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 @ 12:34 AM
Ignite Modification Date: 2025-12-25 @ 10:42 PM
NCT ID: NCT03840967
Description: None
Frequency Threshold: 0
Time Frame: All-Cause Mortality was monitored up to a maximum of 24 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 6 months.
Study: NCT03840967
Study Brief: A Study Evaluating Safety and Efficacy of Niraparib in Patients With Previously Treated Metastatic Esophageal/Gastroesophageal Junction/Proximal Gastric 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
Niraparib Niraparib: Niraparib will be administered as a flat-fixed daily dose depending on weight and platelet count. Subjects will take orally on a daily basis for 28 days. Each cycle = 28 days 12 None 3 14 13 14 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
SEPSIS NON_SYSTEMATIC_ASSESSMENT Infections and infestations CTCAEv5 View
ASPIRATION NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAEv5 View
VOMITING NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAEv5 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
ABDOMINAL PAIN NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAEv5 View
ALANINE AMINOTRANSFERASE INCREASED NON_SYSTEMATIC_ASSESSMENT Investigations CTCAEv5 View
ALKALINE PHOSPHATASE INCREASED NON_SYSTEMATIC_ASSESSMENT Investigations CTCAEv5 View
ALOPECIA NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCAEv5 View
ANEMIA NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders CTCAEv5 View
ANOREXIA NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAEv5 View
ANXIETY NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders CTCAEv5 View
ARTHRALGIA NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders CTCAEv5 View
ASPARTATE AMINOTRANSFERASE INCREASED NON_SYSTEMATIC_ASSESSMENT Investigations CTCAEv5 View
BACK PAIN NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders CTCAEv5 View
BLOOD BILIRUBIN INCREASED NON_SYSTEMATIC_ASSESSMENT Investigations CTCAEv5 View
CHILLS NON_SYSTEMATIC_ASSESSMENT General disorders CTCAEv5 View
CONSTIPATION NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAEv5 View
COUGH NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAEv5 View
CREATININE INCREASED NON_SYSTEMATIC_ASSESSMENT Investigations CTCAEv5 View
DIARRHEA NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAEv5 View
DIZZINESS NON_SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAEv5 View
HYPOALBUMINEMIA NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAEv5 View
HYPOCALCEMIA NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAEv5 View
HYPOGLYCEMIA NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAEv5 View
HYPOKALEMIA NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAEv5 View
HYPOMAGNESEMIA NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAEv5 View
HYPONATREMIA NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAEv5 View
HYPOTENSION NON_SYSTEMATIC_ASSESSMENT Vascular disorders CTCAEv5 View
INFECTIONS AND INFESTATIONS - OTHER, SPECIFY NON_SYSTEMATIC_ASSESSMENT Infections and infestations CTCAEv5 View
INSOMNIA NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders CTCAEv5 View
INVESTIGATIONS - OTHER, SPECIFY NON_SYSTEMATIC_ASSESSMENT Investigations CTCAEv5 View
LUNG INFECTION NON_SYSTEMATIC_ASSESSMENT Infections and infestations CTCAEv5 View
LYMPHOCYTE COUNT DECREASED NON_SYSTEMATIC_ASSESSMENT Investigations CTCAEv5 View
MEMORY IMPAIRMENT NON_SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAEv5 View
MUCOSITIS ORAL NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAEv5 View
MUSCLE CRAMP NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders CTCAEv5 View
MUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDER - OTHER, SPECIFY NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders CTCAEv5 View
NAUSEA NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAEv5 View
NEUTROPHIL COUNT DECREASED NON_SYSTEMATIC_ASSESSMENT Investigations CTCAEv5 View
RECTAL HEMORRHAGE NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAEv5 View
SINUS TACHYCARDIA NON_SYSTEMATIC_ASSESSMENT Cardiac disorders CTCAEv5 View
SURGICAL AND MEDICAL PROCEDURES - OTHER, SPECIFY NON_SYSTEMATIC_ASSESSMENT Surgical and medical procedures CTCAEv5 View
URINARY RETENTION NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders CTCAEv5 View
URINARY TRACT INFECTION NON_SYSTEMATIC_ASSESSMENT Infections and infestations CTCAEv5 View
VOMITING NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAEv5 View
WEIGHT LOSS NON_SYSTEMATIC_ASSESSMENT Investigations CTCAEv5 View
WHITE BLOOD CELL DECREASED NON_SYSTEMATIC_ASSESSMENT Investigations CTCAEv5 View
DRY MOUTH NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAEv5 View
DRY SKIN NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCAEv5 View
DYSGEUSIA NON_SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAEv5 View
DYSPEPSIA NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAEv5 View
DYSPHAGIA NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAEv5 View
DYSPNEA NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAEv5 View
EOSINOPHILIA NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders CTCAEv5 View
FATIGUE NON_SYSTEMATIC_ASSESSMENT General disorders CTCAEv5 View
FEVER NON_SYSTEMATIC_ASSESSMENT General disorders CTCAEv5 View
HEADACHE NON_SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAEv5 View
HEPATIC INFECTION NON_SYSTEMATIC_ASSESSMENT Infections and infestations CTCAEv5 View
HYPERCALCEMIA NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAEv5 View
PAIN NON_SYSTEMATIC_ASSESSMENT General disorders CTCAEv5 View
PERIPHERAL SENSORY NEUROPATHY NON_SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAEv5 View
PLATELET COUNT DECREASED NON_SYSTEMATIC_ASSESSMENT Investigations CTCAEv5 View
RASH MACULO-PAPULAR NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCAEv5 View