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 @ 3:57 AM
Ignite Modification Date: 2025-12-26 @ 2:49 AM
NCT ID: NCT03800602
Description: None
Frequency Threshold: 5
Time Frame: Information on adverse events was collected beginning at the baseline assessment and continued through the final assessment at Month 12.
Study: NCT03800602
Study Brief: Nivolumab and Metformin in Patients With Treatment Refractory MSS Colorectal 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
Treatment (Nivolumab, Metformin) Patients receive metformin PO BID starting on day 1. After 14 days of metformin only period patients also receive nivolumab IV every 4 weeks starting on day 15. Courses repeat every 28 days for up to 2 years in the absence of disease progression, unacceptable toxicity or consent withdrawal. Metformin: Given PO Nivolumab: Given IV 0 None 0 18 18 18 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Diarrhea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Nausea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Abdominal Pain NON_SYSTEMATIC_ASSESSMENT General disorders None View
Vomiting NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Fatigue NON_SYSTEMATIC_ASSESSMENT General disorders None View
Anemia NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Back Pain NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Fever NON_SYSTEMATIC_ASSESSMENT General disorders None View
Weight Loss NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Abdominal Distension NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Anxiety NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Ast Increased NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Constipation NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Dehydration NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Lower Back Pain NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Pelvic Pain NON_SYSTEMATIC_ASSESSMENT General disorders None View
Shortness Of Breath NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Abdominal Cramps NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Alk Phos Increased NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
B/L Le Edema NON_SYSTEMATIC_ASSESSMENT Vascular disorders None View
Bloating NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Blood in Ostomy NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Chest Pain NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Chills NON_SYSTEMATIC_ASSESSMENT General disorders None View
Clostridioides Difficile Colitis NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Decreased Appetite NON_SYSTEMATIC_ASSESSMENT General disorders None View
Dyphasia NON_SYSTEMATIC_ASSESSMENT General disorders None View
Elevated Ldh NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Flatulence NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Hyperbilirubinemia NON_SYSTEMATIC_ASSESSMENT General disorders None View
Hyperhidrosis (Night Sweats) NON_SYSTEMATIC_ASSESSMENT General disorders None View
Hypoalbuminemia NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Hypokalemia NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Left Hip Pain NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Left Hydronephrosis NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Liver Failure NON_SYSTEMATIC_ASSESSMENT Endocrine disorders None View
Lle Dvt NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Loss Of Bladder Control NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Loss Of Taste NON_SYSTEMATIC_ASSESSMENT General disorders None View
Lower Extremity Swelling NON_SYSTEMATIC_ASSESSMENT General disorders None View
Lymphocyte Count Decreased NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Mouth Lesion NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Neck Pain NON_SYSTEMATIC_ASSESSMENT General disorders None View
Netropenia NON_SYSTEMATIC_ASSESSMENT General disorders None View
Pain At Biopsy Site NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Pain Lower Abdomen NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Pulmonary Emoblism NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Rash Underbreast NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Rectal Discharge NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Rectal Obstruction NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Rectal Pain NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Right Droopy Eye NON_SYSTEMATIC_ASSESSMENT Eye disorders None View
Right Internal Juglar Vein Thrombus NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Sepsis NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Skin Itching NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Upper Back Pain NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Wheezing NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View