Trial Outcomes & Findings for Prospekta in the Treatment of Cognitive, Behavioral and Psychiatric Disorders in Patients With Vascular Dementia. (NCT NCT04552041)
NCT ID: NCT04552041
Last Updated: 2024-10-28
Results Overview
MoCA is the test for assessment of cognitive impairment. The score ranges between 0 and 30. A score of 26-30 is normal. A score less than 26 is considered as mild cognitive impairment. Higher values represent a better outcome.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
406 participants
Primary outcome timeframe
Baseline, 24 weeks
Results posted on
2024-10-28
Participant Flow
406 patients signed informed consent, of which 7 patients did not pass the screening.
Participant milestones
| Measure |
Prospekta
Two tablets per intake 2 times a day (approximately at the same time), outside of meal (between meals or 15 minutes prior to meal or drinking). The tablets should be held in mouth until completely dissolved.
Prospekta: Oral administration.
|
Placebo
Two tablets per intake 2 times a day (approximately at the same time), outside of meal (between meals or 15 minutes prior to meal or drinking). The tablets should be held in mouth until completely dissolved.
Placebo: Oral administration.
|
|---|---|---|
|
Overall Study
STARTED
|
204
|
195
|
|
Overall Study
COMPLETED
|
204
|
195
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Prospekta
n=204 Participants
Two tablets per intake 2 times a day (approximately at the same time), outside of meal (between meals or 15 minutes prior to meal or drinking). The tablets should be held in mouth until completely dissolved.
Prospekta: Oral administration.
|
Placebo
n=195 Participants
Two tablets per intake 2 times a day (approximately at the same time), outside of meal (between meals or 15 minutes prior to meal or drinking). The tablets should be held in mouth until completely dissolved.
Placebo: Oral administration.
|
Total
n=399 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=204 Participants
|
0 Participants
n=195 Participants
|
0 Participants
n=399 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
31 Participants
n=204 Participants
|
32 Participants
n=195 Participants
|
63 Participants
n=399 Participants
|
|
Age, Categorical
>=65 years
|
173 Participants
n=204 Participants
|
163 Participants
n=195 Participants
|
336 Participants
n=399 Participants
|
|
Age, Continuous
|
71.9 years
STANDARD_DEVIATION 7.0 • n=204 Participants
|
72.7 years
STANDARD_DEVIATION 6.9 • n=195 Participants
|
72.3 years
STANDARD_DEVIATION 6.9 • n=399 Participants
|
|
Sex: Female, Male
Female
|
149 Participants
n=204 Participants
|
141 Participants
n=195 Participants
|
290 Participants
n=399 Participants
|
|
Sex: Female, Male
Male
|
55 Participants
n=204 Participants
|
54 Participants
n=195 Participants
|
109 Participants
n=399 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
Russia
|
204 participants
n=204 Participants
|
195 participants
n=195 Participants
|
399 participants
n=399 Participants
|
PRIMARY outcome
Timeframe: Baseline, 24 weeksPopulation: 10 patients from Prospekta group and 7 patients from Placebo group were excluded from the trial before 24 week therefore no data was collected on 24 weeks timepoint.
MoCA is the test for assessment of cognitive impairment. The score ranges between 0 and 30. A score of 26-30 is normal. A score less than 26 is considered as mild cognitive impairment. Higher values represent a better outcome.
Outcome measures
| Measure |
Prospekta
n=204 Participants
Two tablets per intake 2 times a day (approximately at the same time), outside of meal (between meals or 15 minutes prior to meal or drinking). The tablets should be held in mouth until completely dissolved.
Prospekta: Oral administration.
|
Placebo
n=195 Participants
Two tablets per intake 2 times a day (approximately at the same time), outside of meal (between meals or 15 minutes prior to meal or drinking). The tablets should be held in mouth until completely dissolved.
Placebo: Oral administration.
|
|---|---|---|
|
Change in Mean Montreal Сognitive Assessment (MoCA) Score
Baseline
|
17.0 score on a scale
Standard Deviation 3.6
|
17.3 score on a scale
Standard Deviation 3.7
|
|
Change in Mean Montreal Сognitive Assessment (MoCA) Score
After 24 weeks
|
20.5 score on a scale
Standard Deviation 4.7
|
19.2 score on a scale
Standard Deviation 4.9
|
|
Change in Mean Montreal Сognitive Assessment (MoCA) Score
∆ between baseline and 24 weeks
|
3.3 score on a scale
Standard Deviation 3.1
|
1.9 score on a scale
Standard Deviation 3.1
|
SECONDARY outcome
Timeframe: Baseline, 24 weeksPopulation: 8 patients from Prospekta group and 6 patients from Placebo group were excluded from the trial before 24 week therefore no data was collected on 24 weeks timepoint.
NPI-C allows to evaluate severity of behavioural and mental disorders associated with dementia. The scale consists of 14 domains. Scoring for "delusional ideas" (8 items) is 0-24 points, for "hallucinations" (7 items) - 0-21, "agitation" (13 items) - 0-39, "aggression" (8 items) - 0-24, "dysphoria" (13 items) - 0-39, "anxiety" (14 items) - 0-42, "euphoria" (6 items) - 0-18, "apathy" (11 items) - 0-33, "disinhibition" (16 items) - 0-48, "irritability" (12 items) - 0-36 , "aberrant motor behaviour" (9 items) - 0-27, "sleep disorders" (8 items) - 0-24, "appetite disorders" (9 items) - 0-27, "aberrant vocalizations" (8 items) - 0-24. Each item is rated for frequency (a 4-point scale from 1 \[occasionally\] to 4 \[very frequent\]) and severity (a 3-point scale from 1 \[mild\] to 3 \[marked\]). The total NPI score is the frequency ratings multiplied by the severity ratings. Total maximum score for all domains is 426 (higher score indicates worse outcome).
Outcome measures
| Measure |
Prospekta
n=204 Participants
Two tablets per intake 2 times a day (approximately at the same time), outside of meal (between meals or 15 minutes prior to meal or drinking). The tablets should be held in mouth until completely dissolved.
Prospekta: Oral administration.
|
Placebo
n=195 Participants
Two tablets per intake 2 times a day (approximately at the same time), outside of meal (between meals or 15 minutes prior to meal or drinking). The tablets should be held in mouth until completely dissolved.
Placebo: Oral administration.
|
|---|---|---|
|
Change in Mean Neuropsychiatric Inventory-Clinician (NPI-С) Score
Baseline
|
57.0 score on a scale
Standard Deviation 26.7
|
55.5 score on a scale
Standard Deviation 25.5
|
|
Change in Mean Neuropsychiatric Inventory-Clinician (NPI-С) Score
After 24 weeks
|
39.8 score on a scale
Standard Deviation 23.6
|
42.8 score on a scale
Standard Deviation 27.6
|
|
Change in Mean Neuropsychiatric Inventory-Clinician (NPI-С) Score
∆ between baseline and 24 weeks
|
-17.1 score on a scale
Standard Deviation 15.1
|
-13.0 score on a scale
Standard Deviation 15.1
|
|
Change in Mean Neuropsychiatric Inventory-Clinician (NPI-С) Score
Domain "Delusional ideas" ∆ between baseline and 24 weeks
|
-0.2 score on a scale
Standard Deviation 0.9
|
-0.1 score on a scale
Standard Deviation 0.6
|
|
Change in Mean Neuropsychiatric Inventory-Clinician (NPI-С) Score
Domain "Hallucinations" ∆ between baseline and 24 weeks
|
-0.1 score on a scale
Standard Deviation 0.4
|
-0.0 score on a scale
Standard Deviation 0.5
|
|
Change in Mean Neuropsychiatric Inventory-Clinician (NPI-С) Score
Domain "Agitation" ∆ between baseline and 24 weeks
|
-4.2 score on a scale
Standard Deviation 3.9
|
-3.6 score on a scale
Standard Deviation 4.3
|
|
Change in Mean Neuropsychiatric Inventory-Clinician (NPI-С) Score
Domain "Aggression" ∆ between baseline and 24 weeks
|
-2.0 score on a scale
Standard Deviation 2.3
|
-1.8 score on a scale
Standard Deviation 2.3
|
|
Change in Mean Neuropsychiatric Inventory-Clinician (NPI-С) Score
Domain "Dysphoria" ∆ between baseline and 24 weeks
|
-1.7 score on a scale
Standard Deviation 3.1
|
-1.3 score on a scale
Standard Deviation 3.5
|
|
Change in Mean Neuropsychiatric Inventory-Clinician (NPI-С) Score
Domain "Anxiety" ∆ between baseline and 24 weeks
|
-2.3 score on a scale
Standard Deviation 3.8
|
-1.6 score on a scale
Standard Deviation 3.4
|
|
Change in Mean Neuropsychiatric Inventory-Clinician (NPI-С) Score
Domain "Euphoria" ∆ between baseline and 24 weeks
|
-0.1 score on a scale
Standard Deviation 0.7
|
-0.2 score on a scale
Standard Deviation 1.0
|
|
Change in Mean Neuropsychiatric Inventory-Clinician (NPI-С) Score
Domain "Apathy" ∆ between baseline and 24 weeks
|
-1.1 score on a scale
Standard Deviation 3.6
|
-0.6 score on a scale
Standard Deviation 4.0
|
|
Change in Mean Neuropsychiatric Inventory-Clinician (NPI-С) Score
Domain "Disinhibition" ∆ between baseline and 24 weeks
|
-0.5 score on a scale
Standard Deviation 2.1
|
-0.4 score on a scale
Standard Deviation 1.6
|
|
Change in Mean Neuropsychiatric Inventory-Clinician (NPI-С) Score
Domain "Irritability" ∆ between baseline and 24 weeks
|
-2.1 score on a scale
Standard Deviation 3.9
|
-1.7 score on a scale
Standard Deviation 3.2
|
|
Change in Mean Neuropsychiatric Inventory-Clinician (NPI-С) Score
Domain "Aberrant motor behaviour" ∆ between baseline and 24 weeks
|
-0.6 score on a scale
Standard Deviation 1.4
|
-0.1 score on a scale
Standard Deviation 1.2
|
|
Change in Mean Neuropsychiatric Inventory-Clinician (NPI-С) Score
Domain "Sleep disorders" ∆ between baseline and 24 weeks
|
-1.5 score on a scale
Standard Deviation 2.4
|
-1.2 score on a scale
Standard Deviation 2.4
|
|
Change in Mean Neuropsychiatric Inventory-Clinician (NPI-С) Score
Domain "Appetite disorders" ∆ between baseline and 24 weeks
|
-0.3 score on a scale
Standard Deviation 1.4
|
-0.1 score on a scale
Standard Deviation 1.1
|
|
Change in Mean Neuropsychiatric Inventory-Clinician (NPI-С) Score
Domain "Aberrant vocalizations" ∆ between baseline and 24 weeks
|
-0.3 score on a scale
Standard Deviation 0.9
|
-0.2 score on a scale
Standard Deviation 1.0
|
SECONDARY outcome
Timeframe: Baseline, 12 weeksPopulation: 8 patients from Prospekta group and 7 patients from Placebo group were excluded from the trial before 12 week therefore no data was collected on 12 weeks timepoint.
MoCA is the test for assessment of cognitive impairment. The score ranges between 0 and 30. A score of 26-30 is normal. A score less than 26 is considered as mild cognitive impairment. Higher values represent a better outcome.
Outcome measures
| Measure |
Prospekta
n=204 Participants
Two tablets per intake 2 times a day (approximately at the same time), outside of meal (between meals or 15 minutes prior to meal or drinking). The tablets should be held in mouth until completely dissolved.
Prospekta: Oral administration.
|
Placebo
n=195 Participants
Two tablets per intake 2 times a day (approximately at the same time), outside of meal (between meals or 15 minutes prior to meal or drinking). The tablets should be held in mouth until completely dissolved.
Placebo: Oral administration.
|
|---|---|---|
|
Change in Mean Montreal Сognitive Assessment (MoCA) Score
Baseline
|
17.0 score on a scale
Standard Deviation 3.6
|
17.3 score on a scale
Standard Deviation 3.7
|
|
Change in Mean Montreal Сognitive Assessment (MoCA) Score
After 12 weeks
|
19.1 score on a scale
Standard Deviation 4.1
|
18.9 score on a scale
Standard Deviation 4.2
|
|
Change in Mean Montreal Сognitive Assessment (MoCA) Score
∆ between baseline and 12 weeks
|
2.0 score on a scale
Standard Deviation 2.2
|
1.6 score on a scale
Standard Deviation 2.2
|
SECONDARY outcome
Timeframe: Baseline, 12 weeksPopulation: 7 patients from Prospekta group and 7 patients from Placebo group were excluded from the trial before 12 week therefore no data was collected on 12 weeks timepoint.
NPI-C allows to evaluate severity of behavioural and mental disorders associated with dementia. The scale consists of 14 domains. Scoring for "delusional ideas" (8 items) is 0-24 points, for "hallucinations" (7 items) - 0-21, "agitation" (13 items) - 0-39, "aggression" (8 items) - 0-24, "dysphoria" (13 items) - 0-39, "anxiety" (14 items) - 0-42, "euphoria" (6 items) - 0-18, "apathy" (11 items) - 0-33, "disinhibition" (16 items) - 0-48, "irritability" (12 items) - 0-36 , "aberrant motor behaviour" (9 items) - 0-27, "sleep disorders" (8 items) - 0-24, "appetite disorders" (9 items) - 0-27, "aberrant vocalizations" (8 items) - 0-24. Each item is rated for frequency (a 4-point scale from 1 \[occasionally\] to 4 \[very frequent\]) and severity (a 3-point scale from 1 \[mild\] to 3 \[marked\]). The total NPI score is the frequency ratings multiplied by the severity ratings. Total maximum score for all domains is 426 (higher score indicates worse outcome).
Outcome measures
| Measure |
Prospekta
n=204 Participants
Two tablets per intake 2 times a day (approximately at the same time), outside of meal (between meals or 15 minutes prior to meal or drinking). The tablets should be held in mouth until completely dissolved.
Prospekta: Oral administration.
|
Placebo
n=195 Participants
Two tablets per intake 2 times a day (approximately at the same time), outside of meal (between meals or 15 minutes prior to meal or drinking). The tablets should be held in mouth until completely dissolved.
Placebo: Oral administration.
|
|---|---|---|
|
Change in Mean Neuropsychiatric Inventory-Clinician (NPI-С) Score
Baseline
|
57.0 score on a scale
Standard Deviation 26.7
|
55.5 score on a scale
Standard Deviation 25.5
|
|
Change in Mean Neuropsychiatric Inventory-Clinician (NPI-С) Score
After 12 weeks
|
47.0 score on a scale
Standard Deviation 24.3
|
47.1 score on a scale
Standard Deviation 24.4
|
|
Change in Mean Neuropsychiatric Inventory-Clinician (NPI-С) Score
∆ between baseline and 12 weeks
|
-10.5 score on a scale
Standard Deviation 15.5
|
-8.1 score on a scale
Standard Deviation 11.8
|
SECONDARY outcome
Timeframe: After 24 weeks of the treatment.Indicators of therapeutic and side effects, efficacy index on the scale of the general clinical impression CGI-EI (Clinical Global Impression Scale - Efficacy Index) after 24 weeks from the start of study therapy. Evaluation of the response to treatment should take into account both therapeutic efficacy and treatment-related side effects. Side effects value from 1 to 4. Therapeutic effect value as 0,4,8 or 12 points. The efficacy index is a sum. The minimum value is 1, the maximum value is 16. A lower score on the scales is the best outcome.
Outcome measures
| Measure |
Prospekta
n=204 Participants
Two tablets per intake 2 times a day (approximately at the same time), outside of meal (between meals or 15 minutes prior to meal or drinking). The tablets should be held in mouth until completely dissolved.
Prospekta: Oral administration.
|
Placebo
n=195 Participants
Two tablets per intake 2 times a day (approximately at the same time), outside of meal (between meals or 15 minutes prior to meal or drinking). The tablets should be held in mouth until completely dissolved.
Placebo: Oral administration.
|
|---|---|---|
|
Mean Clinical Global Impression Efficacy Index (СGI-EI) Score
Therapeutic effect
|
2.4 score on a scale
Standard Deviation 0.9
|
2.1 score on a scale
Standard Deviation 0.8
|
|
Mean Clinical Global Impression Efficacy Index (СGI-EI) Score
Side effects
|
1.1 score on a scale
Standard Deviation 0.3
|
1.1 score on a scale
Standard Deviation 0.2
|
|
Mean Clinical Global Impression Efficacy Index (СGI-EI) Score
Efficiency Index
|
2.3 score on a scale
Standard Deviation 0.9
|
2.0 score on a scale
Standard Deviation 0.8
|
Adverse Events
Prospekta
Serious events: 6 serious events
Other events: 61 other events
Deaths: 2 deaths
Placebo
Serious events: 2 serious events
Other events: 52 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Prospekta
n=204 participants at risk
Two tablets per intake 2 times a day (approximately at the same time), outside of meal (between meals or 15 minutes prior to meal or drinking). The tablets should be held in mouth until completely dissolved.
Prospekta: Oral administration.
|
Placebo
n=195 participants at risk
Two tablets per intake 2 times a day (approximately at the same time), outside of meal (between meals or 15 minutes prior to meal or drinking). The tablets should be held in mouth until completely dissolved.
Placebo: Oral administration.
|
|---|---|---|
|
Infections and infestations
Pneumonia caused by coronavirus infection COVID-19
|
2.0%
4/204 • Number of events 4 • Registration of AEs begins after taking the first dose of the study drug, continues throughout the entire period of study therapy - 24 weeks, as well as for 24 hours after the last dose of the study drug.
|
1.0%
2/195 • Number of events 2 • Registration of AEs begins after taking the first dose of the study drug, continues throughout the entire period of study therapy - 24 weeks, as well as for 24 hours after the last dose of the study drug.
|
|
Cardiac disorders
Progressive angina
|
0.49%
1/204 • Number of events 1 • Registration of AEs begins after taking the first dose of the study drug, continues throughout the entire period of study therapy - 24 weeks, as well as for 24 hours after the last dose of the study drug.
|
0.00%
0/195 • Registration of AEs begins after taking the first dose of the study drug, continues throughout the entire period of study therapy - 24 weeks, as well as for 24 hours after the last dose of the study drug.
|
|
Nervous system disorders
Cardioembolic stroke
|
0.49%
1/204 • Number of events 1 • Registration of AEs begins after taking the first dose of the study drug, continues throughout the entire period of study therapy - 24 weeks, as well as for 24 hours after the last dose of the study drug.
|
0.00%
0/195 • Registration of AEs begins after taking the first dose of the study drug, continues throughout the entire period of study therapy - 24 weeks, as well as for 24 hours after the last dose of the study drug.
|
Other adverse events
| Measure |
Prospekta
n=204 participants at risk
Two tablets per intake 2 times a day (approximately at the same time), outside of meal (between meals or 15 minutes prior to meal or drinking). The tablets should be held in mouth until completely dissolved.
Prospekta: Oral administration.
|
Placebo
n=195 participants at risk
Two tablets per intake 2 times a day (approximately at the same time), outside of meal (between meals or 15 minutes prior to meal or drinking). The tablets should be held in mouth until completely dissolved.
Placebo: Oral administration.
|
|---|---|---|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pancreatic tumor
|
0.49%
1/204 • Number of events 1 • Registration of AEs begins after taking the first dose of the study drug, continues throughout the entire period of study therapy - 24 weeks, as well as for 24 hours after the last dose of the study drug.
|
0.00%
0/195 • Registration of AEs begins after taking the first dose of the study drug, continues throughout the entire period of study therapy - 24 weeks, as well as for 24 hours after the last dose of the study drug.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.49%
1/204 • Number of events 1 • Registration of AEs begins after taking the first dose of the study drug, continues throughout the entire period of study therapy - 24 weeks, as well as for 24 hours after the last dose of the study drug.
|
0.00%
0/195 • Registration of AEs begins after taking the first dose of the study drug, continues throughout the entire period of study therapy - 24 weeks, as well as for 24 hours after the last dose of the study drug.
|
|
Gastrointestinal disorders
Gastritis, worsening
|
0.49%
1/204 • Number of events 1 • Registration of AEs begins after taking the first dose of the study drug, continues throughout the entire period of study therapy - 24 weeks, as well as for 24 hours after the last dose of the study drug.
|
0.00%
0/195 • Registration of AEs begins after taking the first dose of the study drug, continues throughout the entire period of study therapy - 24 weeks, as well as for 24 hours after the last dose of the study drug.
|
|
Gastrointestinal disorders
Diarrhea
|
0.49%
1/204 • Number of events 1 • Registration of AEs begins after taking the first dose of the study drug, continues throughout the entire period of study therapy - 24 weeks, as well as for 24 hours after the last dose of the study drug.
|
0.51%
1/195 • Number of events 1 • Registration of AEs begins after taking the first dose of the study drug, continues throughout the entire period of study therapy - 24 weeks, as well as for 24 hours after the last dose of the study drug.
|
|
Gastrointestinal disorders
Loose stool
|
0.49%
1/204 • Number of events 1 • Registration of AEs begins after taking the first dose of the study drug, continues throughout the entire period of study therapy - 24 weeks, as well as for 24 hours after the last dose of the study drug.
|
0.00%
0/195 • Registration of AEs begins after taking the first dose of the study drug, continues throughout the entire period of study therapy - 24 weeks, as well as for 24 hours after the last dose of the study drug.
|
|
Gastrointestinal disorders
Constipation
|
0.49%
1/204 • Number of events 1 • Registration of AEs begins after taking the first dose of the study drug, continues throughout the entire period of study therapy - 24 weeks, as well as for 24 hours after the last dose of the study drug.
|
1.0%
2/195 • Number of events 2 • Registration of AEs begins after taking the first dose of the study drug, continues throughout the entire period of study therapy - 24 weeks, as well as for 24 hours after the last dose of the study drug.
|
|
Gastrointestinal disorders
Heartburn
|
0.00%
0/204 • Registration of AEs begins after taking the first dose of the study drug, continues throughout the entire period of study therapy - 24 weeks, as well as for 24 hours after the last dose of the study drug.
|
0.51%
1/195 • Number of events 1 • Registration of AEs begins after taking the first dose of the study drug, continues throughout the entire period of study therapy - 24 weeks, as well as for 24 hours after the last dose of the study drug.
|
|
Gastrointestinal disorders
Colitis
|
0.49%
1/204 • Number of events 1 • Registration of AEs begins after taking the first dose of the study drug, continues throughout the entire period of study therapy - 24 weeks, as well as for 24 hours after the last dose of the study drug.
|
0.00%
0/195 • Registration of AEs begins after taking the first dose of the study drug, continues throughout the entire period of study therapy - 24 weeks, as well as for 24 hours after the last dose of the study drug.
|
|
Gastrointestinal disorders
Flatulence
|
0.49%
1/204 • Number of events 1 • Registration of AEs begins after taking the first dose of the study drug, continues throughout the entire period of study therapy - 24 weeks, as well as for 24 hours after the last dose of the study drug.
|
0.00%
0/195 • Registration of AEs begins after taking the first dose of the study drug, continues throughout the entire period of study therapy - 24 weeks, as well as for 24 hours after the last dose of the study drug.
|
|
Gastrointestinal disorders
Vomit
|
0.49%
1/204 • Number of events 1 • Registration of AEs begins after taking the first dose of the study drug, continues throughout the entire period of study therapy - 24 weeks, as well as for 24 hours after the last dose of the study drug.
|
0.00%
0/195 • Registration of AEs begins after taking the first dose of the study drug, continues throughout the entire period of study therapy - 24 weeks, as well as for 24 hours after the last dose of the study drug.
|
|
Gastrointestinal disorders
Rectal hemorrhage
|
0.49%
1/204 • Number of events 1 • Registration of AEs begins after taking the first dose of the study drug, continues throughout the entire period of study therapy - 24 weeks, as well as for 24 hours after the last dose of the study drug.
|
0.00%
0/195 • Registration of AEs begins after taking the first dose of the study drug, continues throughout the entire period of study therapy - 24 weeks, as well as for 24 hours after the last dose of the study drug.
|
|
Gastrointestinal disorders
Dry mouth
|
0.49%
1/204 • Number of events 1 • Registration of AEs begins after taking the first dose of the study drug, continues throughout the entire period of study therapy - 24 weeks, as well as for 24 hours after the last dose of the study drug.
|
0.51%
1/195 • Number of events 1 • Registration of AEs begins after taking the first dose of the study drug, continues throughout the entire period of study therapy - 24 weeks, as well as for 24 hours after the last dose of the study drug.
|
|
Gastrointestinal disorders
Nausea
|
1.5%
3/204 • Number of events 3 • Registration of AEs begins after taking the first dose of the study drug, continues throughout the entire period of study therapy - 24 weeks, as well as for 24 hours after the last dose of the study drug.
|
0.51%
1/195 • Number of events 1 • Registration of AEs begins after taking the first dose of the study drug, continues throughout the entire period of study therapy - 24 weeks, as well as for 24 hours after the last dose of the study drug.
|
|
Gastrointestinal disorders
Chronic gastritis
|
0.00%
0/204 • Registration of AEs begins after taking the first dose of the study drug, continues throughout the entire period of study therapy - 24 weeks, as well as for 24 hours after the last dose of the study drug.
|
0.51%
1/195 • Number of events 1 • Registration of AEs begins after taking the first dose of the study drug, continues throughout the entire period of study therapy - 24 weeks, as well as for 24 hours after the last dose of the study drug.
|
|
Gastrointestinal disorders
Erosive hemorrhagic gastritis
|
0.49%
1/204 • Number of events 1 • Registration of AEs begins after taking the first dose of the study drug, continues throughout the entire period of study therapy - 24 weeks, as well as for 24 hours after the last dose of the study drug.
|
0.00%
0/195 • Registration of AEs begins after taking the first dose of the study drug, continues throughout the entire period of study therapy - 24 weeks, as well as for 24 hours after the last dose of the study drug.
|
|
Infections and infestations
Viral respiratory tract infection
|
3.4%
7/204 • Number of events 7 • Registration of AEs begins after taking the first dose of the study drug, continues throughout the entire period of study therapy - 24 weeks, as well as for 24 hours after the last dose of the study drug.
|
2.1%
4/195 • Number of events 4 • Registration of AEs begins after taking the first dose of the study drug, continues throughout the entire period of study therapy - 24 weeks, as well as for 24 hours after the last dose of the study drug.
|
|
Infections and infestations
Coronavirus infection COVID-19
|
0.49%
1/204 • Number of events 1 • Registration of AEs begins after taking the first dose of the study drug, continues throughout the entire period of study therapy - 24 weeks, as well as for 24 hours after the last dose of the study drug.
|
0.51%
1/195 • Number of events 1 • Registration of AEs begins after taking the first dose of the study drug, continues throughout the entire period of study therapy - 24 weeks, as well as for 24 hours after the last dose of the study drug.
|
|
Infections and infestations
Laboratory confirmed coronavirus infection COVID-19
|
0.00%
0/204 • Registration of AEs begins after taking the first dose of the study drug, continues throughout the entire period of study therapy - 24 weeks, as well as for 24 hours after the last dose of the study drug.
|
0.51%
1/195 • Number of events 1 • Registration of AEs begins after taking the first dose of the study drug, continues throughout the entire period of study therapy - 24 weeks, as well as for 24 hours after the last dose of the study drug.
|
|
Infections and infestations
Exacerbation of chronic bronchitis
|
0.00%
0/204 • Registration of AEs begins after taking the first dose of the study drug, continues throughout the entire period of study therapy - 24 weeks, as well as for 24 hours after the last dose of the study drug.
|
0.51%
1/195 • Number of events 1 • Registration of AEs begins after taking the first dose of the study drug, continues throughout the entire period of study therapy - 24 weeks, as well as for 24 hours after the last dose of the study drug.
|
|
Infections and infestations
Exacerbation of cystitis
|
0.49%
1/204 • Number of events 1 • Registration of AEs begins after taking the first dose of the study drug, continues throughout the entire period of study therapy - 24 weeks, as well as for 24 hours after the last dose of the study drug.
|
0.00%
0/195 • Registration of AEs begins after taking the first dose of the study drug, continues throughout the entire period of study therapy - 24 weeks, as well as for 24 hours after the last dose of the study drug.
|
|
Infections and infestations
Acute upper respiratory tract infection
|
0.00%
0/204 • Registration of AEs begins after taking the first dose of the study drug, continues throughout the entire period of study therapy - 24 weeks, as well as for 24 hours after the last dose of the study drug.
|
0.51%
1/195 • Number of events 1 • Registration of AEs begins after taking the first dose of the study drug, continues throughout the entire period of study therapy - 24 weeks, as well as for 24 hours after the last dose of the study drug.
|
|
Infections and infestations
Acute rhinitis
|
0.49%
1/204 • Number of events 1 • Registration of AEs begins after taking the first dose of the study drug, continues throughout the entire period of study therapy - 24 weeks, as well as for 24 hours after the last dose of the study drug.
|
0.51%
1/195 • Number of events 1 • Registration of AEs begins after taking the first dose of the study drug, continues throughout the entire period of study therapy - 24 weeks, as well as for 24 hours after the last dose of the study drug.
|
|
Infections and infestations
Pneumonia caused by coronavirus infection COVID-19
|
2.0%
4/204 • Number of events 4 • Registration of AEs begins after taking the first dose of the study drug, continues throughout the entire period of study therapy - 24 weeks, as well as for 24 hours after the last dose of the study drug.
|
1.0%
2/195 • Number of events 2 • Registration of AEs begins after taking the first dose of the study drug, continues throughout the entire period of study therapy - 24 weeks, as well as for 24 hours after the last dose of the study drug.
|
|
Infections and infestations
Cold
|
0.49%
1/204 • Number of events 1 • Registration of AEs begins after taking the first dose of the study drug, continues throughout the entire period of study therapy - 24 weeks, as well as for 24 hours after the last dose of the study drug.
|
0.00%
0/195 • Registration of AEs begins after taking the first dose of the study drug, continues throughout the entire period of study therapy - 24 weeks, as well as for 24 hours after the last dose of the study drug.
|
|
Infections and infestations
Chronic rhinitis
|
0.49%
1/204 • Number of events 1 • Registration of AEs begins after taking the first dose of the study drug, continues throughout the entire period of study therapy - 24 weeks, as well as for 24 hours after the last dose of the study drug.
|
0.00%
0/195 • Registration of AEs begins after taking the first dose of the study drug, continues throughout the entire period of study therapy - 24 weeks, as well as for 24 hours after the last dose of the study drug.
|
|
Investigations
Increased blood pressure
|
2.9%
6/204 • Number of events 6 • Registration of AEs begins after taking the first dose of the study drug, continues throughout the entire period of study therapy - 24 weeks, as well as for 24 hours after the last dose of the study drug.
|
3.6%
7/195 • Number of events 7 • Registration of AEs begins after taking the first dose of the study drug, continues throughout the entire period of study therapy - 24 weeks, as well as for 24 hours after the last dose of the study drug.
|
|
Investigations
Increased body temperature
|
0.49%
1/204 • Number of events 1 • Registration of AEs begins after taking the first dose of the study drug, continues throughout the entire period of study therapy - 24 weeks, as well as for 24 hours after the last dose of the study drug.
|
0.00%
0/195 • Registration of AEs begins after taking the first dose of the study drug, continues throughout the entire period of study therapy - 24 weeks, as well as for 24 hours after the last dose of the study drug.
|
|
Investigations
Lower blood pressure
|
0.49%
1/204 • Number of events 1 • Registration of AEs begins after taking the first dose of the study drug, continues throughout the entire period of study therapy - 24 weeks, as well as for 24 hours after the last dose of the study drug.
|
0.00%
0/195 • Registration of AEs begins after taking the first dose of the study drug, continues throughout the entire period of study therapy - 24 weeks, as well as for 24 hours after the last dose of the study drug.
|
|
Investigations
Weight loss
|
0.00%
0/204 • Registration of AEs begins after taking the first dose of the study drug, continues throughout the entire period of study therapy - 24 weeks, as well as for 24 hours after the last dose of the study drug.
|
0.51%
1/195 • Number of events 1 • Registration of AEs begins after taking the first dose of the study drug, continues throughout the entire period of study therapy - 24 weeks, as well as for 24 hours after the last dose of the study drug.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
0.49%
1/204 • Number of events 1 • Registration of AEs begins after taking the first dose of the study drug, continues throughout the entire period of study therapy - 24 weeks, as well as for 24 hours after the last dose of the study drug.
|
0.00%
0/195 • Registration of AEs begins after taking the first dose of the study drug, continues throughout the entire period of study therapy - 24 weeks, as well as for 24 hours after the last dose of the study drug.
|
|
Metabolism and nutrition disorders
Decompensated diabetes mellitus
|
0.49%
1/204 • Number of events 1 • Registration of AEs begins after taking the first dose of the study drug, continues throughout the entire period of study therapy - 24 weeks, as well as for 24 hours after the last dose of the study drug.
|
0.00%
0/195 • Registration of AEs begins after taking the first dose of the study drug, continues throughout the entire period of study therapy - 24 weeks, as well as for 24 hours after the last dose of the study drug.
|
|
Metabolism and nutrition disorders
Impaired fasting glycemia
|
0.00%
0/204 • Registration of AEs begins after taking the first dose of the study drug, continues throughout the entire period of study therapy - 24 weeks, as well as for 24 hours after the last dose of the study drug.
|
0.51%
1/195 • Number of events 1 • Registration of AEs begins after taking the first dose of the study drug, continues throughout the entire period of study therapy - 24 weeks, as well as for 24 hours after the last dose of the study drug.
|
|
Metabolism and nutrition disorders
Obesity
|
1.5%
3/204 • Number of events 3 • Registration of AEs begins after taking the first dose of the study drug, continues throughout the entire period of study therapy - 24 weeks, as well as for 24 hours after the last dose of the study drug.
|
0.00%
0/195 • Registration of AEs begins after taking the first dose of the study drug, continues throughout the entire period of study therapy - 24 weeks, as well as for 24 hours after the last dose of the study drug.
|
|
Metabolism and nutrition disorders
Loss of appetite
|
0.00%
0/204 • Registration of AEs begins after taking the first dose of the study drug, continues throughout the entire period of study therapy - 24 weeks, as well as for 24 hours after the last dose of the study drug.
|
1.5%
3/195 • Number of events 3 • Registration of AEs begins after taking the first dose of the study drug, continues throughout the entire period of study therapy - 24 weeks, as well as for 24 hours after the last dose of the study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchitis, chronic
|
0.49%
1/204 • Number of events 1 • Registration of AEs begins after taking the first dose of the study drug, continues throughout the entire period of study therapy - 24 weeks, as well as for 24 hours after the last dose of the study drug.
|
0.00%
0/195 • Registration of AEs begins after taking the first dose of the study drug, continues throughout the entire period of study therapy - 24 weeks, as well as for 24 hours after the last dose of the study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Bleeding from the paranasal sinus
|
0.49%
1/204 • Number of events 1 • Registration of AEs begins after taking the first dose of the study drug, continues throughout the entire period of study therapy - 24 weeks, as well as for 24 hours after the last dose of the study drug.
|
0.00%
0/195 • Registration of AEs begins after taking the first dose of the study drug, continues throughout the entire period of study therapy - 24 weeks, as well as for 24 hours after the last dose of the study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary hypertension functional class II according to WHO classification
|
0.49%
1/204 • Number of events 1 • Registration of AEs begins after taking the first dose of the study drug, continues throughout the entire period of study therapy - 24 weeks, as well as for 24 hours after the last dose of the study drug.
|
0.00%
0/195 • Registration of AEs begins after taking the first dose of the study drug, continues throughout the entire period of study therapy - 24 weeks, as well as for 24 hours after the last dose of the study drug.
|
|
Immune system disorders
Post-vaccination reaction
|
0.98%
2/204 • Number of events 2 • Registration of AEs begins after taking the first dose of the study drug, continues throughout the entire period of study therapy - 24 weeks, as well as for 24 hours after the last dose of the study drug.
|
0.00%
0/195 • Registration of AEs begins after taking the first dose of the study drug, continues throughout the entire period of study therapy - 24 weeks, as well as for 24 hours after the last dose of the study drug.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.49%
1/204 • Number of events 1 • Registration of AEs begins after taking the first dose of the study drug, continues throughout the entire period of study therapy - 24 weeks, as well as for 24 hours after the last dose of the study drug.
|
0.00%
0/195 • Registration of AEs begins after taking the first dose of the study drug, continues throughout the entire period of study therapy - 24 weeks, as well as for 24 hours after the last dose of the study drug.
|
|
Skin and subcutaneous tissue disorders
Urticaria-like rash
|
0.49%
1/204 • Number of events 1 • Registration of AEs begins after taking the first dose of the study drug, continues throughout the entire period of study therapy - 24 weeks, as well as for 24 hours after the last dose of the study drug.
|
0.00%
0/195 • Registration of AEs begins after taking the first dose of the study drug, continues throughout the entire period of study therapy - 24 weeks, as well as for 24 hours after the last dose of the study drug.
|
|
Blood and lymphatic system disorders
Hypochromic anemia
|
0.49%
1/204 • Number of events 1 • Registration of AEs begins after taking the first dose of the study drug, continues throughout the entire period of study therapy - 24 weeks, as well as for 24 hours after the last dose of the study drug.
|
0.00%
0/195 • Registration of AEs begins after taking the first dose of the study drug, continues throughout the entire period of study therapy - 24 weeks, as well as for 24 hours after the last dose of the study drug.
|
|
Blood and lymphatic system disorders
Chronic iron deficiency anemia
|
0.00%
0/204 • Registration of AEs begins after taking the first dose of the study drug, continues throughout the entire period of study therapy - 24 weeks, as well as for 24 hours after the last dose of the study drug.
|
0.51%
1/195 • Number of events 1 • Registration of AEs begins after taking the first dose of the study drug, continues throughout the entire period of study therapy - 24 weeks, as well as for 24 hours after the last dose of the study drug.
|
|
Musculoskeletal and connective tissue disorders
Knee pain
|
0.49%
1/204 • Number of events 1 • Registration of AEs begins after taking the first dose of the study drug, continues throughout the entire period of study therapy - 24 weeks, as well as for 24 hours after the last dose of the study drug.
|
0.00%
0/195 • Registration of AEs begins after taking the first dose of the study drug, continues throughout the entire period of study therapy - 24 weeks, as well as for 24 hours after the last dose of the study drug.
|
|
Musculoskeletal and connective tissue disorders
Lumbar pain
|
0.49%
1/204 • Number of events 1 • Registration of AEs begins after taking the first dose of the study drug, continues throughout the entire period of study therapy - 24 weeks, as well as for 24 hours after the last dose of the study drug.
|
0.00%
0/195 • Registration of AEs begins after taking the first dose of the study drug, continues throughout the entire period of study therapy - 24 weeks, as well as for 24 hours after the last dose of the study drug.
|
|
Musculoskeletal and connective tissue disorders
Back pain, exacerbation
|
0.00%
0/204 • Registration of AEs begins after taking the first dose of the study drug, continues throughout the entire period of study therapy - 24 weeks, as well as for 24 hours after the last dose of the study drug.
|
1.0%
2/195 • Number of events 2 • Registration of AEs begins after taking the first dose of the study drug, continues throughout the entire period of study therapy - 24 weeks, as well as for 24 hours after the last dose of the study drug.
|
|
Musculoskeletal and connective tissue disorders
Ankle hemarthrosis
|
0.49%
1/204 • Number of events 1 • Registration of AEs begins after taking the first dose of the study drug, continues throughout the entire period of study therapy - 24 weeks, as well as for 24 hours after the last dose of the study drug.
|
0.00%
0/195 • Registration of AEs begins after taking the first dose of the study drug, continues throughout the entire period of study therapy - 24 weeks, as well as for 24 hours after the last dose of the study drug.
|
|
Musculoskeletal and connective tissue disorders
Degenerative spinal disease
|
0.00%
0/204 • Registration of AEs begins after taking the first dose of the study drug, continues throughout the entire period of study therapy - 24 weeks, as well as for 24 hours after the last dose of the study drug.
|
0.51%
1/195 • Number of events 1 • Registration of AEs begins after taking the first dose of the study drug, continues throughout the entire period of study therapy - 24 weeks, as well as for 24 hours after the last dose of the study drug.
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness of the lower limb
|
0.49%
1/204 • Number of events 1 • Registration of AEs begins after taking the first dose of the study drug, continues throughout the entire period of study therapy - 24 weeks, as well as for 24 hours after the last dose of the study drug.
|
0.00%
0/195 • Registration of AEs begins after taking the first dose of the study drug, continues throughout the entire period of study therapy - 24 weeks, as well as for 24 hours after the last dose of the study drug.
|
|
Musculoskeletal and connective tissue disorders
Rheumatoid arthritis, exacerbation
|
0.49%
1/204 • Number of events 1 • Registration of AEs begins after taking the first dose of the study drug, continues throughout the entire period of study therapy - 24 weeks, as well as for 24 hours after the last dose of the study drug.
|
0.00%
0/195 • Registration of AEs begins after taking the first dose of the study drug, continues throughout the entire period of study therapy - 24 weeks, as well as for 24 hours after the last dose of the study drug.
|
|
Musculoskeletal and connective tissue disorders
Weakness of the lower extremities
|
0.00%
0/204 • Registration of AEs begins after taking the first dose of the study drug, continues throughout the entire period of study therapy - 24 weeks, as well as for 24 hours after the last dose of the study drug.
|
0.51%
1/195 • Number of events 1 • Registration of AEs begins after taking the first dose of the study drug, continues throughout the entire period of study therapy - 24 weeks, as well as for 24 hours after the last dose of the study drug.
|
|
Nervous system disorders
Carotid atheroma
|
0.49%
1/204 • Number of events 1 • Registration of AEs begins after taking the first dose of the study drug, continues throughout the entire period of study therapy - 24 weeks, as well as for 24 hours after the last dose of the study drug.
|
0.00%
0/195 • Registration of AEs begins after taking the first dose of the study drug, continues throughout the entire period of study therapy - 24 weeks, as well as for 24 hours after the last dose of the study drug.
|
|
Nervous system disorders
Headache
|
8.8%
18/204 • Number of events 18 • Registration of AEs begins after taking the first dose of the study drug, continues throughout the entire period of study therapy - 24 weeks, as well as for 24 hours after the last dose of the study drug.
|
8.2%
16/195 • Number of events 16 • Registration of AEs begins after taking the first dose of the study drug, continues throughout the entire period of study therapy - 24 weeks, as well as for 24 hours after the last dose of the study drug.
|
|
Nervous system disorders
Tension headache
|
0.49%
1/204 • Number of events 1 • Registration of AEs begins after taking the first dose of the study drug, continues throughout the entire period of study therapy - 24 weeks, as well as for 24 hours after the last dose of the study drug.
|
0.00%
0/195 • Registration of AEs begins after taking the first dose of the study drug, continues throughout the entire period of study therapy - 24 weeks, as well as for 24 hours after the last dose of the study drug.
|
|
Nervous system disorders
Tension type headache
|
0.00%
0/204 • Registration of AEs begins after taking the first dose of the study drug, continues throughout the entire period of study therapy - 24 weeks, as well as for 24 hours after the last dose of the study drug.
|
0.51%
1/195 • Number of events 1 • Registration of AEs begins after taking the first dose of the study drug, continues throughout the entire period of study therapy - 24 weeks, as well as for 24 hours after the last dose of the study drug.
|
|
Nervous system disorders
Dizziness
|
4.4%
9/204 • Number of events 9 • Registration of AEs begins after taking the first dose of the study drug, continues throughout the entire period of study therapy - 24 weeks, as well as for 24 hours after the last dose of the study drug.
|
6.2%
12/195 • Number of events 12 • Registration of AEs begins after taking the first dose of the study drug, continues throughout the entire period of study therapy - 24 weeks, as well as for 24 hours after the last dose of the study drug.
|
|
Nervous system disorders
Dyscirculatory encephalopathy
|
0.00%
0/204 • Registration of AEs begins after taking the first dose of the study drug, continues throughout the entire period of study therapy - 24 weeks, as well as for 24 hours after the last dose of the study drug.
|
1.0%
2/195 • Number of events 2 • Registration of AEs begins after taking the first dose of the study drug, continues throughout the entire period of study therapy - 24 weeks, as well as for 24 hours after the last dose of the study drug.
|
|
Nervous system disorders
Daytime sleepiness
|
0.49%
1/204 • Number of events 1 • Registration of AEs begins after taking the first dose of the study drug, continues throughout the entire period of study therapy - 24 weeks, as well as for 24 hours after the last dose of the study drug.
|
0.51%
1/195 • Number of events 1 • Registration of AEs begins after taking the first dose of the study drug, continues throughout the entire period of study therapy - 24 weeks, as well as for 24 hours after the last dose of the study drug.
|
|
Nervous system disorders
Ischialgia at the stage of exacerbation
|
0.49%
1/204 • Number of events 1 • Registration of AEs begins after taking the first dose of the study drug, continues throughout the entire period of study therapy - 24 weeks, as well as for 24 hours after the last dose of the study drug.
|
0.00%
0/195 • Registration of AEs begins after taking the first dose of the study drug, continues throughout the entire period of study therapy - 24 weeks, as well as for 24 hours after the last dose of the study drug.
|
|
Nervous system disorders
Cardioembolic stroke
|
0.49%
1/204 • Number of events 1 • Registration of AEs begins after taking the first dose of the study drug, continues throughout the entire period of study therapy - 24 weeks, as well as for 24 hours after the last dose of the study drug.
|
0.00%
0/195 • Registration of AEs begins after taking the first dose of the study drug, continues throughout the entire period of study therapy - 24 weeks, as well as for 24 hours after the last dose of the study drug.
|
|
Nervous system disorders
Sour taste
|
0.49%
1/204 • Number of events 1 • Registration of AEs begins after taking the first dose of the study drug, continues throughout the entire period of study therapy - 24 weeks, as well as for 24 hours after the last dose of the study drug.
|
0.00%
0/195 • Registration of AEs begins after taking the first dose of the study drug, continues throughout the entire period of study therapy - 24 weeks, as well as for 24 hours after the last dose of the study drug.
|
|
Nervous system disorders
Cephalgia
|
0.49%
1/204 • Number of events 1 • Registration of AEs begins after taking the first dose of the study drug, continues throughout the entire period of study therapy - 24 weeks, as well as for 24 hours after the last dose of the study drug.
|
0.00%
0/195 • Registration of AEs begins after taking the first dose of the study drug, continues throughout the entire period of study therapy - 24 weeks, as well as for 24 hours after the last dose of the study drug.
|
|
Nervous system disorders
Episodic headache
|
0.00%
0/204 • Registration of AEs begins after taking the first dose of the study drug, continues throughout the entire period of study therapy - 24 weeks, as well as for 24 hours after the last dose of the study drug.
|
0.51%
1/195 • Number of events 1 • Registration of AEs begins after taking the first dose of the study drug, continues throughout the entire period of study therapy - 24 weeks, as well as for 24 hours after the last dose of the study drug.
|
|
Ear and labyrinth disorders
Ear congestion
|
0.49%
1/204 • Number of events 1 • Registration of AEs begins after taking the first dose of the study drug, continues throughout the entire period of study therapy - 24 weeks, as well as for 24 hours after the last dose of the study drug.
|
0.00%
0/195 • Registration of AEs begins after taking the first dose of the study drug, continues throughout the entire period of study therapy - 24 weeks, as well as for 24 hours after the last dose of the study drug.
|
|
Hepatobiliary disorders
Hepatic mass
|
0.49%
1/204 • Number of events 1 • Registration of AEs begins after taking the first dose of the study drug, continues throughout the entire period of study therapy - 24 weeks, as well as for 24 hours after the last dose of the study drug.
|
0.00%
0/195 • Registration of AEs begins after taking the first dose of the study drug, continues throughout the entire period of study therapy - 24 weeks, as well as for 24 hours after the last dose of the study drug.
|
|
Renal and urinary disorders
Incontinence
|
0.00%
0/204 • Registration of AEs begins after taking the first dose of the study drug, continues throughout the entire period of study therapy - 24 weeks, as well as for 24 hours after the last dose of the study drug.
|
0.51%
1/195 • Number of events 1 • Registration of AEs begins after taking the first dose of the study drug, continues throughout the entire period of study therapy - 24 weeks, as well as for 24 hours after the last dose of the study drug.
|
|
Renal and urinary disorders
Nephropathy
|
0.49%
1/204 • Number of events 1 • Registration of AEs begins after taking the first dose of the study drug, continues throughout the entire period of study therapy - 24 weeks, as well as for 24 hours after the last dose of the study drug.
|
0.00%
0/195 • Registration of AEs begins after taking the first dose of the study drug, continues throughout the entire period of study therapy - 24 weeks, as well as for 24 hours after the last dose of the study drug.
|
|
Renal and urinary disorders
Chronic kidney disease, stage 3
|
0.49%
1/204 • Number of events 1 • Registration of AEs begins after taking the first dose of the study drug, continues throughout the entire period of study therapy - 24 weeks, as well as for 24 hours after the last dose of the study drug.
|
0.00%
0/195 • Registration of AEs begins after taking the first dose of the study drug, continues throughout the entire period of study therapy - 24 weeks, as well as for 24 hours after the last dose of the study drug.
|
|
Cardiac disorders
Heart valve insufficiency
|
0.49%
1/204 • Number of events 1 • Registration of AEs begins after taking the first dose of the study drug, continues throughout the entire period of study therapy - 24 weeks, as well as for 24 hours after the last dose of the study drug.
|
0.00%
0/195 • Registration of AEs begins after taking the first dose of the study drug, continues throughout the entire period of study therapy - 24 weeks, as well as for 24 hours after the last dose of the study drug.
|
|
Cardiac disorders
Post-infarction cardiosclerosis
|
0.49%
1/204 • Number of events 1 • Registration of AEs begins after taking the first dose of the study drug, continues throughout the entire period of study therapy - 24 weeks, as well as for 24 hours after the last dose of the study drug.
|
0.00%
0/195 • Registration of AEs begins after taking the first dose of the study drug, continues throughout the entire period of study therapy - 24 weeks, as well as for 24 hours after the last dose of the study drug.
|
|
Cardiac disorders
Persistent atrial fibrillation
|
0.49%
1/204 • Number of events 1 • Registration of AEs begins after taking the first dose of the study drug, continues throughout the entire period of study therapy - 24 weeks, as well as for 24 hours after the last dose of the study drug.
|
0.00%
0/195 • Registration of AEs begins after taking the first dose of the study drug, continues throughout the entire period of study therapy - 24 weeks, as well as for 24 hours after the last dose of the study drug.
|
|
Cardiac disorders
Progressive angina
|
0.49%
1/204 • Number of events 1 • Registration of AEs begins after taking the first dose of the study drug, continues throughout the entire period of study therapy - 24 weeks, as well as for 24 hours after the last dose of the study drug.
|
0.00%
0/195 • Registration of AEs begins after taking the first dose of the study drug, continues throughout the entire period of study therapy - 24 weeks, as well as for 24 hours after the last dose of the study drug.
|
|
Cardiac disorders
NYHA class II heart failure
|
0.98%
2/204 • Number of events 2 • Registration of AEs begins after taking the first dose of the study drug, continues throughout the entire period of study therapy - 24 weeks, as well as for 24 hours after the last dose of the study drug.
|
1.0%
2/195 • Number of events 2 • Registration of AEs begins after taking the first dose of the study drug, continues throughout the entire period of study therapy - 24 weeks, as well as for 24 hours after the last dose of the study drug.
|
|
Cardiac disorders
Angina pectoris class II according to the Canadian classification of angina
|
0.49%
1/204 • Number of events 1 • Registration of AEs begins after taking the first dose of the study drug, continues throughout the entire period of study therapy - 24 weeks, as well as for 24 hours after the last dose of the study drug.
|
0.00%
0/195 • Registration of AEs begins after taking the first dose of the study drug, continues throughout the entire period of study therapy - 24 weeks, as well as for 24 hours after the last dose of the study drug.
|
|
Cardiac disorders
Ventricular extrasystoles
|
0.49%
1/204 • Number of events 1 • Registration of AEs begins after taking the first dose of the study drug, continues throughout the entire period of study therapy - 24 weeks, as well as for 24 hours after the last dose of the study drug.
|
0.00%
0/195 • Registration of AEs begins after taking the first dose of the study drug, continues throughout the entire period of study therapy - 24 weeks, as well as for 24 hours after the last dose of the study drug.
|
|
Vascular disorders
Arterial hypertension
|
0.00%
0/204 • Registration of AEs begins after taking the first dose of the study drug, continues throughout the entire period of study therapy - 24 weeks, as well as for 24 hours after the last dose of the study drug.
|
0.51%
1/195 • Number of events 1 • Registration of AEs begins after taking the first dose of the study drug, continues throughout the entire period of study therapy - 24 weeks, as well as for 24 hours after the last dose of the study drug.
|
|
Vascular disorders
Hypertensive crisis
|
0.00%
0/204 • Registration of AEs begins after taking the first dose of the study drug, continues throughout the entire period of study therapy - 24 weeks, as well as for 24 hours after the last dose of the study drug.
|
0.51%
1/195 • Number of events 1 • Registration of AEs begins after taking the first dose of the study drug, continues throughout the entire period of study therapy - 24 weeks, as well as for 24 hours after the last dose of the study drug.
|
|
Vascular disorders
Essential hypertension
|
0.49%
1/204 • Number of events 1 • Registration of AEs begins after taking the first dose of the study drug, continues throughout the entire period of study therapy - 24 weeks, as well as for 24 hours after the last dose of the study drug.
|
0.51%
1/195 • Number of events 1 • Registration of AEs begins after taking the first dose of the study drug, continues throughout the entire period of study therapy - 24 weeks, as well as for 24 hours after the last dose of the study drug.
|
|
General disorders
Pain at the vaccination site
|
0.00%
0/204 • Registration of AEs begins after taking the first dose of the study drug, continues throughout the entire period of study therapy - 24 weeks, as well as for 24 hours after the last dose of the study drug.
|
1.0%
2/195 • Number of events 2 • Registration of AEs begins after taking the first dose of the study drug, continues throughout the entire period of study therapy - 24 weeks, as well as for 24 hours after the last dose of the study drug.
|
|
General disorders
Localized pain
|
0.00%
0/204 • Registration of AEs begins after taking the first dose of the study drug, continues throughout the entire period of study therapy - 24 weeks, as well as for 24 hours after the last dose of the study drug.
|
0.51%
1/195 • Number of events 1 • Registration of AEs begins after taking the first dose of the study drug, continues throughout the entire period of study therapy - 24 weeks, as well as for 24 hours after the last dose of the study drug.
|
|
General disorders
Local edema
|
0.00%
0/204 • Registration of AEs begins after taking the first dose of the study drug, continues throughout the entire period of study therapy - 24 weeks, as well as for 24 hours after the last dose of the study drug.
|
0.51%
1/195 • Number of events 1 • Registration of AEs begins after taking the first dose of the study drug, continues throughout the entire period of study therapy - 24 weeks, as well as for 24 hours after the last dose of the study drug.
|
|
General disorders
General weakness
|
2.9%
6/204 • Number of events 6 • Registration of AEs begins after taking the first dose of the study drug, continues throughout the entire period of study therapy - 24 weeks, as well as for 24 hours after the last dose of the study drug.
|
1.0%
2/195 • Number of events 2 • Registration of AEs begins after taking the first dose of the study drug, continues throughout the entire period of study therapy - 24 weeks, as well as for 24 hours after the last dose of the study drug.
|
|
General disorders
Weakness
|
2.0%
4/204 • Number of events 4 • Registration of AEs begins after taking the first dose of the study drug, continues throughout the entire period of study therapy - 24 weeks, as well as for 24 hours after the last dose of the study drug.
|
1.5%
3/195 • Number of events 3 • Registration of AEs begins after taking the first dose of the study drug, continues throughout the entire period of study therapy - 24 weeks, as well as for 24 hours after the last dose of the study drug.
|
|
General disorders
Wobbly gait
|
0.00%
0/204 • Registration of AEs begins after taking the first dose of the study drug, continues throughout the entire period of study therapy - 24 weeks, as well as for 24 hours after the last dose of the study drug.
|
1.0%
2/195 • Number of events 2 • Registration of AEs begins after taking the first dose of the study drug, continues throughout the entire period of study therapy - 24 weeks, as well as for 24 hours after the last dose of the study drug.
|
|
Psychiatric disorders
Aggressiveness
|
0.00%
0/204 • Registration of AEs begins after taking the first dose of the study drug, continues throughout the entire period of study therapy - 24 weeks, as well as for 24 hours after the last dose of the study drug.
|
0.51%
1/195 • Number of events 1 • Registration of AEs begins after taking the first dose of the study drug, continues throughout the entire period of study therapy - 24 weeks, as well as for 24 hours after the last dose of the study drug.
|
|
Psychiatric disorders
Aggression, exacerbation
|
0.49%
1/204 • Number of events 1 • Registration of AEs begins after taking the first dose of the study drug, continues throughout the entire period of study therapy - 24 weeks, as well as for 24 hours after the last dose of the study drug.
|
0.00%
0/195 • Registration of AEs begins after taking the first dose of the study drug, continues throughout the entire period of study therapy - 24 weeks, as well as for 24 hours after the last dose of the study drug.
|
|
Psychiatric disorders
Insomnia
|
0.49%
1/204 • Number of events 1 • Registration of AEs begins after taking the first dose of the study drug, continues throughout the entire period of study therapy - 24 weeks, as well as for 24 hours after the last dose of the study drug.
|
0.51%
1/195 • Number of events 1 • Registration of AEs begins after taking the first dose of the study drug, continues throughout the entire period of study therapy - 24 weeks, as well as for 24 hours after the last dose of the study drug.
|
|
Psychiatric disorders
Hallucinatory condition
|
0.49%
1/204 • Number of events 1 • Registration of AEs begins after taking the first dose of the study drug, continues throughout the entire period of study therapy - 24 weeks, as well as for 24 hours after the last dose of the study drug.
|
0.00%
0/195 • Registration of AEs begins after taking the first dose of the study drug, continues throughout the entire period of study therapy - 24 weeks, as well as for 24 hours after the last dose of the study drug.
|
|
Psychiatric disorders
Sleep disturbance
|
0.49%
1/204 • Number of events 1 • Registration of AEs begins after taking the first dose of the study drug, continues throughout the entire period of study therapy - 24 weeks, as well as for 24 hours after the last dose of the study drug.
|
0.00%
0/195 • Registration of AEs begins after taking the first dose of the study drug, continues throughout the entire period of study therapy - 24 weeks, as well as for 24 hours after the last dose of the study drug.
|
|
Psychiatric disorders
Sleep disorder
|
0.49%
1/204 • Number of events 1 • Registration of AEs begins after taking the first dose of the study drug, continues throughout the entire period of study therapy - 24 weeks, as well as for 24 hours after the last dose of the study drug.
|
0.00%
0/195 • Registration of AEs begins after taking the first dose of the study drug, continues throughout the entire period of study therapy - 24 weeks, as well as for 24 hours after the last dose of the study drug.
|
|
Psychiatric disorders
Restlessness
|
0.00%
0/204 • Registration of AEs begins after taking the first dose of the study drug, continues throughout the entire period of study therapy - 24 weeks, as well as for 24 hours after the last dose of the study drug.
|
0.51%
1/195 • Number of events 1 • Registration of AEs begins after taking the first dose of the study drug, continues throughout the entire period of study therapy - 24 weeks, as well as for 24 hours after the last dose of the study drug.
|
|
Psychiatric disorders
Irritability
|
0.49%
1/204 • Number of events 1 • Registration of AEs begins after taking the first dose of the study drug, continues throughout the entire period of study therapy - 24 weeks, as well as for 24 hours after the last dose of the study drug.
|
0.51%
1/195 • Number of events 1 • Registration of AEs begins after taking the first dose of the study drug, continues throughout the entire period of study therapy - 24 weeks, as well as for 24 hours after the last dose of the study drug.
|
|
Psychiatric disorders
Early awakening
|
0.00%
0/204 • Registration of AEs begins after taking the first dose of the study drug, continues throughout the entire period of study therapy - 24 weeks, as well as for 24 hours after the last dose of the study drug.
|
0.51%
1/195 • Number of events 1 • Registration of AEs begins after taking the first dose of the study drug, continues throughout the entire period of study therapy - 24 weeks, as well as for 24 hours after the last dose of the study drug.
|
|
Psychiatric disorders
Lower mood
|
0.00%
0/204 • Registration of AEs begins after taking the first dose of the study drug, continues throughout the entire period of study therapy - 24 weeks, as well as for 24 hours after the last dose of the study drug.
|
0.51%
1/195 • Number of events 1 • Registration of AEs begins after taking the first dose of the study drug, continues throughout the entire period of study therapy - 24 weeks, as well as for 24 hours after the last dose of the study drug.
|
|
Psychiatric disorders
Anxiety during medical manipulation/procedure
|
0.49%
1/204 • Number of events 1 • Registration of AEs begins after taking the first dose of the study drug, continues throughout the entire period of study therapy - 24 weeks, as well as for 24 hours after the last dose of the study drug.
|
0.00%
0/195 • Registration of AEs begins after taking the first dose of the study drug, continues throughout the entire period of study therapy - 24 weeks, as well as for 24 hours after the last dose of the study drug.
|
|
Injury, poisoning and procedural complications
Bimalleolar fracture
|
0.49%
1/204 • Number of events 1 • Registration of AEs begins after taking the first dose of the study drug, continues throughout the entire period of study therapy - 24 weeks, as well as for 24 hours after the last dose of the study drug.
|
0.00%
0/195 • Registration of AEs begins after taking the first dose of the study drug, continues throughout the entire period of study therapy - 24 weeks, as well as for 24 hours after the last dose of the study drug.
|
|
Injury, poisoning and procedural complications
Unspecified hand burn
|
0.49%
1/204 • Number of events 1 • Registration of AEs begins after taking the first dose of the study drug, continues throughout the entire period of study therapy - 24 weeks, as well as for 24 hours after the last dose of the study drug.
|
0.00%
0/195 • Registration of AEs begins after taking the first dose of the study drug, continues throughout the entire period of study therapy - 24 weeks, as well as for 24 hours after the last dose of the study drug.
|
|
Psychiatric disorders
Unspecified burn of forearm
|
0.49%
1/204 • Number of events 1 • Registration of AEs begins after taking the first dose of the study drug, continues throughout the entire period of study therapy - 24 weeks, as well as for 24 hours after the last dose of the study drug.
|
0.00%
0/195 • Registration of AEs begins after taking the first dose of the study drug, continues throughout the entire period of study therapy - 24 weeks, as well as for 24 hours after the last dose of the study drug.
|
|
Injury, poisoning and procedural complications
Fall
|
0.49%
1/204 • Number of events 1 • Registration of AEs begins after taking the first dose of the study drug, continues throughout the entire period of study therapy - 24 weeks, as well as for 24 hours after the last dose of the study drug.
|
0.00%
0/195 • Registration of AEs begins after taking the first dose of the study drug, continues throughout the entire period of study therapy - 24 weeks, as well as for 24 hours after the last dose of the study drug.
|
|
Injury, poisoning and procedural complications
Rib fracture
|
0.49%
1/204 • Number of events 1 • Registration of AEs begins after taking the first dose of the study drug, continues throughout the entire period of study therapy - 24 weeks, as well as for 24 hours after the last dose of the study drug.
|
0.00%
0/195 • Registration of AEs begins after taking the first dose of the study drug, continues throughout the entire period of study therapy - 24 weeks, as well as for 24 hours after the last dose of the study drug.
|
|
Injury, poisoning and procedural complications
Left foot wound
|
0.00%
0/204 • Registration of AEs begins after taking the first dose of the study drug, continues throughout the entire period of study therapy - 24 weeks, as well as for 24 hours after the last dose of the study drug.
|
0.51%
1/195 • Number of events 1 • Registration of AEs begins after taking the first dose of the study drug, continues throughout the entire period of study therapy - 24 weeks, as well as for 24 hours after the last dose of the study drug.
|
|
Injury, poisoning and procedural complications
Ankle sprain
|
0.49%
1/204 • Number of events 1 • Registration of AEs begins after taking the first dose of the study drug, continues throughout the entire period of study therapy - 24 weeks, as well as for 24 hours after the last dose of the study drug.
|
0.51%
1/195 • Number of events 1 • Registration of AEs begins after taking the first dose of the study drug, continues throughout the entire period of study therapy - 24 weeks, as well as for 24 hours after the last dose of the study drug.
|
|
Injury, poisoning and procedural complications
Wrist sprain
|
0.00%
0/204 • Registration of AEs begins after taking the first dose of the study drug, continues throughout the entire period of study therapy - 24 weeks, as well as for 24 hours after the last dose of the study drug.
|
0.51%
1/195 • Number of events 1 • Registration of AEs begins after taking the first dose of the study drug, continues throughout the entire period of study therapy - 24 weeks, as well as for 24 hours after the last dose of the study drug.
|
|
Injury, poisoning and procedural complications
Incised wound of the left thumb
|
0.49%
1/204 • Number of events 1 • Registration of AEs begins after taking the first dose of the study drug, continues throughout the entire period of study therapy - 24 weeks, as well as for 24 hours after the last dose of the study drug.
|
0.00%
0/195 • Registration of AEs begins after taking the first dose of the study drug, continues throughout the entire period of study therapy - 24 weeks, as well as for 24 hours after the last dose of the study drug.
|
|
Injury, poisoning and procedural complications
Skin abrasion
|
0.00%
0/204 • Registration of AEs begins after taking the first dose of the study drug, continues throughout the entire period of study therapy - 24 weeks, as well as for 24 hours after the last dose of the study drug.
|
1.0%
2/195 • Number of events 2 • Registration of AEs begins after taking the first dose of the study drug, continues throughout the entire period of study therapy - 24 weeks, as well as for 24 hours after the last dose of the study drug.
|
|
Injury, poisoning and procedural complications
Abrasions
|
0.49%
1/204 • Number of events 1 • Registration of AEs begins after taking the first dose of the study drug, continues throughout the entire period of study therapy - 24 weeks, as well as for 24 hours after the last dose of the study drug.
|
0.00%
0/195 • Registration of AEs begins after taking the first dose of the study drug, continues throughout the entire period of study therapy - 24 weeks, as well as for 24 hours after the last dose of the study drug.
|
|
Injury, poisoning and procedural complications
Wasp sting
|
0.00%
0/204 • Registration of AEs begins after taking the first dose of the study drug, continues throughout the entire period of study therapy - 24 weeks, as well as for 24 hours after the last dose of the study drug.
|
1.0%
2/195 • Number of events 2 • Registration of AEs begins after taking the first dose of the study drug, continues throughout the entire period of study therapy - 24 weeks, as well as for 24 hours after the last dose of the study drug.
|
|
Injury, poisoning and procedural complications
Bruise in the shoulder joint
|
0.00%
0/204 • Registration of AEs begins after taking the first dose of the study drug, continues throughout the entire period of study therapy - 24 weeks, as well as for 24 hours after the last dose of the study drug.
|
0.51%
1/195 • Number of events 1 • Registration of AEs begins after taking the first dose of the study drug, continues throughout the entire period of study therapy - 24 weeks, as well as for 24 hours after the last dose of the study drug.
|
|
Injury, poisoning and procedural complications
Bruised ankle
|
0.49%
1/204 • Number of events 1 • Registration of AEs begins after taking the first dose of the study drug, continues throughout the entire period of study therapy - 24 weeks, as well as for 24 hours after the last dose of the study drug.
|
0.00%
0/195 • Registration of AEs begins after taking the first dose of the study drug, continues throughout the entire period of study therapy - 24 weeks, as well as for 24 hours after the last dose of the study drug.
|
|
Injury, poisoning and procedural complications
Knee contusion
|
0.98%
2/204 • Number of events 2 • Registration of AEs begins after taking the first dose of the study drug, continues throughout the entire period of study therapy - 24 weeks, as well as for 24 hours after the last dose of the study drug.
|
0.51%
1/195 • Number of events 1 • Registration of AEs begins after taking the first dose of the study drug, continues throughout the entire period of study therapy - 24 weeks, as well as for 24 hours after the last dose of the study drug.
|
Additional Information
Mikhail Putilovskiy, MD, PhD, Clinical and Medical Department Director
MATERIA MEDICA HOLDING
Phone: +74952761571
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place