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 @ 1:43 AM
Ignite Modification Date: 2025-12-26 @ 12:00 AM
NCT ID: NCT01867294
Description: Adverse events were assessed after one 4 week cycle, and after one 4-week observation prior for a maximum of up to 8 weeks.
Frequency Threshold: 0
Time Frame: Adverse events were assessed after one 4 week cycle, and after one 4-week observation prior for a maximum of up to 8 weeks.
Study: NCT01867294
Study Brief: Spironolactone in Preventing Rash in Patients With Advanced Cancer Receiving Panitumumab and Cetuximab
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Study I: Spironolactone .Patients apply spironolactone topically to face BID for 4 weeks. 0 None 2 8 6 8 View
Study I: Placebo Patients apply placebo topically to face BID for 4 weeks. 2 None 2 9 8 9 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Pulmonary edema SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 12 View
Respiratory failure SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 12 View
Pruritus SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 12 View
Rash maculo-papular SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 12 View
Anemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 12 View
Abdominal distension SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 12 View
Abdominal pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 12 View
Ascites SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 12 View
Ileus SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 12 View
Mucositis oral SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 12 View
Death NOS SYSTEMATIC_ASSESSMENT General disorders MedDRA 12 View
Fatigue SYSTEMATIC_ASSESSMENT General disorders MedDRA 12 View
Multi-organ failure SYSTEMATIC_ASSESSMENT General disorders MedDRA 12 View
Hepatobiliary disorders - Other, specify SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 12 View
Sepsis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 12 View
Gastrointestinal stoma necrosis SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 12 View
Intraoperative hemorrhage SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 12 View
Blood bilirubin increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 12 View
Creatinine increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 12 View
INR increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 12 View
Lymphocyte count decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 12 View
Dehydration SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 12 View
Hyperglycemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 12 View
Hypoalbuminemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 12 View
Hypocalcemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 12 View
Hypokalemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 12 View
Acute kidney injury SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 12 View
Hypoxia SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 12 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Anemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 12 View
Hearing impaired SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders MedDRA 12 View
Abdominal pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 12 View
Cholecystitis SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 12 View
Sepsis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 12 View
Lymphocyte count decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 12 View
Neutrophil count decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 12 View
White blood cell decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 12 View
Anorexia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 12 View
Dehydration SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 12 View
Hypokalemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 12 View
Hyponatremia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 12 View
Pruritus SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 12 View
Rash maculo-papular SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 12 View
Hypotension SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 12 View