Trial Outcomes & Findings for Efficacy and Safety Clinical Trial of Tenoten for Children Liquid Dosage Form Therapy in Infants With Sequelae of Perinatal Brain Injury (NCT NCT03159611)
NCT ID: NCT03159611
Last Updated: 2019-08-08
Results Overview
The Jurba-Mastyukova scale is meant to evaluate motor and mental development of 1-12-month-old infants. 10 developmental domains are evaluated every month. The evaluation of each domain is based on a 4-point system (the optimal development equals 3 points, its absence = 0 points). The maximum score is 30 points; 27-29 points are considered as "age-appropriate normal value"; 23-26 points - as "an absolute risk group"; 13-22 points - as "developmental retardation"; below 13 points - as "severe global developmental delay".
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
182 participants
Primary outcome timeframe
in 12 weeks of the treatment
Results posted on
2019-08-08
Participant Flow
Participant milestones
| Measure |
Placebo
Placebo: Oral. A dose of 10 drops daily, at the same time in the morning, 15 minutes before feeding the child.
The drops can be diluted in a small amount of room temperature drinking water (1/2 tsp.) before use.
|
Tenoten for Children
Tenoten for children: Oral. A dose of 10 drops daily, at the same time in the morning, 15 minutes before feeding the child.
The drops can be diluted in a small amount of room temperature drinking water (1/2 tsp.) before use.
|
|---|---|---|
|
Overall Study
STARTED
|
95
|
87
|
|
Overall Study
COMPLETED
|
72
|
72
|
|
Overall Study
NOT COMPLETED
|
23
|
15
|
Reasons for withdrawal
| Measure |
Placebo
Placebo: Oral. A dose of 10 drops daily, at the same time in the morning, 15 minutes before feeding the child.
The drops can be diluted in a small amount of room temperature drinking water (1/2 tsp.) before use.
|
Tenoten for Children
Tenoten for children: Oral. A dose of 10 drops daily, at the same time in the morning, 15 minutes before feeding the child.
The drops can be diluted in a small amount of room temperature drinking water (1/2 tsp.) before use.
|
|---|---|---|
|
Overall Study
Did Not Meet Inclusion Criteria
|
9
|
5
|
|
Overall Study
Did Not Meet Exclusion Criteria
|
1
|
3
|
|
Overall Study
Protocol Violation
|
7
|
4
|
|
Overall Study
Adverse Event
|
1
|
0
|
|
Overall Study
Withdrawal by Subject
|
1
|
1
|
|
Overall Study
Non-compliance with protocol requirement
|
3
|
2
|
|
Overall Study
Inability to perform procedures
|
1
|
0
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Tenoten for Children
n=87 Participants
Tenoten for children: Oral. A dose of 10 drops daily, at the same time in the morning, 15 minutes before feeding the child.
The drops can be diluted in a small amount of room temperature drinking water (1/2 tsp.) before use.
|
Placebo
n=95 Participants
Placebo: Oral. A dose of 10 drops daily, at the same time in the morning, 15 minutes before feeding the child.
The drops can be diluted in a small amount of room temperature drinking water (1/2 tsp.) before use.
|
Total
n=182 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
5.5 months
STANDARD_DEVIATION 2.0 • n=87 Participants
|
5.0 months
STANDARD_DEVIATION 2.3 • n=95 Participants
|
5.2 months
STANDARD_DEVIATION 2.2 • n=182 Participants
|
|
Sex: Female, Male
Female
|
42 Participants
n=87 Participants
|
41 Participants
n=95 Participants
|
83 Participants
n=182 Participants
|
|
Sex: Female, Male
Male
|
45 Participants
n=87 Participants
|
54 Participants
n=95 Participants
|
99 Participants
n=182 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Body length
|
63.9 centimeter
STANDARD_DEVIATION 4.6 • n=87 Participants
|
62.5 centimeter
STANDARD_DEVIATION 5.3 • n=95 Participants
|
63.2 centimeter
STANDARD_DEVIATION 5.0 • n=182 Participants
|
|
Head circumference
|
42.0 centimeter
STANDARD_DEVIATION 2.3 • n=87 Participants
|
41.4 centimeter
STANDARD_DEVIATION 2.7 • n=95 Participants
|
41.7 centimeter
STANDARD_DEVIATION 2.5 • n=182 Participants
|
PRIMARY outcome
Timeframe: in 12 weeks of the treatmentPopulation: Per Protocol set
The Jurba-Mastyukova scale is meant to evaluate motor and mental development of 1-12-month-old infants. 10 developmental domains are evaluated every month. The evaluation of each domain is based on a 4-point system (the optimal development equals 3 points, its absence = 0 points). The maximum score is 30 points; 27-29 points are considered as "age-appropriate normal value"; 23-26 points - as "an absolute risk group"; 13-22 points - as "developmental retardation"; below 13 points - as "severe global developmental delay".
Outcome measures
| Measure |
Tenoten for Children
n=72 Participants
Tenoten for children: Oral. A dose of 10 drops daily, at the same time in the morning, 15 minutes before feeding the child.
The drops can be diluted in a small amount of room temperature drinking water (1/2 tsp.) before use.
|
Placebo
n=72 Participants
Placebo: Oral. A dose of 10 drops daily, at the same time in the morning, 15 minutes before feeding the child.
The drops can be diluted in a small amount of room temperature drinking water (1/2 tsp.) before use.
|
|---|---|---|
|
Percentage of Patients With a 4 and More Point Increase of the Total Score According to Jurba-Mastyukova Psychomotor Development Scale by the End of the Treatment
|
86.1 percentage of participants
|
62.5 percentage of participants
|
SECONDARY outcome
Timeframe: in 12 weeks of the treatmentPopulation: Per Protocol set
The Jurba-Mastyukova scale is meant to evaluate motor and mental development of 1-12-month-old infants. 10 developmental domains are evaluated every month. The evaluation of each domain is based on a 4-point system (the optimal development equals 3 points, its absence = 0 points). The maximum score is 30 points; 27-29 points are considered as "age-appropriate normal value"; 23-26 points - as "an absolute risk group"; 13-22 points - as "developmental retardation"; below 13 points - as "severe global developmental delay".
Outcome measures
| Measure |
Tenoten for Children
n=72 Participants
Tenoten for children: Oral. A dose of 10 drops daily, at the same time in the morning, 15 minutes before feeding the child.
The drops can be diluted in a small amount of room temperature drinking water (1/2 tsp.) before use.
|
Placebo
n=72 Participants
Placebo: Oral. A dose of 10 drops daily, at the same time in the morning, 15 minutes before feeding the child.
The drops can be diluted in a small amount of room temperature drinking water (1/2 tsp.) before use.
|
|---|---|---|
|
Percentage of Patients With Normal Psychomotor Development (≥ 27 Scores on Jurba-Mastyukova Scale) by the End of Treatment Course Compared to Baseline (Time Frame: 0 Weeks, 4 Weeks, 8 Weeks, 12 Weeks)
Week 4
|
45.8 Percentage of patients
|
34.7 Percentage of patients
|
|
Percentage of Patients With Normal Psychomotor Development (≥ 27 Scores on Jurba-Mastyukova Scale) by the End of Treatment Course Compared to Baseline (Time Frame: 0 Weeks, 4 Weeks, 8 Weeks, 12 Weeks)
Week 8
|
79.2 Percentage of patients
|
66.7 Percentage of patients
|
|
Percentage of Patients With Normal Psychomotor Development (≥ 27 Scores on Jurba-Mastyukova Scale) by the End of Treatment Course Compared to Baseline (Time Frame: 0 Weeks, 4 Weeks, 8 Weeks, 12 Weeks)
Week 12
|
93.1 Percentage of patients
|
81.9 Percentage of patients
|
SECONDARY outcome
Timeframe: in 12 weeks of the treatmentPopulation: Per Protocol set
The Clinical Adaptive Test/Clinical Linguistic and Auditory Milestone Scale (CAT/CLAMS) Consists of Three batteries: Clinical adaptive test (CAT), clinical linguistic and auditory milestone scale (CLAMS), and Gross motor (GM). CAT is the visual-motor problem-solving battery; the score on the CAT is based on the child's performance with the administered items. CLAMS is the language battery of the test; the score on the CLAMS is based on the parent's report of language skill attainment. GM evaluates motor skills; the score on the GM is based on the direct observation of a child and examination by the neurologist. The scores from the CAT/CLAMS+GM are expressed as developmental quotients \[DQ = (developmental age/chronologic age)\*100\]. The full-scale CAT/CLAMS+GM DQ (full-scale DQ) is the mean of the CAT DQ, the CLAMS DQ, and GM DQ. Full-scale DQ ≥ 75 is considered as normal value (the child has a normal development).
Outcome measures
| Measure |
Tenoten for Children
n=72 Participants
Tenoten for children: Oral. A dose of 10 drops daily, at the same time in the morning, 15 minutes before feeding the child.
The drops can be diluted in a small amount of room temperature drinking water (1/2 tsp.) before use.
|
Placebo
n=72 Participants
Placebo: Oral. A dose of 10 drops daily, at the same time in the morning, 15 minutes before feeding the child.
The drops can be diluted in a small amount of room temperature drinking water (1/2 tsp.) before use.
|
|---|---|---|
|
Mean Cognitive Adaptive Test/Clinical Linguistic and Auditory Milestone Scale (CAT/CLAMS) Score by the End of the Treatment Course Compared to Baseline (Time Frame: 0 Weeks, 4 Weeks, 8 Weeks, 12 Weeks)
Week 0
|
86.2 score on a scale
Standard Deviation 14.2
|
83.5 score on a scale
Standard Deviation 16.9
|
|
Mean Cognitive Adaptive Test/Clinical Linguistic and Auditory Milestone Scale (CAT/CLAMS) Score by the End of the Treatment Course Compared to Baseline (Time Frame: 0 Weeks, 4 Weeks, 8 Weeks, 12 Weeks)
Week 4
|
92.5 score on a scale
Standard Deviation 14.1
|
90.6 score on a scale
Standard Deviation 12.9
|
|
Mean Cognitive Adaptive Test/Clinical Linguistic and Auditory Milestone Scale (CAT/CLAMS) Score by the End of the Treatment Course Compared to Baseline (Time Frame: 0 Weeks, 4 Weeks, 8 Weeks, 12 Weeks)
Week 8
|
95.4 score on a scale
Standard Deviation 10.5
|
94.6 score on a scale
Standard Deviation 11.3
|
|
Mean Cognitive Adaptive Test/Clinical Linguistic and Auditory Milestone Scale (CAT/CLAMS) Score by the End of the Treatment Course Compared to Baseline (Time Frame: 0 Weeks, 4 Weeks, 8 Weeks, 12 Weeks)
Week 12
|
97.5 score on a scale
Standard Deviation 8.9
|
95.2 score on a scale
Standard Deviation 10.3
|
SECONDARY outcome
Timeframe: in 12 weeks of the treatmentPopulation: Per Protocol set
The Clinical Adaptive Test/Clinical Linguistic and Auditory Milestone Scale (CAT/CLAMS) Consists of Three batteries: Clinical adaptive test (CAT), clinical linguistic and auditory milestone scale (CLAMS), and Gross motor (GM). CAT is the visual-motor problem-solving battery. The score on the CAT is based on the child's performance with the administered items. CLAMS is the language battery of the test. The score on the CLAMS is based on the parent's report of language skill attainment. GM evaluates motor skills. The score on the GM is based on the direct observation of a child and examination by the neurologist. The scores from the CAT/CLAMS+GM are expressed as developmental quotients \[DQ = (developmental age/chronologic age)\*100\]. The full-scale CAT/CLAMS+GM DQ (full-scale DQ) is the mean of the CAT DQ, the CLAMS DQ, and GM DQ. Full-scale DQ ≥ 75 is considered as normal value (the child has a normal development).
Outcome measures
| Measure |
Tenoten for Children
n=72 Participants
Tenoten for children: Oral. A dose of 10 drops daily, at the same time in the morning, 15 minutes before feeding the child.
The drops can be diluted in a small amount of room temperature drinking water (1/2 tsp.) before use.
|
Placebo
n=72 Participants
Placebo: Oral. A dose of 10 drops daily, at the same time in the morning, 15 minutes before feeding the child.
The drops can be diluted in a small amount of room temperature drinking water (1/2 tsp.) before use.
|
|---|---|---|
|
Percentage of Patients With Normal Psychomotor Development (CATS/CLAMS + Gross Motor Developmental Quotients Score ≥ 75) by the End of the Treatment Course Compared to Baseline (Time Frame: 0 Weeks, 4 Weeks, 8 Weeks, 12 Weeks)
Week 0
|
81.9 Percentage of patients
|
77.8 Percentage of patients
|
|
Percentage of Patients With Normal Psychomotor Development (CATS/CLAMS + Gross Motor Developmental Quotients Score ≥ 75) by the End of the Treatment Course Compared to Baseline (Time Frame: 0 Weeks, 4 Weeks, 8 Weeks, 12 Weeks)
Week 4
|
91.7 Percentage of patients
|
91.7 Percentage of patients
|
|
Percentage of Patients With Normal Psychomotor Development (CATS/CLAMS + Gross Motor Developmental Quotients Score ≥ 75) by the End of the Treatment Course Compared to Baseline (Time Frame: 0 Weeks, 4 Weeks, 8 Weeks, 12 Weeks)
Week 8
|
100 Percentage of patients
|
97.2 Percentage of patients
|
|
Percentage of Patients With Normal Psychomotor Development (CATS/CLAMS + Gross Motor Developmental Quotients Score ≥ 75) by the End of the Treatment Course Compared to Baseline (Time Frame: 0 Weeks, 4 Weeks, 8 Weeks, 12 Weeks)
Week 12
|
100 Percentage of patients
|
95.8 Percentage of patients
|
SECONDARY outcome
Timeframe: in 12 weeks of the treatmentPopulation: Per Protocol set
The Clinical Global Impressions - Efficacy Index (CGI-EI) scale provide an evaluation of the treatment response. CGI-EI takes account of both therapeutic efficacy and treatment-related adverse events and ranges from 0 (marked improvement and no side-effects) and 4 (unchanged or worse and side-effects outweigh the therapeutic effects).
Outcome measures
| Measure |
Tenoten for Children
n=72 Participants
Tenoten for children: Oral. A dose of 10 drops daily, at the same time in the morning, 15 minutes before feeding the child.
The drops can be diluted in a small amount of room temperature drinking water (1/2 tsp.) before use.
|
Placebo
n=72 Participants
Placebo: Oral. A dose of 10 drops daily, at the same time in the morning, 15 minutes before feeding the child.
The drops can be diluted in a small amount of room temperature drinking water (1/2 tsp.) before use.
|
|---|---|---|
|
Clinical Global Impression Scale - Efficacy Index (CGI-EI) Score by the End of the Treatment Course.
Efficacy Index
|
3.2 score on a scale
Standard Deviation 0.8
|
3.2 score on a scale
Standard Deviation 0.8
|
|
Clinical Global Impression Scale - Efficacy Index (CGI-EI) Score by the End of the Treatment Course.
Therapeutic effect
|
3.4 score on a scale
Standard Deviation 0.6
|
3.2 score on a scale
Standard Deviation 0.8
|
|
Clinical Global Impression Scale - Efficacy Index (CGI-EI) Score by the End of the Treatment Course.
Side effect
|
1.1 score on a scale
Standard Deviation 0.3
|
1.0 score on a scale
Standard Deviation 0.1
|
Adverse Events
Tenoten for Children
Serious events: 1 serious events
Other events: 24 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 27 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Tenoten for Children
n=87 participants at risk
Tenoten for children: Oral. A dose of 10 drops daily, at the same time in the morning, 15 minutes before feeding the child.
The drops can be diluted in a small amount of room temperature drinking water (1/2 tsp.) before use.
|
Placebo
n=95 participants at risk
Placebo: Oral. A dose of 10 drops daily, at the same time in the morning, 15 minutes before feeding the child.
The drops can be diluted in a small amount of room temperature drinking water (1/2 tsp.) before use.
|
|---|---|---|
|
Infections and infestations
Acute bronchitis
|
1.1%
1/87 • Number of events 1 • Adverse/Serious adverse events were registered during 12 weeks of therapy.
Adverse/Serious adverse events were registered in patients of the Full Analysis Set (n=182, Safety Population)
|
0.00%
0/95 • Adverse/Serious adverse events were registered during 12 weeks of therapy.
Adverse/Serious adverse events were registered in patients of the Full Analysis Set (n=182, Safety Population)
|
Other adverse events
| Measure |
Tenoten for Children
n=87 participants at risk
Tenoten for children: Oral. A dose of 10 drops daily, at the same time in the morning, 15 minutes before feeding the child.
The drops can be diluted in a small amount of room temperature drinking water (1/2 tsp.) before use.
|
Placebo
n=95 participants at risk
Placebo: Oral. A dose of 10 drops daily, at the same time in the morning, 15 minutes before feeding the child.
The drops can be diluted in a small amount of room temperature drinking water (1/2 tsp.) before use.
|
|---|---|---|
|
Renal and urinary disorders
Hyperoxaluria
|
1.1%
1/87 • Number of events 1 • Adverse/Serious adverse events were registered during 12 weeks of therapy.
Adverse/Serious adverse events were registered in patients of the Full Analysis Set (n=182, Safety Population)
|
0.00%
0/95 • Adverse/Serious adverse events were registered during 12 weeks of therapy.
Adverse/Serious adverse events were registered in patients of the Full Analysis Set (n=182, Safety Population)
|
|
Skin and subcutaneous tissue disorders
Eczema weeping
|
1.1%
1/87 • Number of events 1 • Adverse/Serious adverse events were registered during 12 weeks of therapy.
Adverse/Serious adverse events were registered in patients of the Full Analysis Set (n=182, Safety Population)
|
0.00%
0/95 • Adverse/Serious adverse events were registered during 12 weeks of therapy.
Adverse/Serious adverse events were registered in patients of the Full Analysis Set (n=182, Safety Population)
|
|
Infections and infestations
Respiratory tract infection
|
12.6%
11/87 • Number of events 14 • Adverse/Serious adverse events were registered during 12 weeks of therapy.
Adverse/Serious adverse events were registered in patients of the Full Analysis Set (n=182, Safety Population)
|
8.4%
8/95 • Number of events 9 • Adverse/Serious adverse events were registered during 12 weeks of therapy.
Adverse/Serious adverse events were registered in patients of the Full Analysis Set (n=182, Safety Population)
|
|
Blood and lymphatic system disorders
Anaemia
|
2.3%
2/87 • Number of events 2 • Adverse/Serious adverse events were registered during 12 weeks of therapy.
Adverse/Serious adverse events were registered in patients of the Full Analysis Set (n=182, Safety Population)
|
0.00%
0/95 • Adverse/Serious adverse events were registered during 12 weeks of therapy.
Adverse/Serious adverse events were registered in patients of the Full Analysis Set (n=182, Safety Population)
|
|
Injury, poisoning and procedural complications
Vaccination complication
|
1.1%
1/87 • Number of events 1 • Adverse/Serious adverse events were registered during 12 weeks of therapy.
Adverse/Serious adverse events were registered in patients of the Full Analysis Set (n=182, Safety Population)
|
1.1%
1/95 • Number of events 1 • Adverse/Serious adverse events were registered during 12 weeks of therapy.
Adverse/Serious adverse events were registered in patients of the Full Analysis Set (n=182, Safety Population)
|
|
Gastrointestinal disorders
Teething
|
5.7%
5/87 • Number of events 5 • Adverse/Serious adverse events were registered during 12 weeks of therapy.
Adverse/Serious adverse events were registered in patients of the Full Analysis Set (n=182, Safety Population)
|
4.2%
4/95 • Number of events 5 • Adverse/Serious adverse events were registered during 12 weeks of therapy.
Adverse/Serious adverse events were registered in patients of the Full Analysis Set (n=182, Safety Population)
|
|
Infections and infestations
Urinary tract infection
|
1.1%
1/87 • Number of events 1 • Adverse/Serious adverse events were registered during 12 weeks of therapy.
Adverse/Serious adverse events were registered in patients of the Full Analysis Set (n=182, Safety Population)
|
1.1%
1/95 • Number of events 1 • Adverse/Serious adverse events were registered during 12 weeks of therapy.
Adverse/Serious adverse events were registered in patients of the Full Analysis Set (n=182, Safety Population)
|
|
Infections and infestations
Escherichia urinary tract infection
|
1.1%
1/87 • Number of events 1 • Adverse/Serious adverse events were registered during 12 weeks of therapy.
Adverse/Serious adverse events were registered in patients of the Full Analysis Set (n=182, Safety Population)
|
0.00%
0/95 • Adverse/Serious adverse events were registered during 12 weeks of therapy.
Adverse/Serious adverse events were registered in patients of the Full Analysis Set (n=182, Safety Population)
|
|
Infections and infestations
Otitis media
|
1.1%
1/87 • Number of events 1 • Adverse/Serious adverse events were registered during 12 weeks of therapy.
Adverse/Serious adverse events were registered in patients of the Full Analysis Set (n=182, Safety Population)
|
0.00%
0/95 • Adverse/Serious adverse events were registered during 12 weeks of therapy.
Adverse/Serious adverse events were registered in patients of the Full Analysis Set (n=182, Safety Population)
|
|
Infections and infestations
Otitis media acute
|
1.1%
1/87 • Number of events 1 • Adverse/Serious adverse events were registered during 12 weeks of therapy.
Adverse/Serious adverse events were registered in patients of the Full Analysis Set (n=182, Safety Population)
|
0.00%
0/95 • Adverse/Serious adverse events were registered during 12 weeks of therapy.
Adverse/Serious adverse events were registered in patients of the Full Analysis Set (n=182, Safety Population)
|
|
Infections and infestations
Nasopharyngitis
|
3.4%
3/87 • Number of events 3 • Adverse/Serious adverse events were registered during 12 weeks of therapy.
Adverse/Serious adverse events were registered in patients of the Full Analysis Set (n=182, Safety Population)
|
2.1%
2/95 • Number of events 3 • Adverse/Serious adverse events were registered during 12 weeks of therapy.
Adverse/Serious adverse events were registered in patients of the Full Analysis Set (n=182, Safety Population)
|
|
Infections and infestations
Tracheitis
|
1.1%
1/87 • Number of events 1 • Adverse/Serious adverse events were registered during 12 weeks of therapy.
Adverse/Serious adverse events were registered in patients of the Full Analysis Set (n=182, Safety Population)
|
0.00%
0/95 • Adverse/Serious adverse events were registered during 12 weeks of therapy.
Adverse/Serious adverse events were registered in patients of the Full Analysis Set (n=182, Safety Population)
|
|
Infections and infestations
Pharyngitis
|
2.3%
2/87 • Number of events 2 • Adverse/Serious adverse events were registered during 12 weeks of therapy.
Adverse/Serious adverse events were registered in patients of the Full Analysis Set (n=182, Safety Population)
|
0.00%
0/95 • Adverse/Serious adverse events were registered during 12 weeks of therapy.
Adverse/Serious adverse events were registered in patients of the Full Analysis Set (n=182, Safety Population)
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
1.1%
1/87 • Number of events 1 • Adverse/Serious adverse events were registered during 12 weeks of therapy.
Adverse/Serious adverse events were registered in patients of the Full Analysis Set (n=182, Safety Population)
|
0.00%
0/95 • Adverse/Serious adverse events were registered during 12 weeks of therapy.
Adverse/Serious adverse events were registered in patients of the Full Analysis Set (n=182, Safety Population)
|
|
Gastrointestinal disorders
Malabsorption
|
1.1%
1/87 • Number of events 1 • Adverse/Serious adverse events were registered during 12 weeks of therapy.
Adverse/Serious adverse events were registered in patients of the Full Analysis Set (n=182, Safety Population)
|
0.00%
0/95 • Adverse/Serious adverse events were registered during 12 weeks of therapy.
Adverse/Serious adverse events were registered in patients of the Full Analysis Set (n=182, Safety Population)
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/87 • Adverse/Serious adverse events were registered during 12 weeks of therapy.
Adverse/Serious adverse events were registered in patients of the Full Analysis Set (n=182, Safety Population)
|
1.1%
1/95 • Number of events 1 • Adverse/Serious adverse events were registered during 12 weeks of therapy.
Adverse/Serious adverse events were registered in patients of the Full Analysis Set (n=182, Safety Population)
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.00%
0/87 • Adverse/Serious adverse events were registered during 12 weeks of therapy.
Adverse/Serious adverse events were registered in patients of the Full Analysis Set (n=182, Safety Population)
|
1.1%
1/95 • Number of events 1 • Adverse/Serious adverse events were registered during 12 weeks of therapy.
Adverse/Serious adverse events were registered in patients of the Full Analysis Set (n=182, Safety Population)
|
|
Nervous system disorders
Autonomic nervous system imbalance
|
0.00%
0/87 • Adverse/Serious adverse events were registered during 12 weeks of therapy.
Adverse/Serious adverse events were registered in patients of the Full Analysis Set (n=182, Safety Population)
|
1.1%
1/95 • Number of events 1 • Adverse/Serious adverse events were registered during 12 weeks of therapy.
Adverse/Serious adverse events were registered in patients of the Full Analysis Set (n=182, Safety Population)
|
|
Infections and infestations
Bronchitis
|
0.00%
0/87 • Adverse/Serious adverse events were registered during 12 weeks of therapy.
Adverse/Serious adverse events were registered in patients of the Full Analysis Set (n=182, Safety Population)
|
1.1%
1/95 • Number of events 1 • Adverse/Serious adverse events were registered during 12 weeks of therapy.
Adverse/Serious adverse events were registered in patients of the Full Analysis Set (n=182, Safety Population)
|
|
Infections and infestations
Laryngitis
|
0.00%
0/87 • Adverse/Serious adverse events were registered during 12 weeks of therapy.
Adverse/Serious adverse events were registered in patients of the Full Analysis Set (n=182, Safety Population)
|
1.1%
1/95 • Number of events 1 • Adverse/Serious adverse events were registered during 12 weeks of therapy.
Adverse/Serious adverse events were registered in patients of the Full Analysis Set (n=182, Safety Population)
|
|
Infections and infestations
Rhinitis
|
0.00%
0/87 • Adverse/Serious adverse events were registered during 12 weeks of therapy.
Adverse/Serious adverse events were registered in patients of the Full Analysis Set (n=182, Safety Population)
|
2.1%
2/95 • Number of events 2 • Adverse/Serious adverse events were registered during 12 weeks of therapy.
Adverse/Serious adverse events were registered in patients of the Full Analysis Set (n=182, Safety Population)
|
|
Infections and infestations
Tracheobronchitis
|
0.00%
0/87 • Adverse/Serious adverse events were registered during 12 weeks of therapy.
Adverse/Serious adverse events were registered in patients of the Full Analysis Set (n=182, Safety Population)
|
2.1%
2/95 • Number of events 2 • Adverse/Serious adverse events were registered during 12 weeks of therapy.
Adverse/Serious adverse events were registered in patients of the Full Analysis Set (n=182, Safety Population)
|
|
Respiratory, thoracic and mediastinal disorders
Yawning
|
0.00%
0/87 • Adverse/Serious adverse events were registered during 12 weeks of therapy.
Adverse/Serious adverse events were registered in patients of the Full Analysis Set (n=182, Safety Population)
|
1.1%
1/95 • Number of events 1 • Adverse/Serious adverse events were registered during 12 weeks of therapy.
Adverse/Serious adverse events were registered in patients of the Full Analysis Set (n=182, Safety Population)
|
|
General disorders
Pyrexia
|
0.00%
0/87 • Adverse/Serious adverse events were registered during 12 weeks of therapy.
Adverse/Serious adverse events were registered in patients of the Full Analysis Set (n=182, Safety Population)
|
4.2%
4/95 • Number of events 4 • Adverse/Serious adverse events were registered during 12 weeks of therapy.
Adverse/Serious adverse events were registered in patients of the Full Analysis Set (n=182, Safety Population)
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/87 • Adverse/Serious adverse events were registered during 12 weeks of therapy.
Adverse/Serious adverse events were registered in patients of the Full Analysis Set (n=182, Safety Population)
|
1.1%
1/95 • Number of events 1 • Adverse/Serious adverse events were registered during 12 weeks of therapy.
Adverse/Serious adverse events were registered in patients of the Full Analysis Set (n=182, Safety Population)
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/87 • Adverse/Serious adverse events were registered during 12 weeks of therapy.
Adverse/Serious adverse events were registered in patients of the Full Analysis Set (n=182, Safety Population)
|
1.1%
1/95 • Number of events 2 • Adverse/Serious adverse events were registered during 12 weeks of therapy.
Adverse/Serious adverse events were registered in patients of the Full Analysis Set (n=182, Safety Population)
|
|
Infections and infestations
Oral candidiasis
|
0.00%
0/87 • Adverse/Serious adverse events were registered during 12 weeks of therapy.
Adverse/Serious adverse events were registered in patients of the Full Analysis Set (n=182, Safety Population)
|
1.1%
1/95 • Number of events 1 • Adverse/Serious adverse events were registered during 12 weeks of therapy.
Adverse/Serious adverse events were registered in patients of the Full Analysis Set (n=182, Safety Population)
|
|
Infections and infestations
Conjunctivitis
|
0.00%
0/87 • Adverse/Serious adverse events were registered during 12 weeks of therapy.
Adverse/Serious adverse events were registered in patients of the Full Analysis Set (n=182, Safety Population)
|
1.1%
1/95 • Number of events 1 • Adverse/Serious adverse events were registered during 12 weeks of therapy.
Adverse/Serious adverse events were registered in patients of the Full Analysis Set (n=182, Safety Population)
|
|
Injury, poisoning and procedural complications
Concussion
|
0.00%
0/87 • Adverse/Serious adverse events were registered during 12 weeks of therapy.
Adverse/Serious adverse events were registered in patients of the Full Analysis Set (n=182, Safety Population)
|
1.1%
1/95 • Number of events 1 • Adverse/Serious adverse events were registered during 12 weeks of therapy.
Adverse/Serious adverse events were registered in patients of the Full Analysis Set (n=182, Safety Population)
|
|
Musculoskeletal and connective tissue disorders
Rickets
|
0.00%
0/87 • Adverse/Serious adverse events were registered during 12 weeks of therapy.
Adverse/Serious adverse events were registered in patients of the Full Analysis Set (n=182, Safety Population)
|
3.2%
3/95 • Number of events 3 • Adverse/Serious adverse events were registered during 12 weeks of therapy.
Adverse/Serious adverse events were registered in patients of the Full Analysis Set (n=182, Safety Population)
|
|
Skin and subcutaneous tissue disorders
Dermatitis atopic
|
0.00%
0/87 • Adverse/Serious adverse events were registered during 12 weeks of therapy.
Adverse/Serious adverse events were registered in patients of the Full Analysis Set (n=182, Safety Population)
|
1.1%
1/95 • Number of events 1 • Adverse/Serious adverse events were registered during 12 weeks of therapy.
Adverse/Serious adverse events were registered in patients of the Full Analysis Set (n=182, Safety Population)
|
|
Infections and infestations
Cellulitis
|
0.00%
0/87 • Adverse/Serious adverse events were registered during 12 weeks of therapy.
Adverse/Serious adverse events were registered in patients of the Full Analysis Set (n=182, Safety Population)
|
1.1%
1/95 • Number of events 1 • Adverse/Serious adverse events were registered during 12 weeks of therapy.
Adverse/Serious adverse events were registered in patients of the Full Analysis Set (n=182, Safety Population)
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.00%
0/87 • Adverse/Serious adverse events were registered during 12 weeks of therapy.
Adverse/Serious adverse events were registered in patients of the Full Analysis Set (n=182, Safety Population)
|
1.1%
1/95 • Number of events 1 • Adverse/Serious adverse events were registered during 12 weeks of therapy.
Adverse/Serious adverse events were registered in patients of the Full Analysis Set (n=182, Safety Population)
|
|
Infections and infestations
Fungal skin infection
|
0.00%
0/87 • Adverse/Serious adverse events were registered during 12 weeks of therapy.
Adverse/Serious adverse events were registered in patients of the Full Analysis Set (n=182, Safety Population)
|
1.1%
1/95 • Number of events 1 • Adverse/Serious adverse events were registered during 12 weeks of therapy.
Adverse/Serious adverse events were registered in patients of the Full Analysis Set (n=182, Safety Population)
|
|
Skin and subcutaneous tissue disorders
Dermatitis allergic
|
0.00%
0/87 • Adverse/Serious adverse events were registered during 12 weeks of therapy.
Adverse/Serious adverse events were registered in patients of the Full Analysis Set (n=182, Safety Population)
|
2.1%
2/95 • Number of events 3 • Adverse/Serious adverse events were registered during 12 weeks of therapy.
Adverse/Serious adverse events were registered in patients of the Full Analysis Set (n=182, 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