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 @ 5:06 AM
Ignite Modification Date: 2025-12-26 @ 4:10 AM
NCT ID: NCT00601627
Description: None
Frequency Threshold: 0
Time Frame: None
Study: NCT00601627
Study Brief: Panitumumab, Chemotherapy, and External-Beam Radiation Therapy in Treating Patients With Locally Advanced Pancreatic Cancer That Cannot be Removed by 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
Panitumumab 6 mg/kg Panitumumab on days 1 and 15 of each cycle, for 6 cycles. None None 29 51 51 51 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Hemoglobin decreased SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 10 View
Abdominal pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 10 View
Colonic hemorrhage SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 10 View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 10 View
Diarrhea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 10 View
Duodenal obstruction SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 10 View
Duodenal ulcer SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 10 View
Dysphagia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 10 View
Ear, nose and throat examination abnormal SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 10 View
Esophageal stenosis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 10 View
Esophageal ulcer SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 10 View
Mucositis oral SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 10 View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 10 View
Small intestine ulcer SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 10 View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 10 View
Chest pain SYSTEMATIC_ASSESSMENT General disorders MedDRA 10 View
Death SYSTEMATIC_ASSESSMENT General disorders MedDRA 10 View
Fatigue SYSTEMATIC_ASSESSMENT General disorders MedDRA 10 View
Fever SYSTEMATIC_ASSESSMENT General disorders MedDRA 10 View
Cholecystitis SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 10 View
Hepatobiliary disease SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 10 View
Biliary tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 10 View
Bladder infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 10 View
Catheter related infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 10 View
Pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 10 View
Sepsis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 10 View
Alanine aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 10 View
Alkaline phosphatase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 10 View
Aspartate aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 10 View
Bilirubin increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 10 View
Creatinine increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 10 View
INR increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 10 View
Leukocyte count decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 10 View
Lymphocyte count decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 10 View
Neutrophil count decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 10 View
Platelet count decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 10 View
Weight loss SYSTEMATIC_ASSESSMENT Investigations MedDRA 10 View
Anorexia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 10 View
Blood glucose increased SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 10 View
Dehydration SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 10 View
Serum albumin decreased SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 10 View
Serum phosphate decreased SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 10 View
Serum potassium decreased SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 10 View
Serum sodium increased SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 10 View
Muscle weakness SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 10 View
Depressed level of consciousness SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 10 View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 10 View
Ischemia cerebrovascular SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 10 View
Peripheral motor neuropathy SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 10 View
Insomnia SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 10 View
Renal failure SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 10 View
Dyspnea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 10 View
Hypoxia SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 10 View
Pleural effusion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 10 View
Dry skin SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 10 View
Hand-and-foot syndrome SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 10 View
Pruritus SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 10 View
Rash acneiform SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 10 View
Hypotension SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 10 View
Thrombosis SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 10 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Hemoglobin decreased SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 10 View
Tinnitus SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders MedDRA 10 View
Abdominal distension SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 10 View
Abdominal pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 10 View
Ascites SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 10 View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 10 View
Diarrhea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 10 View
Dry mouth SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 10 View
Dyspepsia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 10 View
Ear, nose and throat examination abnormal SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 10 View
Flatulence SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 10 View
Intra-abdominal hemorrhage SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 10 View
Lower gastrointestinal hemorrhage SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 10 View
Mucositis oral SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 10 View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 10 View
Stomach pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 10 View
Upper gastrointestinal hemorrhage SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 10 View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 10 View
Chest pain SYSTEMATIC_ASSESSMENT General disorders MedDRA 10 View
Disease progression SYSTEMATIC_ASSESSMENT General disorders MedDRA 10 View
Edema limbs SYSTEMATIC_ASSESSMENT General disorders MedDRA 10 View
Facial pain SYSTEMATIC_ASSESSMENT General disorders MedDRA 10 View
Fatigue SYSTEMATIC_ASSESSMENT General disorders MedDRA 10 View
Fever SYSTEMATIC_ASSESSMENT General disorders MedDRA 10 View
Abdominal infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 10 View
Catheter related infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 10 View
Esophageal infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 10 View
Infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 10 View
Infectious colitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 10 View
Opportunistic infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 10 View
Otitis externa SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 10 View
Skin infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 10 View
Activated partial thromboplastin time prolonged SYSTEMATIC_ASSESSMENT Investigations MedDRA 10 View
Alanine aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 10 View
Alkaline phosphatase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 10 View
Aspartate aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 10 View
Bilirubin increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 10 View
Creatinine increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 10 View
INR increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 10 View
Leukocyte count decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 10 View
Lymphocyte count decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 10 View
Neutrophil count decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 10 View
Platelet count decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 10 View
Weight loss SYSTEMATIC_ASSESSMENT Investigations MedDRA 10 View
Anorexia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 10 View
Blood bicarbonate decreased SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 10 View
Blood glucose increased SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 10 View
Dehydration SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 10 View
Serum albumin decreased SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 10 View
Serum calcium decreased SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 10 View
Serum magnesium decreased SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 10 View
Serum phosphate decreased SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 10 View
Serum potassium decreased SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 10 View
Serum potassium increased SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 10 View
Serum sodium decreased SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 10 View
Back pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 10 View
Muscle weakness SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 10 View
Myalgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 10 View
Neck pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 10 View
Pain in extremity SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 10 View
Depressed level of consciousness SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 10 View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 10 View
Peripheral motor neuropathy SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 10 View
Peripheral sensory neuropathy SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 10 View
Taste alteration SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 10 View
Depression SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 10 View
Insomnia SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 10 View
Cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 10 View
Dyspnea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 10 View
Pharyngeal mucositis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 10 View
Pleural effusion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 10 View
Pneumonitis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 10 View
Dry skin SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 10 View
Erythema multiforme SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 10 View
Hand-and-foot syndrome SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 10 View
Nail disorder SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 10 View
Petechiae SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 10 View
Pruritus SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 10 View
Rash acneiform SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 10 View
Rash desquamating SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 10 View
Skin disorder SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 10 View
Skin ulceration SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 10 View
Hot flashes SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 10 View
Hypertension SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 10 View
Hypotension SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 10 View
Thrombosis SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 10 View