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 @ 1:43 PM
Ignite Modification Date: 2025-12-25 @ 12:37 PM
NCT ID: NCT01387295
Description: None
Frequency Threshold: 5
Time Frame: Adverse Events were collected from informed consent to 28 days after last treatment, an average of 7 months. All-Cause Mortality was assessed through study completion, up to 7 years
Study: NCT01387295
Study Brief: Intra-hepatic Chemotherapy in Patients With Liver Metastases From Breast Cancer and Limited Extrahepatic Disease
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Chemotherapy oxaliplatin, capecitabine, trastuzumab: Oxaliplatin intrahepatic capecitabine and trastuzumab systemic 33 None 8 38 38 38 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Morphine toxication SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Pulmonary embolism SYSTEMATIC_ASSESSMENT Vascular disorders None View
Fever SYSTEMATIC_ASSESSMENT General disorders None View
gallbladder stone SYSTEMATIC_ASSESSMENT Hepatobiliary disorders None View
Diabetes mellitus SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Alanine aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations None View
Aspartate aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations None View
Alkaline phosphatase increased SYSTEMATIC_ASSESSMENT Investigations None View
Hyperbilirubinaemia SYSTEMATIC_ASSESSMENT Investigations None View
Thrombocytopenia SYSTEMATIC_ASSESSMENT Investigations None View
Neutropenia SYSTEMATIC_ASSESSMENT Investigations None View
Anaemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Dysaesthesia SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Peripheral motor neuropathy SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Peripheral sensory neuropathy SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Allergic reaction SYSTEMATIC_ASSESSMENT General disorders None View
Fatigue SYSTEMATIC_ASSESSMENT General disorders None View
Fever SYSTEMATIC_ASSESSMENT General disorders None View
Pain SYSTEMATIC_ASSESSMENT General disorders None View
Diarrhoea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Stomatitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Dyspepsia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Palmar-plantar erythrodysaesthesia syndrome SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Alopecia SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Myalgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Arthralgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Anorexia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
infection SYSTEMATIC_ASSESSMENT Infections and infestations None View