Study: NCT03040011

Adverse event: Surgical complications
Serious: yes
Organ System: Injury, poisoning and procedural complications
Notes: Surgical complications not thought to be related to study intervention: ureteral obstruction requiring return to the operating room (n=1) and a case with a rectal injury and sponge miscount, which was resolved prior to the procedure conclusion (n=1)
Frequency: 1 affected / 25 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Renal and urinary disorders
Notes: Postoperative urinary tract infection defined as positive urine culture with symptoms
Frequency: 2 affected / 25 at risk

Adverse event: Excess postoperative surgical pain
Serious: no
Organ System: Nervous system disorders
Notes: Excessive postoperative surgical site pain that required additional visits and medications
Frequency: 1 affected / 25 at risk

Adverse event: Leg numbness
Serious: no
Organ System: Nervous system disorders
Notes: Transient lower extremity numbness requiring extended observation and ultimately resolved spontaneously
Frequency: 2 affected / 25 at risk

Adverse event: Pyrexia
Serious: no
Organ System: Infections and infestations
Notes: Presented to emergency room with low grade fever of 100.4 Fahrenheit. Complete evaluation with no evidence of infection or other source of fever. No treatment or intervention required. Not thought to be related to study intervention.
Frequency: 1 affected / 25 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Renal and urinary disorders
Notes: Postoperative urinary tract infection defined as positive urine culture with symptoms
Frequency: 1 affected / 25 at risk

Adverse event: Excess postoperative surgical pain
Serious: no
Organ System: Nervous system disorders
Notes: Excessive postoperative surgical site pain that required additional visits and medications
Frequency: 1 affected / 25 at risk

Adverse event: Leg numbness
Serious: no
Organ System: Nervous system disorders
Notes: Transient lower extremity numbness requiring extended observation and ultimately resolved spontaneously
Frequency: 1 affected / 25 at risk

Adverse event: Nausea and vomiting, diarrhea
Serious: no
Organ System: Gastrointestinal disorders
Notes: Postoperative nausea and vomiting and diarrhea on that required observation and medication administration. Not thought to be related to study intervention.
Frequency: 2 affected / 25 at risk

Adverse event: Wound infection
Serious: no
Organ System: Infections and infestations
Notes: Postoperative malodorous discharge and fever presumed wound infection (no culture obtained). Treated with antibiotics with symptom resolution. Not thought to be related to study intervention.
Frequency: 1 affected / 25 at risk

Adverse event: Surgical complications
Serious: yes
Organ System: Injury, poisoning and procedural complications
Notes: Surgical complications not thought to be related to study intervention: ureteral obstruction requiring return to the operating room (n=1) and a case with a rectal injury and sponge miscount, which was resolved prior to the procedure conclusion (n=1)
Frequency: 1 affected / 25 at risk

Adverse event: Asthma exacerbation
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Postoperative asthma exacerbation requiring emergency room care
Frequency: 1 affected / 25 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Renal and urinary disorders
Notes: Postoperative urinary tract infection defined as positive urine culture with symptoms
Frequency: 2 affected / 25 at risk

Adverse event: Excess postoperative surgical pain
Serious: no
Organ System: Nervous system disorders
Notes: Excessive postoperative surgical site pain that required additional visits and medications
Frequency: 2 affected / 25 at risk

Adverse event: Intraoperative bradycardia
Serious: no
Organ System: Cardiac disorders
Notes: Bradycardia that required additional medication. Occurred after anesthesia but prior to the start of the surgical procedure. Not thought to be related to study intervention.
Frequency: 1 affected / 25 at risk

Adverse event: Fall
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Fell at home one week after surgery requiring evaluation in emergency room. Not thought to be related to study intervention.
Frequency: 1 affected / 25 at risk

Adverse event: Fungal infection
Serious: no
Organ System: Infections and infestations
Notes: Vulvar yeast infection requiring medication. Not thought to be related to study intervention.
Frequency: 1 affected / 25 at risk