Trial Outcomes & Findings for Efficacy of IV Acetaminophen Versus Oral Acetaminophen (NCT NCT03365622)

Last Updated: 2025-06-29

Results Overview

Total opiate dose used from the study start (when the first dose of acetaminophen is administered in the pre-anesthesia holding area) to 24 hours post-operatively (in morphine milligram equivalents (MME)).This will include opiates administered intra-operatively.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

214 participants

Primary outcome timeframe

20 to 24 hours post-operatively

Results posted on

2025-06-29

Participant Flow

Adult patients 18 years to 90 years old with the cognitive ability to rate their pain on the Numeric Rating Scale (NRS) and who were scheduled for laparoscopic donor nephrectomy, robot-assisted laparoscopic donor nephrectomy, or robot-assisted laparoscopic nephrectomy for renal cancer at the University of Rochester Medical Center (URMC) were eligible for enrollment.

There were 57 subjects who were withdrawn, however 6 of those subjects were included in the intent to treat analysis. as they did receive one dose of study medication.

Participant milestones

Participant milestones
Measure	IV Acetaminophen and Placebo Pills acetaminophen: Active Intravenous doses will consist of a single 1,000mg/100 ml IV dose with contents of commercial vials transferred to an empty sterile IV bag. Placebo Oral Tablet: Placebo, opaque capsules that have been filled with inert powder (lactose USP), 2 capsules oral every six hours for 24 hours	Placebo IV (Normal Saline) + Oral Acetaminophen Acetaminophen: 500mg acetaminophen tablet ,2 capsules oral every six hours for 24 hours Placebos: Placebo Intravenous doses will consist of 100ml of normal saline transferred to an empty sterile IV bag.
Overall Study STARTED	108	106
Overall Study COMPLETED	108	106
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Efficacy of IV Acetaminophen Versus Oral Acetaminophen

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	IV Acetaminophen and Placebo Pills n=108 Participants acetaminophen: Active Intravenous doses will consist of a single 1,000mg/100 ml IV dose with contents of commercial vials transferred to an empty sterile IV bag. Placebo Oral Tablet: Placebo, opaque capsules that have been filled with inert powder (lactose USP), 2 capsules oral every six hours for 24 hours	Placebo IV (Normal Saline) + Oral Acetaminophen n=106 Participants Acetaminophen: 500mg acetaminophen tablet ,2 capsules oral every six hours for 24 hours Placebos: Placebo Intravenous doses will consist of 100ml of normal saline transferred to an empty sterile IV bag.	Total n=214 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	80 Participants n=5 Participants	76 Participants n=7 Participants	156 Participants n=5 Participants
Age, Categorical >=65 years	28 Participants n=5 Participants	30 Participants n=7 Participants	58 Participants n=5 Participants
Age, Continuous	54.0 Age in years STANDARD_DEVIATION 14.6 • n=5 Participants	54.4 Age in years STANDARD_DEVIATION 15.1 • n=7 Participants	54.2 Age in years STANDARD_DEVIATION 14.8 • n=5 Participants
Sex: Female, Male Female	51 Participants n=5 Participants	58 Participants n=7 Participants	109 Participants n=5 Participants
Sex: Female, Male Male	57 Participants n=5 Participants	48 Participants n=7 Participants	105 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	7 Participants n=5 Participants	4 Participants n=7 Participants	11 Participants n=5 Participants
Race (NIH/OMB) White	94 Participants n=5 Participants	100 Participants n=7 Participants	194 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	7 Participants n=5 Participants	1 Participants n=7 Participants	8 Participants n=5 Participants
Region of Enrollment United States	108 Participants n=5 Participants	106 Participants n=7 Participants	214 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	3 Participants n=5 Participants	2 Participants n=7 Participants	5 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	94 Participants n=5 Participants	95 Participants n=7 Participants	189 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	11 Participants n=5 Participants	9 Participants n=7 Participants	20 Participants n=5 Participants

PRIMARY outcome

Timeframe: 20 to 24 hours post-operatively

Outcome measures

Outcome measures
Measure	IV Acetaminophen and Placebo Pills n=108 Participants acetaminophen: Active Intravenous doses will consist of a single 1,000mg/100 ml IV dose with contents of commercial vials transferred to an empty sterile IV bag. Placebo Oral Tablet: Placebo, opaque capsules that have been filled with inert powder (lactose USP), 2 capsules oral every six hours for 24 hours	Placebo IV (Normal Saline) + Oral Acetaminophen n=106 Participants Acetaminophen: 500mg acetaminophen tablet ,2 capsules oral every six hours for 24 hours Placebos: Placebo Intravenous doses will consist of 100ml of normal saline transferred to an empty sterile IV bag.
Total Opioid Dose (MME) Used in 24 Hours	103.61 total morphine milligram equivalents Standard Deviation 58.16	109.17 total morphine milligram equivalents Standard Deviation 57.59

SECONDARY outcome

Timeframe: 20-24 hours post-operatively

Population: A total of 6 participants were missing: 4 from the "IV acetaminophen" group and 2 from the "oral acetaminophen" group.

Average surgical pain intensity on a 0-10 numeric rating scale (NRS) administered between 20 and 24 hours post-operatively, with gatekeeping used to control for multiplicity. A larger NRS score means the patient is experiencing more pain, with 0 representing "no pain" and 10 representing "the worst possible pain".

Outcome measures

Outcome measures
Measure	IV Acetaminophen and Placebo Pills n=104 Participants acetaminophen: Active Intravenous doses will consist of a single 1,000mg/100 ml IV dose with contents of commercial vials transferred to an empty sterile IV bag. Placebo Oral Tablet: Placebo, opaque capsules that have been filled with inert powder (lactose USP), 2 capsules oral every six hours for 24 hours	Placebo IV (Normal Saline) + Oral Acetaminophen n=104 Participants Acetaminophen: 500mg acetaminophen tablet ,2 capsules oral every six hours for 24 hours Placebos: Placebo Intravenous doses will consist of 100ml of normal saline transferred to an empty sterile IV bag.
Average Surgical Pain Intensity	4.87 score on a scale Standard Deviation 2.20	5.00 score on a scale Standard Deviation 1.96

SECONDARY outcome

Timeframe: 1-2 hours post-operatively

Population: A total of 5 participants were missing: 3 from the "IV acetaminophen" group and 2 from the "oral acetaminophen" group.

Outcome measures

Outcome measures
Measure	IV Acetaminophen and Placebo Pills n=105 Participants acetaminophen: Active Intravenous doses will consist of a single 1,000mg/100 ml IV dose with contents of commercial vials transferred to an empty sterile IV bag. Placebo Oral Tablet: Placebo, opaque capsules that have been filled with inert powder (lactose USP), 2 capsules oral every six hours for 24 hours	Placebo IV (Normal Saline) + Oral Acetaminophen n=104 Participants Acetaminophen: 500mg acetaminophen tablet ,2 capsules oral every six hours for 24 hours Placebos: Placebo Intravenous doses will consist of 100ml of normal saline transferred to an empty sterile IV bag.
Average Surgical Pain Intensity	4.46 score on a scale Standard Deviation 2.34	4.77 score on a scale Standard Deviation 2.41

SECONDARY outcome

Timeframe: 1-2 hours post-operatively

Population: A total of 6 participants were missing: 3 from the "IV acetaminophen" group and 3 from the "oral acetaminophen" group.

The mean inspiratory capacity is presented as a percentage of the subject's baseline (pre-operative) inspiratory capacity, recorded at the time of pain intensity assessments between 1-2 hours postoperatively. Inspiratory capacity is measured using a Voldyne 5000 incentive spirometer (Hudson RCI, Teleflex Medical) and recorded in milliliters to the nearest 250 cc mark on the incentive spirometer. Higher percentages reflect better recovery of inspiratory function.

Outcome measures

Outcome measures
Measure	IV Acetaminophen and Placebo Pills n=105 Participants acetaminophen: Active Intravenous doses will consist of a single 1,000mg/100 ml IV dose with contents of commercial vials transferred to an empty sterile IV bag. Placebo Oral Tablet: Placebo, opaque capsules that have been filled with inert powder (lactose USP), 2 capsules oral every six hours for 24 hours	Placebo IV (Normal Saline) + Oral Acetaminophen n=103 Participants Acetaminophen: 500mg acetaminophen tablet ,2 capsules oral every six hours for 24 hours Placebos: Placebo Intravenous doses will consist of 100ml of normal saline transferred to an empty sterile IV bag.
Mean Inspiratory Capacity	66.60 percent of baseline inspiratory capacity Standard Deviation 20.26	67.07 percent of baseline inspiratory capacity Standard Deviation 20.74

SECONDARY outcome

Timeframe: 20-24 hours post-operatively

Population: A total of 7 participants were missing: 4 from the "IV acetaminophen" group and 3 from the "oral acetaminophen" group.

The mean inspiratory capacity is presented as a percentage of the subject's baseline (pre-operative) inspiratory capacity, recorded at the time of pain intensity assessments between 20-24 hours postoperatively. Inspiratory capacity is measured using a Voldyne 5000 incentive spirometer (Hudson RCI, Teleflex Medical) and recorded in milliliters to the nearest 250 cc mark on the incentive spirometer. Higher percentages reflect better recovery of inspiratory function.

Outcome measures

Outcome measures
Measure	IV Acetaminophen and Placebo Pills n=104 Participants acetaminophen: Active Intravenous doses will consist of a single 1,000mg/100 ml IV dose with contents of commercial vials transferred to an empty sterile IV bag. Placebo Oral Tablet: Placebo, opaque capsules that have been filled with inert powder (lactose USP), 2 capsules oral every six hours for 24 hours	Placebo IV (Normal Saline) + Oral Acetaminophen n=103 Participants Acetaminophen: 500mg acetaminophen tablet ,2 capsules oral every six hours for 24 hours Placebos: Placebo Intravenous doses will consist of 100ml of normal saline transferred to an empty sterile IV bag.
Mean Inspiratory Capacity	64.41 percent of baseline inspiratory capacity Standard Deviation 21.82	63.35 percent of baseline inspiratory capacity Standard Deviation 22.57

SECONDARY outcome

Timeframe: 1-2 hours post-operatively

Population: A total of 6 participants were missing: 3 from the "IV acetaminophen" group and 3 from the "oral acetaminophen" group.

Dynamic pain score on a 0-10 numeric rating scale (NRS) with incentive spirometer use taken during pain intensity assessments at 1-2 hours post-operatively. A larger NRS score means the patient is experiencing more pain, with 0 representing "no pain" and 10 representing "the worst possible pain".

Outcome measures

Outcome measures
Measure	IV Acetaminophen and Placebo Pills n=105 Participants acetaminophen: Active Intravenous doses will consist of a single 1,000mg/100 ml IV dose with contents of commercial vials transferred to an empty sterile IV bag. Placebo Oral Tablet: Placebo, opaque capsules that have been filled with inert powder (lactose USP), 2 capsules oral every six hours for 24 hours	Placebo IV (Normal Saline) + Oral Acetaminophen n=103 Participants Acetaminophen: 500mg acetaminophen tablet ,2 capsules oral every six hours for 24 hours Placebos: Placebo Intravenous doses will consist of 100ml of normal saline transferred to an empty sterile IV bag.
Dynamic Pain Score During Incentive Spirometer Use	4.73 score on a scale Standard Deviation 2.71	5.15 score on a scale Standard Deviation 2.51

SECONDARY outcome

Timeframe: 20-24 hours post-operatively

Population: A total of 9 participants were missing: 5 from the "IV acetaminophen" group and 4 from the "oral acetaminophen" group.

Dynamic pain score on a 0-10 numeric rating scale (NRS) with incentive spirometer use taken during pain intensity assessments at 20-24 hours post-operatively. A larger NRS score means the patient is experiencing more pain, with 0 representing "no pain" and 10 representing "the worst possible pain".

Outcome measures

Outcome measures
Measure	IV Acetaminophen and Placebo Pills n=103 Participants acetaminophen: Active Intravenous doses will consist of a single 1,000mg/100 ml IV dose with contents of commercial vials transferred to an empty sterile IV bag. Placebo Oral Tablet: Placebo, opaque capsules that have been filled with inert powder (lactose USP), 2 capsules oral every six hours for 24 hours	Placebo IV (Normal Saline) + Oral Acetaminophen n=102 Participants Acetaminophen: 500mg acetaminophen tablet ,2 capsules oral every six hours for 24 hours Placebos: Placebo Intravenous doses will consist of 100ml of normal saline transferred to an empty sterile IV bag.
Dynamic Pain Score During Incentive Spirometer Use	4.62 score on a scale Standard Deviation 2.56	5.12 score on a scale Standard Deviation 2.25

SECONDARY outcome

Timeframe: 20-24 hours post-operatively

Population: A total of 16 participants were missing: 10 from the "IV acetaminophen" group and 6 from the "oral acetaminophen" group.

Pain intensity on a 0-10 numeric rating scale (NRS) prior to incentive spirometry use was taken during pain intensity assessments at 20-24 hours post-operatively. A larger NRS score means the patient is experiencing more pain, with 0 representing "no pain" and 10 representing "the worst possible pain".

Outcome measures

Outcome measures
Measure	IV Acetaminophen and Placebo Pills n=98 Participants acetaminophen: Active Intravenous doses will consist of a single 1,000mg/100 ml IV dose with contents of commercial vials transferred to an empty sterile IV bag. Placebo Oral Tablet: Placebo, opaque capsules that have been filled with inert powder (lactose USP), 2 capsules oral every six hours for 24 hours	Placebo IV (Normal Saline) + Oral Acetaminophen n=100 Participants Acetaminophen: 500mg acetaminophen tablet ,2 capsules oral every six hours for 24 hours Placebos: Placebo Intravenous doses will consist of 100ml of normal saline transferred to an empty sterile IV bag.
Surgical Pain Score During the 20-24 Hour Assessment	3.52 score on a scale Standard Deviation 2.25	3.89 score on a scale Standard Deviation 2.14

SECONDARY outcome

Timeframe: 24 hours post-operatively

Population: A total of 24 participants were missing: 14 from the "IV acetaminophen" group and 10 from the "oral acetaminophen" group.

Time to first postoperative narcotic use, measured in hours (range: 1 to 24).

Outcome measures

Outcome measures
Measure	IV Acetaminophen and Placebo Pills n=94 Participants acetaminophen: Active Intravenous doses will consist of a single 1,000mg/100 ml IV dose with contents of commercial vials transferred to an empty sterile IV bag. Placebo Oral Tablet: Placebo, opaque capsules that have been filled with inert powder (lactose USP), 2 capsules oral every six hours for 24 hours	Placebo IV (Normal Saline) + Oral Acetaminophen n=96 Participants Acetaminophen: 500mg acetaminophen tablet ,2 capsules oral every six hours for 24 hours Placebos: Placebo Intravenous doses will consist of 100ml of normal saline transferred to an empty sterile IV bag.
Time to First Narcotic Use	3.31 hours Standard Deviation 5.34	2.85 hours Standard Deviation 4.91

SECONDARY outcome

Timeframe: 24 hours post-operatively

Number of participants with nausea was assessed based on the administration of anti-emetic medications, with a value of 0 indicating no nausea and 1 indicating the presence of nausea.

Outcome measures

Outcome measures
Measure	IV Acetaminophen and Placebo Pills n=108 Participants acetaminophen: Active Intravenous doses will consist of a single 1,000mg/100 ml IV dose with contents of commercial vials transferred to an empty sterile IV bag. Placebo Oral Tablet: Placebo, opaque capsules that have been filled with inert powder (lactose USP), 2 capsules oral every six hours for 24 hours	Placebo IV (Normal Saline) + Oral Acetaminophen n=106 Participants Acetaminophen: 500mg acetaminophen tablet ,2 capsules oral every six hours for 24 hours Placebos: Placebo Intravenous doses will consist of 100ml of normal saline transferred to an empty sterile IV bag.
Number of Participants With Nausea	58 Participants	40 Participants

SECONDARY outcome

Timeframe: 24 hours

Length of time in minutes from PACU(post-anesthesia care unit) arrival to discharge.

Outcome measures

Outcome measures
Measure	IV Acetaminophen and Placebo Pills n=108 Participants acetaminophen: Active Intravenous doses will consist of a single 1,000mg/100 ml IV dose with contents of commercial vials transferred to an empty sterile IV bag. Placebo Oral Tablet: Placebo, opaque capsules that have been filled with inert powder (lactose USP), 2 capsules oral every six hours for 24 hours	Placebo IV (Normal Saline) + Oral Acetaminophen n=106 Participants Acetaminophen: 500mg acetaminophen tablet ,2 capsules oral every six hours for 24 hours Placebos: Placebo Intravenous doses will consist of 100ml of normal saline transferred to an empty sterile IV bag.
Time to Discharge From Post-anesthesia Care Unit	174.17 Minutes Standard Deviation 82.99	195.48 Minutes Standard Deviation 170.41

SECONDARY outcome

Timeframe: 30 days

Number of days to discharge from hospital

Outcome measures

Outcome measures
Measure	IV Acetaminophen and Placebo Pills n=108 Participants acetaminophen: Active Intravenous doses will consist of a single 1,000mg/100 ml IV dose with contents of commercial vials transferred to an empty sterile IV bag. Placebo Oral Tablet: Placebo, opaque capsules that have been filled with inert powder (lactose USP), 2 capsules oral every six hours for 24 hours	Placebo IV (Normal Saline) + Oral Acetaminophen n=106 Participants Acetaminophen: 500mg acetaminophen tablet ,2 capsules oral every six hours for 24 hours Placebos: Placebo Intravenous doses will consist of 100ml of normal saline transferred to an empty sterile IV bag.
Time to Hospital Discharge	2.33 Days Standard Deviation 1.30	2.60 Days Standard Deviation 2.27

Adverse Events

IV Acetaminophen and Placebo Pills

Serious events: 1 serious events

Other events: 14 other events

Deaths: 0 deaths

Placebo IV (Normal Saline) + Oral Acetaminophen

Serious events: 1 serious events

Other events: 16 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	IV Acetaminophen and Placebo Pills n=108 participants at risk acetaminophen: Active Intravenous doses will consist of a single 1,000mg/100 ml IV dose with contents of commercial vials transferred to an empty sterile IV bag. Placebo Oral Tablet: Placebo, opaque capsules that have been filled with inert powder (lactose USP), 2 capsules oral every six hours for 24 hours	Placebo IV (Normal Saline) + Oral Acetaminophen n=106 participants at risk Acetaminophen: 500mg acetaminophen tablet ,2 capsules oral every six hours for 24 hours Placebos: Placebo Intravenous doses will consist of 100ml of normal saline transferred to an empty sterile IV bag.
Blood and lymphatic system disorders Anemias non-hemolytic and marrow depression	0.93% 1/108 • Up to 24 hours post-operatively or until hospital discharge	0.00% 0/106 • Up to 24 hours post-operatively or until hospital discharge
Nervous system disorders Cognitive and attention disorders	0.00% 0/108 • Up to 24 hours post-operatively or until hospital discharge	0.94% 1/106 • Up to 24 hours post-operatively or until hospital discharge
Infections and infestations Urinary tract infections and Epididymal and testicular infections	0.00% 0/108 • Up to 24 hours post-operatively or until hospital discharge	0.94% 1/106 • Up to 24 hours post-operatively or until hospital discharge

Other adverse events

Additional Information

Joseph Dooley, MD

University of Rochester Medical Center

Phone: 5852752141

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	IV Acetaminophen and Placebo Pills n=108 participants at risk acetaminophen: Active Intravenous doses will consist of a single 1,000mg/100 ml IV dose with contents of commercial vials transferred to an empty sterile IV bag. Placebo Oral Tablet: Placebo, opaque capsules that have been filled with inert powder (lactose USP), 2 capsules oral every six hours for 24 hours	Placebo IV (Normal Saline) + Oral Acetaminophen n=106 participants at risk Acetaminophen: 500mg acetaminophen tablet ,2 capsules oral every six hours for 24 hours Placebos: Placebo Intravenous doses will consist of 100ml of normal saline transferred to an empty sterile IV bag.
Gastrointestinal disorders Gastrointestinal symptoms	1.9% 2/108 • Up to 24 hours post-operatively or until hospital discharge	1.9% 2/106 • Up to 24 hours post-operatively or until hospital discharge
Blood and lymphatic system disorders Anemias non-hemolytic and marrow depression	0.93% 1/108 • Up to 24 hours post-operatively or until hospital discharge	0.94% 1/106 • Up to 24 hours post-operatively or until hospital discharge
Eye disorders Corneal disorders	1.9% 2/108 • Up to 24 hours post-operatively or until hospital discharge	0.00% 0/106 • Up to 24 hours post-operatively or until hospital discharge
Respiratory, thoracic and mediastinal disorders Respiratory failures and dysfunctions	1.9% 2/108 • Up to 24 hours post-operatively or until hospital discharge	0.00% 0/106 • Up to 24 hours post-operatively or until hospital discharge
Musculoskeletal and connective tissue disorders Muscle disorders	0.00% 0/108 • Up to 24 hours post-operatively or until hospital discharge	1.9% 2/106 • Up to 24 hours post-operatively or until hospital discharge
Musculoskeletal and connective tissue disorders Joint disorders	1.9% 2/108 • Up to 24 hours post-operatively or until hospital discharge	1.9% 2/106 • Up to 24 hours post-operatively or until hospital discharge
Vascular disorders Intraoperative and post-op hemorrhages	1.9% 2/108 • Up to 24 hours post-operatively or until hospital discharge	0.00% 0/106 • Up to 24 hours post-operatively or until hospital discharge
Cardiac disorders Cardiac arrhythmias	0.00% 0/108 • Up to 24 hours post-operatively or until hospital discharge	0.94% 1/106 • Up to 24 hours post-operatively or until hospital discharge
Hepatobiliary disorders Liver function analyses	0.93% 1/108 • Up to 24 hours post-operatively or until hospital discharge	0.00% 0/106 • Up to 24 hours post-operatively or until hospital discharge
Respiratory, thoracic and mediastinal disorders Air leak syndromes	0.93% 1/108 • Up to 24 hours post-operatively or until hospital discharge	0.00% 0/106 • Up to 24 hours post-operatively or until hospital discharge
General disorders Body temperature conditions	0.00% 0/108 • Up to 24 hours post-operatively or until hospital discharge	0.94% 1/106 • Up to 24 hours post-operatively or until hospital discharge
Renal and urinary disorders Renal function analyses	0.00% 0/108 • Up to 24 hours post-operatively or until hospital discharge	0.94% 1/106 • Up to 24 hours post-operatively or until hospital discharge
General disorders Infusion site reactions	0.00% 0/108 • Up to 24 hours post-operatively or until hospital discharge	0.94% 1/106 • Up to 24 hours post-operatively or until hospital discharge
Vascular disorders Vascular hypotensive disorders	0.93% 1/108 • Up to 24 hours post-operatively or until hospital discharge	0.00% 0/106 • Up to 24 hours post-operatively or until hospital discharge
Vascular disorders Hypotension post-op	0.00% 0/108 • Up to 24 hours post-operatively or until hospital discharge	0.94% 1/106 • Up to 24 hours post-operatively or until hospital discharge
Infections and infestations Systemic and deep-seated mycoses	0.00% 0/108 • Up to 24 hours post-operatively or until hospital discharge	0.94% 1/106 • Up to 24 hours post-operatively or until hospital discharge
Blood and lymphatic system disorders Post-op disorder of lymphatic vessels	0.93% 1/108 • Up to 24 hours post-operatively or until hospital discharge	0.00% 0/106 • Up to 24 hours post-operatively or until hospital discharge
Renal and urinary disorders Renal function analyses & White blook cell abnormal	0.00% 0/108 • Up to 24 hours post-operatively or until hospital discharge	0.94% 1/106 • Up to 24 hours post-operatively or until hospital discharge
Skin and subcutaneous tissue disorders Skin ulcerations and conditions necrotic	0.00% 0/108 • Up to 24 hours post-operatively or until hospital discharge	0.94% 1/106 • Up to 24 hours post-operatively or until hospital discharge
Nervous system disorders Peripheral neuropathies	0.00% 0/108 • Up to 24 hours post-operatively or until hospital discharge	0.94% 1/106 • Up to 24 hours post-operatively or until hospital discharge
Respiratory, thoracic and mediastinal disorders Respiratory failure post-op	0.00% 0/108 • Up to 24 hours post-operatively or until hospital discharge	0.94% 1/106 • Up to 24 hours post-operatively or until hospital discharge
Gastrointestinal disorders Postoperative ileus	0.00% 0/108 • Up to 24 hours post-operatively or until hospital discharge	0.94% 1/106 • Up to 24 hours post-operatively or until hospital discharge
Renal and urinary disorders Acute and chronic renal failures	0.00% 0/108 • Up to 24 hours post-operatively or until hospital discharge	0.94% 1/106 • Up to 24 hours post-operatively or until hospital discharge
Renal and urinary disorders Abnormal kidney function analyses	0.93% 1/108 • Up to 24 hours post-operatively or until hospital discharge	0.00% 0/106 • Up to 24 hours post-operatively or until hospital discharge
Metabolism and nutrition disorders Electrolyte and fluid balance conditions	0.93% 1/108 • Up to 24 hours post-operatively or until hospital discharge	0.00% 0/106 • Up to 24 hours post-operatively or until hospital discharge