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 @ 3:51 PM
Ignite Modification Date: 2025-12-25 @ 1:57 PM
NCT ID: NCT02745392
Description: The number of subjects at risk includes only subjects who treated with study drug (333). Although 365 subjects were randomized, not all subjects had a migraine (a criterion for administering study drug) between randomization and the end of the trial. 32 subjects (8 in the placebo group, 10 in ZP-Zolmitriptan 1 mg, 5 in ZP-Zolmitriptan 1.9 mg, 9 in ZP-Zolmitriptan 3.8 mg) did not treat with study drug, and that is the difference between the number of subjects randomized and the number at risk.
Frequency Threshold: 2
Time Frame: 2-8 days post-study drug administration for a single migraine
Study: NCT02745392
Study Brief: Safety and Efficacy of ZP-Zolmitriptan Intracutaneous Microneedle Systems for the Acute Treatment of Migraine
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Placebo Placebo (either single or double patch) single administration Placebo: Placebo patch(es) to match ZP-Zolmitriptan single administration delivered via intracutaneous microneedle patch delivery system (one or two patches) 0 None 0 83 15 83 View
ZP-Zolmitriptan 1 mg ZP-Zolmitriptan 1 mg patch single administration ZP-Zolmitriptan: ZP-Zolmitriptan single administration delivered via intracutaneous microneedle patch delivery system 0 None 0 80 26 80 View
ZP-Zolmitriptan 3.8 mg ZP-Zolmitriptan 3.8 mg (1.9 mg x 2 patches) single administration ZP-Zolmitriptan: ZP-Zolmitriptan single administration delivered via intracutaneous microneedle patch delivery system 0 None 0 83 43 83 View
ZP-Zolmitriptan 1.9 mg ZP-Zolmitriptan 1.9 mg patch single administration ZP-Zolmitriptan: ZP-Zolmitriptan single administration delivered via intracutaneous microneedle patch delivery system 0 None 0 87 37 87 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Dizziness NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Paraesthesia NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Muscle tightness NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Application site erythema SYSTEMATIC_ASSESSMENT General disorders None View
Application site bruise SYSTEMATIC_ASSESSMENT General disorders None View
Application site pain SYSTEMATIC_ASSESSMENT General disorders None View
Application site haemorrhage SYSTEMATIC_ASSESSMENT General disorders None View
Application site swelling SYSTEMATIC_ASSESSMENT General disorders None View
Application site oedema SYSTEMATIC_ASSESSMENT General disorders None View