Trial Outcomes & Findings for Investigation of the Effectiveness and Safety of MRZF111 in the Treatment of Décolleté Wrinkles (NCT NCT04177212)
NCT ID: NCT04177212
Last Updated: 2023-12-26
Results Overview
The percentage of responders (responder rate) was defined as greater than or equal to (\>=) 1-point improvement on MAS décolleté wrinkles from baseline to 16 weeks after last treatment as assessed by the blinded live rater. Responder rate for décolleté wrinkles at rest was assessed using MAS-at rest scale. The MAS-at rest scale included five-point scale: 0 = no wrinkles, 1 = mild wrinkles, 2 = moderate wrinkles, 3 = severe wrinkles, 4 = very severe wrinkles. The higher score indicated the worst outcome.
COMPLETED
NA
117 participants
16 weeks after the last treatment on Week 16 (at Week 32)
2023-12-26
Participant Flow
This study was conducted at 9 investigational sites in Germany from 04 December 2019 to 23 February 2021. A total of 117 participants were enrolled and randomized in the study, out of which 90 participants completed the study.
Primary effectiveness analysis was done on pooled data.Further supportive explorative analyses done separately by Groups A and B for primary effectiveness outcome measure(OM) and for secondary effectiveness OM 2,but this analysis was not part of main primary effectiveness analysis.As per planned analysis based on protocol and SAP,data for secondary effectiveness outcome measures(3 to 6)were planned to be analyzed for pooled treatment groups,hence pooled data reported for these outcome measures.
Participant milestones
| Measure |
Group A: MRZF111 (3 Injections)
Participants received three injections of MRZF111, a subdermal injection in the central part of the décolleté area on Day 1, Week 8, and Week 16. Participants received a total volume of 13.5 milliliter (mL) MRZF111 over the complete course of treatment.
|
Group B: MRZF111 (2 Injections)
Participants received two injections of MRZF111, a subdermal injection in the central part of the décolleté area on Day 1 and Week 16. Participants received a total volume of 9.0 mL MRZF111 over the complete course of treatment.
|
|---|---|---|
|
Overall Study
STARTED
|
55
|
62
|
|
Overall Study
Safety Analysis Set
|
43
|
74
|
|
Overall Study
Modified Full Analysis Set
|
46
|
71
|
|
Overall Study
COMPLETED
|
43
|
47
|
|
Overall Study
NOT COMPLETED
|
12
|
15
|
Reasons for withdrawal
| Measure |
Group A: MRZF111 (3 Injections)
Participants received three injections of MRZF111, a subdermal injection in the central part of the décolleté area on Day 1, Week 8, and Week 16. Participants received a total volume of 13.5 milliliter (mL) MRZF111 over the complete course of treatment.
|
Group B: MRZF111 (2 Injections)
Participants received two injections of MRZF111, a subdermal injection in the central part of the décolleté area on Day 1 and Week 16. Participants received a total volume of 9.0 mL MRZF111 over the complete course of treatment.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
9
|
7
|
|
Overall Study
Due to COVID-19 Pandemic
|
1
|
2
|
|
Overall Study
Physician Decision
|
1
|
0
|
|
Overall Study
Lost to Follow-up
|
0
|
3
|
|
Overall Study
Adverse Event
|
0
|
1
|
|
Overall Study
Other
|
1
|
2
|
Baseline Characteristics
Investigation of the Effectiveness and Safety of MRZF111 in the Treatment of Décolleté Wrinkles
Baseline characteristics by cohort
| Measure |
Group A: MRZF111 (3 Injections)
n=43 Participants
Participants received three injections of MRZF111, a subdermal injection in the central part of the décolleté area on Day 1, Week 8, and Week 16. Participants received a total volume of 13.5 mL MRZF111 over the complete course of treatment.
|
Group B: MRZF111 (2 Injections)
n=74 Participants
Participants received two injections of MRZF111, a subdermal injection in the central part of the décolleté area on Day 1 and Week 16. Participants received a total volume of 9.0 mL MRZF111 over the complete course of treatment.
|
Total
n=117 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
53.2 years
STANDARD_DEVIATION 6.0 • n=5 Participants
|
52.8 years
STANDARD_DEVIATION 7.3 • n=7 Participants
|
53.0 years
STANDARD_DEVIATION 6.8 • n=5 Participants
|
|
Sex: Female, Male
Female
|
43 Participants
n=5 Participants
|
74 Participants
n=7 Participants
|
117 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
43 Participants
n=5 Participants
|
74 Participants
n=7 Participants
|
117 Participants
n=5 Participants
|
|
Body Mass Index (BMI)
|
24.0 kilogram per square meter (kg/m^2)
STANDARD_DEVIATION 3.9 • n=5 Participants
|
23.8 kilogram per square meter (kg/m^2)
STANDARD_DEVIATION 3.4 • n=7 Participants
|
23.9 kilogram per square meter (kg/m^2)
STANDARD_DEVIATION 3.5 • n=5 Participants
|
PRIMARY outcome
Timeframe: 16 weeks after the last treatment on Week 16 (at Week 32)Population: The modified full analysis set (FAS) included participants who were treated at least once. Here, overall number of participants analyzed signifies participants who were evaluable for this outcome measure. Modified FAS (observed cases) was used for Groups A and B. Modified FAS (missing data imputed via multiple imputation approach) was used for pooled treatment group.
The percentage of responders (responder rate) was defined as greater than or equal to (\>=) 1-point improvement on MAS décolleté wrinkles from baseline to 16 weeks after last treatment as assessed by the blinded live rater. Responder rate for décolleté wrinkles at rest was assessed using MAS-at rest scale. The MAS-at rest scale included five-point scale: 0 = no wrinkles, 1 = mild wrinkles, 2 = moderate wrinkles, 3 = severe wrinkles, 4 = very severe wrinkles. The higher score indicated the worst outcome.
Outcome measures
| Measure |
Group A: MRZF111 (3 Injections)
n=39 Participants
Participants received three injections of MRZF111, a subdermal injection in the central part of the décolleté area on Day 1, Week 8, and Week 16. Participants received a total volume of 13.5 mL MRZF111 over the complete course of treatment.
|
Group B: MRZF111 (2 Injections)
n=49 Participants
Participants received two injections of MRZF111, a subdermal injection in the central part of the décolleté area on Day 1 and Week 16. Participants received a total volume of 9.0 mL MRZF111 over the complete course of treatment.
|
Pooled Treatment Group (Group A: MRZF111 [3 Injections] + Group B: MRZF111 [2 Injections])
n=117 Participants
Participants received MRZF111 subdermal injection in the central part of the décolleté area (Group A: three injections on Day 1, Week 8, and Week 16; Group B: two injections on Day 1 and Week 16). Participants received a total volume of 13.5 mL (Group A) or 9.0 mL (Group B) MRZF111 over the complete course of treatment.
|
|---|---|---|---|
|
Responder Rate for Décolleté Wrinkles According to the Merz Aesthetics Scale (MAS)-At Rest Scale as Assessed by the Blinded Live Rater
|
71.8 percentage of participants
Interval 56.2 to 83.5
|
83.7 percentage of participants
Interval 71.0 to 91.5
|
73.5 percentage of participants
Interval 62.8 to 82.5
|
SECONDARY outcome
Timeframe: 16 weeks after the last treatment on Week 16 (at Week 32)Population: The modified FAS included participants who were treated at least once. Here, overall number of participants analyzed signifies participants who were evaluable for this outcome measure. Modified FAS (observed cases) was used for Groups A and B. Modified FAS (missing data imputed with LOCF) was used for pooled treatment group.
The percentage of responders (responder rate) was defined as \>= 1-point improvement on MAS décolleté wrinkles from baseline to 16 weeks after last treatment as assessed by the blinded live rater. Responder rate for décolleté wrinkles at dynamic was assessed using MAS-Dynamic Scale. The MAS-Dynamic Scale included five-point scale: 0 = no wrinkles, 1 = mild wrinkles, 2 = moderate wrinkles, 3 = severe wrinkles, 4 = very severe wrinkles. The higher score indicated the worst outcome.
Outcome measures
| Measure |
Group A: MRZF111 (3 Injections)
n=39 Participants
Participants received three injections of MRZF111, a subdermal injection in the central part of the décolleté area on Day 1, Week 8, and Week 16. Participants received a total volume of 13.5 mL MRZF111 over the complete course of treatment.
|
Group B: MRZF111 (2 Injections)
n=49 Participants
Participants received two injections of MRZF111, a subdermal injection in the central part of the décolleté area on Day 1 and Week 16. Participants received a total volume of 9.0 mL MRZF111 over the complete course of treatment.
|
Pooled Treatment Group (Group A: MRZF111 [3 Injections] + Group B: MRZF111 [2 Injections])
n=117 Participants
Participants received MRZF111 subdermal injection in the central part of the décolleté area (Group A: three injections on Day 1, Week 8, and Week 16; Group B: two injections on Day 1 and Week 16). Participants received a total volume of 13.5 mL (Group A) or 9.0 mL (Group B) MRZF111 over the complete course of treatment.
|
|---|---|---|---|
|
Responder Rate for Décolleté Wrinkles According to the MAS-Dynamic Scale as Assessed by the Blinded Live Rater (Last Observation Carried Forward [LOCF])
|
74.4 percentage of participants
Interval 58.9 to 85.4
|
69.4 percentage of participants
Interval 55.5 to 80.5
|
65.8 percentage of participants
Interval 56.8 to 73.8
|
SECONDARY outcome
Timeframe: 16 weeks after the last treatment on Week 16 (at Week 32)Population: The modified pooled FAS included participants who were treated at least once. As per the planned analysis based on protocol and SAP, this secondary effectiveness outcome measure was planned to be analyzed for the pooled treatment groups as Groups A and B comparison was not objective of this investigation, hence pooled data was reported for this secondary outcome measure.
Treatment satisfaction is defined as a rating of +3 (Very satisfied), +2 (Satisfied) or +1 (Somewhat satisfied). The treating investigators were asked to rate their level of satisfaction with the aesthetic appearance of the participant's décolleté after treatment. The investigator responded on a 7-point scale: - 3 = very dissatisfied, - 2 = dissatisfied, - 1 = somewhat dissatisfied, 0 = neither satisfied nor dissatisfied, + 1 = somewhat satisfied, + 2 = satisfied, + 3 = very satisfied. The higher score indicated aesthetic improvement.
Outcome measures
| Measure |
Group A: MRZF111 (3 Injections)
n=117 Participants
Participants received three injections of MRZF111, a subdermal injection in the central part of the décolleté area on Day 1, Week 8, and Week 16. Participants received a total volume of 13.5 mL MRZF111 over the complete course of treatment.
|
Group B: MRZF111 (2 Injections)
Participants received two injections of MRZF111, a subdermal injection in the central part of the décolleté area on Day 1 and Week 16. Participants received a total volume of 9.0 mL MRZF111 over the complete course of treatment.
|
Pooled Treatment Group (Group A: MRZF111 [3 Injections] + Group B: MRZF111 [2 Injections])
Participants received MRZF111 subdermal injection in the central part of the décolleté area (Group A: three injections on Day 1, Week 8, and Week 16; Group B: two injections on Day 1 and Week 16). Participants received a total volume of 13.5 mL (Group A) or 9.0 mL (Group B) MRZF111 over the complete course of treatment.
|
|---|---|---|---|
|
Percentage of Participants With Aesthetic Improvement After the Décolleté Wrinkles Treatments Based on Investigator's Treatment Satisfaction Assessment Scale (LOCF)
|
76.9 percentage of participants
Interval 68.5 to 83.6
|
—
|
—
|
SECONDARY outcome
Timeframe: 16 weeks after the last treatment on Week 16 (at Week 32)Population: The modified pooled FAS included participants who were treated at least once. As per the planned analysis based on protocol and SAP, this secondary effectiveness outcome measure was planned to be analyzed for the pooled treatment groups as Groups A and B comparison was not objective of this investigation, hence pooled data was reported for this secondary outcome measure.
Treatment satisfaction is defined as a rating of +3 (Very satisfied), +2 (Satisfied) or +1 (Somewhat satisfied). The participants were asked to rate their level of satisfaction with the aesthetic appearance of their décolleté after treatment. The participants responded on a 7-point scale: - 3 = very dissatisfied, - 2 = dissatisfied, - 1 = somewhat dissatisfied, 0 = neither satisfied nor dissatisfied, + 1 = somewhat satisfied, + 2 = satisfied, + 3 = very satisfied. The higher score indicated aesthetic improvement.
Outcome measures
| Measure |
Group A: MRZF111 (3 Injections)
n=117 Participants
Participants received three injections of MRZF111, a subdermal injection in the central part of the décolleté area on Day 1, Week 8, and Week 16. Participants received a total volume of 13.5 mL MRZF111 over the complete course of treatment.
|
Group B: MRZF111 (2 Injections)
Participants received two injections of MRZF111, a subdermal injection in the central part of the décolleté area on Day 1 and Week 16. Participants received a total volume of 9.0 mL MRZF111 over the complete course of treatment.
|
Pooled Treatment Group (Group A: MRZF111 [3 Injections] + Group B: MRZF111 [2 Injections])
Participants received MRZF111 subdermal injection in the central part of the décolleté area (Group A: three injections on Day 1, Week 8, and Week 16; Group B: two injections on Day 1 and Week 16). Participants received a total volume of 13.5 mL (Group A) or 9.0 mL (Group B) MRZF111 over the complete course of treatment.
|
|---|---|---|---|
|
Percentage of Participants With Aesthetic Improvement After the Décolleté Wrinkles Treatments Based on Participant's Treatment Satisfaction Assessment Scale (LOCF)
|
70.1 percentage of participants
Interval 61.3 to 77.6
|
—
|
—
|
SECONDARY outcome
Timeframe: 16 weeks after the last treatment on Week 16 (at Week 32)Population: The modified pooled FAS included participants who were treated at least once. As per the planned analysis based on protocol and SAP, this secondary effectiveness outcome measure was planned to be analyzed for the pooled treatment groups as Groups A and B comparison was not objective of this investigation, hence pooled data was reported for this secondary outcome measure.
Improvement is defined as a rating of +1 (Improved), +2 (Much improved) or +3 (Very much improved). Treating investigators used iGAIS-Wrinkles to assess aesthetic improvement in participants. The assessment was performed by treating investigator by live rating using standardized pre-treatment photographs for comparison. Treating investigator was asked based on their clinical experience to rate their overall impression of change of participant's décolleté wrinkles due to treatment. The investigator responded on a 7-point scale: - 3 = very much worse, - 2 = much worse, - 1 = worse, 0 = no change, + 1 = improved, + 2 = much improved, + 3 = very much improved. Higher score indicated aesthetic improvement.
Outcome measures
| Measure |
Group A: MRZF111 (3 Injections)
n=117 Participants
Participants received three injections of MRZF111, a subdermal injection in the central part of the décolleté area on Day 1, Week 8, and Week 16. Participants received a total volume of 13.5 mL MRZF111 over the complete course of treatment.
|
Group B: MRZF111 (2 Injections)
Participants received two injections of MRZF111, a subdermal injection in the central part of the décolleté area on Day 1 and Week 16. Participants received a total volume of 9.0 mL MRZF111 over the complete course of treatment.
|
Pooled Treatment Group (Group A: MRZF111 [3 Injections] + Group B: MRZF111 [2 Injections])
Participants received MRZF111 subdermal injection in the central part of the décolleté area (Group A: three injections on Day 1, Week 8, and Week 16; Group B: two injections on Day 1 and Week 16). Participants received a total volume of 13.5 mL (Group A) or 9.0 mL (Group B) MRZF111 over the complete course of treatment.
|
|---|---|---|---|
|
Percentage of Participants With Global Aesthetic Improvement Based on the Investigator's Global Aesthetic Improvement Scale on Décolleté Wrinkles (iGAIS-Wrinkles) as Assessed by the Treating Investigator (LOCF)
|
78.6 percentage of participants
Interval 70.4 to 85.1
|
—
|
—
|
SECONDARY outcome
Timeframe: 16 weeks after the last treatment on Week 16 (at Week 32)Population: The modified pooled FAS included participants who were treated at least once. As per the planned analysis based on protocol and SAP, this secondary effectiveness outcome measure was planned to be analyzed for the pooled treatment groups as Groups A and B comparison was not objective of this investigation, hence pooled data was reported for this secondary outcome measure.
Improvement is defined as a rating of +1 (Improved), +2 (Much improved) or +3 (Very much improved). The sGAIS-wrinkles was used to assess aesthetic improvement in the participants. The assessment was performed by the participant by live rating using standardized pre-treatment photographs for comparison. The participant was asked to rate their overall impression of change of their décolleté wrinkles due to treatment. The participant responded on a 7-point scale: - 3 = very much worse, - 2 = much worse, - 1 = worse, 0 = no change, + 1 = improved, + 2 = much improved, + 3 = very much improved.
Outcome measures
| Measure |
Group A: MRZF111 (3 Injections)
n=117 Participants
Participants received three injections of MRZF111, a subdermal injection in the central part of the décolleté area on Day 1, Week 8, and Week 16. Participants received a total volume of 13.5 mL MRZF111 over the complete course of treatment.
|
Group B: MRZF111 (2 Injections)
Participants received two injections of MRZF111, a subdermal injection in the central part of the décolleté area on Day 1 and Week 16. Participants received a total volume of 9.0 mL MRZF111 over the complete course of treatment.
|
Pooled Treatment Group (Group A: MRZF111 [3 Injections] + Group B: MRZF111 [2 Injections])
Participants received MRZF111 subdermal injection in the central part of the décolleté area (Group A: three injections on Day 1, Week 8, and Week 16; Group B: two injections on Day 1 and Week 16). Participants received a total volume of 13.5 mL (Group A) or 9.0 mL (Group B) MRZF111 over the complete course of treatment.
|
|---|---|---|---|
|
Percentage of Participants With Global Aesthetic Improvement Based on the Subject's Global Aesthetic Improvement Scale on Décolleté Wrinkles (sGAIS-Wrinkles) as Assessed by the Participant (LOCF)
|
66.7 percentage of participants
Interval 57.7 to 74.6
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to Week 52Population: SAS included participants who were randomized to Group A but treated according to the injection scheme of Group B due to COVID-19 pandemic measures and were analyzed in Group B. Participants who were treated only once were analyzed in Group B.
Outcome measures
| Measure |
Group A: MRZF111 (3 Injections)
n=43 Participants
Participants received three injections of MRZF111, a subdermal injection in the central part of the décolleté area on Day 1, Week 8, and Week 16. Participants received a total volume of 13.5 mL MRZF111 over the complete course of treatment.
|
Group B: MRZF111 (2 Injections)
n=74 Participants
Participants received two injections of MRZF111, a subdermal injection in the central part of the décolleté area on Day 1 and Week 16. Participants received a total volume of 9.0 mL MRZF111 over the complete course of treatment.
|
Pooled Treatment Group (Group A: MRZF111 [3 Injections] + Group B: MRZF111 [2 Injections])
Participants received MRZF111 subdermal injection in the central part of the décolleté area (Group A: three injections on Day 1, Week 8, and Week 16; Group B: two injections on Day 1 and Week 16). Participants received a total volume of 13.5 mL (Group A) or 9.0 mL (Group B) MRZF111 over the complete course of treatment.
|
|---|---|---|---|
|
Percentage of Participants With at Least One Treatment-related Treatment-emergent Adverse Event (TEAE)
|
51.2 percentage of participants
|
31.1 percentage of participants
|
—
|
Adverse Events
Group A: MRZF111 (3 Injections)
Group B: MRZF111 (2 Injections)
Serious adverse events
| Measure |
Group A: MRZF111 (3 Injections)
n=43 participants at risk
Participants received three injections of MRZF111, a subdermal injection in the central part of the décolleté area on Day 1, Week 8, and Week 16. Participants received a total volume of 13.5 mL MRZF111 over the complete course of treatment.
|
Group B: MRZF111 (2 Injections)
n=74 participants at risk
Participants received two injections of MRZF111, a subdermal injection in the central part of the décolleté area on Day 1 and Week 16. Participants received a total volume of 9.0 mL MRZF111 over the complete course of treatment.
|
|---|---|---|
|
Injury, poisoning and procedural complications
Ankle fracture
|
2.3%
1/43 • Up to Week 52
The investigator reported adverse events systematically at each visit.
|
0.00%
0/74 • Up to Week 52
The investigator reported adverse events systematically at each visit.
|
|
Injury, poisoning and procedural complications
Concussion
|
2.3%
1/43 • Up to Week 52
The investigator reported adverse events systematically at each visit.
|
0.00%
0/74 • Up to Week 52
The investigator reported adverse events systematically at each visit.
|
|
Injury, poisoning and procedural complications
Contusion
|
2.3%
1/43 • Up to Week 52
The investigator reported adverse events systematically at each visit.
|
0.00%
0/74 • Up to Week 52
The investigator reported adverse events systematically at each visit.
|
|
Injury, poisoning and procedural complications
Meniscus injury
|
0.00%
0/43 • Up to Week 52
The investigator reported adverse events systematically at each visit.
|
1.4%
1/74 • Up to Week 52
The investigator reported adverse events systematically at each visit.
|
|
Injury, poisoning and procedural complications
Post-traumatic neck syndrome
|
2.3%
1/43 • Up to Week 52
The investigator reported adverse events systematically at each visit.
|
0.00%
0/74 • Up to Week 52
The investigator reported adverse events systematically at each visit.
|
|
Injury, poisoning and procedural complications
Stress fracture
|
0.00%
0/43 • Up to Week 52
The investigator reported adverse events systematically at each visit.
|
1.4%
1/74 • Up to Week 52
The investigator reported adverse events systematically at each visit.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer metastatic
|
0.00%
0/43 • Up to Week 52
The investigator reported adverse events systematically at each visit.
|
1.4%
1/74 • Up to Week 52
The investigator reported adverse events systematically at each visit.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Keratoacanthoma
|
0.00%
0/43 • Up to Week 52
The investigator reported adverse events systematically at each visit.
|
1.4%
1/74 • Up to Week 52
The investigator reported adverse events systematically at each visit.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Superficial spreading melanoma stage unspecified
|
2.3%
1/43 • Up to Week 52
The investigator reported adverse events systematically at each visit.
|
0.00%
0/74 • Up to Week 52
The investigator reported adverse events systematically at each visit.
|
|
Nervous system disorders
Facial paralysis
|
0.00%
0/43 • Up to Week 52
The investigator reported adverse events systematically at each visit.
|
1.4%
1/74 • Up to Week 52
The investigator reported adverse events systematically at each visit.
|
|
Reproductive system and breast disorders
Vaginal haemorrhage
|
2.3%
1/43 • Up to Week 52
The investigator reported adverse events systematically at each visit.
|
0.00%
0/74 • Up to Week 52
The investigator reported adverse events systematically at each visit.
|
Other adverse events
| Measure |
Group A: MRZF111 (3 Injections)
n=43 participants at risk
Participants received three injections of MRZF111, a subdermal injection in the central part of the décolleté area on Day 1, Week 8, and Week 16. Participants received a total volume of 13.5 mL MRZF111 over the complete course of treatment.
|
Group B: MRZF111 (2 Injections)
n=74 participants at risk
Participants received two injections of MRZF111, a subdermal injection in the central part of the décolleté area on Day 1 and Week 16. Participants received a total volume of 9.0 mL MRZF111 over the complete course of treatment.
|
|---|---|---|
|
General disorders
Injection site haematoma
|
27.9%
12/43 • Up to Week 52
The investigator reported adverse events systematically at each visit.
|
9.5%
7/74 • Up to Week 52
The investigator reported adverse events systematically at each visit.
|
|
General disorders
Injection site pain
|
9.3%
4/43 • Up to Week 52
The investigator reported adverse events systematically at each visit.
|
17.6%
13/74 • Up to Week 52
The investigator reported adverse events systematically at each visit.
|
|
General disorders
Injection site erythema
|
7.0%
3/43 • Up to Week 52
The investigator reported adverse events systematically at each visit.
|
10.8%
8/74 • Up to Week 52
The investigator reported adverse events systematically at each visit.
|
|
General disorders
Injection site discolouration
|
14.0%
6/43 • Up to Week 52
The investigator reported adverse events systematically at each visit.
|
4.1%
3/74 • Up to Week 52
The investigator reported adverse events systematically at each visit.
|
|
General disorders
Injection site nodule
|
7.0%
3/43 • Up to Week 52
The investigator reported adverse events systematically at each visit.
|
4.1%
3/74 • Up to Week 52
The investigator reported adverse events systematically at each visit.
|
|
Infections and infestations
Nasopharyngitis
|
9.3%
4/43 • Up to Week 52
The investigator reported adverse events systematically at each visit.
|
13.5%
10/74 • Up to Week 52
The investigator reported adverse events systematically at each visit.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Publication of study information usually requires agreement with the sponsor. In case of justified doubts by the sponsor, the INVESTIGATOR will consider these doubts in the publication as long as the scientific neutrality is not affected.
- Publication restrictions are in place
Restriction type: OTHER