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 @ 11:15 PM
Ignite Modification Date: 2025-12-25 @ 8:52 PM
NCT ID: NCT00003656
Description: Data are only available as a combined Arm/Group based on information contained in the study publication. No additional study data is available despite exhausting all efforts to locate the data.
Frequency Threshold: 0
Time Frame: None
Study: NCT00003656
Study Brief: Tretinoin Plus Interferon Alfa in Treating Patients With Metastatic Kidney 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
Phase 1 Group Weekly ATRA-IV (with three dose levels: 60, 75, and 90 mg/m2) with recombinant interferon alfa recombinant interferon alfa tretinoin liposome 0 None 1 12 12 12 View
Phase 2 Group Weekly ATRA-IV (dosage of 90 mg/m2) with recombinant interferon alfa recombinant interferon alfa tretinoin liposome 0 None 0 14 14 14 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Leukopenia NON_SYSTEMATIC_ASSESSMENT Investigations None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Fatigue - Grade 1 None General disorders None View
Fatigue - Grade 2 None General disorders None View
Constipation - Grade 1 None Gastrointestinal disorders None View
Cough - Grade 1 None Respiratory, thoracic and mediastinal disorders None View
Cough - Grade 2 None Respiratory, thoracic and mediastinal disorders None View
Anemia - Grade 1 None Blood and lymphatic system disorders None View
Anemia - Grade 2 None Blood and lymphatic system disorders None View
Anemia - Grade 3 None Blood and lymphatic system disorders None View
Anorexia - Grade 1 None Metabolism and nutrition disorders None View
Anorexia - Grade 2 None Metabolism and nutrition disorders None View
Skin - Grade 1 None Skin and subcutaneous tissue disorders None View
Xeroderma - Grade 1 None Skin and subcutaneous tissue disorders None View
Neurologic - Grade 1 None Nervous system disorders None View
Neurologic - Grade 3 None Nervous system disorders None View
Diarrhea - Grade 1 None Gastrointestinal disorders None View
Nausea/Vomiting - Grade 1 None Gastrointestinal disorders None View
Nausea/Vomiting - Grade 2 None Gastrointestinal disorders None View
Altered Mood - Grade 1 None Psychiatric disorders None View
Leukopenia - Grade 1 None Blood and lymphatic system disorders None View
Leukopenia - Grade 2 None Blood and lymphatic system disorders None View
Leukopenia - Grade 3 None Blood and lymphatic system disorders None View
Fever - Grade 1 None Immune system disorders None View
Fever - Grade 2 None Immune system disorders None View
Renal - Grade 1 None Renal and urinary disorders None View
Renal - Grade 2 None Renal and urinary disorders None View
Liver - Grade 1 None Hepatobiliary disorders None View
Thrombocytopenia - Grade 1 None Blood and lymphatic system disorders None View
Infusion Reaction - Grade 2 None General disorders None View
Pulmonary - Grade 1 None Respiratory, thoracic and mediastinal disorders None View
Hypotension - Grade 2 None Cardiac disorders None View
Cholesterol/TG - Grade 1 None Blood and lymphatic system disorders None View
Bone Pain - Grade 1 None Musculoskeletal and connective tissue disorders None View
Other Pain - Grade 1 None General disorders None View
Neurologic - Grade 2 None Nervous system disorders None View
Pulmonary - Grade 3 None Respiratory, thoracic and mediastinal disorders None View
Nasal Congestion - Grade 1 None Respiratory, thoracic and mediastinal disorders None View