Trial Outcomes & Findings for Clinical Trial of Anaferon for Children Efficacy in Prevention of Influenza and Other ARVI (NCT NCT03301155)
NCT ID: NCT03301155
Last Updated: 2020-05-06
Results Overview
Based on medical records.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
1036 participants
Primary outcome timeframe
in 12 weeks of the treatment
Results posted on
2020-05-06
Participant Flow
Participant milestones
| Measure |
Anaferon for Children
Tablet for oral use. One tablet per intake, once daily (approximately at the same time).
The product is administered outside a meal (in the interval between meals or 15 min prior to meal or fluid intake), the tablets should be held in mouth until complete dissolution. For young children (aged 1 month to 3 years old), the tablet is recommended to be dissolved in a small amount (1 tablespoon) of drinking water of room temperature.
Anaferon for children: Tablet for oral use.
|
Placebo
Tablet for oral use. Placebo using Anaferon for children scheme.
Placebo: Tablet for oral use.
|
|---|---|---|
|
Overall Study
STARTED
|
528
|
508
|
|
Overall Study
COMPLETED
|
520
|
501
|
|
Overall Study
NOT COMPLETED
|
8
|
7
|
Reasons for withdrawal
| Measure |
Anaferon for Children
Tablet for oral use. One tablet per intake, once daily (approximately at the same time).
The product is administered outside a meal (in the interval between meals or 15 min prior to meal or fluid intake), the tablets should be held in mouth until complete dissolution. For young children (aged 1 month to 3 years old), the tablet is recommended to be dissolved in a small amount (1 tablespoon) of drinking water of room temperature.
Anaferon for children: Tablet for oral use.
|
Placebo
Tablet for oral use. Placebo using Anaferon for children scheme.
Placebo: Tablet for oral use.
|
|---|---|---|
|
Overall Study
Сompliance with exclusion criteria
|
8
|
7
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Anaferon for Children
n=520 Participants
Tablet for oral use. One tablet per intake, once daily (approximately at the same time).
The product is administered outside a meal (in the interval between meals or 15 min prior to meal or fluid intake), the tablets should be held in mouth until complete dissolution. For young children (aged 1 month to 3 years old), the tablet is recommended to be dissolved in a small amount (1 tablespoon) of drinking water of room temperature.
Anaferon for children: Tablet for oral use.
|
Placebo
n=501 Participants
Tablet for oral use. Placebo using Anaferon for children scheme.
Placebo: Tablet for oral use.
|
Total
n=1021 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
520 Participants
n=520 Participants
|
501 Participants
n=501 Participants
|
1021 Participants
n=1021 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=520 Participants
|
0 Participants
n=501 Participants
|
0 Participants
n=1021 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=520 Participants
|
0 Participants
n=501 Participants
|
0 Participants
n=1021 Participants
|
|
Age, Continuous
|
3.1 years
STANDARD_DEVIATION 1.7 • n=520 Participants
|
3.1 years
STANDARD_DEVIATION 1.7 • n=501 Participants
|
3.1 years
STANDARD_DEVIATION 1.7 • n=1021 Participants
|
|
Sex: Female, Male
Female
|
263 Participants
n=520 Participants
|
244 Participants
n=501 Participants
|
507 Participants
n=1021 Participants
|
|
Sex: Female, Male
Male
|
257 Participants
n=520 Participants
|
257 Participants
n=501 Participants
|
514 Participants
n=1021 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
Uzbekistan
|
15 participants
n=520 Participants
|
15 participants
n=501 Participants
|
30 participants
n=1021 Participants
|
|
Region of Enrollment
Russia
|
505 participants
n=520 Participants
|
486 participants
n=501 Participants
|
991 participants
n=1021 Participants
|
PRIMARY outcome
Timeframe: in 12 weeks of the treatmentPopulation: Intention-to-treat (ITT)
Based on medical records.
Outcome measures
| Measure |
Anaferon for Children
n=520 Participants
Tablet for oral use. One tablet per intake, once daily (approximately at the same time).
The product is administered outside a meal (in the interval between meals or 15 min prior to meal or fluid intake), the tablets should be held in mouth until complete dissolution. For young children (aged 1 month to 3 years old), the tablet is recommended to be dissolved in a small amount (1 tablespoon) of drinking water of room temperature.
Anaferon for children: Tablet for oral use.
|
Placebo
n=501 Participants
Tablet for oral use. Placebo using Anaferon for children scheme.
Placebo: Tablet for oral use.
|
|---|---|---|
|
Time From Taking the First Dose of the Study Drug to the Onset of Influenza/ARVI Symptoms.
|
428.8 days
Interval 351.0 to 523.8
|
275.8 days
Interval 232.7 to 326.9
|
SECONDARY outcome
Timeframe: in 12 weeks of the treatmentPopulation: Intention-to-treat (ITT)
Based on medical records. Influenza/ARVI criteria are the following: febrile/subfebrile body temperature, presence at least one flu-like nonspecific symptom (decreased activity/weakness, headache, and chills), and at least one respiratory symptom (runny nose, nasal stuffiness, hoarseness/husky voice, sore throat, and cough).
Outcome measures
| Measure |
Anaferon for Children
n=520 Participants
Tablet for oral use. One tablet per intake, once daily (approximately at the same time).
The product is administered outside a meal (in the interval between meals or 15 min prior to meal or fluid intake), the tablets should be held in mouth until complete dissolution. For young children (aged 1 month to 3 years old), the tablet is recommended to be dissolved in a small amount (1 tablespoon) of drinking water of room temperature.
Anaferon for children: Tablet for oral use.
|
Placebo
n=501 Participants
Tablet for oral use. Placebo using Anaferon for children scheme.
Placebo: Tablet for oral use.
|
|---|---|---|
|
Percentage of Children Not Falling Ill With Influenza or Another ARVI.
4 weeks
|
516 Participants
|
452 Participants
|
|
Percentage of Children Not Falling Ill With Influenza or Another ARVI.
8 weeks
|
482 Participants
|
415 Participants
|
|
Percentage of Children Not Falling Ill With Influenza or Another ARVI.
12 weeks
|
424 Participants
|
368 Participants
|
SECONDARY outcome
Timeframe: in 12 weeks of the treatmentPopulation: Intention-to-treat (ITT)
Based on medical records. Percentage of children with the symptoms of a respiratory or ear-nose-throat bacterial infection requiring antibacterial therapy.
Outcome measures
| Measure |
Anaferon for Children
n=520 Participants
Tablet for oral use. One tablet per intake, once daily (approximately at the same time).
The product is administered outside a meal (in the interval between meals or 15 min prior to meal or fluid intake), the tablets should be held in mouth until complete dissolution. For young children (aged 1 month to 3 years old), the tablet is recommended to be dissolved in a small amount (1 tablespoon) of drinking water of room temperature.
Anaferon for children: Tablet for oral use.
|
Placebo
n=501 Participants
Tablet for oral use. Placebo using Anaferon for children scheme.
Placebo: Tablet for oral use.
|
|---|---|---|
|
Percentage of Children With the Symptoms Requiring Antibacterial Therapy.
|
3 Participants
|
8 Participants
|
SECONDARY outcome
Timeframe: in 12 weeks of the treatmentPopulation: Intention-to-treat (ITT)
Based on medical records. Percentage of children hospitalized for influenza/ARVI or their complications.
Outcome measures
| Measure |
Anaferon for Children
n=528 Participants
Tablet for oral use. One tablet per intake, once daily (approximately at the same time).
The product is administered outside a meal (in the interval between meals or 15 min prior to meal or fluid intake), the tablets should be held in mouth until complete dissolution. For young children (aged 1 month to 3 years old), the tablet is recommended to be dissolved in a small amount (1 tablespoon) of drinking water of room temperature.
Anaferon for children: Tablet for oral use.
|
Placebo
n=508 Participants
Tablet for oral use. Placebo using Anaferon for children scheme.
Placebo: Tablet for oral use.
|
|---|---|---|
|
Percentage of Children Requiring Hospitalized for Influenza/ARVI.
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: in 12 weeks of the treatmentPopulation: Intention-to-treat (ITT)
Based on medical records. Presence and type of adverse events, their severity, relation to investigational drug, outcomes.
Outcome measures
| Measure |
Anaferon for Children
n=528 Participants
Tablet for oral use. One tablet per intake, once daily (approximately at the same time).
The product is administered outside a meal (in the interval between meals or 15 min prior to meal or fluid intake), the tablets should be held in mouth until complete dissolution. For young children (aged 1 month to 3 years old), the tablet is recommended to be dissolved in a small amount (1 tablespoon) of drinking water of room temperature.
Anaferon for children: Tablet for oral use.
|
Placebo
n=508 Participants
Tablet for oral use. Placebo using Anaferon for children scheme.
Placebo: Tablet for oral use.
|
|---|---|---|
|
Presence and Type of Adverse Events (AE).
Mild severity
|
65 Participants
|
54 Participants
|
|
Presence and Type of Adverse Events (AE).
Moderate severity
|
4 Participants
|
4 Participants
|
Adverse Events
Anaferon for Children
Serious events: 1 serious events
Other events: 49 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 44 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Anaferon for Children
n=528 participants at risk
Tablet for oral use. One tablet per intake, once daily (approximately at the same time).
The product is administered outside a meal (in the interval between meals or 15 min prior to meal or fluid intake), the tablets should be held in mouth until complete dissolution. For young children (aged 1 month to 3 years old), the tablet is recommended to be dissolved in a small amount (1 tablespoon) of drinking water of room temperature.
Anaferon for children: Tablet for oral use.
|
Placebo
n=508 participants at risk
Tablet for oral use. Placebo using Anaferon for children scheme.
Placebo: Tablet for oral use.
|
|---|---|---|
|
Nervous system disorders
Partial cramps
|
0.19%
1/528 • Number of events 1 • Adverse/Serious adverse events were registered during 12 weeks therapy.
Safety evaluation was based on the data from all randomized subjects receiving at least one dose of the study drug (n=1036; Safety population).
|
0.00%
0/508 • Adverse/Serious adverse events were registered during 12 weeks therapy.
Safety evaluation was based on the data from all randomized subjects receiving at least one dose of the study drug (n=1036; Safety population).
|
Other adverse events
| Measure |
Anaferon for Children
n=528 participants at risk
Tablet for oral use. One tablet per intake, once daily (approximately at the same time).
The product is administered outside a meal (in the interval between meals or 15 min prior to meal or fluid intake), the tablets should be held in mouth until complete dissolution. For young children (aged 1 month to 3 years old), the tablet is recommended to be dissolved in a small amount (1 tablespoon) of drinking water of room temperature.
Anaferon for children: Tablet for oral use.
|
Placebo
n=508 participants at risk
Tablet for oral use. Placebo using Anaferon for children scheme.
Placebo: Tablet for oral use.
|
|---|---|---|
|
Gastrointestinal disorders
Aphthous ulcer
|
0.00%
0/528 • Adverse/Serious adverse events were registered during 12 weeks therapy.
Safety evaluation was based on the data from all randomized subjects receiving at least one dose of the study drug (n=1036; Safety population).
|
0.20%
1/508 • Number of events 1 • Adverse/Serious adverse events were registered during 12 weeks therapy.
Safety evaluation was based on the data from all randomized subjects receiving at least one dose of the study drug (n=1036; Safety population).
|
|
Gastrointestinal disorders
Diarrhea
|
0.00%
0/528 • Adverse/Serious adverse events were registered during 12 weeks therapy.
Safety evaluation was based on the data from all randomized subjects receiving at least one dose of the study drug (n=1036; Safety population).
|
0.20%
1/508 • Number of events 1 • Adverse/Serious adverse events were registered during 12 weeks therapy.
Safety evaluation was based on the data from all randomized subjects receiving at least one dose of the study drug (n=1036; Safety population).
|
|
Gastrointestinal disorders
Intestinal dysfunction
|
0.19%
1/528 • Number of events 1 • Adverse/Serious adverse events were registered during 12 weeks therapy.
Safety evaluation was based on the data from all randomized subjects receiving at least one dose of the study drug (n=1036; Safety population).
|
0.00%
0/508 • Adverse/Serious adverse events were registered during 12 weeks therapy.
Safety evaluation was based on the data from all randomized subjects receiving at least one dose of the study drug (n=1036; Safety population).
|
|
Gastrointestinal disorders
Teething
|
0.57%
3/528 • Number of events 3 • Adverse/Serious adverse events were registered during 12 weeks therapy.
Safety evaluation was based on the data from all randomized subjects receiving at least one dose of the study drug (n=1036; Safety population).
|
0.20%
1/508 • Number of events 1 • Adverse/Serious adverse events were registered during 12 weeks therapy.
Safety evaluation was based on the data from all randomized subjects receiving at least one dose of the study drug (n=1036; Safety population).
|
|
Gastrointestinal disorders
Vomiting
|
0.19%
1/528 • Number of events 1 • Adverse/Serious adverse events were registered during 12 weeks therapy.
Safety evaluation was based on the data from all randomized subjects receiving at least one dose of the study drug (n=1036; Safety population).
|
0.00%
0/508 • Adverse/Serious adverse events were registered during 12 weeks therapy.
Safety evaluation was based on the data from all randomized subjects receiving at least one dose of the study drug (n=1036; Safety population).
|
|
Gastrointestinal disorders
Functional dyspepsia
|
0.00%
0/528 • Adverse/Serious adverse events were registered during 12 weeks therapy.
Safety evaluation was based on the data from all randomized subjects receiving at least one dose of the study drug (n=1036; Safety population).
|
0.20%
1/508 • Number of events 1 • Adverse/Serious adverse events were registered during 12 weeks therapy.
Safety evaluation was based on the data from all randomized subjects receiving at least one dose of the study drug (n=1036; Safety population).
|
|
Gastrointestinal disorders
Functional gastrointestinal pathology
|
0.57%
3/528 • Number of events 3 • Adverse/Serious adverse events were registered during 12 weeks therapy.
Safety evaluation was based on the data from all randomized subjects receiving at least one dose of the study drug (n=1036; Safety population).
|
0.20%
1/508 • Number of events 1 • Adverse/Serious adverse events were registered during 12 weeks therapy.
Safety evaluation was based on the data from all randomized subjects receiving at least one dose of the study drug (n=1036; Safety population).
|
|
Gastrointestinal disorders
Enteritis
|
0.00%
0/528 • Adverse/Serious adverse events were registered during 12 weeks therapy.
Safety evaluation was based on the data from all randomized subjects receiving at least one dose of the study drug (n=1036; Safety population).
|
0.20%
1/508 • Number of events 1 • Adverse/Serious adverse events were registered during 12 weeks therapy.
Safety evaluation was based on the data from all randomized subjects receiving at least one dose of the study drug (n=1036; Safety population).
|
|
Infections and infestations
Chicken pox
|
0.76%
4/528 • Number of events 4 • Adverse/Serious adverse events were registered during 12 weeks therapy.
Safety evaluation was based on the data from all randomized subjects receiving at least one dose of the study drug (n=1036; Safety population).
|
1.6%
8/508 • Number of events 8 • Adverse/Serious adverse events were registered during 12 weeks therapy.
Safety evaluation was based on the data from all randomized subjects receiving at least one dose of the study drug (n=1036; Safety population).
|
|
Infections and infestations
Respiratory viral infection
|
0.57%
3/528 • Number of events 3 • Adverse/Serious adverse events were registered during 12 weeks therapy.
Safety evaluation was based on the data from all randomized subjects receiving at least one dose of the study drug (n=1036; Safety population).
|
0.79%
4/508 • Number of events 5 • Adverse/Serious adverse events were registered during 12 weeks therapy.
Safety evaluation was based on the data from all randomized subjects receiving at least one dose of the study drug (n=1036; Safety population).
|
|
Infections and infestations
Gastroenteritis caused by norovirus
|
0.00%
0/528 • Adverse/Serious adverse events were registered during 12 weeks therapy.
Safety evaluation was based on the data from all randomized subjects receiving at least one dose of the study drug (n=1036; Safety population).
|
0.20%
1/508 • Number of events 1 • Adverse/Serious adverse events were registered during 12 weeks therapy.
Safety evaluation was based on the data from all randomized subjects receiving at least one dose of the study drug (n=1036; Safety population).
|
|
Infections and infestations
Herpes on the lips
|
0.00%
0/528 • Adverse/Serious adverse events were registered during 12 weeks therapy.
Safety evaluation was based on the data from all randomized subjects receiving at least one dose of the study drug (n=1036; Safety population).
|
0.20%
1/508 • Number of events 1 • Adverse/Serious adverse events were registered during 12 weeks therapy.
Safety evaluation was based on the data from all randomized subjects receiving at least one dose of the study drug (n=1036; Safety population).
|
|
Infections and infestations
Purulent conjunctivitis
|
0.19%
1/528 • Number of events 1 • Adverse/Serious adverse events were registered during 12 weeks therapy.
Safety evaluation was based on the data from all randomized subjects receiving at least one dose of the study drug (n=1036; Safety population).
|
0.20%
1/508 • Number of events 1 • Adverse/Serious adverse events were registered during 12 weeks therapy.
Safety evaluation was based on the data from all randomized subjects receiving at least one dose of the study drug (n=1036; Safety population).
|
|
Infections and infestations
Purulent rhinitis
|
0.19%
1/528 • Number of events 1 • Adverse/Serious adverse events were registered during 12 weeks therapy.
Safety evaluation was based on the data from all randomized subjects receiving at least one dose of the study drug (n=1036; Safety population).
|
0.20%
1/508 • Number of events 1 • Adverse/Serious adverse events were registered during 12 weeks therapy.
Safety evaluation was based on the data from all randomized subjects receiving at least one dose of the study drug (n=1036; Safety population).
|
|
Infections and infestations
Urinary tract infection
|
0.19%
1/528 • Number of events 1 • Adverse/Serious adverse events were registered during 12 weeks therapy.
Safety evaluation was based on the data from all randomized subjects receiving at least one dose of the study drug (n=1036; Safety population).
|
0.00%
0/508 • Adverse/Serious adverse events were registered during 12 weeks therapy.
Safety evaluation was based on the data from all randomized subjects receiving at least one dose of the study drug (n=1036; Safety population).
|
|
Infections and infestations
Non-purulent otitis media
|
0.19%
1/528 • Number of events 1 • Adverse/Serious adverse events were registered during 12 weeks therapy.
Safety evaluation was based on the data from all randomized subjects receiving at least one dose of the study drug (n=1036; Safety population).
|
0.00%
0/508 • Adverse/Serious adverse events were registered during 12 weeks therapy.
Safety evaluation was based on the data from all randomized subjects receiving at least one dose of the study drug (n=1036; Safety population).
|
|
Infections and infestations
Obstructive bronchitis
|
0.19%
1/528 • Number of events 2 • Adverse/Serious adverse events were registered during 12 weeks therapy.
Safety evaluation was based on the data from all randomized subjects receiving at least one dose of the study drug (n=1036; Safety population).
|
0.20%
1/508 • Number of events 1 • Adverse/Serious adverse events were registered during 12 weeks therapy.
Safety evaluation was based on the data from all randomized subjects receiving at least one dose of the study drug (n=1036; Safety population).
|
|
Infections and infestations
Acute respiratory tract infection
|
0.76%
4/528 • Number of events 5 • Adverse/Serious adverse events were registered during 12 weeks therapy.
Safety evaluation was based on the data from all randomized subjects receiving at least one dose of the study drug (n=1036; Safety population).
|
0.79%
4/508 • Number of events 4 • Adverse/Serious adverse events were registered during 12 weeks therapy.
Safety evaluation was based on the data from all randomized subjects receiving at least one dose of the study drug (n=1036; Safety population).
|
|
Infections and infestations
Acute nasopharyngitis
|
1.1%
6/528 • Number of events 8 • Adverse/Serious adverse events were registered during 12 weeks therapy.
Safety evaluation was based on the data from all randomized subjects receiving at least one dose of the study drug (n=1036; Safety population).
|
0.59%
3/508 • Number of events 4 • Adverse/Serious adverse events were registered during 12 weeks therapy.
Safety evaluation was based on the data from all randomized subjects receiving at least one dose of the study drug (n=1036; Safety population).
|
|
Infections and infestations
Acute rhinitis
|
0.00%
0/528 • Adverse/Serious adverse events were registered during 12 weeks therapy.
Safety evaluation was based on the data from all randomized subjects receiving at least one dose of the study drug (n=1036; Safety population).
|
0.20%
1/508 • Number of events 1 • Adverse/Serious adverse events were registered during 12 weeks therapy.
Safety evaluation was based on the data from all randomized subjects receiving at least one dose of the study drug (n=1036; Safety population).
|
|
Infections and infestations
Acute tracheitis
|
0.19%
1/528 • Number of events 1 • Adverse/Serious adverse events were registered during 12 weeks therapy.
Safety evaluation was based on the data from all randomized subjects receiving at least one dose of the study drug (n=1036; Safety population).
|
0.39%
2/508 • Number of events 2 • Adverse/Serious adverse events were registered during 12 weeks therapy.
Safety evaluation was based on the data from all randomized subjects receiving at least one dose of the study drug (n=1036; Safety population).
|
|
Infections and infestations
Acute pharyngitis
|
0.19%
1/528 • Number of events 1 • Adverse/Serious adverse events were registered during 12 weeks therapy.
Safety evaluation was based on the data from all randomized subjects receiving at least one dose of the study drug (n=1036; Safety population).
|
0.20%
1/508 • Number of events 1 • Adverse/Serious adverse events were registered during 12 weeks therapy.
Safety evaluation was based on the data from all randomized subjects receiving at least one dose of the study drug (n=1036; Safety population).
|
|
Infections and infestations
Otitis
|
0.00%
0/528 • Adverse/Serious adverse events were registered during 12 weeks therapy.
Safety evaluation was based on the data from all randomized subjects receiving at least one dose of the study drug (n=1036; Safety population).
|
0.20%
1/508 • Number of events 1 • Adverse/Serious adverse events were registered during 12 weeks therapy.
Safety evaluation was based on the data from all randomized subjects receiving at least one dose of the study drug (n=1036; Safety population).
|
|
Infections and infestations
Felon
|
0.00%
0/528 • Adverse/Serious adverse events were registered during 12 weeks therapy.
Safety evaluation was based on the data from all randomized subjects receiving at least one dose of the study drug (n=1036; Safety population).
|
0.20%
1/508 • Number of events 1 • Adverse/Serious adverse events were registered during 12 weeks therapy.
Safety evaluation was based on the data from all randomized subjects receiving at least one dose of the study drug (n=1036; Safety population).
|
|
Infections and infestations
Rhinitis
|
0.38%
2/528 • Number of events 2 • Adverse/Serious adverse events were registered during 12 weeks therapy.
Safety evaluation was based on the data from all randomized subjects receiving at least one dose of the study drug (n=1036; Safety population).
|
0.20%
1/508 • Number of events 1 • Adverse/Serious adverse events were registered during 12 weeks therapy.
Safety evaluation was based on the data from all randomized subjects receiving at least one dose of the study drug (n=1036; Safety population).
|
|
Infections and infestations
Rhinosinusitis
|
0.19%
1/528 • Number of events 1 • Adverse/Serious adverse events were registered during 12 weeks therapy.
Safety evaluation was based on the data from all randomized subjects receiving at least one dose of the study drug (n=1036; Safety population).
|
0.00%
0/508 • Adverse/Serious adverse events were registered during 12 weeks therapy.
Safety evaluation was based on the data from all randomized subjects receiving at least one dose of the study drug (n=1036; Safety population).
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/528 • Adverse/Serious adverse events were registered during 12 weeks therapy.
Safety evaluation was based on the data from all randomized subjects receiving at least one dose of the study drug (n=1036; Safety population).
|
0.39%
2/508 • Number of events 4 • Adverse/Serious adverse events were registered during 12 weeks therapy.
Safety evaluation was based on the data from all randomized subjects receiving at least one dose of the study drug (n=1036; Safety population).
|
|
Infections and infestations
Rotavirus infection
|
0.19%
1/528 • Number of events 1 • Adverse/Serious adverse events were registered during 12 weeks therapy.
Safety evaluation was based on the data from all randomized subjects receiving at least one dose of the study drug (n=1036; Safety population).
|
0.20%
1/508 • Number of events 1 • Adverse/Serious adverse events were registered during 12 weeks therapy.
Safety evaluation was based on the data from all randomized subjects receiving at least one dose of the study drug (n=1036; Safety population).
|
|
Infections and infestations
Viral otitis media
|
0.00%
0/528 • Adverse/Serious adverse events were registered during 12 weeks therapy.
Safety evaluation was based on the data from all randomized subjects receiving at least one dose of the study drug (n=1036; Safety population).
|
0.20%
1/508 • Number of events 1 • Adverse/Serious adverse events were registered during 12 weeks therapy.
Safety evaluation was based on the data from all randomized subjects receiving at least one dose of the study drug (n=1036; Safety population).
|
|
Infections and infestations
Acute otitis media
|
0.19%
1/528 • Number of events 1 • Adverse/Serious adverse events were registered during 12 weeks therapy.
Safety evaluation was based on the data from all randomized subjects receiving at least one dose of the study drug (n=1036; Safety population).
|
0.20%
1/508 • Number of events 1 • Adverse/Serious adverse events were registered during 12 weeks therapy.
Safety evaluation was based on the data from all randomized subjects receiving at least one dose of the study drug (n=1036; Safety population).
|
|
Infections and infestations
Pharyngotonsillitis
|
0.19%
1/528 • Number of events 1 • Adverse/Serious adverse events were registered during 12 weeks therapy.
Safety evaluation was based on the data from all randomized subjects receiving at least one dose of the study drug (n=1036; Safety population).
|
0.00%
0/508 • Adverse/Serious adverse events were registered during 12 weeks therapy.
Safety evaluation was based on the data from all randomized subjects receiving at least one dose of the study drug (n=1036; Safety population).
|
|
Infections and infestations
Pharyngotracheitis
|
0.19%
1/528 • Number of events 1 • Adverse/Serious adverse events were registered during 12 weeks therapy.
Safety evaluation was based on the data from all randomized subjects receiving at least one dose of the study drug (n=1036; Safety population).
|
0.00%
0/508 • Adverse/Serious adverse events were registered during 12 weeks therapy.
Safety evaluation was based on the data from all randomized subjects receiving at least one dose of the study drug (n=1036; Safety population).
|
|
Respiratory, thoracic and mediastinal disorders
Throat hyperemia
|
0.00%
0/528 • Adverse/Serious adverse events were registered during 12 weeks therapy.
Safety evaluation was based on the data from all randomized subjects receiving at least one dose of the study drug (n=1036; Safety population).
|
0.20%
1/508 • Number of events 1 • Adverse/Serious adverse events were registered during 12 weeks therapy.
Safety evaluation was based on the data from all randomized subjects receiving at least one dose of the study drug (n=1036; Safety population).
|
|
Respiratory, thoracic and mediastinal disorders
Runny nose
|
1.1%
6/528 • Number of events 6 • Adverse/Serious adverse events were registered during 12 weeks therapy.
Safety evaluation was based on the data from all randomized subjects receiving at least one dose of the study drug (n=1036; Safety population).
|
0.39%
2/508 • Number of events 2 • Adverse/Serious adverse events were registered during 12 weeks therapy.
Safety evaluation was based on the data from all randomized subjects receiving at least one dose of the study drug (n=1036; Safety population).
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.19%
1/528 • Number of events 1 • Adverse/Serious adverse events were registered during 12 weeks therapy.
Safety evaluation was based on the data from all randomized subjects receiving at least one dose of the study drug (n=1036; Safety population).
|
0.00%
0/508 • Adverse/Serious adverse events were registered during 12 weeks therapy.
Safety evaluation was based on the data from all randomized subjects receiving at least one dose of the study drug (n=1036; Safety population).
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
0.95%
5/528 • Number of events 5 • Adverse/Serious adverse events were registered during 12 weeks therapy.
Safety evaluation was based on the data from all randomized subjects receiving at least one dose of the study drug (n=1036; Safety population).
|
0.39%
2/508 • Number of events 2 • Adverse/Serious adverse events were registered during 12 weeks therapy.
Safety evaluation was based on the data from all randomized subjects receiving at least one dose of the study drug (n=1036; Safety population).
|
|
Respiratory, thoracic and mediastinal disorders
Dry cough
|
0.38%
2/528 • Number of events 2 • Adverse/Serious adverse events were registered during 12 weeks therapy.
Safety evaluation was based on the data from all randomized subjects receiving at least one dose of the study drug (n=1036; Safety population).
|
0.00%
0/508 • Adverse/Serious adverse events were registered during 12 weeks therapy.
Safety evaluation was based on the data from all randomized subjects receiving at least one dose of the study drug (n=1036; Safety population).
|
|
Skin and subcutaneous tissue disorders
Allergic rash
|
0.00%
0/528 • Adverse/Serious adverse events were registered during 12 weeks therapy.
Safety evaluation was based on the data from all randomized subjects receiving at least one dose of the study drug (n=1036; Safety population).
|
0.59%
3/508 • Number of events 3 • Adverse/Serious adverse events were registered during 12 weeks therapy.
Safety evaluation was based on the data from all randomized subjects receiving at least one dose of the study drug (n=1036; Safety population).
|
|
Skin and subcutaneous tissue disorders
Allergic dermatitis
|
0.19%
1/528 • Number of events 1 • Adverse/Serious adverse events were registered during 12 weeks therapy.
Safety evaluation was based on the data from all randomized subjects receiving at least one dose of the study drug (n=1036; Safety population).
|
0.00%
0/508 • Adverse/Serious adverse events were registered during 12 weeks therapy.
Safety evaluation was based on the data from all randomized subjects receiving at least one dose of the study drug (n=1036; Safety population).
|
|
Skin and subcutaneous tissue disorders
Skin itch
|
0.00%
0/528 • Adverse/Serious adverse events were registered during 12 weeks therapy.
Safety evaluation was based on the data from all randomized subjects receiving at least one dose of the study drug (n=1036; Safety population).
|
0.20%
1/508 • Number of events 1 • Adverse/Serious adverse events were registered during 12 weeks therapy.
Safety evaluation was based on the data from all randomized subjects receiving at least one dose of the study drug (n=1036; Safety population).
|
|
Skin and subcutaneous tissue disorders
Acute allergic urticaria
|
0.19%
1/528 • Number of events 1 • Adverse/Serious adverse events were registered during 12 weeks therapy.
Safety evaluation was based on the data from all randomized subjects receiving at least one dose of the study drug (n=1036; Safety population).
|
0.20%
1/508 • Number of events 1 • Adverse/Serious adverse events were registered during 12 weeks therapy.
Safety evaluation was based on the data from all randomized subjects receiving at least one dose of the study drug (n=1036; Safety population).
|
|
Skin and subcutaneous tissue disorders
Facial rash
|
0.19%
1/528 • Number of events 1 • Adverse/Serious adverse events were registered during 12 weeks therapy.
Safety evaluation was based on the data from all randomized subjects receiving at least one dose of the study drug (n=1036; Safety population).
|
0.00%
0/508 • Adverse/Serious adverse events were registered during 12 weeks therapy.
Safety evaluation was based on the data from all randomized subjects receiving at least one dose of the study drug (n=1036; Safety population).
|
|
Nervous system disorders
Headache
|
0.00%
0/528 • Adverse/Serious adverse events were registered during 12 weeks therapy.
Safety evaluation was based on the data from all randomized subjects receiving at least one dose of the study drug (n=1036; Safety population).
|
0.20%
1/508 • Number of events 1 • Adverse/Serious adverse events were registered during 12 weeks therapy.
Safety evaluation was based on the data from all randomized subjects receiving at least one dose of the study drug (n=1036; Safety population).
|
|
Nervous system disorders
Partial epilepsy
|
0.19%
1/528 • Number of events 1 • Adverse/Serious adverse events were registered during 12 weeks therapy.
Safety evaluation was based on the data from all randomized subjects receiving at least one dose of the study drug (n=1036; Safety population).
|
0.00%
0/508 • Adverse/Serious adverse events were registered during 12 weeks therapy.
Safety evaluation was based on the data from all randomized subjects receiving at least one dose of the study drug (n=1036; Safety population).
|
|
General disorders
Fever
|
1.3%
7/528 • Number of events 7 • Adverse/Serious adverse events were registered during 12 weeks therapy.
Safety evaluation was based on the data from all randomized subjects receiving at least one dose of the study drug (n=1036; Safety population).
|
0.00%
0/508 • Adverse/Serious adverse events were registered during 12 weeks therapy.
Safety evaluation was based on the data from all randomized subjects receiving at least one dose of the study drug (n=1036; Safety population).
|
|
Psychiatric disorders
Stuttering
|
0.19%
1/528 • Number of events 1 • Adverse/Serious adverse events were registered during 12 weeks therapy.
Safety evaluation was based on the data from all randomized subjects receiving at least one dose of the study drug (n=1036; Safety population).
|
0.00%
0/508 • Adverse/Serious adverse events were registered during 12 weeks therapy.
Safety evaluation was based on the data from all randomized subjects receiving at least one dose of the study drug (n=1036; Safety population).
|
|
Injury, poisoning and procedural complications
Foreign body aspiration
|
0.00%
0/528 • Adverse/Serious adverse events were registered during 12 weeks therapy.
Safety evaluation was based on the data from all randomized subjects receiving at least one dose of the study drug (n=1036; Safety population).
|
0.20%
1/508 • Number of events 1 • Adverse/Serious adverse events were registered during 12 weeks therapy.
Safety evaluation was based on the data from all randomized subjects receiving at least one dose of the study drug (n=1036; Safety population).
|
Additional Information
Michael 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