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 @ 4:15 AM
Ignite Modification Date: 2025-12-26 @ 3:14 AM
NCT ID: NCT02457520
Description: All safety analyses were carried out using the safety population, which was defined as all subjects who received at least 1 dose of study treatment. Thus, overall results are depicted for all the subjects
Frequency Threshold: 2
Time Frame: Active Treatment Period- 20 weeks Post-treatment Period- 124 weeks
Study: NCT02457520
Study Brief: ABSORICA in Patients With Severe Recalcitrant Nodular Acne
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Single Treatment Arm Absorica capsules 0.5 mg/kg/day for 4 weeks, followed by 1.0 mg/kg/day for 16 weeks. Study ABS1517LT was a Phase 4, open-label, single-arm study in subjects with severe recalcitrant nodular acne, consisting of 2 phases: a 20-week (5-month) Active Treatment Phase and a 104-week (2-year) Post Treatment Period. 0 None 1 201 54 201 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Diabetes Mellitus SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Dry skin SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Lip dry SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Depression SYSTEMATIC_ASSESSMENT Psychiatric disorders None View