Trial Outcomes & Findings for Moxifloxacin in Pediatric Subjects With Complicated Intra-abdominal Infection (NCT NCT01069900)

NCT ID: NCT01069900

Last Updated: 2018-03-20

Results Overview

An adverse event (AE) was any untoward medical occurrence in a subject who received study drug without regard to possibility of causal relationship. An serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 458 participants
• Primary outcome timeframe: All AEs and SAE were recorded from treatment start to test of cure visit; musculoskeletal AEs were recorded up to 1 year post-end of treatment (EOT) visit; subjects with musculoskeletal AEs 1 year after EOT were followed up to 5 years or until resolution.
• Results posted on: 2018-03-20

Participant Flow

The study was conducted at multicenter between 21 July 2010 (first subject first visit) to 21 January 2015 (last subject last visit).

Overall 478 subjects were enrolled, 20 subjects had screening failures hence, 458 subjects were randomized to receive treatment.

Participant milestones

Measure	Moxifloxacin (Avelox, BAY12-8039) Subjects randomized to the moxifloxacin arm of this study received intravenous moxifloxacin plus ertapenem placebo (0.9 % sodium chloride \[NaCl solution\]) for a minimum of 3 days and, if switched to oral treatment, PO moxifloxacin plus PO amoxicillin/clavulanate placebo. Total treatment duration is 5- 14 days.	Comparator Ertapenem Subjects randomized to the comparator arm of this study received intravenous ertapenem plus moxifloxacin placebo (0.9 % NaCl solution) for a minimum of 3 days and, if switched to oral treatment, amoxicillin/clavulanate as an oral suspension plus PO moxifloxacin placebo. Total treatment duration is 5-14 days.
Overall Study STARTED	305	153
Overall Study Treated	301	150
Overall Study COMPLETED	287	149
Overall Study NOT COMPLETED	18	4

Reasons for withdrawal

Measure	Moxifloxacin (Avelox, BAY12-8039) Subjects randomized to the moxifloxacin arm of this study received intravenous moxifloxacin plus ertapenem placebo (0.9 % sodium chloride \[NaCl solution\]) for a minimum of 3 days and, if switched to oral treatment, PO moxifloxacin plus PO amoxicillin/clavulanate placebo. Total treatment duration is 5- 14 days.	Comparator Ertapenem Subjects randomized to the comparator arm of this study received intravenous ertapenem plus moxifloxacin placebo (0.9 % NaCl solution) for a minimum of 3 days and, if switched to oral treatment, amoxicillin/clavulanate as an oral suspension plus PO moxifloxacin placebo. Total treatment duration is 5-14 days.
Overall Study Technical problems	0	1
Overall Study Lost to Follow-up	7	1
Overall Study Withdrawal by Subject	6	1
Overall Study Protocol Violation	4	1
Overall Study Insufficient Therapeutic effect	1	0

Baseline Characteristics

Moxifloxacin in Pediatric Subjects With Complicated Intra-abdominal Infection

Baseline characteristics by cohort

Measure	Moxifloxacin (Avelox, BAY12-8039) n=305 Participants Subjects randomized to the moxifloxacin arm of this study received intravenous moxifloxacin plus ertapenem placebo (0.9 % sodium chloride \[NaCl solution\]) for a minimum of 3 days and, if switched to oral treatment, PO moxifloxacin plus PO amoxicillin/clavulanate placebo. Total treatment duration is 5- 14 days.	Comparator Ertapenem n=153 Participants Subjects randomized to the comparator arm of this study received intravenous ertapenem plus moxifloxacin placebo (0.9 % NaCl solution) for a minimum of 3 days and, if switched to oral treatment, amoxicillin/clavulanate as an oral suspension plus PO moxifloxacin placebo. Total treatment duration is 5-14 days.	Total n=458 Participants Total of all reporting groups
Age, Continuous	12.05 years STANDARD_DEVIATION 3.66 • n=5 Participants	12.046 years STANDARD_DEVIATION 3.495 • n=7 Participants	12.049 years STANDARD_DEVIATION 3.602 • n=5 Participants
Age, Customized 12 - < 18 years	190 Subjects n=5 Participants	94 Subjects n=7 Participants	284 Subjects n=5 Participants
Age, Customized 6 - < 12 years	100 Subjects n=5 Participants	52 Subjects n=7 Participants	152 Subjects n=5 Participants
Age, Customized 2 - < 6 years	14 Subjects n=5 Participants	7 Subjects n=7 Participants	21 Subjects n=5 Participants
Age, Customized 3 months - < 2 years	1 Subjects n=5 Participants	0 Subjects n=7 Participants	1 Subjects n=5 Participants
Sex: Female, Male Female	124 Participants n=5 Participants	53 Participants n=7 Participants	177 Participants n=5 Participants
Sex: Female, Male Male	181 Participants n=5 Participants	100 Participants n=7 Participants	281 Participants n=5 Participants

PRIMARY outcome

Timeframe: All AEs and SAE were recorded from treatment start to test of cure visit; musculoskeletal AEs were recorded up to 1 year post-end of treatment (EOT) visit; subjects with musculoskeletal AEs 1 year after EOT were followed up to 5 years or until resolution.

Population: Safety analysis set; All subjects (N= 451) treated with at least one dose of study medication.

An adverse event (AE) was any untoward medical occurrence in a subject who received study drug without regard to possibility of causal relationship. An serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.

Outcome measures

Measure	Moxifloxacin (Avelox, BAY12-8039) n=301 Participants Subjects randomized to the moxifloxacin arm of this study received intravenous moxifloxacin plus ertapenem placebo (0.9 % sodium chloride \[NaCl solution\]) for a minimum of 3 days and, if switched to oral treatment, PO moxifloxacin plus PO amoxicillin/clavulanate placebo. Total treatment duration is 5- 14 days.	Comparator Ertapenem n=150 Participants Subjects randomized to the comparator arm of this study received intravenous ertapenem plus moxifloxacin placebo (0.9 % NaCl solution) for a minimum of 3 days and, if switched to oral treatment, amoxicillin/clavulanate as an oral suspension plus PO moxifloxacin placebo. Total treatment duration is 5-14 days.
Number of Subjects With Adverse Events Any AE	175 Subjects	82 Subjects
Number of Subjects With Adverse Events Any SAE	20 Subjects	6 Subjects

PRIMARY outcome

Timeframe: Clinical cardiac event related to QT interval were recorded from treatment start until day 3 of treatment. All other clinical cardiac events were recorded from treatment start to test of cure visit, up to day 56.

Population: Safety analysis set; All subjects (N= 451) treated with at least one dose of study medication.

Outcome measures

Measure	Moxifloxacin (Avelox, BAY12-8039) n=301 Participants Subjects randomized to the moxifloxacin arm of this study received intravenous moxifloxacin plus ertapenem placebo (0.9 % sodium chloride \[NaCl solution\]) for a minimum of 3 days and, if switched to oral treatment, PO moxifloxacin plus PO amoxicillin/clavulanate placebo. Total treatment duration is 5- 14 days.	Comparator Ertapenem n=150 Participants Subjects randomized to the comparator arm of this study received intravenous ertapenem plus moxifloxacin placebo (0.9 % NaCl solution) for a minimum of 3 days and, if switched to oral treatment, amoxicillin/clavulanate as an oral suspension plus PO moxifloxacin placebo. Total treatment duration is 5-14 days.
Number of Subjects With Clinical Cardiac Adverse Events Any AE	38 Subjects	7 Subjects
Number of Subjects With Clinical Cardiac Adverse Events Any SAE	0 Subjects	0 Subjects

PRIMARY outcome

Timeframe: All AEs and SAE were recorded from treatment start to test of cure visit; musculoskeletal AEs were recorded up to 1 year post-end of treatment (EOT) visit; subjects with musculoskeletal AEs 1 year after EOT were followed up to 5 years or until resolution.

Population: Safety analysis set; All subjects (N= 451) treated with at least one dose of study medication.

Outcome measures

Measure	Moxifloxacin (Avelox, BAY12-8039) n=301 Participants Subjects randomized to the moxifloxacin arm of this study received intravenous moxifloxacin plus ertapenem placebo (0.9 % sodium chloride \[NaCl solution\]) for a minimum of 3 days and, if switched to oral treatment, PO moxifloxacin plus PO amoxicillin/clavulanate placebo. Total treatment duration is 5- 14 days.	Comparator Ertapenem n=150 Participants Subjects randomized to the comparator arm of this study received intravenous ertapenem plus moxifloxacin placebo (0.9 % NaCl solution) for a minimum of 3 days and, if switched to oral treatment, amoxicillin/clavulanate as an oral suspension plus PO moxifloxacin placebo. Total treatment duration is 5-14 days.
Number of Subjects With Musculoskeletal Adverse Events Any AE	13 Subjects	5 Subjects
Number of Subjects With Musculoskeletal Adverse Events Any SAE	1 Subjects	0 Subjects

SECONDARY outcome

Timeframe: All AEs and SAE were recorded from treatment start to test of cure visit; musculoskeletal AEs were recorded up to 1 year post-end of treatment (EOT) visit; subjects with musculoskeletal AEs 1 year after EOT were followed up to 5 years or until resolution.

Population: Safety analysis set; All subjects (N= 451) treated with at least one dose of study medication.

Musculoskeletal adverse events were classified as following SOCs (preferred terms): "injury, poisoning and procedural complications" (forearm fracture, joint injury, ligament sprain, muscle strain) "musculoskeletal and connective tissue disorders" (arthralgia, joint swelling, musculoskeletal pain, myalgia). Incidence rates were reported as percentage of subjects categorized under preferred terms.

Outcome measures

Measure	Moxifloxacin (Avelox, BAY12-8039) n=301 Participants Subjects randomized to the moxifloxacin arm of this study received intravenous moxifloxacin plus ertapenem placebo (0.9 % sodium chloride \[NaCl solution\]) for a minimum of 3 days and, if switched to oral treatment, PO moxifloxacin plus PO amoxicillin/clavulanate placebo. Total treatment duration is 5- 14 days.	Comparator Ertapenem n=150 Participants Subjects randomized to the comparator arm of this study received intravenous ertapenem plus moxifloxacin placebo (0.9 % NaCl solution) for a minimum of 3 days and, if switched to oral treatment, amoxicillin/clavulanate as an oral suspension plus PO moxifloxacin placebo. Total treatment duration is 5-14 days.
Incidence Rates of Musculoskeletal Adverse Events by Primary System Organ Class (SOC) and Preferred Term Forearm fracture	0.3 Percentage of subjects Interval 0.01 to 1.84	0 Percentage of subjects Interval 0.0 to 2.43
Incidence Rates of Musculoskeletal Adverse Events by Primary System Organ Class (SOC) and Preferred Term Joint injury	0 Percentage of subjects Interval 0.0 to 1.22	0.7 Percentage of subjects Interval 0.02 to 3.66
Incidence Rates of Musculoskeletal Adverse Events by Primary System Organ Class (SOC) and Preferred Term Ligament sprain	0.3 Percentage of subjects Interval 0.01 to 1.84	0.7 Percentage of subjects Interval 0.02 to 3.66
Incidence Rates of Musculoskeletal Adverse Events by Primary System Organ Class (SOC) and Preferred Term Muscle strain	0 Percentage of subjects Interval 0.0 to 1.22	0.7 Percentage of subjects Interval 0.02 to 3.66
Incidence Rates of Musculoskeletal Adverse Events by Primary System Organ Class (SOC) and Preferred Term Arthralgia	3 Percentage of subjects Interval 1.38 to 5.6	1.3 Percentage of subjects Interval 0.16 to 4.73
Incidence Rates of Musculoskeletal Adverse Events by Primary System Organ Class (SOC) and Preferred Term Joint swelling	0 Percentage of subjects Interval 0.0 to 1.22	0.7 Percentage of subjects Interval 0.02 to 3.66
Incidence Rates of Musculoskeletal Adverse Events by Primary System Organ Class (SOC) and Preferred Term Musculoskeletal pain	1 Percentage of subjects Interval 0.21 to 2.88	0 Percentage of subjects Interval 0.0 to 2.43
Incidence Rates of Musculoskeletal Adverse Events by Primary System Organ Class (SOC) and Preferred Term Myalgia	0.3 Percentage of subjects Interval 0.01 to 1.84	0 Percentage of subjects Interval 0.0 to 2.43

SECONDARY outcome

Timeframe: Baseline (Pre-dose), Day 1, Day 3

Population: Safety analysis set; All subjects (N= 451) treated with at least one dose of study medication.

"N" signifies subjects who were evaluable for the specified parameter for each arm, respectively.

Outcome measures

Measure	Moxifloxacin (Avelox, BAY12-8039) n=301 Participants Subjects randomized to the moxifloxacin arm of this study received intravenous moxifloxacin plus ertapenem placebo (0.9 % sodium chloride \[NaCl solution\]) for a minimum of 3 days and, if switched to oral treatment, PO moxifloxacin plus PO amoxicillin/clavulanate placebo. Total treatment duration is 5- 14 days.	Comparator Ertapenem n=150 Participants Subjects randomized to the comparator arm of this study received intravenous ertapenem plus moxifloxacin placebo (0.9 % NaCl solution) for a minimum of 3 days and, if switched to oral treatment, amoxicillin/clavulanate as an oral suspension plus PO moxifloxacin placebo. Total treatment duration is 5-14 days.
Heart Rate Changes in Electrocardiogram (ECG) Profiles From Pre-dose to Post-dose on Treatment Day 1 and Treatment Day 3 Day 1: Pre-dose (N= 300, 150)	93.4 Beats per minute (bpm) Standard Deviation 19.1	90.4 Beats per minute (bpm) Standard Deviation 16.9
Heart Rate Changes in Electrocardiogram (ECG) Profiles From Pre-dose to Post-dose on Treatment Day 1 and Treatment Day 3 Change at Day 1 ((N= 294, 148)	2.8 Beats per minute (bpm) Standard Deviation 9.7	0.3 Beats per minute (bpm) Standard Deviation 6.9
Heart Rate Changes in Electrocardiogram (ECG) Profiles From Pre-dose to Post-dose on Treatment Day 1 and Treatment Day 3 Day 3: Pre-dose (N= 293, 146)	84.3 Beats per minute (bpm) Standard Deviation 17.2	82.6 Beats per minute (bpm) Standard Deviation 16.2
Heart Rate Changes in Electrocardiogram (ECG) Profiles From Pre-dose to Post-dose on Treatment Day 1 and Treatment Day 3 Change at Day 3 (N= 290, 146)	1 Beats per minute (bpm) Standard Deviation 8.9	-0.9 Beats per minute (bpm) Standard Deviation 7.1

SECONDARY outcome

Timeframe: Baseline (Pre-dose), Day 1, Day 3

Population: Safety analysis set; All subjects (N= 451) treated with at least one dose of study medication.

The PR interval is defined as the period that extends from the onset of atrial depolarization (beginning of the P wave) until the onset of ventricular depolarization. "N" signifies subjects who were evaluable for the specified parameter for each arm, respectively.

Outcome measures

Measure	Moxifloxacin (Avelox, BAY12-8039) n=301 Participants Subjects randomized to the moxifloxacin arm of this study received intravenous moxifloxacin plus ertapenem placebo (0.9 % sodium chloride \[NaCl solution\]) for a minimum of 3 days and, if switched to oral treatment, PO moxifloxacin plus PO amoxicillin/clavulanate placebo. Total treatment duration is 5- 14 days.	Comparator Ertapenem n=150 Participants Subjects randomized to the comparator arm of this study received intravenous ertapenem plus moxifloxacin placebo (0.9 % NaCl solution) for a minimum of 3 days and, if switched to oral treatment, amoxicillin/clavulanate as an oral suspension plus PO moxifloxacin placebo. Total treatment duration is 5-14 days.
PR Interval Changes in Electrocardiogram (ECG) Profiles From Pre-dose to Post-dose on Treatment Day 1 and Treatment Day 3 Day 3: Pre-dose (N= 293, 146)	139.4915 milliseconds Standard Deviation 17.3258	139.5685 milliseconds Standard Deviation 20.8174
PR Interval Changes in Electrocardiogram (ECG) Profiles From Pre-dose to Post-dose on Treatment Day 1 and Treatment Day 3 Change at Day 3 (N= 289, 146)	1.5813 milliseconds Standard Deviation 9.2143	1.5616 milliseconds Standard Deviation 9.9322
PR Interval Changes in Electrocardiogram (ECG) Profiles From Pre-dose to Post-dose on Treatment Day 1 and Treatment Day 3 Day 1: Pre-dose (N= 299, 150)	136.8294 milliseconds Standard Deviation 18.3554	140.5933 milliseconds Standard Deviation 20.5113
PR Interval Changes in Electrocardiogram (ECG) Profiles From Pre-dose to Post-dose on Treatment Day 1 and Treatment Day 3 Change at Day 1 ( N= 292, 148)	0.7123 milliseconds Standard Deviation 8.2587	-0.0203 milliseconds Standard Deviation 8.5631

SECONDARY outcome

Timeframe: Baseline (Pre-dose), Day 1, Day 3

Population: Safety analysis set; All subjects (N= 451) treated with at least one dose of study medication.

The RR interval refers to the respective time interval in the Electrocardiogram. "N" signifies subjects who were evaluable for the specified parameter for each arm, respectively.

Outcome measures

Measure	Moxifloxacin (Avelox, BAY12-8039) n=301 Participants Subjects randomized to the moxifloxacin arm of this study received intravenous moxifloxacin plus ertapenem placebo (0.9 % sodium chloride \[NaCl solution\]) for a minimum of 3 days and, if switched to oral treatment, PO moxifloxacin plus PO amoxicillin/clavulanate placebo. Total treatment duration is 5- 14 days.	Comparator Ertapenem n=150 Participants Subjects randomized to the comparator arm of this study received intravenous ertapenem plus moxifloxacin placebo (0.9 % NaCl solution) for a minimum of 3 days and, if switched to oral treatment, amoxicillin/clavulanate as an oral suspension plus PO moxifloxacin placebo. Total treatment duration is 5-14 days.
RR Interval Changes in Electrocardiogram (ECG) Profiles From Pre-dose to Post-dose on Treatment Day 1 and Treatment Day 3 Day 1: Pre-dose (N= 300, 150)	670.7567 milliseconds Standard Deviation 142.6153	689.3067 milliseconds Standard Deviation 145.5957
RR Interval Changes in Electrocardiogram (ECG) Profiles From Pre-dose to Post-dose on Treatment Day 1 and Treatment Day 3 Change at Day 1 (N= 294, 148)	-20.6429 milliseconds Standard Deviation 74.3401	-3.4797 milliseconds Standard Deviation 56.9955
RR Interval Changes in Electrocardiogram (ECG) Profiles From Pre-dose to Post-dose on Treatment Day 1 and Treatment Day 3 Day 3: Pre-dose (N= 293, 146)	740.4778 milliseconds Standard Deviation 149.0964	754.6027 milliseconds Standard Deviation 150.1203
RR Interval Changes in Electrocardiogram (ECG) Profiles From Pre-dose to Post-dose on Treatment Day 1 and Treatment Day 3 Change at Day 3 (N= 290, 146)	-9.2862 milliseconds Standard Deviation 77.7582	10.5137 milliseconds Standard Deviation 67.1124

SECONDARY outcome

Timeframe: Baseline (Pre-dose), Day 1, Day 3

Population: Safety analysis set; All subjects (N= 451) treated with at least one dose of study medication.

The QRS interval represents the time it takes for ventricular depolarization to occur. "N" signifies subjects who were evaluable for the specified parameter for each arm, respectively.

Outcome measures

Measure	Moxifloxacin (Avelox, BAY12-8039) n=301 Participants Subjects randomized to the moxifloxacin arm of this study received intravenous moxifloxacin plus ertapenem placebo (0.9 % sodium chloride \[NaCl solution\]) for a minimum of 3 days and, if switched to oral treatment, PO moxifloxacin plus PO amoxicillin/clavulanate placebo. Total treatment duration is 5- 14 days.	Comparator Ertapenem n=150 Participants Subjects randomized to the comparator arm of this study received intravenous ertapenem plus moxifloxacin placebo (0.9 % NaCl solution) for a minimum of 3 days and, if switched to oral treatment, amoxicillin/clavulanate as an oral suspension plus PO moxifloxacin placebo. Total treatment duration is 5-14 days.
QRS Interval Changes in Electrocardiogram (ECG) Profiles From Predose to Post-dose on Treatment Day 1 and Treatment Day 3 Day 1: Pre-dose (N= 300, 150)	89.0333 milliseconds Standard Deviation 7.8279	88.8067 milliseconds Standard Deviation 7.9264
QRS Interval Changes in Electrocardiogram (ECG) Profiles From Predose to Post-dose on Treatment Day 1 and Treatment Day 3 Change at Day 1 (N= 294, 148)	0.119 milliseconds Standard Deviation 4.3799	1.223 milliseconds Standard Deviation 4.2568
QRS Interval Changes in Electrocardiogram (ECG) Profiles From Predose to Post-dose on Treatment Day 1 and Treatment Day 3 Day 3: Pre-dose (N= 293, 146)	89.2423 milliseconds Standard Deviation 8.0196	89.3904 milliseconds Standard Deviation 7.8198
QRS Interval Changes in Electrocardiogram (ECG) Profiles From Predose to Post-dose on Treatment Day 1 and Treatment Day 3 Change at Day 3 (N= 289, 146)	0.2768 milliseconds Standard Deviation 4.123	0.2877 milliseconds Standard Deviation 3.1687

SECONDARY outcome

Timeframe: Baseline (Pre-dose), Day 1, Day 3

Population: Safety analysis set; All subjects (N= 451) treated with at least one dose of study medication.

The QT interval is the period that extends from the beginning of ventricular depolarization until the end of ventricular repolarization. "N" signifies subjects who were evaluable for the specified parameter for each arm, respectively.

Outcome measures

Measure	Moxifloxacin (Avelox, BAY12-8039) n=301 Participants Subjects randomized to the moxifloxacin arm of this study received intravenous moxifloxacin plus ertapenem placebo (0.9 % sodium chloride \[NaCl solution\]) for a minimum of 3 days and, if switched to oral treatment, PO moxifloxacin plus PO amoxicillin/clavulanate placebo. Total treatment duration is 5- 14 days.	Comparator Ertapenem n=150 Participants Subjects randomized to the comparator arm of this study received intravenous ertapenem plus moxifloxacin placebo (0.9 % NaCl solution) for a minimum of 3 days and, if switched to oral treatment, amoxicillin/clavulanate as an oral suspension plus PO moxifloxacin placebo. Total treatment duration is 5-14 days.
QT Interval Changes in Electrocardiogram (ECG) Profiles From Pre-dose to Post-dose on Treatment Day 1 and Treatment Day 3 Day 1: Pre-dose (N= 298, 150)	341.1812 milliseconds Standard Deviation 33.9858	344.2333 milliseconds Standard Deviation 33.5494
QT Interval Changes in Electrocardiogram (ECG) Profiles From Pre-dose to Post-dose on Treatment Day 1 and Treatment Day 3 Change at Day 1 (N= 290, 148)	2.5828 milliseconds Standard Deviation 15.213	1.1149 milliseconds Standard Deviation 11.5744
QT Interval Changes in Electrocardiogram (ECG) Profiles From Pre-dose to Post-dose on Treatment Day 1 and Treatment Day 3 Day 3: Pre-dose (N= 292, 146)	358.3082 milliseconds Standard Deviation 34.0504	356.5822 milliseconds Standard Deviation 35.6653
QT Interval Changes in Electrocardiogram (ECG) Profiles From Pre-dose to Post-dose on Treatment Day 1 and Treatment Day 3 Change at Day 3 (N= 287, 146)	6.0906 milliseconds Standard Deviation 16.1875	3.1644 milliseconds Standard Deviation 11.9586

SECONDARY outcome

Timeframe: Baseline (Pre-dose), Day 1, Day 3

Population: Safety analysis set; All subjects (N= 451) treated with at least one dose of study medication.

QTc interval Calc Bazett represent the interval corrected for heart rate (QTc) milliseconds (msec) which was calculated by Bazett's method. "N" signifies subjects who were evaluable for the specified parameter for each arm, respectively.

Outcome measures

Measure	Moxifloxacin (Avelox, BAY12-8039) n=301 Participants Subjects randomized to the moxifloxacin arm of this study received intravenous moxifloxacin plus ertapenem placebo (0.9 % sodium chloride \[NaCl solution\]) for a minimum of 3 days and, if switched to oral treatment, PO moxifloxacin plus PO amoxicillin/clavulanate placebo. Total treatment duration is 5- 14 days.	Comparator Ertapenem n=150 Participants Subjects randomized to the comparator arm of this study received intravenous ertapenem plus moxifloxacin placebo (0.9 % NaCl solution) for a minimum of 3 days and, if switched to oral treatment, amoxicillin/clavulanate as an oral suspension plus PO moxifloxacin placebo. Total treatment duration is 5-14 days.
Corrected QT (QTc) Interval Calculated (Calc) Bazett Changes in Electrocardiogram (ECG) Profiles From Pre-dose to Post-dose on Treatment Day 1 and Treatment Day 3 Day 1: Pre-dose (N= 298, 150)	419.5872 milliseconds Standard Deviation 19.3278	417.34 milliseconds Standard Deviation 18.5718
Corrected QT (QTc) Interval Calculated (Calc) Bazett Changes in Electrocardiogram (ECG) Profiles From Pre-dose to Post-dose on Treatment Day 1 and Treatment Day 3 Change at Day 1 (N= 290, 148)	9.731 milliseconds Standard Deviation 14.2961	2.2905 milliseconds Standard Deviation 14.2544
Corrected QT (QTc) Interval Calculated (Calc) Bazett Changes in Electrocardiogram (ECG) Profiles From Pre-dose to Post-dose on Treatment Day 1 and Treatment Day 3 Day 3: Pre-dose (N= 292, 146)	419.2055 milliseconds Standard Deviation 16.6815	412.7945 milliseconds Standard Deviation 17.0075
Corrected QT (QTc) Interval Calculated (Calc) Bazett Changes in Electrocardiogram (ECG) Profiles From Pre-dose to Post-dose on Treatment Day 1 and Treatment Day 3 Change at Day 3 (N= 287, 146)	9.2509 milliseconds Standard Deviation 16.8132	1 milliseconds Standard Deviation 12.5346

SECONDARY outcome

Timeframe: Baseline (Pre-dose), Day 1, Day 3

Population: Safety analysis set; All subjects (N= 451) treated with at least one dose of study medication.

QTc interval Calc Fridericia represent the interval corrected for heart rate (QTc) msec which was calculated by Fridericia's method. "N" signifies subjects who were evaluable for the specified parameter for each arm, respectively.

Outcome measures

Measure	Moxifloxacin (Avelox, BAY12-8039) n=301 Participants Subjects randomized to the moxifloxacin arm of this study received intravenous moxifloxacin plus ertapenem placebo (0.9 % sodium chloride \[NaCl solution\]) for a minimum of 3 days and, if switched to oral treatment, PO moxifloxacin plus PO amoxicillin/clavulanate placebo. Total treatment duration is 5- 14 days.	Comparator Ertapenem n=150 Participants Subjects randomized to the comparator arm of this study received intravenous ertapenem plus moxifloxacin placebo (0.9 % NaCl solution) for a minimum of 3 days and, if switched to oral treatment, amoxicillin/clavulanate as an oral suspension plus PO moxifloxacin placebo. Total treatment duration is 5-14 days.
Corrected QT (QTc) Interval Calculated (Calc) Fridericia Changes in Electrocardiogram (ECG) Profiles From Pre-dose to Post-dose on Treatment Day 1 and Treatment Day 3 Day 1: Pre-dose (N= 298, 150)	391.1846 milliseconds Standard Deviation 19.1574	390.9467 milliseconds Standard Deviation 18.4339
Corrected QT (QTc) Interval Calculated (Calc) Fridericia Changes in Electrocardiogram (ECG) Profiles From Pre-dose to Post-dose on Treatment Day 1 and Treatment Day 3 Change at Day 1 (N= 290, 148)	7.0724 milliseconds Standard Deviation 11.3219	1.9122 milliseconds Standard Deviation 11.3058
Corrected QT (QTc) Interval Calculated (Calc) Fridericia Changes in Electrocardiogram (ECG) Profiles From Pre-dose to Post-dose on Treatment Day 1 and Treatment Day 3 Day 3: Pre-dose (N= 292, 146)	397.3767 milliseconds Standard Deviation 17.2179	392.6918 milliseconds Standard Deviation 18.8144
Corrected QT (QTc) Interval Calculated (Calc) Fridericia Changes in Electrocardiogram (ECG) Profiles From Pre-dose to Post-dose on Treatment Day 1 and Treatment Day 3 Change at Day 3 (N= 287, 146)	8.115 milliseconds Standard Deviation 13.5805	1.774 milliseconds Standard Deviation 9.3328

SECONDARY outcome

Timeframe: Baseline (Pre-dose), Day 1, Day 3

Population: Safety analysis set; All subjects (N= 451) treated with at least one dose of study medication.

A significant QTc prolongation was considered when the QTc value was more than (>) upper limit of normal (ULN) range or was prolonged for 30 msec or 60msec in comparison with the pre-treatment value measured on Day 1. "N" signifies subjects who were evaluable for the specified parameter for each arm, respectively. Percentage of subjects with potentially clinically significant ECG data was reported.

Outcome measures

Measure	Moxifloxacin (Avelox, BAY12-8039) n=301 Participants Subjects randomized to the moxifloxacin arm of this study received intravenous moxifloxacin plus ertapenem placebo (0.9 % sodium chloride \[NaCl solution\]) for a minimum of 3 days and, if switched to oral treatment, PO moxifloxacin plus PO amoxicillin/clavulanate placebo. Total treatment duration is 5- 14 days.	Comparator Ertapenem n=150 Participants Subjects randomized to the comparator arm of this study received intravenous ertapenem plus moxifloxacin placebo (0.9 % NaCl solution) for a minimum of 3 days and, if switched to oral treatment, amoxicillin/clavulanate as an oral suspension plus PO moxifloxacin placebo. Total treatment duration is 5-14 days.
Potentially Clinically Significant Electrocardiogram (ECG) QTc Interval Prolongation - by QTc Interval Calc Fridericia Correction on Treatment Day 1 and During Therapy Day 3 Day1: Pre-dose QTcCalcFridericia>ULN (N= 300, 150)	0.7 Percentage of subjects 19.1574	1.3 Percentage of subjects 18.4339
Potentially Clinically Significant Electrocardiogram (ECG) QTc Interval Prolongation - by QTc Interval Calc Fridericia Correction on Treatment Day 1 and During Therapy Day 3 Day1: Post-dose QTcCalcFridericia>ULN (N= 297,148)	3 Percentage of subjects 11.3219	2 Percentage of subjects 11.3058
Potentially Clinically Significant Electrocardiogram (ECG) QTc Interval Prolongation - by QTc Interval Calc Fridericia Correction on Treatment Day 1 and During Therapy Day 3 Day1: Post-dose >30 ms from pre-dose (N= 297,148)	2 Percentage of subjects 17.2179	0 Percentage of subjects 18.8144
Potentially Clinically Significant Electrocardiogram (ECG) QTc Interval Prolongation - by QTc Interval Calc Fridericia Correction on Treatment Day 1 and During Therapy Day 3 Day1: Post-dose >60 ms from pre-dose (N= 297,148)	0.3 Percentage of subjects 13.5805	0 Percentage of subjects 9.3328
Potentially Clinically Significant Electrocardiogram (ECG) QTc Interval Prolongation - by QTc Interval Calc Fridericia Correction on Treatment Day 1 and During Therapy Day 3 Day3: Pre-dose QTcCalcFridericia>ULN (N= 293, 146)	1.4 Percentage of subjects	1.4 Percentage of subjects
Potentially Clinically Significant Electrocardiogram (ECG) QTc Interval Prolongation - by QTc Interval Calc Fridericia Correction on Treatment Day 1 and During Therapy Day 3 Day3: Post-dose QTcCalcFridericia>ULN (N= 291,148)	9.6 Percentage of subjects	1.4 Percentage of subjects
Potentially Clinically Significant Electrocardiogram (ECG) QTc Interval Prolongation - by QTc Interval Calc Fridericia Correction on Treatment Day 1 and During Therapy Day 3 Day3: Post-dose >30 ms from pre-dose (N= 291,148)	17.9 Percentage of subjects	3.4 Percentage of subjects
Potentially Clinically Significant Electrocardiogram (ECG) QTc Interval Prolongation - by QTc Interval Calc Fridericia Correction on Treatment Day 1 and During Therapy Day 3 Day3: Post-dose >60 ms from pre-dose (N= 291,148)	1.7 Percentage of subjects	0.7 Percentage of subjects

SECONDARY outcome

Timeframe: Baseline (Pre-dose), Day 1, Day 3

Population: Safety analysis set; All subjects (N= 451) treated with at least one dose of study medication.

A significant QTc prolongation was considered when the QTc value was more than ULN range or was prolonged for 30 msec or 60msec in comparison with the pre-treatment value measured on Day 1. "N" signifies subjects who were evaluable for the specified parameter for each arm, respectively. Percentage of subjects with potentially clinically significant ECG data was reported.

Outcome measures

Measure	Moxifloxacin (Avelox, BAY12-8039) n=301 Participants Subjects randomized to the moxifloxacin arm of this study received intravenous moxifloxacin plus ertapenem placebo (0.9 % sodium chloride \[NaCl solution\]) for a minimum of 3 days and, if switched to oral treatment, PO moxifloxacin plus PO amoxicillin/clavulanate placebo. Total treatment duration is 5- 14 days.	Comparator Ertapenem n=150 Participants Subjects randomized to the comparator arm of this study received intravenous ertapenem plus moxifloxacin placebo (0.9 % NaCl solution) for a minimum of 3 days and, if switched to oral treatment, amoxicillin/clavulanate as an oral suspension plus PO moxifloxacin placebo. Total treatment duration is 5-14 days.
Potentially Clinically Significant Electrocardiogram (ECG) QTc Interval Prolongation - by QTc Calc Bazett Correction on Treatment Day 1 and During Therapy Day 3 Day3: Post-dose >60 ms from pre-dose (N= 291,148)	0.7 Percentage of subjects	0.7 Percentage of subjects
Potentially Clinically Significant Electrocardiogram (ECG) QTc Interval Prolongation - by QTc Calc Bazett Correction on Treatment Day 1 and During Therapy Day 3 Day1: Pre-dose QTc Calc Bazett > ULN (N= 300, 150)	7.7 Percentage of subjects	2.7 Percentage of subjects
Potentially Clinically Significant Electrocardiogram (ECG) QTc Interval Prolongation - by QTc Calc Bazett Correction on Treatment Day 1 and During Therapy Day 3 Day1: Post-dose QTc Calc Bazett > ULN (N= 297,148)	16.2 Percentage of subjects	4.1 Percentage of subjects
Potentially Clinically Significant Electrocardiogram (ECG) QTc Interval Prolongation - by QTc Calc Bazett Correction on Treatment Day 1 and During Therapy Day 3 Day1: Post-dose >30 ms from pre-dose (N= 297,148)	5.4 Percentage of subjects	0 Percentage of subjects
Potentially Clinically Significant Electrocardiogram (ECG) QTc Interval Prolongation - by QTc Calc Bazett Correction on Treatment Day 1 and During Therapy Day 3 Day1: Post-dose >60 ms from pre-dose (N= 297,148)	0 Percentage of subjects	0 Percentage of subjects
Potentially Clinically Significant Electrocardiogram (ECG) QTc Interval Prolongation - by QTc Calc Bazett Correction on Treatment Day 1 and During Therapy Day 3 Day3: Pre-dose QTc Calc Bazett > ULN (N= 293, 146)	3.8 Percentage of subjects	1.4 Percentage of subjects
Potentially Clinically Significant Electrocardiogram (ECG) QTc Interval Prolongation - by QTc Calc Bazett Correction on Treatment Day 1 and During Therapy Day 3 Day3: Post-dose QTc Calc Bazett > ULN (N= 291,148)	15.5 Percentage of subjects	3.4 Percentage of subjects
Potentially Clinically Significant Electrocardiogram (ECG) QTc Interval Prolongation - by QTc Calc Bazett Correction on Treatment Day 1 and During Therapy Day 3 Day3: Post-dose >30 ms from pre-dose (N= 291,148)	9.6 Percentage of subjects	2 Percentage of subjects

SECONDARY outcome

Timeframe: 28 to 42 days

Population: Safety analysis set with subjects evaluable for this outcome

Clinical responses were graded as clinical cure, failure or indeterminate. 'Clinical cure' defined as a resolution or sufficient improvement of clinical signs and symptoms related to the infection; 'failure' defined as a reappearance of the signs and symptoms of the original infection, or wound infection requiring further systemic antimicrobial therapy; 'indeterminate' defined as those subjects in whom a clinical assessment was not possible to determine (due to early withdrawal from the study because of adverse events, protocol violation, withdrawn consent). Percentage of subjects with clinical response at TOC were reported.

Outcome measures

Measure	Moxifloxacin (Avelox, BAY12-8039) n=297 Participants Subjects randomized to the moxifloxacin arm of this study received intravenous moxifloxacin plus ertapenem placebo (0.9 % sodium chloride \[NaCl solution\]) for a minimum of 3 days and, if switched to oral treatment, PO moxifloxacin plus PO amoxicillin/clavulanate placebo. Total treatment duration is 5- 14 days.	Comparator Ertapenem n=150 Participants Subjects randomized to the comparator arm of this study received intravenous ertapenem plus moxifloxacin placebo (0.9 % NaCl solution) for a minimum of 3 days and, if switched to oral treatment, amoxicillin/clavulanate as an oral suspension plus PO moxifloxacin placebo. Total treatment duration is 5-14 days.
Clinical Response at Test-of-Cure (TOC) Visit Clinical Cure	86.2 Percentage of subjects	95.3 Percentage of subjects
Clinical Response at Test-of-Cure (TOC) Visit Clinical Failure	5.7 Percentage of subjects	2 Percentage of subjects
Clinical Response at Test-of-Cure (TOC) Visit Indeterminate	8.1 Percentage of subjects	2.7 Percentage of subjects

SECONDARY outcome

Timeframe: 28 to 42 days

Population: Safety analysis set with subjects evaluable for this outcome

Bacteriological responses were graded as presumed persistence, presumed eradication or indeterminate.

'Presumed persistence' was applicable for subjects judged to be clinical failures, and appropriate culture material is not available for evaluation; 'presumed eradication' defined as the absence of appropriate culture material for evaluation because the subject has clinically responded and invasive procedures are not warranted; índeterminate' was applicable when the bacteriological response to the study drug was not valid for any reason (eg, pre-treatment culture was negative or culture was not obtained when material was available and the subject was not judged a clinical failure). Percentage of subjects with bacteriological response at TOC were reported.

Outcome measures

Measure	Moxifloxacin (Avelox, BAY12-8039) n=249 Participants Subjects randomized to the moxifloxacin arm of this study received intravenous moxifloxacin plus ertapenem placebo (0.9 % sodium chloride \[NaCl solution\]) for a minimum of 3 days and, if switched to oral treatment, PO moxifloxacin plus PO amoxicillin/clavulanate placebo. Total treatment duration is 5- 14 days.	Comparator Ertapenem n=136 Participants Subjects randomized to the comparator arm of this study received intravenous ertapenem plus moxifloxacin placebo (0.9 % NaCl solution) for a minimum of 3 days and, if switched to oral treatment, amoxicillin/clavulanate as an oral suspension plus PO moxifloxacin placebo. Total treatment duration is 5-14 days.
Bacteriological Response at Test-of-Cure (TOC) Visit Presumed Persistence	6.8 Percentage of subjects	2.2 Percentage of subjects
Bacteriological Response at Test-of-Cure (TOC) Visit Presumed Eradication	84.7 Percentage of subjects	94.9 Percentage of subjects
Bacteriological Response at Test-of-Cure (TOC) Visit Indeterminate	8.4 Percentage of subjects	2.9 Percentage of subjects

SECONDARY outcome

Timeframe: 28 to 42 days

Population: Safety analysis set with subjects evaluable for this outcome

Clinical responses were graded as clinical cure, failure or indeterminate. 'Clinical cure' defined as a resolution or sufficient improvement of clinical signs and symptoms related to the infection; 'failure' defined as a reappearance of the signs and symptoms of the original infection, or wound infection requiring further systemic antimicrobial therapy; 'indeterminate' defined as those subjects in whom a clinical assessment was not possible to determine (due to early withdrawal from the study because of adverse events, protocol violation, withdrawn consent). Percentage of subjects with clinical response at TOC were reported

Outcome measures

Measure	Moxifloxacin (Avelox, BAY12-8039) n=297 Participants Subjects randomized to the moxifloxacin arm of this study received intravenous moxifloxacin plus ertapenem placebo (0.9 % sodium chloride \[NaCl solution\]) for a minimum of 3 days and, if switched to oral treatment, PO moxifloxacin plus PO amoxicillin/clavulanate placebo. Total treatment duration is 5- 14 days.	Comparator Ertapenem n=150 Participants Subjects randomized to the comparator arm of this study received intravenous ertapenem plus moxifloxacin placebo (0.9 % NaCl solution) for a minimum of 3 days and, if switched to oral treatment, amoxicillin/clavulanate as an oral suspension plus PO moxifloxacin placebo. Total treatment duration is 5-14 days.
Clinical Response at Test-of-Cure (TOC) Visit in Subjects With Bacteriologically Confirmed Complicated Intra-abdominal Infection (cIAI) Clinical Cure	86.2 Percentage of subjects	95.3 Percentage of subjects
Clinical Response at Test-of-Cure (TOC) Visit in Subjects With Bacteriologically Confirmed Complicated Intra-abdominal Infection (cIAI) Clinical Failure	5.7 Percentage of subjects	2 Percentage of subjects
Clinical Response at Test-of-Cure (TOC) Visit in Subjects With Bacteriologically Confirmed Complicated Intra-abdominal Infection (cIAI) Indeterminate	8.1 Percentage of subjects	2.7 Percentage of subjects

SECONDARY outcome

Timeframe: Day 3 to Day 5

Population: Safety analysis set with subjects evaluable for this outcome

Clinical responses during therapy visit were graded as clinical improvement, clinical failure, or indeterminate. Clinical improvement defined as a reduction in the severity and/or the number of signs and symptoms of infection; 'clinical failure' defined as a failure to respond or insufficient lessening of the signs and symptoms of infection requiring a modification or addition of antibacterial therapy.

'Indeterminate' defined as those subjects in whom a clinical assessment is not possible to determine (eg, due to early withdrawal from the study because of adverse events, protocol violation, withdrawn consent, receipt of an effective concomitant antibacterial for an indication other than the study indication and receipt of less than 3 full days of study drug, etc). Percentage of subjects with clinical response during therapy visit were reported.

Outcome measures

Measure	Moxifloxacin (Avelox, BAY12-8039) n=299 Participants Subjects randomized to the moxifloxacin arm of this study received intravenous moxifloxacin plus ertapenem placebo (0.9 % sodium chloride \[NaCl solution\]) for a minimum of 3 days and, if switched to oral treatment, PO moxifloxacin plus PO amoxicillin/clavulanate placebo. Total treatment duration is 5- 14 days.	Comparator Ertapenem n=148 Participants Subjects randomized to the comparator arm of this study received intravenous ertapenem plus moxifloxacin placebo (0.9 % NaCl solution) for a minimum of 3 days and, if switched to oral treatment, amoxicillin/clavulanate as an oral suspension plus PO moxifloxacin placebo. Total treatment duration is 5-14 days.
Clinical Response at a 'During Therapy' Visit Indeterminate	4.7 Percentage of subjects	1.4 Percentage of subjects
Clinical Response at a 'During Therapy' Visit Clinical Improvement	94.3 Percentage of subjects	98 Percentage of subjects
Clinical Response at a 'During Therapy' Visit Clinical Failure	1 Percentage of subjects	0.7 Percentage of subjects

SECONDARY outcome

Timeframe: Day 3 to Day 5

Population: Safety analysis set with subjects evaluable for this outcome

Bacteriological response during therapy were graded as presumed persistence, presumed eradication, or indeterminate'Presumed persistence' is applicable for subjects judged to be clinical failures and appropriate culture material is not available for evaluation;'presumed eradication' is defined as the absence of appropriate culture material for evaluation because the subject has clinically responded (with a response as a resolution or cure) and invasive procedures are not warranted; 'indeterminate is applicable when the bacteriological response to the study drug is not valid for any reason (eg, pretreatment culture was negative or culture was not obtained when material was available and the subject is not judged a clinical failure). Percentage of subjects with bacteriological response during therapy visit were reported

Outcome measures

Measure	Moxifloxacin (Avelox, BAY12-8039) n=249 Participants Subjects randomized to the moxifloxacin arm of this study received intravenous moxifloxacin plus ertapenem placebo (0.9 % sodium chloride \[NaCl solution\]) for a minimum of 3 days and, if switched to oral treatment, PO moxifloxacin plus PO amoxicillin/clavulanate placebo. Total treatment duration is 5- 14 days.	Comparator Ertapenem n=134 Participants Subjects randomized to the comparator arm of this study received intravenous ertapenem plus moxifloxacin placebo (0.9 % NaCl solution) for a minimum of 3 days and, if switched to oral treatment, amoxicillin/clavulanate as an oral suspension plus PO moxifloxacin placebo. Total treatment duration is 5-14 days.
Bacteriological Response at a 'During Therapy' Visit Presumed Persistence	1.2 Percentage of subjects	0.7 Percentage of subjects
Bacteriological Response at a 'During Therapy' Visit Presumed Eradication	95.6 Percentage of subjects	97.8 Percentage of subjects
Bacteriological Response at a 'During Therapy' Visit Indeterminate	3.2 Percentage of subjects	1.5 Percentage of subjects

SECONDARY outcome

Timeframe: Day 5 to Day 14

Population: Safety analysis set with subjects evaluable for this outcome

Clinical responses at EOT were graded as resolution, failure, or indeterminate. 'Resolution' defined as a disappearance of signs and symptoms related to the infection or sufficient improvement of clinical signs and symptoms related to the infection and the subject does not require any further antibiotic therapy or surgical intervention; 'failure' defined as worsening or insufficient lessening of the signs and symptoms of infection requiring a modification or addition of antibacterial therapy; 'indeterminate' is defined as those subjects in whom a clinical assessment is not possible to determine (eg, due to early withdrawal from the study because of adverse events, protocol violation, withdrawn consent; receipt of less than 3 full days of study drug; receipt of an effective concomitant antibacterial for an indication other than study indication; etc). Percentage of subjects with clinical response at EOT were reported.

Outcome measures

Measure	Moxifloxacin (Avelox, BAY12-8039) n=283 Participants Subjects randomized to the moxifloxacin arm of this study received intravenous moxifloxacin plus ertapenem placebo (0.9 % sodium chloride \[NaCl solution\]) for a minimum of 3 days and, if switched to oral treatment, PO moxifloxacin plus PO amoxicillin/clavulanate placebo. Total treatment duration is 5- 14 days.	Comparator Ertapenem n=148 Participants Subjects randomized to the comparator arm of this study received intravenous ertapenem plus moxifloxacin placebo (0.9 % NaCl solution) for a minimum of 3 days and, if switched to oral treatment, amoxicillin/clavulanate as an oral suspension plus PO moxifloxacin placebo. Total treatment duration is 5-14 days.
Clinical Response at the End-of-Treatment (EOT) Visit Resolution	92.2 Percentage of subjects	98 Percentage of subjects
Clinical Response at the End-of-Treatment (EOT) Visit Clinical Failure	4.6 Percentage of subjects	0.7 Percentage of subjects
Clinical Response at the End-of-Treatment (EOT) Visit Indeterminate	3.2 Percentage of subjects	1.4 Percentage of subjects

SECONDARY outcome

Timeframe: Day 5 to Day 14

Population: Safety analysis set with subjects evaluable for this outcome

Bacteriological response at EOT were grades as presumed persistence, presumed eradication or indeterminate. 'presumed persistence' was applicable for subjects judged to be clinical failures and appropriate culture material is not available for evaluation; 'presumed eradication' defined as the absence of appropriate culture material for evaluation because the subject has clinically responded (with a response as a resolution or cure) and invasive procedures are not warranted; 'indeterminate' is applicable when the bacteriological response to the study drug was not valid for any reason (eg, pretreatment culture was negative or culture was not obtained when material was available and the subject was not judged a clinical failure). Percentage of subjects with bacteriological response at EOT were reported.

Outcome measures

Measure	Moxifloxacin (Avelox, BAY12-8039) n=237 Participants Subjects randomized to the moxifloxacin arm of this study received intravenous moxifloxacin plus ertapenem placebo (0.9 % sodium chloride \[NaCl solution\]) for a minimum of 3 days and, if switched to oral treatment, PO moxifloxacin plus PO amoxicillin/clavulanate placebo. Total treatment duration is 5- 14 days.	Comparator Ertapenem n=134 Participants Subjects randomized to the comparator arm of this study received intravenous ertapenem plus moxifloxacin placebo (0.9 % NaCl solution) for a minimum of 3 days and, if switched to oral treatment, amoxicillin/clavulanate as an oral suspension plus PO moxifloxacin placebo. Total treatment duration is 5-14 days.
Bacteriological Response at the End of Treatment (EOT) Visit Presumed Persistence	5.5 Percentage of subjects	0.7 Percentage of subjects
Bacteriological Response at the End of Treatment (EOT) Visit Presumed Eradication	91.1 Percentage of subjects	97.8 Percentage of subjects
Bacteriological Response at the End of Treatment (EOT) Visit Indeterminate	3.4 Percentage of subjects	1.5 Percentage of subjects

Adverse Events

Moxifloxacin (Avelox, BAY12-8039)

Serious events: 20 serious events

Other events: 127 other events

Deaths: 0 deaths

Comparator Ertapenem

Serious events: 6 serious events

Other events: 63 other events

Deaths: 0 deaths

Serious adverse events

Measure	Moxifloxacin (Avelox, BAY12-8039) n=301 participants at risk Subjects randomized to the moxifloxacin arm of this study received intravenous moxifloxacin plus ertapenem placebo (0.9 % NaCl solution) for a minimum of 3 days and, if switched to oral treatment, PO moxifloxacin plus PO amoxicillin/clavulanate placebo. Total treatment duration is 5-14 days.	Comparator Ertapenem n=150 participants at risk Subjects randomized to the comparator arm of this study received intravenous ertapenem plus moxifloxacin placebo (0.9 % NaCl solution) for a minimum of 3 days and, if switched to oral treatment, amoxicillin/clavulanate as an oral suspension plus PO moxifloxacin placebo. Total treatment duration is 5-14 days.
Blood and lymphatic system disorders Anaemia	0.33% 1/301 • Number of events 1 • All AEs and SAE were recorded from treatment start to test of cure visit; musculoskeletal AEs were recorded up to 1 year post-end of treatment (EOT) visit; subjects with musculoskeletal AEs 1 year after EOT were followed up to 5 years or until resolution.	0.00% 0/150 • All AEs and SAE were recorded from treatment start to test of cure visit; musculoskeletal AEs were recorded up to 1 year post-end of treatment (EOT) visit; subjects with musculoskeletal AEs 1 year after EOT were followed up to 5 years or until resolution.
Congenital, familial and genetic disorders Phimosis	0.00% 0/301 • All AEs and SAE were recorded from treatment start to test of cure visit; musculoskeletal AEs were recorded up to 1 year post-end of treatment (EOT) visit; subjects with musculoskeletal AEs 1 year after EOT were followed up to 5 years or until resolution.	0.67% 1/150 • Number of events 1 • All AEs and SAE were recorded from treatment start to test of cure visit; musculoskeletal AEs were recorded up to 1 year post-end of treatment (EOT) visit; subjects with musculoskeletal AEs 1 year after EOT were followed up to 5 years or until resolution.
Gastrointestinal disorders Constipation	0.33% 1/301 • Number of events 1 • All AEs and SAE were recorded from treatment start to test of cure visit; musculoskeletal AEs were recorded up to 1 year post-end of treatment (EOT) visit; subjects with musculoskeletal AEs 1 year after EOT were followed up to 5 years or until resolution.	0.00% 0/150 • All AEs and SAE were recorded from treatment start to test of cure visit; musculoskeletal AEs were recorded up to 1 year post-end of treatment (EOT) visit; subjects with musculoskeletal AEs 1 year after EOT were followed up to 5 years or until resolution.
Gastrointestinal disorders Crohn's disease	0.33% 1/301 • Number of events 1 • All AEs and SAE were recorded from treatment start to test of cure visit; musculoskeletal AEs were recorded up to 1 year post-end of treatment (EOT) visit; subjects with musculoskeletal AEs 1 year after EOT were followed up to 5 years or until resolution.	0.00% 0/150 • All AEs and SAE were recorded from treatment start to test of cure visit; musculoskeletal AEs were recorded up to 1 year post-end of treatment (EOT) visit; subjects with musculoskeletal AEs 1 year after EOT were followed up to 5 years or until resolution.
Gastrointestinal disorders Ileal perforation	0.33% 1/301 • Number of events 1 • All AEs and SAE were recorded from treatment start to test of cure visit; musculoskeletal AEs were recorded up to 1 year post-end of treatment (EOT) visit; subjects with musculoskeletal AEs 1 year after EOT were followed up to 5 years or until resolution.	0.00% 0/150 • All AEs and SAE were recorded from treatment start to test of cure visit; musculoskeletal AEs were recorded up to 1 year post-end of treatment (EOT) visit; subjects with musculoskeletal AEs 1 year after EOT were followed up to 5 years or until resolution.
Gastrointestinal disorders Intestinal obstruction	0.66% 2/301 • Number of events 2 • All AEs and SAE were recorded from treatment start to test of cure visit; musculoskeletal AEs were recorded up to 1 year post-end of treatment (EOT) visit; subjects with musculoskeletal AEs 1 year after EOT were followed up to 5 years or until resolution.	0.00% 0/150 • All AEs and SAE were recorded from treatment start to test of cure visit; musculoskeletal AEs were recorded up to 1 year post-end of treatment (EOT) visit; subjects with musculoskeletal AEs 1 year after EOT were followed up to 5 years or until resolution.
Gastrointestinal disorders Mechanical ileus	1.00% 3/301 • Number of events 3 • All AEs and SAE were recorded from treatment start to test of cure visit; musculoskeletal AEs were recorded up to 1 year post-end of treatment (EOT) visit; subjects with musculoskeletal AEs 1 year after EOT were followed up to 5 years or until resolution.	1.3% 2/150 • Number of events 2 • All AEs and SAE were recorded from treatment start to test of cure visit; musculoskeletal AEs were recorded up to 1 year post-end of treatment (EOT) visit; subjects with musculoskeletal AEs 1 year after EOT were followed up to 5 years or until resolution.
Gastrointestinal disorders Enterocutaneous fistula	0.33% 1/301 • Number of events 1 • All AEs and SAE were recorded from treatment start to test of cure visit; musculoskeletal AEs were recorded up to 1 year post-end of treatment (EOT) visit; subjects with musculoskeletal AEs 1 year after EOT were followed up to 5 years or until resolution.	0.00% 0/150 • All AEs and SAE were recorded from treatment start to test of cure visit; musculoskeletal AEs were recorded up to 1 year post-end of treatment (EOT) visit; subjects with musculoskeletal AEs 1 year after EOT were followed up to 5 years or until resolution.
Gastrointestinal disorders Faecalith	0.33% 1/301 • Number of events 1 • All AEs and SAE were recorded from treatment start to test of cure visit; musculoskeletal AEs were recorded up to 1 year post-end of treatment (EOT) visit; subjects with musculoskeletal AEs 1 year after EOT were followed up to 5 years or until resolution.	0.00% 0/150 • All AEs and SAE were recorded from treatment start to test of cure visit; musculoskeletal AEs were recorded up to 1 year post-end of treatment (EOT) visit; subjects with musculoskeletal AEs 1 year after EOT were followed up to 5 years or until resolution.
Gastrointestinal disorders Functional gastrointestinal disorder	0.66% 2/301 • Number of events 2 • All AEs and SAE were recorded from treatment start to test of cure visit; musculoskeletal AEs were recorded up to 1 year post-end of treatment (EOT) visit; subjects with musculoskeletal AEs 1 year after EOT were followed up to 5 years or until resolution.	0.00% 0/150 • All AEs and SAE were recorded from treatment start to test of cure visit; musculoskeletal AEs were recorded up to 1 year post-end of treatment (EOT) visit; subjects with musculoskeletal AEs 1 year after EOT were followed up to 5 years or until resolution.
General disorders Surgical failure	0.33% 1/301 • Number of events 1 • All AEs and SAE were recorded from treatment start to test of cure visit; musculoskeletal AEs were recorded up to 1 year post-end of treatment (EOT) visit; subjects with musculoskeletal AEs 1 year after EOT were followed up to 5 years or until resolution.	0.00% 0/150 • All AEs and SAE were recorded from treatment start to test of cure visit; musculoskeletal AEs were recorded up to 1 year post-end of treatment (EOT) visit; subjects with musculoskeletal AEs 1 year after EOT were followed up to 5 years or until resolution.
Infections and infestations Abdominal wall abscess	0.33% 1/301 • Number of events 1 • All AEs and SAE were recorded from treatment start to test of cure visit; musculoskeletal AEs were recorded up to 1 year post-end of treatment (EOT) visit; subjects with musculoskeletal AEs 1 year after EOT were followed up to 5 years or until resolution.	0.00% 0/150 • All AEs and SAE were recorded from treatment start to test of cure visit; musculoskeletal AEs were recorded up to 1 year post-end of treatment (EOT) visit; subjects with musculoskeletal AEs 1 year after EOT were followed up to 5 years or until resolution.
Infections and infestations Cellulitis	0.00% 0/301 • All AEs and SAE were recorded from treatment start to test of cure visit; musculoskeletal AEs were recorded up to 1 year post-end of treatment (EOT) visit; subjects with musculoskeletal AEs 1 year after EOT were followed up to 5 years or until resolution.	0.67% 1/150 • Number of events 1 • All AEs and SAE were recorded from treatment start to test of cure visit; musculoskeletal AEs were recorded up to 1 year post-end of treatment (EOT) visit; subjects with musculoskeletal AEs 1 year after EOT were followed up to 5 years or until resolution.
Infections and infestations Peritoneal abscess	0.33% 1/301 • Number of events 1 • All AEs and SAE were recorded from treatment start to test of cure visit; musculoskeletal AEs were recorded up to 1 year post-end of treatment (EOT) visit; subjects with musculoskeletal AEs 1 year after EOT were followed up to 5 years or until resolution.	0.00% 0/150 • All AEs and SAE were recorded from treatment start to test of cure visit; musculoskeletal AEs were recorded up to 1 year post-end of treatment (EOT) visit; subjects with musculoskeletal AEs 1 year after EOT were followed up to 5 years or until resolution.
Infections and infestations Wound infection	0.33% 1/301 • Number of events 1 • All AEs and SAE were recorded from treatment start to test of cure visit; musculoskeletal AEs were recorded up to 1 year post-end of treatment (EOT) visit; subjects with musculoskeletal AEs 1 year after EOT were followed up to 5 years or until resolution.	0.00% 0/150 • All AEs and SAE were recorded from treatment start to test of cure visit; musculoskeletal AEs were recorded up to 1 year post-end of treatment (EOT) visit; subjects with musculoskeletal AEs 1 year after EOT were followed up to 5 years or until resolution.
Infections and infestations Abdominal infection	0.33% 1/301 • Number of events 1 • All AEs and SAE were recorded from treatment start to test of cure visit; musculoskeletal AEs were recorded up to 1 year post-end of treatment (EOT) visit; subjects with musculoskeletal AEs 1 year after EOT were followed up to 5 years or until resolution.	0.00% 0/150 • All AEs and SAE were recorded from treatment start to test of cure visit; musculoskeletal AEs were recorded up to 1 year post-end of treatment (EOT) visit; subjects with musculoskeletal AEs 1 year after EOT were followed up to 5 years or until resolution.
Infections and infestations Abdominal abscess	1.00% 3/301 • Number of events 3 • All AEs and SAE were recorded from treatment start to test of cure visit; musculoskeletal AEs were recorded up to 1 year post-end of treatment (EOT) visit; subjects with musculoskeletal AEs 1 year after EOT were followed up to 5 years or until resolution.	0.00% 0/150 • All AEs and SAE were recorded from treatment start to test of cure visit; musculoskeletal AEs were recorded up to 1 year post-end of treatment (EOT) visit; subjects with musculoskeletal AEs 1 year after EOT were followed up to 5 years or until resolution.
Injury, poisoning and procedural complications Facial bones fracture	0.00% 0/301 • All AEs and SAE were recorded from treatment start to test of cure visit; musculoskeletal AEs were recorded up to 1 year post-end of treatment (EOT) visit; subjects with musculoskeletal AEs 1 year after EOT were followed up to 5 years or until resolution.	0.67% 1/150 • Number of events 1 • All AEs and SAE were recorded from treatment start to test of cure visit; musculoskeletal AEs were recorded up to 1 year post-end of treatment (EOT) visit; subjects with musculoskeletal AEs 1 year after EOT were followed up to 5 years or until resolution.
Injury, poisoning and procedural complications Forearm fracture	0.33% 1/301 • Number of events 1 • All AEs and SAE were recorded from treatment start to test of cure visit; musculoskeletal AEs were recorded up to 1 year post-end of treatment (EOT) visit; subjects with musculoskeletal AEs 1 year after EOT were followed up to 5 years or until resolution.	0.00% 0/150 • All AEs and SAE were recorded from treatment start to test of cure visit; musculoskeletal AEs were recorded up to 1 year post-end of treatment (EOT) visit; subjects with musculoskeletal AEs 1 year after EOT were followed up to 5 years or until resolution.
Injury, poisoning and procedural complications Abdominal wound dehiscence	0.33% 1/301 • Number of events 1 • All AEs and SAE were recorded from treatment start to test of cure visit; musculoskeletal AEs were recorded up to 1 year post-end of treatment (EOT) visit; subjects with musculoskeletal AEs 1 year after EOT were followed up to 5 years or until resolution.	0.00% 0/150 • All AEs and SAE were recorded from treatment start to test of cure visit; musculoskeletal AEs were recorded up to 1 year post-end of treatment (EOT) visit; subjects with musculoskeletal AEs 1 year after EOT were followed up to 5 years or until resolution.
Metabolism and nutrition disorders Hyponatraemia	0.33% 1/301 • Number of events 1 • All AEs and SAE were recorded from treatment start to test of cure visit; musculoskeletal AEs were recorded up to 1 year post-end of treatment (EOT) visit; subjects with musculoskeletal AEs 1 year after EOT were followed up to 5 years or until resolution.	0.00% 0/150 • All AEs and SAE were recorded from treatment start to test of cure visit; musculoskeletal AEs were recorded up to 1 year post-end of treatment (EOT) visit; subjects with musculoskeletal AEs 1 year after EOT were followed up to 5 years or until resolution.
Musculoskeletal and connective tissue disorders Fasciitis	0.33% 1/301 • Number of events 1 • All AEs and SAE were recorded from treatment start to test of cure visit; musculoskeletal AEs were recorded up to 1 year post-end of treatment (EOT) visit; subjects with musculoskeletal AEs 1 year after EOT were followed up to 5 years or until resolution.	0.00% 0/150 • All AEs and SAE were recorded from treatment start to test of cure visit; musculoskeletal AEs were recorded up to 1 year post-end of treatment (EOT) visit; subjects with musculoskeletal AEs 1 year after EOT were followed up to 5 years or until resolution.
Nervous system disorders Generalised tonic-clonic seizure	0.00% 0/301 • All AEs and SAE were recorded from treatment start to test of cure visit; musculoskeletal AEs were recorded up to 1 year post-end of treatment (EOT) visit; subjects with musculoskeletal AEs 1 year after EOT were followed up to 5 years or until resolution.	0.67% 1/150 • Number of events 1 • All AEs and SAE were recorded from treatment start to test of cure visit; musculoskeletal AEs were recorded up to 1 year post-end of treatment (EOT) visit; subjects with musculoskeletal AEs 1 year after EOT were followed up to 5 years or until resolution.
Nervous system disorders Idiopathic generalised epilepsy	0.00% 0/301 • All AEs and SAE were recorded from treatment start to test of cure visit; musculoskeletal AEs were recorded up to 1 year post-end of treatment (EOT) visit; subjects with musculoskeletal AEs 1 year after EOT were followed up to 5 years or until resolution.	0.67% 1/150 • Number of events 1 • All AEs and SAE were recorded from treatment start to test of cure visit; musculoskeletal AEs were recorded up to 1 year post-end of treatment (EOT) visit; subjects with musculoskeletal AEs 1 year after EOT were followed up to 5 years or until resolution.

Other adverse events

Measure	Moxifloxacin (Avelox, BAY12-8039) n=301 participants at risk Subjects randomized to the moxifloxacin arm of this study received intravenous moxifloxacin plus ertapenem placebo (0.9 % NaCl solution) for a minimum of 3 days and, if switched to oral treatment, PO moxifloxacin plus PO amoxicillin/clavulanate placebo. Total treatment duration is 5-14 days.	Comparator Ertapenem n=150 participants at risk Subjects randomized to the comparator arm of this study received intravenous ertapenem plus moxifloxacin placebo (0.9 % NaCl solution) for a minimum of 3 days and, if switched to oral treatment, amoxicillin/clavulanate as an oral suspension plus PO moxifloxacin placebo. Total treatment duration is 5-14 days.
Gastrointestinal disorders Abdominal pain	2.7% 8/301 • Number of events 8 • All AEs and SAE were recorded from treatment start to test of cure visit; musculoskeletal AEs were recorded up to 1 year post-end of treatment (EOT) visit; subjects with musculoskeletal AEs 1 year after EOT were followed up to 5 years or until resolution.	2.0% 3/150 • Number of events 3 • All AEs and SAE were recorded from treatment start to test of cure visit; musculoskeletal AEs were recorded up to 1 year post-end of treatment (EOT) visit; subjects with musculoskeletal AEs 1 year after EOT were followed up to 5 years or until resolution.
Gastrointestinal disorders Diarrhoea	3.7% 11/301 • Number of events 12 • All AEs and SAE were recorded from treatment start to test of cure visit; musculoskeletal AEs were recorded up to 1 year post-end of treatment (EOT) visit; subjects with musculoskeletal AEs 1 year after EOT were followed up to 5 years or until resolution.	0.67% 1/150 • Number of events 1 • All AEs and SAE were recorded from treatment start to test of cure visit; musculoskeletal AEs were recorded up to 1 year post-end of treatment (EOT) visit; subjects with musculoskeletal AEs 1 year after EOT were followed up to 5 years or until resolution.
Gastrointestinal disorders Nausea	0.33% 1/301 • Number of events 1 • All AEs and SAE were recorded from treatment start to test of cure visit; musculoskeletal AEs were recorded up to 1 year post-end of treatment (EOT) visit; subjects with musculoskeletal AEs 1 year after EOT were followed up to 5 years or until resolution.	1.3% 2/150 • Number of events 2 • All AEs and SAE were recorded from treatment start to test of cure visit; musculoskeletal AEs were recorded up to 1 year post-end of treatment (EOT) visit; subjects with musculoskeletal AEs 1 year after EOT were followed up to 5 years or until resolution.
Gastrointestinal disorders Vomiting	6.6% 20/301 • Number of events 22 • All AEs and SAE were recorded from treatment start to test of cure visit; musculoskeletal AEs were recorded up to 1 year post-end of treatment (EOT) visit; subjects with musculoskeletal AEs 1 year after EOT were followed up to 5 years or until resolution.	8.0% 12/150 • Number of events 12 • All AEs and SAE were recorded from treatment start to test of cure visit; musculoskeletal AEs were recorded up to 1 year post-end of treatment (EOT) visit; subjects with musculoskeletal AEs 1 year after EOT were followed up to 5 years or until resolution.
General disorders Pyrexia	2.0% 6/301 • Number of events 6 • All AEs and SAE were recorded from treatment start to test of cure visit; musculoskeletal AEs were recorded up to 1 year post-end of treatment (EOT) visit; subjects with musculoskeletal AEs 1 year after EOT were followed up to 5 years or until resolution.	2.7% 4/150 • Number of events 4 • All AEs and SAE were recorded from treatment start to test of cure visit; musculoskeletal AEs were recorded up to 1 year post-end of treatment (EOT) visit; subjects with musculoskeletal AEs 1 year after EOT were followed up to 5 years or until resolution.
General disorders Infusion site phlebitis	1.3% 4/301 • Number of events 6 • All AEs and SAE were recorded from treatment start to test of cure visit; musculoskeletal AEs were recorded up to 1 year post-end of treatment (EOT) visit; subjects with musculoskeletal AEs 1 year after EOT were followed up to 5 years or until resolution.	0.00% 0/150 • All AEs and SAE were recorded from treatment start to test of cure visit; musculoskeletal AEs were recorded up to 1 year post-end of treatment (EOT) visit; subjects with musculoskeletal AEs 1 year after EOT were followed up to 5 years or until resolution.
Infections and infestations Wound infection	4.3% 13/301 • Number of events 13 • All AEs and SAE were recorded from treatment start to test of cure visit; musculoskeletal AEs were recorded up to 1 year post-end of treatment (EOT) visit; subjects with musculoskeletal AEs 1 year after EOT were followed up to 5 years or until resolution.	4.0% 6/150 • Number of events 6 • All AEs and SAE were recorded from treatment start to test of cure visit; musculoskeletal AEs were recorded up to 1 year post-end of treatment (EOT) visit; subjects with musculoskeletal AEs 1 year after EOT were followed up to 5 years or until resolution.
Injury, poisoning and procedural complications Wound complication	1.3% 4/301 • Number of events 4 • All AEs and SAE were recorded from treatment start to test of cure visit; musculoskeletal AEs were recorded up to 1 year post-end of treatment (EOT) visit; subjects with musculoskeletal AEs 1 year after EOT were followed up to 5 years or until resolution.	1.3% 2/150 • Number of events 2 • All AEs and SAE were recorded from treatment start to test of cure visit; musculoskeletal AEs were recorded up to 1 year post-end of treatment (EOT) visit; subjects with musculoskeletal AEs 1 year after EOT were followed up to 5 years or until resolution.
Injury, poisoning and procedural complications Incision site pain	8.6% 26/301 • Number of events 26 • All AEs and SAE were recorded from treatment start to test of cure visit; musculoskeletal AEs were recorded up to 1 year post-end of treatment (EOT) visit; subjects with musculoskeletal AEs 1 year after EOT were followed up to 5 years or until resolution.	9.3% 14/150 • Number of events 14 • All AEs and SAE were recorded from treatment start to test of cure visit; musculoskeletal AEs were recorded up to 1 year post-end of treatment (EOT) visit; subjects with musculoskeletal AEs 1 year after EOT were followed up to 5 years or until resolution.
Injury, poisoning and procedural complications Postoperative wound complication	1.00% 3/301 • Number of events 4 • All AEs and SAE were recorded from treatment start to test of cure visit; musculoskeletal AEs were recorded up to 1 year post-end of treatment (EOT) visit; subjects with musculoskeletal AEs 1 year after EOT were followed up to 5 years or until resolution.	1.3% 2/150 • Number of events 2 • All AEs and SAE were recorded from treatment start to test of cure visit; musculoskeletal AEs were recorded up to 1 year post-end of treatment (EOT) visit; subjects with musculoskeletal AEs 1 year after EOT were followed up to 5 years or until resolution.
Injury, poisoning and procedural complications Procedural pain	5.3% 16/301 • Number of events 16 • All AEs and SAE were recorded from treatment start to test of cure visit; musculoskeletal AEs were recorded up to 1 year post-end of treatment (EOT) visit; subjects with musculoskeletal AEs 1 year after EOT were followed up to 5 years or until resolution.	6.7% 10/150 • Number of events 10 • All AEs and SAE were recorded from treatment start to test of cure visit; musculoskeletal AEs were recorded up to 1 year post-end of treatment (EOT) visit; subjects with musculoskeletal AEs 1 year after EOT were followed up to 5 years or until resolution.
Injury, poisoning and procedural complications Incision site inflammation	0.66% 2/301 • Number of events 2 • All AEs and SAE were recorded from treatment start to test of cure visit; musculoskeletal AEs were recorded up to 1 year post-end of treatment (EOT) visit; subjects with musculoskeletal AEs 1 year after EOT were followed up to 5 years or until resolution.	2.0% 3/150 • Number of events 3 • All AEs and SAE were recorded from treatment start to test of cure visit; musculoskeletal AEs were recorded up to 1 year post-end of treatment (EOT) visit; subjects with musculoskeletal AEs 1 year after EOT were followed up to 5 years or until resolution.
Injury, poisoning and procedural complications Procedural vomiting	0.00% 0/301 • All AEs and SAE were recorded from treatment start to test of cure visit; musculoskeletal AEs were recorded up to 1 year post-end of treatment (EOT) visit; subjects with musculoskeletal AEs 1 year after EOT were followed up to 5 years or until resolution.	2.7% 4/150 • Number of events 4 • All AEs and SAE were recorded from treatment start to test of cure visit; musculoskeletal AEs were recorded up to 1 year post-end of treatment (EOT) visit; subjects with musculoskeletal AEs 1 year after EOT were followed up to 5 years or until resolution.
Investigations Alanine aminotransferase increased	1.00% 3/301 • Number of events 3 • All AEs and SAE were recorded from treatment start to test of cure visit; musculoskeletal AEs were recorded up to 1 year post-end of treatment (EOT) visit; subjects with musculoskeletal AEs 1 year after EOT were followed up to 5 years or until resolution.	1.3% 2/150 • Number of events 2 • All AEs and SAE were recorded from treatment start to test of cure visit; musculoskeletal AEs were recorded up to 1 year post-end of treatment (EOT) visit; subjects with musculoskeletal AEs 1 year after EOT were followed up to 5 years or until resolution.
Investigations Aspartate aminotransferase increased	0.66% 2/301 • Number of events 2 • All AEs and SAE were recorded from treatment start to test of cure visit; musculoskeletal AEs were recorded up to 1 year post-end of treatment (EOT) visit; subjects with musculoskeletal AEs 1 year after EOT were followed up to 5 years or until resolution.	2.0% 3/150 • Number of events 3 • All AEs and SAE were recorded from treatment start to test of cure visit; musculoskeletal AEs were recorded up to 1 year post-end of treatment (EOT) visit; subjects with musculoskeletal AEs 1 year after EOT were followed up to 5 years or until resolution.
Investigations Blood creatine phosphokinase increased	1.3% 4/301 • Number of events 4 • All AEs and SAE were recorded from treatment start to test of cure visit; musculoskeletal AEs were recorded up to 1 year post-end of treatment (EOT) visit; subjects with musculoskeletal AEs 1 year after EOT were followed up to 5 years or until resolution.	1.3% 2/150 • Number of events 2 • All AEs and SAE were recorded from treatment start to test of cure visit; musculoskeletal AEs were recorded up to 1 year post-end of treatment (EOT) visit; subjects with musculoskeletal AEs 1 year after EOT were followed up to 5 years or until resolution.
Investigations Electrocardiogram QT prolonged	9.3% 28/301 • Number of events 31 • All AEs and SAE were recorded from treatment start to test of cure visit; musculoskeletal AEs were recorded up to 1 year post-end of treatment (EOT) visit; subjects with musculoskeletal AEs 1 year after EOT were followed up to 5 years or until resolution.	2.7% 4/150 • Number of events 4 • All AEs and SAE were recorded from treatment start to test of cure visit; musculoskeletal AEs were recorded up to 1 year post-end of treatment (EOT) visit; subjects with musculoskeletal AEs 1 year after EOT were followed up to 5 years or until resolution.
Investigations Gamma-glutamyltransferase increased	0.66% 2/301 • Number of events 2 • All AEs and SAE were recorded from treatment start to test of cure visit; musculoskeletal AEs were recorded up to 1 year post-end of treatment (EOT) visit; subjects with musculoskeletal AEs 1 year after EOT were followed up to 5 years or until resolution.	1.3% 2/150 • Number of events 2 • All AEs and SAE were recorded from treatment start to test of cure visit; musculoskeletal AEs were recorded up to 1 year post-end of treatment (EOT) visit; subjects with musculoskeletal AEs 1 year after EOT were followed up to 5 years or until resolution.
Investigations Lipase increased	0.33% 1/301 • Number of events 1 • All AEs and SAE were recorded from treatment start to test of cure visit; musculoskeletal AEs were recorded up to 1 year post-end of treatment (EOT) visit; subjects with musculoskeletal AEs 1 year after EOT were followed up to 5 years or until resolution.	1.3% 2/150 • Number of events 2 • All AEs and SAE were recorded from treatment start to test of cure visit; musculoskeletal AEs were recorded up to 1 year post-end of treatment (EOT) visit; subjects with musculoskeletal AEs 1 year after EOT were followed up to 5 years or until resolution.
Metabolism and nutrition disorders Hyperlipasaemia	0.33% 1/301 • Number of events 1 • All AEs and SAE were recorded from treatment start to test of cure visit; musculoskeletal AEs were recorded up to 1 year post-end of treatment (EOT) visit; subjects with musculoskeletal AEs 1 year after EOT were followed up to 5 years or until resolution.	1.3% 2/150 • Number of events 3 • All AEs and SAE were recorded from treatment start to test of cure visit; musculoskeletal AEs were recorded up to 1 year post-end of treatment (EOT) visit; subjects with musculoskeletal AEs 1 year after EOT were followed up to 5 years or until resolution.
Musculoskeletal and connective tissue disorders Arthralgia	3.0% 9/301 • Number of events 36 • All AEs and SAE were recorded from treatment start to test of cure visit; musculoskeletal AEs were recorded up to 1 year post-end of treatment (EOT) visit; subjects with musculoskeletal AEs 1 year after EOT were followed up to 5 years or until resolution.	1.3% 2/150 • Number of events 2 • All AEs and SAE were recorded from treatment start to test of cure visit; musculoskeletal AEs were recorded up to 1 year post-end of treatment (EOT) visit; subjects with musculoskeletal AEs 1 year after EOT were followed up to 5 years or until resolution.
Musculoskeletal and connective tissue disorders Joint swelling	0.00% 0/301 • All AEs and SAE were recorded from treatment start to test of cure visit; musculoskeletal AEs were recorded up to 1 year post-end of treatment (EOT) visit; subjects with musculoskeletal AEs 1 year after EOT were followed up to 5 years or until resolution.	1.3% 2/150 • Number of events 2 • All AEs and SAE were recorded from treatment start to test of cure visit; musculoskeletal AEs were recorded up to 1 year post-end of treatment (EOT) visit; subjects with musculoskeletal AEs 1 year after EOT were followed up to 5 years or until resolution.
Nervous system disorders Headache	2.0% 6/301 • Number of events 6 • All AEs and SAE were recorded from treatment start to test of cure visit; musculoskeletal AEs were recorded up to 1 year post-end of treatment (EOT) visit; subjects with musculoskeletal AEs 1 year after EOT were followed up to 5 years or until resolution.	1.3% 2/150 • Number of events 2 • All AEs and SAE were recorded from treatment start to test of cure visit; musculoskeletal AEs were recorded up to 1 year post-end of treatment (EOT) visit; subjects with musculoskeletal AEs 1 year after EOT were followed up to 5 years or until resolution.
Surgical and medical procedures Abdominal cavity drainage	0.00% 0/301 • All AEs and SAE were recorded from treatment start to test of cure visit; musculoskeletal AEs were recorded up to 1 year post-end of treatment (EOT) visit; subjects with musculoskeletal AEs 1 year after EOT were followed up to 5 years or until resolution.	1.3% 2/150 • Number of events 2 • All AEs and SAE were recorded from treatment start to test of cure visit; musculoskeletal AEs were recorded up to 1 year post-end of treatment (EOT) visit; subjects with musculoskeletal AEs 1 year after EOT were followed up to 5 years or until resolution.
Vascular disorders Phlebitis	2.7% 8/301 • Number of events 8 • All AEs and SAE were recorded from treatment start to test of cure visit; musculoskeletal AEs were recorded up to 1 year post-end of treatment (EOT) visit; subjects with musculoskeletal AEs 1 year after EOT were followed up to 5 years or until resolution.	0.00% 0/150 • All AEs and SAE were recorded from treatment start to test of cure visit; musculoskeletal AEs were recorded up to 1 year post-end of treatment (EOT) visit; subjects with musculoskeletal AEs 1 year after EOT were followed up to 5 years or until resolution.

Additional Information

Therapeutic Area Head

BAYER

Email: clinical-trials-contact@bayerhealthcare.com

Results disclosure agreements

• Principal investigator is a sponsor employee The agreed point of publication is 12/18 months after database lock at the earliest. * Bayer will have up to 30/45 days to review publications, and may request an additional publication delay of up to 60 days to allow for filing a Patent Application (if applicable). * No publication of single center data should be done prior of publication if multi-center data.
• Publication restrictions are in place

Restriction type: OTHER