This example shows data collected in a study focused on the prevention of AKI after cardiac surgery. Information collected included the type of cardiac surgery performed and details about the actual surgical procedures, because these are known risk factors for AKI. When subjects were scheduled for a valve replacement and a coronary artery bypass graft (CABG) at the same time, these procedures were listed separately.
PRLNKGRP was given a value of "STYSUR" for all components of the study surgery and PRLNKID was populated for CABG surgeries. These variables were used to enable linking to additional information relevant to study surgeries and CABG procedures. PRDECOD was assigned using MedDRA. Note: The PRMODIFY term would be used if the PRTRT term was modified for coding.
Shows the subject had a prior cardiac surgery. The sponsor only collected the surgery date.
|Row 2:||Shows the specific cardiac surgery that the subject had during the study.|
|Rows 3-4:||Show components of the surgery that were considered to be AKI risk factors.|
|Rows 5-6:||Show that the subject had a coronary artery bypass graft and an aortic valve replacement.|
|Rows 7-8:||Show components of the surgery that were considered AKI risk factors.|
|Rows 9-10:||Show follow-up surgeries that were required shortly after the study surgery. These follow-up surgeries were considered to be AKI risk factors.|
|1||AKI001||PR||AKI-001||1||CABG1||Coronary Artery Bypass Graft||Coronary artery bypass||PRIOR CARDIAC SURGERY||2006|
Coronary Artery Bypass Graft
|Coronary artery bypass||STUDY CARDIAC SURGERY||2012-11-06|
|3||AKI001||PR||AKI-001||3||STYSUR||Cardiopulmonary Bypass Perfusion||Cardiopulmonary bypass||STUDY CARDIAC SURGERY||AKI RISK FACTOR||2012-11-06||PT42M|
|4||AKI001||PR||AKI-001||4||STYSUR||Aortic Cross-Clamp||Cardiopulmonary bypass||STUDY CARDIAC SURGERY||AKI RISK FACTOR||2012-11-06||PT48M|
|5||AKI001||PR||AKI-002||1||CABG1||STYSUR||Coronary Artery Bypass Graft||Coronary artery bypass||STUDY CARDIAC SURGERY||2013-12-06|
|6||AKI001||PR||AKI-002||2||STYSUR||Aortic Valve Replacement||Aortic valve replacement||STUDY CARDIAC SURGERY||2013-12-06|
|7||AKI001||PR||AKI-002||3||STYSUR||Cardiopulmonary Bypass Perfusion||Cardiopulmonary bypass||STUDY CARDIAC SURGERY||AKI RISK FACTOR||2013-12-06||PT44M|
|8||AKI001||PR||AKI-002||4||STYSUR||Aortic Cross-Clamp||Cardiopulmonary bypass||STUDY CARDIAC SURGERY||AKI RISK FACTOR||2013-12-06||PT51M|
|9||AKI001||PR||AKI-002||5||Postoperative Value Repair||Heart valve operation||FOLLOWUP||AKI RISK FACTOR||2013-12-13|
|10||AKI001||PR||AKI-002||6||Postoperative Reexploration||Cardiac operation||FOLLOWUP||AKI RISK FACTOR||2013-12-13|
Information collected on the number of grafts that were performed was represented in the FA domain. FALNKID was assigned by the sponsor using a sequential number for each CABG surgery (e.g., CABG1, CABG2) and serves as a linking variable to the parent PR domain. Although VISITNUM is an expected variable, the sponsor did not assign visit numbers.
|1||AKI001||FA||AKI-001||1||CABG1||NUMGFT||Number of Grafts||Coronary Artery Bypass Graft||PRIOR CARDIAC SURGERY||1||1||1|
|2||AKI001||FA||AKI-001||2||CABG2||NUMGFT||Number of Grafts||Coronary Artery Bypass Graft|
STUDY CARDIAC SURGERY
|3||AKI001||FA||AKI-002||3||CABG1||NUMGFT||Number of Grafts||Coronary Artery Bypass Graft||STUDY CARDIAC SURGERY||3||3||3|
The sponsor collected information on whether the subject experienced cardiac arrest during the study surgery. In this study, cardiac arrest was considered a clinical event, rather than an adverse event, because the surgery was performed prior to the start of study treatment. The cardiac arrest was considered to be related to the study surgery session, so the sponsor decided to relate the CE record to the components of the study surgery in the PR domain (CELNKGRP = "STYSUR").
|1||AKI001||CE||AK1-001||1||STYSUR||Cardiac Arrest||Cardiac Arrest||STUDY CARDIAC SURGERY||Y||Y||2012-11-06||2012-11-06|
|2||AKI001||CE||AK1-002||1||STYSUR||Cardiac Arrest||Cardiac Arrest||STUDY CARDIAC SURGERY||Y||N||2013-12-06|
RELREC is used to link data from the CE, PR, and FA domains.