Adverse Events Module

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Adverse Events Module

For researchers submitting trial data to ClinicalTrials.gov, the Adverse Events module is one of four mandatory results sections. It requires reporting in three primary categories: All-Cause Mortality: A table tracking all deaths that occurred during the study, regardless of cause. Serious Adverse Events (SAEs): A tabular summary of events resulting in death, life-threatening conditions, hospitalization, or significant disability. Other Adverse Events: A table for non-serious events that exceed a specific frequency threshold, such as 5% within any study arm.

Adverse Events Module path is as follows:

Study -> Results Section -> Adverse Events Module -> Event Groups

Study -> Results Section -> Adverse Events Module -> Serious Events

Study -> Results Section -> Adverse Events Module -> Other Events

Adverse Events Module

Ignite Creation Date: 2025-12-24 @ 10:23 PM
Ignite Modification Date: 2025-12-25 @ 7:55 PM
NCT ID: NCT03840135
Description: Among 172 randomized patients, 2 patients did not take the study drug for reasons of non-compliance with inclusion criterion No. 3 and withdrawal of informed consent, respectively. Thus, the safety analysis included data from 170 patients (84 in the study drug group and 86 in the comparison drug group) who were included in the study and took the drug at least once.
Frequency Threshold: 0
Time Frame: 12±1 days
Study: NCT03840135
Study Brief: Efficacy and Safety of Polyoxidonium, Nasal and Sublingual Spray, 6 mg/ml in Children Aged 1-12 Years With ARI
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Polyoxidonium 6 mg/ml Polyoxidonium 6 mg/ml nasal and sublingual spray - 0,15 mg/kg daily - 7 days. Polyoxidonium 6 mg/ml: Nasal and sublingual spray Polyoxidonium 6 mg/ml was administered at a dose of 0,15 mg/kg daily for 7 days: in children aged from 1 to 2 years - 1 spray 2 times a day sublingually (every 12 hours); in children aged from 2 to 5 years - 1 spray intranasally (in each nasal passage) 2 times a day (every 12 hours); in children aged from 5 to 8 years - 1 spay intranasally (in each nasal passage) 3 times a day (every 8 hours); in children aged from 8 to 12 years - 2 spay intranasally (in each nasal passage) 2 times a day (every 12 hours). 0 None 0 84 1 84 View
Placebo Placebo, nasal and sublingual spray - 7 days. Placebo: Placebo nasal and sublingual spray will be administered for 7 days: in children aged from 1 to 2 years - 1 spray 2 times a day sublingually (every 12 hours); in children aged from 2 to 5 years - 1 spray intranasally (in each nasal passage) 2 times a day (every 12 hours); in children aged from 5 to 8 years - 1 spay intranasally (in each nasal passage) 3 times a day (every 8 hours); in children aged from 8 to 12 years - 2 spay intranasally (in each nasal passage) 2 times a day (every 12 hours). 0 None 0 86 6 86 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
acute catarrhal otitis media on the left SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders None View
acute purulent otitis media on the left SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders None View
loose stool SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
acute otitis media SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders None View
nose bleed SYSTEMATIC_ASSESSMENT Investigations None View
bronchitis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View