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 @ 2:01 AM
Ignite Modification Date: 2025-12-26 @ 12:25 AM
NCT ID: NCT02145260
Description: None
Frequency Threshold: 5
Time Frame: From randomization to maximum of 6 inpatient study sessions (two-week period)
Study: NCT02145260
Study Brief: Trial of Dialysate Sodium in Chronic Hospitalized Hemodialysis Patients
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Lower Dialysate Sodium Dialysate sodium concentration of 138 mmol/L Lower dialysate sodium (138 mmol/L; using Renasol hemodialysis concentrate): A lower dialysate sodium will bes used in the active comparator arm (138 mmol/L) 0 None 1 69 28 69 View
Higher Dialysate Sodium Dialysate sodium concentration of 142 mmol/L Higher dialysate sodium (142 mmol/L; using Renasol hemodialysis concentrate): A higher dialysate sodium will be used in the experimental arm (142 mmol/L) 0 None 1 70 24 70 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
NSTEMI non-ST segment elevation myocardial infarction NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
post-operative bleed NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Chest pain/myocardial infarction NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Hypotension SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Hypertension (>180 mmHg) SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Cramping NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Other pain NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View