Trial Outcomes & Findings for Dose-Confirmation Study to Evaluate the Safety, Reactogenicity, and Immunogenicity of mRNA-1273 COVID-19 Vaccine in Adults Aged 18 Years and Older (NCT NCT04405076)
NCT ID: NCT04405076
Last Updated: 2022-12-30
Results Overview
Solicited ARs, including local and systemic ARs were collected in the eDiary. Local ARs included: pain at injection site, erythema (redness) at injection site, swelling/induration (hardness) at injection site, and localized axillary swelling or tenderness ipsilateral to the injection arm. Systemic ARs included: headache, fatigue, myalgia (muscle aches all over the body), arthralgia (aching in several joints), nausea/vomiting, rash, body temperature (potentially fever), and chills. All solicited ARs (local and systemic) considered causally related to injection. ARs were graded 0-4 as reviewed and confirmed by Investigator; lower score indicates lower severity and a higher score indicates greater severity. Note, not all solicited ARs were considered adverse events (AEs). The Investigator reviewed whether the solicited AR was also to be recorded as an AE. A summary of SAEs and all nonserious AEs ("Other"), regardless of causality, is located in the Reported "Adverse Events" section.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
660 participants
Primary outcome timeframe
7 days post-vaccination
Results posted on
2022-12-30
Participant Flow
Participants in Part A were blinded to study treatment. After completion of Part A, participants could have chosen to be unblinded and to participate in Part B (open-label). Participants in Part C (proof-of-concept rollover) were unblinded and had received 2 doses of mRNA-1273 in Study mRNA-1273-P301 (Study P301; NCT04470427).
Part A participants received 50 microgram (µg) mRNA-1273, 100 µg mRNA-1273, or placebo (N=600). Participants who received placebo in Part A, received 100 ug mRNA-1273 in Part B (N=158). Participants who received 50 or 100 ug mRNA-1273 in Part A, received 50 ug mRNA-1273 in Part B (N=344). Participants in Part C (N=60) received a booster dose of 20 or 50 µg of mRNA-1273.351 or 50 µg mRNA-1273/mRNA-1273.351 mixture. Total number of enrolled participants for the study=660.
Participant milestones
| Measure |
Part A: 50 ug mRNA-1273
Participants received 1 intramuscular (IM) injection of 50 ug mRNA-1273 on Day 1 and on Day 29.
|
Part A: 100 ug mRNA-1273
Participants received 1 IM injection of 100 ug mRNA-1273 on Day 1 and on Day 29.
|
Part A: Placebo
Participants received 1 IM injection of mRNA-1273-matching placebo on Day 1 and on Day 29.
|
Part B: 50 ug mRNA-1273 Then 50 ug mRNA-1273
Participants who chose to be unblinded and received 50 ug mRNA-1273 during Part A, received 1 IM injection of 50 ug mRNA-1273 during Part B.
|
Part B: 100 ug mRNA-1273 Then 50 ug mRNA-1273
Participants who chose to be unblinded and received 100 ug mRNA-1273 during Part A, received 1 IM injection of 50 ug mRNA-1273 during Part B.
|
Part B: Placebo Then 100 ug mRNA-1273
Participants who chose to be unblinded and received mRNA-1273-matching placebo during Part A, received 2 IM injections of 100 ug mRNA-1273 28 days apart during Part B.
|
Part C: 20 ug mRNA-1273.351
Participants received 1 IM injection of 20 ug mRNA-1273.351 (booster dose) on Day 1.
|
Part C: 50 ug mRNA-1273.351
Participants received 1 IM injection of 50 ug mRNA-1273.351 (booster dose) on Day 1.
|
Part C: 50 ug mRNA-1273/mRNA-1273.351 Mixture
Participants received 1 IM injection of 50 ug mRNA-1273/mRNA-1273.351 mixture (booster dose) on Day 1.
|
|---|---|---|---|---|---|---|---|---|---|
|
Part A (Blinded Phase)
STARTED
|
200
|
200
|
200
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Part A (Blinded Phase)
Received at Least 1 Dose of Study Drug During Part A
|
200
|
200
|
200
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Part A (Blinded Phase)
COMPLETED
|
188
|
185
|
182
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Part A (Blinded Phase)
NOT COMPLETED
|
12
|
15
|
18
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Part B (Open-Label Interventional Phase)
STARTED
|
0
|
0
|
0
|
173
|
171
|
158
|
0
|
0
|
0
|
|
Part B (Open-Label Interventional Phase)
Received at Least 1 Dose of Study Drug During Part B
|
0
|
0
|
0
|
173
|
171
|
158
|
0
|
0
|
0
|
|
Part B (Open-Label Interventional Phase)
COMPLETED
|
0
|
0
|
0
|
161
|
166
|
152
|
0
|
0
|
0
|
|
Part B (Open-Label Interventional Phase)
NOT COMPLETED
|
0
|
0
|
0
|
12
|
5
|
6
|
0
|
0
|
0
|
|
Part C (Rollover Proof of Concept)
STARTED
|
0
|
0
|
0
|
0
|
0
|
0
|
20
|
20
|
20
|
|
Part C (Rollover Proof of Concept)
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
18
|
18
|
19
|
|
Part C (Rollover Proof of Concept)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
2
|
2
|
1
|
Reasons for withdrawal
| Measure |
Part A: 50 ug mRNA-1273
Participants received 1 intramuscular (IM) injection of 50 ug mRNA-1273 on Day 1 and on Day 29.
|
Part A: 100 ug mRNA-1273
Participants received 1 IM injection of 100 ug mRNA-1273 on Day 1 and on Day 29.
|
Part A: Placebo
Participants received 1 IM injection of mRNA-1273-matching placebo on Day 1 and on Day 29.
|
Part B: 50 ug mRNA-1273 Then 50 ug mRNA-1273
Participants who chose to be unblinded and received 50 ug mRNA-1273 during Part A, received 1 IM injection of 50 ug mRNA-1273 during Part B.
|
Part B: 100 ug mRNA-1273 Then 50 ug mRNA-1273
Participants who chose to be unblinded and received 100 ug mRNA-1273 during Part A, received 1 IM injection of 50 ug mRNA-1273 during Part B.
|
Part B: Placebo Then 100 ug mRNA-1273
Participants who chose to be unblinded and received mRNA-1273-matching placebo during Part A, received 2 IM injections of 100 ug mRNA-1273 28 days apart during Part B.
|
Part C: 20 ug mRNA-1273.351
Participants received 1 IM injection of 20 ug mRNA-1273.351 (booster dose) on Day 1.
|
Part C: 50 ug mRNA-1273.351
Participants received 1 IM injection of 50 ug mRNA-1273.351 (booster dose) on Day 1.
|
Part C: 50 ug mRNA-1273/mRNA-1273.351 Mixture
Participants received 1 IM injection of 50 ug mRNA-1273/mRNA-1273.351 mixture (booster dose) on Day 1.
|
|---|---|---|---|---|---|---|---|---|---|
|
Part A (Blinded Phase)
Lost to Follow-up
|
6
|
6
|
7
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Part A (Blinded Phase)
Physician Decision
|
1
|
2
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Part A (Blinded Phase)
Protocol Violation
|
3
|
3
|
8
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Part A (Blinded Phase)
Withdrawal of consent (COVID-19 non-infection related)
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Part A (Blinded Phase)
Withdrawal of consent (other)
|
1
|
4
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Part A (Blinded Phase)
Other than Specified
|
0
|
0
|
3
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Part B (Open-Label Interventional Phase)
Withdrawal by Subject
|
0
|
0
|
0
|
6
|
1
|
4
|
0
|
0
|
0
|
|
Part B (Open-Label Interventional Phase)
Physician Decision
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
|
Part B (Open-Label Interventional Phase)
Lost to Follow-up
|
0
|
0
|
0
|
6
|
3
|
2
|
0
|
0
|
0
|
|
Part C (Rollover Proof of Concept)
Withdrawal of consent (other)
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
2
|
1
|
|
Part C (Rollover Proof of Concept)
Lost to Follow-up
|
0
|
0
|
0
|
0
|
0
|
0
|
2
|
0
|
0
|
Baseline Characteristics
Dose-Confirmation Study to Evaluate the Safety, Reactogenicity, and Immunogenicity of mRNA-1273 COVID-19 Vaccine in Adults Aged 18 Years and Older
Baseline characteristics by cohort
| Measure |
Part A: 50 ug mRNA-1273
n=200 Participants
Participants received 1 IM injection of 50 ug mRNA-1273 on Day 1 and on Day 29.
|
Part A: 100 ug mRNA-1273
n=200 Participants
Participants received 1 IM injection of 100 ug mRNA-1273 on Day 1 and on Day 29.
|
Part A: Placebo
n=200 Participants
Participants received 1 IM injection of mRNA-1273-matching placebo on Day 1 and on Day 29.
|
Part C: 20 ug mRNA-1273.351
n=20 Participants
Participants received 1 IM injection of 20 ug mRNA-1273.351 (booster dose) on Day 1.
|
Part C: 50 ug mRNA-1273.351
n=20 Participants
Participants received 1 IM injection of 50 ug mRNA-1273.351 (booster dose) on Day 1.
|
Part C: 50 ug mRNA-1273/mRNA-1273.351 Mixture
n=20 Participants
Participants received 1 IM injection of 50 ug mRNA-1273/mRNA-1273.351 mixture (booster dose) on Day 1.
|
Total
n=660 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|
|
Age, Customized
Between 18 and 55 years
|
100 Participants
n=5 Participants
|
100 Participants
n=7 Participants
|
100 Participants
n=5 Participants
|
13 Participants
n=4 Participants
|
9 Participants
n=21 Participants
|
9 Participants
n=8 Participants
|
331 Participants
n=8 Participants
|
|
Age, Customized
>=55 years
|
100 Participants
n=5 Participants
|
100 Participants
n=7 Participants
|
100 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
11 Participants
n=21 Participants
|
11 Participants
n=8 Participants
|
329 Participants
n=8 Participants
|
|
Sex: Female, Male
Female
|
137 Participants
n=5 Participants
|
124 Participants
n=7 Participants
|
129 Participants
n=5 Participants
|
15 Participants
n=4 Participants
|
9 Participants
n=21 Participants
|
8 Participants
n=8 Participants
|
422 Participants
n=8 Participants
|
|
Sex: Female, Male
Male
|
63 Participants
n=5 Participants
|
76 Participants
n=7 Participants
|
71 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
11 Participants
n=21 Participants
|
12 Participants
n=8 Participants
|
238 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
15 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
49 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
184 Participants
n=5 Participants
|
184 Participants
n=7 Participants
|
184 Participants
n=5 Participants
|
19 Participants
n=4 Participants
|
20 Participants
n=21 Participants
|
19 Participants
n=8 Participants
|
610 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
1 Participants
n=8 Participants
|
|
Race/Ethnicity, Customized
White
|
188 participants
n=5 Participants
|
188 participants
n=7 Participants
|
193 participants
n=5 Participants
|
20 participants
n=4 Participants
|
19 participants
n=21 Participants
|
19 participants
n=8 Participants
|
627 participants
n=8 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
5 participants
n=5 Participants
|
8 participants
n=7 Participants
|
3 participants
n=5 Participants
|
0 participants
n=4 Participants
|
0 participants
n=21 Participants
|
0 participants
n=8 Participants
|
16 participants
n=8 Participants
|
|
Race/Ethnicity, Customized
Asian
|
2 participants
n=5 Participants
|
2 participants
n=7 Participants
|
3 participants
n=5 Participants
|
0 participants
n=4 Participants
|
1 participants
n=21 Participants
|
0 participants
n=8 Participants
|
8 participants
n=8 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
2 participants
n=5 Participants
|
1 participants
n=7 Participants
|
0 participants
n=5 Participants
|
0 participants
n=4 Participants
|
0 participants
n=21 Participants
|
1 participants
n=8 Participants
|
4 participants
n=8 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or Other Pacific Islander
|
1 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
0 participants
n=4 Participants
|
0 participants
n=21 Participants
|
0 participants
n=8 Participants
|
1 participants
n=8 Participants
|
|
Race/Ethnicity, Customized
Multiracial
|
1 participants
n=5 Participants
|
0 participants
n=7 Participants
|
1 participants
n=5 Participants
|
0 participants
n=4 Participants
|
0 participants
n=21 Participants
|
0 participants
n=8 Participants
|
2 participants
n=8 Participants
|
|
Race/Ethnicity, Customized
Other
|
1 participants
n=5 Participants
|
1 participants
n=7 Participants
|
0 participants
n=5 Participants
|
0 participants
n=4 Participants
|
0 participants
n=21 Participants
|
0 participants
n=8 Participants
|
2 participants
n=8 Participants
|
PRIMARY outcome
Timeframe: 7 days post-vaccinationPopulation: Solicited Safety Set for Parts A, B, and C included all participants who received any study injection in the applicable part of the study and contributed any solicited AR data (that is, had at least 1 post-baseline solicited safety assessment in the applicable part of the study). Number Analyzed = participants who were evaluable at specified timepoints.
Solicited ARs, including local and systemic ARs were collected in the eDiary. Local ARs included: pain at injection site, erythema (redness) at injection site, swelling/induration (hardness) at injection site, and localized axillary swelling or tenderness ipsilateral to the injection arm. Systemic ARs included: headache, fatigue, myalgia (muscle aches all over the body), arthralgia (aching in several joints), nausea/vomiting, rash, body temperature (potentially fever), and chills. All solicited ARs (local and systemic) considered causally related to injection. ARs were graded 0-4 as reviewed and confirmed by Investigator; lower score indicates lower severity and a higher score indicates greater severity. Note, not all solicited ARs were considered adverse events (AEs). The Investigator reviewed whether the solicited AR was also to be recorded as an AE. A summary of SAEs and all nonserious AEs ("Other"), regardless of causality, is located in the Reported "Adverse Events" section.
Outcome measures
| Measure |
Part A: 50 ug mRNA-1273
n=200 Participants
Participants received 1 IM injection of 50 ug mRNA-1273 on Day 1 and on Day 29.
|
Part A: 100 ug mRNA-1273
n=200 Participants
Participants received 1 IM injection of 100 ug mRNA-1273 on Day 1 and on Day 29.
|
Part A: Placebo
n=200 Participants
Participants received 1 IM injection of mRNA-1273-matching placebo on Day 1 and on Day 29.
|
Part B: 50 ug mRNA-1273 Then 50 ug mRNA-1273
n=164 Participants
Participants who chose to be unblinded and received 50 ug mRNA-1273 during Part A, received 1 IM injection of 50 ug mRNA-1273 during Part B.
|
Part B: 100 ug mRNA-1273 Then 50 ug mRNA-1273
n=167 Participants
Participants who chose to be unblinded and received 100 ug mRNA-1273 during Part A, received 1 IM injection of 50 ug mRNA-1273 during Part B.
|
Part B: Placebo Then 100 ug mRNA-1273
n=157 Participants
Participants who chose to be unblinded and received mRNA-1273-matching placebo during Part A, received 2 IM injections of 100 ug mRNA-1273 28 days apart during Part B.
|
Part C: 20 ug mRNA-1273.351
n=19 Participants
Participants received 1 IM injection of 20 ug mRNA-1273.351 (booster dose) on Day 1.
|
Part C: 50 ug mRNA-1273.351
n=19 Participants
Participants received 1 IM injection of 50 ug mRNA-1273.351 (booster dose) on Day 1.
|
Part C: 50 ug mRNA-1273/mRNA-1273.351 Mixture
n=20 Participants
Participants received 1 IM injection of 50 ug mRNA-1273/mRNA-1273.351 mixture (booster dose) on Day 1.
|
|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Solicited Local and Systemic Adverse Reactions (ARs)
Grade 1
|
95 Participants
|
69 Participants
|
72 Participants
|
65 Participants
|
73 Participants
|
50 Participants
|
13 Participants
|
10 Participants
|
12 Participants
|
|
Number of Participants With Solicited Local and Systemic Adverse Reactions (ARs)
Grade 2
|
61 Participants
|
90 Participants
|
21 Participants
|
59 Participants
|
59 Participants
|
71 Participants
|
6 Participants
|
2 Participants
|
3 Participants
|
|
Number of Participants With Solicited Local and Systemic Adverse Reactions (ARs)
Grade 3
|
25 Participants
|
32 Participants
|
6 Participants
|
29 Participants
|
18 Participants
|
28 Participants
|
0 Participants
|
2 Participants
|
2 Participants
|
|
Number of Participants With Solicited Local and Systemic Adverse Reactions (ARs)
Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Up to 28 days post-vaccinationPopulation: Safety Set: All participants who received any study injection in their respective part of the study.
An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. A treatment-emergent AE (TEAE) was defined as any event not present before exposure to vaccine or any event already present that worsens in intensity or frequency after exposure. Any abnormal laboratory test result (hematology, clinical chemistry, or prothrombin time \[PT\]/partial thromboplastin time \[PTT\]) or other safety assessment (for example, electrocardiogram, radiological scan, vital sign measurement), including one that worsens from baseline and is considered clinically significant in the medical and scientific judgment of the Investigator. A summary of SAEs and all nonserious AEs ("Other") reported up to the end of the study (up to Month 15), regardless of causality, is located in the Reported "Adverse Events" section.
Outcome measures
| Measure |
Part A: 50 ug mRNA-1273
n=200 Participants
Participants received 1 IM injection of 50 ug mRNA-1273 on Day 1 and on Day 29.
|
Part A: 100 ug mRNA-1273
n=200 Participants
Participants received 1 IM injection of 100 ug mRNA-1273 on Day 1 and on Day 29.
|
Part A: Placebo
n=200 Participants
Participants received 1 IM injection of mRNA-1273-matching placebo on Day 1 and on Day 29.
|
Part B: 50 ug mRNA-1273 Then 50 ug mRNA-1273
n=173 Participants
Participants who chose to be unblinded and received 50 ug mRNA-1273 during Part A, received 1 IM injection of 50 ug mRNA-1273 during Part B.
|
Part B: 100 ug mRNA-1273 Then 50 ug mRNA-1273
n=171 Participants
Participants who chose to be unblinded and received 100 ug mRNA-1273 during Part A, received 1 IM injection of 50 ug mRNA-1273 during Part B.
|
Part B: Placebo Then 100 ug mRNA-1273
n=158 Participants
Participants who chose to be unblinded and received mRNA-1273-matching placebo during Part A, received 2 IM injections of 100 ug mRNA-1273 28 days apart during Part B.
|
Part C: 20 ug mRNA-1273.351
n=20 Participants
Participants received 1 IM injection of 20 ug mRNA-1273.351 (booster dose) on Day 1.
|
Part C: 50 ug mRNA-1273.351
n=20 Participants
Participants received 1 IM injection of 50 ug mRNA-1273.351 (booster dose) on Day 1.
|
Part C: 50 ug mRNA-1273/mRNA-1273.351 Mixture
n=20 Participants
Participants received 1 IM injection of 50 ug mRNA-1273/mRNA-1273.351 mixture (booster dose) on Day 1.
|
|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Unsolicited AEs
|
57 Participants
|
56 Participants
|
51 Participants
|
17 Participants
|
25 Participants
|
42 Participants
|
3 Participants
|
3 Participants
|
4 Participants
|
PRIMARY outcome
Timeframe: Up to Month 15Population: Safety Set: All participants who received any study injection in their respective part of the study.
An MAAE is an AE that leads to an unscheduled visit to a healthcare practitioner (HCP). A summary of SAEs and all nonserious AEs ("Other"), regardless of causality, is located in the Reported "Adverse Events" section.
Outcome measures
| Measure |
Part A: 50 ug mRNA-1273
n=200 Participants
Participants received 1 IM injection of 50 ug mRNA-1273 on Day 1 and on Day 29.
|
Part A: 100 ug mRNA-1273
n=200 Participants
Participants received 1 IM injection of 100 ug mRNA-1273 on Day 1 and on Day 29.
|
Part A: Placebo
n=200 Participants
Participants received 1 IM injection of mRNA-1273-matching placebo on Day 1 and on Day 29.
|
Part B: 50 ug mRNA-1273 Then 50 ug mRNA-1273
n=173 Participants
Participants who chose to be unblinded and received 50 ug mRNA-1273 during Part A, received 1 IM injection of 50 ug mRNA-1273 during Part B.
|
Part B: 100 ug mRNA-1273 Then 50 ug mRNA-1273
n=171 Participants
Participants who chose to be unblinded and received 100 ug mRNA-1273 during Part A, received 1 IM injection of 50 ug mRNA-1273 during Part B.
|
Part B: Placebo Then 100 ug mRNA-1273
n=158 Participants
Participants who chose to be unblinded and received mRNA-1273-matching placebo during Part A, received 2 IM injections of 100 ug mRNA-1273 28 days apart during Part B.
|
Part C: 20 ug mRNA-1273.351
n=20 Participants
Participants received 1 IM injection of 20 ug mRNA-1273.351 (booster dose) on Day 1.
|
Part C: 50 ug mRNA-1273.351
n=20 Participants
Participants received 1 IM injection of 50 ug mRNA-1273.351 (booster dose) on Day 1.
|
Part C: 50 ug mRNA-1273/mRNA-1273.351 Mixture
n=20 Participants
Participants received 1 IM injection of 50 ug mRNA-1273/mRNA-1273.351 mixture (booster dose) on Day 1.
|
|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Medically-Attended Adverse Events (MAAEs)
|
74 Participants
|
38 Participants
|
64 Participants
|
42 Participants
|
47 Participants
|
59 Participants
|
7 Participants
|
3 Participants
|
7 Participants
|
PRIMARY outcome
Timeframe: Up to Month 15Population: Safety Set: All participants who received any study injection in their respective part of the study.
An SAE was defined as any AE that resulted in death, is life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in disability/permanent damage, was a congenital anomaly/birth defect, or was an important medical event. A summary of SAEs and all nonserious AEs ("Other"), regardless of causality, is located in the Reported "Adverse Events" section.
Outcome measures
| Measure |
Part A: 50 ug mRNA-1273
n=200 Participants
Participants received 1 IM injection of 50 ug mRNA-1273 on Day 1 and on Day 29.
|
Part A: 100 ug mRNA-1273
n=200 Participants
Participants received 1 IM injection of 100 ug mRNA-1273 on Day 1 and on Day 29.
|
Part A: Placebo
n=200 Participants
Participants received 1 IM injection of mRNA-1273-matching placebo on Day 1 and on Day 29.
|
Part B: 50 ug mRNA-1273 Then 50 ug mRNA-1273
n=173 Participants
Participants who chose to be unblinded and received 50 ug mRNA-1273 during Part A, received 1 IM injection of 50 ug mRNA-1273 during Part B.
|
Part B: 100 ug mRNA-1273 Then 50 ug mRNA-1273
n=171 Participants
Participants who chose to be unblinded and received 100 ug mRNA-1273 during Part A, received 1 IM injection of 50 ug mRNA-1273 during Part B.
|
Part B: Placebo Then 100 ug mRNA-1273
n=158 Participants
Participants who chose to be unblinded and received mRNA-1273-matching placebo during Part A, received 2 IM injections of 100 ug mRNA-1273 28 days apart during Part B.
|
Part C: 20 ug mRNA-1273.351
n=20 Participants
Participants received 1 IM injection of 20 ug mRNA-1273.351 (booster dose) on Day 1.
|
Part C: 50 ug mRNA-1273.351
n=20 Participants
Participants received 1 IM injection of 50 ug mRNA-1273.351 (booster dose) on Day 1.
|
Part C: 50 ug mRNA-1273/mRNA-1273.351 Mixture
n=20 Participants
Participants received 1 IM injection of 50 ug mRNA-1273/mRNA-1273.351 mixture (booster dose) on Day 1.
|
|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With SAEs
|
5 Participants
|
2 Participants
|
0 Participants
|
2 Participants
|
2 Participants
|
2 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Days 1 (Baseline), 29, 43, 57, and 209Population: Per-Protocol (PP) Set included randomized participants who received any study injection, had required baseline (Day 1) data, had ≥1 post-injection assessment for the analysis endpoint, complied with injection schedule, had post-injection results available for ≥1 assay component corresponding to immunogenicity analysis, did not have SARS-CoV-2 infection, and had no major protocol deviations impacting applicable immune response. Number Analyzed = participants evaluable at specified timepoints.
The geometric mean (GM) level of VAC58 spike immunoglobulin G (IgG) antibodies, as measured by ELISA specific to the SARS-CoV-2 spike protein is reported. Antibody values reported as below the lower limit of quantification (LLOQ) were replaced by 0.5\*LLOQ. Values that were greater than the upper limit of quantification (ULOQ) were converted to the ULOQ if actual values were not available. LLOQ was 1 and ULOQ was 2052. The 95% confidence intervals (CIs) were calculated based on the t-distribution of the log-transformed values or the difference in the log-transformed values for GM value, respectively, then back transformed to the original scale for presentation.
Outcome measures
| Measure |
Part A: 50 ug mRNA-1273
n=185 Participants
Participants received 1 IM injection of 50 ug mRNA-1273 on Day 1 and on Day 29.
|
Part A: 100 ug mRNA-1273
n=189 Participants
Participants received 1 IM injection of 100 ug mRNA-1273 on Day 1 and on Day 29.
|
Part A: Placebo
n=186 Participants
Participants received 1 IM injection of mRNA-1273-matching placebo on Day 1 and on Day 29.
|
Part B: 50 ug mRNA-1273 Then 50 ug mRNA-1273
Participants who chose to be unblinded and received 50 ug mRNA-1273 during Part A, received 1 IM injection of 50 ug mRNA-1273 during Part B.
|
Part B: 100 ug mRNA-1273 Then 50 ug mRNA-1273
Participants who chose to be unblinded and received 100 ug mRNA-1273 during Part A, received 1 IM injection of 50 ug mRNA-1273 during Part B.
|
Part B: Placebo Then 100 ug mRNA-1273
Participants who chose to be unblinded and received mRNA-1273-matching placebo during Part A, received 2 IM injections of 100 ug mRNA-1273 28 days apart during Part B.
|
Part C: 20 ug mRNA-1273.351
Participants received 1 IM injection of 20 ug mRNA-1273.351 (booster dose) on Day 1.
|
Part C: 50 ug mRNA-1273.351
Participants received 1 IM injection of 50 ug mRNA-1273.351 (booster dose) on Day 1.
|
Part C: 50 ug mRNA-1273/mRNA-1273.351 Mixture
Participants received 1 IM injection of 50 ug mRNA-1273/mRNA-1273.351 mixture (booster dose) on Day 1.
|
|---|---|---|---|---|---|---|---|---|---|
|
Part A: Level of Severe Acute Respiratory Syndrome Coronavirus (SARS-COV-2)-Specific Binding Antibody (bAb) as Measured by Enzyme-Linked Immunosorbent Assay (ELISA)
Day 1 (Baseline)
|
0.70 arbitrary units per mL (AU/mL)
Interval 0.63 to 0.78
|
0.67 arbitrary units per mL (AU/mL)
Interval 0.6 to 0.73
|
0.67 arbitrary units per mL (AU/mL)
Interval 0.61 to 0.73
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part A: Level of Severe Acute Respiratory Syndrome Coronavirus (SARS-COV-2)-Specific Binding Antibody (bAb) as Measured by Enzyme-Linked Immunosorbent Assay (ELISA)
Day 29
|
59.42 arbitrary units per mL (AU/mL)
Interval 52.05 to 67.82
|
81.51 arbitrary units per mL (AU/mL)
Interval 70.19 to 94.67
|
0.68 arbitrary units per mL (AU/mL)
Interval 0.61 to 0.76
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part A: Level of Severe Acute Respiratory Syndrome Coronavirus (SARS-COV-2)-Specific Binding Antibody (bAb) as Measured by Enzyme-Linked Immunosorbent Assay (ELISA)
Day 43
|
720.85 arbitrary units per mL (AU/mL)
Interval 660.3 to 786.96
|
834.66 arbitrary units per mL (AU/mL)
Interval 765.28 to 910.33
|
0.65 arbitrary units per mL (AU/mL)
Interval 0.59 to 0.71
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part A: Level of Severe Acute Respiratory Syndrome Coronavirus (SARS-COV-2)-Specific Binding Antibody (bAb) as Measured by Enzyme-Linked Immunosorbent Assay (ELISA)
Day 57
|
519.48 arbitrary units per mL (AU/mL)
Interval 474.0 to 569.33
|
647.22 arbitrary units per mL (AU/mL)
Interval 588.98 to 711.21
|
0.67 arbitrary units per mL (AU/mL)
Interval 0.6 to 0.75
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part A: Level of Severe Acute Respiratory Syndrome Coronavirus (SARS-COV-2)-Specific Binding Antibody (bAb) as Measured by Enzyme-Linked Immunosorbent Assay (ELISA)
Day 209
|
97.02 arbitrary units per mL (AU/mL)
Interval 87.58 to 107.47
|
128.00 arbitrary units per mL (AU/mL)
Interval 114.44 to 143.18
|
0.91 arbitrary units per mL (AU/mL)
Interval 0.73 to 1.14
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Days 1 (Baseline) and 29Population: PP Set. Number Analyzed=participants evaluable at specified timepoint. Immunogenicity samples from the "Part B: Placebo then 100 ug mRNA" arm were not tested and no data were generated as results were not thought to provide additional information. After Part B samples were obtained, it was determined that the extensive results for immunogenicity profiles of 2 doses of 100 ug mRNA-1273 that were obtained during Part A of this study and in Study P301 demonstrated enough immune response data.
The GM level of VAC65 spike IgG antibodies, as measured by ELISA specific to the SARS-CoV-2 spike protein is reported. Antibody values reported as below the LLOQ were replaced by 0.5\*LLOQ. Values that were greater than the ULOQ are converted to the ULOQ. LLOQ was 1 and ULOQ was 2052. The 95% CIs were calculated based on the t-distribution of the log-transformed values or the difference in the log-transformed values for GM value, respectively, then back transformed to the original scale for presentation. The PP Set included participants with a study injection, required baseline data, had postinjection results at timepoint of primary interest for immunogenicity analysis, no major protocol deviations impacting immune response, and didn't have SARS-CoV-2.
Outcome measures
| Measure |
Part A: 50 ug mRNA-1273
n=146 Participants
Participants received 1 IM injection of 50 ug mRNA-1273 on Day 1 and on Day 29.
|
Part A: 100 ug mRNA-1273
n=149 Participants
Participants received 1 IM injection of 100 ug mRNA-1273 on Day 1 and on Day 29.
|
Part A: Placebo
Participants received 1 IM injection of mRNA-1273-matching placebo on Day 1 and on Day 29.
|
Part B: 50 ug mRNA-1273 Then 50 ug mRNA-1273
Participants who chose to be unblinded and received 50 ug mRNA-1273 during Part A, received 1 IM injection of 50 ug mRNA-1273 during Part B.
|
Part B: 100 ug mRNA-1273 Then 50 ug mRNA-1273
Participants who chose to be unblinded and received 100 ug mRNA-1273 during Part A, received 1 IM injection of 50 ug mRNA-1273 during Part B.
|
Part B: Placebo Then 100 ug mRNA-1273
Participants who chose to be unblinded and received mRNA-1273-matching placebo during Part A, received 2 IM injections of 100 ug mRNA-1273 28 days apart during Part B.
|
Part C: 20 ug mRNA-1273.351
Participants received 1 IM injection of 20 ug mRNA-1273.351 (booster dose) on Day 1.
|
Part C: 50 ug mRNA-1273.351
Participants received 1 IM injection of 50 ug mRNA-1273.351 (booster dose) on Day 1.
|
Part C: 50 ug mRNA-1273/mRNA-1273.351 Mixture
Participants received 1 IM injection of 50 ug mRNA-1273/mRNA-1273.351 mixture (booster dose) on Day 1.
|
|---|---|---|---|---|---|---|---|---|---|
|
Part B: Level of SARS-CoV-2-Specific bAb as Measured by ELISA
Day 1 (Baseline)
|
86.29 AU/mL
Interval 76.89 to 96.83
|
109.56 AU/mL
Interval 96.79 to 124.02
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part B: Level of SARS-CoV-2-Specific bAb as Measured by ELISA
Day 29
|
1069.73 AU/mL
Interval 992.92 to 1152.49
|
1083.21 AU/mL
Interval 1018.75 to 1151.75
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Days 1 (Baseline), 8, 15, and 29Population: PP Set included participants who received any study injection, had required baseline (Day 1) data, had ≥1 post-injection assessment for the analysis endpoint, complied with injection schedule, had post-injection results available for ≥1 assay component corresponding to immunogenicity analysis, did not have SARS-CoV-2 infection, and had no major protocol deviations impacting applicable immune response. Number Analyzed = participants who were evaluable at specified timepoints.
The GM level of SARS-CoV-2 protein antibody against B.1.351, as measured by MSD MULTIPLEX is reported. Antibody values reported as below the LLOQ were replaced by 0.5\*LLOQ. Values that were greater than the ULOQ are converted to the ULOQ. LLOQ was 18 and ULOQ was 4200000. The 95% CIs were calculated based on the t-distribution of the log-transformed values or the difference in the log-transformed values for GM value, respectively, then back transformed to the original scale for presentation.
Outcome measures
| Measure |
Part A: 50 ug mRNA-1273
n=19 Participants
Participants received 1 IM injection of 50 ug mRNA-1273 on Day 1 and on Day 29.
|
Part A: 100 ug mRNA-1273
n=20 Participants
Participants received 1 IM injection of 100 ug mRNA-1273 on Day 1 and on Day 29.
|
Part A: Placebo
n=20 Participants
Participants received 1 IM injection of mRNA-1273-matching placebo on Day 1 and on Day 29.
|
Part B: 50 ug mRNA-1273 Then 50 ug mRNA-1273
Participants who chose to be unblinded and received 50 ug mRNA-1273 during Part A, received 1 IM injection of 50 ug mRNA-1273 during Part B.
|
Part B: 100 ug mRNA-1273 Then 50 ug mRNA-1273
Participants who chose to be unblinded and received 100 ug mRNA-1273 during Part A, received 1 IM injection of 50 ug mRNA-1273 during Part B.
|
Part B: Placebo Then 100 ug mRNA-1273
Participants who chose to be unblinded and received mRNA-1273-matching placebo during Part A, received 2 IM injections of 100 ug mRNA-1273 28 days apart during Part B.
|
Part C: 20 ug mRNA-1273.351
Participants received 1 IM injection of 20 ug mRNA-1273.351 (booster dose) on Day 1.
|
Part C: 50 ug mRNA-1273.351
Participants received 1 IM injection of 50 ug mRNA-1273.351 (booster dose) on Day 1.
|
Part C: 50 ug mRNA-1273/mRNA-1273.351 Mixture
Participants received 1 IM injection of 50 ug mRNA-1273/mRNA-1273.351 mixture (booster dose) on Day 1.
|
|---|---|---|---|---|---|---|---|---|---|
|
Part C: Level of SARS-CoV-2-Specific bAb as Measured by MSD
Day 1 (Baseline)
|
59742.3 AU/mL
Interval 43057.8 to 82891.8
|
44921.5 AU/mL
Interval 28539.6 to 70706.5
|
33409.8 AU/mL
Interval 25264.8 to 44180.6
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part C: Level of SARS-CoV-2-Specific bAb as Measured by MSD
Day 8
|
240180.0 AU/mL
Interval 166361.1 to 346754.3
|
267002.2 AU/mL
Interval 199939.9 to 356558.2
|
228572.0 AU/mL
Interval 178986.7 to 291894.2
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part C: Level of SARS-CoV-2-Specific bAb as Measured by MSD
Day 15
|
297880.2 AU/mL
Interval 224089.6 to 395969.4
|
418215.3 AU/mL
Interval 311988.7 to 560610.2
|
384521.1 AU/mL
Interval 282461.4 to 523457.3
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part C: Level of SARS-CoV-2-Specific bAb as Measured by MSD
Day 29
|
297962.7 AU/mL
Interval 227337.5 to 390528.5
|
345765.9 AU/mL
Interval 251640.5 to 475098.5
|
367714.1 AU/mL
Interval 268913.2 to 502815.1
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Days 1 (Baseline), 29, 43, 57, and 209Population: PP Set included randomized participants who received any study injection, had required baseline (Day 1) data, had ≥1 post-injection assessment for the analysis endpoint, complied with injection schedule, had post-injection results available for ≥1 assay component corresponding to immunogenicity analysis, did not have SARS-CoV-2 infection, and had no major protocol deviations impacting applicable immune response. Number Analyzed = participants who were evaluable at specified timepoints.
The GM titer (microneutralization \[MN\] and MN50) of serum nAb against SARS-CoV-2 as measured by live virus MN assays is reported. Antibody values reported as below the LLOQ were replaced by 0.5\*LLOQ. Values that were greater than the ULOQ were converted to the ULOQ. For MN, LLOQ was 40 and ULOQ was 1280 at Days 1 (Baseline), 29, 43, and 57. For MN50, LLOQ was 91.10 and ULOQ was 2031.87 at Days 1 (Baseline), 29, 43, and 57. For MN, LLOQ was 160 and ULOQ was 1280 at Day 209. For MN50, LLOQ was 318.46 and ULOQ was 1917.83 at Day 209. The 95% CI was calculated based on the t-distribution of the log-transformed values or the difference in the log-transformed values for GM titer, then back transformed to the original scale for presentation.
Outcome measures
| Measure |
Part A: 50 ug mRNA-1273
n=185 Participants
Participants received 1 IM injection of 50 ug mRNA-1273 on Day 1 and on Day 29.
|
Part A: 100 ug mRNA-1273
n=189 Participants
Participants received 1 IM injection of 100 ug mRNA-1273 on Day 1 and on Day 29.
|
Part A: Placebo
n=186 Participants
Participants received 1 IM injection of mRNA-1273-matching placebo on Day 1 and on Day 29.
|
Part B: 50 ug mRNA-1273 Then 50 ug mRNA-1273
Participants who chose to be unblinded and received 50 ug mRNA-1273 during Part A, received 1 IM injection of 50 ug mRNA-1273 during Part B.
|
Part B: 100 ug mRNA-1273 Then 50 ug mRNA-1273
Participants who chose to be unblinded and received 100 ug mRNA-1273 during Part A, received 1 IM injection of 50 ug mRNA-1273 during Part B.
|
Part B: Placebo Then 100 ug mRNA-1273
Participants who chose to be unblinded and received mRNA-1273-matching placebo during Part A, received 2 IM injections of 100 ug mRNA-1273 28 days apart during Part B.
|
Part C: 20 ug mRNA-1273.351
Participants received 1 IM injection of 20 ug mRNA-1273.351 (booster dose) on Day 1.
|
Part C: 50 ug mRNA-1273.351
Participants received 1 IM injection of 50 ug mRNA-1273.351 (booster dose) on Day 1.
|
Part C: 50 ug mRNA-1273/mRNA-1273.351 Mixture
Participants received 1 IM injection of 50 ug mRNA-1273/mRNA-1273.351 mixture (booster dose) on Day 1.
|
|---|---|---|---|---|---|---|---|---|---|
|
Part A: Titer of SARS-CoV-2-Specific Neutralizing Antibody (nAb)
MN, Day 1 (Baseline)
|
20.6 titers
Interval 20.0 to 21.2
|
20.6 titers
Interval 19.7 to 21.5
|
20.8 titers
Interval 20.1 to 21.4
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part A: Titer of SARS-CoV-2-Specific Neutralizing Antibody (nAb)
MN, Day 29
|
112.2 titers
Interval 94.9 to 132.7
|
149.6 titers
Interval 127.3 to 175.9
|
21.9 titers
Interval 20.5 to 23.5
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part A: Titer of SARS-CoV-2-Specific Neutralizing Antibody (nAb)
MN, Day 43
|
1145.4 titers
Interval 1101.3 to 1191.1
|
1185.8 titers
Interval 1142.9 to 1230.3
|
21.2 titers
Interval 20.1 to 22.4
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part A: Titer of SARS-CoV-2-Specific Neutralizing Antibody (nAb)
MN, Day 57
|
1090.6 titers
Interval 1038.9 to 1144.9
|
1095.5 titers
Interval 1041.5 to 1152.2
|
21.8 titers
Interval 20.4 to 23.4
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part A: Titer of SARS-CoV-2-Specific Neutralizing Antibody (nAb)
MN, Day 209
|
254.4 titers
Interval 219.4 to 294.9
|
354.8 titers
Interval 309.2 to 407.2
|
85.3 titers
Interval 80.6 to 90.2
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part A: Titer of SARS-CoV-2-Specific Neutralizing Antibody (nAb)
MN50, Day 1 (Baseline)
|
46.500 titers
Interval 45.425 to 47.6
|
46.684 titers
Interval 44.957 to 48.477
|
47.109 titers
Interval 45.745 to 48.512
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part A: Titer of SARS-CoV-2-Specific Neutralizing Antibody (nAb)
MN50, Day 29
|
173.750 titers
Interval 148.55 to 203.225
|
227.433 titers
Interval 194.207 to 266.343
|
49.231 titers
Interval 46.355 to 52.285
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part A: Titer of SARS-CoV-2-Specific Neutralizing Antibody (nAb)
MN50, Day 43
|
1761.660 titers
Interval 1690.216 to 1836.124
|
1813.480 titers
Interval 1741.28 to 1888.673
|
48.059 titers
Interval 45.82 to 50.408
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part A: Titer of SARS-CoV-2-Specific Neutralizing Antibody (nAb)
MN50, Day 57
|
1632.442 titers
Interval 1550.245 to 1718.998
|
1656.064 titers
Interval 1570.464 to 1746.33
|
49.141 titers
Interval 46.267 to 52.194
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part A: Titer of SARS-CoV-2-Specific Neutralizing Antibody (nAb)
MN50, Day 209
|
401.508 titers
Interval 350.667 to 459.72
|
538.798 titers
Interval 472.772 to 614.045
|
167.002 titers
Interval 159.249 to 175.133
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Days 1 (Baseline), 29, and 181Population: PP Set. Number Analyzed=participants evaluable at specified timepoint. Immunogenicity samples from the "Part B: Placebo then 100 ug mRNA" arm were not tested and no data were generated as results were not thought to provide additional information. After Part B samples were obtained, it was determined that the extensive results for immunogenicity profiles of 2 doses of 100 ug mRNA-1273 that were obtained during Part A of this study and in Study P301 demonstrated enough immune response data.
The GM titer (50% inhibitory dose \[ID50\], 80% inhibitory dose \[ID80\]) of nAb against SARS-CoV-2 pseudotyped viruses as measured by pseudovirus nAb assay is reported. Antibody values reported as below the LLOQ were replaced by 0.5\*LLOQ. Values that were greater than the ULOQ were converted to the ULOQ if actual values were not available. LLOQ was 18.5 and ULOQ was 45118 for IC50. LLOQ was 14.3 and ULOQ was 10232 for ID80. The 95% CI was calculated based on the t-distribution of the log-transformed values for GM titer, then back transformed to the original scale for presentation. The PP Set included participants with a study injection, required baseline data, had postinjection results at timepoint of primary interest for immunogenicity analysis, no major protocol deviations impacting immune response, and didn't have SARS-CoV-2.
Outcome measures
| Measure |
Part A: 50 ug mRNA-1273
n=146 Participants
Participants received 1 IM injection of 50 ug mRNA-1273 on Day 1 and on Day 29.
|
Part A: 100 ug mRNA-1273
n=149 Participants
Participants received 1 IM injection of 100 ug mRNA-1273 on Day 1 and on Day 29.
|
Part A: Placebo
Participants received 1 IM injection of mRNA-1273-matching placebo on Day 1 and on Day 29.
|
Part B: 50 ug mRNA-1273 Then 50 ug mRNA-1273
Participants who chose to be unblinded and received 50 ug mRNA-1273 during Part A, received 1 IM injection of 50 ug mRNA-1273 during Part B.
|
Part B: 100 ug mRNA-1273 Then 50 ug mRNA-1273
Participants who chose to be unblinded and received 100 ug mRNA-1273 during Part A, received 1 IM injection of 50 ug mRNA-1273 during Part B.
|
Part B: Placebo Then 100 ug mRNA-1273
Participants who chose to be unblinded and received mRNA-1273-matching placebo during Part A, received 2 IM injections of 100 ug mRNA-1273 28 days apart during Part B.
|
Part C: 20 ug mRNA-1273.351
Participants received 1 IM injection of 20 ug mRNA-1273.351 (booster dose) on Day 1.
|
Part C: 50 ug mRNA-1273.351
Participants received 1 IM injection of 50 ug mRNA-1273.351 (booster dose) on Day 1.
|
Part C: 50 ug mRNA-1273/mRNA-1273.351 Mixture
Participants received 1 IM injection of 50 ug mRNA-1273/mRNA-1273.351 mixture (booster dose) on Day 1.
|
|---|---|---|---|---|---|---|---|---|---|
|
Part B: Titer of SARS-CoV-2-Specific nAb
ID50, Day 1 (Baseline)
|
104.658 titers
Interval 88.282 to 124.07
|
150.224 titers
Interval 125.726 to 179.495
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part B: Titer of SARS-CoV-2-Specific nAb
ID50, Day 29
|
1834.309 titers
Interval 1600.233 to 2102.623
|
1951.735 titers
Interval 1729.606 to 2202.392
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part B: Titer of SARS-CoV-2-Specific nAb
ID50, Day 181
|
915.331 titers
Interval 622.504 to 1345.904
|
673.273 titers
Interval 578.167 to 784.025
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part B: Titer of SARS-CoV-2-Specific nAb
ID80, Day 1 (Baseline)
|
39.646 titers
Interval 33.789 to 46.518
|
55.686 titers
Interval 47.459 to 65.341
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part B: Titer of SARS-CoV-2-Specific nAb
ID80, Day 29
|
696.085 titers
Interval 609.203 to 795.358
|
736.617 titers
Interval 661.04 to 820.835
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part B: Titer of SARS-CoV-2-Specific nAb
ID80, Day 181
|
291.791 titers
Interval 203.597 to 418.189
|
228.635 titers
Interval 197.044 to 265.291
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Days 1 (Baseline), 8, 15, 29, and 181Population: PP Set included participants who received any study injection, had required baseline (Day 1) data, had ≥1 post-injection assessment for the analysis endpoint, complied with injection schedule, had post-injection results available for ≥1 assay component corresponding to immunogenicity analysis, did not have SARS-CoV-2 infection, and had no major protocol deviations impacting applicable immune response. Number Analyzed = participants who were evaluable at specified timepoints.
The GM titer (ID50, ID80) of nAb against SARS-CoV-2 pseudotyped viruses (original strain and beta variant \[B.1.351\]) as measured by pseudovirus nAb assay is reported. Antibody values reported as below the LLOQ were replaced by 0.5\*LLOQ. Values that were greater than the ULOQ were converted to the ULOQ if actual values were not available. For NAb ID50 Titers, LLOQ was 18.5 and ULOQ was 45118. For NAb ID80 Titers, LLOQ was 14.3 and ULOQ was 10232. For NAb ID50 Titers against B.1.351, LLOQ was 19.5 and ULOQ was 385.7. For NAb ID80 Titers against B.1.351, LLOQ was 12.5 and ULOQ was 102.2. The 95% CI was calculated based on the t-distribution of the log-transformed values for GM titer, then back transformed to the original scale for presentation.
Outcome measures
| Measure |
Part A: 50 ug mRNA-1273
n=19 Participants
Participants received 1 IM injection of 50 ug mRNA-1273 on Day 1 and on Day 29.
|
Part A: 100 ug mRNA-1273
n=20 Participants
Participants received 1 IM injection of 100 ug mRNA-1273 on Day 1 and on Day 29.
|
Part A: Placebo
n=20 Participants
Participants received 1 IM injection of mRNA-1273-matching placebo on Day 1 and on Day 29.
|
Part B: 50 ug mRNA-1273 Then 50 ug mRNA-1273
Participants who chose to be unblinded and received 50 ug mRNA-1273 during Part A, received 1 IM injection of 50 ug mRNA-1273 during Part B.
|
Part B: 100 ug mRNA-1273 Then 50 ug mRNA-1273
Participants who chose to be unblinded and received 100 ug mRNA-1273 during Part A, received 1 IM injection of 50 ug mRNA-1273 during Part B.
|
Part B: Placebo Then 100 ug mRNA-1273
Participants who chose to be unblinded and received mRNA-1273-matching placebo during Part A, received 2 IM injections of 100 ug mRNA-1273 28 days apart during Part B.
|
Part C: 20 ug mRNA-1273.351
Participants received 1 IM injection of 20 ug mRNA-1273.351 (booster dose) on Day 1.
|
Part C: 50 ug mRNA-1273.351
Participants received 1 IM injection of 50 ug mRNA-1273.351 (booster dose) on Day 1.
|
Part C: 50 ug mRNA-1273/mRNA-1273.351 Mixture
Participants received 1 IM injection of 50 ug mRNA-1273/mRNA-1273.351 mixture (booster dose) on Day 1.
|
|---|---|---|---|---|---|---|---|---|---|
|
Part C: Titer of SARS-CoV-2-Specific nAb
ID80 Against Original Strain, Day 29
|
632.263 titers
Interval 460.549 to 868.001
|
615.967 titers
Interval 397.103 to 955.46
|
1156.267 titers
Interval 743.617 to 1797.907
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part C: Titer of SARS-CoV-2-Specific nAb
ID80 Against Original Strain, Day 181
|
—
|
182.837 titers
Interval 108.3 to 308.673
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part C: Titer of SARS-CoV-2-Specific nAb
ID50 Against B.1.351, Day 1 (Baseline)
|
45.574 titers
Interval 28.832 to 72.036
|
32.026 titers
Interval 19.758 to 51.911
|
18.338 titers
Interval 13.572 to 24.776
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part C: Titer of SARS-CoV-2-Specific nAb
ID50 Against B.1.351, Day 8
|
919.281 titers
Interval 592.738 to 1425.72
|
1088.511 titers
Interval 670.315 to 1767.61
|
706.141 titers
Interval 456.01 to 1093.475
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part C: Titer of SARS-CoV-2-Specific nAb
ID50 Against B.1.351, Day 15
|
1088.432 titers
Interval 736.353 to 1608.854
|
1113.392 titers
Interval 652.885 to 1898.716
|
1166.830 titers
Interval 760.23 to 1790.895
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part C: Titer of SARS-CoV-2-Specific nAb
ID50 Against B.1.351, Day 29
|
1537.029 titers
Interval 1066.352 to 2215.458
|
1116.885 titers
Interval 714.119 to 1746.813
|
1129.955 titers
Interval 742.454 to 1719.699
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part C: Titer of SARS-CoV-2-Specific nAb
ID50 Against B.1.351, Day 181
|
—
|
141.773 titers
Interval 76.471 to 262.839
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part C: Titer of SARS-CoV-2-Specific nAb
ID80 Against B.1.351, Day 1 (Baseline)
|
17.403 titers
Interval 10.87 to 27.863
|
15.046 titers
Interval 10.088 to 22.442
|
8.326 titers
Interval 6.727 to 10.306
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part C: Titer of SARS-CoV-2-Specific nAb
ID80 Against B.1.351, Day 8
|
289.360 titers
Interval 196.26 to 426.626
|
313.644 titers
Interval 203.582 to 483.21
|
225.475 titers
Interval 160.419 to 316.915
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part C: Titer of SARS-CoV-2-Specific nAb
ID80 Against B.1.351, Day 15
|
435.078 titers
Interval 300.742 to 629.418
|
371.579 titers
Interval 228.889 to 603.223
|
413.424 titers
Interval 284.856 to 600.02
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part C: Titer of SARS-CoV-2-Specific nAb
ID80 Against B.1.351, Day 29
|
486.398 titers
Interval 341.63 to 692.511
|
345.827 titers
Interval 214.472 to 557.633
|
362.540 titers
Interval 249.138 to 527.56
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part C: Titer of SARS-CoV-2-Specific nAb
ID80 Against B.1.351, Day 181
|
—
|
55.887 titers
Interval 29.969 to 104.22
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part C: Titer of SARS-CoV-2-Specific nAb
ID50 Against Original Strain, Day 1 (Baseline)
|
196.107 titers
Interval 133.338 to 288.424
|
156.011 titers
Interval 80.546 to 302.18
|
79.572 titers
Interval 53.625 to 118.074
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part C: Titer of SARS-CoV-2-Specific nAb
ID50 Against Original Strain, Day 8
|
1089.901 titers
Interval 748.146 to 1587.77
|
1568.894 titers
Interval 1030.722 to 2388.062
|
1183.096 titers
Interval 900.313 to 1554.7
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part C: Titer of SARS-CoV-2-Specific nAb
ID50 Against Original Strain, Day 15
|
2221.382 titers
Interval 1434.353 to 3440.255
|
1725.415 titers
Interval 1212.131 to 2456.053
|
3082.946 titers
Interval 1891.502 to 5024.874
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part C: Titer of SARS-CoV-2-Specific nAb
ID50 Against Original Strain, Day 29
|
1808.133 titers
Interval 1323.211 to 2470.767
|
1757.179 titers
Interval 1117.782 to 2762.324
|
3691.896 titers
Interval 2330.908 to 5847.548
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part C: Titer of SARS-CoV-2-Specific nAb
ID50 Against Original Strain, Day 181
|
—
|
512.129 titers
Interval 303.261 to 864.853
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part C: Titer of SARS-CoV-2-Specific nAb
ID80 Against Original Strain, Day 1 (Baseline)
|
76.279 titers
Interval 53.035 to 109.712
|
56.344 titers
Interval 33.804 to 93.911
|
30.774 titers
Interval 21.565 to 43.915
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part C: Titer of SARS-CoV-2-Specific nAb
ID80 Against Original Strain, Day 8
|
448.109 titers
Interval 300.43 to 668.381
|
500.158 titers
Interval 341.18 to 733.214
|
458.435 titers
Interval 351.348 to 598.161
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part C: Titer of SARS-CoV-2-Specific nAb
ID80 Against Original Strain, Day 15
|
730.018 titers
Interval 509.454 to 1046.073
|
678.926 titers
Interval 462.561 to 996.498
|
947.774 titers
Interval 647.781 to 1386.696
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Days 29, 43, and 57Population: PP Set included randomized participants who received any study injection, had required baseline (Day 1) data, had ≥1 post-injection assessment for the analysis endpoint, complied with injection schedule, had post-injection results available for ≥1 assay component corresponding to immunogenicity analysis, did not have SARS-CoV-2 infection, and had no major protocol deviations impacting applicable immune response. Number Analyzed = participants who were evaluable at specified timepoints.
Based on MN titers and MN50 titers of serum nAb against SARS-CoV-2 as measured by live virus MN assays, percentage of participants with seroconversion from baseline are reported with 2-sided 95% CI using the Clopper-Pearson method at each post-baseline timepoint. Seroconversion at a participant level was defined as a change of nAb titer from below the limit of detection (LOD) or LLOQ to equal to or above LOD or LLOQ (respectively), or a 4-times or higher titer ratio in participants with pre-existing nAb titers. Antibody values reported as below the LLOQ were replaced by 0.5\*LLOQ. Values that were greater than the ULOQ were converted to the ULOQ. For MN, LLOQ was 40 and ULOQ was 1280. For MN50, LLOQ was 91.10 and ULOQ was 2031.87.
Outcome measures
| Measure |
Part A: 50 ug mRNA-1273
n=168 Participants
Participants received 1 IM injection of 50 ug mRNA-1273 on Day 1 and on Day 29.
|
Part A: 100 ug mRNA-1273
n=180 Participants
Participants received 1 IM injection of 100 ug mRNA-1273 on Day 1 and on Day 29.
|
Part A: Placebo
n=178 Participants
Participants received 1 IM injection of mRNA-1273-matching placebo on Day 1 and on Day 29.
|
Part B: 50 ug mRNA-1273 Then 50 ug mRNA-1273
Participants who chose to be unblinded and received 50 ug mRNA-1273 during Part A, received 1 IM injection of 50 ug mRNA-1273 during Part B.
|
Part B: 100 ug mRNA-1273 Then 50 ug mRNA-1273
Participants who chose to be unblinded and received 100 ug mRNA-1273 during Part A, received 1 IM injection of 50 ug mRNA-1273 during Part B.
|
Part B: Placebo Then 100 ug mRNA-1273
Participants who chose to be unblinded and received mRNA-1273-matching placebo during Part A, received 2 IM injections of 100 ug mRNA-1273 28 days apart during Part B.
|
Part C: 20 ug mRNA-1273.351
Participants received 1 IM injection of 20 ug mRNA-1273.351 (booster dose) on Day 1.
|
Part C: 50 ug mRNA-1273.351
Participants received 1 IM injection of 50 ug mRNA-1273.351 (booster dose) on Day 1.
|
Part C: 50 ug mRNA-1273/mRNA-1273.351 Mixture
Participants received 1 IM injection of 50 ug mRNA-1273/mRNA-1273.351 mixture (booster dose) on Day 1.
|
|---|---|---|---|---|---|---|---|---|---|
|
Part A: Percentage of Participants With Seroconversion From Baseline
MN Titer, Day 29
|
78.0 percentage of participants
Interval 70.9 to 84.0
|
88.9 percentage of participants
Interval 83.4 to 93.1
|
1.7 percentage of participants
Interval 0.3 to 4.8
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part A: Percentage of Participants With Seroconversion From Baseline
MN Titer, Day 43
|
100 percentage of participants
Interval 97.4 to 100.0
|
100 percentage of participants
Interval 97.6 to 100.0
|
0.6 percentage of participants
Interval 0.0 to 3.1
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part A: Percentage of Participants With Seroconversion From Baseline
MN Titer, Day 57
|
100 percentage of participants
Interval 97.6 to 100.0
|
100 percentage of participants
Interval 97.6 to 100.0
|
1.8 percentage of participants
Interval 0.4 to 5.0
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part A: Percentage of Participants With Seroconversion From Baseline
MN50 Titer, Day 29
|
65.5 percentage of participants
Interval 57.8 to 72.6
|
76.7 percentage of participants
Interval 69.8 to 82.6
|
1.1 percentage of participants
Interval 0.1 to 4.0
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part A: Percentage of Participants With Seroconversion From Baseline
MN50 Titer, Day 43
|
100 percentage of participants
Interval 97.4 to 100.0
|
100 percentage of participants
Interval 97.6 to 100.0
|
0.6 percentage of participants
Interval 0.0 to 3.1
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part A: Percentage of Participants With Seroconversion From Baseline
MN50 Titer, Day 57
|
100 percentage of participants
Interval 97.6 to 100.0
|
100 percentage of participants
Interval 97.6 to 100.0
|
1.8 percentage of participants
Interval 0.4 to 5.0
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Days 29 and 181Population: PP Set. Number Analyzed=participants evaluable at specified timepoint. Immunogenicity samples from the "Part B: Placebo then 100 ug mRNA" arm were not tested and no data were generated as results were not thought to provide additional information. After Part B samples were obtained, it was determined that the extensive results for immunogenicity profiles of 2 doses of 100 ug mRNA-1273 that were obtained during Part A of this study and in Study P301 demonstrated enough immune response data.
Based on ID50 and ID80 titers of nAb against SARS-CoV-2 pseudotyped viruses as measured by pseudovirus nAb assay, % of participants with seroconversion from baseline reported with 2-sided 95% CI using Clopper-Pearson method at each postbaseline timepoint. Seroconversion at participant level defined as change of nAb titer from below LOD or LLOQ to equal to or above LOD or LLOQ (respectively) or 4-times or higher titer ratio in participants with preexisting nAb titers. Antibody values \<LLOQ replaced by 0.5\*LLOQ. Values \>ULOQ converted to ULOQ. LLOQ: 18.5 and ULOQ: 45118 for IC50. LLOQ: 14.3 and ULOQ: 10232 for ID80. 95% CI calculated based on t-distribution of log-transformed values for GMT, then back transformed to original scale for presentation. PP Set: participants with a study injection, required baseline data, had postinjection results at timepoint of primary interest for immunogenicity analysis, no major protocol deviations impacting immune response, and didn't have SARS-CoV-2.
Outcome measures
| Measure |
Part A: 50 ug mRNA-1273
n=146 Participants
Participants received 1 IM injection of 50 ug mRNA-1273 on Day 1 and on Day 29.
|
Part A: 100 ug mRNA-1273
n=149 Participants
Participants received 1 IM injection of 100 ug mRNA-1273 on Day 1 and on Day 29.
|
Part A: Placebo
Participants received 1 IM injection of mRNA-1273-matching placebo on Day 1 and on Day 29.
|
Part B: 50 ug mRNA-1273 Then 50 ug mRNA-1273
Participants who chose to be unblinded and received 50 ug mRNA-1273 during Part A, received 1 IM injection of 50 ug mRNA-1273 during Part B.
|
Part B: 100 ug mRNA-1273 Then 50 ug mRNA-1273
Participants who chose to be unblinded and received 100 ug mRNA-1273 during Part A, received 1 IM injection of 50 ug mRNA-1273 during Part B.
|
Part B: Placebo Then 100 ug mRNA-1273
Participants who chose to be unblinded and received mRNA-1273-matching placebo during Part A, received 2 IM injections of 100 ug mRNA-1273 28 days apart during Part B.
|
Part C: 20 ug mRNA-1273.351
Participants received 1 IM injection of 20 ug mRNA-1273.351 (booster dose) on Day 1.
|
Part C: 50 ug mRNA-1273.351
Participants received 1 IM injection of 50 ug mRNA-1273.351 (booster dose) on Day 1.
|
Part C: 50 ug mRNA-1273/mRNA-1273.351 Mixture
Participants received 1 IM injection of 50 ug mRNA-1273/mRNA-1273.351 mixture (booster dose) on Day 1.
|
|---|---|---|---|---|---|---|---|---|---|
|
Part B: Percentage of Participants With Seroconversion From Baseline
ID50, Day 29
|
92.4 percentage of participants
Interval 86.8 to 96.2
|
87.9 percentage of participants
Interval 81.6 to 92.7
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part B: Percentage of Participants With Seroconversion From Baseline
ID50, Day 181
|
81.6 percentage of participants
Interval 65.7 to 92.3
|
54.4 percentage of participants
Interval 46.0 to 62.6
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part B: Percentage of Participants With Seroconversion From Baseline
ID80, Day 29
|
95.2 percentage of participants
Interval 90.3 to 98.0
|
93.3 percentage of participants
Interval 88.0 to 96.7
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part B: Percentage of Participants With Seroconversion From Baseline
ID80, Day 181
|
78.9 percentage of participants
Interval 62.7 to 90.4
|
53.7 percentage of participants
Interval 45.3 to 62.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Days 8, 15, 29, and 181Population: PP Set included participants who received any study injection, had required baseline (Day 1) data, had ≥1 post-injection assessment for the analysis endpoint, complied with injection schedule, had post-injection results available for ≥1 assay component corresponding to immunogenicity analysis, did not have SARS-CoV-2 infection, and had no major protocol deviations impacting applicable immune response. Number Analyzed = participants who were evaluable at specified timepoints.
Based on ID50 titers and ID80 titers of nAb against SARS-CoV-2 pseudotyped viruses (original strain and beta variant \[B.1.351\]) as measured by pseudovirus nAb assay, percentage of participants with seroconversion from baseline are reported with 2-sided 95% CI using Clopper-Pearson method at each post-baseline timepoint. Seroconversion at participant level defined as a change of nAb titer from below LOD or LLOQ ≥LOD or LLOQ (respectively), or a 4-times or higher titer ratio in participants with pre-existing nAb titers. Antibody values reported as below LLOQ were replaced by 0.5\*LLOQ. Values \>ULOQ were converted to ULOQ. NAb ID50 Titers: LLOQ was 18.5 and ULOQ was 45118. NAb ID80 Titers: LLOQ was 14.3 and ULOQ was 10232. NAb ID50 Titers against B.1.351: LLOQ was 19.5 and ULOQ was 385.7. NAb ID80 Titers against B.1.351: LLOQ was 12.5 and ULOQ was 102.2. 95% CI calculated based on t-distribution of log-transformed values for GMT, then back transformed to original scale for presentation.
Outcome measures
| Measure |
Part A: 50 ug mRNA-1273
n=19 Participants
Participants received 1 IM injection of 50 ug mRNA-1273 on Day 1 and on Day 29.
|
Part A: 100 ug mRNA-1273
n=20 Participants
Participants received 1 IM injection of 100 ug mRNA-1273 on Day 1 and on Day 29.
|
Part A: Placebo
n=20 Participants
Participants received 1 IM injection of mRNA-1273-matching placebo on Day 1 and on Day 29.
|
Part B: 50 ug mRNA-1273 Then 50 ug mRNA-1273
Participants who chose to be unblinded and received 50 ug mRNA-1273 during Part A, received 1 IM injection of 50 ug mRNA-1273 during Part B.
|
Part B: 100 ug mRNA-1273 Then 50 ug mRNA-1273
Participants who chose to be unblinded and received 100 ug mRNA-1273 during Part A, received 1 IM injection of 50 ug mRNA-1273 during Part B.
|
Part B: Placebo Then 100 ug mRNA-1273
Participants who chose to be unblinded and received mRNA-1273-matching placebo during Part A, received 2 IM injections of 100 ug mRNA-1273 28 days apart during Part B.
|
Part C: 20 ug mRNA-1273.351
Participants received 1 IM injection of 20 ug mRNA-1273.351 (booster dose) on Day 1.
|
Part C: 50 ug mRNA-1273.351
Participants received 1 IM injection of 50 ug mRNA-1273.351 (booster dose) on Day 1.
|
Part C: 50 ug mRNA-1273/mRNA-1273.351 Mixture
Participants received 1 IM injection of 50 ug mRNA-1273/mRNA-1273.351 mixture (booster dose) on Day 1.
|
|---|---|---|---|---|---|---|---|---|---|
|
Part C: Percentage of Participants With Seroconversion From Baseline
ID50 Against Original Strain, Day 8
|
47.4 percentage of participants
Interval 24.4 to 71.1
|
78.9 percentage of participants
Interval 54.4 to 93.9
|
100 percentage of participants
Interval 83.2 to 100.0
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part C: Percentage of Participants With Seroconversion From Baseline
ID50 Against Original Strain, Day 15
|
78.9 percentage of participants
Interval 54.4 to 93.9
|
90.0 percentage of participants
Interval 68.3 to 98.8
|
95.0 percentage of participants
Interval 75.1 to 99.9
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part C: Percentage of Participants With Seroconversion From Baseline
ID50 Against Original Strain, Day 29
|
84.2 percentage of participants
Interval 60.4 to 96.6
|
95.0 percentage of participants
Interval 75.1 to 99.9
|
100 percentage of participants
Interval 83.2 to 100.0
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part C: Percentage of Participants With Seroconversion From Baseline
ID50 Against Original Strain, Day 181
|
—
|
38.9 percentage of participants
Interval 17.3 to 64.3
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part C: Percentage of Participants With Seroconversion From Baseline
ID80 Against Original Strain, Day 8
|
68.4 percentage of participants
Interval 43.4 to 87.4
|
84.2 percentage of participants
Interval 60.4 to 96.6
|
95.0 percentage of participants
Interval 75.1 to 99.9
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part C: Percentage of Participants With Seroconversion From Baseline
ID80 Against Original Strain, Day 15
|
84.2 percentage of participants
Interval 60.4 to 96.6
|
95.0 percentage of participants
Interval 75.1 to 99.9
|
100 percentage of participants
Interval 83.2 to 100.0
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part C: Percentage of Participants With Seroconversion From Baseline
ID80 Against Original Strain, Day 29
|
84.2 percentage of participants
Interval 60.4 to 96.6
|
95.0 percentage of participants
Interval 75.1 to 99.9
|
95.0 percentage of participants
Interval 75.1 to 99.9
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part C: Percentage of Participants With Seroconversion From Baseline
ID80 Against Original Strain, Day 181
|
—
|
38.9 percentage of participants
Interval 17.3 to 64.3
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part C: Percentage of Participants With Seroconversion From Baseline
ID50 Against B.1.351, Day 8
|
100 percentage of participants
Interval 82.4 to 100.0
|
100 percentage of participants
Interval 82.4 to 100.0
|
100 percentage of participants
Interval 83.2 to 100.0
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part C: Percentage of Participants With Seroconversion From Baseline
ID50 Against B.1.351, Day 15
|
94.7 percentage of participants
Interval 74.0 to 99.9
|
100 percentage of participants
Interval 83.2 to 100.0
|
100 percentage of participants
Interval 83.2 to 100.0
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part C: Percentage of Participants With Seroconversion From Baseline
ID50 Against B.1.351, Day 29
|
100 percentage of participants
Interval 82.4 to 100.0
|
100 percentage of participants
Interval 83.2 to 100.0
|
100 percentage of participants
Interval 83.2 to 100.0
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part C: Percentage of Participants With Seroconversion From Baseline
ID50 Against B.1.351, Day 181
|
—
|
61.1 percentage of participants
Interval 35.7 to 82.7
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part C: Percentage of Participants With Seroconversion From Baseline
ID80 Against B.1.351, Day 8
|
94.7 percentage of participants
Interval 74.0 to 99.9
|
94.7 percentage of participants
Interval 74.0 to 99.9
|
100 percentage of participants
Interval 83.2 to 100.0
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part C: Percentage of Participants With Seroconversion From Baseline
ID80 Against B.1.351, Day 15
|
94.7 percentage of participants
Interval 74.0 to 99.9
|
100 percentage of participants
Interval 83.2 to 100.0
|
100 percentage of participants
Interval 83.2 to 100.0
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part C: Percentage of Participants With Seroconversion From Baseline
ID80 Against B.1.351, Day 29
|
100 percentage of participants
Interval 82.4 to 100.0
|
100 percentage of participants
Interval 83.2 to 100.0
|
100 percentage of participants
Interval 83.2 to 100.0
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part C: Percentage of Participants With Seroconversion From Baseline
ID80 Against B.1.351, Day 181
|
—
|
55.6 percentage of participants
Interval 30.8 to 78.5
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
Adverse Events
Part A: 50 ug mRNA-1273
Serious events: 5 serious events
Other events: 105 other events
Deaths: 0 deaths
Part A: 100 ug mRNA-1273
Serious events: 2 serious events
Other events: 76 other events
Deaths: 0 deaths
Part A: Placebo
Serious events: 0 serious events
Other events: 94 other events
Deaths: 0 deaths
Part B: 50 ug mRNA-1273 Then 50 ug mRNA-1273
Serious events: 2 serious events
Other events: 51 other events
Deaths: 0 deaths
Part B: 100 ug mRNA-1273 Then 50 ug mRNA-1273
Serious events: 2 serious events
Other events: 62 other events
Deaths: 0 deaths
Part B: Placebo Then 100 ug mRNA-1273
Serious events: 2 serious events
Other events: 70 other events
Deaths: 0 deaths
Part C: 20 ug mRNA-1273.351
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
Part C: 50 ug mRNA-1273.351
Serious events: 1 serious events
Other events: 4 other events
Deaths: 0 deaths
Part C: 50 ug mRNA-1273/mRNA-1273.351 Mixture
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Part A: 50 ug mRNA-1273
n=200 participants at risk
Participants received 1 IM injection of 50 ug mRNA-1273 on Day 1 and on Day 29.
|
Part A: 100 ug mRNA-1273
n=200 participants at risk
Participants received 1 IM injection of 100 ug mRNA-1273 on Day 1 and on Day 29.
|
Part A: Placebo
n=200 participants at risk
Participants received 1 IM injection of mRNA-1273-matching placebo on Day 1 and on Day 29.
|
Part B: 50 ug mRNA-1273 Then 50 ug mRNA-1273
n=173 participants at risk
Participants who chose to be unblinded and received 50 ug mRNA-1273 during Part A, received 1 IM injection of 50 ug mRNA-1273 during Part B.
|
Part B: 100 ug mRNA-1273 Then 50 ug mRNA-1273
n=171 participants at risk
Participants who chose to be unblinded and received 100 ug mRNA-1273 during Part A, received 1 IM injection of 50 ug mRNA-1273 during Part B.
|
Part B: Placebo Then 100 ug mRNA-1273
n=158 participants at risk
Participants who chose to be unblinded and received mRNA-1273-matching placebo during Part A, received 2 IM injections of 100 ug mRNA-1273 28 days apart during Part B.
|
Part C: 20 ug mRNA-1273.351
n=20 participants at risk
Participants received 1 IM injection of 20 ug mRNA-1273.351 (booster dose) on Day 1.
|
Part C: 50 ug mRNA-1273.351
n=20 participants at risk
Participants received 1 IM injection of 50 ug mRNA-1273.351 (booster dose) on Day 1.
|
Part C: 50 ug mRNA-1273/mRNA-1273.351 Mixture
n=20 participants at risk
Participants received 1 IM injection of 50 ug mRNA-1273/mRNA-1273.351 mixture (booster dose) on Day 1.
|
|---|---|---|---|---|---|---|---|---|---|
|
Infections and infestations
Pneumonia
|
0.50%
1/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/173 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/171 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/158 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
|
Nervous system disorders
Nervous system cyst
|
0.50%
1/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/173 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/171 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/158 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
|
Cardiac disorders
Acute myocardial infarction
|
0.50%
1/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/173 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/171 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/158 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
|
Cardiac disorders
Arrhythmia
|
0.00%
0/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.50%
1/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/173 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/171 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/158 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
|
Cardiac disorders
Bradycardia
|
0.50%
1/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/173 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/171 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.63%
1/158 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
|
Musculoskeletal and connective tissue disorders
Spondylolisthesis
|
0.50%
1/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/173 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/171 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/158 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
|
Pregnancy, puerperium and perinatal conditions
Abortion missed
|
0.00%
0/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.50%
1/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/173 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/171 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/158 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
|
Pregnancy, puerperium and perinatal conditions
Abortion spontaneous
|
0.50%
1/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/173 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.58%
1/171 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/158 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
|
Injury, poisoning and procedural complications
Struck by lightning
|
0.00%
0/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.50%
1/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/173 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/171 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/158 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
|
Cardiac disorders
Pericarditis
|
0.00%
0/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.58%
1/173 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/171 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/158 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
|
Vascular disorders
Deep vein thrombosis
|
0.00%
0/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.58%
1/173 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/171 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/158 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.58%
1/173 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/171 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/158 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
|
Injury, poisoning and procedural complications
Tendon rupture
|
0.00%
0/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/173 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.58%
1/171 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/158 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
|
Infections and infestations
Sepsis
|
0.00%
0/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/173 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/171 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.63%
1/158 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
|
Cardiac disorders
Atrioventricular block complete
|
0.00%
0/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/173 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/171 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.63%
1/158 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
|
Gastrointestinal disorders
Peptic ulcer perforation
|
0.00%
0/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/173 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/171 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.63%
1/158 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
|
Infections and infestations
Pancreatic carcinoma stage IV
|
0.00%
0/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/173 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/171 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/158 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
5.0%
1/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
Other adverse events
| Measure |
Part A: 50 ug mRNA-1273
n=200 participants at risk
Participants received 1 IM injection of 50 ug mRNA-1273 on Day 1 and on Day 29.
|
Part A: 100 ug mRNA-1273
n=200 participants at risk
Participants received 1 IM injection of 100 ug mRNA-1273 on Day 1 and on Day 29.
|
Part A: Placebo
n=200 participants at risk
Participants received 1 IM injection of mRNA-1273-matching placebo on Day 1 and on Day 29.
|
Part B: 50 ug mRNA-1273 Then 50 ug mRNA-1273
n=173 participants at risk
Participants who chose to be unblinded and received 50 ug mRNA-1273 during Part A, received 1 IM injection of 50 ug mRNA-1273 during Part B.
|
Part B: 100 ug mRNA-1273 Then 50 ug mRNA-1273
n=171 participants at risk
Participants who chose to be unblinded and received 100 ug mRNA-1273 during Part A, received 1 IM injection of 50 ug mRNA-1273 during Part B.
|
Part B: Placebo Then 100 ug mRNA-1273
n=158 participants at risk
Participants who chose to be unblinded and received mRNA-1273-matching placebo during Part A, received 2 IM injections of 100 ug mRNA-1273 28 days apart during Part B.
|
Part C: 20 ug mRNA-1273.351
n=20 participants at risk
Participants received 1 IM injection of 20 ug mRNA-1273.351 (booster dose) on Day 1.
|
Part C: 50 ug mRNA-1273.351
n=20 participants at risk
Participants received 1 IM injection of 50 ug mRNA-1273.351 (booster dose) on Day 1.
|
Part C: 50 ug mRNA-1273/mRNA-1273.351 Mixture
n=20 participants at risk
Participants received 1 IM injection of 50 ug mRNA-1273/mRNA-1273.351 mixture (booster dose) on Day 1.
|
|---|---|---|---|---|---|---|---|---|---|
|
Infections and infestations
Herpes simplex
|
0.00%
0/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.50%
1/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/173 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/171 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/158 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
|
Infections and infestations
Upper respiratory tract infection
|
2.0%
4/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
1.0%
2/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
2.0%
4/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
1.2%
2/173 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
1.2%
2/171 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.63%
1/158 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
|
Infections and infestations
COVID-19
|
1.5%
3/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
1.0%
2/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
13.0%
26/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
5.2%
9/173 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
4.7%
8/171 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
10.1%
16/158 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
|
Infections and infestations
Urinary tract infection
|
1.5%
3/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
1.0%
2/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
1.5%
3/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/173 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
1.2%
2/171 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
1.3%
2/158 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
5.0%
1/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
|
Infections and infestations
Sinusitis
|
1.5%
3/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.50%
1/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
1.5%
3/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
2.3%
4/173 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
2.3%
4/171 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.63%
1/158 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
|
Infections and infestations
Viral infection
|
1.5%
3/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.50%
1/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/173 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/171 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/158 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
|
Infections and infestations
Bronchitis
|
1.0%
2/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.50%
1/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.58%
1/173 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/171 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
1.9%
3/158 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
|
Infections and infestations
Viral upper respiratory tract infection
|
1.5%
3/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.50%
1/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
1.2%
2/173 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
1.2%
2/171 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.63%
1/158 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
|
Infections and infestations
Acute sinusitis
|
0.00%
0/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
1.0%
2/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/173 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/171 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
2.5%
4/158 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
|
Infections and infestations
Nasopharyngitis
|
0.50%
1/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.50%
1/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.50%
1/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/173 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/171 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/158 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
|
Infections and infestations
Otitis media
|
0.00%
0/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
1.0%
2/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.50%
1/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/173 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/171 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.63%
1/158 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
|
Infections and infestations
Pharyngitis
|
0.50%
1/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.50%
1/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.58%
1/173 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.58%
1/171 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/158 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
|
Infections and infestations
Suspected COVID-19
|
1.0%
2/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
1.0%
2/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
1.2%
2/173 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
1.2%
2/171 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
1.9%
3/158 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
|
Infections and infestations
Cellulitis
|
0.50%
1/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.50%
1/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/173 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/171 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/158 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
|
Infections and infestations
Eye infection
|
0.50%
1/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.50%
1/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/173 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/171 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/158 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
|
Infections and infestations
Fungal skin infection
|
0.50%
1/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/173 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/171 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/158 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.50%
1/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
1.0%
2/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/173 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.58%
1/171 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.63%
1/158 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
|
Infections and infestations
Gastroenteritis viral
|
0.00%
0/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.50%
1/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/173 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/171 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/158 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
|
Infections and infestations
Herpes zoster
|
0.50%
1/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.58%
1/173 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/171 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/158 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
5.0%
1/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
|
Infections and infestations
Infected bite
|
0.50%
1/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/173 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/171 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/158 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
|
Infections and infestations
Influenza
|
0.00%
0/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.50%
1/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/173 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.58%
1/171 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/158 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
|
Infections and infestations
Oral candidiasis
|
0.50%
1/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.50%
1/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/173 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/171 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.63%
1/158 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
|
Infections and infestations
Pneumonia
|
0.50%
1/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.50%
1/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/173 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/171 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/158 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
|
Infections and infestations
Tinea pedis
|
0.50%
1/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/173 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/171 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/158 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
|
Infections and infestations
Tooth abscess
|
0.50%
1/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
1.7%
3/173 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/171 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/158 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
|
Infections and infestations
Tooth infection
|
0.00%
0/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.50%
1/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/173 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.58%
1/171 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/158 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
|
Infections and infestations
Urethritis
|
0.50%
1/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/173 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/171 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/158 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
|
Infections and infestations
Asymptomatic COVID-19
|
0.00%
0/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.50%
1/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/173 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
1.8%
3/171 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/158 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
5.0%
1/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
|
Infections and infestations
Gingivitis
|
0.00%
0/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.50%
1/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/173 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/171 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/158 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
|
Infections and infestations
Hordeolum
|
0.00%
0/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.50%
1/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.58%
1/173 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/171 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/158 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
|
Infections and infestations
Localised infection
|
0.00%
0/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.50%
1/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.58%
1/173 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/171 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/158 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
|
Infections and infestations
Otitis externa
|
0.00%
0/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.50%
1/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/173 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/171 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.63%
1/158 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
0.00%
0/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.50%
1/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/173 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/171 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/158 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Benign neoplasm of skin
|
0.50%
1/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/173 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.58%
1/171 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/158 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
0.50%
1/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
1.2%
2/173 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.58%
1/171 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/158 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
5.0%
1/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
|
Blood and lymphatic system disorders
Leukopenia
|
0.00%
0/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.50%
1/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/173 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/171 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/158 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
|
Immune system disorders
Seasonal allergy
|
0.50%
1/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
1.0%
2/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/173 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/171 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/158 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
|
Immune system disorders
Allergy to arthropod sting
|
0.00%
0/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.50%
1/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/173 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.58%
1/171 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/158 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
|
Endocrine disorders
Hypothyroidism
|
0.50%
1/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/173 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/171 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/158 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
|
Endocrine disorders
Hyperoestrogenism
|
0.00%
0/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.50%
1/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/173 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/171 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/158 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
|
Metabolism and nutrition disorders
Gout
|
0.00%
0/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.50%
1/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/173 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/171 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/158 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
|
Metabolism and nutrition disorders
Hyperlipidaemia
|
0.50%
1/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.50%
1/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/173 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/171 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/158 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
|
Metabolism and nutrition disorders
Insulin resistance
|
0.50%
1/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/173 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/171 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/158 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
|
Metabolism and nutrition disorders
Vitamin B12 deficiency
|
0.50%
1/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/173 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/171 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/158 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
|
Metabolism and nutrition disorders
Vitamin D deficiency
|
0.00%
0/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.50%
1/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.50%
1/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/173 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.58%
1/171 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.63%
1/158 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
|
Metabolism and nutrition disorders
Hypercholesterolaemia
|
0.00%
0/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.50%
1/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/173 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/171 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/158 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
|
Psychiatric disorders
Anxiety
|
2.5%
5/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
1.0%
2/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
1.5%
3/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
1.2%
2/173 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
1.2%
2/171 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.63%
1/158 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
5.0%
1/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
|
Psychiatric disorders
Depression
|
1.5%
3/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
2.0%
4/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
1.0%
2/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/173 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/171 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/158 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
10.0%
2/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
5.0%
1/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
|
Psychiatric disorders
Insomnia
|
1.5%
3/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
1.2%
2/173 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/171 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.63%
1/158 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
|
Psychiatric disorders
Major depression
|
0.50%
1/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/173 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/171 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/158 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
|
Nervous system disorders
Headache
|
8.0%
16/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
4.5%
9/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
4.0%
8/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
1.7%
3/173 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
4.7%
8/171 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.63%
1/158 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
5.0%
1/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
|
Nervous system disorders
Dizziness
|
1.0%
2/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.50%
1/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/173 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.58%
1/171 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.63%
1/158 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
|
Nervous system disorders
Syncope
|
1.0%
2/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.50%
1/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/173 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/171 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/158 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
|
Nervous system disorders
Migraine
|
0.50%
1/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.50%
1/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/173 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/171 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
1.3%
2/158 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
|
Nervous system disorders
Paraesthesia
|
0.50%
1/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.50%
1/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/173 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/171 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/158 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
|
Nervous system disorders
Tension headache
|
1.0%
2/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/173 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/171 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/158 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
|
Nervous system disorders
Ageusia
|
0.50%
1/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/173 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/171 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/158 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
|
Nervous system disorders
Cerebrovascular accident
|
0.50%
1/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/173 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/171 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/158 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.50%
1/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/173 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/171 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/158 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
|
Nervous system disorders
Lethargy
|
0.50%
1/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
1.0%
2/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/173 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/171 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/158 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
|
Nervous system disorders
Sinus headache
|
0.00%
0/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.50%
1/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.50%
1/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/173 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/171 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/158 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
|
Nervous system disorders
Tremor
|
0.50%
1/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/173 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/171 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/158 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
|
Nervous system disorders
Neuralgia
|
0.00%
0/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.50%
1/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/173 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/171 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/158 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
|
Nervous system disorders
Restless legs syndrome
|
0.00%
0/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.50%
1/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/173 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/171 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/158 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
|
Eye disorders
Cataract
|
0.50%
1/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.58%
1/173 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/171 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.63%
1/158 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
|
Eye disorders
Conjunctivitis allergic
|
0.00%
0/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.50%
1/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/173 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/171 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/158 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
|
Eye disorders
Glaucoma
|
0.00%
0/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.50%
1/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/173 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/171 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/158 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
|
Ear and labyrinth disorders
Deafness unilateral
|
0.50%
1/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/173 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/171 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/158 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
|
Ear and labyrinth disorders
Ear pain
|
0.50%
1/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/173 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.58%
1/171 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/158 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
|
Ear and labyrinth disorders
Excessive cerumen production
|
0.50%
1/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/173 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/171 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/158 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
|
Ear and labyrinth disorders
Tinnitus
|
0.00%
0/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.50%
1/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/173 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.58%
1/171 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.63%
1/158 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
|
Ear and labyrinth disorders
Vertigo
|
0.50%
1/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.58%
1/173 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/171 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/158 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
|
Cardiac disorders
Diastolic dysfunction
|
0.50%
1/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/173 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/171 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/158 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
|
Vascular disorders
Hypertension
|
2.5%
5/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.50%
1/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
1.2%
2/173 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/171 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
1.3%
2/158 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
10.0%
2/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
10.0%
2/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
|
Vascular disorders
Diastolic hypertension
|
0.00%
0/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.50%
1/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/173 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/171 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/158 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/173 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/171 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.63%
1/158 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
1.0%
2/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
1.5%
3/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
1.0%
2/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.58%
1/173 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.58%
1/171 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/158 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
1.5%
3/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
1.5%
3/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.58%
1/173 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
1.2%
2/171 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
2.5%
4/158 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
1.5%
3/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.50%
1/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.58%
1/173 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
1.8%
3/171 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
1.9%
3/158 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
0.50%
1/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.50%
1/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/173 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.58%
1/171 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/158 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.50%
1/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.50%
1/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/173 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/171 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/158 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal pruritus
|
0.50%
1/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/173 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/171 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/158 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngeal erythema
|
0.50%
1/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/173 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/171 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/158 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
|
Respiratory, thoracic and mediastinal disorders
Sneezing
|
0.50%
1/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/173 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.58%
1/171 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/158 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
|
Respiratory, thoracic and mediastinal disorders
Dry throat
|
0.00%
0/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.50%
1/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/173 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/171 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/158 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
|
Respiratory, thoracic and mediastinal disorders
Sinus congestion
|
0.00%
0/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
1.0%
2/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.58%
1/173 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/171 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/158 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
|
Respiratory, thoracic and mediastinal disorders
Upper respiratory tract inflammation
|
0.00%
0/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.50%
1/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/173 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/171 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/158 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
|
Gastrointestinal disorders
Nausea
|
1.5%
3/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
2.0%
4/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/173 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.58%
1/171 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/158 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
|
Gastrointestinal disorders
Diarrhoea
|
2.0%
4/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.50%
1/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.50%
1/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/173 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.58%
1/171 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/158 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
1.5%
3/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.50%
1/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.50%
1/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.58%
1/173 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
1.2%
2/171 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.63%
1/158 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
|
Gastrointestinal disorders
Vomiting
|
0.50%
1/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
1.0%
2/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/173 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/171 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/158 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.00%
0/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
1.0%
2/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/173 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/171 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/158 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
|
Gastrointestinal disorders
Gastritis
|
1.0%
2/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/173 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.58%
1/171 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/158 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.50%
1/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.50%
1/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/173 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/171 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/158 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
|
Gastrointestinal disorders
Toothache
|
1.0%
2/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.50%
1/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/173 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/171 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.63%
1/158 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.50%
1/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/173 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.58%
1/171 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/158 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
|
Gastrointestinal disorders
Aphthous ulcer
|
0.00%
0/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.50%
1/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/173 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/171 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/158 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
|
Gastrointestinal disorders
Dental caries
|
0.50%
1/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.50%
1/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/173 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/171 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/158 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
|
Gastrointestinal disorders
Diverticulum
|
0.00%
0/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.50%
1/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.50%
1/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/173 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/171 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/158 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.50%
1/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/173 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/171 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/158 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
|
Gastrointestinal disorders
Inguinal hernia
|
0.00%
0/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.50%
1/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/173 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/171 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.63%
1/158 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.00%
0/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.50%
1/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/173 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/171 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/158 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
|
Gastrointestinal disorders
Irritable bowel syndrome
|
0.50%
1/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.58%
1/173 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/171 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/158 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
|
General disorders
Mass
|
0.00%
0/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.50%
1/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/173 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/171 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/158 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
|
Gastrointestinal disorders
Oesophageal food impaction
|
0.50%
1/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/173 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/171 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/158 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
|
Gastrointestinal disorders
Paraesthesia oral
|
0.00%
0/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.50%
1/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/173 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/171 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/158 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
|
Gastrointestinal disorders
Tongue discomfort
|
0.50%
1/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/173 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/171 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/158 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
|
Gastrointestinal disorders
Abdominal tenderness
|
0.00%
0/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.50%
1/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/173 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/171 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/158 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
|
Gastrointestinal disorders
Duodenitis
|
0.00%
0/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.50%
1/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/173 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/171 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/158 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
|
Gastrointestinal disorders
Large intestine polyp
|
0.00%
0/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.50%
1/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/173 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/171 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/158 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
|
Gastrointestinal disorders
Odynophagia
|
0.00%
0/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.50%
1/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/173 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/171 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/158 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
|
Gastrointestinal disorders
Oral disorder
|
0.00%
0/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.50%
1/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/173 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/171 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/158 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
2.5%
5/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
1.5%
3/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
1.5%
3/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.58%
1/173 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.58%
1/171 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/158 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
|
Skin and subcutaneous tissue disorders
Rash
|
2.0%
4/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
1.0%
2/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/173 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.58%
1/171 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.63%
1/158 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
|
Skin and subcutaneous tissue disorders
Acne
|
0.50%
1/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.50%
1/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
1.0%
2/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.58%
1/173 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.58%
1/171 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/158 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.50%
1/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.50%
1/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.58%
1/173 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/171 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/158 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
0.50%
1/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/173 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/171 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/158 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
|
Skin and subcutaneous tissue disorders
Ecchymosis
|
0.50%
1/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/173 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/171 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/158 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.00%
0/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.50%
1/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/173 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/171 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/158 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
|
Skin and subcutaneous tissue disorders
Skin discolouration
|
0.00%
0/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.50%
1/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/173 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/171 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/158 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
|
Skin and subcutaneous tissue disorders
Angioedema
|
0.00%
0/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.50%
1/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/173 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/171 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/158 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
|
Skin and subcutaneous tissue disorders
Hirsutism
|
0.00%
0/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.50%
1/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/173 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/171 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/158 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
|
Skin and subcutaneous tissue disorders
Rash papular
|
0.00%
0/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.50%
1/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/173 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/171 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/158 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
3.5%
7/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
2.0%
4/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
2.0%
4/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.58%
1/173 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
1.2%
2/171 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
1.3%
2/158 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
5.0%
1/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
10.0%
2/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
3.0%
6/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
1.0%
2/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
1.5%
3/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/173 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
2.3%
4/171 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
1.3%
2/158 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
5.0%
1/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
15.0%
3/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
1.0%
2/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
1.0%
2/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/173 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/171 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/158 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
1.0%
2/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.50%
1/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
1.0%
2/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/173 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
1.2%
2/171 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
1.3%
2/158 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
5.0%
1/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.50%
1/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
1.0%
2/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/173 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/171 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/158 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
1.0%
2/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.50%
1/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.50%
1/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/173 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.58%
1/171 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/158 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.50%
1/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.50%
1/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/173 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/171 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/158 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
|
Musculoskeletal and connective tissue disorders
Plantar fasciitis
|
0.50%
1/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.50%
1/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.50%
1/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/173 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/171 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/158 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
|
Musculoskeletal and connective tissue disorders
Axillary mass
|
0.00%
0/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.50%
1/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/173 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/171 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/158 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
|
Musculoskeletal and connective tissue disorders
Joint swelling
|
0.50%
1/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/173 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/171 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/158 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal stiffness
|
0.00%
0/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.50%
1/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/173 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/171 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/158 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
|
Musculoskeletal and connective tissue disorders
Periarthritis
|
0.50%
1/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/173 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/171 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/158 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
|
Musculoskeletal and connective tissue disorders
Rotator cuff syndrome
|
0.50%
1/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/173 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/171 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/158 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
|
Musculoskeletal and connective tissue disorders
Tendonitis
|
0.50%
1/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/173 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/171 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/158 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
|
Musculoskeletal and connective tissue disorders
Bursitis
|
0.00%
0/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
1.0%
2/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/173 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.58%
1/171 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/158 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
5.0%
1/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
|
Musculoskeletal and connective tissue disorders
Exostosis
|
0.00%
0/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.50%
1/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/173 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/171 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/158 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.50%
1/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.50%
1/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/173 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/171 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.63%
1/158 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.50%
1/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.50%
1/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/173 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/171 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/158 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
|
Renal and urinary disorders
Hypertonic bladder
|
0.50%
1/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.50%
1/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/173 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.58%
1/171 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/158 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
|
Reproductive system and breast disorders
Breast pain
|
0.00%
0/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.50%
1/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/173 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/171 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/158 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
|
Reproductive system and breast disorders
Prostatomegaly
|
0.00%
0/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.50%
1/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.50%
1/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/173 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/171 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/158 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
|
Reproductive system and breast disorders
Postmenopausal haemorrhage
|
0.00%
0/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.50%
1/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/173 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/171 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/158 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
|
Reproductive system and breast disorders
Testicular cyst
|
0.00%
0/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.50%
1/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/173 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/171 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/158 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
|
General disorders
Fatigue
|
8.0%
16/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
2.5%
5/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
3.5%
7/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.58%
1/173 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
4.1%
7/171 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
3.2%
5/158 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
5.0%
1/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
5.0%
1/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
|
General disorders
Injection site pain
|
1.5%
3/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
1.5%
3/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.50%
1/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/173 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/171 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/158 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
|
General disorders
Injection site induration
|
0.50%
1/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
2.0%
4/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/173 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/171 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.63%
1/158 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
|
General disorders
Injection site erythema
|
0.50%
1/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
1.5%
3/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.50%
1/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/173 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.58%
1/171 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
1.3%
2/158 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
|
General disorders
Injection site swelling
|
0.00%
0/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
2.0%
4/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.50%
1/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/173 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/171 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
1.3%
2/158 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
|
General disorders
Axillary pain
|
0.50%
1/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
1.0%
2/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/173 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/171 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/158 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
|
General disorders
Chest discomfort
|
1.5%
3/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/173 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/171 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/158 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
|
General disorders
Chills
|
0.50%
1/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
1.0%
2/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/173 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.58%
1/171 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/158 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
|
General disorders
Pain
|
1.0%
2/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.50%
1/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.50%
1/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/173 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/171 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/158 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
|
General disorders
Pyrexia
|
0.00%
0/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
1.5%
3/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.50%
1/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.58%
1/173 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/171 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/158 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
|
General disorders
Chest pain
|
0.50%
1/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/173 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/171 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/158 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
|
General disorders
Injection site bruising
|
0.50%
1/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
1.0%
2/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/173 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/171 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/158 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
|
General disorders
Injection site mass
|
0.00%
0/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.50%
1/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/173 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/171 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/158 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
|
General disorders
Injection site pruritus
|
0.50%
1/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/173 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/171 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.63%
1/158 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
|
General disorders
Malaise
|
0.00%
0/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.50%
1/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/173 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/171 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/158 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
|
General disorders
Peripheral swelling
|
0.50%
1/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/173 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/171 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/158 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
5.0%
1/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
|
Investigations
Blood pressure increased
|
0.50%
1/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
1.0%
2/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
1.0%
2/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/173 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/171 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.63%
1/158 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
5.0%
1/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
|
Investigations
Blood alkaline phosphatase increased
|
0.50%
1/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/173 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/171 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/158 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
|
Investigations
Blood cholesterol increased
|
0.50%
1/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.50%
1/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/173 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/171 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.63%
1/158 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
|
Investigations
Blood pressure diastolic increased
|
0.00%
0/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.50%
1/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/173 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/171 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/158 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
|
Investigations
Haematocrit increased
|
0.00%
0/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.50%
1/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/173 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/171 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/158 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
|
Investigations
Haemoglobin increased
|
0.00%
0/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.50%
1/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/173 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/171 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/158 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
|
Investigations
Hormone level abnormal
|
0.50%
1/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/173 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/171 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/158 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
|
Investigations
Platelet count decreased
|
0.50%
1/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/173 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/171 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/158 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
|
Investigations
Platelet count increased
|
0.50%
1/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/173 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/171 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/158 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
|
Investigations
Staphylococcus test positive
|
0.50%
1/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/173 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/171 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/158 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
|
Investigations
White blood cell count decreased
|
0.00%
0/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.50%
1/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/173 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/171 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/158 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
|
Investigations
Blood testosterone decreased
|
0.00%
0/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.50%
1/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.58%
1/173 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/171 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/158 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
|
Investigations
Blood triglycerides increased
|
0.00%
0/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.50%
1/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/173 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/171 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/158 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
|
Investigations
Cardiac murmur
|
0.00%
0/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.50%
1/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/173 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/171 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/158 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
|
Investigations
Computerised tomogram coronary artery abnormal
|
0.00%
0/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.50%
1/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/173 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/171 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/158 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
|
Investigations
Heart rate decreased
|
0.00%
0/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
1.0%
2/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/173 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.58%
1/171 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/158 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
|
Investigations
Vitamin D decreased
|
0.00%
0/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.50%
1/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/173 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/171 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/158 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
|
Injury, poisoning and procedural complications
Arthropod bite
|
1.0%
2/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.50%
1/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.50%
1/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.58%
1/173 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/171 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/158 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
|
Injury, poisoning and procedural complications
Meniscus injury
|
0.50%
1/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
1.0%
2/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/173 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/171 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/158 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
|
Injury, poisoning and procedural complications
Muscle strain
|
0.50%
1/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
1.0%
2/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.50%
1/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/173 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.58%
1/171 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.63%
1/158 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
|
Injury, poisoning and procedural complications
Concussion
|
0.50%
1/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.50%
1/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/173 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/171 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/158 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
|
Injury, poisoning and procedural complications
Breast injury
|
0.50%
1/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/173 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/171 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/158 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
|
Injury, poisoning and procedural complications
Chemical burn
|
0.00%
0/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.50%
1/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/173 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/171 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/158 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
|
Injury, poisoning and procedural complications
Corneal abrasion
|
0.50%
1/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/173 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/171 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/158 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
|
Injury, poisoning and procedural complications
Epicondylitis
|
0.50%
1/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/173 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/171 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/158 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
|
Injury, poisoning and procedural complications
Foreign body in eye
|
0.50%
1/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/173 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/171 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/158 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
|
Injury, poisoning and procedural complications
Heat exhaustion
|
0.50%
1/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/173 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/171 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/158 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
|
Injury, poisoning and procedural complications
Joint injury
|
0.00%
0/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.50%
1/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/173 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/171 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/158 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
|
Injury, poisoning and procedural complications
Limb injury
|
0.00%
0/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.50%
1/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/173 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/171 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/158 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
|
Injury, poisoning and procedural complications
Muscle contusion
|
0.00%
0/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.50%
1/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/173 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/171 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/158 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
|
Injury, poisoning and procedural complications
Muscle rupture
|
0.50%
1/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/173 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/171 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/158 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
|
Injury, poisoning and procedural complications
Post-traumatic pain
|
0.50%
1/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/173 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/171 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/158 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
|
Injury, poisoning and procedural complications
Procedural pain
|
0.50%
1/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/173 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/171 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/158 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
0.50%
1/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/173 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/171 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/158 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
|
Injury, poisoning and procedural complications
Tendon rupture
|
0.00%
0/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.50%
1/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/173 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
1.2%
2/171 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/158 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
|
Injury, poisoning and procedural complications
Tooth fracture
|
0.50%
1/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.50%
1/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.58%
1/173 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.58%
1/171 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/158 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
|
Injury, poisoning and procedural complications
Nail avulsion
|
0.00%
0/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.50%
1/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/173 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/171 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/158 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
|
Injury, poisoning and procedural complications
Skin laceration
|
0.00%
0/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
1.0%
2/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.58%
1/173 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/171 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.63%
1/158 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
|
Injury, poisoning and procedural complications
Tendon injury
|
0.00%
0/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.50%
1/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/173 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/171 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.63%
1/158 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
|
Infections and infestations
Diverticulitis
|
0.00%
0/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.58%
1/173 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/171 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/158 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
|
Infections and infestations
Ear infection
|
0.00%
0/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.58%
1/173 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/171 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/158 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
|
Infections and infestations
Respiratory tract infection viral
|
0.00%
0/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/173 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.58%
1/171 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/158 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
|
Infections and infestations
Sinusitis bacterial
|
0.00%
0/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.58%
1/173 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/171 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
1.3%
2/158 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
5.0%
1/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
5.0%
1/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
|
Infections and infestations
Rhinitis
|
0.00%
0/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/173 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/171 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
1.3%
2/158 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
|
Infections and infestations
Cryptosporidiosis infection
|
0.00%
0/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/173 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/171 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.63%
1/158 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
|
Infections and infestations
Gastrointestinal bacterial overgrowth
|
0.00%
0/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/173 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/171 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.63%
1/158 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
|
Infections and infestations
Laryngitis
|
0.00%
0/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/173 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/171 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.63%
1/158 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
|
Infections and infestations
Onychomycosis
|
0.00%
0/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/173 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/171 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.63%
1/158 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Skin papilloma
|
0.00%
0/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.58%
1/173 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/171 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/158 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
|
Blood and lymphatic system disorders
Lymphadenitis
|
0.00%
0/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.58%
1/173 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/171 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/158 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
|
Endocrine disorders
Thyroid cyst
|
0.00%
0/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/173 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/171 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.63%
1/158 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
|
Metabolism and nutrition disorders
Dyslipidaemia
|
0.00%
0/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/173 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/171 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.63%
1/158 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
|
Metabolism and nutrition disorders
Obesity
|
0.00%
0/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/173 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/171 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.63%
1/158 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
|
Psychiatric disorders
Attention deficit hyperactivity disorder
|
0.00%
0/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/173 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.58%
1/171 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.63%
1/158 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
|
Nervous system disorders
Burning sensation
|
0.00%
0/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/173 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/171 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.63%
1/158 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
|
Nervous system disorders
Memory impairment
|
0.00%
0/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/173 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/171 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.63%
1/158 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
|
Nervous system disorders
Facial paralysis
|
0.00%
0/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.58%
1/173 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/171 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/158 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
|
Eye disorders
Retinal detachment
|
0.00%
0/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/173 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.58%
1/171 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/158 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
5.0%
1/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
|
Eye disorders
Macular fibrosis
|
0.00%
0/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/173 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/171 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.63%
1/158 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/173 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/171 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
1.3%
2/158 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
|
Cardiac disorders
Angina pectoris
|
0.00%
0/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.58%
1/173 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/171 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/158 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
|
Cardiac disorders
Ventricular extrasystoles
|
0.00%
0/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.58%
1/173 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/171 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/158 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
0.00%
0/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.58%
1/173 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/171 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/158 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngeal inflammation
|
0.00%
0/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/173 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.58%
1/171 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/158 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory disorder
|
0.00%
0/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/173 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.58%
1/171 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/158 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
|
Respiratory, thoracic and mediastinal disorders
Sleep apnoea syndrome
|
0.00%
0/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/173 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.58%
1/171 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/158 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
0.00%
0/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/173 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.58%
1/171 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/158 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory tract congestion
|
0.00%
0/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/173 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/171 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
1.3%
2/158 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.00%
0/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/173 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/171 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.63%
1/158 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
|
Respiratory, thoracic and mediastinal disorders
Upper respiratory tract congestion
|
0.00%
0/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/173 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/171 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.63%
1/158 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/173 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.58%
1/171 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/158 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
|
Gastrointestinal disorders
Pulpless tooth
|
0.00%
0/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/173 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.58%
1/171 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/158 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
|
Skin and subcutaneous tissue disorders
Dermatitis exfoliative
|
0.00%
0/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.58%
1/173 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/171 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/158 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
|
Skin and subcutaneous tissue disorders
Rash pruritic
|
0.00%
0/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/173 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/171 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
1.3%
2/158 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
|
Skin and subcutaneous tissue disorders
Eczema
|
0.00%
0/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/173 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/171 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.63%
1/158 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/173 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/171 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
1.9%
3/158 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
|
Musculoskeletal and connective tissue disorders
Haematoma muscle
|
0.00%
0/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/173 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/171 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.63%
1/158 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc degeneration
|
0.00%
0/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/173 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/171 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.63%
1/158 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
|
Musculoskeletal and connective tissue disorders
Osteopenia
|
0.00%
0/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.58%
1/173 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/171 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/158 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
|
Musculoskeletal and connective tissue disorders
Sjogren's syndrome
|
0.00%
0/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/173 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.58%
1/171 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/158 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
|
Musculoskeletal and connective tissue disorders
Spinal osteoarthritis
|
0.00%
0/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.58%
1/173 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/171 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/158 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
|
Pregnancy, puerperium and perinatal conditions
Pregnancy
|
0.00%
0/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/173 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.58%
1/171 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/158 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
|
Reproductive system and breast disorders
Benign prostatic hyperplasia
|
0.00%
0/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.58%
1/173 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/171 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.63%
1/158 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
|
Reproductive system and breast disorders
Ovarian cyst
|
0.00%
0/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/173 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/171 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.63%
1/158 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
|
General disorders
Injection site rash
|
0.00%
0/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/173 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/171 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.63%
1/158 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
|
Investigations
Heart rate increased
|
0.00%
0/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/173 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/171 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.63%
1/158 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
|
Investigations
Glycosylated haemoglobin increased
|
0.00%
0/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/173 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.58%
1/171 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/158 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
|
Injury, poisoning and procedural complications
Animal bite
|
0.00%
0/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
1.2%
2/173 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.58%
1/171 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/158 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
5.0%
1/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
|
Injury, poisoning and procedural complications
Foot fracture
|
0.00%
0/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.58%
1/173 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/171 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/158 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
|
Injury, poisoning and procedural complications
Hand fracture
|
0.00%
0/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.58%
1/173 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/171 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/158 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
|
Injury, poisoning and procedural complications
Fascial rupture
|
0.00%
0/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/173 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/171 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.63%
1/158 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
|
Injury, poisoning and procedural complications
Wrist fracture
|
0.00%
0/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/173 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/171 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.63%
1/158 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
|
Injury, poisoning and procedural complications
Humerus fracture
|
0.00%
0/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/173 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.58%
1/171 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/158 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
|
Infections and infestations
Cystitis
|
0.00%
0/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/173 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/171 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/158 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
5.0%
1/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
|
Infections and infestations
Labyrinthitis
|
0.00%
0/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/173 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/171 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/158 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
5.0%
1/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
|
Infections and infestations
Pyelonephritis
|
0.00%
0/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/173 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/171 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/158 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
5.0%
1/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
|
Infections and infestations
Staphylococcal infection
|
0.00%
0/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/173 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/171 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/158 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
5.0%
1/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
|
Infections and infestations
Pharyngitis streptococcal
|
0.00%
0/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/173 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/171 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/158 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
10.0%
2/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
|
Endocrine disorders
Thyroid disorder
|
0.00%
0/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/173 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/171 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/158 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
5.0%
1/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
|
Cardiac disorders
Arrhythmia
|
0.00%
0/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.50%
1/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/173 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/171 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/158 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
5.0%
1/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
|
Cardiac disorders
Extrasystoles
|
0.00%
0/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/173 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/171 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/158 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
5.0%
1/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.00%
0/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/173 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/171 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/158 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
5.0%
1/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal polyps
|
0.00%
0/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/173 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/171 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/158 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
5.0%
1/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal septum deviation
|
0.00%
0/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/173 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/171 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/158 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
5.0%
1/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
|
Hepatobiliary disorders
Hepatic lesion
|
0.00%
0/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/173 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/171 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/158 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
5.0%
1/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.00%
0/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/173 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/171 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/158 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
10.0%
2/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
|
Investigations
Weight decreased
|
0.00%
0/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/200 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/173 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/171 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/158 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
5.0%
1/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/20 • Up to Month 15
Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
Additional Information
Moderna Clinical Trials Support Center
ModernaTX, Inc.
Phone: 1-877-777-7187
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place