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 @ 3:53 AM
Ignite Modification Date: 2025-12-26 @ 2:42 AM
NCT ID: NCT03861702
Description: None
Frequency Threshold: 0
Time Frame: Up to maximum 31 months
Study: NCT03861702
Study Brief: Liposomal Irinotecan in Combination With Oxaliplatin, Leucovorin, and 5-fluorouracil for Patients With Locally Advanced Pancreatic Carcinoma:
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
FOLFOX + Irinotecan Oxaliplatin 60 mg/m2 Intravenously (IV) over 2 hours Liposomal Irinotecan (free base) 50 mg/m2 IV over 90 minutes after completion of oxaliplatin Leucovorin 400 mg/m2 IV over 30 minutes after completion of liposomal irinotecan 5-Fluorouracil 2,400 mg/m2 IV over 46 hours via infusion pump at home All drugs administered on day 1 of each 14 day cycle. FOLFOX regimen: FOLFOX (Oxaliplatin, Leucovorin, 5-Fluorouracil) Liposomal Irinotecan: Liposomal Irinotecan 13 None 15 28 28 28 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
ENTEROCOLITIS NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAEv5 View
FEBRILE NEUTROPENIA NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders CTCAEv5 View
GALLBLADDER INFECTION NON_SYSTEMATIC_ASSESSMENT Infections and infestations CTCAEv5 View
GASTRITIS NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAEv5 View
HYPOMAGNESEMIA NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAEv5 View
LUNG INFECTION NON_SYSTEMATIC_ASSESSMENT Infections and infestations CTCAEv5 View
PANCREATITIS NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAEv5 View
SUPRAVENTRICULAR TACHYCARDIA NON_SYSTEMATIC_ASSESSMENT Cardiac disorders CTCAEv5 View
URINARY TRACT INFECTION NON_SYSTEMATIC_ASSESSMENT Infections and infestations CTCAEv5 View
ENTEROCOLITIS INFECTIOUS NON_SYSTEMATIC_ASSESSMENT Infections and infestations CTCAEv5 View
HEPATOBILIARY DISORDERS - OTHER, SPECIFY NON_SYSTEMATIC_ASSESSMENT Hepatobiliary disorders CTCAEv5 View
INFECTIONS AND INFESTATIONS - OTHER, SPECIFY NON_SYSTEMATIC_ASSESSMENT Infections and infestations CTCAEv5 View
VENTRICULAR TACHYCARDIA NON_SYSTEMATIC_ASSESSMENT Cardiac disorders CTCAEv5 View
ABDOMINAL PAIN NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAEv5 View
ACUTE KIDNEY INJURY NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders CTCAEv5 View
ALANINE AMINOTRANSFERASE INCREASED NON_SYSTEMATIC_ASSESSMENT Investigations CTCAEv5 View
ASPARTATE AMINOTRANSFERASE INCREASED NON_SYSTEMATIC_ASSESSMENT Investigations CTCAEv5 View
BILIARY TRACT INFECTION NON_SYSTEMATIC_ASSESSMENT Infections and infestations CTCAEv5 View
CONSTIPATION NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAEv5 View
DEHYDRATION NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAEv5 View
DIARRHEA NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAEv5 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
ABDOMINAL DISTENSION NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAEv5 View
ABDOMINAL PAIN NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAEv5 View
ACUTE KIDNEY INJURY NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders CTCAEv5 View
AGITATION NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders CTCAEv5 View
ALANINE AMINOTRANSFERASE INCREASED NON_SYSTEMATIC_ASSESSMENT Investigations CTCAEv5 View
ALKALINE PHOSPHATASE INCREASED NON_SYSTEMATIC_ASSESSMENT Investigations CTCAEv5 View
ALLERGIC RHINITIS NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAEv5 View
ALOPECIA NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCAEv5 View
ANEMIA NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders CTCAEv5 View
ANOREXIA NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAEv5 View
ANOSMIA NON_SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAEv5 View
ANXIETY NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders CTCAEv5 View
ARTHRITIS NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders CTCAEv5 View
ASPARTATE AMINOTRANSFERASE INCREASED NON_SYSTEMATIC_ASSESSMENT Investigations CTCAEv5 View
ATRIAL FIBRILLATION NON_SYSTEMATIC_ASSESSMENT Cardiac disorders CTCAEv5 View
BACK PAIN NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders CTCAEv5 View
BACTEREMIA NON_SYSTEMATIC_ASSESSMENT Infections and infestations CTCAEv5 View
BELCHING NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAEv5 View
BLOATING NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAEv5 View
BLOOD BILIRUBIN INCREASED NON_SYSTEMATIC_ASSESSMENT Investigations CTCAEv5 View
BLURRED VISION NON_SYSTEMATIC_ASSESSMENT Eye disorders CTCAEv5 View
BONE PAIN NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders CTCAEv5 View
CARDIAC DISORDERS - OTHER, SPECIFY NON_SYSTEMATIC_ASSESSMENT Cardiac disorders CTCAEv5 View
CATARACT NON_SYSTEMATIC_ASSESSMENT Eye disorders CTCAEv5 View
CHILLS NON_SYSTEMATIC_ASSESSMENT General disorders CTCAEv5 View
CHOLESTEROL HIGH NON_SYSTEMATIC_ASSESSMENT Investigations CTCAEv5 View
CHRONIC KIDNEY DISEASE NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders CTCAEv5 View
COLITIS NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAEv5 View
CONFUSION NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders CTCAEv5 View
CONSTIPATION NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAEv5 View
COUGH NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAEv5 View
CREATININE INCREASED NON_SYSTEMATIC_ASSESSMENT Investigations CTCAEv5 View
DEHYDRATION NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAEv5 View
DEPRESSION NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders CTCAEv5 View
DIARRHEA NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAEv5 View
DIZZINESS NON_SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAEv5 View
DRY EYE NON_SYSTEMATIC_ASSESSMENT Eye disorders CTCAEv5 View
DRY MOUTH NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAEv5 View
DYSESTHESIA NON_SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAEv5 View
DYSGEUSIA NON_SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAEv5 View
DYSPEPSIA NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAEv5 View
DYSPHAGIA NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAEv5 View
DYSPNEA NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAEv5 View
DYSURIA NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders CTCAEv5 View
ECZEMA NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCAEv5 View
EDEMA LIMBS NON_SYSTEMATIC_ASSESSMENT General disorders CTCAEv5 View
ENDOCRINE DISORDERS - OTHER, SPECIFY NON_SYSTEMATIC_ASSESSMENT Endocrine disorders CTCAEv5 View
ENTEROCOLITIS INFECTIOUS NON_SYSTEMATIC_ASSESSMENT Infections and infestations CTCAEv5 View
EPISTAXIS NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAEv5 View
ERECTILE DYSFUNCTION NON_SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders CTCAEv5 View
EYE DISORDERS - OTHER, SPECIFY NON_SYSTEMATIC_ASSESSMENT Eye disorders CTCAEv5 View
FALL NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications CTCAEv5 View
FATIGUE NON_SYSTEMATIC_ASSESSMENT General disorders CTCAEv5 View
FEVER NON_SYSTEMATIC_ASSESSMENT General disorders CTCAEv5 View
FLANK PAIN NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders CTCAEv5 View
FLATULENCE NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAEv5 View
FLOATERS NON_SYSTEMATIC_ASSESSMENT Eye disorders CTCAEv5 View
FLUSHING NON_SYSTEMATIC_ASSESSMENT Vascular disorders CTCAEv5 View
FUNGEMIA NON_SYSTEMATIC_ASSESSMENT Infections and infestations CTCAEv5 View
GALLBLADDER INFECTION NON_SYSTEMATIC_ASSESSMENT Infections and infestations CTCAEv5 View
GASTROESOPHAGEAL REFLUX DISEASE NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAEv5 View
GASTROINTESTINAL DISORDERS - OTHER, SPECIFY NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAEv5 View
GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS - OTHER, SPECIFY NON_SYSTEMATIC_ASSESSMENT General disorders CTCAEv5 View
HEADACHE NON_SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAEv5 View
HEART FAILURE NON_SYSTEMATIC_ASSESSMENT Cardiac disorders CTCAEv5 View
HEMATURIA NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders CTCAEv5 View
HEMORRHOIDS NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAEv5 View
HERPES SIMPLEX REACTIVATION NON_SYSTEMATIC_ASSESSMENT Infections and infestations CTCAEv5 View
HICCUPS NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAEv5 View
HYPERGLYCEMIA NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAEv5 View
HYPERHIDROSIS NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCAEv5 View
HYPERKALEMIA NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAEv5 View
HYPERLIPIDEMIA NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAEv5 View
HYPERNATREMIA NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAEv5 View
HYPERTENSION NON_SYSTEMATIC_ASSESSMENT Vascular disorders CTCAEv5 View
HYPOALBUMINEMIA NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAEv5 View
HYPOCALCEMIA NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAEv5 View
HYPOKALEMIA NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAEv5 View
HYPOMAGNESEMIA NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAEv5 View
HYPONATREMIA NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAEv5 View
HYPOPHOSPHATEMIA NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAEv5 View
HYPOTENSION NON_SYSTEMATIC_ASSESSMENT Vascular disorders CTCAEv5 View
HYPOTHYROIDISM NON_SYSTEMATIC_ASSESSMENT Endocrine disorders CTCAEv5 View
ILEUS NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAEv5 View
IMMUNE SYSTEM DISORDERS - OTHER, SPECIFY NON_SYSTEMATIC_ASSESSMENT Immune system disorders CTCAEv5 View
INFECTIONS AND INFESTATIONS - OTHER, SPECIFY NON_SYSTEMATIC_ASSESSMENT Infections and infestations CTCAEv5 View
INSOMNIA NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders CTCAEv5 View
INVESTIGATIONS - OTHER, SPECIFY NON_SYSTEMATIC_ASSESSMENT Investigations CTCAEv5 View
LEUKOCYTOSIS NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders CTCAEv5 View
LOCALIZED EDEMA NON_SYSTEMATIC_ASSESSMENT General disorders CTCAEv5 View
LOWER GASTROINTESTINAL HEMORRHAGE NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAEv5 View
LYMPHOCYTE COUNT DECREASED NON_SYSTEMATIC_ASSESSMENT Investigations CTCAEv5 View
METABOLISM AND NUTRITION DISORDERS - OTHER, SPECIFY NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAEv5 View
MUCOSITIS ORAL NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAEv5 View
MUSCLE CRAMP NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders CTCAEv5 View
MUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDER - OTHER, SPECIFY NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders CTCAEv5 View
MYALGIA NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders CTCAEv5 View
NASAL CONGESTION NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAEv5 View
NAUSEA NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAEv5 View
NEOPLASMS BENIGN, MALIGNANT AND UNSPECIFIED (INCL CYSTS AND POLYPS) - OTHER, SPECIFY NON_SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) CTCAEv5 View
NERVOUS SYSTEM DISORDERS - OTHER, SPECIFY NON_SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAEv5 View
NEUTROPHIL COUNT DECREASED NON_SYSTEMATIC_ASSESSMENT Investigations CTCAEv5 View
NON-CARDIAC CHEST PAIN NON_SYSTEMATIC_ASSESSMENT General disorders CTCAEv5 View
OBESITY NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAEv5 View
ORAL PAIN NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAEv5 View
PAIN NON_SYSTEMATIC_ASSESSMENT General disorders CTCAEv5 View
PAIN IN EXTREMITY NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders CTCAEv5 View
PARESTHESIA NON_SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAEv5 View
PERIPHERAL SENSORY NEUROPATHY NON_SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAEv5 View
PLATELET COUNT DECREASED NON_SYSTEMATIC_ASSESSMENT Investigations CTCAEv5 View
PRODUCTIVE COUGH NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAEv5 View
PROSTATIC OBSTRUCTION NON_SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders CTCAEv5 View
PSYCHOSIS NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders CTCAEv5 View
RADICULITIS NON_SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAEv5 View
RASH MACULO-PAPULAR NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCAEv5 View
RECTAL FISSURE NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAEv5 View
RECTAL PAIN NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAEv5 View
RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS - OTHER, SPECIFY NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAEv5 View
RHINORRHEA NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAEv5 View
SEIZURE NON_SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAEv5 View
SINUS BRADYCARDIA NON_SYSTEMATIC_ASSESSMENT Cardiac disorders CTCAEv5 View
SKIN AND SUBCUTANEOUS TISSUE DISORDERS - OTHER, SPECIFY NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCAEv5 View
SKIN HYPERPIGMENTATION NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCAEv5 View
SKIN INFECTION NON_SYSTEMATIC_ASSESSMENT Infections and infestations CTCAEv5 View
SLEEP APNEA NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAEv5 View
SOCIAL CIRCUMSTANCES - OTHER, SPECIFY NON_SYSTEMATIC_ASSESSMENT Social circumstances CTCAEv5 View
STRIDOR NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAEv5 View
SURGICAL AND MEDICAL PROCEDURES - OTHER, SPECIFY NON_SYSTEMATIC_ASSESSMENT Surgical and medical procedures CTCAEv5 View
SYNCOPE NON_SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAEv5 View
TESTICULAR DISORDER NON_SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders CTCAEv5 View
TESTOSTERONE DEFICIENCY NON_SYSTEMATIC_ASSESSMENT Endocrine disorders CTCAEv5 View
THROMBOEMBOLIC EVENT NON_SYSTEMATIC_ASSESSMENT Vascular disorders CTCAEv5 View
TREMOR NON_SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAEv5 View
TUMOR PAIN NON_SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) CTCAEv5 View
UPPER GASTROINTESTINAL HEMORRHAGE NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAEv5 View
UPPER RESPIRATORY INFECTION NON_SYSTEMATIC_ASSESSMENT Infections and infestations CTCAEv5 View
URINARY TRACT OBSTRUCTION NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders CTCAEv5 View
URINARY TRACT PAIN NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders CTCAEv5 View
VASCULAR DISORDERS - OTHER, SPECIFY NON_SYSTEMATIC_ASSESSMENT Vascular disorders CTCAEv5 View
VERTIGO NON_SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders CTCAEv5 View
VOMITING NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAEv5 View
WEIGHT LOSS NON_SYSTEMATIC_ASSESSMENT Investigations CTCAEv5 View
WHEEZING NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAEv5 View
WHITE BLOOD CELL DECREASED NON_SYSTEMATIC_ASSESSMENT Investigations CTCAEv5 View