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: 2025-12-24 @ 7:15 PM
Ignite Modification Date: 2025-12-25 @ 4:53 PM
NCT ID: NCT03019003
Description: None
Frequency Threshold: 0
Time Frame: Adverse events were monitored in participants for up to 2 years.
Study: NCT03019003
Study Brief: Oral Decitabine (ASTX727) and Durvalumab in Recurrent and/or Metastatic Head and Neck Cancer Patients
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Low Dose 5'Aza (40 mg/m^2) for Days 1-5 + Durvalumab + Tremelimumab Low dose 5'aza (40 mg/m\^2) administered subcutaneously daily for 5 days + Durvalumab + Tremelimumab 7 None 1 7 7 7 View
Low Dose 5'Aza (40 mg/m^2) for Days 1-5 and 8-12 + Durvalumab 1500 mg Q4W + Tremelimumab 75 mg Q4W Low dose 5'aza (40 mg/m\^2) administered subcutaneously daily for 10 days + Durvalumab + Tremelimumab 4 None 4 5 2 5 View
Oral Decitabine 35 mg QD Days 1-3 and Durvalumab 1500 mg Q4W Oral Decitabine will be administered orally daily for Days 1-3 + Durvalumab 1500 mg Q4W 1 None 1 1 1 1 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Stroke SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Fall SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Neutropenia SYSTEMATIC_ASSESSMENT Investigations None View
oral hemorrhage SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Fever SYSTEMATIC_ASSESSMENT General disorders None View
Back Pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Pelvic Pain SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders None View
Investigations - Other SYSTEMATIC_ASSESSMENT Investigations None View
Alkaline phosphatase increase SYSTEMATIC_ASSESSMENT Investigations None View
Arthralgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Aspartate aminotrasnferase increased SYSTEMATIC_ASSESSMENT Investigations None View
diarrhea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
fatigue SYSTEMATIC_ASSESSMENT General disorders None View
GGT increased SYSTEMATIC_ASSESSMENT Investigations None View
Hematuria SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Hyperglycemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Hypernatremia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Hyponatremia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Lung infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Pruritus SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Toothache SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Febrile Neutropenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Salivary duct inflammation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Urinary retention SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Ventricular Arrhythmia SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Neutrophil count decreased SYSTEMATIC_ASSESSMENT Investigations None View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
hypomagnesmia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Weight Loss SYSTEMATIC_ASSESSMENT Investigations None View
Anorexia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Hypomagnesemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Lip Pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View