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: 2025-12-25 @ 3:29 AM
Ignite Modification Date: 2025-12-26 @ 2:11 AM
NCT ID: NCT04123405
Description: Any signs or symptoms were collected from first dose of study treatment up to maximum duration of 22 days.
Frequency Threshold: 0
Time Frame: Adverse events were collected from first dose of study treatment up to maximum duration of 22 days.
Study: NCT04123405
Study Brief: Efficacy and Safety of Acetylcysteine for the Treatment of Acute Uncomplicated Rhinosinusitis
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Group A: 600 mg Acetylcysteine one tablet test product plus three tablets placebo per day (taken as two tablets dissolved in a glass of water, twice daily) 0 None 0 235 9 235 View
Group B: 1200 mg Acetylcysteine two tablets test product plus two tablets placebo per day (taken as two tablets dissolved in a glass of water, twice daily) 0 None 0 238 15 238 View
Group C: 2400 mg Acetylcysteine four tablets test product per day (taken as two tablets dissolved in a glass of water, twice daily) 0 None 0 238 15 238 View
Group D: Placebo four tablets placebo per day (taken as two tablets dissolved in a glass of water, twice daily). 0 None 1 233 8 233 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Tibia fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 24.0 View
Concussion SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 24.0 View
Hand fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 24.0 View
Subarachnoid haemorrhage SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 24.0 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Ear congestion SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders MedDRA 24.0 View
Abdominal distension SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 24.0 View
Abdominal pain upper SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 24.0 View
Diarrhoea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 24.0 View
Dyspepsia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 24.0 View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 24.0 View
Asthenia SYSTEMATIC_ASSESSMENT General disorders MedDRA 24.0 View
Pyrexia SYSTEMATIC_ASSESSMENT General disorders MedDRA 24.0 View
Acute sinusitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.0 View
COVID-19 SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.0 View
Otitis media bacterial SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.0 View
Pulpitis dental SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.0 View
Sinusitis bacterial SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.0 View
Gamma-glutamyltransferase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 24.0 View
Hepatic enzyme increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 24.0 View
Human chorionic gonadotropin increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 24.0 View
Back pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 24.0 View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 24.0 View
Cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 24.0 View
Epistaxis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 24.0 View
Nasal crusting SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 24.0 View
Nasal obstruction SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 24.0 View
Productive cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 24.0 View
Rhinitis allergic SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 24.0 View
Rhinorrhoea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 24.0 View
Dermatitis allergic SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 24.0 View
Erythema SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 24.0 View
Rash SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 24.0 View
Hypertension SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 24.0 View
Hypertensive crisis SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 24.0 View