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The FIBROID Registry

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Table 2. Definitions of Adverse Events

SIR Classification

A

No therapy, no consequences.

B

Nominal therapy, observation, no consequences.

A or B

Minor events with insufficient information to distinguish as Class A or B.

C

Required therapy, minor prolongation of hospitalization (< 48 hours) or rehospitalization for < 48 hrs.

D

Major therapy, unplanned increase level of care, prolonged hospitalization (48 hours or longer) or rehospitalization for longer than 48 hrs.

E

Permanent adverse sequelae.

F

Death.

Minor complications

Class A, B.

Major complications

Classes C, D, E, F.

ACOG Classification

Febrile morbidity

Occurrence of infection not present on admission or initiation of antibiotics > 24 hrs after surgery.

Readmission

Unplanned readmission within 14 days or admission after return visit to the emergency department for the same problem.

Unintended surgery

Unplanned removal, injury or repair of organ during operative procedure or unplanned return to operating room for surgery during the same admission.

Hemorrhage

Gynecologic surgery with 2 or more units of blood, post-operative hematocrit of < 24%, or post-operative hemoglobin concentration of < 8 g/dl.

Life-threatening complications

Cardiopulmonary arrest, resuscitation, unplanned admission to special (intensive) care unit, or death.


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