Trial Outcomes & Findings for Study of Different Interventions to Reduce Bruising Following CCH-Aaes Treatment for Cellulite of the Buttocks (NCT NCT05419505)
NCT ID: NCT05419505
Last Updated: 2025-03-07
Results Overview
The investigator assessed the severity of bruising using the IABSS, The IABSS is a 5-point scale ranging from 0-4, with 0 indicating no bruising or almost none, and 4 indicating very severe bruising. Higher scores indicated worse outcomes. The investigator compared the bruising of the left (test) buttock to the right (control) buttock. Responders were participants whose left buttock/test side demonstrated at least a 1-level lower IABSS score versus the right buttock/control side. Percentages are based on the number of participants with an assessment at specified timepoint.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
91 participants
Primary outcome timeframe
3 to 5 days after initial CCH-aaes injection of left buttock (test) and right buttock (control)
Results posted on
2025-03-07
Participant Flow
Ninety-one participants were enrolled in this split-person study to compare different collagenase clostridium histolyticum-aaes (CCH-aaes) treatment regimens. Participants were administered study intervention in a split-buttock arrangement, with each participant's right buttock serving as the control to their assigned intervention administered to the left buttock (test).
Unit of analysis: buttock
Participant milestones
| Measure |
Cohort 1: CCH-aaes Dose Evaluation
Test: Participants left buttock (test) received CCH-aaes injection using half the labeled dose (0.42 milligrams \[mg\]) but maintaining the labeled concentration (0.23 mg/milliliters \[mL\]).
Control: Participants right buttock (control) received CCH-aaes injection using the labeled dose (0.84 mg) and concentration (0.23 mg/mL).
|
Cohort 2: CCH-aaes Concentration Evaluation
Test: Participants left buttock (test) received CCH-aaes injection using the labeled dose (0.84 mg) but using an approximate 5-fold dilution (0.05 mg/mL) of the labeled concentration (0.23 mg/mL).
Control: Participants right buttock (control) received CCH-aaes injection using the labeled dose (0.84 mg) and concentration (0.23 mg/mL).
|
Cohort 3: CCH-aaes Injection Depth Evaluation
Test: Participants left buttock (test) received CCH-aaes injection using the labeled dose (0.84 mg) and concentration (0.23 mg/mL) but with an injection depth of one-quarter inch.
Control: Participants right buttock (control) received CCH-aaes injection using the labeled dose (0.84 mg) and concentration (0.23 mg/mL) with labeled injection depth of one-half inch.
|
Cohort 4: CCH-aaes Injection Method Evaluation
Test: Participants left buttock (test) received CCH-aaes injection using an approximate 2.5-fold dilution of the labeled concentration (0.09 mg/mL) but administering only a single aliquot at one-quarter-inch depth per injection administered at up to 30 injections.
Control" Participants right buttock (control) received CCH-aaes injection using the labeled dose (0.84 mg) and concentration (0.23 mg/mL) but administering only a single aliquot at one-quarter-inch depth per injection administered at up to 12 injections.
|
Cohort 5: CCH-aaes and Diluent Additive Evaluation
Test: Participants left buttock (test) received CCH-aaes injection using half the labeled dose (0.42 mg) with diluent additive.
Control: Participants right buttock (control) received CCH-aaes injection using the labeled dose (0.84 mg) and concentration (0.23 mg/mL).
|
Cohort 6: CCH-aaes Dose, Concentration, and Treatment Schedule Evaluation
Test: Participants left buttock (test) received CCH-aaes injection using one-quarter of the labeled dose (0.21 mg) at one-half the labeled concentration (0.12 mg/mL). Treatment sessions were administered 6 weeks apart.
Control: Participants right buttock (control) received CCH-aaes injection using one-half the labeled dose (0.42 mg) but maintaining the labeled concentration (0.23 mg/mL). Treatment sessions were administered 6 weeks apart.
|
Cohort 7a: CCH-aaes and Antifibrinolytic Agent
Test: Participants left buttock (test) received CCH-aaes injection using the labeled dose (0.84 mg) and concentration (0.23 mg/mL) with an antifibrinolytic agent treatment regimen.
Control: Participants right buttock (control) received CCH-aaes injection using the labeled dose (0.84 mg) and concentration (0.23 mg/mL).
|
Cohort 7b: CCH-aaes and Antifibrinolytic Agent
Test: Participants left buttock (test) received CCH-aaes injection using the labeled dose (0.84 mg) and concentration (0.23 mg/mL) with an antifibrinolytic agent treatment regimen.
Control: Participants right buttock (control) received CCH-aaes injection using the labeled dose (0.84 mg) and concentration (0.23 mg/mL).
|
|---|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
22 44
|
14 28
|
5 10
|
7 14
|
10 20
|
19 38
|
7 14
|
7 14
|
|
Overall Study
COMPLETED
|
19 38
|
11 22
|
5 10
|
6 12
|
9 18
|
17 34
|
6 12
|
6 12
|
|
Overall Study
NOT COMPLETED
|
3 6
|
3 6
|
0 0
|
1 2
|
1 2
|
2 4
|
1 2
|
1 2
|
Reasons for withdrawal
| Measure |
Cohort 1: CCH-aaes Dose Evaluation
Test: Participants left buttock (test) received CCH-aaes injection using half the labeled dose (0.42 milligrams \[mg\]) but maintaining the labeled concentration (0.23 mg/milliliters \[mL\]).
Control: Participants right buttock (control) received CCH-aaes injection using the labeled dose (0.84 mg) and concentration (0.23 mg/mL).
|
Cohort 2: CCH-aaes Concentration Evaluation
Test: Participants left buttock (test) received CCH-aaes injection using the labeled dose (0.84 mg) but using an approximate 5-fold dilution (0.05 mg/mL) of the labeled concentration (0.23 mg/mL).
Control: Participants right buttock (control) received CCH-aaes injection using the labeled dose (0.84 mg) and concentration (0.23 mg/mL).
|
Cohort 3: CCH-aaes Injection Depth Evaluation
Test: Participants left buttock (test) received CCH-aaes injection using the labeled dose (0.84 mg) and concentration (0.23 mg/mL) but with an injection depth of one-quarter inch.
Control: Participants right buttock (control) received CCH-aaes injection using the labeled dose (0.84 mg) and concentration (0.23 mg/mL) with labeled injection depth of one-half inch.
|
Cohort 4: CCH-aaes Injection Method Evaluation
Test: Participants left buttock (test) received CCH-aaes injection using an approximate 2.5-fold dilution of the labeled concentration (0.09 mg/mL) but administering only a single aliquot at one-quarter-inch depth per injection administered at up to 30 injections.
Control" Participants right buttock (control) received CCH-aaes injection using the labeled dose (0.84 mg) and concentration (0.23 mg/mL) but administering only a single aliquot at one-quarter-inch depth per injection administered at up to 12 injections.
|
Cohort 5: CCH-aaes and Diluent Additive Evaluation
Test: Participants left buttock (test) received CCH-aaes injection using half the labeled dose (0.42 mg) with diluent additive.
Control: Participants right buttock (control) received CCH-aaes injection using the labeled dose (0.84 mg) and concentration (0.23 mg/mL).
|
Cohort 6: CCH-aaes Dose, Concentration, and Treatment Schedule Evaluation
Test: Participants left buttock (test) received CCH-aaes injection using one-quarter of the labeled dose (0.21 mg) at one-half the labeled concentration (0.12 mg/mL). Treatment sessions were administered 6 weeks apart.
Control: Participants right buttock (control) received CCH-aaes injection using one-half the labeled dose (0.42 mg) but maintaining the labeled concentration (0.23 mg/mL). Treatment sessions were administered 6 weeks apart.
|
Cohort 7a: CCH-aaes and Antifibrinolytic Agent
Test: Participants left buttock (test) received CCH-aaes injection using the labeled dose (0.84 mg) and concentration (0.23 mg/mL) with an antifibrinolytic agent treatment regimen.
Control: Participants right buttock (control) received CCH-aaes injection using the labeled dose (0.84 mg) and concentration (0.23 mg/mL).
|
Cohort 7b: CCH-aaes and Antifibrinolytic Agent
Test: Participants left buttock (test) received CCH-aaes injection using the labeled dose (0.84 mg) and concentration (0.23 mg/mL) with an antifibrinolytic agent treatment regimen.
Control: Participants right buttock (control) received CCH-aaes injection using the labeled dose (0.84 mg) and concentration (0.23 mg/mL).
|
|---|---|---|---|---|---|---|---|---|
|
Overall Study
Adverse Event
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
|
Overall Study
Withdrawal by Subject
|
1
|
2
|
0
|
0
|
0
|
0
|
1
|
0
|
|
Overall Study
Lost to Follow-up
|
2
|
1
|
0
|
0
|
1
|
2
|
0
|
1
|
Baseline Characteristics
Study of Different Interventions to Reduce Bruising Following CCH-Aaes Treatment for Cellulite of the Buttocks
Baseline characteristics by cohort
| Measure |
Cohort 1: CCH-aaes Dose Evaluation
n=22 Participants
Participants left buttock (test) received CCH-aaes injection using half the labeled dose (0.42 milligrams \[mg\]) but maintaining the labeled concentration (0.23 mg/milliliters \[mL\]).
Participants right buttock (control) received CCH-aaes injection using the labeled dose (0.84 mg) and concentration (0.23 mg/mL)
|
Cohort 2: CCH-aaes Concentration Evaluation
n=14 Participants
Participants left buttock (test) received CCH-aaes injection using the labeled dose (0.84 mg) but using an approximate 5-fold dilution (0.05 mg/mL) of the labeled concentration (0.23 mg/mL).
Participants right buttock (control) received CCH-aaes injection using the labeled dose (0.84 mg) and concentration (0.23 mg/mL).
|
Cohort 3: CCH-aaes Injection Depth Evaluation
n=5 Participants
Participants left buttock (test) received CCH-aaes injection using the labeled dose (0.84 mg) and concentration (0.23 mg/mL) but with an injection depth of one-quarter inch.
Participants right buttock (control) received CCH-aaes injection using the labeled dose (0.84 mg) and concentration (0.23 mg/mL) with labeled injection depth of one-half inch.
|
Cohort 4: CCH-aaes Injection Method Evaluation
n=7 Participants
Participants left buttock (test) received CCH-aaes injection using an approximate 2.5-fold dilution of the labeled concentration (0.09 mg/mL) but administering only a single aliquot at one-quarter-inch depth per injection administered at up to 30 injections.
Participants right buttock (control) received CCH-aaes injection using the labeled dose (0.84 mg) and concentration (0.23 mg/mL) but administering only a single aliquot at one-quarter-inch depth per injection administered at up to 12 injections.
|
Cohort 5: CCH-aaes and Diluent Additive Evaluation
n=10 Participants
Participants left buttock (test) received CCH-aaes injection using half the labeled dose (0.42 mg) with diluent additive.
Participants right buttock (control) received CCH-aaes injection using the labeled dose (0.84 mg) and concentration (0.23 mg/mL).
|
Cohort 6: CCH-aaes Dose, Concentration, and Treatment Schedule Evaluation
n=19 Participants
Participants left buttock (test) received CCH-aaes injection using one-quarter of the labeled dose (0.21 mg) at one-half the labeled concentration (0.12 mg/mL). Treatment sessions were administered 6 weeks apart.
Participants right buttock (control) received CCH-aaes injection using one-half the labeled dose (0.42 mg) but maintaining the labeled concentration (0.23 mg/mL). Treatment sessions were administered 6 weeks apart.
|
Cohort 7a: CCH-aaes and Antifibrinolytic Agent
n=7 Participants
Participants left buttock (test) received CCH-aaes injection using the labeled dose (0.84 mg) and concentration (0.23 mg/mL) with an antifibrinolytic agent treatment regimen.
Participants right buttock (control) received CCH-aaes injection using the labeled dose (0.84 mg) and concentration (0.23 mg/mL).
|
Cohort 7b: CCH-aaes and Antifibrinolytic Agent
n=7 Participants
Participants left buttock (test) received CCH-aaes injection using the labeled dose (0.84 mg) and concentration (0.23 mg/mL) with an antifibrinolytic agent treatment regimen.
Participants right buttock (control) received CCH-aaes injection using the labeled dose (0.84 mg) and concentration (0.23 mg/mL).
|
Total
n=91 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
43.50 years
STANDARD_DEVIATION 10.698 • n=5 Participants
|
44.79 years
STANDARD_DEVIATION 9.125 • n=7 Participants
|
44.40 years
STANDARD_DEVIATION 8.503 • n=5 Participants
|
34.00 years
STANDARD_DEVIATION 8.699 • n=4 Participants
|
46.50 years
STANDARD_DEVIATION 10.179 • n=21 Participants
|
47.74 years
STANDARD_DEVIATION 7.225 • n=8 Participants
|
37.57 years
STANDARD_DEVIATION 10.967 • n=8 Participants
|
38.57 years
STANDARD_DEVIATION 10.549 • n=24 Participants
|
43.40 years
STANDARD_DEVIATION 9.998 • n=42 Participants
|
|
Sex: Female, Male
Female
|
22 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
10 Participants
n=21 Participants
|
19 Participants
n=8 Participants
|
7 Participants
n=8 Participants
|
7 Participants
n=24 Participants
|
91 Participants
n=42 Participants
|
|
Sex: Female, Male
Male
|
0 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
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
|
Race/Ethnicity, Customized
Asian
|
0 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
|
0 Participants
n=24 Participants
|
1 Participants
n=42 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
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
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
1 Participants
n=42 Participants
|
|
Race/Ethnicity, Customized
White
|
18 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
9 Participants
n=21 Participants
|
18 Participants
n=8 Participants
|
6 Participants
n=8 Participants
|
7 Participants
n=24 Participants
|
84 Participants
n=42 Participants
|
|
Race/Ethnicity, Customized
Other
|
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
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
1 Participants
n=42 Participants
|
|
Race/Ethnicity, Customized
Multiple
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
4 Participants
n=42 Participants
|
PRIMARY outcome
Timeframe: 3 to 5 days after initial CCH-aaes injection of left buttock (test) and right buttock (control)Population: All participants who received at least 1 injection of CCH-aaes and who had at least 1 valid IABSS assessment after an injection of CCH-aaes at specified timepoint. Here, 'Overall number of participants analyzed' = participants evaluable for this outcome measure.
The investigator assessed the severity of bruising using the IABSS, The IABSS is a 5-point scale ranging from 0-4, with 0 indicating no bruising or almost none, and 4 indicating very severe bruising. Higher scores indicated worse outcomes. The investigator compared the bruising of the left (test) buttock to the right (control) buttock. Responders were participants whose left buttock/test side demonstrated at least a 1-level lower IABSS score versus the right buttock/control side. Percentages are based on the number of participants with an assessment at specified timepoint.
Outcome measures
| Measure |
Cohort 1: CCH-aaes Dose Evaluation
n=21 Participants
Participants left buttock (test) received CCH-aaes injection using half the labeled dose (0.42 milligrams \[mg\]) but maintaining the labeled concentration (0.23 mg/milliliters \[mL\]).
Participants right buttock (control) received CCH-aaes injection using the labeled dose (0.84 mg) and concentration (0.23 mg/mL).
|
Cohort 2: CCH-aaes Concentration Evaluation
n=12 Participants
Participants left buttock (test) received CCH-aaes injection using the labeled dose (0.84 mg) but using an approximate 5-fold dilution (0.05 mg/mL) of the labeled concentration (0.23 mg/mL).
Participants right buttock (control) received CCH-aaes injection using the labeled dose (0.84 mg) and concentration (0.23 mg/mL).
|
Cohort 3: CCH-aaes Injection Depth Evaluation
n=5 Participants
Participants left buttock (test) received CCH-aaes injection using the labeled dose (0.84 mg) and concentration (0.23 mg/mL) but with an injection depth of one-quarter inch.
Participants right buttock (control) received CCH-aaes injection using the labeled dose (0.84 mg) and concentration (0.23 mg/mL) with labeled injection depth of one-half inch.
|
Cohort 4: CCH-aaes Injection Method Evaluation
n=6 Participants
Participants left buttock (test) received CCH-aaes injection using an approximate 2.5-fold dilution of the labeled concentration (0.09 mg/mL) but administering only a single aliquot at one-quarter-inch depth per injection administered at up to 30 injections.
Participants right buttock (control) received CCH-aaes injection using the labeled dose (0.84 mg) and concentration (0.23 mg/mL) but administering only a single aliquot at one-quarter-inch depth per injection administered at up to 12 injections.
|
Cohort 5: CCH-aaes and Diluent Additive Evaluation
n=9 Participants
Participants left buttock (test) received CCH-aaes injection using half the labeled dose (0.42 mg) with diluent additive.
Participants right buttock (control) received CCH-aaes injection using the labeled dose (0.84 mg) and concentration (0.23 mg/mL).
|
Cohort 6: CCH-aaes Dose, Concentration, and Treatment Schedule Evaluation
n=19 Participants
Participants left buttock (test) received CCH-aaes injection using one-quarter of the labeled dose (0.21 mg) at one-half the labeled concentration (0.12 mg/mL). Treatment sessions were administered 6 weeks apart.
Participants right buttock (control) received CCH-aaes injection using one-half the labeled dose (0.42 mg) but maintaining the labeled concentration (0.23 mg/mL). Treatment sessions were administered 6 weeks apart.
|
Cohort 7a: CCH-aaes and Antifibrinolytic Agent
n=6 Participants
Participants left buttock (test) received CCH-aaes injection using the labeled dose (0.84 mg) and concentration (0.23 mg/mL) with an antifibrinolytic agent treatment regimen.
Participants right buttock (control) received CCH-aaes injection using the labeled dose (0.84 mg) and concentration (0.23 mg/mL).
|
Cohort 7b: CCH-aaes and Antifibrinolytic Agent
n=6 Participants
Participants left buttock (test) received CCH-aaes injection using the labeled dose (0.84 mg) and concentration (0.23 mg/mL) with an antifibrinolytic agent treatment regimen.
Participants right buttock (control) received CCH-aaes injection using the labeled dose (0.84 mg) and concentration (0.23 mg/mL).
|
|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants With at Least 1-Level Lower Score 3 to 5 Days After Initial CCH-aaes Injection, as Assessed by the Investigator Assessment of Bruising Severity Scale (IABSS) After Initial CCH-aaes Injection
|
90.5 percentage of participants
Interval 69.62 to 98.83
|
25.0 percentage of participants
Interval 5.49 to 57.19
|
20.0 percentage of participants
Interval 0.51 to 71.64
|
33.3 percentage of participants
Interval 4.33 to 77.72
|
44.4 percentage of participants
Interval 13.7 to 78.8
|
63.2 percentage of participants
Interval 38.36 to 83.71
|
33.3 percentage of participants
Interval 4.33 to 77.72
|
33.3 percentage of participants
Interval 4.33 to 77.72
|
SECONDARY outcome
Timeframe: Follow-up 1, 2, 3, and 4 after CCH-aaes injection of left buttock (test) and right buttock (control)Population: All participants who received at least 1 injection of CCH-aaes and who had at least 1 valid IABSS assessment after an injection of CCH-aaes at specified timepoint.
The investigator assessed the severity of bruising using the IABSS, The IABSS is a 5-point scale ranging from 0-4, with 0 indicating no bruising or almost none, and 4 indicating very severe bruising. Higher scores indicated worse outcome. The investigator compared the bruising of the left buttock (test) to the right (control) buttock. Responders were participants whose left buttock/test side at Visit A demonstrated at least a 1-level lower IABSS score versus the right buttock/control side at Visit B, where Visit A and B could either be the same or different. Follow-up after first injection is presented: Follow-up 1 is 1 to 2 days after injection visit, Follow-up 2 is 3 to 5 days after injection visit, Follow-up 3 is 6 to 9 days after injection visit, and Follow-up 4 is 10 to 14 days after injection visit. Percentages are based on the number of participants with an assessment at specified timepoint.
Outcome measures
| Measure |
Cohort 1: CCH-aaes Dose Evaluation
n=22 Participants
Participants left buttock (test) received CCH-aaes injection using half the labeled dose (0.42 milligrams \[mg\]) but maintaining the labeled concentration (0.23 mg/milliliters \[mL\]).
Participants right buttock (control) received CCH-aaes injection using the labeled dose (0.84 mg) and concentration (0.23 mg/mL).
|
Cohort 2: CCH-aaes Concentration Evaluation
n=14 Participants
Participants left buttock (test) received CCH-aaes injection using the labeled dose (0.84 mg) but using an approximate 5-fold dilution (0.05 mg/mL) of the labeled concentration (0.23 mg/mL).
Participants right buttock (control) received CCH-aaes injection using the labeled dose (0.84 mg) and concentration (0.23 mg/mL).
|
Cohort 3: CCH-aaes Injection Depth Evaluation
n=5 Participants
Participants left buttock (test) received CCH-aaes injection using the labeled dose (0.84 mg) and concentration (0.23 mg/mL) but with an injection depth of one-quarter inch.
Participants right buttock (control) received CCH-aaes injection using the labeled dose (0.84 mg) and concentration (0.23 mg/mL) with labeled injection depth of one-half inch.
|
Cohort 4: CCH-aaes Injection Method Evaluation
n=7 Participants
Participants left buttock (test) received CCH-aaes injection using an approximate 2.5-fold dilution of the labeled concentration (0.09 mg/mL) but administering only a single aliquot at one-quarter-inch depth per injection administered at up to 30 injections.
Participants right buttock (control) received CCH-aaes injection using the labeled dose (0.84 mg) and concentration (0.23 mg/mL) but administering only a single aliquot at one-quarter-inch depth per injection administered at up to 12 injections.
|
Cohort 5: CCH-aaes and Diluent Additive Evaluation
n=10 Participants
Participants left buttock (test) received CCH-aaes injection using half the labeled dose (0.42 mg) with diluent additive.
Participants right buttock (control) received CCH-aaes injection using the labeled dose (0.84 mg) and concentration (0.23 mg/mL).
|
Cohort 6: CCH-aaes Dose, Concentration, and Treatment Schedule Evaluation
n=19 Participants
Participants left buttock (test) received CCH-aaes injection using one-quarter of the labeled dose (0.21 mg) at one-half the labeled concentration (0.12 mg/mL). Treatment sessions were administered 6 weeks apart.
Participants right buttock (control) received CCH-aaes injection using one-half the labeled dose (0.42 mg) but maintaining the labeled concentration (0.23 mg/mL). Treatment sessions were administered 6 weeks apart.
|
Cohort 7a: CCH-aaes and Antifibrinolytic Agent
n=7 Participants
Participants left buttock (test) received CCH-aaes injection using the labeled dose (0.84 mg) and concentration (0.23 mg/mL) with an antifibrinolytic agent treatment regimen.
Participants right buttock (control) received CCH-aaes injection using the labeled dose (0.84 mg) and concentration (0.23 mg/mL).
|
Cohort 7b: CCH-aaes and Antifibrinolytic Agent
n=7 Participants
Participants left buttock (test) received CCH-aaes injection using the labeled dose (0.84 mg) and concentration (0.23 mg/mL) with an antifibrinolytic agent treatment regimen.
Participants right buttock (control) received CCH-aaes injection using the labeled dose (0.84 mg) and concentration (0.23 mg/mL).
|
|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants With at Least 1-Level Lower Score, as Assessed by the IABSS
Follow-up 1
|
81.8 percentage of participants
Interval 59.72 to 94.81
|
15.4 percentage of participants
Interval 1.92 to 45.45
|
0 percentage of participants
Interval 0.0 to 52.18
|
42.9 percentage of participants
Interval 9.9 to 81.59
|
40.0 percentage of participants
Interval 12.16 to 73.76
|
44.4 percentage of participants
Interval 21.53 to 69.24
|
16.7 percentage of participants
Interval 0.42 to 64.12
|
42.9 percentage of participants
Interval 9.9 to 81.59
|
|
Percentage of Participants With at Least 1-Level Lower Score, as Assessed by the IABSS
Follow-up 2
|
90.5 percentage of participants
Interval 69.62 to 98.83
|
25.0 percentage of participants
Interval 5.49 to 57.19
|
20.0 percentage of participants
Interval 0.51 to 71.64
|
33.3 percentage of participants
Interval 4.33 to 77.72
|
44.4 percentage of participants
Interval 13.7 to 78.8
|
63.2 percentage of participants
Interval 38.36 to 83.71
|
33.3 percentage of participants
Interval 4.33 to 77.72
|
33.3 percentage of participants
Interval 4.33 to 77.72
|
|
Percentage of Participants With at Least 1-Level Lower Score, as Assessed by the IABSS
Follow-up 3
|
40.9 percentage of participants
Interval 20.71 to 63.65
|
38.5 percentage of participants
Interval 13.86 to 68.42
|
40.0 percentage of participants
Interval 5.27 to 85.34
|
28.6 percentage of participants
Interval 3.67 to 70.96
|
10.0 percentage of participants
Interval 0.25 to 44.5
|
31.6 percentage of participants
Interval 12.58 to 56.55
|
40.0 percentage of participants
Interval 5.27 to 85.34
|
42.9 percentage of participants
Interval 9.9 to 81.59
|
|
Percentage of Participants With at Least 1-Level Lower Score, as Assessed by the IABSS
Follow-up 4
|
13.6 percentage of participants
Interval 2.91 to 34.91
|
18.2 percentage of participants
Interval 2.28 to 51.78
|
0 percentage of participants
Interval 0.0 to 52.18
|
14.3 percentage of participants
Interval 0.36 to 57.87
|
10.0 percentage of participants
Interval 0.25 to 44.5
|
21.1 percentage of participants
Interval 6.05 to 45.57
|
16.7 percentage of participants
Interval 0.42 to 64.12
|
71.4 percentage of participants
Interval 29.04 to 96.33
|
SECONDARY outcome
Timeframe: Day 22 and Day 43 for Cohorts 1 to 5, Day 43 for Cohort 6, Day 22, Day 43, and Day 64 for Cohort 7, and Day 90, Day 135, and Day 180 for all cohortsPopulation: All participants who received at least 1 injection of CCH-aaes and who had at least 1 valid assessment at a treatment area after an injection of CCH-aaes. For Cohort 7a, on Day 22, I-GAIS was only assessed for the investigational buttock (left buttock) and for Cohort 7b, on Day 22, I-GAIS was only assessed for the control buttock (right buttock).
The investigator determined the degree of improvement of each buttock by comparing treated cellulite dimples from the Day 1 pre-treatment (Baseline) digital image of each buttock to the treated dimples observed in a live assessment. The investigator determined the degree of improvement of each buttock with the I-GAIS, which uses a 7-point scale ranging from +3 (very much improved) to -3 (very much worse). A higher score indicated a better outcome. The investigator compared the bruising of the left (test) buttock to the right (control) buttock. A 1-level I-GAIS responder was defined as any participant with an improved (+1, +2 or +3) score on the I-GAIS at an analysis visit for that treatment area. Percentages are based on the number of participants with an assessment at specified timepoint.
Outcome measures
| Measure |
Cohort 1: CCH-aaes Dose Evaluation
n=21 Participants
Participants left buttock (test) received CCH-aaes injection using half the labeled dose (0.42 milligrams \[mg\]) but maintaining the labeled concentration (0.23 mg/milliliters \[mL\]).
Participants right buttock (control) received CCH-aaes injection using the labeled dose (0.84 mg) and concentration (0.23 mg/mL).
|
Cohort 2: CCH-aaes Concentration Evaluation
n=13 Participants
Participants left buttock (test) received CCH-aaes injection using the labeled dose (0.84 mg) but using an approximate 5-fold dilution (0.05 mg/mL) of the labeled concentration (0.23 mg/mL).
Participants right buttock (control) received CCH-aaes injection using the labeled dose (0.84 mg) and concentration (0.23 mg/mL).
|
Cohort 3: CCH-aaes Injection Depth Evaluation
n=5 Participants
Participants left buttock (test) received CCH-aaes injection using the labeled dose (0.84 mg) and concentration (0.23 mg/mL) but with an injection depth of one-quarter inch.
Participants right buttock (control) received CCH-aaes injection using the labeled dose (0.84 mg) and concentration (0.23 mg/mL) with labeled injection depth of one-half inch.
|
Cohort 4: CCH-aaes Injection Method Evaluation
n=6 Participants
Participants left buttock (test) received CCH-aaes injection using an approximate 2.5-fold dilution of the labeled concentration (0.09 mg/mL) but administering only a single aliquot at one-quarter-inch depth per injection administered at up to 30 injections.
Participants right buttock (control) received CCH-aaes injection using the labeled dose (0.84 mg) and concentration (0.23 mg/mL) but administering only a single aliquot at one-quarter-inch depth per injection administered at up to 12 injections.
|
Cohort 5: CCH-aaes and Diluent Additive Evaluation
n=10 Participants
Participants left buttock (test) received CCH-aaes injection using half the labeled dose (0.42 mg) with diluent additive.
Participants right buttock (control) received CCH-aaes injection using the labeled dose (0.84 mg) and concentration (0.23 mg/mL).
|
Cohort 6: CCH-aaes Dose, Concentration, and Treatment Schedule Evaluation
n=18 Participants
Participants left buttock (test) received CCH-aaes injection using one-quarter of the labeled dose (0.21 mg) at one-half the labeled concentration (0.12 mg/mL). Treatment sessions were administered 6 weeks apart.
Participants right buttock (control) received CCH-aaes injection using one-half the labeled dose (0.42 mg) but maintaining the labeled concentration (0.23 mg/mL). Treatment sessions were administered 6 weeks apart.
|
Cohort 7a: CCH-aaes and Antifibrinolytic Agent
n=7 Participants
Participants left buttock (test) received CCH-aaes injection using the labeled dose (0.84 mg) and concentration (0.23 mg/mL) with an antifibrinolytic agent treatment regimen.
Participants right buttock (control) received CCH-aaes injection using the labeled dose (0.84 mg) and concentration (0.23 mg/mL).
|
Cohort 7b: CCH-aaes and Antifibrinolytic Agent
n=7 Participants
Participants left buttock (test) received CCH-aaes injection using the labeled dose (0.84 mg) and concentration (0.23 mg/mL) with an antifibrinolytic agent treatment regimen.
Participants right buttock (control) received CCH-aaes injection using the labeled dose (0.84 mg) and concentration (0.23 mg/mL).
|
|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants With at Least +1 or Higher Score on the Investigator-Global Aesthetic Improvement Scale (I-GAIS) After CCH-aaes Injection
Day 180 (End of Study) Right Buttock (Control)
|
36.8 percentage of participants
Interval 16.29 to 61.64
|
81.8 percentage of participants
Interval 48.22 to 97.72
|
100 percentage of participants
Interval 47.82 to 100.0
|
66.7 percentage of participants
Interval 22.28 to 95.67
|
11.1 percentage of participants
Interval 0.28 to 48.25
|
41.2 percentage of participants
Interval 18.44 to 67.08
|
66.7 percentage of participants
Interval 22.28 to 95.67
|
83.3 percentage of participants
Interval 35.88 to 99.58
|
|
Percentage of Participants With at Least +1 or Higher Score on the Investigator-Global Aesthetic Improvement Scale (I-GAIS) After CCH-aaes Injection
Day 22 Left Buttock (Test)
|
42.9 percentage of participants
Interval 21.82 to 65.98
|
58.3 percentage of participants
Interval 27.67 to 84.83
|
100 percentage of participants
Interval 47.82 to 100.0
|
66.7 percentage of participants
Interval 22.28 to 95.67
|
40.0 percentage of participants
Interval 12.16 to 73.76
|
—
|
85.7 percentage of participants
Interval 42.13 to 99.64
|
—
|
|
Percentage of Participants With at Least +1 or Higher Score on the Investigator-Global Aesthetic Improvement Scale (I-GAIS) After CCH-aaes Injection
Day 22 Right Buttock (Control)
|
57.1 percentage of participants
Interval 34.02 to 78.18
|
66.7 percentage of participants
Interval 34.89 to 90.08
|
100 percentage of participants
Interval 47.82 to 100.0
|
66.7 percentage of participants
Interval 22.28 to 95.67
|
40.0 percentage of participants
Interval 12.16 to 73.76
|
—
|
—
|
100 percentage of participants
Interval 59.04 to 100.0
|
|
Percentage of Participants With at Least +1 or Higher Score on the Investigator-Global Aesthetic Improvement Scale (I-GAIS) After CCH-aaes Injection
Day 43 Left Buttock (Test)
|
71.4 percentage of participants
Interval 47.82 to 88.72
|
84.6 percentage of participants
Interval 54.55 to 98.08
|
100 percentage of participants
Interval 47.82 to 100.0
|
83.3 percentage of participants
Interval 35.88 to 99.58
|
66.7 percentage of participants
Interval 29.93 to 92.51
|
44.4 percentage of participants
Interval 21.53 to 69.24
|
100 percentage of participants
Interval 47.82 to 100.0
|
100 percentage of participants
Interval 59.04 to 100.0
|
|
Percentage of Participants With at Least +1 or Higher Score on the Investigator-Global Aesthetic Improvement Scale (I-GAIS) After CCH-aaes Injection
Day 43 Right Buttock (Control)
|
76.2 percentage of participants
Interval 52.83 to 91.78
|
76.9 percentage of participants
Interval 46.19 to 94.96
|
100 percentage of participants
Interval 47.82 to 100.0
|
100 percentage of participants
Interval 54.07 to 100.0
|
66.7 percentage of participants
Interval 29.93 to 92.51
|
50.0 percentage of participants
Interval 26.02 to 73.98
|
40.0 percentage of participants
Interval 5.27 to 85.34
|
100 percentage of participants
Interval 59.94 to 100.0
|
|
Percentage of Participants With at Least +1 or Higher Score on the Investigator-Global Aesthetic Improvement Scale (I-GAIS) After CCH-aaes Injection
Day 64 Left Buttock (Test)
|
—
|
—
|
—
|
—
|
—
|
—
|
100 percentage of participants
Interval 47.82 to 100.0
|
100 percentage of participants
Interval 59.04 to 100.0
|
|
Percentage of Participants With at Least +1 or Higher Score on the Investigator-Global Aesthetic Improvement Scale (I-GAIS) After CCH-aaes Injection
Day 64 Right Buttock (Control)
|
—
|
—
|
—
|
—
|
—
|
—
|
100 percentage of participants
Interval 47.82 to 100.0
|
100 percentage of participants
Interval 59.04 to 100.0
|
|
Percentage of Participants With at Least +1 or Higher Score on the Investigator-Global Aesthetic Improvement Scale (I-GAIS) After CCH-aaes Injection
Day 90 (Follow-up) Left Buttock (Test)
|
38.1 percentage of participants
Interval 18.11 to 61.56
|
70.0 percentage of participants
Interval 34.75 to 93.33
|
100 percentage of participants
Interval 47.82 to 100.0
|
66.7 percentage of participants
Interval 22.8 to 95.67
|
44.4 percentage of participants
Interval 13.7 to 78.8
|
27.8 percentage of participants
Interval 9.69 to 53.48
|
85.7 percentage of participants
Interval 42.13 to 99.64
|
100 percentage of participants
Interval 59.04 to 100.0
|
|
Percentage of Participants With at Least +1 or Higher Score on the Investigator-Global Aesthetic Improvement Scale (I-GAIS) After CCH-aaes Injection
Day 90 (Follow-up) Right Buttock (Control)
|
47.6 percentage of participants
Interval 25.71 to 70.22
|
80.0 percentage of participants
Interval 44.39 to 97.48
|
100 percentage of participants
Interval 47.82 to 100.0
|
83.3 percentage of participants
Interval 35.88 to 99.58
|
44.4 percentage of participants
Interval 13.7 to 78.8
|
38.9 percentage of participants
Interval 17.3 to 64.25
|
71.4 percentage of participants
Interval 29.04 to 96.33
|
100 percentage of participants
Interval 59.04 to 100.0
|
|
Percentage of Participants With at Least +1 or Higher Score on the Investigator-Global Aesthetic Improvement Scale (I-GAIS) After CCH-aaes Injection
Day 135 (Follow-up) Left Buttock (Test)
|
36.8 percentage of participants
Interval 16.29 to 61.64
|
90.9 percentage of participants
Interval 58.72 to 99.77
|
100 percentage of participants
Interval 47.82 to 100.0
|
50.0 percentage of participants
Interval 11.81 to 88.19
|
22.2 percentage of participants
Interval 2.81 to 60.01
|
22.2 percentage of participants
Interval 6.41 to 47.64
|
83.3 percentage of participants
Interval 35.88 to 99.58
|
100 percentage of participants
Interval 54.07 to 100.0
|
|
Percentage of Participants With at Least +1 or Higher Score on the Investigator-Global Aesthetic Improvement Scale (I-GAIS) After CCH-aaes Injection
Day 135 (Follow-up) Right Buttock (Control)
|
47.4 percentage of participants
Interval 24.45 to 71.14
|
81.8 percentage of participants
Interval 48.22 to 97.72
|
100 percentage of participants
Interval 47.82 to 100.0
|
66.7 percentage of participants
Interval 22.28 to 95.67
|
22.2 percentage of participants
Interval 2.81 to 60.01
|
33.3 percentage of participants
Interval 13.34 to 59.01
|
66.7 percentage of participants
Interval 22.28 to 95.67
|
83.3 percentage of participants
Interval 35.88 to 99.58
|
|
Percentage of Participants With at Least +1 or Higher Score on the Investigator-Global Aesthetic Improvement Scale (I-GAIS) After CCH-aaes Injection
Day 180 (End of Study) Left Buttock (Test)
|
36.8 percentage of participants
Interval 16.29 to 61.64
|
100 percentage of participants
Interval 71.51 to 100.0
|
100 percentage of participants
Interval 47.82 to 100.0
|
50.0 percentage of participants
Interval 11.81 to 88.19
|
11.1 percentage of participants
Interval 0.28 to 48.25
|
17.6 percentage of participants
Interval 3.8 to 43.43
|
66.7 percentage of participants
Interval 22.28 to 95.67
|
83.3 percentage of participants
Interval 35.88 to 99.58
|
SECONDARY outcome
Timeframe: From Day 1 (after dose) through Day 180Population: All participants who received at least 1 injection of CCH-aaes.
Treatment-emergent adverse events (TEAEs) were defined as any adverse events (AEs) that occur or worsen (increase in severity) on the same day or after the study intervention administration on Day 1. Percent of participants with TEAEs of injection site reactions are presented by left buttock (test) and right buttock (control). A summary of serious and all other non-serious adverse events regardless of causality is located in the Reported Adverse Events module.
Outcome measures
| Measure |
Cohort 1: CCH-aaes Dose Evaluation
n=22 Participants
Participants left buttock (test) received CCH-aaes injection using half the labeled dose (0.42 milligrams \[mg\]) but maintaining the labeled concentration (0.23 mg/milliliters \[mL\]).
Participants right buttock (control) received CCH-aaes injection using the labeled dose (0.84 mg) and concentration (0.23 mg/mL).
|
Cohort 2: CCH-aaes Concentration Evaluation
n=14 Participants
Participants left buttock (test) received CCH-aaes injection using the labeled dose (0.84 mg) but using an approximate 5-fold dilution (0.05 mg/mL) of the labeled concentration (0.23 mg/mL).
Participants right buttock (control) received CCH-aaes injection using the labeled dose (0.84 mg) and concentration (0.23 mg/mL).
|
Cohort 3: CCH-aaes Injection Depth Evaluation
n=5 Participants
Participants left buttock (test) received CCH-aaes injection using the labeled dose (0.84 mg) and concentration (0.23 mg/mL) but with an injection depth of one-quarter inch.
Participants right buttock (control) received CCH-aaes injection using the labeled dose (0.84 mg) and concentration (0.23 mg/mL) with labeled injection depth of one-half inch.
|
Cohort 4: CCH-aaes Injection Method Evaluation
n=7 Participants
Participants left buttock (test) received CCH-aaes injection using an approximate 2.5-fold dilution of the labeled concentration (0.09 mg/mL) but administering only a single aliquot at one-quarter-inch depth per injection administered at up to 30 injections.
Participants right buttock (control) received CCH-aaes injection using the labeled dose (0.84 mg) and concentration (0.23 mg/mL) but administering only a single aliquot at one-quarter-inch depth per injection administered at up to 12 injections.
|
Cohort 5: CCH-aaes and Diluent Additive Evaluation
n=10 Participants
Participants left buttock (test) received CCH-aaes injection using half the labeled dose (0.42 mg) with diluent additive.
Participants right buttock (control) received CCH-aaes injection using the labeled dose (0.84 mg) and concentration (0.23 mg/mL).
|
Cohort 6: CCH-aaes Dose, Concentration, and Treatment Schedule Evaluation
n=19 Participants
Participants left buttock (test) received CCH-aaes injection using one-quarter of the labeled dose (0.21 mg) at one-half the labeled concentration (0.12 mg/mL). Treatment sessions were administered 6 weeks apart.
Participants right buttock (control) received CCH-aaes injection using one-half the labeled dose (0.42 mg) but maintaining the labeled concentration (0.23 mg/mL). Treatment sessions were administered 6 weeks apart.
|
Cohort 7a: CCH-aaes and Antifibrinolytic Agent
n=7 Participants
Participants left buttock (test) received CCH-aaes injection using the labeled dose (0.84 mg) and concentration (0.23 mg/mL) with an antifibrinolytic agent treatment regimen.
Participants right buttock (control) received CCH-aaes injection using the labeled dose (0.84 mg) and concentration (0.23 mg/mL).
|
Cohort 7b: CCH-aaes and Antifibrinolytic Agent
n=7 Participants
Participants left buttock (test) received CCH-aaes injection using the labeled dose (0.84 mg) and concentration (0.23 mg/mL) with an antifibrinolytic agent treatment regimen.
Participants right buttock (control) received CCH-aaes injection using the labeled dose (0.84 mg) and concentration (0.23 mg/mL).
|
|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants With Injection Site Reactions
Left Buttock (Test)
|
100 percentage of participants
Interval 84.56 to 100.0
|
92.9 percentage of participants
Interval 75.29 to 100.0
|
100 percentage of participants
Interval 47.82 to 100.0
|
100 percentage of participants
Interval 59.04 to 100.0
|
100 percentage of participants
Interval 69.15 to 100.0
|
100 percentage of participants
Interval 82.35 to 100.0
|
100 percentage of participants
Interval 59.04 to 100.0
|
100 percentage of participants
Interval 59.04 to 100.0
|
|
Percentage of Participants With Injection Site Reactions
Right Buttock (Control)
|
100 percentage of participants
Interval 84.56 to 100.0
|
92.9 percentage of participants
Interval 75.29 to 100.0
|
100 percentage of participants
Interval 47.82 to 100.0
|
100 percentage of participants
Interval 59.04 to 100.0
|
100 percentage of participants
Interval 69.15 to 100.0
|
100 percentage of participants
Interval 82.35 to 100.0
|
85.7 percentage of participants
Interval 54.07 to 100.0
|
100 percentage of participants
Interval 59.04 to 100.0
|
Adverse Events
Cohort 1: CCH-aaes Dose Evaluation-Test (ISR)
Serious events: 0 serious events
Other events: 22 other events
Deaths: 0 deaths
Cohort 1: CCH-aaes Dose Evaluation-Control (ISR)
Serious events: 0 serious events
Other events: 22 other events
Deaths: 0 deaths
Cohort 2: CCH-aaes Concentration Evaluation-Test (ISR)
Serious events: 0 serious events
Other events: 13 other events
Deaths: 0 deaths
Cohort 2: CCH-aaes Concentration Evaluation -Control (ISR)
Serious events: 0 serious events
Other events: 13 other events
Deaths: 0 deaths
Cohort 3: CCH-aaes Injection Depth Evaluation-Test (ISR)
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Cohort 3: CCH-aaes Injection Depth Evaluation-Control (ISR)
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Cohort 4: CCH-aaes Injection Method Evaluation-Test (ISR)
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
Cohort 4: CCH-aaes Injection Method Evaluation-Control (ISR)
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
Cohort 5: CCH-aaes and Diluent Additive Evaluation-Test (ISR)
Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths
Cohort 5: CCH-aaes and Diluent Additive Evaluation-Control (ISR)
Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths
Cohort 6: CCH-aaes Dose, Concentration, and Treatment Schedule Evaluation -Test (ISR)
Serious events: 0 serious events
Other events: 19 other events
Deaths: 0 deaths
Cohort 6: CCH-aaes Dose, Concentration, and Treatment Schedule Evaluation-Control (ISR)
Serious events: 0 serious events
Other events: 19 other events
Deaths: 0 deaths
Cohort 7a: CCH-aaes and Antifibrinolytic Agent-Test (ISR)
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
Cohort 7a: CCH-aaes and Antifibrinolytic Agent-Control (ISR)
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Cohort 7b: CCH-aaes and Antifibrinolytic Agent-Test (ISR)
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
Cohort 7b: CCH-aaes and Antifibrinolytic Agent-Control (ISR)
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
Cohort 1: Systemic/Non-ISR AEs
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Cohort 2: Systemic/Non-ISR AEs
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Cohort 3: Systemic/Non-ISR AEs
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Cohort 4: Systemic/Non-ISR AEs
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Cohort 5: Systemic/Non-ISR AEs
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Cohort 6: Systemic/Non-ISR AEs
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Cohort 7a: Systemic/Non-ISR AEs
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Cohort 7b: Systemic/Non-ISR AEs
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Cohort 1: CCH-aaes Dose Evaluation-Test (ISR)
n=22 participants at risk
Participants left buttock (test) received CCH-aaes injection using half the labeled dose (0.42 mg) but maintaining the labeled concentration (0.23 mL).
|
Cohort 1: CCH-aaes Dose Evaluation-Control (ISR)
n=22 participants at risk
Participants right buttock (control) received CCH-aaes injection using the labeled dose (0.84 mg) and concentration (0.23 mg/mL).
|
Cohort 2: CCH-aaes Concentration Evaluation-Test (ISR)
n=14 participants at risk
Participants left buttock (test) received CCH-aaes injection using the labeled dose (0.84 mg) but using an approximate 5-fold dilution (0.05 mg/mL) of the labeled concentration (0.23 mg/mL).
|
Cohort 2: CCH-aaes Concentration Evaluation -Control (ISR)
n=14 participants at risk
Participants right buttock (control) received CCH-aaes injection using the labeled dose (0.84 mg) and concentration (0.23 mg/mL).
|
Cohort 3: CCH-aaes Injection Depth Evaluation-Test (ISR)
n=5 participants at risk
Participants left buttock (test) received CCH-aaes injection using the labeled dose (0.84 mg) and concentration (0.23 mg/mL) but with an injection depth of one-quarter inch.
|
Cohort 3: CCH-aaes Injection Depth Evaluation-Control (ISR)
n=5 participants at risk
Participants right buttock (control) received CCH-aaes injection using the labeled dose (0.84 mg) and concentration (0.23 mg/mL) with labeled injection depth of one-half inch.
|
Cohort 4: CCH-aaes Injection Method Evaluation-Test (ISR)
n=7 participants at risk
Participants left buttock (test) received CCH-aaes injection using an approximate 2.5-fold dilution of the labeled concentration (0.09 mg/mL) but administering only a single aliquot at one-quarter-inch depth per injection administered at up to 30 injections.
|
Cohort 4: CCH-aaes Injection Method Evaluation-Control (ISR)
n=7 participants at risk
Participants right buttock (control) received CCH-aaes injection using the labeled dose (0.84 mg) and concentration (0.23 mg/mL) but administering only a single aliquot at one-quarter-inch depth per injection administered at up to 12 injections.
|
Cohort 5: CCH-aaes and Diluent Additive Evaluation-Test (ISR)
n=10 participants at risk
Participants left buttock (test) received CCH-aaes injection using half the labeled dose (0.42 mg) with diluent additive.
|
Cohort 5: CCH-aaes and Diluent Additive Evaluation-Control (ISR)
n=10 participants at risk
Participants right buttock (control) received CCH-aaes injection using the labeled dose (0.84 mg) and concentration (0.23 mg/mL).
|
Cohort 6: CCH-aaes Dose, Concentration, and Treatment Schedule Evaluation -Test (ISR)
n=19 participants at risk
Participants left buttock (test) received CCH-aaes injection using one-quarter of the labeled dose (0.21 mg) at one-half the labeled concentration (0.12 mg/mL). Treatment sessions were administered 6 weeks apart.
|
Cohort 6: CCH-aaes Dose, Concentration, and Treatment Schedule Evaluation-Control (ISR)
n=19 participants at risk
Participants right buttock (control) received CCH-aaes injection using one-half the labeled dose (0.42 mg) but maintaining the labeled concentration (0.23 mg/mL). Treatment sessions were administered 6 weeks apart.
|
Cohort 7a: CCH-aaes and Antifibrinolytic Agent-Test (ISR)
n=7 participants at risk
Participants left buttock (test) received CCH-aaes injection using the labeled dose (0.84 mg) and concentration (0.23 mg/mL) with an antifibrinolytic agent treatment regimen.
|
Cohort 7a: CCH-aaes and Antifibrinolytic Agent-Control (ISR)
n=7 participants at risk
Participants right buttock (control) received CCH-aaes injection using the labeled dose (0.84 mg) and concentration (0.23 mg/mL).
|
Cohort 7b: CCH-aaes and Antifibrinolytic Agent-Test (ISR)
n=7 participants at risk
Participants left buttock (test) received CCH-aaes injection using the labeled dose (0.84 mg) and concentration (0.23 mg/mL) with an antifibrinolytic agent treatment regimen.
|
Cohort 7b: CCH-aaes and Antifibrinolytic Agent-Control (ISR)
n=7 participants at risk
Participants right buttock (control) received CCH-aaes injection using the labeled dose (0.84 mg) and concentration (0.23 mg/mL).
|
Cohort 1: Systemic/Non-ISR AEs
n=22 participants at risk
Adverse events that affected participants as a whole (systemic events) or non-injection site reactions in Cohort 1.
|
Cohort 2: Systemic/Non-ISR AEs
n=14 participants at risk
Adverse events that affected participants as a whole (systemic events) or non-injection site reactions in Cohort 2.
|
Cohort 3: Systemic/Non-ISR AEs
n=5 participants at risk
Adverse events that affected participants as a whole (systemic events) or non-injection site reactions in Cohort 3.
|
Cohort 4: Systemic/Non-ISR AEs
n=7 participants at risk
Adverse events that affected participants as a whole (systemic events) or non-injection site reactions in Cohort 4.
|
Cohort 5: Systemic/Non-ISR AEs
n=10 participants at risk
Adverse events that affected participants as a whole (systemic events) or non-injection site reactions in Cohort 5.
|
Cohort 6: Systemic/Non-ISR AEs
n=19 participants at risk
Adverse events that affected participants as a whole (systemic events) or non-injection site reactions in Cohort 6.
|
Cohort 7a: Systemic/Non-ISR AEs
n=7 participants at risk
Adverse events that affected participants as a whole (systemic events) or non-injection site reactions in Cohort 7a.
|
Cohort 7b: Systemic/Non-ISR AEs
n=7 participants at risk
Adverse events that affected participants as a whole (systemic events) or non-injection site reactions in Cohort 7b.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Renal and urinary disorders
Haematuria
|
—
0/0 • From Day 1 (after dose) through Day 180
Data on all-cause mortality and serious adverse events were collected irrespective of the event's relation to the buttocks (test/control). The buttock Arms were limited to the analysis of localized events of the injection site region (ISR) only.
|
—
0/0 • From Day 1 (after dose) through Day 180
Data on all-cause mortality and serious adverse events were collected irrespective of the event's relation to the buttocks (test/control). The buttock Arms were limited to the analysis of localized events of the injection site region (ISR) only.
|
—
0/0 • From Day 1 (after dose) through Day 180
Data on all-cause mortality and serious adverse events were collected irrespective of the event's relation to the buttocks (test/control). The buttock Arms were limited to the analysis of localized events of the injection site region (ISR) only.
|
—
0/0 • From Day 1 (after dose) through Day 180
Data on all-cause mortality and serious adverse events were collected irrespective of the event's relation to the buttocks (test/control). The buttock Arms were limited to the analysis of localized events of the injection site region (ISR) only.
|
—
0/0 • From Day 1 (after dose) through Day 180
Data on all-cause mortality and serious adverse events were collected irrespective of the event's relation to the buttocks (test/control). The buttock Arms were limited to the analysis of localized events of the injection site region (ISR) only.
|
—
0/0 • From Day 1 (after dose) through Day 180
Data on all-cause mortality and serious adverse events were collected irrespective of the event's relation to the buttocks (test/control). The buttock Arms were limited to the analysis of localized events of the injection site region (ISR) only.
|
—
0/0 • From Day 1 (after dose) through Day 180
Data on all-cause mortality and serious adverse events were collected irrespective of the event's relation to the buttocks (test/control). The buttock Arms were limited to the analysis of localized events of the injection site region (ISR) only.
|
—
0/0 • From Day 1 (after dose) through Day 180
Data on all-cause mortality and serious adverse events were collected irrespective of the event's relation to the buttocks (test/control). The buttock Arms were limited to the analysis of localized events of the injection site region (ISR) only.
|
—
0/0 • From Day 1 (after dose) through Day 180
Data on all-cause mortality and serious adverse events were collected irrespective of the event's relation to the buttocks (test/control). The buttock Arms were limited to the analysis of localized events of the injection site region (ISR) only.
|
—
0/0 • From Day 1 (after dose) through Day 180
Data on all-cause mortality and serious adverse events were collected irrespective of the event's relation to the buttocks (test/control). The buttock Arms were limited to the analysis of localized events of the injection site region (ISR) only.
|
—
0/0 • From Day 1 (after dose) through Day 180
Data on all-cause mortality and serious adverse events were collected irrespective of the event's relation to the buttocks (test/control). The buttock Arms were limited to the analysis of localized events of the injection site region (ISR) only.
|
—
0/0 • From Day 1 (after dose) through Day 180
Data on all-cause mortality and serious adverse events were collected irrespective of the event's relation to the buttocks (test/control). The buttock Arms were limited to the analysis of localized events of the injection site region (ISR) only.
|
—
0/0 • From Day 1 (after dose) through Day 180
Data on all-cause mortality and serious adverse events were collected irrespective of the event's relation to the buttocks (test/control). The buttock Arms were limited to the analysis of localized events of the injection site region (ISR) only.
|
—
0/0 • From Day 1 (after dose) through Day 180
Data on all-cause mortality and serious adverse events were collected irrespective of the event's relation to the buttocks (test/control). The buttock Arms were limited to the analysis of localized events of the injection site region (ISR) only.
|
—
0/0 • From Day 1 (after dose) through Day 180
Data on all-cause mortality and serious adverse events were collected irrespective of the event's relation to the buttocks (test/control). The buttock Arms were limited to the analysis of localized events of the injection site region (ISR) only.
|
—
0/0 • From Day 1 (after dose) through Day 180
Data on all-cause mortality and serious adverse events were collected irrespective of the event's relation to the buttocks (test/control). The buttock Arms were limited to the analysis of localized events of the injection site region (ISR) only.
|
0.00%
0/22 • From Day 1 (after dose) through Day 180
Data on all-cause mortality and serious adverse events were collected irrespective of the event's relation to the buttocks (test/control). The buttock Arms were limited to the analysis of localized events of the injection site region (ISR) only.
|
0.00%
0/14 • From Day 1 (after dose) through Day 180
Data on all-cause mortality and serious adverse events were collected irrespective of the event's relation to the buttocks (test/control). The buttock Arms were limited to the analysis of localized events of the injection site region (ISR) only.
|
20.0%
1/5 • From Day 1 (after dose) through Day 180
Data on all-cause mortality and serious adverse events were collected irrespective of the event's relation to the buttocks (test/control). The buttock Arms were limited to the analysis of localized events of the injection site region (ISR) only.
|
0.00%
0/7 • From Day 1 (after dose) through Day 180
Data on all-cause mortality and serious adverse events were collected irrespective of the event's relation to the buttocks (test/control). The buttock Arms were limited to the analysis of localized events of the injection site region (ISR) only.
|
0.00%
0/10 • From Day 1 (after dose) through Day 180
Data on all-cause mortality and serious adverse events were collected irrespective of the event's relation to the buttocks (test/control). The buttock Arms were limited to the analysis of localized events of the injection site region (ISR) only.
|
0.00%
0/19 • From Day 1 (after dose) through Day 180
Data on all-cause mortality and serious adverse events were collected irrespective of the event's relation to the buttocks (test/control). The buttock Arms were limited to the analysis of localized events of the injection site region (ISR) only.
|
0.00%
0/7 • From Day 1 (after dose) through Day 180
Data on all-cause mortality and serious adverse events were collected irrespective of the event's relation to the buttocks (test/control). The buttock Arms were limited to the analysis of localized events of the injection site region (ISR) only.
|
0.00%
0/7 • From Day 1 (after dose) through Day 180
Data on all-cause mortality and serious adverse events were collected irrespective of the event's relation to the buttocks (test/control). The buttock Arms were limited to the analysis of localized events of the injection site region (ISR) only.
|
|
Immune system disorders
Hypersensitivity
|
—
0/0 • From Day 1 (after dose) through Day 180
Data on all-cause mortality and serious adverse events were collected irrespective of the event's relation to the buttocks (test/control). The buttock Arms were limited to the analysis of localized events of the injection site region (ISR) only.
|
—
0/0 • From Day 1 (after dose) through Day 180
Data on all-cause mortality and serious adverse events were collected irrespective of the event's relation to the buttocks (test/control). The buttock Arms were limited to the analysis of localized events of the injection site region (ISR) only.
|
—
0/0 • From Day 1 (after dose) through Day 180
Data on all-cause mortality and serious adverse events were collected irrespective of the event's relation to the buttocks (test/control). The buttock Arms were limited to the analysis of localized events of the injection site region (ISR) only.
|
—
0/0 • From Day 1 (after dose) through Day 180
Data on all-cause mortality and serious adverse events were collected irrespective of the event's relation to the buttocks (test/control). The buttock Arms were limited to the analysis of localized events of the injection site region (ISR) only.
|
—
0/0 • From Day 1 (after dose) through Day 180
Data on all-cause mortality and serious adverse events were collected irrespective of the event's relation to the buttocks (test/control). The buttock Arms were limited to the analysis of localized events of the injection site region (ISR) only.
|
—
0/0 • From Day 1 (after dose) through Day 180
Data on all-cause mortality and serious adverse events were collected irrespective of the event's relation to the buttocks (test/control). The buttock Arms were limited to the analysis of localized events of the injection site region (ISR) only.
|
—
0/0 • From Day 1 (after dose) through Day 180
Data on all-cause mortality and serious adverse events were collected irrespective of the event's relation to the buttocks (test/control). The buttock Arms were limited to the analysis of localized events of the injection site region (ISR) only.
|
—
0/0 • From Day 1 (after dose) through Day 180
Data on all-cause mortality and serious adverse events were collected irrespective of the event's relation to the buttocks (test/control). The buttock Arms were limited to the analysis of localized events of the injection site region (ISR) only.
|
—
0/0 • From Day 1 (after dose) through Day 180
Data on all-cause mortality and serious adverse events were collected irrespective of the event's relation to the buttocks (test/control). The buttock Arms were limited to the analysis of localized events of the injection site region (ISR) only.
|
—
0/0 • From Day 1 (after dose) through Day 180
Data on all-cause mortality and serious adverse events were collected irrespective of the event's relation to the buttocks (test/control). The buttock Arms were limited to the analysis of localized events of the injection site region (ISR) only.
|
—
0/0 • From Day 1 (after dose) through Day 180
Data on all-cause mortality and serious adverse events were collected irrespective of the event's relation to the buttocks (test/control). The buttock Arms were limited to the analysis of localized events of the injection site region (ISR) only.
|
—
0/0 • From Day 1 (after dose) through Day 180
Data on all-cause mortality and serious adverse events were collected irrespective of the event's relation to the buttocks (test/control). The buttock Arms were limited to the analysis of localized events of the injection site region (ISR) only.
|
—
0/0 • From Day 1 (after dose) through Day 180
Data on all-cause mortality and serious adverse events were collected irrespective of the event's relation to the buttocks (test/control). The buttock Arms were limited to the analysis of localized events of the injection site region (ISR) only.
|
—
0/0 • From Day 1 (after dose) through Day 180
Data on all-cause mortality and serious adverse events were collected irrespective of the event's relation to the buttocks (test/control). The buttock Arms were limited to the analysis of localized events of the injection site region (ISR) only.
|
—
0/0 • From Day 1 (after dose) through Day 180
Data on all-cause mortality and serious adverse events were collected irrespective of the event's relation to the buttocks (test/control). The buttock Arms were limited to the analysis of localized events of the injection site region (ISR) only.
|
—
0/0 • From Day 1 (after dose) through Day 180
Data on all-cause mortality and serious adverse events were collected irrespective of the event's relation to the buttocks (test/control). The buttock Arms were limited to the analysis of localized events of the injection site region (ISR) only.
|
0.00%
0/22 • From Day 1 (after dose) through Day 180
Data on all-cause mortality and serious adverse events were collected irrespective of the event's relation to the buttocks (test/control). The buttock Arms were limited to the analysis of localized events of the injection site region (ISR) only.
|
0.00%
0/14 • From Day 1 (after dose) through Day 180
Data on all-cause mortality and serious adverse events were collected irrespective of the event's relation to the buttocks (test/control). The buttock Arms were limited to the analysis of localized events of the injection site region (ISR) only.
|
0.00%
0/5 • From Day 1 (after dose) through Day 180
Data on all-cause mortality and serious adverse events were collected irrespective of the event's relation to the buttocks (test/control). The buttock Arms were limited to the analysis of localized events of the injection site region (ISR) only.
|
0.00%
0/7 • From Day 1 (after dose) through Day 180
Data on all-cause mortality and serious adverse events were collected irrespective of the event's relation to the buttocks (test/control). The buttock Arms were limited to the analysis of localized events of the injection site region (ISR) only.
|
0.00%
0/10 • From Day 1 (after dose) through Day 180
Data on all-cause mortality and serious adverse events were collected irrespective of the event's relation to the buttocks (test/control). The buttock Arms were limited to the analysis of localized events of the injection site region (ISR) only.
|
0.00%
0/19 • From Day 1 (after dose) through Day 180
Data on all-cause mortality and serious adverse events were collected irrespective of the event's relation to the buttocks (test/control). The buttock Arms were limited to the analysis of localized events of the injection site region (ISR) only.
|
0.00%
0/7 • From Day 1 (after dose) through Day 180
Data on all-cause mortality and serious adverse events were collected irrespective of the event's relation to the buttocks (test/control). The buttock Arms were limited to the analysis of localized events of the injection site region (ISR) only.
|
14.3%
1/7 • From Day 1 (after dose) through Day 180
Data on all-cause mortality and serious adverse events were collected irrespective of the event's relation to the buttocks (test/control). The buttock Arms were limited to the analysis of localized events of the injection site region (ISR) only.
|
|
Metabolism and nutrition disorders
Insulin resistance
|
—
0/0 • From Day 1 (after dose) through Day 180
Data on all-cause mortality and serious adverse events were collected irrespective of the event's relation to the buttocks (test/control). The buttock Arms were limited to the analysis of localized events of the injection site region (ISR) only.
|
—
0/0 • From Day 1 (after dose) through Day 180
Data on all-cause mortality and serious adverse events were collected irrespective of the event's relation to the buttocks (test/control). The buttock Arms were limited to the analysis of localized events of the injection site region (ISR) only.
|
—
0/0 • From Day 1 (after dose) through Day 180
Data on all-cause mortality and serious adverse events were collected irrespective of the event's relation to the buttocks (test/control). The buttock Arms were limited to the analysis of localized events of the injection site region (ISR) only.
|
—
0/0 • From Day 1 (after dose) through Day 180
Data on all-cause mortality and serious adverse events were collected irrespective of the event's relation to the buttocks (test/control). The buttock Arms were limited to the analysis of localized events of the injection site region (ISR) only.
|
—
0/0 • From Day 1 (after dose) through Day 180
Data on all-cause mortality and serious adverse events were collected irrespective of the event's relation to the buttocks (test/control). The buttock Arms were limited to the analysis of localized events of the injection site region (ISR) only.
|
—
0/0 • From Day 1 (after dose) through Day 180
Data on all-cause mortality and serious adverse events were collected irrespective of the event's relation to the buttocks (test/control). The buttock Arms were limited to the analysis of localized events of the injection site region (ISR) only.
|
—
0/0 • From Day 1 (after dose) through Day 180
Data on all-cause mortality and serious adverse events were collected irrespective of the event's relation to the buttocks (test/control). The buttock Arms were limited to the analysis of localized events of the injection site region (ISR) only.
|
—
0/0 • From Day 1 (after dose) through Day 180
Data on all-cause mortality and serious adverse events were collected irrespective of the event's relation to the buttocks (test/control). The buttock Arms were limited to the analysis of localized events of the injection site region (ISR) only.
|
—
0/0 • From Day 1 (after dose) through Day 180
Data on all-cause mortality and serious adverse events were collected irrespective of the event's relation to the buttocks (test/control). The buttock Arms were limited to the analysis of localized events of the injection site region (ISR) only.
|
—
0/0 • From Day 1 (after dose) through Day 180
Data on all-cause mortality and serious adverse events were collected irrespective of the event's relation to the buttocks (test/control). The buttock Arms were limited to the analysis of localized events of the injection site region (ISR) only.
|
—
0/0 • From Day 1 (after dose) through Day 180
Data on all-cause mortality and serious adverse events were collected irrespective of the event's relation to the buttocks (test/control). The buttock Arms were limited to the analysis of localized events of the injection site region (ISR) only.
|
—
0/0 • From Day 1 (after dose) through Day 180
Data on all-cause mortality and serious adverse events were collected irrespective of the event's relation to the buttocks (test/control). The buttock Arms were limited to the analysis of localized events of the injection site region (ISR) only.
|
—
0/0 • From Day 1 (after dose) through Day 180
Data on all-cause mortality and serious adverse events were collected irrespective of the event's relation to the buttocks (test/control). The buttock Arms were limited to the analysis of localized events of the injection site region (ISR) only.
|
—
0/0 • From Day 1 (after dose) through Day 180
Data on all-cause mortality and serious adverse events were collected irrespective of the event's relation to the buttocks (test/control). The buttock Arms were limited to the analysis of localized events of the injection site region (ISR) only.
|
—
0/0 • From Day 1 (after dose) through Day 180
Data on all-cause mortality and serious adverse events were collected irrespective of the event's relation to the buttocks (test/control). The buttock Arms were limited to the analysis of localized events of the injection site region (ISR) only.
|
—
0/0 • From Day 1 (after dose) through Day 180
Data on all-cause mortality and serious adverse events were collected irrespective of the event's relation to the buttocks (test/control). The buttock Arms were limited to the analysis of localized events of the injection site region (ISR) only.
|
0.00%
0/22 • From Day 1 (after dose) through Day 180
Data on all-cause mortality and serious adverse events were collected irrespective of the event's relation to the buttocks (test/control). The buttock Arms were limited to the analysis of localized events of the injection site region (ISR) only.
|
0.00%
0/14 • From Day 1 (after dose) through Day 180
Data on all-cause mortality and serious adverse events were collected irrespective of the event's relation to the buttocks (test/control). The buttock Arms were limited to the analysis of localized events of the injection site region (ISR) only.
|
0.00%
0/5 • From Day 1 (after dose) through Day 180
Data on all-cause mortality and serious adverse events were collected irrespective of the event's relation to the buttocks (test/control). The buttock Arms were limited to the analysis of localized events of the injection site region (ISR) only.
|
0.00%
0/7 • From Day 1 (after dose) through Day 180
Data on all-cause mortality and serious adverse events were collected irrespective of the event's relation to the buttocks (test/control). The buttock Arms were limited to the analysis of localized events of the injection site region (ISR) only.
|
0.00%
0/10 • From Day 1 (after dose) through Day 180
Data on all-cause mortality and serious adverse events were collected irrespective of the event's relation to the buttocks (test/control). The buttock Arms were limited to the analysis of localized events of the injection site region (ISR) only.
|
5.3%
1/19 • From Day 1 (after dose) through Day 180
Data on all-cause mortality and serious adverse events were collected irrespective of the event's relation to the buttocks (test/control). The buttock Arms were limited to the analysis of localized events of the injection site region (ISR) only.
|
0.00%
0/7 • From Day 1 (after dose) through Day 180
Data on all-cause mortality and serious adverse events were collected irrespective of the event's relation to the buttocks (test/control). The buttock Arms were limited to the analysis of localized events of the injection site region (ISR) only.
|
0.00%
0/7 • From Day 1 (after dose) through Day 180
Data on all-cause mortality and serious adverse events were collected irrespective of the event's relation to the buttocks (test/control). The buttock Arms were limited to the analysis of localized events of the injection site region (ISR) only.
|
|
Infections and infestations
Nasopharyngitis
|
—
0/0 • From Day 1 (after dose) through Day 180
Data on all-cause mortality and serious adverse events were collected irrespective of the event's relation to the buttocks (test/control). The buttock Arms were limited to the analysis of localized events of the injection site region (ISR) only.
|
—
0/0 • From Day 1 (after dose) through Day 180
Data on all-cause mortality and serious adverse events were collected irrespective of the event's relation to the buttocks (test/control). The buttock Arms were limited to the analysis of localized events of the injection site region (ISR) only.
|
—
0/0 • From Day 1 (after dose) through Day 180
Data on all-cause mortality and serious adverse events were collected irrespective of the event's relation to the buttocks (test/control). The buttock Arms were limited to the analysis of localized events of the injection site region (ISR) only.
|
—
0/0 • From Day 1 (after dose) through Day 180
Data on all-cause mortality and serious adverse events were collected irrespective of the event's relation to the buttocks (test/control). The buttock Arms were limited to the analysis of localized events of the injection site region (ISR) only.
|
—
0/0 • From Day 1 (after dose) through Day 180
Data on all-cause mortality and serious adverse events were collected irrespective of the event's relation to the buttocks (test/control). The buttock Arms were limited to the analysis of localized events of the injection site region (ISR) only.
|
—
0/0 • From Day 1 (after dose) through Day 180
Data on all-cause mortality and serious adverse events were collected irrespective of the event's relation to the buttocks (test/control). The buttock Arms were limited to the analysis of localized events of the injection site region (ISR) only.
|
—
0/0 • From Day 1 (after dose) through Day 180
Data on all-cause mortality and serious adverse events were collected irrespective of the event's relation to the buttocks (test/control). The buttock Arms were limited to the analysis of localized events of the injection site region (ISR) only.
|
—
0/0 • From Day 1 (after dose) through Day 180
Data on all-cause mortality and serious adverse events were collected irrespective of the event's relation to the buttocks (test/control). The buttock Arms were limited to the analysis of localized events of the injection site region (ISR) only.
|
—
0/0 • From Day 1 (after dose) through Day 180
Data on all-cause mortality and serious adverse events were collected irrespective of the event's relation to the buttocks (test/control). The buttock Arms were limited to the analysis of localized events of the injection site region (ISR) only.
|
—
0/0 • From Day 1 (after dose) through Day 180
Data on all-cause mortality and serious adverse events were collected irrespective of the event's relation to the buttocks (test/control). The buttock Arms were limited to the analysis of localized events of the injection site region (ISR) only.
|
—
0/0 • From Day 1 (after dose) through Day 180
Data on all-cause mortality and serious adverse events were collected irrespective of the event's relation to the buttocks (test/control). The buttock Arms were limited to the analysis of localized events of the injection site region (ISR) only.
|
—
0/0 • From Day 1 (after dose) through Day 180
Data on all-cause mortality and serious adverse events were collected irrespective of the event's relation to the buttocks (test/control). The buttock Arms were limited to the analysis of localized events of the injection site region (ISR) only.
|
—
0/0 • From Day 1 (after dose) through Day 180
Data on all-cause mortality and serious adverse events were collected irrespective of the event's relation to the buttocks (test/control). The buttock Arms were limited to the analysis of localized events of the injection site region (ISR) only.
|
—
0/0 • From Day 1 (after dose) through Day 180
Data on all-cause mortality and serious adverse events were collected irrespective of the event's relation to the buttocks (test/control). The buttock Arms were limited to the analysis of localized events of the injection site region (ISR) only.
|
—
0/0 • From Day 1 (after dose) through Day 180
Data on all-cause mortality and serious adverse events were collected irrespective of the event's relation to the buttocks (test/control). The buttock Arms were limited to the analysis of localized events of the injection site region (ISR) only.
|
—
0/0 • From Day 1 (after dose) through Day 180
Data on all-cause mortality and serious adverse events were collected irrespective of the event's relation to the buttocks (test/control). The buttock Arms were limited to the analysis of localized events of the injection site region (ISR) only.
|
0.00%
0/22 • From Day 1 (after dose) through Day 180
Data on all-cause mortality and serious adverse events were collected irrespective of the event's relation to the buttocks (test/control). The buttock Arms were limited to the analysis of localized events of the injection site region (ISR) only.
|
0.00%
0/14 • From Day 1 (after dose) through Day 180
Data on all-cause mortality and serious adverse events were collected irrespective of the event's relation to the buttocks (test/control). The buttock Arms were limited to the analysis of localized events of the injection site region (ISR) only.
|
20.0%
1/5 • From Day 1 (after dose) through Day 180
Data on all-cause mortality and serious adverse events were collected irrespective of the event's relation to the buttocks (test/control). The buttock Arms were limited to the analysis of localized events of the injection site region (ISR) only.
|
0.00%
0/7 • From Day 1 (after dose) through Day 180
Data on all-cause mortality and serious adverse events were collected irrespective of the event's relation to the buttocks (test/control). The buttock Arms were limited to the analysis of localized events of the injection site region (ISR) only.
|
0.00%
0/10 • From Day 1 (after dose) through Day 180
Data on all-cause mortality and serious adverse events were collected irrespective of the event's relation to the buttocks (test/control). The buttock Arms were limited to the analysis of localized events of the injection site region (ISR) only.
|
0.00%
0/19 • From Day 1 (after dose) through Day 180
Data on all-cause mortality and serious adverse events were collected irrespective of the event's relation to the buttocks (test/control). The buttock Arms were limited to the analysis of localized events of the injection site region (ISR) only.
|
0.00%
0/7 • From Day 1 (after dose) through Day 180
Data on all-cause mortality and serious adverse events were collected irrespective of the event's relation to the buttocks (test/control). The buttock Arms were limited to the analysis of localized events of the injection site region (ISR) only.
|
0.00%
0/7 • From Day 1 (after dose) through Day 180
Data on all-cause mortality and serious adverse events were collected irrespective of the event's relation to the buttocks (test/control). The buttock Arms were limited to the analysis of localized events of the injection site region (ISR) only.
|
|
Injury, poisoning and procedural complications
Sunburn
|
—
0/0 • From Day 1 (after dose) through Day 180
Data on all-cause mortality and serious adverse events were collected irrespective of the event's relation to the buttocks (test/control). The buttock Arms were limited to the analysis of localized events of the injection site region (ISR) only.
|
—
0/0 • From Day 1 (after dose) through Day 180
Data on all-cause mortality and serious adverse events were collected irrespective of the event's relation to the buttocks (test/control). The buttock Arms were limited to the analysis of localized events of the injection site region (ISR) only.
|
—
0/0 • From Day 1 (after dose) through Day 180
Data on all-cause mortality and serious adverse events were collected irrespective of the event's relation to the buttocks (test/control). The buttock Arms were limited to the analysis of localized events of the injection site region (ISR) only.
|
—
0/0 • From Day 1 (after dose) through Day 180
Data on all-cause mortality and serious adverse events were collected irrespective of the event's relation to the buttocks (test/control). The buttock Arms were limited to the analysis of localized events of the injection site region (ISR) only.
|
—
0/0 • From Day 1 (after dose) through Day 180
Data on all-cause mortality and serious adverse events were collected irrespective of the event's relation to the buttocks (test/control). The buttock Arms were limited to the analysis of localized events of the injection site region (ISR) only.
|
—
0/0 • From Day 1 (after dose) through Day 180
Data on all-cause mortality and serious adverse events were collected irrespective of the event's relation to the buttocks (test/control). The buttock Arms were limited to the analysis of localized events of the injection site region (ISR) only.
|
—
0/0 • From Day 1 (after dose) through Day 180
Data on all-cause mortality and serious adverse events were collected irrespective of the event's relation to the buttocks (test/control). The buttock Arms were limited to the analysis of localized events of the injection site region (ISR) only.
|
—
0/0 • From Day 1 (after dose) through Day 180
Data on all-cause mortality and serious adverse events were collected irrespective of the event's relation to the buttocks (test/control). The buttock Arms were limited to the analysis of localized events of the injection site region (ISR) only.
|
—
0/0 • From Day 1 (after dose) through Day 180
Data on all-cause mortality and serious adverse events were collected irrespective of the event's relation to the buttocks (test/control). The buttock Arms were limited to the analysis of localized events of the injection site region (ISR) only.
|
—
0/0 • From Day 1 (after dose) through Day 180
Data on all-cause mortality and serious adverse events were collected irrespective of the event's relation to the buttocks (test/control). The buttock Arms were limited to the analysis of localized events of the injection site region (ISR) only.
|
—
0/0 • From Day 1 (after dose) through Day 180
Data on all-cause mortality and serious adverse events were collected irrespective of the event's relation to the buttocks (test/control). The buttock Arms were limited to the analysis of localized events of the injection site region (ISR) only.
|
—
0/0 • From Day 1 (after dose) through Day 180
Data on all-cause mortality and serious adverse events were collected irrespective of the event's relation to the buttocks (test/control). The buttock Arms were limited to the analysis of localized events of the injection site region (ISR) only.
|
—
0/0 • From Day 1 (after dose) through Day 180
Data on all-cause mortality and serious adverse events were collected irrespective of the event's relation to the buttocks (test/control). The buttock Arms were limited to the analysis of localized events of the injection site region (ISR) only.
|
—
0/0 • From Day 1 (after dose) through Day 180
Data on all-cause mortality and serious adverse events were collected irrespective of the event's relation to the buttocks (test/control). The buttock Arms were limited to the analysis of localized events of the injection site region (ISR) only.
|
—
0/0 • From Day 1 (after dose) through Day 180
Data on all-cause mortality and serious adverse events were collected irrespective of the event's relation to the buttocks (test/control). The buttock Arms were limited to the analysis of localized events of the injection site region (ISR) only.
|
—
0/0 • From Day 1 (after dose) through Day 180
Data on all-cause mortality and serious adverse events were collected irrespective of the event's relation to the buttocks (test/control). The buttock Arms were limited to the analysis of localized events of the injection site region (ISR) only.
|
0.00%
0/22 • From Day 1 (after dose) through Day 180
Data on all-cause mortality and serious adverse events were collected irrespective of the event's relation to the buttocks (test/control). The buttock Arms were limited to the analysis of localized events of the injection site region (ISR) only.
|
0.00%
0/14 • From Day 1 (after dose) through Day 180
Data on all-cause mortality and serious adverse events were collected irrespective of the event's relation to the buttocks (test/control). The buttock Arms were limited to the analysis of localized events of the injection site region (ISR) only.
|
0.00%
0/5 • From Day 1 (after dose) through Day 180
Data on all-cause mortality and serious adverse events were collected irrespective of the event's relation to the buttocks (test/control). The buttock Arms were limited to the analysis of localized events of the injection site region (ISR) only.
|
0.00%
0/7 • From Day 1 (after dose) through Day 180
Data on all-cause mortality and serious adverse events were collected irrespective of the event's relation to the buttocks (test/control). The buttock Arms were limited to the analysis of localized events of the injection site region (ISR) only.
|
0.00%
0/10 • From Day 1 (after dose) through Day 180
Data on all-cause mortality and serious adverse events were collected irrespective of the event's relation to the buttocks (test/control). The buttock Arms were limited to the analysis of localized events of the injection site region (ISR) only.
|
5.3%
1/19 • From Day 1 (after dose) through Day 180
Data on all-cause mortality and serious adverse events were collected irrespective of the event's relation to the buttocks (test/control). The buttock Arms were limited to the analysis of localized events of the injection site region (ISR) only.
|
0.00%
0/7 • From Day 1 (after dose) through Day 180
Data on all-cause mortality and serious adverse events were collected irrespective of the event's relation to the buttocks (test/control). The buttock Arms were limited to the analysis of localized events of the injection site region (ISR) only.
|
0.00%
0/7 • From Day 1 (after dose) through Day 180
Data on all-cause mortality and serious adverse events were collected irrespective of the event's relation to the buttocks (test/control). The buttock Arms were limited to the analysis of localized events of the injection site region (ISR) only.
|
|
General disorders
Injection site bruising
|
100.0%
22/22 • From Day 1 (after dose) through Day 180
Data on all-cause mortality and serious adverse events were collected irrespective of the event's relation to the buttocks (test/control). The buttock Arms were limited to the analysis of localized events of the injection site region (ISR) only.
|
100.0%
22/22 • From Day 1 (after dose) through Day 180
Data on all-cause mortality and serious adverse events were collected irrespective of the event's relation to the buttocks (test/control). The buttock Arms were limited to the analysis of localized events of the injection site region (ISR) only.
|
92.9%
13/14 • From Day 1 (after dose) through Day 180
Data on all-cause mortality and serious adverse events were collected irrespective of the event's relation to the buttocks (test/control). The buttock Arms were limited to the analysis of localized events of the injection site region (ISR) only.
|
92.9%
13/14 • From Day 1 (after dose) through Day 180
Data on all-cause mortality and serious adverse events were collected irrespective of the event's relation to the buttocks (test/control). The buttock Arms were limited to the analysis of localized events of the injection site region (ISR) only.
|
100.0%
5/5 • From Day 1 (after dose) through Day 180
Data on all-cause mortality and serious adverse events were collected irrespective of the event's relation to the buttocks (test/control). The buttock Arms were limited to the analysis of localized events of the injection site region (ISR) only.
|
100.0%
5/5 • From Day 1 (after dose) through Day 180
Data on all-cause mortality and serious adverse events were collected irrespective of the event's relation to the buttocks (test/control). The buttock Arms were limited to the analysis of localized events of the injection site region (ISR) only.
|
0.00%
0/7 • From Day 1 (after dose) through Day 180
Data on all-cause mortality and serious adverse events were collected irrespective of the event's relation to the buttocks (test/control). The buttock Arms were limited to the analysis of localized events of the injection site region (ISR) only.
|
0.00%
0/7 • From Day 1 (after dose) through Day 180
Data on all-cause mortality and serious adverse events were collected irrespective of the event's relation to the buttocks (test/control). The buttock Arms were limited to the analysis of localized events of the injection site region (ISR) only.
|
100.0%
10/10 • From Day 1 (after dose) through Day 180
Data on all-cause mortality and serious adverse events were collected irrespective of the event's relation to the buttocks (test/control). The buttock Arms were limited to the analysis of localized events of the injection site region (ISR) only.
|
100.0%
10/10 • From Day 1 (after dose) through Day 180
Data on all-cause mortality and serious adverse events were collected irrespective of the event's relation to the buttocks (test/control). The buttock Arms were limited to the analysis of localized events of the injection site region (ISR) only.
|
100.0%
19/19 • From Day 1 (after dose) through Day 180
Data on all-cause mortality and serious adverse events were collected irrespective of the event's relation to the buttocks (test/control). The buttock Arms were limited to the analysis of localized events of the injection site region (ISR) only.
|
100.0%
19/19 • From Day 1 (after dose) through Day 180
Data on all-cause mortality and serious adverse events were collected irrespective of the event's relation to the buttocks (test/control). The buttock Arms were limited to the analysis of localized events of the injection site region (ISR) only.
|
0.00%
0/7 • From Day 1 (after dose) through Day 180
Data on all-cause mortality and serious adverse events were collected irrespective of the event's relation to the buttocks (test/control). The buttock Arms were limited to the analysis of localized events of the injection site region (ISR) only.
|
0.00%
0/7 • From Day 1 (after dose) through Day 180
Data on all-cause mortality and serious adverse events were collected irrespective of the event's relation to the buttocks (test/control). The buttock Arms were limited to the analysis of localized events of the injection site region (ISR) only.
|
100.0%
7/7 • From Day 1 (after dose) through Day 180
Data on all-cause mortality and serious adverse events were collected irrespective of the event's relation to the buttocks (test/control). The buttock Arms were limited to the analysis of localized events of the injection site region (ISR) only.
|
100.0%
7/7 • From Day 1 (after dose) through Day 180
Data on all-cause mortality and serious adverse events were collected irrespective of the event's relation to the buttocks (test/control). The buttock Arms were limited to the analysis of localized events of the injection site region (ISR) only.
|
—
0/0 • From Day 1 (after dose) through Day 180
Data on all-cause mortality and serious adverse events were collected irrespective of the event's relation to the buttocks (test/control). The buttock Arms were limited to the analysis of localized events of the injection site region (ISR) only.
|
—
0/0 • From Day 1 (after dose) through Day 180
Data on all-cause mortality and serious adverse events were collected irrespective of the event's relation to the buttocks (test/control). The buttock Arms were limited to the analysis of localized events of the injection site region (ISR) only.
|
—
0/0 • From Day 1 (after dose) through Day 180
Data on all-cause mortality and serious adverse events were collected irrespective of the event's relation to the buttocks (test/control). The buttock Arms were limited to the analysis of localized events of the injection site region (ISR) only.
|
—
0/0 • From Day 1 (after dose) through Day 180
Data on all-cause mortality and serious adverse events were collected irrespective of the event's relation to the buttocks (test/control). The buttock Arms were limited to the analysis of localized events of the injection site region (ISR) only.
|
—
0/0 • From Day 1 (after dose) through Day 180
Data on all-cause mortality and serious adverse events were collected irrespective of the event's relation to the buttocks (test/control). The buttock Arms were limited to the analysis of localized events of the injection site region (ISR) only.
|
—
0/0 • From Day 1 (after dose) through Day 180
Data on all-cause mortality and serious adverse events were collected irrespective of the event's relation to the buttocks (test/control). The buttock Arms were limited to the analysis of localized events of the injection site region (ISR) only.
|
—
0/0 • From Day 1 (after dose) through Day 180
Data on all-cause mortality and serious adverse events were collected irrespective of the event's relation to the buttocks (test/control). The buttock Arms were limited to the analysis of localized events of the injection site region (ISR) only.
|
—
0/0 • From Day 1 (after dose) through Day 180
Data on all-cause mortality and serious adverse events were collected irrespective of the event's relation to the buttocks (test/control). The buttock Arms were limited to the analysis of localized events of the injection site region (ISR) only.
|
|
General disorders
Injection site pain
|
31.8%
7/22 • From Day 1 (after dose) through Day 180
Data on all-cause mortality and serious adverse events were collected irrespective of the event's relation to the buttocks (test/control). The buttock Arms were limited to the analysis of localized events of the injection site region (ISR) only.
|
36.4%
8/22 • From Day 1 (after dose) through Day 180
Data on all-cause mortality and serious adverse events were collected irrespective of the event's relation to the buttocks (test/control). The buttock Arms were limited to the analysis of localized events of the injection site region (ISR) only.
|
0.00%
0/14 • From Day 1 (after dose) through Day 180
Data on all-cause mortality and serious adverse events were collected irrespective of the event's relation to the buttocks (test/control). The buttock Arms were limited to the analysis of localized events of the injection site region (ISR) only.
|
0.00%
0/14 • From Day 1 (after dose) through Day 180
Data on all-cause mortality and serious adverse events were collected irrespective of the event's relation to the buttocks (test/control). The buttock Arms were limited to the analysis of localized events of the injection site region (ISR) only.
|
20.0%
1/5 • From Day 1 (after dose) through Day 180
Data on all-cause mortality and serious adverse events were collected irrespective of the event's relation to the buttocks (test/control). The buttock Arms were limited to the analysis of localized events of the injection site region (ISR) only.
|
20.0%
1/5 • From Day 1 (after dose) through Day 180
Data on all-cause mortality and serious adverse events were collected irrespective of the event's relation to the buttocks (test/control). The buttock Arms were limited to the analysis of localized events of the injection site region (ISR) only.
|
0.00%
0/7 • From Day 1 (after dose) through Day 180
Data on all-cause mortality and serious adverse events were collected irrespective of the event's relation to the buttocks (test/control). The buttock Arms were limited to the analysis of localized events of the injection site region (ISR) only.
|
0.00%
0/7 • From Day 1 (after dose) through Day 180
Data on all-cause mortality and serious adverse events were collected irrespective of the event's relation to the buttocks (test/control). The buttock Arms were limited to the analysis of localized events of the injection site region (ISR) only.
|
90.0%
9/10 • From Day 1 (after dose) through Day 180
Data on all-cause mortality and serious adverse events were collected irrespective of the event's relation to the buttocks (test/control). The buttock Arms were limited to the analysis of localized events of the injection site region (ISR) only.
|
90.0%
9/10 • From Day 1 (after dose) through Day 180
Data on all-cause mortality and serious adverse events were collected irrespective of the event's relation to the buttocks (test/control). The buttock Arms were limited to the analysis of localized events of the injection site region (ISR) only.
|
10.5%
2/19 • From Day 1 (after dose) through Day 180
Data on all-cause mortality and serious adverse events were collected irrespective of the event's relation to the buttocks (test/control). The buttock Arms were limited to the analysis of localized events of the injection site region (ISR) only.
|
10.5%
2/19 • From Day 1 (after dose) through Day 180
Data on all-cause mortality and serious adverse events were collected irrespective of the event's relation to the buttocks (test/control). The buttock Arms were limited to the analysis of localized events of the injection site region (ISR) only.
|
28.6%
2/7 • From Day 1 (after dose) through Day 180
Data on all-cause mortality and serious adverse events were collected irrespective of the event's relation to the buttocks (test/control). The buttock Arms were limited to the analysis of localized events of the injection site region (ISR) only.
|
0.00%
0/7 • From Day 1 (after dose) through Day 180
Data on all-cause mortality and serious adverse events were collected irrespective of the event's relation to the buttocks (test/control). The buttock Arms were limited to the analysis of localized events of the injection site region (ISR) only.
|
14.3%
1/7 • From Day 1 (after dose) through Day 180
Data on all-cause mortality and serious adverse events were collected irrespective of the event's relation to the buttocks (test/control). The buttock Arms were limited to the analysis of localized events of the injection site region (ISR) only.
|
42.9%
3/7 • From Day 1 (after dose) through Day 180
Data on all-cause mortality and serious adverse events were collected irrespective of the event's relation to the buttocks (test/control). The buttock Arms were limited to the analysis of localized events of the injection site region (ISR) only.
|
—
0/0 • From Day 1 (after dose) through Day 180
Data on all-cause mortality and serious adverse events were collected irrespective of the event's relation to the buttocks (test/control). The buttock Arms were limited to the analysis of localized events of the injection site region (ISR) only.
|
—
0/0 • From Day 1 (after dose) through Day 180
Data on all-cause mortality and serious adverse events were collected irrespective of the event's relation to the buttocks (test/control). The buttock Arms were limited to the analysis of localized events of the injection site region (ISR) only.
|
—
0/0 • From Day 1 (after dose) through Day 180
Data on all-cause mortality and serious adverse events were collected irrespective of the event's relation to the buttocks (test/control). The buttock Arms were limited to the analysis of localized events of the injection site region (ISR) only.
|
—
0/0 • From Day 1 (after dose) through Day 180
Data on all-cause mortality and serious adverse events were collected irrespective of the event's relation to the buttocks (test/control). The buttock Arms were limited to the analysis of localized events of the injection site region (ISR) only.
|
—
0/0 • From Day 1 (after dose) through Day 180
Data on all-cause mortality and serious adverse events were collected irrespective of the event's relation to the buttocks (test/control). The buttock Arms were limited to the analysis of localized events of the injection site region (ISR) only.
|
—
0/0 • From Day 1 (after dose) through Day 180
Data on all-cause mortality and serious adverse events were collected irrespective of the event's relation to the buttocks (test/control). The buttock Arms were limited to the analysis of localized events of the injection site region (ISR) only.
|
—
0/0 • From Day 1 (after dose) through Day 180
Data on all-cause mortality and serious adverse events were collected irrespective of the event's relation to the buttocks (test/control). The buttock Arms were limited to the analysis of localized events of the injection site region (ISR) only.
|
—
0/0 • From Day 1 (after dose) through Day 180
Data on all-cause mortality and serious adverse events were collected irrespective of the event's relation to the buttocks (test/control). The buttock Arms were limited to the analysis of localized events of the injection site region (ISR) only.
|
|
General disorders
Injection site discolouration
|
45.5%
10/22 • From Day 1 (after dose) through Day 180
Data on all-cause mortality and serious adverse events were collected irrespective of the event's relation to the buttocks (test/control). The buttock Arms were limited to the analysis of localized events of the injection site region (ISR) only.
|
45.5%
10/22 • From Day 1 (after dose) through Day 180
Data on all-cause mortality and serious adverse events were collected irrespective of the event's relation to the buttocks (test/control). The buttock Arms were limited to the analysis of localized events of the injection site region (ISR) only.
|
0.00%
0/14 • From Day 1 (after dose) through Day 180
Data on all-cause mortality and serious adverse events were collected irrespective of the event's relation to the buttocks (test/control). The buttock Arms were limited to the analysis of localized events of the injection site region (ISR) only.
|
0.00%
0/14 • From Day 1 (after dose) through Day 180
Data on all-cause mortality and serious adverse events were collected irrespective of the event's relation to the buttocks (test/control). The buttock Arms were limited to the analysis of localized events of the injection site region (ISR) only.
|
60.0%
3/5 • From Day 1 (after dose) through Day 180
Data on all-cause mortality and serious adverse events were collected irrespective of the event's relation to the buttocks (test/control). The buttock Arms were limited to the analysis of localized events of the injection site region (ISR) only.
|
60.0%
3/5 • From Day 1 (after dose) through Day 180
Data on all-cause mortality and serious adverse events were collected irrespective of the event's relation to the buttocks (test/control). The buttock Arms were limited to the analysis of localized events of the injection site region (ISR) only.
|
28.6%
2/7 • From Day 1 (after dose) through Day 180
Data on all-cause mortality and serious adverse events were collected irrespective of the event's relation to the buttocks (test/control). The buttock Arms were limited to the analysis of localized events of the injection site region (ISR) only.
|
28.6%
2/7 • From Day 1 (after dose) through Day 180
Data on all-cause mortality and serious adverse events were collected irrespective of the event's relation to the buttocks (test/control). The buttock Arms were limited to the analysis of localized events of the injection site region (ISR) only.
|
10.0%
1/10 • From Day 1 (after dose) through Day 180
Data on all-cause mortality and serious adverse events were collected irrespective of the event's relation to the buttocks (test/control). The buttock Arms were limited to the analysis of localized events of the injection site region (ISR) only.
|
10.0%
1/10 • From Day 1 (after dose) through Day 180
Data on all-cause mortality and serious adverse events were collected irrespective of the event's relation to the buttocks (test/control). The buttock Arms were limited to the analysis of localized events of the injection site region (ISR) only.
|
5.3%
1/19 • From Day 1 (after dose) through Day 180
Data on all-cause mortality and serious adverse events were collected irrespective of the event's relation to the buttocks (test/control). The buttock Arms were limited to the analysis of localized events of the injection site region (ISR) only.
|
5.3%
1/19 • From Day 1 (after dose) through Day 180
Data on all-cause mortality and serious adverse events were collected irrespective of the event's relation to the buttocks (test/control). The buttock Arms were limited to the analysis of localized events of the injection site region (ISR) only.
|
28.6%
2/7 • From Day 1 (after dose) through Day 180
Data on all-cause mortality and serious adverse events were collected irrespective of the event's relation to the buttocks (test/control). The buttock Arms were limited to the analysis of localized events of the injection site region (ISR) only.
|
28.6%
2/7 • From Day 1 (after dose) through Day 180
Data on all-cause mortality and serious adverse events were collected irrespective of the event's relation to the buttocks (test/control). The buttock Arms were limited to the analysis of localized events of the injection site region (ISR) only.
|
0.00%
0/7 • From Day 1 (after dose) through Day 180
Data on all-cause mortality and serious adverse events were collected irrespective of the event's relation to the buttocks (test/control). The buttock Arms were limited to the analysis of localized events of the injection site region (ISR) only.
|
14.3%
1/7 • From Day 1 (after dose) through Day 180
Data on all-cause mortality and serious adverse events were collected irrespective of the event's relation to the buttocks (test/control). The buttock Arms were limited to the analysis of localized events of the injection site region (ISR) only.
|
—
0/0 • From Day 1 (after dose) through Day 180
Data on all-cause mortality and serious adverse events were collected irrespective of the event's relation to the buttocks (test/control). The buttock Arms were limited to the analysis of localized events of the injection site region (ISR) only.
|
—
0/0 • From Day 1 (after dose) through Day 180
Data on all-cause mortality and serious adverse events were collected irrespective of the event's relation to the buttocks (test/control). The buttock Arms were limited to the analysis of localized events of the injection site region (ISR) only.
|
—
0/0 • From Day 1 (after dose) through Day 180
Data on all-cause mortality and serious adverse events were collected irrespective of the event's relation to the buttocks (test/control). The buttock Arms were limited to the analysis of localized events of the injection site region (ISR) only.
|
—
0/0 • From Day 1 (after dose) through Day 180
Data on all-cause mortality and serious adverse events were collected irrespective of the event's relation to the buttocks (test/control). The buttock Arms were limited to the analysis of localized events of the injection site region (ISR) only.
|
—
0/0 • From Day 1 (after dose) through Day 180
Data on all-cause mortality and serious adverse events were collected irrespective of the event's relation to the buttocks (test/control). The buttock Arms were limited to the analysis of localized events of the injection site region (ISR) only.
|
—
0/0 • From Day 1 (after dose) through Day 180
Data on all-cause mortality and serious adverse events were collected irrespective of the event's relation to the buttocks (test/control). The buttock Arms were limited to the analysis of localized events of the injection site region (ISR) only.
|
—
0/0 • From Day 1 (after dose) through Day 180
Data on all-cause mortality and serious adverse events were collected irrespective of the event's relation to the buttocks (test/control). The buttock Arms were limited to the analysis of localized events of the injection site region (ISR) only.
|
—
0/0 • From Day 1 (after dose) through Day 180
Data on all-cause mortality and serious adverse events were collected irrespective of the event's relation to the buttocks (test/control). The buttock Arms were limited to the analysis of localized events of the injection site region (ISR) only.
|
|
General disorders
Injection site haemorrhage
|
0.00%
0/22 • From Day 1 (after dose) through Day 180
Data on all-cause mortality and serious adverse events were collected irrespective of the event's relation to the buttocks (test/control). The buttock Arms were limited to the analysis of localized events of the injection site region (ISR) only.
|
0.00%
0/22 • From Day 1 (after dose) through Day 180
Data on all-cause mortality and serious adverse events were collected irrespective of the event's relation to the buttocks (test/control). The buttock Arms were limited to the analysis of localized events of the injection site region (ISR) only.
|
0.00%
0/14 • From Day 1 (after dose) through Day 180
Data on all-cause mortality and serious adverse events were collected irrespective of the event's relation to the buttocks (test/control). The buttock Arms were limited to the analysis of localized events of the injection site region (ISR) only.
|
0.00%
0/14 • From Day 1 (after dose) through Day 180
Data on all-cause mortality and serious adverse events were collected irrespective of the event's relation to the buttocks (test/control). The buttock Arms were limited to the analysis of localized events of the injection site region (ISR) only.
|
0.00%
0/5 • From Day 1 (after dose) through Day 180
Data on all-cause mortality and serious adverse events were collected irrespective of the event's relation to the buttocks (test/control). The buttock Arms were limited to the analysis of localized events of the injection site region (ISR) only.
|
0.00%
0/5 • From Day 1 (after dose) through Day 180
Data on all-cause mortality and serious adverse events were collected irrespective of the event's relation to the buttocks (test/control). The buttock Arms were limited to the analysis of localized events of the injection site region (ISR) only.
|
100.0%
7/7 • From Day 1 (after dose) through Day 180
Data on all-cause mortality and serious adverse events were collected irrespective of the event's relation to the buttocks (test/control). The buttock Arms were limited to the analysis of localized events of the injection site region (ISR) only.
|
100.0%
7/7 • From Day 1 (after dose) through Day 180
Data on all-cause mortality and serious adverse events were collected irrespective of the event's relation to the buttocks (test/control). The buttock Arms were limited to the analysis of localized events of the injection site region (ISR) only.
|
0.00%
0/10 • From Day 1 (after dose) through Day 180
Data on all-cause mortality and serious adverse events were collected irrespective of the event's relation to the buttocks (test/control). The buttock Arms were limited to the analysis of localized events of the injection site region (ISR) only.
|
0.00%
0/10 • From Day 1 (after dose) through Day 180
Data on all-cause mortality and serious adverse events were collected irrespective of the event's relation to the buttocks (test/control). The buttock Arms were limited to the analysis of localized events of the injection site region (ISR) only.
|
0.00%
0/19 • From Day 1 (after dose) through Day 180
Data on all-cause mortality and serious adverse events were collected irrespective of the event's relation to the buttocks (test/control). The buttock Arms were limited to the analysis of localized events of the injection site region (ISR) only.
|
0.00%
0/19 • From Day 1 (after dose) through Day 180
Data on all-cause mortality and serious adverse events were collected irrespective of the event's relation to the buttocks (test/control). The buttock Arms were limited to the analysis of localized events of the injection site region (ISR) only.
|
100.0%
7/7 • From Day 1 (after dose) through Day 180
Data on all-cause mortality and serious adverse events were collected irrespective of the event's relation to the buttocks (test/control). The buttock Arms were limited to the analysis of localized events of the injection site region (ISR) only.
|
85.7%
6/7 • From Day 1 (after dose) through Day 180
Data on all-cause mortality and serious adverse events were collected irrespective of the event's relation to the buttocks (test/control). The buttock Arms were limited to the analysis of localized events of the injection site region (ISR) only.
|
0.00%
0/7 • From Day 1 (after dose) through Day 180
Data on all-cause mortality and serious adverse events were collected irrespective of the event's relation to the buttocks (test/control). The buttock Arms were limited to the analysis of localized events of the injection site region (ISR) only.
|
0.00%
0/7 • From Day 1 (after dose) through Day 180
Data on all-cause mortality and serious adverse events were collected irrespective of the event's relation to the buttocks (test/control). The buttock Arms were limited to the analysis of localized events of the injection site region (ISR) only.
|
—
0/0 • From Day 1 (after dose) through Day 180
Data on all-cause mortality and serious adverse events were collected irrespective of the event's relation to the buttocks (test/control). The buttock Arms were limited to the analysis of localized events of the injection site region (ISR) only.
|
—
0/0 • From Day 1 (after dose) through Day 180
Data on all-cause mortality and serious adverse events were collected irrespective of the event's relation to the buttocks (test/control). The buttock Arms were limited to the analysis of localized events of the injection site region (ISR) only.
|
—
0/0 • From Day 1 (after dose) through Day 180
Data on all-cause mortality and serious adverse events were collected irrespective of the event's relation to the buttocks (test/control). The buttock Arms were limited to the analysis of localized events of the injection site region (ISR) only.
|
—
0/0 • From Day 1 (after dose) through Day 180
Data on all-cause mortality and serious adverse events were collected irrespective of the event's relation to the buttocks (test/control). The buttock Arms were limited to the analysis of localized events of the injection site region (ISR) only.
|
—
0/0 • From Day 1 (after dose) through Day 180
Data on all-cause mortality and serious adverse events were collected irrespective of the event's relation to the buttocks (test/control). The buttock Arms were limited to the analysis of localized events of the injection site region (ISR) only.
|
—
0/0 • From Day 1 (after dose) through Day 180
Data on all-cause mortality and serious adverse events were collected irrespective of the event's relation to the buttocks (test/control). The buttock Arms were limited to the analysis of localized events of the injection site region (ISR) only.
|
—
0/0 • From Day 1 (after dose) through Day 180
Data on all-cause mortality and serious adverse events were collected irrespective of the event's relation to the buttocks (test/control). The buttock Arms were limited to the analysis of localized events of the injection site region (ISR) only.
|
—
0/0 • From Day 1 (after dose) through Day 180
Data on all-cause mortality and serious adverse events were collected irrespective of the event's relation to the buttocks (test/control). The buttock Arms were limited to the analysis of localized events of the injection site region (ISR) only.
|
|
General disorders
Injection site nodule
|
4.5%
1/22 • From Day 1 (after dose) through Day 180
Data on all-cause mortality and serious adverse events were collected irrespective of the event's relation to the buttocks (test/control). The buttock Arms were limited to the analysis of localized events of the injection site region (ISR) only.
|
0.00%
0/22 • From Day 1 (after dose) through Day 180
Data on all-cause mortality and serious adverse events were collected irrespective of the event's relation to the buttocks (test/control). The buttock Arms were limited to the analysis of localized events of the injection site region (ISR) only.
|
0.00%
0/14 • From Day 1 (after dose) through Day 180
Data on all-cause mortality and serious adverse events were collected irrespective of the event's relation to the buttocks (test/control). The buttock Arms were limited to the analysis of localized events of the injection site region (ISR) only.
|
0.00%
0/14 • From Day 1 (after dose) through Day 180
Data on all-cause mortality and serious adverse events were collected irrespective of the event's relation to the buttocks (test/control). The buttock Arms were limited to the analysis of localized events of the injection site region (ISR) only.
|
0.00%
0/5 • From Day 1 (after dose) through Day 180
Data on all-cause mortality and serious adverse events were collected irrespective of the event's relation to the buttocks (test/control). The buttock Arms were limited to the analysis of localized events of the injection site region (ISR) only.
|
0.00%
0/5 • From Day 1 (after dose) through Day 180
Data on all-cause mortality and serious adverse events were collected irrespective of the event's relation to the buttocks (test/control). The buttock Arms were limited to the analysis of localized events of the injection site region (ISR) only.
|
0.00%
0/7 • From Day 1 (after dose) through Day 180
Data on all-cause mortality and serious adverse events were collected irrespective of the event's relation to the buttocks (test/control). The buttock Arms were limited to the analysis of localized events of the injection site region (ISR) only.
|
0.00%
0/7 • From Day 1 (after dose) through Day 180
Data on all-cause mortality and serious adverse events were collected irrespective of the event's relation to the buttocks (test/control). The buttock Arms were limited to the analysis of localized events of the injection site region (ISR) only.
|
40.0%
4/10 • From Day 1 (after dose) through Day 180
Data on all-cause mortality and serious adverse events were collected irrespective of the event's relation to the buttocks (test/control). The buttock Arms were limited to the analysis of localized events of the injection site region (ISR) only.
|
40.0%
4/10 • From Day 1 (after dose) through Day 180
Data on all-cause mortality and serious adverse events were collected irrespective of the event's relation to the buttocks (test/control). The buttock Arms were limited to the analysis of localized events of the injection site region (ISR) only.
|
10.5%
2/19 • From Day 1 (after dose) through Day 180
Data on all-cause mortality and serious adverse events were collected irrespective of the event's relation to the buttocks (test/control). The buttock Arms were limited to the analysis of localized events of the injection site region (ISR) only.
|
10.5%
2/19 • From Day 1 (after dose) through Day 180
Data on all-cause mortality and serious adverse events were collected irrespective of the event's relation to the buttocks (test/control). The buttock Arms were limited to the analysis of localized events of the injection site region (ISR) only.
|
14.3%
1/7 • From Day 1 (after dose) through Day 180
Data on all-cause mortality and serious adverse events were collected irrespective of the event's relation to the buttocks (test/control). The buttock Arms were limited to the analysis of localized events of the injection site region (ISR) only.
|
14.3%
1/7 • From Day 1 (after dose) through Day 180
Data on all-cause mortality and serious adverse events were collected irrespective of the event's relation to the buttocks (test/control). The buttock Arms were limited to the analysis of localized events of the injection site region (ISR) only.
|
0.00%
0/7 • From Day 1 (after dose) through Day 180
Data on all-cause mortality and serious adverse events were collected irrespective of the event's relation to the buttocks (test/control). The buttock Arms were limited to the analysis of localized events of the injection site region (ISR) only.
|
0.00%
0/7 • From Day 1 (after dose) through Day 180
Data on all-cause mortality and serious adverse events were collected irrespective of the event's relation to the buttocks (test/control). The buttock Arms were limited to the analysis of localized events of the injection site region (ISR) only.
|
—
0/0 • From Day 1 (after dose) through Day 180
Data on all-cause mortality and serious adverse events were collected irrespective of the event's relation to the buttocks (test/control). The buttock Arms were limited to the analysis of localized events of the injection site region (ISR) only.
|
—
0/0 • From Day 1 (after dose) through Day 180
Data on all-cause mortality and serious adverse events were collected irrespective of the event's relation to the buttocks (test/control). The buttock Arms were limited to the analysis of localized events of the injection site region (ISR) only.
|
—
0/0 • From Day 1 (after dose) through Day 180
Data on all-cause mortality and serious adverse events were collected irrespective of the event's relation to the buttocks (test/control). The buttock Arms were limited to the analysis of localized events of the injection site region (ISR) only.
|
—
0/0 • From Day 1 (after dose) through Day 180
Data on all-cause mortality and serious adverse events were collected irrespective of the event's relation to the buttocks (test/control). The buttock Arms were limited to the analysis of localized events of the injection site region (ISR) only.
|
—
0/0 • From Day 1 (after dose) through Day 180
Data on all-cause mortality and serious adverse events were collected irrespective of the event's relation to the buttocks (test/control). The buttock Arms were limited to the analysis of localized events of the injection site region (ISR) only.
|
—
0/0 • From Day 1 (after dose) through Day 180
Data on all-cause mortality and serious adverse events were collected irrespective of the event's relation to the buttocks (test/control). The buttock Arms were limited to the analysis of localized events of the injection site region (ISR) only.
|
—
0/0 • From Day 1 (after dose) through Day 180
Data on all-cause mortality and serious adverse events were collected irrespective of the event's relation to the buttocks (test/control). The buttock Arms were limited to the analysis of localized events of the injection site region (ISR) only.
|
—
0/0 • From Day 1 (after dose) through Day 180
Data on all-cause mortality and serious adverse events were collected irrespective of the event's relation to the buttocks (test/control). The buttock Arms were limited to the analysis of localized events of the injection site region (ISR) only.
|
|
General disorders
Injection site mass
|
18.2%
4/22 • From Day 1 (after dose) through Day 180
Data on all-cause mortality and serious adverse events were collected irrespective of the event's relation to the buttocks (test/control). The buttock Arms were limited to the analysis of localized events of the injection site region (ISR) only.
|
18.2%
4/22 • From Day 1 (after dose) through Day 180
Data on all-cause mortality and serious adverse events were collected irrespective of the event's relation to the buttocks (test/control). The buttock Arms were limited to the analysis of localized events of the injection site region (ISR) only.
|
0.00%
0/14 • From Day 1 (after dose) through Day 180
Data on all-cause mortality and serious adverse events were collected irrespective of the event's relation to the buttocks (test/control). The buttock Arms were limited to the analysis of localized events of the injection site region (ISR) only.
|
0.00%
0/14 • From Day 1 (after dose) through Day 180
Data on all-cause mortality and serious adverse events were collected irrespective of the event's relation to the buttocks (test/control). The buttock Arms were limited to the analysis of localized events of the injection site region (ISR) only.
|
0.00%
0/5 • From Day 1 (after dose) through Day 180
Data on all-cause mortality and serious adverse events were collected irrespective of the event's relation to the buttocks (test/control). The buttock Arms were limited to the analysis of localized events of the injection site region (ISR) only.
|
0.00%
0/5 • From Day 1 (after dose) through Day 180
Data on all-cause mortality and serious adverse events were collected irrespective of the event's relation to the buttocks (test/control). The buttock Arms were limited to the analysis of localized events of the injection site region (ISR) only.
|
0.00%
0/7 • From Day 1 (after dose) through Day 180
Data on all-cause mortality and serious adverse events were collected irrespective of the event's relation to the buttocks (test/control). The buttock Arms were limited to the analysis of localized events of the injection site region (ISR) only.
|
0.00%
0/7 • From Day 1 (after dose) through Day 180
Data on all-cause mortality and serious adverse events were collected irrespective of the event's relation to the buttocks (test/control). The buttock Arms were limited to the analysis of localized events of the injection site region (ISR) only.
|
10.0%
1/10 • From Day 1 (after dose) through Day 180
Data on all-cause mortality and serious adverse events were collected irrespective of the event's relation to the buttocks (test/control). The buttock Arms were limited to the analysis of localized events of the injection site region (ISR) only.
|
10.0%
1/10 • From Day 1 (after dose) through Day 180
Data on all-cause mortality and serious adverse events were collected irrespective of the event's relation to the buttocks (test/control). The buttock Arms were limited to the analysis of localized events of the injection site region (ISR) only.
|
5.3%
1/19 • From Day 1 (after dose) through Day 180
Data on all-cause mortality and serious adverse events were collected irrespective of the event's relation to the buttocks (test/control). The buttock Arms were limited to the analysis of localized events of the injection site region (ISR) only.
|
5.3%
1/19 • From Day 1 (after dose) through Day 180
Data on all-cause mortality and serious adverse events were collected irrespective of the event's relation to the buttocks (test/control). The buttock Arms were limited to the analysis of localized events of the injection site region (ISR) only.
|
0.00%
0/7 • From Day 1 (after dose) through Day 180
Data on all-cause mortality and serious adverse events were collected irrespective of the event's relation to the buttocks (test/control). The buttock Arms were limited to the analysis of localized events of the injection site region (ISR) only.
|
0.00%
0/7 • From Day 1 (after dose) through Day 180
Data on all-cause mortality and serious adverse events were collected irrespective of the event's relation to the buttocks (test/control). The buttock Arms were limited to the analysis of localized events of the injection site region (ISR) only.
|
0.00%
0/7 • From Day 1 (after dose) through Day 180
Data on all-cause mortality and serious adverse events were collected irrespective of the event's relation to the buttocks (test/control). The buttock Arms were limited to the analysis of localized events of the injection site region (ISR) only.
|
0.00%
0/7 • From Day 1 (after dose) through Day 180
Data on all-cause mortality and serious adverse events were collected irrespective of the event's relation to the buttocks (test/control). The buttock Arms were limited to the analysis of localized events of the injection site region (ISR) only.
|
—
0/0 • From Day 1 (after dose) through Day 180
Data on all-cause mortality and serious adverse events were collected irrespective of the event's relation to the buttocks (test/control). The buttock Arms were limited to the analysis of localized events of the injection site region (ISR) only.
|
—
0/0 • From Day 1 (after dose) through Day 180
Data on all-cause mortality and serious adverse events were collected irrespective of the event's relation to the buttocks (test/control). The buttock Arms were limited to the analysis of localized events of the injection site region (ISR) only.
|
—
0/0 • From Day 1 (after dose) through Day 180
Data on all-cause mortality and serious adverse events were collected irrespective of the event's relation to the buttocks (test/control). The buttock Arms were limited to the analysis of localized events of the injection site region (ISR) only.
|
—
0/0 • From Day 1 (after dose) through Day 180
Data on all-cause mortality and serious adverse events were collected irrespective of the event's relation to the buttocks (test/control). The buttock Arms were limited to the analysis of localized events of the injection site region (ISR) only.
|
—
0/0 • From Day 1 (after dose) through Day 180
Data on all-cause mortality and serious adverse events were collected irrespective of the event's relation to the buttocks (test/control). The buttock Arms were limited to the analysis of localized events of the injection site region (ISR) only.
|
—
0/0 • From Day 1 (after dose) through Day 180
Data on all-cause mortality and serious adverse events were collected irrespective of the event's relation to the buttocks (test/control). The buttock Arms were limited to the analysis of localized events of the injection site region (ISR) only.
|
—
0/0 • From Day 1 (after dose) through Day 180
Data on all-cause mortality and serious adverse events were collected irrespective of the event's relation to the buttocks (test/control). The buttock Arms were limited to the analysis of localized events of the injection site region (ISR) only.
|
—
0/0 • From Day 1 (after dose) through Day 180
Data on all-cause mortality and serious adverse events were collected irrespective of the event's relation to the buttocks (test/control). The buttock Arms were limited to the analysis of localized events of the injection site region (ISR) only.
|
|
General disorders
Injection site pruritus
|
9.1%
2/22 • From Day 1 (after dose) through Day 180
Data on all-cause mortality and serious adverse events were collected irrespective of the event's relation to the buttocks (test/control). The buttock Arms were limited to the analysis of localized events of the injection site region (ISR) only.
|
9.1%
2/22 • From Day 1 (after dose) through Day 180
Data on all-cause mortality and serious adverse events were collected irrespective of the event's relation to the buttocks (test/control). The buttock Arms were limited to the analysis of localized events of the injection site region (ISR) only.
|
0.00%
0/14 • From Day 1 (after dose) through Day 180
Data on all-cause mortality and serious adverse events were collected irrespective of the event's relation to the buttocks (test/control). The buttock Arms were limited to the analysis of localized events of the injection site region (ISR) only.
|
0.00%
0/14 • From Day 1 (after dose) through Day 180
Data on all-cause mortality and serious adverse events were collected irrespective of the event's relation to the buttocks (test/control). The buttock Arms were limited to the analysis of localized events of the injection site region (ISR) only.
|
0.00%
0/5 • From Day 1 (after dose) through Day 180
Data on all-cause mortality and serious adverse events were collected irrespective of the event's relation to the buttocks (test/control). The buttock Arms were limited to the analysis of localized events of the injection site region (ISR) only.
|
0.00%
0/5 • From Day 1 (after dose) through Day 180
Data on all-cause mortality and serious adverse events were collected irrespective of the event's relation to the buttocks (test/control). The buttock Arms were limited to the analysis of localized events of the injection site region (ISR) only.
|
0.00%
0/7 • From Day 1 (after dose) through Day 180
Data on all-cause mortality and serious adverse events were collected irrespective of the event's relation to the buttocks (test/control). The buttock Arms were limited to the analysis of localized events of the injection site region (ISR) only.
|
0.00%
0/7 • From Day 1 (after dose) through Day 180
Data on all-cause mortality and serious adverse events were collected irrespective of the event's relation to the buttocks (test/control). The buttock Arms were limited to the analysis of localized events of the injection site region (ISR) only.
|
30.0%
3/10 • From Day 1 (after dose) through Day 180
Data on all-cause mortality and serious adverse events were collected irrespective of the event's relation to the buttocks (test/control). The buttock Arms were limited to the analysis of localized events of the injection site region (ISR) only.
|
30.0%
3/10 • From Day 1 (after dose) through Day 180
Data on all-cause mortality and serious adverse events were collected irrespective of the event's relation to the buttocks (test/control). The buttock Arms were limited to the analysis of localized events of the injection site region (ISR) only.
|
5.3%
1/19 • From Day 1 (after dose) through Day 180
Data on all-cause mortality and serious adverse events were collected irrespective of the event's relation to the buttocks (test/control). The buttock Arms were limited to the analysis of localized events of the injection site region (ISR) only.
|
5.3%
1/19 • From Day 1 (after dose) through Day 180
Data on all-cause mortality and serious adverse events were collected irrespective of the event's relation to the buttocks (test/control). The buttock Arms were limited to the analysis of localized events of the injection site region (ISR) only.
|
0.00%
0/7 • From Day 1 (after dose) through Day 180
Data on all-cause mortality and serious adverse events were collected irrespective of the event's relation to the buttocks (test/control). The buttock Arms were limited to the analysis of localized events of the injection site region (ISR) only.
|
0.00%
0/7 • From Day 1 (after dose) through Day 180
Data on all-cause mortality and serious adverse events were collected irrespective of the event's relation to the buttocks (test/control). The buttock Arms were limited to the analysis of localized events of the injection site region (ISR) only.
|
0.00%
0/7 • From Day 1 (after dose) through Day 180
Data on all-cause mortality and serious adverse events were collected irrespective of the event's relation to the buttocks (test/control). The buttock Arms were limited to the analysis of localized events of the injection site region (ISR) only.
|
0.00%
0/7 • From Day 1 (after dose) through Day 180
Data on all-cause mortality and serious adverse events were collected irrespective of the event's relation to the buttocks (test/control). The buttock Arms were limited to the analysis of localized events of the injection site region (ISR) only.
|
—
0/0 • From Day 1 (after dose) through Day 180
Data on all-cause mortality and serious adverse events were collected irrespective of the event's relation to the buttocks (test/control). The buttock Arms were limited to the analysis of localized events of the injection site region (ISR) only.
|
—
0/0 • From Day 1 (after dose) through Day 180
Data on all-cause mortality and serious adverse events were collected irrespective of the event's relation to the buttocks (test/control). The buttock Arms were limited to the analysis of localized events of the injection site region (ISR) only.
|
—
0/0 • From Day 1 (after dose) through Day 180
Data on all-cause mortality and serious adverse events were collected irrespective of the event's relation to the buttocks (test/control). The buttock Arms were limited to the analysis of localized events of the injection site region (ISR) only.
|
—
0/0 • From Day 1 (after dose) through Day 180
Data on all-cause mortality and serious adverse events were collected irrespective of the event's relation to the buttocks (test/control). The buttock Arms were limited to the analysis of localized events of the injection site region (ISR) only.
|
—
0/0 • From Day 1 (after dose) through Day 180
Data on all-cause mortality and serious adverse events were collected irrespective of the event's relation to the buttocks (test/control). The buttock Arms were limited to the analysis of localized events of the injection site region (ISR) only.
|
—
0/0 • From Day 1 (after dose) through Day 180
Data on all-cause mortality and serious adverse events were collected irrespective of the event's relation to the buttocks (test/control). The buttock Arms were limited to the analysis of localized events of the injection site region (ISR) only.
|
—
0/0 • From Day 1 (after dose) through Day 180
Data on all-cause mortality and serious adverse events were collected irrespective of the event's relation to the buttocks (test/control). The buttock Arms were limited to the analysis of localized events of the injection site region (ISR) only.
|
—
0/0 • From Day 1 (after dose) through Day 180
Data on all-cause mortality and serious adverse events were collected irrespective of the event's relation to the buttocks (test/control). The buttock Arms were limited to the analysis of localized events of the injection site region (ISR) only.
|
|
General disorders
Injection site swelling
|
4.5%
1/22 • From Day 1 (after dose) through Day 180
Data on all-cause mortality and serious adverse events were collected irrespective of the event's relation to the buttocks (test/control). The buttock Arms were limited to the analysis of localized events of the injection site region (ISR) only.
|
4.5%
1/22 • From Day 1 (after dose) through Day 180
Data on all-cause mortality and serious adverse events were collected irrespective of the event's relation to the buttocks (test/control). The buttock Arms were limited to the analysis of localized events of the injection site region (ISR) only.
|
0.00%
0/14 • From Day 1 (after dose) through Day 180
Data on all-cause mortality and serious adverse events were collected irrespective of the event's relation to the buttocks (test/control). The buttock Arms were limited to the analysis of localized events of the injection site region (ISR) only.
|
0.00%
0/14 • From Day 1 (after dose) through Day 180
Data on all-cause mortality and serious adverse events were collected irrespective of the event's relation to the buttocks (test/control). The buttock Arms were limited to the analysis of localized events of the injection site region (ISR) only.
|
0.00%
0/5 • From Day 1 (after dose) through Day 180
Data on all-cause mortality and serious adverse events were collected irrespective of the event's relation to the buttocks (test/control). The buttock Arms were limited to the analysis of localized events of the injection site region (ISR) only.
|
0.00%
0/5 • From Day 1 (after dose) through Day 180
Data on all-cause mortality and serious adverse events were collected irrespective of the event's relation to the buttocks (test/control). The buttock Arms were limited to the analysis of localized events of the injection site region (ISR) only.
|
0.00%
0/7 • From Day 1 (after dose) through Day 180
Data on all-cause mortality and serious adverse events were collected irrespective of the event's relation to the buttocks (test/control). The buttock Arms were limited to the analysis of localized events of the injection site region (ISR) only.
|
0.00%
0/7 • From Day 1 (after dose) through Day 180
Data on all-cause mortality and serious adverse events were collected irrespective of the event's relation to the buttocks (test/control). The buttock Arms were limited to the analysis of localized events of the injection site region (ISR) only.
|
10.0%
1/10 • From Day 1 (after dose) through Day 180
Data on all-cause mortality and serious adverse events were collected irrespective of the event's relation to the buttocks (test/control). The buttock Arms were limited to the analysis of localized events of the injection site region (ISR) only.
|
10.0%
1/10 • From Day 1 (after dose) through Day 180
Data on all-cause mortality and serious adverse events were collected irrespective of the event's relation to the buttocks (test/control). The buttock Arms were limited to the analysis of localized events of the injection site region (ISR) only.
|
5.3%
1/19 • From Day 1 (after dose) through Day 180
Data on all-cause mortality and serious adverse events were collected irrespective of the event's relation to the buttocks (test/control). The buttock Arms were limited to the analysis of localized events of the injection site region (ISR) only.
|
5.3%
1/19 • From Day 1 (after dose) through Day 180
Data on all-cause mortality and serious adverse events were collected irrespective of the event's relation to the buttocks (test/control). The buttock Arms were limited to the analysis of localized events of the injection site region (ISR) only.
|
0.00%
0/7 • From Day 1 (after dose) through Day 180
Data on all-cause mortality and serious adverse events were collected irrespective of the event's relation to the buttocks (test/control). The buttock Arms were limited to the analysis of localized events of the injection site region (ISR) only.
|
0.00%
0/7 • From Day 1 (after dose) through Day 180
Data on all-cause mortality and serious adverse events were collected irrespective of the event's relation to the buttocks (test/control). The buttock Arms were limited to the analysis of localized events of the injection site region (ISR) only.
|
0.00%
0/7 • From Day 1 (after dose) through Day 180
Data on all-cause mortality and serious adverse events were collected irrespective of the event's relation to the buttocks (test/control). The buttock Arms were limited to the analysis of localized events of the injection site region (ISR) only.
|
0.00%
0/7 • From Day 1 (after dose) through Day 180
Data on all-cause mortality and serious adverse events were collected irrespective of the event's relation to the buttocks (test/control). The buttock Arms were limited to the analysis of localized events of the injection site region (ISR) only.
|
—
0/0 • From Day 1 (after dose) through Day 180
Data on all-cause mortality and serious adverse events were collected irrespective of the event's relation to the buttocks (test/control). The buttock Arms were limited to the analysis of localized events of the injection site region (ISR) only.
|
—
0/0 • From Day 1 (after dose) through Day 180
Data on all-cause mortality and serious adverse events were collected irrespective of the event's relation to the buttocks (test/control). The buttock Arms were limited to the analysis of localized events of the injection site region (ISR) only.
|
—
0/0 • From Day 1 (after dose) through Day 180
Data on all-cause mortality and serious adverse events were collected irrespective of the event's relation to the buttocks (test/control). The buttock Arms were limited to the analysis of localized events of the injection site region (ISR) only.
|
—
0/0 • From Day 1 (after dose) through Day 180
Data on all-cause mortality and serious adverse events were collected irrespective of the event's relation to the buttocks (test/control). The buttock Arms were limited to the analysis of localized events of the injection site region (ISR) only.
|
—
0/0 • From Day 1 (after dose) through Day 180
Data on all-cause mortality and serious adverse events were collected irrespective of the event's relation to the buttocks (test/control). The buttock Arms were limited to the analysis of localized events of the injection site region (ISR) only.
|
—
0/0 • From Day 1 (after dose) through Day 180
Data on all-cause mortality and serious adverse events were collected irrespective of the event's relation to the buttocks (test/control). The buttock Arms were limited to the analysis of localized events of the injection site region (ISR) only.
|
—
0/0 • From Day 1 (after dose) through Day 180
Data on all-cause mortality and serious adverse events were collected irrespective of the event's relation to the buttocks (test/control). The buttock Arms were limited to the analysis of localized events of the injection site region (ISR) only.
|
—
0/0 • From Day 1 (after dose) through Day 180
Data on all-cause mortality and serious adverse events were collected irrespective of the event's relation to the buttocks (test/control). The buttock Arms were limited to the analysis of localized events of the injection site region (ISR) only.
|
|
General disorders
Injection site papule
|
0.00%
0/22 • From Day 1 (after dose) through Day 180
Data on all-cause mortality and serious adverse events were collected irrespective of the event's relation to the buttocks (test/control). The buttock Arms were limited to the analysis of localized events of the injection site region (ISR) only.
|
0.00%
0/22 • From Day 1 (after dose) through Day 180
Data on all-cause mortality and serious adverse events were collected irrespective of the event's relation to the buttocks (test/control). The buttock Arms were limited to the analysis of localized events of the injection site region (ISR) only.
|
0.00%
0/14 • From Day 1 (after dose) through Day 180
Data on all-cause mortality and serious adverse events were collected irrespective of the event's relation to the buttocks (test/control). The buttock Arms were limited to the analysis of localized events of the injection site region (ISR) only.
|
0.00%
0/14 • From Day 1 (after dose) through Day 180
Data on all-cause mortality and serious adverse events were collected irrespective of the event's relation to the buttocks (test/control). The buttock Arms were limited to the analysis of localized events of the injection site region (ISR) only.
|
40.0%
2/5 • From Day 1 (after dose) through Day 180
Data on all-cause mortality and serious adverse events were collected irrespective of the event's relation to the buttocks (test/control). The buttock Arms were limited to the analysis of localized events of the injection site region (ISR) only.
|
40.0%
2/5 • From Day 1 (after dose) through Day 180
Data on all-cause mortality and serious adverse events were collected irrespective of the event's relation to the buttocks (test/control). The buttock Arms were limited to the analysis of localized events of the injection site region (ISR) only.
|
0.00%
0/7 • From Day 1 (after dose) through Day 180
Data on all-cause mortality and serious adverse events were collected irrespective of the event's relation to the buttocks (test/control). The buttock Arms were limited to the analysis of localized events of the injection site region (ISR) only.
|
0.00%
0/7 • From Day 1 (after dose) through Day 180
Data on all-cause mortality and serious adverse events were collected irrespective of the event's relation to the buttocks (test/control). The buttock Arms were limited to the analysis of localized events of the injection site region (ISR) only.
|
0.00%
0/10 • From Day 1 (after dose) through Day 180
Data on all-cause mortality and serious adverse events were collected irrespective of the event's relation to the buttocks (test/control). The buttock Arms were limited to the analysis of localized events of the injection site region (ISR) only.
|
0.00%
0/10 • From Day 1 (after dose) through Day 180
Data on all-cause mortality and serious adverse events were collected irrespective of the event's relation to the buttocks (test/control). The buttock Arms were limited to the analysis of localized events of the injection site region (ISR) only.
|
0.00%
0/19 • From Day 1 (after dose) through Day 180
Data on all-cause mortality and serious adverse events were collected irrespective of the event's relation to the buttocks (test/control). The buttock Arms were limited to the analysis of localized events of the injection site region (ISR) only.
|
0.00%
0/19 • From Day 1 (after dose) through Day 180
Data on all-cause mortality and serious adverse events were collected irrespective of the event's relation to the buttocks (test/control). The buttock Arms were limited to the analysis of localized events of the injection site region (ISR) only.
|
0.00%
0/7 • From Day 1 (after dose) through Day 180
Data on all-cause mortality and serious adverse events were collected irrespective of the event's relation to the buttocks (test/control). The buttock Arms were limited to the analysis of localized events of the injection site region (ISR) only.
|
0.00%
0/7 • From Day 1 (after dose) through Day 180
Data on all-cause mortality and serious adverse events were collected irrespective of the event's relation to the buttocks (test/control). The buttock Arms were limited to the analysis of localized events of the injection site region (ISR) only.
|
0.00%
0/7 • From Day 1 (after dose) through Day 180
Data on all-cause mortality and serious adverse events were collected irrespective of the event's relation to the buttocks (test/control). The buttock Arms were limited to the analysis of localized events of the injection site region (ISR) only.
|
0.00%
0/7 • From Day 1 (after dose) through Day 180
Data on all-cause mortality and serious adverse events were collected irrespective of the event's relation to the buttocks (test/control). The buttock Arms were limited to the analysis of localized events of the injection site region (ISR) only.
|
—
0/0 • From Day 1 (after dose) through Day 180
Data on all-cause mortality and serious adverse events were collected irrespective of the event's relation to the buttocks (test/control). The buttock Arms were limited to the analysis of localized events of the injection site region (ISR) only.
|
—
0/0 • From Day 1 (after dose) through Day 180
Data on all-cause mortality and serious adverse events were collected irrespective of the event's relation to the buttocks (test/control). The buttock Arms were limited to the analysis of localized events of the injection site region (ISR) only.
|
—
0/0 • From Day 1 (after dose) through Day 180
Data on all-cause mortality and serious adverse events were collected irrespective of the event's relation to the buttocks (test/control). The buttock Arms were limited to the analysis of localized events of the injection site region (ISR) only.
|
—
0/0 • From Day 1 (after dose) through Day 180
Data on all-cause mortality and serious adverse events were collected irrespective of the event's relation to the buttocks (test/control). The buttock Arms were limited to the analysis of localized events of the injection site region (ISR) only.
|
—
0/0 • From Day 1 (after dose) through Day 180
Data on all-cause mortality and serious adverse events were collected irrespective of the event's relation to the buttocks (test/control). The buttock Arms were limited to the analysis of localized events of the injection site region (ISR) only.
|
—
0/0 • From Day 1 (after dose) through Day 180
Data on all-cause mortality and serious adverse events were collected irrespective of the event's relation to the buttocks (test/control). The buttock Arms were limited to the analysis of localized events of the injection site region (ISR) only.
|
—
0/0 • From Day 1 (after dose) through Day 180
Data on all-cause mortality and serious adverse events were collected irrespective of the event's relation to the buttocks (test/control). The buttock Arms were limited to the analysis of localized events of the injection site region (ISR) only.
|
—
0/0 • From Day 1 (after dose) through Day 180
Data on all-cause mortality and serious adverse events were collected irrespective of the event's relation to the buttocks (test/control). The buttock Arms were limited to the analysis of localized events of the injection site region (ISR) only.
|
|
General disorders
Injection site erythema
|
0.00%
0/22 • From Day 1 (after dose) through Day 180
Data on all-cause mortality and serious adverse events were collected irrespective of the event's relation to the buttocks (test/control). The buttock Arms were limited to the analysis of localized events of the injection site region (ISR) only.
|
0.00%
0/22 • From Day 1 (after dose) through Day 180
Data on all-cause mortality and serious adverse events were collected irrespective of the event's relation to the buttocks (test/control). The buttock Arms were limited to the analysis of localized events of the injection site region (ISR) only.
|
0.00%
0/14 • From Day 1 (after dose) through Day 180
Data on all-cause mortality and serious adverse events were collected irrespective of the event's relation to the buttocks (test/control). The buttock Arms were limited to the analysis of localized events of the injection site region (ISR) only.
|
0.00%
0/14 • From Day 1 (after dose) through Day 180
Data on all-cause mortality and serious adverse events were collected irrespective of the event's relation to the buttocks (test/control). The buttock Arms were limited to the analysis of localized events of the injection site region (ISR) only.
|
0.00%
0/5 • From Day 1 (after dose) through Day 180
Data on all-cause mortality and serious adverse events were collected irrespective of the event's relation to the buttocks (test/control). The buttock Arms were limited to the analysis of localized events of the injection site region (ISR) only.
|
0.00%
0/5 • From Day 1 (after dose) through Day 180
Data on all-cause mortality and serious adverse events were collected irrespective of the event's relation to the buttocks (test/control). The buttock Arms were limited to the analysis of localized events of the injection site region (ISR) only.
|
0.00%
0/7 • From Day 1 (after dose) through Day 180
Data on all-cause mortality and serious adverse events were collected irrespective of the event's relation to the buttocks (test/control). The buttock Arms were limited to the analysis of localized events of the injection site region (ISR) only.
|
0.00%
0/7 • From Day 1 (after dose) through Day 180
Data on all-cause mortality and serious adverse events were collected irrespective of the event's relation to the buttocks (test/control). The buttock Arms were limited to the analysis of localized events of the injection site region (ISR) only.
|
0.00%
0/10 • From Day 1 (after dose) through Day 180
Data on all-cause mortality and serious adverse events were collected irrespective of the event's relation to the buttocks (test/control). The buttock Arms were limited to the analysis of localized events of the injection site region (ISR) only.
|
0.00%
0/10 • From Day 1 (after dose) through Day 180
Data on all-cause mortality and serious adverse events were collected irrespective of the event's relation to the buttocks (test/control). The buttock Arms were limited to the analysis of localized events of the injection site region (ISR) only.
|
0.00%
0/19 • From Day 1 (after dose) through Day 180
Data on all-cause mortality and serious adverse events were collected irrespective of the event's relation to the buttocks (test/control). The buttock Arms were limited to the analysis of localized events of the injection site region (ISR) only.
|
0.00%
0/19 • From Day 1 (after dose) through Day 180
Data on all-cause mortality and serious adverse events were collected irrespective of the event's relation to the buttocks (test/control). The buttock Arms were limited to the analysis of localized events of the injection site region (ISR) only.
|
0.00%
0/7 • From Day 1 (after dose) through Day 180
Data on all-cause mortality and serious adverse events were collected irrespective of the event's relation to the buttocks (test/control). The buttock Arms were limited to the analysis of localized events of the injection site region (ISR) only.
|
0.00%
0/7 • From Day 1 (after dose) through Day 180
Data on all-cause mortality and serious adverse events were collected irrespective of the event's relation to the buttocks (test/control). The buttock Arms were limited to the analysis of localized events of the injection site region (ISR) only.
|
14.3%
1/7 • From Day 1 (after dose) through Day 180
Data on all-cause mortality and serious adverse events were collected irrespective of the event's relation to the buttocks (test/control). The buttock Arms were limited to the analysis of localized events of the injection site region (ISR) only.
|
0.00%
0/7 • From Day 1 (after dose) through Day 180
Data on all-cause mortality and serious adverse events were collected irrespective of the event's relation to the buttocks (test/control). The buttock Arms were limited to the analysis of localized events of the injection site region (ISR) only.
|
—
0/0 • From Day 1 (after dose) through Day 180
Data on all-cause mortality and serious adverse events were collected irrespective of the event's relation to the buttocks (test/control). The buttock Arms were limited to the analysis of localized events of the injection site region (ISR) only.
|
—
0/0 • From Day 1 (after dose) through Day 180
Data on all-cause mortality and serious adverse events were collected irrespective of the event's relation to the buttocks (test/control). The buttock Arms were limited to the analysis of localized events of the injection site region (ISR) only.
|
—
0/0 • From Day 1 (after dose) through Day 180
Data on all-cause mortality and serious adverse events were collected irrespective of the event's relation to the buttocks (test/control). The buttock Arms were limited to the analysis of localized events of the injection site region (ISR) only.
|
—
0/0 • From Day 1 (after dose) through Day 180
Data on all-cause mortality and serious adverse events were collected irrespective of the event's relation to the buttocks (test/control). The buttock Arms were limited to the analysis of localized events of the injection site region (ISR) only.
|
—
0/0 • From Day 1 (after dose) through Day 180
Data on all-cause mortality and serious adverse events were collected irrespective of the event's relation to the buttocks (test/control). The buttock Arms were limited to the analysis of localized events of the injection site region (ISR) only.
|
—
0/0 • From Day 1 (after dose) through Day 180
Data on all-cause mortality and serious adverse events were collected irrespective of the event's relation to the buttocks (test/control). The buttock Arms were limited to the analysis of localized events of the injection site region (ISR) only.
|
—
0/0 • From Day 1 (after dose) through Day 180
Data on all-cause mortality and serious adverse events were collected irrespective of the event's relation to the buttocks (test/control). The buttock Arms were limited to the analysis of localized events of the injection site region (ISR) only.
|
—
0/0 • From Day 1 (after dose) through Day 180
Data on all-cause mortality and serious adverse events were collected irrespective of the event's relation to the buttocks (test/control). The buttock Arms were limited to the analysis of localized events of the injection site region (ISR) only.
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/22 • From Day 1 (after dose) through Day 180
Data on all-cause mortality and serious adverse events were collected irrespective of the event's relation to the buttocks (test/control). The buttock Arms were limited to the analysis of localized events of the injection site region (ISR) only.
|
0.00%
0/22 • From Day 1 (after dose) through Day 180
Data on all-cause mortality and serious adverse events were collected irrespective of the event's relation to the buttocks (test/control). The buttock Arms were limited to the analysis of localized events of the injection site region (ISR) only.
|
0.00%
0/14 • From Day 1 (after dose) through Day 180
Data on all-cause mortality and serious adverse events were collected irrespective of the event's relation to the buttocks (test/control). The buttock Arms were limited to the analysis of localized events of the injection site region (ISR) only.
|
0.00%
0/14 • From Day 1 (after dose) through Day 180
Data on all-cause mortality and serious adverse events were collected irrespective of the event's relation to the buttocks (test/control). The buttock Arms were limited to the analysis of localized events of the injection site region (ISR) only.
|
0.00%
0/5 • From Day 1 (after dose) through Day 180
Data on all-cause mortality and serious adverse events were collected irrespective of the event's relation to the buttocks (test/control). The buttock Arms were limited to the analysis of localized events of the injection site region (ISR) only.
|
0.00%
0/5 • From Day 1 (after dose) through Day 180
Data on all-cause mortality and serious adverse events were collected irrespective of the event's relation to the buttocks (test/control). The buttock Arms were limited to the analysis of localized events of the injection site region (ISR) only.
|
0.00%
0/7 • From Day 1 (after dose) through Day 180
Data on all-cause mortality and serious adverse events were collected irrespective of the event's relation to the buttocks (test/control). The buttock Arms were limited to the analysis of localized events of the injection site region (ISR) only.
|
0.00%
0/7 • From Day 1 (after dose) through Day 180
Data on all-cause mortality and serious adverse events were collected irrespective of the event's relation to the buttocks (test/control). The buttock Arms were limited to the analysis of localized events of the injection site region (ISR) only.
|
0.00%
0/10 • From Day 1 (after dose) through Day 180
Data on all-cause mortality and serious adverse events were collected irrespective of the event's relation to the buttocks (test/control). The buttock Arms were limited to the analysis of localized events of the injection site region (ISR) only.
|
0.00%
0/10 • From Day 1 (after dose) through Day 180
Data on all-cause mortality and serious adverse events were collected irrespective of the event's relation to the buttocks (test/control). The buttock Arms were limited to the analysis of localized events of the injection site region (ISR) only.
|
0.00%
0/19 • From Day 1 (after dose) through Day 180
Data on all-cause mortality and serious adverse events were collected irrespective of the event's relation to the buttocks (test/control). The buttock Arms were limited to the analysis of localized events of the injection site region (ISR) only.
|
5.3%
1/19 • From Day 1 (after dose) through Day 180
Data on all-cause mortality and serious adverse events were collected irrespective of the event's relation to the buttocks (test/control). The buttock Arms were limited to the analysis of localized events of the injection site region (ISR) only.
|
0.00%
0/7 • From Day 1 (after dose) through Day 180
Data on all-cause mortality and serious adverse events were collected irrespective of the event's relation to the buttocks (test/control). The buttock Arms were limited to the analysis of localized events of the injection site region (ISR) only.
|
0.00%
0/7 • From Day 1 (after dose) through Day 180
Data on all-cause mortality and serious adverse events were collected irrespective of the event's relation to the buttocks (test/control). The buttock Arms were limited to the analysis of localized events of the injection site region (ISR) only.
|
0.00%
0/7 • From Day 1 (after dose) through Day 180
Data on all-cause mortality and serious adverse events were collected irrespective of the event's relation to the buttocks (test/control). The buttock Arms were limited to the analysis of localized events of the injection site region (ISR) only.
|
0.00%
0/7 • From Day 1 (after dose) through Day 180
Data on all-cause mortality and serious adverse events were collected irrespective of the event's relation to the buttocks (test/control). The buttock Arms were limited to the analysis of localized events of the injection site region (ISR) only.
|
—
0/0 • From Day 1 (after dose) through Day 180
Data on all-cause mortality and serious adverse events were collected irrespective of the event's relation to the buttocks (test/control). The buttock Arms were limited to the analysis of localized events of the injection site region (ISR) only.
|
—
0/0 • From Day 1 (after dose) through Day 180
Data on all-cause mortality and serious adverse events were collected irrespective of the event's relation to the buttocks (test/control). The buttock Arms were limited to the analysis of localized events of the injection site region (ISR) only.
|
—
0/0 • From Day 1 (after dose) through Day 180
Data on all-cause mortality and serious adverse events were collected irrespective of the event's relation to the buttocks (test/control). The buttock Arms were limited to the analysis of localized events of the injection site region (ISR) only.
|
—
0/0 • From Day 1 (after dose) through Day 180
Data on all-cause mortality and serious adverse events were collected irrespective of the event's relation to the buttocks (test/control). The buttock Arms were limited to the analysis of localized events of the injection site region (ISR) only.
|
—
0/0 • From Day 1 (after dose) through Day 180
Data on all-cause mortality and serious adverse events were collected irrespective of the event's relation to the buttocks (test/control). The buttock Arms were limited to the analysis of localized events of the injection site region (ISR) only.
|
—
0/0 • From Day 1 (after dose) through Day 180
Data on all-cause mortality and serious adverse events were collected irrespective of the event's relation to the buttocks (test/control). The buttock Arms were limited to the analysis of localized events of the injection site region (ISR) only.
|
—
0/0 • From Day 1 (after dose) through Day 180
Data on all-cause mortality and serious adverse events were collected irrespective of the event's relation to the buttocks (test/control). The buttock Arms were limited to the analysis of localized events of the injection site region (ISR) only.
|
—
0/0 • From Day 1 (after dose) through Day 180
Data on all-cause mortality and serious adverse events were collected irrespective of the event's relation to the buttocks (test/control). The buttock Arms were limited to the analysis of localized events of the injection site region (ISR) only.
|
|
Vascular disorders
Hypertension
|
—
0/0 • From Day 1 (after dose) through Day 180
Data on all-cause mortality and serious adverse events were collected irrespective of the event's relation to the buttocks (test/control). The buttock Arms were limited to the analysis of localized events of the injection site region (ISR) only.
|
—
0/0 • From Day 1 (after dose) through Day 180
Data on all-cause mortality and serious adverse events were collected irrespective of the event's relation to the buttocks (test/control). The buttock Arms were limited to the analysis of localized events of the injection site region (ISR) only.
|
—
0/0 • From Day 1 (after dose) through Day 180
Data on all-cause mortality and serious adverse events were collected irrespective of the event's relation to the buttocks (test/control). The buttock Arms were limited to the analysis of localized events of the injection site region (ISR) only.
|
—
0/0 • From Day 1 (after dose) through Day 180
Data on all-cause mortality and serious adverse events were collected irrespective of the event's relation to the buttocks (test/control). The buttock Arms were limited to the analysis of localized events of the injection site region (ISR) only.
|
—
0/0 • From Day 1 (after dose) through Day 180
Data on all-cause mortality and serious adverse events were collected irrespective of the event's relation to the buttocks (test/control). The buttock Arms were limited to the analysis of localized events of the injection site region (ISR) only.
|
—
0/0 • From Day 1 (after dose) through Day 180
Data on all-cause mortality and serious adverse events were collected irrespective of the event's relation to the buttocks (test/control). The buttock Arms were limited to the analysis of localized events of the injection site region (ISR) only.
|
—
0/0 • From Day 1 (after dose) through Day 180
Data on all-cause mortality and serious adverse events were collected irrespective of the event's relation to the buttocks (test/control). The buttock Arms were limited to the analysis of localized events of the injection site region (ISR) only.
|
—
0/0 • From Day 1 (after dose) through Day 180
Data on all-cause mortality and serious adverse events were collected irrespective of the event's relation to the buttocks (test/control). The buttock Arms were limited to the analysis of localized events of the injection site region (ISR) only.
|
—
0/0 • From Day 1 (after dose) through Day 180
Data on all-cause mortality and serious adverse events were collected irrespective of the event's relation to the buttocks (test/control). The buttock Arms were limited to the analysis of localized events of the injection site region (ISR) only.
|
—
0/0 • From Day 1 (after dose) through Day 180
Data on all-cause mortality and serious adverse events were collected irrespective of the event's relation to the buttocks (test/control). The buttock Arms were limited to the analysis of localized events of the injection site region (ISR) only.
|
—
0/0 • From Day 1 (after dose) through Day 180
Data on all-cause mortality and serious adverse events were collected irrespective of the event's relation to the buttocks (test/control). The buttock Arms were limited to the analysis of localized events of the injection site region (ISR) only.
|
—
0/0 • From Day 1 (after dose) through Day 180
Data on all-cause mortality and serious adverse events were collected irrespective of the event's relation to the buttocks (test/control). The buttock Arms were limited to the analysis of localized events of the injection site region (ISR) only.
|
—
0/0 • From Day 1 (after dose) through Day 180
Data on all-cause mortality and serious adverse events were collected irrespective of the event's relation to the buttocks (test/control). The buttock Arms were limited to the analysis of localized events of the injection site region (ISR) only.
|
—
0/0 • From Day 1 (after dose) through Day 180
Data on all-cause mortality and serious adverse events were collected irrespective of the event's relation to the buttocks (test/control). The buttock Arms were limited to the analysis of localized events of the injection site region (ISR) only.
|
—
0/0 • From Day 1 (after dose) through Day 180
Data on all-cause mortality and serious adverse events were collected irrespective of the event's relation to the buttocks (test/control). The buttock Arms were limited to the analysis of localized events of the injection site region (ISR) only.
|
—
0/0 • From Day 1 (after dose) through Day 180
Data on all-cause mortality and serious adverse events were collected irrespective of the event's relation to the buttocks (test/control). The buttock Arms were limited to the analysis of localized events of the injection site region (ISR) only.
|
4.5%
1/22 • From Day 1 (after dose) through Day 180
Data on all-cause mortality and serious adverse events were collected irrespective of the event's relation to the buttocks (test/control). The buttock Arms were limited to the analysis of localized events of the injection site region (ISR) only.
|
0.00%
0/14 • From Day 1 (after dose) through Day 180
Data on all-cause mortality and serious adverse events were collected irrespective of the event's relation to the buttocks (test/control). The buttock Arms were limited to the analysis of localized events of the injection site region (ISR) only.
|
20.0%
1/5 • From Day 1 (after dose) through Day 180
Data on all-cause mortality and serious adverse events were collected irrespective of the event's relation to the buttocks (test/control). The buttock Arms were limited to the analysis of localized events of the injection site region (ISR) only.
|
0.00%
0/7 • From Day 1 (after dose) through Day 180
Data on all-cause mortality and serious adverse events were collected irrespective of the event's relation to the buttocks (test/control). The buttock Arms were limited to the analysis of localized events of the injection site region (ISR) only.
|
0.00%
0/10 • From Day 1 (after dose) through Day 180
Data on all-cause mortality and serious adverse events were collected irrespective of the event's relation to the buttocks (test/control). The buttock Arms were limited to the analysis of localized events of the injection site region (ISR) only.
|
0.00%
0/19 • From Day 1 (after dose) through Day 180
Data on all-cause mortality and serious adverse events were collected irrespective of the event's relation to the buttocks (test/control). The buttock Arms were limited to the analysis of localized events of the injection site region (ISR) only.
|
0.00%
0/7 • From Day 1 (after dose) through Day 180
Data on all-cause mortality and serious adverse events were collected irrespective of the event's relation to the buttocks (test/control). The buttock Arms were limited to the analysis of localized events of the injection site region (ISR) only.
|
0.00%
0/7 • From Day 1 (after dose) through Day 180
Data on all-cause mortality and serious adverse events were collected irrespective of the event's relation to the buttocks (test/control). The buttock Arms were limited to the analysis of localized events of the injection site region (ISR) only.
|
|
Immune system disorders
Seasonal allergy
|
—
0/0 • From Day 1 (after dose) through Day 180
Data on all-cause mortality and serious adverse events were collected irrespective of the event's relation to the buttocks (test/control). The buttock Arms were limited to the analysis of localized events of the injection site region (ISR) only.
|
—
0/0 • From Day 1 (after dose) through Day 180
Data on all-cause mortality and serious adverse events were collected irrespective of the event's relation to the buttocks (test/control). The buttock Arms were limited to the analysis of localized events of the injection site region (ISR) only.
|
—
0/0 • From Day 1 (after dose) through Day 180
Data on all-cause mortality and serious adverse events were collected irrespective of the event's relation to the buttocks (test/control). The buttock Arms were limited to the analysis of localized events of the injection site region (ISR) only.
|
—
0/0 • From Day 1 (after dose) through Day 180
Data on all-cause mortality and serious adverse events were collected irrespective of the event's relation to the buttocks (test/control). The buttock Arms were limited to the analysis of localized events of the injection site region (ISR) only.
|
—
0/0 • From Day 1 (after dose) through Day 180
Data on all-cause mortality and serious adverse events were collected irrespective of the event's relation to the buttocks (test/control). The buttock Arms were limited to the analysis of localized events of the injection site region (ISR) only.
|
—
0/0 • From Day 1 (after dose) through Day 180
Data on all-cause mortality and serious adverse events were collected irrespective of the event's relation to the buttocks (test/control). The buttock Arms were limited to the analysis of localized events of the injection site region (ISR) only.
|
—
0/0 • From Day 1 (after dose) through Day 180
Data on all-cause mortality and serious adverse events were collected irrespective of the event's relation to the buttocks (test/control). The buttock Arms were limited to the analysis of localized events of the injection site region (ISR) only.
|
—
0/0 • From Day 1 (after dose) through Day 180
Data on all-cause mortality and serious adverse events were collected irrespective of the event's relation to the buttocks (test/control). The buttock Arms were limited to the analysis of localized events of the injection site region (ISR) only.
|
—
0/0 • From Day 1 (after dose) through Day 180
Data on all-cause mortality and serious adverse events were collected irrespective of the event's relation to the buttocks (test/control). The buttock Arms were limited to the analysis of localized events of the injection site region (ISR) only.
|
—
0/0 • From Day 1 (after dose) through Day 180
Data on all-cause mortality and serious adverse events were collected irrespective of the event's relation to the buttocks (test/control). The buttock Arms were limited to the analysis of localized events of the injection site region (ISR) only.
|
—
0/0 • From Day 1 (after dose) through Day 180
Data on all-cause mortality and serious adverse events were collected irrespective of the event's relation to the buttocks (test/control). The buttock Arms were limited to the analysis of localized events of the injection site region (ISR) only.
|
—
0/0 • From Day 1 (after dose) through Day 180
Data on all-cause mortality and serious adverse events were collected irrespective of the event's relation to the buttocks (test/control). The buttock Arms were limited to the analysis of localized events of the injection site region (ISR) only.
|
—
0/0 • From Day 1 (after dose) through Day 180
Data on all-cause mortality and serious adverse events were collected irrespective of the event's relation to the buttocks (test/control). The buttock Arms were limited to the analysis of localized events of the injection site region (ISR) only.
|
—
0/0 • From Day 1 (after dose) through Day 180
Data on all-cause mortality and serious adverse events were collected irrespective of the event's relation to the buttocks (test/control). The buttock Arms were limited to the analysis of localized events of the injection site region (ISR) only.
|
—
0/0 • From Day 1 (after dose) through Day 180
Data on all-cause mortality and serious adverse events were collected irrespective of the event's relation to the buttocks (test/control). The buttock Arms were limited to the analysis of localized events of the injection site region (ISR) only.
|
—
0/0 • From Day 1 (after dose) through Day 180
Data on all-cause mortality and serious adverse events were collected irrespective of the event's relation to the buttocks (test/control). The buttock Arms were limited to the analysis of localized events of the injection site region (ISR) only.
|
9.1%
2/22 • From Day 1 (after dose) through Day 180
Data on all-cause mortality and serious adverse events were collected irrespective of the event's relation to the buttocks (test/control). The buttock Arms were limited to the analysis of localized events of the injection site region (ISR) only.
|
0.00%
0/14 • From Day 1 (after dose) through Day 180
Data on all-cause mortality and serious adverse events were collected irrespective of the event's relation to the buttocks (test/control). The buttock Arms were limited to the analysis of localized events of the injection site region (ISR) only.
|
0.00%
0/5 • From Day 1 (after dose) through Day 180
Data on all-cause mortality and serious adverse events were collected irrespective of the event's relation to the buttocks (test/control). The buttock Arms were limited to the analysis of localized events of the injection site region (ISR) only.
|
0.00%
0/7 • From Day 1 (after dose) through Day 180
Data on all-cause mortality and serious adverse events were collected irrespective of the event's relation to the buttocks (test/control). The buttock Arms were limited to the analysis of localized events of the injection site region (ISR) only.
|
0.00%
0/10 • From Day 1 (after dose) through Day 180
Data on all-cause mortality and serious adverse events were collected irrespective of the event's relation to the buttocks (test/control). The buttock Arms were limited to the analysis of localized events of the injection site region (ISR) only.
|
0.00%
0/19 • From Day 1 (after dose) through Day 180
Data on all-cause mortality and serious adverse events were collected irrespective of the event's relation to the buttocks (test/control). The buttock Arms were limited to the analysis of localized events of the injection site region (ISR) only.
|
0.00%
0/7 • From Day 1 (after dose) through Day 180
Data on all-cause mortality and serious adverse events were collected irrespective of the event's relation to the buttocks (test/control). The buttock Arms were limited to the analysis of localized events of the injection site region (ISR) only.
|
0.00%
0/7 • From Day 1 (after dose) through Day 180
Data on all-cause mortality and serious adverse events were collected irrespective of the event's relation to the buttocks (test/control). The buttock Arms were limited to the analysis of localized events of the injection site region (ISR) only.
|
|
Skin and subcutaneous tissue disorders
Acne
|
—
0/0 • From Day 1 (after dose) through Day 180
Data on all-cause mortality and serious adverse events were collected irrespective of the event's relation to the buttocks (test/control). The buttock Arms were limited to the analysis of localized events of the injection site region (ISR) only.
|
—
0/0 • From Day 1 (after dose) through Day 180
Data on all-cause mortality and serious adverse events were collected irrespective of the event's relation to the buttocks (test/control). The buttock Arms were limited to the analysis of localized events of the injection site region (ISR) only.
|
—
0/0 • From Day 1 (after dose) through Day 180
Data on all-cause mortality and serious adverse events were collected irrespective of the event's relation to the buttocks (test/control). The buttock Arms were limited to the analysis of localized events of the injection site region (ISR) only.
|
—
0/0 • From Day 1 (after dose) through Day 180
Data on all-cause mortality and serious adverse events were collected irrespective of the event's relation to the buttocks (test/control). The buttock Arms were limited to the analysis of localized events of the injection site region (ISR) only.
|
—
0/0 • From Day 1 (after dose) through Day 180
Data on all-cause mortality and serious adverse events were collected irrespective of the event's relation to the buttocks (test/control). The buttock Arms were limited to the analysis of localized events of the injection site region (ISR) only.
|
—
0/0 • From Day 1 (after dose) through Day 180
Data on all-cause mortality and serious adverse events were collected irrespective of the event's relation to the buttocks (test/control). The buttock Arms were limited to the analysis of localized events of the injection site region (ISR) only.
|
—
0/0 • From Day 1 (after dose) through Day 180
Data on all-cause mortality and serious adverse events were collected irrespective of the event's relation to the buttocks (test/control). The buttock Arms were limited to the analysis of localized events of the injection site region (ISR) only.
|
—
0/0 • From Day 1 (after dose) through Day 180
Data on all-cause mortality and serious adverse events were collected irrespective of the event's relation to the buttocks (test/control). The buttock Arms were limited to the analysis of localized events of the injection site region (ISR) only.
|
—
0/0 • From Day 1 (after dose) through Day 180
Data on all-cause mortality and serious adverse events were collected irrespective of the event's relation to the buttocks (test/control). The buttock Arms were limited to the analysis of localized events of the injection site region (ISR) only.
|
—
0/0 • From Day 1 (after dose) through Day 180
Data on all-cause mortality and serious adverse events were collected irrespective of the event's relation to the buttocks (test/control). The buttock Arms were limited to the analysis of localized events of the injection site region (ISR) only.
|
—
0/0 • From Day 1 (after dose) through Day 180
Data on all-cause mortality and serious adverse events were collected irrespective of the event's relation to the buttocks (test/control). The buttock Arms were limited to the analysis of localized events of the injection site region (ISR) only.
|
—
0/0 • From Day 1 (after dose) through Day 180
Data on all-cause mortality and serious adverse events were collected irrespective of the event's relation to the buttocks (test/control). The buttock Arms were limited to the analysis of localized events of the injection site region (ISR) only.
|
—
0/0 • From Day 1 (after dose) through Day 180
Data on all-cause mortality and serious adverse events were collected irrespective of the event's relation to the buttocks (test/control). The buttock Arms were limited to the analysis of localized events of the injection site region (ISR) only.
|
—
0/0 • From Day 1 (after dose) through Day 180
Data on all-cause mortality and serious adverse events were collected irrespective of the event's relation to the buttocks (test/control). The buttock Arms were limited to the analysis of localized events of the injection site region (ISR) only.
|
—
0/0 • From Day 1 (after dose) through Day 180
Data on all-cause mortality and serious adverse events were collected irrespective of the event's relation to the buttocks (test/control). The buttock Arms were limited to the analysis of localized events of the injection site region (ISR) only.
|
—
0/0 • From Day 1 (after dose) through Day 180
Data on all-cause mortality and serious adverse events were collected irrespective of the event's relation to the buttocks (test/control). The buttock Arms were limited to the analysis of localized events of the injection site region (ISR) only.
|
0.00%
0/22 • From Day 1 (after dose) through Day 180
Data on all-cause mortality and serious adverse events were collected irrespective of the event's relation to the buttocks (test/control). The buttock Arms were limited to the analysis of localized events of the injection site region (ISR) only.
|
0.00%
0/14 • From Day 1 (after dose) through Day 180
Data on all-cause mortality and serious adverse events were collected irrespective of the event's relation to the buttocks (test/control). The buttock Arms were limited to the analysis of localized events of the injection site region (ISR) only.
|
20.0%
1/5 • From Day 1 (after dose) through Day 180
Data on all-cause mortality and serious adverse events were collected irrespective of the event's relation to the buttocks (test/control). The buttock Arms were limited to the analysis of localized events of the injection site region (ISR) only.
|
0.00%
0/7 • From Day 1 (after dose) through Day 180
Data on all-cause mortality and serious adverse events were collected irrespective of the event's relation to the buttocks (test/control). The buttock Arms were limited to the analysis of localized events of the injection site region (ISR) only.
|
0.00%
0/10 • From Day 1 (after dose) through Day 180
Data on all-cause mortality and serious adverse events were collected irrespective of the event's relation to the buttocks (test/control). The buttock Arms were limited to the analysis of localized events of the injection site region (ISR) only.
|
0.00%
0/19 • From Day 1 (after dose) through Day 180
Data on all-cause mortality and serious adverse events were collected irrespective of the event's relation to the buttocks (test/control). The buttock Arms were limited to the analysis of localized events of the injection site region (ISR) only.
|
0.00%
0/7 • From Day 1 (after dose) through Day 180
Data on all-cause mortality and serious adverse events were collected irrespective of the event's relation to the buttocks (test/control). The buttock Arms were limited to the analysis of localized events of the injection site region (ISR) only.
|
0.00%
0/7 • From Day 1 (after dose) through Day 180
Data on all-cause mortality and serious adverse events were collected irrespective of the event's relation to the buttocks (test/control). The buttock Arms were limited to the analysis of localized events of the injection site region (ISR) only.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Benign breast neoplasm
|
—
0/0 • From Day 1 (after dose) through Day 180
Data on all-cause mortality and serious adverse events were collected irrespective of the event's relation to the buttocks (test/control). The buttock Arms were limited to the analysis of localized events of the injection site region (ISR) only.
|
—
0/0 • From Day 1 (after dose) through Day 180
Data on all-cause mortality and serious adverse events were collected irrespective of the event's relation to the buttocks (test/control). The buttock Arms were limited to the analysis of localized events of the injection site region (ISR) only.
|
—
0/0 • From Day 1 (after dose) through Day 180
Data on all-cause mortality and serious adverse events were collected irrespective of the event's relation to the buttocks (test/control). The buttock Arms were limited to the analysis of localized events of the injection site region (ISR) only.
|
—
0/0 • From Day 1 (after dose) through Day 180
Data on all-cause mortality and serious adverse events were collected irrespective of the event's relation to the buttocks (test/control). The buttock Arms were limited to the analysis of localized events of the injection site region (ISR) only.
|
—
0/0 • From Day 1 (after dose) through Day 180
Data on all-cause mortality and serious adverse events were collected irrespective of the event's relation to the buttocks (test/control). The buttock Arms were limited to the analysis of localized events of the injection site region (ISR) only.
|
—
0/0 • From Day 1 (after dose) through Day 180
Data on all-cause mortality and serious adverse events were collected irrespective of the event's relation to the buttocks (test/control). The buttock Arms were limited to the analysis of localized events of the injection site region (ISR) only.
|
—
0/0 • From Day 1 (after dose) through Day 180
Data on all-cause mortality and serious adverse events were collected irrespective of the event's relation to the buttocks (test/control). The buttock Arms were limited to the analysis of localized events of the injection site region (ISR) only.
|
—
0/0 • From Day 1 (after dose) through Day 180
Data on all-cause mortality and serious adverse events were collected irrespective of the event's relation to the buttocks (test/control). The buttock Arms were limited to the analysis of localized events of the injection site region (ISR) only.
|
—
0/0 • From Day 1 (after dose) through Day 180
Data on all-cause mortality and serious adverse events were collected irrespective of the event's relation to the buttocks (test/control). The buttock Arms were limited to the analysis of localized events of the injection site region (ISR) only.
|
—
0/0 • From Day 1 (after dose) through Day 180
Data on all-cause mortality and serious adverse events were collected irrespective of the event's relation to the buttocks (test/control). The buttock Arms were limited to the analysis of localized events of the injection site region (ISR) only.
|
—
0/0 • From Day 1 (after dose) through Day 180
Data on all-cause mortality and serious adverse events were collected irrespective of the event's relation to the buttocks (test/control). The buttock Arms were limited to the analysis of localized events of the injection site region (ISR) only.
|
—
0/0 • From Day 1 (after dose) through Day 180
Data on all-cause mortality and serious adverse events were collected irrespective of the event's relation to the buttocks (test/control). The buttock Arms were limited to the analysis of localized events of the injection site region (ISR) only.
|
—
0/0 • From Day 1 (after dose) through Day 180
Data on all-cause mortality and serious adverse events were collected irrespective of the event's relation to the buttocks (test/control). The buttock Arms were limited to the analysis of localized events of the injection site region (ISR) only.
|
—
0/0 • From Day 1 (after dose) through Day 180
Data on all-cause mortality and serious adverse events were collected irrespective of the event's relation to the buttocks (test/control). The buttock Arms were limited to the analysis of localized events of the injection site region (ISR) only.
|
—
0/0 • From Day 1 (after dose) through Day 180
Data on all-cause mortality and serious adverse events were collected irrespective of the event's relation to the buttocks (test/control). The buttock Arms were limited to the analysis of localized events of the injection site region (ISR) only.
|
—
0/0 • From Day 1 (after dose) through Day 180
Data on all-cause mortality and serious adverse events were collected irrespective of the event's relation to the buttocks (test/control). The buttock Arms were limited to the analysis of localized events of the injection site region (ISR) only.
|
0.00%
0/22 • From Day 1 (after dose) through Day 180
Data on all-cause mortality and serious adverse events were collected irrespective of the event's relation to the buttocks (test/control). The buttock Arms were limited to the analysis of localized events of the injection site region (ISR) only.
|
0.00%
0/14 • From Day 1 (after dose) through Day 180
Data on all-cause mortality and serious adverse events were collected irrespective of the event's relation to the buttocks (test/control). The buttock Arms were limited to the analysis of localized events of the injection site region (ISR) only.
|
0.00%
0/5 • From Day 1 (after dose) through Day 180
Data on all-cause mortality and serious adverse events were collected irrespective of the event's relation to the buttocks (test/control). The buttock Arms were limited to the analysis of localized events of the injection site region (ISR) only.
|
0.00%
0/7 • From Day 1 (after dose) through Day 180
Data on all-cause mortality and serious adverse events were collected irrespective of the event's relation to the buttocks (test/control). The buttock Arms were limited to the analysis of localized events of the injection site region (ISR) only.
|
0.00%
0/10 • From Day 1 (after dose) through Day 180
Data on all-cause mortality and serious adverse events were collected irrespective of the event's relation to the buttocks (test/control). The buttock Arms were limited to the analysis of localized events of the injection site region (ISR) only.
|
0.00%
0/19 • From Day 1 (after dose) through Day 180
Data on all-cause mortality and serious adverse events were collected irrespective of the event's relation to the buttocks (test/control). The buttock Arms were limited to the analysis of localized events of the injection site region (ISR) only.
|
0.00%
0/7 • From Day 1 (after dose) through Day 180
Data on all-cause mortality and serious adverse events were collected irrespective of the event's relation to the buttocks (test/control). The buttock Arms were limited to the analysis of localized events of the injection site region (ISR) only.
|
14.3%
1/7 • From Day 1 (after dose) through Day 180
Data on all-cause mortality and serious adverse events were collected irrespective of the event's relation to the buttocks (test/control). The buttock Arms were limited to the analysis of localized events of the injection site region (ISR) only.
|
|
Infections and infestations
Diverticulitis
|
—
0/0 • From Day 1 (after dose) through Day 180
Data on all-cause mortality and serious adverse events were collected irrespective of the event's relation to the buttocks (test/control). The buttock Arms were limited to the analysis of localized events of the injection site region (ISR) only.
|
—
0/0 • From Day 1 (after dose) through Day 180
Data on all-cause mortality and serious adverse events were collected irrespective of the event's relation to the buttocks (test/control). The buttock Arms were limited to the analysis of localized events of the injection site region (ISR) only.
|
—
0/0 • From Day 1 (after dose) through Day 180
Data on all-cause mortality and serious adverse events were collected irrespective of the event's relation to the buttocks (test/control). The buttock Arms were limited to the analysis of localized events of the injection site region (ISR) only.
|
—
0/0 • From Day 1 (after dose) through Day 180
Data on all-cause mortality and serious adverse events were collected irrespective of the event's relation to the buttocks (test/control). The buttock Arms were limited to the analysis of localized events of the injection site region (ISR) only.
|
—
0/0 • From Day 1 (after dose) through Day 180
Data on all-cause mortality and serious adverse events were collected irrespective of the event's relation to the buttocks (test/control). The buttock Arms were limited to the analysis of localized events of the injection site region (ISR) only.
|
—
0/0 • From Day 1 (after dose) through Day 180
Data on all-cause mortality and serious adverse events were collected irrespective of the event's relation to the buttocks (test/control). The buttock Arms were limited to the analysis of localized events of the injection site region (ISR) only.
|
—
0/0 • From Day 1 (after dose) through Day 180
Data on all-cause mortality and serious adverse events were collected irrespective of the event's relation to the buttocks (test/control). The buttock Arms were limited to the analysis of localized events of the injection site region (ISR) only.
|
—
0/0 • From Day 1 (after dose) through Day 180
Data on all-cause mortality and serious adverse events were collected irrespective of the event's relation to the buttocks (test/control). The buttock Arms were limited to the analysis of localized events of the injection site region (ISR) only.
|
—
0/0 • From Day 1 (after dose) through Day 180
Data on all-cause mortality and serious adverse events were collected irrespective of the event's relation to the buttocks (test/control). The buttock Arms were limited to the analysis of localized events of the injection site region (ISR) only.
|
—
0/0 • From Day 1 (after dose) through Day 180
Data on all-cause mortality and serious adverse events were collected irrespective of the event's relation to the buttocks (test/control). The buttock Arms were limited to the analysis of localized events of the injection site region (ISR) only.
|
—
0/0 • From Day 1 (after dose) through Day 180
Data on all-cause mortality and serious adverse events were collected irrespective of the event's relation to the buttocks (test/control). The buttock Arms were limited to the analysis of localized events of the injection site region (ISR) only.
|
—
0/0 • From Day 1 (after dose) through Day 180
Data on all-cause mortality and serious adverse events were collected irrespective of the event's relation to the buttocks (test/control). The buttock Arms were limited to the analysis of localized events of the injection site region (ISR) only.
|
—
0/0 • From Day 1 (after dose) through Day 180
Data on all-cause mortality and serious adverse events were collected irrespective of the event's relation to the buttocks (test/control). The buttock Arms were limited to the analysis of localized events of the injection site region (ISR) only.
|
—
0/0 • From Day 1 (after dose) through Day 180
Data on all-cause mortality and serious adverse events were collected irrespective of the event's relation to the buttocks (test/control). The buttock Arms were limited to the analysis of localized events of the injection site region (ISR) only.
|
—
0/0 • From Day 1 (after dose) through Day 180
Data on all-cause mortality and serious adverse events were collected irrespective of the event's relation to the buttocks (test/control). The buttock Arms were limited to the analysis of localized events of the injection site region (ISR) only.
|
—
0/0 • From Day 1 (after dose) through Day 180
Data on all-cause mortality and serious adverse events were collected irrespective of the event's relation to the buttocks (test/control). The buttock Arms were limited to the analysis of localized events of the injection site region (ISR) only.
|
0.00%
0/22 • From Day 1 (after dose) through Day 180
Data on all-cause mortality and serious adverse events were collected irrespective of the event's relation to the buttocks (test/control). The buttock Arms were limited to the analysis of localized events of the injection site region (ISR) only.
|
0.00%
0/14 • From Day 1 (after dose) through Day 180
Data on all-cause mortality and serious adverse events were collected irrespective of the event's relation to the buttocks (test/control). The buttock Arms were limited to the analysis of localized events of the injection site region (ISR) only.
|
0.00%
0/5 • From Day 1 (after dose) through Day 180
Data on all-cause mortality and serious adverse events were collected irrespective of the event's relation to the buttocks (test/control). The buttock Arms were limited to the analysis of localized events of the injection site region (ISR) only.
|
0.00%
0/7 • From Day 1 (after dose) through Day 180
Data on all-cause mortality and serious adverse events were collected irrespective of the event's relation to the buttocks (test/control). The buttock Arms were limited to the analysis of localized events of the injection site region (ISR) only.
|
0.00%
0/10 • From Day 1 (after dose) through Day 180
Data on all-cause mortality and serious adverse events were collected irrespective of the event's relation to the buttocks (test/control). The buttock Arms were limited to the analysis of localized events of the injection site region (ISR) only.
|
5.3%
1/19 • From Day 1 (after dose) through Day 180
Data on all-cause mortality and serious adverse events were collected irrespective of the event's relation to the buttocks (test/control). The buttock Arms were limited to the analysis of localized events of the injection site region (ISR) only.
|
0.00%
0/7 • From Day 1 (after dose) through Day 180
Data on all-cause mortality and serious adverse events were collected irrespective of the event's relation to the buttocks (test/control). The buttock Arms were limited to the analysis of localized events of the injection site region (ISR) only.
|
0.00%
0/7 • From Day 1 (after dose) through Day 180
Data on all-cause mortality and serious adverse events were collected irrespective of the event's relation to the buttocks (test/control). The buttock Arms were limited to the analysis of localized events of the injection site region (ISR) only.
|
|
Musculoskeletal and connective tissue disorders
Synovial cyst
|
—
0/0 • From Day 1 (after dose) through Day 180
Data on all-cause mortality and serious adverse events were collected irrespective of the event's relation to the buttocks (test/control). The buttock Arms were limited to the analysis of localized events of the injection site region (ISR) only.
|
—
0/0 • From Day 1 (after dose) through Day 180
Data on all-cause mortality and serious adverse events were collected irrespective of the event's relation to the buttocks (test/control). The buttock Arms were limited to the analysis of localized events of the injection site region (ISR) only.
|
—
0/0 • From Day 1 (after dose) through Day 180
Data on all-cause mortality and serious adverse events were collected irrespective of the event's relation to the buttocks (test/control). The buttock Arms were limited to the analysis of localized events of the injection site region (ISR) only.
|
—
0/0 • From Day 1 (after dose) through Day 180
Data on all-cause mortality and serious adverse events were collected irrespective of the event's relation to the buttocks (test/control). The buttock Arms were limited to the analysis of localized events of the injection site region (ISR) only.
|
—
0/0 • From Day 1 (after dose) through Day 180
Data on all-cause mortality and serious adverse events were collected irrespective of the event's relation to the buttocks (test/control). The buttock Arms were limited to the analysis of localized events of the injection site region (ISR) only.
|
—
0/0 • From Day 1 (after dose) through Day 180
Data on all-cause mortality and serious adverse events were collected irrespective of the event's relation to the buttocks (test/control). The buttock Arms were limited to the analysis of localized events of the injection site region (ISR) only.
|
—
0/0 • From Day 1 (after dose) through Day 180
Data on all-cause mortality and serious adverse events were collected irrespective of the event's relation to the buttocks (test/control). The buttock Arms were limited to the analysis of localized events of the injection site region (ISR) only.
|
—
0/0 • From Day 1 (after dose) through Day 180
Data on all-cause mortality and serious adverse events were collected irrespective of the event's relation to the buttocks (test/control). The buttock Arms were limited to the analysis of localized events of the injection site region (ISR) only.
|
—
0/0 • From Day 1 (after dose) through Day 180
Data on all-cause mortality and serious adverse events were collected irrespective of the event's relation to the buttocks (test/control). The buttock Arms were limited to the analysis of localized events of the injection site region (ISR) only.
|
—
0/0 • From Day 1 (after dose) through Day 180
Data on all-cause mortality and serious adverse events were collected irrespective of the event's relation to the buttocks (test/control). The buttock Arms were limited to the analysis of localized events of the injection site region (ISR) only.
|
—
0/0 • From Day 1 (after dose) through Day 180
Data on all-cause mortality and serious adverse events were collected irrespective of the event's relation to the buttocks (test/control). The buttock Arms were limited to the analysis of localized events of the injection site region (ISR) only.
|
—
0/0 • From Day 1 (after dose) through Day 180
Data on all-cause mortality and serious adverse events were collected irrespective of the event's relation to the buttocks (test/control). The buttock Arms were limited to the analysis of localized events of the injection site region (ISR) only.
|
—
0/0 • From Day 1 (after dose) through Day 180
Data on all-cause mortality and serious adverse events were collected irrespective of the event's relation to the buttocks (test/control). The buttock Arms were limited to the analysis of localized events of the injection site region (ISR) only.
|
—
0/0 • From Day 1 (after dose) through Day 180
Data on all-cause mortality and serious adverse events were collected irrespective of the event's relation to the buttocks (test/control). The buttock Arms were limited to the analysis of localized events of the injection site region (ISR) only.
|
—
0/0 • From Day 1 (after dose) through Day 180
Data on all-cause mortality and serious adverse events were collected irrespective of the event's relation to the buttocks (test/control). The buttock Arms were limited to the analysis of localized events of the injection site region (ISR) only.
|
—
0/0 • From Day 1 (after dose) through Day 180
Data on all-cause mortality and serious adverse events were collected irrespective of the event's relation to the buttocks (test/control). The buttock Arms were limited to the analysis of localized events of the injection site region (ISR) only.
|
0.00%
0/22 • From Day 1 (after dose) through Day 180
Data on all-cause mortality and serious adverse events were collected irrespective of the event's relation to the buttocks (test/control). The buttock Arms were limited to the analysis of localized events of the injection site region (ISR) only.
|
0.00%
0/14 • From Day 1 (after dose) through Day 180
Data on all-cause mortality and serious adverse events were collected irrespective of the event's relation to the buttocks (test/control). The buttock Arms were limited to the analysis of localized events of the injection site region (ISR) only.
|
20.0%
1/5 • From Day 1 (after dose) through Day 180
Data on all-cause mortality and serious adverse events were collected irrespective of the event's relation to the buttocks (test/control). The buttock Arms were limited to the analysis of localized events of the injection site region (ISR) only.
|
0.00%
0/7 • From Day 1 (after dose) through Day 180
Data on all-cause mortality and serious adverse events were collected irrespective of the event's relation to the buttocks (test/control). The buttock Arms were limited to the analysis of localized events of the injection site region (ISR) only.
|
0.00%
0/10 • From Day 1 (after dose) through Day 180
Data on all-cause mortality and serious adverse events were collected irrespective of the event's relation to the buttocks (test/control). The buttock Arms were limited to the analysis of localized events of the injection site region (ISR) only.
|
0.00%
0/19 • From Day 1 (after dose) through Day 180
Data on all-cause mortality and serious adverse events were collected irrespective of the event's relation to the buttocks (test/control). The buttock Arms were limited to the analysis of localized events of the injection site region (ISR) only.
|
0.00%
0/7 • From Day 1 (after dose) through Day 180
Data on all-cause mortality and serious adverse events were collected irrespective of the event's relation to the buttocks (test/control). The buttock Arms were limited to the analysis of localized events of the injection site region (ISR) only.
|
0.00%
0/7 • From Day 1 (after dose) through Day 180
Data on all-cause mortality and serious adverse events were collected irrespective of the event's relation to the buttocks (test/control). The buttock Arms were limited to the analysis of localized events of the injection site region (ISR) only.
|
|
Infections and infestations
Upper respiratory tract infection
|
—
0/0 • From Day 1 (after dose) through Day 180
Data on all-cause mortality and serious adverse events were collected irrespective of the event's relation to the buttocks (test/control). The buttock Arms were limited to the analysis of localized events of the injection site region (ISR) only.
|
—
0/0 • From Day 1 (after dose) through Day 180
Data on all-cause mortality and serious adverse events were collected irrespective of the event's relation to the buttocks (test/control). The buttock Arms were limited to the analysis of localized events of the injection site region (ISR) only.
|
—
0/0 • From Day 1 (after dose) through Day 180
Data on all-cause mortality and serious adverse events were collected irrespective of the event's relation to the buttocks (test/control). The buttock Arms were limited to the analysis of localized events of the injection site region (ISR) only.
|
—
0/0 • From Day 1 (after dose) through Day 180
Data on all-cause mortality and serious adverse events were collected irrespective of the event's relation to the buttocks (test/control). The buttock Arms were limited to the analysis of localized events of the injection site region (ISR) only.
|
—
0/0 • From Day 1 (after dose) through Day 180
Data on all-cause mortality and serious adverse events were collected irrespective of the event's relation to the buttocks (test/control). The buttock Arms were limited to the analysis of localized events of the injection site region (ISR) only.
|
—
0/0 • From Day 1 (after dose) through Day 180
Data on all-cause mortality and serious adverse events were collected irrespective of the event's relation to the buttocks (test/control). The buttock Arms were limited to the analysis of localized events of the injection site region (ISR) only.
|
—
0/0 • From Day 1 (after dose) through Day 180
Data on all-cause mortality and serious adverse events were collected irrespective of the event's relation to the buttocks (test/control). The buttock Arms were limited to the analysis of localized events of the injection site region (ISR) only.
|
—
0/0 • From Day 1 (after dose) through Day 180
Data on all-cause mortality and serious adverse events were collected irrespective of the event's relation to the buttocks (test/control). The buttock Arms were limited to the analysis of localized events of the injection site region (ISR) only.
|
—
0/0 • From Day 1 (after dose) through Day 180
Data on all-cause mortality and serious adverse events were collected irrespective of the event's relation to the buttocks (test/control). The buttock Arms were limited to the analysis of localized events of the injection site region (ISR) only.
|
—
0/0 • From Day 1 (after dose) through Day 180
Data on all-cause mortality and serious adverse events were collected irrespective of the event's relation to the buttocks (test/control). The buttock Arms were limited to the analysis of localized events of the injection site region (ISR) only.
|
—
0/0 • From Day 1 (after dose) through Day 180
Data on all-cause mortality and serious adverse events were collected irrespective of the event's relation to the buttocks (test/control). The buttock Arms were limited to the analysis of localized events of the injection site region (ISR) only.
|
—
0/0 • From Day 1 (after dose) through Day 180
Data on all-cause mortality and serious adverse events were collected irrespective of the event's relation to the buttocks (test/control). The buttock Arms were limited to the analysis of localized events of the injection site region (ISR) only.
|
—
0/0 • From Day 1 (after dose) through Day 180
Data on all-cause mortality and serious adverse events were collected irrespective of the event's relation to the buttocks (test/control). The buttock Arms were limited to the analysis of localized events of the injection site region (ISR) only.
|
—
0/0 • From Day 1 (after dose) through Day 180
Data on all-cause mortality and serious adverse events were collected irrespective of the event's relation to the buttocks (test/control). The buttock Arms were limited to the analysis of localized events of the injection site region (ISR) only.
|
—
0/0 • From Day 1 (after dose) through Day 180
Data on all-cause mortality and serious adverse events were collected irrespective of the event's relation to the buttocks (test/control). The buttock Arms were limited to the analysis of localized events of the injection site region (ISR) only.
|
—
0/0 • From Day 1 (after dose) through Day 180
Data on all-cause mortality and serious adverse events were collected irrespective of the event's relation to the buttocks (test/control). The buttock Arms were limited to the analysis of localized events of the injection site region (ISR) only.
|
0.00%
0/22 • From Day 1 (after dose) through Day 180
Data on all-cause mortality and serious adverse events were collected irrespective of the event's relation to the buttocks (test/control). The buttock Arms were limited to the analysis of localized events of the injection site region (ISR) only.
|
0.00%
0/14 • From Day 1 (after dose) through Day 180
Data on all-cause mortality and serious adverse events were collected irrespective of the event's relation to the buttocks (test/control). The buttock Arms were limited to the analysis of localized events of the injection site region (ISR) only.
|
0.00%
0/5 • From Day 1 (after dose) through Day 180
Data on all-cause mortality and serious adverse events were collected irrespective of the event's relation to the buttocks (test/control). The buttock Arms were limited to the analysis of localized events of the injection site region (ISR) only.
|
0.00%
0/7 • From Day 1 (after dose) through Day 180
Data on all-cause mortality and serious adverse events were collected irrespective of the event's relation to the buttocks (test/control). The buttock Arms were limited to the analysis of localized events of the injection site region (ISR) only.
|
0.00%
0/10 • From Day 1 (after dose) through Day 180
Data on all-cause mortality and serious adverse events were collected irrespective of the event's relation to the buttocks (test/control). The buttock Arms were limited to the analysis of localized events of the injection site region (ISR) only.
|
5.3%
1/19 • From Day 1 (after dose) through Day 180
Data on all-cause mortality and serious adverse events were collected irrespective of the event's relation to the buttocks (test/control). The buttock Arms were limited to the analysis of localized events of the injection site region (ISR) only.
|
0.00%
0/7 • From Day 1 (after dose) through Day 180
Data on all-cause mortality and serious adverse events were collected irrespective of the event's relation to the buttocks (test/control). The buttock Arms were limited to the analysis of localized events of the injection site region (ISR) only.
|
0.00%
0/7 • From Day 1 (after dose) through Day 180
Data on all-cause mortality and serious adverse events were collected irrespective of the event's relation to the buttocks (test/control). The buttock Arms were limited to the analysis of localized events of the injection site region (ISR) only.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
—
0/0 • From Day 1 (after dose) through Day 180
Data on all-cause mortality and serious adverse events were collected irrespective of the event's relation to the buttocks (test/control). The buttock Arms were limited to the analysis of localized events of the injection site region (ISR) only.
|
—
0/0 • From Day 1 (after dose) through Day 180
Data on all-cause mortality and serious adverse events were collected irrespective of the event's relation to the buttocks (test/control). The buttock Arms were limited to the analysis of localized events of the injection site region (ISR) only.
|
—
0/0 • From Day 1 (after dose) through Day 180
Data on all-cause mortality and serious adverse events were collected irrespective of the event's relation to the buttocks (test/control). The buttock Arms were limited to the analysis of localized events of the injection site region (ISR) only.
|
—
0/0 • From Day 1 (after dose) through Day 180
Data on all-cause mortality and serious adverse events were collected irrespective of the event's relation to the buttocks (test/control). The buttock Arms were limited to the analysis of localized events of the injection site region (ISR) only.
|
—
0/0 • From Day 1 (after dose) through Day 180
Data on all-cause mortality and serious adverse events were collected irrespective of the event's relation to the buttocks (test/control). The buttock Arms were limited to the analysis of localized events of the injection site region (ISR) only.
|
—
0/0 • From Day 1 (after dose) through Day 180
Data on all-cause mortality and serious adverse events were collected irrespective of the event's relation to the buttocks (test/control). The buttock Arms were limited to the analysis of localized events of the injection site region (ISR) only.
|
—
0/0 • From Day 1 (after dose) through Day 180
Data on all-cause mortality and serious adverse events were collected irrespective of the event's relation to the buttocks (test/control). The buttock Arms were limited to the analysis of localized events of the injection site region (ISR) only.
|
—
0/0 • From Day 1 (after dose) through Day 180
Data on all-cause mortality and serious adverse events were collected irrespective of the event's relation to the buttocks (test/control). The buttock Arms were limited to the analysis of localized events of the injection site region (ISR) only.
|
—
0/0 • From Day 1 (after dose) through Day 180
Data on all-cause mortality and serious adverse events were collected irrespective of the event's relation to the buttocks (test/control). The buttock Arms were limited to the analysis of localized events of the injection site region (ISR) only.
|
—
0/0 • From Day 1 (after dose) through Day 180
Data on all-cause mortality and serious adverse events were collected irrespective of the event's relation to the buttocks (test/control). The buttock Arms were limited to the analysis of localized events of the injection site region (ISR) only.
|
—
0/0 • From Day 1 (after dose) through Day 180
Data on all-cause mortality and serious adverse events were collected irrespective of the event's relation to the buttocks (test/control). The buttock Arms were limited to the analysis of localized events of the injection site region (ISR) only.
|
—
0/0 • From Day 1 (after dose) through Day 180
Data on all-cause mortality and serious adverse events were collected irrespective of the event's relation to the buttocks (test/control). The buttock Arms were limited to the analysis of localized events of the injection site region (ISR) only.
|
—
0/0 • From Day 1 (after dose) through Day 180
Data on all-cause mortality and serious adverse events were collected irrespective of the event's relation to the buttocks (test/control). The buttock Arms were limited to the analysis of localized events of the injection site region (ISR) only.
|
—
0/0 • From Day 1 (after dose) through Day 180
Data on all-cause mortality and serious adverse events were collected irrespective of the event's relation to the buttocks (test/control). The buttock Arms were limited to the analysis of localized events of the injection site region (ISR) only.
|
—
0/0 • From Day 1 (after dose) through Day 180
Data on all-cause mortality and serious adverse events were collected irrespective of the event's relation to the buttocks (test/control). The buttock Arms were limited to the analysis of localized events of the injection site region (ISR) only.
|
—
0/0 • From Day 1 (after dose) through Day 180
Data on all-cause mortality and serious adverse events were collected irrespective of the event's relation to the buttocks (test/control). The buttock Arms were limited to the analysis of localized events of the injection site region (ISR) only.
|
9.1%
2/22 • From Day 1 (after dose) through Day 180
Data on all-cause mortality and serious adverse events were collected irrespective of the event's relation to the buttocks (test/control). The buttock Arms were limited to the analysis of localized events of the injection site region (ISR) only.
|
0.00%
0/14 • From Day 1 (after dose) through Day 180
Data on all-cause mortality and serious adverse events were collected irrespective of the event's relation to the buttocks (test/control). The buttock Arms were limited to the analysis of localized events of the injection site region (ISR) only.
|
0.00%
0/5 • From Day 1 (after dose) through Day 180
Data on all-cause mortality and serious adverse events were collected irrespective of the event's relation to the buttocks (test/control). The buttock Arms were limited to the analysis of localized events of the injection site region (ISR) only.
|
0.00%
0/7 • From Day 1 (after dose) through Day 180
Data on all-cause mortality and serious adverse events were collected irrespective of the event's relation to the buttocks (test/control). The buttock Arms were limited to the analysis of localized events of the injection site region (ISR) only.
|
0.00%
0/10 • From Day 1 (after dose) through Day 180
Data on all-cause mortality and serious adverse events were collected irrespective of the event's relation to the buttocks (test/control). The buttock Arms were limited to the analysis of localized events of the injection site region (ISR) only.
|
0.00%
0/19 • From Day 1 (after dose) through Day 180
Data on all-cause mortality and serious adverse events were collected irrespective of the event's relation to the buttocks (test/control). The buttock Arms were limited to the analysis of localized events of the injection site region (ISR) only.
|
0.00%
0/7 • From Day 1 (after dose) through Day 180
Data on all-cause mortality and serious adverse events were collected irrespective of the event's relation to the buttocks (test/control). The buttock Arms were limited to the analysis of localized events of the injection site region (ISR) only.
|
14.3%
1/7 • From Day 1 (after dose) through Day 180
Data on all-cause mortality and serious adverse events were collected irrespective of the event's relation to the buttocks (test/control). The buttock Arms were limited to the analysis of localized events of the injection site region (ISR) only.
|
|
Nervous system disorders
Headache
|
—
0/0 • From Day 1 (after dose) through Day 180
Data on all-cause mortality and serious adverse events were collected irrespective of the event's relation to the buttocks (test/control). The buttock Arms were limited to the analysis of localized events of the injection site region (ISR) only.
|
—
0/0 • From Day 1 (after dose) through Day 180
Data on all-cause mortality and serious adverse events were collected irrespective of the event's relation to the buttocks (test/control). The buttock Arms were limited to the analysis of localized events of the injection site region (ISR) only.
|
—
0/0 • From Day 1 (after dose) through Day 180
Data on all-cause mortality and serious adverse events were collected irrespective of the event's relation to the buttocks (test/control). The buttock Arms were limited to the analysis of localized events of the injection site region (ISR) only.
|
—
0/0 • From Day 1 (after dose) through Day 180
Data on all-cause mortality and serious adverse events were collected irrespective of the event's relation to the buttocks (test/control). The buttock Arms were limited to the analysis of localized events of the injection site region (ISR) only.
|
—
0/0 • From Day 1 (after dose) through Day 180
Data on all-cause mortality and serious adverse events were collected irrespective of the event's relation to the buttocks (test/control). The buttock Arms were limited to the analysis of localized events of the injection site region (ISR) only.
|
—
0/0 • From Day 1 (after dose) through Day 180
Data on all-cause mortality and serious adverse events were collected irrespective of the event's relation to the buttocks (test/control). The buttock Arms were limited to the analysis of localized events of the injection site region (ISR) only.
|
—
0/0 • From Day 1 (after dose) through Day 180
Data on all-cause mortality and serious adverse events were collected irrespective of the event's relation to the buttocks (test/control). The buttock Arms were limited to the analysis of localized events of the injection site region (ISR) only.
|
—
0/0 • From Day 1 (after dose) through Day 180
Data on all-cause mortality and serious adverse events were collected irrespective of the event's relation to the buttocks (test/control). The buttock Arms were limited to the analysis of localized events of the injection site region (ISR) only.
|
—
0/0 • From Day 1 (after dose) through Day 180
Data on all-cause mortality and serious adverse events were collected irrespective of the event's relation to the buttocks (test/control). The buttock Arms were limited to the analysis of localized events of the injection site region (ISR) only.
|
—
0/0 • From Day 1 (after dose) through Day 180
Data on all-cause mortality and serious adverse events were collected irrespective of the event's relation to the buttocks (test/control). The buttock Arms were limited to the analysis of localized events of the injection site region (ISR) only.
|
—
0/0 • From Day 1 (after dose) through Day 180
Data on all-cause mortality and serious adverse events were collected irrespective of the event's relation to the buttocks (test/control). The buttock Arms were limited to the analysis of localized events of the injection site region (ISR) only.
|
—
0/0 • From Day 1 (after dose) through Day 180
Data on all-cause mortality and serious adverse events were collected irrespective of the event's relation to the buttocks (test/control). The buttock Arms were limited to the analysis of localized events of the injection site region (ISR) only.
|
—
0/0 • From Day 1 (after dose) through Day 180
Data on all-cause mortality and serious adverse events were collected irrespective of the event's relation to the buttocks (test/control). The buttock Arms were limited to the analysis of localized events of the injection site region (ISR) only.
|
—
0/0 • From Day 1 (after dose) through Day 180
Data on all-cause mortality and serious adverse events were collected irrespective of the event's relation to the buttocks (test/control). The buttock Arms were limited to the analysis of localized events of the injection site region (ISR) only.
|
—
0/0 • From Day 1 (after dose) through Day 180
Data on all-cause mortality and serious adverse events were collected irrespective of the event's relation to the buttocks (test/control). The buttock Arms were limited to the analysis of localized events of the injection site region (ISR) only.
|
—
0/0 • From Day 1 (after dose) through Day 180
Data on all-cause mortality and serious adverse events were collected irrespective of the event's relation to the buttocks (test/control). The buttock Arms were limited to the analysis of localized events of the injection site region (ISR) only.
|
4.5%
1/22 • From Day 1 (after dose) through Day 180
Data on all-cause mortality and serious adverse events were collected irrespective of the event's relation to the buttocks (test/control). The buttock Arms were limited to the analysis of localized events of the injection site region (ISR) only.
|
0.00%
0/14 • From Day 1 (after dose) through Day 180
Data on all-cause mortality and serious adverse events were collected irrespective of the event's relation to the buttocks (test/control). The buttock Arms were limited to the analysis of localized events of the injection site region (ISR) only.
|
0.00%
0/5 • From Day 1 (after dose) through Day 180
Data on all-cause mortality and serious adverse events were collected irrespective of the event's relation to the buttocks (test/control). The buttock Arms were limited to the analysis of localized events of the injection site region (ISR) only.
|
0.00%
0/7 • From Day 1 (after dose) through Day 180
Data on all-cause mortality and serious adverse events were collected irrespective of the event's relation to the buttocks (test/control). The buttock Arms were limited to the analysis of localized events of the injection site region (ISR) only.
|
0.00%
0/10 • From Day 1 (after dose) through Day 180
Data on all-cause mortality and serious adverse events were collected irrespective of the event's relation to the buttocks (test/control). The buttock Arms were limited to the analysis of localized events of the injection site region (ISR) only.
|
0.00%
0/19 • From Day 1 (after dose) through Day 180
Data on all-cause mortality and serious adverse events were collected irrespective of the event's relation to the buttocks (test/control). The buttock Arms were limited to the analysis of localized events of the injection site region (ISR) only.
|
0.00%
0/7 • From Day 1 (after dose) through Day 180
Data on all-cause mortality and serious adverse events were collected irrespective of the event's relation to the buttocks (test/control). The buttock Arms were limited to the analysis of localized events of the injection site region (ISR) only.
|
14.3%
1/7 • From Day 1 (after dose) through Day 180
Data on all-cause mortality and serious adverse events were collected irrespective of the event's relation to the buttocks (test/control). The buttock Arms were limited to the analysis of localized events of the injection site region (ISR) only.
|
|
Infections and infestations
Bacterial vaginosis
|
—
0/0 • From Day 1 (after dose) through Day 180
Data on all-cause mortality and serious adverse events were collected irrespective of the event's relation to the buttocks (test/control). The buttock Arms were limited to the analysis of localized events of the injection site region (ISR) only.
|
—
0/0 • From Day 1 (after dose) through Day 180
Data on all-cause mortality and serious adverse events were collected irrespective of the event's relation to the buttocks (test/control). The buttock Arms were limited to the analysis of localized events of the injection site region (ISR) only.
|
—
0/0 • From Day 1 (after dose) through Day 180
Data on all-cause mortality and serious adverse events were collected irrespective of the event's relation to the buttocks (test/control). The buttock Arms were limited to the analysis of localized events of the injection site region (ISR) only.
|
—
0/0 • From Day 1 (after dose) through Day 180
Data on all-cause mortality and serious adverse events were collected irrespective of the event's relation to the buttocks (test/control). The buttock Arms were limited to the analysis of localized events of the injection site region (ISR) only.
|
—
0/0 • From Day 1 (after dose) through Day 180
Data on all-cause mortality and serious adverse events were collected irrespective of the event's relation to the buttocks (test/control). The buttock Arms were limited to the analysis of localized events of the injection site region (ISR) only.
|
—
0/0 • From Day 1 (after dose) through Day 180
Data on all-cause mortality and serious adverse events were collected irrespective of the event's relation to the buttocks (test/control). The buttock Arms were limited to the analysis of localized events of the injection site region (ISR) only.
|
—
0/0 • From Day 1 (after dose) through Day 180
Data on all-cause mortality and serious adverse events were collected irrespective of the event's relation to the buttocks (test/control). The buttock Arms were limited to the analysis of localized events of the injection site region (ISR) only.
|
—
0/0 • From Day 1 (after dose) through Day 180
Data on all-cause mortality and serious adverse events were collected irrespective of the event's relation to the buttocks (test/control). The buttock Arms were limited to the analysis of localized events of the injection site region (ISR) only.
|
—
0/0 • From Day 1 (after dose) through Day 180
Data on all-cause mortality and serious adverse events were collected irrespective of the event's relation to the buttocks (test/control). The buttock Arms were limited to the analysis of localized events of the injection site region (ISR) only.
|
—
0/0 • From Day 1 (after dose) through Day 180
Data on all-cause mortality and serious adverse events were collected irrespective of the event's relation to the buttocks (test/control). The buttock Arms were limited to the analysis of localized events of the injection site region (ISR) only.
|
—
0/0 • From Day 1 (after dose) through Day 180
Data on all-cause mortality and serious adverse events were collected irrespective of the event's relation to the buttocks (test/control). The buttock Arms were limited to the analysis of localized events of the injection site region (ISR) only.
|
—
0/0 • From Day 1 (after dose) through Day 180
Data on all-cause mortality and serious adverse events were collected irrespective of the event's relation to the buttocks (test/control). The buttock Arms were limited to the analysis of localized events of the injection site region (ISR) only.
|
—
0/0 • From Day 1 (after dose) through Day 180
Data on all-cause mortality and serious adverse events were collected irrespective of the event's relation to the buttocks (test/control). The buttock Arms were limited to the analysis of localized events of the injection site region (ISR) only.
|
—
0/0 • From Day 1 (after dose) through Day 180
Data on all-cause mortality and serious adverse events were collected irrespective of the event's relation to the buttocks (test/control). The buttock Arms were limited to the analysis of localized events of the injection site region (ISR) only.
|
—
0/0 • From Day 1 (after dose) through Day 180
Data on all-cause mortality and serious adverse events were collected irrespective of the event's relation to the buttocks (test/control). The buttock Arms were limited to the analysis of localized events of the injection site region (ISR) only.
|
—
0/0 • From Day 1 (after dose) through Day 180
Data on all-cause mortality and serious adverse events were collected irrespective of the event's relation to the buttocks (test/control). The buttock Arms were limited to the analysis of localized events of the injection site region (ISR) only.
|
0.00%
0/22 • From Day 1 (after dose) through Day 180
Data on all-cause mortality and serious adverse events were collected irrespective of the event's relation to the buttocks (test/control). The buttock Arms were limited to the analysis of localized events of the injection site region (ISR) only.
|
0.00%
0/14 • From Day 1 (after dose) through Day 180
Data on all-cause mortality and serious adverse events were collected irrespective of the event's relation to the buttocks (test/control). The buttock Arms were limited to the analysis of localized events of the injection site region (ISR) only.
|
0.00%
0/5 • From Day 1 (after dose) through Day 180
Data on all-cause mortality and serious adverse events were collected irrespective of the event's relation to the buttocks (test/control). The buttock Arms were limited to the analysis of localized events of the injection site region (ISR) only.
|
0.00%
0/7 • From Day 1 (after dose) through Day 180
Data on all-cause mortality and serious adverse events were collected irrespective of the event's relation to the buttocks (test/control). The buttock Arms were limited to the analysis of localized events of the injection site region (ISR) only.
|
0.00%
0/10 • From Day 1 (after dose) through Day 180
Data on all-cause mortality and serious adverse events were collected irrespective of the event's relation to the buttocks (test/control). The buttock Arms were limited to the analysis of localized events of the injection site region (ISR) only.
|
5.3%
1/19 • From Day 1 (after dose) through Day 180
Data on all-cause mortality and serious adverse events were collected irrespective of the event's relation to the buttocks (test/control). The buttock Arms were limited to the analysis of localized events of the injection site region (ISR) only.
|
0.00%
0/7 • From Day 1 (after dose) through Day 180
Data on all-cause mortality and serious adverse events were collected irrespective of the event's relation to the buttocks (test/control). The buttock Arms were limited to the analysis of localized events of the injection site region (ISR) only.
|
0.00%
0/7 • From Day 1 (after dose) through Day 180
Data on all-cause mortality and serious adverse events were collected irrespective of the event's relation to the buttocks (test/control). The buttock Arms were limited to the analysis of localized events of the injection site region (ISR) only.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place