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 @ 12:24 PM
Ignite Modification Date: 2025-12-25 @ 12:04 PM
NCT ID: NCT02512861
Description: The method for collecting adverse event information was via daily collection form/questionnaire by the study coordinator for the first five post-operative days.
Frequency Threshold: 0
Time Frame: Adverse event data was collected over the first five post-operative days.
Study: NCT02512861
Study Brief: Parasternal Nerve Block Using Bupivacaine for Postoperative Analgesia in Children Undergoing Cardiac 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
Bupivacaine Bupivacaine as a parasternal nerve block following pediatric cardiothoracic surgery Bupivacaine: Bupivacaine will be administered bilaterally to the parasternal intercostal spaces during surgery according to these doses: Under 20kgs weight: 0.25% Bupivacaine at 1 milliliter/kilogram (1ml/kg); Above 20kgs weight: 0.5% Bupivacaine at 0.5 ml/kg up to a maximum of 25ml of 0.5% Bupivacaine for patients \> 50 kgs 0 None 3 38 0 38 View
Placebo Normal Saline Placebo: Saline will be administered bilaterally to the parasternal intercostal spaces during surgery according to these doses: Under 20kgs weight: 1 milliliter/kilogram (1ml/kg); Above 20kgs weight: 0.5 ml/kg up to a maximum of 25ml for patients \> 50 kgs 0 None 6 40 0 40 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Shallow Breathing/Increased Work of Breathing SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Significant blood/chest tube losses requiring transfusion or fluid resuscitation SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Pneumothorax or Pleural effusion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Acute respiratory syncytial virus leading to pneumonia SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Other Events(If Any):