Trial Outcomes & Findings for Study of Intravenous (IV) Methylnaltrexone Bromide (MNTX) in the Treatment of Post-Operative Ileus (POI) (NCT NCT00401375)

NCT ID: NCT00401375

Last Updated: 2019-09-04

Results Overview

Time to first bowel movement was measured from the end of surgery (defined as the time when the last skin suture or staple was placed in the participant). Time of the first bowel movement was recorded on the electronic case report form (eCRF). The first bowel movement was defined as a normal stool for a postoperative participant based on the clinical judgment of the investigator or designee. Analysis was performed by Kaplan-Meier estimate. Participants who had a bowel movement but were readmitted to the hospital within 1 week after discharge with a diagnosis of postoperative ileus (POI) were considered censored at the time of the first bowel movement as if the bowel movement had not occurred.

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 524 participants
• Primary outcome timeframe: Day 1 (From the time of end of surgery [that is; from the first dose of study drug administration]) up to Day 10
• Results posted on: 2019-09-04

Participant Flow

Postoperative participants (who underwent segmental colectomy via open laparotomy) were randomized in 1:1:1 ratio to MNTX 12 mg, MNTX 24 mg, or placebo treatment groups. Randomization was based on regional stratification.

Participant milestones

Measure	MNTX 12 mg Participants received methylnaltrexone (MNTX) 12 milligrams (mg) as an intravenous (IV) infusion over approximately 20 minutes for every 6 hours until one of the following occurred: 1) 24 hours elapsed after the first bowel movement and the participant was tolerating clear liquids, 2) the participant was discharged from the hospital, or 3) a maximum of 10 days elapsed. The first dose of study drug was administered within the first 90 minutes after the end of surgery (defined as the time when the last skin suture or staple was placed in the participant).	MNTX 24 mg Participants received MNTX 24 mg as an IV infusion over approximately 20 minutes for every 6 hours until one of the following occurred: 1) 24 hours elapsed after the first bowel movement and the participant was tolerating clear liquids, 2) the participant was discharged from the hospital, or 3) a maximum of 10 days elapsed. The first dose of study drug was administered within the first 90 minutes after the end of surgery (defined as the time when the last skin suture or staple was placed in the participant).	Placebo Participants received placebo matched to MNTX as an IV infusion over approximately 20 minutes for every 6 hours until one of the following occurred: 1) 24 hours elapsed after the first bowel movement and the participant was tolerating clear liquids, 2) the participant was discharged from the hospital, or 3) a maximum of 10 days elapsed. The first dose of study drug was administered within the first 90 minutes after the end of surgery (defined as the time when the last skin suture or staple was placed in the participant).
Overall Study STARTED	174	176	174
Overall Study Received at Least 1 Dose of Study Drug	171	173	171
Overall Study COMPLETED	152	151	149
Overall Study NOT COMPLETED	22	25	25

Reasons for withdrawal

Measure	MNTX 12 mg Participants received methylnaltrexone (MNTX) 12 milligrams (mg) as an intravenous (IV) infusion over approximately 20 minutes for every 6 hours until one of the following occurred: 1) 24 hours elapsed after the first bowel movement and the participant was tolerating clear liquids, 2) the participant was discharged from the hospital, or 3) a maximum of 10 days elapsed. The first dose of study drug was administered within the first 90 minutes after the end of surgery (defined as the time when the last skin suture or staple was placed in the participant).	MNTX 24 mg Participants received MNTX 24 mg as an IV infusion over approximately 20 minutes for every 6 hours until one of the following occurred: 1) 24 hours elapsed after the first bowel movement and the participant was tolerating clear liquids, 2) the participant was discharged from the hospital, or 3) a maximum of 10 days elapsed. The first dose of study drug was administered within the first 90 minutes after the end of surgery (defined as the time when the last skin suture or staple was placed in the participant).	Placebo Participants received placebo matched to MNTX as an IV infusion over approximately 20 minutes for every 6 hours until one of the following occurred: 1) 24 hours elapsed after the first bowel movement and the participant was tolerating clear liquids, 2) the participant was discharged from the hospital, or 3) a maximum of 10 days elapsed. The first dose of study drug was administered within the first 90 minutes after the end of surgery (defined as the time when the last skin suture or staple was placed in the participant).
Overall Study Protocol Violation	2	2	1
Overall Study Adverse Event	6	11	10
Overall Study Withdrawal by Subject	9	7	7
Overall Study Lost to Follow-up	0	1	1
Overall Study Other than specified	2	1	3
Overall Study Randomized but not treated	3	3	3

Baseline Characteristics

Study of Intravenous (IV) Methylnaltrexone Bromide (MNTX) in the Treatment of Post-Operative Ileus (POI)

Baseline characteristics by cohort

Measure	MNTX 12 mg n=171 Participants Participants received MNTX 12 mg as an IV infusion over approximately 20 minutes for every 6 hours until one of the following occurred: 1) 24 hours elapsed after the first bowel movement and the participant was tolerating clear liquids, 2) the participant was discharged from the hospital, or 3) a maximum of 10 days elapsed. The first dose of study drug was administered within the first 90 minutes after the end of surgery (defined as the time when the last skin suture or staple was placed in the participant).	MNTX 24 mg n=173 Participants Participants received MNTX 24 mg as an IV infusion over approximately 20 minutes for every 6 hours until one of the following occurred: 1) 24 hours elapsed after the first bowel movement and the participant was tolerating clear liquids, 2) the participant was discharged from the hospital, or 3) a maximum of 10 days elapsed. The first dose of study drug was administered within the first 90 minutes after the end of surgery (defined as the time when the last skin suture or staple was placed in the participant).	Placebo n=171 Participants Participants received placebo matched to MNTX as an IV infusion over approximately 20 minutes for every 6 hours until one of the following occurred: 1) 24 hours elapsed after the first bowel movement and the participant was tolerating clear liquids, 2) the participant was discharged from the hospital, or 3) a maximum of 10 days elapsed. The first dose of study drug was administered within the first 90 minutes after the end of surgery (defined as the time when the last skin suture or staple was placed in the participant).	Total n=515 Participants Total of all reporting groups
Age, Continuous	56.6 years STANDARD_DEVIATION 15.5 • n=93 Participants	58.2 years STANDARD_DEVIATION 15.6 • n=4 Participants	58.1 years STANDARD_DEVIATION 15.6 • n=27 Participants	57.7 years STANDARD_DEVIATION 15.6 • n=483 Participants
Sex: Female, Male Female	79 Participants n=93 Participants	71 Participants n=4 Participants	77 Participants n=27 Participants	227 Participants n=483 Participants
Sex: Female, Male Male	92 Participants n=93 Participants	102 Participants n=4 Participants	94 Participants n=27 Participants	288 Participants n=483 Participants

PRIMARY outcome

Timeframe: Day 1 (From the time of end of surgery [that is; from the first dose of study drug administration]) up to Day 10

Population: mITT population included all randomized participants who received at least 1 dose of study drug.

Time to first bowel movement was measured from the end of surgery (defined as the time when the last skin suture or staple was placed in the participant). Time of the first bowel movement was recorded on the electronic case report form (eCRF). The first bowel movement was defined as a normal stool for a postoperative participant based on the clinical judgment of the investigator or designee. Analysis was performed by Kaplan-Meier estimate. Participants who had a bowel movement but were readmitted to the hospital within 1 week after discharge with a diagnosis of postoperative ileus (POI) were considered censored at the time of the first bowel movement as if the bowel movement had not occurred.

Outcome measures

Measure	MNTX 12 mg n=171 Participants Participants received MNTX 12 mg as an IV infusion over approximately 20 minutes for every 6 hours until one of the following occurred: 1) 24 hours elapsed after the first bowel movement and the participant was tolerating clear liquids, 2) the participant was discharged from the hospital, or 3) a maximum of 10 days elapsed. The first dose of study drug was administered within the first 90 minutes after the end of surgery (defined as the time when the last skin suture or staple was placed in the participant).	MNTX 24 mg n=173 Participants Participants received MNTX 24 mg as an IV infusion over approximately 20 minutes for every 6 hours until one of the following occurred: 1) 24 hours elapsed after the first bowel movement and the participant was tolerating clear liquids, 2) the participant was discharged from the hospital, or 3) a maximum of 10 days elapsed. The first dose of study drug was administered within the first 90 minutes after the end of surgery (defined as the time when the last skin suture or staple was placed in the participant).	Placebo n=171 Participants Participants received placebo matched to MNTX as an IV infusion over approximately 20 minutes for every 6 hours until one of the following occurred: 1) 24 hours elapsed after the first bowel movement and the participant was tolerating clear liquids, 2) the participant was discharged from the hospital, or 3) a maximum of 10 days elapsed. The first dose of study drug was administered within the first 90 minutes after the end of surgery (defined as the time when the last skin suture or staple was placed in the participant).
Time to First Bowel Movement	4.4 days Standard Error 0.13	4.8 days Standard Error 0.21	4.6 days Standard Error 0.15

SECONDARY outcome

Timeframe: Day 1 (From the time of end of surgery [that is; from the first dose of study drug administration]) up to Day 10

Population: mITT population included all randomized participants who received at least 1 dose of study drug.

Time to discharge eligibility was measured from the end of surgery (defined as the time when the last skin suture or staple was placed in the participant). Discharge eligibility was defined as both tolerance of solid food and at least one bowel movement. Participants were considered to have tolerated solid food when they have eaten greater than or equal to (≥) 50 percent (%), of the first of two successive solid food meals (based on the judgement of the investigator or designee), without vomiting or nausea. Participants readmitted to the hospital with a diagnosis of POI within 7 days of discharge were considered treatment failures. Analysis was performed by Kaplan-Meier estimate.

Outcome measures

Measure	MNTX 12 mg n=171 Participants Participants received MNTX 12 mg as an IV infusion over approximately 20 minutes for every 6 hours until one of the following occurred: 1) 24 hours elapsed after the first bowel movement and the participant was tolerating clear liquids, 2) the participant was discharged from the hospital, or 3) a maximum of 10 days elapsed. The first dose of study drug was administered within the first 90 minutes after the end of surgery (defined as the time when the last skin suture or staple was placed in the participant).	MNTX 24 mg n=173 Participants Participants received MNTX 24 mg as an IV infusion over approximately 20 minutes for every 6 hours until one of the following occurred: 1) 24 hours elapsed after the first bowel movement and the participant was tolerating clear liquids, 2) the participant was discharged from the hospital, or 3) a maximum of 10 days elapsed. The first dose of study drug was administered within the first 90 minutes after the end of surgery (defined as the time when the last skin suture or staple was placed in the participant).	Placebo n=171 Participants Participants received placebo matched to MNTX as an IV infusion over approximately 20 minutes for every 6 hours until one of the following occurred: 1) 24 hours elapsed after the first bowel movement and the participant was tolerating clear liquids, 2) the participant was discharged from the hospital, or 3) a maximum of 10 days elapsed. The first dose of study drug was administered within the first 90 minutes after the end of surgery (defined as the time when the last skin suture or staple was placed in the participant).
Time to Discharge Eligibility	5.8 days Standard Error 0.24	7.0 days Standard Error 0.45	6.5 days Standard Error 0.32

SECONDARY outcome

Timeframe: Day 1 (From the time of end of surgery [that is; from the first dose of study drug administration]) up to Day 10

Population: mITT population included all randomized participants who received at least 1 dose of study drug.

The investigator or designee recorded the time of the order. Participants re-admitted to the hospital with a diagnosis of POI within 7 days after discharge were considered treatment failures. Analysis was performed by Kaplan-Meier estimate.

Outcome measures

Measure	MNTX 12 mg n=171 Participants Participants received MNTX 12 mg as an IV infusion over approximately 20 minutes for every 6 hours until one of the following occurred: 1) 24 hours elapsed after the first bowel movement and the participant was tolerating clear liquids, 2) the participant was discharged from the hospital, or 3) a maximum of 10 days elapsed. The first dose of study drug was administered within the first 90 minutes after the end of surgery (defined as the time when the last skin suture or staple was placed in the participant).	MNTX 24 mg n=173 Participants Participants received MNTX 24 mg as an IV infusion over approximately 20 minutes for every 6 hours until one of the following occurred: 1) 24 hours elapsed after the first bowel movement and the participant was tolerating clear liquids, 2) the participant was discharged from the hospital, or 3) a maximum of 10 days elapsed. The first dose of study drug was administered within the first 90 minutes after the end of surgery (defined as the time when the last skin suture or staple was placed in the participant).	Placebo n=171 Participants Participants received placebo matched to MNTX as an IV infusion over approximately 20 minutes for every 6 hours until one of the following occurred: 1) 24 hours elapsed after the first bowel movement and the participant was tolerating clear liquids, 2) the participant was discharged from the hospital, or 3) a maximum of 10 days elapsed. The first dose of study drug was administered within the first 90 minutes after the end of surgery (defined as the time when the last skin suture or staple was placed in the participant).
Time to Discharge Order Written From the End of Surgery	6.8 days Standard Error 0.26	9.1 days Standard Error 0.76	7.3 days Standard Error 0.29

SECONDARY outcome

Timeframe: 0 and 24 hours

Population: mITT population included all randomized participants who received at least 1 dose of study drug. Here, 'Overall number of participants analyzed' signifies participants evaluable for this outcome measure.

CMEs were defined using opioid-related SDS (assessed participant-reported levels of severity concerning 10 symptoms associated with opioid medication usage: fatigue, drowsiness, inability to concentrate, nausea, dizziness, constipation, itching, difficulty with urination, confusion and retching/vomiting). CME = any symptom rated as severe (3) or very severe (4), with the exception of confusion. A total CME score was calculated by summing the number of CMEs across symptoms and ranged from 0 to 9. CME was counted for either nausea or vomiting/retching, or both and reported in this outcome measure.

Outcome measures

Measure	MNTX 12 mg n=171 Participants Participants received MNTX 12 mg as an IV infusion over approximately 20 minutes for every 6 hours until one of the following occurred: 1) 24 hours elapsed after the first bowel movement and the participant was tolerating clear liquids, 2) the participant was discharged from the hospital, or 3) a maximum of 10 days elapsed. The first dose of study drug was administered within the first 90 minutes after the end of surgery (defined as the time when the last skin suture or staple was placed in the participant).	MNTX 24 mg n=173 Participants Participants received MNTX 24 mg as an IV infusion over approximately 20 minutes for every 6 hours until one of the following occurred: 1) 24 hours elapsed after the first bowel movement and the participant was tolerating clear liquids, 2) the participant was discharged from the hospital, or 3) a maximum of 10 days elapsed. The first dose of study drug was administered within the first 90 minutes after the end of surgery (defined as the time when the last skin suture or staple was placed in the participant).	Placebo n=171 Participants Participants received placebo matched to MNTX as an IV infusion over approximately 20 minutes for every 6 hours until one of the following occurred: 1) 24 hours elapsed after the first bowel movement and the participant was tolerating clear liquids, 2) the participant was discharged from the hospital, or 3) a maximum of 10 days elapsed. The first dose of study drug was administered within the first 90 minutes after the end of surgery (defined as the time when the last skin suture or staple was placed in the participant).
Number of Participants With Clinically Meaningful Events (CMEs) for Nausea or Retching/Vomiting at 0 or 24 Hours as Evaluated by the Opioid-Related Symptom Distress Scale (SDS) Nausea	13 Participants	12 Participants	17 Participants
Number of Participants With Clinically Meaningful Events (CMEs) for Nausea or Retching/Vomiting at 0 or 24 Hours as Evaluated by the Opioid-Related Symptom Distress Scale (SDS) Vomiting/Retching	9 Participants	4 Participants	5 Participants

Adverse Events

MNTX 12 mg

Serious events: 26 serious events

Other events: 121 other events

Deaths: 0 deaths

MNTX 24 mg

Serious events: 33 serious events

Other events: 124 other events

Deaths: 0 deaths

Placebo

Serious events: 38 serious events

Other events: 138 other events

Deaths: 0 deaths

Serious adverse events

Measure	MNTX 12 mg n=171 participants at risk Participants received MNTX 12 mg as an IV infusion over approximately 20 minutes for every 6 hours until one of the following occurred: 1) 24 hours elapsed after the first bowel movement and the participant was tolerating clear liquids, 2) the participant was discharged from the hospital, or 3) a maximum of 10 days elapsed. The first dose of study drug was administered within the first 90 minutes after the end of surgery (defined as the time when the last skin suture or staple was placed in the participant).	MNTX 24 mg n=173 participants at risk Participants received MNTX 24 mg as an IV infusion over approximately 20 minutes for every 6 hours until one of the following occurred: 1) 24 hours elapsed after the first bowel movement and the participant was tolerating clear liquids, 2) the participant was discharged from the hospital, or 3) a maximum of 10 days elapsed. The first dose of study drug was administered within the first 90 minutes after the end of surgery (defined as the time when the last skin suture or staple was placed in the participant).	Placebo n=171 participants at risk Participants received placebo matched to MNTX as an IV infusion over approximately 20 minutes for every 6 hours until one of the following occurred: 1) 24 hours elapsed after the first bowel movement and the participant was tolerating clear liquids, 2) the participant was discharged from the hospital, or 3) a maximum of 10 days elapsed. The first dose of study drug was administered within the first 90 minutes after the end of surgery (defined as the time when the last skin suture or staple was placed in the participant).
Cardiac disorders Atrial fibrillation	0.58% 1/171 • Day 1 (From the time of end of surgery [that is; from the first dose of study drug administration]) up to end of follow-up visit (Day 17) Safety population included all randomized participants who received at least 1 dose of study drug.	0.58% 1/173 • Day 1 (From the time of end of surgery [that is; from the first dose of study drug administration]) up to end of follow-up visit (Day 17) Safety population included all randomized participants who received at least 1 dose of study drug.	1.2% 2/171 • Day 1 (From the time of end of surgery [that is; from the first dose of study drug administration]) up to end of follow-up visit (Day 17) Safety population included all randomized participants who received at least 1 dose of study drug.
Cardiac disorders Cardiac failure congestive	0.00% 0/171 • Day 1 (From the time of end of surgery [that is; from the first dose of study drug administration]) up to end of follow-up visit (Day 17) Safety population included all randomized participants who received at least 1 dose of study drug.	0.58% 1/173 • Day 1 (From the time of end of surgery [that is; from the first dose of study drug administration]) up to end of follow-up visit (Day 17) Safety population included all randomized participants who received at least 1 dose of study drug.	0.58% 1/171 • Day 1 (From the time of end of surgery [that is; from the first dose of study drug administration]) up to end of follow-up visit (Day 17) Safety population included all randomized participants who received at least 1 dose of study drug.
Cardiac disorders Cardio-respiratory arrest	0.00% 0/171 • Day 1 (From the time of end of surgery [that is; from the first dose of study drug administration]) up to end of follow-up visit (Day 17) Safety population included all randomized participants who received at least 1 dose of study drug.	0.00% 0/173 • Day 1 (From the time of end of surgery [that is; from the first dose of study drug administration]) up to end of follow-up visit (Day 17) Safety population included all randomized participants who received at least 1 dose of study drug.	0.58% 1/171 • Day 1 (From the time of end of surgery [that is; from the first dose of study drug administration]) up to end of follow-up visit (Day 17) Safety population included all randomized participants who received at least 1 dose of study drug.
Cardiac disorders Myocardial infarction	0.00% 0/171 • Day 1 (From the time of end of surgery [that is; from the first dose of study drug administration]) up to end of follow-up visit (Day 17) Safety population included all randomized participants who received at least 1 dose of study drug.	0.58% 1/173 • Day 1 (From the time of end of surgery [that is; from the first dose of study drug administration]) up to end of follow-up visit (Day 17) Safety population included all randomized participants who received at least 1 dose of study drug.	0.58% 1/171 • Day 1 (From the time of end of surgery [that is; from the first dose of study drug administration]) up to end of follow-up visit (Day 17) Safety population included all randomized participants who received at least 1 dose of study drug.
Gastrointestinal disorders Abdominal adhesions	0.00% 0/171 • Day 1 (From the time of end of surgery [that is; from the first dose of study drug administration]) up to end of follow-up visit (Day 17) Safety population included all randomized participants who received at least 1 dose of study drug.	0.00% 0/173 • Day 1 (From the time of end of surgery [that is; from the first dose of study drug administration]) up to end of follow-up visit (Day 17) Safety population included all randomized participants who received at least 1 dose of study drug.	0.58% 1/171 • Day 1 (From the time of end of surgery [that is; from the first dose of study drug administration]) up to end of follow-up visit (Day 17) Safety population included all randomized participants who received at least 1 dose of study drug.
Gastrointestinal disorders Abdominal discomfort	0.00% 0/171 • Day 1 (From the time of end of surgery [that is; from the first dose of study drug administration]) up to end of follow-up visit (Day 17) Safety population included all randomized participants who received at least 1 dose of study drug.	0.58% 1/173 • Day 1 (From the time of end of surgery [that is; from the first dose of study drug administration]) up to end of follow-up visit (Day 17) Safety population included all randomized participants who received at least 1 dose of study drug.	0.00% 0/171 • Day 1 (From the time of end of surgery [that is; from the first dose of study drug administration]) up to end of follow-up visit (Day 17) Safety population included all randomized participants who received at least 1 dose of study drug.
Gastrointestinal disorders Abdominal distension	0.00% 0/171 • Day 1 (From the time of end of surgery [that is; from the first dose of study drug administration]) up to end of follow-up visit (Day 17) Safety population included all randomized participants who received at least 1 dose of study drug.	0.00% 0/173 • Day 1 (From the time of end of surgery [that is; from the first dose of study drug administration]) up to end of follow-up visit (Day 17) Safety population included all randomized participants who received at least 1 dose of study drug.	0.58% 1/171 • Day 1 (From the time of end of surgery [that is; from the first dose of study drug administration]) up to end of follow-up visit (Day 17) Safety population included all randomized participants who received at least 1 dose of study drug.
Gastrointestinal disorders Abdominal haematoma	0.58% 1/171 • Day 1 (From the time of end of surgery [that is; from the first dose of study drug administration]) up to end of follow-up visit (Day 17) Safety population included all randomized participants who received at least 1 dose of study drug.	0.00% 0/173 • Day 1 (From the time of end of surgery [that is; from the first dose of study drug administration]) up to end of follow-up visit (Day 17) Safety population included all randomized participants who received at least 1 dose of study drug.	0.00% 0/171 • Day 1 (From the time of end of surgery [that is; from the first dose of study drug administration]) up to end of follow-up visit (Day 17) Safety population included all randomized participants who received at least 1 dose of study drug.
Gastrointestinal disorders Colonic obstruction	0.00% 0/171 • Day 1 (From the time of end of surgery [that is; from the first dose of study drug administration]) up to end of follow-up visit (Day 17) Safety population included all randomized participants who received at least 1 dose of study drug.	0.00% 0/173 • Day 1 (From the time of end of surgery [that is; from the first dose of study drug administration]) up to end of follow-up visit (Day 17) Safety population included all randomized participants who received at least 1 dose of study drug.	0.58% 1/171 • Day 1 (From the time of end of surgery [that is; from the first dose of study drug administration]) up to end of follow-up visit (Day 17) Safety population included all randomized participants who received at least 1 dose of study drug.
Gastrointestinal disorders Colonic stenosis	0.00% 0/171 • Day 1 (From the time of end of surgery [that is; from the first dose of study drug administration]) up to end of follow-up visit (Day 17) Safety population included all randomized participants who received at least 1 dose of study drug.	0.00% 0/173 • Day 1 (From the time of end of surgery [that is; from the first dose of study drug administration]) up to end of follow-up visit (Day 17) Safety population included all randomized participants who received at least 1 dose of study drug.	0.58% 1/171 • Day 1 (From the time of end of surgery [that is; from the first dose of study drug administration]) up to end of follow-up visit (Day 17) Safety population included all randomized participants who received at least 1 dose of study drug.
Gastrointestinal disorders Diarrhoea	0.00% 0/171 • Day 1 (From the time of end of surgery [that is; from the first dose of study drug administration]) up to end of follow-up visit (Day 17) Safety population included all randomized participants who received at least 1 dose of study drug.	0.58% 1/173 • Day 1 (From the time of end of surgery [that is; from the first dose of study drug administration]) up to end of follow-up visit (Day 17) Safety population included all randomized participants who received at least 1 dose of study drug.	0.00% 0/171 • Day 1 (From the time of end of surgery [that is; from the first dose of study drug administration]) up to end of follow-up visit (Day 17) Safety population included all randomized participants who received at least 1 dose of study drug.
Gastrointestinal disorders Intestinal obstruction	0.00% 0/171 • Day 1 (From the time of end of surgery [that is; from the first dose of study drug administration]) up to end of follow-up visit (Day 17) Safety population included all randomized participants who received at least 1 dose of study drug.	0.58% 1/173 • Day 1 (From the time of end of surgery [that is; from the first dose of study drug administration]) up to end of follow-up visit (Day 17) Safety population included all randomized participants who received at least 1 dose of study drug.	0.58% 1/171 • Day 1 (From the time of end of surgery [that is; from the first dose of study drug administration]) up to end of follow-up visit (Day 17) Safety population included all randomized participants who received at least 1 dose of study drug.
Gastrointestinal disorders Nausea	0.00% 0/171 • Day 1 (From the time of end of surgery [that is; from the first dose of study drug administration]) up to end of follow-up visit (Day 17) Safety population included all randomized participants who received at least 1 dose of study drug.	0.00% 0/173 • Day 1 (From the time of end of surgery [that is; from the first dose of study drug administration]) up to end of follow-up visit (Day 17) Safety population included all randomized participants who received at least 1 dose of study drug.	0.58% 1/171 • Day 1 (From the time of end of surgery [that is; from the first dose of study drug administration]) up to end of follow-up visit (Day 17) Safety population included all randomized participants who received at least 1 dose of study drug.
Gastrointestinal disorders Pancreatic fistula	0.00% 0/171 • Day 1 (From the time of end of surgery [that is; from the first dose of study drug administration]) up to end of follow-up visit (Day 17) Safety population included all randomized participants who received at least 1 dose of study drug.	0.00% 0/173 • Day 1 (From the time of end of surgery [that is; from the first dose of study drug administration]) up to end of follow-up visit (Day 17) Safety population included all randomized participants who received at least 1 dose of study drug.	0.58% 1/171 • Day 1 (From the time of end of surgery [that is; from the first dose of study drug administration]) up to end of follow-up visit (Day 17) Safety population included all randomized participants who received at least 1 dose of study drug.
Gastrointestinal disorders Pancreatitis	0.00% 0/171 • Day 1 (From the time of end of surgery [that is; from the first dose of study drug administration]) up to end of follow-up visit (Day 17) Safety population included all randomized participants who received at least 1 dose of study drug.	0.58% 1/173 • Day 1 (From the time of end of surgery [that is; from the first dose of study drug administration]) up to end of follow-up visit (Day 17) Safety population included all randomized participants who received at least 1 dose of study drug.	0.58% 1/171 • Day 1 (From the time of end of surgery [that is; from the first dose of study drug administration]) up to end of follow-up visit (Day 17) Safety population included all randomized participants who received at least 1 dose of study drug.
Gastrointestinal disorders Peritoneal effusion	0.00% 0/171 • Day 1 (From the time of end of surgery [that is; from the first dose of study drug administration]) up to end of follow-up visit (Day 17) Safety population included all randomized participants who received at least 1 dose of study drug.	0.00% 0/173 • Day 1 (From the time of end of surgery [that is; from the first dose of study drug administration]) up to end of follow-up visit (Day 17) Safety population included all randomized participants who received at least 1 dose of study drug.	0.58% 1/171 • Day 1 (From the time of end of surgery [that is; from the first dose of study drug administration]) up to end of follow-up visit (Day 17) Safety population included all randomized participants who received at least 1 dose of study drug.
Gastrointestinal disorders Peritoneal haemorrhage	0.00% 0/171 • Day 1 (From the time of end of surgery [that is; from the first dose of study drug administration]) up to end of follow-up visit (Day 17) Safety population included all randomized participants who received at least 1 dose of study drug.	0.00% 0/173 • Day 1 (From the time of end of surgery [that is; from the first dose of study drug administration]) up to end of follow-up visit (Day 17) Safety population included all randomized participants who received at least 1 dose of study drug.	0.58% 1/171 • Day 1 (From the time of end of surgery [that is; from the first dose of study drug administration]) up to end of follow-up visit (Day 17) Safety population included all randomized participants who received at least 1 dose of study drug.
Gastrointestinal disorders Peritonitis	0.58% 1/171 • Day 1 (From the time of end of surgery [that is; from the first dose of study drug administration]) up to end of follow-up visit (Day 17) Safety population included all randomized participants who received at least 1 dose of study drug.	1.7% 3/173 • Day 1 (From the time of end of surgery [that is; from the first dose of study drug administration]) up to end of follow-up visit (Day 17) Safety population included all randomized participants who received at least 1 dose of study drug.	0.00% 0/171 • Day 1 (From the time of end of surgery [that is; from the first dose of study drug administration]) up to end of follow-up visit (Day 17) Safety population included all randomized participants who received at least 1 dose of study drug.
Gastrointestinal disorders Rectal haemorrhage	0.58% 1/171 • Day 1 (From the time of end of surgery [that is; from the first dose of study drug administration]) up to end of follow-up visit (Day 17) Safety population included all randomized participants who received at least 1 dose of study drug.	0.00% 0/173 • Day 1 (From the time of end of surgery [that is; from the first dose of study drug administration]) up to end of follow-up visit (Day 17) Safety population included all randomized participants who received at least 1 dose of study drug.	0.00% 0/171 • Day 1 (From the time of end of surgery [that is; from the first dose of study drug administration]) up to end of follow-up visit (Day 17) Safety population included all randomized participants who received at least 1 dose of study drug.
Gastrointestinal disorders Small intestinal obstruction	0.58% 1/171 • Day 1 (From the time of end of surgery [that is; from the first dose of study drug administration]) up to end of follow-up visit (Day 17) Safety population included all randomized participants who received at least 1 dose of study drug.	1.2% 2/173 • Day 1 (From the time of end of surgery [that is; from the first dose of study drug administration]) up to end of follow-up visit (Day 17) Safety population included all randomized participants who received at least 1 dose of study drug.	1.8% 3/171 • Day 1 (From the time of end of surgery [that is; from the first dose of study drug administration]) up to end of follow-up visit (Day 17) Safety population included all randomized participants who received at least 1 dose of study drug.
Gastrointestinal disorders Thrombosis mesenteric vessel	0.00% 0/171 • Day 1 (From the time of end of surgery [that is; from the first dose of study drug administration]) up to end of follow-up visit (Day 17) Safety population included all randomized participants who received at least 1 dose of study drug.	0.00% 0/173 • Day 1 (From the time of end of surgery [that is; from the first dose of study drug administration]) up to end of follow-up visit (Day 17) Safety population included all randomized participants who received at least 1 dose of study drug.	0.58% 1/171 • Day 1 (From the time of end of surgery [that is; from the first dose of study drug administration]) up to end of follow-up visit (Day 17) Safety population included all randomized participants who received at least 1 dose of study drug.
Gastrointestinal disorders Vomiting	0.00% 0/171 • Day 1 (From the time of end of surgery [that is; from the first dose of study drug administration]) up to end of follow-up visit (Day 17) Safety population included all randomized participants who received at least 1 dose of study drug.	0.00% 0/173 • Day 1 (From the time of end of surgery [that is; from the first dose of study drug administration]) up to end of follow-up visit (Day 17) Safety population included all randomized participants who received at least 1 dose of study drug.	0.58% 1/171 • Day 1 (From the time of end of surgery [that is; from the first dose of study drug administration]) up to end of follow-up visit (Day 17) Safety population included all randomized participants who received at least 1 dose of study drug.
Gastrointestinal disorders Chronic gastrointestinal bleeding	0.58% 1/171 • Day 1 (From the time of end of surgery [that is; from the first dose of study drug administration]) up to end of follow-up visit (Day 17) Safety population included all randomized participants who received at least 1 dose of study drug.	0.00% 0/173 • Day 1 (From the time of end of surgery [that is; from the first dose of study drug administration]) up to end of follow-up visit (Day 17) Safety population included all randomized participants who received at least 1 dose of study drug.	0.00% 0/171 • Day 1 (From the time of end of surgery [that is; from the first dose of study drug administration]) up to end of follow-up visit (Day 17) Safety population included all randomized participants who received at least 1 dose of study drug.
General disorders Multi-organ failure	0.00% 0/171 • Day 1 (From the time of end of surgery [that is; from the first dose of study drug administration]) up to end of follow-up visit (Day 17) Safety population included all randomized participants who received at least 1 dose of study drug.	0.00% 0/173 • Day 1 (From the time of end of surgery [that is; from the first dose of study drug administration]) up to end of follow-up visit (Day 17) Safety population included all randomized participants who received at least 1 dose of study drug.	0.58% 1/171 • Day 1 (From the time of end of surgery [that is; from the first dose of study drug administration]) up to end of follow-up visit (Day 17) Safety population included all randomized participants who received at least 1 dose of study drug.
General disorders Non-cardiac chest pain	0.00% 0/171 • Day 1 (From the time of end of surgery [that is; from the first dose of study drug administration]) up to end of follow-up visit (Day 17) Safety population included all randomized participants who received at least 1 dose of study drug.	0.00% 0/173 • Day 1 (From the time of end of surgery [that is; from the first dose of study drug administration]) up to end of follow-up visit (Day 17) Safety population included all randomized participants who received at least 1 dose of study drug.	0.58% 1/171 • Day 1 (From the time of end of surgery [that is; from the first dose of study drug administration]) up to end of follow-up visit (Day 17) Safety population included all randomized participants who received at least 1 dose of study drug.
General disorders Pyrexia	0.58% 1/171 • Day 1 (From the time of end of surgery [that is; from the first dose of study drug administration]) up to end of follow-up visit (Day 17) Safety population included all randomized participants who received at least 1 dose of study drug.	0.58% 1/173 • Day 1 (From the time of end of surgery [that is; from the first dose of study drug administration]) up to end of follow-up visit (Day 17) Safety population included all randomized participants who received at least 1 dose of study drug.	0.00% 0/171 • Day 1 (From the time of end of surgery [that is; from the first dose of study drug administration]) up to end of follow-up visit (Day 17) Safety population included all randomized participants who received at least 1 dose of study drug.
Hepatobiliary disorders Cholecystitis acute	0.00% 0/171 • Day 1 (From the time of end of surgery [that is; from the first dose of study drug administration]) up to end of follow-up visit (Day 17) Safety population included all randomized participants who received at least 1 dose of study drug.	0.00% 0/173 • Day 1 (From the time of end of surgery [that is; from the first dose of study drug administration]) up to end of follow-up visit (Day 17) Safety population included all randomized participants who received at least 1 dose of study drug.	0.58% 1/171 • Day 1 (From the time of end of surgery [that is; from the first dose of study drug administration]) up to end of follow-up visit (Day 17) Safety population included all randomized participants who received at least 1 dose of study drug.
Hepatobiliary disorders Portal vein thrombosis	0.00% 0/171 • Day 1 (From the time of end of surgery [that is; from the first dose of study drug administration]) up to end of follow-up visit (Day 17) Safety population included all randomized participants who received at least 1 dose of study drug.	0.00% 0/173 • Day 1 (From the time of end of surgery [that is; from the first dose of study drug administration]) up to end of follow-up visit (Day 17) Safety population included all randomized participants who received at least 1 dose of study drug.	0.58% 1/171 • Day 1 (From the time of end of surgery [that is; from the first dose of study drug administration]) up to end of follow-up visit (Day 17) Safety population included all randomized participants who received at least 1 dose of study drug.
Infections and infestations Abdominal abscess	0.58% 1/171 • Day 1 (From the time of end of surgery [that is; from the first dose of study drug administration]) up to end of follow-up visit (Day 17) Safety population included all randomized participants who received at least 1 dose of study drug.	1.7% 3/173 • Day 1 (From the time of end of surgery [that is; from the first dose of study drug administration]) up to end of follow-up visit (Day 17) Safety population included all randomized participants who received at least 1 dose of study drug.	1.2% 2/171 • Day 1 (From the time of end of surgery [that is; from the first dose of study drug administration]) up to end of follow-up visit (Day 17) Safety population included all randomized participants who received at least 1 dose of study drug.
Infections and infestations Abdominal infection	0.58% 1/171 • Day 1 (From the time of end of surgery [that is; from the first dose of study drug administration]) up to end of follow-up visit (Day 17) Safety population included all randomized participants who received at least 1 dose of study drug.	0.00% 0/173 • Day 1 (From the time of end of surgery [that is; from the first dose of study drug administration]) up to end of follow-up visit (Day 17) Safety population included all randomized participants who received at least 1 dose of study drug.	0.00% 0/171 • Day 1 (From the time of end of surgery [that is; from the first dose of study drug administration]) up to end of follow-up visit (Day 17) Safety population included all randomized participants who received at least 1 dose of study drug.
Infections and infestations Abdominal sepsis	0.00% 0/171 • Day 1 (From the time of end of surgery [that is; from the first dose of study drug administration]) up to end of follow-up visit (Day 17) Safety population included all randomized participants who received at least 1 dose of study drug.	0.58% 1/173 • Day 1 (From the time of end of surgery [that is; from the first dose of study drug administration]) up to end of follow-up visit (Day 17) Safety population included all randomized participants who received at least 1 dose of study drug.	0.58% 1/171 • Day 1 (From the time of end of surgery [that is; from the first dose of study drug administration]) up to end of follow-up visit (Day 17) Safety population included all randomized participants who received at least 1 dose of study drug.
Infections and infestations Cellulitis	0.00% 0/171 • Day 1 (From the time of end of surgery [that is; from the first dose of study drug administration]) up to end of follow-up visit (Day 17) Safety population included all randomized participants who received at least 1 dose of study drug.	0.00% 0/173 • Day 1 (From the time of end of surgery [that is; from the first dose of study drug administration]) up to end of follow-up visit (Day 17) Safety population included all randomized participants who received at least 1 dose of study drug.	0.58% 1/171 • Day 1 (From the time of end of surgery [that is; from the first dose of study drug administration]) up to end of follow-up visit (Day 17) Safety population included all randomized participants who received at least 1 dose of study drug.
Infections and infestations Clostridial infection	0.00% 0/171 • Day 1 (From the time of end of surgery [that is; from the first dose of study drug administration]) up to end of follow-up visit (Day 17) Safety population included all randomized participants who received at least 1 dose of study drug.	0.00% 0/173 • Day 1 (From the time of end of surgery [that is; from the first dose of study drug administration]) up to end of follow-up visit (Day 17) Safety population included all randomized participants who received at least 1 dose of study drug.	0.58% 1/171 • Day 1 (From the time of end of surgery [that is; from the first dose of study drug administration]) up to end of follow-up visit (Day 17) Safety population included all randomized participants who received at least 1 dose of study drug.
Infections and infestations Diverticulitis	0.00% 0/171 • Day 1 (From the time of end of surgery [that is; from the first dose of study drug administration]) up to end of follow-up visit (Day 17) Safety population included all randomized participants who received at least 1 dose of study drug.	0.58% 1/173 • Day 1 (From the time of end of surgery [that is; from the first dose of study drug administration]) up to end of follow-up visit (Day 17) Safety population included all randomized participants who received at least 1 dose of study drug.	0.00% 0/171 • Day 1 (From the time of end of surgery [that is; from the first dose of study drug administration]) up to end of follow-up visit (Day 17) Safety population included all randomized participants who received at least 1 dose of study drug.
Infections and infestations Gastroenteritis	0.00% 0/171 • Day 1 (From the time of end of surgery [that is; from the first dose of study drug administration]) up to end of follow-up visit (Day 17) Safety population included all randomized participants who received at least 1 dose of study drug.	0.58% 1/173 • Day 1 (From the time of end of surgery [that is; from the first dose of study drug administration]) up to end of follow-up visit (Day 17) Safety population included all randomized participants who received at least 1 dose of study drug.	0.00% 0/171 • Day 1 (From the time of end of surgery [that is; from the first dose of study drug administration]) up to end of follow-up visit (Day 17) Safety population included all randomized participants who received at least 1 dose of study drug.
Infections and infestations Haematoma infection	0.58% 1/171 • Day 1 (From the time of end of surgery [that is; from the first dose of study drug administration]) up to end of follow-up visit (Day 17) Safety population included all randomized participants who received at least 1 dose of study drug.	0.00% 0/173 • Day 1 (From the time of end of surgery [that is; from the first dose of study drug administration]) up to end of follow-up visit (Day 17) Safety population included all randomized participants who received at least 1 dose of study drug.	0.58% 1/171 • Day 1 (From the time of end of surgery [that is; from the first dose of study drug administration]) up to end of follow-up visit (Day 17) Safety population included all randomized participants who received at least 1 dose of study drug.
Infections and infestations Incision site cellulitis	0.00% 0/171 • Day 1 (From the time of end of surgery [that is; from the first dose of study drug administration]) up to end of follow-up visit (Day 17) Safety population included all randomized participants who received at least 1 dose of study drug.	0.58% 1/173 • Day 1 (From the time of end of surgery [that is; from the first dose of study drug administration]) up to end of follow-up visit (Day 17) Safety population included all randomized participants who received at least 1 dose of study drug.	0.00% 0/171 • Day 1 (From the time of end of surgery [that is; from the first dose of study drug administration]) up to end of follow-up visit (Day 17) Safety population included all randomized participants who received at least 1 dose of study drug.
Infections and infestations Incision site infection	0.58% 1/171 • Day 1 (From the time of end of surgery [that is; from the first dose of study drug administration]) up to end of follow-up visit (Day 17) Safety population included all randomized participants who received at least 1 dose of study drug.	0.00% 0/173 • Day 1 (From the time of end of surgery [that is; from the first dose of study drug administration]) up to end of follow-up visit (Day 17) Safety population included all randomized participants who received at least 1 dose of study drug.	0.00% 0/171 • Day 1 (From the time of end of surgery [that is; from the first dose of study drug administration]) up to end of follow-up visit (Day 17) Safety population included all randomized participants who received at least 1 dose of study drug.
Infections and infestations Liver abscess	0.00% 0/171 • Day 1 (From the time of end of surgery [that is; from the first dose of study drug administration]) up to end of follow-up visit (Day 17) Safety population included all randomized participants who received at least 1 dose of study drug.	0.58% 1/173 • Day 1 (From the time of end of surgery [that is; from the first dose of study drug administration]) up to end of follow-up visit (Day 17) Safety population included all randomized participants who received at least 1 dose of study drug.	0.00% 0/171 • Day 1 (From the time of end of surgery [that is; from the first dose of study drug administration]) up to end of follow-up visit (Day 17) Safety population included all randomized participants who received at least 1 dose of study drug.
Infections and infestations Pelvic abscess	1.2% 2/171 • Day 1 (From the time of end of surgery [that is; from the first dose of study drug administration]) up to end of follow-up visit (Day 17) Safety population included all randomized participants who received at least 1 dose of study drug.	0.00% 0/173 • Day 1 (From the time of end of surgery [that is; from the first dose of study drug administration]) up to end of follow-up visit (Day 17) Safety population included all randomized participants who received at least 1 dose of study drug.	0.00% 0/171 • Day 1 (From the time of end of surgery [that is; from the first dose of study drug administration]) up to end of follow-up visit (Day 17) Safety population included all randomized participants who received at least 1 dose of study drug.
Infections and infestations Pneumonia	0.58% 1/171 • Day 1 (From the time of end of surgery [that is; from the first dose of study drug administration]) up to end of follow-up visit (Day 17) Safety population included all randomized participants who received at least 1 dose of study drug.	1.7% 3/173 • Day 1 (From the time of end of surgery [that is; from the first dose of study drug administration]) up to end of follow-up visit (Day 17) Safety population included all randomized participants who received at least 1 dose of study drug.	0.00% 0/171 • Day 1 (From the time of end of surgery [that is; from the first dose of study drug administration]) up to end of follow-up visit (Day 17) Safety population included all randomized participants who received at least 1 dose of study drug.
Infections and infestations Postoperative wound infection	0.58% 1/171 • Day 1 (From the time of end of surgery [that is; from the first dose of study drug administration]) up to end of follow-up visit (Day 17) Safety population included all randomized participants who received at least 1 dose of study drug.	0.58% 1/173 • Day 1 (From the time of end of surgery [that is; from the first dose of study drug administration]) up to end of follow-up visit (Day 17) Safety population included all randomized participants who received at least 1 dose of study drug.	0.58% 1/171 • Day 1 (From the time of end of surgery [that is; from the first dose of study drug administration]) up to end of follow-up visit (Day 17) Safety population included all randomized participants who received at least 1 dose of study drug.
Infections and infestations Sepsis	1.8% 3/171 • Day 1 (From the time of end of surgery [that is; from the first dose of study drug administration]) up to end of follow-up visit (Day 17) Safety population included all randomized participants who received at least 1 dose of study drug.	2.3% 4/173 • Day 1 (From the time of end of surgery [that is; from the first dose of study drug administration]) up to end of follow-up visit (Day 17) Safety population included all randomized participants who received at least 1 dose of study drug.	2.3% 4/171 • Day 1 (From the time of end of surgery [that is; from the first dose of study drug administration]) up to end of follow-up visit (Day 17) Safety population included all randomized participants who received at least 1 dose of study drug.
Infections and infestations Septic shock	0.00% 0/171 • Day 1 (From the time of end of surgery [that is; from the first dose of study drug administration]) up to end of follow-up visit (Day 17) Safety population included all randomized participants who received at least 1 dose of study drug.	0.00% 0/173 • Day 1 (From the time of end of surgery [that is; from the first dose of study drug administration]) up to end of follow-up visit (Day 17) Safety population included all randomized participants who received at least 1 dose of study drug.	0.58% 1/171 • Day 1 (From the time of end of surgery [that is; from the first dose of study drug administration]) up to end of follow-up visit (Day 17) Safety population included all randomized participants who received at least 1 dose of study drug.
Infections and infestations Wound infection	0.58% 1/171 • Day 1 (From the time of end of surgery [that is; from the first dose of study drug administration]) up to end of follow-up visit (Day 17) Safety population included all randomized participants who received at least 1 dose of study drug.	0.58% 1/173 • Day 1 (From the time of end of surgery [that is; from the first dose of study drug administration]) up to end of follow-up visit (Day 17) Safety population included all randomized participants who received at least 1 dose of study drug.	1.2% 2/171 • Day 1 (From the time of end of surgery [that is; from the first dose of study drug administration]) up to end of follow-up visit (Day 17) Safety population included all randomized participants who received at least 1 dose of study drug.
Injury, poisoning and procedural complications Anaemia postoperative	0.58% 1/171 • Day 1 (From the time of end of surgery [that is; from the first dose of study drug administration]) up to end of follow-up visit (Day 17) Safety population included all randomized participants who received at least 1 dose of study drug.	0.00% 0/173 • Day 1 (From the time of end of surgery [that is; from the first dose of study drug administration]) up to end of follow-up visit (Day 17) Safety population included all randomized participants who received at least 1 dose of study drug.	0.00% 0/171 • Day 1 (From the time of end of surgery [that is; from the first dose of study drug administration]) up to end of follow-up visit (Day 17) Safety population included all randomized participants who received at least 1 dose of study drug.
Injury, poisoning and procedural complications Anastomotic leak	3.5% 6/171 • Day 1 (From the time of end of surgery [that is; from the first dose of study drug administration]) up to end of follow-up visit (Day 17) Safety population included all randomized participants who received at least 1 dose of study drug.	3.5% 6/173 • Day 1 (From the time of end of surgery [that is; from the first dose of study drug administration]) up to end of follow-up visit (Day 17) Safety population included all randomized participants who received at least 1 dose of study drug.	3.5% 6/171 • Day 1 (From the time of end of surgery [that is; from the first dose of study drug administration]) up to end of follow-up visit (Day 17) Safety population included all randomized participants who received at least 1 dose of study drug.
Injury, poisoning and procedural complications Ankle fracture	0.58% 1/171 • Day 1 (From the time of end of surgery [that is; from the first dose of study drug administration]) up to end of follow-up visit (Day 17) Safety population included all randomized participants who received at least 1 dose of study drug.	0.00% 0/173 • Day 1 (From the time of end of surgery [that is; from the first dose of study drug administration]) up to end of follow-up visit (Day 17) Safety population included all randomized participants who received at least 1 dose of study drug.	0.00% 0/171 • Day 1 (From the time of end of surgery [that is; from the first dose of study drug administration]) up to end of follow-up visit (Day 17) Safety population included all randomized participants who received at least 1 dose of study drug.
Injury, poisoning and procedural complications Failure to anastomose	0.00% 0/171 • Day 1 (From the time of end of surgery [that is; from the first dose of study drug administration]) up to end of follow-up visit (Day 17) Safety population included all randomized participants who received at least 1 dose of study drug.	0.58% 1/173 • Day 1 (From the time of end of surgery [that is; from the first dose of study drug administration]) up to end of follow-up visit (Day 17) Safety population included all randomized participants who received at least 1 dose of study drug.	0.00% 0/171 • Day 1 (From the time of end of surgery [that is; from the first dose of study drug administration]) up to end of follow-up visit (Day 17) Safety population included all randomized participants who received at least 1 dose of study drug.
Injury, poisoning and procedural complications Gastrointestinal anastomotic leak	0.00% 0/171 • Day 1 (From the time of end of surgery [that is; from the first dose of study drug administration]) up to end of follow-up visit (Day 17) Safety population included all randomized participants who received at least 1 dose of study drug.	1.2% 2/173 • Day 1 (From the time of end of surgery [that is; from the first dose of study drug administration]) up to end of follow-up visit (Day 17) Safety population included all randomized participants who received at least 1 dose of study drug.	0.00% 0/171 • Day 1 (From the time of end of surgery [that is; from the first dose of study drug administration]) up to end of follow-up visit (Day 17) Safety population included all randomized participants who received at least 1 dose of study drug.
Injury, poisoning and procedural complications Incision site erythema	0.00% 0/171 • Day 1 (From the time of end of surgery [that is; from the first dose of study drug administration]) up to end of follow-up visit (Day 17) Safety population included all randomized participants who received at least 1 dose of study drug.	0.00% 0/173 • Day 1 (From the time of end of surgery [that is; from the first dose of study drug administration]) up to end of follow-up visit (Day 17) Safety population included all randomized participants who received at least 1 dose of study drug.	0.58% 1/171 • Day 1 (From the time of end of surgery [that is; from the first dose of study drug administration]) up to end of follow-up visit (Day 17) Safety population included all randomized participants who received at least 1 dose of study drug.
Injury, poisoning and procedural complications Incisional hernia	0.58% 1/171 • Day 1 (From the time of end of surgery [that is; from the first dose of study drug administration]) up to end of follow-up visit (Day 17) Safety population included all randomized participants who received at least 1 dose of study drug.	0.00% 0/173 • Day 1 (From the time of end of surgery [that is; from the first dose of study drug administration]) up to end of follow-up visit (Day 17) Safety population included all randomized participants who received at least 1 dose of study drug.	0.00% 0/171 • Day 1 (From the time of end of surgery [that is; from the first dose of study drug administration]) up to end of follow-up visit (Day 17) Safety population included all randomized participants who received at least 1 dose of study drug.
Injury, poisoning and procedural complications Post procedural haemorrhage	1.2% 2/171 • Day 1 (From the time of end of surgery [that is; from the first dose of study drug administration]) up to end of follow-up visit (Day 17) Safety population included all randomized participants who received at least 1 dose of study drug.	0.00% 0/173 • Day 1 (From the time of end of surgery [that is; from the first dose of study drug administration]) up to end of follow-up visit (Day 17) Safety population included all randomized participants who received at least 1 dose of study drug.	0.00% 0/171 • Day 1 (From the time of end of surgery [that is; from the first dose of study drug administration]) up to end of follow-up visit (Day 17) Safety population included all randomized participants who received at least 1 dose of study drug.
Injury, poisoning and procedural complications Post procedural pulmonary embolism	1.8% 3/171 • Day 1 (From the time of end of surgery [that is; from the first dose of study drug administration]) up to end of follow-up visit (Day 17) Safety population included all randomized participants who received at least 1 dose of study drug.	1.2% 2/173 • Day 1 (From the time of end of surgery [that is; from the first dose of study drug administration]) up to end of follow-up visit (Day 17) Safety population included all randomized participants who received at least 1 dose of study drug.	0.00% 0/171 • Day 1 (From the time of end of surgery [that is; from the first dose of study drug administration]) up to end of follow-up visit (Day 17) Safety population included all randomized participants who received at least 1 dose of study drug.
Injury, poisoning and procedural complications Postoperative ileus	0.58% 1/171 • Day 1 (From the time of end of surgery [that is; from the first dose of study drug administration]) up to end of follow-up visit (Day 17) Safety population included all randomized participants who received at least 1 dose of study drug.	1.7% 3/173 • Day 1 (From the time of end of surgery [that is; from the first dose of study drug administration]) up to end of follow-up visit (Day 17) Safety population included all randomized participants who received at least 1 dose of study drug.	2.9% 5/171 • Day 1 (From the time of end of surgery [that is; from the first dose of study drug administration]) up to end of follow-up visit (Day 17) Safety population included all randomized participants who received at least 1 dose of study drug.
Injury, poisoning and procedural complications Postoperative respiratory distress	0.00% 0/171 • Day 1 (From the time of end of surgery [that is; from the first dose of study drug administration]) up to end of follow-up visit (Day 17) Safety population included all randomized participants who received at least 1 dose of study drug.	0.58% 1/173 • Day 1 (From the time of end of surgery [that is; from the first dose of study drug administration]) up to end of follow-up visit (Day 17) Safety population included all randomized participants who received at least 1 dose of study drug.	0.00% 0/171 • Day 1 (From the time of end of surgery [that is; from the first dose of study drug administration]) up to end of follow-up visit (Day 17) Safety population included all randomized participants who received at least 1 dose of study drug.
Injury, poisoning and procedural complications Postoperative thrombosis	0.58% 1/171 • Day 1 (From the time of end of surgery [that is; from the first dose of study drug administration]) up to end of follow-up visit (Day 17) Safety population included all randomized participants who received at least 1 dose of study drug.	0.00% 0/173 • Day 1 (From the time of end of surgery [that is; from the first dose of study drug administration]) up to end of follow-up visit (Day 17) Safety population included all randomized participants who received at least 1 dose of study drug.	0.00% 0/171 • Day 1 (From the time of end of surgery [that is; from the first dose of study drug administration]) up to end of follow-up visit (Day 17) Safety population included all randomized participants who received at least 1 dose of study drug.
Injury, poisoning and procedural complications Wound dehiscence	1.8% 3/171 • Day 1 (From the time of end of surgery [that is; from the first dose of study drug administration]) up to end of follow-up visit (Day 17) Safety population included all randomized participants who received at least 1 dose of study drug.	0.58% 1/173 • Day 1 (From the time of end of surgery [that is; from the first dose of study drug administration]) up to end of follow-up visit (Day 17) Safety population included all randomized participants who received at least 1 dose of study drug.	0.00% 0/171 • Day 1 (From the time of end of surgery [that is; from the first dose of study drug administration]) up to end of follow-up visit (Day 17) Safety population included all randomized participants who received at least 1 dose of study drug.
Investigations Hepatic enzyme abnormal	0.00% 0/171 • Day 1 (From the time of end of surgery [that is; from the first dose of study drug administration]) up to end of follow-up visit (Day 17) Safety population included all randomized participants who received at least 1 dose of study drug.	0.00% 0/173 • Day 1 (From the time of end of surgery [that is; from the first dose of study drug administration]) up to end of follow-up visit (Day 17) Safety population included all randomized participants who received at least 1 dose of study drug.	0.58% 1/171 • Day 1 (From the time of end of surgery [that is; from the first dose of study drug administration]) up to end of follow-up visit (Day 17) Safety population included all randomized participants who received at least 1 dose of study drug.
Metabolism and nutrition disorders Anorexia	0.00% 0/171 • Day 1 (From the time of end of surgery [that is; from the first dose of study drug administration]) up to end of follow-up visit (Day 17) Safety population included all randomized participants who received at least 1 dose of study drug.	0.00% 0/173 • Day 1 (From the time of end of surgery [that is; from the first dose of study drug administration]) up to end of follow-up visit (Day 17) Safety population included all randomized participants who received at least 1 dose of study drug.	0.58% 1/171 • Day 1 (From the time of end of surgery [that is; from the first dose of study drug administration]) up to end of follow-up visit (Day 17) Safety population included all randomized participants who received at least 1 dose of study drug.
Metabolism and nutrition disorders Dehydration	0.00% 0/171 • Day 1 (From the time of end of surgery [that is; from the first dose of study drug administration]) up to end of follow-up visit (Day 17) Safety population included all randomized participants who received at least 1 dose of study drug.	0.58% 1/173 • Day 1 (From the time of end of surgery [that is; from the first dose of study drug administration]) up to end of follow-up visit (Day 17) Safety population included all randomized participants who received at least 1 dose of study drug.	0.00% 0/171 • Day 1 (From the time of end of surgery [that is; from the first dose of study drug administration]) up to end of follow-up visit (Day 17) Safety population included all randomized participants who received at least 1 dose of study drug.
Metabolism and nutrition disorders Fluid retention	0.58% 1/171 • Day 1 (From the time of end of surgery [that is; from the first dose of study drug administration]) up to end of follow-up visit (Day 17) Safety population included all randomized participants who received at least 1 dose of study drug.	0.58% 1/173 • Day 1 (From the time of end of surgery [that is; from the first dose of study drug administration]) up to end of follow-up visit (Day 17) Safety population included all randomized participants who received at least 1 dose of study drug.	0.00% 0/171 • Day 1 (From the time of end of surgery [that is; from the first dose of study drug administration]) up to end of follow-up visit (Day 17) Safety population included all randomized participants who received at least 1 dose of study drug.
Metabolism and nutrition disorders General nutrition disorder	0.00% 0/171 • Day 1 (From the time of end of surgery [that is; from the first dose of study drug administration]) up to end of follow-up visit (Day 17) Safety population included all randomized participants who received at least 1 dose of study drug.	0.00% 0/173 • Day 1 (From the time of end of surgery [that is; from the first dose of study drug administration]) up to end of follow-up visit (Day 17) Safety population included all randomized participants who received at least 1 dose of study drug.	0.58% 1/171 • Day 1 (From the time of end of surgery [that is; from the first dose of study drug administration]) up to end of follow-up visit (Day 17) Safety population included all randomized participants who received at least 1 dose of study drug.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Colon cancer stage I	0.00% 0/171 • Day 1 (From the time of end of surgery [that is; from the first dose of study drug administration]) up to end of follow-up visit (Day 17) Safety population included all randomized participants who received at least 1 dose of study drug.	0.58% 1/173 • Day 1 (From the time of end of surgery [that is; from the first dose of study drug administration]) up to end of follow-up visit (Day 17) Safety population included all randomized participants who received at least 1 dose of study drug.	0.00% 0/171 • Day 1 (From the time of end of surgery [that is; from the first dose of study drug administration]) up to end of follow-up visit (Day 17) Safety population included all randomized participants who received at least 1 dose of study drug.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Malignant pleural effusion	0.00% 0/171 • Day 1 (From the time of end of surgery [that is; from the first dose of study drug administration]) up to end of follow-up visit (Day 17) Safety population included all randomized participants who received at least 1 dose of study drug.	0.00% 0/173 • Day 1 (From the time of end of surgery [that is; from the first dose of study drug administration]) up to end of follow-up visit (Day 17) Safety population included all randomized participants who received at least 1 dose of study drug.	0.58% 1/171 • Day 1 (From the time of end of surgery [that is; from the first dose of study drug administration]) up to end of follow-up visit (Day 17) Safety population included all randomized participants who received at least 1 dose of study drug.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases to lymph nodes	0.00% 0/171 • Day 1 (From the time of end of surgery [that is; from the first dose of study drug administration]) up to end of follow-up visit (Day 17) Safety population included all randomized participants who received at least 1 dose of study drug.	0.00% 0/173 • Day 1 (From the time of end of surgery [that is; from the first dose of study drug administration]) up to end of follow-up visit (Day 17) Safety population included all randomized participants who received at least 1 dose of study drug.	0.58% 1/171 • Day 1 (From the time of end of surgery [that is; from the first dose of study drug administration]) up to end of follow-up visit (Day 17) Safety population included all randomized participants who received at least 1 dose of study drug.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Small cell lung cancer stage unspecified	0.00% 0/171 • Day 1 (From the time of end of surgery [that is; from the first dose of study drug administration]) up to end of follow-up visit (Day 17) Safety population included all randomized participants who received at least 1 dose of study drug.	0.00% 0/173 • Day 1 (From the time of end of surgery [that is; from the first dose of study drug administration]) up to end of follow-up visit (Day 17) Safety population included all randomized participants who received at least 1 dose of study drug.	0.58% 1/171 • Day 1 (From the time of end of surgery [that is; from the first dose of study drug administration]) up to end of follow-up visit (Day 17) Safety population included all randomized participants who received at least 1 dose of study drug.
Nervous system disorders Encephalopathy	0.00% 0/171 • Day 1 (From the time of end of surgery [that is; from the first dose of study drug administration]) up to end of follow-up visit (Day 17) Safety population included all randomized participants who received at least 1 dose of study drug.	0.58% 1/173 • Day 1 (From the time of end of surgery [that is; from the first dose of study drug administration]) up to end of follow-up visit (Day 17) Safety population included all randomized participants who received at least 1 dose of study drug.	0.00% 0/171 • Day 1 (From the time of end of surgery [that is; from the first dose of study drug administration]) up to end of follow-up visit (Day 17) Safety population included all randomized participants who received at least 1 dose of study drug.
Psychiatric disorders Delirium	0.00% 0/171 • Day 1 (From the time of end of surgery [that is; from the first dose of study drug administration]) up to end of follow-up visit (Day 17) Safety population included all randomized participants who received at least 1 dose of study drug.	0.58% 1/173 • Day 1 (From the time of end of surgery [that is; from the first dose of study drug administration]) up to end of follow-up visit (Day 17) Safety population included all randomized participants who received at least 1 dose of study drug.	0.00% 0/171 • Day 1 (From the time of end of surgery [that is; from the first dose of study drug administration]) up to end of follow-up visit (Day 17) Safety population included all randomized participants who received at least 1 dose of study drug.
Renal and urinary disorders Haematuria	0.58% 1/171 • Day 1 (From the time of end of surgery [that is; from the first dose of study drug administration]) up to end of follow-up visit (Day 17) Safety population included all randomized participants who received at least 1 dose of study drug.	0.00% 0/173 • Day 1 (From the time of end of surgery [that is; from the first dose of study drug administration]) up to end of follow-up visit (Day 17) Safety population included all randomized participants who received at least 1 dose of study drug.	0.00% 0/171 • Day 1 (From the time of end of surgery [that is; from the first dose of study drug administration]) up to end of follow-up visit (Day 17) Safety population included all randomized participants who received at least 1 dose of study drug.
Renal and urinary disorders Oliguria	0.58% 1/171 • Day 1 (From the time of end of surgery [that is; from the first dose of study drug administration]) up to end of follow-up visit (Day 17) Safety population included all randomized participants who received at least 1 dose of study drug.	0.00% 0/173 • Day 1 (From the time of end of surgery [that is; from the first dose of study drug administration]) up to end of follow-up visit (Day 17) Safety population included all randomized participants who received at least 1 dose of study drug.	0.00% 0/171 • Day 1 (From the time of end of surgery [that is; from the first dose of study drug administration]) up to end of follow-up visit (Day 17) Safety population included all randomized participants who received at least 1 dose of study drug.
Renal and urinary disorders Renal failure	0.58% 1/171 • Day 1 (From the time of end of surgery [that is; from the first dose of study drug administration]) up to end of follow-up visit (Day 17) Safety population included all randomized participants who received at least 1 dose of study drug.	0.58% 1/173 • Day 1 (From the time of end of surgery [that is; from the first dose of study drug administration]) up to end of follow-up visit (Day 17) Safety population included all randomized participants who received at least 1 dose of study drug.	0.00% 0/171 • Day 1 (From the time of end of surgery [that is; from the first dose of study drug administration]) up to end of follow-up visit (Day 17) Safety population included all randomized participants who received at least 1 dose of study drug.
Renal and urinary disorders Renal failure acute	0.58% 1/171 • Day 1 (From the time of end of surgery [that is; from the first dose of study drug administration]) up to end of follow-up visit (Day 17) Safety population included all randomized participants who received at least 1 dose of study drug.	0.00% 0/173 • Day 1 (From the time of end of surgery [that is; from the first dose of study drug administration]) up to end of follow-up visit (Day 17) Safety population included all randomized participants who received at least 1 dose of study drug.	0.00% 0/171 • Day 1 (From the time of end of surgery [that is; from the first dose of study drug administration]) up to end of follow-up visit (Day 17) Safety population included all randomized participants who received at least 1 dose of study drug.
Renal and urinary disorders Urinary retention	0.58% 1/171 • Day 1 (From the time of end of surgery [that is; from the first dose of study drug administration]) up to end of follow-up visit (Day 17) Safety population included all randomized participants who received at least 1 dose of study drug.	0.00% 0/173 • Day 1 (From the time of end of surgery [that is; from the first dose of study drug administration]) up to end of follow-up visit (Day 17) Safety population included all randomized participants who received at least 1 dose of study drug.	0.00% 0/171 • Day 1 (From the time of end of surgery [that is; from the first dose of study drug administration]) up to end of follow-up visit (Day 17) Safety population included all randomized participants who received at least 1 dose of study drug.
Reproductive system and breast disorders Female genital tract fistula	0.00% 0/171 • Day 1 (From the time of end of surgery [that is; from the first dose of study drug administration]) up to end of follow-up visit (Day 17) Safety population included all randomized participants who received at least 1 dose of study drug.	0.00% 0/173 • Day 1 (From the time of end of surgery [that is; from the first dose of study drug administration]) up to end of follow-up visit (Day 17) Safety population included all randomized participants who received at least 1 dose of study drug.	0.58% 1/171 • Day 1 (From the time of end of surgery [that is; from the first dose of study drug administration]) up to end of follow-up visit (Day 17) Safety population included all randomized participants who received at least 1 dose of study drug.
Respiratory, thoracic and mediastinal disorders Acute pulmonary oedema	0.00% 0/171 • Day 1 (From the time of end of surgery [that is; from the first dose of study drug administration]) up to end of follow-up visit (Day 17) Safety population included all randomized participants who received at least 1 dose of study drug.	0.58% 1/173 • Day 1 (From the time of end of surgery [that is; from the first dose of study drug administration]) up to end of follow-up visit (Day 17) Safety population included all randomized participants who received at least 1 dose of study drug.	0.00% 0/171 • Day 1 (From the time of end of surgery [that is; from the first dose of study drug administration]) up to end of follow-up visit (Day 17) Safety population included all randomized participants who received at least 1 dose of study drug.
Respiratory, thoracic and mediastinal disorders Acute respiratory distress syndrome	0.58% 1/171 • Day 1 (From the time of end of surgery [that is; from the first dose of study drug administration]) up to end of follow-up visit (Day 17) Safety population included all randomized participants who received at least 1 dose of study drug.	0.00% 0/173 • Day 1 (From the time of end of surgery [that is; from the first dose of study drug administration]) up to end of follow-up visit (Day 17) Safety population included all randomized participants who received at least 1 dose of study drug.	0.00% 0/171 • Day 1 (From the time of end of surgery [that is; from the first dose of study drug administration]) up to end of follow-up visit (Day 17) Safety population included all randomized participants who received at least 1 dose of study drug.
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	1.2% 2/171 • Day 1 (From the time of end of surgery [that is; from the first dose of study drug administration]) up to end of follow-up visit (Day 17) Safety population included all randomized participants who received at least 1 dose of study drug.	0.00% 0/173 • Day 1 (From the time of end of surgery [that is; from the first dose of study drug administration]) up to end of follow-up visit (Day 17) Safety population included all randomized participants who received at least 1 dose of study drug.	0.00% 0/171 • Day 1 (From the time of end of surgery [that is; from the first dose of study drug administration]) up to end of follow-up visit (Day 17) Safety population included all randomized participants who received at least 1 dose of study drug.
Respiratory, thoracic and mediastinal disorders Respiratory failure	0.58% 1/171 • Day 1 (From the time of end of surgery [that is; from the first dose of study drug administration]) up to end of follow-up visit (Day 17) Safety population included all randomized participants who received at least 1 dose of study drug.	1.2% 2/173 • Day 1 (From the time of end of surgery [that is; from the first dose of study drug administration]) up to end of follow-up visit (Day 17) Safety population included all randomized participants who received at least 1 dose of study drug.	1.8% 3/171 • Day 1 (From the time of end of surgery [that is; from the first dose of study drug administration]) up to end of follow-up visit (Day 17) Safety population included all randomized participants who received at least 1 dose of study drug.
Vascular disorders Deep vein thrombosis	0.00% 0/171 • Day 1 (From the time of end of surgery [that is; from the first dose of study drug administration]) up to end of follow-up visit (Day 17) Safety population included all randomized participants who received at least 1 dose of study drug.	0.00% 0/173 • Day 1 (From the time of end of surgery [that is; from the first dose of study drug administration]) up to end of follow-up visit (Day 17) Safety population included all randomized participants who received at least 1 dose of study drug.	1.2% 2/171 • Day 1 (From the time of end of surgery [that is; from the first dose of study drug administration]) up to end of follow-up visit (Day 17) Safety population included all randomized participants who received at least 1 dose of study drug.
Vascular disorders Hypertension	0.58% 1/171 • Day 1 (From the time of end of surgery [that is; from the first dose of study drug administration]) up to end of follow-up visit (Day 17) Safety population included all randomized participants who received at least 1 dose of study drug.	0.00% 0/173 • Day 1 (From the time of end of surgery [that is; from the first dose of study drug administration]) up to end of follow-up visit (Day 17) Safety population included all randomized participants who received at least 1 dose of study drug.	0.00% 0/171 • Day 1 (From the time of end of surgery [that is; from the first dose of study drug administration]) up to end of follow-up visit (Day 17) Safety population included all randomized participants who received at least 1 dose of study drug.
Vascular disorders Hypotension	0.58% 1/171 • Day 1 (From the time of end of surgery [that is; from the first dose of study drug administration]) up to end of follow-up visit (Day 17) Safety population included all randomized participants who received at least 1 dose of study drug.	1.2% 2/173 • Day 1 (From the time of end of surgery [that is; from the first dose of study drug administration]) up to end of follow-up visit (Day 17) Safety population included all randomized participants who received at least 1 dose of study drug.	0.00% 0/171 • Day 1 (From the time of end of surgery [that is; from the first dose of study drug administration]) up to end of follow-up visit (Day 17) Safety population included all randomized participants who received at least 1 dose of study drug.

Other adverse events

Measure	MNTX 12 mg n=171 participants at risk Participants received MNTX 12 mg as an IV infusion over approximately 20 minutes for every 6 hours until one of the following occurred: 1) 24 hours elapsed after the first bowel movement and the participant was tolerating clear liquids, 2) the participant was discharged from the hospital, or 3) a maximum of 10 days elapsed. The first dose of study drug was administered within the first 90 minutes after the end of surgery (defined as the time when the last skin suture or staple was placed in the participant).	MNTX 24 mg n=173 participants at risk Participants received MNTX 24 mg as an IV infusion over approximately 20 minutes for every 6 hours until one of the following occurred: 1) 24 hours elapsed after the first bowel movement and the participant was tolerating clear liquids, 2) the participant was discharged from the hospital, or 3) a maximum of 10 days elapsed. The first dose of study drug was administered within the first 90 minutes after the end of surgery (defined as the time when the last skin suture or staple was placed in the participant).	Placebo n=171 participants at risk Participants received placebo matched to MNTX as an IV infusion over approximately 20 minutes for every 6 hours until one of the following occurred: 1) 24 hours elapsed after the first bowel movement and the participant was tolerating clear liquids, 2) the participant was discharged from the hospital, or 3) a maximum of 10 days elapsed. The first dose of study drug was administered within the first 90 minutes after the end of surgery (defined as the time when the last skin suture or staple was placed in the participant).
Blood and lymphatic system disorders Anaemia	11.1% 19/171 • Day 1 (From the time of end of surgery [that is; from the first dose of study drug administration]) up to end of follow-up visit (Day 17) Safety population included all randomized participants who received at least 1 dose of study drug.	8.1% 14/173 • Day 1 (From the time of end of surgery [that is; from the first dose of study drug administration]) up to end of follow-up visit (Day 17) Safety population included all randomized participants who received at least 1 dose of study drug.	5.8% 10/171 • Day 1 (From the time of end of surgery [that is; from the first dose of study drug administration]) up to end of follow-up visit (Day 17) Safety population included all randomized participants who received at least 1 dose of study drug.
Cardiac disorders Tachycardia	12.9% 22/171 • Day 1 (From the time of end of surgery [that is; from the first dose of study drug administration]) up to end of follow-up visit (Day 17) Safety population included all randomized participants who received at least 1 dose of study drug.	12.1% 21/173 • Day 1 (From the time of end of surgery [that is; from the first dose of study drug administration]) up to end of follow-up visit (Day 17) Safety population included all randomized participants who received at least 1 dose of study drug.	5.8% 10/171 • Day 1 (From the time of end of surgery [that is; from the first dose of study drug administration]) up to end of follow-up visit (Day 17) Safety population included all randomized participants who received at least 1 dose of study drug.
Gastrointestinal disorders Abdominal distension	7.6% 13/171 • Day 1 (From the time of end of surgery [that is; from the first dose of study drug administration]) up to end of follow-up visit (Day 17) Safety population included all randomized participants who received at least 1 dose of study drug.	9.8% 17/173 • Day 1 (From the time of end of surgery [that is; from the first dose of study drug administration]) up to end of follow-up visit (Day 17) Safety population included all randomized participants who received at least 1 dose of study drug.	8.8% 15/171 • Day 1 (From the time of end of surgery [that is; from the first dose of study drug administration]) up to end of follow-up visit (Day 17) Safety population included all randomized participants who received at least 1 dose of study drug.
Gastrointestinal disorders Abdominal pain	14.0% 24/171 • Day 1 (From the time of end of surgery [that is; from the first dose of study drug administration]) up to end of follow-up visit (Day 17) Safety population included all randomized participants who received at least 1 dose of study drug.	12.7% 22/173 • Day 1 (From the time of end of surgery [that is; from the first dose of study drug administration]) up to end of follow-up visit (Day 17) Safety population included all randomized participants who received at least 1 dose of study drug.	8.8% 15/171 • Day 1 (From the time of end of surgery [that is; from the first dose of study drug administration]) up to end of follow-up visit (Day 17) Safety population included all randomized participants who received at least 1 dose of study drug.
Gastrointestinal disorders Constipation	5.3% 9/171 • Day 1 (From the time of end of surgery [that is; from the first dose of study drug administration]) up to end of follow-up visit (Day 17) Safety population included all randomized participants who received at least 1 dose of study drug.	6.4% 11/173 • Day 1 (From the time of end of surgery [that is; from the first dose of study drug administration]) up to end of follow-up visit (Day 17) Safety population included all randomized participants who received at least 1 dose of study drug.	5.8% 10/171 • Day 1 (From the time of end of surgery [that is; from the first dose of study drug administration]) up to end of follow-up visit (Day 17) Safety population included all randomized participants who received at least 1 dose of study drug.
Gastrointestinal disorders Diarrhoea	7.0% 12/171 • Day 1 (From the time of end of surgery [that is; from the first dose of study drug administration]) up to end of follow-up visit (Day 17) Safety population included all randomized participants who received at least 1 dose of study drug.	4.0% 7/173 • Day 1 (From the time of end of surgery [that is; from the first dose of study drug administration]) up to end of follow-up visit (Day 17) Safety population included all randomized participants who received at least 1 dose of study drug.	8.2% 14/171 • Day 1 (From the time of end of surgery [that is; from the first dose of study drug administration]) up to end of follow-up visit (Day 17) Safety population included all randomized participants who received at least 1 dose of study drug.
Gastrointestinal disorders Dyspepsia	3.5% 6/171 • Day 1 (From the time of end of surgery [that is; from the first dose of study drug administration]) up to end of follow-up visit (Day 17) Safety population included all randomized participants who received at least 1 dose of study drug.	5.2% 9/173 • Day 1 (From the time of end of surgery [that is; from the first dose of study drug administration]) up to end of follow-up visit (Day 17) Safety population included all randomized participants who received at least 1 dose of study drug.	4.1% 7/171 • Day 1 (From the time of end of surgery [that is; from the first dose of study drug administration]) up to end of follow-up visit (Day 17) Safety population included all randomized participants who received at least 1 dose of study drug.
Gastrointestinal disorders Nausea	42.7% 73/171 • Day 1 (From the time of end of surgery [that is; from the first dose of study drug administration]) up to end of follow-up visit (Day 17) Safety population included all randomized participants who received at least 1 dose of study drug.	37.0% 64/173 • Day 1 (From the time of end of surgery [that is; from the first dose of study drug administration]) up to end of follow-up visit (Day 17) Safety population included all randomized participants who received at least 1 dose of study drug.	48.5% 83/171 • Day 1 (From the time of end of surgery [that is; from the first dose of study drug administration]) up to end of follow-up visit (Day 17) Safety population included all randomized participants who received at least 1 dose of study drug.
Gastrointestinal disorders Vomiting	12.3% 21/171 • Day 1 (From the time of end of surgery [that is; from the first dose of study drug administration]) up to end of follow-up visit (Day 17) Safety population included all randomized participants who received at least 1 dose of study drug.	13.9% 24/173 • Day 1 (From the time of end of surgery [that is; from the first dose of study drug administration]) up to end of follow-up visit (Day 17) Safety population included all randomized participants who received at least 1 dose of study drug.	18.1% 31/171 • Day 1 (From the time of end of surgery [that is; from the first dose of study drug administration]) up to end of follow-up visit (Day 17) Safety population included all randomized participants who received at least 1 dose of study drug.
General disorders Pyrexia	15.8% 27/171 • Day 1 (From the time of end of surgery [that is; from the first dose of study drug administration]) up to end of follow-up visit (Day 17) Safety population included all randomized participants who received at least 1 dose of study drug.	19.1% 33/173 • Day 1 (From the time of end of surgery [that is; from the first dose of study drug administration]) up to end of follow-up visit (Day 17) Safety population included all randomized participants who received at least 1 dose of study drug.	27.5% 47/171 • Day 1 (From the time of end of surgery [that is; from the first dose of study drug administration]) up to end of follow-up visit (Day 17) Safety population included all randomized participants who received at least 1 dose of study drug.
Infections and infestations Urinary tract infection	5.8% 10/171 • Day 1 (From the time of end of surgery [that is; from the first dose of study drug administration]) up to end of follow-up visit (Day 17) Safety population included all randomized participants who received at least 1 dose of study drug.	2.3% 4/173 • Day 1 (From the time of end of surgery [that is; from the first dose of study drug administration]) up to end of follow-up visit (Day 17) Safety population included all randomized participants who received at least 1 dose of study drug.	6.4% 11/171 • Day 1 (From the time of end of surgery [that is; from the first dose of study drug administration]) up to end of follow-up visit (Day 17) Safety population included all randomized participants who received at least 1 dose of study drug.
Injury, poisoning and procedural complications Procedural hypotension	5.3% 9/171 • Day 1 (From the time of end of surgery [that is; from the first dose of study drug administration]) up to end of follow-up visit (Day 17) Safety population included all randomized participants who received at least 1 dose of study drug.	4.6% 8/173 • Day 1 (From the time of end of surgery [that is; from the first dose of study drug administration]) up to end of follow-up visit (Day 17) Safety population included all randomized participants who received at least 1 dose of study drug.	5.3% 9/171 • Day 1 (From the time of end of surgery [that is; from the first dose of study drug administration]) up to end of follow-up visit (Day 17) Safety population included all randomized participants who received at least 1 dose of study drug.
Injury, poisoning and procedural complications Procedural pain	17.5% 30/171 • Day 1 (From the time of end of surgery [that is; from the first dose of study drug administration]) up to end of follow-up visit (Day 17) Safety population included all randomized participants who received at least 1 dose of study drug.	14.5% 25/173 • Day 1 (From the time of end of surgery [that is; from the first dose of study drug administration]) up to end of follow-up visit (Day 17) Safety population included all randomized participants who received at least 1 dose of study drug.	16.4% 28/171 • Day 1 (From the time of end of surgery [that is; from the first dose of study drug administration]) up to end of follow-up visit (Day 17) Safety population included all randomized participants who received at least 1 dose of study drug.
Metabolism and nutrition disorders Hyperglycaemia	4.1% 7/171 • Day 1 (From the time of end of surgery [that is; from the first dose of study drug administration]) up to end of follow-up visit (Day 17) Safety population included all randomized participants who received at least 1 dose of study drug.	5.8% 10/173 • Day 1 (From the time of end of surgery [that is; from the first dose of study drug administration]) up to end of follow-up visit (Day 17) Safety population included all randomized participants who received at least 1 dose of study drug.	2.9% 5/171 • Day 1 (From the time of end of surgery [that is; from the first dose of study drug administration]) up to end of follow-up visit (Day 17) Safety population included all randomized participants who received at least 1 dose of study drug.
Metabolism and nutrition disorders Hypokalaemia	12.3% 21/171 • Day 1 (From the time of end of surgery [that is; from the first dose of study drug administration]) up to end of follow-up visit (Day 17) Safety population included all randomized participants who received at least 1 dose of study drug.	11.6% 20/173 • Day 1 (From the time of end of surgery [that is; from the first dose of study drug administration]) up to end of follow-up visit (Day 17) Safety population included all randomized participants who received at least 1 dose of study drug.	15.2% 26/171 • Day 1 (From the time of end of surgery [that is; from the first dose of study drug administration]) up to end of follow-up visit (Day 17) Safety population included all randomized participants who received at least 1 dose of study drug.
Metabolism and nutrition disorders Hypomagnesaemia	4.7% 8/171 • Day 1 (From the time of end of surgery [that is; from the first dose of study drug administration]) up to end of follow-up visit (Day 17) Safety population included all randomized participants who received at least 1 dose of study drug.	7.5% 13/173 • Day 1 (From the time of end of surgery [that is; from the first dose of study drug administration]) up to end of follow-up visit (Day 17) Safety population included all randomized participants who received at least 1 dose of study drug.	1.8% 3/171 • Day 1 (From the time of end of surgery [that is; from the first dose of study drug administration]) up to end of follow-up visit (Day 17) Safety population included all randomized participants who received at least 1 dose of study drug.
Nervous system disorders Headache	4.7% 8/171 • Day 1 (From the time of end of surgery [that is; from the first dose of study drug administration]) up to end of follow-up visit (Day 17) Safety population included all randomized participants who received at least 1 dose of study drug.	6.9% 12/173 • Day 1 (From the time of end of surgery [that is; from the first dose of study drug administration]) up to end of follow-up visit (Day 17) Safety population included all randomized participants who received at least 1 dose of study drug.	6.4% 11/171 • Day 1 (From the time of end of surgery [that is; from the first dose of study drug administration]) up to end of follow-up visit (Day 17) Safety population included all randomized participants who received at least 1 dose of study drug.
Psychiatric disorders Anxiety	7.0% 12/171 • Day 1 (From the time of end of surgery [that is; from the first dose of study drug administration]) up to end of follow-up visit (Day 17) Safety population included all randomized participants who received at least 1 dose of study drug.	5.2% 9/173 • Day 1 (From the time of end of surgery [that is; from the first dose of study drug administration]) up to end of follow-up visit (Day 17) Safety population included all randomized participants who received at least 1 dose of study drug.	8.2% 14/171 • Day 1 (From the time of end of surgery [that is; from the first dose of study drug administration]) up to end of follow-up visit (Day 17) Safety population included all randomized participants who received at least 1 dose of study drug.
Psychiatric disorders Insomnia	5.8% 10/171 • Day 1 (From the time of end of surgery [that is; from the first dose of study drug administration]) up to end of follow-up visit (Day 17) Safety population included all randomized participants who received at least 1 dose of study drug.	5.8% 10/173 • Day 1 (From the time of end of surgery [that is; from the first dose of study drug administration]) up to end of follow-up visit (Day 17) Safety population included all randomized participants who received at least 1 dose of study drug.	9.9% 17/171 • Day 1 (From the time of end of surgery [that is; from the first dose of study drug administration]) up to end of follow-up visit (Day 17) Safety population included all randomized participants who received at least 1 dose of study drug.
Renal and urinary disorders Dysuria	1.2% 2/171 • Day 1 (From the time of end of surgery [that is; from the first dose of study drug administration]) up to end of follow-up visit (Day 17) Safety population included all randomized participants who received at least 1 dose of study drug.	1.7% 3/173 • Day 1 (From the time of end of surgery [that is; from the first dose of study drug administration]) up to end of follow-up visit (Day 17) Safety population included all randomized participants who received at least 1 dose of study drug.	5.3% 9/171 • Day 1 (From the time of end of surgery [that is; from the first dose of study drug administration]) up to end of follow-up visit (Day 17) Safety population included all randomized participants who received at least 1 dose of study drug.
Renal and urinary disorders Urinary retention	4.1% 7/171 • Day 1 (From the time of end of surgery [that is; from the first dose of study drug administration]) up to end of follow-up visit (Day 17) Safety population included all randomized participants who received at least 1 dose of study drug.	6.4% 11/173 • Day 1 (From the time of end of surgery [that is; from the first dose of study drug administration]) up to end of follow-up visit (Day 17) Safety population included all randomized participants who received at least 1 dose of study drug.	7.6% 13/171 • Day 1 (From the time of end of surgery [that is; from the first dose of study drug administration]) up to end of follow-up visit (Day 17) Safety population included all randomized participants who received at least 1 dose of study drug.
Respiratory, thoracic and mediastinal disorders Atelectasis	7.0% 12/171 • Day 1 (From the time of end of surgery [that is; from the first dose of study drug administration]) up to end of follow-up visit (Day 17) Safety population included all randomized participants who received at least 1 dose of study drug.	4.0% 7/173 • Day 1 (From the time of end of surgery [that is; from the first dose of study drug administration]) up to end of follow-up visit (Day 17) Safety population included all randomized participants who received at least 1 dose of study drug.	3.5% 6/171 • Day 1 (From the time of end of surgery [that is; from the first dose of study drug administration]) up to end of follow-up visit (Day 17) Safety population included all randomized participants who received at least 1 dose of study drug.
Respiratory, thoracic and mediastinal disorders Dyspnoea	6.4% 11/171 • Day 1 (From the time of end of surgery [that is; from the first dose of study drug administration]) up to end of follow-up visit (Day 17) Safety population included all randomized participants who received at least 1 dose of study drug.	5.8% 10/173 • Day 1 (From the time of end of surgery [that is; from the first dose of study drug administration]) up to end of follow-up visit (Day 17) Safety population included all randomized participants who received at least 1 dose of study drug.	4.1% 7/171 • Day 1 (From the time of end of surgery [that is; from the first dose of study drug administration]) up to end of follow-up visit (Day 17) Safety population included all randomized participants who received at least 1 dose of study drug.
Skin and subcutaneous tissue disorders Pruritus	11.1% 19/171 • Day 1 (From the time of end of surgery [that is; from the first dose of study drug administration]) up to end of follow-up visit (Day 17) Safety population included all randomized participants who received at least 1 dose of study drug.	12.7% 22/173 • Day 1 (From the time of end of surgery [that is; from the first dose of study drug administration]) up to end of follow-up visit (Day 17) Safety population included all randomized participants who received at least 1 dose of study drug.	11.1% 19/171 • Day 1 (From the time of end of surgery [that is; from the first dose of study drug administration]) up to end of follow-up visit (Day 17) Safety population included all randomized participants who received at least 1 dose of study drug.
Vascular disorders Hypertension	11.1% 19/171 • Day 1 (From the time of end of surgery [that is; from the first dose of study drug administration]) up to end of follow-up visit (Day 17) Safety population included all randomized participants who received at least 1 dose of study drug.	12.7% 22/173 • Day 1 (From the time of end of surgery [that is; from the first dose of study drug administration]) up to end of follow-up visit (Day 17) Safety population included all randomized participants who received at least 1 dose of study drug.	9.4% 16/171 • Day 1 (From the time of end of surgery [that is; from the first dose of study drug administration]) up to end of follow-up visit (Day 17) Safety population included all randomized participants who received at least 1 dose of study drug.
Vascular disorders Hypotension	9.4% 16/171 • Day 1 (From the time of end of surgery [that is; from the first dose of study drug administration]) up to end of follow-up visit (Day 17) Safety population included all randomized participants who received at least 1 dose of study drug.	10.4% 18/173 • Day 1 (From the time of end of surgery [that is; from the first dose of study drug administration]) up to end of follow-up visit (Day 17) Safety population included all randomized participants who received at least 1 dose of study drug.	6.4% 11/171 • Day 1 (From the time of end of surgery [that is; from the first dose of study drug administration]) up to end of follow-up visit (Day 17) Safety population included all randomized participants who received at least 1 dose of study drug.

Additional Information

Director of Clinical Operations

Bausch Health Americas, Inc

Email: Lindsey.Mathew@bauschhealth.com

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