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: 2025-12-26 @ 11:13 PM
Ignite Modification Date: 2025-12-26 @ 11:13 PM
NCT ID: NCT00630812
Description: Safety information reported is for the 26 week double blind period only
Frequency Threshold: 5
Time Frame: 26 weeks
Study: NCT00630812
Study Brief: Long Term Administration of Inhaled Mannitol in Cystic Fibrosis
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Mannitol 400mg active treatment inhaled mannitol: 400 mg BD for 26 + 26 weeks 0 None 31 184 165 184 View
Control Control (40mg inhaled mannitol) : BD for 26 weeks followed by 26 weeks of inhaled mannitol in the open label phase 1 None 30 121 106 121 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Condition Aggravated NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA (11.0) View
Haemoptysis NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA (11.0) View
Asthmatic Crisis NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA (11.0) View
Pleuritic Pain NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA (11.0) View
Pneumothorax NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA (11.0) View
Bronchopneumonia NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (11.0) View
Lower respiratory tract infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (11.0) View
Acute tonsillitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (11.0) View
Appendicitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (11.0) View
Pneumonia NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (11.0) View
Pneumonia bacterial NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (11.0) View
Pyelonephritis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (11.0) View
Pancreatitis NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (11.0) View
Distal intestinal obstruction syndrome NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (11.0) View
Intestinal obstruction NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (11.0) View
Pancreatis acute NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (11.0) View
Vomiting NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (11.0) View
Cholecystitis NON_SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA (11.0) View
Diabetes mellitus NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA (11.0) View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Condition Aggravated NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA (11.0) View
Cough NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA (11.0) View
Headache NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA (11.0) View
Pharyngolaryngeal pain NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA (11.0) View
Pyrexia NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA (11.0) View
Abdominal pain NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (11.0) View
Haemoptysis NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA (11.0) View
Nasopharyngitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (11.0) View
Upper respiratory tract infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (11.0) View
Sinusitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (11.0) View
Abdominal pain upper NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (11.0) View