to end of observational extension part (up to Day 509)
|
0.00%
0/20 • From study start to end of observational extension part (up to Day 509)
|
|
Musculoskeletal and connective tissue disorders
Groin pain
|
0.00%
0/103 • From study start to end of observational extension part (up to Day 509)
|
0.93%
1/108 • From study start to end of observational extension part (up to Day 509)
|
0.00%
0/53 • From study start to end of observational extension part (up to Day 509)
|
0.00%
0/35 • From study start to end of observational extension part (up to Day 509)
|
0.00%
0/20 • From study start to end of observational extension part (up to Day 509)
|
|
Musculoskeletal and connective tissue disorders
Joint swelling
|
0.00%
0/103 • From study start to end of observational extension part (up to Day 509)
|
0.00%
0/108 • From study start to end of observational extension part (up to Day 509)
|
1.9%
1/53 • From study start to end of observational extension part (up to Day 509)
|
0.00%
0/35 • From study start to end of observational extension part (up to Day 509)
|
0.00%
0/20 • From study start to end of observational extension part (up to Day 509)
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/103 • From study start to end of observational extension part (up to Day 509)
|
0.93%
1/108 • From study start to end of observational extension part (up to Day 509)
|
0.00%
0/53 • From study start to end of observational extension part (up to Day 509)
|
0.00%
0/35 • From study start to end of observational extension part (up to Day 509)
|
0.00%
0/20 • From study start to end of observational extension part (up to Day 509)
|
|
Musculoskeletal and connective tissue disorders
Osteopenia
|
0.97%
1/103 • From study start to end of observational extension part (up to Day 509)
|
0.00%
0/108 • From study start to end of observational extension part (up to Day 509)
|
0.00%
0/53 • From study start to end of observational extension part (up to Day 509)
|
0.00%
0/35 • From study start to end of observational extension part (up to Day 509)
|
0.00%
0/20 • From study start to end of observational extension part (up to Day 509)
|
|
Musculoskeletal and connective tissue disorders
Osteoporosis
|
0.00%
0/103 • From study start to end of observational extension part (up to Day 509)
|
0.93%
1/108 • From study start to end of observational extension part (up to Day 509)
|
0.00%
0/53 • From study start to end of observational extension part (up to Day 509)
|
0.00%
0/35 • From study start to end of observational extension part (up to Day 509)
|
0.00%
0/20 • From study start to end of observational extension part (up to Day 509)
|
|
General disorders
Influenza like illness
|
0.97%
1/103 • From study start to end of observational extension part (up to Day 509)
|
2.8%
3/108 • From study start to end of observational extension part (up to Day 509)
|
1.9%
1/53 • From study start to end of observational extension part (up to Day 509)
|
0.00%
0/35 • From study start to end of observational extension part (up to Day 509)
|
5.0%
1/20 • From study start to end of observational extension part (up to Day 509)
|
|
General disorders
Chest pain
|
0.00%
0/103 • From study start to end of observational extension part (up to Day 509)
|
0.00%
0/108 • From study start to end of observational extension part (up to Day 509)
|
1.9%
1/53 • From study start to end of observational extension part (up to Day 509)
|
0.00%
0/35 • From study start to end of observational extension part (up to Day 509)
|
0.00%
0/20 • From study start to end of observational extension part (up to Day 509)
|
|
General disorders
Chills
|
0.00%
0/103 • From study start to end of observational extension part (up to Day 509)
|
0.93%
1/108 • From study start to end of observational extension part (up to Day 509)
|
0.00%
0/53 • From study start to end of observational extension part (up to Day 509)
|
0.00%
0/35 • From study start to end of observational extension part (up to Day 509)
|
0.00%
0/20 • From study start to end of observational extension part (up to Day 509)
|
|
General disorders
Effusion
|
0.00%
0/103 • From study start to end of observational extension part (up to Day 509)
|
0.00%
0/108 • From study start to end of observational extension part (up to Day 509)
|
1.9%
1/53 • From study start to end of observational extension part (up to Day 509)
|
0.00%
0/35 • From study start to end of observational extension part (up to Day 509)
|
0.00%
0/20 • From study start to end of observational extension part (up to Day 509)
|
|
General disorders
Injection site pain
|
0.97%
1/103 • From study start to end of observational extension part (up to Day 509)
|
0.00%
0/108 • From study start to end of observational extension part (up to Day 509)
|
0.00%
0/53 • From study start to end of observational extension part (up to Day 509)
|
0.00%
0/35 • From study start to end of observational extension part (up to Day 509)
|
0.00%
0/20 • From study start to end of observational extension part (up to Day 509)
|
|
General disorders
Pain
|
0.00%
0/103 • From study start to end of observational extension part (up to Day 509)
|
0.00%
0/108 • From study start to end of observational extension part (up to Day 509)
|
1.9%
1/53 • From study start to end of observational extension part (up to Day 509)
|
0.00%
0/35 • From study start to end of observational extension part (up to Day 509)
|
0.00%
0/20 • From study start to end of observational extension part (up to Day 509)
|
|
Nervous system disorders
Sciatica
|
0.97%
1/103 • From study start to end of observational extension part (up to Day 509)
|
0.93%
1/108 • From study start to end of observational extension part (up to Day 509)
|
1.9%
1/53 • From study start to end of observational extension part (up to Day 509)
|
0.00%
0/35 • From study start to end of observational extension part (up to Day 509)
|
0.00%
0/20 • From study start to end of observational extension part (up to Day 509)
|
|
Nervous system disorders
Dizziness
|
0.97%
1/103 • From study start to end of observational extension part (up to Day 509)
|
0.93%
1/108 • From study start to end of observational extension part (up to Day 509)
|
0.00%
0/53 • From study start to end of observational extension part (up to Day 509)
|
0.00%
0/35 • From study start to end of observational extension part (up to Day 509)
|
0.00%
0/20 • From study start to end of observational extension part (up to Day 509)
|
|
Nervous system disorders
Carpal tunnel syndrome
|
0.00%
0/103 • From study start to end of observational extension part (up to Day 509)
|
0.93%
1/108 • From study start to end of observational extension part (up to Day 509)
|
0.00%
0/53 • From study start to end of observational extension part (up to Day 509)
|
0.00%
0/35 • From study start to end of observational extension part (up to Day 509)
|
0.00%
0/20 • From study start to end of observational extension part (up to Day 509)
|
|
Nervous system disorders
Tardive dyskinesia
|
0.97%
1/103 • From study start to end of observational extension part (up to Day 509)
|
0.00%
0/108 • From study start to end of observational extension part (up to Day 509)
|
0.00%
0/53 • From study start to end of observational extension part (up to Day 509)
|
0.00%
0/35 • From study start to end of observational extension part (up to Day 509)
|
0.00%
0/20 • From study start to end of observational extension part (up to Day 509)
|
|
Nervous system disorders
Trigeminal neuralgia
|
0.00%
0/103 • From study start to end of observational extension part (up to Day 509)
|
0.93%
1/108 • From study start to end of observational extension part (up to Day 509)
|
0.00%
0/53 • From study start to end of observational extension part (up to Day 509)
|
0.00%
0/35 • From study start to end of observational extension part (up to Day 509)
|
0.00%
0/20 • From study start to end of observational extension part (up to Day 509)
|
|
Metabolism and nutrition disorders
Decreased appetite
|
2.9%
3/103 • From study start to end of observational extension part (up to Day 509)
|
2.8%
3/108 • From study start to end of observational extension part (up to Day 509)
|
5.7%
3/53 • From study start to end of observational extension part (up to Day 509)
|
0.00%
0/35 • From study start to end of observational extension part (up to Day 509)
|
0.00%
0/20 • From study start to end of observational extension part (up to Day 509)
|
|
Metabolism and nutrition disorders
Hyperlipidaemia
|
1.9%
2/103 • From study start to end of observational extension part (up to Day 509)
|
1.9%
2/108 • From study start to end of observational extension part (up to Day 509)
|
1.9%
1/53 • From study start to end of observational extension part (up to Day 509)
|
0.00%
0/35 • From study start to end of observational extension part (up to Day 509)
|
0.00%
0/20 • From study start to end of observational extension part (up to Day 509)
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
0.97%
1/103 • From study start to end of observational extension part (up to Day 509)
|
2.8%
3/108 • From study start to end of observational extension part (up to Day 509)
|
0.00%
0/53 • From study start to end of observational extension part (up to Day 509)
|
0.00%
0/35 • From study start to end of observational extension part (up to Day 509)
|
0.00%
0/20 • From study start to end of observational extension part (up to Day 509)
|
|
Metabolism and nutrition disorders
Hypercholesterolaemia
|
1.9%
2/103 • From study start to end of observational extension part (up to Day 509)
|
0.93%
1/108 • From study start to end of observational extension part (up to Day 509)
|
0.00%
0/53 • From study start to end of observational extension part (up to Day 509)
|
0.00%
0/35 • From study start to end of observational extension part (up to Day 509)
|
0.00%
0/20 • From study start to end of observational extension part (up to Day 509)
|
|
Metabolism and nutrition disorders
Type 2 diabetes mellitus
|
0.97%
1/103 • From study start to end of observational extension part (up to Day 509)
|
0.93%
1/108 • From study start to end of observational extension part (up to Day 509)
|
0.00%
0/53 • From study start to end of observational extension part (up to Day 509)
|
0.00%
0/35 • From study start to end of observational extension part (up to Day 509)
|
0.00%
0/20 • From study start to end of observational extension part (up to Day 509)
|
|
Metabolism and nutrition disorders
Dyslipidaemia
|
0.00%
0/103 • From study start to end of observational extension part (up to Day 509)
|
0.00%
0/108 • From study start to end of observational extension part (up to Day 509)
|
1.9%
1/53 • From study start to end of observational extension part (up to Day 509)
|
0.00%
0/35 • From study start to end of observational extension part (up to Day 509)
|
0.00%
0/20 • From study start to end of observational extension part (up to Day 509)
|
|
Metabolism and nutrition disorders
Glucose tolerance impaired
|
0.00%
0/103 • From study start to end of observational extension part (up to Day 509)
|
0.93%
1/108 • From study start to end of observational extension part (up to Day 509)
|
0.00%
0/53 • From study start to end of observational extension part (up to Day 509)
|
0.00%
0/35 • From study start to end of observational extension part (up to Day 509)
|
0.00%
0/20 • From study start to end of observational extension part (up to Day 509)
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/103 • From study start to end of observational extension part (up to Day 509)
|
0.00%
0/108 • From study start to end of observational extension part (up to Day 509)
|
1.9%
1/53 • From study start to end of observational extension part (up to Day 509)
|
0.00%
0/35 • From study start to end of observational extension part (up to Day 509)
|
0.00%
0/20 • From study start to end of observational extension part (up to Day 509)
|
|
Metabolism and nutrition disorders
Vitamin B12 deficiency
|
0.00%
0/103 • From study start to end of observational extension part (up to Day 509)
|
0.93%
1/108 • From study start to end of observational extension part (up to Day 509)
|
0.00%
0/53 • From study start to end of observational extension part (up to Day 509)
|
0.00%
0/35 • From study start to end of observational extension part (up to Day 509)
|
0.00%
0/20 • From study start to end of observational extension part (up to Day 509)
|
|
Metabolism and nutrition disorders
Vitamin D deficiency
|
0.97%
1/103 • From study start to end of observational extension part (up to Day 509)
|
0.00%
0/108 • From study start to end of observational extension part (up to Day 509)
|
0.00%
0/53 • From study start to end of observational extension part (up to Day 509)
|
0.00%
0/35 • From study start to end of observational extension part (up to Day 509)
|
0.00%
0/20 • From study start to end of observational extension part (up to Day 509)
|
|
Product Issues
Device physical property issue
|
0.00%
0/103 • From study start to end of observational extension part (up to Day 509)
|
0.00%
0/108 • From study start to end of observational extension part (up to Day 509)
|
1.9%
1/53 • From study start to end of observational extension part (up to Day 509)
|
0.00%
0/35 • From study start to end of observational extension part (up to Day 509)
|
0.00%
0/20 • From study start to end of observational extension part (up to Day 509)
|
|
Hepatobiliary disorders
Hepatic steatosis
|
0.00%
0/103 • From study start to end of observational extension part (up to Day 509)
|
0.93%
1/108 • From study start to end of observational extension part (up to Day 509)
|
0.00%
0/53 • From study start to end of observational extension part (up to Day 509)
|
0.00%
0/35 • From study start to end of observational extension part (up to Day 509)
|
0.00%
0/20 • From study start to end of observational extension part (up to Day 509)
|
|
Congenital, familial and genetic disorders
Type V hyperlipidaemia
|
0.97%
1/103 • From study start to end of observational extension part (up to Day 509)
|
0.00%
0/108 • From study start to end of observational extension part (up to Day 509)
|
0.00%
0/53 • From study start to end of observational extension part (up to Day 509)
|
0.00%
0/35 • From study start to end of observational extension part (up to Day 509)
|
0.00%
0/20 • From study start to end of observational extension part (up to Day 509)
|
|
Reproductive system and breast disorders
Breast cyst
|
0.00%
0/103 • From study start to end of observational extension part (up to Day 509)
|
0.93%
1/108 • From study start to end of observational extension part (up to Day 509)
|
0.00%
0/53 • From study start to end of observational extension part (up to Day 509)
|
0.00%
0/35 • From study start to end of observational extension part (up to Day 509)
|
0.00%
0/20 • From study start to end of observational extension part (up to Day 509)
|
|
Reproductive system and breast disorders
Menopausal symptoms
|
0.97%
1/103 • From study start to end of observational extension part (up to Day 509)
|
0.00%
0/108 • From study start to end of observational extension part (up to Day 509)
|
0.00%
0/53 • From study start to end of observational extension part (up to Day 509)
|
0.00%
0/35 • From study start to end of observational extension part (up to Day 509)
|
0.00%
0/20 • From study start to end of observational extension part (up to Day 509)
|
|
Eye disorders
Macular degeneration
|
0.00%
0/103 • From study start to end of observational extension part (up to Day 509)
|
0.93%
1/108 • From study start to end of observational extension part (up to Day 509)
|
0.00%
0/53 • From study start to end of observational extension part (up to Day 509)
|
0.00%
0/35 • From study start to end of observational extension part (up to Day 509)
|
0.00%
0/20 • From study start to end of observational extension part (up to Day 509)
|
|
Eye disorders
Glaucoma
|
0.00%
0/103 • From study start to end of observational extension part (up to Day 509)
|
0.00%
0/108 • From study start to end of observational extension part (up to Day 509)
|
1.9%
1/53 • From study start to end of observational extension part (up to Day 509)
|
0.00%
0/35 • From study start to end of observational extension part (up to Day 509)
|
0.00%
0/20 • From study start to end of observational extension part (up to Day 509)
|
|
Endocrine disorders
Hypothyroidism
|
0.97%
1/103 • From study start to end of observational extension part (up to Day 509)
|
0.00%
0/108 • From study start to end of observational extension part (up to Day 509)
|
0.00%
0/53 • From study start to end of observational extension part (up to Day 509)
|
0.00%
0/35 • From study start to end of observational extension part (up to Day 509)
|
0.00%
0/20 • From study start to end of observational extension part (up to Day 509)
|
|
Endocrine disorders
Thyroid mass
|
0.00%
0/103 • From study start to end of observational extension part (up to Day 509)
|
0.93%
1/108 • From study start to end of observational extension part (up to Day 509)
|
0.00%
0/53 • From study start to end of observational extension part (up to Day 509)
|
0.00%
0/35 • From study start to end of observational extension part (up to Day 509)
|
0.00%
0/20 • From study start to end of observational extension part (up to Day 509)
|
|
Blood and lymphatic system disorders
Anaemia
|
0.97%
1/103 • From study start to end of observational extension part (up to Day 509)
|
0.00%
0/108 • From study start to end of observational extension part (up to Day 509)
|
0.00%
0/53 • From study start to end of observational extension part (up to Day 509)
|
0.00%
0/35 • From study start to end of observational extension part (up to Day 509)
|
0.00%
0/20 • From study start to end of observational extension part (up to Day 509)
|
|
Blood and lymphatic system disorders
Leukopenia
|
0.97%
1/103 • From study start to end of observational extension part (up to Day 509)
|
0.00%
0/108 • From study start to end of observational extension part (up to Day 509)
|
0.00%
0/53 • From study start to end of observational extension part (up to Day 509)
|
0.00%
0/35 • From study start to end of observational extension part (up to Day 509)
|
0.00%
0/20 • From study start to end of observational extension part (up to Day 509)
|
|
Psychiatric disorders
Depression
|
0.97%
1/103 • From study start to end of observational extension part (up to Day 509)
|
0.93%
1/108 • From study start to end of observational extension part (up to Day 509)
|
0.00%
0/53 • From study start to end of observational extension part (up to Day 509)
|
0.00%
0/35 • From study start to end of observational extension part (up to Day 509)
|
0.00%
0/20 • From study start to end of observational extension part (up to Day 509)
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/103 • From study start to end of observational extension part (up to Day 509)
|
0.93%
1/108 • From study start to end of observational extension part (up to Day 509)
|
1.9%
1/53 • From study start to end of observational extension part (up to Day 509)
|
0.00%
0/35 • From study start to end of observational extension part (up to Day 509)
|
0.00%
0/20 • From study start to end of observational extension part (up to Day 509)
|
|
Psychiatric disorders
Alcohol abuse
|
0.00%
0/103 • From study start to end of observational extension part (up to Day 509)
|
0.93%
1/108 • From study start to end of observational extension part (up to Day 509)
|
0.00%
0/53 • From study start to end of observational extension part (up to Day 509)
|
0.00%
0/35 • From study start to end of observational extension part (up to Day 509)
|
0.00%
0/20 • From study start to end of observational extension part (up to Day 509)
|
|
Psychiatric disorders
Claustrophobia
|
0.97%
1/103 • From study start to end of observational extension part (up to Day 509)
|
0.00%
0/108 • From study start to end of observational extension part (up to Day 509)
|
0.00%
0/53 • From study start to end of observational extension part (up to Day 509)
|
0.00%
0/35 • From study start to end of observational extension part (up to Day 509)
|
0.00%
0/20 • From study start to end of observational extension part (up to Day 509)
|
|
Psychiatric disorders
Generalised anxiety disorder
|
0.00%
0/103 • From study start to end of observational extension part (up to Day 509)
|
0.93%
1/108 • From study start to end of observational extension part (up to Day 509)
|
0.00%
0/53 • From study start to end of observational extension part (up to Day 509)
|
0.00%
0/35 • From study start to end of observational extension part (up to Day 509)
|
0.00%
0/20 • From study start to end of observational extension part (up to Day 509)
|
|
Immune system disorders
Drug hypersensitivity
|
0.97%
1/103 • From study start to end of observational extension part (up to Day 509)
|
0.93%
1/108 • From study start to end of observational extension part (up to Day 509)
|
0.00%
0/53 • From study start to end of observational extension part (up to Day 509)
|
0.00%
0/35 • From study start to end of observational extension part (up to Day 509)
|
0.00%
0/20 • From study start to end of observational extension part (up to Day 509)
|
|
Immune system disorders
Hypersensitivity
|
0.00%
0/103 • From study start to end of observational extension part (up to Day 509)
|
1.9%
2/108 • From study start to end of observational extension part (up to Day 509)
|
0.00%
0/53 • From study start to end of observational extension part (up to Day 509)
|
0.00%
0/35 • From study start to end of observational extension part (up to Day 509)
|
0.00%
0/20 • From study start to end of observational extension part (up to Day 509)
|
|
Immune system disorders
Seasonal allergy
|
0.97%
1/103 • From study start to end of observational extension part (up to Day 509)
|
0.93%
1/108 • From study start to end of observational extension part (up to Day 509)
|
0.00%
0/53 • From study start to end of observational extension part (up to Day 509)
|
0.00%
0/35 • From study start to end of observational extension part (up to Day 509)
|
0.00%
0/20 • From study start to end of observational extension part (up to Day 509)
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.97%
1/103 • From study start to end of observational extension part (up to Day 509)
|
0.93%
1/108 • From study start to end of observational extension part (up to Day 509)
|
0.00%
0/53 • From study start to end of observational extension part (up to Day 509)
|
0.00%
0/35 • From study start to end of observational extension part (up to Day 509)
|
0.00%
0/20 • From study start to end of observational extension part (up to Day 509)
|
|
Renal and urinary disorders
Renal impairment
|
0.97%
1/103 • From study start to end of observational extension part (up to Day 509)
|
0.00%
0/108 • From study start to end of observational extension part (up to Day 509)
|
0.00%
0/53 • From study start to end of observational extension part (up to Day 509)
|
0.00%
0/35 • From study start to end of observational extension part (up to Day 509)
|
0.00%
0/20 • From study start to end of observational extension part (up to Day 509)
|
|
Renal and urinary disorders
Stag horn calculus
|
0.97%
1/103 • From study start to end of observational extension part (up to Day 509)
|
0.00%
0/108 • From study start to end of observational extension part (up to Day 509)
|
0.00%
0/53 • From study start to end of observational extension part (up to Day 509)
|
0.00%
0/35 • From study start to end of observational extension part (up to Day 509)
|
0.00%
0/20 • From study start to end of observational extension part (up to Day 509)
|
|
Renal and urinary disorders
Ureteric obstruction
|
0.97%
1/103 • From study start to end of observational extension part (up to Day 509)
|
0.00%
0/108 • From study start to end of observational extension part (up to Day 509)
|
0.00%
0/53 • From study start to end of observational extension part (up to Day 509)
|
0.00%
0/35 • From study start to end of observational extension part (up to Day 509)
|
0.00%
0/20 • From study start to end of observational extension part (up to Day 509)
|
|
Renal and urinary disorders
Urethral obstruction
|
0.97%
1/103 • From study start to end of observational extension part (up to Day 509)
|
0.00%
0/108 • From study start to end of observational extension part (up to Day 509)
|
0.00%
0/53 • From study start to end of observational extension part (up to Day 509)
|
0.00%
0/35 • From study start to end of observational extension part (up to Day 509)
|
0.00%
0/20 • From study start to end of observational extension part (up to Day 509)
|
|
Ear and labyrinth disorders
Deafness
|
0.00%
0/103 • From study start to end of observational extension part (up to Day 509)
|
0.93%
1/108 • From study start to end of observational extension part (up to Day 509)
|
0.00%
0/53 • From study start to end of observational extension part (up to Day 509)
|
0.00%
0/35 • From study start to end of observational extension part (up to Day 509)
|
0.00%
0/20 • From study start to end of observational extension part (up to Day 509)
|
|
Ear and labyrinth disorders
Tympanic membrane disorder
|
0.97%
1/103 • From study start to end of observational extension part (up to Day 509)
|
0.00%
0/108 • From study start to end of observational extension part (up to Day 509)
|
0.00%
0/53 • From study start to end of observational extension part (up to Day 509)
|
0.00%
0/35 • From study start to end of observational extension part (up to Day 509)
|
0.00%
0/20 • From study start to end of observational extension part (up to Day 509)
|
|
Ear and labyrinth disorders
Vertigo positional
|
0.97%
1/103 • From study start to end of observational extension part (up to Day 509)
|
0.00%
0/108 • From study start to end of observational extension part (up to Day 509)
|
0.00%
0/53 • From study start to end of observational extension part (up to Day 509)
|
0.00%
0/35 • From study start to end of observational extension part (up to Day 509)
|
0.00%
0/20 • From study start to end of observational extension part (up to Day 509)
|
|
Vascular disorders
Arteriosclerosis
|
0.00%
0/103 • From study start to end of observational extension part (up to Day 509)
|
0.93%
1/108 • From study start to end of observational extension part (up to Day 509)
|
0.00%
0/53 • From study start to end of observational extension part (up to Day 509)
|
0.00%
0/35 • From study start to end of observational extension part (up to Day 509)
|
0.00%
0/20 • From study start to end of observational extension part (up to Day 509)
|
|
Vascular disorders
Haematoma
|
0.00%
0/103 • From study start to end of observational extension part (up to Day 509)
|
0.00%
0/108 • From study start to end of observational extension part (up to Day 509)
|
1.9%
1/53 • From study start to end of observational extension part (up to Day 509)
|
0.00%
0/35 • From study start to end of observational extension part (up to Day 509)
|
0.00%
0/20 • From study start to end of observational extension part (up to Day 509)
|
|
Vascular disorders
Raynaud's phenomenon
|
0.97%
1/103 • From study start to end of observational extension part (up to Day 509)
|
0.00%
0/108 • From study start to end of observational extension part (up to Day 509)
|
0.00%
0/53 • From study start to end of observational extension part (up to Day 509)
|
0.00%
0/35 • From study start to end of observational extension part (up to Day 509)
|
0.00%
0/20 • From study start to end of observational extension part (up to Day 509)
|
|
Cardiac disorders
Cardiac failure
|
0.00%
0/103 • From study start to end of observational extension part (up to Day 509)
|
0.93%
1/108 • From study start to end of observational extension part (up to Day 509)
|
1.9%
1/53 • From study start to end of observational extension part (up to Day 509)
|
0.00%
0/35 • From study start to end of observational extension part (up to Day 509)
|
0.00%
0/20 • From study start to end of observational extension part (up to Day 509)
|
|
Cardiac disorders
Angina pectoris
|
0.97%
1/103 • From study start to end of observational extension part (up to Day 509)
|
0.00%
0/108 • From study start to end of observational extension part (up to Day 509)
|
0.00%
0/53 • From study start to end of observational extension part (up to Day 509)
|
0.00%
0/35 • From study start to end of observational extension part (up to Day 509)
|
0.00%
0/20 • From study start to end of observational extension part (up to Day 509)
|
|
Cardiac disorders
Atrial flutter
|
0.00%
0/103 • From study start to end of observational extension part (up to Day 509)
|
0.93%
1/108 • From study start to end of observational extension part (up to Day 509)
|
0.00%
0/53 • From study start to end of observational extension part (up to Day 509)
|
0.00%
0/35 • From study start to end of observational extension part (up to Day 509)
|
0.00%
0/20 • From study start to end of observational extension part (up to Day 509)
|
|
Cardiac disorders
Bundle branch block left
|
0.00%
0/103 • From study start to end of observational extension part (up to Day 509)
|
0.00%
0/108 • From study start to end of observational extension part (up to Day 509)
|
1.9%
1/53 • From study start to end of observational extension part (up to Day 509)
|
0.00%
0/35 • From study start to end of observational extension part (up to Day 509)
|
0.00%
0/20 • From study start to end of observational extension part (up to Day 509)
|
|
Injury, poisoning and procedural complications
Concussion
|
0.00%
0/103 • From study start to end of observational extension part (up to Day 509)
|
0.93%
1/108 • From study start to end of observational extension part (up to Day 509)
|
0.00%
0/53 • From study start to end of observational extension part (up to Day 509)
|
0.00%
0/35 • From study start to end of observational extension part (up to Day 509)
|
0.00%
0/20 • From study start to end of observational extension part (up to Day 509)
|
|
Injury, poisoning and procedural complications
Meniscus injury
|
0.00%
0/103 • From study start to end of observational extension part (up to Day 509)
|
0.00%
0/108 • From study start to end of observational extension part (up to Day 509)
|
1.9%
1/53 • From study start to end of observational extension part (up to Day 509)
|
0.00%
0/35 • From study start to end of observational extension part (up to Day 509)
|
0.00%
0/20 • From study start to end of observational extension part (up to Day 509)
|
|
Injury, poisoning and procedural complications
Rib fracture
|
0.00%
0/103 • From study start to end of observational extension part (up to Day 509)
|
0.93%
1/108 • From study start to end of observational extension part (up to Day 509)
|
0.00%
0/53 • From study start to end of observational extension part (up to Day 509)
|
0.00%
0/35 • From study start to end of observational extension part (up to Day 509)
|
0.00%
0/20 • From study start to end of observational extension part (up to Day 509)
|
|
Gastrointestinal disorders
Abdominal pain
|
0.97%
1/103 • From study start to end of observational extension part (up to Day 509)
|
0.00%
0/108 • From study start to end of observational extension part (up to Day 509)
|
0.00%
0/53 • From study start to end of observational extension part (up to Day 509)
|
0.00%
0/35 • From study start to end of observational extension part (up to Day 509)
|
0.00%
0/20 • From study start to end of observational extension part (up to Day 509)
|
|
Gastrointestinal disorders
Abdominal pain lower
|
0.00%
0/103 • From study start to end of observational extension part (up to Day 509)
|
0.93%
1/108 • From study start to end of observational extension part (up to Day 509)
|
0.00%
0/53 • From study start to end of observational extension part (up to Day 509)
|
0.00%
0/35 • From study start to end of observational extension part (up to Day 509)
|
0.00%
0/20 • From study start to end of observational extension part (up to Day 509)
|
|
Gastrointestinal disorders
Chronic gastritis
|
0.00%
0/103 • From study start to end of observational extension part (up to Day 509)
|
0.93%
1/108 • From study start to end of observational extension part (up to Day 509)
|
0.00%
0/53 • From study start to end of observational extension part (up to Day 509)
|
0.00%
0/35 • From study start to end of observational extension part (up to Day 509)
|
0.00%
0/20 • From study start to end of observational extension part (up to Day 509)
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/103 • From study start to end of observational extension part (up to Day 509)
|
0.93%
1/108 • From study start to end of observational extension part (up to Day 509)
|
0.00%
0/53 • From study start to end of observational extension part (up to Day 509)
|
0.00%
0/35 • From study start to end of observational extension part (up to Day 509)
|
0.00%
0/20 • From study start to end of observational extension part (up to Day 509)
|
|
Gastrointestinal disorders
Hiatus hernia
|
0.00%
0/103 • From study start to end of observational extension part (up to Day 509)
|
0.93%
1/108 • From study start to end of observational extension part (up to Day 509)
|
0.00%
0/53 • From study start to end of observational extension part (up to Day 509)
|
0.00%
0/35 • From study start to end of observational extension part (up to Day 509)
|
0.00%
0/20 • From study start to end of observational extension part (up to Day 509)
|
|
Gastrointestinal disorders
Inguinal hernia
|
0.00%
0/103 • From study start to end of observational extension part (up to Day 509)
|
0.93%
1/108 • From study start to end of observational extension part (up to Day 509)
|
0.00%
0/53 • From study start to end of observational extension part (up to Day 509)
|
0.00%
0/35 • From study start to end of observational extension part (up to Day 509)
|
0.00%
0/20 • From study start to end of observational extension part (up to Day 509)
|
|
Gastrointestinal disorders
Irritable bowel syndrome
|
0.00%
0/103 • From study start to end of observational extension part (up to Day 509)
|
0.93%
1/108 • From study start to end of observational extension part (up to Day 509)
|
0.00%
0/53 • From study start to end of observational extension part (up to Day 509)
|
0.00%
0/35 • From study start to end of observational extension part (up to Day 509)
|
0.00%
0/20 • From study start to end of observational extension part (up to Day 509)
|
|
Gastrointestinal disorders
Poor dental condition
|
0.00%
0/103 • From study start to end of observational extension part (up to Day 509)
|
0.00%
0/108 • From study start to end of observational extension part (up to Day 509)
|
1.9%
1/53 • From study start to end of observational extension part (up to Day 509)
|
0.00%
0/35 • From study start to end of observational extension part (up to Day 509)
|
0.00%
0/20 • From study start to end of observational extension part (up to Day 509)
|
|
Gastrointestinal disorders
Tooth disorder
|
0.97%
1/103 • From study start to end of observational extension part (up to Day 509)
|
0.00%
0/108 • From study start to end of observational extension part (up to Day 509)
|
0.00%
0/53 • From study start to end of observational extension part (up to Day 509)
|
0.00%
0/35 • From study start to end of observational extension part (up to Day 509)
|
0.00%
0/20 • From study start to end of observational extension part (up to Day 509)
|
|
Gastrointestinal disorders
Tooth erosion
|
0.00%
0/103 • From study start to end of observational extension part (up to Day 509)
|
0.93%
1/108 • From study start to end of observational extension part (up to Day 509)
|
0.00%
0/53 • From study start to end of observational extension part (up to Day 509)
|
0.00%
0/35 • From study start to end of observational extension part (up to Day 509)
|
0.00%
0/20 • From study start to end of observational extension part (up to Day 509)
|
|
Gastrointestinal disorders
Tooth impacted
|
0.00%
0/103 • From study start to end of observational extension part (up to Day 509)
|
0.93%
1/108 • From study start to end of observational extension part (up to Day 509)
|
0.00%
0/53 • From study start to end of observational extension part (up to Day 509)
|
0.00%
0/35 • From study start to end of observational extension part (up to Day 509)
|
0.00%
0/20 • From study start to end of observational extension part (up to Day 509)
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/103 • From study start to end of observational extension part (up to Day 509)
|
0.00%
0/108 • From study start to end of observational extension part (up to Day 509)
|
1.9%
1/53 • From study start to end of observational extension part (up to Day 509)
|
0.00%
0/35 • From study start to end of observational extension part (up to Day 509)
|
0.00%
0/20 • From study start to end of observational extension part (up to Day 509)
|
|
Investigations
Blood cholesterol increased
|
0.00%
0/103 • From study start to end of observational extension part (up to Day 509)
|
0.93%
1/108 • From study start to end of observational extension part (up to Day 509)
|
1.9%
1/53 • From study start to end of observational extension part (up to Day 509)
|
0.00%
0/35 • From study start to end of observational extension part (up to Day 509)
|
0.00%
0/20 • From study start to end of observational extension part (up to Day 509)
|
|
Investigations
Protein urine present
|
0.97%
1/103 • From study start to end of observational extension part (up to Day 509)
|
0.00%
0/108 • From study start to end of observational extension part (up to Day 509)
|
1.9%
1/53 • From study start to end of observational extension part (up to Day 509)
|
0.00%
0/35 • From study start to end of observational extension part (up to Day 509)
|
0.00%
0/20 • From study start to end of observational extension part (up to Day 509)
|
|
Investigations
White blood cell count increased
|
0.00%
0/103 • From study start to end of observational extension part (up to Day 509)
|
0.93%
1/108 • From study start to end of observational extension part (up to Day 509)
|
1.9%
1/53 • From study start to end of observational extension part (up to Day 509)
|
0.00%
0/35 • From study start to end of observational extension part (up to Day 509)
|
0.00%
0/20 • From study start to end of observational extension part (up to Day 509)
|
|
Investigations
Neutrophil count increased
|
0.00%
0/103 • From study start to end of observational extension part (up to Day 509)
|
0.93%
1/108 • From study start to end of observational extension part (up to Day 509)
|
0.00%
0/53 • From study start to end of observational extension part (up to Day 509)
|
0.00%
0/35 • From study start to end of observational extension part (up to Day 509)
|
0.00%
0/20 • From study start to end of observational extension part (up to Day 509)
|
|
Investigations
Renal function test abnormal
|
0.00%
0/103 • From study start to end of observational extension part (up to Day 509)
|
0.93%
1/108 • From study start to end of observational extension part (up to Day 509)
|
0.00%
0/53 • From study start to end of observational extension part (up to Day 509)
|
0.00%
0/35 • From study start to end of observational extension part (up to Day 509)
|
0.00%
0/20 • From study start to end of observational extension part (up to Day 509)
|
|
Investigations
White blood cell count decreased
|
0.97%
1/103 • From study start to end of observational extension part (up to Day 509)
|
0.00%
0/108 • From study start to end of observational extension part (up to Day 509)
|
0.00%
0/53 • From study start to end of observational extension part (up to Day 509)
|
0.00%
0/35 • From study start to end of observational extension part (up to Day 509)
|
0.00%
0/20 • From study start to end of observational extension part (up to Day 509)
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
1.9%
2/103 • From study start to end of observational extension part (up to Day 509)
|
0.00%
0/108 • From study start to end of observational extension part (up to Day 509)
|
0.00%
0/53 • From study start to end of observational extension part (up to Day 509)
|
2.9%
1/35 • From study start to end of observational extension part (up to Day 509)
|
0.00%
0/20 • From study start to end of observational extension part (up to Day 509)
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/103 • From study start to end of observational extension part (up to Day 509)
|
0.93%
1/108 • From study start to end of observational extension part (up to Day 509)
|
1.9%
1/53 • From study start to end of observational extension part (up to Day 509)
|
0.00%
0/35 • From study start to end of observational extension part (up to Day 509)
|
0.00%
0/20 • From study start to end of observational extension part (up to Day 509)
|
|
Skin and subcutaneous tissue disorders
Actinic keratosis
|
0.00%
0/103 • From study start to end of observational extension part (up to Day 509)
|
0.93%
1/108 • From study start to end of observational extension part (up to Day 509)
|
0.00%
0/53 • From study start to end of observational extension part (up to Day 509)
|
0.00%
0/35 • From study start to end of observational extension part (up to Day 509)
|
0.00%
0/20 • From study start to end of observational extension part (up to Day 509)
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
0.97%
1/103 • From study start to end of observational extension part (up to Day 509)
|
0.00%
0/108 • From study start to end of observational extension part (up to Day 509)
|
0.00%
0/53 • From study start to end of observational extension part (up to Day 509)
|
0.00%
0/35 • From study start to end of observational extension part (up to Day 509)
|
0.00%
0/20 • From study start to end of observational extension part (up to Day 509)
|
|
Skin and subcutaneous tissue disorders
Diffuse alopecia
|
0.97%
1/103 • From study start to end of observational extension part (up to Day 509)
|
0.00%
0/108 • From study start to end of observational extension part (up to Day 509)
|
0.00%
0/53 • From study start to end of observational extension part (up to Day 509)
|
0.00%
0/35 • From study start to end of observational extension part (up to Day 509)
|
0.00%
0/20 • From study start to end of observational extension part (up to Day 509)
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/103 • From study start to end of observational extension part (up to Day 509)
|
0.93%
1/108 • From study start to end of observational extension part (up to Day 509)
|
0.00%
0/53 • From study start to end of observational extension part (up to Day 509)
|
0.00%
0/35 • From study start to end of observational extension part (up to Day 509)
|
0.00%
0/20 • From study start to end of observational extension part (up to Day 509)
|
|
Skin and subcutaneous tissue disorders
Perioral dermatitis
|
0.00%
0/103 • From study start to end of observational extension part (up to Day 509)
|
0.93%
1/108 • From study start to end of observational extension part (up to Day 509)
|
0.00%
0/53 • From study start to end of observational extension part (up to Day 509)
|
0.00%
0/35 • From study start to end of observational extension part (up to Day 509)
|
0.00%
0/20 • From study start to end of observational extension part (up to Day 509)
|
|
Skin and subcutaneous tissue disorders
Psoriasis
|
0.97%
1/103 • From study start to end of observational extension part (up to Day 509)
|
0.00%
0/108 • From study start to end of observational extension part (up to Day 509)
|
0.00%
0/53 • From study start to end of observational extension part (up to Day 509)
|
0.00%
0/35 • From study start to end of observational extension part (up to Day 509)
|
0.00%
0/20 • From study start to end of observational extension part (up to Day 509)
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/103 • From study start to end of observational extension part (up to Day 509)
|
0.00%
0/108 • From study start to end of observational extension part (up to Day 509)
|
1.9%
1/53 • From study start to end of observational extension part (up to Day 509)
|
0.00%
0/35 • From study start to end of observational extension part (up to Day 509)
|
0.00%
0/20 • From study start to end of observational extension part (up to Day 509)
|
|
Skin and subcutaneous tissue disorders
Rosacea
|
0.97%
1/103 • From study start to end of observational extension part (up to Day 509)
|
0.00%
0/108 • From study start to end of observational extension part (up to Day 509)
|
0.00%
0/53 • From study start to end of observational extension part (up to Day 509)
|
0.00%
0/35 • From study start to end of observational extension part (up to Day 509)
|
0.00%
0/20 • From study start to end of observational extension part (up to Day 509)
|
|
Skin and subcutaneous tissue disorders
Skin lesion
|
0.97%
1/103 • From study start to end of observational extension part (up to Day 509)
|
0.00%
0/108 • From study start to end of observational extension part (up to Day 509)
|
0.00%
0/53 • From study start to end of observational extension part (up to Day 509)
|
2.9%
1/35 • From study start to end of observational extension part (up to Day 509)
|
0.00%
0/20 • From study start to end of observational extension part (up to Day 509)
|
|
Skin and subcutaneous tissue disorders
Skin ulcer
|
0.00%
0/103 • From study start to end of observational extension part (up to Day 509)
|
0.93%
1/108 • From study start to end of observational extension part (up to Day 509)
|
0.00%
0/53 • From study start to end of observational extension part (up to Day 509)
|
0.00%
0/35 • From study start to end of observational extension part (up to Day 509)
|
0.00%
0/20 • From study start to end of observational extension part (up to Day 509)
|
|
Investigations
Blood glucose increased
|
0.00%
0/103 • From study start to end of observational extension part (up to Day 509)
|
0.93%
1/108 • From study start to end of observational extension part (up to Day 509)
|
0.00%
0/53 • From study start to end of observational extension part (up to Day 509)
|
0.00%
0/35 • From study start to end of observational extension part (up to Day 509)
|
0.00%
0/20 • From study start to end of observational extension part (up to Day 509)
|
|
Investigations
Blood potassium decreased
|
0.00%
0/103 • From study start to end of observational extension part (up to Day 509)
|
0.93%
1/108 • From study start to end of observational extension part (up to Day 509)
|
0.00%
0/53 • From study start to end of observational extension part (up to Day 509)
|
0.00%
0/35 • From study start to end of observational extension part (up to Day 509)
|
0.00%
0/20 • From study start to end of observational extension part (up to Day 509)
|
|
Investigations
Blood urea increased
|
0.00%
0/103 • From study start to end of observational extension part (up to Day 509)
|
0.93%
1/108 • From study start to end of observational extension part (up to Day 509)
|
0.00%
0/53 • From study start to end of observational extension part (up to Day 509)
|
0.00%
0/35 • From study start to end of observational extension part (up to Day 509)
|
0.00%
0/20 • From study start to end of observational extension part (up to Day 509)
|
|
Investigations
Human metapneumovirus test positive
|
0.00%
0/103 • From study start to end of observational extension part (up to Day 509)
|
0.93%
1/108 • From study start to end of observational extension part (up to Day 509)
|
0.00%
0/53 • From study start to end of observational extension part (up to Day 509)
|
0.00%
0/35 • From study start to end of observational extension part (up to Day 509)
|
0.00%
0/20 • From study start to end of observational extension part (up to Day 509)
|
|
Investigations
Lymphocyte count decreased
|
0.00%
0/103 • From study start to end of observational extension part (up to Day 509)
|
0.93%
1/108 • From study start to end of observational extension part (up to Day 509)
|
0.00%
0/53 • From study start to end of observational extension part (up to Day 509)
|
0.00%
0/35 • From study start to end of observational extension part (up to Day 509)
|
0.00%
0/20 • From study start to end of observational extension part (up to Day 509)
|
|
Investigations
Lymphocyte count increased
|
0.00%
0/103 • From study start to end of observational extension part (up to Day 509)
|
0.00%
0/108 • From study start to end of observational extension part (up to Day 509)
|
1.9%
1/53 • From study start to end of observational extension part (up to Day 509)
|
0.00%
0/35 • From study start to end of observational extension part (up to Day 509)
|
0.00%
0/20 • From study start to end of observational extension part (up to Day 509)
|
|
Investigations
Neutrophil count decreased
|
0.97%
1/103 • From study start to end of observational extension part (up to Day 509)
|
0.00%
0/108 • From study start to end of observational extension part (up to Day 509)
|
0.00%
0/53 • From study start to end of observational extension part (up to Day 509)
|
0.00%
0/35 • From study start to end of observational extension part (up to Day 509)
|
0.00%
0/20 • From study start to end of observational extension part (up to Day 509)
|
|
Injury, poisoning and procedural complications
Limb injury
|
0.97%
1/103 • From study start to end of observational extension part (up to Day 509)
|
0.93%
1/108 • From study start to end of observational extension part (up to Day 509)
|
0.00%
0/53 • From study start to end of observational extension part (up to Day 509)
|
0.00%
0/35 • From study start to end of observational extension part (up to Day 509)
|
0.00%
0/20 • From study start to end of observational extension part (up to Day 509)
|
|
Injury, poisoning and procedural complications
Animal bite
|
0.00%
0/103 • From study start to end of observational extension part (up to Day 509)
|
0.00%
0/108 • From study start to end of observational extension part (up to Day 509)
|
1.9%
1/53 • From study start to end of observational extension part (up to Day 509)
|
0.00%
0/35 • From study start to end of observational extension part (up to Day 509)
|
0.00%
0/20 • From study start to end of observational extension part (up to Day 509)
|
|
Injury, poisoning and procedural complications
Arthropod sting
|
0.97%
1/103 • From study start to end of observational extension part (up to Day 509)
|
0.00%
0/108 • From study start to end of observational extension part (up to Day 509)
|
0.00%
0/53 • From study start to end of observational extension part (up to Day 509)
|
0.00%
0/35 • From study start to end of observational extension part (up to Day 509)
|
0.00%
0/20 • From study start to end of observational extension part (up to Day 509)
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
0.00%
0/103 • From study start to end of observational extension part (up to Day 509)
|
0.93%
1/108 • From study start to end of observational extension part (up to Day 509)
|
0.00%
0/53 • From study start to end of observational extension part (up to Day 509)
|
0.00%
0/35 • From study start to end of observational extension part (up to Day 509)
|
0.00%
0/20 • From study start to end of observational extension part (up to Day 509)
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.00%
0/103 • From study start to end of observational extension part (up to Day 509)
|
0.93%
1/108 • From study start to end of observational extension part (up to Day 509)
|
0.00%
0/53 • From study start to end of observational extension part (up to Day 509)
|
0.00%
0/35 • From study start to end of observational extension part (up to Day 509)
|
0.00%
0/20 • From study start to end of observational extension part (up to Day 509)
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhea
|
9.7%
10/103 • From study start to end of observational extension part (up to Day 509)
|
9.3%
10/108 • From study start to end of observational extension part (up to Day 509)
|
11.3%
6/53 • From study start to end of observational extension part (up to Day 509)
|
0.00%
0/35 • From study start to end of observational extension part (up to Day 509)
|
0.00%
0/20 • From study start to end of observational extension part (up to Day 509)
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
7.8%
8/103 • From study start to end of observational extension part (up to Day 509)
|
8.3%
9/108 • From study start to end of observational extension part (up to Day 509)
|
11.3%
6/53 • From study start to end of observational extension part (up to Day 509)
|
0.00%
0/35 • From study start to end of observational extension part (up to Day 509)
|
0.00%
0/20 • From study start to end of observational extension part (up to Day 509)
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
5.8%
6/103 • From study start to end of observational extension part (up to Day 509)
|
8.3%
9/108 • From study start to end of observational extension part (up to Day 509)
|
11.3%
6/53 • From study start to end of observational extension part (up to Day 509)
|
0.00%
0/35 • From study start to end of observational extension part (up to Day 509)
|
0.00%
0/20 • From study start to end of observational extension part (up to Day 509)
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
4.9%
5/103 • From study start to end of observational extension part (up to Day 509)
|
9.3%
10/108 • From study start to end of observational extension part (up to Day 509)
|
7.5%
4/53 • From study start to end of observational extension part (up to Day 509)
|
0.00%
0/35 • From study start to end of observational extension part (up to Day 509)
|
0.00%
0/20 • From study start to end of observational extension part (up to Day 509)
|
|
Infections and infestations
Upper respiratory tract infection
|
10.7%
11/103 • From study start to end of observational extension part (up to Day 509)
|
15.7%
17/108 • From study start to end of observational extension part (up to Day 509)
|
15.1%
8/53 • From study start to end of observational extension part (up to Day 509)
|
0.00%
0/35 • From study start to end of observational extension part (up to Day 509)
|
0.00%
0/20 • From study start to end of observational extension part (up to Day 509)
|
|
Infections and infestations
Rhinovirus infection
|
8.7%
9/103 • From study start to end of observational extension part (up to Day 509)
|
7.4%
8/108 • From study start to end of observational extension part (up to Day 509)
|
9.4%
5/53 • From study start to end of observational extension part (up to Day 509)
|
0.00%
0/35 • From study start to end of observational extension part (up to Day 509)
|
0.00%
0/20 • From study start to end of observational extension part (up to Day 509)
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
9.7%
10/103 • From study start to end of observational extension part (up to Day 509)
|
10.2%
11/108 • From study start to end of observational extension part (up to Day 509)
|
7.5%
4/53 • From study start to end of observational extension part (up to Day 509)
|
0.00%
0/35 • From study start to end of observational extension part (up to Day 509)
|
0.00%
0/20 • From study start to end of observational extension part (up to Day 509)
|
|
Infections and infestations
Respiratory syncytial virus infection
|
4.9%
5/103 • From study start to end of observational extension part (up to Day 509)
|
0.93%
1/108 • From study start to end of observational extension part (up to Day 509)
|
0.00%
0/53 • From study start to end of observational extension part (up to Day 509)
|
0.00%
0/35 • From study start to end of observational extension part (up to Day 509)
|
0.00%
0/20 • From study start to end of observational extension part (up to Day 509)
|
|
Infections and infestations
Bronchitis
|
1.9%
2/103 • From study start to end of observational extension part (up to Day 509)
|
1.9%
2/108 • From study start to end of observational extension part (up to Day 509)
|
0.00%
0/53 • From study start to end of observational extension part (up to Day 509)
|
0.00%
0/35 • From study start to end of observational extension part (up to Day 509)
|
0.00%
0/20 • From study start to end of observational extension part (up to Day 509)
|
|
Infections and infestations
Influenza
|
1.9%
2/103 • From study start to end of observational extension part (up to Day 509)
|
1.9%
2/108 • From study start to end of observational extension part (up to Day 509)
|
0.00%
0/53 • From study start to end of observational extension part (up to Day 509)
|
0.00%
0/35 • From study start to end of observational extension part (up to Day 509)
|
0.00%
0/20 • From study start to end of observational extension part (up to Day 509)
|
|
Infections and infestations
Parainfluenzae virus infection
|
2.9%
3/103 • From study start to end of observational extension part (up to Day 509)
|
0.93%
1/108 • From study start to end of observational extension part (up to Day 509)
|
0.00%
0/53 • From study start to end of observational extension part (up to Day 509)
|
0.00%
0/35 • From study start to end of observational extension part (up to Day 509)
|
0.00%
0/20 • From study start to end of observational extension part (up to Day 509)
|
|
Infections and infestations
Pneumonia
|
1.9%
2/103 • From study start to end of observational extension part (up to Day 509)
|
0.93%
1/108 • From study start to end of observational extension part (up to Day 509)
|
0.00%
0/53 • From study start to end of observational extension part (up to Day 509)
|
2.9%
1/35 • From study start to end of observational extension part (up to Day 509)
|
0.00%
0/20 • From study start to end of observational extension part (up to Day 509)
|
|
Infections and infestations
Tooth abscess
|
0.97%
1/103 • From study start to end of observational extension part (up to Day 509)
|
1.9%
2/108 • From study start to end of observational extension part (up to Day 509)
|
0.00%
0/53 • From study start to end of observational extension part (up to Day 509)
|
0.00%
0/35 • From study start to end of observational extension part (up to Day 509)
|
0.00%
0/20 • From study start to end of observational extension part (up to Day 509)
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
0.97%
1/103 • From study start to end of observational extension part (up to Day 509)
|
0.00%
0/108 • From study start to end of observational extension part (up to Day 509)
|
0.00%
0/53 • From study start to end of observational extension part (up to Day 509)
|
0.00%
0/35 • From study start to end of observational extension part (up to Day 509)
|
0.00%
0/20 • From study start to end of observational extension part (up to Day 509)
|
|
Respiratory, thoracic and mediastinal disorders
Sleep apnoea syndrome
|
0.00%
0/103 • From study start to end of observational extension part (up to Day 509)
|
0.93%
1/108 • From study start to end of observational extension part (up to Day 509)
|
0.00%
0/53 • From study start to end of observational extension part (up to Day 509)
|
0.00%
0/35 • From study start to end of observational extension part (up to Day 509)
|
0.00%
0/20 • From study start to end of observational extension part (up to Day 509)
|
|
Respiratory, thoracic and mediastinal disorders
Obstructive sleep apnoea syndrome
|
0.97%
1/103 • From study start to end of observational extension part (up to Day 509)
|
0.00%
0/108 • From study start to end of observational extension part (up to Day 509)
|
0.00%
0/53 • From study start to end of observational extension part (up to Day 509)
|
0.00%
0/35 • From study start to end of observational extension part (up to Day 509)
|
0.00%
0/20 • From study start to end of observational extension part (up to Day 509)
|
|
Infections and infestations
HCoV-229E infection
|
0.97%
1/103 • From study start to end of observational extension part (up to Day 509)
|
0.00%
0/108 • From study start to end of observational extension part (up to Day 509)
|
0.00%
0/53 • From study start to end of observational extension part (up to Day 509)
|
0.00%
0/35 • From study start to end of observational extension part (up to Day 509)
|
0.00%
0/20 • From study start to end of observational extension part (up to Day 509)
|
|
Infections and infestations
Lower respiratory tract infection
|
0.97%
1/103 • From study start to end of observational extension part (up to Day 509)
|
0.00%
0/108 • From study start to end of observational extension part (up to Day 509)
|
0.00%
0/53 • From study start to end of observational extension part (up to Day 509)
|
0.00%
0/35 • From study start to end of observational extension part (up to Day 509)
|
0.00%
0/20 • From study start to end of observational extension part (up to Day 509)
|
|
Musculoskeletal and connective tissue disorders
Rotator cuff syndrome
|
0.97%
1/103 • From study start to end of observational extension part (up to Day 509)
|
0.00%
0/108 • From study start to end of observational extension part (up to Day 509)
|
0.00%
0/53 • From study start to end of observational extension part (up to Day 509)
|
0.00%
0/35 • From study start to end of observational extension part (up to Day 509)
|
0.00%
0/20 • From study start to end of observational extension part (up to Day 509)
|
|
Musculoskeletal and connective tissue disorders
Sacral pain
|
0.00%
0/103 • From study start to end of observational extension part (up to Day 509)
|
0.00%
0/108 • From study start to end of observational extension part (up to Day 509)
|
1.9%
1/53 • From study start to end of observational extension part (up to Day 509)
|
0.00%
0/35 • From study start to end of observational extension part (up to Day 509)
|
0.00%
0/20 • From study start to end of observational extension part (up to Day 509)
|
|
Musculoskeletal and connective tissue disorders
Spinal osteoarthritis
|
0.00%
0/103 • From study start to end of observational extension part (up to Day 509)
|
0.93%
1/108 • From study start to end of observational extension part (up to Day 509)
|
0.00%
0/53 • From study start to end of observational extension part (up to Day 509)
|
0.00%
0/35 • From study start to end of observational extension part (up to Day 509)
|
0.00%
0/20 • From study start to end of observational extension part (up to Day 509)
|
|
Musculoskeletal and connective tissue disorders
Tenosynovitis
|
0.97%
1/103 • From study start to end of observational extension part (up to Day 509)
|
0.00%
0/108 • From study start to end of observational extension part (up to Day 509)
|
0.00%
0/53 • From study start to end of observational extension part (up to Day 509)
|
0.00%
0/35 • From study start to end of observational extension part (up to Day 509)
|
0.00%
0/20 • From study start to end of observational extension part (up to Day 509)
|
|
Musculoskeletal and connective tissue disorders
Trigger finger
|
0.00%
0/103 • From study start to end of observational extension part (up to Day 509)
|
0.93%
1/108 • From study start to end of observational extension part (up to Day 509)
|
0.00%
0/53 • From study start to end of observational extension part (up to Day 509)
|
0.00%
0/35 • From study start to end of observational extension part (up to Day 509)
|
0.00%
0/20 • From study start to end of observational extension part (up to Day 509)
|
|
General disorders
Pyrexia
|
1.9%
2/103 • From study start to end of observational extension part (up to Day 509)
|
1.9%
2/108 • From study start to end of observational extension part (up to Day 509)
|
3.8%
2/53 • From study start to end of observational extension part (up to Day 509)
|
0.00%
0/35 • From study start to end of observational extension part (up to Day 509)
|
0.00%
0/20 • From study start to end of observational extension part (up to Day 509)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma
|
0.00%
0/103 • From study start to end of observational extension part (up to Day 509)
|
1.9%
2/108 • From study start to end of observational extension part (up to Day 509)
|
1.9%
1/53 • From study start to end of observational extension part (up to Day 509)
|
0.00%
0/35 • From study start to end of observational extension part (up to Day 509)
|
0.00%
0/20 • From study start to end of observational extension part (up to Day 509)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
0.00%
0/103 • From study start to end of observational extension part (up to Day 509)
|
0.00%
0/108 • From study start to end of observational extension part (up to Day 509)
|
3.8%
2/53 • From study start to end of observational extension part (up to Day 509)
|
0.00%
0/35 • From study start to end of observational extension part (up to Day 509)
|
0.00%
0/20 • From study start to end of observational extension part (up to Day 509)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bowen's disease
|
0.97%
1/103 • From study start to end of observational extension part (up to Day 509)
|
0.00%
0/108 • From study start to end of observational extension part (up to Day 509)
|
0.00%
0/53 • From study start to end of observational extension part (up to Day 509)
|
0.00%
0/35 • From study start to end of observational extension part (up to Day 509)
|
0.00%
0/20 • From study start to end of observational extension part (up to Day 509)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Mantle cell lymphoma
|
0.00%
0/103 • From study start to end of observational extension part (up to Day 509)
|
0.00%
0/108 • From study start to end of observational extension part (up to Day 509)
|
1.9%
1/53 • From study start to end of observational extension part (up to Day 509)
|
0.00%
0/35 • From study start to end of observational extension part (up to Day 509)
|
0.00%
0/20 • From study start to end of observational extension part (up to Day 509)
|
|
Renal and urinary disorders
Hypertonic bladder
|
0.97%
1/103 • From study start to end of observational extension part (up to Day 509)
|
0.93%
1/108 • From study start to end of observational extension part (up to Day 509)
|
0.00%
0/53 • From study start to end of observational extension part (up to Day 509)
|
0.00%
0/35 • From study start to end of observational extension part (up to Day 509)
|
0.00%
0/20 • From study start to end of observational extension part (up to Day 509)
|
|
Injury, poisoning and procedural complications
Spinal compression fracture
|
0.00%
0/103 • From study start to end of observational extension part (up to Day 509)
|
0.00%
0/108 • From study start to end of observational extension part (up to Day 509)
|
1.9%
1/53 • From study start to end of observational extension part (up to Day 509)
|
0.00%
0/35 • From study start to end of observational extension part (up to Day 509)
|
0.00%
0/20 • From study start to end of observational extension part (up to Day 509)
|
|
Injury, poisoning and procedural complications
Thermal burn
|
0.00%
0/103 • From study start to end of observational extension part (up to Day 509)
|
0.93%
1/108 • From study start to end of observational extension part (up to Day 509)
|
0.00%
0/53 • From study start to end of observational extension part (up to Day 509)
|
0.00%
0/35 • From study start to end of observational extension part (up to Day 509)
|
0.00%
0/20 • From study start to end of observational extension part (up to Day 509)
|
|
Injury, poisoning and procedural complications
Tongue injury
|
0.00%
0/103 • From study start to end of observational extension part (up to Day 509)
|
0.00%
0/108 • From study start to end of observational extension part (up to Day 509)
|
1.9%
1/53 • From study start to end of observational extension part (up to Day 509)
|
0.00%
0/35 • From study start to end of observational extension part (up to Day 509)
|
0.00%
0/20 • From study start to end of observational extension part (up to Day 509)
|
|
Injury, poisoning and procedural complications
Tooth fracture
|
0.00%
0/103 • From study start to end of observational extension part (up to Day 509)
|
0.00%
0/108 • From study start to end of observational extension part (up to Day 509)
|
1.9%
1/53 • From study start to end of observational extension part (up to Day 509)
|
0.00%
0/35 • From study start to end of observational extension part (up to Day 509)
|
0.00%
0/20 • From study start to end of observational extension part (up to Day 509)
|
|
Injury, poisoning and procedural complications
Wound
|
0.00%
0/103 • From study start to end of observational extension part (up to Day 509)
|
0.93%
1/108 • From study start to end of observational extension part (up to Day 509)
|
0.00%
0/53 • From study start to end of observational extension part (up to Day 509)
|
0.00%
0/35 • From study start to end of observational extension part (up to Day 509)
|
0.00%
0/20 • From study start to end of observational extension part (up to Day 509)
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.97%
1/103 • From study start to end of observational extension part (up to Day 509)
|
2.8%
3/108 • From study start to end of observational extension part (up to Day 509)
|
0.00%
0/53 • From study start to end of observational extension part (up to Day 509)
|
0.00%
0/35 • From study start to end of observational extension part (up to Day 509)
|
0.00%
0/20 • From study start to end of observational extension part (up to Day 509)
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory symptom
|
0.97%
1/103 • From study start to end of observational extension part (up to Day 509)
|
0.93%
1/108 • From study start to end of observational extension part (up to Day 509)
|
0.00%
0/53 • From study start to end of observational extension part (up to Day 509)
|
0.00%
0/35 • From study start to end of observational extension part (up to Day 509)
|
0.00%
0/20 • From study start to end of observational extension part (up to Day 509)
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
0.00%
0/103 • From study start to end of observational extension part (up to Day 509)
|
0.93%
1/108 • From study start to end of observational extension part (up to Day 509)
|
0.00%
0/53 • From study start to end of observational extension part (up to Day 509)
|
0.00%
0/35 • From study start to end of observational extension part (up to Day 509)
|
0.00%
0/20 • From study start to end of observational extension part (up to Day 509)
|
|
Injury, poisoning and procedural complications
Procedural pain
|
0.97%
1/103 • From study start to end of observational extension part (up to Day 509)
|
3.7%
4/108 • From study start to end of observational extension part (up to Day 509)
|
1.9%
1/53 • From study start to end of observational extension part (up to Day 509)
|
0.00%
0/35 • From study start to end of observational extension part (up to Day 509)
|
0.00%
0/20 • From study start to end of observational extension part (up to Day 509)
|
|
Injury, poisoning and procedural complications
Skin laceration
|
0.97%
1/103 • From study start to end of observational extension part (up to Day 509)
|
3.7%
4/108 • From study start to end of observational extension part (up to Day 509)
|
0.00%
0/53 • From study start to end of observational extension part (up to Day 509)
|
0.00%
0/35 • From study start to end of observational extension part (up to Day 509)
|
0.00%
0/20 • From study start to end of observational extension part (up to Day 509)
|
|
Injury, poisoning and procedural complications
Muscle strain
|
0.97%
1/103 • From study start to end of observational extension part (up to Day 509)
|
1.9%
2/108 • From study start to end of observational extension part (up to Day 509)
|
1.9%
1/53 • From study start to end of observational extension part (up to Day 509)
|
0.00%
0/35 • From study start to end of observational extension part (up to Day 509)
|
0.00%
0/20 • From study start to end of observational extension part (up to Day 509)
|
|
Injury, poisoning and procedural complications
Ligament sprain
|
0.00%
0/103 • From study start to end of observational extension part (up to Day 509)
|
1.9%
2/108 • From study start to end of observational extension part (up to Day 509)
|
0.00%
0/53 • From study start to end of observational extension part (up to Day 509)
|
0.00%
0/35 • From study start to end of observational extension part (up to Day 509)
|
0.00%
0/20 • From study start to end of observational extension part (up to Day 509)
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place