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 @ 3:28 AM
Ignite Modification Date: 2025-12-26 @ 2:08 AM
NCT ID: NCT02166905
Description: None
Frequency Threshold: 0
Time Frame: Between the start date of intervention until 30 days after the last intervention or until the study participant is lost to follow up, the start of new treatment, or until the study investigator assesses the event(s) as stable or irreversible, up to 1 year.
Study: NCT02166905
Study Brief: DEC-205/NY-ESO-1 Fusion Protein CDX-1401, Poly ICLC, and IDO1 Inhibitor INCB024360 in Treating Patients With Ovarian, Fallopian Tube, or Primary Peritoneal Cancer in Remission
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 I (CDX-1401, Poly ICLC, and a Fixed Daily Dose of INCB024360 ) Patients will receive a fixed intracutaneous dose of DEC205mAb-NY-ESO-1 fusion protein (CDX-1401) (Day 1) given with subcutaneous adjuvant poly-ICLC (Day 1 and Day 2) for each 28 day cycle for a total of 5 cycles; and Cohort 1 patient enrollment will begin INCB024360 at a fixed daily dose of BID orally 0 None 2 6 6 6 View
Phase II 2a (CDX-1401, Poly ICLC) Patients receive DEC-205/NY-ESO-1 fusion protein CDX-1401, poly ICLC, without IDO1 inhibitor INCB024360 in phase IIb. DEC-205/NY-ESO-1 Fusion Protein CDX-1401: Given via intracutaneous injection Epacadostat: Given PO Laboratory Biomarker Analysis: Correlative studies Pharmacological Study: Correlative studies Poly ICLC: Given SC 0 None 1 16 14 16 View
Phase II 2b (CDX-1401, Poly ICLC With INCB024360) Patients receive DEC-205/NY-ESO-1 fusion protein CDX-1401, poly ICLC, with IDO1 inhibitor INCB024360 in phase IIb. DEC-205/NY-ESO-1 Fusion Protein CDX-1401: Given via intracutaneous injection Epacadostat: Given PO Laboratory Biomarker Analysis: Correlative studies Pharmacological Study: Correlative studies Poly ICLC: Given SC 3 None 2 15 15 15 View
Phase II 3 (Exploratory Cohort) 4 cycles of sirolimus in combination with DEC205mAb-NY-ESO-01 fusion protein (CDX-1401) with adjuvant poly-ICLC 0 None 0 2 2 2 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Hypersensitivity SYSTEMATIC_ASSESSMENT Immune system disorders CTCAE Version 4.0. View
Abdominal pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE Version 4.0. View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE Version 4.0. View
Cardiac death SYSTEMATIC_ASSESSMENT General disorders CTCAE Version 4.0. View
Syncope SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE Version 4.0. View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Anaemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders CTCAE Version 4.0. View
Sinus tachycardia SYSTEMATIC_ASSESSMENT Cardiac disorders CTCAE Version 4.0. View
Abdominal distension SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE Version 4.0. View
Abdominal pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE Version 4.0. View
Abdominal pain upper SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE Version 4.0. View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE Version 4.0. View
Diarrhoea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE Version 4.0. View
Dry mouth SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE Version 4.0. View
Dyspepsia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE Version 4.0. View
Flatulence SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE Version 4.0. View
Gastrooesophageal reflux disease SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE Version 4.0. View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE Version 4.0. View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE Version 4.0. View
Asthenia SYSTEMATIC_ASSESSMENT General disorders CTCAE Version 4.0. View
Chills SYSTEMATIC_ASSESSMENT General disorders CTCAE Version 4.0. View
Early satiety SYSTEMATIC_ASSESSMENT General disorders CTCAE Version 4.0. View
Fatigue SYSTEMATIC_ASSESSMENT General disorders CTCAE Version 4.0. View
Influenza like illness SYSTEMATIC_ASSESSMENT General disorders CTCAE Version 4.0. View
Injection site discolouration SYSTEMATIC_ASSESSMENT General disorders CTCAE Version 4.0. View
Injection site discomfort SYSTEMATIC_ASSESSMENT General disorders CTCAE Version 4.0. View
Injection site erythema SYSTEMATIC_ASSESSMENT General disorders CTCAE Version 4.0. View
Injection site nodule SYSTEMATIC_ASSESSMENT General disorders CTCAE Version 4.0. View
Injection site reaction SYSTEMATIC_ASSESSMENT General disorders CTCAE Version 4.0. View
Injection site swelling SYSTEMATIC_ASSESSMENT General disorders CTCAE Version 4.0. View
Non-cardiac chest pain SYSTEMATIC_ASSESSMENT General disorders CTCAE Version 4.0. View
Oedema SYSTEMATIC_ASSESSMENT General disorders CTCAE Version 4.0. View
Pain SYSTEMATIC_ASSESSMENT General disorders CTCAE Version 4.0. View
Pyrexia SYSTEMATIC_ASSESSMENT General disorders CTCAE Version 4.0. View
Diverticulitis SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE Version 4.0. View
Herpes zoster SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE Version 4.0. View
Influenza SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE Version 4.0. View
Nasopharyngitis SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE Version 4.0. View
Onychomycosis SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE Version 4.0. View
Upper respiratory tract infection SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE Version 4.0. View
Accidental overdose SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications CTCAE Version 4.0. View
Arthropod bite SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications CTCAE Version 4.0. View
Infusion related reaction SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications CTCAE Version 4.0. View
Splinter SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications CTCAE Version 4.0. View
Alanine aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations CTCAE Version 4.0. View
Aspartate aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations CTCAE Version 4.0. View
Blood creatinine increased SYSTEMATIC_ASSESSMENT Investigations CTCAE Version 4.0. View
Carbon dioxide increased SYSTEMATIC_ASSESSMENT Investigations CTCAE Version 4.0. View
Lymphocyte count decreased SYSTEMATIC_ASSESSMENT Investigations CTCAE Version 4.0. View
Platelet count decreased SYSTEMATIC_ASSESSMENT Investigations CTCAE Version 4.0. View
White blood cell count decreased SYSTEMATIC_ASSESSMENT Investigations CTCAE Version 4.0. View
Decreased appetite SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE Version 4.0. View
Hyperglycaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE Version 4.0. View
Hyponatraemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE Version 4.0. View
Arthralgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders CTCAE Version 4.0. View
Back pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders CTCAE Version 4.0. View
Muscular weakness SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders CTCAE Version 4.0. View
Myalgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders CTCAE Version 4.0. View
Osteoarthritis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders CTCAE Version 4.0. View
Pain in extremity SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders CTCAE Version 4.0. View
Dysgeusia SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE Version 4.0. View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE Version 4.0. View
Lethargy SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE Version 4.0. View
Neuropathy peripheral SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE Version 4.0. View
Paraesthesia SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE Version 4.0. View
Thrombosis in device SYSTEMATIC_ASSESSMENT Product Issues CTCAE Version 4.0. View
Agitation SYSTEMATIC_ASSESSMENT Psychiatric disorders CTCAE Version 4.0. View
Anxiety SYSTEMATIC_ASSESSMENT Psychiatric disorders CTCAE Version 4.0. View
Mental status changes SYSTEMATIC_ASSESSMENT Psychiatric disorders CTCAE Version 4.0. View
Vulvovaginal discomfort SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders CTCAE Version 4.0. View
Cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE Version 4.0. View
Dyspnoea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE Version 4.0. View
Nasal congestion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE Version 4.0. View
Oropharyngeal pain SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE Version 4.0. View
Upper-airway cough syndrome SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE Version 4.0. View
Dry skin SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCAE Version 4.0. View
Pruritus SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCAE Version 4.0. View
Rash SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCAE Version 4.0. View
Rash maculo-papular SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCAE Version 4.0. View
Skin disorder SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCAE Version 4.0. View
Flushing SYSTEMATIC_ASSESSMENT Vascular disorders CTCAE Version 4.0. View
Hypertension SYSTEMATIC_ASSESSMENT Vascular disorders CTCAE Version 4.0. View
Injection site pain SYSTEMATIC_ASSESSMENT General disorders CTCAE Version 4.0. View
Injection site pruritus SYSTEMATIC_ASSESSMENT General disorders CTCAE Version 4.0. View
Urticaria SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCAE Version 4.0. View