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 @ 3:47 AM
Ignite Modification Date: 2025-12-26 @ 2:34 AM
NCT ID: NCT02856802
Description: None
Frequency Threshold: 0
Time Frame: Adverse Events were assessed from the initial dose of study medication up to 5 days after the last dose of study medication.
Study: NCT02856802
Study Brief: An Efficacy and Safety Study of DFN-02 (Sumatriptan Nasal Spray 10 mg)
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
DFN-02 (DB1) DFN-02 Active Nasal Sumatriptan 10-mg spray upon onset of acute migraine pain during each acute migraine episode DFN-02 Active in Double-blind Treatment Period 1 0 None 0 50 5 50 View
Placebo (DB1) DFN-02 Placebo spray upon onset of acute migraine pain during each acute migraine episode DFN-02 Placebo in Double-blind Treatment Period 1 0 None 0 43 0 43 View
DFN-02 (DB2) DFN-02 Active Nasal Sumatriptan 10-mg spray upon onset of acute migraine pain during each acute migraine episode DFN-02 Active in Double-blind Treatment Period 2 0 None 0 37 5 37 View
Placebo (DB2) DFN-02 Placebo spray upon onset of acute migraine pain during each acute migraine episode DFN-02 Placebo in Double-blind Treatment Period 2 0 None 0 38 0 38 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Application site pain NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA 19.0 View
Chest Discomfort NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA 19.0 View
Laceration NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 19.0 View
Dysgeusia NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 19.0 View
Rhinorrhoea NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 19.0 View
Malaise NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA 19.0 View
Ear Infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 19.0 View
Burning sensation NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 19.0 View