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 @ 12:01 AM
Ignite Modification Date: 2025-12-25 @ 9:59 PM
NCT ID: NCT01553058
Description: None
Frequency Threshold: 5
Time Frame: Baseline - Week 12
Study: NCT01553058
Study Brief: Vascular Inflammation in Psoriasis Trial (The VIP Trial)
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Adalimumab (Humira) Injection of the active drug Humira. Adalimumab (Humira): Humira will be given at an initial dose of 80mg followed by 40 mg the second week, subsequent doses will be given at 40mg and follow FDA dosing schedule. None None 2 33 7 33 View
Placebo Injection Injection of placebo in place of active Humira injection. Placebo Injection: Placebo injection will be given according to the same dose and schedule as the active comparator. None None 0 31 15 31 View
NB-UVB Phototherapy NB-UVB Phototherapy 3 times per week, no other intervention. NB-UVB phototherapy: Phototherapy will be given 3 times per week according to the Fitzpatrick scale for skin types. None None 0 33 33 33 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
vasovagal syncope NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
erythema NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA View
myalgia NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
tooth infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
pruritis NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA View
photosensitivity NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA View
upper respiratory infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
nasal congestion NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA View
cough NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA View
sore throat NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA View
headache NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA View
joint range of motion decrease NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
depression NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA View