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 @ 1:11 AM
Ignite Modification Date: 2025-12-25 @ 11:22 PM
NCT ID: NCT00775593
Description: Non-serious adverse events have not been analyzed
Frequency Threshold: 0
Time Frame: None
Study: NCT00775593
Study Brief: Clofarabine and Temsirolimus in Treating Older Patients With Relapsed or Refractory Acute Myeloid Leukemia
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Study Group Evaluable patients None None 15 53 0 0 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Cardiac arrest NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Gastrointestinal mucositis NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Melaena NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Disease Progression NON_SYSTEMATIC_ASSESSMENT General disorders None View
Mucosal inflammation NON_SYSTEMATIC_ASSESSMENT General disorders None View
E. coli sepsis NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Pseudomonal sepsis NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Septic shock NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Sepsis NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Pneumonia NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Cerebral ischemia NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Neuropathy NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Convulsion NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Optic ischaemic neuropathy NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Acute renal failure NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Acute respiratory distress syndrome NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Acute respiratory failure NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Pneumonia NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Other Events(If Any):