Trial Outcomes & Findings for GSK2251052 in the Treatment of Complicated Intra-abdominal Infections (NCT NCT01381562)

Last Updated: 2017-11-29

Results Overview

AE was defined as any untoward medical occurrence in a participant temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. SAE included AEs those result in death, a life-threatening AE, inpatient hospitalization or prolongation of existing hospitalization, a persistent or significant incapacity or substantial disruption of the ability to conduct normal functions, or a congenital anomaly/birth defect. Important medical events that may not result in death, be life-threatening, or require hospitalization may be considered serious when, based upon appropriate medical judgment, they may jeopardize the participant and may require medical or surgical intervention to prevent one of the outcomes listed in this definition

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

15 participants

Primary outcome timeframe

Up to Day 42

Results posted on

2017-11-29

Participant Flow

The study was conducted at five centers in four countries (United Stated of America, Spain, France and Russia) between 03-October-2011 and 05-March-2012.

A total of 15 participants were enrolled in the study; of those, 5 participants each were randomised to receive GSK2251052, 750 milligram (mg) or 1500 mg or meropenem 1.0 gram (g), intravenously. One participant in the GSK2251052 1500 mg group was randomised but not treated, thus safety and efficacy populations consisted of 14 participants.

Participant milestones

Participant milestones
Measure	GSK2251052 750 mg Eligible participants received GSK2251052, 750 mg, in 200 or 250 millilitre (mL) saline solution as intravenous (IV) infusion administered over 60 minutes, twice a day (BID) and meropenem matching placebo solution, 100 ml, administered over 30 minutes, thrice a day (TID) from Day 2 to Day 14 of the study.	GSK2251052 1500 mg Eligible participants received GSK2251052, 1500 mg, in 200 or 250 mL saline solution as IV infusion administered over 60 minutes, BID and meropenem placebo solution, 100 ml, administered over 30 minutes, TID from Day 2 to Day 14 of the study.	Meropenem 1.0 g Eligible participants received meropenem, 1.0 g, in 100 ml saline solution as IV infusion administered over 30 minutes TID and two doses of GSK2251052 matching placebo saline solution, 200 or 250 ml, administered over 60 minutes, BID from Day 2 to Day 14 of the study.
Overall Study STARTED	5	4	5
Overall Study COMPLETED	5	3	5
Overall Study NOT COMPLETED	0	1	0

Reasons for withdrawal

Reasons for withdrawal
Measure	GSK2251052 750 mg Eligible participants received GSK2251052, 750 mg, in 200 or 250 millilitre (mL) saline solution as intravenous (IV) infusion administered over 60 minutes, twice a day (BID) and meropenem matching placebo solution, 100 ml, administered over 30 minutes, thrice a day (TID) from Day 2 to Day 14 of the study.	GSK2251052 1500 mg Eligible participants received GSK2251052, 1500 mg, in 200 or 250 mL saline solution as IV infusion administered over 60 minutes, BID and meropenem placebo solution, 100 ml, administered over 30 minutes, TID from Day 2 to Day 14 of the study.	Meropenem 1.0 g Eligible participants received meropenem, 1.0 g, in 100 ml saline solution as IV infusion administered over 30 minutes TID and two doses of GSK2251052 matching placebo saline solution, 200 or 250 ml, administered over 60 minutes, BID from Day 2 to Day 14 of the study.
Overall Study Adverse Event	0	1	0

Baseline Characteristics

GSK2251052 in the Treatment of Complicated Intra-abdominal Infections

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	GSK2251052 750 mg n=5 Participants Eligible participants received GSK2251052, 750 mg, in 200 or 250 mL saline solution as IV infusion administered over 60 minutes, BID and meropenem matching placebo solution, 100 ml, administered over 30 minutes, TID from Day 2 to Day 14 of the study.	GSK2251052 1500 mg n=4 Participants Eligible participants received GSK2251052, 1500 mg, in 200 or 250 mL saline solution as IV infusion administered over 60 minutes, BID and meropenem placebo solution, 100 ml, administered over 30 minutes, TID from Day 2 to Day 14 of the study.	Meropenem 1 g n=5 Participants Eligible participants received meropenem, 1.0 g, in 100 ml saline solution as IV infusion administered over 30 minutes TID and two doses of GSK2251052 matching placebo saline solution, 200 or 250 ml, administered over 60 minutes, BID from Day 2 to Day 14 of the study.	Total n=14 Participants Total of all reporting groups
Age, Continuous	34.0 Years STANDARD_DEVIATION 15.05 • n=5 Participants	41.3 Years STANDARD_DEVIATION 13.65 • n=7 Participants	34.6 Years STANDARD_DEVIATION 10.31 • n=5 Participants	36.3 Years STANDARD_DEVIATION 12.49 • n=4 Participants
Sex: Female, Male Female	1 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants	3 Participants n=4 Participants
Sex: Female, Male Male	4 Participants n=5 Participants	3 Participants n=7 Participants	4 Participants n=5 Participants	11 Participants n=4 Participants
Race/Ethnicity, Customized African American/African Heritage	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	2 Participants n=4 Participants
Race/Ethnicity, Customized Asian - Central/South Asian Heritage	0 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	1 Participants n=4 Participants
Race/Ethnicity, Customized Asian - East Asian Heritage	0 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants
Race/Ethnicity, Customized White - White/Caucasian/European	4 Participants n=5 Participants	3 Participants n=7 Participants	3 Participants n=5 Participants	10 Participants n=4 Participants

PRIMARY outcome

Timeframe: Up to Day 42

Population: Safety Population comprised of all participants who received at least one dose of study medication.

Outcome measures

Outcome measures
Measure	GSK2251052 750 mg n=5 Participants Eligible participants received GSK2251052, 750 mg, in 200 or 250 mL saline solution as IV infusion administered over 60 minutes, BID and meropenem matching placebo solution, 100 ml, administered over 30 minutes, TID from Day 2 to Day 14 of the study.	GSK2251052 1500 mg n=4 Participants Eligible participants received GSK2251052, 1500 mg, in 200 or 250 mL saline solution as IV infusion administered over 60 minutes, BID and meropenem placebo solution, 100 ml, administered over 30 minutes, TID from Day 2 to Day 14 of the study.	Meropenem 1g n=5 Participants Eligible participants received meropenem, 1.0 g, in 100 ml saline solution as IV infusion administered over 30 minutes TID and two doses of GSK2251052 matching placebo saline solution, 200 or 250 ml, administered over 60 minutes, BID from Day 2 to Day 14 of the study.
Number of Participants With Any Adverse Event Any AE	5 Participants	4 Participants	3 Participants
Number of Participants With Any Adverse Event Any SAE	2 Participants	3 Participants	0 Participants

PRIMARY outcome

Timeframe: Up to Day 42

Population: Safety Population.

Vital parameters including systolic and diastolic blood pressure, heart rate, respiration rate, and temperature were recorded. The number of participants with potentially clinically concern value of any vital parameter at any visit were reported.

Outcome measures

Outcome measures
Measure	GSK2251052 750 mg n=5 Participants Eligible participants received GSK2251052, 750 mg, in 200 or 250 mL saline solution as IV infusion administered over 60 minutes, BID and meropenem matching placebo solution, 100 ml, administered over 30 minutes, TID from Day 2 to Day 14 of the study.	GSK2251052 1500 mg n=4 Participants Eligible participants received GSK2251052, 1500 mg, in 200 or 250 mL saline solution as IV infusion administered over 60 minutes, BID and meropenem placebo solution, 100 ml, administered over 30 minutes, TID from Day 2 to Day 14 of the study.	Meropenem 1g n=5 Participants Eligible participants received meropenem, 1.0 g, in 100 ml saline solution as IV infusion administered over 30 minutes TID and two doses of GSK2251052 matching placebo saline solution, 200 or 250 ml, administered over 60 minutes, BID from Day 2 to Day 14 of the study.
Number of Participants With Clinically Significant Trends in Vital Signs Over the Period of Study Duration	0 Participants	0 Participants	0 Participants

PRIMARY outcome

Timeframe: Up to Day 42

Population: Safety population.

12-lead ECGs was obtained during the study using an ECG machine and performed with the participant in a semi-supine position rested in this position for at least 10 minutes beforehand. Measurements deviated substantially from previous readings were repeated immediately. Number of participants with normal and abnormal ECG findings were reported.

Outcome measures

Outcome measures
Measure	GSK2251052 750 mg n=5 Participants Eligible participants received GSK2251052, 750 mg, in 200 or 250 mL saline solution as IV infusion administered over 60 minutes, BID and meropenem matching placebo solution, 100 ml, administered over 30 minutes, TID from Day 2 to Day 14 of the study.	GSK2251052 1500 mg n=4 Participants Eligible participants received GSK2251052, 1500 mg, in 200 or 250 mL saline solution as IV infusion administered over 60 minutes, BID and meropenem placebo solution, 100 ml, administered over 30 minutes, TID from Day 2 to Day 14 of the study.	Meropenem 1g n=5 Participants Eligible participants received meropenem, 1.0 g, in 100 ml saline solution as IV infusion administered over 30 minutes TID and two doses of GSK2251052 matching placebo saline solution, 200 or 250 ml, administered over 60 minutes, BID from Day 2 to Day 14 of the study.
Number of Participants With Normal and Abnormal ECG Findings Baseline, Pre-dose 1, Normal	4 Participants	4 Participants	4 Participants
Number of Participants With Normal and Abnormal ECG Findings Baseline, Pre-dose 1, Unable to evaluate	0 Participants	0 Participants	1 Participants
Number of Participants With Normal and Abnormal ECG Findings Baseline, Pre-dose 1, Abnormal	1 Participants	0 Participants	0 Participants
Number of Participants With Normal and Abnormal ECG Findings Baseline, Pre-dose 2, Normal	4 Participants	4 Participants	5 Participants
Number of Participants With Normal and Abnormal ECG Findings Baseline, Pre-dose 2, Abnormal	1 Participants	0 Participants	0 Participants
Number of Participants With Normal and Abnormal ECG Findings Baseline, Pre-dose 3, Normal	4 Participants	4 Participants	5 Participants
Number of Participants With Normal and Abnormal ECG Findings Baseline, Pre-dose 3, Abnormal	1 Participants	0 Participants	0 Participants
Number of Participants With Normal and Abnormal ECG Findings Baseline, Post-dose , Normal	4 Participants	3 Participants	4 Participants
Number of Participants With Normal and Abnormal ECG Findings Baseline, Post-dose , Abnormal	1 Participants	1 Participants	1 Participants
Number of Participants With Normal and Abnormal ECG Findings On IV Therapy (Day 4), Pre-dose, Normal	4 Participants	4 Participants	5 Participants
Number of Participants With Normal and Abnormal ECG Findings On IV Therapy (Day 4), Pre-dose, Abnormal	1 Participants	0 Participants	0 Participants
Number of Participants With Normal and Abnormal ECG Findings On IV Therapy (Day 4), Post-dose, Normal	5 Participants	4 Participants	5 Participants
Number of Participants With Normal and Abnormal ECG Findings Early Follow-up	5 Participants	3 Participants	5 Participants

PRIMARY outcome

Timeframe: Up to Day 42

Population: Safety population.

Absolute mean hemoglobin values recorded over the period of duration were reported.

Outcome measures

Outcome measures
Measure	GSK2251052 750 mg n=5 Participants Eligible participants received GSK2251052, 750 mg, in 200 or 250 mL saline solution as IV infusion administered over 60 minutes, BID and meropenem matching placebo solution, 100 ml, administered over 30 minutes, TID from Day 2 to Day 14 of the study.	GSK2251052 1500 mg n=4 Participants Eligible participants received GSK2251052, 1500 mg, in 200 or 250 mL saline solution as IV infusion administered over 60 minutes, BID and meropenem placebo solution, 100 ml, administered over 30 minutes, TID from Day 2 to Day 14 of the study.	Meropenem 1g n=5 Participants Eligible participants received meropenem, 1.0 g, in 100 ml saline solution as IV infusion administered over 30 minutes TID and two doses of GSK2251052 matching placebo saline solution, 200 or 250 ml, administered over 60 minutes, BID from Day 2 to Day 14 of the study.
Laboratory Parameters of Interest- Mean Hemoglobin Over the Period of Study Duration Baseline (Day 1)	142.2 Gram per Litre Standard Deviation 8.76	121.5 Gram per Litre Standard Deviation 12.23	125.0 Gram per Litre Standard Deviation 14.85
Laboratory Parameters of Interest- Mean Hemoglobin Over the Period of Study Duration On IV Therapy (Day 3)	134.4 Gram per Litre Standard Deviation 13.61	112.3 Gram per Litre Standard Deviation 16.30	137.3 Gram per Litre Standard Deviation 19.64
Laboratory Parameters of Interest- Mean Hemoglobin Over the Period of Study Duration On IV Therapy (Day 5)	127.2 Gram per Litre Standard Deviation 14.79	120.7 Gram per Litre Standard Deviation 11.02	131.0 Gram per Litre Standard Deviation 18.63
Laboratory Parameters of Interest- Mean Hemoglobin Over the Period of Study Duration On IV Therapy (Day 8)	148.0 Gram per Litre Standard Deviation NA Only one participant was analyzed.	132.0 Gram per Litre Standard Deviation NA Only one participant was analyzed.	143.0 Gram per Litre Standard Deviation NA Only one participant was analyzed.
Laboratory Parameters of Interest- Mean Hemoglobin Over the Period of Study Duration On IV Therapy (Day 11)	97.0 Gram per Litre Standard Deviation NA Only one participant was analyzed.	—	—
Laboratory Parameters of Interest- Mean Hemoglobin Over the Period of Study Duration End Of IV Therapy	126.2 Gram per Litre Standard Deviation 23.35	123.8 Gram per Litre Standard Deviation 9.88	130.8 Gram per Litre Standard Deviation 20.22
Laboratory Parameters of Interest- Mean Hemoglobin Over the Period of Study Duration Haematology Safety	131.4 Gram per Litre Standard Deviation 15.21	118.0 Gram per Litre Standard Deviation 9.93	138.6 Gram per Litre Standard Deviation 14.72
Laboratory Parameters of Interest- Mean Hemoglobin Over the Period of Study Duration Test of cure	131.0 Gram per Litre Standard Deviation 25.26	116.0 Gram per Litre Standard Deviation 5.77	138.2 Gram per Litre Standard Deviation 11.52
Laboratory Parameters of Interest- Mean Hemoglobin Over the Period of Study Duration Early Follow up	125.5 Gram per Litre Standard Deviation 31.16	121.5 Gram per Litre Standard Deviation 3.54	138.5 Gram per Litre Standard Deviation 10.54
Laboratory Parameters of Interest- Mean Hemoglobin Over the Period of Study Duration Late Follow up	133.2 Gram per Litre Standard Deviation 19.38	126.5 Gram per Litre Standard Deviation 0.71	146.8 Gram per Litre Standard Deviation 17.25

PRIMARY outcome

Timeframe: Up to 42 days

Population: Safety population.

Absolute mean reticulocytes values recorded over the period of duration were reported.

Outcome measures

Outcome measures
Measure	GSK2251052 750 mg n=5 Participants Eligible participants received GSK2251052, 750 mg, in 200 or 250 mL saline solution as IV infusion administered over 60 minutes, BID and meropenem matching placebo solution, 100 ml, administered over 30 minutes, TID from Day 2 to Day 14 of the study.	GSK2251052 1500 mg n=4 Participants Eligible participants received GSK2251052, 1500 mg, in 200 or 250 mL saline solution as IV infusion administered over 60 minutes, BID and meropenem placebo solution, 100 ml, administered over 30 minutes, TID from Day 2 to Day 14 of the study.	Meropenem 1g n=5 Participants Eligible participants received meropenem, 1.0 g, in 100 ml saline solution as IV infusion administered over 30 minutes TID and two doses of GSK2251052 matching placebo saline solution, 200 or 250 ml, administered over 60 minutes, BID from Day 2 to Day 14 of the study.
Laboratory Parameters of Interest- Mean Reticulocytes Over the Period of Study Duration End Of IV Therapy	0.0564 Trillion cells per Litre Standard Deviation 0.02919	0.0602 Trillion cells per Litre Standard Deviation 0.01899	0.0872 Trillion cells per Litre Standard Deviation 0.02792
Laboratory Parameters of Interest- Mean Reticulocytes Over the Period of Study Duration Baseline (Day 1)	0.0589 Trillion cells per Litre Standard Deviation 0.01839	0.0573 Trillion cells per Litre Standard Deviation 0.00761	0.0810 Trillion cells per Litre Standard Deviation 0.02547
Laboratory Parameters of Interest- Mean Reticulocytes Over the Period of Study Duration On IV Therapy (Day 3)	0.0487 Trillion cells per Litre Standard Deviation 0.01874	0.0638 Trillion cells per Litre Standard Deviation 0.03074	0.0725 Trillion cells per Litre Standard Deviation 0.02418
Laboratory Parameters of Interest- Mean Reticulocytes Over the Period of Study Duration On IV Therapy (Day 5)	0.0580 Trillion cells per Litre Standard Deviation 0.02377	0.0480 Trillion cells per Litre Standard Deviation 0.00515	0.0870 Trillion cells per Litre Standard Deviation 0.02888
Laboratory Parameters of Interest- Mean Reticulocytes Over the Period of Study Duration On IV Therapy (Day 8)	0.0077 Trillion cells per Litre Standard Deviation NA Only one participant was analyzed.	0.0444 Trillion cells per Litre Standard Deviation NA Only one participant was analyzed.	0.0650 Trillion cells per Litre Standard Deviation NA Only one participant was analyzed.
Laboratory Parameters of Interest- Mean Reticulocytes Over the Period of Study Duration On IV Therapy (Day 11)	0.0335 Trillion cells per Litre Standard Deviation NA Only one participant was analyzed.	—	—
Laboratory Parameters of Interest- Mean Reticulocytes Over the Period of Study Duration Haematology Safety	0.0640 Trillion cells per Litre Standard Deviation 0.02406	0.0478 Trillion cells per Litre Standard Deviation 0.01937	0.0815 Trillion cells per Litre Standard Deviation 0.03405
Laboratory Parameters of Interest- Mean Reticulocytes Over the Period of Study Duration Test Of Cure	0.0959 Trillion cells per Litre Standard Deviation 0.01260	0.0860 Trillion cells per Litre Standard Deviation 0.01764	0.0846 Trillion cells per Litre Standard Deviation 0.01270
Laboratory Parameters of Interest- Mean Reticulocytes Over the Period of Study Duration Early Follow up	0.0842 Trillion cells per Litre Standard Deviation 0.02559	0.0769 Trillion cells per Litre Standard Deviation 0.00537	0.0796 Trillion cells per Litre Standard Deviation 0.02874
Laboratory Parameters of Interest- Mean Reticulocytes Over the Period of Study Duration Late Follow up	0.1046 Trillion cells per Litre Standard Deviation 0.02945	0.0870 Trillion cells per Litre Standard Deviation 0.01018	0.0828 Trillion cells per Litre Standard Deviation 0.01431

PRIMARY outcome

Timeframe: Baseline (Day 1) and up to Day 42

Population: Safety Population. Only those participants available at the specified time points were analyzed.

Participants in whom the hemoglobin level dropped by more than 30% from Baseline that was not attributable to acute blood loss were recorded and immediately withdrawn from study treatment. Baseline assessments were recorded on Visit 1 (Day 1) and used as Baseline values. The change from Baseline was calculated by subtracting the Baseline values from Day 42 values. If either the Baseline or post-randomization value was missing, the change from Baseline was set to missing. The mean change from Baseline in hemoglobin for participants with significant hemoglobin drop were reported.

Outcome measures

Outcome measures
Measure	GSK2251052 750 mg n=5 Participants Eligible participants received GSK2251052, 750 mg, in 200 or 250 mL saline solution as IV infusion administered over 60 minutes, BID and meropenem matching placebo solution, 100 ml, administered over 30 minutes, TID from Day 2 to Day 14 of the study.	GSK2251052 1500 mg n=4 Participants Eligible participants received GSK2251052, 1500 mg, in 200 or 250 mL saline solution as IV infusion administered over 60 minutes, BID and meropenem placebo solution, 100 ml, administered over 30 minutes, TID from Day 2 to Day 14 of the study.	Meropenem 1g n=5 Participants Eligible participants received meropenem, 1.0 g, in 100 ml saline solution as IV infusion administered over 30 minutes TID and two doses of GSK2251052 matching placebo saline solution, 200 or 250 ml, administered over 60 minutes, BID from Day 2 to Day 14 of the study.
Mean Change From Baseline in Hemoglobin for Partcipants With Significant Hemoglobin Drop Early Follow-up	-16.5 grams/L Standard Deviation 39.31	6.0 grams/L Standard Deviation 5.66	1.5 grams/L Standard Deviation 7.78
Mean Change From Baseline in Hemoglobin for Partcipants With Significant Hemoglobin Drop Test for Cure	-13.3 grams/L Standard Deviation 32.09	-8.7 grams/L Standard Deviation 15.95	11.0 grams/L Standard Deviation 10.58
Mean Change From Baseline in Hemoglobin for Partcipants With Significant Hemoglobin Drop On IV Therapy, Day 3	-7.8 grams/L Standard Deviation 18.07	-13.3 grams/L Standard Deviation 8.62	0.0 grams/L Standard Deviation 9.90
Mean Change From Baseline in Hemoglobin for Partcipants With Significant Hemoglobin Drop On IV Therapy, Day 5	-15.0 grams/L Standard Deviation 18.88	1.5 grams/L Standard Deviation 3.54	-1.7 grams/L Standard Deviation 8.62
Mean Change From Baseline in Hemoglobin for Partcipants With Significant Hemoglobin Drop On IV Therapy, Day 8	3.0 grams/L Standard Deviation NA Only one participants was available at the time of analysis. Dispersion was not calculated.	-6.0 grams/L Standard Deviation NA Only one participants was available at the time of analysis. Dispersion was not calculated.	—
Mean Change From Baseline in Hemoglobin for Partcipants With Significant Hemoglobin Drop On IV Therapy, Day 11	-58.0 grams/L Standard Deviation NA Only one participants was available at the time of analysis. Dispersion was not calculated.	—	—
Mean Change From Baseline in Hemoglobin for Partcipants With Significant Hemoglobin Drop End of IV Therapy	-16.0 grams/L Standard Deviation 28.88	-0.7 grams/L Standard Deviation 3.79	-2.3 grams/L Standard Deviation 3.79
Mean Change From Baseline in Hemoglobin for Partcipants With Significant Hemoglobin Drop Hematology Safety	-10.8 grams/L Standard Deviation 22.48	-8.3 grams/L Standard Deviation 13.80	10.0 grams/L Standard Deviation 8.72
Mean Change From Baseline in Hemoglobin for Partcipants With Significant Hemoglobin Drop Late Follow-up	-9.0 grams/L Standard Deviation 25.82	11.0 grams/L Standard Deviation 9.90	20.0 grams/L Standard Deviation 2.65

PRIMARY outcome

Timeframe: Day 5 to 9 post IV therapy

Population: MITT Population comprised of all randomized participants who received at least one dose of study medication and had at least one Gram-negative pathogen identified at Baseline. Only those participants available at the specified time points were analyzed.

Test of cure-clinical success was resolution of signs and symptoms of complicated intra-abdominal infection (cIAI) for participants who were clinical successes at the end of IV therapy visit with no new symptoms recorded that were not present at Baseline and no use of additional antibiotic therapy for cIAI. Test of cure-clinical failure was persistence of signs and symptoms of cIAI recorded at Baseline, or reappearance of signs and symptoms that had previously resolved, or new signs and symptoms recorded that were not present at a previous visit, or receipt of additional or alternate antibiotic therapy for cIAI or participant had died. Test of cure- unable to determine was refusal to consent to a clinical examination, lost to follow-up. Participants who were 'unable to determine' at End of IV therapy were considered 'unable to determine' Test of cure Visit as well. Due to early termination of the study, a Bayesian approach for informal hypothesis testing was not performed.

Outcome measures

Outcome measures
Measure	GSK2251052 750 mg n=4 Participants Eligible participants received GSK2251052, 750 mg, in 200 or 250 mL saline solution as IV infusion administered over 60 minutes, BID and meropenem matching placebo solution, 100 ml, administered over 30 minutes, TID from Day 2 to Day 14 of the study.	GSK2251052 1500 mg n=2 Participants Eligible participants received GSK2251052, 1500 mg, in 200 or 250 mL saline solution as IV infusion administered over 60 minutes, BID and meropenem placebo solution, 100 ml, administered over 30 minutes, TID from Day 2 to Day 14 of the study.	Meropenem 1g n=4 Participants Eligible participants received meropenem, 1.0 g, in 100 ml saline solution as IV infusion administered over 30 minutes TID and two doses of GSK2251052 matching placebo saline solution, 200 or 250 ml, administered over 60 minutes, BID from Day 2 to Day 14 of the study.
Number of Participants With Clinical Response at Test of Cure Visit (5-9 Days Post-therapy) in Microbiological Intent to Treat (MITT) Population Test of Cure Clinical Success	3 Participants	1 Participants	4 Participants
Number of Participants With Clinical Response at Test of Cure Visit (5-9 Days Post-therapy) in Microbiological Intent to Treat (MITT) Population Test of Cure Clinical Failure	1 Participants	1 Participants	0 Participants

SECONDARY outcome

Timeframe: Day 5 to 9 post IV therapy

Population: Microbial evaluation population comprised of participants from the MITT population who adhered to the protocol (do not violate the protocol) and received at least 5 days of IV therapy.

Outcome measures

Outcome measures
Measure	GSK2251052 750 mg n=4 Participants Eligible participants received GSK2251052, 750 mg, in 200 or 250 mL saline solution as IV infusion administered over 60 minutes, BID and meropenem matching placebo solution, 100 ml, administered over 30 minutes, TID from Day 2 to Day 14 of the study.	GSK2251052 1500 mg n=2 Participants Eligible participants received GSK2251052, 1500 mg, in 200 or 250 mL saline solution as IV infusion administered over 60 minutes, BID and meropenem placebo solution, 100 ml, administered over 30 minutes, TID from Day 2 to Day 14 of the study.	Meropenem 1g n=4 Participants Eligible participants received meropenem, 1.0 g, in 100 ml saline solution as IV infusion administered over 30 minutes TID and two doses of GSK2251052 matching placebo saline solution, 200 or 250 ml, administered over 60 minutes, BID from Day 2 to Day 14 of the study.
Number of Participants With Clinical Response at Test of Cure Visit (5-9 Days Post-therapy) in Microbiological Evaluable Population. Test of Cure Clinical Success	3 Participants	1 Participants	4 Participants
Number of Participants With Clinical Response at Test of Cure Visit (5-9 Days Post-therapy) in Microbiological Evaluable Population. End of IV Clinical Failure	1 Participants	1 Participants	0 Participants

SECONDARY outcome

Timeframe: End of IV therapy (0-24 hours post-therapy); Test of cure (5-9 days post-therapy); Late Follow-up (21-28 days post-therapy)

Population: MITT Population. Only those participants available at the specified time points were analyzed.

Microbiological Response at End of IV Therapy was assessed as Microbiological Success (MS) or Microbiological Failure (MF). MS was categorized as microbiological eradication (ME) and presumed microbiological eradication (PME). MF was categorized as microbiological persistence (MP), presumed microbiological persistence (PMP), unable to determine, new infection and colonization. Number of participants with microbiological response in MITT population were reported.

Outcome measures

Outcome measures
Measure	GSK2251052 750 mg n=4 Participants Eligible participants received GSK2251052, 750 mg, in 200 or 250 mL saline solution as IV infusion administered over 60 minutes, BID and meropenem matching placebo solution, 100 ml, administered over 30 minutes, TID from Day 2 to Day 14 of the study.	GSK2251052 1500 mg n=2 Participants Eligible participants received GSK2251052, 1500 mg, in 200 or 250 mL saline solution as IV infusion administered over 60 minutes, BID and meropenem placebo solution, 100 ml, administered over 30 minutes, TID from Day 2 to Day 14 of the study.	Meropenem 1g n=4 Participants Eligible participants received meropenem, 1.0 g, in 100 ml saline solution as IV infusion administered over 30 minutes TID and two doses of GSK2251052 matching placebo saline solution, 200 or 250 ml, administered over 60 minutes, BID from Day 2 to Day 14 of the study.
Number of Participants With Microbiological Response in MITT Population End of IV Therapy, MS, PME	3 Participants	1 Participants	4 Participants
Number of Participants With Microbiological Response in MITT Population End of IV Therapy, MF, MP	0 Participants	1 Participants	0 Participants
Number of Participants With Microbiological Response in MITT Population End of IV Therapy, MF, PMP	1 Participants	0 Participants	0 Participants
Number of Participants With Microbiological Response in MITT Population Test of Cure, MS, PME	3 Participants	1 Participants	4 Participants
Number of Participants With Microbiological Response in MITT Population Test of Cure, MF, PMP	1 Participants	1 Participants	0 Participants
Number of Participants With Microbiological Response in MITT Population Late follow-up, MS, PME	3 Participants	1 Participants	4 Participants
Number of Participants With Microbiological Response in MITT Population Late follow-up, MF, PMP	1 Participants	1 Participants	0 Participants

SECONDARY outcome

Timeframe: End of IV therapy (0-24 hours post-therapy); Test of cure (5-9 days post-therapy); Late Follow-up (21-28 days post-therapy)

Population: Microbiological evaluable population. Only those participants available at the specified time points were analyzed

Microbiological Response at End of IV Therapy was assessed as MS or MF. MS was categorized as ME and PME. MF was categorized as MP and PMP, unable to determine, new infection and colonization. Number of participants with microbiological response in microbiological evaluable population were reported.

Outcome measures

Outcome measures
Measure	GSK2251052 750 mg n=4 Participants Eligible participants received GSK2251052, 750 mg, in 200 or 250 mL saline solution as IV infusion administered over 60 minutes, BID and meropenem matching placebo solution, 100 ml, administered over 30 minutes, TID from Day 2 to Day 14 of the study.	GSK2251052 1500 mg n=2 Participants Eligible participants received GSK2251052, 1500 mg, in 200 or 250 mL saline solution as IV infusion administered over 60 minutes, BID and meropenem placebo solution, 100 ml, administered over 30 minutes, TID from Day 2 to Day 14 of the study.	Meropenem 1g n=4 Participants Eligible participants received meropenem, 1.0 g, in 100 ml saline solution as IV infusion administered over 30 minutes TID and two doses of GSK2251052 matching placebo saline solution, 200 or 250 ml, administered over 60 minutes, BID from Day 2 to Day 14 of the study.
Number of Participants With Microbiological Response in Microbiological Evaluable Population Test of Cure, MS, PME	3 Participants	1 Participants	4 Participants
Number of Participants With Microbiological Response in Microbiological Evaluable Population Test of Cure, MF, PMP	1 Participants	1 Participants	0 Participants
Number of Participants With Microbiological Response in Microbiological Evaluable Population Late follow-up, MS, PME	3 Participants	1 Participants	4 Participants
Number of Participants With Microbiological Response in Microbiological Evaluable Population Late follow-up, MF, PMP	1 Participants	0 Participants	0 Participants
Number of Participants With Microbiological Response in Microbiological Evaluable Population End of IV Therapy, MS, PME	3 Participants	1 Participants	4 Participants
Number of Participants With Microbiological Response in Microbiological Evaluable Population End of IV Therapy, MF, MP	0 Participants	1 Participants	0 Participants
Number of Participants With Microbiological Response in Microbiological Evaluable Population End of IV Therapy, MF, PMP	1 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: End of IV therapy (0-24 hours post-therapy); Test of cure (5-9 days post-therapy); Late Follow-up (21-28 days post-therapy)

Population: Microbiological evaluable population. Only those participants available at the specified time points were analyzed.

Clinical success was defined as resolution or improvement of Baseline signs and symptoms of cIAI, including white blood cell count within normal limits, participant was afebrile and peritoneal findings consistent with cIAI were no longer present with no new symptoms present that were not present at Baseline and no use of additional or alternate antibiotic therapy. Clinical failure was defined as (1) Lack of improvement or worsening in one or more signs and symptoms of cIAI recorded at Baseline, or reappearance of signs and symptoms that had previously resolved, or (2) signs and symptoms recorded that were not present at Baseline, or (3) receipt of additional or alternate antibiotic therapy for cIAI or (4) participant had died, or (5) participant had an adverse event leading to study drug discontinuation and the participant required additional or alternative antibacterial therapy for the current cIAI.

Outcome measures

Outcome measures
Measure	GSK2251052 750 mg n=4 Participants Eligible participants received GSK2251052, 750 mg, in 200 or 250 mL saline solution as IV infusion administered over 60 minutes, BID and meropenem matching placebo solution, 100 ml, administered over 30 minutes, TID from Day 2 to Day 14 of the study.	GSK2251052 1500 mg n=2 Participants Eligible participants received GSK2251052, 1500 mg, in 200 or 250 mL saline solution as IV infusion administered over 60 minutes, BID and meropenem placebo solution, 100 ml, administered over 30 minutes, TID from Day 2 to Day 14 of the study.	Meropenem 1g n=4 Participants Eligible participants received meropenem, 1.0 g, in 100 ml saline solution as IV infusion administered over 30 minutes TID and two doses of GSK2251052 matching placebo saline solution, 200 or 250 ml, administered over 60 minutes, BID from Day 2 to Day 14 of the study.
Number of Participants With Clinical Response in Microbiological Evaluable Population End of IV Therapy, Clinical Success	3 Participants	1 Participants	4 Participants
Number of Participants With Clinical Response in Microbiological Evaluable Population End of IV Therapy, Clinical Failure	1 Participants	1 Participants	0 Participants
Number of Participants With Clinical Response in Microbiological Evaluable Population Late follow-up, Follow-up Clinical Success	3 Participants	1 Participants	4 Participants
Number of Participants With Clinical Response in Microbiological Evaluable Population Late follow-up, End of IV Clinical Failure	1 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: End of IV therapy (0-24 hours post-therapy) and Late Follow-up (21-28 days post-therapy)

Population: MITT Population. Only those participants available at the specified time points were analyzed.

Outcome measures

Outcome measures
Measure	GSK2251052 750 mg n=4 Participants Eligible participants received GSK2251052, 750 mg, in 200 or 250 mL saline solution as IV infusion administered over 60 minutes, BID and meropenem matching placebo solution, 100 ml, administered over 30 minutes, TID from Day 2 to Day 14 of the study.	GSK2251052 1500 mg n=2 Participants Eligible participants received GSK2251052, 1500 mg, in 200 or 250 mL saline solution as IV infusion administered over 60 minutes, BID and meropenem placebo solution, 100 ml, administered over 30 minutes, TID from Day 2 to Day 14 of the study.	Meropenem 1g n=4 Participants Eligible participants received meropenem, 1.0 g, in 100 ml saline solution as IV infusion administered over 30 minutes TID and two doses of GSK2251052 matching placebo saline solution, 200 or 250 ml, administered over 60 minutes, BID from Day 2 to Day 14 of the study.
Number of Participants With Clinical Response in MITT Population End of IV Therapy, Clinical Success,	3 Participants	1 Participants	4 Participants
Number of Participants With Clinical Response in MITT Population End of IV Therapy, Clinical Failure	1 Participants	1 Participants	0 Participants
Number of Participants With Clinical Response in MITT Population Late follow-up, Follow-up Clinical Success	3 Participants	1 Participants	4 Participants
Number of Participants With Clinical Response in MITT Population Late follow-up, End of IV Clinical Failure	1 Participants	1 Participants	0 Participants

SECONDARY outcome

Timeframe: End of IV therapy (0-24 hours post-therapy); Test of cure (5-9 days post-therapy); Late Follow-up (21-28 days post-therapy)

Population: Microbiological evaluable population. Only those participants available at the specified time points were analyzed.

Therapeutic response was a measure of the overall efficacy response, and a therapeutic success referred to participants who had been deemed both a 'clinical success' and a 'microbiological success'. All other combinations (other than 'clinical success' + 'microbiological success') were deemed failures for therapeutic response. Therapeutic response was determined programmatically.

Outcome measures

Outcome measures
Measure	GSK2251052 750 mg n=4 Participants Eligible participants received GSK2251052, 750 mg, in 200 or 250 mL saline solution as IV infusion administered over 60 minutes, BID and meropenem matching placebo solution, 100 ml, administered over 30 minutes, TID from Day 2 to Day 14 of the study.	GSK2251052 1500 mg n=2 Participants Eligible participants received GSK2251052, 1500 mg, in 200 or 250 mL saline solution as IV infusion administered over 60 minutes, BID and meropenem placebo solution, 100 ml, administered over 30 minutes, TID from Day 2 to Day 14 of the study.	Meropenem 1g n=4 Participants Eligible participants received meropenem, 1.0 g, in 100 ml saline solution as IV infusion administered over 30 minutes TID and two doses of GSK2251052 matching placebo saline solution, 200 or 250 ml, administered over 60 minutes, BID from Day 2 to Day 14 of the study.
Number of Participants With Therapeutic Response in Microbiological Evaluable Population End of IV Therapy, Therapeutic Success	3 Participants	1 Participants	4 Participants
Number of Participants With Therapeutic Response in Microbiological Evaluable Population End of IV Therapy, Therapeutic Failure	1 Participants	1 Participants	0 Participants
Number of Participants With Therapeutic Response in Microbiological Evaluable Population Test of Cure, Therapeutic Success	3 Participants	1 Participants	4 Participants
Number of Participants With Therapeutic Response in Microbiological Evaluable Population Test of Cure, Therapeutic Failure	1 Participants	1 Participants	0 Participants
Number of Participants With Therapeutic Response in Microbiological Evaluable Population Late Follow-up, Therapeutic Success	3 Participants	1 Participants	4 Participants
Number of Participants With Therapeutic Response in Microbiological Evaluable Population Late Follow-up, Therapeutic Failure	1 Participants	1 Participants	0 Participants

SECONDARY outcome

Timeframe: End of IV therapy (0-24 hours post-therapy); Test of cure (5-9 days post-therapy); Late Follow-up (21-28 days post-therapy)

Population: MITT Population. Only those participants available at the specified time points were analyzed.

Outcome measures

Outcome measures
Measure	GSK2251052 750 mg n=4 Participants Eligible participants received GSK2251052, 750 mg, in 200 or 250 mL saline solution as IV infusion administered over 60 minutes, BID and meropenem matching placebo solution, 100 ml, administered over 30 minutes, TID from Day 2 to Day 14 of the study.	GSK2251052 1500 mg n=2 Participants Eligible participants received GSK2251052, 1500 mg, in 200 or 250 mL saline solution as IV infusion administered over 60 minutes, BID and meropenem placebo solution, 100 ml, administered over 30 minutes, TID from Day 2 to Day 14 of the study.	Meropenem 1g n=4 Participants Eligible participants received meropenem, 1.0 g, in 100 ml saline solution as IV infusion administered over 30 minutes TID and two doses of GSK2251052 matching placebo saline solution, 200 or 250 ml, administered over 60 minutes, BID from Day 2 to Day 14 of the study.
Number of Participants With Therapeutic Response in MITT Population End of IV Therapy, Therapeutic Success	3 Participants	1 Participants	4 Participants
Number of Participants With Therapeutic Response in MITT Population End of IV Therapy, Therapeutic Failure	1 Participants	1 Participants	0 Participants
Number of Participants With Therapeutic Response in MITT Population Test of Cure, Therapeutic Success	3 Participants	1 Participants	4 Participants
Number of Participants With Therapeutic Response in MITT Population Test of Cure, Therapeutic Failure	1 Participants	1 Participants	0 Participants
Number of Participants With Therapeutic Response in MITT Population Late Follow-up, Therapeutic Success	3 Participants	1 Participants	4 Participants
Number of Participants With Therapeutic Response in MITT Population Late Follow-up, Therapeutic Failure	1 Participants	1 Participants	0 Participants

GSK2251052 750 mg

Serious events: 2 serious events

Other events: 4 other events

Deaths: 0 deaths

GSK2251052 1500 mg

Serious events: 3 serious events

Other events: 4 other events

Deaths: 0 deaths

Meropenem 1g

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	GSK2251052 750 mg n=5 participants at risk Eligible participants received GSK2251052, 750 mg, in 200 or 250 mL saline solution as IV infusion administered over 60 minutes, BID and meropenem matching placebo solution, 100 ml, administered over 30 minutes, TID from Day 2 to Day 14 of the study.	GSK2251052 1500 mg n=4 participants at risk Eligible participants received GSK2251052, 1500 mg, in 200 or 250 mL saline solution as IV infusion administered over 60 minutes, BID and meropenem placebo solution, 100 ml, administered over 30 minutes, TID from Day 2 to Day 14 of the study.	Meropenem 1g n=5 participants at risk Eligible participants received meropenem, 1.0 g, in 100 ml saline solution as IV infusion administered over 30 minutes TID and two doses of GSK2251052 matching placebo saline solution, 200 or 250 ml, administered over 60 minutes, BID from Day 2 to Day 14 of the study.
Infections and infestations Abdominal abscess	0.00% 0/5 • AEs were reported up to Late Follow-up visit (Day 42) Safety population was used to used to collect the AEs.	50.0% 2/4 • AEs were reported up to Late Follow-up visit (Day 42) Safety population was used to used to collect the AEs.	0.00% 0/5 • AEs were reported up to Late Follow-up visit (Day 42) Safety population was used to used to collect the AEs.
Infections and infestations Pelvic abscess	20.0% 1/5 • AEs were reported up to Late Follow-up visit (Day 42) Safety population was used to used to collect the AEs.	0.00% 0/4 • AEs were reported up to Late Follow-up visit (Day 42) Safety population was used to used to collect the AEs.	0.00% 0/5 • AEs were reported up to Late Follow-up visit (Day 42) Safety population was used to used to collect the AEs.
Investigations Blood creatinine increased	0.00% 0/5 • AEs were reported up to Late Follow-up visit (Day 42) Safety population was used to used to collect the AEs.	25.0% 1/4 • AEs were reported up to Late Follow-up visit (Day 42) Safety population was used to used to collect the AEs.	0.00% 0/5 • AEs were reported up to Late Follow-up visit (Day 42) Safety population was used to used to collect the AEs.
Investigations Haemoglobin decreased	20.0% 1/5 • AEs were reported up to Late Follow-up visit (Day 42) Safety population was used to used to collect the AEs.	0.00% 0/4 • AEs were reported up to Late Follow-up visit (Day 42) Safety population was used to used to collect the AEs.	0.00% 0/5 • AEs were reported up to Late Follow-up visit (Day 42) Safety population was used to used to collect the AEs.
Gastrointestinal disorders Pancreatitis acute	20.0% 1/5 • AEs were reported up to Late Follow-up visit (Day 42) Safety population was used to used to collect the AEs.	0.00% 0/4 • AEs were reported up to Late Follow-up visit (Day 42) Safety population was used to used to collect the AEs.	0.00% 0/5 • AEs were reported up to Late Follow-up visit (Day 42) Safety population was used to used to collect the AEs.
Hepatobiliary disorders Bile duct stone	0.00% 0/5 • AEs were reported up to Late Follow-up visit (Day 42) Safety population was used to used to collect the AEs.	25.0% 1/4 • AEs were reported up to Late Follow-up visit (Day 42) Safety population was used to used to collect the AEs.	0.00% 0/5 • AEs were reported up to Late Follow-up visit (Day 42) Safety population was used to used to collect the AEs.

Other adverse events

Additional Information

GSK Response Center

GlaxoSmithKline

Phone: 866-435-7343

Results disclosure agreements

Principal investigator is a sponsor employee GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
Publication restrictions are in place

Restriction type: OTHER

Measure	GSK2251052 750 mg n=5 participants at risk Eligible participants received GSK2251052, 750 mg, in 200 or 250 mL saline solution as IV infusion administered over 60 minutes, BID and meropenem matching placebo solution, 100 ml, administered over 30 minutes, TID from Day 2 to Day 14 of the study.	GSK2251052 1500 mg n=4 participants at risk Eligible participants received GSK2251052, 1500 mg, in 200 or 250 mL saline solution as IV infusion administered over 60 minutes, BID and meropenem placebo solution, 100 ml, administered over 30 minutes, TID from Day 2 to Day 14 of the study.	Meropenem 1g n=5 participants at risk Eligible participants received meropenem, 1.0 g, in 100 ml saline solution as IV infusion administered over 30 minutes TID and two doses of GSK2251052 matching placebo saline solution, 200 or 250 ml, administered over 60 minutes, BID from Day 2 to Day 14 of the study.
Nervous system disorders Dizziness	0.00% 0/5 • AEs were reported up to Late Follow-up visit (Day 42) Safety population was used to used to collect the AEs.	25.0% 1/4 • AEs were reported up to Late Follow-up visit (Day 42) Safety population was used to used to collect the AEs.	0.00% 0/5 • AEs were reported up to Late Follow-up visit (Day 42) Safety population was used to used to collect the AEs.
Nervous system disorders Headache	0.00% 0/5 • AEs were reported up to Late Follow-up visit (Day 42) Safety population was used to used to collect the AEs.	0.00% 0/4 • AEs were reported up to Late Follow-up visit (Day 42) Safety population was used to used to collect the AEs.	20.0% 1/5 • AEs were reported up to Late Follow-up visit (Day 42) Safety population was used to used to collect the AEs.
Psychiatric disorders Anxiety	0.00% 0/5 • AEs were reported up to Late Follow-up visit (Day 42) Safety population was used to used to collect the AEs.	0.00% 0/4 • AEs were reported up to Late Follow-up visit (Day 42) Safety population was used to used to collect the AEs.	20.0% 1/5 • AEs were reported up to Late Follow-up visit (Day 42) Safety population was used to used to collect the AEs.
Psychiatric disorders Dyssomnia	0.00% 0/5 • AEs were reported up to Late Follow-up visit (Day 42) Safety population was used to used to collect the AEs.	0.00% 0/4 • AEs were reported up to Late Follow-up visit (Day 42) Safety population was used to used to collect the AEs.	20.0% 1/5 • AEs were reported up to Late Follow-up visit (Day 42) Safety population was used to used to collect the AEs.
Respiratory, thoracic and mediastinal disorders Cough	0.00% 0/5 • AEs were reported up to Late Follow-up visit (Day 42) Safety population was used to used to collect the AEs.	25.0% 1/4 • AEs were reported up to Late Follow-up visit (Day 42) Safety population was used to used to collect the AEs.	0.00% 0/5 • AEs were reported up to Late Follow-up visit (Day 42) Safety population was used to used to collect the AEs.
Respiratory, thoracic and mediastinal disorders Rhinorrhoea	0.00% 0/5 • AEs were reported up to Late Follow-up visit (Day 42) Safety population was used to used to collect the AEs.	25.0% 1/4 • AEs were reported up to Late Follow-up visit (Day 42) Safety population was used to used to collect the AEs.	0.00% 0/5 • AEs were reported up to Late Follow-up visit (Day 42) Safety population was used to used to collect the AEs.
Blood and lymphatic system disorders Anisocytosis	0.00% 0/5 • AEs were reported up to Late Follow-up visit (Day 42) Safety population was used to used to collect the AEs.	0.00% 0/4 • AEs were reported up to Late Follow-up visit (Day 42) Safety population was used to used to collect the AEs.	20.0% 1/5 • AEs were reported up to Late Follow-up visit (Day 42) Safety population was used to used to collect the AEs.
Blood and lymphatic system disorders Poikilocytosis	0.00% 0/5 • AEs were reported up to Late Follow-up visit (Day 42) Safety population was used to used to collect the AEs.	0.00% 0/4 • AEs were reported up to Late Follow-up visit (Day 42) Safety population was used to used to collect the AEs.	20.0% 1/5 • AEs were reported up to Late Follow-up visit (Day 42) Safety population was used to used to collect the AEs.
Musculoskeletal and connective tissue disorders Flank pain	0.00% 0/5 • AEs were reported up to Late Follow-up visit (Day 42) Safety population was used to used to collect the AEs.	0.00% 0/4 • AEs were reported up to Late Follow-up visit (Day 42) Safety population was used to used to collect the AEs.	20.0% 1/5 • AEs were reported up to Late Follow-up visit (Day 42) Safety population was used to used to collect the AEs.
Renal and urinary disorders Pollakiuria	0.00% 0/5 • AEs were reported up to Late Follow-up visit (Day 42) Safety population was used to used to collect the AEs.	25.0% 1/4 • AEs were reported up to Late Follow-up visit (Day 42) Safety population was used to used to collect the AEs.	0.00% 0/5 • AEs were reported up to Late Follow-up visit (Day 42) Safety population was used to used to collect the AEs.
Skin and subcutaneous tissue disorders Rash	20.0% 1/5 • AEs were reported up to Late Follow-up visit (Day 42) Safety population was used to used to collect the AEs.	0.00% 0/4 • AEs were reported up to Late Follow-up visit (Day 42) Safety population was used to used to collect the AEs.	0.00% 0/5 • AEs were reported up to Late Follow-up visit (Day 42) Safety population was used to used to collect the AEs.
Vascular disorders Jugular vein thrombosis	20.0% 1/5 • AEs were reported up to Late Follow-up visit (Day 42) Safety population was used to used to collect the AEs.	0.00% 0/4 • AEs were reported up to Late Follow-up visit (Day 42) Safety population was used to used to collect the AEs.	0.00% 0/5 • AEs were reported up to Late Follow-up visit (Day 42) Safety population was used to used to collect the AEs.
Investigations Electrocardiogram repolarisation abnormality	0.00% 0/5 • AEs were reported up to Late Follow-up visit (Day 42) Safety population was used to used to collect the AEs.	0.00% 0/4 • AEs were reported up to Late Follow-up visit (Day 42) Safety population was used to used to collect the AEs.	20.0% 1/5 • AEs were reported up to Late Follow-up visit (Day 42) Safety population was used to used to collect the AEs.
Gastrointestinal disorders Diarrhoea	20.0% 1/5 • AEs were reported up to Late Follow-up visit (Day 42) Safety population was used to used to collect the AEs.	25.0% 1/4 • AEs were reported up to Late Follow-up visit (Day 42) Safety population was used to used to collect the AEs.	20.0% 1/5 • AEs were reported up to Late Follow-up visit (Day 42) Safety population was used to used to collect the AEs.
Gastrointestinal disorders Abdominal distension	0.00% 0/5 • AEs were reported up to Late Follow-up visit (Day 42) Safety population was used to used to collect the AEs.	0.00% 0/4 • AEs were reported up to Late Follow-up visit (Day 42) Safety population was used to used to collect the AEs.	20.0% 1/5 • AEs were reported up to Late Follow-up visit (Day 42) Safety population was used to used to collect the AEs.
Gastrointestinal disorders Constipation	20.0% 1/5 • AEs were reported up to Late Follow-up visit (Day 42) Safety population was used to used to collect the AEs.	0.00% 0/4 • AEs were reported up to Late Follow-up visit (Day 42) Safety population was used to used to collect the AEs.	0.00% 0/5 • AEs were reported up to Late Follow-up visit (Day 42) Safety population was used to used to collect the AEs.
Gastrointestinal disorders Dyspepsia	0.00% 0/5 • AEs were reported up to Late Follow-up visit (Day 42) Safety population was used to used to collect the AEs.	25.0% 1/4 • AEs were reported up to Late Follow-up visit (Day 42) Safety population was used to used to collect the AEs.	0.00% 0/5 • AEs were reported up to Late Follow-up visit (Day 42) Safety population was used to used to collect the AEs.
Gastrointestinal disorders Nausea	20.0% 1/5 • AEs were reported up to Late Follow-up visit (Day 42) Safety population was used to used to collect the AEs.	0.00% 0/4 • AEs were reported up to Late Follow-up visit (Day 42) Safety population was used to used to collect the AEs.	0.00% 0/5 • AEs were reported up to Late Follow-up visit (Day 42) Safety population was used to used to collect the AEs.
Gastrointestinal disorders Vomiting	20.0% 1/5 • AEs were reported up to Late Follow-up visit (Day 42) Safety population was used to used to collect the AEs.	0.00% 0/4 • AEs were reported up to Late Follow-up visit (Day 42) Safety population was used to used to collect the AEs.	0.00% 0/5 • AEs were reported up to Late Follow-up visit (Day 42) Safety population was used to used to collect the AEs.
General disorders Pyrexia	0.00% 0/5 • AEs were reported up to Late Follow-up visit (Day 42) Safety population was used to used to collect the AEs.	50.0% 2/4 • AEs were reported up to Late Follow-up visit (Day 42) Safety population was used to used to collect the AEs.	20.0% 1/5 • AEs were reported up to Late Follow-up visit (Day 42) Safety population was used to used to collect the AEs.
General disorders Infusion site pain	0.00% 0/5 • AEs were reported up to Late Follow-up visit (Day 42) Safety population was used to used to collect the AEs.	25.0% 1/4 • AEs were reported up to Late Follow-up visit (Day 42) Safety population was used to used to collect the AEs.	0.00% 0/5 • AEs were reported up to Late Follow-up visit (Day 42) Safety population was used to used to collect the AEs.
Infections and infestations Incision site infection	20.0% 1/5 • AEs were reported up to Late Follow-up visit (Day 42) Safety population was used to used to collect the AEs.	0.00% 0/4 • AEs were reported up to Late Follow-up visit (Day 42) Safety population was used to used to collect the AEs.	0.00% 0/5 • AEs were reported up to Late Follow-up visit (Day 42) Safety population was used to used to collect the AEs.
Infections and infestations Oral herpes	0.00% 0/5 • AEs were reported up to Late Follow-up visit (Day 42) Safety population was used to used to collect the AEs.	0.00% 0/4 • AEs were reported up to Late Follow-up visit (Day 42) Safety population was used to used to collect the AEs.	20.0% 1/5 • AEs were reported up to Late Follow-up visit (Day 42) Safety population was used to used to collect the AEs.
Infections and infestations Pelvic abscess	20.0% 1/5 • AEs were reported up to Late Follow-up visit (Day 42) Safety population was used to used to collect the AEs.	0.00% 0/4 • AEs were reported up to Late Follow-up visit (Day 42) Safety population was used to used to collect the AEs.	0.00% 0/5 • AEs were reported up to Late Follow-up visit (Day 42) Safety population was used to used to collect the AEs.
Infections and infestations Peritoneal abscess	20.0% 1/5 • AEs were reported up to Late Follow-up visit (Day 42) Safety population was used to used to collect the AEs.	0.00% 0/4 • AEs were reported up to Late Follow-up visit (Day 42) Safety population was used to used to collect the AEs.	0.00% 0/5 • AEs were reported up to Late Follow-up visit (Day 42) Safety population was used to used to collect the AEs.
Investigations Alanine aminotransferase increased	20.0% 1/5 • AEs were reported up to Late Follow-up visit (Day 42) Safety population was used to used to collect the AEs.	0.00% 0/4 • AEs were reported up to Late Follow-up visit (Day 42) Safety population was used to used to collect the AEs.	20.0% 1/5 • AEs were reported up to Late Follow-up visit (Day 42) Safety population was used to used to collect the AEs.
Investigations Aspartate aminotransferase increased	20.0% 1/5 • AEs were reported up to Late Follow-up visit (Day 42) Safety population was used to used to collect the AEs.	0.00% 0/4 • AEs were reported up to Late Follow-up visit (Day 42) Safety population was used to used to collect the AEs.	20.0% 1/5 • AEs were reported up to Late Follow-up visit (Day 42) Safety population was used to used to collect the AEs.
Investigations Blood creatine phosphokinase increased	0.00% 0/5 • AEs were reported up to Late Follow-up visit (Day 42) Safety population was used to used to collect the AEs.	0.00% 0/4 • AEs were reported up to Late Follow-up visit (Day 42) Safety population was used to used to collect the AEs.	20.0% 1/5 • AEs were reported up to Late Follow-up visit (Day 42) Safety population was used to used to collect the AEs.
Investigations Blood creatinine increased	0.00% 0/5 • AEs were reported up to Late Follow-up visit (Day 42) Safety population was used to used to collect the AEs.	25.0% 1/4 • AEs were reported up to Late Follow-up visit (Day 42) Safety population was used to used to collect the AEs.	0.00% 0/5 • AEs were reported up to Late Follow-up visit (Day 42) Safety population was used to used to collect the AEs.
Investigations Electrocardiogram ST segment elevation	0.00% 0/5 • AEs were reported up to Late Follow-up visit (Day 42) Safety population was used to used to collect the AEs.	0.00% 0/4 • AEs were reported up to Late Follow-up visit (Day 42) Safety population was used to used to collect the AEs.	20.0% 1/5 • AEs were reported up to Late Follow-up visit (Day 42) Safety population was used to used to collect the AEs.
Investigations Platelet count decreased	0.00% 0/5 • AEs were reported up to Late Follow-up visit (Day 42) Safety population was used to used to collect the AEs.	0.00% 0/4 • AEs were reported up to Late Follow-up visit (Day 42) Safety population was used to used to collect the AEs.	20.0% 1/5 • AEs were reported up to Late Follow-up visit (Day 42) Safety population was used to used to collect the AEs.
Investigations Platelet count increased	0.00% 0/5 • AEs were reported up to Late Follow-up visit (Day 42) Safety population was used to used to collect the AEs.	0.00% 0/4 • AEs were reported up to Late Follow-up visit (Day 42) Safety population was used to used to collect the AEs.	20.0% 1/5 • AEs were reported up to Late Follow-up visit (Day 42) Safety population was used to used to collect the AEs.
Investigations Reticulocyte count increased	20.0% 1/5 • AEs were reported up to Late Follow-up visit (Day 42) Safety population was used to used to collect the AEs.	0.00% 0/4 • AEs were reported up to Late Follow-up visit (Day 42) Safety population was used to used to collect the AEs.	0.00% 0/5 • AEs were reported up to Late Follow-up visit (Day 42) Safety population was used to used to collect the AEs.
Metabolism and nutrition disorders Electrolyte imbalance	20.0% 1/5 • AEs were reported up to Late Follow-up visit (Day 42) Safety population was used to used to collect the AEs.	25.0% 1/4 • AEs were reported up to Late Follow-up visit (Day 42) Safety population was used to used to collect the AEs.	0.00% 0/5 • AEs were reported up to Late Follow-up visit (Day 42) Safety population was used to used to collect the AEs.
Metabolism and nutrition disorders Hypokalaemia	0.00% 0/5 • AEs were reported up to Late Follow-up visit (Day 42) Safety population was used to used to collect the AEs.	25.0% 1/4 • AEs were reported up to Late Follow-up visit (Day 42) Safety population was used to used to collect the AEs.	0.00% 0/5 • AEs were reported up to Late Follow-up visit (Day 42) Safety population was used to used to collect the AEs.
Metabolism and nutrition disorders Hypophosphataemia	0.00% 0/5 • AEs were reported up to Late Follow-up visit (Day 42) Safety population was used to used to collect the AEs.	25.0% 1/4 • AEs were reported up to Late Follow-up visit (Day 42) Safety population was used to used to collect the AEs.	0.00% 0/5 • AEs were reported up to Late Follow-up visit (Day 42) Safety population was used to used to collect the AEs.
Cardiac disorders Sinus bradycardia	0.00% 0/5 • AEs were reported up to Late Follow-up visit (Day 42) Safety population was used to used to collect the AEs.	0.00% 0/4 • AEs were reported up to Late Follow-up visit (Day 42) Safety population was used to used to collect the AEs.	20.0% 1/5 • AEs were reported up to Late Follow-up visit (Day 42) Safety population was used to used to collect the AEs.
Cardiac disorders Tachycardia	20.0% 1/5 • AEs were reported up to Late Follow-up visit (Day 42) Safety population was used to used to collect the AEs.	0.00% 0/4 • AEs were reported up to Late Follow-up visit (Day 42) Safety population was used to used to collect the AEs.	0.00% 0/5 • AEs were reported up to Late Follow-up visit (Day 42) Safety population was used to used to collect the AEs.