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 @ 5:52 PM
Ignite Modification Date: 2025-12-25 @ 3:17 PM
NCT ID: NCT01698268
Description: None
Frequency Threshold: 1
Time Frame: Adverse Events were collected from the time of consent through the time of a followup phone call 24 hours post discharge from the hospital.
Study: NCT01698268
Study Brief: Study of Transverse Abdominis Plane (TAP) Block in Children Undergoing Hydrocelectomy and/or Hernia Repair Surgery
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
TAP Group Enrolled subjects will receive a TAP block with 0.5cc/kg of 0.25% ropivacaine. TAP block: TAP Block will be performed under ultrasound guidance via Sonosite device with an in-plane technique by the anesthesiologist. 0 None 0 23 9 23 View
Local Infiltration Group Enrolled subjects will receive will receive local infiltration of 0.5 cc/kg of 0.25% ropivacaine. Local Infiltration: Local infiltration of 0.5 cc/kg of 0.25% ropivacaine will be administered by the surgeon. 0 None 0 24 7 24 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Diarrhea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Agitation SYSTEMATIC_ASSESSMENT General disorders None View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Abdominal swelling SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Restlessness SYSTEMATIC_ASSESSMENT General disorders None View
Incisional pain SYSTEMATIC_ASSESSMENT Surgical and medical procedures None View
Skin irritation SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
skin inflammation SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Urinary urgency SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View