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 @ 2:47 AM
Ignite Modification Date: 2025-12-26 @ 1:28 AM
NCT ID: NCT01856933
Description: None
Frequency Threshold: 0
Time Frame: None
Study: NCT01856933
Study Brief: BrUOG 263: Prostate Specific Membrane Antigen (PSMA) Glioblastoma Multiforme (GBM)
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
PSMA ADC 2.5 mg/kg, IV, over 60 minutes every 3 weeks PSMA ADC: 2.5 mg/kg, IV, over 60 minutes every 3 weeks None None 4 6 6 6 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
eye disorder/ vision changes SYSTEMATIC_ASSESSMENT Investigations None View
H/A SYSTEMATIC_ASSESSMENT Investigations None View
Hypermagnesemia SYSTEMATIC_ASSESSMENT Investigations None View
Hypokalemia SYSTEMATIC_ASSESSMENT Investigations None View
Intratumoral hemorrhage SYSTEMATIC_ASSESSMENT Investigations None View
Nausea SYSTEMATIC_ASSESSMENT Investigations None View
Thrombocytopenia SYSTEMATIC_ASSESSMENT Investigations None View
seizure SYSTEMATIC_ASSESSMENT Investigations None View
UTI SYSTEMATIC_ASSESSMENT Investigations None View
WBC SYSTEMATIC_ASSESSMENT Investigations None View
confusion SYSTEMATIC_ASSESSMENT Investigations None View
muscle weakness/weakness general SYSTEMATIC_ASSESSMENT Investigations None View
dyspnea SYSTEMATIC_ASSESSMENT Investigations None View
Facial muscle weakness SYSTEMATIC_ASSESSMENT Investigations None View
CD4 Lymph count SYSTEMATIC_ASSESSMENT Investigations None View
Lymphopenia SYSTEMATIC_ASSESSMENT Investigations None View
Anorexia SYSTEMATIC_ASSESSMENT Investigations None View
syncope SYSTEMATIC_ASSESSMENT Investigations None View
pain SYSTEMATIC_ASSESSMENT Investigations None View
perforation-sigmoid SYSTEMATIC_ASSESSMENT Investigations None View
cholesterol SYSTEMATIC_ASSESSMENT Investigations None View
creatinine SYSTEMATIC_ASSESSMENT Investigations None View
hyperglycemia SYSTEMATIC_ASSESSMENT Investigations None View
hypoalbumin SYSTEMATIC_ASSESSMENT Investigations None View
troponin SYSTEMATIC_ASSESSMENT Investigations None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
AKI SYSTEMATIC_ASSESSMENT Investigations None View
Alopecia SYSTEMATIC_ASSESSMENT Investigations None View
ALT SYSTEMATIC_ASSESSMENT Investigations None View
AST SYSTEMATIC_ASSESSMENT Investigations None View
anemia SYSTEMATIC_ASSESSMENT Investigations None View
edema, lower leg SYSTEMATIC_ASSESSMENT Investigations None View
eye disorder/ vision changes SYSTEMATIC_ASSESSMENT Investigations None View
fatigue SYSTEMATIC_ASSESSMENT Investigations None View
H/A SYSTEMATIC_ASSESSMENT Investigations None View
Hypermagnesemia SYSTEMATIC_ASSESSMENT Investigations None View
Hypokalemia SYSTEMATIC_ASSESSMENT Investigations None View
Hyponatremia SYSTEMATIC_ASSESSMENT Investigations None View
Infection/shingles/thrush SYSTEMATIC_ASSESSMENT Investigations None View
Nausea SYSTEMATIC_ASSESSMENT Investigations None View
Neutrophil count SYSTEMATIC_ASSESSMENT Investigations None View
Thrombocytopenia SYSTEMATIC_ASSESSMENT Investigations None View
vomiting SYSTEMATIC_ASSESSMENT Investigations None View
rash- torso SYSTEMATIC_ASSESSMENT Investigations None View
parathesia/neuropathy SYSTEMATIC_ASSESSMENT Investigations None View
rash- papular SYSTEMATIC_ASSESSMENT Investigations None View
urinary incontinence SYSTEMATIC_ASSESSMENT Investigations None View
right ankle swelling SYSTEMATIC_ASSESSMENT Investigations None View
UTI SYSTEMATIC_ASSESSMENT Investigations None View
WBC SYSTEMATIC_ASSESSMENT Investigations None View
intracerebral hematoma SYSTEMATIC_ASSESSMENT Investigations None View
Lymphopenia SYSTEMATIC_ASSESSMENT Investigations None View
dysphasia SYSTEMATIC_ASSESSMENT Investigations None View
gait disturbance SYSTEMATIC_ASSESSMENT Investigations None View
cognitive disturbance/impairment SYSTEMATIC_ASSESSMENT Investigations None View
dysgeusia (taste) SYSTEMATIC_ASSESSMENT Investigations None View
pain- left calf/leg SYSTEMATIC_ASSESSMENT Investigations None View