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 @ 9:34 PM
Ignite Modification Date: 2025-12-25 @ 7:18 PM
NCT ID: NCT00783432
Description: None
Frequency Threshold: 5
Time Frame: None
Study: NCT00783432
Study Brief: Study to Evaluate the Safety and Tolerability of a Nasal Spray in Patients With Chronic Allergic or Nonallergic Rhinitis
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Astelin Nasal Spray (0.1% azelastine hydrochloride) None None 10 None 146 None View
Astepro Nasal Spray (0.1% azelastine hydrochloride) None None 7 None 163 None View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Battery change for internal cardiac defibrillator SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA View
Sialoadenitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Dyspnoea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Acute Pyelonephritis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Knee traumatism SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
Rectal Carcinoma SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA View
Exacerbation angina pectoris SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA View
Central Chest Pain SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA View
Exacerbation right shoulder pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
Basal Cell Carcinoma SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA View
Removal of bladder stones SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA View
Ovarian Cyst SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA View
Exertional dyspnoea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Prostate cancer SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA View
Pneumonia Chlamidalis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Spontaneous Abortion SYSTEMATIC_ASSESSMENT Pregnancy, puerperium and perinatal conditions MedDRA View
Fracture left foot SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
Broken nose SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
Syncope SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Upper Abdominal Colic SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Total right hip replacement SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Dysgeusia NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Headache NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Nasopharyngitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Epistaxis NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Pharyngolaryngeal Pain NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View