Trial Outcomes & Findings for A Study to Evaluate the Effects of RAD1901 in the Treatment of Vasomotor Symptoms in Postmenopausal Women (NCT NCT00875420)
NCT ID: NCT00875420
Last Updated: 2018-09-26
Results Overview
Percent change of moderate and severe hot flash frequency at 4 weeks compared to baseline using weekly Subject diary data, in the intent-to-treat population.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
100 participants
Primary outcome timeframe
Week 4 minus baseline week
Results posted on
2018-09-26
Participant Flow
Participant milestones
| Measure |
RAD1901 10 mg
Oral once a day for 28 days
|
RAD1901 25 mg
Oral once a day for 28 days
|
RAD1901 50 mg
Oral once a day for 28 days
|
RAD1901 100 mg
Oral once a day for 28 days
|
Placebo
Oral once a day for 28 days
|
|---|---|---|---|---|---|
|
Overall Study
STARTED
|
22
|
20
|
21
|
18
|
19
|
|
Overall Study
COMPLETED
|
20
|
18
|
18
|
16
|
17
|
|
Overall Study
NOT COMPLETED
|
2
|
2
|
3
|
2
|
2
|
Reasons for withdrawal
| Measure |
RAD1901 10 mg
Oral once a day for 28 days
|
RAD1901 25 mg
Oral once a day for 28 days
|
RAD1901 50 mg
Oral once a day for 28 days
|
RAD1901 100 mg
Oral once a day for 28 days
|
Placebo
Oral once a day for 28 days
|
|---|---|---|---|---|---|
|
Overall Study
Adverse Event
|
0
|
1
|
1
|
0
|
0
|
|
Overall Study
Inability to complete study procedures
|
1
|
0
|
1
|
1
|
1
|
|
Overall Study
Lost to Follow-up
|
1
|
0
|
0
|
0
|
0
|
|
Overall Study
Personal reason
|
0
|
0
|
0
|
0
|
1
|
|
Overall Study
Prohibited medication
|
0
|
0
|
0
|
1
|
0
|
|
Overall Study
Sponsor decision
|
0
|
1
|
0
|
0
|
0
|
|
Overall Study
Withdrawal by Subject
|
0
|
0
|
1
|
0
|
0
|
Baseline Characteristics
A Study to Evaluate the Effects of RAD1901 in the Treatment of Vasomotor Symptoms in Postmenopausal Women
Baseline characteristics by cohort
| Measure |
RAD1901 10 mg
n=22 Participants
Oral once a day for 28 days
|
RAD1901 25 mg
n=20 Participants
Oral once a day for 28 days
|
RAD1901 50 mg
n=21 Participants
Oral once a day for 28 days
|
RAD1901 100 mg
n=18 Participants
Oral once a day for 28 days
|
Placebo
n=19 Participants
Oral once a day for 28 days
|
Total
n=100 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Continuous
|
53.5 years
STANDARD_DEVIATION 5.74 • n=99 Participants
|
55.2 years
STANDARD_DEVIATION 7.74 • n=107 Participants
|
53.7 years
STANDARD_DEVIATION 5.68 • n=206 Participants
|
55.7 years
STANDARD_DEVIATION 6.45 • n=7 Participants
|
53.8 years
STANDARD_DEVIATION 5.74 • n=31 Participants
|
54.3 years
STANDARD_DEVIATION 6.24 • n=30 Participants
|
|
Sex: Female, Male
Female
|
22 Participants
n=99 Participants
|
20 Participants
n=107 Participants
|
21 Participants
n=206 Participants
|
18 Participants
n=7 Participants
|
19 Participants
n=31 Participants
|
100 Participants
n=30 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
|
Race (NIH/OMB)
White
|
22 Participants
n=99 Participants
|
20 Participants
n=107 Participants
|
21 Participants
n=206 Participants
|
18 Participants
n=7 Participants
|
19 Participants
n=31 Participants
|
100 Participants
n=30 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
PRIMARY outcome
Timeframe: Week 4 minus baseline weekPopulation: The intent-to-treat population is defined as all patients who received one or more doses of study drug.
Percent change of moderate and severe hot flash frequency at 4 weeks compared to baseline using weekly Subject diary data, in the intent-to-treat population.
Outcome measures
| Measure |
RAD1901 10 mg
n=22 Participants
Oral once a day for 28 days
|
RAD1901 25 mg
n=20 Participants
Oral once a day for 28 days
|
RAD1901 50 mg
n=21 Participants
Oral once a day for 28 days
|
RAD1901 100 mg
n=18 Participants
Oral once a day for 28 days
|
Placebo
n=19 Participants
Oral once a day for 28 days
|
|---|---|---|---|---|---|
|
Percent Change in Frequency of Hot Flashes Over Time
|
-77.2 Percent change from baseline
Standard Deviation 20.43
|
-51.8 Percent change from baseline
Standard Deviation 45.02
|
-53.8 Percent change from baseline
Standard Deviation 39.16
|
-67.0 Percent change from baseline
Standard Deviation 33.85
|
-54.1 Percent change from baseline
Standard Deviation 37.72
|
PRIMARY outcome
Timeframe: Week 4 minus baseline weekPopulation: The intent-to-treat population is defined as all patients who received one or more doses of study drug.
Percent change in composite score (frequency x severity) of hot flashes (Mild=1, Moderate=2, Severe=3) at 4 weeks compared to baseline, in the intent-to-treat population.
Outcome measures
| Measure |
RAD1901 10 mg
n=22 Participants
Oral once a day for 28 days
|
RAD1901 25 mg
n=20 Participants
Oral once a day for 28 days
|
RAD1901 50 mg
n=21 Participants
Oral once a day for 28 days
|
RAD1901 100 mg
n=18 Participants
Oral once a day for 28 days
|
Placebo
n=19 Participants
Oral once a day for 28 days
|
|---|---|---|---|---|---|
|
Percent Change in Composite Score Over Time
|
-75.65 Percent change from baseline
Standard Deviation 18.655
|
-55.48 Percent change from baseline
Standard Deviation 39.442
|
-48.78 Percent change from baseline
Standard Deviation 39.806
|
-66.21 Percent change from baseline
Standard Deviation 33.226
|
-55.80 Percent change from baseline
Standard Deviation 35.523
|
SECONDARY outcome
Timeframe: Day 29 minus baselinePopulation: The intent-to-treat (ITT) population is defined as all patients who received one or more doses of study drug. Based on patients who had a result on Day 29.
Percent change in FSH at Day 29 compared to baseline, in the intent-to-treat population.
Outcome measures
| Measure |
RAD1901 10 mg
n=20 Participants
Oral once a day for 28 days
|
RAD1901 25 mg
n=18 Participants
Oral once a day for 28 days
|
RAD1901 50 mg
n=18 Participants
Oral once a day for 28 days
|
RAD1901 100 mg
n=16 Participants
Oral once a day for 28 days
|
Placebo
n=17 Participants
Oral once a day for 28 days
|
|---|---|---|---|---|---|
|
Determine the Effects of RAD1901 on Follicular Stimulating Hormone (FSH) Over Time.
|
4.24 Percent change from baseline
Standard Deviation 34.077
|
-6.56 Percent change from baseline
Standard Deviation 13.933
|
-4.42 Percent change from baseline
Standard Deviation 24.381
|
-3.26 Percent change from baseline
Standard Deviation 11.373
|
8.67 Percent change from baseline
Standard Deviation 62.175
|
SECONDARY outcome
Timeframe: Day 29 minus baselinePopulation: The intent-to-treat (ITT) population is defined as all patients who received one or more doses of study drug. Based on patients who had a result on Day 29.
Percent change in LH levels at Day 29 compared to baseline, in the intent-to-treat population.
Outcome measures
| Measure |
RAD1901 10 mg
n=20 Participants
Oral once a day for 28 days
|
RAD1901 25 mg
n=18 Participants
Oral once a day for 28 days
|
RAD1901 50 mg
n=18 Participants
Oral once a day for 28 days
|
RAD1901 100 mg
n=16 Participants
Oral once a day for 28 days
|
Placebo
n=17 Participants
Oral once a day for 28 days
|
|---|---|---|---|---|---|
|
Determine the Effects of RAD1901 on Luteinizing Hormone (LH) Over Time.
|
-12.81 Percent change from baseline
Standard Deviation 27.551
|
-0.19 Percent change from baseline
Standard Deviation 19.573
|
-10.94 Percent change from baseline
Standard Deviation 22.609
|
3.57 Percent change from baseline
Standard Deviation 22.392
|
6.70 Percent change from baseline
Standard Deviation 36.270
|
Adverse Events
RAD1901 10 mg
Serious events: 0 serious events
Other events: 16 other events
Deaths: 0 deaths
RAD1901 25 mg
Serious events: 0 serious events
Other events: 14 other events
Deaths: 0 deaths
RAD1901 50 mg
Serious events: 0 serious events
Other events: 14 other events
Deaths: 0 deaths
RAD1901 100 mg
Serious events: 0 serious events
Other events: 14 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 11 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
RAD1901 10 mg
n=22 participants at risk
Oral once a day for 28 days
|
RAD1901 25 mg
n=20 participants at risk
Oral once a day for 28 days
|
RAD1901 50 mg
n=21 participants at risk
Oral once a day for 28 days
|
RAD1901 100 mg
n=18 participants at risk
Oral once a day for 28 days
|
Placebo
n=19 participants at risk
Oral once a day for 28 days
|
|---|---|---|---|---|---|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal Pain
|
0.00%
0/22 • Adverse events were collected for 2 months during this study; from start of treatment to the end-of-treatment visit (Day 29) and 30 days after end-of-treatment visit.
Method of routinely determining whether or not certain adverse events have occurred was by regular investigator assessment and regular laboratory testing.
|
0.00%
0/20 • Adverse events were collected for 2 months during this study; from start of treatment to the end-of-treatment visit (Day 29) and 30 days after end-of-treatment visit.
Method of routinely determining whether or not certain adverse events have occurred was by regular investigator assessment and regular laboratory testing.
|
0.00%
0/21 • Adverse events were collected for 2 months during this study; from start of treatment to the end-of-treatment visit (Day 29) and 30 days after end-of-treatment visit.
Method of routinely determining whether or not certain adverse events have occurred was by regular investigator assessment and regular laboratory testing.
|
5.6%
1/18 • Adverse events were collected for 2 months during this study; from start of treatment to the end-of-treatment visit (Day 29) and 30 days after end-of-treatment visit.
Method of routinely determining whether or not certain adverse events have occurred was by regular investigator assessment and regular laboratory testing.
|
0.00%
0/19 • Adverse events were collected for 2 months during this study; from start of treatment to the end-of-treatment visit (Day 29) and 30 days after end-of-treatment visit.
Method of routinely determining whether or not certain adverse events have occurred was by regular investigator assessment and regular laboratory testing.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/22 • Adverse events were collected for 2 months during this study; from start of treatment to the end-of-treatment visit (Day 29) and 30 days after end-of-treatment visit.
Method of routinely determining whether or not certain adverse events have occurred was by regular investigator assessment and regular laboratory testing.
|
0.00%
0/20 • Adverse events were collected for 2 months during this study; from start of treatment to the end-of-treatment visit (Day 29) and 30 days after end-of-treatment visit.
Method of routinely determining whether or not certain adverse events have occurred was by regular investigator assessment and regular laboratory testing.
|
0.00%
0/21 • Adverse events were collected for 2 months during this study; from start of treatment to the end-of-treatment visit (Day 29) and 30 days after end-of-treatment visit.
Method of routinely determining whether or not certain adverse events have occurred was by regular investigator assessment and regular laboratory testing.
|
0.00%
0/18 • Adverse events were collected for 2 months during this study; from start of treatment to the end-of-treatment visit (Day 29) and 30 days after end-of-treatment visit.
Method of routinely determining whether or not certain adverse events have occurred was by regular investigator assessment and regular laboratory testing.
|
5.3%
1/19 • Adverse events were collected for 2 months during this study; from start of treatment to the end-of-treatment visit (Day 29) and 30 days after end-of-treatment visit.
Method of routinely determining whether or not certain adverse events have occurred was by regular investigator assessment and regular laboratory testing.
|
|
Blood and lymphatic system disorders
Leukopenia
|
0.00%
0/22 • Adverse events were collected for 2 months during this study; from start of treatment to the end-of-treatment visit (Day 29) and 30 days after end-of-treatment visit.
Method of routinely determining whether or not certain adverse events have occurred was by regular investigator assessment and regular laboratory testing.
|
0.00%
0/20 • Adverse events were collected for 2 months during this study; from start of treatment to the end-of-treatment visit (Day 29) and 30 days after end-of-treatment visit.
Method of routinely determining whether or not certain adverse events have occurred was by regular investigator assessment and regular laboratory testing.
|
0.00%
0/21 • Adverse events were collected for 2 months during this study; from start of treatment to the end-of-treatment visit (Day 29) and 30 days after end-of-treatment visit.
Method of routinely determining whether or not certain adverse events have occurred was by regular investigator assessment and regular laboratory testing.
|
5.6%
1/18 • Adverse events were collected for 2 months during this study; from start of treatment to the end-of-treatment visit (Day 29) and 30 days after end-of-treatment visit.
Method of routinely determining whether or not certain adverse events have occurred was by regular investigator assessment and regular laboratory testing.
|
0.00%
0/19 • Adverse events were collected for 2 months during this study; from start of treatment to the end-of-treatment visit (Day 29) and 30 days after end-of-treatment visit.
Method of routinely determining whether or not certain adverse events have occurred was by regular investigator assessment and regular laboratory testing.
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/22 • Adverse events were collected for 2 months during this study; from start of treatment to the end-of-treatment visit (Day 29) and 30 days after end-of-treatment visit.
Method of routinely determining whether or not certain adverse events have occurred was by regular investigator assessment and regular laboratory testing.
|
5.0%
1/20 • Adverse events were collected for 2 months during this study; from start of treatment to the end-of-treatment visit (Day 29) and 30 days after end-of-treatment visit.
Method of routinely determining whether or not certain adverse events have occurred was by regular investigator assessment and regular laboratory testing.
|
0.00%
0/21 • Adverse events were collected for 2 months during this study; from start of treatment to the end-of-treatment visit (Day 29) and 30 days after end-of-treatment visit.
Method of routinely determining whether or not certain adverse events have occurred was by regular investigator assessment and regular laboratory testing.
|
5.6%
1/18 • Adverse events were collected for 2 months during this study; from start of treatment to the end-of-treatment visit (Day 29) and 30 days after end-of-treatment visit.
Method of routinely determining whether or not certain adverse events have occurred was by regular investigator assessment and regular laboratory testing.
|
5.3%
1/19 • Adverse events were collected for 2 months during this study; from start of treatment to the end-of-treatment visit (Day 29) and 30 days after end-of-treatment visit.
Method of routinely determining whether or not certain adverse events have occurred was by regular investigator assessment and regular laboratory testing.
|
|
Ear and labyrinth disorders
Ear Pain
|
0.00%
0/22 • Adverse events were collected for 2 months during this study; from start of treatment to the end-of-treatment visit (Day 29) and 30 days after end-of-treatment visit.
Method of routinely determining whether or not certain adverse events have occurred was by regular investigator assessment and regular laboratory testing.
|
0.00%
0/20 • Adverse events were collected for 2 months during this study; from start of treatment to the end-of-treatment visit (Day 29) and 30 days after end-of-treatment visit.
Method of routinely determining whether or not certain adverse events have occurred was by regular investigator assessment and regular laboratory testing.
|
0.00%
0/21 • Adverse events were collected for 2 months during this study; from start of treatment to the end-of-treatment visit (Day 29) and 30 days after end-of-treatment visit.
Method of routinely determining whether or not certain adverse events have occurred was by regular investigator assessment and regular laboratory testing.
|
5.6%
1/18 • Adverse events were collected for 2 months during this study; from start of treatment to the end-of-treatment visit (Day 29) and 30 days after end-of-treatment visit.
Method of routinely determining whether or not certain adverse events have occurred was by regular investigator assessment and regular laboratory testing.
|
0.00%
0/19 • Adverse events were collected for 2 months during this study; from start of treatment to the end-of-treatment visit (Day 29) and 30 days after end-of-treatment visit.
Method of routinely determining whether or not certain adverse events have occurred was by regular investigator assessment and regular laboratory testing.
|
|
Gastrointestinal disorders
Abdominal Distension
|
0.00%
0/22 • Adverse events were collected for 2 months during this study; from start of treatment to the end-of-treatment visit (Day 29) and 30 days after end-of-treatment visit.
Method of routinely determining whether or not certain adverse events have occurred was by regular investigator assessment and regular laboratory testing.
|
5.0%
1/20 • Adverse events were collected for 2 months during this study; from start of treatment to the end-of-treatment visit (Day 29) and 30 days after end-of-treatment visit.
Method of routinely determining whether or not certain adverse events have occurred was by regular investigator assessment and regular laboratory testing.
|
0.00%
0/21 • Adverse events were collected for 2 months during this study; from start of treatment to the end-of-treatment visit (Day 29) and 30 days after end-of-treatment visit.
Method of routinely determining whether or not certain adverse events have occurred was by regular investigator assessment and regular laboratory testing.
|
5.6%
1/18 • Adverse events were collected for 2 months during this study; from start of treatment to the end-of-treatment visit (Day 29) and 30 days after end-of-treatment visit.
Method of routinely determining whether or not certain adverse events have occurred was by regular investigator assessment and regular laboratory testing.
|
0.00%
0/19 • Adverse events were collected for 2 months during this study; from start of treatment to the end-of-treatment visit (Day 29) and 30 days after end-of-treatment visit.
Method of routinely determining whether or not certain adverse events have occurred was by regular investigator assessment and regular laboratory testing.
|
|
Gastrointestinal disorders
Abdominal Pain Lower
|
0.00%
0/22 • Adverse events were collected for 2 months during this study; from start of treatment to the end-of-treatment visit (Day 29) and 30 days after end-of-treatment visit.
Method of routinely determining whether or not certain adverse events have occurred was by regular investigator assessment and regular laboratory testing.
|
0.00%
0/20 • Adverse events were collected for 2 months during this study; from start of treatment to the end-of-treatment visit (Day 29) and 30 days after end-of-treatment visit.
Method of routinely determining whether or not certain adverse events have occurred was by regular investigator assessment and regular laboratory testing.
|
0.00%
0/21 • Adverse events were collected for 2 months during this study; from start of treatment to the end-of-treatment visit (Day 29) and 30 days after end-of-treatment visit.
Method of routinely determining whether or not certain adverse events have occurred was by regular investigator assessment and regular laboratory testing.
|
0.00%
0/18 • Adverse events were collected for 2 months during this study; from start of treatment to the end-of-treatment visit (Day 29) and 30 days after end-of-treatment visit.
Method of routinely determining whether or not certain adverse events have occurred was by regular investigator assessment and regular laboratory testing.
|
5.3%
1/19 • Adverse events were collected for 2 months during this study; from start of treatment to the end-of-treatment visit (Day 29) and 30 days after end-of-treatment visit.
Method of routinely determining whether or not certain adverse events have occurred was by regular investigator assessment and regular laboratory testing.
|
|
Gastrointestinal disorders
Abdominal Pain Upper
|
4.5%
1/22 • Adverse events were collected for 2 months during this study; from start of treatment to the end-of-treatment visit (Day 29) and 30 days after end-of-treatment visit.
Method of routinely determining whether or not certain adverse events have occurred was by regular investigator assessment and regular laboratory testing.
|
0.00%
0/20 • Adverse events were collected for 2 months during this study; from start of treatment to the end-of-treatment visit (Day 29) and 30 days after end-of-treatment visit.
Method of routinely determining whether or not certain adverse events have occurred was by regular investigator assessment and regular laboratory testing.
|
9.5%
2/21 • Adverse events were collected for 2 months during this study; from start of treatment to the end-of-treatment visit (Day 29) and 30 days after end-of-treatment visit.
Method of routinely determining whether or not certain adverse events have occurred was by regular investigator assessment and regular laboratory testing.
|
0.00%
0/18 • Adverse events were collected for 2 months during this study; from start of treatment to the end-of-treatment visit (Day 29) and 30 days after end-of-treatment visit.
Method of routinely determining whether or not certain adverse events have occurred was by regular investigator assessment and regular laboratory testing.
|
5.3%
1/19 • Adverse events were collected for 2 months during this study; from start of treatment to the end-of-treatment visit (Day 29) and 30 days after end-of-treatment visit.
Method of routinely determining whether or not certain adverse events have occurred was by regular investigator assessment and regular laboratory testing.
|
|
Gastrointestinal disorders
Dental Caries
|
0.00%
0/22 • Adverse events were collected for 2 months during this study; from start of treatment to the end-of-treatment visit (Day 29) and 30 days after end-of-treatment visit.
Method of routinely determining whether or not certain adverse events have occurred was by regular investigator assessment and regular laboratory testing.
|
0.00%
0/20 • Adverse events were collected for 2 months during this study; from start of treatment to the end-of-treatment visit (Day 29) and 30 days after end-of-treatment visit.
Method of routinely determining whether or not certain adverse events have occurred was by regular investigator assessment and regular laboratory testing.
|
0.00%
0/21 • Adverse events were collected for 2 months during this study; from start of treatment to the end-of-treatment visit (Day 29) and 30 days after end-of-treatment visit.
Method of routinely determining whether or not certain adverse events have occurred was by regular investigator assessment and regular laboratory testing.
|
5.6%
1/18 • Adverse events were collected for 2 months during this study; from start of treatment to the end-of-treatment visit (Day 29) and 30 days after end-of-treatment visit.
Method of routinely determining whether or not certain adverse events have occurred was by regular investigator assessment and regular laboratory testing.
|
0.00%
0/19 • Adverse events were collected for 2 months during this study; from start of treatment to the end-of-treatment visit (Day 29) and 30 days after end-of-treatment visit.
Method of routinely determining whether or not certain adverse events have occurred was by regular investigator assessment and regular laboratory testing.
|
|
Gastrointestinal disorders
Dry Mouth
|
4.5%
1/22 • Adverse events were collected for 2 months during this study; from start of treatment to the end-of-treatment visit (Day 29) and 30 days after end-of-treatment visit.
Method of routinely determining whether or not certain adverse events have occurred was by regular investigator assessment and regular laboratory testing.
|
0.00%
0/20 • Adverse events were collected for 2 months during this study; from start of treatment to the end-of-treatment visit (Day 29) and 30 days after end-of-treatment visit.
Method of routinely determining whether or not certain adverse events have occurred was by regular investigator assessment and regular laboratory testing.
|
4.8%
1/21 • Adverse events were collected for 2 months during this study; from start of treatment to the end-of-treatment visit (Day 29) and 30 days after end-of-treatment visit.
Method of routinely determining whether or not certain adverse events have occurred was by regular investigator assessment and regular laboratory testing.
|
0.00%
0/18 • Adverse events were collected for 2 months during this study; from start of treatment to the end-of-treatment visit (Day 29) and 30 days after end-of-treatment visit.
Method of routinely determining whether or not certain adverse events have occurred was by regular investigator assessment and regular laboratory testing.
|
5.3%
1/19 • Adverse events were collected for 2 months during this study; from start of treatment to the end-of-treatment visit (Day 29) and 30 days after end-of-treatment visit.
Method of routinely determining whether or not certain adverse events have occurred was by regular investigator assessment and regular laboratory testing.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/22 • Adverse events were collected for 2 months during this study; from start of treatment to the end-of-treatment visit (Day 29) and 30 days after end-of-treatment visit.
Method of routinely determining whether or not certain adverse events have occurred was by regular investigator assessment and regular laboratory testing.
|
0.00%
0/20 • Adverse events were collected for 2 months during this study; from start of treatment to the end-of-treatment visit (Day 29) and 30 days after end-of-treatment visit.
Method of routinely determining whether or not certain adverse events have occurred was by regular investigator assessment and regular laboratory testing.
|
4.8%
1/21 • Adverse events were collected for 2 months during this study; from start of treatment to the end-of-treatment visit (Day 29) and 30 days after end-of-treatment visit.
Method of routinely determining whether or not certain adverse events have occurred was by regular investigator assessment and regular laboratory testing.
|
11.1%
2/18 • Adverse events were collected for 2 months during this study; from start of treatment to the end-of-treatment visit (Day 29) and 30 days after end-of-treatment visit.
Method of routinely determining whether or not certain adverse events have occurred was by regular investigator assessment and regular laboratory testing.
|
0.00%
0/19 • Adverse events were collected for 2 months during this study; from start of treatment to the end-of-treatment visit (Day 29) and 30 days after end-of-treatment visit.
Method of routinely determining whether or not certain adverse events have occurred was by regular investigator assessment and regular laboratory testing.
|
|
Gastrointestinal disorders
Gastritis
|
13.6%
3/22 • Adverse events were collected for 2 months during this study; from start of treatment to the end-of-treatment visit (Day 29) and 30 days after end-of-treatment visit.
Method of routinely determining whether or not certain adverse events have occurred was by regular investigator assessment and regular laboratory testing.
|
5.0%
1/20 • Adverse events were collected for 2 months during this study; from start of treatment to the end-of-treatment visit (Day 29) and 30 days after end-of-treatment visit.
Method of routinely determining whether or not certain adverse events have occurred was by regular investigator assessment and regular laboratory testing.
|
4.8%
1/21 • Adverse events were collected for 2 months during this study; from start of treatment to the end-of-treatment visit (Day 29) and 30 days after end-of-treatment visit.
Method of routinely determining whether or not certain adverse events have occurred was by regular investigator assessment and regular laboratory testing.
|
11.1%
2/18 • Adverse events were collected for 2 months during this study; from start of treatment to the end-of-treatment visit (Day 29) and 30 days after end-of-treatment visit.
Method of routinely determining whether or not certain adverse events have occurred was by regular investigator assessment and regular laboratory testing.
|
0.00%
0/19 • Adverse events were collected for 2 months during this study; from start of treatment to the end-of-treatment visit (Day 29) and 30 days after end-of-treatment visit.
Method of routinely determining whether or not certain adverse events have occurred was by regular investigator assessment and regular laboratory testing.
|
|
Gastrointestinal disorders
Hyperchlorhydria
|
0.00%
0/22 • Adverse events were collected for 2 months during this study; from start of treatment to the end-of-treatment visit (Day 29) and 30 days after end-of-treatment visit.
Method of routinely determining whether or not certain adverse events have occurred was by regular investigator assessment and regular laboratory testing.
|
10.0%
2/20 • Adverse events were collected for 2 months during this study; from start of treatment to the end-of-treatment visit (Day 29) and 30 days after end-of-treatment visit.
Method of routinely determining whether or not certain adverse events have occurred was by regular investigator assessment and regular laboratory testing.
|
0.00%
0/21 • Adverse events were collected for 2 months during this study; from start of treatment to the end-of-treatment visit (Day 29) and 30 days after end-of-treatment visit.
Method of routinely determining whether or not certain adverse events have occurred was by regular investigator assessment and regular laboratory testing.
|
0.00%
0/18 • Adverse events were collected for 2 months during this study; from start of treatment to the end-of-treatment visit (Day 29) and 30 days after end-of-treatment visit.
Method of routinely determining whether or not certain adverse events have occurred was by regular investigator assessment and regular laboratory testing.
|
5.3%
1/19 • Adverse events were collected for 2 months during this study; from start of treatment to the end-of-treatment visit (Day 29) and 30 days after end-of-treatment visit.
Method of routinely determining whether or not certain adverse events have occurred was by regular investigator assessment and regular laboratory testing.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/22 • Adverse events were collected for 2 months during this study; from start of treatment to the end-of-treatment visit (Day 29) and 30 days after end-of-treatment visit.
Method of routinely determining whether or not certain adverse events have occurred was by regular investigator assessment and regular laboratory testing.
|
0.00%
0/20 • Adverse events were collected for 2 months during this study; from start of treatment to the end-of-treatment visit (Day 29) and 30 days after end-of-treatment visit.
Method of routinely determining whether or not certain adverse events have occurred was by regular investigator assessment and regular laboratory testing.
|
4.8%
1/21 • Adverse events were collected for 2 months during this study; from start of treatment to the end-of-treatment visit (Day 29) and 30 days after end-of-treatment visit.
Method of routinely determining whether or not certain adverse events have occurred was by regular investigator assessment and regular laboratory testing.
|
0.00%
0/18 • Adverse events were collected for 2 months during this study; from start of treatment to the end-of-treatment visit (Day 29) and 30 days after end-of-treatment visit.
Method of routinely determining whether or not certain adverse events have occurred was by regular investigator assessment and regular laboratory testing.
|
5.3%
1/19 • Adverse events were collected for 2 months during this study; from start of treatment to the end-of-treatment visit (Day 29) and 30 days after end-of-treatment visit.
Method of routinely determining whether or not certain adverse events have occurred was by regular investigator assessment and regular laboratory testing.
|
|
Gastrointestinal disorders
Salivary Gland Enlargement
|
0.00%
0/22 • Adverse events were collected for 2 months during this study; from start of treatment to the end-of-treatment visit (Day 29) and 30 days after end-of-treatment visit.
Method of routinely determining whether or not certain adverse events have occurred was by regular investigator assessment and regular laboratory testing.
|
0.00%
0/20 • Adverse events were collected for 2 months during this study; from start of treatment to the end-of-treatment visit (Day 29) and 30 days after end-of-treatment visit.
Method of routinely determining whether or not certain adverse events have occurred was by regular investigator assessment and regular laboratory testing.
|
0.00%
0/21 • Adverse events were collected for 2 months during this study; from start of treatment to the end-of-treatment visit (Day 29) and 30 days after end-of-treatment visit.
Method of routinely determining whether or not certain adverse events have occurred was by regular investigator assessment and regular laboratory testing.
|
0.00%
0/18 • Adverse events were collected for 2 months during this study; from start of treatment to the end-of-treatment visit (Day 29) and 30 days after end-of-treatment visit.
Method of routinely determining whether or not certain adverse events have occurred was by regular investigator assessment and regular laboratory testing.
|
5.3%
1/19 • Adverse events were collected for 2 months during this study; from start of treatment to the end-of-treatment visit (Day 29) and 30 days after end-of-treatment visit.
Method of routinely determining whether or not certain adverse events have occurred was by regular investigator assessment and regular laboratory testing.
|
|
Gastrointestinal disorders
Vomiting
|
4.5%
1/22 • Adverse events were collected for 2 months during this study; from start of treatment to the end-of-treatment visit (Day 29) and 30 days after end-of-treatment visit.
Method of routinely determining whether or not certain adverse events have occurred was by regular investigator assessment and regular laboratory testing.
|
0.00%
0/20 • Adverse events were collected for 2 months during this study; from start of treatment to the end-of-treatment visit (Day 29) and 30 days after end-of-treatment visit.
Method of routinely determining whether or not certain adverse events have occurred was by regular investigator assessment and regular laboratory testing.
|
0.00%
0/21 • Adverse events were collected for 2 months during this study; from start of treatment to the end-of-treatment visit (Day 29) and 30 days after end-of-treatment visit.
Method of routinely determining whether or not certain adverse events have occurred was by regular investigator assessment and regular laboratory testing.
|
5.6%
1/18 • Adverse events were collected for 2 months during this study; from start of treatment to the end-of-treatment visit (Day 29) and 30 days after end-of-treatment visit.
Method of routinely determining whether or not certain adverse events have occurred was by regular investigator assessment and regular laboratory testing.
|
0.00%
0/19 • Adverse events were collected for 2 months during this study; from start of treatment to the end-of-treatment visit (Day 29) and 30 days after end-of-treatment visit.
Method of routinely determining whether or not certain adverse events have occurred was by regular investigator assessment and regular laboratory testing.
|
|
General disorders
Chest Pain
|
0.00%
0/22 • Adverse events were collected for 2 months during this study; from start of treatment to the end-of-treatment visit (Day 29) and 30 days after end-of-treatment visit.
Method of routinely determining whether or not certain adverse events have occurred was by regular investigator assessment and regular laboratory testing.
|
0.00%
0/20 • Adverse events were collected for 2 months during this study; from start of treatment to the end-of-treatment visit (Day 29) and 30 days after end-of-treatment visit.
Method of routinely determining whether or not certain adverse events have occurred was by regular investigator assessment and regular laboratory testing.
|
0.00%
0/21 • Adverse events were collected for 2 months during this study; from start of treatment to the end-of-treatment visit (Day 29) and 30 days after end-of-treatment visit.
Method of routinely determining whether or not certain adverse events have occurred was by regular investigator assessment and regular laboratory testing.
|
5.6%
1/18 • Adverse events were collected for 2 months during this study; from start of treatment to the end-of-treatment visit (Day 29) and 30 days after end-of-treatment visit.
Method of routinely determining whether or not certain adverse events have occurred was by regular investigator assessment and regular laboratory testing.
|
0.00%
0/19 • Adverse events were collected for 2 months during this study; from start of treatment to the end-of-treatment visit (Day 29) and 30 days after end-of-treatment visit.
Method of routinely determining whether or not certain adverse events have occurred was by regular investigator assessment and regular laboratory testing.
|
|
Infections and infestations
Bronchitis
|
4.5%
1/22 • Adverse events were collected for 2 months during this study; from start of treatment to the end-of-treatment visit (Day 29) and 30 days after end-of-treatment visit.
Method of routinely determining whether or not certain adverse events have occurred was by regular investigator assessment and regular laboratory testing.
|
5.0%
1/20 • Adverse events were collected for 2 months during this study; from start of treatment to the end-of-treatment visit (Day 29) and 30 days after end-of-treatment visit.
Method of routinely determining whether or not certain adverse events have occurred was by regular investigator assessment and regular laboratory testing.
|
0.00%
0/21 • Adverse events were collected for 2 months during this study; from start of treatment to the end-of-treatment visit (Day 29) and 30 days after end-of-treatment visit.
Method of routinely determining whether or not certain adverse events have occurred was by regular investigator assessment and regular laboratory testing.
|
5.6%
1/18 • Adverse events were collected for 2 months during this study; from start of treatment to the end-of-treatment visit (Day 29) and 30 days after end-of-treatment visit.
Method of routinely determining whether or not certain adverse events have occurred was by regular investigator assessment and regular laboratory testing.
|
0.00%
0/19 • Adverse events were collected for 2 months during this study; from start of treatment to the end-of-treatment visit (Day 29) and 30 days after end-of-treatment visit.
Method of routinely determining whether or not certain adverse events have occurred was by regular investigator assessment and regular laboratory testing.
|
|
Infections and infestations
Influenza
|
9.1%
2/22 • Adverse events were collected for 2 months during this study; from start of treatment to the end-of-treatment visit (Day 29) and 30 days after end-of-treatment visit.
Method of routinely determining whether or not certain adverse events have occurred was by regular investigator assessment and regular laboratory testing.
|
20.0%
4/20 • Adverse events were collected for 2 months during this study; from start of treatment to the end-of-treatment visit (Day 29) and 30 days after end-of-treatment visit.
Method of routinely determining whether or not certain adverse events have occurred was by regular investigator assessment and regular laboratory testing.
|
9.5%
2/21 • Adverse events were collected for 2 months during this study; from start of treatment to the end-of-treatment visit (Day 29) and 30 days after end-of-treatment visit.
Method of routinely determining whether or not certain adverse events have occurred was by regular investigator assessment and regular laboratory testing.
|
5.6%
1/18 • Adverse events were collected for 2 months during this study; from start of treatment to the end-of-treatment visit (Day 29) and 30 days after end-of-treatment visit.
Method of routinely determining whether or not certain adverse events have occurred was by regular investigator assessment and regular laboratory testing.
|
0.00%
0/19 • Adverse events were collected for 2 months during this study; from start of treatment to the end-of-treatment visit (Day 29) and 30 days after end-of-treatment visit.
Method of routinely determining whether or not certain adverse events have occurred was by regular investigator assessment and regular laboratory testing.
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/22 • Adverse events were collected for 2 months during this study; from start of treatment to the end-of-treatment visit (Day 29) and 30 days after end-of-treatment visit.
Method of routinely determining whether or not certain adverse events have occurred was by regular investigator assessment and regular laboratory testing.
|
5.0%
1/20 • Adverse events were collected for 2 months during this study; from start of treatment to the end-of-treatment visit (Day 29) and 30 days after end-of-treatment visit.
Method of routinely determining whether or not certain adverse events have occurred was by regular investigator assessment and regular laboratory testing.
|
0.00%
0/21 • Adverse events were collected for 2 months during this study; from start of treatment to the end-of-treatment visit (Day 29) and 30 days after end-of-treatment visit.
Method of routinely determining whether or not certain adverse events have occurred was by regular investigator assessment and regular laboratory testing.
|
5.6%
1/18 • Adverse events were collected for 2 months during this study; from start of treatment to the end-of-treatment visit (Day 29) and 30 days after end-of-treatment visit.
Method of routinely determining whether or not certain adverse events have occurred was by regular investigator assessment and regular laboratory testing.
|
5.3%
1/19 • Adverse events were collected for 2 months during this study; from start of treatment to the end-of-treatment visit (Day 29) and 30 days after end-of-treatment visit.
Method of routinely determining whether or not certain adverse events have occurred was by regular investigator assessment and regular laboratory testing.
|
|
Infections and infestations
Oral Herpes
|
0.00%
0/22 • Adverse events were collected for 2 months during this study; from start of treatment to the end-of-treatment visit (Day 29) and 30 days after end-of-treatment visit.
Method of routinely determining whether or not certain adverse events have occurred was by regular investigator assessment and regular laboratory testing.
|
0.00%
0/20 • Adverse events were collected for 2 months during this study; from start of treatment to the end-of-treatment visit (Day 29) and 30 days after end-of-treatment visit.
Method of routinely determining whether or not certain adverse events have occurred was by regular investigator assessment and regular laboratory testing.
|
0.00%
0/21 • Adverse events were collected for 2 months during this study; from start of treatment to the end-of-treatment visit (Day 29) and 30 days after end-of-treatment visit.
Method of routinely determining whether or not certain adverse events have occurred was by regular investigator assessment and regular laboratory testing.
|
0.00%
0/18 • Adverse events were collected for 2 months during this study; from start of treatment to the end-of-treatment visit (Day 29) and 30 days after end-of-treatment visit.
Method of routinely determining whether or not certain adverse events have occurred was by regular investigator assessment and regular laboratory testing.
|
5.3%
1/19 • Adverse events were collected for 2 months during this study; from start of treatment to the end-of-treatment visit (Day 29) and 30 days after end-of-treatment visit.
Method of routinely determining whether or not certain adverse events have occurred was by regular investigator assessment and regular laboratory testing.
|
|
Infections and infestations
Pharyngitis
|
9.1%
2/22 • Adverse events were collected for 2 months during this study; from start of treatment to the end-of-treatment visit (Day 29) and 30 days after end-of-treatment visit.
Method of routinely determining whether or not certain adverse events have occurred was by regular investigator assessment and regular laboratory testing.
|
5.0%
1/20 • Adverse events were collected for 2 months during this study; from start of treatment to the end-of-treatment visit (Day 29) and 30 days after end-of-treatment visit.
Method of routinely determining whether or not certain adverse events have occurred was by regular investigator assessment and regular laboratory testing.
|
0.00%
0/21 • Adverse events were collected for 2 months during this study; from start of treatment to the end-of-treatment visit (Day 29) and 30 days after end-of-treatment visit.
Method of routinely determining whether or not certain adverse events have occurred was by regular investigator assessment and regular laboratory testing.
|
0.00%
0/18 • Adverse events were collected for 2 months during this study; from start of treatment to the end-of-treatment visit (Day 29) and 30 days after end-of-treatment visit.
Method of routinely determining whether or not certain adverse events have occurred was by regular investigator assessment and regular laboratory testing.
|
5.3%
1/19 • Adverse events were collected for 2 months during this study; from start of treatment to the end-of-treatment visit (Day 29) and 30 days after end-of-treatment visit.
Method of routinely determining whether or not certain adverse events have occurred was by regular investigator assessment and regular laboratory testing.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/22 • Adverse events were collected for 2 months during this study; from start of treatment to the end-of-treatment visit (Day 29) and 30 days after end-of-treatment visit.
Method of routinely determining whether or not certain adverse events have occurred was by regular investigator assessment and regular laboratory testing.
|
0.00%
0/20 • Adverse events were collected for 2 months during this study; from start of treatment to the end-of-treatment visit (Day 29) and 30 days after end-of-treatment visit.
Method of routinely determining whether or not certain adverse events have occurred was by regular investigator assessment and regular laboratory testing.
|
0.00%
0/21 • Adverse events were collected for 2 months during this study; from start of treatment to the end-of-treatment visit (Day 29) and 30 days after end-of-treatment visit.
Method of routinely determining whether or not certain adverse events have occurred was by regular investigator assessment and regular laboratory testing.
|
5.6%
1/18 • Adverse events were collected for 2 months during this study; from start of treatment to the end-of-treatment visit (Day 29) and 30 days after end-of-treatment visit.
Method of routinely determining whether or not certain adverse events have occurred was by regular investigator assessment and regular laboratory testing.
|
0.00%
0/19 • Adverse events were collected for 2 months during this study; from start of treatment to the end-of-treatment visit (Day 29) and 30 days after end-of-treatment visit.
Method of routinely determining whether or not certain adverse events have occurred was by regular investigator assessment and regular laboratory testing.
|
|
Infections and infestations
Urinary Tract Infection
|
4.5%
1/22 • Adverse events were collected for 2 months during this study; from start of treatment to the end-of-treatment visit (Day 29) and 30 days after end-of-treatment visit.
Method of routinely determining whether or not certain adverse events have occurred was by regular investigator assessment and regular laboratory testing.
|
10.0%
2/20 • Adverse events were collected for 2 months during this study; from start of treatment to the end-of-treatment visit (Day 29) and 30 days after end-of-treatment visit.
Method of routinely determining whether or not certain adverse events have occurred was by regular investigator assessment and regular laboratory testing.
|
4.8%
1/21 • Adverse events were collected for 2 months during this study; from start of treatment to the end-of-treatment visit (Day 29) and 30 days after end-of-treatment visit.
Method of routinely determining whether or not certain adverse events have occurred was by regular investigator assessment and regular laboratory testing.
|
0.00%
0/18 • Adverse events were collected for 2 months during this study; from start of treatment to the end-of-treatment visit (Day 29) and 30 days after end-of-treatment visit.
Method of routinely determining whether or not certain adverse events have occurred was by regular investigator assessment and regular laboratory testing.
|
0.00%
0/19 • Adverse events were collected for 2 months during this study; from start of treatment to the end-of-treatment visit (Day 29) and 30 days after end-of-treatment visit.
Method of routinely determining whether or not certain adverse events have occurred was by regular investigator assessment and regular laboratory testing.
|
|
Injury, poisoning and procedural complications
Limb Injury
|
0.00%
0/22 • Adverse events were collected for 2 months during this study; from start of treatment to the end-of-treatment visit (Day 29) and 30 days after end-of-treatment visit.
Method of routinely determining whether or not certain adverse events have occurred was by regular investigator assessment and regular laboratory testing.
|
0.00%
0/20 • Adverse events were collected for 2 months during this study; from start of treatment to the end-of-treatment visit (Day 29) and 30 days after end-of-treatment visit.
Method of routinely determining whether or not certain adverse events have occurred was by regular investigator assessment and regular laboratory testing.
|
0.00%
0/21 • Adverse events were collected for 2 months during this study; from start of treatment to the end-of-treatment visit (Day 29) and 30 days after end-of-treatment visit.
Method of routinely determining whether or not certain adverse events have occurred was by regular investigator assessment and regular laboratory testing.
|
5.6%
1/18 • Adverse events were collected for 2 months during this study; from start of treatment to the end-of-treatment visit (Day 29) and 30 days after end-of-treatment visit.
Method of routinely determining whether or not certain adverse events have occurred was by regular investigator assessment and regular laboratory testing.
|
0.00%
0/19 • Adverse events were collected for 2 months during this study; from start of treatment to the end-of-treatment visit (Day 29) and 30 days after end-of-treatment visit.
Method of routinely determining whether or not certain adverse events have occurred was by regular investigator assessment and regular laboratory testing.
|
|
Investigations
Blood Creatine Phosphokinase Increased
|
4.5%
1/22 • Adverse events were collected for 2 months during this study; from start of treatment to the end-of-treatment visit (Day 29) and 30 days after end-of-treatment visit.
Method of routinely determining whether or not certain adverse events have occurred was by regular investigator assessment and regular laboratory testing.
|
0.00%
0/20 • Adverse events were collected for 2 months during this study; from start of treatment to the end-of-treatment visit (Day 29) and 30 days after end-of-treatment visit.
Method of routinely determining whether or not certain adverse events have occurred was by regular investigator assessment and regular laboratory testing.
|
4.8%
1/21 • Adverse events were collected for 2 months during this study; from start of treatment to the end-of-treatment visit (Day 29) and 30 days after end-of-treatment visit.
Method of routinely determining whether or not certain adverse events have occurred was by regular investigator assessment and regular laboratory testing.
|
0.00%
0/18 • Adverse events were collected for 2 months during this study; from start of treatment to the end-of-treatment visit (Day 29) and 30 days after end-of-treatment visit.
Method of routinely determining whether or not certain adverse events have occurred was by regular investigator assessment and regular laboratory testing.
|
5.3%
1/19 • Adverse events were collected for 2 months during this study; from start of treatment to the end-of-treatment visit (Day 29) and 30 days after end-of-treatment visit.
Method of routinely determining whether or not certain adverse events have occurred was by regular investigator assessment and regular laboratory testing.
|
|
Investigations
Blood Triglyerides Increased
|
0.00%
0/22 • Adverse events were collected for 2 months during this study; from start of treatment to the end-of-treatment visit (Day 29) and 30 days after end-of-treatment visit.
Method of routinely determining whether or not certain adverse events have occurred was by regular investigator assessment and regular laboratory testing.
|
0.00%
0/20 • Adverse events were collected for 2 months during this study; from start of treatment to the end-of-treatment visit (Day 29) and 30 days after end-of-treatment visit.
Method of routinely determining whether or not certain adverse events have occurred was by regular investigator assessment and regular laboratory testing.
|
0.00%
0/21 • Adverse events were collected for 2 months during this study; from start of treatment to the end-of-treatment visit (Day 29) and 30 days after end-of-treatment visit.
Method of routinely determining whether or not certain adverse events have occurred was by regular investigator assessment and regular laboratory testing.
|
0.00%
0/18 • Adverse events were collected for 2 months during this study; from start of treatment to the end-of-treatment visit (Day 29) and 30 days after end-of-treatment visit.
Method of routinely determining whether or not certain adverse events have occurred was by regular investigator assessment and regular laboratory testing.
|
5.3%
1/19 • Adverse events were collected for 2 months during this study; from start of treatment to the end-of-treatment visit (Day 29) and 30 days after end-of-treatment visit.
Method of routinely determining whether or not certain adverse events have occurred was by regular investigator assessment and regular laboratory testing.
|
|
Investigations
Gamma-Glutamyltransferase Increased
|
0.00%
0/22 • Adverse events were collected for 2 months during this study; from start of treatment to the end-of-treatment visit (Day 29) and 30 days after end-of-treatment visit.
Method of routinely determining whether or not certain adverse events have occurred was by regular investigator assessment and regular laboratory testing.
|
0.00%
0/20 • Adverse events were collected for 2 months during this study; from start of treatment to the end-of-treatment visit (Day 29) and 30 days after end-of-treatment visit.
Method of routinely determining whether or not certain adverse events have occurred was by regular investigator assessment and regular laboratory testing.
|
0.00%
0/21 • Adverse events were collected for 2 months during this study; from start of treatment to the end-of-treatment visit (Day 29) and 30 days after end-of-treatment visit.
Method of routinely determining whether or not certain adverse events have occurred was by regular investigator assessment and regular laboratory testing.
|
5.6%
1/18 • Adverse events were collected for 2 months during this study; from start of treatment to the end-of-treatment visit (Day 29) and 30 days after end-of-treatment visit.
Method of routinely determining whether or not certain adverse events have occurred was by regular investigator assessment and regular laboratory testing.
|
0.00%
0/19 • Adverse events were collected for 2 months during this study; from start of treatment to the end-of-treatment visit (Day 29) and 30 days after end-of-treatment visit.
Method of routinely determining whether or not certain adverse events have occurred was by regular investigator assessment and regular laboratory testing.
|
|
Metabolism and nutrition disorders
Hypocholesterolaemia
|
13.6%
3/22 • Adverse events were collected for 2 months during this study; from start of treatment to the end-of-treatment visit (Day 29) and 30 days after end-of-treatment visit.
Method of routinely determining whether or not certain adverse events have occurred was by regular investigator assessment and regular laboratory testing.
|
5.0%
1/20 • Adverse events were collected for 2 months during this study; from start of treatment to the end-of-treatment visit (Day 29) and 30 days after end-of-treatment visit.
Method of routinely determining whether or not certain adverse events have occurred was by regular investigator assessment and regular laboratory testing.
|
0.00%
0/21 • Adverse events were collected for 2 months during this study; from start of treatment to the end-of-treatment visit (Day 29) and 30 days after end-of-treatment visit.
Method of routinely determining whether or not certain adverse events have occurred was by regular investigator assessment and regular laboratory testing.
|
0.00%
0/18 • Adverse events were collected for 2 months during this study; from start of treatment to the end-of-treatment visit (Day 29) and 30 days after end-of-treatment visit.
Method of routinely determining whether or not certain adverse events have occurred was by regular investigator assessment and regular laboratory testing.
|
0.00%
0/19 • Adverse events were collected for 2 months during this study; from start of treatment to the end-of-treatment visit (Day 29) and 30 days after end-of-treatment visit.
Method of routinely determining whether or not certain adverse events have occurred was by regular investigator assessment and regular laboratory testing.
|
|
Metabolism and nutrition disorders
Hypertriglyceridaemia
|
4.5%
1/22 • Adverse events were collected for 2 months during this study; from start of treatment to the end-of-treatment visit (Day 29) and 30 days after end-of-treatment visit.
Method of routinely determining whether or not certain adverse events have occurred was by regular investigator assessment and regular laboratory testing.
|
5.0%
1/20 • Adverse events were collected for 2 months during this study; from start of treatment to the end-of-treatment visit (Day 29) and 30 days after end-of-treatment visit.
Method of routinely determining whether or not certain adverse events have occurred was by regular investigator assessment and regular laboratory testing.
|
4.8%
1/21 • Adverse events were collected for 2 months during this study; from start of treatment to the end-of-treatment visit (Day 29) and 30 days after end-of-treatment visit.
Method of routinely determining whether or not certain adverse events have occurred was by regular investigator assessment and regular laboratory testing.
|
5.6%
1/18 • Adverse events were collected for 2 months during this study; from start of treatment to the end-of-treatment visit (Day 29) and 30 days after end-of-treatment visit.
Method of routinely determining whether or not certain adverse events have occurred was by regular investigator assessment and regular laboratory testing.
|
0.00%
0/19 • Adverse events were collected for 2 months during this study; from start of treatment to the end-of-treatment visit (Day 29) and 30 days after end-of-treatment visit.
Method of routinely determining whether or not certain adverse events have occurred was by regular investigator assessment and regular laboratory testing.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/22 • Adverse events were collected for 2 months during this study; from start of treatment to the end-of-treatment visit (Day 29) and 30 days after end-of-treatment visit.
Method of routinely determining whether or not certain adverse events have occurred was by regular investigator assessment and regular laboratory testing.
|
0.00%
0/20 • Adverse events were collected for 2 months during this study; from start of treatment to the end-of-treatment visit (Day 29) and 30 days after end-of-treatment visit.
Method of routinely determining whether or not certain adverse events have occurred was by regular investigator assessment and regular laboratory testing.
|
0.00%
0/21 • Adverse events were collected for 2 months during this study; from start of treatment to the end-of-treatment visit (Day 29) and 30 days after end-of-treatment visit.
Method of routinely determining whether or not certain adverse events have occurred was by regular investigator assessment and regular laboratory testing.
|
5.6%
1/18 • Adverse events were collected for 2 months during this study; from start of treatment to the end-of-treatment visit (Day 29) and 30 days after end-of-treatment visit.
Method of routinely determining whether or not certain adverse events have occurred was by regular investigator assessment and regular laboratory testing.
|
0.00%
0/19 • Adverse events were collected for 2 months during this study; from start of treatment to the end-of-treatment visit (Day 29) and 30 days after end-of-treatment visit.
Method of routinely determining whether or not certain adverse events have occurred was by regular investigator assessment and regular laboratory testing.
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
0.00%
0/22 • Adverse events were collected for 2 months during this study; from start of treatment to the end-of-treatment visit (Day 29) and 30 days after end-of-treatment visit.
Method of routinely determining whether or not certain adverse events have occurred was by regular investigator assessment and regular laboratory testing.
|
0.00%
0/20 • Adverse events were collected for 2 months during this study; from start of treatment to the end-of-treatment visit (Day 29) and 30 days after end-of-treatment visit.
Method of routinely determining whether or not certain adverse events have occurred was by regular investigator assessment and regular laboratory testing.
|
4.8%
1/21 • Adverse events were collected for 2 months during this study; from start of treatment to the end-of-treatment visit (Day 29) and 30 days after end-of-treatment visit.
Method of routinely determining whether or not certain adverse events have occurred was by regular investigator assessment and regular laboratory testing.
|
5.6%
1/18 • Adverse events were collected for 2 months during this study; from start of treatment to the end-of-treatment visit (Day 29) and 30 days after end-of-treatment visit.
Method of routinely determining whether or not certain adverse events have occurred was by regular investigator assessment and regular laboratory testing.
|
0.00%
0/19 • Adverse events were collected for 2 months during this study; from start of treatment to the end-of-treatment visit (Day 29) and 30 days after end-of-treatment visit.
Method of routinely determining whether or not certain adverse events have occurred was by regular investigator assessment and regular laboratory testing.
|
|
Musculoskeletal and connective tissue disorders
Bone Pain
|
0.00%
0/22 • Adverse events were collected for 2 months during this study; from start of treatment to the end-of-treatment visit (Day 29) and 30 days after end-of-treatment visit.
Method of routinely determining whether or not certain adverse events have occurred was by regular investigator assessment and regular laboratory testing.
|
0.00%
0/20 • Adverse events were collected for 2 months during this study; from start of treatment to the end-of-treatment visit (Day 29) and 30 days after end-of-treatment visit.
Method of routinely determining whether or not certain adverse events have occurred was by regular investigator assessment and regular laboratory testing.
|
0.00%
0/21 • Adverse events were collected for 2 months during this study; from start of treatment to the end-of-treatment visit (Day 29) and 30 days after end-of-treatment visit.
Method of routinely determining whether or not certain adverse events have occurred was by regular investigator assessment and regular laboratory testing.
|
0.00%
0/18 • Adverse events were collected for 2 months during this study; from start of treatment to the end-of-treatment visit (Day 29) and 30 days after end-of-treatment visit.
Method of routinely determining whether or not certain adverse events have occurred was by regular investigator assessment and regular laboratory testing.
|
5.3%
1/19 • Adverse events were collected for 2 months during this study; from start of treatment to the end-of-treatment visit (Day 29) and 30 days after end-of-treatment visit.
Method of routinely determining whether or not certain adverse events have occurred was by regular investigator assessment and regular laboratory testing.
|
|
Musculoskeletal and connective tissue disorders
Muscle Contracture
|
0.00%
0/22 • Adverse events were collected for 2 months during this study; from start of treatment to the end-of-treatment visit (Day 29) and 30 days after end-of-treatment visit.
Method of routinely determining whether or not certain adverse events have occurred was by regular investigator assessment and regular laboratory testing.
|
0.00%
0/20 • Adverse events were collected for 2 months during this study; from start of treatment to the end-of-treatment visit (Day 29) and 30 days after end-of-treatment visit.
Method of routinely determining whether or not certain adverse events have occurred was by regular investigator assessment and regular laboratory testing.
|
0.00%
0/21 • Adverse events were collected for 2 months during this study; from start of treatment to the end-of-treatment visit (Day 29) and 30 days after end-of-treatment visit.
Method of routinely determining whether or not certain adverse events have occurred was by regular investigator assessment and regular laboratory testing.
|
5.6%
1/18 • Adverse events were collected for 2 months during this study; from start of treatment to the end-of-treatment visit (Day 29) and 30 days after end-of-treatment visit.
Method of routinely determining whether or not certain adverse events have occurred was by regular investigator assessment and regular laboratory testing.
|
0.00%
0/19 • Adverse events were collected for 2 months during this study; from start of treatment to the end-of-treatment visit (Day 29) and 30 days after end-of-treatment visit.
Method of routinely determining whether or not certain adverse events have occurred was by regular investigator assessment and regular laboratory testing.
|
|
Musculoskeletal and connective tissue disorders
Sensation of Heaviness
|
0.00%
0/22 • Adverse events were collected for 2 months during this study; from start of treatment to the end-of-treatment visit (Day 29) and 30 days after end-of-treatment visit.
Method of routinely determining whether or not certain adverse events have occurred was by regular investigator assessment and regular laboratory testing.
|
0.00%
0/20 • Adverse events were collected for 2 months during this study; from start of treatment to the end-of-treatment visit (Day 29) and 30 days after end-of-treatment visit.
Method of routinely determining whether or not certain adverse events have occurred was by regular investigator assessment and regular laboratory testing.
|
0.00%
0/21 • Adverse events were collected for 2 months during this study; from start of treatment to the end-of-treatment visit (Day 29) and 30 days after end-of-treatment visit.
Method of routinely determining whether or not certain adverse events have occurred was by regular investigator assessment and regular laboratory testing.
|
5.6%
1/18 • Adverse events were collected for 2 months during this study; from start of treatment to the end-of-treatment visit (Day 29) and 30 days after end-of-treatment visit.
Method of routinely determining whether or not certain adverse events have occurred was by regular investigator assessment and regular laboratory testing.
|
0.00%
0/19 • Adverse events were collected for 2 months during this study; from start of treatment to the end-of-treatment visit (Day 29) and 30 days after end-of-treatment visit.
Method of routinely determining whether or not certain adverse events have occurred was by regular investigator assessment and regular laboratory testing.
|
|
Nervous system disorders
Cluster Headache
|
0.00%
0/22 • Adverse events were collected for 2 months during this study; from start of treatment to the end-of-treatment visit (Day 29) and 30 days after end-of-treatment visit.
Method of routinely determining whether or not certain adverse events have occurred was by regular investigator assessment and regular laboratory testing.
|
0.00%
0/20 • Adverse events were collected for 2 months during this study; from start of treatment to the end-of-treatment visit (Day 29) and 30 days after end-of-treatment visit.
Method of routinely determining whether or not certain adverse events have occurred was by regular investigator assessment and regular laboratory testing.
|
0.00%
0/21 • Adverse events were collected for 2 months during this study; from start of treatment to the end-of-treatment visit (Day 29) and 30 days after end-of-treatment visit.
Method of routinely determining whether or not certain adverse events have occurred was by regular investigator assessment and regular laboratory testing.
|
5.6%
1/18 • Adverse events were collected for 2 months during this study; from start of treatment to the end-of-treatment visit (Day 29) and 30 days after end-of-treatment visit.
Method of routinely determining whether or not certain adverse events have occurred was by regular investigator assessment and regular laboratory testing.
|
0.00%
0/19 • Adverse events were collected for 2 months during this study; from start of treatment to the end-of-treatment visit (Day 29) and 30 days after end-of-treatment visit.
Method of routinely determining whether or not certain adverse events have occurred was by regular investigator assessment and regular laboratory testing.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/22 • Adverse events were collected for 2 months during this study; from start of treatment to the end-of-treatment visit (Day 29) and 30 days after end-of-treatment visit.
Method of routinely determining whether or not certain adverse events have occurred was by regular investigator assessment and regular laboratory testing.
|
0.00%
0/20 • Adverse events were collected for 2 months during this study; from start of treatment to the end-of-treatment visit (Day 29) and 30 days after end-of-treatment visit.
Method of routinely determining whether or not certain adverse events have occurred was by regular investigator assessment and regular laboratory testing.
|
0.00%
0/21 • Adverse events were collected for 2 months during this study; from start of treatment to the end-of-treatment visit (Day 29) and 30 days after end-of-treatment visit.
Method of routinely determining whether or not certain adverse events have occurred was by regular investigator assessment and regular laboratory testing.
|
5.6%
1/18 • Adverse events were collected for 2 months during this study; from start of treatment to the end-of-treatment visit (Day 29) and 30 days after end-of-treatment visit.
Method of routinely determining whether or not certain adverse events have occurred was by regular investigator assessment and regular laboratory testing.
|
0.00%
0/19 • Adverse events were collected for 2 months during this study; from start of treatment to the end-of-treatment visit (Day 29) and 30 days after end-of-treatment visit.
Method of routinely determining whether or not certain adverse events have occurred was by regular investigator assessment and regular laboratory testing.
|
|
Nervous system disorders
Headache
|
18.2%
4/22 • Adverse events were collected for 2 months during this study; from start of treatment to the end-of-treatment visit (Day 29) and 30 days after end-of-treatment visit.
Method of routinely determining whether or not certain adverse events have occurred was by regular investigator assessment and regular laboratory testing.
|
10.0%
2/20 • Adverse events were collected for 2 months during this study; from start of treatment to the end-of-treatment visit (Day 29) and 30 days after end-of-treatment visit.
Method of routinely determining whether or not certain adverse events have occurred was by regular investigator assessment and regular laboratory testing.
|
9.5%
2/21 • Adverse events were collected for 2 months during this study; from start of treatment to the end-of-treatment visit (Day 29) and 30 days after end-of-treatment visit.
Method of routinely determining whether or not certain adverse events have occurred was by regular investigator assessment and regular laboratory testing.
|
11.1%
2/18 • Adverse events were collected for 2 months during this study; from start of treatment to the end-of-treatment visit (Day 29) and 30 days after end-of-treatment visit.
Method of routinely determining whether or not certain adverse events have occurred was by regular investigator assessment and regular laboratory testing.
|
10.5%
2/19 • Adverse events were collected for 2 months during this study; from start of treatment to the end-of-treatment visit (Day 29) and 30 days after end-of-treatment visit.
Method of routinely determining whether or not certain adverse events have occurred was by regular investigator assessment and regular laboratory testing.
|
|
Nervous system disorders
Sciatica
|
0.00%
0/22 • Adverse events were collected for 2 months during this study; from start of treatment to the end-of-treatment visit (Day 29) and 30 days after end-of-treatment visit.
Method of routinely determining whether or not certain adverse events have occurred was by regular investigator assessment and regular laboratory testing.
|
0.00%
0/20 • Adverse events were collected for 2 months during this study; from start of treatment to the end-of-treatment visit (Day 29) and 30 days after end-of-treatment visit.
Method of routinely determining whether or not certain adverse events have occurred was by regular investigator assessment and regular laboratory testing.
|
0.00%
0/21 • Adverse events were collected for 2 months during this study; from start of treatment to the end-of-treatment visit (Day 29) and 30 days after end-of-treatment visit.
Method of routinely determining whether or not certain adverse events have occurred was by regular investigator assessment and regular laboratory testing.
|
0.00%
0/18 • Adverse events were collected for 2 months during this study; from start of treatment to the end-of-treatment visit (Day 29) and 30 days after end-of-treatment visit.
Method of routinely determining whether or not certain adverse events have occurred was by regular investigator assessment and regular laboratory testing.
|
5.3%
1/19 • Adverse events were collected for 2 months during this study; from start of treatment to the end-of-treatment visit (Day 29) and 30 days after end-of-treatment visit.
Method of routinely determining whether or not certain adverse events have occurred was by regular investigator assessment and regular laboratory testing.
|
|
Nervous system disorders
Somnolence
|
0.00%
0/22 • Adverse events were collected for 2 months during this study; from start of treatment to the end-of-treatment visit (Day 29) and 30 days after end-of-treatment visit.
Method of routinely determining whether or not certain adverse events have occurred was by regular investigator assessment and regular laboratory testing.
|
0.00%
0/20 • Adverse events were collected for 2 months during this study; from start of treatment to the end-of-treatment visit (Day 29) and 30 days after end-of-treatment visit.
Method of routinely determining whether or not certain adverse events have occurred was by regular investigator assessment and regular laboratory testing.
|
0.00%
0/21 • Adverse events were collected for 2 months during this study; from start of treatment to the end-of-treatment visit (Day 29) and 30 days after end-of-treatment visit.
Method of routinely determining whether or not certain adverse events have occurred was by regular investigator assessment and regular laboratory testing.
|
0.00%
0/18 • Adverse events were collected for 2 months during this study; from start of treatment to the end-of-treatment visit (Day 29) and 30 days after end-of-treatment visit.
Method of routinely determining whether or not certain adverse events have occurred was by regular investigator assessment and regular laboratory testing.
|
10.5%
2/19 • Adverse events were collected for 2 months during this study; from start of treatment to the end-of-treatment visit (Day 29) and 30 days after end-of-treatment visit.
Method of routinely determining whether or not certain adverse events have occurred was by regular investigator assessment and regular laboratory testing.
|
|
Nervous system disorders
Syncope
|
0.00%
0/22 • Adverse events were collected for 2 months during this study; from start of treatment to the end-of-treatment visit (Day 29) and 30 days after end-of-treatment visit.
Method of routinely determining whether or not certain adverse events have occurred was by regular investigator assessment and regular laboratory testing.
|
0.00%
0/20 • Adverse events were collected for 2 months during this study; from start of treatment to the end-of-treatment visit (Day 29) and 30 days after end-of-treatment visit.
Method of routinely determining whether or not certain adverse events have occurred was by regular investigator assessment and regular laboratory testing.
|
0.00%
0/21 • Adverse events were collected for 2 months during this study; from start of treatment to the end-of-treatment visit (Day 29) and 30 days after end-of-treatment visit.
Method of routinely determining whether or not certain adverse events have occurred was by regular investigator assessment and regular laboratory testing.
|
0.00%
0/18 • Adverse events were collected for 2 months during this study; from start of treatment to the end-of-treatment visit (Day 29) and 30 days after end-of-treatment visit.
Method of routinely determining whether or not certain adverse events have occurred was by regular investigator assessment and regular laboratory testing.
|
5.3%
1/19 • Adverse events were collected for 2 months during this study; from start of treatment to the end-of-treatment visit (Day 29) and 30 days after end-of-treatment visit.
Method of routinely determining whether or not certain adverse events have occurred was by regular investigator assessment and regular laboratory testing.
|
|
Nervous system disorders
Trigeminal Neuralgia
|
0.00%
0/22 • Adverse events were collected for 2 months during this study; from start of treatment to the end-of-treatment visit (Day 29) and 30 days after end-of-treatment visit.
Method of routinely determining whether or not certain adverse events have occurred was by regular investigator assessment and regular laboratory testing.
|
0.00%
0/20 • Adverse events were collected for 2 months during this study; from start of treatment to the end-of-treatment visit (Day 29) and 30 days after end-of-treatment visit.
Method of routinely determining whether or not certain adverse events have occurred was by regular investigator assessment and regular laboratory testing.
|
0.00%
0/21 • Adverse events were collected for 2 months during this study; from start of treatment to the end-of-treatment visit (Day 29) and 30 days after end-of-treatment visit.
Method of routinely determining whether or not certain adverse events have occurred was by regular investigator assessment and regular laboratory testing.
|
5.6%
1/18 • Adverse events were collected for 2 months during this study; from start of treatment to the end-of-treatment visit (Day 29) and 30 days after end-of-treatment visit.
Method of routinely determining whether or not certain adverse events have occurred was by regular investigator assessment and regular laboratory testing.
|
0.00%
0/19 • Adverse events were collected for 2 months during this study; from start of treatment to the end-of-treatment visit (Day 29) and 30 days after end-of-treatment visit.
Method of routinely determining whether or not certain adverse events have occurred was by regular investigator assessment and regular laboratory testing.
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/22 • Adverse events were collected for 2 months during this study; from start of treatment to the end-of-treatment visit (Day 29) and 30 days after end-of-treatment visit.
Method of routinely determining whether or not certain adverse events have occurred was by regular investigator assessment and regular laboratory testing.
|
10.0%
2/20 • Adverse events were collected for 2 months during this study; from start of treatment to the end-of-treatment visit (Day 29) and 30 days after end-of-treatment visit.
Method of routinely determining whether or not certain adverse events have occurred was by regular investigator assessment and regular laboratory testing.
|
0.00%
0/21 • Adverse events were collected for 2 months during this study; from start of treatment to the end-of-treatment visit (Day 29) and 30 days after end-of-treatment visit.
Method of routinely determining whether or not certain adverse events have occurred was by regular investigator assessment and regular laboratory testing.
|
0.00%
0/18 • Adverse events were collected for 2 months during this study; from start of treatment to the end-of-treatment visit (Day 29) and 30 days after end-of-treatment visit.
Method of routinely determining whether or not certain adverse events have occurred was by regular investigator assessment and regular laboratory testing.
|
0.00%
0/19 • Adverse events were collected for 2 months during this study; from start of treatment to the end-of-treatment visit (Day 29) and 30 days after end-of-treatment visit.
Method of routinely determining whether or not certain adverse events have occurred was by regular investigator assessment and regular laboratory testing.
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/22 • Adverse events were collected for 2 months during this study; from start of treatment to the end-of-treatment visit (Day 29) and 30 days after end-of-treatment visit.
Method of routinely determining whether or not certain adverse events have occurred was by regular investigator assessment and regular laboratory testing.
|
0.00%
0/20 • Adverse events were collected for 2 months during this study; from start of treatment to the end-of-treatment visit (Day 29) and 30 days after end-of-treatment visit.
Method of routinely determining whether or not certain adverse events have occurred was by regular investigator assessment and regular laboratory testing.
|
0.00%
0/21 • Adverse events were collected for 2 months during this study; from start of treatment to the end-of-treatment visit (Day 29) and 30 days after end-of-treatment visit.
Method of routinely determining whether or not certain adverse events have occurred was by regular investigator assessment and regular laboratory testing.
|
5.6%
1/18 • Adverse events were collected for 2 months during this study; from start of treatment to the end-of-treatment visit (Day 29) and 30 days after end-of-treatment visit.
Method of routinely determining whether or not certain adverse events have occurred was by regular investigator assessment and regular laboratory testing.
|
0.00%
0/19 • Adverse events were collected for 2 months during this study; from start of treatment to the end-of-treatment visit (Day 29) and 30 days after end-of-treatment visit.
Method of routinely determining whether or not certain adverse events have occurred was by regular investigator assessment and regular laboratory testing.
|
|
Renal and urinary disorders
Micturition Urgency
|
0.00%
0/22 • Adverse events were collected for 2 months during this study; from start of treatment to the end-of-treatment visit (Day 29) and 30 days after end-of-treatment visit.
Method of routinely determining whether or not certain adverse events have occurred was by regular investigator assessment and regular laboratory testing.
|
0.00%
0/20 • Adverse events were collected for 2 months during this study; from start of treatment to the end-of-treatment visit (Day 29) and 30 days after end-of-treatment visit.
Method of routinely determining whether or not certain adverse events have occurred was by regular investigator assessment and regular laboratory testing.
|
0.00%
0/21 • Adverse events were collected for 2 months during this study; from start of treatment to the end-of-treatment visit (Day 29) and 30 days after end-of-treatment visit.
Method of routinely determining whether or not certain adverse events have occurred was by regular investigator assessment and regular laboratory testing.
|
0.00%
0/18 • Adverse events were collected for 2 months during this study; from start of treatment to the end-of-treatment visit (Day 29) and 30 days after end-of-treatment visit.
Method of routinely determining whether or not certain adverse events have occurred was by regular investigator assessment and regular laboratory testing.
|
5.3%
1/19 • Adverse events were collected for 2 months during this study; from start of treatment to the end-of-treatment visit (Day 29) and 30 days after end-of-treatment visit.
Method of routinely determining whether or not certain adverse events have occurred was by regular investigator assessment and regular laboratory testing.
|
|
Reproductive system and breast disorders
Vaginal Haemorrhage
|
0.00%
0/22 • Adverse events were collected for 2 months during this study; from start of treatment to the end-of-treatment visit (Day 29) and 30 days after end-of-treatment visit.
Method of routinely determining whether or not certain adverse events have occurred was by regular investigator assessment and regular laboratory testing.
|
0.00%
0/20 • Adverse events were collected for 2 months during this study; from start of treatment to the end-of-treatment visit (Day 29) and 30 days after end-of-treatment visit.
Method of routinely determining whether or not certain adverse events have occurred was by regular investigator assessment and regular laboratory testing.
|
4.8%
1/21 • Adverse events were collected for 2 months during this study; from start of treatment to the end-of-treatment visit (Day 29) and 30 days after end-of-treatment visit.
Method of routinely determining whether or not certain adverse events have occurred was by regular investigator assessment and regular laboratory testing.
|
0.00%
0/18 • Adverse events were collected for 2 months during this study; from start of treatment to the end-of-treatment visit (Day 29) and 30 days after end-of-treatment visit.
Method of routinely determining whether or not certain adverse events have occurred was by regular investigator assessment and regular laboratory testing.
|
5.3%
1/19 • Adverse events were collected for 2 months during this study; from start of treatment to the end-of-treatment visit (Day 29) and 30 days after end-of-treatment visit.
Method of routinely determining whether or not certain adverse events have occurred was by regular investigator assessment and regular laboratory testing.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/22 • Adverse events were collected for 2 months during this study; from start of treatment to the end-of-treatment visit (Day 29) and 30 days after end-of-treatment visit.
Method of routinely determining whether or not certain adverse events have occurred was by regular investigator assessment and regular laboratory testing.
|
0.00%
0/20 • Adverse events were collected for 2 months during this study; from start of treatment to the end-of-treatment visit (Day 29) and 30 days after end-of-treatment visit.
Method of routinely determining whether or not certain adverse events have occurred was by regular investigator assessment and regular laboratory testing.
|
0.00%
0/21 • Adverse events were collected for 2 months during this study; from start of treatment to the end-of-treatment visit (Day 29) and 30 days after end-of-treatment visit.
Method of routinely determining whether or not certain adverse events have occurred was by regular investigator assessment and regular laboratory testing.
|
0.00%
0/18 • Adverse events were collected for 2 months during this study; from start of treatment to the end-of-treatment visit (Day 29) and 30 days after end-of-treatment visit.
Method of routinely determining whether or not certain adverse events have occurred was by regular investigator assessment and regular laboratory testing.
|
5.3%
1/19 • Adverse events were collected for 2 months during this study; from start of treatment to the end-of-treatment visit (Day 29) and 30 days after end-of-treatment visit.
Method of routinely determining whether or not certain adverse events have occurred was by regular investigator assessment and regular laboratory testing.
|
|
Respiratory, thoracic and mediastinal disorders
Productive Cough
|
0.00%
0/22 • Adverse events were collected for 2 months during this study; from start of treatment to the end-of-treatment visit (Day 29) and 30 days after end-of-treatment visit.
Method of routinely determining whether or not certain adverse events have occurred was by regular investigator assessment and regular laboratory testing.
|
0.00%
0/20 • Adverse events were collected for 2 months during this study; from start of treatment to the end-of-treatment visit (Day 29) and 30 days after end-of-treatment visit.
Method of routinely determining whether or not certain adverse events have occurred was by regular investigator assessment and regular laboratory testing.
|
0.00%
0/21 • Adverse events were collected for 2 months during this study; from start of treatment to the end-of-treatment visit (Day 29) and 30 days after end-of-treatment visit.
Method of routinely determining whether or not certain adverse events have occurred was by regular investigator assessment and regular laboratory testing.
|
0.00%
0/18 • Adverse events were collected for 2 months during this study; from start of treatment to the end-of-treatment visit (Day 29) and 30 days after end-of-treatment visit.
Method of routinely determining whether or not certain adverse events have occurred was by regular investigator assessment and regular laboratory testing.
|
5.3%
1/19 • Adverse events were collected for 2 months during this study; from start of treatment to the end-of-treatment visit (Day 29) and 30 days after end-of-treatment visit.
Method of routinely determining whether or not certain adverse events have occurred was by regular investigator assessment and regular laboratory testing.
|
|
Vascular disorders
Hot Flush
|
0.00%
0/22 • Adverse events were collected for 2 months during this study; from start of treatment to the end-of-treatment visit (Day 29) and 30 days after end-of-treatment visit.
Method of routinely determining whether or not certain adverse events have occurred was by regular investigator assessment and regular laboratory testing.
|
0.00%
0/20 • Adverse events were collected for 2 months during this study; from start of treatment to the end-of-treatment visit (Day 29) and 30 days after end-of-treatment visit.
Method of routinely determining whether or not certain adverse events have occurred was by regular investigator assessment and regular laboratory testing.
|
0.00%
0/21 • Adverse events were collected for 2 months during this study; from start of treatment to the end-of-treatment visit (Day 29) and 30 days after end-of-treatment visit.
Method of routinely determining whether or not certain adverse events have occurred was by regular investigator assessment and regular laboratory testing.
|
5.6%
1/18 • Adverse events were collected for 2 months during this study; from start of treatment to the end-of-treatment visit (Day 29) and 30 days after end-of-treatment visit.
Method of routinely determining whether or not certain adverse events have occurred was by regular investigator assessment and regular laboratory testing.
|
0.00%
0/19 • Adverse events were collected for 2 months during this study; from start of treatment to the end-of-treatment visit (Day 29) and 30 days after end-of-treatment visit.
Method of routinely determining whether or not certain adverse events have occurred was by regular investigator assessment and regular laboratory testing.
|
|
Vascular disorders
Hypertension
|
0.00%
0/22 • Adverse events were collected for 2 months during this study; from start of treatment to the end-of-treatment visit (Day 29) and 30 days after end-of-treatment visit.
Method of routinely determining whether or not certain adverse events have occurred was by regular investigator assessment and regular laboratory testing.
|
0.00%
0/20 • Adverse events were collected for 2 months during this study; from start of treatment to the end-of-treatment visit (Day 29) and 30 days after end-of-treatment visit.
Method of routinely determining whether or not certain adverse events have occurred was by regular investigator assessment and regular laboratory testing.
|
4.8%
1/21 • Adverse events were collected for 2 months during this study; from start of treatment to the end-of-treatment visit (Day 29) and 30 days after end-of-treatment visit.
Method of routinely determining whether or not certain adverse events have occurred was by regular investigator assessment and regular laboratory testing.
|
5.6%
1/18 • Adverse events were collected for 2 months during this study; from start of treatment to the end-of-treatment visit (Day 29) and 30 days after end-of-treatment visit.
Method of routinely determining whether or not certain adverse events have occurred was by regular investigator assessment and regular laboratory testing.
|
10.5%
2/19 • Adverse events were collected for 2 months during this study; from start of treatment to the end-of-treatment visit (Day 29) and 30 days after end-of-treatment visit.
Method of routinely determining whether or not certain adverse events have occurred was by regular investigator assessment and regular laboratory testing.
|
|
Vascular disorders
Hypotension
|
0.00%
0/22 • Adverse events were collected for 2 months during this study; from start of treatment to the end-of-treatment visit (Day 29) and 30 days after end-of-treatment visit.
Method of routinely determining whether or not certain adverse events have occurred was by regular investigator assessment and regular laboratory testing.
|
0.00%
0/20 • Adverse events were collected for 2 months during this study; from start of treatment to the end-of-treatment visit (Day 29) and 30 days after end-of-treatment visit.
Method of routinely determining whether or not certain adverse events have occurred was by regular investigator assessment and regular laboratory testing.
|
4.8%
1/21 • Adverse events were collected for 2 months during this study; from start of treatment to the end-of-treatment visit (Day 29) and 30 days after end-of-treatment visit.
Method of routinely determining whether or not certain adverse events have occurred was by regular investigator assessment and regular laboratory testing.
|
0.00%
0/18 • Adverse events were collected for 2 months during this study; from start of treatment to the end-of-treatment visit (Day 29) and 30 days after end-of-treatment visit.
Method of routinely determining whether or not certain adverse events have occurred was by regular investigator assessment and regular laboratory testing.
|
5.3%
1/19 • Adverse events were collected for 2 months during this study; from start of treatment to the end-of-treatment visit (Day 29) and 30 days after end-of-treatment visit.
Method of routinely determining whether or not certain adverse events have occurred was by regular investigator assessment and regular laboratory testing.
|
|
Vascular disorders
Varicose Vein
|
0.00%
0/22 • Adverse events were collected for 2 months during this study; from start of treatment to the end-of-treatment visit (Day 29) and 30 days after end-of-treatment visit.
Method of routinely determining whether or not certain adverse events have occurred was by regular investigator assessment and regular laboratory testing.
|
0.00%
0/20 • Adverse events were collected for 2 months during this study; from start of treatment to the end-of-treatment visit (Day 29) and 30 days after end-of-treatment visit.
Method of routinely determining whether or not certain adverse events have occurred was by regular investigator assessment and regular laboratory testing.
|
0.00%
0/21 • Adverse events were collected for 2 months during this study; from start of treatment to the end-of-treatment visit (Day 29) and 30 days after end-of-treatment visit.
Method of routinely determining whether or not certain adverse events have occurred was by regular investigator assessment and regular laboratory testing.
|
5.6%
1/18 • Adverse events were collected for 2 months during this study; from start of treatment to the end-of-treatment visit (Day 29) and 30 days after end-of-treatment visit.
Method of routinely determining whether or not certain adverse events have occurred was by regular investigator assessment and regular laboratory testing.
|
0.00%
0/19 • Adverse events were collected for 2 months during this study; from start of treatment to the end-of-treatment visit (Day 29) and 30 days after end-of-treatment visit.
Method of routinely determining whether or not certain adverse events have occurred was by regular investigator assessment and regular laboratory testing.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Results may not be published prior to Study Report completion. Subsequent to formation of a Publications Committee, Investigators may publish results, providing a manuscript to Sponsor =/\> 30 days prior to its submission. Sponsor will provide manuscript to Investigators =/\> 30 days prior to its submission. Investigator will comply with Sponsor's policy, withholding publication for another 60 days to permit Sponsor to obtain patent or other proprietary rights protection, if deemed necessary.
- Publication restrictions are in place
Restriction type: OTHER