Trial Outcomes & Findings for EN3835 for the Treatment of Edematous Fibrosclerotic Panniculopathy (Commonly Known as Cellulite) (NCT NCT02724644)
NCT ID: NCT02724644
Last Updated: 2017-11-06
Results Overview
Percentage of composite responders defined as subjects with an improvement from baseline of at least 2-levels of severity on each, the Clinician-Reported Photonumeric Cellulite Severity Scale (CR-PCSS) and Patient-Reported Photonumeric Cellulite Severity Scale (PR-PCSS), at Day 71 in the ITT population. The CR-PCSS is a photonumeric scale that was used by the Investigator to evaluate cellulite ranging from 0 (none), 1 (almost none), 2 (mild), 3 (moderate), to 4 (severe). The PR-PCSS is a photonumeric scale that was used by the subjects to evaluate cellulite ranging from 0 (none), 1 (almost none), 2 (mild), 3 (moderate), to 4 (severe). A 2-level improvement on each scale for example would represent a change from a 4 (severe) to a 2 (mild). In order to be considered a responder a subject needs to have at least a 2-level improvement on both scales.
COMPLETED
PHASE2
375 participants
Baseline, Day 71
2017-11-06
Participant Flow
Participant milestones
| Measure |
EN3835 0.84 mg
Three (3) treatment sessions of 0.84 mg of collagenase clostridium histolyticum separated by approximately 21 days.
Injectable intervention
|
Placebo
Three (3) treatment sessions of placebo separated by approximately 21 days. Injectable intervention
|
|---|---|---|
|
Overall Study
STARTED
|
189
|
186
|
|
Overall Study
COMPLETED
|
168
|
182
|
|
Overall Study
NOT COMPLETED
|
21
|
4
|
Reasons for withdrawal
| Measure |
EN3835 0.84 mg
Three (3) treatment sessions of 0.84 mg of collagenase clostridium histolyticum separated by approximately 21 days.
Injectable intervention
|
Placebo
Three (3) treatment sessions of placebo separated by approximately 21 days. Injectable intervention
|
|---|---|---|
|
Overall Study
Adverse Event
|
7
|
1
|
|
Overall Study
Lost to Follow-up
|
6
|
2
|
|
Overall Study
Withdrawal by Subject
|
7
|
1
|
|
Overall Study
Administrative
|
1
|
0
|
Baseline Characteristics
EN3835 for the Treatment of Edematous Fibrosclerotic Panniculopathy (Commonly Known as Cellulite)
Baseline characteristics by cohort
| Measure |
EN3835 0.84 mg
n=189 Participants
Three (3) treatment sessions of 0.84 mg of collagenase clostridium histolyticum separated by approximately 21 days.
Injectable intervention
|
Placebo
n=186 Participants
Three (3) treatment sessions of placebo separated by approximately 21 days. Injectable intervention
|
Total
n=375 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
47.2 Participants
STANDARD_DEVIATION 11.21 • n=5 Participants
|
45.8 Participants
STANDARD_DEVIATION 11.02 • n=7 Participants
|
46.5 Participants
STANDARD_DEVIATION 11.13 • n=5 Participants
|
|
Age, Customized
18-<25 years
|
8 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
|
Age, Customized
25-34 years
|
18 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
39 Participants
n=5 Participants
|
|
Age, Customized
35-44 years
|
46 Participants
n=5 Participants
|
47 Participants
n=7 Participants
|
93 Participants
n=5 Participants
|
|
Age, Customized
>=45 years
|
117 Participants
n=5 Participants
|
109 Participants
n=7 Participants
|
226 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
189 Participants
n=5 Participants
|
186 Participants
n=7 Participants
|
375 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
37 Participants
n=5 Participants
|
41 Participants
n=7 Participants
|
78 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
152 Participants
n=5 Participants
|
145 Participants
n=7 Participants
|
297 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
15 Participants
n=5 Participants
|
26 Participants
n=7 Participants
|
41 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
167 Participants
n=5 Participants
|
157 Participants
n=7 Participants
|
324 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
3 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
189 Participants
n=5 Participants
|
186 Participants
n=7 Participants
|
375 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline, Day 71Population: Analysis is based on ITT population; all randomized subjects who received at least 1 injection of study medication
Percentage of composite responders defined as subjects with an improvement from baseline of at least 2-levels of severity on each, the Clinician-Reported Photonumeric Cellulite Severity Scale (CR-PCSS) and Patient-Reported Photonumeric Cellulite Severity Scale (PR-PCSS), at Day 71 in the ITT population. The CR-PCSS is a photonumeric scale that was used by the Investigator to evaluate cellulite ranging from 0 (none), 1 (almost none), 2 (mild), 3 (moderate), to 4 (severe). The PR-PCSS is a photonumeric scale that was used by the subjects to evaluate cellulite ranging from 0 (none), 1 (almost none), 2 (mild), 3 (moderate), to 4 (severe). A 2-level improvement on each scale for example would represent a change from a 4 (severe) to a 2 (mild). In order to be considered a responder a subject needs to have at least a 2-level improvement on both scales.
Outcome measures
| Measure |
EN3835 0.84 mg
n=189 Participants
Three (3) treatment sessions of 0.84 mg of collagenase clostridium histolyticum separated by approximately 21 days.
Injectable intervention
|
Placebo
n=186 Participants
Three (3) treatment sessions of placebo separated by approximately 21 days. Injectable intervention
|
|---|---|---|
|
Percentage of Composite Responders of at Least 2-Level Improvement of Severity
|
20 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: Baseline, Day 71Population: Analysis is based on ITT population; all randomized subjects who received at least 1 injection of study medication
Percentage of composite responders defined as subjects with improvement from baseline of at least 1-level of severity on each, the Clinician-Reported Photonumeric Cellulite Severity Scale (CR-PCSS) and Patient-Reported Photonumeric Cellulite Severity Scale (PR-PCSS), at Day 71 in the ITT population. The CR-PCSS is a photonumeric scale that was used by the Investigator to evaluate cellulite ranging from 0 (none), 1 (almost none), 2 (mild), 3 (moderate), to 4 (severe). The PR-PCSS is a photonumeric scale that was used by the subjects to evaluate cellulite ranging from 0 (none), 1 (almost none), 2 (mild), 3 (moderate), to 4 (severe). A 1-level improvement on each scale for example would represent a change from a 4 (severe) to a 3 (moderate). In order to be considered a responder a subject needs to have at least a 1-level improvement on both scales.
Outcome measures
| Measure |
EN3835 0.84 mg
n=189 Participants
Three (3) treatment sessions of 0.84 mg of collagenase clostridium histolyticum separated by approximately 21 days.
Injectable intervention
|
Placebo
n=186 Participants
Three (3) treatment sessions of placebo separated by approximately 21 days. Injectable intervention
|
|---|---|---|
|
Percentage of Composite Responders of at Least 1-Level Improvement of Severity
|
79 Participants
|
33 Participants
|
SECONDARY outcome
Timeframe: Baseline, Day 71Population: Analysis is based on modified intent-to-treat (mITT) population; all randomized subjects who received at least 1 injection of study medication and had at least 1 post-injection evaluation of both CR-PCSS by investigator and PR PCSS
Percentage of subjects with improvement from baseline of at least 2-levels of severity on the Investigator-rated Clinician-Reported Photonumeric Cellulite Severity Scale (CR-PCSS) at Day 71.The CR-PCSS is a photonumeric scale that was used by the Investigator to evaluate cellulite ranging from 0 (none), 1 (almost none), 2 (mild), 3 (moderate), to 4 (severe). A 2-level improvement would be for example a change from 4 (severe) to 2 (mild).
Outcome measures
| Measure |
EN3835 0.84 mg
n=177 Participants
Three (3) treatment sessions of 0.84 mg of collagenase clostridium histolyticum separated by approximately 21 days.
Injectable intervention
|
Placebo
n=184 Participants
Three (3) treatment sessions of placebo separated by approximately 21 days. Injectable intervention
|
|---|---|---|
|
CR-PCSS Responder Analysis: 2-Levels of Severity
|
32 Participants
|
9 Participants
|
SECONDARY outcome
Timeframe: Baseline, Day 71Population: Analysis is based on modified intent-to-treat (mITT) population; all randomized subjects who received at least 1 injection of study medication and had at least 1 post-injection evaluation of both CR-PCSS by investigator and PR PCSS
Percentage of subjects with improvement from baseline of at least 1-level of severity on the Investigator-rated Clinician-Reported Photonumeric Cellulite Severity Scale (CR-PCSS) at Day 71.The CR-PCSS is a photonumeric scale that was used by the investigator to evaluate cellulite ranging from 0 (none), 1 (almost none), 2 (mild), 3 (moderate), to 4 (severe). A 1-level improvement would be for example a change from 4 (severe) to 3 (moderate).
Outcome measures
| Measure |
EN3835 0.84 mg
n=177 Participants
Three (3) treatment sessions of 0.84 mg of collagenase clostridium histolyticum separated by approximately 21 days.
Injectable intervention
|
Placebo
n=184 Participants
Three (3) treatment sessions of placebo separated by approximately 21 days. Injectable intervention
|
|---|---|---|
|
CR-PCSS Responder Analysis: 1-Level of Severity
|
96 Participants
|
53 Participants
|
SECONDARY outcome
Timeframe: Baseline, Day 71Population: Analysis is based on mITT population; all randomized subjects who received at least 1 injection of study medication and had at least 1 post-injection evaluation of both CR-PCSS by investigator and PR PCSS
The CR-PCSS is a photonumeric scale that was used by the investigator to evaluate cellulite ranging from 0 (none), 1 (almost none), 2 (mild), 3 (moderate), to 4 (severe). Change is Day 71 study visit rating minus baseline visit; negative values indicate a lessening in cellulite severity.
Outcome measures
| Measure |
EN3835 0.84 mg
n=177 Participants
Three (3) treatment sessions of 0.84 mg of collagenase clostridium histolyticum separated by approximately 21 days.
Injectable intervention
|
Placebo
n=184 Participants
Three (3) treatment sessions of placebo separated by approximately 21 days. Injectable intervention
|
|---|---|---|
|
CR-PCSS Change From Baseline
|
-0.7 units on a scale
Standard Deviation 0.83
|
-0.3 units on a scale
Standard Deviation 0.62
|
SECONDARY outcome
Timeframe: Baseline, Day 71Population: Analysis is based on mITT population; all randomized subjects who received at least 1 injection of study medication and had at least 1 post-injection evaluation of both CR-PCSS by investigator and PR PCSS
Percentage of subjects with improvement from baseline of at least 2-levels of severity on the subject-rated Patient-Reported Photonumeric Cellulite Severity Scale (PR-PCSS) at Day 71.The PR-PCSS is a photonumeric scale that was used by the subject to evaluate cellulite ranging from 0 (none), 1 (almost none), 2 (mild), 3 (moderate), to 4 (severe). A 2-level improvement would be for example a change from 4 (severe) to 2 (mild).
Outcome measures
| Measure |
EN3835 0.84 mg
n=177 Participants
Three (3) treatment sessions of 0.84 mg of collagenase clostridium histolyticum separated by approximately 21 days.
Injectable intervention
|
Placebo
n=184 Participants
Three (3) treatment sessions of placebo separated by approximately 21 days. Injectable intervention
|
|---|---|---|
|
PR-PCSS Responder Analysis: 2-Levels of Severity
|
51 Participants
|
24 Participants
|
SECONDARY outcome
Timeframe: Baseline, Day 71Population: Analysis is based on mITT population; all randomized subjects who received at least 1 injection of study medication and had at least 1 post-injection evaluation of both CR-PCSS by investigator and PR PCSS
Percentage of subjects with improvement from baseline of at least 1-level of severity on the subject-rated Patient-Reported Photonumeric Cellulite Severity Scale (PR-PCSS) at Day 71.The PR-PCSS is a photonumeric scale that was used by the subject to evaluate cellulite ranging from 0 (none), 1 (almost none), 2 (mild), 3 (moderate), to 4 (severe). A 1-level improvement would be for example a change from 4 (severe) to 3 (moderate).
Outcome measures
| Measure |
EN3835 0.84 mg
n=177 Participants
Three (3) treatment sessions of 0.84 mg of collagenase clostridium histolyticum separated by approximately 21 days.
Injectable intervention
|
Placebo
n=184 Participants
Three (3) treatment sessions of placebo separated by approximately 21 days. Injectable intervention
|
|---|---|---|
|
PR-PCSS Responder Analysis: 1-Level of Severity
|
128 Participants
|
95 Participants
|
SECONDARY outcome
Timeframe: Baseline, Day 71Population: Analysis is based on mITT population; all randomized subjects who received at least 1 injection of study medication and had at least 1 post-injection evaluation of both CR-PCSS by investigator and PR PCSS
The PR-PCSS is a photonumeric scale that was used by the subjects to evaluate cellulite ranging from 0 (none), 1 (almost none), 2 (mild), 3 (moderate), to 4 (severe). Change is Day 71 study visit rating minus baseline visit; negative values indicate a lessening in cellulite severity.
Outcome measures
| Measure |
EN3835 0.84 mg
n=177 Participants
Three (3) treatment sessions of 0.84 mg of collagenase clostridium histolyticum separated by approximately 21 days.
Injectable intervention
|
Placebo
n=184 Participants
Three (3) treatment sessions of placebo separated by approximately 21 days. Injectable intervention
|
|---|---|---|
|
PR-PCSS Change From Baseline
|
-1.0 units on a scale
Standard Deviation 0.89
|
-0.7 units on a scale
Standard Deviation 0.79
|
SECONDARY outcome
Timeframe: Day 71Population: Analysis is based on mITT population; all randomized subjects who received at least 1 injection of study medication and had at least 1 post-injection evaluation of both CR-PCSS by investigator and PR PCSS
On Day 71, the Investigator determined the degree of improvement from baseline in the treated area using the 7-point I-GAIS. Ratings could be improved (+1), much improved (+2), or very much improved (+3), or no change (0), or worse (-1), much worse (-2) or very much worse (-3).
Outcome measures
| Measure |
EN3835 0.84 mg
n=177 Participants
Three (3) treatment sessions of 0.84 mg of collagenase clostridium histolyticum separated by approximately 21 days.
Injectable intervention
|
Placebo
n=184 Participants
Three (3) treatment sessions of placebo separated by approximately 21 days. Injectable intervention
|
|---|---|---|
|
Investigator Assessment of Improvement Based on the Investigator Global Aesthetic Improvement Scale (I-GAIS)
Very Much Improved (3)
|
6 Participants
|
2 Participants
|
|
Investigator Assessment of Improvement Based on the Investigator Global Aesthetic Improvement Scale (I-GAIS)
Much improved (2)
|
40 Participants
|
15 Participants
|
|
Investigator Assessment of Improvement Based on the Investigator Global Aesthetic Improvement Scale (I-GAIS)
Improved (1)
|
64 Participants
|
43 Participants
|
|
Investigator Assessment of Improvement Based on the Investigator Global Aesthetic Improvement Scale (I-GAIS)
No Change( 0)
|
57 Participants
|
119 Participants
|
|
Investigator Assessment of Improvement Based on the Investigator Global Aesthetic Improvement Scale (I-GAIS)
Worse (-1)
|
6 Participants
|
4 Participants
|
|
Investigator Assessment of Improvement Based on the Investigator Global Aesthetic Improvement Scale (I-GAIS)
Much worse (-2)
|
2 Participants
|
0 Participants
|
|
Investigator Assessment of Improvement Based on the Investigator Global Aesthetic Improvement Scale (I-GAIS)
Very Much Worse (-3)
|
0 Participants
|
0 Participants
|
|
Investigator Assessment of Improvement Based on the Investigator Global Aesthetic Improvement Scale (I-GAIS)
Not done
|
2 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Day 71Population: Analysis is based on mITT population; all randomized subjects who received at least 1 injection of study medication and had at least 1 post-injection evaluation of both CR-PCSS by investigator and PR PCSS
At Day 71, subjects were asked to rate their opinion of the overall improvement of their treated area using the 7-point S-GAIS. Ratings could be improved (+1), much improved (+2), or very much improved (+3), or no change (0), or worse (-1), much worse (-2) or very much worse (-3)
Outcome measures
| Measure |
EN3835 0.84 mg
n=177 Participants
Three (3) treatment sessions of 0.84 mg of collagenase clostridium histolyticum separated by approximately 21 days.
Injectable intervention
|
Placebo
n=184 Participants
Three (3) treatment sessions of placebo separated by approximately 21 days. Injectable intervention
|
|---|---|---|
|
Subject Assessment of Improvement Based on the Subject Global Aesthetic Improvement Scale (S-GAIS)
Very Much Improved (3)
|
21 Participants
|
11 Participants
|
|
Subject Assessment of Improvement Based on the Subject Global Aesthetic Improvement Scale (S-GAIS)
Much Improved (2)
|
43 Participants
|
17 Participants
|
|
Subject Assessment of Improvement Based on the Subject Global Aesthetic Improvement Scale (S-GAIS)
Improved (1)
|
64 Participants
|
52 Participants
|
|
Subject Assessment of Improvement Based on the Subject Global Aesthetic Improvement Scale (S-GAIS)
No change (0)
|
38 Participants
|
97 Participants
|
|
Subject Assessment of Improvement Based on the Subject Global Aesthetic Improvement Scale (S-GAIS)
Worse (-1)
|
6 Participants
|
5 Participants
|
|
Subject Assessment of Improvement Based on the Subject Global Aesthetic Improvement Scale (S-GAIS)
Much Worse (-2)
|
3 Participants
|
0 Participants
|
|
Subject Assessment of Improvement Based on the Subject Global Aesthetic Improvement Scale (S-GAIS)
Very Much Worse (-3)
|
0 Participants
|
0 Participants
|
|
Subject Assessment of Improvement Based on the Subject Global Aesthetic Improvement Scale (S-GAIS)
Not done
|
2 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: Day 71Population: Analysis is based on mITT population; all randomized subjects who received at least 1 injection of study medication and had at least 1 post-injection evaluation of both CR-PCSS by investigator and PR PCSS
At Day 71, subjects were asked to rate their satisfaction with cellulite treatment using the 5-point subject satisfaction scale. Ratings could be satisfied (+1), very satisfied (+2), neither satisfied nor dissatisfied (0), or dissatisfied (-1), very dissatisfied (-2).
Outcome measures
| Measure |
EN3835 0.84 mg
n=177 Participants
Three (3) treatment sessions of 0.84 mg of collagenase clostridium histolyticum separated by approximately 21 days.
Injectable intervention
|
Placebo
n=184 Participants
Three (3) treatment sessions of placebo separated by approximately 21 days. Injectable intervention
|
|---|---|---|
|
Subject Satisfaction Assessment Based on the the Subject Satisfaction Scale
Not done
|
2 Participants
|
3 Participants
|
|
Subject Satisfaction Assessment Based on the the Subject Satisfaction Scale
Very Satisfied (2)
|
41 Participants
|
25 Participants
|
|
Subject Satisfaction Assessment Based on the the Subject Satisfaction Scale
Satisfied (1)
|
69 Participants
|
40 Participants
|
|
Subject Satisfaction Assessment Based on the the Subject Satisfaction Scale
Neither Satisfied nor Dissatisfied (0)
|
45 Participants
|
82 Participants
|
|
Subject Satisfaction Assessment Based on the the Subject Satisfaction Scale
Dissatisfied (-1)
|
11 Participants
|
18 Participants
|
|
Subject Satisfaction Assessment Based on the the Subject Satisfaction Scale
Very Dissatisfied (-2)
|
9 Participants
|
16 Participants
|
SECONDARY outcome
Timeframe: Baseline, Day 71Population: Analysis is based on mITT population; all randomized subjects who received at least 1 injection of study medication and had at least 1 post-injection evaluation of both CR-PCSS by investigator and PR PCSS
Investigator used the Hexsel CSS to assess the severity of cellulite. The total score could range from 0 (no cellulite) to 15 (extremely severe cellulite). Negative change in Hexsel CSS total score indicates an improvement in cellulite severity
Outcome measures
| Measure |
EN3835 0.84 mg
n=177 Participants
Three (3) treatment sessions of 0.84 mg of collagenase clostridium histolyticum separated by approximately 21 days.
Injectable intervention
|
Placebo
n=184 Participants
Three (3) treatment sessions of placebo separated by approximately 21 days. Injectable intervention
|
|---|---|---|
|
Change in the Hexsel Cellulite Severity Scale (CSS) Total Score
|
-1.7 units on a scale
Standard Deviation 2.20
|
-0.9 units on a scale
Standard Deviation 2.00
|
Adverse Events
EN3835 0.84 mg
Placebo
Serious adverse events
| Measure |
EN3835 0.84 mg
n=189 participants at risk
Three (3) treatment sessions of 0.84 mg of collagenase clostridium histolyticum separated by approximately 21 days.
Injectable intervention
|
Placebo
n=186 participants at risk
Three (3) treatment sessions of placebo separated by approximately 21 days. Injectable intervention
|
|---|---|---|
|
Pregnancy, puerperium and perinatal conditions
Abortion spontaneous
|
0.53%
1/189 • Number of events 1 • Baseline, Day 71
Serious Adverse Events by Frequency (Safety Population)
|
0.00%
0/186 • Baseline, Day 71
Serious Adverse Events by Frequency (Safety Population)
|
Other adverse events
| Measure |
EN3835 0.84 mg
n=189 participants at risk
Three (3) treatment sessions of 0.84 mg of collagenase clostridium histolyticum separated by approximately 21 days.
Injectable intervention
|
Placebo
n=186 participants at risk
Three (3) treatment sessions of placebo separated by approximately 21 days. Injectable intervention
|
|---|---|---|
|
General disorders
Injection site bruising
|
75.1%
142/189 • Number of events 314 • Baseline, Day 71
Serious Adverse Events by Frequency (Safety Population)
|
13.4%
25/186 • Number of events 33 • Baseline, Day 71
Serious Adverse Events by Frequency (Safety Population)
|
|
General disorders
Injection site pain
|
59.3%
112/189 • Number of events 228 • Baseline, Day 71
Serious Adverse Events by Frequency (Safety Population)
|
5.4%
10/186 • Number of events 11 • Baseline, Day 71
Serious Adverse Events by Frequency (Safety Population)
|
|
General disorders
Injection site nodule
|
14.3%
27/189 • Number of events 33 • Baseline, Day 71
Serious Adverse Events by Frequency (Safety Population)
|
0.00%
0/186 • Baseline, Day 71
Serious Adverse Events by Frequency (Safety Population)
|
|
General disorders
Injection site pruritus
|
11.1%
21/189 • Number of events 29 • Baseline, Day 71
Serious Adverse Events by Frequency (Safety Population)
|
0.54%
1/186 • Number of events 1 • Baseline, Day 71
Serious Adverse Events by Frequency (Safety Population)
|
|
General disorders
Injection site induration
|
5.8%
11/189 • Number of events 17 • Baseline, Day 71
Serious Adverse Events by Frequency (Safety Population)
|
0.00%
0/186 • Baseline, Day 71
Serious Adverse Events by Frequency (Safety Population)
|
|
General disorders
Injection site swelling
|
7.4%
14/189 • Number of events 17 • Baseline, Day 71
Serious Adverse Events by Frequency (Safety Population)
|
0.54%
1/186 • Number of events 2 • Baseline, Day 71
Serious Adverse Events by Frequency (Safety Population)
|
|
General disorders
Injection site mass
|
5.3%
10/189 • Number of events 12 • Baseline, Day 71
Serious Adverse Events by Frequency (Safety Population)
|
0.54%
1/186 • Number of events 1 • Baseline, Day 71
Serious Adverse Events by Frequency (Safety Population)
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: OTHER