Trial Outcomes & Findings for Clinical Trial of Safety and Efficacy of Afalaza in Patients With Symptoms of Benign Prostatic Hyperplasia and Risk of Progression (NCT NCT01716104)
NCT ID: NCT01716104
Last Updated: 2018-11-28
Results Overview
The International Prostate Symptom Score (IPSS) is based on the answers to 7 questions concerning urinary symptoms plus one question concerning quality of life (QoL). Each of the seven symptoms includes the assignment of scores from 0 to 5. The total score can therefore range from 0 to 35 points (asymptomatic to very symptomatic). The patient's quality of life (QoL) was evaluated separately in this clinical study.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
260 participants
Primary outcome timeframe
Baseline, 1, 3, 6 and 12 months
Results posted on
2018-11-28
Participant Flow
Selection procedures were carried out after participant enrollment to determine whether the patient could participate in the study in accordance with the inclusion criteria. Of the 260 patients enrolled, 11 did not meet inclusion criteria after screening procedures, they were not randomized.
Participant milestones
| Measure |
Afalaza
Afalaza (2 tablets twice a day) One tablet contains: affinity purified antibodies to endothelial nitric oxide synthase - 0.006g\*, affinity purified antibodies to prostate-specific antigen - 0.006g\*.
\*applied onto isomalt crystals as a mixture of three active aqueous-alcoholic dilutions of the drug substance - diluted 100\^12, 100\^30, 100\^50 times, respectively.
Excipients: lactose monohydrate; microcrystalline cellulose; magnesium stearate.
|
Placebo
Placebo (2 tablets twice a day)
|
|---|---|---|
|
Overall Study
STARTED
|
125
|
124
|
|
Overall Study
COMPLETED
|
119
|
117
|
|
Overall Study
NOT COMPLETED
|
6
|
7
|
Reasons for withdrawal
| Measure |
Afalaza
Afalaza (2 tablets twice a day) One tablet contains: affinity purified antibodies to endothelial nitric oxide synthase - 0.006g\*, affinity purified antibodies to prostate-specific antigen - 0.006g\*.
\*applied onto isomalt crystals as a mixture of three active aqueous-alcoholic dilutions of the drug substance - diluted 100\^12, 100\^30, 100\^50 times, respectively.
Excipients: lactose monohydrate; microcrystalline cellulose; magnesium stearate.
|
Placebo
Placebo (2 tablets twice a day)
|
|---|---|---|
|
Overall Study
Do not meet inclusion criteria
|
6
|
7
|
Baseline Characteristics
Clinical Trial of Safety and Efficacy of Afalaza in Patients With Symptoms of Benign Prostatic Hyperplasia and Risk of Progression
Baseline characteristics by cohort
| Measure |
Afalaza
n=119 Participants
Afalaza (2 tablets twice a day): Safety and Efficiency
|
Placebo
n=117 Participants
Placebo (2 tablets twice a day): Safety and Efficiency
|
Total
n=236 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
54.3 years
STANDARD_DEVIATION 4.2 • n=99 Participants
|
54.4 years
STANDARD_DEVIATION 4.4 • n=107 Participants
|
54.4 years
STANDARD_DEVIATION 4.3 • n=206 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
119 Participants
n=99 Participants
|
117 Participants
n=107 Participants
|
236 Participants
n=206 Participants
|
|
Region of Enrollment
Ukraine
|
1 participants
n=99 Participants
|
3 participants
n=107 Participants
|
4 participants
n=206 Participants
|
|
Region of Enrollment
Russia
|
118 participants
n=99 Participants
|
114 participants
n=107 Participants
|
232 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Baseline, 1, 3, 6 and 12 monthsPopulation: ITT set
The International Prostate Symptom Score (IPSS) is based on the answers to 7 questions concerning urinary symptoms plus one question concerning quality of life (QoL). Each of the seven symptoms includes the assignment of scores from 0 to 5. The total score can therefore range from 0 to 35 points (asymptomatic to very symptomatic). The patient's quality of life (QoL) was evaluated separately in this clinical study.
Outcome measures
| Measure |
Afalaza
n=119 Participants
Afalaza (2 tablets twice a day): Safety and Efficacy
|
Placebo
n=117 Participants
Placebo (2 tablets twice a day): Safety and Efficacy
|
|---|---|---|
|
Change in Total IPSS Scores (International Prostate Symptome Score) After 1, 3, 6 and 12 Months Compared to Baseline.
Month 1
|
-1.3 Scores on a scale
Standard Deviation 1.7
|
-0.6 Scores on a scale
Standard Deviation 1.3
|
|
Change in Total IPSS Scores (International Prostate Symptome Score) After 1, 3, 6 and 12 Months Compared to Baseline.
Month 3
|
-2.3 Scores on a scale
Standard Deviation 2.1
|
-1.5 Scores on a scale
Standard Deviation 1.9
|
|
Change in Total IPSS Scores (International Prostate Symptome Score) After 1, 3, 6 and 12 Months Compared to Baseline.
Month 6
|
-3.0 Scores on a scale
Standard Deviation 2.5
|
-1.9 Scores on a scale
Standard Deviation 2.5
|
|
Change in Total IPSS Scores (International Prostate Symptome Score) After 1, 3, 6 and 12 Months Compared to Baseline.
Month 12
|
-3.7 Scores on a scale
Standard Deviation 3.0
|
-2.9 Scores on a scale
Standard Deviation 2.4
|
SECONDARY outcome
Timeframe: Baseline and 1, 3, 6, 12 monthsPopulation: ITT set
The International Prostate Symptom Score (IPSS) is based on the answers to 7 questions concerning urinary symptoms plus one question concerning quality of life (QoL). Each of the seven symptoms includes the assignment of scores from 0 to 5. The total score can therefore range from 0 to 35 points (asymptomatic to very symptomatic). The patient's quality of life (QoL) was evaluated separately in this clinical study. The sum of IPSS questions 2, 4, and 7 related to irritative symptoms. The total score of irritative symptoms can therefore range from 0 to 15 points (asymptomatic to very symptomatic).
Outcome measures
| Measure |
Afalaza
n=119 Participants
Afalaza (2 tablets twice a day): Safety and Efficacy
|
Placebo
n=117 Participants
Placebo (2 tablets twice a day): Safety and Efficacy
|
|---|---|---|
|
Change in Dynamics of Irritative Symptoms Evaluated by IPSS (International Prostate Symptome Score) After 1, 3, 6 and 12 Months Compared to Baseline
Month 1
|
-0.5 Scores on a scale
Standard Deviation 0.9
|
-0.3 Scores on a scale
Standard Deviation 1.1
|
|
Change in Dynamics of Irritative Symptoms Evaluated by IPSS (International Prostate Symptome Score) After 1, 3, 6 and 12 Months Compared to Baseline
Month 3
|
-0.9 Scores on a scale
Standard Deviation 1.2
|
-0.6 Scores on a scale
Standard Deviation 1.2
|
|
Change in Dynamics of Irritative Symptoms Evaluated by IPSS (International Prostate Symptome Score) After 1, 3, 6 and 12 Months Compared to Baseline
Month 6
|
-1.3 Scores on a scale
Standard Deviation 1.5
|
-0.8 Scores on a scale
Standard Deviation 1.4
|
|
Change in Dynamics of Irritative Symptoms Evaluated by IPSS (International Prostate Symptome Score) After 1, 3, 6 and 12 Months Compared to Baseline
Month 12
|
-1.5 Scores on a scale
Standard Deviation 1.6
|
-1.3 Scores on a scale
Standard Deviation 1.5
|
SECONDARY outcome
Timeframe: Baseline and 1, 3, 6 and 12 monthsPopulation: ITT set
Outcome measures
| Measure |
Afalaza
n=119 Participants
Afalaza (2 tablets twice a day): Safety and Efficacy
|
Placebo
n=117 Participants
Placebo (2 tablets twice a day): Safety and Efficacy
|
|---|---|---|
|
Change in Maximum Urinary Flow Rate After 1, 3, 6 and 12 Months Compared to Baseline
Month 1
|
1.3 ml/s
Standard Deviation 3.2
|
0.2 ml/s
Standard Deviation 2.6
|
|
Change in Maximum Urinary Flow Rate After 1, 3, 6 and 12 Months Compared to Baseline
Month 3
|
1.5 ml/s
Standard Deviation 3.2
|
0.7 ml/s
Standard Deviation 3.3
|
|
Change in Maximum Urinary Flow Rate After 1, 3, 6 and 12 Months Compared to Baseline
Month 6
|
1.7 ml/s
Standard Deviation 3.2
|
0.5 ml/s
Standard Deviation 2.7
|
|
Change in Maximum Urinary Flow Rate After 1, 3, 6 and 12 Months Compared to Baseline
Month 12
|
2.5 ml/s
Standard Deviation 4.3
|
1.4 ml/s
Standard Deviation 3.3
|
SECONDARY outcome
Timeframe: Baseline and 1, 3, 6 and 12 monthsPopulation: ITT set
Outcome measures
| Measure |
Afalaza
n=119 Participants
Afalaza (2 tablets twice a day): Safety and Efficacy
|
Placebo
n=117 Participants
Placebo (2 tablets twice a day): Safety and Efficacy
|
|---|---|---|
|
Change in Average Urinary Flow Rate After 1, 3, 6 and 12 Months Compared to Baseline
Month 1
|
0.9 ml/s
Standard Deviation 2.0
|
0.2 ml/s
Standard Deviation 1.9
|
|
Change in Average Urinary Flow Rate After 1, 3, 6 and 12 Months Compared to Baseline
Month 3
|
1.3 ml/s
Standard Deviation 2.1
|
0.7 ml/s
Standard Deviation 2.5
|
|
Change in Average Urinary Flow Rate After 1, 3, 6 and 12 Months Compared to Baseline
Month 6
|
1.4 ml/s
Standard Deviation 2.0
|
0.5 ml/s
Standard Deviation 2.2
|
|
Change in Average Urinary Flow Rate After 1, 3, 6 and 12 Months Compared to Baseline
Month 12
|
1.4 ml/s
Standard Deviation 2.2
|
0.6 ml/s
Standard Deviation 2.5
|
SECONDARY outcome
Timeframe: Baseline and 3, 6 and 12 monthsPopulation: ITT set
Change in the volume of the prostate gland as a percentage of the baseline according to transrectal ultrasound
Outcome measures
| Measure |
Afalaza
n=119 Participants
Afalaza (2 tablets twice a day): Safety and Efficacy
|
Placebo
n=117 Participants
Placebo (2 tablets twice a day): Safety and Efficacy
|
|---|---|---|
|
Percent Change in Mean Values of Prostate Gland Volume at 3, 6 and 12 Months Compared to Baseline
Month 12
|
-11.8 percentage of prostate gland volume
Standard Deviation 16.0
|
-6.5 percentage of prostate gland volume
Standard Deviation 14.7
|
|
Percent Change in Mean Values of Prostate Gland Volume at 3, 6 and 12 Months Compared to Baseline
Month 3
|
-6.6 percentage of prostate gland volume
Standard Deviation 13.1
|
-2.9 percentage of prostate gland volume
Standard Deviation 12.5
|
|
Percent Change in Mean Values of Prostate Gland Volume at 3, 6 and 12 Months Compared to Baseline
Month 6
|
-10.0 percentage of prostate gland volume
Standard Deviation 13.4
|
-4.9 percentage of prostate gland volume
Standard Deviation 14.1
|
SECONDARY outcome
Timeframe: Baseline and 3, 6 and 12 monthsPopulation: ITT set
Outcome measures
| Measure |
Afalaza
n=119 Participants
Afalaza (2 tablets twice a day): Safety and Efficacy
|
Placebo
n=117 Participants
Placebo (2 tablets twice a day): Safety and Efficacy
|
|---|---|---|
|
Change in Mean Values of Micturition Volume at 3, 6 and 12 Months Compared to Baseline
Month 3
|
14.6 ml
Standard Deviation 105.0
|
1.4 ml
Standard Deviation 76.8
|
|
Change in Mean Values of Micturition Volume at 3, 6 and 12 Months Compared to Baseline
Month 6
|
27.5 ml
Standard Deviation 96.6
|
5.0 ml
Standard Deviation 88.4
|
|
Change in Mean Values of Micturition Volume at 3, 6 and 12 Months Compared to Baseline
Month 12
|
17.9 ml
Standard Deviation 106.0
|
0.4 ml
Standard Deviation 71.2
|
SECONDARY outcome
Timeframe: Baseline and 3, 6 and 12 monthsPopulation: ITT set
according to transabdominal ultrasound
Outcome measures
| Measure |
Afalaza
n=119 Participants
Afalaza (2 tablets twice a day): Safety and Efficacy
|
Placebo
n=117 Participants
Placebo (2 tablets twice a day): Safety and Efficacy
|
|---|---|---|
|
Change in the Mean Values of Residual Urine Volume at 3, 6 and 12 Months Compared to Baseline
Month 3
|
-6.5 ml
Standard Deviation 26.5
|
-0.9 ml
Standard Deviation 21.6
|
|
Change in the Mean Values of Residual Urine Volume at 3, 6 and 12 Months Compared to Baseline
Month 6
|
-8.8 ml
Standard Deviation 28.1
|
-4.3 ml
Standard Deviation 20.9
|
|
Change in the Mean Values of Residual Urine Volume at 3, 6 and 12 Months Compared to Baseline
Month 12
|
-8.0 ml
Standard Deviation 30.1
|
-3.5 ml
Standard Deviation 26.9
|
SECONDARY outcome
Timeframe: Baseline and 3, 6 and 12 monthsPopulation: ITT set
Quality of life (QoL) Due to Urinary Symptoms is an eight point of the IPSS scale referred to the patient's quality of life. The answers to this question range from "delighted" to "terrible" or 0 to 5.
Outcome measures
| Measure |
Afalaza
n=119 Participants
Afalaza (2 tablets twice a day): Safety and Efficacy
|
Placebo
n=117 Participants
Placebo (2 tablets twice a day): Safety and Efficacy
|
|---|---|---|
|
Change in Quality of Life (QoL Index of IPSS) at 3, 6 and 12 Months Compared to Baseline
Month 3
|
-0.4 Scores on a scale
Standard Deviation 0.8
|
-0.4 Scores on a scale
Standard Deviation 0.7
|
|
Change in Quality of Life (QoL Index of IPSS) at 3, 6 and 12 Months Compared to Baseline
Month 6
|
-0.7 Scores on a scale
Standard Deviation 0.8
|
-0.5 Scores on a scale
Standard Deviation 1.0
|
|
Change in Quality of Life (QoL Index of IPSS) at 3, 6 and 12 Months Compared to Baseline
Month 12
|
-1.0 Scores on a scale
Standard Deviation 1.0
|
-0.6 Scores on a scale
Standard Deviation 1.2
|
SECONDARY outcome
Timeframe: Baseline and 3, 6 and 12 monthsPopulation: ITT set
To assess the risk of BPH progression, the following were used: 1) moderate to severe BPH symptoms (ie, IPSS total score\> 7); 2) an increase in the volume of the prostate gland (\> 30 cm\^2); 3) increased PSA level in the blood (≥ 1.4 ng / ml); 4) a decrease in Qmax (\<12 ml / s) and 5) a large volume of residual urine (\> 200 ml). The total value of risk factors for progression is assessed as the sum of the risk factors that the patient had at the time of inclusion in the study (presence of risk factors = 1 point, absence = 0 points). After 3, 6 and 12 months of treatment, the dynamics of risk factors for progression was assessed: an increase in the severity of the risk factor meant +1, no change = 0, a decrease in the severity of the risk factor of -1.
Outcome measures
| Measure |
Afalaza
n=119 Participants
Afalaza (2 tablets twice a day): Safety and Efficacy
|
Placebo
n=117 Participants
Placebo (2 tablets twice a day): Safety and Efficacy
|
|---|---|---|
|
Change in Total Value of Risk Factors for Progression (Total Score of IPSS, Prostate Volume, PSA Level, Maximum Urinary Flow Rate, Residual Urine Volume) Compared to Baseline
Month 3
|
-0.9 Scores
Standard Deviation 0.9
|
-0.7 Scores
Standard Deviation 0.8
|
|
Change in Total Value of Risk Factors for Progression (Total Score of IPSS, Prostate Volume, PSA Level, Maximum Urinary Flow Rate, Residual Urine Volume) Compared to Baseline
Month 6
|
-0.7 Scores
Standard Deviation 1.0
|
-0.4 Scores
Standard Deviation 0.8
|
|
Change in Total Value of Risk Factors for Progression (Total Score of IPSS, Prostate Volume, PSA Level, Maximum Urinary Flow Rate, Residual Urine Volume) Compared to Baseline
Month 12
|
-1.0 Scores
Standard Deviation 1.0
|
-0.6 Scores
Standard Deviation 1.0
|
SECONDARY outcome
Timeframe: 12 monthsPopulation: ITT set
Outcome measures
| Measure |
Afalaza
n=119 Participants
Afalaza (2 tablets twice a day): Safety and Efficacy
|
Placebo
n=117 Participants
Placebo (2 tablets twice a day): Safety and Efficacy
|
|---|---|---|
|
Number of Episodes of Acute Urinary Retention, Surgical Intervention During the Observation Period
|
0 episodes
|
0 episodes
|
Adverse Events
Afalaza
Serious events: 0 serious events
Other events: 25 other events
Deaths: 0 deaths
Placebo
Serious events: 1 serious events
Other events: 29 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Afalaza
n=125 participants at risk
Afalaza (2 tablets twice a day): Safety and Efficiency
|
Placebo
n=124 participants at risk
Placebo (2 tablets twice a day): Safety and Efficiency
|
|---|---|---|
|
Musculoskeletal and connective tissue disorders
Arthralgia/Meniscus injury/Meniscus operation
|
0.00%
0/125 • Adverse/Serious adverse events were registered during 12 months of therapy and 30 days after the end of the research
Adverse/Serious adverse events were registered in patients of the Full Analysis Set (n=249, Safety Population)
|
0.81%
1/124 • Number of events 1 • Adverse/Serious adverse events were registered during 12 months of therapy and 30 days after the end of the research
Adverse/Serious adverse events were registered in patients of the Full Analysis Set (n=249, Safety Population)
|
Other adverse events
| Measure |
Afalaza
n=125 participants at risk
Afalaza (2 tablets twice a day): Safety and Efficiency
|
Placebo
n=124 participants at risk
Placebo (2 tablets twice a day): Safety and Efficiency
|
|---|---|---|
|
Investigations
Prostatic specific antigen increased
|
3.2%
4/125 • Adverse/Serious adverse events were registered during 12 months of therapy and 30 days after the end of the research
Adverse/Serious adverse events were registered in patients of the Full Analysis Set (n=249, Safety Population)
|
4.8%
6/124 • Adverse/Serious adverse events were registered during 12 months of therapy and 30 days after the end of the research
Adverse/Serious adverse events were registered in patients of the Full Analysis Set (n=249, Safety Population)
|
|
Gastrointestinal disorders
Epigastric pain
|
0.80%
1/125 • Adverse/Serious adverse events were registered during 12 months of therapy and 30 days after the end of the research
Adverse/Serious adverse events were registered in patients of the Full Analysis Set (n=249, Safety Population)
|
0.00%
0/124 • Adverse/Serious adverse events were registered during 12 months of therapy and 30 days after the end of the research
Adverse/Serious adverse events were registered in patients of the Full Analysis Set (n=249, Safety Population)
|
|
Gastrointestinal disorders
Right-sided inguinal hernia
|
0.80%
1/125 • Adverse/Serious adverse events were registered during 12 months of therapy and 30 days after the end of the research
Adverse/Serious adverse events were registered in patients of the Full Analysis Set (n=249, Safety Population)
|
0.00%
0/124 • Adverse/Serious adverse events were registered during 12 months of therapy and 30 days after the end of the research
Adverse/Serious adverse events were registered in patients of the Full Analysis Set (n=249, Safety Population)
|
|
Gastrointestinal disorders
Diarrhea
|
0.80%
1/125 • Adverse/Serious adverse events were registered during 12 months of therapy and 30 days after the end of the research
Adverse/Serious adverse events were registered in patients of the Full Analysis Set (n=249, Safety Population)
|
0.00%
0/124 • Adverse/Serious adverse events were registered during 12 months of therapy and 30 days after the end of the research
Adverse/Serious adverse events were registered in patients of the Full Analysis Set (n=249, Safety Population)
|
|
Gastrointestinal disorders
Heartburn
|
0.00%
0/125 • Adverse/Serious adverse events were registered during 12 months of therapy and 30 days after the end of the research
Adverse/Serious adverse events were registered in patients of the Full Analysis Set (n=249, Safety Population)
|
0.81%
1/124 • Adverse/Serious adverse events were registered during 12 months of therapy and 30 days after the end of the research
Adverse/Serious adverse events were registered in patients of the Full Analysis Set (n=249, Safety Population)
|
|
Gastrointestinal disorders
Swollen tongue
|
0.00%
0/125 • Adverse/Serious adverse events were registered during 12 months of therapy and 30 days after the end of the research
Adverse/Serious adverse events were registered in patients of the Full Analysis Set (n=249, Safety Population)
|
0.81%
1/124 • Adverse/Serious adverse events were registered during 12 months of therapy and 30 days after the end of the research
Adverse/Serious adverse events were registered in patients of the Full Analysis Set (n=249, Safety Population)
|
|
Gastrointestinal disorders
Nausea
|
0.80%
1/125 • Adverse/Serious adverse events were registered during 12 months of therapy and 30 days after the end of the research
Adverse/Serious adverse events were registered in patients of the Full Analysis Set (n=249, Safety Population)
|
1.6%
2/124 • Adverse/Serious adverse events were registered during 12 months of therapy and 30 days after the end of the research
Adverse/Serious adverse events were registered in patients of the Full Analysis Set (n=249, Safety Population)
|
|
Gastrointestinal disorders
Chronic gastritis, exacerbation
|
0.00%
0/125 • Adverse/Serious adverse events were registered during 12 months of therapy and 30 days after the end of the research
Adverse/Serious adverse events were registered in patients of the Full Analysis Set (n=249, Safety Population)
|
0.81%
1/124 • Adverse/Serious adverse events were registered during 12 months of therapy and 30 days after the end of the research
Adverse/Serious adverse events were registered in patients of the Full Analysis Set (n=249, Safety Population)
|
|
General disorders
Asthenia and Depressive weariness
|
0.00%
0/125 • Adverse/Serious adverse events were registered during 12 months of therapy and 30 days after the end of the research
Adverse/Serious adverse events were registered in patients of the Full Analysis Set (n=249, Safety Population)
|
0.81%
1/124 • Adverse/Serious adverse events were registered during 12 months of therapy and 30 days after the end of the research
Adverse/Serious adverse events were registered in patients of the Full Analysis Set (n=249, Safety Population)
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/125 • Adverse/Serious adverse events were registered during 12 months of therapy and 30 days after the end of the research
Adverse/Serious adverse events were registered in patients of the Full Analysis Set (n=249, Safety Population)
|
0.81%
1/124 • Adverse/Serious adverse events were registered during 12 months of therapy and 30 days after the end of the research
Adverse/Serious adverse events were registered in patients of the Full Analysis Set (n=249, Safety Population)
|
|
Infections and infestations
Urinary tract infection
|
0.80%
1/125 • Adverse/Serious adverse events were registered during 12 months of therapy and 30 days after the end of the research
Adverse/Serious adverse events were registered in patients of the Full Analysis Set (n=249, Safety Population)
|
0.00%
0/124 • Adverse/Serious adverse events were registered during 12 months of therapy and 30 days after the end of the research
Adverse/Serious adverse events were registered in patients of the Full Analysis Set (n=249, Safety Population)
|
|
Infections and infestations
Labial herpes
|
0.80%
1/125 • Adverse/Serious adverse events were registered during 12 months of therapy and 30 days after the end of the research
Adverse/Serious adverse events were registered in patients of the Full Analysis Set (n=249, Safety Population)
|
0.00%
0/124 • Adverse/Serious adverse events were registered during 12 months of therapy and 30 days after the end of the research
Adverse/Serious adverse events were registered in patients of the Full Analysis Set (n=249, Safety Population)
|
|
Infections and infestations
Acute respiratory viral infection
|
7.2%
9/125 • Adverse/Serious adverse events were registered during 12 months of therapy and 30 days after the end of the research
Adverse/Serious adverse events were registered in patients of the Full Analysis Set (n=249, Safety Population)
|
8.1%
10/124 • Adverse/Serious adverse events were registered during 12 months of therapy and 30 days after the end of the research
Adverse/Serious adverse events were registered in patients of the Full Analysis Set (n=249, Safety Population)
|
|
Infections and infestations
Acute bronchitis
|
0.80%
1/125 • Adverse/Serious adverse events were registered during 12 months of therapy and 30 days after the end of the research
Adverse/Serious adverse events were registered in patients of the Full Analysis Set (n=249, Safety Population)
|
0.00%
0/124 • Adverse/Serious adverse events were registered during 12 months of therapy and 30 days after the end of the research
Adverse/Serious adverse events were registered in patients of the Full Analysis Set (n=249, Safety Population)
|
|
Infections and infestations
Rhinitis
|
0.00%
0/125 • Adverse/Serious adverse events were registered during 12 months of therapy and 30 days after the end of the research
Adverse/Serious adverse events were registered in patients of the Full Analysis Set (n=249, Safety Population)
|
1.6%
2/124 • Adverse/Serious adverse events were registered during 12 months of therapy and 30 days after the end of the research
Adverse/Serious adverse events were registered in patients of the Full Analysis Set (n=249, Safety Population)
|
|
Infections and infestations
Pharyngitis
|
0.80%
1/125 • Adverse/Serious adverse events were registered during 12 months of therapy and 30 days after the end of the research
Adverse/Serious adverse events were registered in patients of the Full Analysis Set (n=249, Safety Population)
|
0.00%
0/124 • Adverse/Serious adverse events were registered during 12 months of therapy and 30 days after the end of the research
Adverse/Serious adverse events were registered in patients of the Full Analysis Set (n=249, Safety Population)
|
|
Investigations
Blood pressure increased
|
0.00%
0/125 • Adverse/Serious adverse events were registered during 12 months of therapy and 30 days after the end of the research
Adverse/Serious adverse events were registered in patients of the Full Analysis Set (n=249, Safety Population)
|
0.81%
1/124 • Adverse/Serious adverse events were registered during 12 months of therapy and 30 days after the end of the research
Adverse/Serious adverse events were registered in patients of the Full Analysis Set (n=249, Safety Population)
|
|
Nervous system disorders
Headache
|
0.80%
1/125 • Adverse/Serious adverse events were registered during 12 months of therapy and 30 days after the end of the research
Adverse/Serious adverse events were registered in patients of the Full Analysis Set (n=249, Safety Population)
|
4.0%
5/124 • Adverse/Serious adverse events were registered during 12 months of therapy and 30 days after the end of the research
Adverse/Serious adverse events were registered in patients of the Full Analysis Set (n=249, Safety Population)
|
|
Respiratory, thoracic and mediastinal disorders
Vasomotor rhinitis chronic, exacerbation
|
0.80%
1/125 • Adverse/Serious adverse events were registered during 12 months of therapy and 30 days after the end of the research
Adverse/Serious adverse events were registered in patients of the Full Analysis Set (n=249, Safety Population)
|
0.00%
0/124 • Adverse/Serious adverse events were registered during 12 months of therapy and 30 days after the end of the research
Adverse/Serious adverse events were registered in patients of the Full Analysis Set (n=249, Safety Population)
|
|
Respiratory, thoracic and mediastinal disorders
Discomfort in the oropharynx
|
0.80%
1/125 • Adverse/Serious adverse events were registered during 12 months of therapy and 30 days after the end of the research
Adverse/Serious adverse events were registered in patients of the Full Analysis Set (n=249, Safety Population)
|
0.00%
0/124 • Adverse/Serious adverse events were registered during 12 months of therapy and 30 days after the end of the research
Adverse/Serious adverse events were registered in patients of the Full Analysis Set (n=249, Safety Population)
|
|
Respiratory, thoracic and mediastinal disorders
Сough
|
0.80%
1/125 • Adverse/Serious adverse events were registered during 12 months of therapy and 30 days after the end of the research
Adverse/Serious adverse events were registered in patients of the Full Analysis Set (n=249, Safety Population)
|
0.00%
0/124 • Adverse/Serious adverse events were registered during 12 months of therapy and 30 days after the end of the research
Adverse/Serious adverse events were registered in patients of the Full Analysis Set (n=249, Safety Population)
|
|
Skin and subcutaneous tissue disorders
Allergic contact dermatitis
|
0.00%
0/125 • Adverse/Serious adverse events were registered during 12 months of therapy and 30 days after the end of the research
Adverse/Serious adverse events were registered in patients of the Full Analysis Set (n=249, Safety Population)
|
0.81%
1/124 • Adverse/Serious adverse events were registered during 12 months of therapy and 30 days after the end of the research
Adverse/Serious adverse events were registered in patients of the Full Analysis Set (n=249, Safety Population)
|
|
Vascular disorders
Hypertensive crisis
|
0.80%
1/125 • Adverse/Serious adverse events were registered during 12 months of therapy and 30 days after the end of the research
Adverse/Serious adverse events were registered in patients of the Full Analysis Set (n=249, Safety Population)
|
0.81%
1/124 • Adverse/Serious adverse events were registered during 12 months of therapy and 30 days after the end of the research
Adverse/Serious adverse events were registered in patients of the Full Analysis Set (n=249, Safety Population)
|
|
Vascular disorders
Hypertensive crisis, accompanied by headache and nausea
|
0.80%
1/125 • Adverse/Serious adverse events were registered during 12 months of therapy and 30 days after the end of the research
Adverse/Serious adverse events were registered in patients of the Full Analysis Set (n=249, Safety Population)
|
0.00%
0/124 • Adverse/Serious adverse events were registered during 12 months of therapy and 30 days after the end of the research
Adverse/Serious adverse events were registered in patients of the Full Analysis Set (n=249, Safety Population)
|
|
Vascular disorders
Chronic hemorrhoids, exacerbation
|
0.80%
1/125 • Adverse/Serious adverse events were registered during 12 months of therapy and 30 days after the end of the research
Adverse/Serious adverse events were registered in patients of the Full Analysis Set (n=249, Safety Population)
|
0.00%
0/124 • Adverse/Serious adverse events were registered during 12 months of therapy and 30 days after the end of the research
Adverse/Serious adverse events were registered in patients of the Full Analysis Set (n=249, Safety Population)
|
Additional Information
Mikhail Putilovskiy, MD, PhD, Director of Clinical Research and Medical Information
Materia Medica Holding
Phone: +74952761571
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place