Adverse Events Module

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 @ 4:54 AM
Ignite Modification Date: 2025-12-26 @ 3:55 AM
NCT ID: NCT02879318
Description: Only patients who received at least one dose of protocol treatment were included in the evaluation of adverse events.
Frequency Threshold: 5
Time Frame: 35 months
Study: NCT02879318
Study Brief: Gemcitabine and Nab-Paclitaxel vs Gemcitabine, Nab-Paclitaxel, Durvalumab and Tremelimumab as 1st Line Therapy in Metastatic Pancreatic Adenocarcinoma
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Gemcitabine Plus Nab-Paclitaxel Gemcitabine 1000 mg/m2 IV \& Nab-Paclitaxel 125 mg/m2 until unequivocal progression or unacceptable toxicity. Days 1, 8, 15 Q28 days. Gemcitabine Nab-paclitaxel 52 None 26 58 57 58 View
Gemcitabine + Nab-Paclitaxel + Durvalumab + Tremelimumab Gemcitabine 1000 mg/m2 IV \& Nab-Paclitaxel 125 mg/m2 until unequivocal progression or unacceptable toxicity. Day 1, 8, 15 Q28 days. plus Durvalumab 1500mg IV day 1 only Q28 days; and Tremelimumab 75 mg IV Days 1 cycles 1, 2, 3 and 4 only until unequivocal progression or unacceptable toxicity. Gemcitabine Nab-paclitaxel Durvalumab Tremelimumab 102 None 82 119 118 119 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Febrile neutropenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders CTCAE (4.0) View
Leukocytosis SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders CTCAE (4.0) View
Cardiac arrest SYSTEMATIC_ASSESSMENT Cardiac disorders CTCAE (4.0) View
Abdominal distension SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (4.0) View
Abdominal pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (4.0) View
Duodenal obstruction SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (4.0) View
Duodenal stenosis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (4.0) View
Enterocolitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (4.0) View
Gastric ulcer SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (4.0) View
Gastrointestinal pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (4.0) View
Biliary tract infection SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE (4.0) View
Stroke SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE (4.0) View
Confusion SYSTEMATIC_ASSESSMENT Psychiatric disorders CTCAE (4.0) View
Ileal obstruction SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (4.0) View
Ileus SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (4.0) View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (4.0) View
Obstruction gastric SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (4.0) View
Other gastrointestinal disorders SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (4.0) View
Pancreatic duct stenosis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (4.0) View
Pancreatitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (4.0) View
Proctitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (4.0) View
Small intestinal obstruction SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (4.0) View
Small intestinal perforation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (4.0) View
Upper gastrointestinal hemorrhage SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (4.0) View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (4.0) View
Chills SYSTEMATIC_ASSESSMENT General disorders CTCAE (4.0) View
Death NOS SYSTEMATIC_ASSESSMENT General disorders CTCAE (4.0) View
Edema limbs SYSTEMATIC_ASSESSMENT General disorders CTCAE (4.0) View
Edema trunk SYSTEMATIC_ASSESSMENT General disorders CTCAE (4.0) View
Fatigue SYSTEMATIC_ASSESSMENT General disorders CTCAE (4.0) View
Fever SYSTEMATIC_ASSESSMENT General disorders CTCAE (4.0) View
Sudden death NOS SYSTEMATIC_ASSESSMENT General disorders CTCAE (4.0) View
Bile duct stenosis SYSTEMATIC_ASSESSMENT Hepatobiliary disorders CTCAE (4.0) View
Gallbladder obstruction SYSTEMATIC_ASSESSMENT Hepatobiliary disorders CTCAE (4.0) View
Hepatic failure SYSTEMATIC_ASSESSMENT Hepatobiliary disorders CTCAE (4.0) View
Other immune system disorders SYSTEMATIC_ASSESSMENT Immune system disorders CTCAE (4.0) View
Appendicitis SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE (4.0) View
Catheter related infection SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE (4.0) View
Enterocolitis infectious SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE (4.0) View
Hepatic infection SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE (4.0) View
Lung infection SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE (4.0) View
Other infections and infestations SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE (4.0) View
Sepsis SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE (4.0) View
Skin infection SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE (4.0) View
Upper respiratory infection SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE (4.0) View
Urinary tract infection SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE (4.0) View
Aortic injury SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications CTCAE (4.0) View
Fall SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications CTCAE (4.0) View
Hip fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications CTCAE (4.0) View
Spinal fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications CTCAE (4.0) View
Blood bilirubin increased SYSTEMATIC_ASSESSMENT Investigations CTCAE (4.0) View
Platelet count decreased SYSTEMATIC_ASSESSMENT Investigations CTCAE (4.0) View
Dehydration SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE (4.0) View
Hypercalcemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE (4.0) View
Back pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders CTCAE (4.0) View
Bone pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders CTCAE (4.0) View
Generalized muscle weakness SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders CTCAE (4.0) View
Muscle weakness lower limb SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders CTCAE (4.0) View
Encephalopathy SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE (4.0) View
Ischemia cerebrovascular SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE (4.0) View
Lethargy SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE (4.0) View
Presyncope SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE (4.0) View
Radiculitis SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE (4.0) View
Reversible posterior leukoencephalopathy syndrome SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE (4.0) View
Delirium SYSTEMATIC_ASSESSMENT Psychiatric disorders CTCAE (4.0) View
Insomnia SYSTEMATIC_ASSESSMENT Psychiatric disorders CTCAE (4.0) View
Acute kidney injury SYSTEMATIC_ASSESSMENT Renal and urinary disorders CTCAE (4.0) View
Urinary tract obstruction SYSTEMATIC_ASSESSMENT Renal and urinary disorders CTCAE (4.0) View
Adult respiratory distress syndrome SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE (4.0) View
Dyspnea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE (4.0) View
Hiccups SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE (4.0) View
Pleural effusion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE (4.0) View
Pneumonitis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE (4.0) View
Pulmonary edema SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE (4.0) View
Pulmonary fibrosis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE (4.0) View
Photosensitivity SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCAE (4.0) View
Pruritus SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCAE (4.0) View
Rash maculo-papular SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCAE (4.0) View
Skin ulceration SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCAE (4.0) View
Hypertension SYSTEMATIC_ASSESSMENT Vascular disorders CTCAE (4.0) View
Hypotension SYSTEMATIC_ASSESSMENT Vascular disorders CTCAE (4.0) View
Other vascular disorders SYSTEMATIC_ASSESSMENT Vascular disorders CTCAE (4.0) View
Superficial thrombophlebitis SYSTEMATIC_ASSESSMENT Vascular disorders CTCAE (4.0) View
Thromboembolic event SYSTEMATIC_ASSESSMENT Vascular disorders CTCAE (4.0) View
Heart failure SYSTEMATIC_ASSESSMENT Cardiac disorders CTCAE (4.0) View
Myocarditis SYSTEMATIC_ASSESSMENT Cardiac disorders CTCAE (4.0) View
Pericardial effusion SYSTEMATIC_ASSESSMENT Cardiac disorders CTCAE (4.0) View
Colitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (4.0) View
Colonic obstruction SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (4.0) View
Colonic perforation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (4.0) View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (4.0) View
Diarrhea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (4.0) View
Gastric hemorrhage SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (4.0) View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Hearing impaired SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders CTCAE (4.0) View
Blurred vision SYSTEMATIC_ASSESSMENT Eye disorders CTCAE (4.0) View
Dry eye SYSTEMATIC_ASSESSMENT Eye disorders CTCAE (4.0) View
Abdominal distension SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (4.0) View
Abdominal pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (4.0) View
Ascites SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (4.0) View
Bloating SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (4.0) View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (4.0) View
Diarrhea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (4.0) View
Dry mouth SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (4.0) View
Dyspepsia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (4.0) View
Flatulence SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (4.0) View
Gastroesophageal reflux disease SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (4.0) View
Gastrointestinal pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (4.0) View
Hemorrhoidal hemorrhage SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (4.0) View
Hemorrhoids SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (4.0) View
Mucositis oral SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (4.0) View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (4.0) View
Other gastrointestinal disorders SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (4.0) View
Stomach pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (4.0) View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (4.0) View
Chills SYSTEMATIC_ASSESSMENT General disorders CTCAE (4.0) View
Edema face SYSTEMATIC_ASSESSMENT General disorders CTCAE (4.0) View
Edema limbs SYSTEMATIC_ASSESSMENT General disorders CTCAE (4.0) View
Fatigue SYSTEMATIC_ASSESSMENT General disorders CTCAE (4.0) View
Fever SYSTEMATIC_ASSESSMENT General disorders CTCAE (4.0) View
Flu like symptoms SYSTEMATIC_ASSESSMENT General disorders CTCAE (4.0) View
Non-cardiac chest pain SYSTEMATIC_ASSESSMENT General disorders CTCAE (4.0) View
Pain SYSTEMATIC_ASSESSMENT General disorders CTCAE (4.0) View
Lung infection SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE (4.0) View
Mucosal infection SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE (4.0) View
Skin infection SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE (4.0) View
Upper respiratory infection SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE (4.0) View
Urinary tract infection SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE (4.0) View
Bruising SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications CTCAE (4.0) View
Fall SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications CTCAE (4.0) View
Wound complication SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications CTCAE (4.0) View
Weight loss SYSTEMATIC_ASSESSMENT Investigations CTCAE (4.0) View
Anorexia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE (4.0) View
Dehydration SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE (4.0) View
Arthralgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders CTCAE (4.0) View
Back pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders CTCAE (4.0) View
Bone pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders CTCAE (4.0) View
Flank pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders CTCAE (4.0) View
Generalized muscle weakness SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders CTCAE (4.0) View
Muscle weakness lower limb SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders CTCAE (4.0) View
Myalgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders CTCAE (4.0) View
Pain in extremity SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders CTCAE (4.0) View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE (4.0) View
Dysgeusia SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE (4.0) View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE (4.0) View
Paresthesia SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE (4.0) View
Peripheral motor neuropathy SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE (4.0) View
Peripheral sensory neuropathy SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE (4.0) View
Somnolence SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE (4.0) View
Anxiety SYSTEMATIC_ASSESSMENT Psychiatric disorders CTCAE (4.0) View
Confusion SYSTEMATIC_ASSESSMENT Psychiatric disorders CTCAE (4.0) View
Depression SYSTEMATIC_ASSESSMENT Psychiatric disorders CTCAE (4.0) View
Insomnia SYSTEMATIC_ASSESSMENT Psychiatric disorders CTCAE (4.0) View
Libido decreased SYSTEMATIC_ASSESSMENT Psychiatric disorders CTCAE (4.0) View
Hematuria SYSTEMATIC_ASSESSMENT Renal and urinary disorders CTCAE (4.0) View
Urinary frequency SYSTEMATIC_ASSESSMENT Renal and urinary disorders CTCAE (4.0) View
Allergic rhinitis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE (4.0) View
Cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE (4.0) View
Dyspnea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE (4.0) View
Epistaxis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE (4.0) View
Hiccups SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE (4.0) View
Nasal congestion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE (4.0) View
Pleural effusion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE (4.0) View
Pneumonitis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE (4.0) View
Productive cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE (4.0) View
Sore throat SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE (4.0) View
Alopecia SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCAE (4.0) View
Dry skin SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCAE (4.0) View
Erythema multiforme SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCAE (4.0) View
Hyperhidrosis SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCAE (4.0) View
Nail discoloration SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCAE (4.0) View
Other skin and subcutaneous tissue disorders SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCAE (4.0) View
Pain of skin SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCAE (4.0) View
Pruritus SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCAE (4.0) View
Rash acneiform SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCAE (4.0) View
Rash maculo-papular SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCAE (4.0) View
Hot flashes SYSTEMATIC_ASSESSMENT Vascular disorders CTCAE (4.0) View
Hypertension SYSTEMATIC_ASSESSMENT Vascular disorders CTCAE (4.0) View
Hypotension SYSTEMATIC_ASSESSMENT Vascular disorders CTCAE (4.0) View
Thromboembolic event SYSTEMATIC_ASSESSMENT Vascular disorders CTCAE (4.0) View