Trial Outcomes & Findings for Real World CCH Study in Adult Females With Cellulite (NCT NCT04170296)
NCT ID: NCT04170296
Last Updated: 2022-02-22
Results Overview
Investigator Global Aesthetic Improvement Scale (I-GAIS) is a 7-point scale rating global aesthetic improvement in appearance, compared to pretreatment, as judged by the investigator. The rating categories are "Very Much Worse", "Much Worse", "Worse", "No Change", "Improved", "Much Improved", and "Very Much Improved".
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
153 participants
Primary outcome timeframe
90 Days
Results posted on
2022-02-22
Participant Flow
Participant milestones
| Measure |
Cohort 1: Posterolateral Thigh
EN3835 up to 1.68mg (Collagenase Clostridium Histolyticum)
EN3835: Collagenase Clostridium Histolyticum (CCH)
|
Cohort 2: Buttocks
EN3835 up to 1.68mg (Collagenase Clostridium Histolyticum)
EN3835: Collagenase Clostridium Histolyticum (CCH)
|
|---|---|---|
|
Overall Study
STARTED
|
81
|
72
|
|
Overall Study
COMPLETED
|
73
|
68
|
|
Overall Study
NOT COMPLETED
|
8
|
4
|
Reasons for withdrawal
| Measure |
Cohort 1: Posterolateral Thigh
EN3835 up to 1.68mg (Collagenase Clostridium Histolyticum)
EN3835: Collagenase Clostridium Histolyticum (CCH)
|
Cohort 2: Buttocks
EN3835 up to 1.68mg (Collagenase Clostridium Histolyticum)
EN3835: Collagenase Clostridium Histolyticum (CCH)
|
|---|---|---|
|
Overall Study
Adverse Event
|
1
|
0
|
|
Overall Study
Withdrawal by Subject
|
3
|
2
|
|
Overall Study
Lost to Follow-up
|
4
|
2
|
Baseline Characteristics
Real World CCH Study in Adult Females With Cellulite
Baseline characteristics by cohort
| Measure |
Cohort 1: Posterolateral Thigh
n=81 Participants
EN3835 up to 1.68mg (Collagenase Clostridium Histolyticum)
EN3835: Collagenase Clostridium Histolyticum (CCH)
|
Cohort 2: Buttocks
n=72 Participants
EN3835 up to 1.68mg (Collagenase Clostridium Histolyticum)
EN3835: Collagenase Clostridium Histolyticum (CCH)
|
Total
n=153 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
43.2 years
STANDARD_DEVIATION 9.40 • n=99 Participants
|
42.7 years
STANDARD_DEVIATION 9.35 • n=107 Participants
|
43.0 years
STANDARD_DEVIATION 9.35 • n=206 Participants
|
|
Sex: Female, Male
Female
|
81 Participants
n=99 Participants
|
72 Participants
n=107 Participants
|
153 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
10 Participants
n=99 Participants
|
18 Participants
n=107 Participants
|
28 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
71 Participants
n=99 Participants
|
54 Participants
n=107 Participants
|
125 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
74 Participants
n=99 Participants
|
65 Participants
n=107 Participants
|
139 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
|
Weight
|
65.082 kg
STANDARD_DEVIATION 8.3341 • n=99 Participants
|
65.042 kg
STANDARD_DEVIATION 8.9403 • n=107 Participants
|
65.063 kg
STANDARD_DEVIATION 8.5961 • n=206 Participants
|
|
Height
|
164.548 cm
STANDARD_DEVIATION 6.2671 • n=99 Participants
|
165.192 cm
STANDARD_DEVIATION 6.6315 • n=107 Participants
|
164.851 cm
STANDARD_DEVIATION 6.4279 • n=206 Participants
|
|
BMI
|
24.03 kg/m^2
STANDARD_DEVIATION 2.640 • n=99 Participants
|
23.89 kg/m^2
STANDARD_DEVIATION 2.759 • n=107 Participants
|
23.96 kg/m^2
STANDARD_DEVIATION 2.689 • n=206 Participants
|
|
Skin Category (Fitzpatrick Scale)
I (Pale White)
|
2 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
|
Skin Category (Fitzpatrick Scale)
II (Fair)
|
33 Participants
n=99 Participants
|
24 Participants
n=107 Participants
|
57 Participants
n=206 Participants
|
|
Skin Category (Fitzpatrick Scale)
III (Darker White)
|
24 Participants
n=99 Participants
|
28 Participants
n=107 Participants
|
52 Participants
n=206 Participants
|
|
Skin Category (Fitzpatrick Scale)
IV (Light Brown)
|
18 Participants
n=99 Participants
|
14 Participants
n=107 Participants
|
32 Participants
n=206 Participants
|
|
Skin Category (Fitzpatrick Scale)
V (Brown)
|
4 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
8 Participants
n=206 Participants
|
|
Skin Category (Fitzpatrick Scale)
VI (Dark Brown or Black)
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: 90 DaysPopulation: Evaluable Population includes all participants who have at least 1 injection of study medication and have at least 1 I-GAIS evaluation
Investigator Global Aesthetic Improvement Scale (I-GAIS) is a 7-point scale rating global aesthetic improvement in appearance, compared to pretreatment, as judged by the investigator. The rating categories are "Very Much Worse", "Much Worse", "Worse", "No Change", "Improved", "Much Improved", and "Very Much Improved".
Outcome measures
| Measure |
Cohort 1: Posterolateral Thigh
n=63 Participants
EN3835 up to 1.68mg (Collagenase Clostridium Histolyticum)
EN3835: Collagenase Clostridium Histolyticum (CCH)
|
Cohort 2: Buttocks (Right)
EN3835 up to 1.68mg (Collagenase Clostridium Histolyticum)
EN3835: Collagenase Clostridium Histolyticum (CCH)
|
|---|---|---|
|
The Proportion of Participants With Improved (+1 or Better) Score on I-GAIS for Either Posterolateral Thigh
|
58 Participants
|
—
|
PRIMARY outcome
Timeframe: 90 DaysPopulation: Evaluable Population includes all participants who have at least 1 injection of study medication and have at least 1 I-GAIS evaluation
Investigator Global Aesthetic Improvement Scale (I-GAIS) is a 7-point scale rating global aesthetic improvement in appearance, compared to pretreatment, as judged by the investigator. The rating categories are "Very Much Worse", "Much Worse", "Worse", "No Change", "Improved", "Much Improved", and "Very Much Improved".
Outcome measures
| Measure |
Cohort 1: Posterolateral Thigh
n=61 Participants
EN3835 up to 1.68mg (Collagenase Clostridium Histolyticum)
EN3835: Collagenase Clostridium Histolyticum (CCH)
|
Cohort 2: Buttocks (Right)
EN3835 up to 1.68mg (Collagenase Clostridium Histolyticum)
EN3835: Collagenase Clostridium Histolyticum (CCH)
|
|---|---|---|
|
The Proportion of Participants With Improved (+1 or Better) Score on I-GAIS for Either Buttock
|
58 Participants
|
—
|
SECONDARY outcome
Timeframe: Day 22, 43, 90 and 180Population: Evaluable Population includes all participants who received at least 1 injection of study medication and had at least 1 I-GAIS evaluation. Number of participants analyzed are evaluable population participants that had a change from baseline at the specified visit
Clinician-Reported Photonumeric Cellulite Severity Scale (CR-PCSS) is a 5-point photonumeric scale rating cellulite severity from "0" (none) to "4" (severe) from a clinician's perspective.
Outcome measures
| Measure |
Cohort 1: Posterolateral Thigh
n=71 Participants
EN3835 up to 1.68mg (Collagenase Clostridium Histolyticum)
EN3835: Collagenase Clostridium Histolyticum (CCH)
|
Cohort 2: Buttocks (Right)
n=71 Participants
EN3835 up to 1.68mg (Collagenase Clostridium Histolyticum)
EN3835: Collagenase Clostridium Histolyticum (CCH)
|
|---|---|---|
|
Mean Change From Baseline in CR-PCSS for Each Buttock
Day 43
|
-0.6 units on a scale
Standard Deviation 0.63
|
-0.5 units on a scale
Standard Deviation 0.59
|
|
Mean Change From Baseline in CR-PCSS for Each Buttock
Day 22
|
-0.3 units on a scale
Standard Deviation 0.52
|
-0.3 units on a scale
Standard Deviation 0.50
|
|
Mean Change From Baseline in CR-PCSS for Each Buttock
Day 90
|
-0.7 units on a scale
Standard Deviation 0.70
|
-0.7 units on a scale
Standard Deviation 0.53
|
|
Mean Change From Baseline in CR-PCSS for Each Buttock
Day 180
|
-0.7 units on a scale
Standard Deviation 0.63
|
-0.6 units on a scale
Standard Deviation 0.63
|
SECONDARY outcome
Timeframe: Day 90, Day 180Population: Evaluable Population includes all participants who received at least 1 injection of study medication and had at least 1 I-GAIS evaluation.
The Body-Q Appraisal of Cellulite is a subset of questions from the Body-Q questionnaire developed to measure participant perceptions of weight loss and/or body contouring. The minimum possible score is 11 and the maximum possible score is 44. Higher scores indicate the individual is less bothered by their cellulite. Copyright Memorial Sloan-Kettering Cancer Center
Outcome measures
| Measure |
Cohort 1: Posterolateral Thigh
n=76 Participants
EN3835 up to 1.68mg (Collagenase Clostridium Histolyticum)
EN3835: Collagenase Clostridium Histolyticum (CCH)
|
Cohort 2: Buttocks (Right)
EN3835 up to 1.68mg (Collagenase Clostridium Histolyticum)
EN3835: Collagenase Clostridium Histolyticum (CCH)
|
|---|---|---|
|
Mean Change From Baseline in Body Q Appraisal of Cellulite for Posterolateral Thigh Based on Total Score
Day 90
|
10.9 units on a scale
Standard Deviation 9.84
|
—
|
|
Mean Change From Baseline in Body Q Appraisal of Cellulite for Posterolateral Thigh Based on Total Score
Day 180
|
10.9 units on a scale
Standard Deviation 9.76
|
—
|
SECONDARY outcome
Timeframe: Day 90, Day 180Population: Evaluable Population includes all participants who received at least 1 injection of study medication and had at least 1 I-GAIS evaluation.
The Body-Q Appraisal of Cellulite is a subset of questions from the Body-Q questionnaire developed to measure participant perceptions of weight loss and/or body contouring. The minimum possible score is 11 and the maximum possible score is 44. Higher scores indicate the individual is less bothered by their cellulite. Copyright Memorial Sloan-Kettering Cancer Center
Outcome measures
| Measure |
Cohort 1: Posterolateral Thigh
n=71 Participants
EN3835 up to 1.68mg (Collagenase Clostridium Histolyticum)
EN3835: Collagenase Clostridium Histolyticum (CCH)
|
Cohort 2: Buttocks (Right)
EN3835 up to 1.68mg (Collagenase Clostridium Histolyticum)
EN3835: Collagenase Clostridium Histolyticum (CCH)
|
|---|---|---|
|
Mean Change From Baseline in Body Q Appraisal of Cellulite for Buttock Based on Total Score
Day 90
|
8.8 units on a scale
Standard Deviation 8.38
|
—
|
|
Mean Change From Baseline in Body Q Appraisal of Cellulite for Buttock Based on Total Score
Day 180
|
8.8 units on a scale
Standard Deviation 9.57
|
—
|
SECONDARY outcome
Timeframe: Day 22, 43, and 180Population: Population includes all participants who received at least 1 injection of study medication and had at least 1 I-GAIS evaluation.
Investigator Global Aesthetic Improvement Scale (I-GAIS) is a 7-point scale rating global aesthetic improvement in appearance, compared to pretreatment, as judged by the investigator. The rating categories are "Very Much Worse", "Much Worse", "Worse", "No Change", "Improved", "Much Improved", and "Very Much Improved".
Outcome measures
| Measure |
Cohort 1: Posterolateral Thigh
n=76 Participants
EN3835 up to 1.68mg (Collagenase Clostridium Histolyticum)
EN3835: Collagenase Clostridium Histolyticum (CCH)
|
Cohort 2: Buttocks (Right)
EN3835 up to 1.68mg (Collagenase Clostridium Histolyticum)
EN3835: Collagenase Clostridium Histolyticum (CCH)
|
|---|---|---|
|
The Proportion of Participants With Improved (+1 or Better) Score on I GAIS for Either Posterolateral Thigh
Day 22
|
64 Participants
|
—
|
|
The Proportion of Participants With Improved (+1 or Better) Score on I GAIS for Either Posterolateral Thigh
Day 43
|
59 Participants
|
—
|
|
The Proportion of Participants With Improved (+1 or Better) Score on I GAIS for Either Posterolateral Thigh
Day 180
|
61 Participants
|
—
|
SECONDARY outcome
Timeframe: Day 22, 43, and 180Population: Evaluable Population includes all Participants who received at least 1 injection of study medication and had at least 1 I-GAIS evaluation
Investigator Global Aesthetic Improvement Scale (I-GAIS) is a 7-point scale rating global aesthetic improvement in appearance, compared to pretreatment, as judged by the investigator. The rating categories are "Very Much Worse", "Much Worse", "Worse", "No Change", "Improved", "Much Improved", and "Very Much Improved".
Outcome measures
| Measure |
Cohort 1: Posterolateral Thigh
n=71 Participants
EN3835 up to 1.68mg (Collagenase Clostridium Histolyticum)
EN3835: Collagenase Clostridium Histolyticum (CCH)
|
Cohort 2: Buttocks (Right)
EN3835 up to 1.68mg (Collagenase Clostridium Histolyticum)
EN3835: Collagenase Clostridium Histolyticum (CCH)
|
|---|---|---|
|
The Proportion of Participants With Improved (+1 or Better) Score on I-GAIS for Either Buttock
Day 22
|
50 Participants
|
—
|
|
The Proportion of Participants With Improved (+1 or Better) Score on I-GAIS for Either Buttock
Day 43
|
62 Participants
|
—
|
|
The Proportion of Participants With Improved (+1 or Better) Score on I-GAIS for Either Buttock
Day 180
|
59 Participants
|
—
|
SECONDARY outcome
Timeframe: Day 1, 90, and 180Population: Safety Population includes all participants who received at least 1 injection of study medication
Immunogenicity samples with a positive titer value will undergo a log transformation for analyses. Samples with titer level less than 10 were assigned or imputed as a log transformed titer of 1 for analyses
Outcome measures
| Measure |
Cohort 1: Posterolateral Thigh
n=81 Participants
EN3835 up to 1.68mg (Collagenase Clostridium Histolyticum)
EN3835: Collagenase Clostridium Histolyticum (CCH)
|
Cohort 2: Buttocks (Right)
n=81 Participants
EN3835 up to 1.68mg (Collagenase Clostridium Histolyticum)
EN3835: Collagenase Clostridium Histolyticum (CCH)
|
|---|---|---|
|
Percentage of Participants With Positive Antibody Titers for Anti-AUX-I and Anti AUX-II (Posterolateral Thigh)
Day 1
|
5 Participants
|
5 Participants
|
|
Percentage of Participants With Positive Antibody Titers for Anti-AUX-I and Anti AUX-II (Posterolateral Thigh)
Day 90
|
60 Participants
|
60 Participants
|
|
Percentage of Participants With Positive Antibody Titers for Anti-AUX-I and Anti AUX-II (Posterolateral Thigh)
Day 180
|
68 Participants
|
68 Participants
|
SECONDARY outcome
Timeframe: Day 1, 90 and 180Population: Safety Population includes all participants who received at least 1 injection of study medication
Immunogenicity samples with a positive titer value will undergo a log transformation for analyses. Samples with titer level less than 10 were assigned or imputed as a log transformed titer of 1 for analyses
Outcome measures
| Measure |
Cohort 1: Posterolateral Thigh
n=72 Participants
EN3835 up to 1.68mg (Collagenase Clostridium Histolyticum)
EN3835: Collagenase Clostridium Histolyticum (CCH)
|
Cohort 2: Buttocks (Right)
n=72 Participants
EN3835 up to 1.68mg (Collagenase Clostridium Histolyticum)
EN3835: Collagenase Clostridium Histolyticum (CCH)
|
|---|---|---|
|
Percentage of Participants With Positive Antibody Titers for Anti-AUX-I and Anti AUX-II (Buttocks)
Day 1
|
7 Participants
|
5 Participants
|
|
Percentage of Participants With Positive Antibody Titers for Anti-AUX-I and Anti AUX-II (Buttocks)
Day 90
|
61 Participants
|
61 Participants
|
|
Percentage of Participants With Positive Antibody Titers for Anti-AUX-I and Anti AUX-II (Buttocks)
Day 180
|
66 Participants
|
65 Participants
|
SECONDARY outcome
Timeframe: Day 1, 90 and 180Population: Subset of Safety Population samples were analyzed for NAbs. All the samples with positive ADAs for the participants who had had every other titer levels in the first quartile and fourth quartile of all positive ADAs at Day 90 (performed separately for AUX-I and AUX-II) were tested for NAb. Here, "Overall Number of Participants Analyzed" signifies those participants who were evaluable for the assessment. Percentages are based on number of participants tested for NAb at the visit.
All the samples with positive ADAs for the participants who had had every other titer levels in the first quartile and fourth quartile of all positive ADAs at Day 90 (performed separately for AUX-I and AUX-II) were tested for NAb.
Outcome measures
| Measure |
Cohort 1: Posterolateral Thigh
n=13 Participants
EN3835 up to 1.68mg (Collagenase Clostridium Histolyticum)
EN3835: Collagenase Clostridium Histolyticum (CCH)
|
Cohort 2: Buttocks (Right)
n=17 Participants
EN3835 up to 1.68mg (Collagenase Clostridium Histolyticum)
EN3835: Collagenase Clostridium Histolyticum (CCH)
|
|---|---|---|
|
Presence of Neutralizing Antibody (NAb) Anti AUX-I and AUX-II (Posterolateral Thigh)
Day 1 · Positive
|
1 Participants
|
0 Participants
|
|
Presence of Neutralizing Antibody (NAb) Anti AUX-I and AUX-II (Posterolateral Thigh)
Day 1 · Negative
|
1 Participants
|
1 Participants
|
|
Presence of Neutralizing Antibody (NAb) Anti AUX-I and AUX-II (Posterolateral Thigh)
Day 90 · Positive
|
13 Participants
|
16 Participants
|
|
Presence of Neutralizing Antibody (NAb) Anti AUX-I and AUX-II (Posterolateral Thigh)
Day 90 · Negative
|
0 Participants
|
1 Participants
|
|
Presence of Neutralizing Antibody (NAb) Anti AUX-I and AUX-II (Posterolateral Thigh)
Day 180 · Positive
|
8 Participants
|
12 Participants
|
|
Presence of Neutralizing Antibody (NAb) Anti AUX-I and AUX-II (Posterolateral Thigh)
Day 180 · Negative
|
3 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: Day 1, 90 and 180Population: Subset of Safety Population samples were analyzed for NAbs. All the samples with positive ADAs for the participants who had had every other titer levels in the first quartile and fourth quartile of all positive ADAs at Day 90 (performed separately for AUX-I and AUX-II) were tested for NAb. Here, "Overall Number of Participants Analyzed" signifies those participants who were evaluable for the assessment. Percentages are based on number of participants tested for NAb at the visit.
All the samples with positive ADAs for the participants who had had every other titer levels in the first quartile and fourth quartile of all positive ADAs at Day 90 (performed separately for AUX-I and AUX-II) were tested for NAb.
Outcome measures
| Measure |
Cohort 1: Posterolateral Thigh
n=17 Participants
EN3835 up to 1.68mg (Collagenase Clostridium Histolyticum)
EN3835: Collagenase Clostridium Histolyticum (CCH)
|
Cohort 2: Buttocks (Right)
n=13 Participants
EN3835 up to 1.68mg (Collagenase Clostridium Histolyticum)
EN3835: Collagenase Clostridium Histolyticum (CCH)
|
|---|---|---|
|
Presence of NAb Anti AUX-I and AUX-II (Buttocks)
Day 90 · Negative
|
2 Participants
|
4 Participants
|
|
Presence of NAb Anti AUX-I and AUX-II (Buttocks)
Day 1 · Positive
|
2 Participants
|
2 Participants
|
|
Presence of NAb Anti AUX-I and AUX-II (Buttocks)
Day 1 · Negative
|
0 Participants
|
0 Participants
|
|
Presence of NAb Anti AUX-I and AUX-II (Buttocks)
Day 90 · Positive
|
15 Participants
|
9 Participants
|
|
Presence of NAb Anti AUX-I and AUX-II (Buttocks)
Day 180 · Positive
|
15 Participants
|
9 Participants
|
|
Presence of NAb Anti AUX-I and AUX-II (Buttocks)
Day 180 · Negative
|
2 Participants
|
4 Participants
|
Adverse Events
Cohort 1: Posterolateral Thigh
Serious events: 0 serious events
Other events: 75 other events
Deaths: 0 deaths
Cohort 2: Buttocks
Serious events: 0 serious events
Other events: 69 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Cohort 1: Posterolateral Thigh
n=81 participants at risk
EN3835 up to 1.68mg (Collagenase Clostridium Histolyticum)
EN3835: Collagenase Clostridium Histolyticum (CCH)
|
Cohort 2: Buttocks
n=72 participants at risk
EN3835 up to 1.68mg (Collagenase Clostridium Histolyticum)
EN3835: Collagenase Clostridium Histolyticum (CCH)
|
|---|---|---|
|
General disorders
Injection site oedema
|
9.9%
8/81 • Number of events 34 • Time of informed consent signature until Day 180
All serious and non-serious AEs, whether elicited or observed during study visit or spontaneously reported by the participant, including events that occurred from the time the participant signed the study specific consent form until completion of or discharge from the study
|
6.9%
5/72 • Number of events 22 • Time of informed consent signature until Day 180
All serious and non-serious AEs, whether elicited or observed during study visit or spontaneously reported by the participant, including events that occurred from the time the participant signed the study specific consent form until completion of or discharge from the study
|
|
General disorders
Injection site pain
|
65.4%
53/81 • Number of events 244 • Time of informed consent signature until Day 180
All serious and non-serious AEs, whether elicited or observed during study visit or spontaneously reported by the participant, including events that occurred from the time the participant signed the study specific consent form until completion of or discharge from the study
|
79.2%
57/72 • Number of events 298 • Time of informed consent signature until Day 180
All serious and non-serious AEs, whether elicited or observed during study visit or spontaneously reported by the participant, including events that occurred from the time the participant signed the study specific consent form until completion of or discharge from the study
|
|
General disorders
Injection site pruritus
|
12.3%
10/81 • Number of events 37 • Time of informed consent signature until Day 180
All serious and non-serious AEs, whether elicited or observed during study visit or spontaneously reported by the participant, including events that occurred from the time the participant signed the study specific consent form until completion of or discharge from the study
|
19.4%
14/72 • Number of events 35 • Time of informed consent signature until Day 180
All serious and non-serious AEs, whether elicited or observed during study visit or spontaneously reported by the participant, including events that occurred from the time the participant signed the study specific consent form until completion of or discharge from the study
|
|
General disorders
Injection site rash
|
1.2%
1/81 • Number of events 2 • Time of informed consent signature until Day 180
All serious and non-serious AEs, whether elicited or observed during study visit or spontaneously reported by the participant, including events that occurred from the time the participant signed the study specific consent form until completion of or discharge from the study
|
0.00%
0/72 • Time of informed consent signature until Day 180
All serious and non-serious AEs, whether elicited or observed during study visit or spontaneously reported by the participant, including events that occurred from the time the participant signed the study specific consent form until completion of or discharge from the study
|
|
General disorders
Injection site bruising
|
86.4%
70/81 • Number of events 311 • Time of informed consent signature until Day 180
All serious and non-serious AEs, whether elicited or observed during study visit or spontaneously reported by the participant, including events that occurred from the time the participant signed the study specific consent form until completion of or discharge from the study
|
93.1%
67/72 • Number of events 327 • Time of informed consent signature until Day 180
All serious and non-serious AEs, whether elicited or observed during study visit or spontaneously reported by the participant, including events that occurred from the time the participant signed the study specific consent form until completion of or discharge from the study
|
|
General disorders
Injection site dermatitis
|
0.00%
0/81 • Time of informed consent signature until Day 180
All serious and non-serious AEs, whether elicited or observed during study visit or spontaneously reported by the participant, including events that occurred from the time the participant signed the study specific consent form until completion of or discharge from the study
|
1.4%
1/72 • Number of events 1 • Time of informed consent signature until Day 180
All serious and non-serious AEs, whether elicited or observed during study visit or spontaneously reported by the participant, including events that occurred from the time the participant signed the study specific consent form until completion of or discharge from the study
|
|
General disorders
Injection site discolouration
|
17.3%
14/81 • Number of events 32 • Time of informed consent signature until Day 180
All serious and non-serious AEs, whether elicited or observed during study visit or spontaneously reported by the participant, including events that occurred from the time the participant signed the study specific consent form until completion of or discharge from the study
|
33.3%
24/72 • Number of events 46 • Time of informed consent signature until Day 180
All serious and non-serious AEs, whether elicited or observed during study visit or spontaneously reported by the participant, including events that occurred from the time the participant signed the study specific consent form until completion of or discharge from the study
|
|
General disorders
Injection site erythema
|
1.2%
1/81 • Number of events 1 • Time of informed consent signature until Day 180
All serious and non-serious AEs, whether elicited or observed during study visit or spontaneously reported by the participant, including events that occurred from the time the participant signed the study specific consent form until completion of or discharge from the study
|
0.00%
0/72 • Time of informed consent signature until Day 180
All serious and non-serious AEs, whether elicited or observed during study visit or spontaneously reported by the participant, including events that occurred from the time the participant signed the study specific consent form until completion of or discharge from the study
|
|
General disorders
Injection site haemorrhage
|
3.7%
3/81 • Number of events 18 • Time of informed consent signature until Day 180
All serious and non-serious AEs, whether elicited or observed during study visit or spontaneously reported by the participant, including events that occurred from the time the participant signed the study specific consent form until completion of or discharge from the study
|
2.8%
2/72 • Number of events 12 • Time of informed consent signature until Day 180
All serious and non-serious AEs, whether elicited or observed during study visit or spontaneously reported by the participant, including events that occurred from the time the participant signed the study specific consent form until completion of or discharge from the study
|
|
General disorders
Injection site mass
|
4.9%
4/81 • Number of events 7 • Time of informed consent signature until Day 180
All serious and non-serious AEs, whether elicited or observed during study visit or spontaneously reported by the participant, including events that occurred from the time the participant signed the study specific consent form until completion of or discharge from the study
|
6.9%
5/72 • Number of events 10 • Time of informed consent signature until Day 180
All serious and non-serious AEs, whether elicited or observed during study visit or spontaneously reported by the participant, including events that occurred from the time the participant signed the study specific consent form until completion of or discharge from the study
|
|
General disorders
Injection site nodule
|
8.6%
7/81 • Number of events 17 • Time of informed consent signature until Day 180
All serious and non-serious AEs, whether elicited or observed during study visit or spontaneously reported by the participant, including events that occurred from the time the participant signed the study specific consent form until completion of or discharge from the study
|
6.9%
5/72 • Number of events 14 • Time of informed consent signature until Day 180
All serious and non-serious AEs, whether elicited or observed during study visit or spontaneously reported by the participant, including events that occurred from the time the participant signed the study specific consent form until completion of or discharge from the study
|
|
General disorders
Injection site reaction
|
2.5%
2/81 • Number of events 3 • Time of informed consent signature until Day 180
All serious and non-serious AEs, whether elicited or observed during study visit or spontaneously reported by the participant, including events that occurred from the time the participant signed the study specific consent form until completion of or discharge from the study
|
0.00%
0/72 • Time of informed consent signature until Day 180
All serious and non-serious AEs, whether elicited or observed during study visit or spontaneously reported by the participant, including events that occurred from the time the participant signed the study specific consent form until completion of or discharge from the study
|
|
General disorders
Injection site swelling
|
14.8%
12/81 • Number of events 32 • Time of informed consent signature until Day 180
All serious and non-serious AEs, whether elicited or observed during study visit or spontaneously reported by the participant, including events that occurred from the time the participant signed the study specific consent form until completion of or discharge from the study
|
18.1%
13/72 • Number of events 34 • Time of informed consent signature until Day 180
All serious and non-serious AEs, whether elicited or observed during study visit or spontaneously reported by the participant, including events that occurred from the time the participant signed the study specific consent form until completion of or discharge from the study
|
|
General disorders
Injection site warmth
|
1.2%
1/81 • Number of events 2 • Time of informed consent signature until Day 180
All serious and non-serious AEs, whether elicited or observed during study visit or spontaneously reported by the participant, including events that occurred from the time the participant signed the study specific consent form until completion of or discharge from the study
|
0.00%
0/72 • Time of informed consent signature until Day 180
All serious and non-serious AEs, whether elicited or observed during study visit or spontaneously reported by the participant, including events that occurred from the time the participant signed the study specific consent form until completion of or discharge from the study
|
|
General disorders
Pyrexia
|
0.00%
0/81 • Time of informed consent signature until Day 180
All serious and non-serious AEs, whether elicited or observed during study visit or spontaneously reported by the participant, including events that occurred from the time the participant signed the study specific consent form until completion of or discharge from the study
|
1.4%
1/72 • Number of events 1 • Time of informed consent signature until Day 180
All serious and non-serious AEs, whether elicited or observed during study visit or spontaneously reported by the participant, including events that occurred from the time the participant signed the study specific consent form until completion of or discharge from the study
|
|
Immune system disorders
Drug hypersensitivity
|
1.2%
1/81 • Number of events 1 • Time of informed consent signature until Day 180
All serious and non-serious AEs, whether elicited or observed during study visit or spontaneously reported by the participant, including events that occurred from the time the participant signed the study specific consent form until completion of or discharge from the study
|
0.00%
0/72 • Time of informed consent signature until Day 180
All serious and non-serious AEs, whether elicited or observed during study visit or spontaneously reported by the participant, including events that occurred from the time the participant signed the study specific consent form until completion of or discharge from the study
|
|
Infections and infestations
Nasopharyngitis
|
2.5%
2/81 • Number of events 3 • Time of informed consent signature until Day 180
All serious and non-serious AEs, whether elicited or observed during study visit or spontaneously reported by the participant, including events that occurred from the time the participant signed the study specific consent form until completion of or discharge from the study
|
0.00%
0/72 • Time of informed consent signature until Day 180
All serious and non-serious AEs, whether elicited or observed during study visit or spontaneously reported by the participant, including events that occurred from the time the participant signed the study specific consent form until completion of or discharge from the study
|
|
Infections and infestations
Oral herpes
|
1.2%
1/81 • Number of events 2 • Time of informed consent signature until Day 180
All serious and non-serious AEs, whether elicited or observed during study visit or spontaneously reported by the participant, including events that occurred from the time the participant signed the study specific consent form until completion of or discharge from the study
|
0.00%
0/72 • Time of informed consent signature until Day 180
All serious and non-serious AEs, whether elicited or observed during study visit or spontaneously reported by the participant, including events that occurred from the time the participant signed the study specific consent form until completion of or discharge from the study
|
|
Infections and infestations
Sinusitis
|
1.2%
1/81 • Number of events 1 • Time of informed consent signature until Day 180
All serious and non-serious AEs, whether elicited or observed during study visit or spontaneously reported by the participant, including events that occurred from the time the participant signed the study specific consent form until completion of or discharge from the study
|
0.00%
0/72 • Time of informed consent signature until Day 180
All serious and non-serious AEs, whether elicited or observed during study visit or spontaneously reported by the participant, including events that occurred from the time the participant signed the study specific consent form until completion of or discharge from the study
|
|
Infections and infestations
Urinary tract infection
|
2.5%
2/81 • Number of events 2 • Time of informed consent signature until Day 180
All serious and non-serious AEs, whether elicited or observed during study visit or spontaneously reported by the participant, including events that occurred from the time the participant signed the study specific consent form until completion of or discharge from the study
|
1.4%
1/72 • Number of events 1 • Time of informed consent signature until Day 180
All serious and non-serious AEs, whether elicited or observed during study visit or spontaneously reported by the participant, including events that occurred from the time the participant signed the study specific consent form until completion of or discharge from the study
|
|
Injury, poisoning and procedural complications
Thermal burn
|
1.2%
1/81 • Number of events 1 • Time of informed consent signature until Day 180
All serious and non-serious AEs, whether elicited or observed during study visit or spontaneously reported by the participant, including events that occurred from the time the participant signed the study specific consent form until completion of or discharge from the study
|
0.00%
0/72 • Time of informed consent signature until Day 180
All serious and non-serious AEs, whether elicited or observed during study visit or spontaneously reported by the participant, including events that occurred from the time the participant signed the study specific consent form until completion of or discharge from the study
|
|
Investigations
Alanine aminotransferase increased
|
1.2%
1/81 • Number of events 1 • Time of informed consent signature until Day 180
All serious and non-serious AEs, whether elicited or observed during study visit or spontaneously reported by the participant, including events that occurred from the time the participant signed the study specific consent form until completion of or discharge from the study
|
0.00%
0/72 • Time of informed consent signature until Day 180
All serious and non-serious AEs, whether elicited or observed during study visit or spontaneously reported by the participant, including events that occurred from the time the participant signed the study specific consent form until completion of or discharge from the study
|
|
Investigations
Aspartate aminotransferase increased
|
1.2%
1/81 • Number of events 1 • Time of informed consent signature until Day 180
All serious and non-serious AEs, whether elicited or observed during study visit or spontaneously reported by the participant, including events that occurred from the time the participant signed the study specific consent form until completion of or discharge from the study
|
0.00%
0/72 • Time of informed consent signature until Day 180
All serious and non-serious AEs, whether elicited or observed during study visit or spontaneously reported by the participant, including events that occurred from the time the participant signed the study specific consent form until completion of or discharge from the study
|
|
Investigations
Blood potassium increased
|
0.00%
0/81 • Time of informed consent signature until Day 180
All serious and non-serious AEs, whether elicited or observed during study visit or spontaneously reported by the participant, including events that occurred from the time the participant signed the study specific consent form until completion of or discharge from the study
|
1.4%
1/72 • Number of events 1 • Time of informed consent signature until Day 180
All serious and non-serious AEs, whether elicited or observed during study visit or spontaneously reported by the participant, including events that occurred from the time the participant signed the study specific consent form until completion of or discharge from the study
|
|
Investigations
Blood sodium increased
|
1.2%
1/81 • Number of events 1 • Time of informed consent signature until Day 180
All serious and non-serious AEs, whether elicited or observed during study visit or spontaneously reported by the participant, including events that occurred from the time the participant signed the study specific consent form until completion of or discharge from the study
|
0.00%
0/72 • Time of informed consent signature until Day 180
All serious and non-serious AEs, whether elicited or observed during study visit or spontaneously reported by the participant, including events that occurred from the time the participant signed the study specific consent form until completion of or discharge from the study
|
|
Investigations
Blood urine present
|
1.2%
1/81 • Number of events 1 • Time of informed consent signature until Day 180
All serious and non-serious AEs, whether elicited or observed during study visit or spontaneously reported by the participant, including events that occurred from the time the participant signed the study specific consent form until completion of or discharge from the study
|
0.00%
0/72 • Time of informed consent signature until Day 180
All serious and non-serious AEs, whether elicited or observed during study visit or spontaneously reported by the participant, including events that occurred from the time the participant signed the study specific consent form until completion of or discharge from the study
|
|
Investigations
Coronavirus test positive
|
0.00%
0/81 • Time of informed consent signature until Day 180
All serious and non-serious AEs, whether elicited or observed during study visit or spontaneously reported by the participant, including events that occurred from the time the participant signed the study specific consent form until completion of or discharge from the study
|
1.4%
1/72 • Number of events 1 • Time of informed consent signature until Day 180
All serious and non-serious AEs, whether elicited or observed during study visit or spontaneously reported by the participant, including events that occurred from the time the participant signed the study specific consent form until completion of or discharge from the study
|
|
Investigations
Hepatic enzyme increased
|
1.2%
1/81 • Number of events 1 • Time of informed consent signature until Day 180
All serious and non-serious AEs, whether elicited or observed during study visit or spontaneously reported by the participant, including events that occurred from the time the participant signed the study specific consent form until completion of or discharge from the study
|
0.00%
0/72 • Time of informed consent signature until Day 180
All serious and non-serious AEs, whether elicited or observed during study visit or spontaneously reported by the participant, including events that occurred from the time the participant signed the study specific consent form until completion of or discharge from the study
|
|
Investigations
Nitrite urine present
|
0.00%
0/81 • Time of informed consent signature until Day 180
All serious and non-serious AEs, whether elicited or observed during study visit or spontaneously reported by the participant, including events that occurred from the time the participant signed the study specific consent form until completion of or discharge from the study
|
1.4%
1/72 • Number of events 1 • Time of informed consent signature until Day 180
All serious and non-serious AEs, whether elicited or observed during study visit or spontaneously reported by the participant, including events that occurred from the time the participant signed the study specific consent form until completion of or discharge from the study
|
|
Investigations
Urine ketone body present
|
1.2%
1/81 • Number of events 1 • Time of informed consent signature until Day 180
All serious and non-serious AEs, whether elicited or observed during study visit or spontaneously reported by the participant, including events that occurred from the time the participant signed the study specific consent form until completion of or discharge from the study
|
0.00%
0/72 • Time of informed consent signature until Day 180
All serious and non-serious AEs, whether elicited or observed during study visit or spontaneously reported by the participant, including events that occurred from the time the participant signed the study specific consent form until completion of or discharge from the study
|
|
Investigations
Urine leukocyte esterase positive
|
0.00%
0/81 • Time of informed consent signature until Day 180
All serious and non-serious AEs, whether elicited or observed during study visit or spontaneously reported by the participant, including events that occurred from the time the participant signed the study specific consent form until completion of or discharge from the study
|
1.4%
1/72 • Number of events 1 • Time of informed consent signature until Day 180
All serious and non-serious AEs, whether elicited or observed during study visit or spontaneously reported by the participant, including events that occurred from the time the participant signed the study specific consent form until completion of or discharge from the study
|
|
Investigations
White blood cell count increased
|
1.2%
1/81 • Number of events 1 • Time of informed consent signature until Day 180
All serious and non-serious AEs, whether elicited or observed during study visit or spontaneously reported by the participant, including events that occurred from the time the participant signed the study specific consent form until completion of or discharge from the study
|
1.4%
1/72 • Number of events 1 • Time of informed consent signature until Day 180
All serious and non-serious AEs, whether elicited or observed during study visit or spontaneously reported by the participant, including events that occurred from the time the participant signed the study specific consent form until completion of or discharge from the study
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
1.2%
1/81 • Number of events 1 • Time of informed consent signature until Day 180
All serious and non-serious AEs, whether elicited or observed during study visit or spontaneously reported by the participant, including events that occurred from the time the participant signed the study specific consent form until completion of or discharge from the study
|
0.00%
0/72 • Time of informed consent signature until Day 180
All serious and non-serious AEs, whether elicited or observed during study visit or spontaneously reported by the participant, including events that occurred from the time the participant signed the study specific consent form until completion of or discharge from the study
|
|
Nervous system disorders
Dizziness
|
1.2%
1/81 • Number of events 1 • Time of informed consent signature until Day 180
All serious and non-serious AEs, whether elicited or observed during study visit or spontaneously reported by the participant, including events that occurred from the time the participant signed the study specific consent form until completion of or discharge from the study
|
0.00%
0/72 • Time of informed consent signature until Day 180
All serious and non-serious AEs, whether elicited or observed during study visit or spontaneously reported by the participant, including events that occurred from the time the participant signed the study specific consent form until completion of or discharge from the study
|
|
Nervous system disorders
Migraine
|
1.2%
1/81 • Number of events 1 • Time of informed consent signature until Day 180
All serious and non-serious AEs, whether elicited or observed during study visit or spontaneously reported by the participant, including events that occurred from the time the participant signed the study specific consent form until completion of or discharge from the study
|
0.00%
0/72 • Time of informed consent signature until Day 180
All serious and non-serious AEs, whether elicited or observed during study visit or spontaneously reported by the participant, including events that occurred from the time the participant signed the study specific consent form until completion of or discharge from the study
|
|
Psychiatric disorders
Anxiety
|
1.2%
1/81 • Number of events 1 • Time of informed consent signature until Day 180
All serious and non-serious AEs, whether elicited or observed during study visit or spontaneously reported by the participant, including events that occurred from the time the participant signed the study specific consent form until completion of or discharge from the study
|
0.00%
0/72 • Time of informed consent signature until Day 180
All serious and non-serious AEs, whether elicited or observed during study visit or spontaneously reported by the participant, including events that occurred from the time the participant signed the study specific consent form until completion of or discharge from the study
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/81 • Time of informed consent signature until Day 180
All serious and non-serious AEs, whether elicited or observed during study visit or spontaneously reported by the participant, including events that occurred from the time the participant signed the study specific consent form until completion of or discharge from the study
|
1.4%
1/72 • Number of events 1 • Time of informed consent signature until Day 180
All serious and non-serious AEs, whether elicited or observed during study visit or spontaneously reported by the participant, including events that occurred from the time the participant signed the study specific consent form until completion of or discharge from the study
|
|
Skin and subcutaneous tissue disorders
Diffuse alopecia
|
0.00%
0/81 • Time of informed consent signature until Day 180
All serious and non-serious AEs, whether elicited or observed during study visit or spontaneously reported by the participant, including events that occurred from the time the participant signed the study specific consent form until completion of or discharge from the study
|
1.4%
1/72 • Number of events 1 • Time of informed consent signature until Day 180
All serious and non-serious AEs, whether elicited or observed during study visit or spontaneously reported by the participant, including events that occurred from the time the participant signed the study specific consent form until completion of or discharge from the study
|
|
Skin and subcutaneous tissue disorders
Post-inflammatory pigmentation change
|
6.2%
5/81 • Number of events 10 • Time of informed consent signature until Day 180
All serious and non-serious AEs, whether elicited or observed during study visit or spontaneously reported by the participant, including events that occurred from the time the participant signed the study specific consent form until completion of or discharge from the study
|
2.8%
2/72 • Number of events 4 • Time of informed consent signature until Day 180
All serious and non-serious AEs, whether elicited or observed during study visit or spontaneously reported by the participant, including events that occurred from the time the participant signed the study specific consent form until completion of or discharge from the study
|
|
Vascular disorders
Hypertension
|
1.2%
1/81 • Number of events 1 • Time of informed consent signature until Day 180
All serious and non-serious AEs, whether elicited or observed during study visit or spontaneously reported by the participant, including events that occurred from the time the participant signed the study specific consent form until completion of or discharge from the study
|
0.00%
0/72 • Time of informed consent signature until Day 180
All serious and non-serious AEs, whether elicited or observed during study visit or spontaneously reported by the participant, including events that occurred from the time the participant signed the study specific consent form until completion of or discharge from the study
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place