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 @ 7:09 PM
Ignite Modification Date: 2025-12-25 @ 4:42 PM
NCT ID: NCT01221857
Description: None
Frequency Threshold: 5
Time Frame: None
Study: NCT01221857
Study Brief: Pilot Study Evaluating Safety & Efficacy of DCBT: NiCord® & UNM CBU to Patients With Hematological Malignancies
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
NiCord NiCord®: NiCord® is a cell-based product composed of umbilical cord-derived ex vivo expanded stem and progenitor cells. 3 None 8 12 11 12 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Hemoptysis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Graft rejection SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations None View
Gastrointestinal Disorder SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Depression SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Hypertension SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Altered mental status SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Supraventricular tachycardia SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Hematuria SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Acute renal failure SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Disease relapse SYSTEMATIC_ASSESSMENT Investigations None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
aGvHD SYSTEMATIC_ASSESSMENT Immune system disorders None View
CMV reactivation SYSTEMATIC_ASSESSMENT Infections and infestations None View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Hypotension SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Tachycardia SYSTEMATIC_ASSESSMENT Cardiac disorders None View
HHV-6 Reactivation SYSTEMATIC_ASSESSMENT Infections and infestations None View
Hypertension SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Hypomagnesemia SYSTEMATIC_ASSESSMENT Investigations None View
Staph Coagulase Infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Hypocalcemia SYSTEMATIC_ASSESSMENT Investigations None View
BK virus infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Elevated LFTs SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
E coli infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Hematuria SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Sinus bradycardia SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Proteinuria SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Arrhythmia SYSTEMATIC_ASSESSMENT Cardiac disorders None View
RSV infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Pseudomonas infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Enterococcus infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
CMV gastritis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Hypoalbuminemia SYSTEMATIC_ASSESSMENT Investigations None View
Cystitis SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Hypoxia SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Dyspnea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View