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 @ 9:21 PM
Ignite Modification Date: 2025-12-25 @ 7:08 PM
NCT ID: NCT04075604
Description: None
Frequency Threshold: 5
Time Frame: Adverse Events (AEs) were monitored from first dose to 100 days after last dose of study therapy (up to approximately 8 months). Serious Adverse events were monitored between first dose and 30 days after last dose of study therapy. (Up to approximately 6 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 21 months)
Study: NCT04075604
Study Brief: A Study of Neoadjuvant Nivolumab + Palbociclib + Anastrozole in Post-Menopausal Women and Men With Primary 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
Cohort 1: Dose Level 1 Nivolumab: 480 mg every 4 weeks (Q4W) intravenously (IV) Abemaciclib: 150 mg twice daily (BID) per os (by mouth) Anastrozole: 1 mg once daily (QD) per os (by mouth) Participants will be treated for a maximum of 5 cycles (1 cycle = 4 weeks) 0 None 0 2 2 2 View
Cohort 2: Dose Level 1 Nivolumab: 480 mg every 4 weeks (Q4W) intravenously (IV) Palbociclib: 125 mg once daily (QD) per os (by mouth) for 3 weeks of each cycle (1 week off) Anastrozole: 1 mg once daily (QD) per os (by mouth) Participants will be treated for a maximum of 5 cycles (1 cycle = 4 weeks) 0 None 5 9 8 9 View
Cohort 2: Dose Level 2 Nivolumab: 480 mg every 4 weeks (Q4W) intravenously (IV) Palbociclib: 100 mg once daily (QD) per os (by mouth) for 3 weeks of each cycle (1 week off) Anastrozole: 1 mg once daily (QD) per os (by mouth) Participants will be treated for a maximum of 5 cycles (1 cycle = 4 weeks) 0 None 3 12 12 12 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Anaemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders 24.1 View
Febrile neutropenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders 24.1 View
Atrial fibrillation SYSTEMATIC_ASSESSMENT Cardiac disorders 24.1 View
Hepatitis SYSTEMATIC_ASSESSMENT Hepatobiliary disorders 24.1 View
Hypertransaminasaemia SYSTEMATIC_ASSESSMENT Hepatobiliary disorders 24.1 View
Alanine aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations 24.1 View
Aspartate aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations 24.1 View
Second primary malignancy SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) 24.1 View
Dyspnoea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders 24.1 View
Immune-mediated lung disease SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders 24.1 View
Rash SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders 24.1 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Anaemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders 24.1 View
Leukopenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders 24.1 View
Macrocytosis SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders 24.1 View
Neutropenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders 24.1 View
Thrombocytopenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders 24.1 View
Thrombocytosis SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders 24.1 View
Tinnitus SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders 24.1 View
Hyperthyroidism SYSTEMATIC_ASSESSMENT Endocrine disorders 24.1 View
Hypothyroidism SYSTEMATIC_ASSESSMENT Endocrine disorders 24.1 View
Vascular access site pain SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications 24.1 View
Platelet count decreased SYSTEMATIC_ASSESSMENT Investigations 24.1 View
Transaminases increased SYSTEMATIC_ASSESSMENT Investigations 24.1 View
White blood cell count decreased SYSTEMATIC_ASSESSMENT Investigations 24.1 View
Decreased appetite SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders 24.1 View
Hyperglycaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders 24.1 View
Hypoalbuminaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders 24.1 View
Hypokalaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders 24.1 View
Hypomagnesaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders 24.1 View
Hyponatraemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders 24.1 View
Arthralgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders 24.1 View
Back pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders 24.1 View
Bone pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders 24.1 View
Muscle spasms SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders 24.1 View
Musculoskeletal pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders 24.1 View
Myalgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders 24.1 View
Pain in extremity SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders 24.1 View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders 24.1 View
Dysgeusia SYSTEMATIC_ASSESSMENT Nervous system disorders 24.1 View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders 24.1 View
Peripheral sensory neuropathy SYSTEMATIC_ASSESSMENT Nervous system disorders 24.1 View
Sinus headache SYSTEMATIC_ASSESSMENT Nervous system disorders 24.1 View
Somnolence SYSTEMATIC_ASSESSMENT Nervous system disorders 24.1 View
Syncope SYSTEMATIC_ASSESSMENT Nervous system disorders 24.1 View
Anxiety SYSTEMATIC_ASSESSMENT Psychiatric disorders 24.1 View
Insomnia SYSTEMATIC_ASSESSMENT Psychiatric disorders 24.1 View
Breast pain SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders 24.1 View
Cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders 24.1 View
Dyspnoea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders 24.1 View
Pneumonitis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders 24.1 View
Alopecia SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders 24.1 View
Eczema SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders 24.1 View
Pruritus SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders 24.1 View
Rash SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders 24.1 View
Rash maculo-papular SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders 24.1 View
Rash pruritic SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders 24.1 View
Skin toxicity SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders 24.1 View
Embolism SYSTEMATIC_ASSESSMENT Vascular disorders 24.1 View
Hot flush SYSTEMATIC_ASSESSMENT Vascular disorders 24.1 View
Ocular discomfort SYSTEMATIC_ASSESSMENT Eye disorders 24.1 View
Vision blurred SYSTEMATIC_ASSESSMENT Eye disorders 24.1 View
Abdominal pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders 24.1 View
Abdominal pain upper SYSTEMATIC_ASSESSMENT Gastrointestinal disorders 24.1 View
Diarrhoea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders 24.1 View
Dyspepsia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders 24.1 View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders 24.1 View
Odynophagia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders 24.1 View
Oral pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders 24.1 View
Stomatitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders 24.1 View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders 24.1 View
Asthenia SYSTEMATIC_ASSESSMENT General disorders 24.1 View
Axillary pain SYSTEMATIC_ASSESSMENT General disorders 24.1 View
Fatigue SYSTEMATIC_ASSESSMENT General disorders 24.1 View
Mucosal inflammation SYSTEMATIC_ASSESSMENT General disorders 24.1 View
Oedema peripheral SYSTEMATIC_ASSESSMENT General disorders 24.1 View
Pyrexia SYSTEMATIC_ASSESSMENT General disorders 24.1 View
Xerosis SYSTEMATIC_ASSESSMENT General disorders 24.1 View
Hypertransaminasaemia SYSTEMATIC_ASSESSMENT Hepatobiliary disorders 24.1 View
COVID-19 SYSTEMATIC_ASSESSMENT Infections and infestations 24.1 View
Diverticulitis SYSTEMATIC_ASSESSMENT Infections and infestations 24.1 View
Gastroenteritis SYSTEMATIC_ASSESSMENT Infections and infestations 24.1 View
Oral herpes SYSTEMATIC_ASSESSMENT Infections and infestations 24.1 View
Sinusitis SYSTEMATIC_ASSESSMENT Infections and infestations 24.1 View
Upper respiratory tract infection SYSTEMATIC_ASSESSMENT Infections and infestations 24.1 View
Viral infection SYSTEMATIC_ASSESSMENT Infections and infestations 24.1 View
Animal bite SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications 24.1 View
Radiation skin injury SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications 24.1 View
Alanine aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations 24.1 View
Amylase increased SYSTEMATIC_ASSESSMENT Investigations 24.1 View
Aspartate aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations 24.1 View
Blood alkaline phosphatase increased SYSTEMATIC_ASSESSMENT Investigations 24.1 View
Blood bilirubin increased SYSTEMATIC_ASSESSMENT Investigations 24.1 View
Blood creatinine increased SYSTEMATIC_ASSESSMENT Investigations 24.1 View
Blood lactate dehydrogenase increased SYSTEMATIC_ASSESSMENT Investigations 24.1 View
Lymphocyte count decreased SYSTEMATIC_ASSESSMENT Investigations 24.1 View
Neutrophil count decreased SYSTEMATIC_ASSESSMENT Investigations 24.1 View