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 @ 1:19 PM
Ignite Modification Date: 2025-12-25 @ 12:25 PM
NCT ID: NCT02873195
Description: Participants who started treatment and were assessed for adverse events are summarized below.
Frequency Threshold: 0
Time Frame: Up to 20 months
Study: NCT02873195
Study Brief: Capecitabine and Bevacizumab With or Without Atezolizumab in Treating Patients With Refractory Metastatic 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
Atezolizumab, Bevacizumab, Capecitabine Patients receive 1200 mg atezolizumab IV over 30-60 minutes on day 1, 7.5 mg/kg bevacizumab IV over 30-90 minutes on day 1, and 850 or 1000 mg/m\^2 capecitabine PO BID on days 1-14. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. 45 None 36 81 77 81 View
Placebo, Bevacizumab, Capecitabine Patients receive 1200 mg placebo IV over 30-60 minutes on day 1, 7.5 mg/kg bevacizumab IV over 30-90 minutes on day 1, and 850 or 1000 mg/m\^2 capecitabine PO BID on days 1-14. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. 23 None 12 46 42 46 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Myocarditis SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 12 View
Blurred vision SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 12 View
Abdominal pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 12 View
Colitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 12 View
Diarrhea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 12 View
Duodenal obstruction SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 12 View
Gastric hemorrhage SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 12 View
Gastrointestinal disorders - Oth spec SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 12 View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 12 View
Rectal hemorrhage SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 12 View
Small intestinal obstruction SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 12 View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 12 View
Death NOS SYSTEMATIC_ASSESSMENT General disorders MedDRA 12 View
Fatigue SYSTEMATIC_ASSESSMENT General disorders MedDRA 12 View
Fever SYSTEMATIC_ASSESSMENT General disorders MedDRA 12 View
Flu like symptoms SYSTEMATIC_ASSESSMENT General disorders MedDRA 12 View
Multi-organ failure SYSTEMATIC_ASSESSMENT General disorders MedDRA 12 View
Non-cardiac chest pain SYSTEMATIC_ASSESSMENT General disorders MedDRA 12 View
Sudden death NOS SYSTEMATIC_ASSESSMENT General disorders MedDRA 12 View
Infections and infestations - Oth spec SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 12 View
Lung infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 12 View
Papulopustular rash SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 12 View
Peripheral nerve infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 12 View
Sepsis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 12 View
Upper respiratory infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 12 View
Urinary tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 12 View
Fall SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 12 View
Alanine aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 12 View
Aspartate aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 12 View
Platelet count decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 12 View
Dehydration SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 12 View
Hyperkalemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 12 View
Hypokalemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 12 View
Back pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 12 View
Neoplasms benign, mal, uncpec - Oth spec SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 12 View
Dysarthria SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 12 View
Encephalopathy SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 12 View
Facial muscle weakness SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 12 View
Nervous system disorders - Oth spec SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 12 View
Confusion SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 12 View
Acute kidney injury SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 12 View
Hematuria SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 12 View
Urinary retention SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 12 View
Pelvic pain SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA 12 View
Dyspnea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 12 View
Hypoxia SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 12 View
Pleural effusion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 12 View
Respiratory failure SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 12 View
Palmar-plantar erythrodysesthesia syndrm SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 12 View
Rash maculo-papular SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 12 View
Hypertension SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 12 View
Thromboembolic event SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 12 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Tinnitus SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders MedDRA 12 View
Dental caries SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 12 View
Diarrhea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 12 View
Dry mouth SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 12 View
Dyspepsia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 12 View
Oral pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 12 View
Rectal hemorrhage SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 12 View
Rectal pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 12 View
Stomach pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 12 View
Edema limbs SYSTEMATIC_ASSESSMENT General disorders MedDRA 12 View
Fatigue SYSTEMATIC_ASSESSMENT General disorders MedDRA 12 View
Fever SYSTEMATIC_ASSESSMENT General disorders MedDRA 12 View
Gen disord and admin site conds-Oth spec SYSTEMATIC_ASSESSMENT General disorders MedDRA 12 View
Non-cardiac chest pain SYSTEMATIC_ASSESSMENT General disorders MedDRA 12 View
Pain SYSTEMATIC_ASSESSMENT General disorders MedDRA 12 View
Hepatobiliary disorders - Other, specify SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 12 View
Allergic reaction SYSTEMATIC_ASSESSMENT Immune system disorders MedDRA 12 View
Infections and infestations - Oth spec SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 12 View
Mucosal infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 12 View
Pleural infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 12 View
Rhinitis infective SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 12 View
Sinusitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 12 View
Spinal fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 12 View
Alanine aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 12 View
Alkaline phosphatase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 12 View
Aspartate aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 12 View
Serum amylase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 12 View
Weight loss 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
Hypocalcemia 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
Arthralgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 12 View
Arthritis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 12 View
Back pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 12 View
Bone pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 12 View
Urinary tract obstruction SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 12 View
Urinary tract pain SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 12 View
Vaginal dryness SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA 12 View
Vaginal pain SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA 12 View
Allergic rhinitis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 12 View
Atelectasis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 12 View
Cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 12 View
Dyspnea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 12 View
Epistaxis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 12 View
Hiccups SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 12 View
Hoarseness SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 12 View
Nasal congestion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 12 View
Pleural effusion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 12 View
Pleuritic pain SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 12 View
Resp, thoracic, mediastinal - Oth spec SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 12 View
Hematoma SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 12 View
Hypertension SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 12 View
Anemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 12 View
Cardiac disorders - Other, specify SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 12 View
Blurred vision SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 12 View
Eye disorders - Other, specify SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 12 View
Watering eyes SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 12 View
Abdominal distension SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 12 View
Abdominal pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 12 View
Anal hemorrhage SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 12 View
Ascites SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 12 View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 12 View
Flatulence SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 12 View
Gastroesophageal reflux disease SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 12 View
Gastrointestinal disorders - Oth spec SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 12 View
Gastrointestinal pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 12 View
Mucositis oral SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 12 View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 12 View
Obstruction gastric SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 12 View
Toothache SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 12 View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 12 View
Chills SYSTEMATIC_ASSESSMENT General disorders MedDRA 12 View
Skin infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 12 View
Upper respiratory infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 12 View
Urinary tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 12 View
Vaginal infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 12 View
Dermatitis radiation SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 12 View
Fall SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 12 View
Inj, pois and proced complic - Oth spec SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 12 View
Blood bilirubin increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 12 View
CPK 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
Lymphocyte count increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 12 View
Neutrophil count decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 12 View
Platelet 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
Hyperkalemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 12 View
Hypernatremia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 12 View
Hypoalbuminemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 12 View
Chest wall pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 12 View
Flank pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 12 View
Generalized muscle weakness SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 12 View
Myalgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 12 View
Neck pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 12 View
Pain in extremity SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 12 View
Tumor pain SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 12 View
Cognitive disturbance SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 12 View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 12 View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 12 View
Peripheral sensory neuropathy SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 12 View
Anxiety SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 12 View
Confusion SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 12 View
Depression SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 12 View
Insomnia SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 12 View
Acute kidney injury SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 12 View
Chronic kidney disease SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 12 View
Hematuria SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 12 View
Proteinuria SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 12 View
Renal and urinary disorders - Oth spec SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 12 View
Wheezing SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 12 View
Alopecia SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 12 View
Dry skin SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 12 View
Pain of skin SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 12 View
Palmar-plantar erythrodysesthesia syndrm SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 12 View
Pruritus SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 12 View
Skin and subcut tissue disord - Oth spec SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 12 View
Skin hyperpigmentation SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 12 View
Hypotension SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 12 View
Thromboembolic event SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 12 View
Vascular disorders - Other, specify SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 12 View