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 @ 2:16 AM
Ignite Modification Date: 2025-12-26 @ 12:46 AM
NCT ID: NCT01146860
Description: None
Frequency Threshold: 0
Time Frame: None
Study: NCT01146860
Study Brief: Efficacy and Safety of a Herbal Medicinal Product (Dry Extract BNO 1016) in Patients With Acute 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
BNO 1016 sugar coated tablets None None 0 194 19 194 View
Placebo sugar coated tablets None None 0 191 27 191 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Palpitations NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 12.0 View
Cerumen impaction NON_SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders MedDRA 12.0 View
Ear pain NON_SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders MedDRA 12.0 View
Tinnitus NON_SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders MedDRA 12.0 View
Eye discharge NON_SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 12.0 View
Abdominal discomfort NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 12.0 View
Abdominal upper pain NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 12.0 View
Diarrhoea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 12.0 View
Flatulence NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 12.0 View
Nausea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 12.0 View
Toothache NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 12.0 View
Facial pain NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA 12.0 View
Cholelithiasis NON_SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 12.0 View
Hypersensitivity NON_SYSTEMATIC_ASSESSMENT Immune system disorders MedDRA 12.0 View
Bronchitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 12.0 View
Furuncle NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 12.0 View
Gastroenteritis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 12.0 View
Laryngitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 12.0 View
Viral infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 12.0 View
Contusion NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 12.0 View
Injury NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 12.0 View
ASAT increased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA 12.0 View
Arthropathy NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 12.0 View
Back pain NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 12.0 View
Dizziness NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 12.0 View
Depressed mood NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 12.0 View
Genital discharge NON_SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA 12.0 View
Cough NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 12.0 View
Epistaxis NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 12.0 View
Nasal discomfort NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 12.0 View
Oropharyngeal pain NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 12.0 View
Ingrown hair NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 12.0 View
Pruritus NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 12.0 View
Surgery NON_SYSTEMATIC_ASSESSMENT Surgical and medical procedures MedDRA 12.0 View