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 @ 7:10 PM
Ignite Modification Date: 2025-12-25 @ 4:45 PM
NCT ID: NCT01108003
Description: None
Frequency Threshold: 0
Time Frame: None
Study: NCT01108003
Study Brief: Broccoli Sprout Extract in Treating Patients With Transitional Cell Bladder Cancer Undergoing Surgery
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 2 Patients receive mango juice alone. Mango Juice: given orally None None 1 3 3 3 View
Arm I Patients receive oral broccoli sprout extract once daily on days 1-14 in the absence of disease progression or unacceptable toxicity. broccoli sprout extract: Given orally laboratory biomarker analysis: Correlative studies None None 2 4 4 4 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Fungaemia SYSTEMATIC_ASSESSMENT Infections and infestations None View
Sepsis SYSTEMATIC_ASSESSMENT Infections and infestations None View
Urosepsis SYSTEMATIC_ASSESSMENT Infections and infestations None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Anaemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Lymphopenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Ileus SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Pain SYSTEMATIC_ASSESSMENT General disorders None View
Pyrexia SYSTEMATIC_ASSESSMENT General disorders None View
Skin infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Aspartate aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations None View
Blood albumin decreased SYSTEMATIC_ASSESSMENT Investigations None View
Blood alkaline phosphatase increased SYSTEMATIC_ASSESSMENT Investigations None View
Blood calcium decreased SYSTEMATIC_ASSESSMENT Investigations None View
Blood creatinine increased SYSTEMATIC_ASSESSMENT Investigations None View
Blood magnesium increased SYSTEMATIC_ASSESSMENT Investigations None View
Cardiac enzymes increased SYSTEMATIC_ASSESSMENT Investigations None View
Electrocardiogram abnormal SYSTEMATIC_ASSESSMENT Investigations None View
Haemoglobin decreased SYSTEMATIC_ASSESSMENT Investigations None View
Lymphocyte count decreased SYSTEMATIC_ASSESSMENT Investigations None View
Platelet count decreased SYSTEMATIC_ASSESSMENT Investigations None View
White blood cell analysis increased SYSTEMATIC_ASSESSMENT Investigations None View
Hyperglycaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Hypermagnesaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Hyperphosphataemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Hypocalcaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Hypokalaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Hypomagnesaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Hyponatraemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Hypophosphataemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Confusional state SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Haematuria SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Penile discharge SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders None View
Pruritus SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View