Trial Outcomes & Findings for Clinical Trial of Safety and Efficacy of Various Dosage Schedules for Dietressa Drug in Treatment of Obese Patients (NCT NCT01535014)
NCT ID: NCT01535014
Last Updated: 2018-11-28
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
493 participants
Primary outcome timeframe
assessed after 24 weeks of treatment
Results posted on
2018-11-28
Participant Flow
Participant milestones
| Measure |
Dietressa 1
Dietressa: 1 tablet 6 times daily
|
Dietressa 2
Dietressa: 2 tablets 3 times daily
|
Placebo 3
Placebo: 1 tablet 6 times daily
|
Placebo 4
Placebo: 2 tablets 3 times daily
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
210
|
200
|
50
|
33
|
|
Overall Study
COMPLETED
|
208
|
194
|
49
|
33
|
|
Overall Study
NOT COMPLETED
|
2
|
6
|
1
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Clinical Trial of Safety and Efficacy of Various Dosage Schedules for Dietressa Drug in Treatment of Obese Patients
Baseline characteristics by cohort
| Measure |
Dietressa 1
n=208 Participants
Dietressa: 1 tablet 6 times daily
|
Dietressa 2
n=194 Participants
Dietressa: 2 tablets 3 times daily
|
Placebo 3
n=49 Participants
Placebo: 1 tablet 6 times daily
|
Placebo 4
n=33 Participants
Placebo: 2 tablets 3 times daily
|
Total
n=484 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
41.2 years
STANDARD_DEVIATION 12.1 • n=99 Participants
|
42.4 years
STANDARD_DEVIATION 12.1 • n=107 Participants
|
41.4 years
STANDARD_DEVIATION 10.3 • n=206 Participants
|
42.8 years
STANDARD_DEVIATION 11.3 • n=7 Participants
|
41.9 years
STANDARD_DEVIATION 11.8 • n=31 Participants
|
|
Sex: Female, Male
Female
|
181 Participants
n=99 Participants
|
167 Participants
n=107 Participants
|
44 Participants
n=206 Participants
|
30 Participants
n=7 Participants
|
422 Participants
n=31 Participants
|
|
Sex: Female, Male
Male
|
27 Participants
n=99 Participants
|
27 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
3 Participants
n=7 Participants
|
62 Participants
n=31 Participants
|
|
Height
|
166.4 centimeter
STANDARD_DEVIATION 8.3 • n=99 Participants
|
165.1 centimeter
STANDARD_DEVIATION 7.9 • n=107 Participants
|
164.4 centimeter
STANDARD_DEVIATION 6.7 • n=206 Participants
|
164.9 centimeter
STANDARD_DEVIATION 7.8 • n=7 Participants
|
165.6 centimeter
STANDARD_DEVIATION 8.0 • n=31 Participants
|
|
Weight
|
89.1 kilogram
STANDARD_DEVIATION 10.6 • n=99 Participants
|
87.5 kilogram
STANDARD_DEVIATION 9.5 • n=107 Participants
|
87.1 kilogram
STANDARD_DEVIATION 7.7 • n=206 Participants
|
86.1 kilogram
STANDARD_DEVIATION 9.8 • n=7 Participants
|
88.1 kilogram
STANDARD_DEVIATION 9.9 • n=31 Participants
|
|
BMI
|
32.1 kilogram/m^2
STANDARD_DEVIATION 1.4 • n=99 Participants
|
32.0 kilogram/m^2
STANDARD_DEVIATION 1.5 • n=107 Participants
|
32.2 kilogram/m^2
STANDARD_DEVIATION 1.5 • n=206 Participants
|
31.6 kilogram/m^2
STANDARD_DEVIATION 1.3 • n=7 Participants
|
32.0 kilogram/m^2
STANDARD_DEVIATION 1.4 • n=31 Participants
|
PRIMARY outcome
Timeframe: assessed after 24 weeks of treatmentPopulation: Intention to treat
Outcome measures
| Measure |
Dietressa 1
n=208 Participants
Dietressa: 1 tablet 6 times daily
|
Dietressa 2
n=194 Participants
Dietressa: 2 tablets 3 times daily
|
Placebo 3
n=49 Participants
Placebo: 1 tablet 6 times daily
|
Placebo 4
n=33 Participants
Placebo: 2 tablets 3 times daily
|
|---|---|---|---|---|
|
Percentage of Subjects Who Lose at Least 5 Percent of Baseline Body Weight After 24 Weeks of Treatment Weeks of Treatment
|
49 percentage of participants
|
48 percentage of participants
|
33 percentage of participants
|
21 percentage of participants
|
PRIMARY outcome
Timeframe: assessed after 24 weeks of treatmentPopulation: Intention to treat
Outcome measures
| Measure |
Dietressa 1
n=208 Participants
Dietressa: 1 tablet 6 times daily
|
Dietressa 2
n=194 Participants
Dietressa: 2 tablets 3 times daily
|
Placebo 3
n=49 Participants
Placebo: 1 tablet 6 times daily
|
Placebo 4
n=33 Participants
Placebo: 2 tablets 3 times daily
|
|---|---|---|---|---|
|
Average Body Weight Change After 24 Weeks of Treatment
|
-4.4 kilogram
Standard Deviation 4.2
|
-4.4 kilogram
Standard Deviation 4.4
|
-3.0 kilogram
Standard Deviation 3.5
|
-2.9 kilogram
Standard Deviation 2.8
|
PRIMARY outcome
Timeframe: assessed after 24 weeks of treatmentPopulation: Intention to treat
Outcome measures
| Measure |
Dietressa 1
n=208 Participants
Dietressa: 1 tablet 6 times daily
|
Dietressa 2
n=194 Participants
Dietressa: 2 tablets 3 times daily
|
Placebo 3
n=49 Participants
Placebo: 1 tablet 6 times daily
|
Placebo 4
n=33 Participants
Placebo: 2 tablets 3 times daily
|
|---|---|---|---|---|
|
Average Relative Change in Body Weight After 24 Weeks of Treatment
|
-4.9 percentage of body weight
Standard Deviation 4.7
|
-4.9 percentage of body weight
Standard Deviation 4.9
|
-3.4 percentage of body weight
Standard Deviation 4.2
|
-3.4 percentage of body weight
Standard Deviation 3.3
|
SECONDARY outcome
Timeframe: assessed after 4, 8, 12, 16, 20, and 24 weeks of treatmentPopulation: Intention to treat
Outcome measures
| Measure |
Dietressa 1
n=208 Participants
Dietressa: 1 tablet 6 times daily
|
Dietressa 2
n=194 Participants
Dietressa: 2 tablets 3 times daily
|
Placebo 3
n=49 Participants
Placebo: 1 tablet 6 times daily
|
Placebo 4
n=33 Participants
Placebo: 2 tablets 3 times daily
|
|---|---|---|---|---|
|
Percentage of Subjects With a Decrease in Body Weight by 5 or More Percent of Baseline Body Weight After 4, 8, 12, 16, 20 and 24 Weeks of Treatment
4 weeks
|
4 percentage of participants
|
5 percentage of participants
|
4 percentage of participants
|
0 percentage of participants
|
|
Percentage of Subjects With a Decrease in Body Weight by 5 or More Percent of Baseline Body Weight After 4, 8, 12, 16, 20 and 24 Weeks of Treatment
20 weeks
|
38 percentage of participants
|
42 percentage of participants
|
22 percentage of participants
|
15 percentage of participants
|
|
Percentage of Subjects With a Decrease in Body Weight by 5 or More Percent of Baseline Body Weight After 4, 8, 12, 16, 20 and 24 Weeks of Treatment
24 weeks
|
49 percentage of participants
|
48 percentage of participants
|
33 percentage of participants
|
21 percentage of participants
|
|
Percentage of Subjects With a Decrease in Body Weight by 5 or More Percent of Baseline Body Weight After 4, 8, 12, 16, 20 and 24 Weeks of Treatment
8 weeks
|
17 percentage of participants
|
16 percentage of participants
|
8 percentage of participants
|
3 percentage of participants
|
|
Percentage of Subjects With a Decrease in Body Weight by 5 or More Percent of Baseline Body Weight After 4, 8, 12, 16, 20 and 24 Weeks of Treatment
12 weeks
|
26 percentage of participants
|
24 percentage of participants
|
12 percentage of participants
|
15 percentage of participants
|
|
Percentage of Subjects With a Decrease in Body Weight by 5 or More Percent of Baseline Body Weight After 4, 8, 12, 16, 20 and 24 Weeks of Treatment
16 weeks
|
34 percentage of participants
|
36 percentage of participants
|
16 percentage of participants
|
18 percentage of participants
|
SECONDARY outcome
Timeframe: assessed after 4, 8, 12, 16, 20 and 24 weeks of treatmentPopulation: Intention to treat
Outcome measures
| Measure |
Dietressa 1
n=208 Participants
Dietressa: 1 tablet 6 times daily
|
Dietressa 2
n=194 Participants
Dietressa: 2 tablets 3 times daily
|
Placebo 3
n=49 Participants
Placebo: 1 tablet 6 times daily
|
Placebo 4
n=33 Participants
Placebo: 2 tablets 3 times daily
|
|---|---|---|---|---|
|
Average Relative Weight Change After 4, 8, 12, 16, 20 and 24 Weeks of Treatment
4 weeks
|
-1.5 percentage of body weight
Standard Deviation 1.8
|
-1.4 percentage of body weight
Standard Deviation 2.1
|
-0.8 percentage of body weight
Standard Deviation 2.1
|
-0.8 percentage of body weight
Standard Deviation 1.4
|
|
Average Relative Weight Change After 4, 8, 12, 16, 20 and 24 Weeks of Treatment
8 weeks
|
-2.5 percentage of body weight
Standard Deviation 2.6
|
-2.5 percentage of body weight
Standard Deviation 2.7
|
-1.3 percentage of body weight
Standard Deviation 3.8
|
-1.5 percentage of body weight
Standard Deviation 1.9
|
|
Average Relative Weight Change After 4, 8, 12, 16, 20 and 24 Weeks of Treatment
12 weeks
|
-3.2 percentage of body weight
Standard Deviation 3.1
|
-3.3 percentage of body weight
Standard Deviation 3.4
|
-2.1 percentage of body weight
Standard Deviation 3.2
|
-2.2 percentage of body weight
Standard Deviation 2.7
|
|
Average Relative Weight Change After 4, 8, 12, 16, 20 and 24 Weeks of Treatment
16 weeks
|
-3.9 percentage of body weight
Standard Deviation 3.7
|
-4.0 percentage of body weight
Standard Deviation 3.9
|
-2.8 percentage of body weight
Standard Deviation 3.7
|
-2.6 percentage of body weight
Standard Deviation 2.8
|
|
Average Relative Weight Change After 4, 8, 12, 16, 20 and 24 Weeks of Treatment
20 weeks
|
-4.3 percentage of body weight
Standard Deviation 4.1
|
-4.5 percentage of body weight
Standard Deviation 4.4
|
-3.1 percentage of body weight
Standard Deviation 4.0
|
-2.8 percentage of body weight
Standard Deviation 3.1
|
|
Average Relative Weight Change After 4, 8, 12, 16, 20 and 24 Weeks of Treatment
24 weeks
|
-4.9 percentage of body weight
Standard Deviation 4.7
|
-4.9 percentage of body weight
Standard Deviation 4.9
|
-3.4 percentage of body weight
Standard Deviation 4.2
|
-3.4 percentage of body weight
Standard Deviation 3.3
|
SECONDARY outcome
Timeframe: assessed after 4,12 and 24 weeks of treatmentPopulation: Intention to treat
Outcome measures
| Measure |
Dietressa 1
n=208 Participants
Dietressa: 1 tablet 6 times daily
|
Dietressa 2
n=194 Participants
Dietressa: 2 tablets 3 times daily
|
Placebo 3
n=49 Participants
Placebo: 1 tablet 6 times daily
|
Placebo 4
n=33 Participants
Placebo: 2 tablets 3 times daily
|
|---|---|---|---|---|
|
Waist Hip Ratio After 4, 12 and 24 Weeks of Treatment
0 week
|
0.88 waist hip ratio
Standard Deviation 0.08
|
0.89 waist hip ratio
Standard Deviation 0.09
|
0.89 waist hip ratio
Standard Deviation 0.07
|
0.86 waist hip ratio
Standard Deviation 0.08
|
|
Waist Hip Ratio After 4, 12 and 24 Weeks of Treatment
4 weeks
|
0.88 waist hip ratio
Standard Deviation 0.08
|
0.89 waist hip ratio
Standard Deviation 0.09
|
0.88 waist hip ratio
Standard Deviation 0.08
|
0.85 waist hip ratio
Standard Deviation 0.08
|
|
Waist Hip Ratio After 4, 12 and 24 Weeks of Treatment
12 weeks
|
0.88 waist hip ratio
Standard Deviation 0.08
|
0.88 waist hip ratio
Standard Deviation 0.09
|
0.87 waist hip ratio
Standard Deviation 0.08
|
0.85 waist hip ratio
Standard Deviation 0.08
|
|
Waist Hip Ratio After 4, 12 and 24 Weeks of Treatment
24 weeks
|
0.87 waist hip ratio
Standard Deviation 0.08
|
0.88 waist hip ratio
Standard Deviation 0.09
|
0.87 waist hip ratio
Standard Deviation 0.08
|
0.85 waist hip ratio
Standard Deviation 0.08
|
SECONDARY outcome
Timeframe: baseline, 4, 12 and 24 weeksPopulation: Intention to treat
36 items of the questionnaire are grouped into eight subscales. The subscales are grouped in two scales: the "physical component of health" and "mental health component". The scores of each scale range between 0 and 100: the higher the score, the better the quality of life and the better the patient's health. The instruction is not given completely because of the large volume. For more information, see: Ware J.E., Snow K.K., Kosinski M., Gandek B. SF-36 Health Survey. Manual and interpretation guide //The Health Institute, New England Medical Center. Boston, Mass.-1993. In this instruction is explained how eight subscales are combined to compute a total score.
Outcome measures
| Measure |
Dietressa 1
n=208 Participants
Dietressa: 1 tablet 6 times daily
|
Dietressa 2
n=194 Participants
Dietressa: 2 tablets 3 times daily
|
Placebo 3
n=49 Participants
Placebo: 1 tablet 6 times daily
|
Placebo 4
n=33 Participants
Placebo: 2 tablets 3 times daily
|
|---|---|---|---|---|
|
Change in the Quality of Life According to the Data of SF-36 Health Status Survey Questionnaire (SF-36) After 4, 12 and 24 Weeks of Treatment
12 weeks (mental)
|
46.5 scores on a scale
Standard Deviation 9.3
|
46.6 scores on a scale
Standard Deviation 10.2
|
49.3 scores on a scale
Standard Deviation 6.3
|
49.0 scores on a scale
Standard Deviation 8.6
|
|
Change in the Quality of Life According to the Data of SF-36 Health Status Survey Questionnaire (SF-36) After 4, 12 and 24 Weeks of Treatment
0 week (mental)
|
43.7 scores on a scale
Standard Deviation 9.5
|
43.4 scores on a scale
Standard Deviation 10.4
|
44.3 scores on a scale
Standard Deviation 9.5
|
47.5 scores on a scale
Standard Deviation 7.3
|
|
Change in the Quality of Life According to the Data of SF-36 Health Status Survey Questionnaire (SF-36) After 4, 12 and 24 Weeks of Treatment
4 weeks (mental)
|
46.4 scores on a scale
Standard Deviation 9.3
|
46.1 scores on a scale
Standard Deviation 9.8
|
49.0 scores on a scale
Standard Deviation 9.1
|
49.5 scores on a scale
Standard Deviation 8.0
|
|
Change in the Quality of Life According to the Data of SF-36 Health Status Survey Questionnaire (SF-36) After 4, 12 and 24 Weeks of Treatment
24 weeks (mental)
|
48.3 scores on a scale
Standard Deviation 8.7
|
47.5 scores on a scale
Standard Deviation 9.2
|
50.6 scores on a scale
Standard Deviation 7.0
|
50.0 scores on a scale
Standard Deviation 8.6
|
|
Change in the Quality of Life According to the Data of SF-36 Health Status Survey Questionnaire (SF-36) After 4, 12 and 24 Weeks of Treatment
24 weeks (physical)
|
52.4 scores on a scale
Standard Deviation 6.5
|
51.3 scores on a scale
Standard Deviation 6.9
|
51.7 scores on a scale
Standard Deviation 6.2
|
52.3 scores on a scale
Standard Deviation 6.2
|
|
Change in the Quality of Life According to the Data of SF-36 Health Status Survey Questionnaire (SF-36) After 4, 12 and 24 Weeks of Treatment
0 week (physical)
|
50.0 scores on a scale
Standard Deviation 7.9
|
49.5 scores on a scale
Standard Deviation 7.3
|
49.5 scores on a scale
Standard Deviation 7.3
|
50.7 scores on a scale
Standard Deviation 7.6
|
|
Change in the Quality of Life According to the Data of SF-36 Health Status Survey Questionnaire (SF-36) After 4, 12 and 24 Weeks of Treatment
4 weeks (physical)
|
51.2 scores on a scale
Standard Deviation 7.1
|
50.1 scores on a scale
Standard Deviation 6.8
|
51.0 scores on a scale
Standard Deviation 6.8
|
51.5 scores on a scale
Standard Deviation 6.9
|
|
Change in the Quality of Life According to the Data of SF-36 Health Status Survey Questionnaire (SF-36) After 4, 12 and 24 Weeks of Treatment
12 weeks (physical)
|
52.2 scores on a scale
Standard Deviation 6.4
|
50.8 scores on a scale
Standard Deviation 7.2
|
51.3 scores on a scale
Standard Deviation 5.9
|
50.7 scores on a scale
Standard Deviation 7.8
|
Adverse Events
Dietressa 1+2
Serious events: 3 serious events
Other events: 160 other events
Deaths: 0 deaths
Placebo 3+4
Serious events: 0 serious events
Other events: 33 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Dietressa 1+2
n=410 participants at risk
Dietressa 1: 1 tablet 6 times daily; Dietressa 2: 2 tablets 3 times daily
|
Placebo 3+4
n=83 participants at risk
Placebo 3: 1 tablet 6 times daily; Placebo 4: 2 tablets 3 times daily
|
|---|---|---|
|
Reproductive system and breast disorders
Uterine bleeding
|
0.24%
1/410 • Number of events 1 • Adverse/Serious adverse events were registered during 12 months of therapy and 30 days after the end of the research
Adverse/Serious adverse events were registered in patients of the Full Analysis Set (n=493, Safety Population)
|
0.00%
0/83 • Adverse/Serious adverse events were registered during 12 months of therapy and 30 days after the end of the research
Adverse/Serious adverse events were registered in patients of the Full Analysis Set (n=493, Safety Population)
|
|
Pregnancy, puerperium and perinatal conditions
Pregnancy NOS
|
0.24%
1/410 • Number of events 2 • Adverse/Serious adverse events were registered during 12 months of therapy and 30 days after the end of the research
Adverse/Serious adverse events were registered in patients of the Full Analysis Set (n=493, Safety Population)
|
0.00%
0/83 • Adverse/Serious adverse events were registered during 12 months of therapy and 30 days after the end of the research
Adverse/Serious adverse events were registered in patients of the Full Analysis Set (n=493, Safety Population)
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc sequestration
|
0.24%
1/410 • Number of events 3 • Adverse/Serious adverse events were registered during 12 months of therapy and 30 days after the end of the research
Adverse/Serious adverse events were registered in patients of the Full Analysis Set (n=493, Safety Population)
|
0.00%
0/83 • Adverse/Serious adverse events were registered during 12 months of therapy and 30 days after the end of the research
Adverse/Serious adverse events were registered in patients of the Full Analysis Set (n=493, Safety Population)
|
|
Musculoskeletal and connective tissue disorders
Vertebral osteochondrosis
|
0.24%
1/410 • Number of events 4 • Adverse/Serious adverse events were registered during 12 months of therapy and 30 days after the end of the research
Adverse/Serious adverse events were registered in patients of the Full Analysis Set (n=493, Safety Population)
|
0.00%
0/83 • Adverse/Serious adverse events were registered during 12 months of therapy and 30 days after the end of the research
Adverse/Serious adverse events were registered in patients of the Full Analysis Set (n=493, Safety Population)
|
Other adverse events
| Measure |
Dietressa 1+2
n=410 participants at risk
Dietressa 1: 1 tablet 6 times daily; Dietressa 2: 2 tablets 3 times daily
|
Placebo 3+4
n=83 participants at risk
Placebo 3: 1 tablet 6 times daily; Placebo 4: 2 tablets 3 times daily
|
|---|---|---|
|
Investigations
Erytrocytosis
|
0.00%
0/410 • Adverse/Serious adverse events were registered during 12 months of therapy and 30 days after the end of the research
Adverse/Serious adverse events were registered in patients of the Full Analysis Set (n=493, Safety Population)
|
2.4%
2/83 • Adverse/Serious adverse events were registered during 12 months of therapy and 30 days after the end of the research
Adverse/Serious adverse events were registered in patients of the Full Analysis Set (n=493, Safety Population)
|
|
Investigations
Leukocytosis
|
0.00%
0/410 • Adverse/Serious adverse events were registered during 12 months of therapy and 30 days after the end of the research
Adverse/Serious adverse events were registered in patients of the Full Analysis Set (n=493, Safety Population)
|
1.2%
1/83 • Adverse/Serious adverse events were registered during 12 months of therapy and 30 days after the end of the research
Adverse/Serious adverse events were registered in patients of the Full Analysis Set (n=493, Safety Population)
|
|
Investigations
Monocytosis
|
0.00%
0/410 • Adverse/Serious adverse events were registered during 12 months of therapy and 30 days after the end of the research
Adverse/Serious adverse events were registered in patients of the Full Analysis Set (n=493, Safety Population)
|
2.4%
2/83 • Adverse/Serious adverse events were registered during 12 months of therapy and 30 days after the end of the research
Adverse/Serious adverse events were registered in patients of the Full Analysis Set (n=493, Safety Population)
|
|
Investigations
Thrombocytopenia
|
0.00%
0/410 • Adverse/Serious adverse events were registered during 12 months of therapy and 30 days after the end of the research
Adverse/Serious adverse events were registered in patients of the Full Analysis Set (n=493, Safety Population)
|
1.2%
1/83 • Adverse/Serious adverse events were registered during 12 months of therapy and 30 days after the end of the research
Adverse/Serious adverse events were registered in patients of the Full Analysis Set (n=493, Safety Population)
|
|
Metabolism and nutrition disorders
Increased appetite
|
0.24%
1/410 • Adverse/Serious adverse events were registered during 12 months of therapy and 30 days after the end of the research
Adverse/Serious adverse events were registered in patients of the Full Analysis Set (n=493, Safety Population)
|
1.2%
1/83 • Adverse/Serious adverse events were registered during 12 months of therapy and 30 days after the end of the research
Adverse/Serious adverse events were registered in patients of the Full Analysis Set (n=493, Safety Population)
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.24%
1/410 • Adverse/Serious adverse events were registered during 12 months of therapy and 30 days after the end of the research
Adverse/Serious adverse events were registered in patients of the Full Analysis Set (n=493, Safety Population)
|
0.00%
0/83 • Adverse/Serious adverse events were registered during 12 months of therapy and 30 days after the end of the research
Adverse/Serious adverse events were registered in patients of the Full Analysis Set (n=493, Safety Population)
|
|
Metabolism and nutrition disorders
Suppressing appetite
|
0.24%
1/410 • Adverse/Serious adverse events were registered during 12 months of therapy and 30 days after the end of the research
Adverse/Serious adverse events were registered in patients of the Full Analysis Set (n=493, Safety Population)
|
0.00%
0/83 • Adverse/Serious adverse events were registered during 12 months of therapy and 30 days after the end of the research
Adverse/Serious adverse events were registered in patients of the Full Analysis Set (n=493, Safety Population)
|
|
Metabolism and nutrition disorders
Dyslipidaemia
|
1.2%
5/410 • Adverse/Serious adverse events were registered during 12 months of therapy and 30 days after the end of the research
Adverse/Serious adverse events were registered in patients of the Full Analysis Set (n=493, Safety Population)
|
1.2%
1/83 • Adverse/Serious adverse events were registered during 12 months of therapy and 30 days after the end of the research
Adverse/Serious adverse events were registered in patients of the Full Analysis Set (n=493, Safety Population)
|
|
Investigations
Suppressing appetite
|
0.24%
1/410 • Adverse/Serious adverse events were registered during 12 months of therapy and 30 days after the end of the research
Adverse/Serious adverse events were registered in patients of the Full Analysis Set (n=493, Safety Population)
|
0.00%
0/83 • Adverse/Serious adverse events were registered during 12 months of therapy and 30 days after the end of the research
Adverse/Serious adverse events were registered in patients of the Full Analysis Set (n=493, Safety Population)
|
|
Metabolism and nutrition disorders
Hyperglycaemia fasting
|
0.73%
3/410 • Adverse/Serious adverse events were registered during 12 months of therapy and 30 days after the end of the research
Adverse/Serious adverse events were registered in patients of the Full Analysis Set (n=493, Safety Population)
|
0.00%
0/83 • Adverse/Serious adverse events were registered during 12 months of therapy and 30 days after the end of the research
Adverse/Serious adverse events were registered in patients of the Full Analysis Set (n=493, Safety Population)
|
|
Metabolism and nutrition disorders
Glucose intolerance
|
0.49%
2/410 • Adverse/Serious adverse events were registered during 12 months of therapy and 30 days after the end of the research
Adverse/Serious adverse events were registered in patients of the Full Analysis Set (n=493, Safety Population)
|
1.2%
1/83 • Adverse/Serious adverse events were registered during 12 months of therapy and 30 days after the end of the research
Adverse/Serious adverse events were registered in patients of the Full Analysis Set (n=493, Safety Population)
|
|
Metabolism and nutrition disorders
Hypercholesteremia
|
0.73%
3/410 • Adverse/Serious adverse events were registered during 12 months of therapy and 30 days after the end of the research
Adverse/Serious adverse events were registered in patients of the Full Analysis Set (n=493, Safety Population)
|
1.2%
1/83 • Adverse/Serious adverse events were registered during 12 months of therapy and 30 days after the end of the research
Adverse/Serious adverse events were registered in patients of the Full Analysis Set (n=493, Safety Population)
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.49%
2/410 • Adverse/Serious adverse events were registered during 12 months of therapy and 30 days after the end of the research
Adverse/Serious adverse events were registered in patients of the Full Analysis Set (n=493, Safety Population)
|
1.2%
1/83 • Adverse/Serious adverse events were registered during 12 months of therapy and 30 days after the end of the research
Adverse/Serious adverse events were registered in patients of the Full Analysis Set (n=493, Safety Population)
|
|
Metabolism and nutrition disorders
Periodic strong desire to eat something
|
0.00%
0/410 • Adverse/Serious adverse events were registered during 12 months of therapy and 30 days after the end of the research
Adverse/Serious adverse events were registered in patients of the Full Analysis Set (n=493, Safety Population)
|
1.2%
1/83 • Adverse/Serious adverse events were registered during 12 months of therapy and 30 days after the end of the research
Adverse/Serious adverse events were registered in patients of the Full Analysis Set (n=493, Safety Population)
|
|
Musculoskeletal and connective tissue disorders
Dorsopathy of a spine
|
0.49%
2/410 • Adverse/Serious adverse events were registered during 12 months of therapy and 30 days after the end of the research
Adverse/Serious adverse events were registered in patients of the Full Analysis Set (n=493, Safety Population)
|
0.00%
0/83 • Adverse/Serious adverse events were registered during 12 months of therapy and 30 days after the end of the research
Adverse/Serious adverse events were registered in patients of the Full Analysis Set (n=493, Safety Population)
|
|
Musculoskeletal and connective tissue disorders
gonarthrosis
|
0.24%
1/410 • Adverse/Serious adverse events were registered during 12 months of therapy and 30 days after the end of the research
Adverse/Serious adverse events were registered in patients of the Full Analysis Set (n=493, Safety Population)
|
0.00%
0/83 • Adverse/Serious adverse events were registered during 12 months of therapy and 30 days after the end of the research
Adverse/Serious adverse events were registered in patients of the Full Analysis Set (n=493, Safety Population)
|
|
Musculoskeletal and connective tissue disorders
Stiffness in hands
|
0.24%
1/410 • Adverse/Serious adverse events were registered during 12 months of therapy and 30 days after the end of the research
Adverse/Serious adverse events were registered in patients of the Full Analysis Set (n=493, Safety Population)
|
0.00%
0/83 • Adverse/Serious adverse events were registered during 12 months of therapy and 30 days after the end of the research
Adverse/Serious adverse events were registered in patients of the Full Analysis Set (n=493, Safety Population)
|
|
Musculoskeletal and connective tissue disorders
Lumbar osteochondrosis
|
0.24%
1/410 • Adverse/Serious adverse events were registered during 12 months of therapy and 30 days after the end of the research
Adverse/Serious adverse events were registered in patients of the Full Analysis Set (n=493, Safety Population)
|
0.00%
0/83 • Adverse/Serious adverse events were registered during 12 months of therapy and 30 days after the end of the research
Adverse/Serious adverse events were registered in patients of the Full Analysis Set (n=493, Safety Population)
|
|
Musculoskeletal and connective tissue disorders
Right shoulder joint arthritis
|
0.00%
0/410 • Adverse/Serious adverse events were registered during 12 months of therapy and 30 days after the end of the research
Adverse/Serious adverse events were registered in patients of the Full Analysis Set (n=493, Safety Population)
|
1.2%
1/83 • Adverse/Serious adverse events were registered during 12 months of therapy and 30 days after the end of the research
Adverse/Serious adverse events were registered in patients of the Full Analysis Set (n=493, Safety Population)
|
|
Musculoskeletal and connective tissue disorders
Left hip joint arthrosis
|
0.00%
0/410 • Adverse/Serious adverse events were registered during 12 months of therapy and 30 days after the end of the research
Adverse/Serious adverse events were registered in patients of the Full Analysis Set (n=493, Safety Population)
|
1.2%
1/83 • Adverse/Serious adverse events were registered during 12 months of therapy and 30 days after the end of the research
Adverse/Serious adverse events were registered in patients of the Full Analysis Set (n=493, Safety Population)
|
|
Nervous system disorders
Headache
|
0.98%
4/410 • Adverse/Serious adverse events were registered during 12 months of therapy and 30 days after the end of the research
Adverse/Serious adverse events were registered in patients of the Full Analysis Set (n=493, Safety Population)
|
1.2%
1/83 • Adverse/Serious adverse events were registered during 12 months of therapy and 30 days after the end of the research
Adverse/Serious adverse events were registered in patients of the Full Analysis Set (n=493, Safety Population)
|
|
Nervous system disorders
Unpleasant sweetish taste in a mouth
|
0.24%
1/410 • Adverse/Serious adverse events were registered during 12 months of therapy and 30 days after the end of the research
Adverse/Serious adverse events were registered in patients of the Full Analysis Set (n=493, Safety Population)
|
0.00%
0/83 • Adverse/Serious adverse events were registered during 12 months of therapy and 30 days after the end of the research
Adverse/Serious adverse events were registered in patients of the Full Analysis Set (n=493, Safety Population)
|
|
Nervous system disorders
Vertebral radiculopathy with moderate musculo-tonic and pain syndrome
|
0.00%
0/410 • Adverse/Serious adverse events were registered during 12 months of therapy and 30 days after the end of the research
Adverse/Serious adverse events were registered in patients of the Full Analysis Set (n=493, Safety Population)
|
1.2%
1/83 • Adverse/Serious adverse events were registered during 12 months of therapy and 30 days after the end of the research
Adverse/Serious adverse events were registered in patients of the Full Analysis Set (n=493, Safety Population)
|
|
Psychiatric disorders
Anxiety
|
1.2%
5/410 • Adverse/Serious adverse events were registered during 12 months of therapy and 30 days after the end of the research
Adverse/Serious adverse events were registered in patients of the Full Analysis Set (n=493, Safety Population)
|
1.2%
1/83 • Adverse/Serious adverse events were registered during 12 months of therapy and 30 days after the end of the research
Adverse/Serious adverse events were registered in patients of the Full Analysis Set (n=493, Safety Population)
|
|
Psychiatric disorders
Clinical anxiety
|
0.98%
4/410 • Adverse/Serious adverse events were registered during 12 months of therapy and 30 days after the end of the research
Adverse/Serious adverse events were registered in patients of the Full Analysis Set (n=493, Safety Population)
|
0.00%
0/83 • Adverse/Serious adverse events were registered during 12 months of therapy and 30 days after the end of the research
Adverse/Serious adverse events were registered in patients of the Full Analysis Set (n=493, Safety Population)
|
|
Psychiatric disorders
Subclinical anxiety
|
7.8%
32/410 • Adverse/Serious adverse events were registered during 12 months of therapy and 30 days after the end of the research
Adverse/Serious adverse events were registered in patients of the Full Analysis Set (n=493, Safety Population)
|
7.2%
6/83 • Adverse/Serious adverse events were registered during 12 months of therapy and 30 days after the end of the research
Adverse/Serious adverse events were registered in patients of the Full Analysis Set (n=493, Safety Population)
|
|
Psychiatric disorders
Increased anxiety on a scale HADS
|
10.2%
42/410 • Adverse/Serious adverse events were registered during 12 months of therapy and 30 days after the end of the research
Adverse/Serious adverse events were registered in patients of the Full Analysis Set (n=493, Safety Population)
|
9.6%
8/83 • Adverse/Serious adverse events were registered during 12 months of therapy and 30 days after the end of the research
Adverse/Serious adverse events were registered in patients of the Full Analysis Set (n=493, Safety Population)
|
|
Psychiatric disorders
Mood changes: a tendency towards depression, aggressiveness
|
0.24%
1/410 • Adverse/Serious adverse events were registered during 12 months of therapy and 30 days after the end of the research
Adverse/Serious adverse events were registered in patients of the Full Analysis Set (n=493, Safety Population)
|
0.00%
0/83 • Adverse/Serious adverse events were registered during 12 months of therapy and 30 days after the end of the research
Adverse/Serious adverse events were registered in patients of the Full Analysis Set (n=493, Safety Population)
|
|
Psychiatric disorders
Subclinical depression
|
4.9%
20/410 • Adverse/Serious adverse events were registered during 12 months of therapy and 30 days after the end of the research
Adverse/Serious adverse events were registered in patients of the Full Analysis Set (n=493, Safety Population)
|
2.4%
2/83 • Adverse/Serious adverse events were registered during 12 months of therapy and 30 days after the end of the research
Adverse/Serious adverse events were registered in patients of the Full Analysis Set (n=493, Safety Population)
|
|
Psychiatric disorders
Clinical depression
|
1.5%
6/410 • Adverse/Serious adverse events were registered during 12 months of therapy and 30 days after the end of the research
Adverse/Serious adverse events were registered in patients of the Full Analysis Set (n=493, Safety Population)
|
0.00%
0/83 • Adverse/Serious adverse events were registered during 12 months of therapy and 30 days after the end of the research
Adverse/Serious adverse events were registered in patients of the Full Analysis Set (n=493, Safety Population)
|
|
Psychiatric disorders
Increased depression on a scale HADS
|
8.8%
36/410 • Adverse/Serious adverse events were registered during 12 months of therapy and 30 days after the end of the research
Adverse/Serious adverse events were registered in patients of the Full Analysis Set (n=493, Safety Population)
|
4.8%
4/83 • Adverse/Serious adverse events were registered during 12 months of therapy and 30 days after the end of the research
Adverse/Serious adverse events were registered in patients of the Full Analysis Set (n=493, Safety Population)
|
|
Psychiatric disorders
Exaggeratedly mood, unreasonable euphoria
|
0.24%
1/410 • Adverse/Serious adverse events were registered during 12 months of therapy and 30 days after the end of the research
Adverse/Serious adverse events were registered in patients of the Full Analysis Set (n=493, Safety Population)
|
0.00%
0/83 • Adverse/Serious adverse events were registered during 12 months of therapy and 30 days after the end of the research
Adverse/Serious adverse events were registered in patients of the Full Analysis Set (n=493, Safety Population)
|
|
Renal and urinary disorders
Unpleasant smell of urine
|
0.24%
1/410 • Adverse/Serious adverse events were registered during 12 months of therapy and 30 days after the end of the research
Adverse/Serious adverse events were registered in patients of the Full Analysis Set (n=493, Safety Population)
|
0.00%
0/83 • Adverse/Serious adverse events were registered during 12 months of therapy and 30 days after the end of the research
Adverse/Serious adverse events were registered in patients of the Full Analysis Set (n=493, Safety Population)
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.24%
1/410 • Adverse/Serious adverse events were registered during 12 months of therapy and 30 days after the end of the research
Adverse/Serious adverse events were registered in patients of the Full Analysis Set (n=493, Safety Population)
|
0.00%
0/83 • Adverse/Serious adverse events were registered during 12 months of therapy and 30 days after the end of the research
Adverse/Serious adverse events were registered in patients of the Full Analysis Set (n=493, Safety Population)
|
|
Respiratory, thoracic and mediastinal disorders
Hoarseness and throat irritation
|
0.24%
1/410 • Adverse/Serious adverse events were registered during 12 months of therapy and 30 days after the end of the research
Adverse/Serious adverse events were registered in patients of the Full Analysis Set (n=493, Safety Population)
|
0.00%
0/83 • Adverse/Serious adverse events were registered during 12 months of therapy and 30 days after the end of the research
Adverse/Serious adverse events were registered in patients of the Full Analysis Set (n=493, Safety Population)
|
|
Skin and subcutaneous tissue disorders
Skin rash (allergic reaction)
|
0.24%
1/410 • Adverse/Serious adverse events were registered during 12 months of therapy and 30 days after the end of the research
Adverse/Serious adverse events were registered in patients of the Full Analysis Set (n=493, Safety Population)
|
0.00%
0/83 • Adverse/Serious adverse events were registered during 12 months of therapy and 30 days after the end of the research
Adverse/Serious adverse events were registered in patients of the Full Analysis Set (n=493, Safety Population)
|
|
Skin and subcutaneous tissue disorders
Increased brittleness of nails
|
0.24%
1/410 • Adverse/Serious adverse events were registered during 12 months of therapy and 30 days after the end of the research
Adverse/Serious adverse events were registered in patients of the Full Analysis Set (n=493, Safety Population)
|
1.2%
1/83 • Adverse/Serious adverse events were registered during 12 months of therapy and 30 days after the end of the research
Adverse/Serious adverse events were registered in patients of the Full Analysis Set (n=493, Safety Population)
|
|
Skin and subcutaneous tissue disorders
Atopic dermatitis
|
0.24%
1/410 • Adverse/Serious adverse events were registered during 12 months of therapy and 30 days after the end of the research
Adverse/Serious adverse events were registered in patients of the Full Analysis Set (n=493, Safety Population)
|
0.00%
0/83 • Adverse/Serious adverse events were registered during 12 months of therapy and 30 days after the end of the research
Adverse/Serious adverse events were registered in patients of the Full Analysis Set (n=493, Safety Population)
|
|
Skin and subcutaneous tissue disorders
Xerosis
|
0.00%
0/410 • Adverse/Serious adverse events were registered during 12 months of therapy and 30 days after the end of the research
Adverse/Serious adverse events were registered in patients of the Full Analysis Set (n=493, Safety Population)
|
1.2%
1/83 • Adverse/Serious adverse events were registered during 12 months of therapy and 30 days after the end of the research
Adverse/Serious adverse events were registered in patients of the Full Analysis Set (n=493, Safety Population)
|
|
Vascular disorders
Hypertensic crisis
|
0.24%
1/410 • Adverse/Serious adverse events were registered during 12 months of therapy and 30 days after the end of the research
Adverse/Serious adverse events were registered in patients of the Full Analysis Set (n=493, Safety Population)
|
0.00%
0/83 • Adverse/Serious adverse events were registered during 12 months of therapy and 30 days after the end of the research
Adverse/Serious adverse events were registered in patients of the Full Analysis Set (n=493, Safety Population)
|
|
Vascular disorders
Hypotonia
|
0.24%
1/410 • Adverse/Serious adverse events were registered during 12 months of therapy and 30 days after the end of the research
Adverse/Serious adverse events were registered in patients of the Full Analysis Set (n=493, Safety Population)
|
0.00%
0/83 • Adverse/Serious adverse events were registered during 12 months of therapy and 30 days after the end of the research
Adverse/Serious adverse events were registered in patients of the Full Analysis Set (n=493, Safety Population)
|
|
Investigations
Increase in arterial pressure
|
0.49%
2/410 • Adverse/Serious adverse events were registered during 12 months of therapy and 30 days after the end of the research
Adverse/Serious adverse events were registered in patients of the Full Analysis Set (n=493, Safety Population)
|
1.2%
1/83 • Adverse/Serious adverse events were registered during 12 months of therapy and 30 days after the end of the research
Adverse/Serious adverse events were registered in patients of the Full Analysis Set (n=493, Safety Population)
|
|
Investigations
LDL increase
|
0.24%
1/410 • Adverse/Serious adverse events were registered during 12 months of therapy and 30 days after the end of the research
Adverse/Serious adverse events were registered in patients of the Full Analysis Set (n=493, Safety Population)
|
0.00%
0/83 • Adverse/Serious adverse events were registered during 12 months of therapy and 30 days after the end of the research
Adverse/Serious adverse events were registered in patients of the Full Analysis Set (n=493, Safety Population)
|
|
Investigations
C-reactive protein increase
|
0.24%
1/410 • Adverse/Serious adverse events were registered during 12 months of therapy and 30 days after the end of the research
Adverse/Serious adverse events were registered in patients of the Full Analysis Set (n=493, Safety Population)
|
0.00%
0/83 • Adverse/Serious adverse events were registered during 12 months of therapy and 30 days after the end of the research
Adverse/Serious adverse events were registered in patients of the Full Analysis Set (n=493, Safety Population)
|
|
Investigations
Glucose level increase
|
0.73%
3/410 • Adverse/Serious adverse events were registered during 12 months of therapy and 30 days after the end of the research
Adverse/Serious adverse events were registered in patients of the Full Analysis Set (n=493, Safety Population)
|
0.00%
0/83 • Adverse/Serious adverse events were registered during 12 months of therapy and 30 days after the end of the research
Adverse/Serious adverse events were registered in patients of the Full Analysis Set (n=493, Safety Population)
|
|
Investigations
Total cholesterol increase
|
0.24%
1/410 • Adverse/Serious adverse events were registered during 12 months of therapy and 30 days after the end of the research
Adverse/Serious adverse events were registered in patients of the Full Analysis Set (n=493, Safety Population)
|
0.00%
0/83 • Adverse/Serious adverse events were registered during 12 months of therapy and 30 days after the end of the research
Adverse/Serious adverse events were registered in patients of the Full Analysis Set (n=493, Safety Population)
|
|
Investigations
HDL increase
|
0.49%
2/410 • Adverse/Serious adverse events were registered during 12 months of therapy and 30 days after the end of the research
Adverse/Serious adverse events were registered in patients of the Full Analysis Set (n=493, Safety Population)
|
1.2%
1/83 • Adverse/Serious adverse events were registered during 12 months of therapy and 30 days after the end of the research
Adverse/Serious adverse events were registered in patients of the Full Analysis Set (n=493, Safety Population)
|
|
Investigations
ALT increase
|
0.00%
0/410 • Adverse/Serious adverse events were registered during 12 months of therapy and 30 days after the end of the research
Adverse/Serious adverse events were registered in patients of the Full Analysis Set (n=493, Safety Population)
|
2.4%
2/83 • Adverse/Serious adverse events were registered during 12 months of therapy and 30 days after the end of the research
Adverse/Serious adverse events were registered in patients of the Full Analysis Set (n=493, Safety Population)
|
|
Investigations
Basophilia
|
0.00%
0/410 • Adverse/Serious adverse events were registered during 12 months of therapy and 30 days after the end of the research
Adverse/Serious adverse events were registered in patients of the Full Analysis Set (n=493, Safety Population)
|
1.2%
1/83 • Adverse/Serious adverse events were registered during 12 months of therapy and 30 days after the end of the research
Adverse/Serious adverse events were registered in patients of the Full Analysis Set (n=493, Safety Population)
|
|
Investigations
Erythrocyte sedimentation rate increase
|
0.49%
2/410 • Adverse/Serious adverse events were registered during 12 months of therapy and 30 days after the end of the research
Adverse/Serious adverse events were registered in patients of the Full Analysis Set (n=493, Safety Population)
|
2.4%
2/83 • Adverse/Serious adverse events were registered during 12 months of therapy and 30 days after the end of the research
Adverse/Serious adverse events were registered in patients of the Full Analysis Set (n=493, Safety Population)
|
|
Investigations
Lymphocytosis level increase
|
0.24%
1/410 • Adverse/Serious adverse events were registered during 12 months of therapy and 30 days after the end of the research
Adverse/Serious adverse events were registered in patients of the Full Analysis Set (n=493, Safety Population)
|
0.00%
0/83 • Adverse/Serious adverse events were registered during 12 months of therapy and 30 days after the end of the research
Adverse/Serious adverse events were registered in patients of the Full Analysis Set (n=493, Safety Population)
|
|
Blood and lymphatic system disorders
Eosinophilia
|
0.24%
1/410 • Adverse/Serious adverse events were registered during 12 months of therapy and 30 days after the end of the research
Adverse/Serious adverse events were registered in patients of the Full Analysis Set (n=493, Safety Population)
|
3.6%
3/83 • Adverse/Serious adverse events were registered during 12 months of therapy and 30 days after the end of the research
Adverse/Serious adverse events were registered in patients of the Full Analysis Set (n=493, Safety Population)
|
|
Blood and lymphatic system disorders
iron-deficient anemia
|
0.24%
1/410 • Adverse/Serious adverse events were registered during 12 months of therapy and 30 days after the end of the research
Adverse/Serious adverse events were registered in patients of the Full Analysis Set (n=493, Safety Population)
|
0.00%
0/83 • Adverse/Serious adverse events were registered during 12 months of therapy and 30 days after the end of the research
Adverse/Serious adverse events were registered in patients of the Full Analysis Set (n=493, Safety Population)
|
|
Cardiac disorders
Сoronary artery disease
|
0.24%
1/410 • Adverse/Serious adverse events were registered during 12 months of therapy and 30 days after the end of the research
Adverse/Serious adverse events were registered in patients of the Full Analysis Set (n=493, Safety Population)
|
0.00%
0/83 • Adverse/Serious adverse events were registered during 12 months of therapy and 30 days after the end of the research
Adverse/Serious adverse events were registered in patients of the Full Analysis Set (n=493, Safety Population)
|
|
Cardiac disorders
Complaints about palpitations, sweating
|
0.00%
0/410 • Adverse/Serious adverse events were registered during 12 months of therapy and 30 days after the end of the research
Adverse/Serious adverse events were registered in patients of the Full Analysis Set (n=493, Safety Population)
|
1.2%
1/83 • Adverse/Serious adverse events were registered during 12 months of therapy and 30 days after the end of the research
Adverse/Serious adverse events were registered in patients of the Full Analysis Set (n=493, Safety Population)
|
|
Endocrine disorders
Autoimmune thyroiditis. Subclinical hypothyroidism
|
0.24%
1/410 • Adverse/Serious adverse events were registered during 12 months of therapy and 30 days after the end of the research
Adverse/Serious adverse events were registered in patients of the Full Analysis Set (n=493, Safety Population)
|
0.00%
0/83 • Adverse/Serious adverse events were registered during 12 months of therapy and 30 days after the end of the research
Adverse/Serious adverse events were registered in patients of the Full Analysis Set (n=493, Safety Population)
|
|
Gastrointestinal disorders
Epigastric pain
|
0.24%
1/410 • Adverse/Serious adverse events were registered during 12 months of therapy and 30 days after the end of the research
Adverse/Serious adverse events were registered in patients of the Full Analysis Set (n=493, Safety Population)
|
0.00%
0/83 • Adverse/Serious adverse events were registered during 12 months of therapy and 30 days after the end of the research
Adverse/Serious adverse events were registered in patients of the Full Analysis Set (n=493, Safety Population)
|
|
Gastrointestinal disorders
Dentalgia
|
0.24%
1/410 • Adverse/Serious adverse events were registered during 12 months of therapy and 30 days after the end of the research
Adverse/Serious adverse events were registered in patients of the Full Analysis Set (n=493, Safety Population)
|
0.00%
0/83 • Adverse/Serious adverse events were registered during 12 months of therapy and 30 days after the end of the research
Adverse/Serious adverse events were registered in patients of the Full Analysis Set (n=493, Safety Population)
|
|
Gastrointestinal disorders
Epigastric burning
|
0.73%
3/410 • Adverse/Serious adverse events were registered during 12 months of therapy and 30 days after the end of the research
Adverse/Serious adverse events were registered in patients of the Full Analysis Set (n=493, Safety Population)
|
1.2%
1/83 • Adverse/Serious adverse events were registered during 12 months of therapy and 30 days after the end of the research
Adverse/Serious adverse events were registered in patients of the Full Analysis Set (n=493, Safety Population)
|
|
Gastrointestinal disorders
Dry mouth
|
0.24%
1/410 • Adverse/Serious adverse events were registered during 12 months of therapy and 30 days after the end of the research
Adverse/Serious adverse events were registered in patients of the Full Analysis Set (n=493, Safety Population)
|
1.2%
1/83 • Adverse/Serious adverse events were registered during 12 months of therapy and 30 days after the end of the research
Adverse/Serious adverse events were registered in patients of the Full Analysis Set (n=493, Safety Population)
|
|
Gastrointestinal disorders
Nausea
|
0.24%
1/410 • Adverse/Serious adverse events were registered during 12 months of therapy and 30 days after the end of the research
Adverse/Serious adverse events were registered in patients of the Full Analysis Set (n=493, Safety Population)
|
0.00%
0/83 • Adverse/Serious adverse events were registered during 12 months of therapy and 30 days after the end of the research
Adverse/Serious adverse events were registered in patients of the Full Analysis Set (n=493, Safety Population)
|
|
Gastrointestinal disorders
Heaviness in the right hypochondrium
|
0.24%
1/410 • Adverse/Serious adverse events were registered during 12 months of therapy and 30 days after the end of the research
Adverse/Serious adverse events were registered in patients of the Full Analysis Set (n=493, Safety Population)
|
0.00%
0/83 • Adverse/Serious adverse events were registered during 12 months of therapy and 30 days after the end of the research
Adverse/Serious adverse events were registered in patients of the Full Analysis Set (n=493, Safety Population)
|
|
Gastrointestinal disorders
Enzymatic insufficiency
|
0.24%
1/410 • Adverse/Serious adverse events were registered during 12 months of therapy and 30 days after the end of the research
Adverse/Serious adverse events were registered in patients of the Full Analysis Set (n=493, Safety Population)
|
0.00%
0/83 • Adverse/Serious adverse events were registered during 12 months of therapy and 30 days after the end of the research
Adverse/Serious adverse events were registered in patients of the Full Analysis Set (n=493, Safety Population)
|
|
Gastrointestinal disorders
Сhronic gastritis
|
0.24%
1/410 • Adverse/Serious adverse events were registered during 12 months of therapy and 30 days after the end of the research
Adverse/Serious adverse events were registered in patients of the Full Analysis Set (n=493, Safety Population)
|
0.00%
0/83 • Adverse/Serious adverse events were registered during 12 months of therapy and 30 days after the end of the research
Adverse/Serious adverse events were registered in patients of the Full Analysis Set (n=493, Safety Population)
|
|
Gastrointestinal disorders
Frequent stool up to 3 times a day
|
0.24%
1/410 • Adverse/Serious adverse events were registered during 12 months of therapy and 30 days after the end of the research
Adverse/Serious adverse events were registered in patients of the Full Analysis Set (n=493, Safety Population)
|
0.00%
0/83 • Adverse/Serious adverse events were registered during 12 months of therapy and 30 days after the end of the research
Adverse/Serious adverse events were registered in patients of the Full Analysis Set (n=493, Safety Population)
|
|
Gastrointestinal disorders
intestinal obstruction
|
0.00%
0/410 • Adverse/Serious adverse events were registered during 12 months of therapy and 30 days after the end of the research
Adverse/Serious adverse events were registered in patients of the Full Analysis Set (n=493, Safety Population)
|
1.2%
1/83 • Adverse/Serious adverse events were registered during 12 months of therapy and 30 days after the end of the research
Adverse/Serious adverse events were registered in patients of the Full Analysis Set (n=493, Safety Population)
|
|
Gastrointestinal disorders
exacerbation of chronic pancreatitis
|
0.00%
0/410 • Adverse/Serious adverse events were registered during 12 months of therapy and 30 days after the end of the research
Adverse/Serious adverse events were registered in patients of the Full Analysis Set (n=493, Safety Population)
|
1.2%
1/83 • Adverse/Serious adverse events were registered during 12 months of therapy and 30 days after the end of the research
Adverse/Serious adverse events were registered in patients of the Full Analysis Set (n=493, Safety Population)
|
|
General disorders
Pastosity of the shins
|
0.24%
1/410 • Adverse/Serious adverse events were registered during 12 months of therapy and 30 days after the end of the research
Adverse/Serious adverse events were registered in patients of the Full Analysis Set (n=493, Safety Population)
|
0.00%
0/83 • Adverse/Serious adverse events were registered during 12 months of therapy and 30 days after the end of the research
Adverse/Serious adverse events were registered in patients of the Full Analysis Set (n=493, Safety Population)
|
|
General disorders
Acroedema
|
0.24%
1/410 • Adverse/Serious adverse events were registered during 12 months of therapy and 30 days after the end of the research
Adverse/Serious adverse events were registered in patients of the Full Analysis Set (n=493, Safety Population)
|
0.00%
0/83 • Adverse/Serious adverse events were registered during 12 months of therapy and 30 days after the end of the research
Adverse/Serious adverse events were registered in patients of the Full Analysis Set (n=493, Safety Population)
|
|
General disorders
Increase of ability to work
|
0.24%
1/410 • Adverse/Serious adverse events were registered during 12 months of therapy and 30 days after the end of the research
Adverse/Serious adverse events were registered in patients of the Full Analysis Set (n=493, Safety Population)
|
0.00%
0/83 • Adverse/Serious adverse events were registered during 12 months of therapy and 30 days after the end of the research
Adverse/Serious adverse events were registered in patients of the Full Analysis Set (n=493, Safety Population)
|
|
General disorders
Thirst perception
|
0.00%
0/410 • Adverse/Serious adverse events were registered during 12 months of therapy and 30 days after the end of the research
Adverse/Serious adverse events were registered in patients of the Full Analysis Set (n=493, Safety Population)
|
1.2%
1/83 • Adverse/Serious adverse events were registered during 12 months of therapy and 30 days after the end of the research
Adverse/Serious adverse events were registered in patients of the Full Analysis Set (n=493, Safety Population)
|
|
Hepatobiliary disorders
Hepatitis
|
0.24%
1/410 • Adverse/Serious adverse events were registered during 12 months of therapy and 30 days after the end of the research
Adverse/Serious adverse events were registered in patients of the Full Analysis Set (n=493, Safety Population)
|
0.00%
0/83 • Adverse/Serious adverse events were registered during 12 months of therapy and 30 days after the end of the research
Adverse/Serious adverse events were registered in patients of the Full Analysis Set (n=493, Safety Population)
|
|
Immune system disorders
Allergic reaction
|
0.24%
1/410 • Adverse/Serious adverse events were registered during 12 months of therapy and 30 days after the end of the research
Adverse/Serious adverse events were registered in patients of the Full Analysis Set (n=493, Safety Population)
|
0.00%
0/83 • Adverse/Serious adverse events were registered during 12 months of therapy and 30 days after the end of the research
Adverse/Serious adverse events were registered in patients of the Full Analysis Set (n=493, Safety Population)
|
|
Infections and infestations
Acute respiratory viral infection
|
2.9%
12/410 • Adverse/Serious adverse events were registered during 12 months of therapy and 30 days after the end of the research
Adverse/Serious adverse events were registered in patients of the Full Analysis Set (n=493, Safety Population)
|
4.8%
4/83 • Adverse/Serious adverse events were registered during 12 months of therapy and 30 days after the end of the research
Adverse/Serious adverse events were registered in patients of the Full Analysis Set (n=493, Safety Population)
|
|
Infections and infestations
Acute respiratory disease
|
0.24%
1/410 • Adverse/Serious adverse events were registered during 12 months of therapy and 30 days after the end of the research
Adverse/Serious adverse events were registered in patients of the Full Analysis Set (n=493, Safety Population)
|
0.00%
0/83 • Adverse/Serious adverse events were registered during 12 months of therapy and 30 days after the end of the research
Adverse/Serious adverse events were registered in patients of the Full Analysis Set (n=493, Safety Population)
|
|
Infections and infestations
Acute bronchitis
|
0.98%
4/410 • Adverse/Serious adverse events were registered during 12 months of therapy and 30 days after the end of the research
Adverse/Serious adverse events were registered in patients of the Full Analysis Set (n=493, Safety Population)
|
0.00%
0/83 • Adverse/Serious adverse events were registered during 12 months of therapy and 30 days after the end of the research
Adverse/Serious adverse events were registered in patients of the Full Analysis Set (n=493, Safety Population)
|
|
Infections and infestations
Acute laryngitis
|
0.24%
1/410 • Adverse/Serious adverse events were registered during 12 months of therapy and 30 days after the end of the research
Adverse/Serious adverse events were registered in patients of the Full Analysis Set (n=493, Safety Population)
|
0.00%
0/83 • Adverse/Serious adverse events were registered during 12 months of therapy and 30 days after the end of the research
Adverse/Serious adverse events were registered in patients of the Full Analysis Set (n=493, Safety Population)
|
|
Infections and infestations
Acute rhinopharyngitis
|
0.49%
2/410 • Adverse/Serious adverse events were registered during 12 months of therapy and 30 days after the end of the research
Adverse/Serious adverse events were registered in patients of the Full Analysis Set (n=493, Safety Population)
|
2.4%
2/83 • Adverse/Serious adverse events were registered during 12 months of therapy and 30 days after the end of the research
Adverse/Serious adverse events were registered in patients of the Full Analysis Set (n=493, Safety Population)
|
|
Infections and infestations
Acute pharyngitis
|
0.24%
1/410 • Adverse/Serious adverse events were registered during 12 months of therapy and 30 days after the end of the research
Adverse/Serious adverse events were registered in patients of the Full Analysis Set (n=493, Safety Population)
|
1.2%
1/83 • Adverse/Serious adverse events were registered during 12 months of therapy and 30 days after the end of the research
Adverse/Serious adverse events were registered in patients of the Full Analysis Set (n=493, Safety Population)
|
|
Infections and infestations
Cold
|
0.49%
2/410 • Adverse/Serious adverse events were registered during 12 months of therapy and 30 days after the end of the research
Adverse/Serious adverse events were registered in patients of the Full Analysis Set (n=493, Safety Population)
|
0.00%
0/83 • Adverse/Serious adverse events were registered during 12 months of therapy and 30 days after the end of the research
Adverse/Serious adverse events were registered in patients of the Full Analysis Set (n=493, Safety Population)
|
|
Infections and infestations
Rhinitis
|
0.24%
1/410 • Adverse/Serious adverse events were registered during 12 months of therapy and 30 days after the end of the research
Adverse/Serious adverse events were registered in patients of the Full Analysis Set (n=493, Safety Population)
|
0.00%
0/83 • Adverse/Serious adverse events were registered during 12 months of therapy and 30 days after the end of the research
Adverse/Serious adverse events were registered in patients of the Full Analysis Set (n=493, Safety Population)
|
|
Injury, poisoning and procedural complications
Ligamentous injury
|
0.00%
0/410 • Adverse/Serious adverse events were registered during 12 months of therapy and 30 days after the end of the research
Adverse/Serious adverse events were registered in patients of the Full Analysis Set (n=493, Safety Population)
|
1.2%
1/83 • Adverse/Serious adverse events were registered during 12 months of therapy and 30 days after the end of the research
Adverse/Serious adverse events were registered in patients of the Full Analysis Set (n=493, Safety Population)
|
Additional Information
Michael Putilovskiy, MD, PhD, Clinical Research and Medical Information Director
Materia Medica Holding
Phone: +74952761571
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: OTHER