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 @ 3:21 AM
Ignite Modification Date: 2025-12-26 @ 1:59 AM
NCT ID: NCT03604705
Description: None
Frequency Threshold: 5
Time Frame: One to forty-nine days
Study: NCT03604705
Study Brief: An Efficacy and Safety Study of APX001 in Non-Neutropenic Patients With Candidemia
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Safety Population Twenty-one patients were dosed with APX001 and composed the ITT/Safety Population. 5 None 9 21 20 21 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Septic shock SYSTEMATIC_ASSESSMENT Infections and infestations None View
Bacteraemia SYSTEMATIC_ASSESSMENT Infections and infestations None View
Enterobacter sepsis SYSTEMATIC_ASSESSMENT Infections and infestations None View
Necrotising fasciitis SYSTEMATIC_ASSESSMENT Infections and infestations None View
Stenotrophomonas sepsis SYSTEMATIC_ASSESSMENT Infections and infestations None View
Systemic candida SYSTEMATIC_ASSESSMENT Infections and infestations None View
Urinary tract infection bacterial SYSTEMATIC_ASSESSMENT Infections and infestations None View
Cardiac failure congestive SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Cardio-respiratory arrest SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Euthanasia SYSTEMATIC_ASSESSMENT General disorders None View
Acute respiratory failure SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Interstitial lung disease SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Leukopenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Gastrointestinal fistula SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Bacterial sepsis SYSTEMATIC_ASSESSMENT Infections and infestations None View
Sepsis SYSTEMATIC_ASSESSMENT Infections and infestations None View
General physical health deterioration SYSTEMATIC_ASSESSMENT General disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Septic shock SYSTEMATIC_ASSESSMENT Infections and infestations None View
Diarrhoea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Pyrexia SYSTEMATIC_ASSESSMENT General disorders None View
Pleural effusion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Dyspnoea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Acute kidney injury SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Hydronephrosis SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Renal failure SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Bacteraemia SYSTEMATIC_ASSESSMENT Infections and infestations None View
Oedema peripheral SYSTEMATIC_ASSESSMENT General disorders None View