Adverse Events Module

Home Icon Home Search Icon Search Certify Doc Icon Certify Doc Certify Doc Icon Genes Certify Doc Icon Clinical Trials Certify Doc Icon CompTox Processes Icon DrugMatrix Open Targets Icon Open Targets Processes Icon Products Support Icon Support Bugs Icon Bugs
Main Search Make This Study a Gene Therapy Make This Study a Not Gene Therapy Report Bug
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 @ 5:19 PM
Ignite Modification Date: 2025-12-25 @ 2:55 PM
NCT ID: NCT00869050
Description: Number at risk reflects the participants who passed the screening.
Frequency Threshold: 0
Time Frame: None
Study: NCT00869050
Study Brief: Capecitabine and Temozolomide for Neuroendocrine Cancers
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Capecitabine and Temozolomide Capecitabine 1500 mg/m2/day (PO divided BID) with a maximum daily dose of 2500mg and Temozolomide 150-200 mg/m2/day (PO divided BID). Capecitabine: Capecitabine 1500 mg/m2/day (PO divided BID) with a maximum daily dose of 2500mg Two week treatment regimen followed by two weeks off treatment, repeated for 12 cycles After patients have completed 12 cycles with no signs of progression of disease, radiologic evaluation (CT or MRI) will be done after three cycles. This will result in two 28 day cycles and one 35 day cycle. Temozolomide: Temozolomide 150-200 mg/m2/day (PO divided BID). Two week treatment regimen followed by two weeks off treatment, repeated for 12 cycles After patients have completed 12 cycles with no signs of progression of disease, radiologic evaluation (CT or MRI) will be done after three cycles. This will result in two 28 day cycles and one 35 day cycle. None None 4 38 28 38 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Death NON_SYSTEMATIC_ASSESSMENT General disorders None View
Syncope NON_SYSTEMATIC_ASSESSMENT General disorders None View
Hypoglycemia NON_SYSTEMATIC_ASSESSMENT General disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Erythema NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Fatigue NON_SYSTEMATIC_ASSESSMENT General disorders None View
Dizziness NON_SYSTEMATIC_ASSESSMENT General disorders None View
Vomiting NON_SYSTEMATIC_ASSESSMENT General disorders None View
Confusion NON_SYSTEMATIC_ASSESSMENT General disorders None View
Loss of apetite NON_SYSTEMATIC_ASSESSMENT General disorders None View
Liver pain NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Nausea NON_SYSTEMATIC_ASSESSMENT General disorders None View
Cough NON_SYSTEMATIC_ASSESSMENT General disorders None View
Edema NON_SYSTEMATIC_ASSESSMENT General disorders None View
Mucositis NON_SYSTEMATIC_ASSESSMENT General disorders None View
Rash NON_SYSTEMATIC_ASSESSMENT Surgical and medical procedures None View
Allergy to dye NON_SYSTEMATIC_ASSESSMENT Immune system disorders None View
Anxiety NON_SYSTEMATIC_ASSESSMENT General disorders None View
Depression NON_SYSTEMATIC_ASSESSMENT General disorders None View
Thrombocytopenia NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Pancytopenia NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Pain abdomen NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Facial flushing NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Night sweats NON_SYSTEMATIC_ASSESSMENT General disorders None View
Diarrhea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Arm and ankle pain NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Nail changes NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Constipation NON_SYSTEMATIC_ASSESSMENT General disorders None View
Tingling lower lip NON_SYSTEMATIC_ASSESSMENT General disorders None View
Nausea NON_SYSTEMATIC_ASSESSMENT General disorders None View
Pruritus NON_SYSTEMATIC_ASSESSMENT General disorders None View