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: 2025-12-26 @ 2:41 PM
Ignite Modification Date: 2025-12-26 @ 2:41 PM
NCT ID: NCT02975206
Description: The at risk safety population is a subset of participants who received at least one dose of study medication. This population is analyzed based upon the actual treatment received, at the highest dose received.
Frequency Threshold: 3
Time Frame: Adverse Events (AEs) and Serious Adverse Events (SAEs) were recorded from the first study drug administration through the follow-up visit at Week 10. After the Week 10 visit, SAEs that are believed to be drug related will be reported, without a specific end time.
Study: NCT02975206
Study Brief: Study of the Efficacy, Safety, and Tolerability of Serlopitant for Pruritus (Itch) in Atopic Dermatitis
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Serlopitant 5 mg Subjects received a 3-tablet oral loading dose on the first day of the treatment period followed by an oral 5 mg dose of Serlopitant taken once daily by mouth for 6 weeks 1 None 2 161 27 161 View
Serlopitant 1 mg Subjects received a 3-tablet oral loading dose on the first day of the treatment period followed by an oral 1 mg dose of Serlopitant taken once daily by mouth for 6 weeks 0 None 1 160 22 160 View
Placebo Oral Tablet Subjects received a 3-tablet oral loading dose on the first day of the treatment period followed by an oral Placebo tablet taken once daily by mouth for 6 weeks 0 None 2 158 32 158 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Abscess jaw SYSTEMATIC_ASSESSMENT Infections and infestations None View
Eye injury SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Colon cancer metastatic SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) None View
Cholecystitis acute SYSTEMATIC_ASSESSMENT Hepatobiliary disorders None View
Abortion spontaneous SYSTEMATIC_ASSESSMENT Pregnancy, puerperium and perinatal conditions None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Urinary tract infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Nasopharyngitis SYSTEMATIC_ASSESSMENT Infections and infestations None View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Somnolence SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Pruritus SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Dermatitis atopic SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View