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 @ 11:15 PM
Ignite Modification Date: 2025-12-25 @ 8:52 PM
NCT ID: NCT04071756
Description: Of the eight participants enrolled, six reported one or more adverse events (Placebo:2, Tazarotene:4), and two reported no adverse events. All events were classified as either "unrelated" or "unlikely related" to study therapy. In the table below, each participant is classified according to the worst grade reported for each adverse event type. All events were grade 1 or 2.
Frequency Threshold: 0
Time Frame: 24 weeks
Study: NCT04071756
Study Brief: Topical Tazarotene Vs Placebo In Hand-Foot-Skin Reactions
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Topical Tazarotene 0.1% Gel Plus BPS * Pharmacy teaching call * DFCI approved teaching sheets will be provided * 20% urea applied to the palms and soles in the morning + tazarotene 0.1% gel, applied to the palms and soles nightly Topical Tazarotene: This medicine works by making the skin less inflamed and reducing the thickness and pain from lesions of the skin 0 None 1 5 5 5 View
Placebo Gel Plus BPS * A substance that has no therapeutic effect, used as a control in testing new drugs * Pharmacy teaching call * DFCI approved teaching sheets will be provided * 20% urea applied to the palms and soles in the morning with placebo gel applied in the evening. Placebo: A substance that has no therapeutic effect, used as a control in testing new drugs 0 None 0 3 3 3 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Biliary stent blockage SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (5.0) View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Dry Skin SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCAE (5.0) View
Hyperkeratosis SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCAE (5.0) View
psoriasis SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCAE (5.0) View
Palmar-plantar erythrodysesthesia syndrome SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCAE (5.0) View
rash SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCAE (5.0) View
rash, maculo-papular SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCAE (5.0) View