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 @ 9:17 PM
Ignite Modification Date: 2025-12-25 @ 7:05 PM
NCT ID: NCT01196104
Description: None
Frequency Threshold: 5
Time Frame: From first dose to 30d post last dose
Study: NCT01196104
Study Brief: Clinical Trial Evaluating the Efficacy and Safety of Technosphere® Inhalation Insulin (TI) Inhalation Powder Using the Gen2 Inhaler
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Technosphere® Insulin Inhalation Powder (TI) Insulin Glargine and Technosphere® Insulin Inhalation Powder Technosphere® Insulin Inhalation Powder Insulin Glargine None None 1 19 13 19 View
Comparator Insulin Glargine and Insulin Aspart Insulin Aspart: Usual Care Insulin Glargine None None 1 18 11 18 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Angina unstable SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 7.1 View
Rib Fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 7.1 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Angina Pectoris SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 15.1 View
Atrial Fibrillation SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 15.1 View
Ventricular extrasystoles SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 15.1 View
Hypothyroidism SYSTEMATIC_ASSESSMENT Endocrine disorders MedDRA 15.1 View
Mydriasis SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 15.1 View
Vitreous haemorrhage SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 15.1 View
Abdominal pain upper SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 15.1 View
Diarrhea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 15.1 View
Oedema SYSTEMATIC_ASSESSMENT General disorders MedDRA 15.1 View
Oedema Peripheral SYSTEMATIC_ASSESSMENT General disorders MedDRA 15.1 View
Upper Respiratory Tract Infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 15.1 View
Ear Infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 15.1 View
Onychomycosis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 15.1 View
Sinusitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 15.1 View
Urinary Tract Infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 15.1 View
Nasopharyngitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 15.1 View
Pharyngitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 15.1 View
Blood Testosterone Decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA15.1 View
Arthralgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 15.1 View
Back Pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 15.1 View
Chest Wall Pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 15.1 View
Plantar Fasciitis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 15.1 View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 15.1 View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 15.1 View
Hypoaesthesia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 15.1 View
Depression SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 15.1 View
Renal Failure SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 15.1 View
Cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 15.1 View
Sinus Congestion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 15.1 View
Throat Irritation SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 15.1 View
Dry Throat SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 15.1 View
Dyspnoea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 15.1 View
Productive Cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 15.1 View
Respiratory Tract Congestion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 15.1 View
Wheezing SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 15.1 View
Cataract Operation SYSTEMATIC_ASSESSMENT Surgical and medical procedures MedDRA 15.1 View
Hypertension SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 15.1 View