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 @ 2:32 PM
Ignite Modification Date: 2025-12-25 @ 1:05 PM
NCT ID: NCT01313559
Description: None
Frequency Threshold: 0
Time Frame: None
Study: NCT01313559
Study Brief: Pasireotide (SOM230) With or Without Everolimus in Treating Patients With Hormone Resistant, Chemotherapy Naive Prostate 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
Cohort B (Pasireotide and Everolimus) Patients receive pasireotide as in cohort A and everolimus PO QD Pasireotide: Given IM Everolimus: Given PO Laboratory biomarker analysis: Correlative studies None None 0 2 2 2 View
Cohort A (Pasireotide) Patients receive pasireotide IM once every 4 weeks Pasireotide: Given IM Laboratory biomarker analysis: Correlative studies None None 1 4 4 4 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Elevated creatinine None Blood and lymphatic system disorders None View
Urinary tract obstruction None Renal and urinary disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Anorexia None General disorders None View
Chest discomfort None General disorders None View
Cough None General disorders None View
Decreased appetite None General disorders None View
Dehydration None General disorders None View
Elevated creatinine None Blood and lymphatic system disorders None View
Fall None General disorders None View
Fatigue None General disorders None View
Flatulence None General disorders None View
Gastroesophageal reflux disease None Gastrointestinal disorders None View
Headache None General disorders None View
Hematuria None Renal and urinary disorders None View
Hip pain None General disorders None View
Hot flashes None General disorders None View
Hyperglycemia None Blood and lymphatic system disorders None View
Hypertension None Blood and lymphatic system disorders None View
Hypocalcemia None Blood and lymphatic system disorders None View
Hypokalemia None Blood and lymphatic system disorders None View
Hypophosphatemia None Blood and lymphatic system disorders None View
Infection None Infections and infestations None View
Mucositis None General disorders None View
Rash None Skin and subcutaneous tissue disorders None View
Side pain None General disorders None View
Sinus bradycardia None Cardiac disorders None View
Sweating None General disorders None View
Tremors None General disorders None View
Urinary frequency None Renal and urinary disorders None View
Abdominal pain None General disorders None View
Anemia None Blood and lymphatic system disorders None View
Chills None General disorders None View
Constipation None Gastrointestinal disorders None View
Diarrhea None Gastrointestinal disorders None View
Dizziness None General disorders None View
Dry mouth None General disorders None View
Dry skin None General disorders None View
Dysgeusia None General disorders None View
Dyspepsia None Gastrointestinal disorders None View
Dyspnea None Respiratory, thoracic and mediastinal disorders None View
Elevated transaminase None Blood and lymphatic system disorders None View
Mood alteration None General disorders None View
Muscular pain None General disorders None View
Nausea None General disorders None View
Pain at injection site None General disorders None View
Shoulder pain None General disorders None View
Urinary incontinence None General disorders None View
Urinary retention None Renal and urinary disorders None View
Vomiting None General disorders None View
Weakness None General disorders None View
Weight loss None General disorders None View