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 @ 2:01 AM
Ignite Modification Date: 2025-12-26 @ 12:25 AM
NCT ID: NCT03137160
Description: Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
Frequency Threshold: 0
Time Frame: Adverse event data was collected over 16 weeks per patient and 1 year for the trial. Patient 01: data collected for 16 weeks. Patient EOT at week 16 Patient 02: Data collected for 2 weeks. Lost to FU after week 2 Patient 03: data collected for 6 weeks. Patient EOT visit at week 6 Patient 04: data collected for 6 weeks. EOT visit at week 6
Study: NCT03137160
Study Brief: An Open-Label, Proof-of-Concept Study of Ixekizumab in the Treatment of Pyoderma Gangrenosum
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Ixekizumab (Taltz) We have received funding for only a small pilot study to prove a benefit from Interleukin-17 inhibition in Pyoderma Gangrenosum . Therefore, there is only one treatment arm. The primary outcome will be a comparison of week 12 to baseline regarding a two-point improvement in the Investigator Global Assessment. Ixekizumab: Injection 0 None 3 4 4 4 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
sepsis SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
sepsis SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
hypotension SYSTEMATIC_ASSESSMENT Cardiac disorders None View
fever SYSTEMATIC_ASSESSMENT Immune system disorders None View
vomitting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
diarrhea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
infection of ulcer SYSTEMATIC_ASSESSMENT Infections and infestations None View
pneumonia SYSTEMATIC_ASSESSMENT Immune system disorders None View
h influenza SYSTEMATIC_ASSESSMENT Immune system disorders None View
low WBC SYSTEMATIC_ASSESSMENT Infections and infestations None View
low igG levels SYSTEMATIC_ASSESSMENT Immune system disorders None View