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 @ 1:33 AM
Ignite Modification Date: 2025-12-25 @ 11:46 PM
NCT ID: NCT01816594
Description: All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of approx. 18 months.
Frequency Threshold: 5
Time Frame: AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for a median of approximately 18 months. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of approx. 18 months.
Study: NCT01816594
Study Brief: NeoPHOEBE: Neoadjuvant Trastuzumab + BKM120 in Combination With Weekly Paclitaxel in HER2-positive 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
Trastuzumab + BKM120 + Paclitaxel BKM120 (oral, pan-class I PI3K inhibitor) in combination with trastuzumab and paclitaxel. 0 None 8 25 21 25 View
Trastuzumab + BKM120 PBO + Paclitaxel BKM120 placebo in combination with trastuzumab and paclitaxel 0 None 2 25 19 25 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Diarrhoea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Thrombosis in device SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Mental disorder SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA View
Catheter site pain SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Pyrexia SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Hepatotoxicity SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA View
Hypersensitivity SYSTEMATIC_ASSESSMENT Immune system disorders MedDRA View
Acute sinusitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Hepatic enzyme increased SYSTEMATIC_ASSESSMENT Investigations MedDRA View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Pulmonary oedema SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Anemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA View
Leukopenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA View
Lymphopenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA View
Neutropenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA View
Thrombopenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA View
Cardiac disorders not yet listed SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA View
Ear and labyrinth disorders SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders MedDRA View
Eye disorders SYSTEMATIC_ASSESSMENT Eye disorders MedDRA View
Abdominal pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Diarrhea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Dysgeusia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Dyspepsia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Mucositis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Allergic reactions SYSTEMATIC_ASSESSMENT Immune system disorders MedDRA View
Fever without neutropenia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Injury and poisoning and procedural complications SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
Decreased calcium SYSTEMATIC_ASSESSMENT Investigations MedDRA View
Decreased potassium SYSTEMATIC_ASSESSMENT Investigations MedDRA View
Decreased serum albumin SYSTEMATIC_ASSESSMENT Investigations MedDRA View
Decreased sodium SYSTEMATIC_ASSESSMENT Investigations MedDRA View
Increased ALT SYSTEMATIC_ASSESSMENT Investigations MedDRA View
Increased AP SYSTEMATIC_ASSESSMENT Investigations MedDRA View
Increased AST SYSTEMATIC_ASSESSMENT Investigations MedDRA View
Increased FPG SYSTEMATIC_ASSESSMENT Investigations MedDRA View
Increased GGT SYSTEMATIC_ASSESSMENT Investigations MedDRA View
Increased aPTT SYSTEMATIC_ASSESSMENT Investigations MedDRA View
Increased potassium SYSTEMATIC_ASSESSMENT Investigations MedDRA View
Increased serum creatinine SYSTEMATIC_ASSESSMENT Investigations MedDRA View
Increased sodium SYSTEMATIC_ASSESSMENT Investigations MedDRA View
Increased total bilirubin SYSTEMATIC_ASSESSMENT Investigations MedDRA View
Increased total cholesterol SYSTEMATIC_ASSESSMENT Investigations MedDRA View
Increased triglycerides SYSTEMATIC_ASSESSMENT Investigations MedDRA View
Increased uric acid SYSTEMATIC_ASSESSMENT Investigations MedDRA View
Anorexia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA View
Arthralgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
Bone pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
Myalgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
Other musculo-skeletal and connective tissue disorders SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Other neurological disorder SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Peripheral sensory neuropathy SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Anxiety SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA View
Depression SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA View
Insomnia SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA View
Psychiatric disorders SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA View
Renal and urinary disorders SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA View
Reproductive system and breast disorders SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA View
Dyspnea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Epistaxis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Other respiratory and mediastinal disorders SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Alopecia SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA View
Dry skin SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA View
Erythema SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA View
Nail disorder SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA View
Other skin and subcutaneous tissue disorders SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA View
Pruritus SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA View
Rash maculo-papular SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA View
Rash other than macular-papular or NOS SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA View
Hot flushes SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA View
Vascular disorders SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Other gastrointestinal disorders SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Upper abdominal pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Chills SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Fatigue SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Oedema SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Other general disorders and administration site conditions SYSTEMATIC_ASSESSMENT General disorders MedDRA View