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 @ 3:57 PM
Ignite Modification Date: 2025-12-25 @ 2:00 PM
NCT ID: NCT00209092
Description: None
Frequency Threshold: 5
Time Frame: None
Study: NCT00209092
Study Brief: Randomized Phase II Trial Induction Therapy for Early Stage 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
Arm A:Sequential Therapy Docetaxel will be given at 100mg/m\^2 intravenously Day1 every 3 weeks for 4 cycles followed by capecitabine 1000 mg/m\^2 twice a day by mouth D1-14 every 3 weeks for 4 cycles (total 8 cycles) (total 24 weeks). None None 6 25 25 25 View
Arm B:Concurrent Therapy Docetaxel will be given at 50mg/m\^2 intravenously Day 1 concomitantly with capecitabine 1000 mg/m\^2 twice a day by mouth Day 1-7 every 2 weeks for 8 cycles (total 16 weeks). None None 11 26 26 26 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Neuropathy NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Hand and Foot Syndrome NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Anemia NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Fatigue NON_SYSTEMATIC_ASSESSMENT General disorders None View
Liver Tests NON_SYSTEMATIC_ASSESSMENT Hepatobiliary disorders None View
Syncope NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Chest Pain NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Febrile Neutropenia NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Diarrhea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Neutropenia NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Diarrhea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Neuropathy NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Neutropenia NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Hand-Foot Syndrome NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Anemia NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Fatigue NON_SYSTEMATIC_ASSESSMENT General disorders None View
Nausea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Anorexia NON_SYSTEMATIC_ASSESSMENT General disorders None View
Myalgias/Arthralgias NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Liver Tests NON_SYSTEMATIC_ASSESSMENT Hepatobiliary disorders None View
Muscositis NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Hyperglycemia NON_SYSTEMATIC_ASSESSMENT Endocrine disorders None View
Nail changes NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View