Trial Outcomes & Findings for Clinical Trial of Clinical Efficiency and Safety of Ergoferon in Treatment of Influenza (NCT NCT01804946)
NCT ID: NCT01804946
Last Updated: 2015-06-23
Results Overview
Axillary temperature (morning and evening) decline to or below 37.0 ºС (without subsequent increase during ≥24 h)
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
161 participants
Primary outcome timeframe
Day 1 to Day 5
Results posted on
2015-06-23
Participant Flow
Participant milestones
| Measure |
Ergoferon Group (EG)
Adults aged 18 to 60 years were on the treatment regimen with Ergoferon for 5 days. 1 tablet per 1 intake: on day 1 of the treatment 8 tablets (1 tablet every 30 minutes for the first 2 hours, then 1 tablet 3 times a day with equal intervals starting on the same day. From day 2 to day 5 1 tablet t.i.d.
|
Oseltamivir Group (OG)
Adults aged 18 to 60 years were on Oseltamivir for 5 days (75 mg b.i.d.).
|
|---|---|---|
|
Overall Study
STARTED
|
81
|
80
|
|
Overall Study
COMPLETED
|
79
|
76
|
|
Overall Study
NOT COMPLETED
|
2
|
4
|
Reasons for withdrawal
| Measure |
Ergoferon Group (EG)
Adults aged 18 to 60 years were on the treatment regimen with Ergoferon for 5 days. 1 tablet per 1 intake: on day 1 of the treatment 8 tablets (1 tablet every 30 minutes for the first 2 hours, then 1 tablet 3 times a day with equal intervals starting on the same day. From day 2 to day 5 1 tablet t.i.d.
|
Oseltamivir Group (OG)
Adults aged 18 to 60 years were on Oseltamivir for 5 days (75 mg b.i.d.).
|
|---|---|---|
|
Overall Study
Protocol Violation
|
1
|
0
|
|
Overall Study
Adverse Event
|
0
|
1
|
|
Overall Study
Insufficient data available
|
0
|
1
|
|
Overall Study
Do not meet inclusion criteria
|
1
|
2
|
Baseline Characteristics
Clinical Trial of Clinical Efficiency and Safety of Ergoferon in Treatment of Influenza
Baseline characteristics by cohort
| Measure |
Ergoferon Group (EG)
n=81 Participants
1 tablet per 1 intake: on day 1 of the treatment 8 tablets (1 tablet every 30 minutes for the first 2 hours, then 1 tablet 3 times a day with equal intervals starting on the same day. From day 2 to day 5 1 tablet TID.
Ergoferon: Safety and Efficiency of Ergoferon in treatment of Influenza
|
Oseltamivir Group (OG)
n=80 Participants
Oseltamivir(Tamiflu): Safety and Efficiency in treatment of Influenza
|
Total
n=161 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
34.5 years
STANDARD_DEVIATION 11.6 • n=5 Participants
|
34.9 years
STANDARD_DEVIATION 12.6 • n=7 Participants
|
34.7 years
STANDARD_DEVIATION 12.1 • n=5 Participants
|
|
Sex: Female, Male
Female
|
49 Participants
n=5 Participants
|
55 Participants
n=7 Participants
|
104 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
32 Participants
n=5 Participants
|
25 Participants
n=7 Participants
|
57 Participants
n=5 Participants
|
|
Region of Enrollment
Russian Federation
|
81 participants
n=5 Participants
|
80 participants
n=7 Participants
|
161 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Day 1 to Day 5Population: The Per Protocol (PP) set includes subjects received full per protocol therapy, completed all scheduled visits and had no substantial deviations from the protocol. Since PP-analysis and ITT-analysis demonstrated similar (confirmative) results the results of PP-analysis are presented.
Axillary temperature (morning and evening) decline to or below 37.0 ºС (without subsequent increase during ≥24 h)
Outcome measures
| Measure |
Ergoferon Group (EG)
n=75 Participants
1 tablet per 1 intake: on day 1 of the treatment 8 tablets (1 tablet every 30 minutes for the first 2 hours, then 1 tablet 3 times a day with equal intervals starting on the same day. From day 2 to day 5 1 tablet TID.
Ergoferon: Safety and Efficiency of Ergoferon in treatment of Influenza
|
Oseltamivir Goup (OG)
n=72 Participants
Oseltamivir(Tamiflu): Safety and Efficiency in treatment of Influenza
|
|---|---|---|
|
Percentage of Patients With Normal Body Temperature
Evening, Day 1
|
4 Percentage of participants
|
1 Percentage of participants
|
|
Percentage of Patients With Normal Body Temperature
Evening, Day 2
|
15 Percentage of participants
|
15 Percentage of participants
|
|
Percentage of Patients With Normal Body Temperature
Evening, Day 3
|
41 Percentage of participants
|
43 Percentage of participants
|
|
Percentage of Patients With Normal Body Temperature
Evening, Day 4
|
68 Percentage of participants
|
72 Percentage of participants
|
|
Percentage of Patients With Normal Body Temperature
Evening, Day 5
|
84 Percentage of participants
|
88 Percentage of participants
|
SECONDARY outcome
Timeframe: on the day 7 of the observationPopulation: Per Protocol set.
Assessment of the proportion of subjects with no clinical symptoms of the disease (fever, common and respiratory symptoms) at Study Day 7 (Visit 3). The severity of influenza symptoms was assessed by a physician with 0 to 3 point scale, where 0 means no symptom, 1=mild symptom, 2=moderate symptom, and 3=severe symptom
Outcome measures
| Measure |
Ergoferon Group (EG)
n=75 Participants
1 tablet per 1 intake: on day 1 of the treatment 8 tablets (1 tablet every 30 minutes for the first 2 hours, then 1 tablet 3 times a day with equal intervals starting on the same day. From day 2 to day 5 1 tablet TID.
Ergoferon: Safety and Efficiency of Ergoferon in treatment of Influenza
|
Oseltamivir Goup (OG)
n=72 Participants
Oseltamivir(Tamiflu): Safety and Efficiency in treatment of Influenza
|
|---|---|---|
|
Percentage of Patients With Resolution of Influenza Symptoms
Fever
|
100 Percentage of participants
|
100 Percentage of participants
|
|
Percentage of Patients With Resolution of Influenza Symptoms
Common symptoms
|
61 Percentage of participants
|
64 Percentage of participants
|
|
Percentage of Patients With Resolution of Influenza Symptoms
Respiratory symptoms
|
83 Percentage of participants
|
76 Percentage of participants
|
|
Percentage of Patients With Resolution of Influenza Symptoms
All symptoms
|
47 Percentage of participants
|
49 Percentage of participants
|
SECONDARY outcome
Timeframe: Day 1 to Day 7Population: Per Protocol set
Time to resolution was considered as time to the absence of any flu symptom. Absence of symptoms was considered as axillary temperature decline to or below 37.0 ºС without subsequent rise, resolution of the common and respiratory symptoms. The duration of a symptom was defined by physician recorded presence/absence of the symptoms during a physical examination at Day 1 to Day 7.
Outcome measures
| Measure |
Ergoferon Group (EG)
n=75 Participants
1 tablet per 1 intake: on day 1 of the treatment 8 tablets (1 tablet every 30 minutes for the first 2 hours, then 1 tablet 3 times a day with equal intervals starting on the same day. From day 2 to day 5 1 tablet TID.
Ergoferon: Safety and Efficiency of Ergoferon in treatment of Influenza
|
Oseltamivir Goup (OG)
n=72 Participants
Oseltamivir(Tamiflu): Safety and Efficiency in treatment of Influenza
|
|---|---|---|
|
Time to Resolution of the Influenza
Fever
|
2.1 Days
Standard Deviation 1.4
|
2.3 Days
Standard Deviation 1.6
|
|
Time to Resolution of the Influenza
Common symptoms
|
2.6 Days
Standard Deviation 2.2
|
2.4 Days
Standard Deviation 2.1
|
|
Time to Resolution of the Influenza
Respiratory symptoms
|
2.7 Days
Standard Deviation 2.5
|
2.6 Days
Standard Deviation 2.6
|
|
Time to Resolution of the Influenza
All influenza symptoms
|
2.6 Days
Standard Deviation 2.3
|
2.5 Days
Standard Deviation 2.2
|
SECONDARY outcome
Timeframe: on days 1, 3 and 7 of the observationPopulation: Per Protocol set
The axillary temperature was assessed during a physical examination at Day 1, 3 and 7; axillary temperature was assessed in degrees (Celsius, °С)
Outcome measures
| Measure |
Ergoferon Group (EG)
n=75 Participants
1 tablet per 1 intake: on day 1 of the treatment 8 tablets (1 tablet every 30 minutes for the first 2 hours, then 1 tablet 3 times a day with equal intervals starting on the same day. From day 2 to day 5 1 tablet TID.
Ergoferon: Safety and Efficiency of Ergoferon in treatment of Influenza
|
Oseltamivir Goup (OG)
n=72 Participants
Oseltamivir(Tamiflu): Safety and Efficiency in treatment of Influenza
|
|---|---|---|
|
Mean Body Temperature
Axillary temperature, Day 1
|
38.3 °C
Standard Deviation 0.4
|
38.3 °C
Standard Deviation 0.4
|
|
Mean Body Temperature
Axillary temperature, Day 3
|
37.0 °C
Standard Deviation 0.5
|
37.0 °C
Standard Deviation 0.5
|
|
Mean Body Temperature
Axillary temperature, Day 7
|
36.5 °C
Standard Deviation 0.2
|
36.6 °C
Standard Deviation 0.3
|
SECONDARY outcome
Timeframe: on days 1, 3 and 7 of the observationPopulation: Per Protocol set
The severity of influenza symptoms was assessed during a physical examination at Day 1, 3 and 7; common (10 symptoms) and respiratory (5 symptoms) symptom's total score was assessed with using the point scale: 0=No symptom; 1=Mild symptom; 2=Moderate symptom ; 3=Severe symptom. The Common Symptoms total score ranged from 0 (no symptoms) to 30 (severe symptoms). The Respiration Symptoms total score ranged from 0 (no symptoms) to 15 (severe symptoms)
Outcome measures
| Measure |
Ergoferon Group (EG)
n=75 Participants
1 tablet per 1 intake: on day 1 of the treatment 8 tablets (1 tablet every 30 minutes for the first 2 hours, then 1 tablet 3 times a day with equal intervals starting on the same day. From day 2 to day 5 1 tablet TID.
Ergoferon: Safety and Efficiency of Ergoferon in treatment of Influenza
|
Oseltamivir Goup (OG)
n=72 Participants
Oseltamivir(Tamiflu): Safety and Efficiency in treatment of Influenza
|
|---|---|---|
|
Severity of Influenza Symptoms (Total Score of the Common Symptoms and Respiratory Symptoms)
Common symptoms, Day 1
|
19.0 Scores on a scale
Standard Deviation 6.7
|
18.6 Scores on a scale
Standard Deviation 6.3
|
|
Severity of Influenza Symptoms (Total Score of the Common Symptoms and Respiratory Symptoms)
Common symptoms, Day 3
|
9.2 Scores on a scale
Standard Deviation 5.1
|
7.8 Scores on a scale
Standard Deviation 4.3
|
|
Severity of Influenza Symptoms (Total Score of the Common Symptoms and Respiratory Symptoms)
Common symptoms, Day 7
|
2.3 Scores on a scale
Standard Deviation 2.7
|
1.9 Scores on a scale
Standard Deviation 2.3
|
|
Severity of Influenza Symptoms (Total Score of the Common Symptoms and Respiratory Symptoms)
Respiratory symptoms, Day 1
|
6.1 Scores on a scale
Standard Deviation 3.7
|
5.9 Scores on a scale
Standard Deviation 3.6
|
|
Severity of Influenza Symptoms (Total Score of the Common Symptoms and Respiratory Symptoms)
Respiratory symptoms, Day 3
|
4.3 Scores on a scale
Standard Deviation 2.4
|
4.0 Scores on a scale
Standard Deviation 2.7
|
|
Severity of Influenza Symptoms (Total Score of the Common Symptoms and Respiratory Symptoms)
Respiratory symptoms, Day 7
|
1.3 Scores on a scale
Standard Deviation 1.5
|
1.4 Scores on a scale
Standard Deviation 1.8
|
SECONDARY outcome
Timeframe: Day 1 to Day 5Population: Per Protocol set
A subject recorded the number of antipyretic intake in patient diary.
Outcome measures
| Measure |
Ergoferon Group (EG)
n=75 Participants
1 tablet per 1 intake: on day 1 of the treatment 8 tablets (1 tablet every 30 minutes for the first 2 hours, then 1 tablet 3 times a day with equal intervals starting on the same day. From day 2 to day 5 1 tablet TID.
Ergoferon: Safety and Efficiency of Ergoferon in treatment of Influenza
|
Oseltamivir Goup (OG)
n=72 Participants
Oseltamivir(Tamiflu): Safety and Efficiency in treatment of Influenza
|
|---|---|---|
|
The Number of the Antipyretic Intake
Day 2
|
0.40 Number of Doses
Standard Deviation 0.49
|
0.49 Number of Doses
Standard Deviation 0.50
|
|
The Number of the Antipyretic Intake
Day 3
|
0.19 Number of Doses
Standard Deviation 0.39
|
0.15 Number of Doses
Standard Deviation 0.36
|
|
The Number of the Antipyretic Intake
Day 1
|
0.65 Number of Doses
Standard Deviation 0.48
|
0.72 Number of Doses
Standard Deviation 0.45
|
|
The Number of the Antipyretic Intake
Day 4
|
0.01 Number of Doses
Standard Deviation 0.12
|
0.03 Number of Doses
Standard Deviation 0.17
|
|
The Number of the Antipyretic Intake
Day 5
|
0.00 Number of Doses
Standard Deviation 0.00
|
0.01 Number of Doses
Standard Deviation 0.12
|
SECONDARY outcome
Timeframe: Day 7 vs. Day 1Population: Per Protocol set
The quality of life was assessed in influenza patients at baseline and at the end of the treatment period using the European Quality of Life Questionnaire (EQ5D) measuring the health status by five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression (each dimension is assessed by 1 to 3 point scale; the minimum score 5 points refers to the best status, 15 points refers to the worst status).
Outcome measures
| Measure |
Ergoferon Group (EG)
n=75 Participants
1 tablet per 1 intake: on day 1 of the treatment 8 tablets (1 tablet every 30 minutes for the first 2 hours, then 1 tablet 3 times a day with equal intervals starting on the same day. From day 2 to day 5 1 tablet TID.
Ergoferon: Safety and Efficiency of Ergoferon in treatment of Influenza
|
Oseltamivir Goup (OG)
n=72 Participants
Oseltamivir(Tamiflu): Safety and Efficiency in treatment of Influenza
|
|---|---|---|
|
Change in the Patient's Quality of Life.
Day 1
|
9.5 Scores on a scale
Standard Deviation 1.9
|
9.4 Scores on a scale
Standard Deviation 2.2
|
|
Change in the Patient's Quality of Life.
Day 7
|
5.4 Scores on a scale
Standard Deviation 0.9
|
5.4 Scores on a scale
Standard Deviation 0.8
|
SECONDARY outcome
Timeframe: Day 7 vs. Day 1Population: Per Protocol set
The patient subjective health status assessment was based on Visual Analogue Scale - VAS). VAS includes a rating of current health status from 0 (worst) to 100 (best).
Outcome measures
| Measure |
Ergoferon Group (EG)
n=75 Participants
1 tablet per 1 intake: on day 1 of the treatment 8 tablets (1 tablet every 30 minutes for the first 2 hours, then 1 tablet 3 times a day with equal intervals starting on the same day. From day 2 to day 5 1 tablet TID.
Ergoferon: Safety and Efficiency of Ergoferon in treatment of Influenza
|
Oseltamivir Goup (OG)
n=72 Participants
Oseltamivir(Tamiflu): Safety and Efficiency in treatment of Influenza
|
|---|---|---|
|
Change in the Subjective Health Status
Day 1
|
41.6 Scores on a scale
Standard Deviation 18.2
|
46.2 Scores on a scale
Standard Deviation 15.4
|
|
Change in the Subjective Health Status
Day 7
|
87.7 Scores on a scale
Standard Deviation 10.7
|
88.0 Scores on a scale
Standard Deviation 10.6
|
SECONDARY outcome
Timeframe: Day 1 to Day 7Population: Per Protocol set
Pneumonia, sinusitis, otitis media are examples of the influenza complications
Outcome measures
| Measure |
Ergoferon Group (EG)
n=75 Participants
1 tablet per 1 intake: on day 1 of the treatment 8 tablets (1 tablet every 30 minutes for the first 2 hours, then 1 tablet 3 times a day with equal intervals starting on the same day. From day 2 to day 5 1 tablet TID.
Ergoferon: Safety and Efficiency of Ergoferon in treatment of Influenza
|
Oseltamivir Goup (OG)
n=72 Participants
Oseltamivir(Tamiflu): Safety and Efficiency in treatment of Influenza
|
|---|---|---|
|
Percentage of Patients With Complications of the Influenza
|
0 Percentage of participants
|
2 Percentage of participants
|
Adverse Events
Ergoferon Group
Serious events: 0 serious events
Other events: 11 other events
Deaths: 0 deaths
Oseltamivir Group
Serious events: 0 serious events
Other events: 15 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Ergoferon Group
n=81 participants at risk
Adults aged 18 to 60 years were on the treatment regimen with Ergoferon for 5 days. 1 tablet per 1 intake: on day 1 of the treatment 8 tablets (1 tablet every 30 minutes for the first 2 hours, then 1 tablet 3 times a day with equal intervals starting on the same day. From day 2 to day 5 1 tablet t.i.d.
|
Oseltamivir Group
n=80 participants at risk
Adults aged 18 to 60 years were on Oseltamivir for 5 days (75 mg b.i.d.).
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Difficulty breathing
|
0.00%
0/81 • Adverse/Serious adverse events were registered from Day 1 to Day 7 and during 30 days after the end of the research
Adverse/Serious adverse events were registered in patients of the Full Analysis Set (n=161, Safety Population)
|
1.2%
1/80 • Number of events 1 • Adverse/Serious adverse events were registered from Day 1 to Day 7 and during 30 days after the end of the research
Adverse/Serious adverse events were registered in patients of the Full Analysis Set (n=161, Safety Population)
|
|
Infections and infestations
Acute pneumonia
|
0.00%
0/81 • Adverse/Serious adverse events were registered from Day 1 to Day 7 and during 30 days after the end of the research
Adverse/Serious adverse events were registered in patients of the Full Analysis Set (n=161, Safety Population)
|
1.2%
1/80 • Number of events 1 • Adverse/Serious adverse events were registered from Day 1 to Day 7 and during 30 days after the end of the research
Adverse/Serious adverse events were registered in patients of the Full Analysis Set (n=161, Safety Population)
|
|
Infections and infestations
Acute sinusitis
|
0.00%
0/81 • Adverse/Serious adverse events were registered from Day 1 to Day 7 and during 30 days after the end of the research
Adverse/Serious adverse events were registered in patients of the Full Analysis Set (n=161, Safety Population)
|
1.2%
1/80 • Number of events 1 • Adverse/Serious adverse events were registered from Day 1 to Day 7 and during 30 days after the end of the research
Adverse/Serious adverse events were registered in patients of the Full Analysis Set (n=161, Safety Population)
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/81 • Adverse/Serious adverse events were registered from Day 1 to Day 7 and during 30 days after the end of the research
Adverse/Serious adverse events were registered in patients of the Full Analysis Set (n=161, Safety Population)
|
2.5%
2/80 • Number of events 2 • Adverse/Serious adverse events were registered from Day 1 to Day 7 and during 30 days after the end of the research
Adverse/Serious adverse events were registered in patients of the Full Analysis Set (n=161, Safety Population)
|
|
Gastrointestinal disorders
Throat burning sensation of
|
1.2%
1/81 • Number of events 1 • Adverse/Serious adverse events were registered from Day 1 to Day 7 and during 30 days after the end of the research
Adverse/Serious adverse events were registered in patients of the Full Analysis Set (n=161, Safety Population)
|
0.00%
0/80 • Adverse/Serious adverse events were registered from Day 1 to Day 7 and during 30 days after the end of the research
Adverse/Serious adverse events were registered in patients of the Full Analysis Set (n=161, Safety Population)
|
|
Gastrointestinal disorders
Abnormal feces
|
1.2%
1/81 • Number of events 1 • Adverse/Serious adverse events were registered from Day 1 to Day 7 and during 30 days after the end of the research
Adverse/Serious adverse events were registered in patients of the Full Analysis Set (n=161, Safety Population)
|
0.00%
0/80 • Adverse/Serious adverse events were registered from Day 1 to Day 7 and during 30 days after the end of the research
Adverse/Serious adverse events were registered in patients of the Full Analysis Set (n=161, Safety Population)
|
|
Psychiatric disorders
Depression
|
0.00%
0/81 • Adverse/Serious adverse events were registered from Day 1 to Day 7 and during 30 days after the end of the research
Adverse/Serious adverse events were registered in patients of the Full Analysis Set (n=161, Safety Population)
|
1.2%
1/80 • Number of events 1 • Adverse/Serious adverse events were registered from Day 1 to Day 7 and during 30 days after the end of the research
Adverse/Serious adverse events were registered in patients of the Full Analysis Set (n=161, Safety Population)
|
|
Blood and lymphatic system disorders
Monocytosis
|
1.2%
1/81 • Number of events 1 • Adverse/Serious adverse events were registered from Day 1 to Day 7 and during 30 days after the end of the research
Adverse/Serious adverse events were registered in patients of the Full Analysis Set (n=161, Safety Population)
|
1.2%
1/80 • Number of events 1 • Adverse/Serious adverse events were registered from Day 1 to Day 7 and during 30 days after the end of the research
Adverse/Serious adverse events were registered in patients of the Full Analysis Set (n=161, Safety Population)
|
|
Blood and lymphatic system disorders
Lymphocytosis
|
0.00%
0/81 • Adverse/Serious adverse events were registered from Day 1 to Day 7 and during 30 days after the end of the research
Adverse/Serious adverse events were registered in patients of the Full Analysis Set (n=161, Safety Population)
|
1.2%
1/80 • Number of events 1 • Adverse/Serious adverse events were registered from Day 1 to Day 7 and during 30 days after the end of the research
Adverse/Serious adverse events were registered in patients of the Full Analysis Set (n=161, Safety Population)
|
|
Blood and lymphatic system disorders
Thrombocytosis
|
1.2%
1/81 • Number of events 1 • Adverse/Serious adverse events were registered from Day 1 to Day 7 and during 30 days after the end of the research
Adverse/Serious adverse events were registered in patients of the Full Analysis Set (n=161, Safety Population)
|
0.00%
0/80 • Adverse/Serious adverse events were registered from Day 1 to Day 7 and during 30 days after the end of the research
Adverse/Serious adverse events were registered in patients of the Full Analysis Set (n=161, Safety Population)
|
|
Blood and lymphatic system disorders
Granulocytopenia
|
1.2%
1/81 • Number of events 1 • Adverse/Serious adverse events were registered from Day 1 to Day 7 and during 30 days after the end of the research
Adverse/Serious adverse events were registered in patients of the Full Analysis Set (n=161, Safety Population)
|
1.2%
1/80 • Number of events 1 • Adverse/Serious adverse events were registered from Day 1 to Day 7 and during 30 days after the end of the research
Adverse/Serious adverse events were registered in patients of the Full Analysis Set (n=161, Safety Population)
|
|
Blood and lymphatic system disorders
Leukopenia
|
1.2%
1/81 • Number of events 1 • Adverse/Serious adverse events were registered from Day 1 to Day 7 and during 30 days after the end of the research
Adverse/Serious adverse events were registered in patients of the Full Analysis Set (n=161, Safety Population)
|
0.00%
0/80 • Adverse/Serious adverse events were registered from Day 1 to Day 7 and during 30 days after the end of the research
Adverse/Serious adverse events were registered in patients of the Full Analysis Set (n=161, Safety Population)
|
|
Blood and lymphatic system disorders
Eosinophilia
|
0.00%
0/81 • Adverse/Serious adverse events were registered from Day 1 to Day 7 and during 30 days after the end of the research
Adverse/Serious adverse events were registered in patients of the Full Analysis Set (n=161, Safety Population)
|
1.2%
1/80 • Number of events 1 • Adverse/Serious adverse events were registered from Day 1 to Day 7 and during 30 days after the end of the research
Adverse/Serious adverse events were registered in patients of the Full Analysis Set (n=161, Safety Population)
|
|
Renal and urinary disorders
Urine mucous
|
3.7%
3/81 • Number of events 3 • Adverse/Serious adverse events were registered from Day 1 to Day 7 and during 30 days after the end of the research
Adverse/Serious adverse events were registered in patients of the Full Analysis Set (n=161, Safety Population)
|
1.2%
1/80 • Number of events 1 • Adverse/Serious adverse events were registered from Day 1 to Day 7 and during 30 days after the end of the research
Adverse/Serious adverse events were registered in patients of the Full Analysis Set (n=161, Safety Population)
|
|
Renal and urinary disorders
Proteinuria
|
4.9%
4/81 • Number of events 4 • Adverse/Serious adverse events were registered from Day 1 to Day 7 and during 30 days after the end of the research
Adverse/Serious adverse events were registered in patients of the Full Analysis Set (n=161, Safety Population)
|
5.0%
4/80 • Number of events 4 • Adverse/Serious adverse events were registered from Day 1 to Day 7 and during 30 days after the end of the research
Adverse/Serious adverse events were registered in patients of the Full Analysis Set (n=161, Safety Population)
|
|
Renal and urinary disorders
Glycosuria
|
1.2%
1/81 • Number of events 1 • Adverse/Serious adverse events were registered from Day 1 to Day 7 and during 30 days after the end of the research
Adverse/Serious adverse events were registered in patients of the Full Analysis Set (n=161, Safety Population)
|
0.00%
0/80 • Adverse/Serious adverse events were registered from Day 1 to Day 7 and during 30 days after the end of the research
Adverse/Serious adverse events were registered in patients of the Full Analysis Set (n=161, Safety Population)
|
|
Investigations
Urine white blood cells increased
|
2.5%
2/81 • Number of events 2 • Adverse/Serious adverse events were registered from Day 1 to Day 7 and during 30 days after the end of the research
Adverse/Serious adverse events were registered in patients of the Full Analysis Set (n=161, Safety Population)
|
1.2%
1/80 • Number of events 1 • Adverse/Serious adverse events were registered from Day 1 to Day 7 and during 30 days after the end of the research
Adverse/Serious adverse events were registered in patients of the Full Analysis Set (n=161, Safety Population)
|
|
Investigations
Urine red blood cells increased
|
2.5%
2/81 • Number of events 2 • Adverse/Serious adverse events were registered from Day 1 to Day 7 and during 30 days after the end of the research
Adverse/Serious adverse events were registered in patients of the Full Analysis Set (n=161, Safety Population)
|
2.5%
2/80 • Number of events 2 • Adverse/Serious adverse events were registered from Day 1 to Day 7 and during 30 days after the end of the research
Adverse/Serious adverse events were registered in patients of the Full Analysis Set (n=161, Safety Population)
|
|
Investigations
Crystal urine
|
1.2%
1/81 • Number of events 1 • Adverse/Serious adverse events were registered from Day 1 to Day 7 and during 30 days after the end of the research
Adverse/Serious adverse events were registered in patients of the Full Analysis Set (n=161, Safety Population)
|
0.00%
0/80 • Adverse/Serious adverse events were registered from Day 1 to Day 7 and during 30 days after the end of the research
Adverse/Serious adverse events were registered in patients of the Full Analysis Set (n=161, Safety Population)
|
|
Investigations
Bacteria urine
|
2.5%
2/81 • Number of events 2 • Adverse/Serious adverse events were registered from Day 1 to Day 7 and during 30 days after the end of the research
Adverse/Serious adverse events were registered in patients of the Full Analysis Set (n=161, Safety Population)
|
1.2%
1/80 • Number of events 1 • Adverse/Serious adverse events were registered from Day 1 to Day 7 and during 30 days after the end of the research
Adverse/Serious adverse events were registered in patients of the Full Analysis Set (n=161, Safety Population)
|
|
Investigations
Specific gravity urine increased
|
0.00%
0/81 • Adverse/Serious adverse events were registered from Day 1 to Day 7 and during 30 days after the end of the research
Adverse/Serious adverse events were registered in patients of the Full Analysis Set (n=161, Safety Population)
|
1.2%
1/80 • Number of events 1 • Adverse/Serious adverse events were registered from Day 1 to Day 7 and during 30 days after the end of the research
Adverse/Serious adverse events were registered in patients of the Full Analysis Set (n=161, Safety Population)
|
|
Investigations
Transaminases increased
|
1.2%
1/81 • Number of events 1 • Adverse/Serious adverse events were registered from Day 1 to Day 7 and during 30 days after the end of the research
Adverse/Serious adverse events were registered in patients of the Full Analysis Set (n=161, Safety Population)
|
1.2%
1/80 • Number of events 1 • Adverse/Serious adverse events were registered from Day 1 to Day 7 and during 30 days after the end of the research
Adverse/Serious adverse events were registered in patients of the Full Analysis Set (n=161, Safety Population)
|
|
Investigations
Bilirubin increased
|
2.5%
2/81 • Number of events 2 • Adverse/Serious adverse events were registered from Day 1 to Day 7 and during 30 days after the end of the research
Adverse/Serious adverse events were registered in patients of the Full Analysis Set (n=161, Safety Population)
|
0.00%
0/80 • Adverse/Serious adverse events were registered from Day 1 to Day 7 and during 30 days after the end of the research
Adverse/Serious adverse events were registered in patients of the Full Analysis Set (n=161, Safety Population)
|
|
Investigations
Blood monocytes increased
|
1.2%
1/81 • Number of events 1 • Adverse/Serious adverse events were registered from Day 1 to Day 7 and during 30 days after the end of the research
Adverse/Serious adverse events were registered in patients of the Full Analysis Set (n=161, Safety Population)
|
0.00%
0/80 • Adverse/Serious adverse events were registered from Day 1 to Day 7 and during 30 days after the end of the research
Adverse/Serious adverse events were registered in patients of the Full Analysis Set (n=161, Safety Population)
|
|
Investigations
ESR increased
|
0.00%
0/81 • Adverse/Serious adverse events were registered from Day 1 to Day 7 and during 30 days after the end of the research
Adverse/Serious adverse events were registered in patients of the Full Analysis Set (n=161, Safety Population)
|
1.2%
1/80 • Number of events 1 • Adverse/Serious adverse events were registered from Day 1 to Day 7 and during 30 days after the end of the research
Adverse/Serious adverse events were registered in patients of the Full Analysis Set (n=161, Safety Population)
|
Additional Information
Mikhail Putilovskiy, MD, PhD, Head of department of clinical trials
Materia Medica Holding
Phone: +74952761575
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: OTHER