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 @ 4:46 PM
Ignite Modification Date: 2025-12-25 @ 2:32 PM
NCT ID: NCT01077050
Description: The Safety analysis population includes all subjects for whom there was any contact with subject's skin and the SciBase III investigational device. Therefore the number of subjects included in the safety analysis deviates from both the total number of enrolled and eligible subjects.
Frequency Threshold: 0
Time Frame: A post-procedure follow up, either by a telephone or investigational site visit, was to be conducted at 7 (seven) +/- 3 (three) days from the SciBase III evaluation, at which time the subject were to be evaluated for any adverse events.
Study: NCT01077050
Study Brief: SciBase International Melanoma Pivotal Study
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Biopsied Skin Lesions Any adverse advent that occured on a skin/lesion site for whom there had been any contact between the subject's skin and investigational device (SciBase III). Note that multiple adverse event occured on some subjects. In total 36 Adverse Events were reported on 28 subjects. None None 0 1915 28 1915 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Experienced a headache/migrane post SciBase measurements and surgical excision. NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Lesion started to bleed during examination/measurement NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Experience of slight pain/pin pricks from probe NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Experience of soreness/itch/tingling at excisional/measurement site NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Developed infection following excision NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Suffered from a cold NON_SYSTEMATIC_ASSESSMENT General disorders None View
Experience nausea NON_SYSTEMATIC_ASSESSMENT General disorders None View
Suffered from diarrhea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Suture came out prematurely NON_SYSTEMATIC_ASSESSMENT General disorders None View
Minimal brusing NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Experienced sensation of fainting NON_SYSTEMATIC_ASSESSMENT General disorders None View
Experienced mild chest pain NON_SYSTEMATIC_ASSESSMENT General disorders None View
Experienced bleeding through the bandage after excision. NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Experience of slight pain from excision NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Neck and facial swelling after lymph node dissection NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View