Trial Outcomes & Findings for Clinical Trial of Efficacy and Safety of Anaferon for Children Liquid Dosage Form in the Treatment of Acute Upper Respiratory Infections (NCT NCT03162458)
NCT ID: NCT03162458
Last Updated: 2018-11-28
Results Overview
based on patient diary data
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
142 participants
Primary outcome timeframe
From the time of randomization until the time of recovery/improvement, assessed up to 14 days
Results posted on
2018-11-28
Participant Flow
Participant milestones
| Measure |
Anaferon for Children
Anaferon for children (liquid dosage form): 10 drops per dose. Day 1: 10 drops every 30 minutes for the first 2 hours, followed by three more doses regularly spaced during the rest of the day. Day 2 to 5: 10 drops three times daily.
|
Placebo
Placebo (liquid dosage form): 10 drops per dose. Day 1: 10 drops every 30 minutes for the first 2 hours, followed by three more doses regularly spaced during the rest of the day. Day 2 to 5: 10 drops three times daily.
|
|---|---|---|
|
Overall Study
STARTED
|
71
|
71
|
|
Overall Study
COMPLETED
|
71
|
71
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Clinical Trial of Efficacy and Safety of Anaferon for Children Liquid Dosage Form in the Treatment of Acute Upper Respiratory Infections
Baseline characteristics by cohort
| Measure |
Anaferon for Children
n=71 Participants
Anaferon for children (liquid dosage form): 10 drops per dose. Day 1: 10 drops every 30 minutes for the first 2 hours, followed by three more doses regularly spaced during the rest of the day. Day 2 to 5: 10 drops three times daily.
|
Placebo
n=71 Participants
Placebo (liquid dosage form): 10 drops per dose. Day 1: 10 drops every 30 minutes for the first 2 hours, followed by three more doses regularly spaced during the rest of the day. Day 2 to 5: 10 drops three times daily.
|
Total
n=142 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
1.8 years
STANDARD_DEVIATION 1.0 • n=5 Participants
|
1.9 years
STANDARD_DEVIATION 1.0 • n=7 Participants
|
1.9 years
STANDARD_DEVIATION 1.0 • n=5 Participants
|
|
Sex: Female, Male
Female
|
36 Participants
n=5 Participants
|
32 Participants
n=7 Participants
|
68 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
35 Participants
n=5 Participants
|
39 Participants
n=7 Participants
|
74 Participants
n=5 Participants
|
|
Region of Enrollment
Russia
|
71 Participants
n=5 Participants
|
71 Participants
n=7 Participants
|
142 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: From the time of randomization until the time of recovery/improvement, assessed up to 14 daysPopulation: Intention to treat set
based on patient diary data
Outcome measures
| Measure |
Anaferon for Children
n=71 Participants
Anaferon for children (liquid dosage form): 10 drops per dose. Day 1: 10 drops every 30 minutes for the first 2 hours, followed by three more doses regularly spaced during the rest of the day. Day 2 to 5: 10 drops three times daily.
|
Placebo
n=71 Participants
Placebo (liquid dosage form): 10 drops per dose. Day 1: 10 drops every 30 minutes for the first 2 hours, followed by three more doses regularly spaced during the rest of the day. Day 2 to 5: 10 drops three times daily.
|
|---|---|---|
|
Average Illness Duration (the Interval Between the Start of the Trial Treatment and the Time When Recovery/Improvement - Based on Patient Diary Data)
|
87.7 hours
Standard Deviation 31.5
|
103.3 hours
Standard Deviation 19.4
|
PRIMARY outcome
Timeframe: On days 1-5 of observationPopulation: Intention to treat set
The TSS was based on the severity of each of acute upper respiratory tract infection (URTI) symptom. The TSS includes 11 symptoms: Body temperature / fever, Non-specific URTI symptoms (Decreased activity / Malaise, Impaired appetite / refusal of feeding, Painful appearance, Sleep disturbance) and Nose /Throat symptoms (Runny nose, Nasal congestion, Sneezing, Hoarseness, Sore throat, Cough). The severity of each URTI symptom was scored on a symptom severity scale (0 = no symptoms; 1 = mild symptoms; 2 = moderate symptoms; 3 = severe symptoms). Minimum score=0; maximum score=33. The severity of URTI symptoms was recorded by one of the patient's parents/adopter on a diary card twice a day (morning and evening) on Days 1-5.
Outcome measures
| Measure |
Anaferon for Children
n=71 Participants
Anaferon for children (liquid dosage form): 10 drops per dose. Day 1: 10 drops every 30 minutes for the first 2 hours, followed by three more doses regularly spaced during the rest of the day. Day 2 to 5: 10 drops three times daily.
|
Placebo
n=71 Participants
Placebo (liquid dosage form): 10 drops per dose. Day 1: 10 drops every 30 minutes for the first 2 hours, followed by three more doses regularly spaced during the rest of the day. Day 2 to 5: 10 drops three times daily.
|
|---|---|---|
|
Severity of the Disease Within 5 Days Was Assessed Using the "Area Under the Curve" for the Total Symptom Score (TSS) at 1-5 Days (According to the Diary of the Patient).
|
25.6 AUC score*day
Standard Deviation 17.2
|
33.6 AUC score*day
Standard Deviation 17.7
|
SECONDARY outcome
Timeframe: On Days 2-5 of the treatmentPopulation: Intention to treat set
based on patient diary data
Outcome measures
| Measure |
Anaferon for Children
n=71 Participants
Anaferon for children (liquid dosage form): 10 drops per dose. Day 1: 10 drops every 30 minutes for the first 2 hours, followed by three more doses regularly spaced during the rest of the day. Day 2 to 5: 10 drops three times daily.
|
Placebo
n=71 Participants
Placebo (liquid dosage form): 10 drops per dose. Day 1: 10 drops every 30 minutes for the first 2 hours, followed by three more doses regularly spaced during the rest of the day. Day 2 to 5: 10 drops three times daily.
|
|---|---|---|
|
Percentage of Patients With Recovery on Days 2, 3, 4 and 5 of Observation (Based on Patient Diary Data)
Day 4
|
39.4 percentage of participants
|
18.3 percentage of participants
|
|
Percentage of Patients With Recovery on Days 2, 3, 4 and 5 of Observation (Based on Patient Diary Data)
Day 2
|
9.9 percentage of participants
|
0 percentage of participants
|
|
Percentage of Patients With Recovery on Days 2, 3, 4 and 5 of Observation (Based on Patient Diary Data)
Day 3
|
29.6 percentage of participants
|
4.2 percentage of participants
|
|
Percentage of Patients With Recovery on Days 2, 3, 4 and 5 of Observation (Based on Patient Diary Data)
Day 5
|
64.8 percentage of participants
|
57.8 percentage of participants
|
SECONDARY outcome
Timeframe: From the time of randomization until the time of normal body temperature, assessed up to 14 daysPopulation: Intention to treat set
based on patient diary data
Outcome measures
| Measure |
Anaferon for Children
n=71 Participants
Anaferon for children (liquid dosage form): 10 drops per dose. Day 1: 10 drops every 30 minutes for the first 2 hours, followed by three more doses regularly spaced during the rest of the day. Day 2 to 5: 10 drops three times daily.
|
Placebo
n=71 Participants
Placebo (liquid dosage form): 10 drops per dose. Day 1: 10 drops every 30 minutes for the first 2 hours, followed by three more doses regularly spaced during the rest of the day. Day 2 to 5: 10 drops three times daily.
|
|---|---|---|
|
Average Duration of Fever (i.e. Body Temperature >37.3°С)
|
47.3 hours
Standard Deviation 30.3
|
57.0 hours
Standard Deviation 31.6
|
SECONDARY outcome
Timeframe: On Days 2-5 of the treatmentPopulation: Intention to treat set
based on patient diary data
Outcome measures
| Measure |
Anaferon for Children
n=71 Participants
Anaferon for children (liquid dosage form): 10 drops per dose. Day 1: 10 drops every 30 minutes for the first 2 hours, followed by three more doses regularly spaced during the rest of the day. Day 2 to 5: 10 drops three times daily.
|
Placebo
n=71 Participants
Placebo (liquid dosage form): 10 drops per dose. Day 1: 10 drops every 30 minutes for the first 2 hours, followed by three more doses regularly spaced during the rest of the day. Day 2 to 5: 10 drops three times daily.
|
|---|---|---|
|
Mean Body Temperatures, Measured in the Morning and Evening on Days 2-5 (Based on Patient Diary Data)
Day 2, Morning
|
37.4 °C
Standard Deviation 0.7
|
37.6 °C
Standard Deviation 0.7
|
|
Mean Body Temperatures, Measured in the Morning and Evening on Days 2-5 (Based on Patient Diary Data)
Day 3, Morning
|
37.0 °C
Standard Deviation 0.6
|
37.1 °C
Standard Deviation 0.5
|
|
Mean Body Temperatures, Measured in the Morning and Evening on Days 2-5 (Based on Patient Diary Data)
Day 4, Morning
|
36.9 °C
Standard Deviation 0.6
|
36.9 °C
Standard Deviation 0.4
|
|
Mean Body Temperatures, Measured in the Morning and Evening on Days 2-5 (Based on Patient Diary Data)
Day 5, Morning
|
36.7 °C
Standard Deviation 0.5
|
36.7 °C
Standard Deviation 0.6
|
|
Mean Body Temperatures, Measured in the Morning and Evening on Days 2-5 (Based on Patient Diary Data)
Day 2, Evening
|
37.4 °C
Standard Deviation 0.8
|
37.5 °C
Standard Deviation 0.8
|
|
Mean Body Temperatures, Measured in the Morning and Evening on Days 2-5 (Based on Patient Diary Data)
Day 3, Evening
|
37.1 °C
Standard Deviation 0.7
|
37.1 °C
Standard Deviation 0.6
|
|
Mean Body Temperatures, Measured in the Morning and Evening on Days 2-5 (Based on Patient Diary Data)
Day 4, Evening
|
36.9 °C
Standard Deviation 0.6
|
36.9 °C
Standard Deviation 0.6
|
|
Mean Body Temperatures, Measured in the Morning and Evening on Days 2-5 (Based on Patient Diary Data)
Day 5, Evening
|
36.7 °C
Standard Deviation 0.3
|
36.8 °C
Standard Deviation 0.5
|
SECONDARY outcome
Timeframe: On Days 2-5 of observationPopulation: Intention to treat set
based on patient diary data
Outcome measures
| Measure |
Anaferon for Children
n=71 Participants
Anaferon for children (liquid dosage form): 10 drops per dose. Day 1: 10 drops every 30 minutes for the first 2 hours, followed by three more doses regularly spaced during the rest of the day. Day 2 to 5: 10 drops three times daily.
|
Placebo
n=71 Participants
Placebo (liquid dosage form): 10 drops per dose. Day 1: 10 drops every 30 minutes for the first 2 hours, followed by three more doses regularly spaced during the rest of the day. Day 2 to 5: 10 drops three times daily.
|
|---|---|---|
|
Percentage of Patients With Body Temperature ≤37.30С on Days 2-5 of Observation
Day 2
|
28.2 percentage of participants
|
12.7 percentage of participants
|
|
Percentage of Patients With Body Temperature ≤37.30С on Days 2-5 of Observation
Day 3
|
56.3 percentage of participants
|
43.7 percentage of participants
|
|
Percentage of Patients With Body Temperature ≤37.30С on Days 2-5 of Observation
Day 4
|
73.2 percentage of participants
|
74.7 percentage of participants
|
|
Percentage of Patients With Body Temperature ≤37.30С on Days 2-5 of Observation
Day 5
|
88.7 percentage of participants
|
83.1 percentage of participants
|
SECONDARY outcome
Timeframe: On Days 1, 3, 6 of the treatmentPopulation: Intention to treat set
The Total Symptom Score (TSS) was based on the severity of each of acute upper respiratory tract infection (URTI) symptom. The TSS includes 11 symptoms: Body temperature / fever, Non-specific URTI symptoms (Decreased activity / Malaise, Impaired appetite / refusal of feeding, Painful appearance, Sleep disturbance) and Nose /Throat symptoms (Runny nose, Nasal congestion, Sneezing, Hoarseness, Sore throat, Cough). The severity of each URTI symptom was scored on a symptom severity scale (0 = no symptoms; 1 = mild symptoms; 2 = moderate symptoms; 3 = severe symptoms). Minimum score=0; maximum score=33. The severity of URTI symptoms was recorded by the study researchers (pediatricians) on the case record form on Days 1, 3, 6.
Outcome measures
| Measure |
Anaferon for Children
n=71 Participants
Anaferon for children (liquid dosage form): 10 drops per dose. Day 1: 10 drops every 30 minutes for the first 2 hours, followed by three more doses regularly spaced during the rest of the day. Day 2 to 5: 10 drops three times daily.
|
Placebo
n=71 Participants
Placebo (liquid dosage form): 10 drops per dose. Day 1: 10 drops every 30 minutes for the first 2 hours, followed by three more doses regularly spaced during the rest of the day. Day 2 to 5: 10 drops three times daily.
|
|---|---|---|
|
Total Symptom Score on Days 3 and 6 of Observation Based on the Results of Pediatrician's Examination
Day 1
|
11.8 Score
Standard Deviation 3.9
|
12.5 Score
Standard Deviation 4.6
|
|
Total Symptom Score on Days 3 and 6 of Observation Based on the Results of Pediatrician's Examination
Day 3
|
6.0 Score
Standard Deviation 4.7
|
8.0 Score
Standard Deviation 4.6
|
|
Total Symptom Score on Days 3 and 6 of Observation Based on the Results of Pediatrician's Examination
Day 6
|
1.9 Score
Standard Deviation 2.7
|
2.8 Score
Standard Deviation 4.8
|
SECONDARY outcome
Timeframe: on Days 1, 3, 6Population: Intention to treat set
The TSS was based on the severity of each of acute upper respiratory tract infection (URTI) symptom. The TSS includes 11 symptoms: Body temperature / fever, Non-specific URTI symptoms (Decreased activity / Malaise, Impaired appetite / refusal of feeding, Painful appearance, Sleep disturbance) and Nose /Throat symptoms (Runny nose, Nasal congestion, Sneezing, Hoarseness, Sore throat, Cough). The severity of each URTI symptom was scored on a symptom severity scale (0 = no symptoms; 1 = mild symptoms; 2 = moderate symptoms; 3 = severe symptoms). Minimum score=0; maximum score=33. The severity of URTI symptoms was recorded by the study researchers (pediatricians) on the case record form on Days 1, 3, 6.
Outcome measures
| Measure |
Anaferon for Children
n=71 Participants
Anaferon for children (liquid dosage form): 10 drops per dose. Day 1: 10 drops every 30 minutes for the first 2 hours, followed by three more doses regularly spaced during the rest of the day. Day 2 to 5: 10 drops three times daily.
|
Placebo
n=71 Participants
Placebo (liquid dosage form): 10 drops per dose. Day 1: 10 drops every 30 minutes for the first 2 hours, followed by three more doses regularly spaced during the rest of the day. Day 2 to 5: 10 drops three times daily.
|
|---|---|---|
|
Severity of the Disease Within 5 Days Was Assessed Using the "Area Under the Curve" for the Total Symptom Score (TSS) on Days 1, 3, 6 (According to the Results of Pediatrician's Examination)
|
12.6 AUC score*day
Standard Deviation 7.0
|
16.0 AUC score*day
Standard Deviation 7.6
|
SECONDARY outcome
Timeframe: on Days 1-5 of treatmentPopulation: Intention to treat set
based on patient diary data
Outcome measures
| Measure |
Anaferon for Children
n=71 Participants
Anaferon for children (liquid dosage form): 10 drops per dose. Day 1: 10 drops every 30 minutes for the first 2 hours, followed by three more doses regularly spaced during the rest of the day. Day 2 to 5: 10 drops three times daily.
|
Placebo
n=71 Participants
Placebo (liquid dosage form): 10 drops per dose. Day 1: 10 drops every 30 minutes for the first 2 hours, followed by three more doses regularly spaced during the rest of the day. Day 2 to 5: 10 drops three times daily.
|
|---|---|---|
|
Number of Antipyretic Use (for Prescribed Indications) on Days 1-5 of Treatment (Based on Patient Diary Data)
Day 1
|
0.8 Number of intakes
Standard Deviation 0.9
|
0.7 Number of intakes
Standard Deviation 0.9
|
|
Number of Antipyretic Use (for Prescribed Indications) on Days 1-5 of Treatment (Based on Patient Diary Data)
Day 2
|
0.5 Number of intakes
Standard Deviation 1.1
|
0.5 Number of intakes
Standard Deviation 0.8
|
|
Number of Antipyretic Use (for Prescribed Indications) on Days 1-5 of Treatment (Based on Patient Diary Data)
Day 3
|
0.2 Number of intakes
Standard Deviation 0.7
|
0.2 Number of intakes
Standard Deviation 0.5
|
|
Number of Antipyretic Use (for Prescribed Indications) on Days 1-5 of Treatment (Based on Patient Diary Data)
Day 4
|
0.2 Number of intakes
Standard Deviation 0.7
|
0.1 Number of intakes
Standard Deviation 0.5
|
|
Number of Antipyretic Use (for Prescribed Indications) on Days 1-5 of Treatment (Based on Patient Diary Data)
Day 5
|
0.1 Number of intakes
Standard Deviation 0.3
|
0.1 Number of intakes
Standard Deviation 0.4
|
SECONDARY outcome
Timeframe: From the time of randomization up to 14 daysPopulation: Intention to treat
Outcome measures
| Measure |
Anaferon for Children
n=71 Participants
Anaferon for children (liquid dosage form): 10 drops per dose. Day 1: 10 drops every 30 minutes for the first 2 hours, followed by three more doses regularly spaced during the rest of the day. Day 2 to 5: 10 drops three times daily.
|
Placebo
n=71 Participants
Placebo (liquid dosage form): 10 drops per dose. Day 1: 10 drops every 30 minutes for the first 2 hours, followed by three more doses regularly spaced during the rest of the day. Day 2 to 5: 10 drops three times daily.
|
|---|---|---|
|
Percentage of Patients With Complications of Illness, Including Those Requiring Antibiotic Administration or Hospitalization) for 14 Days of Observation
|
2.8 percentage of participants
|
4.2 percentage of participants
|
Adverse Events
Anaferon for Children
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Anaferon for Children
n=71 participants at risk
Anaferon for children (liquid dosage form): 10 drops per dose. Day 1: 10 drops every 30 minutes for the first 2 hours, followed by three more doses regularly spaced during the rest of the day. Day 2 to 5: 10 drops three times daily.
|
Placebo
n=71 participants at risk
Placebo (liquid dosage form): 10 drops per dose. Day 1: 10 drops every 30 minutes for the first 2 hours, followed by three more doses regularly spaced during the rest of the day. Day 2 to 5: 10 drops three times daily.
|
|---|---|---|
|
Nervous system disorders
Hyperactivity
|
1.4%
1/71 • Number of events 1 • Adverse/Serious adverse events were registered from Day 1 to Day 14
Adverse/Serious adverse events were registered in patients of the Full Analysis Set (n=142, Safety Population)
|
0.00%
0/71 • Adverse/Serious adverse events were registered from Day 1 to Day 14
Adverse/Serious adverse events were registered in patients of the Full Analysis Set (n=142, Safety Population)
|
|
Infections and infestations
Herpes Labialis
|
1.4%
1/71 • Number of events 1 • Adverse/Serious adverse events were registered from Day 1 to Day 14
Adverse/Serious adverse events were registered in patients of the Full Analysis Set (n=142, Safety Population)
|
0.00%
0/71 • Adverse/Serious adverse events were registered from Day 1 to Day 14
Adverse/Serious adverse events were registered in patients of the Full Analysis Set (n=142, Safety Population)
|
|
Skin and subcutaneous tissue disorders
Rash
|
2.8%
2/71 • Number of events 2 • Adverse/Serious adverse events were registered from Day 1 to Day 14
Adverse/Serious adverse events were registered in patients of the Full Analysis Set (n=142, Safety Population)
|
0.00%
0/71 • Adverse/Serious adverse events were registered from Day 1 to Day 14
Adverse/Serious adverse events were registered in patients of the Full Analysis Set (n=142, Safety Population)
|
|
Gastrointestinal disorders
Diarrhea
|
1.4%
1/71 • Number of events 1 • Adverse/Serious adverse events were registered from Day 1 to Day 14
Adverse/Serious adverse events were registered in patients of the Full Analysis Set (n=142, Safety Population)
|
0.00%
0/71 • Adverse/Serious adverse events were registered from Day 1 to Day 14
Adverse/Serious adverse events were registered in patients of the Full Analysis Set (n=142, Safety Population)
|
|
Immune system disorders
Administration related reaction
|
1.4%
1/71 • Number of events 1 • Adverse/Serious adverse events were registered from Day 1 to Day 14
Adverse/Serious adverse events were registered in patients of the Full Analysis Set (n=142, Safety Population)
|
0.00%
0/71 • Adverse/Serious adverse events were registered from Day 1 to Day 14
Adverse/Serious adverse events were registered in patients of the Full Analysis Set (n=142, Safety Population)
|
|
Ear and labyrinth disorders
Eustachitis
|
1.4%
1/71 • Number of events 1 • Adverse/Serious adverse events were registered from Day 1 to Day 14
Adverse/Serious adverse events were registered in patients of the Full Analysis Set (n=142, Safety Population)
|
0.00%
0/71 • Adverse/Serious adverse events were registered from Day 1 to Day 14
Adverse/Serious adverse events were registered in patients of the Full Analysis Set (n=142, Safety Population)
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis purulent
|
2.8%
2/71 • Number of events 2 • Adverse/Serious adverse events were registered from Day 1 to Day 14
Adverse/Serious adverse events were registered in patients of the Full Analysis Set (n=142, Safety Population)
|
0.00%
0/71 • Adverse/Serious adverse events were registered from Day 1 to Day 14
Adverse/Serious adverse events were registered in patients of the Full Analysis Set (n=142, Safety Population)
|
|
Respiratory, thoracic and mediastinal disorders
Acute bronchitis
|
1.4%
1/71 • Number of events 1 • Adverse/Serious adverse events were registered from Day 1 to Day 14
Adverse/Serious adverse events were registered in patients of the Full Analysis Set (n=142, Safety Population)
|
0.00%
0/71 • Adverse/Serious adverse events were registered from Day 1 to Day 14
Adverse/Serious adverse events were registered in patients of the Full Analysis Set (n=142, Safety Population)
|
|
Nervous system disorders
Daytime sleepiness
|
0.00%
0/71 • Adverse/Serious adverse events were registered from Day 1 to Day 14
Adverse/Serious adverse events were registered in patients of the Full Analysis Set (n=142, Safety Population)
|
1.4%
1/71 • Number of events 1 • Adverse/Serious adverse events were registered from Day 1 to Day 14
Adverse/Serious adverse events were registered in patients of the Full Analysis Set (n=142, Safety Population)
|
|
Eye disorders
Purulent conjunctivitis
|
0.00%
0/71 • Adverse/Serious adverse events were registered from Day 1 to Day 14
Adverse/Serious adverse events were registered in patients of the Full Analysis Set (n=142, Safety Population)
|
1.4%
1/71 • Number of events 1 • Adverse/Serious adverse events were registered from Day 1 to Day 14
Adverse/Serious adverse events were registered in patients of the Full Analysis Set (n=142, Safety Population)
|
|
Ear and labyrinth disorders
Right otitis media (acute, non-suppurative)
|
0.00%
0/71 • Adverse/Serious adverse events were registered from Day 1 to Day 14
Adverse/Serious adverse events were registered in patients of the Full Analysis Set (n=142, Safety Population)
|
1.4%
1/71 • Number of events 1 • Adverse/Serious adverse events were registered from Day 1 to Day 14
Adverse/Serious adverse events were registered in patients of the Full Analysis Set (n=142, Safety Population)
|
|
Ear and labyrinth disorders
Bilateral otitis media
|
0.00%
0/71 • Adverse/Serious adverse events were registered from Day 1 to Day 14
Adverse/Serious adverse events were registered in patients of the Full Analysis Set (n=142, Safety Population)
|
1.4%
1/71 • Number of events 1 • Adverse/Serious adverse events were registered from Day 1 to Day 14
Adverse/Serious adverse events were registered in patients of the Full Analysis Set (n=142, Safety Population)
|
Additional Information
Mikhail Putilovskiy, MD, PhD, Head of department of clinical trials
Materia Medica Holding
Phone: +74952761571
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: OTHER