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 @ 3:09 AM
Ignite Modification Date: 2025-12-26 @ 1:48 AM
NCT ID: NCT02351505
Description: Frequency and severity of adverse events and tolerability of the regimen were collected and summarized by descriptive statistics for each of the disease cohorts. As per NCI CTCAE v4.0, the term toxicity is defined as adverse events that are classified as either not related, possibly, probably, or definitely related to study treatment.
Frequency Threshold: 5
Time Frame: None
Study: NCT02351505
Study Brief: Selinexor in Treating Patients With Relapsed Small Cell Lung 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
Arm A: Selinexor (KPT-330) Patients receive selinexor PO twice weekly. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. None None 0 1 1 1 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Activated PTT prolonged SYSTEMATIC_ASSESSMENT Investigations CTCAE (4.0) View
Anemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders CTCAE (4.0) View
Anorexia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (4.0) View
Concentration impairment SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE (4.0) View
Depressed level of conciousness SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE (4.0) View
Fall SYSTEMATIC_ASSESSMENT Eye disorders CTCAE (4.0) View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE (4.0) View
Hypomagnesemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE (4.0) View
Hyponatremia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE (4.0) View
Edema SYSTEMATIC_ASSESSMENT General disorders CTCAE (4.0) View
Myalgias SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders CTCAE (4.0) View
Platelet count decreased SYSTEMATIC_ASSESSMENT Investigations CTCAE (4.0) View
Urinary tract infection SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE (4.0) View
Wheezing SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE (4.0) View
Eye disorder-decreased visual acuity SYSTEMATIC_ASSESSMENT Eye disorders CTCAE (4.0) View
Fatigue SYSTEMATIC_ASSESSMENT General disorders CTCAE (4.0) View
Generalized Muscle Weakness SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders CTCAE (4.0) View
Hematuria SYSTEMATIC_ASSESSMENT Renal and urinary disorders CTCAE (4.0) View
Hyperglycemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE (4.0) View
Hypoalbuminemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE (4.0) View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (4.0) View