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 @ 4:56 AM
Ignite Modification Date: 2025-12-26 @ 3:56 AM
NCT ID: NCT04167618
Description: None
Frequency Threshold: 0
Time Frame: From 1st dose to 5 weeks after last dose, up to 10 weeks (2 cycles).
Study: NCT04167618
Study Brief: 177Lu-DTPA-Omburtamab Radioimmunotherapy for Recurrent or Refractory Medulloblastoma
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
10 mCi 177Lu-DTPA-omburtamab Intracerebroventricular administration of 10 mCi 177Lu-DTPA-omburtamab for up to two cycles (Part 1). 177Lu-DTPA-omburtamab: Biological, radiolabeled DPTA-omburtamab 0 None 1 1 0 1 View
25 mCi 177Lu-DTPA-omburtamab Intracerebroventricular administration of 25 mCi 177Lu-DTPA-omburtamab for up to two cycles (Part 1). 177Lu-DTPA-omburtamab: Biological, radiolabeled DPTA-omburtamab 0 None 0 1 1 1 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Partial seizures SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 24.1 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Platelet count decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 24.1 View
White blood cell count decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 24.1 View
Alanine aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 24.1 View
Blood albumin decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 24.1 View
Neutrophil count decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 24.1 View