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 @ 5:05 PM
Ignite Modification Date: 2025-12-25 @ 2:44 PM
NCT ID: NCT04238650
Description: Coded according to Medical Dictionary for Regulatory Activities (version 22.1), and graded on the basis of the US National Cancer Institute's Common Terminology for Adverse Events (version 5.0). For the purpose of safety reporting in healthy volunteers, all serious adverse events were considered unexpected and reported as suspected unexpected adverse reactions (SUSARs).
Frequency Threshold: 0
Time Frame: Day 1-Day 70
Study: NCT04238650
Study Brief: A Pharmacokinetic Study Comparing MB02 And EU Avastin® In Healthy Male Volunteers
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
MB02 (Bevacizumab Biosimilar) Intervention Description: Sterile vial 400mg/16ml, single-dose 3mg/kg administered as 90-minute infusion on day 1. MB02 (Bevacizumab Biosimilar): Solution for intravenous infusion, single dose of 3mg/kg, administered as 90- minute infusion 0 None 0 24 8 24 View
EU Approved Avastin® Intervention Description: Sterile vial 400mg/16ml, single-dose 3mg/kg administered as 90-minute infusion on day 1. EU approved Avastin®: Solution for intravenous infusion, single dose of 3mg/kg, administered as 90- minute infusion 0 None 0 24 12 24 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Nasopharyngitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 22.1 View
Pharyngitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 22.1 View
Blood Creatine Phosphokinase Increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 22.1 View
Alanine Aminotransferase Increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 22.1 View
Aspartate Aminotransferase Increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 22.1 View
Blood Lactate Dehydrogenase Increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 22.1 View