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 @ 2:16 AM
Ignite Modification Date: 2025-12-26 @ 12:45 AM
NCT ID: NCT04493060
Description: None
Frequency Threshold: 0
Time Frame: Up to 4 years and 5 months
Study: NCT04493060
Study Brief: Niraparib and Dostarlimab for the Treatment of Germline or Somatic BRCA1/2 and PALB2 Mutated Metastatic Pancreatic 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
Treatment (Niraparib, Dostarlimab) Niraparib: Given PO 2 None 2 20 20 20 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Asystole SYSTEMATIC_ASSESSMENT Cardiac disorders CTCAE 5 View
Infections and infestations - Oth spec SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE 5 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Gait disturbance SYSTEMATIC_ASSESSMENT General disorders CTCAE 5 View
Pain SYSTEMATIC_ASSESSMENT General disorders CTCAE 5 View
Hepatobiliary disorders - Other, specify SYSTEMATIC_ASSESSMENT Hepatobiliary disorders CTCAE 5 View
Abdominal infection SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE 5 View
Anorectal infection SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE 5 View
Sepsis SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE 5 View
Alanine aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations CTCAE 5 View
Alkaline phosphatase increased SYSTEMATIC_ASSESSMENT Investigations CTCAE 5 View
Aspartate aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations CTCAE 5 View
Blood bilirubin increased SYSTEMATIC_ASSESSMENT Investigations CTCAE 5 View
Creatinine increased SYSTEMATIC_ASSESSMENT Investigations CTCAE 5 View
Lymphocyte count decreased SYSTEMATIC_ASSESSMENT Investigations CTCAE 5 View
Neutrophil count decreased SYSTEMATIC_ASSESSMENT Investigations CTCAE 5 View
Platelet count decreased SYSTEMATIC_ASSESSMENT Investigations CTCAE 5 View
Weight loss SYSTEMATIC_ASSESSMENT Investigations CTCAE 5 View
White blood cell decreased SYSTEMATIC_ASSESSMENT Investigations CTCAE 5 View
Hyperglycemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE 5 View
Hyperkalemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE 5 View
Hypoalbuminemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE 5 View
Hypocalcemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE 5 View
Hypokalemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE 5 View
Hyponatremia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE 5 View
Muscle weakness lower limb SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders CTCAE 5 View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE 5 View
Encephalopathy SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE 5 View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE 5 View
Confusion SYSTEMATIC_ASSESSMENT Psychiatric disorders CTCAE 5 View
Delirium SYSTEMATIC_ASSESSMENT Psychiatric disorders CTCAE 5 View
Acute kidney injury SYSTEMATIC_ASSESSMENT Renal and urinary disorders CTCAE 5 View
Pelvic pain SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders CTCAE 5 View
Dyspnea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE 5 View
Hypoxia SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE 5 View
Pleural effusion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE 5 View
Pneumonitis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE 5 View
Photosensitivity SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCAE 5 View
Rash acneiform SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCAE 5 View
Hypertension SYSTEMATIC_ASSESSMENT Vascular disorders CTCAE 5 View
Thromboembolic event SYSTEMATIC_ASSESSMENT Vascular disorders CTCAE 5 View
Anemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders CTCAE 5 View
Blood and lymph sys disorders - Oth Spec SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders CTCAE 5 View
Hypothyroidism SYSTEMATIC_ASSESSMENT Endocrine disorders CTCAE 5 View
Abdominal distension SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE 5 View
Abdominal pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE 5 View
Ascites SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE 5 View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE 5 View
Diarrhea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE 5 View
Duodenal obstruction SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE 5 View
Esophageal hemorrhage SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE 5 View
Flatulence SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE 5 View
Gastrointestinal disorders - Oth spec SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE 5 View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE 5 View
Rectal hemorrhage SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE 5 View
Fatigue SYSTEMATIC_ASSESSMENT General disorders CTCAE 5 View
Fever SYSTEMATIC_ASSESSMENT General disorders CTCAE 5 View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE 5 View