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: 2025-12-25 @ 12:37 AM
Ignite Modification Date: 2025-12-25 @ 10:47 PM
NCT ID: NCT00288067
Description: None
Frequency Threshold: 5
Time Frame: None
Study: NCT00288067
Study Brief: Fenretinide and Rituximab in Treating Patients With B-Cell Non-Hodgkin Lymphoma
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Fenretinide and Rituximab PHASE I: Patients receive fenretinide PO BID on days 1-5. Treatment repeats weekly for at least 4 weeks in the absence of disease progression or unacceptable toxicity. PHASE II: Patients receive fenretinide PO BID on days 1-5 in weeks 1-8 and rituximab IV once weekly in weeks 5-8. Treatment continues in the absence of disease progression or unacceptable toxicity. pharmacological study : Correlative studies rituximab : Given IV fenretinide : Given PO None None 6 32 32 32 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Allergic Reaction NON_SYSTEMATIC_ASSESSMENT Immune system disorders 10002218 View
Hypotension NON_SYSTEMATIC_ASSESSMENT Vascular disorders 10021097 View
Rash Maculo-papular NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders 10037868 View
Infections and infestations - Other, specify, Infection with Grade 3 or 4 neutrophils (ANC <1.0 x 10 NON_SYSTEMATIC_ASSESSMENT Infections and infestations 10021881 View
Acute Coronary Syndrome NON_SYSTEMATIC_ASSESSMENT Cardiac disorders 10051592 View
Wound Infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations 10048038 View
Pruritus NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders 10037087 View
Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, specify, Papillary Thy NON_SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10029104 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Night Blindness NON_SYSTEMATIC_ASSESSMENT Eye disorders 10029404 View
Abdominal Distention NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Abdominal Pain NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Alanine aminotransferase increased NON_SYSTEMATIC_ASSESSMENT Investigations None View
Alkaline phosphatase increased NON_SYSTEMATIC_ASSESSMENT Investigations None View
Allergic Reaction NON_SYSTEMATIC_ASSESSMENT Immune system disorders None View
Alopecia NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Anemia NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Anorexia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Anxiety NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Arthralgia NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Aspartate aminotransferase increased NON_SYSTEMATIC_ASSESSMENT Investigations None View
Atelectasis NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Blood Bilirubin Increased NON_SYSTEMATIC_ASSESSMENT Investigations None View
Blurred Vision NON_SYSTEMATIC_ASSESSMENT Eye disorders None View
Bone marrow hypocellular NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Bone Pain NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Bruising NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Cataract NON_SYSTEMATIC_ASSESSMENT Eye disorders None View
Chills NON_SYSTEMATIC_ASSESSMENT General disorders None View
Cholesterol High NON_SYSTEMATIC_ASSESSMENT Investigations None View
Constipation NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Cough NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Creatinine Increased NON_SYSTEMATIC_ASSESSMENT Investigations None View
Cytokine release syndrome NON_SYSTEMATIC_ASSESSMENT Immune system disorders None View
Depression NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Diarrhea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Dizziness NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Dry Eye NON_SYSTEMATIC_ASSESSMENT Eye disorders None View
Dry Skin NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Dyspnea NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Edema Limbs NON_SYSTEMATIC_ASSESSMENT General disorders None View
Eye disorders - Other, specify, yellowing/discoloration of lights NON_SYSTEMATIC_ASSESSMENT Eye disorders None View
Eye disorders - Other, specify, Altered color perception NON_SYSTEMATIC_ASSESSMENT Eye disorders None View
Fatigue NON_SYSTEMATIC_ASSESSMENT General disorders None View
Febrile Neutropenia NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Fever NON_SYSTEMATIC_ASSESSMENT General disorders None View
Flashing Lights NON_SYSTEMATIC_ASSESSMENT Eye disorders None View
Flatulance NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Fracture NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Hot Flashes NON_SYSTEMATIC_ASSESSMENT Vascular disorders None View
Hyperglycemia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Hyperhidrosis NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Hypernatremia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Hypoalbuminemia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Hypocalcemia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Hypokalemia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Hyponatremia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Hypotension NON_SYSTEMATIC_ASSESSMENT Vascular disorders None View
Insomnia NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Lymphocyte Count Decreased NON_SYSTEMATIC_ASSESSMENT Investigations None View
Myalgia NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Nausea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Neutrophil Count Decreased NON_SYSTEMATIC_ASSESSMENT Investigations None View
Pain NON_SYSTEMATIC_ASSESSMENT General disorders None View
Pain in Extremity NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Peripheral Sensory Neuropathy NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Pharyngolaryngeal Pain NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Photosensitivity NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Platelet Count Decreased NON_SYSTEMATIC_ASSESSMENT Investigations None View
Pruritus NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Rash maculo-papular NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Sinusitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Thromboembolic Event NON_SYSTEMATIC_ASSESSMENT Vascular disorders None View
Upper Respiratory Infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Urinary Frequency NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Urinary Tract Infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Vaginal Infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
White Blood Cell Decreased NON_SYSTEMATIC_ASSESSMENT Investigations None View