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 @ 5:10 PM
Ignite Modification Date: 2025-12-25 @ 2:47 PM
NCT ID: NCT01424150
Description: Please note that the patients reviewed for adverse events are the patients that completed the 30 day follow up data collection. There fore as per the Figure one according to follow up
Frequency Threshold: 1
Time Frame: Adverse events were collected at 30 days following surgery
Study: NCT01424150
Study Brief: REstrictive Versus LIbEral Fluid Therapy in Major Abdominal Surgery: RELIEF 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
Liberal At the commencement of surgery a bolus of Hartmann's balanced salt crystalloid 10 ml/kg followed by 8 ml/kg/h will be administered until the end of surgery. A maintenance infusion will then continue at 1.5 ml/kg/h, for at least 24 hours, but this can be reduced postoperatively if there is evidence of fluid overload and no hypotension, and increased if there is evidence of hypovolaemia or hypotension. Alternative fluid types (crystalloid, dextrose, colloid) and electrolyte supplements will be allowed postoperatively in order to account for local preferences and patient biochemistry, for which we will collect data. Liberal fluid therapy: Liberal protocol group is designed to provide approximately 6.0L per day. 96 None 295 1493 78 1493 View
Restrictive Will provide less than 2.0 L water and 120 mmol sodium per day. Induction of anaesthesia will limit IV bolus fluid to ≤5 ml/kg; no other IV fluids will be used at the commencement of surgery (unless indicated by goal-directed device \[see below\]). Hartmann's balanced salt crystalloid 5 ml/kg/h will be administered until the end of surgery, and bolus colloid/blood used intraoperatively to replace blood loss (ml for ml); then an infusion at 1 ml/kg/h until expedited cessation of IV fluid therapy within 24 hours. The rate of postoperative fluid replacement can be reduced if there is evidence of fluid overload and no hypotension, and can be increased if there is hypotension AND evidence of hypovolaemia. Restrictive fluid therapy: Restrictive protocol group is designed to provide less than 2.0 L water and 120 mmol sodium per day. 95 None 323 1490 79 1490 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Pneumonia SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA (10.0) View
Surgical site infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (10.0) View
Sepsis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (10.0) View
Anastomotic leak SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (10.0) View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Cardiovascular SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA (10.0) View
Thrombolism SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA (10.0) View