Trial Outcomes & Findings for Safety and Efficacy Study of Botulinum Toxin Type A to Treat Glabellar Lines (NCT NCT01485601)
NCT ID: NCT01485601
Last Updated: 2024-02-22
Results Overview
Subjects included in the analysis had to have a baseline glabellar line (GL) severity rating at maximum frown of moderate (2) or severe (3). The GL severity were measured using a 4-point scale (0: none; 1: mild; 2: moderate; 3: Severe). A responder was defined as having a severity rating of none (0) or mild (1) at the corresponding post-baseline visit. Percentages are based on the number of subjects with an assessment at the relevant visit (Day 30).
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
121 participants
Primary outcome timeframe
at Day 30
Results posted on
2024-02-22
Participant Flow
Participant milestones
| Measure |
MT10109 A Unit
Single dose intramuscular injection of MT10109 (A Unit) at glabellar line (GL)
|
MT10109 B Unit
Single dose intramuscular injection of MT10109 (B Unit) at glabellar line (GL)
|
MT10109 C Unit
Single dose intramuscular injection of MT10109 (C Unit) at glabellar line (GL)
|
Botox (Registered Trade Mark)
Single dose intramuscular injection of Botox (B Unit) at glabellar line (GL)
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
31
|
31
|
27
|
32
|
|
Overall Study
COMPLETED
|
28
|
23
|
25
|
26
|
|
Overall Study
NOT COMPLETED
|
3
|
8
|
2
|
6
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Safety and Efficacy Study of Botulinum Toxin Type A to Treat Glabellar Lines
Baseline characteristics by cohort
| Measure |
MT10109 A Unit
n=31 Participants
Single dose intramuscular injection of MT10109 (A Unit) at glabellar line (GL)
|
MT10109 B Unit
n=31 Participants
Single dose intramuscular injection of MT10109 (B Unit) at glabellar line (GL)
|
MT10109 C Unit
n=27 Participants
Single dose intramuscular injection of MT10109 (C Unit) at glabellar line (GL)
|
Botox (Registered Trade Mark)
n=32 Participants
Single dose intramuscular injection of Botox (B Unit) at glabellar line (GL)
|
Total
n=121 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Customized
Age
|
44.9 years
STANDARD_DEVIATION 8.32 • n=5 Participants
|
44.0 years
STANDARD_DEVIATION 9.77 • n=7 Participants
|
45.3 years
STANDARD_DEVIATION 9.51 • n=5 Participants
|
45.1 years
STANDARD_DEVIATION 9.53 • n=4 Participants
|
44.8 years
STANDARD_DEVIATION 9.19 • n=21 Participants
|
|
Sex: Female, Male
Female
|
27 Participants
n=5 Participants
|
29 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
27 Participants
n=4 Participants
|
107 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
14 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
31 Participants
n=5 Participants
|
31 Participants
n=7 Participants
|
27 Participants
n=5 Participants
|
31 Participants
n=4 Participants
|
120 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Region of Enrollment
Australia
|
31 participants
n=5 Participants
|
31 participants
n=7 Participants
|
27 participants
n=5 Participants
|
32 participants
n=4 Participants
|
121 participants
n=21 Participants
|
PRIMARY outcome
Timeframe: at Day 30Population: Full Analysis Set - comprised all randomized subjects who received at least one dose of study treatment and who had a glabellar lines severity rating at maximum frown at baseline and at least one post-baseline measurement.
Subjects included in the analysis had to have a baseline glabellar line (GL) severity rating at maximum frown of moderate (2) or severe (3). The GL severity were measured using a 4-point scale (0: none; 1: mild; 2: moderate; 3: Severe). A responder was defined as having a severity rating of none (0) or mild (1) at the corresponding post-baseline visit. Percentages are based on the number of subjects with an assessment at the relevant visit (Day 30).
Outcome measures
| Measure |
MT10109 A Unit
n=30 Participants
Single dose intramuscular injection of MT10109 (A Unit) at glabellar line (GL)
|
MT0109 B Unit
n=26 Participants
Single dose intramuscular injection of MT10109 (B Unit) at glabellar line (GL)
|
MT10109 C Unit
n=25 Participants
Single dose intramuscular injection of MT10109 (C Unit) at glabellar line (GL)
|
Botox (Registered Trade Mark)
n=26 Participants
Single dose intramuscular injection of Botox (B Unit) at glabellar line (GL)
|
|---|---|---|---|---|
|
Investigator's Rating of Glabellar Line Severity at Maximum Frown by Live Assessment.
Responders at Day 30 at Max Frown
|
18 Participants
|
18 Participants
|
22 Participants
|
19 Participants
|
|
Investigator's Rating of Glabellar Line Severity at Maximum Frown by Live Assessment.
Non-responders at Day 30 at Max Frown
|
12 Participants
|
8 Participants
|
3 Participants
|
7 Participants
|
Adverse Events
MT10109 A Unit
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
MT10109 B Unit
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
MT10109 C Unit
Serious events: 1 serious events
Other events: 10 other events
Deaths: 0 deaths
Botox (Registered Trade Mark)
Serious events: 1 serious events
Other events: 10 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
MT10109 A Unit
n=31 participants at risk
Single dose intramuscular injection of MT10109 (A Unit) at glabellar line (GL)
|
MT10109 B Unit
n=31 participants at risk
Single dose intramuscular injection of MT10109 (B Unit) at glabellar line (GL)
|
MT10109 C Unit
n=27 participants at risk
Single dose intramuscular injection of MT10109 (C Unit) at glabellar line (GL)
|
Botox (Registered Trade Mark)
n=32 participants at risk
Single dose intramuscular injection of Botox (B Unit) at glabellar line (GL)
|
|---|---|---|---|---|
|
Hepatobiliary disorders
Cholelithiasis
|
0.00%
0/31 • Until the End-of-Study Visit (Day 120)
This section focuses primarily on treatment-emergent adverse events (TEAEs), i.e., Adverse Events that started or worsened after the administration of study treatment.
|
0.00%
0/31 • Until the End-of-Study Visit (Day 120)
This section focuses primarily on treatment-emergent adverse events (TEAEs), i.e., Adverse Events that started or worsened after the administration of study treatment.
|
0.00%
0/27 • Until the End-of-Study Visit (Day 120)
This section focuses primarily on treatment-emergent adverse events (TEAEs), i.e., Adverse Events that started or worsened after the administration of study treatment.
|
3.1%
1/32 • Until the End-of-Study Visit (Day 120)
This section focuses primarily on treatment-emergent adverse events (TEAEs), i.e., Adverse Events that started or worsened after the administration of study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast Cancer
|
0.00%
0/31 • Until the End-of-Study Visit (Day 120)
This section focuses primarily on treatment-emergent adverse events (TEAEs), i.e., Adverse Events that started or worsened after the administration of study treatment.
|
0.00%
0/31 • Until the End-of-Study Visit (Day 120)
This section focuses primarily on treatment-emergent adverse events (TEAEs), i.e., Adverse Events that started or worsened after the administration of study treatment.
|
3.7%
1/27 • Until the End-of-Study Visit (Day 120)
This section focuses primarily on treatment-emergent adverse events (TEAEs), i.e., Adverse Events that started or worsened after the administration of study treatment.
|
0.00%
0/32 • Until the End-of-Study Visit (Day 120)
This section focuses primarily on treatment-emergent adverse events (TEAEs), i.e., Adverse Events that started or worsened after the administration of study treatment.
|
Other adverse events
| Measure |
MT10109 A Unit
n=31 participants at risk
Single dose intramuscular injection of MT10109 (A Unit) at glabellar line (GL)
|
MT10109 B Unit
n=31 participants at risk
Single dose intramuscular injection of MT10109 (B Unit) at glabellar line (GL)
|
MT10109 C Unit
n=27 participants at risk
Single dose intramuscular injection of MT10109 (C Unit) at glabellar line (GL)
|
Botox (Registered Trade Mark)
n=32 participants at risk
Single dose intramuscular injection of Botox (B Unit) at glabellar line (GL)
|
|---|---|---|---|---|
|
Gastrointestinal disorders
NAUSEA
|
0.00%
0/31 • Until the End-of-Study Visit (Day 120)
This section focuses primarily on treatment-emergent adverse events (TEAEs), i.e., Adverse Events that started or worsened after the administration of study treatment.
|
0.00%
0/31 • Until the End-of-Study Visit (Day 120)
This section focuses primarily on treatment-emergent adverse events (TEAEs), i.e., Adverse Events that started or worsened after the administration of study treatment.
|
0.00%
0/27 • Until the End-of-Study Visit (Day 120)
This section focuses primarily on treatment-emergent adverse events (TEAEs), i.e., Adverse Events that started or worsened after the administration of study treatment.
|
3.1%
1/32 • Until the End-of-Study Visit (Day 120)
This section focuses primarily on treatment-emergent adverse events (TEAEs), i.e., Adverse Events that started or worsened after the administration of study treatment.
|
|
General disorders
NODULE
|
0.00%
0/31 • Until the End-of-Study Visit (Day 120)
This section focuses primarily on treatment-emergent adverse events (TEAEs), i.e., Adverse Events that started or worsened after the administration of study treatment.
|
3.2%
1/31 • Until the End-of-Study Visit (Day 120)
This section focuses primarily on treatment-emergent adverse events (TEAEs), i.e., Adverse Events that started or worsened after the administration of study treatment.
|
0.00%
0/27 • Until the End-of-Study Visit (Day 120)
This section focuses primarily on treatment-emergent adverse events (TEAEs), i.e., Adverse Events that started or worsened after the administration of study treatment.
|
0.00%
0/32 • Until the End-of-Study Visit (Day 120)
This section focuses primarily on treatment-emergent adverse events (TEAEs), i.e., Adverse Events that started or worsened after the administration of study treatment.
|
|
Infections and infestations
ACUTE TONSILLITIS
|
0.00%
0/31 • Until the End-of-Study Visit (Day 120)
This section focuses primarily on treatment-emergent adverse events (TEAEs), i.e., Adverse Events that started or worsened after the administration of study treatment.
|
0.00%
0/31 • Until the End-of-Study Visit (Day 120)
This section focuses primarily on treatment-emergent adverse events (TEAEs), i.e., Adverse Events that started or worsened after the administration of study treatment.
|
3.7%
1/27 • Until the End-of-Study Visit (Day 120)
This section focuses primarily on treatment-emergent adverse events (TEAEs), i.e., Adverse Events that started or worsened after the administration of study treatment.
|
0.00%
0/32 • Until the End-of-Study Visit (Day 120)
This section focuses primarily on treatment-emergent adverse events (TEAEs), i.e., Adverse Events that started or worsened after the administration of study treatment.
|
|
Infections and infestations
BRONCHITIS
|
3.2%
1/31 • Until the End-of-Study Visit (Day 120)
This section focuses primarily on treatment-emergent adverse events (TEAEs), i.e., Adverse Events that started or worsened after the administration of study treatment.
|
0.00%
0/31 • Until the End-of-Study Visit (Day 120)
This section focuses primarily on treatment-emergent adverse events (TEAEs), i.e., Adverse Events that started or worsened after the administration of study treatment.
|
0.00%
0/27 • Until the End-of-Study Visit (Day 120)
This section focuses primarily on treatment-emergent adverse events (TEAEs), i.e., Adverse Events that started or worsened after the administration of study treatment.
|
0.00%
0/32 • Until the End-of-Study Visit (Day 120)
This section focuses primarily on treatment-emergent adverse events (TEAEs), i.e., Adverse Events that started or worsened after the administration of study treatment.
|
|
Infections and infestations
EYELID INFECTION
|
0.00%
0/31 • Until the End-of-Study Visit (Day 120)
This section focuses primarily on treatment-emergent adverse events (TEAEs), i.e., Adverse Events that started or worsened after the administration of study treatment.
|
0.00%
0/31 • Until the End-of-Study Visit (Day 120)
This section focuses primarily on treatment-emergent adverse events (TEAEs), i.e., Adverse Events that started or worsened after the administration of study treatment.
|
3.7%
1/27 • Until the End-of-Study Visit (Day 120)
This section focuses primarily on treatment-emergent adverse events (TEAEs), i.e., Adverse Events that started or worsened after the administration of study treatment.
|
0.00%
0/32 • Until the End-of-Study Visit (Day 120)
This section focuses primarily on treatment-emergent adverse events (TEAEs), i.e., Adverse Events that started or worsened after the administration of study treatment.
|
|
Infections and infestations
GASTROENTERITIS
|
0.00%
0/31 • Until the End-of-Study Visit (Day 120)
This section focuses primarily on treatment-emergent adverse events (TEAEs), i.e., Adverse Events that started or worsened after the administration of study treatment.
|
0.00%
0/31 • Until the End-of-Study Visit (Day 120)
This section focuses primarily on treatment-emergent adverse events (TEAEs), i.e., Adverse Events that started or worsened after the administration of study treatment.
|
3.7%
1/27 • Until the End-of-Study Visit (Day 120)
This section focuses primarily on treatment-emergent adverse events (TEAEs), i.e., Adverse Events that started or worsened after the administration of study treatment.
|
0.00%
0/32 • Until the End-of-Study Visit (Day 120)
This section focuses primarily on treatment-emergent adverse events (TEAEs), i.e., Adverse Events that started or worsened after the administration of study treatment.
|
|
Infections and infestations
HERPES ZOSTER
|
0.00%
0/31 • Until the End-of-Study Visit (Day 120)
This section focuses primarily on treatment-emergent adverse events (TEAEs), i.e., Adverse Events that started or worsened after the administration of study treatment.
|
3.2%
1/31 • Until the End-of-Study Visit (Day 120)
This section focuses primarily on treatment-emergent adverse events (TEAEs), i.e., Adverse Events that started or worsened after the administration of study treatment.
|
0.00%
0/27 • Until the End-of-Study Visit (Day 120)
This section focuses primarily on treatment-emergent adverse events (TEAEs), i.e., Adverse Events that started or worsened after the administration of study treatment.
|
0.00%
0/32 • Until the End-of-Study Visit (Day 120)
This section focuses primarily on treatment-emergent adverse events (TEAEs), i.e., Adverse Events that started or worsened after the administration of study treatment.
|
|
Infections and infestations
INFLUENZA
|
3.2%
1/31 • Until the End-of-Study Visit (Day 120)
This section focuses primarily on treatment-emergent adverse events (TEAEs), i.e., Adverse Events that started or worsened after the administration of study treatment.
|
0.00%
0/31 • Until the End-of-Study Visit (Day 120)
This section focuses primarily on treatment-emergent adverse events (TEAEs), i.e., Adverse Events that started or worsened after the administration of study treatment.
|
3.7%
1/27 • Until the End-of-Study Visit (Day 120)
This section focuses primarily on treatment-emergent adverse events (TEAEs), i.e., Adverse Events that started or worsened after the administration of study treatment.
|
0.00%
0/32 • Until the End-of-Study Visit (Day 120)
This section focuses primarily on treatment-emergent adverse events (TEAEs), i.e., Adverse Events that started or worsened after the administration of study treatment.
|
|
Infections and infestations
LOWER RESPIRATORY TRACT INFECTION
|
0.00%
0/31 • Until the End-of-Study Visit (Day 120)
This section focuses primarily on treatment-emergent adverse events (TEAEs), i.e., Adverse Events that started or worsened after the administration of study treatment.
|
0.00%
0/31 • Until the End-of-Study Visit (Day 120)
This section focuses primarily on treatment-emergent adverse events (TEAEs), i.e., Adverse Events that started or worsened after the administration of study treatment.
|
3.7%
1/27 • Until the End-of-Study Visit (Day 120)
This section focuses primarily on treatment-emergent adverse events (TEAEs), i.e., Adverse Events that started or worsened after the administration of study treatment.
|
0.00%
0/32 • Until the End-of-Study Visit (Day 120)
This section focuses primarily on treatment-emergent adverse events (TEAEs), i.e., Adverse Events that started or worsened after the administration of study treatment.
|
|
Infections and infestations
OTITIS MEDIA
|
0.00%
0/31 • Until the End-of-Study Visit (Day 120)
This section focuses primarily on treatment-emergent adverse events (TEAEs), i.e., Adverse Events that started or worsened after the administration of study treatment.
|
0.00%
0/31 • Until the End-of-Study Visit (Day 120)
This section focuses primarily on treatment-emergent adverse events (TEAEs), i.e., Adverse Events that started or worsened after the administration of study treatment.
|
3.7%
1/27 • Until the End-of-Study Visit (Day 120)
This section focuses primarily on treatment-emergent adverse events (TEAEs), i.e., Adverse Events that started or worsened after the administration of study treatment.
|
0.00%
0/32 • Until the End-of-Study Visit (Day 120)
This section focuses primarily on treatment-emergent adverse events (TEAEs), i.e., Adverse Events that started or worsened after the administration of study treatment.
|
|
Infections and infestations
RESPIRATORY TRACT INFECTION
|
0.00%
0/31 • Until the End-of-Study Visit (Day 120)
This section focuses primarily on treatment-emergent adverse events (TEAEs), i.e., Adverse Events that started or worsened after the administration of study treatment.
|
3.2%
1/31 • Until the End-of-Study Visit (Day 120)
This section focuses primarily on treatment-emergent adverse events (TEAEs), i.e., Adverse Events that started or worsened after the administration of study treatment.
|
0.00%
0/27 • Until the End-of-Study Visit (Day 120)
This section focuses primarily on treatment-emergent adverse events (TEAEs), i.e., Adverse Events that started or worsened after the administration of study treatment.
|
0.00%
0/32 • Until the End-of-Study Visit (Day 120)
This section focuses primarily on treatment-emergent adverse events (TEAEs), i.e., Adverse Events that started or worsened after the administration of study treatment.
|
|
Infections and infestations
UPPER RESPIRATORY TRACT INFECTION
|
6.5%
2/31 • Until the End-of-Study Visit (Day 120)
This section focuses primarily on treatment-emergent adverse events (TEAEs), i.e., Adverse Events that started or worsened after the administration of study treatment.
|
3.2%
1/31 • Until the End-of-Study Visit (Day 120)
This section focuses primarily on treatment-emergent adverse events (TEAEs), i.e., Adverse Events that started or worsened after the administration of study treatment.
|
0.00%
0/27 • Until the End-of-Study Visit (Day 120)
This section focuses primarily on treatment-emergent adverse events (TEAEs), i.e., Adverse Events that started or worsened after the administration of study treatment.
|
9.4%
3/32 • Until the End-of-Study Visit (Day 120)
This section focuses primarily on treatment-emergent adverse events (TEAEs), i.e., Adverse Events that started or worsened after the administration of study treatment.
|
|
Infections and infestations
URINARY TRACT INFECTION
|
3.2%
1/31 • Until the End-of-Study Visit (Day 120)
This section focuses primarily on treatment-emergent adverse events (TEAEs), i.e., Adverse Events that started or worsened after the administration of study treatment.
|
0.00%
0/31 • Until the End-of-Study Visit (Day 120)
This section focuses primarily on treatment-emergent adverse events (TEAEs), i.e., Adverse Events that started or worsened after the administration of study treatment.
|
0.00%
0/27 • Until the End-of-Study Visit (Day 120)
This section focuses primarily on treatment-emergent adverse events (TEAEs), i.e., Adverse Events that started or worsened after the administration of study treatment.
|
0.00%
0/32 • Until the End-of-Study Visit (Day 120)
This section focuses primarily on treatment-emergent adverse events (TEAEs), i.e., Adverse Events that started or worsened after the administration of study treatment.
|
|
Infections and infestations
VULVOVAGINAL CANDIDIASIS
|
0.00%
0/31 • Until the End-of-Study Visit (Day 120)
This section focuses primarily on treatment-emergent adverse events (TEAEs), i.e., Adverse Events that started or worsened after the administration of study treatment.
|
0.00%
0/31 • Until the End-of-Study Visit (Day 120)
This section focuses primarily on treatment-emergent adverse events (TEAEs), i.e., Adverse Events that started or worsened after the administration of study treatment.
|
3.7%
1/27 • Until the End-of-Study Visit (Day 120)
This section focuses primarily on treatment-emergent adverse events (TEAEs), i.e., Adverse Events that started or worsened after the administration of study treatment.
|
0.00%
0/32 • Until the End-of-Study Visit (Day 120)
This section focuses primarily on treatment-emergent adverse events (TEAEs), i.e., Adverse Events that started or worsened after the administration of study treatment.
|
|
Injury, poisoning and procedural complications
CLAVICLE FRACTURE
|
0.00%
0/31 • Until the End-of-Study Visit (Day 120)
This section focuses primarily on treatment-emergent adverse events (TEAEs), i.e., Adverse Events that started or worsened after the administration of study treatment.
|
3.2%
1/31 • Until the End-of-Study Visit (Day 120)
This section focuses primarily on treatment-emergent adverse events (TEAEs), i.e., Adverse Events that started or worsened after the administration of study treatment.
|
0.00%
0/27 • Until the End-of-Study Visit (Day 120)
This section focuses primarily on treatment-emergent adverse events (TEAEs), i.e., Adverse Events that started or worsened after the administration of study treatment.
|
0.00%
0/32 • Until the End-of-Study Visit (Day 120)
This section focuses primarily on treatment-emergent adverse events (TEAEs), i.e., Adverse Events that started or worsened after the administration of study treatment.
|
|
Injury, poisoning and procedural complications
LOWER LIMB FRACTURE
|
0.00%
0/31 • Until the End-of-Study Visit (Day 120)
This section focuses primarily on treatment-emergent adverse events (TEAEs), i.e., Adverse Events that started or worsened after the administration of study treatment.
|
0.00%
0/31 • Until the End-of-Study Visit (Day 120)
This section focuses primarily on treatment-emergent adverse events (TEAEs), i.e., Adverse Events that started or worsened after the administration of study treatment.
|
0.00%
0/27 • Until the End-of-Study Visit (Day 120)
This section focuses primarily on treatment-emergent adverse events (TEAEs), i.e., Adverse Events that started or worsened after the administration of study treatment.
|
3.1%
1/32 • Until the End-of-Study Visit (Day 120)
This section focuses primarily on treatment-emergent adverse events (TEAEs), i.e., Adverse Events that started or worsened after the administration of study treatment.
|
|
Injury, poisoning and procedural complications
THERMAL BURN
|
0.00%
0/31 • Until the End-of-Study Visit (Day 120)
This section focuses primarily on treatment-emergent adverse events (TEAEs), i.e., Adverse Events that started or worsened after the administration of study treatment.
|
0.00%
0/31 • Until the End-of-Study Visit (Day 120)
This section focuses primarily on treatment-emergent adverse events (TEAEs), i.e., Adverse Events that started or worsened after the administration of study treatment.
|
3.7%
1/27 • Until the End-of-Study Visit (Day 120)
This section focuses primarily on treatment-emergent adverse events (TEAEs), i.e., Adverse Events that started or worsened after the administration of study treatment.
|
0.00%
0/32 • Until the End-of-Study Visit (Day 120)
This section focuses primarily on treatment-emergent adverse events (TEAEs), i.e., Adverse Events that started or worsened after the administration of study treatment.
|
|
Metabolism and nutrition disorders
VITAMIN D DEFICIENCY
|
3.2%
1/31 • Until the End-of-Study Visit (Day 120)
This section focuses primarily on treatment-emergent adverse events (TEAEs), i.e., Adverse Events that started or worsened after the administration of study treatment.
|
0.00%
0/31 • Until the End-of-Study Visit (Day 120)
This section focuses primarily on treatment-emergent adverse events (TEAEs), i.e., Adverse Events that started or worsened after the administration of study treatment.
|
0.00%
0/27 • Until the End-of-Study Visit (Day 120)
This section focuses primarily on treatment-emergent adverse events (TEAEs), i.e., Adverse Events that started or worsened after the administration of study treatment.
|
0.00%
0/32 • Until the End-of-Study Visit (Day 120)
This section focuses primarily on treatment-emergent adverse events (TEAEs), i.e., Adverse Events that started or worsened after the administration of study treatment.
|
|
Musculoskeletal and connective tissue disorders
BACK PAIN
|
3.2%
1/31 • Until the End-of-Study Visit (Day 120)
This section focuses primarily on treatment-emergent adverse events (TEAEs), i.e., Adverse Events that started or worsened after the administration of study treatment.
|
0.00%
0/31 • Until the End-of-Study Visit (Day 120)
This section focuses primarily on treatment-emergent adverse events (TEAEs), i.e., Adverse Events that started or worsened after the administration of study treatment.
|
0.00%
0/27 • Until the End-of-Study Visit (Day 120)
This section focuses primarily on treatment-emergent adverse events (TEAEs), i.e., Adverse Events that started or worsened after the administration of study treatment.
|
3.1%
1/32 • Until the End-of-Study Visit (Day 120)
This section focuses primarily on treatment-emergent adverse events (TEAEs), i.e., Adverse Events that started or worsened after the administration of study treatment.
|
|
Musculoskeletal and connective tissue disorders
MUSCLE SPASMS
|
0.00%
0/31 • Until the End-of-Study Visit (Day 120)
This section focuses primarily on treatment-emergent adverse events (TEAEs), i.e., Adverse Events that started or worsened after the administration of study treatment.
|
0.00%
0/31 • Until the End-of-Study Visit (Day 120)
This section focuses primarily on treatment-emergent adverse events (TEAEs), i.e., Adverse Events that started or worsened after the administration of study treatment.
|
3.7%
1/27 • Until the End-of-Study Visit (Day 120)
This section focuses primarily on treatment-emergent adverse events (TEAEs), i.e., Adverse Events that started or worsened after the administration of study treatment.
|
0.00%
0/32 • Until the End-of-Study Visit (Day 120)
This section focuses primarily on treatment-emergent adverse events (TEAEs), i.e., Adverse Events that started or worsened after the administration of study treatment.
|
|
Musculoskeletal and connective tissue disorders
TENOSYNOVITIS STENOSANS
|
0.00%
0/31 • Until the End-of-Study Visit (Day 120)
This section focuses primarily on treatment-emergent adverse events (TEAEs), i.e., Adverse Events that started or worsened after the administration of study treatment.
|
0.00%
0/31 • Until the End-of-Study Visit (Day 120)
This section focuses primarily on treatment-emergent adverse events (TEAEs), i.e., Adverse Events that started or worsened after the administration of study treatment.
|
3.7%
1/27 • Until the End-of-Study Visit (Day 120)
This section focuses primarily on treatment-emergent adverse events (TEAEs), i.e., Adverse Events that started or worsened after the administration of study treatment.
|
0.00%
0/32 • Until the End-of-Study Visit (Day 120)
This section focuses primarily on treatment-emergent adverse events (TEAEs), i.e., Adverse Events that started or worsened after the administration of study treatment.
|
|
Nervous system disorders
HEAD DISCOMFORT
|
0.00%
0/31 • Until the End-of-Study Visit (Day 120)
This section focuses primarily on treatment-emergent adverse events (TEAEs), i.e., Adverse Events that started or worsened after the administration of study treatment.
|
3.2%
1/31 • Until the End-of-Study Visit (Day 120)
This section focuses primarily on treatment-emergent adverse events (TEAEs), i.e., Adverse Events that started or worsened after the administration of study treatment.
|
0.00%
0/27 • Until the End-of-Study Visit (Day 120)
This section focuses primarily on treatment-emergent adverse events (TEAEs), i.e., Adverse Events that started or worsened after the administration of study treatment.
|
0.00%
0/32 • Until the End-of-Study Visit (Day 120)
This section focuses primarily on treatment-emergent adverse events (TEAEs), i.e., Adverse Events that started or worsened after the administration of study treatment.
|
|
Nervous system disorders
HEADACHE
|
3.2%
1/31 • Until the End-of-Study Visit (Day 120)
This section focuses primarily on treatment-emergent adverse events (TEAEs), i.e., Adverse Events that started or worsened after the administration of study treatment.
|
3.2%
1/31 • Until the End-of-Study Visit (Day 120)
This section focuses primarily on treatment-emergent adverse events (TEAEs), i.e., Adverse Events that started or worsened after the administration of study treatment.
|
0.00%
0/27 • Until the End-of-Study Visit (Day 120)
This section focuses primarily on treatment-emergent adverse events (TEAEs), i.e., Adverse Events that started or worsened after the administration of study treatment.
|
12.5%
4/32 • Until the End-of-Study Visit (Day 120)
This section focuses primarily on treatment-emergent adverse events (TEAEs), i.e., Adverse Events that started or worsened after the administration of study treatment.
|
|
Nervous system disorders
MIGRAINE
|
0.00%
0/31 • Until the End-of-Study Visit (Day 120)
This section focuses primarily on treatment-emergent adverse events (TEAEs), i.e., Adverse Events that started or worsened after the administration of study treatment.
|
3.2%
1/31 • Until the End-of-Study Visit (Day 120)
This section focuses primarily on treatment-emergent adverse events (TEAEs), i.e., Adverse Events that started or worsened after the administration of study treatment.
|
3.7%
1/27 • Until the End-of-Study Visit (Day 120)
This section focuses primarily on treatment-emergent adverse events (TEAEs), i.e., Adverse Events that started or worsened after the administration of study treatment.
|
0.00%
0/32 • Until the End-of-Study Visit (Day 120)
This section focuses primarily on treatment-emergent adverse events (TEAEs), i.e., Adverse Events that started or worsened after the administration of study treatment.
|
|
Nervous system disorders
SYNCOPE
|
0.00%
0/31 • Until the End-of-Study Visit (Day 120)
This section focuses primarily on treatment-emergent adverse events (TEAEs), i.e., Adverse Events that started or worsened after the administration of study treatment.
|
3.2%
1/31 • Until the End-of-Study Visit (Day 120)
This section focuses primarily on treatment-emergent adverse events (TEAEs), i.e., Adverse Events that started or worsened after the administration of study treatment.
|
0.00%
0/27 • Until the End-of-Study Visit (Day 120)
This section focuses primarily on treatment-emergent adverse events (TEAEs), i.e., Adverse Events that started or worsened after the administration of study treatment.
|
0.00%
0/32 • Until the End-of-Study Visit (Day 120)
This section focuses primarily on treatment-emergent adverse events (TEAEs), i.e., Adverse Events that started or worsened after the administration of study treatment.
|
|
Nervous system disorders
TENSION HEADACHE
|
0.00%
0/31 • Until the End-of-Study Visit (Day 120)
This section focuses primarily on treatment-emergent adverse events (TEAEs), i.e., Adverse Events that started or worsened after the administration of study treatment.
|
3.2%
1/31 • Until the End-of-Study Visit (Day 120)
This section focuses primarily on treatment-emergent adverse events (TEAEs), i.e., Adverse Events that started or worsened after the administration of study treatment.
|
3.7%
1/27 • Until the End-of-Study Visit (Day 120)
This section focuses primarily on treatment-emergent adverse events (TEAEs), i.e., Adverse Events that started or worsened after the administration of study treatment.
|
0.00%
0/32 • Until the End-of-Study Visit (Day 120)
This section focuses primarily on treatment-emergent adverse events (TEAEs), i.e., Adverse Events that started or worsened after the administration of study treatment.
|
|
Psychiatric disorders
DEPRESSION
|
0.00%
0/31 • Until the End-of-Study Visit (Day 120)
This section focuses primarily on treatment-emergent adverse events (TEAEs), i.e., Adverse Events that started or worsened after the administration of study treatment.
|
0.00%
0/31 • Until the End-of-Study Visit (Day 120)
This section focuses primarily on treatment-emergent adverse events (TEAEs), i.e., Adverse Events that started or worsened after the administration of study treatment.
|
0.00%
0/27 • Until the End-of-Study Visit (Day 120)
This section focuses primarily on treatment-emergent adverse events (TEAEs), i.e., Adverse Events that started or worsened after the administration of study treatment.
|
3.1%
1/32 • Until the End-of-Study Visit (Day 120)
This section focuses primarily on treatment-emergent adverse events (TEAEs), i.e., Adverse Events that started or worsened after the administration of study treatment.
|
|
Renal and urinary disorders
RENAL COLIC
|
0.00%
0/31 • Until the End-of-Study Visit (Day 120)
This section focuses primarily on treatment-emergent adverse events (TEAEs), i.e., Adverse Events that started or worsened after the administration of study treatment.
|
3.2%
1/31 • Until the End-of-Study Visit (Day 120)
This section focuses primarily on treatment-emergent adverse events (TEAEs), i.e., Adverse Events that started or worsened after the administration of study treatment.
|
0.00%
0/27 • Until the End-of-Study Visit (Day 120)
This section focuses primarily on treatment-emergent adverse events (TEAEs), i.e., Adverse Events that started or worsened after the administration of study treatment.
|
0.00%
0/32 • Until the End-of-Study Visit (Day 120)
This section focuses primarily on treatment-emergent adverse events (TEAEs), i.e., Adverse Events that started or worsened after the administration of study treatment.
|
|
Reproductive system and breast disorders
BREAST MASS
|
0.00%
0/31 • Until the End-of-Study Visit (Day 120)
This section focuses primarily on treatment-emergent adverse events (TEAEs), i.e., Adverse Events that started or worsened after the administration of study treatment.
|
0.00%
0/31 • Until the End-of-Study Visit (Day 120)
This section focuses primarily on treatment-emergent adverse events (TEAEs), i.e., Adverse Events that started or worsened after the administration of study treatment.
|
3.7%
1/27 • Until the End-of-Study Visit (Day 120)
This section focuses primarily on treatment-emergent adverse events (TEAEs), i.e., Adverse Events that started or worsened after the administration of study treatment.
|
0.00%
0/32 • Until the End-of-Study Visit (Day 120)
This section focuses primarily on treatment-emergent adverse events (TEAEs), i.e., Adverse Events that started or worsened after the administration of study treatment.
|
|
Reproductive system and breast disorders
DYSMENORRHOEA
|
0.00%
0/31 • Until the End-of-Study Visit (Day 120)
This section focuses primarily on treatment-emergent adverse events (TEAEs), i.e., Adverse Events that started or worsened after the administration of study treatment.
|
3.2%
1/31 • Until the End-of-Study Visit (Day 120)
This section focuses primarily on treatment-emergent adverse events (TEAEs), i.e., Adverse Events that started or worsened after the administration of study treatment.
|
0.00%
0/27 • Until the End-of-Study Visit (Day 120)
This section focuses primarily on treatment-emergent adverse events (TEAEs), i.e., Adverse Events that started or worsened after the administration of study treatment.
|
0.00%
0/32 • Until the End-of-Study Visit (Day 120)
This section focuses primarily on treatment-emergent adverse events (TEAEs), i.e., Adverse Events that started or worsened after the administration of study treatment.
|
|
Skin and subcutaneous tissue disorders
ALOPECIA
|
3.2%
1/31 • Until the End-of-Study Visit (Day 120)
This section focuses primarily on treatment-emergent adverse events (TEAEs), i.e., Adverse Events that started or worsened after the administration of study treatment.
|
0.00%
0/31 • Until the End-of-Study Visit (Day 120)
This section focuses primarily on treatment-emergent adverse events (TEAEs), i.e., Adverse Events that started or worsened after the administration of study treatment.
|
0.00%
0/27 • Until the End-of-Study Visit (Day 120)
This section focuses primarily on treatment-emergent adverse events (TEAEs), i.e., Adverse Events that started or worsened after the administration of study treatment.
|
0.00%
0/32 • Until the End-of-Study Visit (Day 120)
This section focuses primarily on treatment-emergent adverse events (TEAEs), i.e., Adverse Events that started or worsened after the administration of study treatment.
|
|
Skin and subcutaneous tissue disorders
DERMATITIS ACNEIFORM
|
0.00%
0/31 • Until the End-of-Study Visit (Day 120)
This section focuses primarily on treatment-emergent adverse events (TEAEs), i.e., Adverse Events that started or worsened after the administration of study treatment.
|
0.00%
0/31 • Until the End-of-Study Visit (Day 120)
This section focuses primarily on treatment-emergent adverse events (TEAEs), i.e., Adverse Events that started or worsened after the administration of study treatment.
|
3.7%
1/27 • Until the End-of-Study Visit (Day 120)
This section focuses primarily on treatment-emergent adverse events (TEAEs), i.e., Adverse Events that started or worsened after the administration of study treatment.
|
0.00%
0/32 • Until the End-of-Study Visit (Day 120)
This section focuses primarily on treatment-emergent adverse events (TEAEs), i.e., Adverse Events that started or worsened after the administration of study treatment.
|
|
Skin and subcutaneous tissue disorders
RASH
|
3.2%
1/31 • Until the End-of-Study Visit (Day 120)
This section focuses primarily on treatment-emergent adverse events (TEAEs), i.e., Adverse Events that started or worsened after the administration of study treatment.
|
0.00%
0/31 • Until the End-of-Study Visit (Day 120)
This section focuses primarily on treatment-emergent adverse events (TEAEs), i.e., Adverse Events that started or worsened after the administration of study treatment.
|
0.00%
0/27 • Until the End-of-Study Visit (Day 120)
This section focuses primarily on treatment-emergent adverse events (TEAEs), i.e., Adverse Events that started or worsened after the administration of study treatment.
|
0.00%
0/32 • Until the End-of-Study Visit (Day 120)
This section focuses primarily on treatment-emergent adverse events (TEAEs), i.e., Adverse Events that started or worsened after the administration of study treatment.
|
|
Skin and subcutaneous tissue disorders
SEBACEOUS HYPERPLASIA
|
3.2%
1/31 • Until the End-of-Study Visit (Day 120)
This section focuses primarily on treatment-emergent adverse events (TEAEs), i.e., Adverse Events that started or worsened after the administration of study treatment.
|
0.00%
0/31 • Until the End-of-Study Visit (Day 120)
This section focuses primarily on treatment-emergent adverse events (TEAEs), i.e., Adverse Events that started or worsened after the administration of study treatment.
|
0.00%
0/27 • Until the End-of-Study Visit (Day 120)
This section focuses primarily on treatment-emergent adverse events (TEAEs), i.e., Adverse Events that started or worsened after the administration of study treatment.
|
0.00%
0/32 • Until the End-of-Study Visit (Day 120)
This section focuses primarily on treatment-emergent adverse events (TEAEs), i.e., Adverse Events that started or worsened after the administration of study treatment.
|
|
Skin and subcutaneous tissue disorders
TELANGIECTASIA
|
0.00%
0/31 • Until the End-of-Study Visit (Day 120)
This section focuses primarily on treatment-emergent adverse events (TEAEs), i.e., Adverse Events that started or worsened after the administration of study treatment.
|
0.00%
0/31 • Until the End-of-Study Visit (Day 120)
This section focuses primarily on treatment-emergent adverse events (TEAEs), i.e., Adverse Events that started or worsened after the administration of study treatment.
|
3.7%
1/27 • Until the End-of-Study Visit (Day 120)
This section focuses primarily on treatment-emergent adverse events (TEAEs), i.e., Adverse Events that started or worsened after the administration of study treatment.
|
0.00%
0/32 • Until the End-of-Study Visit (Day 120)
This section focuses primarily on treatment-emergent adverse events (TEAEs), i.e., Adverse Events that started or worsened after the administration of study treatment.
|
|
Hepatobiliary disorders
CHOLELITHIASIS
|
0.00%
0/31 • Until the End-of-Study Visit (Day 120)
This section focuses primarily on treatment-emergent adverse events (TEAEs), i.e., Adverse Events that started or worsened after the administration of study treatment.
|
0.00%
0/31 • Until the End-of-Study Visit (Day 120)
This section focuses primarily on treatment-emergent adverse events (TEAEs), i.e., Adverse Events that started or worsened after the administration of study treatment.
|
0.00%
0/27 • Until the End-of-Study Visit (Day 120)
This section focuses primarily on treatment-emergent adverse events (TEAEs), i.e., Adverse Events that started or worsened after the administration of study treatment.
|
3.1%
1/32 • Until the End-of-Study Visit (Day 120)
This section focuses primarily on treatment-emergent adverse events (TEAEs), i.e., Adverse Events that started or worsened after the administration of study treatment.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60