Trial Outcomes & Findings for A Clinical Study to Evaluate the Immunogenicity and Safety of an Adjuvanted Quadrivalent Influenza Vaccine Compared With a Licensed Quadrivalent Vaccine in Adults 50 to 64 Years of Age (NCT NCT05044195)
NCT ID: NCT05044195
Last Updated: 2023-09-28
Results Overview
The GMT ratio is defined as the geometric mean of the postvaccination HI titer for Comparator QIV over the geometric mean of the postvaccination HI titer for aQIV.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
2044 participants
Primary outcome timeframe
Day 22
Results posted on
2023-09-28
Participant Flow
Subjects were enrolled in the 2021/2022 Northern Hemisphere influenza season from 29 centers in Estonia (6 centers), Germany (11 centers), and the United States (12 centers).
In total, 2044 subjects were enrolled in the study.
Participant milestones
| Measure |
Comparator QIV
Non-adjuvanted comparator QIV containing 2 influenza type A strains and 2 influenza type B strains
Comparator QIV: Participants receive a 0.5-mL intramuscular dose of Comparator QIV on Day 1
|
aQIV
Adjuvanted QIV containing 2 influenza type A strains and 2 influenza type B strains
aQIV: Participants receive a 0.5-mL intramuscular dose of aQIV on Day 1
|
|---|---|---|
|
Overall Study
STARTED
|
1017
|
1027
|
|
Overall Study
Received Study Vaccine
|
1016
|
1027
|
|
Overall Study
COMPLETED
|
989
|
982
|
|
Overall Study
NOT COMPLETED
|
28
|
45
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Clinical Study to Evaluate the Immunogenicity and Safety of an Adjuvanted Quadrivalent Influenza Vaccine Compared With a Licensed Quadrivalent Vaccine in Adults 50 to 64 Years of Age
Baseline characteristics by cohort
| Measure |
aQIV
n=1027 Participants
Adjuvanted QIV containing 2 influenza type A strains and 2 influenza type B strains
aQIV: Participants receive a 0.5-mL intramuscular dose of aQIV on Day 1
|
Comparator QIV
n=1017 Participants
Non-adjuvanted comparator QIV containing 2 influenza type A strains and 2 influenza type B strains
Comparator QIV: Participants receive a 0.5-mL intramuscular dose of Comparator QIV on Day 1
|
Total
n=2044 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
1027 Participants
n=99 Participants
|
1017 Participants
n=107 Participants
|
2044 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Continuous
|
57.8 years
STANDARD_DEVIATION 4.17 • n=99 Participants
|
57.8 years
STANDARD_DEVIATION 4.21 • n=107 Participants
|
57.8 years
STANDARD_DEVIATION 4.19 • n=206 Participants
|
|
Age, Customized
50 to 59 years
|
609 Participants
n=99 Participants
|
596 Participants
n=107 Participants
|
1205 Participants
n=206 Participants
|
|
Age, Customized
60 to 64 years
|
418 Participants
n=99 Participants
|
421 Participants
n=107 Participants
|
839 Participants
n=206 Participants
|
|
Sex: Female, Male
Female
|
635 Participants
n=99 Participants
|
615 Participants
n=107 Participants
|
1250 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
392 Participants
n=99 Participants
|
402 Participants
n=107 Participants
|
794 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
14 Participants
n=99 Participants
|
12 Participants
n=107 Participants
|
26 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
1013 Participants
n=99 Participants
|
1001 Participants
n=107 Participants
|
2014 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
2 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Asian
|
2 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
39 Participants
n=99 Participants
|
36 Participants
n=107 Participants
|
75 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
White
|
982 Participants
n=99 Participants
|
972 Participants
n=107 Participants
|
1954 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Other
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
377 Participants
n=99 Participants
|
367 Participants
n=107 Participants
|
744 Participants
n=206 Participants
|
|
Region of Enrollment
Germany
|
259 Participants
n=99 Participants
|
254 Participants
n=107 Participants
|
513 Participants
n=206 Participants
|
|
Region of Enrollment
Estonia
|
391 Participants
n=99 Participants
|
396 Participants
n=107 Participants
|
787 Participants
n=206 Participants
|
|
Received an influenza vaccination in the previous 3 influenza seasons
Yes
|
586 Participants
n=99 Participants
|
598 Participants
n=107 Participants
|
1184 Participants
n=206 Participants
|
|
Received an influenza vaccination in the previous 3 influenza seasons
No
|
441 Participants
n=99 Participants
|
419 Participants
n=107 Participants
|
860 Participants
n=206 Participants
|
|
Comorbidity Risk Score
<50
|
912 Participants
n=99 Participants
|
919 Participants
n=107 Participants
|
1831 Participants
n=206 Participants
|
|
Comorbidity Risk Score
≥50
|
115 Participants
n=99 Participants
|
98 Participants
n=107 Participants
|
213 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Day 22Population: Per Protocol Set (PPS) Immunogenicity, defined as all subjects in the Full Analysis Set (FAS) Immunogenicity who: had both Day 1 and Day 22 immunogenicity assessment; correctly received the vaccine (ie, received the vaccine to which the subjects were randomized and at the scheduled time points); had no protocol deviations leading to exclusion as defined prior to unblinding/analysis; were not excluded due to other reasons defined prior to unblinding or analysis. Note: Adjusted GMTs are presented.
The GMT ratio is defined as the geometric mean of the postvaccination HI titer for Comparator QIV over the geometric mean of the postvaccination HI titer for aQIV.
Outcome measures
| Measure |
aQIV
n=983 Participants
Adjuvanted QIV containing 2 influenza type A strains and 2 influenza type B strains
aQIV: Participants receive a 0.5-mL intramuscular dose of aQIV on Day 1
|
Comparator QIV
n=985 Participants
Non-adjuvanted comparator QIV containing 2 influenza type A strains and 2 influenza type B strains
Comparator QIV: Participants receive a 0.5-mL intramuscular dose of Comparator QIV on Day 1
|
|---|---|---|
|
Immunogenicity Endpoint: Geometric Mean Titer (GMT) and GMT Ratio of Hemagglutination Inhibition (HI) Antibodies at Day 22 for the A/H1N1, A/H3N2, B/Yamagata, and B/Victoria Vaccine Strains
A/H1N1
|
731.90 Titer
Interval 689.39 to 777.04
|
586.85 Titer
Interval 552.83 to 622.96
|
|
Immunogenicity Endpoint: Geometric Mean Titer (GMT) and GMT Ratio of Hemagglutination Inhibition (HI) Antibodies at Day 22 for the A/H1N1, A/H3N2, B/Yamagata, and B/Victoria Vaccine Strains
A/H3N2
|
347.89 Titer
Interval 324.78 to 372.64
|
313.16 Titer
Interval 292.42 to 335.36
|
|
Immunogenicity Endpoint: Geometric Mean Titer (GMT) and GMT Ratio of Hemagglutination Inhibition (HI) Antibodies at Day 22 for the A/H1N1, A/H3N2, B/Yamagata, and B/Victoria Vaccine Strains
B/Yamagata
|
154.40 Titer
Interval 146.8 to 162.4
|
145.74 Titer
Interval 138.57 to 153.27
|
|
Immunogenicity Endpoint: Geometric Mean Titer (GMT) and GMT Ratio of Hemagglutination Inhibition (HI) Antibodies at Day 22 for the A/H1N1, A/H3N2, B/Yamagata, and B/Victoria Vaccine Strains
B/Victoria
|
144.41 Titer
Interval 136.97 to 152.26
|
143.32 Titer
Interval 135.97 to 151.07
|
PRIMARY outcome
Timeframe: Day 1 to Day 22Population: PPS Immunogenicity
The SCR defined as the percentage of subjects with either a prevaccination HI titer \<1:10 and a postvaccination (Day 22) HI titer ≥1:40, or with either a prevaccination HI titer ≥1:10 and a ≥4-fold increase in postvaccination HI titer. The SCR difference is defined as the Comparator QIV SCR minus the aQIV SCR.
Outcome measures
| Measure |
aQIV
n=983 Participants
Adjuvanted QIV containing 2 influenza type A strains and 2 influenza type B strains
aQIV: Participants receive a 0.5-mL intramuscular dose of aQIV on Day 1
|
Comparator QIV
n=985 Participants
Non-adjuvanted comparator QIV containing 2 influenza type A strains and 2 influenza type B strains
Comparator QIV: Participants receive a 0.5-mL intramuscular dose of Comparator QIV on Day 1
|
|---|---|---|
|
Immunogenicity Endpoint: Seroconversion Rate (SCR) and SCR Difference for the A/H1N1, A/H3N2, B/Yamagata, and B/Victoria Vaccine Strains
A/H1N1
|
81.2 percentage of participants
Interval 78.57 to 83.58
|
76.8 percentage of participants
Interval 74.04 to 79.42
|
|
Immunogenicity Endpoint: Seroconversion Rate (SCR) and SCR Difference for the A/H1N1, A/H3N2, B/Yamagata, and B/Victoria Vaccine Strains
A/H3N2
|
63.6 percentage of participants
Interval 60.46 to 66.63
|
61.8 percentage of participants
Interval 58.61 to 64.82
|
|
Immunogenicity Endpoint: Seroconversion Rate (SCR) and SCR Difference for the A/H1N1, A/H3N2, B/Yamagata, and B/Victoria Vaccine Strains
B/Yamagata
|
43.4 percentage of participants
Interval 40.27 to 46.6
|
41.0 percentage of participants
Interval 37.92 to 44.19
|
|
Immunogenicity Endpoint: Seroconversion Rate (SCR) and SCR Difference for the A/H1N1, A/H3N2, B/Yamagata, and B/Victoria Vaccine Strains
B/Victoria
|
44.5 percentage of participants
Interval 41.39 to 47.74
|
40.6 percentage of participants
Interval 37.52 to 43.76
|
PRIMARY outcome
Timeframe: Day 22Population: FAS Immunogenicity, defined as all subjects in the All Enrolled Set who were randomized, received study vaccination and provided immunogenicity data at any time point. Note: Adjusted GMTs are presented.
The GMT ratio is defined as the geometric mean of the postvaccination HI titer for Comparator QIV over the geometric mean of the postvaccination HI titer for aQIV.
Outcome measures
| Measure |
aQIV
n=1027 Participants
Adjuvanted QIV containing 2 influenza type A strains and 2 influenza type B strains
aQIV: Participants receive a 0.5-mL intramuscular dose of aQIV on Day 1
|
Comparator QIV
n=1016 Participants
Non-adjuvanted comparator QIV containing 2 influenza type A strains and 2 influenza type B strains
Comparator QIV: Participants receive a 0.5-mL intramuscular dose of Comparator QIV on Day 1
|
|---|---|---|
|
Immunogenicity Endpoint: GMT and GMT Ratio of HI Antibodies at Day 22 for the A/H1N1, A/H3N2, B/Yamagata, and B/Victoria Vaccine Strains
A/H1N1
|
729.17 Titer
Interval 687.51 to 773.36
|
589.07 Titer
Interval 555.25 to 624.94
|
|
Immunogenicity Endpoint: GMT and GMT Ratio of HI Antibodies at Day 22 for the A/H1N1, A/H3N2, B/Yamagata, and B/Victoria Vaccine Strains
A/H3N2
|
347.09 Titer
Interval 324.44 to 371.33
|
315.69 Titer
Interval 295.04 to 337.79
|
|
Immunogenicity Endpoint: GMT and GMT Ratio of HI Antibodies at Day 22 for the A/H1N1, A/H3N2, B/Yamagata, and B/Victoria Vaccine Strains
B/Yamagata
|
155.19 Titer
Interval 147.67 to 163.09
|
146.89 Titer
Interval 139.74 to 154.4
|
|
Immunogenicity Endpoint: GMT and GMT Ratio of HI Antibodies at Day 22 for the A/H1N1, A/H3N2, B/Yamagata, and B/Victoria Vaccine Strains
B/Victoria
|
143.73 Titer
Interval 136.44 to 151.42
|
143.74 Titer
Interval 136.42 to 151.45
|
SECONDARY outcome
Timeframe: Day 181Population: FAS Immunogenicity. Note: Adjusted GMTs are presented.
The GMT ratio is defined as the geometric mean of the postvaccination HI titer for Comparator QIV over the geometric mean of the postvaccination HI titer for aQIV.
Outcome measures
| Measure |
aQIV
n=1027 Participants
Adjuvanted QIV containing 2 influenza type A strains and 2 influenza type B strains
aQIV: Participants receive a 0.5-mL intramuscular dose of aQIV on Day 1
|
Comparator QIV
n=1016 Participants
Non-adjuvanted comparator QIV containing 2 influenza type A strains and 2 influenza type B strains
Comparator QIV: Participants receive a 0.5-mL intramuscular dose of Comparator QIV on Day 1
|
|---|---|---|
|
Immunogenicity Endpoint: GMT and GMT Ratio of HI Antibodies at Day 181 for the A/H1N1, A/H3N2, B/Yamagata, and B/Victoria Vaccine Strains
A/H1N1
|
351.73 Titer
Interval 331.61 to 373.06
|
306.11 Titer
Interval 288.62 to 324.66
|
|
Immunogenicity Endpoint: GMT and GMT Ratio of HI Antibodies at Day 181 for the A/H1N1, A/H3N2, B/Yamagata, and B/Victoria Vaccine Strains
A/H3N2
|
165.17 Titer
Interval 155.85 to 175.05
|
157.34 Titer
Interval 148.48 to 166.73
|
|
Immunogenicity Endpoint: GMT and GMT Ratio of HI Antibodies at Day 181 for the A/H1N1, A/H3N2, B/Yamagata, and B/Victoria Vaccine Strains
B/Yamagata
|
83.42 Titer
Interval 79.81 to 87.2
|
84.53 Titer
Interval 80.87 to 88.36
|
|
Immunogenicity Endpoint: GMT and GMT Ratio of HI Antibodies at Day 181 for the A/H1N1, A/H3N2, B/Yamagata, and B/Victoria Vaccine Strains
B/Victoria
|
79.51 Titer
Interval 75.81 to 83.4
|
81.73 Titer
Interval 77.92 to 85.72
|
SECONDARY outcome
Timeframe: Day 1 to Day 181Population: FAS Immunogenicity. Note: Unadjusted GMTs are presented.
GMTs on Day 1 (prior to vaccination), Day 22 (3 weeks after vaccination), and Day 181 (6 months after vaccination) as determined by HI assay against each of the four vaccine strains
Outcome measures
| Measure |
aQIV
n=1027 Participants
Adjuvanted QIV containing 2 influenza type A strains and 2 influenza type B strains
aQIV: Participants receive a 0.5-mL intramuscular dose of aQIV on Day 1
|
Comparator QIV
n=1016 Participants
Non-adjuvanted comparator QIV containing 2 influenza type A strains and 2 influenza type B strains
Comparator QIV: Participants receive a 0.5-mL intramuscular dose of Comparator QIV on Day 1
|
|---|---|---|
|
Immunogenicity Endpoint: GMT of HI Antibodies on Day 1, Day 22, and Day 181 for the A/H1N1, A/H3N2, B/Yamagata, and B/Victoria Vaccine Strains
A/H3N2 Day 22 GMT
|
323.40 Titer
Interval 300.77 to 347.73
|
292.50 Titer
Interval 271.72 to 314.88
|
|
Immunogenicity Endpoint: GMT of HI Antibodies on Day 1, Day 22, and Day 181 for the A/H1N1, A/H3N2, B/Yamagata, and B/Victoria Vaccine Strains
A/H3N2 Day 181 GMT
|
151.92 Titer
Interval 141.27 to 163.37
|
143.80 Titer
Interval 133.33 to 155.09
|
|
Immunogenicity Endpoint: GMT of HI Antibodies on Day 1, Day 22, and Day 181 for the A/H1N1, A/H3N2, B/Yamagata, and B/Victoria Vaccine Strains
B/Yamagata Day 1 GMT
|
38.50 Titer
Interval 35.83 to 41.38
|
38.33 Titer
Interval 35.68 to 41.18
|
|
Immunogenicity Endpoint: GMT of HI Antibodies on Day 1, Day 22, and Day 181 for the A/H1N1, A/H3N2, B/Yamagata, and B/Victoria Vaccine Strains
B/Yamagata Day 22 GMT
|
144.30 Titer
Interval 136.02 to 153.08
|
134.15 Titer
Interval 126.31 to 142.48
|
|
Immunogenicity Endpoint: GMT of HI Antibodies on Day 1, Day 22, and Day 181 for the A/H1N1, A/H3N2, B/Yamagata, and B/Victoria Vaccine Strains
B/Yamagata Day 181 GMT
|
76.87 Titer
Interval 72.33 to 81.7
|
77.34 Titer
Interval 72.72 to 82.25
|
|
Immunogenicity Endpoint: GMT of HI Antibodies on Day 1, Day 22, and Day 181 for the A/H1N1, A/H3N2, B/Yamagata, and B/Victoria Vaccine Strains
B/Victoria Day 1 GMT
|
36.24 Titer
Interval 33.78 to 38.87
|
37.06 Titer
Interval 34.56 to 39.73
|
|
Immunogenicity Endpoint: GMT of HI Antibodies on Day 1, Day 22, and Day 181 for the A/H1N1, A/H3N2, B/Yamagata, and B/Victoria Vaccine Strains
B/Victoria Day 22 GMT
|
134.45 Titer
Interval 126.24 to 143.21
|
132.45 Titer
Interval 124.32 to 141.1
|
|
Immunogenicity Endpoint: GMT of HI Antibodies on Day 1, Day 22, and Day 181 for the A/H1N1, A/H3N2, B/Yamagata, and B/Victoria Vaccine Strains
B/Victoria Day 181 GMT
|
74.17 Titer
Interval 69.66 to 78.97
|
75.99 Titer
Interval 71.42 to 80.85
|
|
Immunogenicity Endpoint: GMT of HI Antibodies on Day 1, Day 22, and Day 181 for the A/H1N1, A/H3N2, B/Yamagata, and B/Victoria Vaccine Strains
A/H1N1 Day 1 GMT
|
54.37 Titer
Interval 49.71 to 59.47
|
50.41 Titer
Interval 46.13 to 55.09
|
|
Immunogenicity Endpoint: GMT of HI Antibodies on Day 1, Day 22, and Day 181 for the A/H1N1, A/H3N2, B/Yamagata, and B/Victoria Vaccine Strains
A/H1N1 Day 22 GMT
|
708.36 Titer
Interval 666.39 to 752.98
|
553.70 Titer
Interval 519.14 to 590.56
|
|
Immunogenicity Endpoint: GMT of HI Antibodies on Day 1, Day 22, and Day 181 for the A/H1N1, A/H3N2, B/Yamagata, and B/Victoria Vaccine Strains
A/H1N1 Day 181 GMT
|
330.76 Titer
Interval 308.44 to 354.7
|
276.24 Titer
Interval 257.32 to 296.56
|
|
Immunogenicity Endpoint: GMT of HI Antibodies on Day 1, Day 22, and Day 181 for the A/H1N1, A/H3N2, B/Yamagata, and B/Victoria Vaccine Strains
A/H3N2 Day 1 GMT
|
45.97 Titer
Interval 42.06 to 50.25
|
46.54 Titer
Interval 42.63 to 50.81
|
SECONDARY outcome
Timeframe: Day 1 to Day 181Population: FAS Immunogenicity
The GMFI is defined as the geometric mean of the fold increase of postvaccination HI titer over the prevaccination HI titer.
Outcome measures
| Measure |
aQIV
n=1027 Participants
Adjuvanted QIV containing 2 influenza type A strains and 2 influenza type B strains
aQIV: Participants receive a 0.5-mL intramuscular dose of aQIV on Day 1
|
Comparator QIV
n=1016 Participants
Non-adjuvanted comparator QIV containing 2 influenza type A strains and 2 influenza type B strains
Comparator QIV: Participants receive a 0.5-mL intramuscular dose of Comparator QIV on Day 1
|
|---|---|---|
|
Immunogenicity Endpoint: Geometric Mean Fold Increase (GMFI) for Day 22/Day 1 and Day 181/Day 1 for the A/H1N1, A/H3N2, B/Yamagata, and B/Victoria Vaccine Strains
A/H1N1 Fold increase Day 22 HI Titer
|
13.07 Fold Increase
Interval 11.92 to 14.34
|
11.00 Fold Increase
Interval 10.07 to 12.02
|
|
Immunogenicity Endpoint: Geometric Mean Fold Increase (GMFI) for Day 22/Day 1 and Day 181/Day 1 for the A/H1N1, A/H3N2, B/Yamagata, and B/Victoria Vaccine Strains
A/H1N1 Fold increase Day 181 HI Titer
|
6.22 Fold Increase
Interval 5.71 to 6.76
|
5.47 Fold Increase
Interval 5.03 to 5.95
|
|
Immunogenicity Endpoint: Geometric Mean Fold Increase (GMFI) for Day 22/Day 1 and Day 181/Day 1 for the A/H1N1, A/H3N2, B/Yamagata, and B/Victoria Vaccine Strains
A/H3N2 Fold increase Day 22 HI Titer
|
7.09 Fold Increase
Interval 6.43 to 7.83
|
6.31 Fold Increase
Interval 5.78 to 6.89
|
|
Immunogenicity Endpoint: Geometric Mean Fold Increase (GMFI) for Day 22/Day 1 and Day 181/Day 1 for the A/H1N1, A/H3N2, B/Yamagata, and B/Victoria Vaccine Strains
A/H3N2 Fold increase Day 181 HI Titer
|
3.29 Fold Increase
Interval 3.04 to 3.56
|
3.08 Fold Increase
Interval 2.86 to 3.31
|
|
Immunogenicity Endpoint: Geometric Mean Fold Increase (GMFI) for Day 22/Day 1 and Day 181/Day 1 for the A/H1N1, A/H3N2, B/Yamagata, and B/Victoria Vaccine Strains
B/Yamagata Fold increase Day 22 HI Titer
|
3.77 Fold Increase
Interval 3.5 to 4.07
|
3.50 Fold Increase
Interval 3.25 to 3.77
|
|
Immunogenicity Endpoint: Geometric Mean Fold Increase (GMFI) for Day 22/Day 1 and Day 181/Day 1 for the A/H1N1, A/H3N2, B/Yamagata, and B/Victoria Vaccine Strains
B/Yamagata Fold increase Day 181 HI Titer
|
2.03 Fold Increase
Interval 1.91 to 2.16
|
2.01 Fold Increase
Interval 1.89 to 2.14
|
|
Immunogenicity Endpoint: Geometric Mean Fold Increase (GMFI) for Day 22/Day 1 and Day 181/Day 1 for the A/H1N1, A/H3N2, B/Yamagata, and B/Victoria Vaccine Strains
B/Victoria Fold increase Day 22 HI Titer
|
3.73 Fold Increase
Interval 3.45 to 4.02
|
3.60 Fold Increase
Interval 3.33 to 3.88
|
|
Immunogenicity Endpoint: Geometric Mean Fold Increase (GMFI) for Day 22/Day 1 and Day 181/Day 1 for the A/H1N1, A/H3N2, B/Yamagata, and B/Victoria Vaccine Strains
B/Victoria Fold increase Day 181 HI Titer
|
2.06 Fold Increase
Interval 1.93 to 2.19
|
2.05 Fold Increase
Interval 1.92 to 2.2
|
SECONDARY outcome
Timeframe: Day 1 to Day 181Population: FAS Immunogenicity
Percentage of subjects with a titer ≥1:40 on Day 1, Day 22, and Day 181 as determined by HI assay against each of the four vaccine strains
Outcome measures
| Measure |
aQIV
n=1027 Participants
Adjuvanted QIV containing 2 influenza type A strains and 2 influenza type B strains
aQIV: Participants receive a 0.5-mL intramuscular dose of aQIV on Day 1
|
Comparator QIV
n=1016 Participants
Non-adjuvanted comparator QIV containing 2 influenza type A strains and 2 influenza type B strains
Comparator QIV: Participants receive a 0.5-mL intramuscular dose of Comparator QIV on Day 1
|
|---|---|---|
|
Immunogenicity Endpoint: The Percentage of Subjects With a Titer ≥1:40 at Day 1, Day 22, and Day 181 for the A/H1N1, A/H3N2, B/Yamagata, and B/Victoria Vaccine Strains
A/H1N1 HI Titer ≥1:40 at Day 181
|
98.2 percentage of participants
Interval 97.13 to 98.92
|
96.3 percentage of participants
Interval 94.89 to 97.36
|
|
Immunogenicity Endpoint: The Percentage of Subjects With a Titer ≥1:40 at Day 1, Day 22, and Day 181 for the A/H1N1, A/H3N2, B/Yamagata, and B/Victoria Vaccine Strains
A/H3N2 HI Titer ≥1:40 at Day 1
|
60.3 percentage of participants
Interval 57.16 to 63.3
|
61.7 percentage of participants
Interval 58.61 to 64.72
|
|
Immunogenicity Endpoint: The Percentage of Subjects With a Titer ≥1:40 at Day 1, Day 22, and Day 181 for the A/H1N1, A/H3N2, B/Yamagata, and B/Victoria Vaccine Strains
A/H3N2 HI Titer ≥1:40 at Day 22
|
97.5 percentage of participants
Interval 96.39 to 98.4
|
97.3 percentage of participants
Interval 96.12 to 98.23
|
|
Immunogenicity Endpoint: The Percentage of Subjects With a Titer ≥1:40 at Day 1, Day 22, and Day 181 for the A/H1N1, A/H3N2, B/Yamagata, and B/Victoria Vaccine Strains
A/H3N2 HI Titer ≥1:40 at Day 181
|
92.0 percentage of participants
Interval 90.08 to 93.59
|
89.9 percentage of participants
Interval 87.81 to 91.68
|
|
Immunogenicity Endpoint: The Percentage of Subjects With a Titer ≥1:40 at Day 1, Day 22, and Day 181 for the A/H1N1, A/H3N2, B/Yamagata, and B/Victoria Vaccine Strains
B/Yamagata HI Titer ≥1:40 at Day 1
|
60.8 percentage of participants
Interval 57.77 to 63.87
|
61.9 percentage of participants
Interval 58.81 to 64.9
|
|
Immunogenicity Endpoint: The Percentage of Subjects With a Titer ≥1:40 at Day 1, Day 22, and Day 181 for the A/H1N1, A/H3N2, B/Yamagata, and B/Victoria Vaccine Strains
B/Yamagata HI Titer ≥1:40 at Day 22
|
95.9 percentage of participants
Interval 94.47 to 97.01
|
94.6 percentage of participants
Interval 93.05 to 95.94
|
|
Immunogenicity Endpoint: The Percentage of Subjects With a Titer ≥1:40 at Day 1, Day 22, and Day 181 for the A/H1N1, A/H3N2, B/Yamagata, and B/Victoria Vaccine Strains
B/Yamagata HI Titer ≥1:40 at Day 181
|
83.9 percentage of participants
Interval 81.48 to 86.17
|
84.0 percentage of participants
Interval 81.6 to 86.28
|
|
Immunogenicity Endpoint: The Percentage of Subjects With a Titer ≥1:40 at Day 1, Day 22, and Day 181 for the A/H1N1, A/H3N2, B/Yamagata, and B/Victoria Vaccine Strains
B/Victoria HI Titer ≥1:40 at Day 1
|
58.5 percentage of participants
Interval 55.42 to 61.57
|
60.4 percentage of participants
Interval 57.3 to 63.43
|
|
Immunogenicity Endpoint: The Percentage of Subjects With a Titer ≥1:40 at Day 1, Day 22, and Day 181 for the A/H1N1, A/H3N2, B/Yamagata, and B/Victoria Vaccine Strains
B/Victoria HI Titer ≥1:40 at Day 22
|
94.4 percentage of participants
Interval 92.79 to 95.72
|
93.3 percentage of participants
Interval 91.63 to 94.81
|
|
Immunogenicity Endpoint: The Percentage of Subjects With a Titer ≥1:40 at Day 1, Day 22, and Day 181 for the A/H1N1, A/H3N2, B/Yamagata, and B/Victoria Vaccine Strains
B/Victoria HI Titer ≥1:40 at Day 181
|
83.4 percentage of participants
Interval 80.9 to 85.66
|
84.3 percentage of participants
Interval 81.84 to 86.48
|
|
Immunogenicity Endpoint: The Percentage of Subjects With a Titer ≥1:40 at Day 1, Day 22, and Day 181 for the A/H1N1, A/H3N2, B/Yamagata, and B/Victoria Vaccine Strains
A/H1N1 HI Titer ≥1:40 at Day 1
|
65.2 percentage of participants
Interval 62.2 to 68.15
|
64.2 percentage of participants
Interval 61.14 to 67.15
|
|
Immunogenicity Endpoint: The Percentage of Subjects With a Titer ≥1:40 at Day 1, Day 22, and Day 181 for the A/H1N1, A/H3N2, B/Yamagata, and B/Victoria Vaccine Strains
A/H1N1 HI Titer ≥1:40 at Day 22
|
99.7 percentage of participants
Interval 99.14 to 99.94
|
99.2 percentage of participants
Interval 98.44 to 99.66
|
SECONDARY outcome
Timeframe: Day 1 to Day 181Population: FAS Immunogenicity
The SCR defined as the percentage of subjects with either a prevaccination HI titer \<1:10 and a postvaccination (Day 22 or Day 181) HI titer ≥1:40, or with either a prevaccination HI titer ≥1:10 and a ≥4-fold increase in postvaccination HI titer.
Outcome measures
| Measure |
aQIV
n=1027 Participants
Adjuvanted QIV containing 2 influenza type A strains and 2 influenza type B strains
aQIV: Participants receive a 0.5-mL intramuscular dose of aQIV on Day 1
|
Comparator QIV
n=1016 Participants
Non-adjuvanted comparator QIV containing 2 influenza type A strains and 2 influenza type B strains
Comparator QIV: Participants receive a 0.5-mL intramuscular dose of Comparator QIV on Day 1
|
|---|---|---|
|
Immunogenicity Endpoint: SCR at Day 22 and Day 181 for the A/H1N1, A/H3N2, B/Yamagata, and B/Victoria Vaccine Strains
A/H1N1 Day 181 SCR
|
64.5 percentage of participants
Interval 61.46 to 67.55
|
56.1 percentage of participants
Interval 52.94 to 59.24
|
|
Immunogenicity Endpoint: SCR at Day 22 and Day 181 for the A/H1N1, A/H3N2, B/Yamagata, and B/Victoria Vaccine Strains
A/H1N1 Day 22 SCR
|
80.8 percentage of participants
Interval 78.24 to 83.2
|
77.1 percentage of participants
Interval 74.34 to 79.65
|
|
Immunogenicity Endpoint: SCR at Day 22 and Day 181 for the A/H1N1, A/H3N2, B/Yamagata, and B/Victoria Vaccine Strains
A/H3N2 Day 22 SCR
|
63.4 percentage of participants
Interval 60.35 to 66.42
|
61.8 percentage of participants
Interval 58.65 to 64.79
|
|
Immunogenicity Endpoint: SCR at Day 22 and Day 181 for the A/H1N1, A/H3N2, B/Yamagata, and B/Victoria Vaccine Strains
A/H3N2 Day 181 SCR
|
39.4 percentage of participants
Interval 36.28 to 42.54
|
38.6 percentage of participants
Interval 35.51 to 41.72
|
|
Immunogenicity Endpoint: SCR at Day 22 and Day 181 for the A/H1N1, A/H3N2, B/Yamagata, and B/Victoria Vaccine Strains
B/Yamagata Day 22 SCR
|
42.9 percentage of participants
Interval 39.82 to 46.02
|
41.1 percentage of participants
Interval 37.99 to 44.19
|
|
Immunogenicity Endpoint: SCR at Day 22 and Day 181 for the A/H1N1, A/H3N2, B/Yamagata, and B/Victoria Vaccine Strains
B/Yamagata Day 181 SCR
|
22.4 percentage of participants
Interval 19.82 to 25.16
|
22.4 percentage of participants
Interval 19.86 to 25.19
|
|
Immunogenicity Endpoint: SCR at Day 22 and Day 181 for the A/H1N1, A/H3N2, B/Yamagata, and B/Victoria Vaccine Strains
B/Victoria Day 22 SCR
|
43.9 percentage of participants
Interval 40.86 to 47.08
|
40.6 percentage of participants
Interval 37.5 to 43.68
|
|
Immunogenicity Endpoint: SCR at Day 22 and Day 181 for the A/H1N1, A/H3N2, B/Yamagata, and B/Victoria Vaccine Strains
B/Victoria Day 181 SCR
|
24.3 percentage of participants
Interval 21.64 to 27.13
|
23.6 percentage of participants
Interval 20.97 to 26.38
|
SECONDARY outcome
Timeframe: Day 1 through Day 7Population: Solicited Safety Set, defined as all subjects in the All Exposed Set with any solicited AE data including temperature measurements or use of analgesics/antipyretics
Number and percentage of subjects with solicited local and systemic AEs occurring for 7 days following vaccination
Outcome measures
| Measure |
aQIV
n=1020 Participants
Adjuvanted QIV containing 2 influenza type A strains and 2 influenza type B strains
aQIV: Participants receive a 0.5-mL intramuscular dose of aQIV on Day 1
|
Comparator QIV
n=1008 Participants
Non-adjuvanted comparator QIV containing 2 influenza type A strains and 2 influenza type B strains
Comparator QIV: Participants receive a 0.5-mL intramuscular dose of Comparator QIV on Day 1
|
|---|---|---|
|
Safety Endpoint: Solicited Local and Systemic AEs for 7 Days Following Vaccination
Analgesic/Antipyretic Use
|
132 Participants
|
97 Participants
|
|
Safety Endpoint: Solicited Local and Systemic AEs for 7 Days Following Vaccination
Any Solicited AEs
|
672 Participants
|
541 Participants
|
|
Safety Endpoint: Solicited Local and Systemic AEs for 7 Days Following Vaccination
Any Solicited Local AEs
|
508 Participants
|
306 Participants
|
|
Safety Endpoint: Solicited Local and Systemic AEs for 7 Days Following Vaccination
Any Solicited Systemic AEs
|
462 Participants
|
403 Participants
|
SECONDARY outcome
Timeframe: Day 1 through Day 22Population: Unsolicited Safety Set, defined as all subjects in the All Exposed Set with any unsolicited AE data. Note: Subjects are categorized according to the maximum symptom severity.
The percentage of subjects with at least one unsolicited AE occurring 21 days following vaccination The severity of AEs is based on the maximum severity associated with a Preferred Term for a reported AE. Related AEs include possibly related AEs, probably related AEs and AEs with missing relatedness assessment. The severity and relatedness of AEs were determined by the investigator. For the any AE summary by severity, a subject with multiple AEs is counted according to the highest severity of their reported AEs.
Outcome measures
| Measure |
aQIV
n=1027 Participants
Adjuvanted QIV containing 2 influenza type A strains and 2 influenza type B strains
aQIV: Participants receive a 0.5-mL intramuscular dose of aQIV on Day 1
|
Comparator QIV
n=1016 Participants
Non-adjuvanted comparator QIV containing 2 influenza type A strains and 2 influenza type B strains
Comparator QIV: Participants receive a 0.5-mL intramuscular dose of Comparator QIV on Day 1
|
|---|---|---|
|
Safety Endpoint: All Unsolicited AEs for 21 Days Following Vaccination
Any AE
|
169 Participants
|
172 Participants
|
|
Safety Endpoint: All Unsolicited AEs for 21 Days Following Vaccination
Any AE (Mild)
|
116 Participants
|
115 Participants
|
|
Safety Endpoint: All Unsolicited AEs for 21 Days Following Vaccination
Any AE (Moderate)
|
51 Participants
|
50 Participants
|
|
Safety Endpoint: All Unsolicited AEs for 21 Days Following Vaccination
Any AE (Severe)
|
2 Participants
|
7 Participants
|
|
Safety Endpoint: All Unsolicited AEs for 21 Days Following Vaccination
Related AE
|
33 Participants
|
32 Participants
|
SECONDARY outcome
Timeframe: Day 1 through Day 271Population: Unsolicited Safety Set
The percentage of subjects with any SAE, AE leading to withdrawal, or AESI during the study period
Outcome measures
| Measure |
aQIV
n=1027 Participants
Adjuvanted QIV containing 2 influenza type A strains and 2 influenza type B strains
aQIV: Participants receive a 0.5-mL intramuscular dose of aQIV on Day 1
|
Comparator QIV
n=1016 Participants
Non-adjuvanted comparator QIV containing 2 influenza type A strains and 2 influenza type B strains
Comparator QIV: Participants receive a 0.5-mL intramuscular dose of Comparator QIV on Day 1
|
|---|---|---|
|
Safety Endpoint: Serious Adverse Events (SAEs), Adverse Events (AEs) Leading to Withdrawal From the Study, and Adverse Events of Special Interest (AESIs)
SAE
|
31 Participants
|
31 Participants
|
|
Safety Endpoint: Serious Adverse Events (SAEs), Adverse Events (AEs) Leading to Withdrawal From the Study, and Adverse Events of Special Interest (AESIs)
Related SAE
|
0 Participants
|
1 Participants
|
|
Safety Endpoint: Serious Adverse Events (SAEs), Adverse Events (AEs) Leading to Withdrawal From the Study, and Adverse Events of Special Interest (AESIs)
AE leading to study withdrawal
|
0 Participants
|
1 Participants
|
|
Safety Endpoint: Serious Adverse Events (SAEs), Adverse Events (AEs) Leading to Withdrawal From the Study, and Adverse Events of Special Interest (AESIs)
AESI
|
2 Participants
|
0 Participants
|
|
Safety Endpoint: Serious Adverse Events (SAEs), Adverse Events (AEs) Leading to Withdrawal From the Study, and Adverse Events of Special Interest (AESIs)
Death
|
1 Participants
|
0 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Day 22Population: FAS Immunogenicity. Subgroup analysis by age (50 to 59 years; 60 to 64 years). Note: Adjusted GMTs are presented.
The GMT ratio is defined as the geometric mean of the postvaccination HI titer for Comparator QIV over the geometric mean of the postvaccination HI titer for aQIV.
Outcome measures
| Measure |
aQIV
n=1027 Participants
Adjuvanted QIV containing 2 influenza type A strains and 2 influenza type B strains
aQIV: Participants receive a 0.5-mL intramuscular dose of aQIV on Day 1
|
Comparator QIV
n=1016 Participants
Non-adjuvanted comparator QIV containing 2 influenza type A strains and 2 influenza type B strains
Comparator QIV: Participants receive a 0.5-mL intramuscular dose of Comparator QIV on Day 1
|
|---|---|---|
|
Immunogenicity Endpoint: GMT and GMT Ratio of HI Antibodies at Day 22 for the A/H1N1, A/H3N2, B/Yamagata, and B/Victoria Vaccine Strains by Age (Subgroup Analysis)
A/H1N1 (50 to 59 years)
|
674.25 Titer
Interval 622.7 to 730.07
|
565.33 Titer
Interval 521.77 to 612.53
|
|
Immunogenicity Endpoint: GMT and GMT Ratio of HI Antibodies at Day 22 for the A/H1N1, A/H3N2, B/Yamagata, and B/Victoria Vaccine Strains by Age (Subgroup Analysis)
A/H3N2 (50 to 59 years)
|
345.83 Titer
Interval 317.55 to 376.63
|
319.55 Titer
Interval 293.19 to 348.27
|
|
Immunogenicity Endpoint: GMT and GMT Ratio of HI Antibodies at Day 22 for the A/H1N1, A/H3N2, B/Yamagata, and B/Victoria Vaccine Strains by Age (Subgroup Analysis)
B/Yamagata (50 to 59 years)
|
161.27 Titer
Interval 150.98 to 172.25
|
149.36 Titer
Interval 139.72 to 159.67
|
|
Immunogenicity Endpoint: GMT and GMT Ratio of HI Antibodies at Day 22 for the A/H1N1, A/H3N2, B/Yamagata, and B/Victoria Vaccine Strains by Age (Subgroup Analysis)
B/Victoria (50 to 59 years)
|
167.60 Titer
Interval 156.68 to 179.27
|
165.81 Titer
Interval 154.92 to 177.47
|
|
Immunogenicity Endpoint: GMT and GMT Ratio of HI Antibodies at Day 22 for the A/H1N1, A/H3N2, B/Yamagata, and B/Victoria Vaccine Strains by Age (Subgroup Analysis)
A/H1N1 (60 to 64 years)
|
806.65 Titer
Interval 740.51 to 878.7
|
618.90 Titer
Interval 567.97 to 674.41
|
|
Immunogenicity Endpoint: GMT and GMT Ratio of HI Antibodies at Day 22 for the A/H1N1, A/H3N2, B/Yamagata, and B/Victoria Vaccine Strains by Age (Subgroup Analysis)
A/H3N2 (60 to 64 years)
|
348.59 Titer
Interval 312.82 to 388.45
|
310.23 Titer
Interval 278.52 to 345.54
|
|
Immunogenicity Endpoint: GMT and GMT Ratio of HI Antibodies at Day 22 for the A/H1N1, A/H3N2, B/Yamagata, and B/Victoria Vaccine Strains by Age (Subgroup Analysis)
B/Yamagata (60 to 64 years)
|
148.20 Titer
Interval 137.62 to 159.59
|
144.34 Titer
Interval 134.1 to 155.36
|
|
Immunogenicity Endpoint: GMT and GMT Ratio of HI Antibodies at Day 22 for the A/H1N1, A/H3N2, B/Yamagata, and B/Victoria Vaccine Strains by Age (Subgroup Analysis)
B/Victoria (60 to 64 years)
|
119.64 Titer
Interval 110.33 to 129.75
|
121.16 Titer
Interval 111.79 to 131.32
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Day 22Population: FAS Immunogenicity. Subgroup analysis by influenza vaccination history (Received at least one influenza vaccination within the previous 3 influenza seasons: yes; no). Note: Adjusted GMTs are presented.
The GMT ratio is defined as the geometric mean of the postvaccination HI titer for Comparator QIV over the geometric mean of the postvaccination HI titer for aQIV.
Outcome measures
| Measure |
aQIV
n=1027 Participants
Adjuvanted QIV containing 2 influenza type A strains and 2 influenza type B strains
aQIV: Participants receive a 0.5-mL intramuscular dose of aQIV on Day 1
|
Comparator QIV
n=1016 Participants
Non-adjuvanted comparator QIV containing 2 influenza type A strains and 2 influenza type B strains
Comparator QIV: Participants receive a 0.5-mL intramuscular dose of Comparator QIV on Day 1
|
|---|---|---|
|
Immunogenicity Endpoint: GMT and GMT Ratio of HI Antibodies at Day 22 for the A/H1N1, A/H3N2, B/Yamagata, and B/Victoria Vaccine Strains by Influenza Vaccination History (Subgroup Analysis)
A/H1N1 (yes)
|
648.75 Titer
Interval 601.45 to 699.78
|
547.54 Titer
Interval 508.79 to 589.24
|
|
Immunogenicity Endpoint: GMT and GMT Ratio of HI Antibodies at Day 22 for the A/H1N1, A/H3N2, B/Yamagata, and B/Victoria Vaccine Strains by Influenza Vaccination History (Subgroup Analysis)
A/H3N2 (yes)
|
279.61 Titer
Interval 257.7 to 303.38
|
282.44 Titer
Interval 260.95 to 305.71
|
|
Immunogenicity Endpoint: GMT and GMT Ratio of HI Antibodies at Day 22 for the A/H1N1, A/H3N2, B/Yamagata, and B/Victoria Vaccine Strains by Influenza Vaccination History (Subgroup Analysis)
B/Yamagata (yes)
|
116.48 Titer
Interval 110.62 to 122.65
|
110.37 Titer
Interval 104.98 to 116.04
|
|
Immunogenicity Endpoint: GMT and GMT Ratio of HI Antibodies at Day 22 for the A/H1N1, A/H3N2, B/Yamagata, and B/Victoria Vaccine Strains by Influenza Vaccination History (Subgroup Analysis)
B/Victoria (yes)
|
101.89 Titer
Interval 96.5 to 107.59
|
101.59 Titer
Interval 96.39 to 107.07
|
|
Immunogenicity Endpoint: GMT and GMT Ratio of HI Antibodies at Day 22 for the A/H1N1, A/H3N2, B/Yamagata, and B/Victoria Vaccine Strains by Influenza Vaccination History (Subgroup Analysis)
A/H1N1 (no)
|
755.46 Titer
Interval 688.45 to 829.0
|
582.90 Titer
Interval 529.83 to 641.28
|
|
Immunogenicity Endpoint: GMT and GMT Ratio of HI Antibodies at Day 22 for the A/H1N1, A/H3N2, B/Yamagata, and B/Victoria Vaccine Strains by Influenza Vaccination History (Subgroup Analysis)
A/H3N2 (no)
|
389.77 Titer
Interval 347.94 to 436.63
|
312.38 Titer
Interval 277.97 to 351.06
|
|
Immunogenicity Endpoint: GMT and GMT Ratio of HI Antibodies at Day 22 for the A/H1N1, A/H3N2, B/Yamagata, and B/Victoria Vaccine Strains by Influenza Vaccination History (Subgroup Analysis)
B/Yamagata (no)
|
188.78 Titer
Interval 172.28 to 206.85
|
178.45 Titer
Interval 162.38 to 196.12
|
|
Immunogenicity Endpoint: GMT and GMT Ratio of HI Antibodies at Day 22 for the A/H1N1, A/H3N2, B/Yamagata, and B/Victoria Vaccine Strains by Influenza Vaccination History (Subgroup Analysis)
B/Victoria (no)
|
185.31 Titer
Interval 168.62 to 203.65
|
186.65 Titer
Interval 169.3 to 205.78
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Day 22Population: FAS Immunogenicity. Subgroup analysis by comorbidity risk score (\<50; ≥50). Note: Adjusted GMTs are presented.
The GMT ratio is defined as the geometric mean of the postvaccination HI titer for Comparator QIV over the geometric mean of the postvaccination HI titer for aQIV.
Outcome measures
| Measure |
aQIV
n=1027 Participants
Adjuvanted QIV containing 2 influenza type A strains and 2 influenza type B strains
aQIV: Participants receive a 0.5-mL intramuscular dose of aQIV on Day 1
|
Comparator QIV
n=1016 Participants
Non-adjuvanted comparator QIV containing 2 influenza type A strains and 2 influenza type B strains
Comparator QIV: Participants receive a 0.5-mL intramuscular dose of Comparator QIV on Day 1
|
|---|---|---|
|
Immunogenicity Endpoint: GMT and GMT Ratio of HI Antibodies at Day 22 for the A/H1N1, A/H3N2, B/Yamagata, and B/Victoria Vaccine Strains by Comorbidity Risk Score (Subgroup Analysis)
A/H1N1 (Comorbidity Risk Score <50)
|
715.26 Titer
Interval 671.75 to 761.6
|
586.42 Titer
Interval 550.95 to 624.16
|
|
Immunogenicity Endpoint: GMT and GMT Ratio of HI Antibodies at Day 22 for the A/H1N1, A/H3N2, B/Yamagata, and B/Victoria Vaccine Strains by Comorbidity Risk Score (Subgroup Analysis)
A/H3N2 (Comorbidity Risk Score <50)
|
337.43 Titer
Interval 314.06 to 362.53
|
314.75 Titer
Interval 293.14 to 337.96
|
|
Immunogenicity Endpoint: GMT and GMT Ratio of HI Antibodies at Day 22 for the A/H1N1, A/H3N2, B/Yamagata, and B/Victoria Vaccine Strains by Comorbidity Risk Score (Subgroup Analysis)
B/Yamagata (Comorbidity Risk Score <50)
|
150.17 Titer
Interval 142.37 to 158.4
|
145.98 Titer
Interval 138.44 to 153.93
|
|
Immunogenicity Endpoint: GMT and GMT Ratio of HI Antibodies at Day 22 for the A/H1N1, A/H3N2, B/Yamagata, and B/Victoria Vaccine Strains by Comorbidity Risk Score (Subgroup Analysis)
B/Victoria (Comorbidity Risk Score <50)
|
139.76 Titer
Interval 132.15 to 147.82
|
141.58 Titer
Interval 133.93 to 149.68
|
|
Immunogenicity Endpoint: GMT and GMT Ratio of HI Antibodies at Day 22 for the A/H1N1, A/H3N2, B/Yamagata, and B/Victoria Vaccine Strains by Comorbidity Risk Score (Subgroup Analysis)
A/H1N1 (Comorbidity Risk Score ≥50)
|
812.59 Titer
Interval 681.59 to 968.76
|
573.86 Titer
Interval 473.11 to 696.06
|
|
Immunogenicity Endpoint: GMT and GMT Ratio of HI Antibodies at Day 22 for the A/H1N1, A/H3N2, B/Yamagata, and B/Victoria Vaccine Strains by Comorbidity Risk Score (Subgroup Analysis)
A/H3N2 (Comorbidity Risk Score ≥50)
|
453.60 Titer
Interval 368.59 to 558.2
|
333.16 Titer
Interval 265.15 to 418.62
|
|
Immunogenicity Endpoint: GMT and GMT Ratio of HI Antibodies at Day 22 for the A/H1N1, A/H3N2, B/Yamagata, and B/Victoria Vaccine Strains by Comorbidity Risk Score (Subgroup Analysis)
B/Yamagata (Comorbidity Risk Score ≥50)
|
198.10 Titer
Interval 172.89 to 227.0
|
153.05 Titer
Interval 131.91 to 177.58
|
|
Immunogenicity Endpoint: GMT and GMT Ratio of HI Antibodies at Day 22 for the A/H1N1, A/H3N2, B/Yamagata, and B/Victoria Vaccine Strains by Comorbidity Risk Score (Subgroup Analysis)
B/Victoria (Comorbidity Risk Score ≥50)
|
174.79 Titer
Interval 151.43 to 201.74
|
158.12 Titer
Interval 135.26 to 184.85
|
Adverse Events
aQIV
Serious events: 31 serious events
Other events: 660 other events
Deaths: 1 deaths
Comparator QIV
Serious events: 31 serious events
Other events: 519 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
aQIV
n=1020 participants at risk；n=1027 participants at risk
Adjuvanted QIV containing 2 influenza type A strains and 2 influenza type B strains
aQIV: Participants receive a 0.5-mL intramuscular dose of aQIV on Day 1
|
Comparator QIV
n=1008 participants at risk；n=1016 participants at risk
Non-adjuvanted comparator QIV containing 2 influenza type A strains and 2 influenza type B strains
Comparator QIV: Participants receive a 0.5-mL intramuscular dose of Comparator QIV on Day 1
|
|---|---|---|
|
Infections and infestations
COVID-19
|
0.29%
3/1027 • SAEs: Day 1 through Day 271; nonserious unsolicited AEs: Day 1 through Day 22; solicited AEs: Day 1 through Day 7
Number and percentage of subjects with SAEs and other AEs (ie, nonserious unsolicited AEs and solicited AEs) All-cause mortality and SAEs are reported for the Unsolicited Safety Set. In the category of "Other Adverse Events", no nonserious unsolicited AEs were reported at a frequency \>5%; therefore, only solicited AEs occurring at a frequency \>5% in the Solicited Safety Set are reported in this section.
|
0.00%
0/1016 • SAEs: Day 1 through Day 271; nonserious unsolicited AEs: Day 1 through Day 22; solicited AEs: Day 1 through Day 7
Number and percentage of subjects with SAEs and other AEs (ie, nonserious unsolicited AEs and solicited AEs) All-cause mortality and SAEs are reported for the Unsolicited Safety Set. In the category of "Other Adverse Events", no nonserious unsolicited AEs were reported at a frequency \>5%; therefore, only solicited AEs occurring at a frequency \>5% in the Solicited Safety Set are reported in this section.
|
|
Infections and infestations
Abscess limb
|
0.10%
1/1027 • SAEs: Day 1 through Day 271; nonserious unsolicited AEs: Day 1 through Day 22; solicited AEs: Day 1 through Day 7
Number and percentage of subjects with SAEs and other AEs (ie, nonserious unsolicited AEs and solicited AEs) All-cause mortality and SAEs are reported for the Unsolicited Safety Set. In the category of "Other Adverse Events", no nonserious unsolicited AEs were reported at a frequency \>5%; therefore, only solicited AEs occurring at a frequency \>5% in the Solicited Safety Set are reported in this section.
|
0.10%
1/1016 • SAEs: Day 1 through Day 271; nonserious unsolicited AEs: Day 1 through Day 22; solicited AEs: Day 1 through Day 7
Number and percentage of subjects with SAEs and other AEs (ie, nonserious unsolicited AEs and solicited AEs) All-cause mortality and SAEs are reported for the Unsolicited Safety Set. In the category of "Other Adverse Events", no nonserious unsolicited AEs were reported at a frequency \>5%; therefore, only solicited AEs occurring at a frequency \>5% in the Solicited Safety Set are reported in this section.
|
|
Infections and infestations
Streptococcal sepsis
|
0.10%
1/1027 • SAEs: Day 1 through Day 271; nonserious unsolicited AEs: Day 1 through Day 22; solicited AEs: Day 1 through Day 7
Number and percentage of subjects with SAEs and other AEs (ie, nonserious unsolicited AEs and solicited AEs) All-cause mortality and SAEs are reported for the Unsolicited Safety Set. In the category of "Other Adverse Events", no nonserious unsolicited AEs were reported at a frequency \>5%; therefore, only solicited AEs occurring at a frequency \>5% in the Solicited Safety Set are reported in this section.
|
0.00%
0/1016 • SAEs: Day 1 through Day 271; nonserious unsolicited AEs: Day 1 through Day 22; solicited AEs: Day 1 through Day 7
Number and percentage of subjects with SAEs and other AEs (ie, nonserious unsolicited AEs and solicited AEs) All-cause mortality and SAEs are reported for the Unsolicited Safety Set. In the category of "Other Adverse Events", no nonserious unsolicited AEs were reported at a frequency \>5%; therefore, only solicited AEs occurring at a frequency \>5% in the Solicited Safety Set are reported in this section.
|
|
Infections and infestations
Viral upper respiratory tract infection
|
0.10%
1/1027 • SAEs: Day 1 through Day 271; nonserious unsolicited AEs: Day 1 through Day 22; solicited AEs: Day 1 through Day 7
Number and percentage of subjects with SAEs and other AEs (ie, nonserious unsolicited AEs and solicited AEs) All-cause mortality and SAEs are reported for the Unsolicited Safety Set. In the category of "Other Adverse Events", no nonserious unsolicited AEs were reported at a frequency \>5%; therefore, only solicited AEs occurring at a frequency \>5% in the Solicited Safety Set are reported in this section.
|
0.00%
0/1016 • SAEs: Day 1 through Day 271; nonserious unsolicited AEs: Day 1 through Day 22; solicited AEs: Day 1 through Day 7
Number and percentage of subjects with SAEs and other AEs (ie, nonserious unsolicited AEs and solicited AEs) All-cause mortality and SAEs are reported for the Unsolicited Safety Set. In the category of "Other Adverse Events", no nonserious unsolicited AEs were reported at a frequency \>5%; therefore, only solicited AEs occurring at a frequency \>5% in the Solicited Safety Set are reported in this section.
|
|
Infections and infestations
Cellulitis
|
0.00%
0/1027 • SAEs: Day 1 through Day 271; nonserious unsolicited AEs: Day 1 through Day 22; solicited AEs: Day 1 through Day 7
Number and percentage of subjects with SAEs and other AEs (ie, nonserious unsolicited AEs and solicited AEs) All-cause mortality and SAEs are reported for the Unsolicited Safety Set. In the category of "Other Adverse Events", no nonserious unsolicited AEs were reported at a frequency \>5%; therefore, only solicited AEs occurring at a frequency \>5% in the Solicited Safety Set are reported in this section.
|
0.10%
1/1016 • SAEs: Day 1 through Day 271; nonserious unsolicited AEs: Day 1 through Day 22; solicited AEs: Day 1 through Day 7
Number and percentage of subjects with SAEs and other AEs (ie, nonserious unsolicited AEs and solicited AEs) All-cause mortality and SAEs are reported for the Unsolicited Safety Set. In the category of "Other Adverse Events", no nonserious unsolicited AEs were reported at a frequency \>5%; therefore, only solicited AEs occurring at a frequency \>5% in the Solicited Safety Set are reported in this section.
|
|
Infections and infestations
Device related infection
|
0.00%
0/1027 • SAEs: Day 1 through Day 271; nonserious unsolicited AEs: Day 1 through Day 22; solicited AEs: Day 1 through Day 7
Number and percentage of subjects with SAEs and other AEs (ie, nonserious unsolicited AEs and solicited AEs) All-cause mortality and SAEs are reported for the Unsolicited Safety Set. In the category of "Other Adverse Events", no nonserious unsolicited AEs were reported at a frequency \>5%; therefore, only solicited AEs occurring at a frequency \>5% in the Solicited Safety Set are reported in this section.
|
0.10%
1/1016 • SAEs: Day 1 through Day 271; nonserious unsolicited AEs: Day 1 through Day 22; solicited AEs: Day 1 through Day 7
Number and percentage of subjects with SAEs and other AEs (ie, nonserious unsolicited AEs and solicited AEs) All-cause mortality and SAEs are reported for the Unsolicited Safety Set. In the category of "Other Adverse Events", no nonserious unsolicited AEs were reported at a frequency \>5%; therefore, only solicited AEs occurring at a frequency \>5% in the Solicited Safety Set are reported in this section.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/1027 • SAEs: Day 1 through Day 271; nonserious unsolicited AEs: Day 1 through Day 22; solicited AEs: Day 1 through Day 7
Number and percentage of subjects with SAEs and other AEs (ie, nonserious unsolicited AEs and solicited AEs) All-cause mortality and SAEs are reported for the Unsolicited Safety Set. In the category of "Other Adverse Events", no nonserious unsolicited AEs were reported at a frequency \>5%; therefore, only solicited AEs occurring at a frequency \>5% in the Solicited Safety Set are reported in this section.
|
0.10%
1/1016 • SAEs: Day 1 through Day 271; nonserious unsolicited AEs: Day 1 through Day 22; solicited AEs: Day 1 through Day 7
Number and percentage of subjects with SAEs and other AEs (ie, nonserious unsolicited AEs and solicited AEs) All-cause mortality and SAEs are reported for the Unsolicited Safety Set. In the category of "Other Adverse Events", no nonserious unsolicited AEs were reported at a frequency \>5%; therefore, only solicited AEs occurring at a frequency \>5% in the Solicited Safety Set are reported in this section.
|
|
Infections and infestations
Rectal abscess
|
0.00%
0/1027 • SAEs: Day 1 through Day 271; nonserious unsolicited AEs: Day 1 through Day 22; solicited AEs: Day 1 through Day 7
Number and percentage of subjects with SAEs and other AEs (ie, nonserious unsolicited AEs and solicited AEs) All-cause mortality and SAEs are reported for the Unsolicited Safety Set. In the category of "Other Adverse Events", no nonserious unsolicited AEs were reported at a frequency \>5%; therefore, only solicited AEs occurring at a frequency \>5% in the Solicited Safety Set are reported in this section.
|
0.10%
1/1016 • SAEs: Day 1 through Day 271; nonserious unsolicited AEs: Day 1 through Day 22; solicited AEs: Day 1 through Day 7
Number and percentage of subjects with SAEs and other AEs (ie, nonserious unsolicited AEs and solicited AEs) All-cause mortality and SAEs are reported for the Unsolicited Safety Set. In the category of "Other Adverse Events", no nonserious unsolicited AEs were reported at a frequency \>5%; therefore, only solicited AEs occurring at a frequency \>5% in the Solicited Safety Set are reported in this section.
|
|
Infections and infestations
Septic shock
|
0.00%
0/1027 • SAEs: Day 1 through Day 271; nonserious unsolicited AEs: Day 1 through Day 22; solicited AEs: Day 1 through Day 7
Number and percentage of subjects with SAEs and other AEs (ie, nonserious unsolicited AEs and solicited AEs) All-cause mortality and SAEs are reported for the Unsolicited Safety Set. In the category of "Other Adverse Events", no nonserious unsolicited AEs were reported at a frequency \>5%; therefore, only solicited AEs occurring at a frequency \>5% in the Solicited Safety Set are reported in this section.
|
0.10%
1/1016 • SAEs: Day 1 through Day 271; nonserious unsolicited AEs: Day 1 through Day 22; solicited AEs: Day 1 through Day 7
Number and percentage of subjects with SAEs and other AEs (ie, nonserious unsolicited AEs and solicited AEs) All-cause mortality and SAEs are reported for the Unsolicited Safety Set. In the category of "Other Adverse Events", no nonserious unsolicited AEs were reported at a frequency \>5%; therefore, only solicited AEs occurring at a frequency \>5% in the Solicited Safety Set are reported in this section.
|
|
Infections and infestations
Staphylococcal sepsis
|
0.00%
0/1027 • SAEs: Day 1 through Day 271; nonserious unsolicited AEs: Day 1 through Day 22; solicited AEs: Day 1 through Day 7
Number and percentage of subjects with SAEs and other AEs (ie, nonserious unsolicited AEs and solicited AEs) All-cause mortality and SAEs are reported for the Unsolicited Safety Set. In the category of "Other Adverse Events", no nonserious unsolicited AEs were reported at a frequency \>5%; therefore, only solicited AEs occurring at a frequency \>5% in the Solicited Safety Set are reported in this section.
|
0.10%
1/1016 • SAEs: Day 1 through Day 271; nonserious unsolicited AEs: Day 1 through Day 22; solicited AEs: Day 1 through Day 7
Number and percentage of subjects with SAEs and other AEs (ie, nonserious unsolicited AEs and solicited AEs) All-cause mortality and SAEs are reported for the Unsolicited Safety Set. In the category of "Other Adverse Events", no nonserious unsolicited AEs were reported at a frequency \>5%; therefore, only solicited AEs occurring at a frequency \>5% in the Solicited Safety Set are reported in this section.
|
|
Infections and infestations
Urosepsis
|
0.00%
0/1027 • SAEs: Day 1 through Day 271; nonserious unsolicited AEs: Day 1 through Day 22; solicited AEs: Day 1 through Day 7
Number and percentage of subjects with SAEs and other AEs (ie, nonserious unsolicited AEs and solicited AEs) All-cause mortality and SAEs are reported for the Unsolicited Safety Set. In the category of "Other Adverse Events", no nonserious unsolicited AEs were reported at a frequency \>5%; therefore, only solicited AEs occurring at a frequency \>5% in the Solicited Safety Set are reported in this section.
|
0.10%
1/1016 • SAEs: Day 1 through Day 271; nonserious unsolicited AEs: Day 1 through Day 22; solicited AEs: Day 1 through Day 7
Number and percentage of subjects with SAEs and other AEs (ie, nonserious unsolicited AEs and solicited AEs) All-cause mortality and SAEs are reported for the Unsolicited Safety Set. In the category of "Other Adverse Events", no nonserious unsolicited AEs were reported at a frequency \>5%; therefore, only solicited AEs occurring at a frequency \>5% in the Solicited Safety Set are reported in this section.
|
|
Cardiac disorders
Acute myocardial infarction
|
0.19%
2/1027 • SAEs: Day 1 through Day 271; nonserious unsolicited AEs: Day 1 through Day 22; solicited AEs: Day 1 through Day 7
Number and percentage of subjects with SAEs and other AEs (ie, nonserious unsolicited AEs and solicited AEs) All-cause mortality and SAEs are reported for the Unsolicited Safety Set. In the category of "Other Adverse Events", no nonserious unsolicited AEs were reported at a frequency \>5%; therefore, only solicited AEs occurring at a frequency \>5% in the Solicited Safety Set are reported in this section.
|
0.00%
0/1016 • SAEs: Day 1 through Day 271; nonserious unsolicited AEs: Day 1 through Day 22; solicited AEs: Day 1 through Day 7
Number and percentage of subjects with SAEs and other AEs (ie, nonserious unsolicited AEs and solicited AEs) All-cause mortality and SAEs are reported for the Unsolicited Safety Set. In the category of "Other Adverse Events", no nonserious unsolicited AEs were reported at a frequency \>5%; therefore, only solicited AEs occurring at a frequency \>5% in the Solicited Safety Set are reported in this section.
|
|
Cardiac disorders
Angina pectoris
|
0.10%
1/1027 • SAEs: Day 1 through Day 271; nonserious unsolicited AEs: Day 1 through Day 22; solicited AEs: Day 1 through Day 7
Number and percentage of subjects with SAEs and other AEs (ie, nonserious unsolicited AEs and solicited AEs) All-cause mortality and SAEs are reported for the Unsolicited Safety Set. In the category of "Other Adverse Events", no nonserious unsolicited AEs were reported at a frequency \>5%; therefore, only solicited AEs occurring at a frequency \>5% in the Solicited Safety Set are reported in this section.
|
0.10%
1/1016 • SAEs: Day 1 through Day 271; nonserious unsolicited AEs: Day 1 through Day 22; solicited AEs: Day 1 through Day 7
Number and percentage of subjects with SAEs and other AEs (ie, nonserious unsolicited AEs and solicited AEs) All-cause mortality and SAEs are reported for the Unsolicited Safety Set. In the category of "Other Adverse Events", no nonserious unsolicited AEs were reported at a frequency \>5%; therefore, only solicited AEs occurring at a frequency \>5% in the Solicited Safety Set are reported in this section.
|
|
Cardiac disorders
Aortic valve stenosis
|
0.10%
1/1027 • SAEs: Day 1 through Day 271; nonserious unsolicited AEs: Day 1 through Day 22; solicited AEs: Day 1 through Day 7
Number and percentage of subjects with SAEs and other AEs (ie, nonserious unsolicited AEs and solicited AEs) All-cause mortality and SAEs are reported for the Unsolicited Safety Set. In the category of "Other Adverse Events", no nonserious unsolicited AEs were reported at a frequency \>5%; therefore, only solicited AEs occurring at a frequency \>5% in the Solicited Safety Set are reported in this section.
|
0.10%
1/1016 • SAEs: Day 1 through Day 271; nonserious unsolicited AEs: Day 1 through Day 22; solicited AEs: Day 1 through Day 7
Number and percentage of subjects with SAEs and other AEs (ie, nonserious unsolicited AEs and solicited AEs) All-cause mortality and SAEs are reported for the Unsolicited Safety Set. In the category of "Other Adverse Events", no nonserious unsolicited AEs were reported at a frequency \>5%; therefore, only solicited AEs occurring at a frequency \>5% in the Solicited Safety Set are reported in this section.
|
|
Cardiac disorders
Cardiac failure congestive
|
0.10%
1/1027 • SAEs: Day 1 through Day 271; nonserious unsolicited AEs: Day 1 through Day 22; solicited AEs: Day 1 through Day 7
Number and percentage of subjects with SAEs and other AEs (ie, nonserious unsolicited AEs and solicited AEs) All-cause mortality and SAEs are reported for the Unsolicited Safety Set. In the category of "Other Adverse Events", no nonserious unsolicited AEs were reported at a frequency \>5%; therefore, only solicited AEs occurring at a frequency \>5% in the Solicited Safety Set are reported in this section.
|
0.00%
0/1016 • SAEs: Day 1 through Day 271; nonserious unsolicited AEs: Day 1 through Day 22; solicited AEs: Day 1 through Day 7
Number and percentage of subjects with SAEs and other AEs (ie, nonserious unsolicited AEs and solicited AEs) All-cause mortality and SAEs are reported for the Unsolicited Safety Set. In the category of "Other Adverse Events", no nonserious unsolicited AEs were reported at a frequency \>5%; therefore, only solicited AEs occurring at a frequency \>5% in the Solicited Safety Set are reported in this section.
|
|
Cardiac disorders
Cardiomyopathy
|
0.00%
0/1027 • SAEs: Day 1 through Day 271; nonserious unsolicited AEs: Day 1 through Day 22; solicited AEs: Day 1 through Day 7
Number and percentage of subjects with SAEs and other AEs (ie, nonserious unsolicited AEs and solicited AEs) All-cause mortality and SAEs are reported for the Unsolicited Safety Set. In the category of "Other Adverse Events", no nonserious unsolicited AEs were reported at a frequency \>5%; therefore, only solicited AEs occurring at a frequency \>5% in the Solicited Safety Set are reported in this section.
|
0.10%
1/1016 • SAEs: Day 1 through Day 271; nonserious unsolicited AEs: Day 1 through Day 22; solicited AEs: Day 1 through Day 7
Number and percentage of subjects with SAEs and other AEs (ie, nonserious unsolicited AEs and solicited AEs) All-cause mortality and SAEs are reported for the Unsolicited Safety Set. In the category of "Other Adverse Events", no nonserious unsolicited AEs were reported at a frequency \>5%; therefore, only solicited AEs occurring at a frequency \>5% in the Solicited Safety Set are reported in this section.
|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/1027 • SAEs: Day 1 through Day 271; nonserious unsolicited AEs: Day 1 through Day 22; solicited AEs: Day 1 through Day 7
Number and percentage of subjects with SAEs and other AEs (ie, nonserious unsolicited AEs and solicited AEs) All-cause mortality and SAEs are reported for the Unsolicited Safety Set. In the category of "Other Adverse Events", no nonserious unsolicited AEs were reported at a frequency \>5%; therefore, only solicited AEs occurring at a frequency \>5% in the Solicited Safety Set are reported in this section.
|
0.20%
2/1016 • SAEs: Day 1 through Day 271; nonserious unsolicited AEs: Day 1 through Day 22; solicited AEs: Day 1 through Day 7
Number and percentage of subjects with SAEs and other AEs (ie, nonserious unsolicited AEs and solicited AEs) All-cause mortality and SAEs are reported for the Unsolicited Safety Set. In the category of "Other Adverse Events", no nonserious unsolicited AEs were reported at a frequency \>5%; therefore, only solicited AEs occurring at a frequency \>5% in the Solicited Safety Set are reported in this section.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
B-cell lymphoma
|
0.10%
1/1027 • SAEs: Day 1 through Day 271; nonserious unsolicited AEs: Day 1 through Day 22; solicited AEs: Day 1 through Day 7
Number and percentage of subjects with SAEs and other AEs (ie, nonserious unsolicited AEs and solicited AEs) All-cause mortality and SAEs are reported for the Unsolicited Safety Set. In the category of "Other Adverse Events", no nonserious unsolicited AEs were reported at a frequency \>5%; therefore, only solicited AEs occurring at a frequency \>5% in the Solicited Safety Set are reported in this section.
|
0.00%
0/1016 • SAEs: Day 1 through Day 271; nonserious unsolicited AEs: Day 1 through Day 22; solicited AEs: Day 1 through Day 7
Number and percentage of subjects with SAEs and other AEs (ie, nonserious unsolicited AEs and solicited AEs) All-cause mortality and SAEs are reported for the Unsolicited Safety Set. In the category of "Other Adverse Events", no nonserious unsolicited AEs were reported at a frequency \>5%; therefore, only solicited AEs occurring at a frequency \>5% in the Solicited Safety Set are reported in this section.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Endometrial adenocarcinoma
|
0.10%
1/1027 • SAEs: Day 1 through Day 271; nonserious unsolicited AEs: Day 1 through Day 22; solicited AEs: Day 1 through Day 7
Number and percentage of subjects with SAEs and other AEs (ie, nonserious unsolicited AEs and solicited AEs) All-cause mortality and SAEs are reported for the Unsolicited Safety Set. In the category of "Other Adverse Events", no nonserious unsolicited AEs were reported at a frequency \>5%; therefore, only solicited AEs occurring at a frequency \>5% in the Solicited Safety Set are reported in this section.
|
0.00%
0/1016 • SAEs: Day 1 through Day 271; nonserious unsolicited AEs: Day 1 through Day 22; solicited AEs: Day 1 through Day 7
Number and percentage of subjects with SAEs and other AEs (ie, nonserious unsolicited AEs and solicited AEs) All-cause mortality and SAEs are reported for the Unsolicited Safety Set. In the category of "Other Adverse Events", no nonserious unsolicited AEs were reported at a frequency \>5%; therefore, only solicited AEs occurring at a frequency \>5% in the Solicited Safety Set are reported in this section.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Follicular lymphoma
|
0.10%
1/1027 • SAEs: Day 1 through Day 271; nonserious unsolicited AEs: Day 1 through Day 22; solicited AEs: Day 1 through Day 7
Number and percentage of subjects with SAEs and other AEs (ie, nonserious unsolicited AEs and solicited AEs) All-cause mortality and SAEs are reported for the Unsolicited Safety Set. In the category of "Other Adverse Events", no nonserious unsolicited AEs were reported at a frequency \>5%; therefore, only solicited AEs occurring at a frequency \>5% in the Solicited Safety Set are reported in this section.
|
0.00%
0/1016 • SAEs: Day 1 through Day 271; nonserious unsolicited AEs: Day 1 through Day 22; solicited AEs: Day 1 through Day 7
Number and percentage of subjects with SAEs and other AEs (ie, nonserious unsolicited AEs and solicited AEs) All-cause mortality and SAEs are reported for the Unsolicited Safety Set. In the category of "Other Adverse Events", no nonserious unsolicited AEs were reported at a frequency \>5%; therefore, only solicited AEs occurring at a frequency \>5% in the Solicited Safety Set are reported in this section.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Huerthle cell carcinoma
|
0.10%
1/1027 • SAEs: Day 1 through Day 271; nonserious unsolicited AEs: Day 1 through Day 22; solicited AEs: Day 1 through Day 7
Number and percentage of subjects with SAEs and other AEs (ie, nonserious unsolicited AEs and solicited AEs) All-cause mortality and SAEs are reported for the Unsolicited Safety Set. In the category of "Other Adverse Events", no nonserious unsolicited AEs were reported at a frequency \>5%; therefore, only solicited AEs occurring at a frequency \>5% in the Solicited Safety Set are reported in this section.
|
0.00%
0/1016 • SAEs: Day 1 through Day 271; nonserious unsolicited AEs: Day 1 through Day 22; solicited AEs: Day 1 through Day 7
Number and percentage of subjects with SAEs and other AEs (ie, nonserious unsolicited AEs and solicited AEs) All-cause mortality and SAEs are reported for the Unsolicited Safety Set. In the category of "Other Adverse Events", no nonserious unsolicited AEs were reported at a frequency \>5%; therefore, only solicited AEs occurring at a frequency \>5% in the Solicited Safety Set are reported in this section.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung adenocarcinoma
|
0.10%
1/1027 • SAEs: Day 1 through Day 271; nonserious unsolicited AEs: Day 1 through Day 22; solicited AEs: Day 1 through Day 7
Number and percentage of subjects with SAEs and other AEs (ie, nonserious unsolicited AEs and solicited AEs) All-cause mortality and SAEs are reported for the Unsolicited Safety Set. In the category of "Other Adverse Events", no nonserious unsolicited AEs were reported at a frequency \>5%; therefore, only solicited AEs occurring at a frequency \>5% in the Solicited Safety Set are reported in this section.
|
0.00%
0/1016 • SAEs: Day 1 through Day 271; nonserious unsolicited AEs: Day 1 through Day 22; solicited AEs: Day 1 through Day 7
Number and percentage of subjects with SAEs and other AEs (ie, nonserious unsolicited AEs and solicited AEs) All-cause mortality and SAEs are reported for the Unsolicited Safety Set. In the category of "Other Adverse Events", no nonserious unsolicited AEs were reported at a frequency \>5%; therefore, only solicited AEs occurring at a frequency \>5% in the Solicited Safety Set are reported in this section.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder cancer
|
0.00%
0/1027 • SAEs: Day 1 through Day 271; nonserious unsolicited AEs: Day 1 through Day 22; solicited AEs: Day 1 through Day 7
Number and percentage of subjects with SAEs and other AEs (ie, nonserious unsolicited AEs and solicited AEs) All-cause mortality and SAEs are reported for the Unsolicited Safety Set. In the category of "Other Adverse Events", no nonserious unsolicited AEs were reported at a frequency \>5%; therefore, only solicited AEs occurring at a frequency \>5% in the Solicited Safety Set are reported in this section.
|
0.10%
1/1016 • SAEs: Day 1 through Day 271; nonserious unsolicited AEs: Day 1 through Day 22; solicited AEs: Day 1 through Day 7
Number and percentage of subjects with SAEs and other AEs (ie, nonserious unsolicited AEs and solicited AEs) All-cause mortality and SAEs are reported for the Unsolicited Safety Set. In the category of "Other Adverse Events", no nonserious unsolicited AEs were reported at a frequency \>5%; therefore, only solicited AEs occurring at a frequency \>5% in the Solicited Safety Set are reported in this section.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hepatic neoplasm
|
0.00%
0/1027 • SAEs: Day 1 through Day 271; nonserious unsolicited AEs: Day 1 through Day 22; solicited AEs: Day 1 through Day 7
Number and percentage of subjects with SAEs and other AEs (ie, nonserious unsolicited AEs and solicited AEs) All-cause mortality and SAEs are reported for the Unsolicited Safety Set. In the category of "Other Adverse Events", no nonserious unsolicited AEs were reported at a frequency \>5%; therefore, only solicited AEs occurring at a frequency \>5% in the Solicited Safety Set are reported in this section.
|
0.10%
1/1016 • SAEs: Day 1 through Day 271; nonserious unsolicited AEs: Day 1 through Day 22; solicited AEs: Day 1 through Day 7
Number and percentage of subjects with SAEs and other AEs (ie, nonserious unsolicited AEs and solicited AEs) All-cause mortality and SAEs are reported for the Unsolicited Safety Set. In the category of "Other Adverse Events", no nonserious unsolicited AEs were reported at a frequency \>5%; therefore, only solicited AEs occurring at a frequency \>5% in the Solicited Safety Set are reported in this section.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lip and/or oral cavity cancer
|
0.00%
0/1027 • SAEs: Day 1 through Day 271; nonserious unsolicited AEs: Day 1 through Day 22; solicited AEs: Day 1 through Day 7
Number and percentage of subjects with SAEs and other AEs (ie, nonserious unsolicited AEs and solicited AEs) All-cause mortality and SAEs are reported for the Unsolicited Safety Set. In the category of "Other Adverse Events", no nonserious unsolicited AEs were reported at a frequency \>5%; therefore, only solicited AEs occurring at a frequency \>5% in the Solicited Safety Set are reported in this section.
|
0.10%
1/1016 • SAEs: Day 1 through Day 271; nonserious unsolicited AEs: Day 1 through Day 22; solicited AEs: Day 1 through Day 7
Number and percentage of subjects with SAEs and other AEs (ie, nonserious unsolicited AEs and solicited AEs) All-cause mortality and SAEs are reported for the Unsolicited Safety Set. In the category of "Other Adverse Events", no nonserious unsolicited AEs were reported at a frequency \>5%; therefore, only solicited AEs occurring at a frequency \>5% in the Solicited Safety Set are reported in this section.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pancreatic carcinoma
|
0.00%
0/1027 • SAEs: Day 1 through Day 271; nonserious unsolicited AEs: Day 1 through Day 22; solicited AEs: Day 1 through Day 7
Number and percentage of subjects with SAEs and other AEs (ie, nonserious unsolicited AEs and solicited AEs) All-cause mortality and SAEs are reported for the Unsolicited Safety Set. In the category of "Other Adverse Events", no nonserious unsolicited AEs were reported at a frequency \>5%; therefore, only solicited AEs occurring at a frequency \>5% in the Solicited Safety Set are reported in this section.
|
0.10%
1/1016 • SAEs: Day 1 through Day 271; nonserious unsolicited AEs: Day 1 through Day 22; solicited AEs: Day 1 through Day 7
Number and percentage of subjects with SAEs and other AEs (ie, nonserious unsolicited AEs and solicited AEs) All-cause mortality and SAEs are reported for the Unsolicited Safety Set. In the category of "Other Adverse Events", no nonserious unsolicited AEs were reported at a frequency \>5%; therefore, only solicited AEs occurring at a frequency \>5% in the Solicited Safety Set are reported in this section.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Plasmacytoma
|
0.00%
0/1027 • SAEs: Day 1 through Day 271; nonserious unsolicited AEs: Day 1 through Day 22; solicited AEs: Day 1 through Day 7
Number and percentage of subjects with SAEs and other AEs (ie, nonserious unsolicited AEs and solicited AEs) All-cause mortality and SAEs are reported for the Unsolicited Safety Set. In the category of "Other Adverse Events", no nonserious unsolicited AEs were reported at a frequency \>5%; therefore, only solicited AEs occurring at a frequency \>5% in the Solicited Safety Set are reported in this section.
|
0.10%
1/1016 • SAEs: Day 1 through Day 271; nonserious unsolicited AEs: Day 1 through Day 22; solicited AEs: Day 1 through Day 7
Number and percentage of subjects with SAEs and other AEs (ie, nonserious unsolicited AEs and solicited AEs) All-cause mortality and SAEs are reported for the Unsolicited Safety Set. In the category of "Other Adverse Events", no nonserious unsolicited AEs were reported at a frequency \>5%; therefore, only solicited AEs occurring at a frequency \>5% in the Solicited Safety Set are reported in this section.
|
|
Gastrointestinal disorders
Diverticulum
|
0.19%
2/1027 • SAEs: Day 1 through Day 271; nonserious unsolicited AEs: Day 1 through Day 22; solicited AEs: Day 1 through Day 7
Number and percentage of subjects with SAEs and other AEs (ie, nonserious unsolicited AEs and solicited AEs) All-cause mortality and SAEs are reported for the Unsolicited Safety Set. In the category of "Other Adverse Events", no nonserious unsolicited AEs were reported at a frequency \>5%; therefore, only solicited AEs occurring at a frequency \>5% in the Solicited Safety Set are reported in this section.
|
0.00%
0/1016 • SAEs: Day 1 through Day 271; nonserious unsolicited AEs: Day 1 through Day 22; solicited AEs: Day 1 through Day 7
Number and percentage of subjects with SAEs and other AEs (ie, nonserious unsolicited AEs and solicited AEs) All-cause mortality and SAEs are reported for the Unsolicited Safety Set. In the category of "Other Adverse Events", no nonserious unsolicited AEs were reported at a frequency \>5%; therefore, only solicited AEs occurring at a frequency \>5% in the Solicited Safety Set are reported in this section.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.10%
1/1027 • SAEs: Day 1 through Day 271; nonserious unsolicited AEs: Day 1 through Day 22; solicited AEs: Day 1 through Day 7
Number and percentage of subjects with SAEs and other AEs (ie, nonserious unsolicited AEs and solicited AEs) All-cause mortality and SAEs are reported for the Unsolicited Safety Set. In the category of "Other Adverse Events", no nonserious unsolicited AEs were reported at a frequency \>5%; therefore, only solicited AEs occurring at a frequency \>5% in the Solicited Safety Set are reported in this section.
|
0.00%
0/1016 • SAEs: Day 1 through Day 271; nonserious unsolicited AEs: Day 1 through Day 22; solicited AEs: Day 1 through Day 7
Number and percentage of subjects with SAEs and other AEs (ie, nonserious unsolicited AEs and solicited AEs) All-cause mortality and SAEs are reported for the Unsolicited Safety Set. In the category of "Other Adverse Events", no nonserious unsolicited AEs were reported at a frequency \>5%; therefore, only solicited AEs occurring at a frequency \>5% in the Solicited Safety Set are reported in this section.
|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.10%
1/1027 • SAEs: Day 1 through Day 271; nonserious unsolicited AEs: Day 1 through Day 22; solicited AEs: Day 1 through Day 7
Number and percentage of subjects with SAEs and other AEs (ie, nonserious unsolicited AEs and solicited AEs) All-cause mortality and SAEs are reported for the Unsolicited Safety Set. In the category of "Other Adverse Events", no nonserious unsolicited AEs were reported at a frequency \>5%; therefore, only solicited AEs occurring at a frequency \>5% in the Solicited Safety Set are reported in this section.
|
0.00%
0/1016 • SAEs: Day 1 through Day 271; nonserious unsolicited AEs: Day 1 through Day 22; solicited AEs: Day 1 through Day 7
Number and percentage of subjects with SAEs and other AEs (ie, nonserious unsolicited AEs and solicited AEs) All-cause mortality and SAEs are reported for the Unsolicited Safety Set. In the category of "Other Adverse Events", no nonserious unsolicited AEs were reported at a frequency \>5%; therefore, only solicited AEs occurring at a frequency \>5% in the Solicited Safety Set are reported in this section.
|
|
Gastrointestinal disorders
Gastritis erosive
|
0.00%
0/1027 • SAEs: Day 1 through Day 271; nonserious unsolicited AEs: Day 1 through Day 22; solicited AEs: Day 1 through Day 7
Number and percentage of subjects with SAEs and other AEs (ie, nonserious unsolicited AEs and solicited AEs) All-cause mortality and SAEs are reported for the Unsolicited Safety Set. In the category of "Other Adverse Events", no nonserious unsolicited AEs were reported at a frequency \>5%; therefore, only solicited AEs occurring at a frequency \>5% in the Solicited Safety Set are reported in this section.
|
0.10%
1/1016 • SAEs: Day 1 through Day 271; nonserious unsolicited AEs: Day 1 through Day 22; solicited AEs: Day 1 through Day 7
Number and percentage of subjects with SAEs and other AEs (ie, nonserious unsolicited AEs and solicited AEs) All-cause mortality and SAEs are reported for the Unsolicited Safety Set. In the category of "Other Adverse Events", no nonserious unsolicited AEs were reported at a frequency \>5%; therefore, only solicited AEs occurring at a frequency \>5% in the Solicited Safety Set are reported in this section.
|
|
Gastrointestinal disorders
Large intestine polyp
|
0.00%
0/1027 • SAEs: Day 1 through Day 271; nonserious unsolicited AEs: Day 1 through Day 22; solicited AEs: Day 1 through Day 7
Number and percentage of subjects with SAEs and other AEs (ie, nonserious unsolicited AEs and solicited AEs) All-cause mortality and SAEs are reported for the Unsolicited Safety Set. In the category of "Other Adverse Events", no nonserious unsolicited AEs were reported at a frequency \>5%; therefore, only solicited AEs occurring at a frequency \>5% in the Solicited Safety Set are reported in this section.
|
0.10%
1/1016 • SAEs: Day 1 through Day 271; nonserious unsolicited AEs: Day 1 through Day 22; solicited AEs: Day 1 through Day 7
Number and percentage of subjects with SAEs and other AEs (ie, nonserious unsolicited AEs and solicited AEs) All-cause mortality and SAEs are reported for the Unsolicited Safety Set. In the category of "Other Adverse Events", no nonserious unsolicited AEs were reported at a frequency \>5%; therefore, only solicited AEs occurring at a frequency \>5% in the Solicited Safety Set are reported in this section.
|
|
Gastrointestinal disorders
Pancreatitis acute
|
0.00%
0/1027 • SAEs: Day 1 through Day 271; nonserious unsolicited AEs: Day 1 through Day 22; solicited AEs: Day 1 through Day 7
Number and percentage of subjects with SAEs and other AEs (ie, nonserious unsolicited AEs and solicited AEs) All-cause mortality and SAEs are reported for the Unsolicited Safety Set. In the category of "Other Adverse Events", no nonserious unsolicited AEs were reported at a frequency \>5%; therefore, only solicited AEs occurring at a frequency \>5% in the Solicited Safety Set are reported in this section.
|
0.10%
1/1016 • SAEs: Day 1 through Day 271; nonserious unsolicited AEs: Day 1 through Day 22; solicited AEs: Day 1 through Day 7
Number and percentage of subjects with SAEs and other AEs (ie, nonserious unsolicited AEs and solicited AEs) All-cause mortality and SAEs are reported for the Unsolicited Safety Set. In the category of "Other Adverse Events", no nonserious unsolicited AEs were reported at a frequency \>5%; therefore, only solicited AEs occurring at a frequency \>5% in the Solicited Safety Set are reported in this section.
|
|
Injury, poisoning and procedural complications
Clavicle fracture
|
0.10%
1/1027 • SAEs: Day 1 through Day 271; nonserious unsolicited AEs: Day 1 through Day 22; solicited AEs: Day 1 through Day 7
Number and percentage of subjects with SAEs and other AEs (ie, nonserious unsolicited AEs and solicited AEs) All-cause mortality and SAEs are reported for the Unsolicited Safety Set. In the category of "Other Adverse Events", no nonserious unsolicited AEs were reported at a frequency \>5%; therefore, only solicited AEs occurring at a frequency \>5% in the Solicited Safety Set are reported in this section.
|
0.00%
0/1016 • SAEs: Day 1 through Day 271; nonserious unsolicited AEs: Day 1 through Day 22; solicited AEs: Day 1 through Day 7
Number and percentage of subjects with SAEs and other AEs (ie, nonserious unsolicited AEs and solicited AEs) All-cause mortality and SAEs are reported for the Unsolicited Safety Set. In the category of "Other Adverse Events", no nonserious unsolicited AEs were reported at a frequency \>5%; therefore, only solicited AEs occurring at a frequency \>5% in the Solicited Safety Set are reported in this section.
|
|
Injury, poisoning and procedural complications
Femoral neck fracture
|
0.10%
1/1027 • SAEs: Day 1 through Day 271; nonserious unsolicited AEs: Day 1 through Day 22; solicited AEs: Day 1 through Day 7
Number and percentage of subjects with SAEs and other AEs (ie, nonserious unsolicited AEs and solicited AEs) All-cause mortality and SAEs are reported for the Unsolicited Safety Set. In the category of "Other Adverse Events", no nonserious unsolicited AEs were reported at a frequency \>5%; therefore, only solicited AEs occurring at a frequency \>5% in the Solicited Safety Set are reported in this section.
|
0.00%
0/1016 • SAEs: Day 1 through Day 271; nonserious unsolicited AEs: Day 1 through Day 22; solicited AEs: Day 1 through Day 7
Number and percentage of subjects with SAEs and other AEs (ie, nonserious unsolicited AEs and solicited AEs) All-cause mortality and SAEs are reported for the Unsolicited Safety Set. In the category of "Other Adverse Events", no nonserious unsolicited AEs were reported at a frequency \>5%; therefore, only solicited AEs occurring at a frequency \>5% in the Solicited Safety Set are reported in this section.
|
|
Injury, poisoning and procedural complications
Limb crushing injury
|
0.10%
1/1027 • SAEs: Day 1 through Day 271; nonserious unsolicited AEs: Day 1 through Day 22; solicited AEs: Day 1 through Day 7
Number and percentage of subjects with SAEs and other AEs (ie, nonserious unsolicited AEs and solicited AEs) All-cause mortality and SAEs are reported for the Unsolicited Safety Set. In the category of "Other Adverse Events", no nonserious unsolicited AEs were reported at a frequency \>5%; therefore, only solicited AEs occurring at a frequency \>5% in the Solicited Safety Set are reported in this section.
|
0.00%
0/1016 • SAEs: Day 1 through Day 271; nonserious unsolicited AEs: Day 1 through Day 22; solicited AEs: Day 1 through Day 7
Number and percentage of subjects with SAEs and other AEs (ie, nonserious unsolicited AEs and solicited AEs) All-cause mortality and SAEs are reported for the Unsolicited Safety Set. In the category of "Other Adverse Events", no nonserious unsolicited AEs were reported at a frequency \>5%; therefore, only solicited AEs occurring at a frequency \>5% in the Solicited Safety Set are reported in this section.
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
0.10%
1/1027 • SAEs: Day 1 through Day 271; nonserious unsolicited AEs: Day 1 through Day 22; solicited AEs: Day 1 through Day 7
Number and percentage of subjects with SAEs and other AEs (ie, nonserious unsolicited AEs and solicited AEs) All-cause mortality and SAEs are reported for the Unsolicited Safety Set. In the category of "Other Adverse Events", no nonserious unsolicited AEs were reported at a frequency \>5%; therefore, only solicited AEs occurring at a frequency \>5% in the Solicited Safety Set are reported in this section.
|
0.00%
0/1016 • SAEs: Day 1 through Day 271; nonserious unsolicited AEs: Day 1 through Day 22; solicited AEs: Day 1 through Day 7
Number and percentage of subjects with SAEs and other AEs (ie, nonserious unsolicited AEs and solicited AEs) All-cause mortality and SAEs are reported for the Unsolicited Safety Set. In the category of "Other Adverse Events", no nonserious unsolicited AEs were reported at a frequency \>5%; therefore, only solicited AEs occurring at a frequency \>5% in the Solicited Safety Set are reported in this section.
|
|
Injury, poisoning and procedural complications
Scapula fracture
|
0.10%
1/1027 • SAEs: Day 1 through Day 271; nonserious unsolicited AEs: Day 1 through Day 22; solicited AEs: Day 1 through Day 7
Number and percentage of subjects with SAEs and other AEs (ie, nonserious unsolicited AEs and solicited AEs) All-cause mortality and SAEs are reported for the Unsolicited Safety Set. In the category of "Other Adverse Events", no nonserious unsolicited AEs were reported at a frequency \>5%; therefore, only solicited AEs occurring at a frequency \>5% in the Solicited Safety Set are reported in this section.
|
0.00%
0/1016 • SAEs: Day 1 through Day 271; nonserious unsolicited AEs: Day 1 through Day 22; solicited AEs: Day 1 through Day 7
Number and percentage of subjects with SAEs and other AEs (ie, nonserious unsolicited AEs and solicited AEs) All-cause mortality and SAEs are reported for the Unsolicited Safety Set. In the category of "Other Adverse Events", no nonserious unsolicited AEs were reported at a frequency \>5%; therefore, only solicited AEs occurring at a frequency \>5% in the Solicited Safety Set are reported in this section.
|
|
Injury, poisoning and procedural complications
Alcohol poisoning
|
0.00%
0/1027 • SAEs: Day 1 through Day 271; nonserious unsolicited AEs: Day 1 through Day 22; solicited AEs: Day 1 through Day 7
Number and percentage of subjects with SAEs and other AEs (ie, nonserious unsolicited AEs and solicited AEs) All-cause mortality and SAEs are reported for the Unsolicited Safety Set. In the category of "Other Adverse Events", no nonserious unsolicited AEs were reported at a frequency \>5%; therefore, only solicited AEs occurring at a frequency \>5% in the Solicited Safety Set are reported in this section.
|
0.10%
1/1016 • SAEs: Day 1 through Day 271; nonserious unsolicited AEs: Day 1 through Day 22; solicited AEs: Day 1 through Day 7
Number and percentage of subjects with SAEs and other AEs (ie, nonserious unsolicited AEs and solicited AEs) All-cause mortality and SAEs are reported for the Unsolicited Safety Set. In the category of "Other Adverse Events", no nonserious unsolicited AEs were reported at a frequency \>5%; therefore, only solicited AEs occurring at a frequency \>5% in the Solicited Safety Set are reported in this section.
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
0.00%
0/1027 • SAEs: Day 1 through Day 271; nonserious unsolicited AEs: Day 1 through Day 22; solicited AEs: Day 1 through Day 7
Number and percentage of subjects with SAEs and other AEs (ie, nonserious unsolicited AEs and solicited AEs) All-cause mortality and SAEs are reported for the Unsolicited Safety Set. In the category of "Other Adverse Events", no nonserious unsolicited AEs were reported at a frequency \>5%; therefore, only solicited AEs occurring at a frequency \>5% in the Solicited Safety Set are reported in this section.
|
0.10%
1/1016 • SAEs: Day 1 through Day 271; nonserious unsolicited AEs: Day 1 through Day 22; solicited AEs: Day 1 through Day 7
Number and percentage of subjects with SAEs and other AEs (ie, nonserious unsolicited AEs and solicited AEs) All-cause mortality and SAEs are reported for the Unsolicited Safety Set. In the category of "Other Adverse Events", no nonserious unsolicited AEs were reported at a frequency \>5%; therefore, only solicited AEs occurring at a frequency \>5% in the Solicited Safety Set are reported in this section.
|
|
Injury, poisoning and procedural complications
Bladder injury
|
0.00%
0/1027 • SAEs: Day 1 through Day 271; nonserious unsolicited AEs: Day 1 through Day 22; solicited AEs: Day 1 through Day 7
Number and percentage of subjects with SAEs and other AEs (ie, nonserious unsolicited AEs and solicited AEs) All-cause mortality and SAEs are reported for the Unsolicited Safety Set. In the category of "Other Adverse Events", no nonserious unsolicited AEs were reported at a frequency \>5%; therefore, only solicited AEs occurring at a frequency \>5% in the Solicited Safety Set are reported in this section.
|
0.10%
1/1016 • SAEs: Day 1 through Day 271; nonserious unsolicited AEs: Day 1 through Day 22; solicited AEs: Day 1 through Day 7
Number and percentage of subjects with SAEs and other AEs (ie, nonserious unsolicited AEs and solicited AEs) All-cause mortality and SAEs are reported for the Unsolicited Safety Set. In the category of "Other Adverse Events", no nonserious unsolicited AEs were reported at a frequency \>5%; therefore, only solicited AEs occurring at a frequency \>5% in the Solicited Safety Set are reported in this section.
|
|
Injury, poisoning and procedural complications
Radius fracture
|
0.00%
0/1027 • SAEs: Day 1 through Day 271; nonserious unsolicited AEs: Day 1 through Day 22; solicited AEs: Day 1 through Day 7
Number and percentage of subjects with SAEs and other AEs (ie, nonserious unsolicited AEs and solicited AEs) All-cause mortality and SAEs are reported for the Unsolicited Safety Set. In the category of "Other Adverse Events", no nonserious unsolicited AEs were reported at a frequency \>5%; therefore, only solicited AEs occurring at a frequency \>5% in the Solicited Safety Set are reported in this section.
|
0.10%
1/1016 • SAEs: Day 1 through Day 271; nonserious unsolicited AEs: Day 1 through Day 22; solicited AEs: Day 1 through Day 7
Number and percentage of subjects with SAEs and other AEs (ie, nonserious unsolicited AEs and solicited AEs) All-cause mortality and SAEs are reported for the Unsolicited Safety Set. In the category of "Other Adverse Events", no nonserious unsolicited AEs were reported at a frequency \>5%; therefore, only solicited AEs occurring at a frequency \>5% in the Solicited Safety Set are reported in this section.
|
|
General disorders
Adverse drug reaction
|
0.10%
1/1027 • SAEs: Day 1 through Day 271; nonserious unsolicited AEs: Day 1 through Day 22; solicited AEs: Day 1 through Day 7
Number and percentage of subjects with SAEs and other AEs (ie, nonserious unsolicited AEs and solicited AEs) All-cause mortality and SAEs are reported for the Unsolicited Safety Set. In the category of "Other Adverse Events", no nonserious unsolicited AEs were reported at a frequency \>5%; therefore, only solicited AEs occurring at a frequency \>5% in the Solicited Safety Set are reported in this section.
|
0.00%
0/1016 • SAEs: Day 1 through Day 271; nonserious unsolicited AEs: Day 1 through Day 22; solicited AEs: Day 1 through Day 7
Number and percentage of subjects with SAEs and other AEs (ie, nonserious unsolicited AEs and solicited AEs) All-cause mortality and SAEs are reported for the Unsolicited Safety Set. In the category of "Other Adverse Events", no nonserious unsolicited AEs were reported at a frequency \>5%; therefore, only solicited AEs occurring at a frequency \>5% in the Solicited Safety Set are reported in this section.
|
|
General disorders
Chest pain
|
0.10%
1/1027 • SAEs: Day 1 through Day 271; nonserious unsolicited AEs: Day 1 through Day 22; solicited AEs: Day 1 through Day 7
Number and percentage of subjects with SAEs and other AEs (ie, nonserious unsolicited AEs and solicited AEs) All-cause mortality and SAEs are reported for the Unsolicited Safety Set. In the category of "Other Adverse Events", no nonserious unsolicited AEs were reported at a frequency \>5%; therefore, only solicited AEs occurring at a frequency \>5% in the Solicited Safety Set are reported in this section.
|
0.10%
1/1016 • SAEs: Day 1 through Day 271; nonserious unsolicited AEs: Day 1 through Day 22; solicited AEs: Day 1 through Day 7
Number and percentage of subjects with SAEs and other AEs (ie, nonserious unsolicited AEs and solicited AEs) All-cause mortality and SAEs are reported for the Unsolicited Safety Set. In the category of "Other Adverse Events", no nonserious unsolicited AEs were reported at a frequency \>5%; therefore, only solicited AEs occurring at a frequency \>5% in the Solicited Safety Set are reported in this section.
|
|
General disorders
Hernia pain
|
0.00%
0/1027 • SAEs: Day 1 through Day 271; nonserious unsolicited AEs: Day 1 through Day 22; solicited AEs: Day 1 through Day 7
Number and percentage of subjects with SAEs and other AEs (ie, nonserious unsolicited AEs and solicited AEs) All-cause mortality and SAEs are reported for the Unsolicited Safety Set. In the category of "Other Adverse Events", no nonserious unsolicited AEs were reported at a frequency \>5%; therefore, only solicited AEs occurring at a frequency \>5% in the Solicited Safety Set are reported in this section.
|
0.10%
1/1016 • SAEs: Day 1 through Day 271; nonserious unsolicited AEs: Day 1 through Day 22; solicited AEs: Day 1 through Day 7
Number and percentage of subjects with SAEs and other AEs (ie, nonserious unsolicited AEs and solicited AEs) All-cause mortality and SAEs are reported for the Unsolicited Safety Set. In the category of "Other Adverse Events", no nonserious unsolicited AEs were reported at a frequency \>5%; therefore, only solicited AEs occurring at a frequency \>5% in the Solicited Safety Set are reported in this section.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.19%
2/1027 • SAEs: Day 1 through Day 271; nonserious unsolicited AEs: Day 1 through Day 22; solicited AEs: Day 1 through Day 7
Number and percentage of subjects with SAEs and other AEs (ie, nonserious unsolicited AEs and solicited AEs) All-cause mortality and SAEs are reported for the Unsolicited Safety Set. In the category of "Other Adverse Events", no nonserious unsolicited AEs were reported at a frequency \>5%; therefore, only solicited AEs occurring at a frequency \>5% in the Solicited Safety Set are reported in this section.
|
0.00%
0/1016 • SAEs: Day 1 through Day 271; nonserious unsolicited AEs: Day 1 through Day 22; solicited AEs: Day 1 through Day 7
Number and percentage of subjects with SAEs and other AEs (ie, nonserious unsolicited AEs and solicited AEs) All-cause mortality and SAEs are reported for the Unsolicited Safety Set. In the category of "Other Adverse Events", no nonserious unsolicited AEs were reported at a frequency \>5%; therefore, only solicited AEs occurring at a frequency \>5% in the Solicited Safety Set are reported in this section.
|
|
Musculoskeletal and connective tissue disorders
Spondylolisthesis
|
0.00%
0/1027 • SAEs: Day 1 through Day 271; nonserious unsolicited AEs: Day 1 through Day 22; solicited AEs: Day 1 through Day 7
Number and percentage of subjects with SAEs and other AEs (ie, nonserious unsolicited AEs and solicited AEs) All-cause mortality and SAEs are reported for the Unsolicited Safety Set. In the category of "Other Adverse Events", no nonserious unsolicited AEs were reported at a frequency \>5%; therefore, only solicited AEs occurring at a frequency \>5% in the Solicited Safety Set are reported in this section.
|
0.10%
1/1016 • SAEs: Day 1 through Day 271; nonserious unsolicited AEs: Day 1 through Day 22; solicited AEs: Day 1 through Day 7
Number and percentage of subjects with SAEs and other AEs (ie, nonserious unsolicited AEs and solicited AEs) All-cause mortality and SAEs are reported for the Unsolicited Safety Set. In the category of "Other Adverse Events", no nonserious unsolicited AEs were reported at a frequency \>5%; therefore, only solicited AEs occurring at a frequency \>5% in the Solicited Safety Set are reported in this section.
|
|
Reproductive system and breast disorders
Ovarian cyst
|
0.10%
1/1027 • SAEs: Day 1 through Day 271; nonserious unsolicited AEs: Day 1 through Day 22; solicited AEs: Day 1 through Day 7
Number and percentage of subjects with SAEs and other AEs (ie, nonserious unsolicited AEs and solicited AEs) All-cause mortality and SAEs are reported for the Unsolicited Safety Set. In the category of "Other Adverse Events", no nonserious unsolicited AEs were reported at a frequency \>5%; therefore, only solicited AEs occurring at a frequency \>5% in the Solicited Safety Set are reported in this section.
|
0.00%
0/1016 • SAEs: Day 1 through Day 271; nonserious unsolicited AEs: Day 1 through Day 22; solicited AEs: Day 1 through Day 7
Number and percentage of subjects with SAEs and other AEs (ie, nonserious unsolicited AEs and solicited AEs) All-cause mortality and SAEs are reported for the Unsolicited Safety Set. In the category of "Other Adverse Events", no nonserious unsolicited AEs were reported at a frequency \>5%; therefore, only solicited AEs occurring at a frequency \>5% in the Solicited Safety Set are reported in this section.
|
|
Reproductive system and breast disorders
Vaginal prolapse
|
0.10%
1/1027 • SAEs: Day 1 through Day 271; nonserious unsolicited AEs: Day 1 through Day 22; solicited AEs: Day 1 through Day 7
Number and percentage of subjects with SAEs and other AEs (ie, nonserious unsolicited AEs and solicited AEs) All-cause mortality and SAEs are reported for the Unsolicited Safety Set. In the category of "Other Adverse Events", no nonserious unsolicited AEs were reported at a frequency \>5%; therefore, only solicited AEs occurring at a frequency \>5% in the Solicited Safety Set are reported in this section.
|
0.00%
0/1016 • SAEs: Day 1 through Day 271; nonserious unsolicited AEs: Day 1 through Day 22; solicited AEs: Day 1 through Day 7
Number and percentage of subjects with SAEs and other AEs (ie, nonserious unsolicited AEs and solicited AEs) All-cause mortality and SAEs are reported for the Unsolicited Safety Set. In the category of "Other Adverse Events", no nonserious unsolicited AEs were reported at a frequency \>5%; therefore, only solicited AEs occurring at a frequency \>5% in the Solicited Safety Set are reported in this section.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.10%
1/1027 • SAEs: Day 1 through Day 271; nonserious unsolicited AEs: Day 1 through Day 22; solicited AEs: Day 1 through Day 7
Number and percentage of subjects with SAEs and other AEs (ie, nonserious unsolicited AEs and solicited AEs) All-cause mortality and SAEs are reported for the Unsolicited Safety Set. In the category of "Other Adverse Events", no nonserious unsolicited AEs were reported at a frequency \>5%; therefore, only solicited AEs occurring at a frequency \>5% in the Solicited Safety Set are reported in this section.
|
0.00%
0/1016 • SAEs: Day 1 through Day 271; nonserious unsolicited AEs: Day 1 through Day 22; solicited AEs: Day 1 through Day 7
Number and percentage of subjects with SAEs and other AEs (ie, nonserious unsolicited AEs and solicited AEs) All-cause mortality and SAEs are reported for the Unsolicited Safety Set. In the category of "Other Adverse Events", no nonserious unsolicited AEs were reported at a frequency \>5%; therefore, only solicited AEs occurring at a frequency \>5% in the Solicited Safety Set are reported in this section.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary thrombosis
|
0.10%
1/1027 • SAEs: Day 1 through Day 271; nonserious unsolicited AEs: Day 1 through Day 22; solicited AEs: Day 1 through Day 7
Number and percentage of subjects with SAEs and other AEs (ie, nonserious unsolicited AEs and solicited AEs) All-cause mortality and SAEs are reported for the Unsolicited Safety Set. In the category of "Other Adverse Events", no nonserious unsolicited AEs were reported at a frequency \>5%; therefore, only solicited AEs occurring at a frequency \>5% in the Solicited Safety Set are reported in this section.
|
0.00%
0/1016 • SAEs: Day 1 through Day 271; nonserious unsolicited AEs: Day 1 through Day 22; solicited AEs: Day 1 through Day 7
Number and percentage of subjects with SAEs and other AEs (ie, nonserious unsolicited AEs and solicited AEs) All-cause mortality and SAEs are reported for the Unsolicited Safety Set. In the category of "Other Adverse Events", no nonserious unsolicited AEs were reported at a frequency \>5%; therefore, only solicited AEs occurring at a frequency \>5% in the Solicited Safety Set are reported in this section.
|
|
Respiratory, thoracic and mediastinal disorders
Haemothorax
|
0.00%
0/1027 • SAEs: Day 1 through Day 271; nonserious unsolicited AEs: Day 1 through Day 22; solicited AEs: Day 1 through Day 7
Number and percentage of subjects with SAEs and other AEs (ie, nonserious unsolicited AEs and solicited AEs) All-cause mortality and SAEs are reported for the Unsolicited Safety Set. In the category of "Other Adverse Events", no nonserious unsolicited AEs were reported at a frequency \>5%; therefore, only solicited AEs occurring at a frequency \>5% in the Solicited Safety Set are reported in this section.
|
0.10%
1/1016 • SAEs: Day 1 through Day 271; nonserious unsolicited AEs: Day 1 through Day 22; solicited AEs: Day 1 through Day 7
Number and percentage of subjects with SAEs and other AEs (ie, nonserious unsolicited AEs and solicited AEs) All-cause mortality and SAEs are reported for the Unsolicited Safety Set. In the category of "Other Adverse Events", no nonserious unsolicited AEs were reported at a frequency \>5%; therefore, only solicited AEs occurring at a frequency \>5% in the Solicited Safety Set are reported in this section.
|
|
Endocrine disorders
Hypothyroidism
|
0.10%
1/1027 • SAEs: Day 1 through Day 271; nonserious unsolicited AEs: Day 1 through Day 22; solicited AEs: Day 1 through Day 7
Number and percentage of subjects with SAEs and other AEs (ie, nonserious unsolicited AEs and solicited AEs) All-cause mortality and SAEs are reported for the Unsolicited Safety Set. In the category of "Other Adverse Events", no nonserious unsolicited AEs were reported at a frequency \>5%; therefore, only solicited AEs occurring at a frequency \>5% in the Solicited Safety Set are reported in this section.
|
0.00%
0/1016 • SAEs: Day 1 through Day 271; nonserious unsolicited AEs: Day 1 through Day 22; solicited AEs: Day 1 through Day 7
Number and percentage of subjects with SAEs and other AEs (ie, nonserious unsolicited AEs and solicited AEs) All-cause mortality and SAEs are reported for the Unsolicited Safety Set. In the category of "Other Adverse Events", no nonserious unsolicited AEs were reported at a frequency \>5%; therefore, only solicited AEs occurring at a frequency \>5% in the Solicited Safety Set are reported in this section.
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.10%
1/1027 • SAEs: Day 1 through Day 271; nonserious unsolicited AEs: Day 1 through Day 22; solicited AEs: Day 1 through Day 7
Number and percentage of subjects with SAEs and other AEs (ie, nonserious unsolicited AEs and solicited AEs) All-cause mortality and SAEs are reported for the Unsolicited Safety Set. In the category of "Other Adverse Events", no nonserious unsolicited AEs were reported at a frequency \>5%; therefore, only solicited AEs occurring at a frequency \>5% in the Solicited Safety Set are reported in this section.
|
0.10%
1/1016 • SAEs: Day 1 through Day 271; nonserious unsolicited AEs: Day 1 through Day 22; solicited AEs: Day 1 through Day 7
Number and percentage of subjects with SAEs and other AEs (ie, nonserious unsolicited AEs and solicited AEs) All-cause mortality and SAEs are reported for the Unsolicited Safety Set. In the category of "Other Adverse Events", no nonserious unsolicited AEs were reported at a frequency \>5%; therefore, only solicited AEs occurring at a frequency \>5% in the Solicited Safety Set are reported in this section.
|
|
Hepatobiliary disorders
Bile duct stenosis
|
0.00%
0/1027 • SAEs: Day 1 through Day 271; nonserious unsolicited AEs: Day 1 through Day 22; solicited AEs: Day 1 through Day 7
Number and percentage of subjects with SAEs and other AEs (ie, nonserious unsolicited AEs and solicited AEs) All-cause mortality and SAEs are reported for the Unsolicited Safety Set. In the category of "Other Adverse Events", no nonserious unsolicited AEs were reported at a frequency \>5%; therefore, only solicited AEs occurring at a frequency \>5% in the Solicited Safety Set are reported in this section.
|
0.10%
1/1016 • SAEs: Day 1 through Day 271; nonserious unsolicited AEs: Day 1 through Day 22; solicited AEs: Day 1 through Day 7
Number and percentage of subjects with SAEs and other AEs (ie, nonserious unsolicited AEs and solicited AEs) All-cause mortality and SAEs are reported for the Unsolicited Safety Set. In the category of "Other Adverse Events", no nonserious unsolicited AEs were reported at a frequency \>5%; therefore, only solicited AEs occurring at a frequency \>5% in the Solicited Safety Set are reported in this section.
|
|
Metabolism and nutrition disorders
Ketoacidosis
|
0.10%
1/1027 • SAEs: Day 1 through Day 271; nonserious unsolicited AEs: Day 1 through Day 22; solicited AEs: Day 1 through Day 7
Number and percentage of subjects with SAEs and other AEs (ie, nonserious unsolicited AEs and solicited AEs) All-cause mortality and SAEs are reported for the Unsolicited Safety Set. In the category of "Other Adverse Events", no nonserious unsolicited AEs were reported at a frequency \>5%; therefore, only solicited AEs occurring at a frequency \>5% in the Solicited Safety Set are reported in this section.
|
0.00%
0/1016 • SAEs: Day 1 through Day 271; nonserious unsolicited AEs: Day 1 through Day 22; solicited AEs: Day 1 through Day 7
Number and percentage of subjects with SAEs and other AEs (ie, nonserious unsolicited AEs and solicited AEs) All-cause mortality and SAEs are reported for the Unsolicited Safety Set. In the category of "Other Adverse Events", no nonserious unsolicited AEs were reported at a frequency \>5%; therefore, only solicited AEs occurring at a frequency \>5% in the Solicited Safety Set are reported in this section.
|
|
Psychiatric disorders
Conversion disorder
|
0.10%
1/1027 • SAEs: Day 1 through Day 271; nonserious unsolicited AEs: Day 1 through Day 22; solicited AEs: Day 1 through Day 7
Number and percentage of subjects with SAEs and other AEs (ie, nonserious unsolicited AEs and solicited AEs) All-cause mortality and SAEs are reported for the Unsolicited Safety Set. In the category of "Other Adverse Events", no nonserious unsolicited AEs were reported at a frequency \>5%; therefore, only solicited AEs occurring at a frequency \>5% in the Solicited Safety Set are reported in this section.
|
0.00%
0/1016 • SAEs: Day 1 through Day 271; nonserious unsolicited AEs: Day 1 through Day 22; solicited AEs: Day 1 through Day 7
Number and percentage of subjects with SAEs and other AEs (ie, nonserious unsolicited AEs and solicited AEs) All-cause mortality and SAEs are reported for the Unsolicited Safety Set. In the category of "Other Adverse Events", no nonserious unsolicited AEs were reported at a frequency \>5%; therefore, only solicited AEs occurring at a frequency \>5% in the Solicited Safety Set are reported in this section.
|
|
Psychiatric disorders
Psychiatric decompensation
|
0.10%
1/1027 • SAEs: Day 1 through Day 271; nonserious unsolicited AEs: Day 1 through Day 22; solicited AEs: Day 1 through Day 7
Number and percentage of subjects with SAEs and other AEs (ie, nonserious unsolicited AEs and solicited AEs) All-cause mortality and SAEs are reported for the Unsolicited Safety Set. In the category of "Other Adverse Events", no nonserious unsolicited AEs were reported at a frequency \>5%; therefore, only solicited AEs occurring at a frequency \>5% in the Solicited Safety Set are reported in this section.
|
0.00%
0/1016 • SAEs: Day 1 through Day 271; nonserious unsolicited AEs: Day 1 through Day 22; solicited AEs: Day 1 through Day 7
Number and percentage of subjects with SAEs and other AEs (ie, nonserious unsolicited AEs and solicited AEs) All-cause mortality and SAEs are reported for the Unsolicited Safety Set. In the category of "Other Adverse Events", no nonserious unsolicited AEs were reported at a frequency \>5%; therefore, only solicited AEs occurring at a frequency \>5% in the Solicited Safety Set are reported in this section.
|
|
Psychiatric disorders
Alcohol abuse
|
0.00%
0/1027 • SAEs: Day 1 through Day 271; nonserious unsolicited AEs: Day 1 through Day 22; solicited AEs: Day 1 through Day 7
Number and percentage of subjects with SAEs and other AEs (ie, nonserious unsolicited AEs and solicited AEs) All-cause mortality and SAEs are reported for the Unsolicited Safety Set. In the category of "Other Adverse Events", no nonserious unsolicited AEs were reported at a frequency \>5%; therefore, only solicited AEs occurring at a frequency \>5% in the Solicited Safety Set are reported in this section.
|
0.10%
1/1016 • SAEs: Day 1 through Day 271; nonserious unsolicited AEs: Day 1 through Day 22; solicited AEs: Day 1 through Day 7
Number and percentage of subjects with SAEs and other AEs (ie, nonserious unsolicited AEs and solicited AEs) All-cause mortality and SAEs are reported for the Unsolicited Safety Set. In the category of "Other Adverse Events", no nonserious unsolicited AEs were reported at a frequency \>5%; therefore, only solicited AEs occurring at a frequency \>5% in the Solicited Safety Set are reported in this section.
|
|
Psychiatric disorders
Depression
|
0.00%
0/1027 • SAEs: Day 1 through Day 271; nonserious unsolicited AEs: Day 1 through Day 22; solicited AEs: Day 1 through Day 7
Number and percentage of subjects with SAEs and other AEs (ie, nonserious unsolicited AEs and solicited AEs) All-cause mortality and SAEs are reported for the Unsolicited Safety Set. In the category of "Other Adverse Events", no nonserious unsolicited AEs were reported at a frequency \>5%; therefore, only solicited AEs occurring at a frequency \>5% in the Solicited Safety Set are reported in this section.
|
0.10%
1/1016 • SAEs: Day 1 through Day 271; nonserious unsolicited AEs: Day 1 through Day 22; solicited AEs: Day 1 through Day 7
Number and percentage of subjects with SAEs and other AEs (ie, nonserious unsolicited AEs and solicited AEs) All-cause mortality and SAEs are reported for the Unsolicited Safety Set. In the category of "Other Adverse Events", no nonserious unsolicited AEs were reported at a frequency \>5%; therefore, only solicited AEs occurring at a frequency \>5% in the Solicited Safety Set are reported in this section.
|
|
Vascular disorders
Hypovolaemic shock
|
0.10%
1/1027 • SAEs: Day 1 through Day 271; nonserious unsolicited AEs: Day 1 through Day 22; solicited AEs: Day 1 through Day 7
Number and percentage of subjects with SAEs and other AEs (ie, nonserious unsolicited AEs and solicited AEs) All-cause mortality and SAEs are reported for the Unsolicited Safety Set. In the category of "Other Adverse Events", no nonserious unsolicited AEs were reported at a frequency \>5%; therefore, only solicited AEs occurring at a frequency \>5% in the Solicited Safety Set are reported in this section.
|
0.00%
0/1016 • SAEs: Day 1 through Day 271; nonserious unsolicited AEs: Day 1 through Day 22; solicited AEs: Day 1 through Day 7
Number and percentage of subjects with SAEs and other AEs (ie, nonserious unsolicited AEs and solicited AEs) All-cause mortality and SAEs are reported for the Unsolicited Safety Set. In the category of "Other Adverse Events", no nonserious unsolicited AEs were reported at a frequency \>5%; therefore, only solicited AEs occurring at a frequency \>5% in the Solicited Safety Set are reported in this section.
|
|
Vascular disorders
Deep vein thrombosis
|
0.00%
0/1027 • SAEs: Day 1 through Day 271; nonserious unsolicited AEs: Day 1 through Day 22; solicited AEs: Day 1 through Day 7
Number and percentage of subjects with SAEs and other AEs (ie, nonserious unsolicited AEs and solicited AEs) All-cause mortality and SAEs are reported for the Unsolicited Safety Set. In the category of "Other Adverse Events", no nonserious unsolicited AEs were reported at a frequency \>5%; therefore, only solicited AEs occurring at a frequency \>5% in the Solicited Safety Set are reported in this section.
|
0.10%
1/1016 • SAEs: Day 1 through Day 271; nonserious unsolicited AEs: Day 1 through Day 22; solicited AEs: Day 1 through Day 7
Number and percentage of subjects with SAEs and other AEs (ie, nonserious unsolicited AEs and solicited AEs) All-cause mortality and SAEs are reported for the Unsolicited Safety Set. In the category of "Other Adverse Events", no nonserious unsolicited AEs were reported at a frequency \>5%; therefore, only solicited AEs occurring at a frequency \>5% in the Solicited Safety Set are reported in this section.
|
|
Vascular disorders
Hypertensive crisis
|
0.00%
0/1027 • SAEs: Day 1 through Day 271; nonserious unsolicited AEs: Day 1 through Day 22; solicited AEs: Day 1 through Day 7
Number and percentage of subjects with SAEs and other AEs (ie, nonserious unsolicited AEs and solicited AEs) All-cause mortality and SAEs are reported for the Unsolicited Safety Set. In the category of "Other Adverse Events", no nonserious unsolicited AEs were reported at a frequency \>5%; therefore, only solicited AEs occurring at a frequency \>5% in the Solicited Safety Set are reported in this section.
|
0.10%
1/1016 • SAEs: Day 1 through Day 271; nonserious unsolicited AEs: Day 1 through Day 22; solicited AEs: Day 1 through Day 7
Number and percentage of subjects with SAEs and other AEs (ie, nonserious unsolicited AEs and solicited AEs) All-cause mortality and SAEs are reported for the Unsolicited Safety Set. In the category of "Other Adverse Events", no nonserious unsolicited AEs were reported at a frequency \>5%; therefore, only solicited AEs occurring at a frequency \>5% in the Solicited Safety Set are reported in this section.
|
|
Ear and labyrinth disorders
Middle ear adhesions
|
0.00%
0/1027 • SAEs: Day 1 through Day 271; nonserious unsolicited AEs: Day 1 through Day 22; solicited AEs: Day 1 through Day 7
Number and percentage of subjects with SAEs and other AEs (ie, nonserious unsolicited AEs and solicited AEs) All-cause mortality and SAEs are reported for the Unsolicited Safety Set. In the category of "Other Adverse Events", no nonserious unsolicited AEs were reported at a frequency \>5%; therefore, only solicited AEs occurring at a frequency \>5% in the Solicited Safety Set are reported in this section.
|
0.10%
1/1016 • SAEs: Day 1 through Day 271; nonserious unsolicited AEs: Day 1 through Day 22; solicited AEs: Day 1 through Day 7
Number and percentage of subjects with SAEs and other AEs (ie, nonserious unsolicited AEs and solicited AEs) All-cause mortality and SAEs are reported for the Unsolicited Safety Set. In the category of "Other Adverse Events", no nonserious unsolicited AEs were reported at a frequency \>5%; therefore, only solicited AEs occurring at a frequency \>5% in the Solicited Safety Set are reported in this section.
|
|
Immune system disorders
Allergy to metals
|
0.00%
0/1027 • SAEs: Day 1 through Day 271; nonserious unsolicited AEs: Day 1 through Day 22; solicited AEs: Day 1 through Day 7
Number and percentage of subjects with SAEs and other AEs (ie, nonserious unsolicited AEs and solicited AEs) All-cause mortality and SAEs are reported for the Unsolicited Safety Set. In the category of "Other Adverse Events", no nonserious unsolicited AEs were reported at a frequency \>5%; therefore, only solicited AEs occurring at a frequency \>5% in the Solicited Safety Set are reported in this section.
|
0.10%
1/1016 • SAEs: Day 1 through Day 271; nonserious unsolicited AEs: Day 1 through Day 22; solicited AEs: Day 1 through Day 7
Number and percentage of subjects with SAEs and other AEs (ie, nonserious unsolicited AEs and solicited AEs) All-cause mortality and SAEs are reported for the Unsolicited Safety Set. In the category of "Other Adverse Events", no nonserious unsolicited AEs were reported at a frequency \>5%; therefore, only solicited AEs occurring at a frequency \>5% in the Solicited Safety Set are reported in this section.
|
|
Immune system disorders
Drug hypersensitivity
|
0.00%
0/1027 • SAEs: Day 1 through Day 271; nonserious unsolicited AEs: Day 1 through Day 22; solicited AEs: Day 1 through Day 7
Number and percentage of subjects with SAEs and other AEs (ie, nonserious unsolicited AEs and solicited AEs) All-cause mortality and SAEs are reported for the Unsolicited Safety Set. In the category of "Other Adverse Events", no nonserious unsolicited AEs were reported at a frequency \>5%; therefore, only solicited AEs occurring at a frequency \>5% in the Solicited Safety Set are reported in this section.
|
0.10%
1/1016 • SAEs: Day 1 through Day 271; nonserious unsolicited AEs: Day 1 through Day 22; solicited AEs: Day 1 through Day 7
Number and percentage of subjects with SAEs and other AEs (ie, nonserious unsolicited AEs and solicited AEs) All-cause mortality and SAEs are reported for the Unsolicited Safety Set. In the category of "Other Adverse Events", no nonserious unsolicited AEs were reported at a frequency \>5%; therefore, only solicited AEs occurring at a frequency \>5% in the Solicited Safety Set are reported in this section.
|
|
Nervous system disorders
Cerebellar stroke
|
0.00%
0/1027 • SAEs: Day 1 through Day 271; nonserious unsolicited AEs: Day 1 through Day 22; solicited AEs: Day 1 through Day 7
Number and percentage of subjects with SAEs and other AEs (ie, nonserious unsolicited AEs and solicited AEs) All-cause mortality and SAEs are reported for the Unsolicited Safety Set. In the category of "Other Adverse Events", no nonserious unsolicited AEs were reported at a frequency \>5%; therefore, only solicited AEs occurring at a frequency \>5% in the Solicited Safety Set are reported in this section.
|
0.10%
1/1016 • SAEs: Day 1 through Day 271; nonserious unsolicited AEs: Day 1 through Day 22; solicited AEs: Day 1 through Day 7
Number and percentage of subjects with SAEs and other AEs (ie, nonserious unsolicited AEs and solicited AEs) All-cause mortality and SAEs are reported for the Unsolicited Safety Set. In the category of "Other Adverse Events", no nonserious unsolicited AEs were reported at a frequency \>5%; therefore, only solicited AEs occurring at a frequency \>5% in the Solicited Safety Set are reported in this section.
|
|
Nervous system disorders
Cerebral infarction
|
0.00%
0/1027 • SAEs: Day 1 through Day 271; nonserious unsolicited AEs: Day 1 through Day 22; solicited AEs: Day 1 through Day 7
Number and percentage of subjects with SAEs and other AEs (ie, nonserious unsolicited AEs and solicited AEs) All-cause mortality and SAEs are reported for the Unsolicited Safety Set. In the category of "Other Adverse Events", no nonserious unsolicited AEs were reported at a frequency \>5%; therefore, only solicited AEs occurring at a frequency \>5% in the Solicited Safety Set are reported in this section.
|
0.10%
1/1016 • SAEs: Day 1 through Day 271; nonserious unsolicited AEs: Day 1 through Day 22; solicited AEs: Day 1 through Day 7
Number and percentage of subjects with SAEs and other AEs (ie, nonserious unsolicited AEs and solicited AEs) All-cause mortality and SAEs are reported for the Unsolicited Safety Set. In the category of "Other Adverse Events", no nonserious unsolicited AEs were reported at a frequency \>5%; therefore, only solicited AEs occurring at a frequency \>5% in the Solicited Safety Set are reported in this section.
|
|
Nervous system disorders
Status epilepticus
|
0.00%
0/1027 • SAEs: Day 1 through Day 271; nonserious unsolicited AEs: Day 1 through Day 22; solicited AEs: Day 1 through Day 7
Number and percentage of subjects with SAEs and other AEs (ie, nonserious unsolicited AEs and solicited AEs) All-cause mortality and SAEs are reported for the Unsolicited Safety Set. In the category of "Other Adverse Events", no nonserious unsolicited AEs were reported at a frequency \>5%; therefore, only solicited AEs occurring at a frequency \>5% in the Solicited Safety Set are reported in this section.
|
0.10%
1/1016 • SAEs: Day 1 through Day 271; nonserious unsolicited AEs: Day 1 through Day 22; solicited AEs: Day 1 through Day 7
Number and percentage of subjects with SAEs and other AEs (ie, nonserious unsolicited AEs and solicited AEs) All-cause mortality and SAEs are reported for the Unsolicited Safety Set. In the category of "Other Adverse Events", no nonserious unsolicited AEs were reported at a frequency \>5%; therefore, only solicited AEs occurring at a frequency \>5% in the Solicited Safety Set are reported in this section.
|
|
Nervous system disorders
Subarachnoid haemorrhage
|
0.00%
0/1027 • SAEs: Day 1 through Day 271; nonserious unsolicited AEs: Day 1 through Day 22; solicited AEs: Day 1 through Day 7
Number and percentage of subjects with SAEs and other AEs (ie, nonserious unsolicited AEs and solicited AEs) All-cause mortality and SAEs are reported for the Unsolicited Safety Set. In the category of "Other Adverse Events", no nonserious unsolicited AEs were reported at a frequency \>5%; therefore, only solicited AEs occurring at a frequency \>5% in the Solicited Safety Set are reported in this section.
|
0.10%
1/1016 • SAEs: Day 1 through Day 271; nonserious unsolicited AEs: Day 1 through Day 22; solicited AEs: Day 1 through Day 7
Number and percentage of subjects with SAEs and other AEs (ie, nonserious unsolicited AEs and solicited AEs) All-cause mortality and SAEs are reported for the Unsolicited Safety Set. In the category of "Other Adverse Events", no nonserious unsolicited AEs were reported at a frequency \>5%; therefore, only solicited AEs occurring at a frequency \>5% in the Solicited Safety Set are reported in this section.
|
Other adverse events
| Measure |
aQIV
n=1020 participants at risk；n=1027 participants at risk
Adjuvanted QIV containing 2 influenza type A strains and 2 influenza type B strains
aQIV: Participants receive a 0.5-mL intramuscular dose of aQIV on Day 1
|
Comparator QIV
n=1008 participants at risk；n=1016 participants at risk
Non-adjuvanted comparator QIV containing 2 influenza type A strains and 2 influenza type B strains
Comparator QIV: Participants receive a 0.5-mL intramuscular dose of Comparator QIV on Day 1
|
|---|---|---|
|
Gastrointestinal disorders
Diarrhea
|
7.9%
81/1020 • SAEs: Day 1 through Day 271; nonserious unsolicited AEs: Day 1 through Day 22; solicited AEs: Day 1 through Day 7
Number and percentage of subjects with SAEs and other AEs (ie, nonserious unsolicited AEs and solicited AEs) All-cause mortality and SAEs are reported for the Unsolicited Safety Set. In the category of "Other Adverse Events", no nonserious unsolicited AEs were reported at a frequency \>5%; therefore, only solicited AEs occurring at a frequency \>5% in the Solicited Safety Set are reported in this section.
|
7.0%
71/1008 • SAEs: Day 1 through Day 271; nonserious unsolicited AEs: Day 1 through Day 22; solicited AEs: Day 1 through Day 7
Number and percentage of subjects with SAEs and other AEs (ie, nonserious unsolicited AEs and solicited AEs) All-cause mortality and SAEs are reported for the Unsolicited Safety Set. In the category of "Other Adverse Events", no nonserious unsolicited AEs were reported at a frequency \>5%; therefore, only solicited AEs occurring at a frequency \>5% in the Solicited Safety Set are reported in this section.
|
|
Gastrointestinal disorders
Nausea
|
7.3%
74/1020 • SAEs: Day 1 through Day 271; nonserious unsolicited AEs: Day 1 through Day 22; solicited AEs: Day 1 through Day 7
Number and percentage of subjects with SAEs and other AEs (ie, nonserious unsolicited AEs and solicited AEs) All-cause mortality and SAEs are reported for the Unsolicited Safety Set. In the category of "Other Adverse Events", no nonserious unsolicited AEs were reported at a frequency \>5%; therefore, only solicited AEs occurring at a frequency \>5% in the Solicited Safety Set are reported in this section.
|
4.4%
44/1008 • SAEs: Day 1 through Day 271; nonserious unsolicited AEs: Day 1 through Day 22; solicited AEs: Day 1 through Day 7
Number and percentage of subjects with SAEs and other AEs (ie, nonserious unsolicited AEs and solicited AEs) All-cause mortality and SAEs are reported for the Unsolicited Safety Set. In the category of "Other Adverse Events", no nonserious unsolicited AEs were reported at a frequency \>5%; therefore, only solicited AEs occurring at a frequency \>5% in the Solicited Safety Set are reported in this section.
|
|
General disorders
Chills
|
6.6%
67/1020 • SAEs: Day 1 through Day 271; nonserious unsolicited AEs: Day 1 through Day 22; solicited AEs: Day 1 through Day 7
Number and percentage of subjects with SAEs and other AEs (ie, nonserious unsolicited AEs and solicited AEs) All-cause mortality and SAEs are reported for the Unsolicited Safety Set. In the category of "Other Adverse Events", no nonserious unsolicited AEs were reported at a frequency \>5%; therefore, only solicited AEs occurring at a frequency \>5% in the Solicited Safety Set are reported in this section.
|
5.5%
55/1008 • SAEs: Day 1 through Day 271; nonserious unsolicited AEs: Day 1 through Day 22; solicited AEs: Day 1 through Day 7
Number and percentage of subjects with SAEs and other AEs (ie, nonserious unsolicited AEs and solicited AEs) All-cause mortality and SAEs are reported for the Unsolicited Safety Set. In the category of "Other Adverse Events", no nonserious unsolicited AEs were reported at a frequency \>5%; therefore, only solicited AEs occurring at a frequency \>5% in the Solicited Safety Set are reported in this section.
|
|
General disorders
Fatigue
|
29.5%
301/1020 • SAEs: Day 1 through Day 271; nonserious unsolicited AEs: Day 1 through Day 22; solicited AEs: Day 1 through Day 7
Number and percentage of subjects with SAEs and other AEs (ie, nonserious unsolicited AEs and solicited AEs) All-cause mortality and SAEs are reported for the Unsolicited Safety Set. In the category of "Other Adverse Events", no nonserious unsolicited AEs were reported at a frequency \>5%; therefore, only solicited AEs occurring at a frequency \>5% in the Solicited Safety Set are reported in this section.
|
24.3%
245/1008 • SAEs: Day 1 through Day 271; nonserious unsolicited AEs: Day 1 through Day 22; solicited AEs: Day 1 through Day 7
Number and percentage of subjects with SAEs and other AEs (ie, nonserious unsolicited AEs and solicited AEs) All-cause mortality and SAEs are reported for the Unsolicited Safety Set. In the category of "Other Adverse Events", no nonserious unsolicited AEs were reported at a frequency \>5%; therefore, only solicited AEs occurring at a frequency \>5% in the Solicited Safety Set are reported in this section.
|
|
General disorders
Induration
|
7.9%
81/1020 • SAEs: Day 1 through Day 271; nonserious unsolicited AEs: Day 1 through Day 22; solicited AEs: Day 1 through Day 7
Number and percentage of subjects with SAEs and other AEs (ie, nonserious unsolicited AEs and solicited AEs) All-cause mortality and SAEs are reported for the Unsolicited Safety Set. In the category of "Other Adverse Events", no nonserious unsolicited AEs were reported at a frequency \>5%; therefore, only solicited AEs occurring at a frequency \>5% in the Solicited Safety Set are reported in this section.
|
3.5%
35/1008 • SAEs: Day 1 through Day 271; nonserious unsolicited AEs: Day 1 through Day 22; solicited AEs: Day 1 through Day 7
Number and percentage of subjects with SAEs and other AEs (ie, nonserious unsolicited AEs and solicited AEs) All-cause mortality and SAEs are reported for the Unsolicited Safety Set. In the category of "Other Adverse Events", no nonserious unsolicited AEs were reported at a frequency \>5%; therefore, only solicited AEs occurring at a frequency \>5% in the Solicited Safety Set are reported in this section.
|
|
General disorders
Injection site pain
|
47.1%
480/1020 • SAEs: Day 1 through Day 271; nonserious unsolicited AEs: Day 1 through Day 22; solicited AEs: Day 1 through Day 7
Number and percentage of subjects with SAEs and other AEs (ie, nonserious unsolicited AEs and solicited AEs) All-cause mortality and SAEs are reported for the Unsolicited Safety Set. In the category of "Other Adverse Events", no nonserious unsolicited AEs were reported at a frequency \>5%; therefore, only solicited AEs occurring at a frequency \>5% in the Solicited Safety Set are reported in this section.
|
28.1%
283/1008 • SAEs: Day 1 through Day 271; nonserious unsolicited AEs: Day 1 through Day 22; solicited AEs: Day 1 through Day 7
Number and percentage of subjects with SAEs and other AEs (ie, nonserious unsolicited AEs and solicited AEs) All-cause mortality and SAEs are reported for the Unsolicited Safety Set. In the category of "Other Adverse Events", no nonserious unsolicited AEs were reported at a frequency \>5%; therefore, only solicited AEs occurring at a frequency \>5% in the Solicited Safety Set are reported in this section.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
6.1%
62/1020 • SAEs: Day 1 through Day 271; nonserious unsolicited AEs: Day 1 through Day 22; solicited AEs: Day 1 through Day 7
Number and percentage of subjects with SAEs and other AEs (ie, nonserious unsolicited AEs and solicited AEs) All-cause mortality and SAEs are reported for the Unsolicited Safety Set. In the category of "Other Adverse Events", no nonserious unsolicited AEs were reported at a frequency \>5%; therefore, only solicited AEs occurring at a frequency \>5% in the Solicited Safety Set are reported in this section.
|
4.8%
48/1008 • SAEs: Day 1 through Day 271; nonserious unsolicited AEs: Day 1 through Day 22; solicited AEs: Day 1 through Day 7
Number and percentage of subjects with SAEs and other AEs (ie, nonserious unsolicited AEs and solicited AEs) All-cause mortality and SAEs are reported for the Unsolicited Safety Set. In the category of "Other Adverse Events", no nonserious unsolicited AEs were reported at a frequency \>5%; therefore, only solicited AEs occurring at a frequency \>5% in the Solicited Safety Set are reported in this section.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
13.7%
140/1020 • SAEs: Day 1 through Day 271; nonserious unsolicited AEs: Day 1 through Day 22; solicited AEs: Day 1 through Day 7
Number and percentage of subjects with SAEs and other AEs (ie, nonserious unsolicited AEs and solicited AEs) All-cause mortality and SAEs are reported for the Unsolicited Safety Set. In the category of "Other Adverse Events", no nonserious unsolicited AEs were reported at a frequency \>5%; therefore, only solicited AEs occurring at a frequency \>5% in the Solicited Safety Set are reported in this section.
|
9.4%
95/1008 • SAEs: Day 1 through Day 271; nonserious unsolicited AEs: Day 1 through Day 22; solicited AEs: Day 1 through Day 7
Number and percentage of subjects with SAEs and other AEs (ie, nonserious unsolicited AEs and solicited AEs) All-cause mortality and SAEs are reported for the Unsolicited Safety Set. In the category of "Other Adverse Events", no nonserious unsolicited AEs were reported at a frequency \>5%; therefore, only solicited AEs occurring at a frequency \>5% in the Solicited Safety Set are reported in this section.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
13.0%
133/1020 • SAEs: Day 1 through Day 271; nonserious unsolicited AEs: Day 1 through Day 22; solicited AEs: Day 1 through Day 7
Number and percentage of subjects with SAEs and other AEs (ie, nonserious unsolicited AEs and solicited AEs) All-cause mortality and SAEs are reported for the Unsolicited Safety Set. In the category of "Other Adverse Events", no nonserious unsolicited AEs were reported at a frequency \>5%; therefore, only solicited AEs occurring at a frequency \>5% in the Solicited Safety Set are reported in this section.
|
7.2%
73/1008 • SAEs: Day 1 through Day 271; nonserious unsolicited AEs: Day 1 through Day 22; solicited AEs: Day 1 through Day 7
Number and percentage of subjects with SAEs and other AEs (ie, nonserious unsolicited AEs and solicited AEs) All-cause mortality and SAEs are reported for the Unsolicited Safety Set. In the category of "Other Adverse Events", no nonserious unsolicited AEs were reported at a frequency \>5%; therefore, only solicited AEs occurring at a frequency \>5% in the Solicited Safety Set are reported in this section.
|
|
Nervous system disorders
Headache
|
22.2%
226/1020 • SAEs: Day 1 through Day 271; nonserious unsolicited AEs: Day 1 through Day 22; solicited AEs: Day 1 through Day 7
Number and percentage of subjects with SAEs and other AEs (ie, nonserious unsolicited AEs and solicited AEs) All-cause mortality and SAEs are reported for the Unsolicited Safety Set. In the category of "Other Adverse Events", no nonserious unsolicited AEs were reported at a frequency \>5%; therefore, only solicited AEs occurring at a frequency \>5% in the Solicited Safety Set are reported in this section.
|
20.4%
206/1008 • SAEs: Day 1 through Day 271; nonserious unsolicited AEs: Day 1 through Day 22; solicited AEs: Day 1 through Day 7
Number and percentage of subjects with SAEs and other AEs (ie, nonserious unsolicited AEs and solicited AEs) All-cause mortality and SAEs are reported for the Unsolicited Safety Set. In the category of "Other Adverse Events", no nonserious unsolicited AEs were reported at a frequency \>5%; therefore, only solicited AEs occurring at a frequency \>5% in the Solicited Safety Set are reported in this section.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
7.8%
80/1020 • SAEs: Day 1 through Day 271; nonserious unsolicited AEs: Day 1 through Day 22; solicited AEs: Day 1 through Day 7
Number and percentage of subjects with SAEs and other AEs (ie, nonserious unsolicited AEs and solicited AEs) All-cause mortality and SAEs are reported for the Unsolicited Safety Set. In the category of "Other Adverse Events", no nonserious unsolicited AEs were reported at a frequency \>5%; therefore, only solicited AEs occurring at a frequency \>5% in the Solicited Safety Set are reported in this section.
|
3.1%
31/1008 • SAEs: Day 1 through Day 271; nonserious unsolicited AEs: Day 1 through Day 22; solicited AEs: Day 1 through Day 7
Number and percentage of subjects with SAEs and other AEs (ie, nonserious unsolicited AEs and solicited AEs) All-cause mortality and SAEs are reported for the Unsolicited Safety Set. In the category of "Other Adverse Events", no nonserious unsolicited AEs were reported at a frequency \>5%; therefore, only solicited AEs occurring at a frequency \>5% in the Solicited Safety Set are reported in this section.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Seqirus will generally support publication of multicenter studies only in their entirety and not as individual center data. Seqirus must be notified of any intent to publish data collected from the study and prior approval from Seqirus must be obtained prior to submission for publication.
- Publication restrictions are in place
Restriction type: OTHER