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 @ 2:24 AM
Ignite Modification Date: 2025-12-26 @ 12:56 AM
NCT ID: NCT03311334
Description: None
Frequency Threshold: 5
Time Frame: Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 12 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 24 months.
Study: NCT03311334
Study Brief: A Study of DSP-7888 Dosing Emulsion in Combination With Immune Checkpoint Inhibitors in Adult Patients With Advanced Solid Tumors
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Phase 1b - Arm 1 DSP-7888 Dosing Emulsion in combination with Nivolumab DSP-7888 Dosing Emulsion: DSP-7888 Dosing Emulsion will be administered intradermally (ID) every 7 days until cycle 3, and then every 14 days for combination with Nivolumab arm or every 21 days for combination with Pembrolizumab arm. Nivolumab: Nivolumab will be administered in the approved dose and schedule starting on Day 29 of the study. 1 None 3 7 7 7 View
Phase 1b - Arm 2 DSP-7888 Dosing Emulsion in combination with Pembrolizumab DSP-7888 Dosing Emulsion: DSP-7888 Dosing Emulsion will be administered intradermally (ID) every 7 days until cycle 3, and then every 14 days for combination with Nivolumab arm or every 21 days for combination with Pembrolizumab arm. Pembrolizumab: Pembrolizumab will be administered in the approved dose and schedule starting on Day 22 of the study. 0 None 5 9 9 9 View
Phase 2 - Ombipepimut-S + Pembrolizumab The Phase 2 dose of ombipepimut-S Dosing Emulsion will be the recommended dose as determined in the Phase 1b Arm 2 part of the study. 1 None 8 31 31 31 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Hypersensitivity SYSTEMATIC_ASSESSMENT Immune system disorders None View
Pyrexia SYSTEMATIC_ASSESSMENT General disorders None View
Syncope SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Spinal Cord Compression SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Diabetic Ketoacidosis SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Hypoglycemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Urine Output Decreased SYSTEMATIC_ASSESSMENT Investigations None View
Haemorrhagic Anaemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Acute Kidney Injury SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Hydronephrosis SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Pleural Effusion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Pnemonia SYSTEMATIC_ASSESSMENT Infections and infestations None View
Fall SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Lower Limb Fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Hypotension SYSTEMATIC_ASSESSMENT Vascular disorders None View
Cancer Pain SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) None View
Pericardial Effusion SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Acute Myocardial Infarction SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Cardiac Tamponade SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Abdominal Pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Large Intestinal Obstruction SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Small Intestinal Obstruction SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Abdominal Distension SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Ileus SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Inappropriate Antidiuretic Hormone Secretion SYSTEMATIC_ASSESSMENT Endocrine disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Pyrexia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Dyspepsia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Dental Caries SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Diabetic Ketoacidosis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Dysphagia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Gastrooesophageal Reflux Disease SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Melaena SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Diarrhoea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Ascites SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Flatulence SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Large Intestinal Obstruction SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Early Satiety SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Rectal Haemorrhage SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Injection Site Reaction SYSTEMATIC_ASSESSMENT General disorders None View
Decreased Appetite SYSTEMATIC_ASSESSMENT General disorders None View
Pain in Extremity SYSTEMATIC_ASSESSMENT General disorders None View
Dysphonia SYSTEMATIC_ASSESSMENT General disorders None View
Infusion Related Reaction SYSTEMATIC_ASSESSMENT General disorders None View
Night Sweats SYSTEMATIC_ASSESSMENT General disorders None View
Non-cardiac Chest Pain SYSTEMATIC_ASSESSMENT General disorders None View
Sunburn SYSTEMATIC_ASSESSMENT General disorders None View
Tooth Infection SYSTEMATIC_ASSESSMENT General disorders None View
Abdominal Pain SYSTEMATIC_ASSESSMENT General disorders None View
Abdominal Distension SYSTEMATIC_ASSESSMENT General disorders None View
Injection Site Pain SYSTEMATIC_ASSESSMENT General disorders None View
Injection Site Pain SYSTEMATIC_ASSESSMENT General disorders None View
Pain SYSTEMATIC_ASSESSMENT General disorders None View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Insomnia SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Paraesthesia SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Presyncope SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Dysgeusia SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Hot Flush SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Peripheral Sensory Neuropathy SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Syncope SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Pyrexia SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Dehydration SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Hyperuricaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Amylase Increased SYSTEMATIC_ASSESSMENT Investigations None View
Blood Urine SYSTEMATIC_ASSESSMENT Investigations None View
Fibrin D Dimer Increased SYSTEMATIC_ASSESSMENT Investigations None View
Hypoalbuminaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Hypoglycaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Hypomagnesaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Hypokalaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Hyponatraemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Blood Creatinine Increased SYSTEMATIC_ASSESSMENT Investigations None View
Hyperkalaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Platelet Count Decreased SYSTEMATIC_ASSESSMENT Investigations None View
Vitamin B12 Deficiency SYSTEMATIC_ASSESSMENT Investigations None View
Weight Increased SYSTEMATIC_ASSESSMENT Investigations None View
Haematuria SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Lymphocyte Count Decreased SYSTEMATIC_ASSESSMENT Investigations None View
Alanine Aminotransferase Increased SYSTEMATIC_ASSESSMENT Investigations None View
Aspartate Aminotransferase Increased SYSTEMATIC_ASSESSMENT Investigations None View
Blood Alkaline Phosphatase Increased SYSTEMATIC_ASSESSMENT Investigations None View
Gamma-glutamyltransferase Increased SYSTEMATIC_ASSESSMENT Investigations None View
Hyponatraemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Weight Decreased SYSTEMATIC_ASSESSMENT Investigations None View
Anaemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Conjunctival Haemorrhage SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Thrombocytosis SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Chest Pain SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Electrocardiogram QT Prolonged SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Back Pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Abdominal Pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Neck Pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Arthralgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Muscular Weakness SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Musculoskeletal Pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Myalgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Musculoskeletal Chest Pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Osteomyelitis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Osteonecrosis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Muscle Spasms SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Muscular Weakness SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Flank Pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Bone Pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations None View
Influenza Like Illness SYSTEMATIC_ASSESSMENT Infections and infestations None View
Sinusitis SYSTEMATIC_ASSESSMENT Infections and infestations None View
Herpes Zoster SYSTEMATIC_ASSESSMENT Infections and infestations None View
Nail Disorder SYSTEMATIC_ASSESSMENT Infections and infestations None View
Nail Infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Otitis Media SYSTEMATIC_ASSESSMENT Infections and infestations None View
Urinary Tract Infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Corona Virus Infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Oral Infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Myringitis SYSTEMATIC_ASSESSMENT Infections and infestations None View
Depression SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Confusional State SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Agitation SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Anxiety SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Psychomotor Hyperactivity SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Hypotension SYSTEMATIC_ASSESSMENT Vascular disorders None View
Fall SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Arthropod Bite SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Contusion SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Fibula Fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Laceration SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Spinal Compression Fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Spinal Cord Compression SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Lower Limb Fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Tibia Fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Hypothyroidism SYSTEMATIC_ASSESSMENT Endocrine disorders None View
Hypersensitivity SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Tympanic Membrane Perforation SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders None View
Tinnitus SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders None View
Vision Blurred SYSTEMATIC_ASSESSMENT Eye disorders None View
Dry Eye SYSTEMATIC_ASSESSMENT Eye disorders None View
Eye Pain SYSTEMATIC_ASSESSMENT Eye disorders None View
Photopsia SYSTEMATIC_ASSESSMENT Eye disorders None View
Cancer Pain SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) None View
Oedema peripheral SYSTEMATIC_ASSESSMENT General disorders None View
Hypophosphataemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Haematochezia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Small Intestinal Obstruction SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Ileus SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Stomatitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Oral Pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Fatigue SYSTEMATIC_ASSESSMENT General disorders None View
Localised Oedema SYSTEMATIC_ASSESSMENT General disorders None View
Hypophosphataemia SYSTEMATIC_ASSESSMENT General disorders None View
Abdominal Pain Upper SYSTEMATIC_ASSESSMENT General disorders None View
Chest Discomfort SYSTEMATIC_ASSESSMENT General disorders None View
Periorbital Oedema SYSTEMATIC_ASSESSMENT General disorders None View
Peripheral Swelling SYSTEMATIC_ASSESSMENT General disorders None View
Dry Mouth SYSTEMATIC_ASSESSMENT General disorders None View