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 @ 9:25 PM
Ignite Modification Date: 2025-12-25 @ 7:11 PM
NCT ID: NCT00061932
Description: None
Frequency Threshold: 5
Time Frame: None
Study: NCT00061932
Study Brief: Bortezomib With or Without Irinotecan in Treating Patients With Cancer of the Gastroesophageal Junction or Stomach
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Stratum 1 (Previously Untreated) Patients receive bortezomib IV over 3-5 seconds on days 1, 4, 8, and 11 and irinotecan IV over 90 minutes on days 1 and 8. bortezomib: Given IV irinotecan: Given IV None None 24 29 25 29 View
Stratum 2 (Previously Treated) (closed to accrual as of 9/19/2006): Patients receive bortezomib as in stratum 1. bortezomib: Given IV irinotecan: Given IV None None 8 12 10 12 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Anemia None Blood and lymphatic system disorders None View
Leukocytopenia None Investigations None View
Neutropenia None Investigations None View
Thrombocytopenia None Investigations None View
Hypoalbuminemia None Metabolism and nutrition disorders None View
Anorexia None Gastrointestinal disorders None View
Heart stoppage None Cardiac disorders None View
Cardiac ischemia/infarction None Cardiac disorders None View
Dehydration None Gastrointestinal disorders None View
Diarrhea None Gastrointestinal disorders None View
Abdominal distension None Gastrointestinal disorders None View
Dyspnea None Respiratory, thoracic and mediastinal disorders None View
Edema: trunk/genital None General disorders None View
Fatigue None General disorders None View
Febrile neutropenia None Blood and lymphatic system disorders None View
Hemorrhage, GU: Urinary NOS None Renal and urinary disorders None View
Hypocalcemia None Metabolism and nutrition disorders None View
Hypotension None Vascular disorders None View
Infection: Lung None Infections and infestations None View
Malabsorption None Gastrointestinal disorders None View
Nausea None Gastrointestinal disorders None View
Obstruction: Small bowel NOS None Gastrointestinal disorders None View
Pain: right hip None Musculoskeletal and connective tissue disorders None View
Abdominal pain None Gastrointestinal disorders None View
Rash: desquamation None Skin and subcutaneous tissue disorders None View
Vomiting None Gastrointestinal disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Fever (in the absence of neutropenia) None General disorders None View
Flatulence None Gastrointestinal disorders None View
Alopecia None Skin and subcutaneous tissue disorders None View
Neuropathy: Sensory None Nervous system disorders None View
Chills None General disorders None View
Edema:limbs None General disorders None View
Constipation None Gastrointestinal disorders None View
Insomnia None Psychiatric disorders None View
Rash: desquamation None Skin and subcutaneous tissue disorders None View