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 @ 10:48 PM
Ignite Modification Date: 2025-12-25 @ 8:18 PM
NCT ID: NCT01149369
Description: None
Frequency Threshold: 0
Time Frame: 4 weeks
Study: NCT01149369
Study Brief: Aprepitant for the Relief of Nausea in Patients With Chronic Nausea and Vomiting of Presumed Gastric Origin Trial
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Aprepitant Aprepitant 125 mg per day Aprepitant: Aprepitant, 125 mg, 1 capsule, q.d. (everyday) with lunch for 4 weeks 0 None 1 63 21 63 View
Aprepitant-placebo Placebo aprepitant 125mg per day Placebo: Aprepitant-placebo, 125 mg, 1 capsule, q.d. (everyday) with lunch for 4 weeks 0 None 0 63 11 63 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Hypoglycemia NON_SYSTEMATIC_ASSESSMENT Endocrine disorders CTCAE (3.0) View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Nausea, vomiting NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (3.0) View
Nausea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (3.0) View
Vomiting NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (3.0) View
Flashing lights/floaters NON_SYSTEMATIC_ASSESSMENT Eye disorders CTCAE (3.0) View
Bruising NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCAE (3.0) View
Fatigue NON_SYSTEMATIC_ASSESSMENT General disorders CTCAE (3.0) View
Gastrointestinal - Other (abdominal pain) NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (3.0) View
Diarrhea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (3.0) View
Nausea, abdominal pain, diarrhea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (3.0) View
Hypokalemia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE (3.0) View
Diarrhea, syncope NON_SYSTEMATIC_ASSESSMENT General disorders CTCAE (3.0) View
Musculoskeletal - Other (neck and right hand pain) NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders CTCAE (3.0) View
Diarrhea, loss of appetite NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (3.0) View
Gastrointestinal - Other (fainting sensation) NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (3.0) View
Renal/Genitourinary - Other (Bleeding) NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders CTCAE (3.0) View
Fibromyalgia cystitis NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders CTCAE (3.0) View
Dizziness NON_SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE (3.0) View
Constipation NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (3.0) View
Rhinitis NON_SYSTEMATIC_ASSESSMENT Immune system disorders CTCAE (3.0) View
Arthralgia NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders CTCAE (3.0) View
Headache NON_SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE (3.0) View
Gastrointestinal - Other (Nausea, malaise) NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (3.0) View
Musculoskeletal - Other (Limb pain) NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders CTCAE (3.0) View
Nosebleed NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders CTCAE (3.0) View
Bruising NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders CTCAE (3.0) View
Asthmatic crisis NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE (3.0) View
Depression NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders CTCAE (3.0) View
Neurology - other NON_SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE (3.0) View