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 @ 3:39 AM
Ignite Modification Date: 2025-12-26 @ 2:23 AM
NCT ID: NCT03006302
Description: None
Frequency Threshold: 5
Time Frame: Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
Study: NCT03006302
Study Brief: Epacadostat, Pembrolizumab, and CRS-207, With or Without CY/GVAX Pancreas in Patients With Metastatic Pancreas 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
Part 1: Dose Level 1 Epacadostat/Pembrolizumab/CY/GVAX/CRS-207 Epacadostat: Patients will receive treatment every 3 weeks for 6 cycles of treatment within a course (total of 18 weeks). Epacadostat (100 mg) is taken by mouth twice a day, every day. Pembrolizumab: Patients will receive treatment every 3 weeks for 6 cycles of treatment within a course (total of 18 weeks). Pembrolizumab (200 mg) will be administered IV on day 1 of Cycles 1-6. CRS-207: CRS-207: Patients will receive treatment every 3 weeks for 6 cycles of treatment within a course (total of 18 weeks). CRS-207 (1 × 10\^9 CFU) will be administered IV on Day 2 of Cycles 3-6. Cyclophosphamide: Patients will receive treatment every 3 weeks for 6 cycles of treatment within a course (total of 18 weeks). Cyclophosphamide (200 mg/m\^2) will be administered IV on day 1 of Cycles 1 and 2. GVAX Pancreas Vaccine: Patients will receive treatment every 3 weeks for 6 cycles of treatment within a course (total of 18 weeks). GVAX will be administered on Day 2 of Cycles 1 and 2. 5 None 3 6 6 6 View
Part 1: Dose Level 2 Epacadostat/Pembrolizumab/CY/GVAX/CRS-207 Epacadostat: Patients will receive treatment every 3 weeks for 6 cycles of treatment within a course (total of 18 weeks). Epacadostat (300 mg) is taken by mouth twice a day, every day. Pembrolizumab: Patients will receive treatment every 3 weeks for 6 cycles of treatment within a course (total of 18 weeks). Pembrolizumab (200 mg) will be administered IV on day 1 of Cycles 1-6. CRS-207: CRS-207: Patients will receive treatment every 3 weeks for 6 cycles of treatment within a course (total of 18 weeks). CRS-207 (1 × 10\^9 CFU) will be administered IV on Day 2 of Cycles 3-6. Cyclophosphamide: Patients will receive treatment every 3 weeks for 6 cycles of treatment within a course (total of 18 weeks). Cyclophosphamide (200 mg/m\^2) will be administered IV on day 1 of Cycles 1 and 2. GVAX Pancreas Vaccine: Patients will receive treatment every 3 weeks for 6 cycles of treatment within a course (total of 18 weeks). GVAX will be administered on Day 2 of Cycles 1 and 2. 4 None 3 4 4 4 View
Part 1X: Dose Level 2 Epacadostat/Pembrolizumab/CRS-207 Epacadostat: Patients will receive treatment every 3 weeks for 6 cycles of treatment within a course (total of 18 weeks). Epacadostat (300 mg) is taken by mouth twice a day, every day. Pembrolizumab: Patients will receive treatment every 3 weeks for 6 cycles of treatment within a course (total of 18 weeks). Pembrolizumab (200 mg) will be administered IV on day 1 of Cycles 1-6. CRS-207: CRS-207: Patients will receive treatment every 3 weeks for 6 cycles of treatment within a course (total of 18 weeks). CRS-207 (1 × 10\^9 CFU) will be administered IV on Day 2 of Cycles 3-6. 3 None 1 3 3 3 View
Part 1X: Dose Level 3 Epacadostat/Pembrolizumab/CRS-207 Epacadostat: Patients will receive treatment every 3 weeks for 6 cycles of treatment within a course (total of 18 weeks). Epacadostat (600 mg) is taken by mouth twice a day, every day. Pembrolizumab: Patients will receive treatment every 3 weeks for 6 cycles of treatment within a course (total of 18 weeks). Pembrolizumab (200 mg) will be administered IV on day 1 of Cycles 1-6. CRS-207: CRS-207: Patients will receive treatment every 3 weeks for 6 cycles of treatment within a course (total of 18 weeks). CRS-207 (1 × 10\^9 CFU) will be administered IV on Day 2 of Cycles 3-6. 7 None 2 7 7 7 View
Part 2: Dose Expansion Epacadostat/Pembrolizumab/CRS-207 Epacadostat: Patients will receive treatment every 3 weeks for 6 cycles of treatment within a course (total of 18 weeks). Epacadostat (600 mg) is taken by mouth twice a day, every day. Pembrolizumab: Patients will receive treatment every 3 weeks for 6 cycles of treatment within a course (total of 18 weeks). Pembrolizumab (200 mg) will be administered IV on day 1 of Cycles 1-6. CRS-207: CRS-207: Patients will receive treatment every 3 weeks for 6 cycles of treatment within a course (total of 18 weeks). CRS-207 (1 × 10\^9 CFU) will be administered IV on Day 2 of Cycles 3-6. 19 None 7 20 20 20 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Fever SYSTEMATIC_ASSESSMENT General disorders CTCAE version 4.03 View
Pancreatitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE version 4.03 View
Gastroparesis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE version 4.03 View
Disease progression SYSTEMATIC_ASSESSMENT General disorders CTCAE version 4.03 View
Visceral arterial ischemia SYSTEMATIC_ASSESSMENT Vascular disorders CTCAE version 4.03 View
Thromboembolic event SYSTEMATIC_ASSESSMENT Vascular disorders CTCAE version 4.03 View
Abdominal pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE version 4.03 View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE version 4.03 View
Small intestinal obstruction SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE version 4.03 View
Sepsis SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE version 5 View
Volume overload SYSTEMATIC_ASSESSMENT Vascular disorders CTCAE version 4.03 View
IVC stenosis SYSTEMATIC_ASSESSMENT Vascular disorders CTCAE version 4.03 View
Jejunal stenosis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE version 4.03 View
Hepatic infection SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE version 4.03 View
Immune Thrombocytopenic Purpura SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders CTCAE version 4.03 View
Transaminitis SYSTEMATIC_ASSESSMENT Investigations CTCAE version 4.03 View
Myocardial infarction SYSTEMATIC_ASSESSMENT Cardiac disorders CTCAE version 4.03 View
Ascites SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE version 4.03 View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE version 4.03 View
Billiary track infection SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE version 4.03 View
Tumor pain SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) CTCAE version 4.03 View
Stroke SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE version 4.03 View
Hepatic encephalopathy SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE version 4.03 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Anemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders CTCAE version 4.03 View
Enlarged lymp nodes SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders CTCAE version 4.03 View
Sinus tachycardia SYSTEMATIC_ASSESSMENT Cardiac disorders CTCAE version 4.03 View
Sinus bradycardia SYSTEMATIC_ASSESSMENT Cardiac disorders CTCAE version 4.03 View
Palpitations SYSTEMATIC_ASSESSMENT Cardiac disorders CTCAE version 4.03 View
Left ventricular systolic dysfunction SYSTEMATIC_ASSESSMENT Cardiac disorders CTCAE version 4.03 View
Pseudoaneurysm SYSTEMATIC_ASSESSMENT Cardiac disorders CTCAE version 4.03 View
Ear pain SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders CTCAE version 4.03 View
Ear bleading SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders CTCAE version 4.03 View
Hyperthyroidism SYSTEMATIC_ASSESSMENT Endocrine disorders CTCAE version 4.03 View
Hypothyroidism SYSTEMATIC_ASSESSMENT Endocrine disorders CTCAE version 4.03 View
Dry eye SYSTEMATIC_ASSESSMENT Eye disorders CTCAE version 4.03 View
Abdominal pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE version 4.03 View
Ascites SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE version 4.03 View
Belching SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE version 4.03 View
Bloating SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE version 4.03 View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE version 4.03 View
Diarrhea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE version 4.03 View
Dyspepsia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE version 4.03 View
Flatulence SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE version 4.03 View
Gastroesophageal reflux disease SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE version 4.03 View
Polydipsia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE version 4.03 View
Pancreatic duct stricture SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE version 4.03 View
Gingival pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE version 4.03 View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE version 4.03 View
Oral pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE version 4.03 View
Stomach pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE version 4.03 View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE version 4.03 View
Chills SYSTEMATIC_ASSESSMENT General disorders CTCAE version 4.03 View
Edema face SYSTEMATIC_ASSESSMENT General disorders CTCAE version 4.03 View
Edema limbs SYSTEMATIC_ASSESSMENT General disorders CTCAE version 4.03 View
Fatigue SYSTEMATIC_ASSESSMENT General disorders CTCAE version 4.03 View
Fever SYSTEMATIC_ASSESSMENT General disorders CTCAE version 4.03 View
Flu like symptoms SYSTEMATIC_ASSESSMENT General disorders CTCAE version 4.03 View
Infusion related reaction SYSTEMATIC_ASSESSMENT General disorders CTCAE version 4.03 View
Non-cardiac chest pain SYSTEMATIC_ASSESSMENT General disorders CTCAE version 4.03 View
Pain at biopsy site SYSTEMATIC_ASSESSMENT General disorders CTCAE version 4.03 View
Groin pain SYSTEMATIC_ASSESSMENT General disorders CTCAE version 4.03 View
Influenza viral infection SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE version 4.03 View
COVID-19-infection SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE version 4.03 View
Thrush SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE version 4.03 View
Upper respiratory infection SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE version 4.03 View
Urinary tract infection SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE version 4.03 View
Fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications CTCAE version 4.03 View
Fall SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications CTCAE version 4.03 View
Alanine aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations CTCAE version 4.03 View
Alkaline phosphatase increased SYSTEMATIC_ASSESSMENT Investigations CTCAE version 4.03 View
Aspartate aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations CTCAE version 4.03 View
Blood bilirubin increased SYSTEMATIC_ASSESSMENT Investigations CTCAE version 4.03 View
Creatinine increased SYSTEMATIC_ASSESSMENT Investigations CTCAE version 4.03 View
Lipase increased SYSTEMATIC_ASSESSMENT Investigations CTCAE version 4.03 View
Lymphocyte count decreased SYSTEMATIC_ASSESSMENT Investigations CTCAE version 4.03 View
Platelet count decreased SYSTEMATIC_ASSESSMENT Investigations CTCAE version 4.03 View
Serum amylase increased SYSTEMATIC_ASSESSMENT Investigations CTCAE version 4.03 View
Weight gain SYSTEMATIC_ASSESSMENT Investigations CTCAE version 4.03 View
Weight loss SYSTEMATIC_ASSESSMENT Investigations CTCAE version 4.03 View
Anorexia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE version 4.03 View
Dehydration SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE version 4.03 View
Glucose intolerance SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE version 4.03 View
Hyperglycemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE version 4.03 View
Hypokalemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE version 4.03 View
Hypomagnesemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE version 4.03 View
Hyponatremia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE version 4.03 View
Hypophosphatemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE version 4.03 View
Arthralgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders CTCAE version 4.03 View
Back pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders CTCAE version 4.03 View
Bone pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders CTCAE version 4.03 View
Pain in extremity SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE version 4.03 View
Flank pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders CTCAE version 4.03 View
Generalized muscle weakness SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders CTCAE version 4.03 View
Muscle cramp SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders CTCAE version 4.03 View
Myalgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders CTCAE version 4.03 View
Neck pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders CTCAE version 4.03 View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE version 4.03 View
Dysgeusia SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE version 4.03 View
Encephalopathy SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE version 4.03 View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE version 4.03 View
Lethargy SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE version 4.03 View
Cold intolerance-hands and feet SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE version 4.03 View
Paresthesia SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE version 4.03 View
Peripheral sensory neuropathy SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE version 4.03 View
Presyncope SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE version 4.03 View
Syncope SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE version 4.03 View
Agitation SYSTEMATIC_ASSESSMENT Psychiatric disorders CTCAE version 4.03 View
Anxiety SYSTEMATIC_ASSESSMENT Psychiatric disorders CTCAE version 4.03 View
Depression SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE version 4.03 View
Insomnia SYSTEMATIC_ASSESSMENT Psychiatric disorders CTCAE version 4.03 View
Nocturia SYSTEMATIC_ASSESSMENT Renal and urinary disorders CTCAE version 4.03 View
Urinary retention SYSTEMATIC_ASSESSMENT Renal and urinary disorders CTCAE version 4.03 View
Urinary urgency SYSTEMATIC_ASSESSMENT Renal and urinary disorders CTCAE version 4.03 View
Urine discoloration SYSTEMATIC_ASSESSMENT Renal and urinary disorders CTCAE version 4.03 View
Uterine obstruction SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders CTCAE version 4.03 View
Vaginal pain SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders CTCAE version 4.03 View
Cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE version 4.03 View
Dyspnea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE version 4.03 View
Epistaxis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE version 4.03 View
Hiccups SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE version 4.03 View
Hoarseness SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE version 4.03 View
Pleural effusion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE version 4.03 View
Postnasal drip SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE version 4.03 View
Productive cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE version 4.03 View
Pulmonary edema SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE version 4.03 View
Throat tightness SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE version 4.03 View
Rhinorrhea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE version 4.03 View
Sore throat SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE version 4.03 View
Dry skin SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCAE version 4.03 View
Erythema multiforme SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCAE version 4.03 View
Hyperhidrosis SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCAE version 4.03 View
Pruritus SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCAE version 4.03 View
Rash maculo-papular SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCAE version 4.03 View
Rash pustular SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCAE version 4.03 View
Skin induration SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCAE version 4.03 View
Flushing SYSTEMATIC_ASSESSMENT Vascular disorders CTCAE version 4.03 View
Subungual hematoma SYSTEMATIC_ASSESSMENT Vascular disorders CTCAE version 4.03 View
Hypertension SYSTEMATIC_ASSESSMENT Vascular disorders CTCAE version 4.03 View
Hypotension SYSTEMATIC_ASSESSMENT Vascular disorders CTCAE version 4.03 View
Phlebitis SYSTEMATIC_ASSESSMENT Vascular disorders CTCAE version 4.03 View
Thromboembolic event SYSTEMATIC_ASSESSMENT Vascular disorders CTCAE version 4.03 View
Pain SYSTEMATIC_ASSESSMENT General disorders CTCAE version 4.03 View
MRSA infection SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE version 4.03 View
Abdominal mass SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) CTCAE version 4.03 View
Electrocardiogram QT corrected interval prolonged SYSTEMATIC_ASSESSMENT Investigations CTCAE version 4.03 View
Skin peeling SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCAE version 4.03 View
Nail changes SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCAE version 4.03 View
Upper gastrointestinal hemorrhage SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE version 4.03 View
Vaccine site erythema SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCAE version 4.03 View
Vaccine site hyperpigmentation SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCAE version 4.03 View
Vaccine site induration SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCAE version 4.03 View
Vaccine site pain SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCAE version 4.03 View
Vaccine site pruritis SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCAE version 4.03 View
IVC stenosis SYSTEMATIC_ASSESSMENT Vascular disorders CTCAE version 4.03 View
Erythema SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCAE version 4.03 View
Skin laceration SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCAE version 4.03 View