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 @ 12:16 PM
Ignite Modification Date: 2025-12-25 @ 12:01 PM
NCT ID: NCT01023061
Description: Tracked grade 1 and 2 toxicities \>10% and grade 3 toxicities that were either possibly or probably related to radiation, abiraterone or prednisone, or Luteinizing hormone releasing hormone agonist.
Frequency Threshold: 5
Time Frame: Median follow-up 21 months
Study: NCT01023061
Study Brief: Abiraterone Prednisone and Hormonal Therapy Before and During Radiation Therapy in Localized Prostate Cancer
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Treatment (Antihormone Therapy and Radiation Therapy) Patients receive abiraterone acetate and prednisone for 24 weeks. Patients also receive leuprolide acetate or goserelin in weeks 1 and 13. Patients undergo external beam radiotherapy starting in week 15 for 8.5 weeks. Treatment continues in the absence of disease progression or unacceptable toxicity. abiraterone acetate: Given orally prednisone: Given orally leuprolide acetate: Given via injection laboratory biomarker analysis: Correlative study external beam radiation therapy: Undergo radiotherapy goserelin acetate: Given via injection 0 None 0 22 19 22 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Lymphopenia NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA (10.0) View
Hypertension NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA (10.0) View
ALT and AST: increased NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA (10.0) View
fatigue NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA (10.0) View
hypokalemia syndrome NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA (10.0) View
Hot flashes NON_SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA (10.0) View
Hyperbilirubinemia NON_SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA (10.0) View
insomnia NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA (10.0) View
erectile dysfunction NON_SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA (10.0) View
Diarrhea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (10.0) View
urinary tract discomfort NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA (10.0) View