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 @ 10:46 PM
Ignite Modification Date: 2025-12-25 @ 8:16 PM
NCT ID: NCT04620369
Description: None
Frequency Threshold: 0
Time Frame: Up to 2 weeks
Study: NCT04620369
Study Brief: Rose Geranium in Sesame Oil Nasal Spray for the Improvement of Nasal Vestibulitis Symptoms in Cancer Patients Receiving Chemotherapy
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 (Rose Geranium in Sesame Oil Nasal Spray) Rose Geranium in Sesame Oil Nasal Spray: Instill intranasally 0 None 0 53 10 53 View
Arm B (Isotonic Nasal Saline) Rose Geranium in Sesame Oil Nasal Spray: Instill intranasally 0 None 0 53 9 53 View
Arm A Crossover Rose Geranium in Sesame Oil Nasal Spray: Instill intranasally 0 None 0 2 0 2 View
Arm B Crossover Rose Geranium in Sesame Oil Nasal Spray: Instill intranasally 0 None 0 37 4 37 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab 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
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE 5 View
Oral pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE 5 View
Fatigue SYSTEMATIC_ASSESSMENT General disorders CTCAE 5 View
Flu like symptoms SYSTEMATIC_ASSESSMENT General disorders CTCAE 5 View
Gen disord and admin site conds-Oth spec SYSTEMATIC_ASSESSMENT General disorders CTCAE 5 View
Pain SYSTEMATIC_ASSESSMENT General disorders CTCAE 5 View
Infections and infestations - Oth spec SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE 5 View
Aspartate aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations CTCAE 5 View
Neutrophil count decreased 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
Hypomagnesemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE 5 View
Superficial soft tissue fibrosis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders CTCAE 5 View
Dysgeusia SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE 5 View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE 5 View
Paresthesia SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE 5 View
Peripheral sensory neuropathy SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE 5 View
Epistaxis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE 5 View
Nasal congestion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE 5 View
Oropharyngeal pain SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE 5 View
Postnasal drip SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE 5 View
Skin and subcut tissue disord - Oth spec 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