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 @ 10:32 PM
Ignite Modification Date: 2025-12-25 @ 8:04 PM
NCT ID: NCT03483935
Description: Participants were asked at every visit about the occurrence of adverse events at the site of treatment and biopsy and details of hospitalization. Expected adverse events following microwave therapy include stinging, redness, tingling, numbness or soreness. Participants were asked to score their pain immediately following microwave treatment and 30 minutes after treatment.
Frequency Threshold: 0
Time Frame: Adverse event data was collected from the date of consent until the participant's last study visit. For Stage 1, study duration was 1 day. For stage 2, RCT, maximum participant duration on the trial was 35 days washout period (if required) and 120 days trial duration. SAEs were followed up for both stages until 30 days after the participant's last visit.
Study: NCT03483935
Study Brief: Microwave Therapy for Treatment of Precancerous Actinic Keratoses
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Stage 1 Dose Finding Study To determine the electrical properties of permitivity in AK on the hand and scalp. 0 None 0 7 0 7 View
Stage 2 RCT The microwave treatment delivered using the microwave instrument, SWIFT, manufactured by Emblation and CE marked for this indication. The microwave dose was between 5 Watt for the first two participants and 2 Watt and 4 Watt for the remaining nine participants. The treatment will consist of 3, 2 to 3 second bursts delivered to the same lesion with 5-20 seconds between bursts. 0 None 1 11 11 11 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Tibia fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Treatment administration site scab SYSTEMATIC_ASSESSMENT General disorders None View
Treatment administration site exfoliation SYSTEMATIC_ASSESSMENT General disorders None View
Treatment administration site paraesthesia SYSTEMATIC_ASSESSMENT General disorders None View
Procedural headache SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Paronychia SYSTEMATIC_ASSESSMENT Infections and infestations None View
Tibia fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Humerus fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Treatment administration site pain SYSTEMATIC_ASSESSMENT General disorders None View
Treatment administration site pruritus SYSTEMATIC_ASSESSMENT General disorders None View
Treatment administration site erythema SYSTEMATIC_ASSESSMENT General disorders None View
Treatment administration site erosion SYSTEMATIC_ASSESSMENT General disorders None View
Skin tightness SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Skin wound SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Tooth abscess SYSTEMATIC_ASSESSMENT Infections and infestations None View
Lower respiratory tract infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Abdominal discomfort SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Gastroesophageal reflux disease SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View