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 @ 12:23 PM
Ignite Modification Date: 2025-12-24 @ 12:23 PM
NCT ID: NCT03205761
Description: AE were reported after Informed Consent Document (ICD) and before study drugs until approximately 30 days following the discontinuation of study treatment.
Frequency Threshold: 5
Time Frame: AEs have been recorded through study treatment, an average of 8 weeks. Deaths were assessed up to 14 months.
Study: NCT03205761
Study Brief: Analysis of Olaparib Response in Patients With BRCA1 and/or 2 Promoter Methylation Diagnosed of Advanced Breast 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
Olaparib Patients with a positive methylation status on at least one of the two genes and lacking of known deleterious or suspected deleterious mutations in both genes could be included in the study to receive olaparib tablet formulation at 600 mg total daily dose (given in two oral administrations of 300 mg every 12 hours approximately). Patients will continue to receive their treatment until objective disease progression, symptomatic deterioration, unacceptable toxicity, death or withdrawal of consent, whichever occurs first. 8 None 4 11 8 11 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Progression Disease SYSTEMATIC_ASSESSMENT General disorders NCI CTC-AE v 4.03 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Anaemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders NCI CTC-AE v 4.03 View
Vertigo SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders NCI CTC-AE v 4.03 View
Abdominal pain upper SYSTEMATIC_ASSESSMENT Gastrointestinal disorders NCI CTC-AE v 4.03 View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders NCI CTC-AE v 4.03 View
Dyspepsia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders NCI CTC-AE v 4.03 View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders NCI CTC-AE v 4.03 View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders NCI CTC-AE v 4.03 View
Asthenia SYSTEMATIC_ASSESSMENT General disorders NCI CTC-AE v 4.03 View
Oedema peripheral SYSTEMATIC_ASSESSMENT General disorders NCI CTC-AE v 4.03 View
Haemoglobin SYSTEMATIC_ASSESSMENT Investigations NCI CTC-AE v 4.03 View
Decreased appetite SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders NCI CTC-AE v 4.03 View
Back pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders NCI CTC-AE v 4.03 View
Musculoskeletal pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders NCI CTC-AE v 4.03 View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders NCI CTC-AE v 4.03 View
Depressed mood SYSTEMATIC_ASSESSMENT Psychiatric disorders NCI CTC-AE v 4.03 View
Insomnia SYSTEMATIC_ASSESSMENT Psychiatric disorders NCI CTC-AE v 4.03 View
Cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders NCI CTC-AE v 4.03 View
Dyspnoea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders NCI CTC-AE v 4.03 View
Orthopnoea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders NCI CTC-AE v 4.03 View
Hypertension SYSTEMATIC_ASSESSMENT Vascular disorders NCI CTC-AE v 4.03 View
Lymphoedema SYSTEMATIC_ASSESSMENT Vascular disorders NCI CTC-AE v 4.03 View