Adverse Events Module

Home Icon Home Search Icon Search Certify Doc Icon Certify Doc Certify Doc Icon Genes Certify Doc Icon Clinical Trials Certify Doc Icon CompTox Processes Icon DrugMatrix Open Targets Icon Open Targets Processes Icon Products Support Icon Support Bugs Icon Bugs
Main Search Make This Study a Gene Therapy Make This Study a Not Gene Therapy Report Bug
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 @ 3:44 AM
Ignite Modification Date: 2025-12-26 @ 2:30 AM
NCT ID: NCT01850602
Description: None
Frequency Threshold: 5
Time Frame: 12 weeks
Study: NCT01850602
Study Brief: A Phase III Study of PA21 in Hemodialysis Patients With Hyperphosphatemia
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
PA21 PA21 0 None 6 108 47 108 View
Sevelamer Hydrochloride Sevelamer hydrochloride 0 None 5 105 42 105 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Colon cancer NON_SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) None View
Supraventricular tachycardia NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Intervertebral disc protrusion NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Diverticulitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Pneumonia NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Gastric cancer NON_SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) None View
Cerebral infarction NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Cardiac failure congestive NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Acute pulmonary oedema NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Pulmonary oedema NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Renal cyst ruptured NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Shunt stenosis NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Nasopharyngitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Constipation NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Diarrhoea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View