Trial Outcomes & Findings for Botulinum Toxin Type A (BOTOX®) Treatment of Masseter Muscle Hypertrophy (NCT NCT02010775)
NCT ID: NCT02010775
Last Updated: 2019-05-28
Results Overview
Lower facial volume was calculated from 3-dimensional (3D) images captured with the VECTRA M3 3D Stereophotogrammetry imaging system and was analyzed using computer assisted systems and predetermined facial landmarks. The difference in volume was measured between the select region of the baseline surface 3D model and the select region of the posttreatment surface 3D model. A negative change from Baseline (decrease in volume) indicates improvement.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
187 participants
Primary outcome timeframe
Baseline (Day 1) to Day 90 of Treatment Cycle 1
Results posted on
2019-05-28
Participant Flow
Participant milestones
| Measure |
BOTOX® 96U
Botulinum Toxin Type A (BOTOX®) 96U total dose administered intramuscularly to the bilateral masseter muscles on Day 1 and retreatment at Day 180 if applicable.
|
BOTOX® 72U
Botulinum Toxin Type A (BOTOX®) 72U total dose administered intramuscularly to the bilateral masseter muscles on Day 1 and retreatment at Day 180 if applicable.
|
BOTOX® 48U
Botulinum Toxin Type A (BOTOX®) 48U total dose administered intramuscularly to the bilateral masseter muscles on Day 1 and retreatment at Day 180 if applicable.
|
BOTOX® 24U
Botulinum Toxin Type A (BOTOX®) 24U total dose administered intramuscularly to the bilateral masseter muscles on Day 1 and retreatment at Day 180 if applicable.
|
Placebo
Placebo (Normal saline) administered intramuscularly to the bilateral masseter muscles on Day 1 and retreatment at Day 180 if applicable.
|
|---|---|---|---|---|---|
|
Overall Study
STARTED
|
38
|
38
|
37
|
37
|
37
|
|
Overall Study
COMPLETED
|
33
|
35
|
34
|
34
|
31
|
|
Overall Study
NOT COMPLETED
|
5
|
3
|
3
|
3
|
6
|
Reasons for withdrawal
| Measure |
BOTOX® 96U
Botulinum Toxin Type A (BOTOX®) 96U total dose administered intramuscularly to the bilateral masseter muscles on Day 1 and retreatment at Day 180 if applicable.
|
BOTOX® 72U
Botulinum Toxin Type A (BOTOX®) 72U total dose administered intramuscularly to the bilateral masseter muscles on Day 1 and retreatment at Day 180 if applicable.
|
BOTOX® 48U
Botulinum Toxin Type A (BOTOX®) 48U total dose administered intramuscularly to the bilateral masseter muscles on Day 1 and retreatment at Day 180 if applicable.
|
BOTOX® 24U
Botulinum Toxin Type A (BOTOX®) 24U total dose administered intramuscularly to the bilateral masseter muscles on Day 1 and retreatment at Day 180 if applicable.
|
Placebo
Placebo (Normal saline) administered intramuscularly to the bilateral masseter muscles on Day 1 and retreatment at Day 180 if applicable.
|
|---|---|---|---|---|---|
|
Overall Study
Adverse Event
|
0
|
0
|
0
|
0
|
1
|
|
Overall Study
Pregnancy
|
0
|
0
|
2
|
0
|
0
|
|
Overall Study
Lost to Follow-up
|
2
|
0
|
0
|
1
|
1
|
|
Overall Study
Personal Reasons
|
3
|
3
|
1
|
2
|
4
|
Baseline Characteristics
Botulinum Toxin Type A (BOTOX®) Treatment of Masseter Muscle Hypertrophy
Baseline characteristics by cohort
| Measure |
BOTOX® 96U
n=38 Participants
Botulinum Toxin Type A (BOTOX®) 96U total dose administered intramuscularly to the bilateral masseter muscles on Day 1 and retreatment at Day 180 if applicable.
|
BOTOX® 72U
n=38 Participants
Botulinum Toxin Type A (BOTOX®) 72U total dose administered intramuscularly to the bilateral masseter muscles on Day 1 and retreatment at Day 180 if applicable.
|
BOTOX® 48U
n=37 Participants
Botulinum Toxin Type A (BOTOX®) 48U total dose administered intramuscularly to the bilateral masseter muscles on Day 1 and retreatment at Day 180 if applicable.
|
BOTOX® 24U
n=37 Participants
Botulinum Toxin Type A (BOTOX®) 24U total dose administered intramuscularly to the bilateral masseter muscles on Day 1 and retreatment at Day 180 if applicable.
|
Placebo
n=37 Participants
Placebo (Normal saline) administered intramuscularly to the bilateral masseter muscles on Day 1 and retreatment at Day 180 if applicable.
|
Total
n=187 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Continuous
|
35.3 Years
STANDARD_DEVIATION 9.10 • n=5 Participants
|
34.9 Years
STANDARD_DEVIATION 8.35 • n=7 Participants
|
37.2 Years
STANDARD_DEVIATION 7.69 • n=5 Participants
|
34.0 Years
STANDARD_DEVIATION 9.08 • n=4 Participants
|
35.4 Years
STANDARD_DEVIATION 8.08 • n=21 Participants
|
35.4 Years
STANDARD_DEVIATION 8.45 • n=8 Participants
|
|
Sex: Female, Male
Female
|
30 Participants
n=5 Participants
|
28 Participants
n=7 Participants
|
31 Participants
n=5 Participants
|
32 Participants
n=4 Participants
|
32 Participants
n=21 Participants
|
153 Participants
n=8 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
5 Participants
n=21 Participants
|
34 Participants
n=8 Participants
|
|
Race/Ethnicity, Customized
Caucasian
|
7 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
10 Participants
n=21 Participants
|
36 Participants
n=8 Participants
|
|
Race/Ethnicity, Customized
Asian
|
30 Participants
n=5 Participants
|
30 Participants
n=7 Participants
|
30 Participants
n=5 Participants
|
32 Participants
n=4 Participants
|
27 Participants
n=21 Participants
|
149 Participants
n=8 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
|
Race/Ethnicity, Customized
Other Race
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
PRIMARY outcome
Timeframe: Baseline (Day 1) to Day 90 of Treatment Cycle 1Population: Participants from the mITT population, all randomized participants who received at least 1 injection of study treatment and had at least 1 follow-up visit, with data available for analysis at Day 90. Change in lower facial volume was quantified in cm\^3 using image subtraction techniques; as the Baseline is an image, no Baseline data are reported.
Lower facial volume was calculated from 3-dimensional (3D) images captured with the VECTRA M3 3D Stereophotogrammetry imaging system and was analyzed using computer assisted systems and predetermined facial landmarks. The difference in volume was measured between the select region of the baseline surface 3D model and the select region of the posttreatment surface 3D model. A negative change from Baseline (decrease in volume) indicates improvement.
Outcome measures
| Measure |
BOTOX® 96U
n=38 Participants
Botulinum Toxin Type A (BOTOX®) 96U total dose administered intramuscularly to the bilateral masseter muscles on Day 1 and retreatment at Day 180 if applicable.
|
BOTOX® 72U
n=38 Participants
Botulinum Toxin Type A (BOTOX®) 72U total dose administered intramuscularly to the bilateral masseter muscles on Day 1 and retreatment at Day 180 if applicable.
|
BOTOX® 48U
n=36 Participants
Botulinum Toxin Type A (BOTOX®) 48U total dose administered intramuscularly to the bilateral masseter muscles on Day 1 and retreatment at Day 180 if applicable.
|
BOTOX® 24U
n=36 Participants
Botulinum Toxin Type A (BOTOX®) 24U total dose administered intramuscularly to the bilateral masseter muscles on Day 1 and retreatment at Day 180 if applicable.
|
Placebo
n=37 Participants
Placebo (Normal saline) administered intramuscularly to the bilateral masseter muscles on Day 1 and retreatment at Day 180 if applicable.
|
|---|---|---|---|---|---|
|
Change From Baseline in Lower Facial Volume Using VECTRA 3D Images
|
-8.20 cubic centimeter (cm^3)
Interval -15.6 to -1.4
|
-7.41 cubic centimeter (cm^3)
Interval -16.5 to -0.8
|
-6.84 cubic centimeter (cm^3)
Interval -17.4 to 1.6
|
-4.40 cubic centimeter (cm^3)
Interval -13.2 to 2.0
|
-0.52 cubic centimeter (cm^3)
Interval -6.7 to 9.0
|
SECONDARY outcome
Timeframe: Day 90 of Treatment Cycle 1Population: Participants from the mITT population, all randomized participants who received at least 1 injection of study treatment and had at least 1 follow-up visit, with data available for analysis at Day 90. Missing data was imputed using last observation carried forward.
The investigator used visual inspection and palpation to grade the prominence of the participant's masseter muscle on the left and right sides of the face using the MMPS where: 1=minimal prominence (best), 2=mild prominence, 3=moderate prominence, 4=marked prominence, 5=very marked prominence (worst). The percentage of participants with grade 3 or less is reported.
Outcome measures
| Measure |
BOTOX® 96U
n=38 Participants
Botulinum Toxin Type A (BOTOX®) 96U total dose administered intramuscularly to the bilateral masseter muscles on Day 1 and retreatment at Day 180 if applicable.
|
BOTOX® 72U
n=38 Participants
Botulinum Toxin Type A (BOTOX®) 72U total dose administered intramuscularly to the bilateral masseter muscles on Day 1 and retreatment at Day 180 if applicable.
|
BOTOX® 48U
n=36 Participants
Botulinum Toxin Type A (BOTOX®) 48U total dose administered intramuscularly to the bilateral masseter muscles on Day 1 and retreatment at Day 180 if applicable.
|
BOTOX® 24U
n=36 Participants
Botulinum Toxin Type A (BOTOX®) 24U total dose administered intramuscularly to the bilateral masseter muscles on Day 1 and retreatment at Day 180 if applicable.
|
Placebo
n=37 Participants
Placebo (Normal saline) administered intramuscularly to the bilateral masseter muscles on Day 1 and retreatment at Day 180 if applicable.
|
|---|---|---|---|---|---|
|
Percentage of Participants Who Achieved a Masseter Muscle Prominence Scale (MMPS) Grade ≤ 3 as Assessed by the Investigator
|
89.5 Percentage of participants
Interval 75.2 to 97.1
|
89.5 Percentage of participants
Interval 75.2 to 97.1
|
83.3 Percentage of participants
Interval 67.2 to 93.6
|
66.7 Percentage of participants
Interval 49.0 to 81.4
|
35.1 Percentage of participants
Interval 20.2 to 52.5
|
Adverse Events
BOTOX® 96U
Serious events: 1 serious events
Other events: 13 other events
Deaths: 0 deaths
BOTOX® 72U
Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths
BOTOX® 48U
Serious events: 0 serious events
Other events: 12 other events
Deaths: 0 deaths
BOTOX® 24U
Serious events: 2 serious events
Other events: 16 other events
Deaths: 0 deaths
Placebo
Serious events: 3 serious events
Other events: 10 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
BOTOX® 96U
n=38 participants at risk
Botulinum Toxin Type A (BOTOX®) 96U total dose administered intramuscularly to the bilateral masseter muscles on Day 1 and retreatment at Day 180 if applicable.
|
BOTOX® 72U
n=38 participants at risk
Botulinum Toxin Type A (BOTOX®) 72U total dose administered intramuscularly to the bilateral masseter muscles on Day 1 and retreatment at Day 180 if applicable.
|
BOTOX® 48U
n=37 participants at risk
Botulinum Toxin Type A (BOTOX®) 48U total dose administered intramuscularly to the bilateral masseter muscles on Day 1 and retreatment at Day 180 if applicable.
|
BOTOX® 24U
n=37 participants at risk
Botulinum Toxin Type A (BOTOX®) 24U total dose administered intramuscularly to the bilateral masseter muscles on Day 1 and retreatment at Day 180 if applicable.
|
Placebo
n=37 participants at risk
Placebo (Normal saline) administered intramuscularly to the bilateral masseter muscles on Day 1 and retreatment at Day 180 if applicable.
|
|---|---|---|---|---|---|
|
Infections and infestations
Appendicitis perforated
|
2.6%
1/38 • Baseline (Day 1) to the end of study (Month 12)
Safety Population, all treated participants based on the treatment received, was used to determine the number of participants at risk for Serious Adverse Events and Adverse Events.
|
0.00%
0/38 • Baseline (Day 1) to the end of study (Month 12)
Safety Population, all treated participants based on the treatment received, was used to determine the number of participants at risk for Serious Adverse Events and Adverse Events.
|
0.00%
0/37 • Baseline (Day 1) to the end of study (Month 12)
Safety Population, all treated participants based on the treatment received, was used to determine the number of participants at risk for Serious Adverse Events and Adverse Events.
|
0.00%
0/37 • Baseline (Day 1) to the end of study (Month 12)
Safety Population, all treated participants based on the treatment received, was used to determine the number of participants at risk for Serious Adverse Events and Adverse Events.
|
0.00%
0/37 • Baseline (Day 1) to the end of study (Month 12)
Safety Population, all treated participants based on the treatment received, was used to determine the number of participants at risk for Serious Adverse Events and Adverse Events.
|
|
Infections and infestations
Peritonitis
|
2.6%
1/38 • Baseline (Day 1) to the end of study (Month 12)
Safety Population, all treated participants based on the treatment received, was used to determine the number of participants at risk for Serious Adverse Events and Adverse Events.
|
0.00%
0/38 • Baseline (Day 1) to the end of study (Month 12)
Safety Population, all treated participants based on the treatment received, was used to determine the number of participants at risk for Serious Adverse Events and Adverse Events.
|
0.00%
0/37 • Baseline (Day 1) to the end of study (Month 12)
Safety Population, all treated participants based on the treatment received, was used to determine the number of participants at risk for Serious Adverse Events and Adverse Events.
|
0.00%
0/37 • Baseline (Day 1) to the end of study (Month 12)
Safety Population, all treated participants based on the treatment received, was used to determine the number of participants at risk for Serious Adverse Events and Adverse Events.
|
0.00%
0/37 • Baseline (Day 1) to the end of study (Month 12)
Safety Population, all treated participants based on the treatment received, was used to determine the number of participants at risk for Serious Adverse Events and Adverse Events.
|
|
Infections and infestations
Kidney infection
|
0.00%
0/38 • Baseline (Day 1) to the end of study (Month 12)
Safety Population, all treated participants based on the treatment received, was used to determine the number of participants at risk for Serious Adverse Events and Adverse Events.
|
0.00%
0/38 • Baseline (Day 1) to the end of study (Month 12)
Safety Population, all treated participants based on the treatment received, was used to determine the number of participants at risk for Serious Adverse Events and Adverse Events.
|
0.00%
0/37 • Baseline (Day 1) to the end of study (Month 12)
Safety Population, all treated participants based on the treatment received, was used to determine the number of participants at risk for Serious Adverse Events and Adverse Events.
|
2.7%
1/37 • Baseline (Day 1) to the end of study (Month 12)
Safety Population, all treated participants based on the treatment received, was used to determine the number of participants at risk for Serious Adverse Events and Adverse Events.
|
0.00%
0/37 • Baseline (Day 1) to the end of study (Month 12)
Safety Population, all treated participants based on the treatment received, was used to determine the number of participants at risk for Serious Adverse Events and Adverse Events.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/38 • Baseline (Day 1) to the end of study (Month 12)
Safety Population, all treated participants based on the treatment received, was used to determine the number of participants at risk for Serious Adverse Events and Adverse Events.
|
0.00%
0/38 • Baseline (Day 1) to the end of study (Month 12)
Safety Population, all treated participants based on the treatment received, was used to determine the number of participants at risk for Serious Adverse Events and Adverse Events.
|
0.00%
0/37 • Baseline (Day 1) to the end of study (Month 12)
Safety Population, all treated participants based on the treatment received, was used to determine the number of participants at risk for Serious Adverse Events and Adverse Events.
|
0.00%
0/37 • Baseline (Day 1) to the end of study (Month 12)
Safety Population, all treated participants based on the treatment received, was used to determine the number of participants at risk for Serious Adverse Events and Adverse Events.
|
2.7%
1/37 • Baseline (Day 1) to the end of study (Month 12)
Safety Population, all treated participants based on the treatment received, was used to determine the number of participants at risk for Serious Adverse Events and Adverse Events.
|
|
Injury, poisoning and procedural complications
Wrist fracture
|
0.00%
0/38 • Baseline (Day 1) to the end of study (Month 12)
Safety Population, all treated participants based on the treatment received, was used to determine the number of participants at risk for Serious Adverse Events and Adverse Events.
|
0.00%
0/38 • Baseline (Day 1) to the end of study (Month 12)
Safety Population, all treated participants based on the treatment received, was used to determine the number of participants at risk for Serious Adverse Events and Adverse Events.
|
0.00%
0/37 • Baseline (Day 1) to the end of study (Month 12)
Safety Population, all treated participants based on the treatment received, was used to determine the number of participants at risk for Serious Adverse Events and Adverse Events.
|
0.00%
0/37 • Baseline (Day 1) to the end of study (Month 12)
Safety Population, all treated participants based on the treatment received, was used to determine the number of participants at risk for Serious Adverse Events and Adverse Events.
|
2.7%
1/37 • Baseline (Day 1) to the end of study (Month 12)
Safety Population, all treated participants based on the treatment received, was used to determine the number of participants at risk for Serious Adverse Events and Adverse Events.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hepatic cancer
|
0.00%
0/38 • Baseline (Day 1) to the end of study (Month 12)
Safety Population, all treated participants based on the treatment received, was used to determine the number of participants at risk for Serious Adverse Events and Adverse Events.
|
0.00%
0/38 • Baseline (Day 1) to the end of study (Month 12)
Safety Population, all treated participants based on the treatment received, was used to determine the number of participants at risk for Serious Adverse Events and Adverse Events.
|
0.00%
0/37 • Baseline (Day 1) to the end of study (Month 12)
Safety Population, all treated participants based on the treatment received, was used to determine the number of participants at risk for Serious Adverse Events and Adverse Events.
|
0.00%
0/37 • Baseline (Day 1) to the end of study (Month 12)
Safety Population, all treated participants based on the treatment received, was used to determine the number of participants at risk for Serious Adverse Events and Adverse Events.
|
2.7%
1/37 • Baseline (Day 1) to the end of study (Month 12)
Safety Population, all treated participants based on the treatment received, was used to determine the number of participants at risk for Serious Adverse Events and Adverse Events.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Uterine leiomyomax
|
0.00%
0/30 • Baseline (Day 1) to the end of study (Month 12)
Safety Population, all treated participants based on the treatment received, was used to determine the number of participants at risk for Serious Adverse Events and Adverse Events.
|
0.00%
0/28 • Baseline (Day 1) to the end of study (Month 12)
Safety Population, all treated participants based on the treatment received, was used to determine the number of participants at risk for Serious Adverse Events and Adverse Events.
|
0.00%
0/31 • Baseline (Day 1) to the end of study (Month 12)
Safety Population, all treated participants based on the treatment received, was used to determine the number of participants at risk for Serious Adverse Events and Adverse Events.
|
0.00%
0/32 • Baseline (Day 1) to the end of study (Month 12)
Safety Population, all treated participants based on the treatment received, was used to determine the number of participants at risk for Serious Adverse Events and Adverse Events.
|
3.1%
1/32 • Baseline (Day 1) to the end of study (Month 12)
Safety Population, all treated participants based on the treatment received, was used to determine the number of participants at risk for Serious Adverse Events and Adverse Events.
|
|
Surgical and medical procedures
Abortion induced
|
0.00%
0/30 • Baseline (Day 1) to the end of study (Month 12)
Safety Population, all treated participants based on the treatment received, was used to determine the number of participants at risk for Serious Adverse Events and Adverse Events.
|
0.00%
0/28 • Baseline (Day 1) to the end of study (Month 12)
Safety Population, all treated participants based on the treatment received, was used to determine the number of participants at risk for Serious Adverse Events and Adverse Events.
|
0.00%
0/31 • Baseline (Day 1) to the end of study (Month 12)
Safety Population, all treated participants based on the treatment received, was used to determine the number of participants at risk for Serious Adverse Events and Adverse Events.
|
3.1%
1/32 • Baseline (Day 1) to the end of study (Month 12)
Safety Population, all treated participants based on the treatment received, was used to determine the number of participants at risk for Serious Adverse Events and Adverse Events.
|
0.00%
0/32 • Baseline (Day 1) to the end of study (Month 12)
Safety Population, all treated participants based on the treatment received, was used to determine the number of participants at risk for Serious Adverse Events and Adverse Events.
|
Other adverse events
| Measure |
BOTOX® 96U
n=38 participants at risk
Botulinum Toxin Type A (BOTOX®) 96U total dose administered intramuscularly to the bilateral masseter muscles on Day 1 and retreatment at Day 180 if applicable.
|
BOTOX® 72U
n=38 participants at risk
Botulinum Toxin Type A (BOTOX®) 72U total dose administered intramuscularly to the bilateral masseter muscles on Day 1 and retreatment at Day 180 if applicable.
|
BOTOX® 48U
n=37 participants at risk
Botulinum Toxin Type A (BOTOX®) 48U total dose administered intramuscularly to the bilateral masseter muscles on Day 1 and retreatment at Day 180 if applicable.
|
BOTOX® 24U
n=37 participants at risk
Botulinum Toxin Type A (BOTOX®) 24U total dose administered intramuscularly to the bilateral masseter muscles on Day 1 and retreatment at Day 180 if applicable.
|
Placebo
n=37 participants at risk
Placebo (Normal saline) administered intramuscularly to the bilateral masseter muscles on Day 1 and retreatment at Day 180 if applicable.
|
|---|---|---|---|---|---|
|
Nervous system disorders
Facial paresis
|
10.5%
4/38 • Baseline (Day 1) to the end of study (Month 12)
Safety Population, all treated participants based on the treatment received, was used to determine the number of participants at risk for Serious Adverse Events and Adverse Events.
|
0.00%
0/38 • Baseline (Day 1) to the end of study (Month 12)
Safety Population, all treated participants based on the treatment received, was used to determine the number of participants at risk for Serious Adverse Events and Adverse Events.
|
0.00%
0/37 • Baseline (Day 1) to the end of study (Month 12)
Safety Population, all treated participants based on the treatment received, was used to determine the number of participants at risk for Serious Adverse Events and Adverse Events.
|
0.00%
0/37 • Baseline (Day 1) to the end of study (Month 12)
Safety Population, all treated participants based on the treatment received, was used to determine the number of participants at risk for Serious Adverse Events and Adverse Events.
|
0.00%
0/37 • Baseline (Day 1) to the end of study (Month 12)
Safety Population, all treated participants based on the treatment received, was used to determine the number of participants at risk for Serious Adverse Events and Adverse Events.
|
|
Infections and infestations
Upper respiratory tract infection
|
7.9%
3/38 • Baseline (Day 1) to the end of study (Month 12)
Safety Population, all treated participants based on the treatment received, was used to determine the number of participants at risk for Serious Adverse Events and Adverse Events.
|
7.9%
3/38 • Baseline (Day 1) to the end of study (Month 12)
Safety Population, all treated participants based on the treatment received, was used to determine the number of participants at risk for Serious Adverse Events and Adverse Events.
|
0.00%
0/37 • Baseline (Day 1) to the end of study (Month 12)
Safety Population, all treated participants based on the treatment received, was used to determine the number of participants at risk for Serious Adverse Events and Adverse Events.
|
0.00%
0/37 • Baseline (Day 1) to the end of study (Month 12)
Safety Population, all treated participants based on the treatment received, was used to determine the number of participants at risk for Serious Adverse Events and Adverse Events.
|
2.7%
1/37 • Baseline (Day 1) to the end of study (Month 12)
Safety Population, all treated participants based on the treatment received, was used to determine the number of participants at risk for Serious Adverse Events and Adverse Events.
|
|
Nervous system disorders
Headache
|
7.9%
3/38 • Baseline (Day 1) to the end of study (Month 12)
Safety Population, all treated participants based on the treatment received, was used to determine the number of participants at risk for Serious Adverse Events and Adverse Events.
|
5.3%
2/38 • Baseline (Day 1) to the end of study (Month 12)
Safety Population, all treated participants based on the treatment received, was used to determine the number of participants at risk for Serious Adverse Events and Adverse Events.
|
5.4%
2/37 • Baseline (Day 1) to the end of study (Month 12)
Safety Population, all treated participants based on the treatment received, was used to determine the number of participants at risk for Serious Adverse Events and Adverse Events.
|
2.7%
1/37 • Baseline (Day 1) to the end of study (Month 12)
Safety Population, all treated participants based on the treatment received, was used to determine the number of participants at risk for Serious Adverse Events and Adverse Events.
|
2.7%
1/37 • Baseline (Day 1) to the end of study (Month 12)
Safety Population, all treated participants based on the treatment received, was used to determine the number of participants at risk for Serious Adverse Events and Adverse Events.
|
|
Gastrointestinal disorders
Irritable bowel syndrome
|
7.9%
3/38 • Baseline (Day 1) to the end of study (Month 12)
Safety Population, all treated participants based on the treatment received, was used to determine the number of participants at risk for Serious Adverse Events and Adverse Events.
|
0.00%
0/38 • Baseline (Day 1) to the end of study (Month 12)
Safety Population, all treated participants based on the treatment received, was used to determine the number of participants at risk for Serious Adverse Events and Adverse Events.
|
0.00%
0/37 • Baseline (Day 1) to the end of study (Month 12)
Safety Population, all treated participants based on the treatment received, was used to determine the number of participants at risk for Serious Adverse Events and Adverse Events.
|
0.00%
0/37 • Baseline (Day 1) to the end of study (Month 12)
Safety Population, all treated participants based on the treatment received, was used to determine the number of participants at risk for Serious Adverse Events and Adverse Events.
|
0.00%
0/37 • Baseline (Day 1) to the end of study (Month 12)
Safety Population, all treated participants based on the treatment received, was used to determine the number of participants at risk for Serious Adverse Events and Adverse Events.
|
|
Infections and infestations
Pneumonia
|
5.3%
2/38 • Baseline (Day 1) to the end of study (Month 12)
Safety Population, all treated participants based on the treatment received, was used to determine the number of participants at risk for Serious Adverse Events and Adverse Events.
|
2.6%
1/38 • Baseline (Day 1) to the end of study (Month 12)
Safety Population, all treated participants based on the treatment received, was used to determine the number of participants at risk for Serious Adverse Events and Adverse Events.
|
2.7%
1/37 • Baseline (Day 1) to the end of study (Month 12)
Safety Population, all treated participants based on the treatment received, was used to determine the number of participants at risk for Serious Adverse Events and Adverse Events.
|
0.00%
0/37 • Baseline (Day 1) to the end of study (Month 12)
Safety Population, all treated participants based on the treatment received, was used to determine the number of participants at risk for Serious Adverse Events and Adverse Events.
|
0.00%
0/37 • Baseline (Day 1) to the end of study (Month 12)
Safety Population, all treated participants based on the treatment received, was used to determine the number of participants at risk for Serious Adverse Events and Adverse Events.
|
|
Musculoskeletal and connective tissue disorders
Pain in jaw
|
5.3%
2/38 • Baseline (Day 1) to the end of study (Month 12)
Safety Population, all treated participants based on the treatment received, was used to determine the number of participants at risk for Serious Adverse Events and Adverse Events.
|
0.00%
0/38 • Baseline (Day 1) to the end of study (Month 12)
Safety Population, all treated participants based on the treatment received, was used to determine the number of participants at risk for Serious Adverse Events and Adverse Events.
|
0.00%
0/37 • Baseline (Day 1) to the end of study (Month 12)
Safety Population, all treated participants based on the treatment received, was used to determine the number of participants at risk for Serious Adverse Events and Adverse Events.
|
5.4%
2/37 • Baseline (Day 1) to the end of study (Month 12)
Safety Population, all treated participants based on the treatment received, was used to determine the number of participants at risk for Serious Adverse Events and Adverse Events.
|
0.00%
0/37 • Baseline (Day 1) to the end of study (Month 12)
Safety Population, all treated participants based on the treatment received, was used to determine the number of participants at risk for Serious Adverse Events and Adverse Events.
|
|
General disorders
Injection site pain
|
2.6%
1/38 • Baseline (Day 1) to the end of study (Month 12)
Safety Population, all treated participants based on the treatment received, was used to determine the number of participants at risk for Serious Adverse Events and Adverse Events.
|
2.6%
1/38 • Baseline (Day 1) to the end of study (Month 12)
Safety Population, all treated participants based on the treatment received, was used to determine the number of participants at risk for Serious Adverse Events and Adverse Events.
|
5.4%
2/37 • Baseline (Day 1) to the end of study (Month 12)
Safety Population, all treated participants based on the treatment received, was used to determine the number of participants at risk for Serious Adverse Events and Adverse Events.
|
2.7%
1/37 • Baseline (Day 1) to the end of study (Month 12)
Safety Population, all treated participants based on the treatment received, was used to determine the number of participants at risk for Serious Adverse Events and Adverse Events.
|
0.00%
0/37 • Baseline (Day 1) to the end of study (Month 12)
Safety Population, all treated participants based on the treatment received, was used to determine the number of participants at risk for Serious Adverse Events and Adverse Events.
|
|
Musculoskeletal and connective tissue disorders
Mastication disorder
|
0.00%
0/38 • Baseline (Day 1) to the end of study (Month 12)
Safety Population, all treated participants based on the treatment received, was used to determine the number of participants at risk for Serious Adverse Events and Adverse Events.
|
7.9%
3/38 • Baseline (Day 1) to the end of study (Month 12)
Safety Population, all treated participants based on the treatment received, was used to determine the number of participants at risk for Serious Adverse Events and Adverse Events.
|
10.8%
4/37 • Baseline (Day 1) to the end of study (Month 12)
Safety Population, all treated participants based on the treatment received, was used to determine the number of participants at risk for Serious Adverse Events and Adverse Events.
|
5.4%
2/37 • Baseline (Day 1) to the end of study (Month 12)
Safety Population, all treated participants based on the treatment received, was used to determine the number of participants at risk for Serious Adverse Events and Adverse Events.
|
2.7%
1/37 • Baseline (Day 1) to the end of study (Month 12)
Safety Population, all treated participants based on the treatment received, was used to determine the number of participants at risk for Serious Adverse Events and Adverse Events.
|
|
Infections and infestations
Influenza
|
0.00%
0/38 • Baseline (Day 1) to the end of study (Month 12)
Safety Population, all treated participants based on the treatment received, was used to determine the number of participants at risk for Serious Adverse Events and Adverse Events.
|
7.9%
3/38 • Baseline (Day 1) to the end of study (Month 12)
Safety Population, all treated participants based on the treatment received, was used to determine the number of participants at risk for Serious Adverse Events and Adverse Events.
|
0.00%
0/37 • Baseline (Day 1) to the end of study (Month 12)
Safety Population, all treated participants based on the treatment received, was used to determine the number of participants at risk for Serious Adverse Events and Adverse Events.
|
13.5%
5/37 • Baseline (Day 1) to the end of study (Month 12)
Safety Population, all treated participants based on the treatment received, was used to determine the number of participants at risk for Serious Adverse Events and Adverse Events.
|
0.00%
0/37 • Baseline (Day 1) to the end of study (Month 12)
Safety Population, all treated participants based on the treatment received, was used to determine the number of participants at risk for Serious Adverse Events and Adverse Events.
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/38 • Baseline (Day 1) to the end of study (Month 12)
Safety Population, all treated participants based on the treatment received, was used to determine the number of participants at risk for Serious Adverse Events and Adverse Events.
|
2.6%
1/38 • Baseline (Day 1) to the end of study (Month 12)
Safety Population, all treated participants based on the treatment received, was used to determine the number of participants at risk for Serious Adverse Events and Adverse Events.
|
18.9%
7/37 • Baseline (Day 1) to the end of study (Month 12)
Safety Population, all treated participants based on the treatment received, was used to determine the number of participants at risk for Serious Adverse Events and Adverse Events.
|
10.8%
4/37 • Baseline (Day 1) to the end of study (Month 12)
Safety Population, all treated participants based on the treatment received, was used to determine the number of participants at risk for Serious Adverse Events and Adverse Events.
|
5.4%
2/37 • Baseline (Day 1) to the end of study (Month 12)
Safety Population, all treated participants based on the treatment received, was used to determine the number of participants at risk for Serious Adverse Events and Adverse Events.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/38 • Baseline (Day 1) to the end of study (Month 12)
Safety Population, all treated participants based on the treatment received, was used to determine the number of participants at risk for Serious Adverse Events and Adverse Events.
|
0.00%
0/38 • Baseline (Day 1) to the end of study (Month 12)
Safety Population, all treated participants based on the treatment received, was used to determine the number of participants at risk for Serious Adverse Events and Adverse Events.
|
5.4%
2/37 • Baseline (Day 1) to the end of study (Month 12)
Safety Population, all treated participants based on the treatment received, was used to determine the number of participants at risk for Serious Adverse Events and Adverse Events.
|
0.00%
0/37 • Baseline (Day 1) to the end of study (Month 12)
Safety Population, all treated participants based on the treatment received, was used to determine the number of participants at risk for Serious Adverse Events and Adverse Events.
|
5.4%
2/37 • Baseline (Day 1) to the end of study (Month 12)
Safety Population, all treated participants based on the treatment received, was used to determine the number of participants at risk for Serious Adverse Events and Adverse Events.
|
|
Injury, poisoning and procedural complications
Muscle strain
|
0.00%
0/38 • Baseline (Day 1) to the end of study (Month 12)
Safety Population, all treated participants based on the treatment received, was used to determine the number of participants at risk for Serious Adverse Events and Adverse Events.
|
0.00%
0/38 • Baseline (Day 1) to the end of study (Month 12)
Safety Population, all treated participants based on the treatment received, was used to determine the number of participants at risk for Serious Adverse Events and Adverse Events.
|
2.7%
1/37 • Baseline (Day 1) to the end of study (Month 12)
Safety Population, all treated participants based on the treatment received, was used to determine the number of participants at risk for Serious Adverse Events and Adverse Events.
|
8.1%
3/37 • Baseline (Day 1) to the end of study (Month 12)
Safety Population, all treated participants based on the treatment received, was used to determine the number of participants at risk for Serious Adverse Events and Adverse Events.
|
2.7%
1/37 • Baseline (Day 1) to the end of study (Month 12)
Safety Population, all treated participants based on the treatment received, was used to determine the number of participants at risk for Serious Adverse Events and Adverse Events.
|
|
Injury, poisoning and procedural complications
Ligament sprain
|
0.00%
0/38 • Baseline (Day 1) to the end of study (Month 12)
Safety Population, all treated participants based on the treatment received, was used to determine the number of participants at risk for Serious Adverse Events and Adverse Events.
|
0.00%
0/38 • Baseline (Day 1) to the end of study (Month 12)
Safety Population, all treated participants based on the treatment received, was used to determine the number of participants at risk for Serious Adverse Events and Adverse Events.
|
0.00%
0/37 • Baseline (Day 1) to the end of study (Month 12)
Safety Population, all treated participants based on the treatment received, was used to determine the number of participants at risk for Serious Adverse Events and Adverse Events.
|
5.4%
2/37 • Baseline (Day 1) to the end of study (Month 12)
Safety Population, all treated participants based on the treatment received, was used to determine the number of participants at risk for Serious Adverse Events and Adverse Events.
|
0.00%
0/37 • Baseline (Day 1) to the end of study (Month 12)
Safety Population, all treated participants based on the treatment received, was used to determine the number of participants at risk for Serious Adverse Events and Adverse Events.
|
|
Immune system disorders
Food allergy
|
0.00%
0/38 • Baseline (Day 1) to the end of study (Month 12)
Safety Population, all treated participants based on the treatment received, was used to determine the number of participants at risk for Serious Adverse Events and Adverse Events.
|
0.00%
0/38 • Baseline (Day 1) to the end of study (Month 12)
Safety Population, all treated participants based on the treatment received, was used to determine the number of participants at risk for Serious Adverse Events and Adverse Events.
|
0.00%
0/37 • Baseline (Day 1) to the end of study (Month 12)
Safety Population, all treated participants based on the treatment received, was used to determine the number of participants at risk for Serious Adverse Events and Adverse Events.
|
0.00%
0/37 • Baseline (Day 1) to the end of study (Month 12)
Safety Population, all treated participants based on the treatment received, was used to determine the number of participants at risk for Serious Adverse Events and Adverse Events.
|
5.4%
2/37 • Baseline (Day 1) to the end of study (Month 12)
Safety Population, all treated participants based on the treatment received, was used to determine the number of participants at risk for Serious Adverse Events and Adverse Events.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee A disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 90 days from the time submitted to the sponsor for review. The sponsor cannot require changes to the communication and cannot extend the embargo.
- Publication restrictions are in place
Restriction type: OTHER