Efficacy of Anaferon for Children in the Treatment of Inf... | NCT02072174

Description Module

Detailed Description

The study will enroll outpatient subjects of both sexes aged 3-12 years with clinical manifestations of influenza/Acute Respiratory Viral Infections (ARVI), including fever

≥ 38.0°С having an appointment with a doctor within the first day after the illness onset.

Тhe physician will collect medical history information, perform an objective examination, record the concomitant therapy, and obtain nasal swab specimens for a rapid diagnostic influenza test. If the swab is positive, the doctor shall obtain swab specimens from the nasal cavity and oropharynx (nasopharyngeal swab) for a subsequent real time reverse transcription-polymerase chain reaction (RT-PCR) to determine the viral load of influenza A and/or B virus. If the swab is negative for influenza the doctor shall collect a nasopharyngeal swab for a subsequent PCR test for other respiratory viruses.

If inclusion criteria are met and exclusion criteria are absent at visit 1 (Day 1), the patient will be enrolled in the trial and randomized into one of the two groups: group 1 patients will take Anaferon for children following a 5-day regimen; group 2 patients will receive Placebo using the Anaferon for children 5-day regimen. The parent/adopter of patient will receive a diary where they should record the child's axillary temperature data in the morning and evening, and score the severity of symptoms.

The subject will be monitored for 14 days (screening, randomization - 1 day, treatment - 5 days, follow-up - 1 day; late-scheduled phone "visit" - day 14).

At Visits 2-4, the physician will document objective examination data; obtain nasopharyngeal swabs from subjects with positive influenza tests for subsequent RT-PCR to determine the viral load and its reduction in the course of treatment; monitor the prescribed and concomitant therapy, and check the patient's diary data. The phone "visit" will be made to elicit information from the parents regarding the patient's general health, presence/absence of secondary bacterial/viral complications, and use of antibacterial drugs.

Interim statistical analysis is stipulated by the study protocol. Interim analysis will be performed using the data obtained from the examination and treatment of the protocol-defined number of patients who completed the study. Based on the expected effect, the minimum required Particular Per Protocol (pPP) sample size will be 254 patients (127 subjects in each group - Anaferon for children and Placebo).

Label	Type	Description	Intervention Names
Anaferon for Children	Experimental	On day 1, five tablets are taken in the first 2 hours (one tablet every 30 min), followed by three more tablets regularly spaced during the rest of the day. From day 2 through 5, one tablet is administered three times daily.	Drug: Anaferon for Children
Placebo	Placebo Comparator	On day 1, five tablets are taken in the first 2 hours (one tablet every 30 min), followed by three more tablets regularly spaced during the rest of the day. From day 2 through 5, one tablet is administered three times daily.	Drug: Anaferon for Children

Name	Type	Description	Arm Group Labels	Other Names
Anaferon for Children	Drug	Anaferon for children: For oral use.	Anaferon for Children Placebo

Measure	Description	Time Frame
Average Illness Duration	Disease duration is assessed until recovery or significant improvement. Average illness duration is defined as the interval between the start of the trial treatment and the start of the first 24-hour period in which the non-specific symptoms and nasal/ throat/ chest symptoms improve to "absent" or "mild" (Total Symptom Score of severity had decreased to ≤2 points) and body temperature returns to 37.2°C or below. Based on patient diary data.	From the time of randomization until the time of recovery/improvement (days 1-14)

Measure	Description	Time Frame
Percentage of Patients With Recovery/Improvement in Health	Based on Days 2, 3, 4 and 5 of observation treatment (according to the patient's diary), on days 3 and 5 of therapy (according to physician's objective examination).	on days 2, 3, 4 and 5 of the treatment
Changes in Body Temperature

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients of both sexes aged 3-12 years inclusively.
Diagnosis of influenza/ARVI according to physician's examination: body temperature ≥ 38.0°C at the time of examination + symptom score ≥ 4 (at least 1 systemic symptom ≥2 and 1 nasal/throat/chest symptom ≥2 or several symptoms ≥ 1 score).
The first 24 hours from the beginning of manifestations of influenza/ARVI.
The possibility to start therapy within 24 hours from the first symptoms of ARVI.
Availability of a patient information sheet (Informed Consent form) for parents/adoptive parents for participation in the study signed by one of the parents/adoptive parents.

Exclusion Criteria:

Suspected pneumonia, bacterial infection or severe disease requiring antibacterial products (including sulfanilamides) starting from the first day of the disease.
Clinical symptoms of severe influenza/ARVI requiring hospitalization.
Suspected initial manifestations of the diseases having the symptoms similar to the ones of influenza/ARVI (other infectious diseases, influenza-like syndrome at debut of systemic connective tissue diseases, oncohematological and other diseases).
Medical history of primary and secondary immunodeficiencies: а) lymphoid system immunodeficiencies (Т-cell and/or B-cell, immunodeficiencies with predominant antibody deficiency); b) phagocytic deficiencies; c) complement factor deficiency; d) combined immunodeficiencies including AIDS secondary to HIV-infection; toxic, autoimmune, infectious, radiation panleukopenic syndrome; systemic lymphocytopenic syndrome; polyclonal lymphocytic activation syndrome; postsplenectomic syndrome; congenital asplenia; immune complex pathological syndrome associated with infectious, autoimmune and allergic diseases.
Medical history of sarcoidosis.
Oncology.
Exacerbation or decompensation of chronic diseases affecting ability to participate in the clinical study.
Medical history of polyvalent allergy.
Allergy/intolerance to any of the components of medications used in the treatment.
Malabsorption syndrome, including congenital or acquired lactase or other disaccharidase deficiency, galactosemia.
Intake of medicines listed in the section "Prohibited concomitant therapy" within 1 month prior to the inclusion in the study.
Drug addiction, alcohol consumption at more than 2 alcohol units per day by the subject's parents/adoptive parents.
Mental diseases of the subject, parents/adoptive parents.
Subjects whose parents/adoptive parents, according to the investigator's point of view, will not follow the observation requirements during the study or study product dosing regimen.
Participation in other clinical studies within 3 months prior to the inclusion in the study.
Parent/adoptive parent of the subject is related to the investigator team of medical facility directly involved in the study or is a close relative of the investigator. Close relatives include spouse, parents, children or brothers (sisters) regardless of whether they are biological or adoptive ones.
Parent/adoptive parent of the subject is working in OOO "NPF "Materia Medica Holding", i.e. is the company official, temporary contract worker or an appointed official responsible for the study or their close relatives.

Name	Affiliation	Role
Elena Andrianova, Professor	Materia Medica Holding	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
City Child Health Clinical Polyclinic №13		Minsk		220024	Belarus
Municipal Health Care Institution "City Child Health Clinical Polyclinic №10"

ID	Title	Description
FG000	Anaferon for Children	Anaferon for Children: 1 tablet per 1 intake. On the first day of treatment: the first 2 hours of 1 tablet every 30 minutes, then, during the first day, 3 more times at regular intervals. From the second to the fifth day: 1 tablet 3 times a day. The drug is taken out of the reception of food (in the interval between meals or 15-30 minutes before eating), should be kept in your mouth, not swallowed, until it is dissolved completely.

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot_SAP	Yes	Yes	No	Study Protocol and Statistical Analysis Plan	Aug 1, 2016

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Average Illness Duration

Disease duration is assessed until recovery or significant improvement. Average illness duration is defined as the interval between the start of the trial treatment and the start of the first 24-hour period in which the non-specific symptoms and nasal/ throat/ chest symptoms improve to "absent" or "mild" (Total Symptom Score of severity had decreased to ≤2 points) and body temperature returns to 37.2°C or below.

Based on patient diary data.

Per Protocol set

Posted

Mean

Standard Deviation

days

From the time of randomization until the time of recovery/improvement (days 1-14)

ID	Title	Description
OG000	Anaferon for Children	Anaferon for Children: 1 tablet per 1 intake. On the first day of treatment: the first 2 hours of 1 tablet every 30 minutes, then, during the first day, 3 more times at regular intervals. From the second to the fifth day: 1 tablet 3 times a day. The drug is taken out of the reception of food (in the interval between meals or 15-30 minutes before eating), should be kept in your mouth, not swallowed, until it is dissolved completely.
OG001	Placebo	Placebo: 1 tablet per 1 intake. On the first day of treatment: the first 2 hours of 1 tablet every 30 minutes, then, during the first day, 3 more times at regular intervals. From the second to the fifth day: 1 tablet 3 times a day. The drug is taken out of the reception of food (in the interval between meals or 15-30 minutes before eating), should be kept in your mouth, not swallowed, until it is dissolved completely.

Units	Counts
Participants	OG000258 OG001240

Title

Denominators

Categories

Title	Measurements
	OG0004.6± 1.4 OG0014.9± 1.3

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001		Kruskal-Wallis		0.0242														Superiority

Secondary

Percentage of Patients With Recovery/Improvement in Health

Based on Days 2, 3, 4 and 5 of observation treatment (according to the patient's diary), on days 3 and 5 of therapy (according to physician's objective examination).

Per Protocol set

Posted

Count of Participants

Participants

on days 2, 3, 4 and 5 of the treatment

ID	Title	Description
OG000	Anaferon for Children	Anaferon for Children: 1 tablet per 1 intake. On the first day of treatment: the first 2 hours of 1 tablet every 30 minutes, then, during the first day, 3 more times at regular intervals. From the second to the fifth day: 1 tablet 3 times a day. The drug is taken out of the reception of food (in the interval between meals or 15-30 minutes before eating), should be kept in your mouth, not swallowed, until it is dissolved completely.
OG001	Placebo	Placebo: 1 tablet per 1 intake. On the first day of treatment: the first 2 hours of 1 tablet every 30 minutes, then, during the first day, 3 more times at regular intervals. From the second to the fifth day: 1 tablet 3 times a day. The drug is taken out of the reception of food (in the interval between meals or 15-30 minutes before eating), should be kept in your mouth, not swallowed, until it is dissolved completely.

Secondary

Changes in Body Temperature

Changes in Body Temperature Based on Patient Diary Data

Per Protocol set

Posted

Mean

Standard Deviation

°C

baseline and days 2, 3, 4 and 5 of observation treatment

ID	Title	Description
OG000	Anaferon for Children	Anaferon for Children: 1 tablet per 1 intake. On the first day of treatment: the first 2 hours of 1 tablet every 30 minutes, then, during the first day, 3 more times at regular intervals. From the second to the fifth day: 1 tablet 3 times a day. The drug is taken out of the reception of food (in the interval between meals or 15-30 minutes before eating), should be kept in your mouth, not swallowed, until it is dissolved completely.
OG001	Placebo	Placebo: 1 tablet per 1 intake. On the first day of treatment: the first 2 hours of 1 tablet every 30 minutes, then, during the first day, 3 more times at regular intervals. From the second to the fifth day: 1 tablet 3 times a day. The drug is taken out of the reception of food (in the interval between meals or 15-30 minutes before eating), should be kept in your mouth, not swallowed, until it is dissolved completely.

Units	Counts

Secondary

Percentage of Patients With Normal Body Temperature (≤37.0ºС)

Based on the patient diary data. Axillary temperature (morning and evening) decline to or below 37.0 ºС.

Per Protocol set

Posted

Count of Participants

Participants

on days 2, 3, 4 and 5 of observation treatment

ID	Title	Description
OG000	Anaferon for Children	Anaferon for Children: 1 tablet per 1 intake. On the first day of treatment: the first 2 hours of 1 tablet every 30 minutes, then, during the first day, 3 more times at regular intervals. From the second to the fifth day: 1 tablet 3 times a day. The drug is taken out of the reception of food (in the interval between meals or 15-30 minutes before eating), should be kept in your mouth, not swallowed, until it is dissolved completely.
OG001	Placebo	Placebo: 1 tablet per 1 intake. On the first day of treatment: the first 2 hours of 1 tablet every 30 minutes, then, during the first day, 3 more times at regular intervals. From the second to the fifth day: 1 tablet 3 times a day. The drug is taken out of the reception of food (in the interval between meals or 15-30 minutes before eating), should be kept in your mouth, not swallowed, until it is dissolved completely.

Secondary

Severity of Clinical Manifestations of Influenza / Acute Respiratory Viral Infection by Total Symptom Score.

Total Symptom Score is based on the severity of each Influenza / Acute Respiratory Viral Infection symptom.

Total Symptom Score includes 13 symptoms: body temperature, non-specific symptoms (headache, chills, sweating, weakness, muscle pain, drowsiness), nasal/throat/chest symptoms.

The severity of non-specific and nasal/throat/chest symptom is scored on a symptom severity scale (0=no symptoms; 1=mild symptoms; 2=moderate symptoms; 3=severe symptoms).

Minimum score=0; maximum score=39. The severity of symptoms is recorded by the doctors on the case record form on days 3, 5 and by parents/adopter on a diary card twice a day on days 2-6.

Per Protocol set

Posted

Mean

Standard Deviation

score on a scale

on days 2-6 of observation treatment

ID	Title	Description
OG000	Anaferon for Children	Anaferon for Children: 1 tablet per 1 intake. On the first day of treatment: the first 2 hours of 1 tablet every 30 minutes, then, during the first day, 3 more times at regular intervals. From the second to the fifth day: 1 tablet 3 times a day. The drug is taken out of the reception of food (in the interval between meals or 15-30 minutes before eating), should be kept in your mouth, not swallowed, until it is dissolved completely.
OG001	Placebo	Placebo: 1 tablet per 1 intake. On the first day of treatment: the first 2 hours of 1 tablet every 30 minutes, then, during the first day, 3 more times at regular intervals. From the second to the fifth day: 1 tablet 3 times a day. The drug is taken out of the reception of food (in the interval between meals or 15-30 minutes before eating), should be kept in your mouth, not swallowed, until it is dissolved completely.

Secondary

Assessment of the Severity of Influenza Virus / Acute Respiratory Viral Infection Using the "Area Under the Curve" for an Overall Symptom Assessment

Total Symptom Score is based on the severity of each disease symptom. The TSS includes 13 symptoms: body temperature/fever, non-specific symptoms (headache, chills, sweating, weakness, muscle pain, drowsiness), nasal/throat/chest symptoms (runny nose, nasal congestion, sneezing, sore throat, hoarseness, cough, chest pain/tightness of the chest).

Minimum score=0; maximum score=39. The area under the curve 1 = on days 1, 3, 5 and 7 on the results of doctor's examination The area under the curve 2 = based on days 1-7 on the patient diary data

Per Protocol set

Posted

Mean

Standard Deviation

score*day

on days 1-7 of observation (based on days 1-7 on the patient diary data; on days 1, 3, 5 and 7 of observation - according to physician's objective examination)

ID	Title	Description
OG000	Anaferon for Children	Anaferon for children: Anaferon for children: 1 tablet per 1 intake. On the first day of treatment: the first 2 hours of 1 tablet every 30 minutes, then, during the first day, 3 more times at regular intervals. From the second to the fifth day: 1 tablet 3 times a day. The drug is taken out of the reception of food (in the interval between meals or 15-30 minutes before eating), should be kept in your mouth, not swallowed, until it is dissolved completely.
OG001	Placebo	Placebo: Placebo: 1 tablet per 1 intake. On the first day of treatment: the first 2 hours of 1 tablet every 30 minutes, then, during the first day, 3 more times at regular intervals. From the second to the fifth day: 1 tablet 3 times a day. The drug is taken out of the reception of food (in the interval between meals or 15-30 minutes before eating), should be kept in your mouth, not swallowed, until it is dissolved completely.

Secondary

Number of Intakes of Antipyretics

Number of Intakes of Antipyretics based on patient diary data

Per Protocol set

Posted

Mean

Standard Deviation

Number of intakes

on days 1-5 of therapy

ID	Title	Description
OG000	Anaferon for Children	Anaferon for Children: 1 tablet per 1 intake. On the first day of treatment: the first 2 hours of 1 tablet every 30 minutes, then, during the first day, 3 more times at regular intervals. From the second to the fifth day: 1 tablet 3 times a day. The drug is taken out of the reception of food (in the interval between meals or 15-30 minutes before eating), should be kept in your mouth, not swallowed, until it is dissolved completely.
OG001	Placebo	Placebo: 1 tablet per 1 intake. On the first day of treatment: the first 2 hours of 1 tablet every 30 minutes, then, during the first day, 3 more times at regular intervals. From the second to the fifth day: 1 tablet 3 times a day. The drug is taken out of the reception of food (in the interval between meals or 15-30 minutes before eating), should be kept in your mouth, not swallowed, until it is dissolved completely.

Units	Counts

Secondary

Change in Viral Load During the Treatment and Follow-up Periods

Viral load is evaluated in subjects with positive influenza A and B tests. Virus load [log10 copies influenza А/В RNA per 1 mL] in nasal and pharyngeal swabs is determined using real-time PCR on days 1, 3, 5 and 7.

Viral load is evaluated in subjects with positive influenza A and B tests.

Posted

Mean

Standard Deviation

log10 copies influenza А/В RNA per 1 mL

on days 1, 3, 5, 7 of observation treatment

ID	Title	Description
OG000	Anaferon for Children	Anaferon for Children: 1 tablet per 1 intake. On the first day of treatment: the first 2 hours of 1 tablet every 30 minutes, then, during the first day, 3 more times at regular intervals. From the second to the fifth day: 1 tablet 3 times a day. The drug is taken out of the reception of food (in the interval between meals or 15-30 minutes before eating), should be kept in your mouth, not swallowed, until it is dissolved completely.
OG001	Placebo	Placebo: 1 tablet per 1 intake. On the first day of treatment: the first 2 hours of 1 tablet every 30 minutes, then, during the first day, 3 more times at regular intervals. From the second to the fifth day: 1 tablet 3 times a day. The drug is taken out of the reception of food (in the interval between meals or 15-30 minutes before eating), should be kept in your mouth, not swallowed, until it is dissolved completely.

Secondary

Percentage of Patients With Exacerbation of the Disease Course

The development of disease complications requiring antibiotics drugs or hospitalization

Per Protocol set

Posted

Count of Participants

Participants

14 days of observation treatment

ID	Title	Description
OG000	Anaferon for Children	Anaferon for Children: 1 tablet per 1 intake. On the first day of treatment: the first 2 hours of 1 tablet every 30 minutes, then, during the first day, 3 more times at regular intervals. From the second to the fifth day: 1 tablet 3 times a day. The drug is taken out of the reception of food (in the interval between meals or 15-30 minutes before eating), should be kept in your mouth, not swallowed, until it is dissolved completely.
OG001	Placebo	Placebo: 1 tablet per 1 intake. On the first day of treatment: the first 2 hours of 1 tablet every 30 minutes, then, during the first day, 3 more times at regular intervals. From the second to the fifth day: 1 tablet 3 times a day. The drug is taken out of the reception of food (in the interval between meals or 15-30 minutes before eating), should be kept in your mouth, not swallowed, until it is dissolved completely.

Units	Counts

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Abdominal pain	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0003 events3 affected290 at risk EG0012 events2 affected279 at risk
Adenoiditis	Infections and infestations	MedDRA	Systematic Assessment	EG0001 events1 affected290 at risk EG0010 events0 affected279 at risk
Bacterial infection	Infections and infestations	MedDRA	Systematic Assessment	EG0000 events0 affected290 at risk EG0012 events2 affected279 at risk
Bronchitis	Infections and infestations	MedDRA	Systematic Assessment	EG0003 events3 affected290 at risk EG0014 events4 affected279 at risk
Conjunctivitis	Infections and infestations	MedDRA	Systematic Assessment	EG0001 events1 affected290 at risk EG0013 events3 affected279 at risk
Cryptorchism	Congenital, familial and genetic disorders	MedDRA	Systematic Assessment	EG0000 events0 affected290 at risk EG0011 events1 affected279 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0002 events2 affected290 at risk EG0011 events1 affected279 at risk
Dizziness	Nervous system disorders	MedDRA	Systematic Assessment	EG0000 events0 affected290 at risk EG0011 events1 affected279 at risk
Dizziness postural	Nervous system disorders	MedDRA	Systematic Assessment	EG0001 events1 affected290 at risk EG0010 events0 affected279 at risk
Dysbacteriosis	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0000 events0 affected290 at risk EG0011 events1 affected279 at risk
Enteritis	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0000 events0 affected290 at risk EG0011 events1 affected279 at risk
Epistaxis	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG0004 events3 affected290 at risk EG0010 events0 affected279 at risk
Gastrointestinal disorder	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0000 events0 affected290 at risk EG0011 events1 affected279 at risk
Hypersensitivity	Immune system disorders	MedDRA	Systematic Assessment	EG0000 events0 affected290 at risk EG0011 events1 affected279 at risk
Infection	Infections and infestations	MedDRA	Systematic Assessment	EG0001 events1 affected290 at risk EG0012 events2 affected279 at risk
Inguinal hernia	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0000 events0 affected290 at risk EG0011 events1 affected279 at risk
Nasopharyngitis	Infections and infestations	MedDRA	Systematic Assessment	EG0000 events0 affected290 at risk EG0012 events2 affected279 at risk
Nausea	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0000 events0 affected290 at risk EG0013 events2 affected279 at risk
Otitis media acute	Infections and infestations	MedDRA	Systematic Assessment	EG0004 events4 affected290 at risk EG0015 events5 affected279 at risk
Otosalpingitis	Infections and infestations	MedDRA	Systematic Assessment	EG0000 events0 affected290 at risk EG0011 events1 affected279 at risk
Petechiae	Skin and subcutaneous tissue disorders	MedDRA	Systematic Assessment	EG0001 events1 affected290 at risk EG0010 events0 affected279 at risk
Pharyngotonsillitis	Infections and infestations	MedDRA	Systematic Assessment	EG0000 events0 affected290 at risk EG0011 events1 affected279 at risk
Polyneuropathy	Nervous system disorders	MedDRA	Systematic Assessment	EG0001 events1 affected290 at risk EG0010 events0 affected279 at risk
Fever	General disorders	MedDRA	Systematic Assessment	EG0001 events1 affected290 at risk EG0010 events0 affected279 at risk
Rash maculo-papular	Skin and subcutaneous tissue disorders	MedDRA	Systematic Assessment	EG0000 events0 affected290 at risk EG0012 events2 affected279 at risk
Rhinitis	Infections and infestations	MedDRA	Systematic Assessment	EG0003 events3 affected290 at risk EG0011 events1 affected279 at risk
Sinusitis	Infections and infestations	MedDRA	Systematic Assessment	EG0000 events0 affected290 at risk EG0012 events2 affected279 at risk
Superinfection bacterial	Infections and infestations	MedDRA	Systematic Assessment	EG0001 events1 affected290 at risk EG0010 events0 affected279 at risk
Tonsillitis	Infections and infestations	MedDRA	Systematic Assessment	EG0002 events2 affected290 at risk EG0011 events1 affected279 at risk
Tonsillitis bacterial	Infections and infestations	MedDRA	Systematic Assessment	EG0000 events0 affected290 at risk EG0011 events1 affected279 at risk
Tracheobronchitis	Infections and infestations	MedDRA	Systematic Assessment	EG0000 events0 affected290 at risk EG0011 events1 affected279 at risk
Viral rash	Infections and infestations	MedDRA	Systematic Assessment	EG0000 events0 affected290 at risk EG0011 events1 affected279 at risk
Vomiting	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0000 events0 affected290 at risk EG0013 events2 affected279 at risk

ID	Term
D012141	Respiratory Tract Infections
D007239	Infections
D009976	Orthomyxoviridae Infections
D012327	RNA Virus Infections
D014777	Virus Diseases
D012140	Respiratory Tract Diseases

ID	Term
C547732	anaferon
D013607	Tablets

ID	Term
D004304	Dosage Forms
D004364	Pharmaceutical Preparations

ID	Title	Description
BG000	Anaferon for Children	Anaferon for Children: 1 tablet per 1 intake. On the first day of treatment: the first 2 hours of 1 tablet every 30 minutes, then, during the first day, 3 more times at regular intervals. From the second to the fifth day: 1 tablet 3 times a day. The drug is taken out of the reception of food (in the interval between meals or 15-30 minutes before eating), should be kept in your mouth, not swallowed, until it is dissolved completely.
BG001	Placebo	Placebo: 1 tablet per 1 intake. On the first day of treatment: the first 2 hours of 1 tablet every 30 minutes, then, during the first day, 3 more times at regular intervals. From the second to the fifth day: 1 tablet 3 times a day. The drug is taken out of the reception of food (in the interval between meals or 15-30 minutes before eating), should be kept in your mouth, not swallowed, until it is dissolved completely.
BG002	Total	Total of all reporting groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Anaferon for Children	Anaferon for Children: 1 tablet per 1 intake. On the first day of treatment: the first 2 hours of 1 tablet every 30 minutes, then, during the first day, 3 more times at regular intervals. From the second to the fifth day: 1 tablet 3 times a day. The drug is taken out of the reception of food (in the interval between meals or 15-30 minutes before eating), should be kept in your mouth, not swallowed, until it is dissolved completely.	0	290	1	290	26	290
EG001	Placebo	Placebo: 1 tablet per 1 intake. On the first day of treatment: the first 2 hours of 1 tablet every 30 minutes, then, during the first day, 3 more times at regular intervals. From the second to the fifth day: 1 tablet 3 times a day. The drug is taken out of the reception of food (in the interval between meals or 15-30 minutes before eating), should be kept in your mouth, not swallowed, until it is dissolved completely.	0	279	1	279	30	279