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 @ 7:45 PM
Ignite Modification Date: 2025-12-25 @ 5:22 PM
NCT ID: NCT00915603
Description: Adverse Event analysis includes only patients who were enrolled, randomized and treated
Frequency Threshold: 5
Time Frame: None
Study: NCT00915603
Study Brief: Trial of Paclitaxel/Bevacizumab +/- Everolimus for Patients With HER2-Negative Metastatic 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
Paclitaxel/Bevacizumab/Everolimus None None None 16 55 55 55 View
Paclitaxel/Bevacizumab/Placebo None None None 16 56 56 56 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
NEUTROPENIA SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA View
FEBRILE NEUTROPENIA SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA View
LEFT VENTRICULAR DYSFUNCTION SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA View
ABDOMINAL PAIN SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
PANCREATITIS SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
MUCOSAL INFLAMMATION SYSTEMATIC_ASSESSMENT General disorders MedDRA View
JAUNDICE SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA View
BRONCHITIS SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
CLOSTRIDIUM DIFFICILE COLITIS SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
DIVERTICULITIS SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
INFECTION SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
PELVIC INFLAMMATORY DISEASE SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
PNEUMONIA SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
DEHYDRATION SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA View
HYPERGLYCAEMIA SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA View
MUSCULAR WEAKNESS SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
LYMPHANGIOSIS CARCINOMATOSA SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA View
CONVULSION SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
RENAL FAILURE ACUTE SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA View
CHRONIC OBSTRUCTIVE PULMONARY DISEASE SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
HYPOXIA SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
PULMONARY EMBOLISM SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
DEEP VEIN THROMBOSIS SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA View
PANCYTOPENIA SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA View
TACHYCARDIA SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA View
HAEMATEMESIS SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
INTESTINAL PERFORATION SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
OESOPHAGEAL OBSTRUCTION SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
CATHETER RELATED INFECTION SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
CENTRAL LINE INFECTION SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
METASTASES TO CENTRAL NERVOUS SYSTEM SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA View
TRANSIENT ISCHAEMIC ATTACK SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
CONFUSIONAL STATE SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA View
RENAL FAILURE SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA View
BRONCHIAL OBSTRUCTION SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
PNEUMONITIS SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
RESPIRATORY FAILURE SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
THROMBOSIS SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
ANAEMIA SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA View
LEUKOPENIA SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA View
NEUTROPENIA SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA View
THROMBOCYTOPENIA SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA View
ABDOMINAL PAIN SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
GASTROOESOPHAGEAL REFLUX DISEASE SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
HAEMORRHOIDS SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
NAUSEA SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
ORAL PAIN SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
STOMATITIS SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
VOMITING SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
ASTHENIA SYSTEMATIC_ASSESSMENT General disorders MedDRA View
FATIGUE SYSTEMATIC_ASSESSMENT General disorders MedDRA View
MUCOSAL INFLAMMATION SYSTEMATIC_ASSESSMENT General disorders MedDRA View
OEDEMA PERIPHERAL SYSTEMATIC_ASSESSMENT General disorders MedDRA View
PAIN SYSTEMATIC_ASSESSMENT General disorders MedDRA View
PYREXIA SYSTEMATIC_ASSESSMENT General disorders MedDRA View
SINUSITIS SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
UPPER RESPIRATORY TRACT INFECTION SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
URINARY TRACT INFECTION SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
ASPARTATE AMINOTRANSFERASE INCREASED SYSTEMATIC_ASSESSMENT Investigations MedDRA View
WEIGHT DECREASED SYSTEMATIC_ASSESSMENT Investigations MedDRA View
ANOREXIA SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA View
DEHYDRATION SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA View
HYPERCHOLESTEROLAEMIA SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA View
HYPERGLYCAEMIA SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA View
HYPOKALAEMIA SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA View
ARTHRALGIA SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
BACK PAIN SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
BONE PAIN SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
OROPHARYNGEAL PAIN SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
PRODUCTIVE COUGH SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
RHINORRHOEA SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
ALOPECIA SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA View
MUSCULOSKELETAL PAIN SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
MYALGIA SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
PAIN IN EXTREMITY SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
DIZZINESS SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
DYSGEUSIA SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
HEADACHE SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
HYPOAESTHESIA SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
NEUROPATHY PERIPHERAL 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
DYSURIA SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA View
PROTEINURIA SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA View
COUGH SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
DYSPHONIA SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
DYSPNOEA SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
EPISTAXIS SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
NASAL CONGESTION SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
DERMATITIS ACNEIFORM SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA View
DRY SKIN SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA View
NAIL DISORDER SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA View
NIGHT SWEATS SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA View
RASH SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA View
FLUSHING SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA View
HOT FLUSH SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA View
HYPERTENSION SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA View
LYMPHOEDEMA SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA View
MUSCULOSKELETAL CHEST PAIN SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
ABDOMINAL PAIN UPPER SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
CONSTIPATION SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
DIARRHOEA SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
DRY MOUTH SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
DYSPEPSIA SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View