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 @ 9:37 PM
Ignite Modification Date: 2025-12-25 @ 7:20 PM
NCT ID: NCT04752332
Description: All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse event analysis was planned as per the cohort's corresponding regimen received.
Frequency Threshold: 5
Time Frame: Baseline Up To 890 Days
Study: NCT04752332
Study Brief: A Study of Abemaciclib (LY2835219) Plus Hormone Therapy in Participants With Early 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
150 mg Abemaciclib + ET Participants received 150 mg of abemaciclib administered BID orally along with standard adjuvant ET. 0 None 6 55 53 55 View
Placebo + ET Participants received placebo administered BID orally along with standard adjuvant ET. 0 None 2 56 40 56 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Neutropenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 27 View
Anal abscess SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 27 View
Covid-19 SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 27 View
Radius fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 27 View
Alanine aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 27 View
Uterine leiomyoma SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 27 View
Pulmonary embolism SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 27 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Leukopenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 27 View
Lymphopenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 27 View
Alanine aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 27 View
Aspartate aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 27 View
Arthralgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 27 View
Back pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 27 View
Myalgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 27 View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 27 View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 27 View
Pruritus SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 27 View
Hot flush SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 27 View
Anaemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 27 View
Neutropenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 27 View
Thrombocytopenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 27 View
Palpitations SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 27 View
Abdominal distension SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 27 View
Abdominal pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 27 View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 27 View
Diarrhoea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 27 View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 27 View
Stomatitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 27 View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 27 View
Fatigue SYSTEMATIC_ASSESSMENT General disorders MedDRA 27 View
Oedema peripheral SYSTEMATIC_ASSESSMENT General disorders MedDRA 27 View
Pyrexia SYSTEMATIC_ASSESSMENT General disorders MedDRA 27 View
Covid-19 SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 27 View
Nasopharyngitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 27 View
Upper respiratory tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 27 View
Urinary tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 27 View
Blood creatinine increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 27 View
Decreased appetite SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 27 View
Pain in extremity SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 27 View
Cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 27 View
Rash SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 27 View