Trial Outcomes & Findings for Study to Evaluate Efficacy, Safety, and Tolerability of MT-7117 in Subjects With Erythropoietic Protoporphyria (NCT NCT03520036)
NCT ID: NCT03520036
Last Updated: 2025-12-31
Results Overview
Duration in minutes, of sunlight exposure between 1 hour post sunrise and 1 hour pre-sunset. The average Duration in minutes, of sunlight exposure before the first prodromal symptom between 1 hour post sunrise and 1 hour pre-sunset. The average duration means that average of daily durations in 14-day windows before Day 1 (or week 16 Day) applied.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
102 participants
Primary outcome timeframe
Baseline (Week 0) and Week 16
Results posted on
2025-12-31
Participant Flow
Participant milestones
| Measure |
MT-7117 Low Dose
MT-7117 low dose: MT-7117 low dose QD, oral, 16 weeks
|
MT-7117 High Dose
MT-7117 high dose: MT-7117 high dose QD, oral, 16 weeks
|
Placebo
Placebo: Placebo QD, oral, 16 weeks
|
|---|---|---|---|
|
Overall Study
STARTED
|
33
|
34
|
35
|
|
Overall Study
COMPLETED
|
31
|
30
|
31
|
|
Overall Study
NOT COMPLETED
|
2
|
4
|
4
|
Reasons for withdrawal
| Measure |
MT-7117 Low Dose
MT-7117 low dose: MT-7117 low dose QD, oral, 16 weeks
|
MT-7117 High Dose
MT-7117 high dose: MT-7117 high dose QD, oral, 16 weeks
|
Placebo
Placebo: Placebo QD, oral, 16 weeks
|
|---|---|---|---|
|
Overall Study
Adverse Event
|
1
|
2
|
0
|
|
Overall Study
Protocol Violation
|
1
|
0
|
0
|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
4
|
|
Overall Study
CS Adverse Findings from Post- Baseline Nevi Evaluation
|
0
|
1
|
0
|
Baseline Characteristics
Study to Evaluate Efficacy, Safety, and Tolerability of MT-7117 in Subjects With Erythropoietic Protoporphyria
Baseline characteristics by cohort
| Measure |
MT-7117 Low Dose
n=33 Participants
MT-7117 low dose: MT-7117 low dose QD, oral, 16 weeks
|
MT-7117 High Dose
n=34 Participants
MT-7117 high dose: MT-7117 high dose QD, oral, 16 weeks
|
Placebo
n=35 Participants
Placebo: Placebo QD, oral, 16 weeks
|
Total
n=102 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
41.8 years
STANDARD_DEVIATION 12.8 • n=1000 Participants
|
41.9 years
STANDARD_DEVIATION 14 • n=1986 Participants
|
38.1 years
STANDARD_DEVIATION 12.6 • n=2008 Participants
|
40.6 years
STANDARD_DEVIATION 13.1 • n=4994 Participants
|
|
Sex: Female, Male
Female
|
15 Participants
n=1000 Participants
|
25 Participants
n=1986 Participants
|
13 Participants
n=2008 Participants
|
53 Participants
n=4994 Participants
|
|
Sex: Female, Male
Male
|
18 Participants
n=1000 Participants
|
9 Participants
n=1986 Participants
|
22 Participants
n=2008 Participants
|
49 Participants
n=4994 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=1000 Participants
|
2 Participants
n=1986 Participants
|
1 Participants
n=2008 Participants
|
4 Participants
n=4994 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
32 Participants
n=1000 Participants
|
32 Participants
n=1986 Participants
|
34 Participants
n=2008 Participants
|
98 Participants
n=4994 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=1000 Participants
|
0 Participants
n=1986 Participants
|
0 Participants
n=2008 Participants
|
0 Participants
n=4994 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=1000 Participants
|
0 Participants
n=1986 Participants
|
0 Participants
n=2008 Participants
|
0 Participants
n=4994 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=1000 Participants
|
0 Participants
n=1986 Participants
|
1 Participants
n=2008 Participants
|
1 Participants
n=4994 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=1000 Participants
|
0 Participants
n=1986 Participants
|
0 Participants
n=2008 Participants
|
0 Participants
n=4994 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=1000 Participants
|
0 Participants
n=1986 Participants
|
0 Participants
n=2008 Participants
|
0 Participants
n=4994 Participants
|
|
Race (NIH/OMB)
White
|
33 Participants
n=1000 Participants
|
33 Participants
n=1986 Participants
|
32 Participants
n=2008 Participants
|
98 Participants
n=4994 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=1000 Participants
|
0 Participants
n=1986 Participants
|
0 Participants
n=2008 Participants
|
0 Participants
n=4994 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=1000 Participants
|
1 Participants
n=1986 Participants
|
2 Participants
n=2008 Participants
|
3 Participants
n=4994 Participants
|
PRIMARY outcome
Timeframe: Baseline (Week 0) and Week 16Population: ITT Population
Duration in minutes, of sunlight exposure between 1 hour post sunrise and 1 hour pre-sunset. The average Duration in minutes, of sunlight exposure before the first prodromal symptom between 1 hour post sunrise and 1 hour pre-sunset. The average duration means that average of daily durations in 14-day windows before Day 1 (or week 16 Day) applied.
Outcome measures
| Measure |
MT-7117 High Dose
n=34 Participants
MT-7117 high dose: MT-7117 high dose QD, oral, 16 weeks
|
Placebo
n=35 Participants
Placebo: Placebo QD, oral, 16 weeks
|
MT-7117 Low Dose
n=33 Participants
MT-7117 low dose: MT-7117 low dose QD, oral, 16 weeks
|
|---|---|---|---|
|
Change From Baseline in Average Daily Time (Minutes) to First Prodromal Symptom Associated With Sunlight Exposure Between Hour Post Sunrise and 1 Hour Pre-Sunset at Week 16.
|
92.4 Minutes
Standard Deviation 100
|
21.0 Minutes
Standard Deviation 63.4
|
74.7 Minutes
Standard Deviation 76.8
|
PRIMARY outcome
Timeframe: Baseline (Week 0), and Week 16Population: ITT Population
Change from baseline to week 16 in Average Daily Duration (Minutes) of Sunlight Exposure sums any sunlight exposure time excluding any overlapped time with prodromal symptoms, including if the patients go out multiple times on the same day after the prodromal symptom had previously ended.
Outcome measures
| Measure |
MT-7117 High Dose
n=34 Participants
MT-7117 high dose: MT-7117 high dose QD, oral, 16 weeks
|
Placebo
n=35 Participants
Placebo: Placebo QD, oral, 16 weeks
|
MT-7117 Low Dose
n=33 Participants
MT-7117 low dose: MT-7117 low dose QD, oral, 16 weeks
|
|---|---|---|---|
|
Change From Baseline in Average Daily Duration (Minutes) of Sunlight Exposure Between 1 Hour Post Sunrise and 1 Hour Pre-Sunset Without Prodromal Symptoms at Week 16
|
86.1 Minutes
Standard Deviation 83.9
|
19.9 Minutes
Standard Deviation 63.2
|
72.6 Minutes
Standard Deviation 76.2
|
PRIMARY outcome
Timeframe: Baseline (Week 0), and Week 16Population: ITT Population
Change from baseline to week 16 in Average Daily Mean Duration (Minutes) of Sunlight Exposure without prodromal symptoms divided by the number of sunlight exposures periods applicable that day.
Outcome measures
| Measure |
MT-7117 High Dose
n=34 Participants
MT-7117 high dose: MT-7117 high dose QD, oral, 16 weeks
|
Placebo
n=35 Participants
Placebo: Placebo QD, oral, 16 weeks
|
MT-7117 Low Dose
n=33 Participants
MT-7117 low dose: MT-7117 low dose QD, oral, 16 weeks
|
|---|---|---|---|
|
Change From Baseline in Average Daily Mean Duration (Minutes) of Sunlight Exposure Between 1 Hour Post Sunrise and 1 Hour Pre-Sunset Without Prodromal Symptoms at Week 16
|
59.3 Minutes
Standard Deviation 85.2
|
12.8 Minutes
Standard Deviation 46.9
|
70.2 Minutes
Standard Deviation 73.4
|
SECONDARY outcome
Timeframe: Week 16Population: ITT Population
Outcome measures
| Measure |
MT-7117 High Dose
n=34 Participants
MT-7117 high dose: MT-7117 high dose QD, oral, 16 weeks
|
Placebo
n=35 Participants
Placebo: Placebo QD, oral, 16 weeks
|
MT-7117 Low Dose
n=33 Participants
MT-7117 low dose: MT-7117 low dose QD, oral, 16 weeks
|
|---|---|---|---|
|
Total Number of Sunlight Exposure Episodes With Prodromal Symptoms During 16-Week Double-Blind Treatment Period
|
7.7 sunlight exposure episodes
Standard Deviation 6.6
|
11.1 sunlight exposure episodes
Standard Deviation 13.3
|
8.6 sunlight exposure episodes
Standard Deviation 9.3
|
SECONDARY outcome
Timeframe: Baseline (Week 0), and Week 16Population: ITT Population
The Intensity of Prodromal Symptoms is measured by 11-point Likert scale ranges from 0 (no symptom) to 10 (greatest severity of symptom).
Outcome measures
| Measure |
MT-7117 High Dose
n=34 Participants
MT-7117 high dose: MT-7117 high dose QD, oral, 16 weeks
|
Placebo
n=35 Participants
Placebo: Placebo QD, oral, 16 weeks
|
MT-7117 Low Dose
n=33 Participants
MT-7117 low dose: MT-7117 low dose QD, oral, 16 weeks
|
|---|---|---|---|
|
Change From Baseline in Average Daily Mean Intensity of Prodromal Symptoms During 16-week Double-blind Treatment Period in 11-point Likert Scale
Baseline
|
2.1 score on a scale
Standard Deviation 0.9
|
2.0 score on a scale
Standard Deviation 1.1
|
2.0 score on a scale
Standard Deviation 1.1
|
|
Change From Baseline in Average Daily Mean Intensity of Prodromal Symptoms During 16-week Double-blind Treatment Period in 11-point Likert Scale
Week 16
|
2.4 score on a scale
Standard Deviation 1.7
|
2.4 score on a scale
Standard Deviation 1.4
|
1.7 score on a scale
Standard Deviation 1.1
|
SECONDARY outcome
Timeframe: Baseline (Week 0), and Week 16Population: ITT Population
Outcome measures
| Measure |
MT-7117 High Dose
n=34 Participants
MT-7117 high dose: MT-7117 high dose QD, oral, 16 weeks
|
Placebo
n=35 Participants
Placebo: Placebo QD, oral, 16 weeks
|
MT-7117 Low Dose
n=33 Participants
MT-7117 low dose: MT-7117 low dose QD, oral, 16 weeks
|
|---|---|---|---|
|
Change From Baseline in Average Daily Duration (Minutes) of Prodromal Symptoms at 16-Week Double-Blind Treatment Period
|
111.0 Minutes
Standard Deviation 466.1
|
83.3 Minutes
Standard Deviation 267.2
|
55.3 Minutes
Standard Deviation 321.0
|
SECONDARY outcome
Timeframe: Baseline (Week 0), Week 8, and Week 16Population: ITT Population
Pigmentation will be assessed in melanin density which are numeric scores measured by spectrophotometer on 6 skin segments (forehead, left cheek, right inside upper arm, left medial forearm, right-hand side of abdomen, and left-hand side of buttock).
Outcome measures
| Measure |
MT-7117 High Dose
n=34 Participants
MT-7117 high dose: MT-7117 high dose QD, oral, 16 weeks
|
Placebo
n=35 Participants
Placebo: Placebo QD, oral, 16 weeks
|
MT-7117 Low Dose
n=33 Participants
MT-7117 low dose: MT-7117 low dose QD, oral, 16 weeks
|
|---|---|---|---|
|
Change From Baseline in Pigmentation as Measured by Melanin Density for Average of 6 Skin Segments at Week 8 and Week 16.
Change from Baseline at Week 8
|
1.6557 unitless
Standard Deviation 2.2099
|
0.1390 unitless
Standard Deviation 0.3376
|
1.4635 unitless
Standard Deviation 3.1644
|
|
Change From Baseline in Pigmentation as Measured by Melanin Density for Average of 6 Skin Segments at Week 8 and Week 16.
Change from Baseline at Week 16
|
1.5307 unitless
Standard Deviation 0.6881
|
0.1639 unitless
Standard Deviation 0.3939
|
1.1413 unitless
Standard Deviation 0.7285
|
SECONDARY outcome
Timeframe: Baseline (Week 0), Week 8, and Week 16Population: ITT Population
Outcome measures
| Measure |
MT-7117 High Dose
n=34 Participants
MT-7117 high dose: MT-7117 high dose QD, oral, 16 weeks
|
Placebo
n=35 Participants
Placebo: Placebo QD, oral, 16 weeks
|
MT-7117 Low Dose
n=33 Participants
MT-7117 low dose: MT-7117 low dose QD, oral, 16 weeks
|
|---|---|---|---|
|
Percent Change From Baseline in Pigmentation as Measured by Melanin Density for Average of 6 Skin Segments at Week 8 and Week 16.
% Change from Baseline at Week 8
|
42.5543 percent change
Standard Deviation 38.8390
|
4.2394 percent change
Standard Deviation 11.9435
|
30.4135 percent change
Standard Deviation 32.8302
|
|
Percent Change From Baseline in Pigmentation as Measured by Melanin Density for Average of 6 Skin Segments at Week 8 and Week 16.
% Change from Baseline at Week 16
|
56.2871 percent change
Standard Deviation 41.0660
|
7.4214 percent change
Standard Deviation 16.7074
|
44.0135 percent change
Standard Deviation 43.7325
|
SECONDARY outcome
Timeframe: Week 16Population: ITT Population
Outcome measures
| Measure |
MT-7117 High Dose
n=34 Participants
MT-7117 high dose: MT-7117 high dose QD, oral, 16 weeks
|
Placebo
n=35 Participants
Placebo: Placebo QD, oral, 16 weeks
|
MT-7117 Low Dose
n=33 Participants
MT-7117 low dose: MT-7117 low dose QD, oral, 16 weeks
|
|---|---|---|---|
|
Total Number of Pain Events During 16-Week Double-Blind Treatment Period
|
3.3 pain events
Standard Deviation 2.8
|
5.4 pain events
Standard Deviation 4.9
|
4.0 pain events
Standard Deviation 6.4
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline (Week 0) and Week 16Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline (Week 0) and Week 16Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline (Week 0) and Week 16Outcome measures
Outcome data not reported
Adverse Events
MT-7117 Low Dose
Serious events: 1 serious events
Other events: 31 other events
Deaths: 0 deaths
MT-7117 High Dose
Serious events: 0 serious events
Other events: 34 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 31 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
MT-7117 Low Dose
n=33 participants at risk
MT-7117 low dose: MT-7117 low dose QD, oral, 16 weeks
|
MT-7117 High Dose
n=35 participants at risk
MT-7117 high dose: MT-7117 high dose QD, oral, 16 weeks
|
Placebo
n=34 participants at risk
Placebo: Placebo QD, oral, 16 weeks
|
|---|---|---|---|
|
Immune system disorders
Anaphylactic reaction
|
3.0%
1/33 • All AEs and SAEs that occurred from the time written informed consent was obtained until the end of the follow-up period (6 weeks after the last treatment visit, for safety monitoring)
One subject who was randomized to Placebo received MT-7117 high Dose instead of placebo. Therefore, the subject was counted as MT-7117 high Dose Group in the Safety Population.
|
0.00%
0/35 • All AEs and SAEs that occurred from the time written informed consent was obtained until the end of the follow-up period (6 weeks after the last treatment visit, for safety monitoring)
One subject who was randomized to Placebo received MT-7117 high Dose instead of placebo. Therefore, the subject was counted as MT-7117 high Dose Group in the Safety Population.
|
0.00%
0/34 • All AEs and SAEs that occurred from the time written informed consent was obtained until the end of the follow-up period (6 weeks after the last treatment visit, for safety monitoring)
One subject who was randomized to Placebo received MT-7117 high Dose instead of placebo. Therefore, the subject was counted as MT-7117 high Dose Group in the Safety Population.
|
Other adverse events
| Measure |
MT-7117 Low Dose
n=33 participants at risk
MT-7117 low dose: MT-7117 low dose QD, oral, 16 weeks
|
MT-7117 High Dose
n=35 participants at risk
MT-7117 high dose: MT-7117 high dose QD, oral, 16 weeks
|
Placebo
n=34 participants at risk
Placebo: Placebo QD, oral, 16 weeks
|
|---|---|---|---|
|
Cardiac disorders
Atrial fibrillation
|
3.0%
1/33 • All AEs and SAEs that occurred from the time written informed consent was obtained until the end of the follow-up period (6 weeks after the last treatment visit, for safety monitoring)
One subject who was randomized to Placebo received MT-7117 high Dose instead of placebo. Therefore, the subject was counted as MT-7117 high Dose Group in the Safety Population.
|
0.00%
0/35 • All AEs and SAEs that occurred from the time written informed consent was obtained until the end of the follow-up period (6 weeks after the last treatment visit, for safety monitoring)
One subject who was randomized to Placebo received MT-7117 high Dose instead of placebo. Therefore, the subject was counted as MT-7117 high Dose Group in the Safety Population.
|
0.00%
0/34 • All AEs and SAEs that occurred from the time written informed consent was obtained until the end of the follow-up period (6 weeks after the last treatment visit, for safety monitoring)
One subject who was randomized to Placebo received MT-7117 high Dose instead of placebo. Therefore, the subject was counted as MT-7117 high Dose Group in the Safety Population.
|
|
Congenital, familial and genetic disorders
Congenital naevus
|
3.0%
1/33 • All AEs and SAEs that occurred from the time written informed consent was obtained until the end of the follow-up period (6 weeks after the last treatment visit, for safety monitoring)
One subject who was randomized to Placebo received MT-7117 high Dose instead of placebo. Therefore, the subject was counted as MT-7117 high Dose Group in the Safety Population.
|
0.00%
0/35 • All AEs and SAEs that occurred from the time written informed consent was obtained until the end of the follow-up period (6 weeks after the last treatment visit, for safety monitoring)
One subject who was randomized to Placebo received MT-7117 high Dose instead of placebo. Therefore, the subject was counted as MT-7117 high Dose Group in the Safety Population.
|
0.00%
0/34 • All AEs and SAEs that occurred from the time written informed consent was obtained until the end of the follow-up period (6 weeks after the last treatment visit, for safety monitoring)
One subject who was randomized to Placebo received MT-7117 high Dose instead of placebo. Therefore, the subject was counted as MT-7117 high Dose Group in the Safety Population.
|
|
Gastrointestinal disorders
Abdominal discomfort
|
3.0%
1/33 • All AEs and SAEs that occurred from the time written informed consent was obtained until the end of the follow-up period (6 weeks after the last treatment visit, for safety monitoring)
One subject who was randomized to Placebo received MT-7117 high Dose instead of placebo. Therefore, the subject was counted as MT-7117 high Dose Group in the Safety Population.
|
2.9%
1/35 • All AEs and SAEs that occurred from the time written informed consent was obtained until the end of the follow-up period (6 weeks after the last treatment visit, for safety monitoring)
One subject who was randomized to Placebo received MT-7117 high Dose instead of placebo. Therefore, the subject was counted as MT-7117 high Dose Group in the Safety Population.
|
5.9%
2/34 • All AEs and SAEs that occurred from the time written informed consent was obtained until the end of the follow-up period (6 weeks after the last treatment visit, for safety monitoring)
One subject who was randomized to Placebo received MT-7117 high Dose instead of placebo. Therefore, the subject was counted as MT-7117 high Dose Group in the Safety Population.
|
|
Gastrointestinal disorders
Abdominal pain
|
3.0%
1/33 • All AEs and SAEs that occurred from the time written informed consent was obtained until the end of the follow-up period (6 weeks after the last treatment visit, for safety monitoring)
One subject who was randomized to Placebo received MT-7117 high Dose instead of placebo. Therefore, the subject was counted as MT-7117 high Dose Group in the Safety Population.
|
2.9%
1/35 • All AEs and SAEs that occurred from the time written informed consent was obtained until the end of the follow-up period (6 weeks after the last treatment visit, for safety monitoring)
One subject who was randomized to Placebo received MT-7117 high Dose instead of placebo. Therefore, the subject was counted as MT-7117 high Dose Group in the Safety Population.
|
2.9%
1/34 • All AEs and SAEs that occurred from the time written informed consent was obtained until the end of the follow-up period (6 weeks after the last treatment visit, for safety monitoring)
One subject who was randomized to Placebo received MT-7117 high Dose instead of placebo. Therefore, the subject was counted as MT-7117 high Dose Group in the Safety Population.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
9.1%
3/33 • All AEs and SAEs that occurred from the time written informed consent was obtained until the end of the follow-up period (6 weeks after the last treatment visit, for safety monitoring)
One subject who was randomized to Placebo received MT-7117 high Dose instead of placebo. Therefore, the subject was counted as MT-7117 high Dose Group in the Safety Population.
|
2.9%
1/35 • All AEs and SAEs that occurred from the time written informed consent was obtained until the end of the follow-up period (6 weeks after the last treatment visit, for safety monitoring)
One subject who was randomized to Placebo received MT-7117 high Dose instead of placebo. Therefore, the subject was counted as MT-7117 high Dose Group in the Safety Population.
|
14.7%
5/34 • All AEs and SAEs that occurred from the time written informed consent was obtained until the end of the follow-up period (6 weeks after the last treatment visit, for safety monitoring)
One subject who was randomized to Placebo received MT-7117 high Dose instead of placebo. Therefore, the subject was counted as MT-7117 high Dose Group in the Safety Population.
|
|
Gastrointestinal disorders
Chapped lips
|
3.0%
1/33 • All AEs and SAEs that occurred from the time written informed consent was obtained until the end of the follow-up period (6 weeks after the last treatment visit, for safety monitoring)
One subject who was randomized to Placebo received MT-7117 high Dose instead of placebo. Therefore, the subject was counted as MT-7117 high Dose Group in the Safety Population.
|
0.00%
0/35 • All AEs and SAEs that occurred from the time written informed consent was obtained until the end of the follow-up period (6 weeks after the last treatment visit, for safety monitoring)
One subject who was randomized to Placebo received MT-7117 high Dose instead of placebo. Therefore, the subject was counted as MT-7117 high Dose Group in the Safety Population.
|
0.00%
0/34 • All AEs and SAEs that occurred from the time written informed consent was obtained until the end of the follow-up period (6 weeks after the last treatment visit, for safety monitoring)
One subject who was randomized to Placebo received MT-7117 high Dose instead of placebo. Therefore, the subject was counted as MT-7117 high Dose Group in the Safety Population.
|
|
Gastrointestinal disorders
Diarrhoea
|
12.1%
4/33 • All AEs and SAEs that occurred from the time written informed consent was obtained until the end of the follow-up period (6 weeks after the last treatment visit, for safety monitoring)
One subject who was randomized to Placebo received MT-7117 high Dose instead of placebo. Therefore, the subject was counted as MT-7117 high Dose Group in the Safety Population.
|
22.9%
8/35 • All AEs and SAEs that occurred from the time written informed consent was obtained until the end of the follow-up period (6 weeks after the last treatment visit, for safety monitoring)
One subject who was randomized to Placebo received MT-7117 high Dose instead of placebo. Therefore, the subject was counted as MT-7117 high Dose Group in the Safety Population.
|
11.8%
4/34 • All AEs and SAEs that occurred from the time written informed consent was obtained until the end of the follow-up period (6 weeks after the last treatment visit, for safety monitoring)
One subject who was randomized to Placebo received MT-7117 high Dose instead of placebo. Therefore, the subject was counted as MT-7117 high Dose Group in the Safety Population.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/33 • All AEs and SAEs that occurred from the time written informed consent was obtained until the end of the follow-up period (6 weeks after the last treatment visit, for safety monitoring)
One subject who was randomized to Placebo received MT-7117 high Dose instead of placebo. Therefore, the subject was counted as MT-7117 high Dose Group in the Safety Population.
|
2.9%
1/35 • All AEs and SAEs that occurred from the time written informed consent was obtained until the end of the follow-up period (6 weeks after the last treatment visit, for safety monitoring)
One subject who was randomized to Placebo received MT-7117 high Dose instead of placebo. Therefore, the subject was counted as MT-7117 high Dose Group in the Safety Population.
|
8.8%
3/34 • All AEs and SAEs that occurred from the time written informed consent was obtained until the end of the follow-up period (6 weeks after the last treatment visit, for safety monitoring)
One subject who was randomized to Placebo received MT-7117 high Dose instead of placebo. Therefore, the subject was counted as MT-7117 high Dose Group in the Safety Population.
|
|
Gastrointestinal disorders
Nausea
|
15.2%
5/33 • All AEs and SAEs that occurred from the time written informed consent was obtained until the end of the follow-up period (6 weeks after the last treatment visit, for safety monitoring)
One subject who was randomized to Placebo received MT-7117 high Dose instead of placebo. Therefore, the subject was counted as MT-7117 high Dose Group in the Safety Population.
|
45.7%
16/35 • All AEs and SAEs that occurred from the time written informed consent was obtained until the end of the follow-up period (6 weeks after the last treatment visit, for safety monitoring)
One subject who was randomized to Placebo received MT-7117 high Dose instead of placebo. Therefore, the subject was counted as MT-7117 high Dose Group in the Safety Population.
|
11.8%
4/34 • All AEs and SAEs that occurred from the time written informed consent was obtained until the end of the follow-up period (6 weeks after the last treatment visit, for safety monitoring)
One subject who was randomized to Placebo received MT-7117 high Dose instead of placebo. Therefore, the subject was counted as MT-7117 high Dose Group in the Safety Population.
|
|
Gastrointestinal disorders
Oral discomfort
|
3.0%
1/33 • All AEs and SAEs that occurred from the time written informed consent was obtained until the end of the follow-up period (6 weeks after the last treatment visit, for safety monitoring)
One subject who was randomized to Placebo received MT-7117 high Dose instead of placebo. Therefore, the subject was counted as MT-7117 high Dose Group in the Safety Population.
|
0.00%
0/35 • All AEs and SAEs that occurred from the time written informed consent was obtained until the end of the follow-up period (6 weeks after the last treatment visit, for safety monitoring)
One subject who was randomized to Placebo received MT-7117 high Dose instead of placebo. Therefore, the subject was counted as MT-7117 high Dose Group in the Safety Population.
|
0.00%
0/34 • All AEs and SAEs that occurred from the time written informed consent was obtained until the end of the follow-up period (6 weeks after the last treatment visit, for safety monitoring)
One subject who was randomized to Placebo received MT-7117 high Dose instead of placebo. Therefore, the subject was counted as MT-7117 high Dose Group in the Safety Population.
|
|
Gastrointestinal disorders
Paraesthesia oral
|
3.0%
1/33 • All AEs and SAEs that occurred from the time written informed consent was obtained until the end of the follow-up period (6 weeks after the last treatment visit, for safety monitoring)
One subject who was randomized to Placebo received MT-7117 high Dose instead of placebo. Therefore, the subject was counted as MT-7117 high Dose Group in the Safety Population.
|
0.00%
0/35 • All AEs and SAEs that occurred from the time written informed consent was obtained until the end of the follow-up period (6 weeks after the last treatment visit, for safety monitoring)
One subject who was randomized to Placebo received MT-7117 high Dose instead of placebo. Therefore, the subject was counted as MT-7117 high Dose Group in the Safety Population.
|
0.00%
0/34 • All AEs and SAEs that occurred from the time written informed consent was obtained until the end of the follow-up period (6 weeks after the last treatment visit, for safety monitoring)
One subject who was randomized to Placebo received MT-7117 high Dose instead of placebo. Therefore, the subject was counted as MT-7117 high Dose Group in the Safety Population.
|
|
Gastrointestinal disorders
Pigmentation lip
|
0.00%
0/33 • All AEs and SAEs that occurred from the time written informed consent was obtained until the end of the follow-up period (6 weeks after the last treatment visit, for safety monitoring)
One subject who was randomized to Placebo received MT-7117 high Dose instead of placebo. Therefore, the subject was counted as MT-7117 high Dose Group in the Safety Population.
|
8.6%
3/35 • All AEs and SAEs that occurred from the time written informed consent was obtained until the end of the follow-up period (6 weeks after the last treatment visit, for safety monitoring)
One subject who was randomized to Placebo received MT-7117 high Dose instead of placebo. Therefore, the subject was counted as MT-7117 high Dose Group in the Safety Population.
|
0.00%
0/34 • All AEs and SAEs that occurred from the time written informed consent was obtained until the end of the follow-up period (6 weeks after the last treatment visit, for safety monitoring)
One subject who was randomized to Placebo received MT-7117 high Dose instead of placebo. Therefore, the subject was counted as MT-7117 high Dose Group in the Safety Population.
|
|
Gastrointestinal disorders
Vomiting
|
6.1%
2/33 • All AEs and SAEs that occurred from the time written informed consent was obtained until the end of the follow-up period (6 weeks after the last treatment visit, for safety monitoring)
One subject who was randomized to Placebo received MT-7117 high Dose instead of placebo. Therefore, the subject was counted as MT-7117 high Dose Group in the Safety Population.
|
8.6%
3/35 • All AEs and SAEs that occurred from the time written informed consent was obtained until the end of the follow-up period (6 weeks after the last treatment visit, for safety monitoring)
One subject who was randomized to Placebo received MT-7117 high Dose instead of placebo. Therefore, the subject was counted as MT-7117 high Dose Group in the Safety Population.
|
2.9%
1/34 • All AEs and SAEs that occurred from the time written informed consent was obtained until the end of the follow-up period (6 weeks after the last treatment visit, for safety monitoring)
One subject who was randomized to Placebo received MT-7117 high Dose instead of placebo. Therefore, the subject was counted as MT-7117 high Dose Group in the Safety Population.
|
|
General disorders
Chest discomfort
|
3.0%
1/33 • All AEs and SAEs that occurred from the time written informed consent was obtained until the end of the follow-up period (6 weeks after the last treatment visit, for safety monitoring)
One subject who was randomized to Placebo received MT-7117 high Dose instead of placebo. Therefore, the subject was counted as MT-7117 high Dose Group in the Safety Population.
|
0.00%
0/35 • All AEs and SAEs that occurred from the time written informed consent was obtained until the end of the follow-up period (6 weeks after the last treatment visit, for safety monitoring)
One subject who was randomized to Placebo received MT-7117 high Dose instead of placebo. Therefore, the subject was counted as MT-7117 high Dose Group in the Safety Population.
|
0.00%
0/34 • All AEs and SAEs that occurred from the time written informed consent was obtained until the end of the follow-up period (6 weeks after the last treatment visit, for safety monitoring)
One subject who was randomized to Placebo received MT-7117 high Dose instead of placebo. Therefore, the subject was counted as MT-7117 high Dose Group in the Safety Population.
|
|
General disorders
Chills
|
3.0%
1/33 • All AEs and SAEs that occurred from the time written informed consent was obtained until the end of the follow-up period (6 weeks after the last treatment visit, for safety monitoring)
One subject who was randomized to Placebo received MT-7117 high Dose instead of placebo. Therefore, the subject was counted as MT-7117 high Dose Group in the Safety Population.
|
5.7%
2/35 • All AEs and SAEs that occurred from the time written informed consent was obtained until the end of the follow-up period (6 weeks after the last treatment visit, for safety monitoring)
One subject who was randomized to Placebo received MT-7117 high Dose instead of placebo. Therefore, the subject was counted as MT-7117 high Dose Group in the Safety Population.
|
0.00%
0/34 • All AEs and SAEs that occurred from the time written informed consent was obtained until the end of the follow-up period (6 weeks after the last treatment visit, for safety monitoring)
One subject who was randomized to Placebo received MT-7117 high Dose instead of placebo. Therefore, the subject was counted as MT-7117 high Dose Group in the Safety Population.
|
|
General disorders
Fatigue
|
3.0%
1/33 • All AEs and SAEs that occurred from the time written informed consent was obtained until the end of the follow-up period (6 weeks after the last treatment visit, for safety monitoring)
One subject who was randomized to Placebo received MT-7117 high Dose instead of placebo. Therefore, the subject was counted as MT-7117 high Dose Group in the Safety Population.
|
17.1%
6/35 • All AEs and SAEs that occurred from the time written informed consent was obtained until the end of the follow-up period (6 weeks after the last treatment visit, for safety monitoring)
One subject who was randomized to Placebo received MT-7117 high Dose instead of placebo. Therefore, the subject was counted as MT-7117 high Dose Group in the Safety Population.
|
2.9%
1/34 • All AEs and SAEs that occurred from the time written informed consent was obtained until the end of the follow-up period (6 weeks after the last treatment visit, for safety monitoring)
One subject who was randomized to Placebo received MT-7117 high Dose instead of placebo. Therefore, the subject was counted as MT-7117 high Dose Group in the Safety Population.
|
|
General disorders
Pain
|
3.0%
1/33 • All AEs and SAEs that occurred from the time written informed consent was obtained until the end of the follow-up period (6 weeks after the last treatment visit, for safety monitoring)
One subject who was randomized to Placebo received MT-7117 high Dose instead of placebo. Therefore, the subject was counted as MT-7117 high Dose Group in the Safety Population.
|
0.00%
0/35 • All AEs and SAEs that occurred from the time written informed consent was obtained until the end of the follow-up period (6 weeks after the last treatment visit, for safety monitoring)
One subject who was randomized to Placebo received MT-7117 high Dose instead of placebo. Therefore, the subject was counted as MT-7117 high Dose Group in the Safety Population.
|
2.9%
1/34 • All AEs and SAEs that occurred from the time written informed consent was obtained until the end of the follow-up period (6 weeks after the last treatment visit, for safety monitoring)
One subject who was randomized to Placebo received MT-7117 high Dose instead of placebo. Therefore, the subject was counted as MT-7117 high Dose Group in the Safety Population.
|
|
General disorders
Pyrexia
|
6.1%
2/33 • All AEs and SAEs that occurred from the time written informed consent was obtained until the end of the follow-up period (6 weeks after the last treatment visit, for safety monitoring)
One subject who was randomized to Placebo received MT-7117 high Dose instead of placebo. Therefore, the subject was counted as MT-7117 high Dose Group in the Safety Population.
|
2.9%
1/35 • All AEs and SAEs that occurred from the time written informed consent was obtained until the end of the follow-up period (6 weeks after the last treatment visit, for safety monitoring)
One subject who was randomized to Placebo received MT-7117 high Dose instead of placebo. Therefore, the subject was counted as MT-7117 high Dose Group in the Safety Population.
|
2.9%
1/34 • All AEs and SAEs that occurred from the time written informed consent was obtained until the end of the follow-up period (6 weeks after the last treatment visit, for safety monitoring)
One subject who was randomized to Placebo received MT-7117 high Dose instead of placebo. Therefore, the subject was counted as MT-7117 high Dose Group in the Safety Population.
|
|
Immune system disorders
Anaphylactic reaction
|
3.0%
1/33 • All AEs and SAEs that occurred from the time written informed consent was obtained until the end of the follow-up period (6 weeks after the last treatment visit, for safety monitoring)
One subject who was randomized to Placebo received MT-7117 high Dose instead of placebo. Therefore, the subject was counted as MT-7117 high Dose Group in the Safety Population.
|
0.00%
0/35 • All AEs and SAEs that occurred from the time written informed consent was obtained until the end of the follow-up period (6 weeks after the last treatment visit, for safety monitoring)
One subject who was randomized to Placebo received MT-7117 high Dose instead of placebo. Therefore, the subject was counted as MT-7117 high Dose Group in the Safety Population.
|
0.00%
0/34 • All AEs and SAEs that occurred from the time written informed consent was obtained until the end of the follow-up period (6 weeks after the last treatment visit, for safety monitoring)
One subject who was randomized to Placebo received MT-7117 high Dose instead of placebo. Therefore, the subject was counted as MT-7117 high Dose Group in the Safety Population.
|
|
Immune system disorders
Seasonal allergy
|
3.0%
1/33 • All AEs and SAEs that occurred from the time written informed consent was obtained until the end of the follow-up period (6 weeks after the last treatment visit, for safety monitoring)
One subject who was randomized to Placebo received MT-7117 high Dose instead of placebo. Therefore, the subject was counted as MT-7117 high Dose Group in the Safety Population.
|
2.9%
1/35 • All AEs and SAEs that occurred from the time written informed consent was obtained until the end of the follow-up period (6 weeks after the last treatment visit, for safety monitoring)
One subject who was randomized to Placebo received MT-7117 high Dose instead of placebo. Therefore, the subject was counted as MT-7117 high Dose Group in the Safety Population.
|
0.00%
0/34 • All AEs and SAEs that occurred from the time written informed consent was obtained until the end of the follow-up period (6 weeks after the last treatment visit, for safety monitoring)
One subject who was randomized to Placebo received MT-7117 high Dose instead of placebo. Therefore, the subject was counted as MT-7117 high Dose Group in the Safety Population.
|
|
Infections and infestations
Bronchitis
|
3.0%
1/33 • All AEs and SAEs that occurred from the time written informed consent was obtained until the end of the follow-up period (6 weeks after the last treatment visit, for safety monitoring)
One subject who was randomized to Placebo received MT-7117 high Dose instead of placebo. Therefore, the subject was counted as MT-7117 high Dose Group in the Safety Population.
|
5.7%
2/35 • All AEs and SAEs that occurred from the time written informed consent was obtained until the end of the follow-up period (6 weeks after the last treatment visit, for safety monitoring)
One subject who was randomized to Placebo received MT-7117 high Dose instead of placebo. Therefore, the subject was counted as MT-7117 high Dose Group in the Safety Population.
|
2.9%
1/34 • All AEs and SAEs that occurred from the time written informed consent was obtained until the end of the follow-up period (6 weeks after the last treatment visit, for safety monitoring)
One subject who was randomized to Placebo received MT-7117 high Dose instead of placebo. Therefore, the subject was counted as MT-7117 high Dose Group in the Safety Population.
|
|
Infections and infestations
Ear infection
|
0.00%
0/33 • All AEs and SAEs that occurred from the time written informed consent was obtained until the end of the follow-up period (6 weeks after the last treatment visit, for safety monitoring)
One subject who was randomized to Placebo received MT-7117 high Dose instead of placebo. Therefore, the subject was counted as MT-7117 high Dose Group in the Safety Population.
|
5.7%
2/35 • All AEs and SAEs that occurred from the time written informed consent was obtained until the end of the follow-up period (6 weeks after the last treatment visit, for safety monitoring)
One subject who was randomized to Placebo received MT-7117 high Dose instead of placebo. Therefore, the subject was counted as MT-7117 high Dose Group in the Safety Population.
|
0.00%
0/34 • All AEs and SAEs that occurred from the time written informed consent was obtained until the end of the follow-up period (6 weeks after the last treatment visit, for safety monitoring)
One subject who was randomized to Placebo received MT-7117 high Dose instead of placebo. Therefore, the subject was counted as MT-7117 high Dose Group in the Safety Population.
|
|
Infections and infestations
Folliculitis
|
3.0%
1/33 • All AEs and SAEs that occurred from the time written informed consent was obtained until the end of the follow-up period (6 weeks after the last treatment visit, for safety monitoring)
One subject who was randomized to Placebo received MT-7117 high Dose instead of placebo. Therefore, the subject was counted as MT-7117 high Dose Group in the Safety Population.
|
2.9%
1/35 • All AEs and SAEs that occurred from the time written informed consent was obtained until the end of the follow-up period (6 weeks after the last treatment visit, for safety monitoring)
One subject who was randomized to Placebo received MT-7117 high Dose instead of placebo. Therefore, the subject was counted as MT-7117 high Dose Group in the Safety Population.
|
0.00%
0/34 • All AEs and SAEs that occurred from the time written informed consent was obtained until the end of the follow-up period (6 weeks after the last treatment visit, for safety monitoring)
One subject who was randomized to Placebo received MT-7117 high Dose instead of placebo. Therefore, the subject was counted as MT-7117 high Dose Group in the Safety Population.
|
|
Infections and infestations
Fungal infection
|
3.0%
1/33 • All AEs and SAEs that occurred from the time written informed consent was obtained until the end of the follow-up period (6 weeks after the last treatment visit, for safety monitoring)
One subject who was randomized to Placebo received MT-7117 high Dose instead of placebo. Therefore, the subject was counted as MT-7117 high Dose Group in the Safety Population.
|
0.00%
0/35 • All AEs and SAEs that occurred from the time written informed consent was obtained until the end of the follow-up period (6 weeks after the last treatment visit, for safety monitoring)
One subject who was randomized to Placebo received MT-7117 high Dose instead of placebo. Therefore, the subject was counted as MT-7117 high Dose Group in the Safety Population.
|
0.00%
0/34 • All AEs and SAEs that occurred from the time written informed consent was obtained until the end of the follow-up period (6 weeks after the last treatment visit, for safety monitoring)
One subject who was randomized to Placebo received MT-7117 high Dose instead of placebo. Therefore, the subject was counted as MT-7117 high Dose Group in the Safety Population.
|
|
Infections and infestations
Gastric infection
|
3.0%
1/33 • All AEs and SAEs that occurred from the time written informed consent was obtained until the end of the follow-up period (6 weeks after the last treatment visit, for safety monitoring)
One subject who was randomized to Placebo received MT-7117 high Dose instead of placebo. Therefore, the subject was counted as MT-7117 high Dose Group in the Safety Population.
|
0.00%
0/35 • All AEs and SAEs that occurred from the time written informed consent was obtained until the end of the follow-up period (6 weeks after the last treatment visit, for safety monitoring)
One subject who was randomized to Placebo received MT-7117 high Dose instead of placebo. Therefore, the subject was counted as MT-7117 high Dose Group in the Safety Population.
|
0.00%
0/34 • All AEs and SAEs that occurred from the time written informed consent was obtained until the end of the follow-up period (6 weeks after the last treatment visit, for safety monitoring)
One subject who was randomized to Placebo received MT-7117 high Dose instead of placebo. Therefore, the subject was counted as MT-7117 high Dose Group in the Safety Population.
|
|
Infections and infestations
Influenza
|
0.00%
0/33 • All AEs and SAEs that occurred from the time written informed consent was obtained until the end of the follow-up period (6 weeks after the last treatment visit, for safety monitoring)
One subject who was randomized to Placebo received MT-7117 high Dose instead of placebo. Therefore, the subject was counted as MT-7117 high Dose Group in the Safety Population.
|
2.9%
1/35 • All AEs and SAEs that occurred from the time written informed consent was obtained until the end of the follow-up period (6 weeks after the last treatment visit, for safety monitoring)
One subject who was randomized to Placebo received MT-7117 high Dose instead of placebo. Therefore, the subject was counted as MT-7117 high Dose Group in the Safety Population.
|
5.9%
2/34 • All AEs and SAEs that occurred from the time written informed consent was obtained until the end of the follow-up period (6 weeks after the last treatment visit, for safety monitoring)
One subject who was randomized to Placebo received MT-7117 high Dose instead of placebo. Therefore, the subject was counted as MT-7117 high Dose Group in the Safety Population.
|
|
Infections and infestations
Nasopharyngitis
|
30.3%
10/33 • All AEs and SAEs that occurred from the time written informed consent was obtained until the end of the follow-up period (6 weeks after the last treatment visit, for safety monitoring)
One subject who was randomized to Placebo received MT-7117 high Dose instead of placebo. Therefore, the subject was counted as MT-7117 high Dose Group in the Safety Population.
|
11.4%
4/35 • All AEs and SAEs that occurred from the time written informed consent was obtained until the end of the follow-up period (6 weeks after the last treatment visit, for safety monitoring)
One subject who was randomized to Placebo received MT-7117 high Dose instead of placebo. Therefore, the subject was counted as MT-7117 high Dose Group in the Safety Population.
|
20.6%
7/34 • All AEs and SAEs that occurred from the time written informed consent was obtained until the end of the follow-up period (6 weeks after the last treatment visit, for safety monitoring)
One subject who was randomized to Placebo received MT-7117 high Dose instead of placebo. Therefore, the subject was counted as MT-7117 high Dose Group in the Safety Population.
|
|
Infections and infestations
Sinusitis
|
0.00%
0/33 • All AEs and SAEs that occurred from the time written informed consent was obtained until the end of the follow-up period (6 weeks after the last treatment visit, for safety monitoring)
One subject who was randomized to Placebo received MT-7117 high Dose instead of placebo. Therefore, the subject was counted as MT-7117 high Dose Group in the Safety Population.
|
11.4%
4/35 • All AEs and SAEs that occurred from the time written informed consent was obtained until the end of the follow-up period (6 weeks after the last treatment visit, for safety monitoring)
One subject who was randomized to Placebo received MT-7117 high Dose instead of placebo. Therefore, the subject was counted as MT-7117 high Dose Group in the Safety Population.
|
5.9%
2/34 • All AEs and SAEs that occurred from the time written informed consent was obtained until the end of the follow-up period (6 weeks after the last treatment visit, for safety monitoring)
One subject who was randomized to Placebo received MT-7117 high Dose instead of placebo. Therefore, the subject was counted as MT-7117 high Dose Group in the Safety Population.
|
|
Infections and infestations
Upper respiratory tract infection
|
3.0%
1/33 • All AEs and SAEs that occurred from the time written informed consent was obtained until the end of the follow-up period (6 weeks after the last treatment visit, for safety monitoring)
One subject who was randomized to Placebo received MT-7117 high Dose instead of placebo. Therefore, the subject was counted as MT-7117 high Dose Group in the Safety Population.
|
0.00%
0/35 • All AEs and SAEs that occurred from the time written informed consent was obtained until the end of the follow-up period (6 weeks after the last treatment visit, for safety monitoring)
One subject who was randomized to Placebo received MT-7117 high Dose instead of placebo. Therefore, the subject was counted as MT-7117 high Dose Group in the Safety Population.
|
0.00%
0/34 • All AEs and SAEs that occurred from the time written informed consent was obtained until the end of the follow-up period (6 weeks after the last treatment visit, for safety monitoring)
One subject who was randomized to Placebo received MT-7117 high Dose instead of placebo. Therefore, the subject was counted as MT-7117 high Dose Group in the Safety Population.
|
|
Infections and infestations
Urinary tract infection
|
6.1%
2/33 • All AEs and SAEs that occurred from the time written informed consent was obtained until the end of the follow-up period (6 weeks after the last treatment visit, for safety monitoring)
One subject who was randomized to Placebo received MT-7117 high Dose instead of placebo. Therefore, the subject was counted as MT-7117 high Dose Group in the Safety Population.
|
5.7%
2/35 • All AEs and SAEs that occurred from the time written informed consent was obtained until the end of the follow-up period (6 weeks after the last treatment visit, for safety monitoring)
One subject who was randomized to Placebo received MT-7117 high Dose instead of placebo. Therefore, the subject was counted as MT-7117 high Dose Group in the Safety Population.
|
2.9%
1/34 • All AEs and SAEs that occurred from the time written informed consent was obtained until the end of the follow-up period (6 weeks after the last treatment visit, for safety monitoring)
One subject who was randomized to Placebo received MT-7117 high Dose instead of placebo. Therefore, the subject was counted as MT-7117 high Dose Group in the Safety Population.
|
|
Injury, poisoning and procedural complications
Accidental overdose
|
3.0%
1/33 • All AEs and SAEs that occurred from the time written informed consent was obtained until the end of the follow-up period (6 weeks after the last treatment visit, for safety monitoring)
One subject who was randomized to Placebo received MT-7117 high Dose instead of placebo. Therefore, the subject was counted as MT-7117 high Dose Group in the Safety Population.
|
0.00%
0/35 • All AEs and SAEs that occurred from the time written informed consent was obtained until the end of the follow-up period (6 weeks after the last treatment visit, for safety monitoring)
One subject who was randomized to Placebo received MT-7117 high Dose instead of placebo. Therefore, the subject was counted as MT-7117 high Dose Group in the Safety Population.
|
0.00%
0/34 • All AEs and SAEs that occurred from the time written informed consent was obtained until the end of the follow-up period (6 weeks after the last treatment visit, for safety monitoring)
One subject who was randomized to Placebo received MT-7117 high Dose instead of placebo. Therefore, the subject was counted as MT-7117 high Dose Group in the Safety Population.
|
|
Injury, poisoning and procedural complications
Arthropod bite
|
3.0%
1/33 • All AEs and SAEs that occurred from the time written informed consent was obtained until the end of the follow-up period (6 weeks after the last treatment visit, for safety monitoring)
One subject who was randomized to Placebo received MT-7117 high Dose instead of placebo. Therefore, the subject was counted as MT-7117 high Dose Group in the Safety Population.
|
0.00%
0/35 • All AEs and SAEs that occurred from the time written informed consent was obtained until the end of the follow-up period (6 weeks after the last treatment visit, for safety monitoring)
One subject who was randomized to Placebo received MT-7117 high Dose instead of placebo. Therefore, the subject was counted as MT-7117 high Dose Group in the Safety Population.
|
2.9%
1/34 • All AEs and SAEs that occurred from the time written informed consent was obtained until the end of the follow-up period (6 weeks after the last treatment visit, for safety monitoring)
One subject who was randomized to Placebo received MT-7117 high Dose instead of placebo. Therefore, the subject was counted as MT-7117 high Dose Group in the Safety Population.
|
|
Injury, poisoning and procedural complications
Arthropod sting
|
3.0%
1/33 • All AEs and SAEs that occurred from the time written informed consent was obtained until the end of the follow-up period (6 weeks after the last treatment visit, for safety monitoring)
One subject who was randomized to Placebo received MT-7117 high Dose instead of placebo. Therefore, the subject was counted as MT-7117 high Dose Group in the Safety Population.
|
0.00%
0/35 • All AEs and SAEs that occurred from the time written informed consent was obtained until the end of the follow-up period (6 weeks after the last treatment visit, for safety monitoring)
One subject who was randomized to Placebo received MT-7117 high Dose instead of placebo. Therefore, the subject was counted as MT-7117 high Dose Group in the Safety Population.
|
0.00%
0/34 • All AEs and SAEs that occurred from the time written informed consent was obtained until the end of the follow-up period (6 weeks after the last treatment visit, for safety monitoring)
One subject who was randomized to Placebo received MT-7117 high Dose instead of placebo. Therefore, the subject was counted as MT-7117 high Dose Group in the Safety Population.
|
|
Injury, poisoning and procedural complications
Chemical burn of skin
|
3.0%
1/33 • All AEs and SAEs that occurred from the time written informed consent was obtained until the end of the follow-up period (6 weeks after the last treatment visit, for safety monitoring)
One subject who was randomized to Placebo received MT-7117 high Dose instead of placebo. Therefore, the subject was counted as MT-7117 high Dose Group in the Safety Population.
|
0.00%
0/35 • All AEs and SAEs that occurred from the time written informed consent was obtained until the end of the follow-up period (6 weeks after the last treatment visit, for safety monitoring)
One subject who was randomized to Placebo received MT-7117 high Dose instead of placebo. Therefore, the subject was counted as MT-7117 high Dose Group in the Safety Population.
|
0.00%
0/34 • All AEs and SAEs that occurred from the time written informed consent was obtained until the end of the follow-up period (6 weeks after the last treatment visit, for safety monitoring)
One subject who was randomized to Placebo received MT-7117 high Dose instead of placebo. Therefore, the subject was counted as MT-7117 high Dose Group in the Safety Population.
|
|
Injury, poisoning and procedural complications
Contusion
|
6.1%
2/33 • All AEs and SAEs that occurred from the time written informed consent was obtained until the end of the follow-up period (6 weeks after the last treatment visit, for safety monitoring)
One subject who was randomized to Placebo received MT-7117 high Dose instead of placebo. Therefore, the subject was counted as MT-7117 high Dose Group in the Safety Population.
|
5.7%
2/35 • All AEs and SAEs that occurred from the time written informed consent was obtained until the end of the follow-up period (6 weeks after the last treatment visit, for safety monitoring)
One subject who was randomized to Placebo received MT-7117 high Dose instead of placebo. Therefore, the subject was counted as MT-7117 high Dose Group in the Safety Population.
|
2.9%
1/34 • All AEs and SAEs that occurred from the time written informed consent was obtained until the end of the follow-up period (6 weeks after the last treatment visit, for safety monitoring)
One subject who was randomized to Placebo received MT-7117 high Dose instead of placebo. Therefore, the subject was counted as MT-7117 high Dose Group in the Safety Population.
|
|
Injury, poisoning and procedural complications
Skin abrasion
|
3.0%
1/33 • All AEs and SAEs that occurred from the time written informed consent was obtained until the end of the follow-up period (6 weeks after the last treatment visit, for safety monitoring)
One subject who was randomized to Placebo received MT-7117 high Dose instead of placebo. Therefore, the subject was counted as MT-7117 high Dose Group in the Safety Population.
|
2.9%
1/35 • All AEs and SAEs that occurred from the time written informed consent was obtained until the end of the follow-up period (6 weeks after the last treatment visit, for safety monitoring)
One subject who was randomized to Placebo received MT-7117 high Dose instead of placebo. Therefore, the subject was counted as MT-7117 high Dose Group in the Safety Population.
|
0.00%
0/34 • All AEs and SAEs that occurred from the time written informed consent was obtained until the end of the follow-up period (6 weeks after the last treatment visit, for safety monitoring)
One subject who was randomized to Placebo received MT-7117 high Dose instead of placebo. Therefore, the subject was counted as MT-7117 high Dose Group in the Safety Population.
|
|
Injury, poisoning and procedural complications
Sunburn
|
9.1%
3/33 • All AEs and SAEs that occurred from the time written informed consent was obtained until the end of the follow-up period (6 weeks after the last treatment visit, for safety monitoring)
One subject who was randomized to Placebo received MT-7117 high Dose instead of placebo. Therefore, the subject was counted as MT-7117 high Dose Group in the Safety Population.
|
2.9%
1/35 • All AEs and SAEs that occurred from the time written informed consent was obtained until the end of the follow-up period (6 weeks after the last treatment visit, for safety monitoring)
One subject who was randomized to Placebo received MT-7117 high Dose instead of placebo. Therefore, the subject was counted as MT-7117 high Dose Group in the Safety Population.
|
0.00%
0/34 • All AEs and SAEs that occurred from the time written informed consent was obtained until the end of the follow-up period (6 weeks after the last treatment visit, for safety monitoring)
One subject who was randomized to Placebo received MT-7117 high Dose instead of placebo. Therefore, the subject was counted as MT-7117 high Dose Group in the Safety Population.
|
|
Injury, poisoning and procedural complications
Thermal burn
|
3.0%
1/33 • All AEs and SAEs that occurred from the time written informed consent was obtained until the end of the follow-up period (6 weeks after the last treatment visit, for safety monitoring)
One subject who was randomized to Placebo received MT-7117 high Dose instead of placebo. Therefore, the subject was counted as MT-7117 high Dose Group in the Safety Population.
|
0.00%
0/35 • All AEs and SAEs that occurred from the time written informed consent was obtained until the end of the follow-up period (6 weeks after the last treatment visit, for safety monitoring)
One subject who was randomized to Placebo received MT-7117 high Dose instead of placebo. Therefore, the subject was counted as MT-7117 high Dose Group in the Safety Population.
|
0.00%
0/34 • All AEs and SAEs that occurred from the time written informed consent was obtained until the end of the follow-up period (6 weeks after the last treatment visit, for safety monitoring)
One subject who was randomized to Placebo received MT-7117 high Dose instead of placebo. Therefore, the subject was counted as MT-7117 high Dose Group in the Safety Population.
|
|
Injury, poisoning and procedural complications
Tooth fracture
|
3.0%
1/33 • All AEs and SAEs that occurred from the time written informed consent was obtained until the end of the follow-up period (6 weeks after the last treatment visit, for safety monitoring)
One subject who was randomized to Placebo received MT-7117 high Dose instead of placebo. Therefore, the subject was counted as MT-7117 high Dose Group in the Safety Population.
|
0.00%
0/35 • All AEs and SAEs that occurred from the time written informed consent was obtained until the end of the follow-up period (6 weeks after the last treatment visit, for safety monitoring)
One subject who was randomized to Placebo received MT-7117 high Dose instead of placebo. Therefore, the subject was counted as MT-7117 high Dose Group in the Safety Population.
|
0.00%
0/34 • All AEs and SAEs that occurred from the time written informed consent was obtained until the end of the follow-up period (6 weeks after the last treatment visit, for safety monitoring)
One subject who was randomized to Placebo received MT-7117 high Dose instead of placebo. Therefore, the subject was counted as MT-7117 high Dose Group in the Safety Population.
|
|
Investigations
Blood creatine phosphokinase increased
|
3.0%
1/33 • All AEs and SAEs that occurred from the time written informed consent was obtained until the end of the follow-up period (6 weeks after the last treatment visit, for safety monitoring)
One subject who was randomized to Placebo received MT-7117 high Dose instead of placebo. Therefore, the subject was counted as MT-7117 high Dose Group in the Safety Population.
|
0.00%
0/35 • All AEs and SAEs that occurred from the time written informed consent was obtained until the end of the follow-up period (6 weeks after the last treatment visit, for safety monitoring)
One subject who was randomized to Placebo received MT-7117 high Dose instead of placebo. Therefore, the subject was counted as MT-7117 high Dose Group in the Safety Population.
|
2.9%
1/34 • All AEs and SAEs that occurred from the time written informed consent was obtained until the end of the follow-up period (6 weeks after the last treatment visit, for safety monitoring)
One subject who was randomized to Placebo received MT-7117 high Dose instead of placebo. Therefore, the subject was counted as MT-7117 high Dose Group in the Safety Population.
|
|
Investigations
Hepatic enzyme increased
|
3.0%
1/33 • All AEs and SAEs that occurred from the time written informed consent was obtained until the end of the follow-up period (6 weeks after the last treatment visit, for safety monitoring)
One subject who was randomized to Placebo received MT-7117 high Dose instead of placebo. Therefore, the subject was counted as MT-7117 high Dose Group in the Safety Population.
|
0.00%
0/35 • All AEs and SAEs that occurred from the time written informed consent was obtained until the end of the follow-up period (6 weeks after the last treatment visit, for safety monitoring)
One subject who was randomized to Placebo received MT-7117 high Dose instead of placebo. Therefore, the subject was counted as MT-7117 high Dose Group in the Safety Population.
|
0.00%
0/34 • All AEs and SAEs that occurred from the time written informed consent was obtained until the end of the follow-up period (6 weeks after the last treatment visit, for safety monitoring)
One subject who was randomized to Placebo received MT-7117 high Dose instead of placebo. Therefore, the subject was counted as MT-7117 high Dose Group in the Safety Population.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
3.0%
1/33 • All AEs and SAEs that occurred from the time written informed consent was obtained until the end of the follow-up period (6 weeks after the last treatment visit, for safety monitoring)
One subject who was randomized to Placebo received MT-7117 high Dose instead of placebo. Therefore, the subject was counted as MT-7117 high Dose Group in the Safety Population.
|
5.7%
2/35 • All AEs and SAEs that occurred from the time written informed consent was obtained until the end of the follow-up period (6 weeks after the last treatment visit, for safety monitoring)
One subject who was randomized to Placebo received MT-7117 high Dose instead of placebo. Therefore, the subject was counted as MT-7117 high Dose Group in the Safety Population.
|
0.00%
0/34 • All AEs and SAEs that occurred from the time written informed consent was obtained until the end of the follow-up period (6 weeks after the last treatment visit, for safety monitoring)
One subject who was randomized to Placebo received MT-7117 high Dose instead of placebo. Therefore, the subject was counted as MT-7117 high Dose Group in the Safety Population.
|
|
Metabolism and nutrition disorders
Iron deficiency
|
0.00%
0/33 • All AEs and SAEs that occurred from the time written informed consent was obtained until the end of the follow-up period (6 weeks after the last treatment visit, for safety monitoring)
One subject who was randomized to Placebo received MT-7117 high Dose instead of placebo. Therefore, the subject was counted as MT-7117 high Dose Group in the Safety Population.
|
0.00%
0/35 • All AEs and SAEs that occurred from the time written informed consent was obtained until the end of the follow-up period (6 weeks after the last treatment visit, for safety monitoring)
One subject who was randomized to Placebo received MT-7117 high Dose instead of placebo. Therefore, the subject was counted as MT-7117 high Dose Group in the Safety Population.
|
5.9%
2/34 • All AEs and SAEs that occurred from the time written informed consent was obtained until the end of the follow-up period (6 weeks after the last treatment visit, for safety monitoring)
One subject who was randomized to Placebo received MT-7117 high Dose instead of placebo. Therefore, the subject was counted as MT-7117 high Dose Group in the Safety Population.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
6.1%
2/33 • All AEs and SAEs that occurred from the time written informed consent was obtained until the end of the follow-up period (6 weeks after the last treatment visit, for safety monitoring)
One subject who was randomized to Placebo received MT-7117 high Dose instead of placebo. Therefore, the subject was counted as MT-7117 high Dose Group in the Safety Population.
|
2.9%
1/35 • All AEs and SAEs that occurred from the time written informed consent was obtained until the end of the follow-up period (6 weeks after the last treatment visit, for safety monitoring)
One subject who was randomized to Placebo received MT-7117 high Dose instead of placebo. Therefore, the subject was counted as MT-7117 high Dose Group in the Safety Population.
|
0.00%
0/34 • All AEs and SAEs that occurred from the time written informed consent was obtained until the end of the follow-up period (6 weeks after the last treatment visit, for safety monitoring)
One subject who was randomized to Placebo received MT-7117 high Dose instead of placebo. Therefore, the subject was counted as MT-7117 high Dose Group in the Safety Population.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/33 • All AEs and SAEs that occurred from the time written informed consent was obtained until the end of the follow-up period (6 weeks after the last treatment visit, for safety monitoring)
One subject who was randomized to Placebo received MT-7117 high Dose instead of placebo. Therefore, the subject was counted as MT-7117 high Dose Group in the Safety Population.
|
0.00%
0/35 • All AEs and SAEs that occurred from the time written informed consent was obtained until the end of the follow-up period (6 weeks after the last treatment visit, for safety monitoring)
One subject who was randomized to Placebo received MT-7117 high Dose instead of placebo. Therefore, the subject was counted as MT-7117 high Dose Group in the Safety Population.
|
8.8%
3/34 • All AEs and SAEs that occurred from the time written informed consent was obtained until the end of the follow-up period (6 weeks after the last treatment visit, for safety monitoring)
One subject who was randomized to Placebo received MT-7117 high Dose instead of placebo. Therefore, the subject was counted as MT-7117 high Dose Group in the Safety Population.
|
|
Musculoskeletal and connective tissue disorders
Facet joint syndrome
|
3.0%
1/33 • All AEs and SAEs that occurred from the time written informed consent was obtained until the end of the follow-up period (6 weeks after the last treatment visit, for safety monitoring)
One subject who was randomized to Placebo received MT-7117 high Dose instead of placebo. Therefore, the subject was counted as MT-7117 high Dose Group in the Safety Population.
|
0.00%
0/35 • All AEs and SAEs that occurred from the time written informed consent was obtained until the end of the follow-up period (6 weeks after the last treatment visit, for safety monitoring)
One subject who was randomized to Placebo received MT-7117 high Dose instead of placebo. Therefore, the subject was counted as MT-7117 high Dose Group in the Safety Population.
|
0.00%
0/34 • All AEs and SAEs that occurred from the time written informed consent was obtained until the end of the follow-up period (6 weeks after the last treatment visit, for safety monitoring)
One subject who was randomized to Placebo received MT-7117 high Dose instead of placebo. Therefore, the subject was counted as MT-7117 high Dose Group in the Safety Population.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
3.0%
1/33 • All AEs and SAEs that occurred from the time written informed consent was obtained until the end of the follow-up period (6 weeks after the last treatment visit, for safety monitoring)
One subject who was randomized to Placebo received MT-7117 high Dose instead of placebo. Therefore, the subject was counted as MT-7117 high Dose Group in the Safety Population.
|
0.00%
0/35 • All AEs and SAEs that occurred from the time written informed consent was obtained until the end of the follow-up period (6 weeks after the last treatment visit, for safety monitoring)
One subject who was randomized to Placebo received MT-7117 high Dose instead of placebo. Therefore, the subject was counted as MT-7117 high Dose Group in the Safety Population.
|
0.00%
0/34 • All AEs and SAEs that occurred from the time written informed consent was obtained until the end of the follow-up period (6 weeks after the last treatment visit, for safety monitoring)
One subject who was randomized to Placebo received MT-7117 high Dose instead of placebo. Therefore, the subject was counted as MT-7117 high Dose Group in the Safety Population.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
3.0%
1/33 • All AEs and SAEs that occurred from the time written informed consent was obtained until the end of the follow-up period (6 weeks after the last treatment visit, for safety monitoring)
One subject who was randomized to Placebo received MT-7117 high Dose instead of placebo. Therefore, the subject was counted as MT-7117 high Dose Group in the Safety Population.
|
2.9%
1/35 • All AEs and SAEs that occurred from the time written informed consent was obtained until the end of the follow-up period (6 weeks after the last treatment visit, for safety monitoring)
One subject who was randomized to Placebo received MT-7117 high Dose instead of placebo. Therefore, the subject was counted as MT-7117 high Dose Group in the Safety Population.
|
2.9%
1/34 • All AEs and SAEs that occurred from the time written informed consent was obtained until the end of the follow-up period (6 weeks after the last treatment visit, for safety monitoring)
One subject who was randomized to Placebo received MT-7117 high Dose instead of placebo. Therefore, the subject was counted as MT-7117 high Dose Group in the Safety Population.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
6.1%
2/33 • All AEs and SAEs that occurred from the time written informed consent was obtained until the end of the follow-up period (6 weeks after the last treatment visit, for safety monitoring)
One subject who was randomized to Placebo received MT-7117 high Dose instead of placebo. Therefore, the subject was counted as MT-7117 high Dose Group in the Safety Population.
|
0.00%
0/35 • All AEs and SAEs that occurred from the time written informed consent was obtained until the end of the follow-up period (6 weeks after the last treatment visit, for safety monitoring)
One subject who was randomized to Placebo received MT-7117 high Dose instead of placebo. Therefore, the subject was counted as MT-7117 high Dose Group in the Safety Population.
|
0.00%
0/34 • All AEs and SAEs that occurred from the time written informed consent was obtained until the end of the follow-up period (6 weeks after the last treatment visit, for safety monitoring)
One subject who was randomized to Placebo received MT-7117 high Dose instead of placebo. Therefore, the subject was counted as MT-7117 high Dose Group in the Safety Population.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/33 • All AEs and SAEs that occurred from the time written informed consent was obtained until the end of the follow-up period (6 weeks after the last treatment visit, for safety monitoring)
One subject who was randomized to Placebo received MT-7117 high Dose instead of placebo. Therefore, the subject was counted as MT-7117 high Dose Group in the Safety Population.
|
5.7%
2/35 • All AEs and SAEs that occurred from the time written informed consent was obtained until the end of the follow-up period (6 weeks after the last treatment visit, for safety monitoring)
One subject who was randomized to Placebo received MT-7117 high Dose instead of placebo. Therefore, the subject was counted as MT-7117 high Dose Group in the Safety Population.
|
0.00%
0/34 • All AEs and SAEs that occurred from the time written informed consent was obtained until the end of the follow-up period (6 weeks after the last treatment visit, for safety monitoring)
One subject who was randomized to Placebo received MT-7117 high Dose instead of placebo. Therefore, the subject was counted as MT-7117 high Dose Group in the Safety Population.
|
|
Musculoskeletal and connective tissue disorders
Tendonitis
|
3.0%
1/33 • All AEs and SAEs that occurred from the time written informed consent was obtained until the end of the follow-up period (6 weeks after the last treatment visit, for safety monitoring)
One subject who was randomized to Placebo received MT-7117 high Dose instead of placebo. Therefore, the subject was counted as MT-7117 high Dose Group in the Safety Population.
|
0.00%
0/35 • All AEs and SAEs that occurred from the time written informed consent was obtained until the end of the follow-up period (6 weeks after the last treatment visit, for safety monitoring)
One subject who was randomized to Placebo received MT-7117 high Dose instead of placebo. Therefore, the subject was counted as MT-7117 high Dose Group in the Safety Population.
|
0.00%
0/34 • All AEs and SAEs that occurred from the time written informed consent was obtained until the end of the follow-up period (6 weeks after the last treatment visit, for safety monitoring)
One subject who was randomized to Placebo received MT-7117 high Dose instead of placebo. Therefore, the subject was counted as MT-7117 high Dose Group in the Safety Population.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Acrochordon
|
3.0%
1/33 • All AEs and SAEs that occurred from the time written informed consent was obtained until the end of the follow-up period (6 weeks after the last treatment visit, for safety monitoring)
One subject who was randomized to Placebo received MT-7117 high Dose instead of placebo. Therefore, the subject was counted as MT-7117 high Dose Group in the Safety Population.
|
0.00%
0/35 • All AEs and SAEs that occurred from the time written informed consent was obtained until the end of the follow-up period (6 weeks after the last treatment visit, for safety monitoring)
One subject who was randomized to Placebo received MT-7117 high Dose instead of placebo. Therefore, the subject was counted as MT-7117 high Dose Group in the Safety Population.
|
0.00%
0/34 • All AEs and SAEs that occurred from the time written informed consent was obtained until the end of the follow-up period (6 weeks after the last treatment visit, for safety monitoring)
One subject who was randomized to Placebo received MT-7117 high Dose instead of placebo. Therefore, the subject was counted as MT-7117 high Dose Group in the Safety Population.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Benign neoplasm of skin
|
3.0%
1/33 • All AEs and SAEs that occurred from the time written informed consent was obtained until the end of the follow-up period (6 weeks after the last treatment visit, for safety monitoring)
One subject who was randomized to Placebo received MT-7117 high Dose instead of placebo. Therefore, the subject was counted as MT-7117 high Dose Group in the Safety Population.
|
0.00%
0/35 • All AEs and SAEs that occurred from the time written informed consent was obtained until the end of the follow-up period (6 weeks after the last treatment visit, for safety monitoring)
One subject who was randomized to Placebo received MT-7117 high Dose instead of placebo. Therefore, the subject was counted as MT-7117 high Dose Group in the Safety Population.
|
0.00%
0/34 • All AEs and SAEs that occurred from the time written informed consent was obtained until the end of the follow-up period (6 weeks after the last treatment visit, for safety monitoring)
One subject who was randomized to Placebo received MT-7117 high Dose instead of placebo. Therefore, the subject was counted as MT-7117 high Dose Group in the Safety Population.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Fibrous histiocytoma
|
3.0%
1/33 • All AEs and SAEs that occurred from the time written informed consent was obtained until the end of the follow-up period (6 weeks after the last treatment visit, for safety monitoring)
One subject who was randomized to Placebo received MT-7117 high Dose instead of placebo. Therefore, the subject was counted as MT-7117 high Dose Group in the Safety Population.
|
2.9%
1/35 • All AEs and SAEs that occurred from the time written informed consent was obtained until the end of the follow-up period (6 weeks after the last treatment visit, for safety monitoring)
One subject who was randomized to Placebo received MT-7117 high Dose instead of placebo. Therefore, the subject was counted as MT-7117 high Dose Group in the Safety Population.
|
5.9%
2/34 • All AEs and SAEs that occurred from the time written informed consent was obtained until the end of the follow-up period (6 weeks after the last treatment visit, for safety monitoring)
One subject who was randomized to Placebo received MT-7117 high Dose instead of placebo. Therefore, the subject was counted as MT-7117 high Dose Group in the Safety Population.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Haemangioma of skin
|
3.0%
1/33 • All AEs and SAEs that occurred from the time written informed consent was obtained until the end of the follow-up period (6 weeks after the last treatment visit, for safety monitoring)
One subject who was randomized to Placebo received MT-7117 high Dose instead of placebo. Therefore, the subject was counted as MT-7117 high Dose Group in the Safety Population.
|
2.9%
1/35 • All AEs and SAEs that occurred from the time written informed consent was obtained until the end of the follow-up period (6 weeks after the last treatment visit, for safety monitoring)
One subject who was randomized to Placebo received MT-7117 high Dose instead of placebo. Therefore, the subject was counted as MT-7117 high Dose Group in the Safety Population.
|
2.9%
1/34 • All AEs and SAEs that occurred from the time written informed consent was obtained until the end of the follow-up period (6 weeks after the last treatment visit, for safety monitoring)
One subject who was randomized to Placebo received MT-7117 high Dose instead of placebo. Therefore, the subject was counted as MT-7117 high Dose Group in the Safety Population.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Melanocytic naevus
|
12.1%
4/33 • All AEs and SAEs that occurred from the time written informed consent was obtained until the end of the follow-up period (6 weeks after the last treatment visit, for safety monitoring)
One subject who was randomized to Placebo received MT-7117 high Dose instead of placebo. Therefore, the subject was counted as MT-7117 high Dose Group in the Safety Population.
|
20.0%
7/35 • All AEs and SAEs that occurred from the time written informed consent was obtained until the end of the follow-up period (6 weeks after the last treatment visit, for safety monitoring)
One subject who was randomized to Placebo received MT-7117 high Dose instead of placebo. Therefore, the subject was counted as MT-7117 high Dose Group in the Safety Population.
|
8.8%
3/34 • All AEs and SAEs that occurred from the time written informed consent was obtained until the end of the follow-up period (6 weeks after the last treatment visit, for safety monitoring)
One subject who was randomized to Placebo received MT-7117 high Dose instead of placebo. Therefore, the subject was counted as MT-7117 high Dose Group in the Safety Population.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Seborrhoeic keratosis
|
3.0%
1/33 • All AEs and SAEs that occurred from the time written informed consent was obtained until the end of the follow-up period (6 weeks after the last treatment visit, for safety monitoring)
One subject who was randomized to Placebo received MT-7117 high Dose instead of placebo. Therefore, the subject was counted as MT-7117 high Dose Group in the Safety Population.
|
2.9%
1/35 • All AEs and SAEs that occurred from the time written informed consent was obtained until the end of the follow-up period (6 weeks after the last treatment visit, for safety monitoring)
One subject who was randomized to Placebo received MT-7117 high Dose instead of placebo. Therefore, the subject was counted as MT-7117 high Dose Group in the Safety Population.
|
0.00%
0/34 • All AEs and SAEs that occurred from the time written informed consent was obtained until the end of the follow-up period (6 weeks after the last treatment visit, for safety monitoring)
One subject who was randomized to Placebo received MT-7117 high Dose instead of placebo. Therefore, the subject was counted as MT-7117 high Dose Group in the Safety Population.
|
|
Nervous system disorders
Amnesia
|
3.0%
1/33 • All AEs and SAEs that occurred from the time written informed consent was obtained until the end of the follow-up period (6 weeks after the last treatment visit, for safety monitoring)
One subject who was randomized to Placebo received MT-7117 high Dose instead of placebo. Therefore, the subject was counted as MT-7117 high Dose Group in the Safety Population.
|
0.00%
0/35 • All AEs and SAEs that occurred from the time written informed consent was obtained until the end of the follow-up period (6 weeks after the last treatment visit, for safety monitoring)
One subject who was randomized to Placebo received MT-7117 high Dose instead of placebo. Therefore, the subject was counted as MT-7117 high Dose Group in the Safety Population.
|
0.00%
0/34 • All AEs and SAEs that occurred from the time written informed consent was obtained until the end of the follow-up period (6 weeks after the last treatment visit, for safety monitoring)
One subject who was randomized to Placebo received MT-7117 high Dose instead of placebo. Therefore, the subject was counted as MT-7117 high Dose Group in the Safety Population.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/33 • All AEs and SAEs that occurred from the time written informed consent was obtained until the end of the follow-up period (6 weeks after the last treatment visit, for safety monitoring)
One subject who was randomized to Placebo received MT-7117 high Dose instead of placebo. Therefore, the subject was counted as MT-7117 high Dose Group in the Safety Population.
|
8.6%
3/35 • All AEs and SAEs that occurred from the time written informed consent was obtained until the end of the follow-up period (6 weeks after the last treatment visit, for safety monitoring)
One subject who was randomized to Placebo received MT-7117 high Dose instead of placebo. Therefore, the subject was counted as MT-7117 high Dose Group in the Safety Population.
|
0.00%
0/34 • All AEs and SAEs that occurred from the time written informed consent was obtained until the end of the follow-up period (6 weeks after the last treatment visit, for safety monitoring)
One subject who was randomized to Placebo received MT-7117 high Dose instead of placebo. Therefore, the subject was counted as MT-7117 high Dose Group in the Safety Population.
|
|
Nervous system disorders
Head discomfort
|
3.0%
1/33 • All AEs and SAEs that occurred from the time written informed consent was obtained until the end of the follow-up period (6 weeks after the last treatment visit, for safety monitoring)
One subject who was randomized to Placebo received MT-7117 high Dose instead of placebo. Therefore, the subject was counted as MT-7117 high Dose Group in the Safety Population.
|
0.00%
0/35 • All AEs and SAEs that occurred from the time written informed consent was obtained until the end of the follow-up period (6 weeks after the last treatment visit, for safety monitoring)
One subject who was randomized to Placebo received MT-7117 high Dose instead of placebo. Therefore, the subject was counted as MT-7117 high Dose Group in the Safety Population.
|
0.00%
0/34 • All AEs and SAEs that occurred from the time written informed consent was obtained until the end of the follow-up period (6 weeks after the last treatment visit, for safety monitoring)
One subject who was randomized to Placebo received MT-7117 high Dose instead of placebo. Therefore, the subject was counted as MT-7117 high Dose Group in the Safety Population.
|
|
Nervous system disorders
Headache
|
18.2%
6/33 • All AEs and SAEs that occurred from the time written informed consent was obtained until the end of the follow-up period (6 weeks after the last treatment visit, for safety monitoring)
One subject who was randomized to Placebo received MT-7117 high Dose instead of placebo. Therefore, the subject was counted as MT-7117 high Dose Group in the Safety Population.
|
28.6%
10/35 • All AEs and SAEs that occurred from the time written informed consent was obtained until the end of the follow-up period (6 weeks after the last treatment visit, for safety monitoring)
One subject who was randomized to Placebo received MT-7117 high Dose instead of placebo. Therefore, the subject was counted as MT-7117 high Dose Group in the Safety Population.
|
17.6%
6/34 • All AEs and SAEs that occurred from the time written informed consent was obtained until the end of the follow-up period (6 weeks after the last treatment visit, for safety monitoring)
One subject who was randomized to Placebo received MT-7117 high Dose instead of placebo. Therefore, the subject was counted as MT-7117 high Dose Group in the Safety Population.
|
|
Nervous system disorders
Paraesthesia
|
3.0%
1/33 • All AEs and SAEs that occurred from the time written informed consent was obtained until the end of the follow-up period (6 weeks after the last treatment visit, for safety monitoring)
One subject who was randomized to Placebo received MT-7117 high Dose instead of placebo. Therefore, the subject was counted as MT-7117 high Dose Group in the Safety Population.
|
5.7%
2/35 • All AEs and SAEs that occurred from the time written informed consent was obtained until the end of the follow-up period (6 weeks after the last treatment visit, for safety monitoring)
One subject who was randomized to Placebo received MT-7117 high Dose instead of placebo. Therefore, the subject was counted as MT-7117 high Dose Group in the Safety Population.
|
2.9%
1/34 • All AEs and SAEs that occurred from the time written informed consent was obtained until the end of the follow-up period (6 weeks after the last treatment visit, for safety monitoring)
One subject who was randomized to Placebo received MT-7117 high Dose instead of placebo. Therefore, the subject was counted as MT-7117 high Dose Group in the Safety Population.
|
|
Nervous system disorders
Sciatica
|
3.0%
1/33 • All AEs and SAEs that occurred from the time written informed consent was obtained until the end of the follow-up period (6 weeks after the last treatment visit, for safety monitoring)
One subject who was randomized to Placebo received MT-7117 high Dose instead of placebo. Therefore, the subject was counted as MT-7117 high Dose Group in the Safety Population.
|
0.00%
0/35 • All AEs and SAEs that occurred from the time written informed consent was obtained until the end of the follow-up period (6 weeks after the last treatment visit, for safety monitoring)
One subject who was randomized to Placebo received MT-7117 high Dose instead of placebo. Therefore, the subject was counted as MT-7117 high Dose Group in the Safety Population.
|
0.00%
0/34 • All AEs and SAEs that occurred from the time written informed consent was obtained until the end of the follow-up period (6 weeks after the last treatment visit, for safety monitoring)
One subject who was randomized to Placebo received MT-7117 high Dose instead of placebo. Therefore, the subject was counted as MT-7117 high Dose Group in the Safety Population.
|
|
Psychiatric disorders
Anxiety
|
3.0%
1/33 • All AEs and SAEs that occurred from the time written informed consent was obtained until the end of the follow-up period (6 weeks after the last treatment visit, for safety monitoring)
One subject who was randomized to Placebo received MT-7117 high Dose instead of placebo. Therefore, the subject was counted as MT-7117 high Dose Group in the Safety Population.
|
0.00%
0/35 • All AEs and SAEs that occurred from the time written informed consent was obtained until the end of the follow-up period (6 weeks after the last treatment visit, for safety monitoring)
One subject who was randomized to Placebo received MT-7117 high Dose instead of placebo. Therefore, the subject was counted as MT-7117 high Dose Group in the Safety Population.
|
0.00%
0/34 • All AEs and SAEs that occurred from the time written informed consent was obtained until the end of the follow-up period (6 weeks after the last treatment visit, for safety monitoring)
One subject who was randomized to Placebo received MT-7117 high Dose instead of placebo. Therefore, the subject was counted as MT-7117 high Dose Group in the Safety Population.
|
|
Renal and urinary disorders
Nephrolithiasis
|
3.0%
1/33 • All AEs and SAEs that occurred from the time written informed consent was obtained until the end of the follow-up period (6 weeks after the last treatment visit, for safety monitoring)
One subject who was randomized to Placebo received MT-7117 high Dose instead of placebo. Therefore, the subject was counted as MT-7117 high Dose Group in the Safety Population.
|
0.00%
0/35 • All AEs and SAEs that occurred from the time written informed consent was obtained until the end of the follow-up period (6 weeks after the last treatment visit, for safety monitoring)
One subject who was randomized to Placebo received MT-7117 high Dose instead of placebo. Therefore, the subject was counted as MT-7117 high Dose Group in the Safety Population.
|
0.00%
0/34 • All AEs and SAEs that occurred from the time written informed consent was obtained until the end of the follow-up period (6 weeks after the last treatment visit, for safety monitoring)
One subject who was randomized to Placebo received MT-7117 high Dose instead of placebo. Therefore, the subject was counted as MT-7117 high Dose Group in the Safety Population.
|
|
Renal and urinary disorders
Pollakiuria
|
3.0%
1/33 • All AEs and SAEs that occurred from the time written informed consent was obtained until the end of the follow-up period (6 weeks after the last treatment visit, for safety monitoring)
One subject who was randomized to Placebo received MT-7117 high Dose instead of placebo. Therefore, the subject was counted as MT-7117 high Dose Group in the Safety Population.
|
0.00%
0/35 • All AEs and SAEs that occurred from the time written informed consent was obtained until the end of the follow-up period (6 weeks after the last treatment visit, for safety monitoring)
One subject who was randomized to Placebo received MT-7117 high Dose instead of placebo. Therefore, the subject was counted as MT-7117 high Dose Group in the Safety Population.
|
0.00%
0/34 • All AEs and SAEs that occurred from the time written informed consent was obtained until the end of the follow-up period (6 weeks after the last treatment visit, for safety monitoring)
One subject who was randomized to Placebo received MT-7117 high Dose instead of placebo. Therefore, the subject was counted as MT-7117 high Dose Group in the Safety Population.
|
|
Reproductive system and breast disorders
Menorrhagia
|
0.00%
0/33 • All AEs and SAEs that occurred from the time written informed consent was obtained until the end of the follow-up period (6 weeks after the last treatment visit, for safety monitoring)
One subject who was randomized to Placebo received MT-7117 high Dose instead of placebo. Therefore, the subject was counted as MT-7117 high Dose Group in the Safety Population.
|
5.7%
2/35 • All AEs and SAEs that occurred from the time written informed consent was obtained until the end of the follow-up period (6 weeks after the last treatment visit, for safety monitoring)
One subject who was randomized to Placebo received MT-7117 high Dose instead of placebo. Therefore, the subject was counted as MT-7117 high Dose Group in the Safety Population.
|
0.00%
0/34 • All AEs and SAEs that occurred from the time written informed consent was obtained until the end of the follow-up period (6 weeks after the last treatment visit, for safety monitoring)
One subject who was randomized to Placebo received MT-7117 high Dose instead of placebo. Therefore, the subject was counted as MT-7117 high Dose Group in the Safety Population.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
6.1%
2/33 • All AEs and SAEs that occurred from the time written informed consent was obtained until the end of the follow-up period (6 weeks after the last treatment visit, for safety monitoring)
One subject who was randomized to Placebo received MT-7117 high Dose instead of placebo. Therefore, the subject was counted as MT-7117 high Dose Group in the Safety Population.
|
8.6%
3/35 • All AEs and SAEs that occurred from the time written informed consent was obtained until the end of the follow-up period (6 weeks after the last treatment visit, for safety monitoring)
One subject who was randomized to Placebo received MT-7117 high Dose instead of placebo. Therefore, the subject was counted as MT-7117 high Dose Group in the Safety Population.
|
0.00%
0/34 • All AEs and SAEs that occurred from the time written informed consent was obtained until the end of the follow-up period (6 weeks after the last treatment visit, for safety monitoring)
One subject who was randomized to Placebo received MT-7117 high Dose instead of placebo. Therefore, the subject was counted as MT-7117 high Dose Group in the Safety Population.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
6.1%
2/33 • All AEs and SAEs that occurred from the time written informed consent was obtained until the end of the follow-up period (6 weeks after the last treatment visit, for safety monitoring)
One subject who was randomized to Placebo received MT-7117 high Dose instead of placebo. Therefore, the subject was counted as MT-7117 high Dose Group in the Safety Population.
|
5.7%
2/35 • All AEs and SAEs that occurred from the time written informed consent was obtained until the end of the follow-up period (6 weeks after the last treatment visit, for safety monitoring)
One subject who was randomized to Placebo received MT-7117 high Dose instead of placebo. Therefore, the subject was counted as MT-7117 high Dose Group in the Safety Population.
|
5.9%
2/34 • All AEs and SAEs that occurred from the time written informed consent was obtained until the end of the follow-up period (6 weeks after the last treatment visit, for safety monitoring)
One subject who was randomized to Placebo received MT-7117 high Dose instead of placebo. Therefore, the subject was counted as MT-7117 high Dose Group in the Safety Population.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
3.0%
1/33 • All AEs and SAEs that occurred from the time written informed consent was obtained until the end of the follow-up period (6 weeks after the last treatment visit, for safety monitoring)
One subject who was randomized to Placebo received MT-7117 high Dose instead of placebo. Therefore, the subject was counted as MT-7117 high Dose Group in the Safety Population.
|
5.7%
2/35 • All AEs and SAEs that occurred from the time written informed consent was obtained until the end of the follow-up period (6 weeks after the last treatment visit, for safety monitoring)
One subject who was randomized to Placebo received MT-7117 high Dose instead of placebo. Therefore, the subject was counted as MT-7117 high Dose Group in the Safety Population.
|
2.9%
1/34 • All AEs and SAEs that occurred from the time written informed consent was obtained until the end of the follow-up period (6 weeks after the last treatment visit, for safety monitoring)
One subject who was randomized to Placebo received MT-7117 high Dose instead of placebo. Therefore, the subject was counted as MT-7117 high Dose Group in the Safety Population.
|
|
Respiratory, thoracic and mediastinal disorders
Paranasal sinus discomfort
|
3.0%
1/33 • All AEs and SAEs that occurred from the time written informed consent was obtained until the end of the follow-up period (6 weeks after the last treatment visit, for safety monitoring)
One subject who was randomized to Placebo received MT-7117 high Dose instead of placebo. Therefore, the subject was counted as MT-7117 high Dose Group in the Safety Population.
|
2.9%
1/35 • All AEs and SAEs that occurred from the time written informed consent was obtained until the end of the follow-up period (6 weeks after the last treatment visit, for safety monitoring)
One subject who was randomized to Placebo received MT-7117 high Dose instead of placebo. Therefore, the subject was counted as MT-7117 high Dose Group in the Safety Population.
|
0.00%
0/34 • All AEs and SAEs that occurred from the time written informed consent was obtained until the end of the follow-up period (6 weeks after the last treatment visit, for safety monitoring)
One subject who was randomized to Placebo received MT-7117 high Dose instead of placebo. Therefore, the subject was counted as MT-7117 high Dose Group in the Safety Population.
|
|
Respiratory, thoracic and mediastinal disorders
Sputum retention
|
3.0%
1/33 • All AEs and SAEs that occurred from the time written informed consent was obtained until the end of the follow-up period (6 weeks after the last treatment visit, for safety monitoring)
One subject who was randomized to Placebo received MT-7117 high Dose instead of placebo. Therefore, the subject was counted as MT-7117 high Dose Group in the Safety Population.
|
2.9%
1/35 • All AEs and SAEs that occurred from the time written informed consent was obtained until the end of the follow-up period (6 weeks after the last treatment visit, for safety monitoring)
One subject who was randomized to Placebo received MT-7117 high Dose instead of placebo. Therefore, the subject was counted as MT-7117 high Dose Group in the Safety Population.
|
0.00%
0/34 • All AEs and SAEs that occurred from the time written informed consent was obtained until the end of the follow-up period (6 weeks after the last treatment visit, for safety monitoring)
One subject who was randomized to Placebo received MT-7117 high Dose instead of placebo. Therefore, the subject was counted as MT-7117 high Dose Group in the Safety Population.
|
|
Skin and subcutaneous tissue disorders
Acne
|
3.0%
1/33 • All AEs and SAEs that occurred from the time written informed consent was obtained until the end of the follow-up period (6 weeks after the last treatment visit, for safety monitoring)
One subject who was randomized to Placebo received MT-7117 high Dose instead of placebo. Therefore, the subject was counted as MT-7117 high Dose Group in the Safety Population.
|
2.9%
1/35 • All AEs and SAEs that occurred from the time written informed consent was obtained until the end of the follow-up period (6 weeks after the last treatment visit, for safety monitoring)
One subject who was randomized to Placebo received MT-7117 high Dose instead of placebo. Therefore, the subject was counted as MT-7117 high Dose Group in the Safety Population.
|
0.00%
0/34 • All AEs and SAEs that occurred from the time written informed consent was obtained until the end of the follow-up period (6 weeks after the last treatment visit, for safety monitoring)
One subject who was randomized to Placebo received MT-7117 high Dose instead of placebo. Therefore, the subject was counted as MT-7117 high Dose Group in the Safety Population.
|
|
Skin and subcutaneous tissue disorders
Actinic prurigo
|
3.0%
1/33 • All AEs and SAEs that occurred from the time written informed consent was obtained until the end of the follow-up period (6 weeks after the last treatment visit, for safety monitoring)
One subject who was randomized to Placebo received MT-7117 high Dose instead of placebo. Therefore, the subject was counted as MT-7117 high Dose Group in the Safety Population.
|
0.00%
0/35 • All AEs and SAEs that occurred from the time written informed consent was obtained until the end of the follow-up period (6 weeks after the last treatment visit, for safety monitoring)
One subject who was randomized to Placebo received MT-7117 high Dose instead of placebo. Therefore, the subject was counted as MT-7117 high Dose Group in the Safety Population.
|
0.00%
0/34 • All AEs and SAEs that occurred from the time written informed consent was obtained until the end of the follow-up period (6 weeks after the last treatment visit, for safety monitoring)
One subject who was randomized to Placebo received MT-7117 high Dose instead of placebo. Therefore, the subject was counted as MT-7117 high Dose Group in the Safety Population.
|
|
Skin and subcutaneous tissue disorders
Ephelides
|
15.2%
5/33 • All AEs and SAEs that occurred from the time written informed consent was obtained until the end of the follow-up period (6 weeks after the last treatment visit, for safety monitoring)
One subject who was randomized to Placebo received MT-7117 high Dose instead of placebo. Therefore, the subject was counted as MT-7117 high Dose Group in the Safety Population.
|
31.4%
11/35 • All AEs and SAEs that occurred from the time written informed consent was obtained until the end of the follow-up period (6 weeks after the last treatment visit, for safety monitoring)
One subject who was randomized to Placebo received MT-7117 high Dose instead of placebo. Therefore, the subject was counted as MT-7117 high Dose Group in the Safety Population.
|
0.00%
0/34 • All AEs and SAEs that occurred from the time written informed consent was obtained until the end of the follow-up period (6 weeks after the last treatment visit, for safety monitoring)
One subject who was randomized to Placebo received MT-7117 high Dose instead of placebo. Therefore, the subject was counted as MT-7117 high Dose Group in the Safety Population.
|
|
Skin and subcutaneous tissue disorders
Hair colour changes
|
0.00%
0/33 • All AEs and SAEs that occurred from the time written informed consent was obtained until the end of the follow-up period (6 weeks after the last treatment visit, for safety monitoring)
One subject who was randomized to Placebo received MT-7117 high Dose instead of placebo. Therefore, the subject was counted as MT-7117 high Dose Group in the Safety Population.
|
5.7%
2/35 • All AEs and SAEs that occurred from the time written informed consent was obtained until the end of the follow-up period (6 weeks after the last treatment visit, for safety monitoring)
One subject who was randomized to Placebo received MT-7117 high Dose instead of placebo. Therefore, the subject was counted as MT-7117 high Dose Group in the Safety Population.
|
0.00%
0/34 • All AEs and SAEs that occurred from the time written informed consent was obtained until the end of the follow-up period (6 weeks after the last treatment visit, for safety monitoring)
One subject who was randomized to Placebo received MT-7117 high Dose instead of placebo. Therefore, the subject was counted as MT-7117 high Dose Group in the Safety Population.
|
|
Skin and subcutaneous tissue disorders
Milia
|
3.0%
1/33 • All AEs and SAEs that occurred from the time written informed consent was obtained until the end of the follow-up period (6 weeks after the last treatment visit, for safety monitoring)
One subject who was randomized to Placebo received MT-7117 high Dose instead of placebo. Therefore, the subject was counted as MT-7117 high Dose Group in the Safety Population.
|
2.9%
1/35 • All AEs and SAEs that occurred from the time written informed consent was obtained until the end of the follow-up period (6 weeks after the last treatment visit, for safety monitoring)
One subject who was randomized to Placebo received MT-7117 high Dose instead of placebo. Therefore, the subject was counted as MT-7117 high Dose Group in the Safety Population.
|
0.00%
0/34 • All AEs and SAEs that occurred from the time written informed consent was obtained until the end of the follow-up period (6 weeks after the last treatment visit, for safety monitoring)
One subject who was randomized to Placebo received MT-7117 high Dose instead of placebo. Therefore, the subject was counted as MT-7117 high Dose Group in the Safety Population.
|
|
Skin and subcutaneous tissue disorders
Papule
|
3.0%
1/33 • All AEs and SAEs that occurred from the time written informed consent was obtained until the end of the follow-up period (6 weeks after the last treatment visit, for safety monitoring)
One subject who was randomized to Placebo received MT-7117 high Dose instead of placebo. Therefore, the subject was counted as MT-7117 high Dose Group in the Safety Population.
|
2.9%
1/35 • All AEs and SAEs that occurred from the time written informed consent was obtained until the end of the follow-up period (6 weeks after the last treatment visit, for safety monitoring)
One subject who was randomized to Placebo received MT-7117 high Dose instead of placebo. Therefore, the subject was counted as MT-7117 high Dose Group in the Safety Population.
|
2.9%
1/34 • All AEs and SAEs that occurred from the time written informed consent was obtained until the end of the follow-up period (6 weeks after the last treatment visit, for safety monitoring)
One subject who was randomized to Placebo received MT-7117 high Dose instead of placebo. Therefore, the subject was counted as MT-7117 high Dose Group in the Safety Population.
|
|
Skin and subcutaneous tissue disorders
Petechiae
|
3.0%
1/33 • All AEs and SAEs that occurred from the time written informed consent was obtained until the end of the follow-up period (6 weeks after the last treatment visit, for safety monitoring)
One subject who was randomized to Placebo received MT-7117 high Dose instead of placebo. Therefore, the subject was counted as MT-7117 high Dose Group in the Safety Population.
|
0.00%
0/35 • All AEs and SAEs that occurred from the time written informed consent was obtained until the end of the follow-up period (6 weeks after the last treatment visit, for safety monitoring)
One subject who was randomized to Placebo received MT-7117 high Dose instead of placebo. Therefore, the subject was counted as MT-7117 high Dose Group in the Safety Population.
|
2.9%
1/34 • All AEs and SAEs that occurred from the time written informed consent was obtained until the end of the follow-up period (6 weeks after the last treatment visit, for safety monitoring)
One subject who was randomized to Placebo received MT-7117 high Dose instead of placebo. Therefore, the subject was counted as MT-7117 high Dose Group in the Safety Population.
|
|
Skin and subcutaneous tissue disorders
Photosensitivity reaction
|
15.2%
5/33 • All AEs and SAEs that occurred from the time written informed consent was obtained until the end of the follow-up period (6 weeks after the last treatment visit, for safety monitoring)
One subject who was randomized to Placebo received MT-7117 high Dose instead of placebo. Therefore, the subject was counted as MT-7117 high Dose Group in the Safety Population.
|
14.3%
5/35 • All AEs and SAEs that occurred from the time written informed consent was obtained until the end of the follow-up period (6 weeks after the last treatment visit, for safety monitoring)
One subject who was randomized to Placebo received MT-7117 high Dose instead of placebo. Therefore, the subject was counted as MT-7117 high Dose Group in the Safety Population.
|
8.8%
3/34 • All AEs and SAEs that occurred from the time written informed consent was obtained until the end of the follow-up period (6 weeks after the last treatment visit, for safety monitoring)
One subject who was randomized to Placebo received MT-7117 high Dose instead of placebo. Therefore, the subject was counted as MT-7117 high Dose Group in the Safety Population.
|
|
Skin and subcutaneous tissue disorders
Pigmentation disorder
|
9.1%
3/33 • All AEs and SAEs that occurred from the time written informed consent was obtained until the end of the follow-up period (6 weeks after the last treatment visit, for safety monitoring)
One subject who was randomized to Placebo received MT-7117 high Dose instead of placebo. Therefore, the subject was counted as MT-7117 high Dose Group in the Safety Population.
|
2.9%
1/35 • All AEs and SAEs that occurred from the time written informed consent was obtained until the end of the follow-up period (6 weeks after the last treatment visit, for safety monitoring)
One subject who was randomized to Placebo received MT-7117 high Dose instead of placebo. Therefore, the subject was counted as MT-7117 high Dose Group in the Safety Population.
|
0.00%
0/34 • All AEs and SAEs that occurred from the time written informed consent was obtained until the end of the follow-up period (6 weeks after the last treatment visit, for safety monitoring)
One subject who was randomized to Placebo received MT-7117 high Dose instead of placebo. Therefore, the subject was counted as MT-7117 high Dose Group in the Safety Population.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
3.0%
1/33 • All AEs and SAEs that occurred from the time written informed consent was obtained until the end of the follow-up period (6 weeks after the last treatment visit, for safety monitoring)
One subject who was randomized to Placebo received MT-7117 high Dose instead of placebo. Therefore, the subject was counted as MT-7117 high Dose Group in the Safety Population.
|
0.00%
0/35 • All AEs and SAEs that occurred from the time written informed consent was obtained until the end of the follow-up period (6 weeks after the last treatment visit, for safety monitoring)
One subject who was randomized to Placebo received MT-7117 high Dose instead of placebo. Therefore, the subject was counted as MT-7117 high Dose Group in the Safety Population.
|
2.9%
1/34 • All AEs and SAEs that occurred from the time written informed consent was obtained until the end of the follow-up period (6 weeks after the last treatment visit, for safety monitoring)
One subject who was randomized to Placebo received MT-7117 high Dose instead of placebo. Therefore, the subject was counted as MT-7117 high Dose Group in the Safety Population.
|
|
Skin and subcutaneous tissue disorders
Rash
|
3.0%
1/33 • All AEs and SAEs that occurred from the time written informed consent was obtained until the end of the follow-up period (6 weeks after the last treatment visit, for safety monitoring)
One subject who was randomized to Placebo received MT-7117 high Dose instead of placebo. Therefore, the subject was counted as MT-7117 high Dose Group in the Safety Population.
|
2.9%
1/35 • All AEs and SAEs that occurred from the time written informed consent was obtained until the end of the follow-up period (6 weeks after the last treatment visit, for safety monitoring)
One subject who was randomized to Placebo received MT-7117 high Dose instead of placebo. Therefore, the subject was counted as MT-7117 high Dose Group in the Safety Population.
|
2.9%
1/34 • All AEs and SAEs that occurred from the time written informed consent was obtained until the end of the follow-up period (6 weeks after the last treatment visit, for safety monitoring)
One subject who was randomized to Placebo received MT-7117 high Dose instead of placebo. Therefore, the subject was counted as MT-7117 high Dose Group in the Safety Population.
|
|
Skin and subcutaneous tissue disorders
Sebaceous hyperplasia
|
3.0%
1/33 • All AEs and SAEs that occurred from the time written informed consent was obtained until the end of the follow-up period (6 weeks after the last treatment visit, for safety monitoring)
One subject who was randomized to Placebo received MT-7117 high Dose instead of placebo. Therefore, the subject was counted as MT-7117 high Dose Group in the Safety Population.
|
0.00%
0/35 • All AEs and SAEs that occurred from the time written informed consent was obtained until the end of the follow-up period (6 weeks after the last treatment visit, for safety monitoring)
One subject who was randomized to Placebo received MT-7117 high Dose instead of placebo. Therefore, the subject was counted as MT-7117 high Dose Group in the Safety Population.
|
0.00%
0/34 • All AEs and SAEs that occurred from the time written informed consent was obtained until the end of the follow-up period (6 weeks after the last treatment visit, for safety monitoring)
One subject who was randomized to Placebo received MT-7117 high Dose instead of placebo. Therefore, the subject was counted as MT-7117 high Dose Group in the Safety Population.
|
|
Skin and subcutaneous tissue disorders
Skin discolouration
|
3.0%
1/33 • All AEs and SAEs that occurred from the time written informed consent was obtained until the end of the follow-up period (6 weeks after the last treatment visit, for safety monitoring)
One subject who was randomized to Placebo received MT-7117 high Dose instead of placebo. Therefore, the subject was counted as MT-7117 high Dose Group in the Safety Population.
|
8.6%
3/35 • All AEs and SAEs that occurred from the time written informed consent was obtained until the end of the follow-up period (6 weeks after the last treatment visit, for safety monitoring)
One subject who was randomized to Placebo received MT-7117 high Dose instead of placebo. Therefore, the subject was counted as MT-7117 high Dose Group in the Safety Population.
|
0.00%
0/34 • All AEs and SAEs that occurred from the time written informed consent was obtained until the end of the follow-up period (6 weeks after the last treatment visit, for safety monitoring)
One subject who was randomized to Placebo received MT-7117 high Dose instead of placebo. Therefore, the subject was counted as MT-7117 high Dose Group in the Safety Population.
|
|
Skin and subcutaneous tissue disorders
Skin exfoliation
|
3.0%
1/33 • All AEs and SAEs that occurred from the time written informed consent was obtained until the end of the follow-up period (6 weeks after the last treatment visit, for safety monitoring)
One subject who was randomized to Placebo received MT-7117 high Dose instead of placebo. Therefore, the subject was counted as MT-7117 high Dose Group in the Safety Population.
|
0.00%
0/35 • All AEs and SAEs that occurred from the time written informed consent was obtained until the end of the follow-up period (6 weeks after the last treatment visit, for safety monitoring)
One subject who was randomized to Placebo received MT-7117 high Dose instead of placebo. Therefore, the subject was counted as MT-7117 high Dose Group in the Safety Population.
|
0.00%
0/34 • All AEs and SAEs that occurred from the time written informed consent was obtained until the end of the follow-up period (6 weeks after the last treatment visit, for safety monitoring)
One subject who was randomized to Placebo received MT-7117 high Dose instead of placebo. Therefore, the subject was counted as MT-7117 high Dose Group in the Safety Population.
|
|
Skin and subcutaneous tissue disorders
Skin hyperpigmentation
|
9.1%
3/33 • All AEs and SAEs that occurred from the time written informed consent was obtained until the end of the follow-up period (6 weeks after the last treatment visit, for safety monitoring)
One subject who was randomized to Placebo received MT-7117 high Dose instead of placebo. Therefore, the subject was counted as MT-7117 high Dose Group in the Safety Population.
|
31.4%
11/35 • All AEs and SAEs that occurred from the time written informed consent was obtained until the end of the follow-up period (6 weeks after the last treatment visit, for safety monitoring)
One subject who was randomized to Placebo received MT-7117 high Dose instead of placebo. Therefore, the subject was counted as MT-7117 high Dose Group in the Safety Population.
|
0.00%
0/34 • All AEs and SAEs that occurred from the time written informed consent was obtained until the end of the follow-up period (6 weeks after the last treatment visit, for safety monitoring)
One subject who was randomized to Placebo received MT-7117 high Dose instead of placebo. Therefore, the subject was counted as MT-7117 high Dose Group in the Safety Population.
|
|
Skin and subcutaneous tissue disorders
Solar dermatitis
|
3.0%
1/33 • All AEs and SAEs that occurred from the time written informed consent was obtained until the end of the follow-up period (6 weeks after the last treatment visit, for safety monitoring)
One subject who was randomized to Placebo received MT-7117 high Dose instead of placebo. Therefore, the subject was counted as MT-7117 high Dose Group in the Safety Population.
|
0.00%
0/35 • All AEs and SAEs that occurred from the time written informed consent was obtained until the end of the follow-up period (6 weeks after the last treatment visit, for safety monitoring)
One subject who was randomized to Placebo received MT-7117 high Dose instead of placebo. Therefore, the subject was counted as MT-7117 high Dose Group in the Safety Population.
|
0.00%
0/34 • All AEs and SAEs that occurred from the time written informed consent was obtained until the end of the follow-up period (6 weeks after the last treatment visit, for safety monitoring)
One subject who was randomized to Placebo received MT-7117 high Dose instead of placebo. Therefore, the subject was counted as MT-7117 high Dose Group in the Safety Population.
|
|
Skin and subcutaneous tissue disorders
Solar lentigo
|
3.0%
1/33 • All AEs and SAEs that occurred from the time written informed consent was obtained until the end of the follow-up period (6 weeks after the last treatment visit, for safety monitoring)
One subject who was randomized to Placebo received MT-7117 high Dose instead of placebo. Therefore, the subject was counted as MT-7117 high Dose Group in the Safety Population.
|
0.00%
0/35 • All AEs and SAEs that occurred from the time written informed consent was obtained until the end of the follow-up period (6 weeks after the last treatment visit, for safety monitoring)
One subject who was randomized to Placebo received MT-7117 high Dose instead of placebo. Therefore, the subject was counted as MT-7117 high Dose Group in the Safety Population.
|
0.00%
0/34 • All AEs and SAEs that occurred from the time written informed consent was obtained until the end of the follow-up period (6 weeks after the last treatment visit, for safety monitoring)
One subject who was randomized to Placebo received MT-7117 high Dose instead of placebo. Therefore, the subject was counted as MT-7117 high Dose Group in the Safety Population.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.00%
0/33 • All AEs and SAEs that occurred from the time written informed consent was obtained until the end of the follow-up period (6 weeks after the last treatment visit, for safety monitoring)
One subject who was randomized to Placebo received MT-7117 high Dose instead of placebo. Therefore, the subject was counted as MT-7117 high Dose Group in the Safety Population.
|
5.7%
2/35 • All AEs and SAEs that occurred from the time written informed consent was obtained until the end of the follow-up period (6 weeks after the last treatment visit, for safety monitoring)
One subject who was randomized to Placebo received MT-7117 high Dose instead of placebo. Therefore, the subject was counted as MT-7117 high Dose Group in the Safety Population.
|
0.00%
0/34 • All AEs and SAEs that occurred from the time written informed consent was obtained until the end of the follow-up period (6 weeks after the last treatment visit, for safety monitoring)
One subject who was randomized to Placebo received MT-7117 high Dose instead of placebo. Therefore, the subject was counted as MT-7117 high Dose Group in the Safety Population.
|
|
Skin and subcutaneous tissue disorders
Yellow skin
|
3.0%
1/33 • All AEs and SAEs that occurred from the time written informed consent was obtained until the end of the follow-up period (6 weeks after the last treatment visit, for safety monitoring)
One subject who was randomized to Placebo received MT-7117 high Dose instead of placebo. Therefore, the subject was counted as MT-7117 high Dose Group in the Safety Population.
|
0.00%
0/35 • All AEs and SAEs that occurred from the time written informed consent was obtained until the end of the follow-up period (6 weeks after the last treatment visit, for safety monitoring)
One subject who was randomized to Placebo received MT-7117 high Dose instead of placebo. Therefore, the subject was counted as MT-7117 high Dose Group in the Safety Population.
|
0.00%
0/34 • All AEs and SAEs that occurred from the time written informed consent was obtained until the end of the follow-up period (6 weeks after the last treatment visit, for safety monitoring)
One subject who was randomized to Placebo received MT-7117 high Dose instead of placebo. Therefore, the subject was counted as MT-7117 high Dose Group in the Safety Population.
|
Additional Information
Clinical Trials, Information Desk
Tanabe Pharma America, Inc.
Phone: 908-607-1980
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: OTHER