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 @ 5:21 PM
Ignite Modification Date: 2025-12-25 @ 2:56 PM
NCT ID: NCT00820950
Description: Adverse Events were reported at the participant level, not the treatment level within each cohort.
Frequency Threshold: 5
Time Frame: Up to approximately 2 months
Study: NCT00820950
Study Brief: A Study of Ruxolitinib Phosphate Cream When Applied to Patients With Plaque Psoriasis
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Part 1 Cohort A: Ruxolitinib 0.5% Cream vs. Vehicle Cream Ruxolitinib 0.5% vs. vehicle cream once a day for 28 days 0 None 0 6 6 6 View
Part 1 Cohort B: Ruxolitinib 1.0% Cream vs. Vehicle Cream Ruxolitinib 1.0% cream once a day for 28 days 0 None 0 6 1 6 View
Part 1 Cohort C: Ruxolitinib 1.5% Cream vs. Vehicle Cream Ruxolitinib 1.5% vs. vehicle cream twice a day for 28 days 0 None 0 6 5 6 View
Part 2 Cohort E: Ruxolitinib vs. Betamethasone Dipropionate (Diprolene® AF) Part 2 INCB018424, up to 1.5% cream versus Betamethasone Dipropionate (Diprolene® AF) 0.05% cream applied twice a day for 28 days 0 None 0 5 2 5 View
Total Total 0 None 0 29 18 29 View
Part 2 Cohort D: Ruxolitinib vs. Calcipotriene (Dovonex®) Ruxolitinib up to 1.5% versus Calcipotriene (Dovonex®) 0.005% cream applied twice a day for 28 days 0 None 0 6 4 6 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
APPLICATION SITE REACTION SYSTEMATIC_ASSESSMENT General disorders MedDRA 9 View
ATRIOVENTRICULAR BLOCK SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 9 View
BLOOD CREATINE PHOSPHOKINASE INCREASED SYSTEMATIC_ASSESSMENT Investigations MedDRA 9 View
BLOOD GLUCOSE INCREASED SYSTEMATIC_ASSESSMENT Investigations MedDRA 9 View
CONTUSION SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 9 View
DRY SKIN SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 9 View
ELECTROCARDIOGRAM QT CORRECTED INTERVAL PROLONGED SYSTEMATIC_ASSESSMENT Investigations MedDRA 9 View
ELECTROCARDIOGRAM QT INTERVAL ABNORMAL SYSTEMATIC_ASSESSMENT Investigations MedDRA 9 View
ELECTROCARDIOGRAM QT PROLONGED SYSTEMATIC_ASSESSMENT Investigations MedDRA 9 View
ELECTROCARDIOGRAM T WAVE ABNORMAL SYSTEMATIC_ASSESSMENT Investigations MedDRA 9 View
ERYTHEMA SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 9 View
FEELING COLD SYSTEMATIC_ASSESSMENT General disorders MedDRA 9 View
GAMMA-GLUTAMYLTRANSFERASE INCREASED SYSTEMATIC_ASSESSMENT Investigations MedDRA 9 View
HAEMATOCRIT DECREASED SYSTEMATIC_ASSESSMENT Investigations MedDRA 9 View
HAEMOGLOBIN DECREASED SYSTEMATIC_ASSESSMENT Investigations MedDRA 9 View
HEADACHE SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 9 View
NASOPHARYNGITIS SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 9 View
PAIN SYSTEMATIC_ASSESSMENT General disorders MedDRA 9 View
PROCEDURAL PAIN SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 9 View
PRURITUS SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 9 View
RASH PRURITIC SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 9 View
RETICULOCYTE COUNT INCREASED SYSTEMATIC_ASSESSMENT Investigations MedDRA 9 View
SINUS BRADYCARDIA SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 9 View
SKIN IRRITATION SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 9 View
SUNBURN SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 9 View
UPPER RESPIRATORY TRACT INFECTION SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 9 View
URINE KETONE BODY PRESENT SYSTEMATIC_ASSESSMENT Investigations MedDRA 9 View
SKIN EXFOLIATION SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 9 View