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 @ 11:33 PM
Ignite Modification Date: 2025-12-25 @ 9:21 PM
NCT ID: NCT01980056
Description: The adverse events and SAEs were assessed and graded by the principal investigator throughout the study.
Frequency Threshold: 5
Time Frame: Adverse events were collected over a period of 15 months.
Study: NCT01980056
Study Brief: Vosaroxin for Intermediate 2 or High-risk MDS After Failure With Hypomethylating Agent-based Therapy
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Dose Level 1: Vosaroxin 50 mg/m2 IV on Days 1 and 4 of 28 Day Vosaroxin: Dose level 1: Vosaroxin 50 mg/m2 IV on Days 1 and 4 of 28 day cycle 1 None 3 4 3 4 View
Dose Level 2: Vosaroxin 72 mg/m2 IV on Days 1 and 4 of 28 Day Dose level 2: Vosaroxin 72 mg/m2 IV on Days 1 and 4 of 28 day cycle 1 None 1 4 3 4 View
Dose Level 3: Vosaroxin 50 mg/m2 IV on Days 1, 4, 8 and 11 of Dose level 3: Vosaroxin 50 mg/m2 IV on Days 1, 4, 8 and 11 of 28 day cycle 0 None 2 2 2 2 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Febrile Neutropenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Non- Cardiogenic Shock SYSTEMATIC_ASSESSMENT General disorders None View
Respiratory Distress SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Disease Progression SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Sudden Death SYSTEMATIC_ASSESSMENT General disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Diarrhea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Fatigue SYSTEMATIC_ASSESSMENT General disorders None View
Febrile Neutropenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Oral Thrush SYSTEMATIC_ASSESSMENT Infections and infestations None View
Epistaxis SYSTEMATIC_ASSESSMENT General disorders None View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Mucositis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Bacterimia SYSTEMATIC_ASSESSMENT Infections and infestations None View