Trial Outcomes & Findings for Safety and Tolerability of Ertapenem Sodium in the Treatment of Complicated Urinary Tract Infections (0826-055) (NCT NCT01014013)

NCT ID: NCT01014013

Last Updated: 2017-03-22

Results Overview

The difference in favorable microbiological response rates between the 2 treatment groups (MK0826 response rate minus ceftriaxone response rate) was assessed

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 271 participants
• Primary outcome timeframe: 5 to 9 days post-therapy
• Results posted on: 2017-03-22

Participant Flow

Patients were recruited from 9 Medical Centers of Korea between April 2008 and January 2009. Last patient has visited on 27 Feb 2009.

1 patient was excluded due to ineligibility. The patient had a positive at screening pregnancy test.

Participant milestones

Measure	MK0826 A single daily dose of MK0826 1.0 g intravenous infused over 30 minutes, for 7-14 days (patients may be switched to oral ciprofloxacin at a dose of 500 mg twice daily after 3 doses of parentheral therapy)	Ceftriaxone A single daily dose of 2.0 g Ceftriaxone sodium intravenous infused over 30 minutes, for 7-14 days (patients may be switched to oral ciprofloxacin at a dose of 500 mg twice daily after 3 doses of parentheral therapy)
Overall Study STARTED	135	136
Overall Study Adverse Event Reporting	132	135
Overall Study Completed Parenteral Therapy	87	88
Overall Study COMPLETED	84	80
Overall Study NOT COMPLETED	51	56

Reasons for withdrawal

Measure	MK0826 A single daily dose of MK0826 1.0 g intravenous infused over 30 minutes, for 7-14 days (patients may be switched to oral ciprofloxacin at a dose of 500 mg twice daily after 3 doses of parentheral therapy)	Ceftriaxone A single daily dose of 2.0 g Ceftriaxone sodium intravenous infused over 30 minutes, for 7-14 days (patients may be switched to oral ciprofloxacin at a dose of 500 mg twice daily after 3 doses of parentheral therapy)
Overall Study Inclusion/Exclusion criteria not met	1	3
Overall Study Clinical adverse experience	4	2
Overall Study Laboratory adverse experience	1	1
Overall Study Protocol Violation	1	3
Overall Study Withdrawal by Subject	7	4
Overall Study Clinical/microbiologic failure	1	2
Overall Study Pathogen culture = no growth	26	34
Overall Study Negative urine culture	2	0
Overall Study Pathogen resistant	7	4
Overall Study Physician Decision	0	1
Overall Study Another antibiotic therapy required	0	1
Overall Study Appendectomy	1	0
Overall Study Inappropriate therapy duration, < 7 Days	0	1

Baseline Characteristics

Safety and Tolerability of Ertapenem Sodium in the Treatment of Complicated Urinary Tract Infections (0826-055)

Baseline characteristics by cohort

Measure	MK0826 n=135 Participants A single daily dose of MK0826 1.0 g intravenous infused over 30 minutes, for 7-14 days (patients may be switched to oral ciprofloxacin at a dose of 500 mg twice daily after 3 doses of parentheral therapy)	Ceftriaxone n=136 Participants A single daily dose of 2.0 g Ceftriaxone sodium intravenous infused over 30 minutes, for 7-14 days (patients may be switched to oral ciprofloxacin at a dose of 500 mg twice daily after 3 doses of parentheral therapy)	Total n=271 Participants Total of all reporting groups
Age, Continuous	55.4 years STANDARD_DEVIATION 19.5 • n=5 Participants	56.5 years STANDARD_DEVIATION 17.6 • n=7 Participants	55.9 years STANDARD_DEVIATION 18.5 • n=5 Participants
Sex: Female, Male Female	119 Participants n=5 Participants	126 Participants n=7 Participants	245 Participants n=5 Participants
Sex: Female, Male Male	16 Participants n=5 Participants	10 Participants n=7 Participants	26 Participants n=5 Participants
Stratum Acute pyelonephritis	103 participants n=5 Participants	107 participants n=7 Participants	210 participants n=5 Participants
Stratum Other complicated urinary tract infection	32 participants n=5 Participants	29 participants n=7 Participants	61 participants n=5 Participants
Duration of Symptoms(Days)	4.1 Days STANDARD_DEVIATION 4.6 • n=5 Participants	4.7 Days STANDARD_DEVIATION 6.4 • n=7 Participants	4.4 Days STANDARD_DEVIATION 5.6 • n=5 Participants

PRIMARY outcome

Timeframe: 5 to 9 days post-therapy

Population: Primary efficacy analysis was done for 137 evaluable patients (66 patients from MK0826 and 71 patients from Ceftriaxone)

The difference in favorable microbiological response rates between the 2 treatment groups (MK0826 response rate minus ceftriaxone response rate) was assessed

Outcome measures

Measure	MK0826 n=66 Participants MK0826 as a single daily dose of 1.0 g intravenous infusion and be switched to oral ciprofloxacin at a dose of 500 mg twice daily and patients who 1) received a proper course of therapy. 2) had a confirmed diagnosis of complicated urinary tract infection, including acute pyelonephritis, 3) had not comment an major protocol violations, and 4) were microbiologically evaluable at the early follow-up (5 to 9 days post-therapy). Those patients were considered as evaluable.	Ceftriaxone n=71 Participants Ceftriaxone sodium as a single daily dose of 2.0 g intravenous infusion and be switched to oral ciprofloxacin at a dose of 500 mg twice daily and patients who 1) received a proper course of therapy. 2) had a confirmed diagnosis of complicated urinary tract infection, including acute pyelonephritis, 3) had not comment an major protocol violations, and 4) were microbiologically evaluable at the early follow-up(5 to 9 days post-therapy) were considered as evaluable.(66 patients from MK0826 and 71 patients from Ceftriaxone). Those patients were considered as evaluable.
Microbiological Response Assessment Profile	58 Participants	63 Participants

PRIMARY outcome

Timeframe: Adverse experiences that occurred during the study parenteral therapy period were analyzed. The period of parenteral therapy is from 3 days up to 14 days

Population: Safety Analysis has been done 267 patients who received at least 1 dose of parenteral therapy (132 patients from MK0826 and 135 patients from Ceftriaxone)

Safety was assessed by statistical and/or clinical review of all safety parameters, including adverse experiences, physical examination, vital signs, and laboratory results during parenteral therapy. As per the primary safety hypothesis, it was expected that, at the end of the parenteral therapy only, MK0826 would be similar to ceftriaxone with respect to the proportion of patients with any drug-related clinical or laboratory adverse experiences leading to discontinuation of study drug and also with respect to the proportion of patients with any serious drug-related adverse experiences.

Outcome measures

Measure	MK0826 n=132 Participants MK0826 as a single daily dose of 1.0 g intravenous infusion and be switched to oral ciprofloxacin at a dose of 500 mg twice daily and patients who 1) received a proper course of therapy. 2) had a confirmed diagnosis of complicated urinary tract infection, including acute pyelonephritis, 3) had not comment an major protocol violations, and 4) were microbiologically evaluable at the early follow-up (5 to 9 days post-therapy). Those patients were considered as evaluable.	Ceftriaxone n=135 Participants Ceftriaxone sodium as a single daily dose of 2.0 g intravenous infusion and be switched to oral ciprofloxacin at a dose of 500 mg twice daily and patients who 1) received a proper course of therapy. 2) had a confirmed diagnosis of complicated urinary tract infection, including acute pyelonephritis, 3) had not comment an major protocol violations, and 4) were microbiologically evaluable at the early follow-up(5 to 9 days post-therapy) were considered as evaluable.(66 patients from MK0826 and 71 patients from Ceftriaxone). Those patients were considered as evaluable.
The Number of Patients Who Experience Any Drug-related Adverse Experiences Leading to Discontinuation of Parenteral Study Drug and the Number of Patients With Any Drug-related Serious Adverse Experiences (AEs) During Parenteral Treatment Serious drug-related Laboratory AEs	0 Participants	0 Participants
The Number of Patients Who Experience Any Drug-related Adverse Experiences Leading to Discontinuation of Parenteral Study Drug and the Number of Patients With Any Drug-related Serious Adverse Experiences (AEs) During Parenteral Treatment Discontinued due to drug-related clinical AEs	1 Participants	0 Participants
The Number of Patients Who Experience Any Drug-related Adverse Experiences Leading to Discontinuation of Parenteral Study Drug and the Number of Patients With Any Drug-related Serious Adverse Experiences (AEs) During Parenteral Treatment Serious drug-related clinical AEs	0 Participants	0 Participants
The Number of Patients Who Experience Any Drug-related Adverse Experiences Leading to Discontinuation of Parenteral Study Drug and the Number of Patients With Any Drug-related Serious Adverse Experiences (AEs) During Parenteral Treatment Discontinued due to drug-related laboratory AEs	1 Participants	1 Participants

SECONDARY outcome

Timeframe: 5 to 9 days post-therapy

Population: Secondary efficacy analysis was done for 137 evaluable patients (66 patients from MK0826 and 71 patients from Ceftriaxone)

The difference in favorable clinical response rates between the 2 treatment groups (MK0826 response rate minus ceftriaxone response rate) was assessed

Outcome measures

Measure	MK0826 n=66 Participants MK0826 as a single daily dose of 1.0 g intravenous infusion and be switched to oral ciprofloxacin at a dose of 500 mg twice daily and patients who 1) received a proper course of therapy. 2) had a confirmed diagnosis of complicated urinary tract infection, including acute pyelonephritis, 3) had not comment an major protocol violations, and 4) were microbiologically evaluable at the early follow-up (5 to 9 days post-therapy). Those patients were considered as evaluable.	Ceftriaxone n=71 Participants Ceftriaxone sodium as a single daily dose of 2.0 g intravenous infusion and be switched to oral ciprofloxacin at a dose of 500 mg twice daily and patients who 1) received a proper course of therapy. 2) had a confirmed diagnosis of complicated urinary tract infection, including acute pyelonephritis, 3) had not comment an major protocol violations, and 4) were microbiologically evaluable at the early follow-up(5 to 9 days post-therapy) were considered as evaluable.(66 patients from MK0826 and 71 patients from Ceftriaxone). Those patients were considered as evaluable.
Clinical Response Assessment Profile	64 Participants	70 Participants

Adverse Events

MK0826

Serious events: 12 serious events

Other events: 85 other events

Deaths: 0 deaths

Ceftriaxone

Serious events: 8 serious events

Other events: 90 other events

Deaths: 0 deaths

Serious adverse events

Measure	MK0826 n=132 participants at risk MK0826 as a single daily dose of 1.0 g intravenous infusion and be switched to oral ciprofloxacin at a dose of 500 mg twice daily and patients who received at least 1 dose of parentheral therapy	Ceftriaxone n=135 participants at risk Ceftriaxone sodium as a single daily dose of 2.0 g intravenous infusion and be switched to oral ciprofloxacin at a dose of 500 mg twice daily and patients who received at least 1 dose of parentheral therapy
Nervous system disorders Cerebral infarction	0.00% 0/132 • Adverse experiences were recorded during parenteral therapy and for 14 days after the end of study therapy including oral study therapy (safety follow-up period) Safety was assessed by statistical and/or clinical review of all safety parameters, including adverse experiences (AE), physical examination, vital signs, and laboratory results	0.74% 1/135 • Adverse experiences were recorded during parenteral therapy and for 14 days after the end of study therapy including oral study therapy (safety follow-up period) Safety was assessed by statistical and/or clinical review of all safety parameters, including adverse experiences (AE), physical examination, vital signs, and laboratory results
Nervous system disorders Cerebrovascular accident	0.76% 1/132 • Adverse experiences were recorded during parenteral therapy and for 14 days after the end of study therapy including oral study therapy (safety follow-up period) Safety was assessed by statistical and/or clinical review of all safety parameters, including adverse experiences (AE), physical examination, vital signs, and laboratory results	0.00% 0/135 • Adverse experiences were recorded during parenteral therapy and for 14 days after the end of study therapy including oral study therapy (safety follow-up period) Safety was assessed by statistical and/or clinical review of all safety parameters, including adverse experiences (AE), physical examination, vital signs, and laboratory results
Nervous system disorders Hydrocephalus	0.76% 1/132 • Adverse experiences were recorded during parenteral therapy and for 14 days after the end of study therapy including oral study therapy (safety follow-up period) Safety was assessed by statistical and/or clinical review of all safety parameters, including adverse experiences (AE), physical examination, vital signs, and laboratory results	0.00% 0/135 • Adverse experiences were recorded during parenteral therapy and for 14 days after the end of study therapy including oral study therapy (safety follow-up period) Safety was assessed by statistical and/or clinical review of all safety parameters, including adverse experiences (AE), physical examination, vital signs, and laboratory results
Nervous system disorders Somnolence	0.76% 1/132 • Adverse experiences were recorded during parenteral therapy and for 14 days after the end of study therapy including oral study therapy (safety follow-up period) Safety was assessed by statistical and/or clinical review of all safety parameters, including adverse experiences (AE), physical examination, vital signs, and laboratory results	0.00% 0/135 • Adverse experiences were recorded during parenteral therapy and for 14 days after the end of study therapy including oral study therapy (safety follow-up period) Safety was assessed by statistical and/or clinical review of all safety parameters, including adverse experiences (AE), physical examination, vital signs, and laboratory results
Respiratory, thoracic and mediastinal disorders Sleep apnoea syndrome	0.76% 1/132 • Adverse experiences were recorded during parenteral therapy and for 14 days after the end of study therapy including oral study therapy (safety follow-up period) Safety was assessed by statistical and/or clinical review of all safety parameters, including adverse experiences (AE), physical examination, vital signs, and laboratory results	0.00% 0/135 • Adverse experiences were recorded during parenteral therapy and for 14 days after the end of study therapy including oral study therapy (safety follow-up period) Safety was assessed by statistical and/or clinical review of all safety parameters, including adverse experiences (AE), physical examination, vital signs, and laboratory results
Infections and infestations Pyelonephritis acute	0.76% 1/132 • Adverse experiences were recorded during parenteral therapy and for 14 days after the end of study therapy including oral study therapy (safety follow-up period) Safety was assessed by statistical and/or clinical review of all safety parameters, including adverse experiences (AE), physical examination, vital signs, and laboratory results	0.74% 1/135 • Adverse experiences were recorded during parenteral therapy and for 14 days after the end of study therapy including oral study therapy (safety follow-up period) Safety was assessed by statistical and/or clinical review of all safety parameters, including adverse experiences (AE), physical examination, vital signs, and laboratory results
Infections and infestations Tuberculosis	0.00% 0/132 • Adverse experiences were recorded during parenteral therapy and for 14 days after the end of study therapy including oral study therapy (safety follow-up period) Safety was assessed by statistical and/or clinical review of all safety parameters, including adverse experiences (AE), physical examination, vital signs, and laboratory results	0.74% 1/135 • Adverse experiences were recorded during parenteral therapy and for 14 days after the end of study therapy including oral study therapy (safety follow-up period) Safety was assessed by statistical and/or clinical review of all safety parameters, including adverse experiences (AE), physical examination, vital signs, and laboratory results
Infections and infestations Renal abcess	0.00% 0/132 • Adverse experiences were recorded during parenteral therapy and for 14 days after the end of study therapy including oral study therapy (safety follow-up period) Safety was assessed by statistical and/or clinical review of all safety parameters, including adverse experiences (AE), physical examination, vital signs, and laboratory results	0.74% 1/135 • Adverse experiences were recorded during parenteral therapy and for 14 days after the end of study therapy including oral study therapy (safety follow-up period) Safety was assessed by statistical and/or clinical review of all safety parameters, including adverse experiences (AE), physical examination, vital signs, and laboratory results
Infections and infestations Sepsis	0.76% 1/132 • Adverse experiences were recorded during parenteral therapy and for 14 days after the end of study therapy including oral study therapy (safety follow-up period) Safety was assessed by statistical and/or clinical review of all safety parameters, including adverse experiences (AE), physical examination, vital signs, and laboratory results	0.00% 0/135 • Adverse experiences were recorded during parenteral therapy and for 14 days after the end of study therapy including oral study therapy (safety follow-up period) Safety was assessed by statistical and/or clinical review of all safety parameters, including adverse experiences (AE), physical examination, vital signs, and laboratory results
Infections and infestations Tonsillitis	0.76% 1/132 • Adverse experiences were recorded during parenteral therapy and for 14 days after the end of study therapy including oral study therapy (safety follow-up period) Safety was assessed by statistical and/or clinical review of all safety parameters, including adverse experiences (AE), physical examination, vital signs, and laboratory results	0.00% 0/135 • Adverse experiences were recorded during parenteral therapy and for 14 days after the end of study therapy including oral study therapy (safety follow-up period) Safety was assessed by statistical and/or clinical review of all safety parameters, including adverse experiences (AE), physical examination, vital signs, and laboratory results
Infections and infestations Urinary tract infection	0.00% 0/132 • Adverse experiences were recorded during parenteral therapy and for 14 days after the end of study therapy including oral study therapy (safety follow-up period) Safety was assessed by statistical and/or clinical review of all safety parameters, including adverse experiences (AE), physical examination, vital signs, and laboratory results	0.74% 1/135 • Adverse experiences were recorded during parenteral therapy and for 14 days after the end of study therapy including oral study therapy (safety follow-up period) Safety was assessed by statistical and/or clinical review of all safety parameters, including adverse experiences (AE), physical examination, vital signs, and laboratory results
Infections and infestations Viral infection	0.76% 1/132 • Adverse experiences were recorded during parenteral therapy and for 14 days after the end of study therapy including oral study therapy (safety follow-up period) Safety was assessed by statistical and/or clinical review of all safety parameters, including adverse experiences (AE), physical examination, vital signs, and laboratory results	0.00% 0/135 • Adverse experiences were recorded during parenteral therapy and for 14 days after the end of study therapy including oral study therapy (safety follow-up period) Safety was assessed by statistical and/or clinical review of all safety parameters, including adverse experiences (AE), physical examination, vital signs, and laboratory results
Psychiatric disorders Mental status changes	0.76% 1/132 • Adverse experiences were recorded during parenteral therapy and for 14 days after the end of study therapy including oral study therapy (safety follow-up period) Safety was assessed by statistical and/or clinical review of all safety parameters, including adverse experiences (AE), physical examination, vital signs, and laboratory results	0.00% 0/135 • Adverse experiences were recorded during parenteral therapy and for 14 days after the end of study therapy including oral study therapy (safety follow-up period) Safety was assessed by statistical and/or clinical review of all safety parameters, including adverse experiences (AE), physical examination, vital signs, and laboratory results
Metabolism and nutrition disorders Dehydration	0.76% 1/132 • Adverse experiences were recorded during parenteral therapy and for 14 days after the end of study therapy including oral study therapy (safety follow-up period) Safety was assessed by statistical and/or clinical review of all safety parameters, including adverse experiences (AE), physical examination, vital signs, and laboratory results	0.00% 0/135 • Adverse experiences were recorded during parenteral therapy and for 14 days after the end of study therapy including oral study therapy (safety follow-up period) Safety was assessed by statistical and/or clinical review of all safety parameters, including adverse experiences (AE), physical examination, vital signs, and laboratory results
Metabolism and nutrition disorders Ketoacidosis	0.76% 1/132 • Adverse experiences were recorded during parenteral therapy and for 14 days after the end of study therapy including oral study therapy (safety follow-up period) Safety was assessed by statistical and/or clinical review of all safety parameters, including adverse experiences (AE), physical examination, vital signs, and laboratory results	0.00% 0/135 • Adverse experiences were recorded during parenteral therapy and for 14 days after the end of study therapy including oral study therapy (safety follow-up period) Safety was assessed by statistical and/or clinical review of all safety parameters, including adverse experiences (AE), physical examination, vital signs, and laboratory results
Vascular disorders Hypotension	0.76% 1/132 • Adverse experiences were recorded during parenteral therapy and for 14 days after the end of study therapy including oral study therapy (safety follow-up period) Safety was assessed by statistical and/or clinical review of all safety parameters, including adverse experiences (AE), physical examination, vital signs, and laboratory results	0.00% 0/135 • Adverse experiences were recorded during parenteral therapy and for 14 days after the end of study therapy including oral study therapy (safety follow-up period) Safety was assessed by statistical and/or clinical review of all safety parameters, including adverse experiences (AE), physical examination, vital signs, and laboratory results
Renal and urinary disorders Hydronephrosis	0.00% 0/132 • Adverse experiences were recorded during parenteral therapy and for 14 days after the end of study therapy including oral study therapy (safety follow-up period) Safety was assessed by statistical and/or clinical review of all safety parameters, including adverse experiences (AE), physical examination, vital signs, and laboratory results	0.74% 1/135 • Adverse experiences were recorded during parenteral therapy and for 14 days after the end of study therapy including oral study therapy (safety follow-up period) Safety was assessed by statistical and/or clinical review of all safety parameters, including adverse experiences (AE), physical examination, vital signs, and laboratory results
Renal and urinary disorders Haematuria	0.00% 0/132 • Adverse experiences were recorded during parenteral therapy and for 14 days after the end of study therapy including oral study therapy (safety follow-up period) Safety was assessed by statistical and/or clinical review of all safety parameters, including adverse experiences (AE), physical examination, vital signs, and laboratory results	0.74% 1/135 • Adverse experiences were recorded during parenteral therapy and for 14 days after the end of study therapy including oral study therapy (safety follow-up period) Safety was assessed by statistical and/or clinical review of all safety parameters, including adverse experiences (AE), physical examination, vital signs, and laboratory results
Renal and urinary disorders Renal and urinary disorders	0.00% 0/132 • Adverse experiences were recorded during parenteral therapy and for 14 days after the end of study therapy including oral study therapy (safety follow-up period) Safety was assessed by statistical and/or clinical review of all safety parameters, including adverse experiences (AE), physical examination, vital signs, and laboratory results	0.74% 1/135 • Adverse experiences were recorded during parenteral therapy and for 14 days after the end of study therapy including oral study therapy (safety follow-up period) Safety was assessed by statistical and/or clinical review of all safety parameters, including adverse experiences (AE), physical examination, vital signs, and laboratory results
Blood and lymphatic system disorders Neutropenia	0.76% 1/132 • Adverse experiences were recorded during parenteral therapy and for 14 days after the end of study therapy including oral study therapy (safety follow-up period) Safety was assessed by statistical and/or clinical review of all safety parameters, including adverse experiences (AE), physical examination, vital signs, and laboratory results	0.00% 0/135 • Adverse experiences were recorded during parenteral therapy and for 14 days after the end of study therapy including oral study therapy (safety follow-up period) Safety was assessed by statistical and/or clinical review of all safety parameters, including adverse experiences (AE), physical examination, vital signs, and laboratory results
Cardiac disorders Cardiac discomfort	0.76% 1/132 • Adverse experiences were recorded during parenteral therapy and for 14 days after the end of study therapy including oral study therapy (safety follow-up period) Safety was assessed by statistical and/or clinical review of all safety parameters, including adverse experiences (AE), physical examination, vital signs, and laboratory results	0.00% 0/135 • Adverse experiences were recorded during parenteral therapy and for 14 days after the end of study therapy including oral study therapy (safety follow-up period) Safety was assessed by statistical and/or clinical review of all safety parameters, including adverse experiences (AE), physical examination, vital signs, and laboratory results
Cardiac disorders Myocardial infarction	0.76% 1/132 • Adverse experiences were recorded during parenteral therapy and for 14 days after the end of study therapy including oral study therapy (safety follow-up period) Safety was assessed by statistical and/or clinical review of all safety parameters, including adverse experiences (AE), physical examination, vital signs, and laboratory results	0.00% 0/135 • Adverse experiences were recorded during parenteral therapy and for 14 days after the end of study therapy including oral study therapy (safety follow-up period) Safety was assessed by statistical and/or clinical review of all safety parameters, including adverse experiences (AE), physical examination, vital signs, and laboratory results
Cardiac disorders Pericarditis	0.76% 1/132 • Adverse experiences were recorded during parenteral therapy and for 14 days after the end of study therapy including oral study therapy (safety follow-up period) Safety was assessed by statistical and/or clinical review of all safety parameters, including adverse experiences (AE), physical examination, vital signs, and laboratory results	0.00% 0/135 • Adverse experiences were recorded during parenteral therapy and for 14 days after the end of study therapy including oral study therapy (safety follow-up period) Safety was assessed by statistical and/or clinical review of all safety parameters, including adverse experiences (AE), physical examination, vital signs, and laboratory results
Injury, poisoning and procedural complications Accidental overdose	0.00% 0/132 • Adverse experiences were recorded during parenteral therapy and for 14 days after the end of study therapy including oral study therapy (safety follow-up period) Safety was assessed by statistical and/or clinical review of all safety parameters, including adverse experiences (AE), physical examination, vital signs, and laboratory results	0.74% 1/135 • Adverse experiences were recorded during parenteral therapy and for 14 days after the end of study therapy including oral study therapy (safety follow-up period) Safety was assessed by statistical and/or clinical review of all safety parameters, including adverse experiences (AE), physical examination, vital signs, and laboratory results
Injury, poisoning and procedural complications Renal haematoma	0.76% 1/132 • Adverse experiences were recorded during parenteral therapy and for 14 days after the end of study therapy including oral study therapy (safety follow-up period) Safety was assessed by statistical and/or clinical review of all safety parameters, including adverse experiences (AE), physical examination, vital signs, and laboratory results	0.00% 0/135 • Adverse experiences were recorded during parenteral therapy and for 14 days after the end of study therapy including oral study therapy (safety follow-up period) Safety was assessed by statistical and/or clinical review of all safety parameters, including adverse experiences (AE), physical examination, vital signs, and laboratory results
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastatic neoplasm	0.00% 0/132 • Adverse experiences were recorded during parenteral therapy and for 14 days after the end of study therapy including oral study therapy (safety follow-up period) Safety was assessed by statistical and/or clinical review of all safety parameters, including adverse experiences (AE), physical examination, vital signs, and laboratory results	0.74% 1/135 • Adverse experiences were recorded during parenteral therapy and for 14 days after the end of study therapy including oral study therapy (safety follow-up period) Safety was assessed by statistical and/or clinical review of all safety parameters, including adverse experiences (AE), physical examination, vital signs, and laboratory results
Metabolism and nutrition disorders Hypokalaemia	0.76% 1/132 • Adverse experiences were recorded during parenteral therapy and for 14 days after the end of study therapy including oral study therapy (safety follow-up period) Safety was assessed by statistical and/or clinical review of all safety parameters, including adverse experiences (AE), physical examination, vital signs, and laboratory results	0.00% 0/135 • Adverse experiences were recorded during parenteral therapy and for 14 days after the end of study therapy including oral study therapy (safety follow-up period) Safety was assessed by statistical and/or clinical review of all safety parameters, including adverse experiences (AE), physical examination, vital signs, and laboratory results
Metabolism and nutrition disorders Hypernatraemia	0.76% 1/132 • Adverse experiences were recorded during parenteral therapy and for 14 days after the end of study therapy including oral study therapy (safety follow-up period) Safety was assessed by statistical and/or clinical review of all safety parameters, including adverse experiences (AE), physical examination, vital signs, and laboratory results	0.00% 0/135 • Adverse experiences were recorded during parenteral therapy and for 14 days after the end of study therapy including oral study therapy (safety follow-up period) Safety was assessed by statistical and/or clinical review of all safety parameters, including adverse experiences (AE), physical examination, vital signs, and laboratory results
Renal and urinary disorders Azotaemia	0.76% 1/132 • Adverse experiences were recorded during parenteral therapy and for 14 days after the end of study therapy including oral study therapy (safety follow-up period) Safety was assessed by statistical and/or clinical review of all safety parameters, including adverse experiences (AE), physical examination, vital signs, and laboratory results	0.00% 0/135 • Adverse experiences were recorded during parenteral therapy and for 14 days after the end of study therapy including oral study therapy (safety follow-up period) Safety was assessed by statistical and/or clinical review of all safety parameters, including adverse experiences (AE), physical examination, vital signs, and laboratory results
Blood and lymphatic system disorders Thrombocytopenia	0.76% 1/132 • Adverse experiences were recorded during parenteral therapy and for 14 days after the end of study therapy including oral study therapy (safety follow-up period) Safety was assessed by statistical and/or clinical review of all safety parameters, including adverse experiences (AE), physical examination, vital signs, and laboratory results	0.00% 0/135 • Adverse experiences were recorded during parenteral therapy and for 14 days after the end of study therapy including oral study therapy (safety follow-up period) Safety was assessed by statistical and/or clinical review of all safety parameters, including adverse experiences (AE), physical examination, vital signs, and laboratory results

Other adverse events

Measure	MK0826 n=132 participants at risk MK0826 as a single daily dose of 1.0 g intravenous infusion and be switched to oral ciprofloxacin at a dose of 500 mg twice daily and patients who received at least 1 dose of parentheral therapy	Ceftriaxone n=135 participants at risk Ceftriaxone sodium as a single daily dose of 2.0 g intravenous infusion and be switched to oral ciprofloxacin at a dose of 500 mg twice daily and patients who received at least 1 dose of parentheral therapy
Gastrointestinal disorders Diarrhea	20.5% 27/132 • Adverse experiences were recorded during parenteral therapy and for 14 days after the end of study therapy including oral study therapy (safety follow-up period) Safety was assessed by statistical and/or clinical review of all safety parameters, including adverse experiences (AE), physical examination, vital signs, and laboratory results	14.8% 20/135 • Adverse experiences were recorded during parenteral therapy and for 14 days after the end of study therapy including oral study therapy (safety follow-up period) Safety was assessed by statistical and/or clinical review of all safety parameters, including adverse experiences (AE), physical examination, vital signs, and laboratory results
Gastrointestinal disorders Dyspepsia	6.1% 8/132 • Adverse experiences were recorded during parenteral therapy and for 14 days after the end of study therapy including oral study therapy (safety follow-up period) Safety was assessed by statistical and/or clinical review of all safety parameters, including adverse experiences (AE), physical examination, vital signs, and laboratory results	11.1% 15/135 • Adverse experiences were recorded during parenteral therapy and for 14 days after the end of study therapy including oral study therapy (safety follow-up period) Safety was assessed by statistical and/or clinical review of all safety parameters, including adverse experiences (AE), physical examination, vital signs, and laboratory results
Gastrointestinal disorders Constipation	6.8% 9/132 • Adverse experiences were recorded during parenteral therapy and for 14 days after the end of study therapy including oral study therapy (safety follow-up period) Safety was assessed by statistical and/or clinical review of all safety parameters, including adverse experiences (AE), physical examination, vital signs, and laboratory results	6.7% 9/135 • Adverse experiences were recorded during parenteral therapy and for 14 days after the end of study therapy including oral study therapy (safety follow-up period) Safety was assessed by statistical and/or clinical review of all safety parameters, including adverse experiences (AE), physical examination, vital signs, and laboratory results
Gastrointestinal disorders Nausea	6.1% 8/132 • Adverse experiences were recorded during parenteral therapy and for 14 days after the end of study therapy including oral study therapy (safety follow-up period) Safety was assessed by statistical and/or clinical review of all safety parameters, including adverse experiences (AE), physical examination, vital signs, and laboratory results	6.7% 9/135 • Adverse experiences were recorded during parenteral therapy and for 14 days after the end of study therapy including oral study therapy (safety follow-up period) Safety was assessed by statistical and/or clinical review of all safety parameters, including adverse experiences (AE), physical examination, vital signs, and laboratory results
Gastrointestinal disorders Abdominal pain	3.0% 4/132 • Adverse experiences were recorded during parenteral therapy and for 14 days after the end of study therapy including oral study therapy (safety follow-up period) Safety was assessed by statistical and/or clinical review of all safety parameters, including adverse experiences (AE), physical examination, vital signs, and laboratory results	5.9% 8/135 • Adverse experiences were recorded during parenteral therapy and for 14 days after the end of study therapy including oral study therapy (safety follow-up period) Safety was assessed by statistical and/or clinical review of all safety parameters, including adverse experiences (AE), physical examination, vital signs, and laboratory results
Gastrointestinal disorders Abdominal discomfort	2.3% 3/132 • Adverse experiences were recorded during parenteral therapy and for 14 days after the end of study therapy including oral study therapy (safety follow-up period) Safety was assessed by statistical and/or clinical review of all safety parameters, including adverse experiences (AE), physical examination, vital signs, and laboratory results	3.7% 5/135 • Adverse experiences were recorded during parenteral therapy and for 14 days after the end of study therapy including oral study therapy (safety follow-up period) Safety was assessed by statistical and/or clinical review of all safety parameters, including adverse experiences (AE), physical examination, vital signs, and laboratory results
Gastrointestinal disorders Vomiting	4.5% 6/132 • Adverse experiences were recorded during parenteral therapy and for 14 days after the end of study therapy including oral study therapy (safety follow-up period) Safety was assessed by statistical and/or clinical review of all safety parameters, including adverse experiences (AE), physical examination, vital signs, and laboratory results	0.74% 1/135 • Adverse experiences were recorded during parenteral therapy and for 14 days after the end of study therapy including oral study therapy (safety follow-up period) Safety was assessed by statistical and/or clinical review of all safety parameters, including adverse experiences (AE), physical examination, vital signs, and laboratory results
Gastrointestinal disorders Abdominal pain upper	2.3% 3/132 • Adverse experiences were recorded during parenteral therapy and for 14 days after the end of study therapy including oral study therapy (safety follow-up period) Safety was assessed by statistical and/or clinical review of all safety parameters, including adverse experiences (AE), physical examination, vital signs, and laboratory results	2.2% 3/135 • Adverse experiences were recorded during parenteral therapy and for 14 days after the end of study therapy including oral study therapy (safety follow-up period) Safety was assessed by statistical and/or clinical review of all safety parameters, including adverse experiences (AE), physical examination, vital signs, and laboratory results
Gastrointestinal disorders Abdominal distension	0.76% 1/132 • Adverse experiences were recorded during parenteral therapy and for 14 days after the end of study therapy including oral study therapy (safety follow-up period) Safety was assessed by statistical and/or clinical review of all safety parameters, including adverse experiences (AE), physical examination, vital signs, and laboratory results	1.5% 2/135 • Adverse experiences were recorded during parenteral therapy and for 14 days after the end of study therapy including oral study therapy (safety follow-up period) Safety was assessed by statistical and/or clinical review of all safety parameters, including adverse experiences (AE), physical examination, vital signs, and laboratory results
Gastrointestinal disorders Epigastric discomfort	0.76% 1/132 • Adverse experiences were recorded during parenteral therapy and for 14 days after the end of study therapy including oral study therapy (safety follow-up period) Safety was assessed by statistical and/or clinical review of all safety parameters, including adverse experiences (AE), physical examination, vital signs, and laboratory results	1.5% 2/135 • Adverse experiences were recorded during parenteral therapy and for 14 days after the end of study therapy including oral study therapy (safety follow-up period) Safety was assessed by statistical and/or clinical review of all safety parameters, including adverse experiences (AE), physical examination, vital signs, and laboratory results
Gastrointestinal disorders Gastric ulcer	1.5% 2/132 • Adverse experiences were recorded during parenteral therapy and for 14 days after the end of study therapy including oral study therapy (safety follow-up period) Safety was assessed by statistical and/or clinical review of all safety parameters, including adverse experiences (AE), physical examination, vital signs, and laboratory results	0.74% 1/135 • Adverse experiences were recorded during parenteral therapy and for 14 days after the end of study therapy including oral study therapy (safety follow-up period) Safety was assessed by statistical and/or clinical review of all safety parameters, including adverse experiences (AE), physical examination, vital signs, and laboratory results
Gastrointestinal disorders Gastritis atrophic	1.5% 2/132 • Adverse experiences were recorded during parenteral therapy and for 14 days after the end of study therapy including oral study therapy (safety follow-up period) Safety was assessed by statistical and/or clinical review of all safety parameters, including adverse experiences (AE), physical examination, vital signs, and laboratory results	0.74% 1/135 • Adverse experiences were recorded during parenteral therapy and for 14 days after the end of study therapy including oral study therapy (safety follow-up period) Safety was assessed by statistical and/or clinical review of all safety parameters, including adverse experiences (AE), physical examination, vital signs, and laboratory results
Gastrointestinal disorders Dry mouth	0.76% 1/132 • Adverse experiences were recorded during parenteral therapy and for 14 days after the end of study therapy including oral study therapy (safety follow-up period) Safety was assessed by statistical and/or clinical review of all safety parameters, including adverse experiences (AE), physical examination, vital signs, and laboratory results	0.74% 1/135 • Adverse experiences were recorded during parenteral therapy and for 14 days after the end of study therapy including oral study therapy (safety follow-up period) Safety was assessed by statistical and/or clinical review of all safety parameters, including adverse experiences (AE), physical examination, vital signs, and laboratory results
Gastrointestinal disorders Mouth ulceration	0.00% 0/132 • Adverse experiences were recorded during parenteral therapy and for 14 days after the end of study therapy including oral study therapy (safety follow-up period) Safety was assessed by statistical and/or clinical review of all safety parameters, including adverse experiences (AE), physical examination, vital signs, and laboratory results	1.5% 2/135 • Adverse experiences were recorded during parenteral therapy and for 14 days after the end of study therapy including oral study therapy (safety follow-up period) Safety was assessed by statistical and/or clinical review of all safety parameters, including adverse experiences (AE), physical examination, vital signs, and laboratory results
Gastrointestinal disorders Colonic polyp	0.76% 1/132 • Adverse experiences were recorded during parenteral therapy and for 14 days after the end of study therapy including oral study therapy (safety follow-up period) Safety was assessed by statistical and/or clinical review of all safety parameters, including adverse experiences (AE), physical examination, vital signs, and laboratory results	0.00% 0/135 • Adverse experiences were recorded during parenteral therapy and for 14 days after the end of study therapy including oral study therapy (safety follow-up period) Safety was assessed by statistical and/or clinical review of all safety parameters, including adverse experiences (AE), physical examination, vital signs, and laboratory results
Gastrointestinal disorders Duodenal ulcer	0.76% 1/132 • Adverse experiences were recorded during parenteral therapy and for 14 days after the end of study therapy including oral study therapy (safety follow-up period) Safety was assessed by statistical and/or clinical review of all safety parameters, including adverse experiences (AE), physical examination, vital signs, and laboratory results	0.00% 0/135 • Adverse experiences were recorded during parenteral therapy and for 14 days after the end of study therapy including oral study therapy (safety follow-up period) Safety was assessed by statistical and/or clinical review of all safety parameters, including adverse experiences (AE), physical examination, vital signs, and laboratory results
Gastrointestinal disorders Faecal incontinence	0.00% 0/132 • Adverse experiences were recorded during parenteral therapy and for 14 days after the end of study therapy including oral study therapy (safety follow-up period) Safety was assessed by statistical and/or clinical review of all safety parameters, including adverse experiences (AE), physical examination, vital signs, and laboratory results	0.74% 1/135 • Adverse experiences were recorded during parenteral therapy and for 14 days after the end of study therapy including oral study therapy (safety follow-up period) Safety was assessed by statistical and/or clinical review of all safety parameters, including adverse experiences (AE), physical examination, vital signs, and laboratory results
Gastrointestinal disorders Gastritis	0.76% 1/132 • Adverse experiences were recorded during parenteral therapy and for 14 days after the end of study therapy including oral study therapy (safety follow-up period) Safety was assessed by statistical and/or clinical review of all safety parameters, including adverse experiences (AE), physical examination, vital signs, and laboratory results	0.00% 0/135 • Adverse experiences were recorded during parenteral therapy and for 14 days after the end of study therapy including oral study therapy (safety follow-up period) Safety was assessed by statistical and/or clinical review of all safety parameters, including adverse experiences (AE), physical examination, vital signs, and laboratory results
Gastrointestinal disorders Gastritis erosive	0.76% 1/132 • Adverse experiences were recorded during parenteral therapy and for 14 days after the end of study therapy including oral study therapy (safety follow-up period) Safety was assessed by statistical and/or clinical review of all safety parameters, including adverse experiences (AE), physical examination, vital signs, and laboratory results	0.00% 0/135 • Adverse experiences were recorded during parenteral therapy and for 14 days after the end of study therapy including oral study therapy (safety follow-up period) Safety was assessed by statistical and/or clinical review of all safety parameters, including adverse experiences (AE), physical examination, vital signs, and laboratory results
Gastrointestinal disorders Gastrooesophageal reflux disease	0.76% 1/132 • Adverse experiences were recorded during parenteral therapy and for 14 days after the end of study therapy including oral study therapy (safety follow-up period) Safety was assessed by statistical and/or clinical review of all safety parameters, including adverse experiences (AE), physical examination, vital signs, and laboratory results	0.00% 0/135 • Adverse experiences were recorded during parenteral therapy and for 14 days after the end of study therapy including oral study therapy (safety follow-up period) Safety was assessed by statistical and/or clinical review of all safety parameters, including adverse experiences (AE), physical examination, vital signs, and laboratory results
Gastrointestinal disorders Haemorrhoids	0.76% 1/132 • Adverse experiences were recorded during parenteral therapy and for 14 days after the end of study therapy including oral study therapy (safety follow-up period) Safety was assessed by statistical and/or clinical review of all safety parameters, including adverse experiences (AE), physical examination, vital signs, and laboratory results	0.00% 0/135 • Adverse experiences were recorded during parenteral therapy and for 14 days after the end of study therapy including oral study therapy (safety follow-up period) Safety was assessed by statistical and/or clinical review of all safety parameters, including adverse experiences (AE), physical examination, vital signs, and laboratory results
Gastrointestinal disorders Lip blister	0.76% 1/132 • Adverse experiences were recorded during parenteral therapy and for 14 days after the end of study therapy including oral study therapy (safety follow-up period) Safety was assessed by statistical and/or clinical review of all safety parameters, including adverse experiences (AE), physical examination, vital signs, and laboratory results	0.00% 0/135 • Adverse experiences were recorded during parenteral therapy and for 14 days after the end of study therapy including oral study therapy (safety follow-up period) Safety was assessed by statistical and/or clinical review of all safety parameters, including adverse experiences (AE), physical examination, vital signs, and laboratory results
Nervous system disorders Headache	16.7% 22/132 • Adverse experiences were recorded during parenteral therapy and for 14 days after the end of study therapy including oral study therapy (safety follow-up period) Safety was assessed by statistical and/or clinical review of all safety parameters, including adverse experiences (AE), physical examination, vital signs, and laboratory results	14.1% 19/135 • Adverse experiences were recorded during parenteral therapy and for 14 days after the end of study therapy including oral study therapy (safety follow-up period) Safety was assessed by statistical and/or clinical review of all safety parameters, including adverse experiences (AE), physical examination, vital signs, and laboratory results
Nervous system disorders Dizziness	1.5% 2/132 • Adverse experiences were recorded during parenteral therapy and for 14 days after the end of study therapy including oral study therapy (safety follow-up period) Safety was assessed by statistical and/or clinical review of all safety parameters, including adverse experiences (AE), physical examination, vital signs, and laboratory results	3.0% 4/135 • Adverse experiences were recorded during parenteral therapy and for 14 days after the end of study therapy including oral study therapy (safety follow-up period) Safety was assessed by statistical and/or clinical review of all safety parameters, including adverse experiences (AE), physical examination, vital signs, and laboratory results
Nervous system disorders Paraesthesia	0.00% 0/132 • Adverse experiences were recorded during parenteral therapy and for 14 days after the end of study therapy including oral study therapy (safety follow-up period) Safety was assessed by statistical and/or clinical review of all safety parameters, including adverse experiences (AE), physical examination, vital signs, and laboratory results	1.5% 2/135 • Adverse experiences were recorded during parenteral therapy and for 14 days after the end of study therapy including oral study therapy (safety follow-up period) Safety was assessed by statistical and/or clinical review of all safety parameters, including adverse experiences (AE), physical examination, vital signs, and laboratory results
Nervous system disorders Burning sensation	0.00% 0/132 • Adverse experiences were recorded during parenteral therapy and for 14 days after the end of study therapy including oral study therapy (safety follow-up period) Safety was assessed by statistical and/or clinical review of all safety parameters, including adverse experiences (AE), physical examination, vital signs, and laboratory results	0.74% 1/135 • Adverse experiences were recorded during parenteral therapy and for 14 days after the end of study therapy including oral study therapy (safety follow-up period) Safety was assessed by statistical and/or clinical review of all safety parameters, including adverse experiences (AE), physical examination, vital signs, and laboratory results
Nervous system disorders Convulsion	0.76% 1/132 • Adverse experiences were recorded during parenteral therapy and for 14 days after the end of study therapy including oral study therapy (safety follow-up period) Safety was assessed by statistical and/or clinical review of all safety parameters, including adverse experiences (AE), physical examination, vital signs, and laboratory results	0.00% 0/135 • Adverse experiences were recorded during parenteral therapy and for 14 days after the end of study therapy including oral study therapy (safety follow-up period) Safety was assessed by statistical and/or clinical review of all safety parameters, including adverse experiences (AE), physical examination, vital signs, and laboratory results
Nervous system disorders Hypoaesthesia	0.76% 1/132 • Adverse experiences were recorded during parenteral therapy and for 14 days after the end of study therapy including oral study therapy (safety follow-up period) Safety was assessed by statistical and/or clinical review of all safety parameters, including adverse experiences (AE), physical examination, vital signs, and laboratory results	0.00% 0/135 • Adverse experiences were recorded during parenteral therapy and for 14 days after the end of study therapy including oral study therapy (safety follow-up period) Safety was assessed by statistical and/or clinical review of all safety parameters, including adverse experiences (AE), physical examination, vital signs, and laboratory results
Nervous system disorders Syncope	0.00% 0/132 • Adverse experiences were recorded during parenteral therapy and for 14 days after the end of study therapy including oral study therapy (safety follow-up period) Safety was assessed by statistical and/or clinical review of all safety parameters, including adverse experiences (AE), physical examination, vital signs, and laboratory results	0.74% 1/135 • Adverse experiences were recorded during parenteral therapy and for 14 days after the end of study therapy including oral study therapy (safety follow-up period) Safety was assessed by statistical and/or clinical review of all safety parameters, including adverse experiences (AE), physical examination, vital signs, and laboratory results
Respiratory, thoracic and mediastinal disorders Cough	6.1% 8/132 • Adverse experiences were recorded during parenteral therapy and for 14 days after the end of study therapy including oral study therapy (safety follow-up period) Safety was assessed by statistical and/or clinical review of all safety parameters, including adverse experiences (AE), physical examination, vital signs, and laboratory results	8.1% 11/135 • Adverse experiences were recorded during parenteral therapy and for 14 days after the end of study therapy including oral study therapy (safety follow-up period) Safety was assessed by statistical and/or clinical review of all safety parameters, including adverse experiences (AE), physical examination, vital signs, and laboratory results
Respiratory, thoracic and mediastinal disorders Dyspnoea	2.3% 3/132 • Adverse experiences were recorded during parenteral therapy and for 14 days after the end of study therapy including oral study therapy (safety follow-up period) Safety was assessed by statistical and/or clinical review of all safety parameters, including adverse experiences (AE), physical examination, vital signs, and laboratory results	6.7% 9/135 • Adverse experiences were recorded during parenteral therapy and for 14 days after the end of study therapy including oral study therapy (safety follow-up period) Safety was assessed by statistical and/or clinical review of all safety parameters, including adverse experiences (AE), physical examination, vital signs, and laboratory results
Respiratory, thoracic and mediastinal disorders Productive cough	3.0% 4/132 • Adverse experiences were recorded during parenteral therapy and for 14 days after the end of study therapy including oral study therapy (safety follow-up period) Safety was assessed by statistical and/or clinical review of all safety parameters, including adverse experiences (AE), physical examination, vital signs, and laboratory results	5.2% 7/135 • Adverse experiences were recorded during parenteral therapy and for 14 days after the end of study therapy including oral study therapy (safety follow-up period) Safety was assessed by statistical and/or clinical review of all safety parameters, including adverse experiences (AE), physical examination, vital signs, and laboratory results
Respiratory, thoracic and mediastinal disorders Rhinorrhoea	1.5% 2/132 • Adverse experiences were recorded during parenteral therapy and for 14 days after the end of study therapy including oral study therapy (safety follow-up period) Safety was assessed by statistical and/or clinical review of all safety parameters, including adverse experiences (AE), physical examination, vital signs, and laboratory results	4.4% 6/135 • Adverse experiences were recorded during parenteral therapy and for 14 days after the end of study therapy including oral study therapy (safety follow-up period) Safety was assessed by statistical and/or clinical review of all safety parameters, including adverse experiences (AE), physical examination, vital signs, and laboratory results
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	0.76% 1/132 • Adverse experiences were recorded during parenteral therapy and for 14 days after the end of study therapy including oral study therapy (safety follow-up period) Safety was assessed by statistical and/or clinical review of all safety parameters, including adverse experiences (AE), physical examination, vital signs, and laboratory results	2.2% 3/135 • Adverse experiences were recorded during parenteral therapy and for 14 days after the end of study therapy including oral study therapy (safety follow-up period) Safety was assessed by statistical and/or clinical review of all safety parameters, including adverse experiences (AE), physical examination, vital signs, and laboratory results
Respiratory, thoracic and mediastinal disorders Pleural effusion	0.00% 0/132 • Adverse experiences were recorded during parenteral therapy and for 14 days after the end of study therapy including oral study therapy (safety follow-up period) Safety was assessed by statistical and/or clinical review of all safety parameters, including adverse experiences (AE), physical examination, vital signs, and laboratory results	3.0% 4/135 • Adverse experiences were recorded during parenteral therapy and for 14 days after the end of study therapy including oral study therapy (safety follow-up period) Safety was assessed by statistical and/or clinical review of all safety parameters, including adverse experiences (AE), physical examination, vital signs, and laboratory results
Respiratory, thoracic and mediastinal disorders Epistaxis	0.00% 0/132 • Adverse experiences were recorded during parenteral therapy and for 14 days after the end of study therapy including oral study therapy (safety follow-up period) Safety was assessed by statistical and/or clinical review of all safety parameters, including adverse experiences (AE), physical examination, vital signs, and laboratory results	1.5% 2/135 • Adverse experiences were recorded during parenteral therapy and for 14 days after the end of study therapy including oral study therapy (safety follow-up period) Safety was assessed by statistical and/or clinical review of all safety parameters, including adverse experiences (AE), physical examination, vital signs, and laboratory results
Respiratory, thoracic and mediastinal disorders Dyspnoea exertional	0.76% 1/132 • Adverse experiences were recorded during parenteral therapy and for 14 days after the end of study therapy including oral study therapy (safety follow-up period) Safety was assessed by statistical and/or clinical review of all safety parameters, including adverse experiences (AE), physical examination, vital signs, and laboratory results	0.00% 0/135 • Adverse experiences were recorded during parenteral therapy and for 14 days after the end of study therapy including oral study therapy (safety follow-up period) Safety was assessed by statistical and/or clinical review of all safety parameters, including adverse experiences (AE), physical examination, vital signs, and laboratory results
Respiratory, thoracic and mediastinal disorders Nasal congestion	0.00% 0/132 • Adverse experiences were recorded during parenteral therapy and for 14 days after the end of study therapy including oral study therapy (safety follow-up period) Safety was assessed by statistical and/or clinical review of all safety parameters, including adverse experiences (AE), physical examination, vital signs, and laboratory results	0.74% 1/135 • Adverse experiences were recorded during parenteral therapy and for 14 days after the end of study therapy including oral study therapy (safety follow-up period) Safety was assessed by statistical and/or clinical review of all safety parameters, including adverse experiences (AE), physical examination, vital signs, and laboratory results
Respiratory, thoracic and mediastinal disorders Pulmonary congestion	0.00% 0/132 • Adverse experiences were recorded during parenteral therapy and for 14 days after the end of study therapy including oral study therapy (safety follow-up period) Safety was assessed by statistical and/or clinical review of all safety parameters, including adverse experiences (AE), physical examination, vital signs, and laboratory results	0.74% 1/135 • Adverse experiences were recorded during parenteral therapy and for 14 days after the end of study therapy including oral study therapy (safety follow-up period) Safety was assessed by statistical and/or clinical review of all safety parameters, including adverse experiences (AE), physical examination, vital signs, and laboratory results
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	0.00% 0/132 • Adverse experiences were recorded during parenteral therapy and for 14 days after the end of study therapy including oral study therapy (safety follow-up period) Safety was assessed by statistical and/or clinical review of all safety parameters, including adverse experiences (AE), physical examination, vital signs, and laboratory results	0.74% 1/135 • Adverse experiences were recorded during parenteral therapy and for 14 days after the end of study therapy including oral study therapy (safety follow-up period) Safety was assessed by statistical and/or clinical review of all safety parameters, including adverse experiences (AE), physical examination, vital signs, and laboratory results
Respiratory, thoracic and mediastinal disorders Sputum discoloured	0.00% 0/132 • Adverse experiences were recorded during parenteral therapy and for 14 days after the end of study therapy including oral study therapy (safety follow-up period) Safety was assessed by statistical and/or clinical review of all safety parameters, including adverse experiences (AE), physical examination, vital signs, and laboratory results	0.74% 1/135 • Adverse experiences were recorded during parenteral therapy and for 14 days after the end of study therapy including oral study therapy (safety follow-up period) Safety was assessed by statistical and/or clinical review of all safety parameters, including adverse experiences (AE), physical examination, vital signs, and laboratory results
General disorders Chest discomfort	0.76% 1/132 • Adverse experiences were recorded during parenteral therapy and for 14 days after the end of study therapy including oral study therapy (safety follow-up period) Safety was assessed by statistical and/or clinical review of all safety parameters, including adverse experiences (AE), physical examination, vital signs, and laboratory results	2.2% 3/135 • Adverse experiences were recorded during parenteral therapy and for 14 days after the end of study therapy including oral study therapy (safety follow-up period) Safety was assessed by statistical and/or clinical review of all safety parameters, including adverse experiences (AE), physical examination, vital signs, and laboratory results
General disorders Pyrexia	2.3% 3/132 • Adverse experiences were recorded during parenteral therapy and for 14 days after the end of study therapy including oral study therapy (safety follow-up period) Safety was assessed by statistical and/or clinical review of all safety parameters, including adverse experiences (AE), physical examination, vital signs, and laboratory results	0.74% 1/135 • Adverse experiences were recorded during parenteral therapy and for 14 days after the end of study therapy including oral study therapy (safety follow-up period) Safety was assessed by statistical and/or clinical review of all safety parameters, including adverse experiences (AE), physical examination, vital signs, and laboratory results
General disorders Application site pain	0.76% 1/132 • Adverse experiences were recorded during parenteral therapy and for 14 days after the end of study therapy including oral study therapy (safety follow-up period) Safety was assessed by statistical and/or clinical review of all safety parameters, including adverse experiences (AE), physical examination, vital signs, and laboratory results	0.74% 1/135 • Adverse experiences were recorded during parenteral therapy and for 14 days after the end of study therapy including oral study therapy (safety follow-up period) Safety was assessed by statistical and/or clinical review of all safety parameters, including adverse experiences (AE), physical examination, vital signs, and laboratory results
General disorders Chest pain	0.76% 1/132 • Adverse experiences were recorded during parenteral therapy and for 14 days after the end of study therapy including oral study therapy (safety follow-up period) Safety was assessed by statistical and/or clinical review of all safety parameters, including adverse experiences (AE), physical examination, vital signs, and laboratory results	0.74% 1/135 • Adverse experiences were recorded during parenteral therapy and for 14 days after the end of study therapy including oral study therapy (safety follow-up period) Safety was assessed by statistical and/or clinical review of all safety parameters, including adverse experiences (AE), physical examination, vital signs, and laboratory results
General disorders Face oedema	1.5% 2/132 • Adverse experiences were recorded during parenteral therapy and for 14 days after the end of study therapy including oral study therapy (safety follow-up period) Safety was assessed by statistical and/or clinical review of all safety parameters, including adverse experiences (AE), physical examination, vital signs, and laboratory results	0.00% 0/135 • Adverse experiences were recorded during parenteral therapy and for 14 days after the end of study therapy including oral study therapy (safety follow-up period) Safety was assessed by statistical and/or clinical review of all safety parameters, including adverse experiences (AE), physical examination, vital signs, and laboratory results
General disorders Fatigue	0.76% 1/132 • Adverse experiences were recorded during parenteral therapy and for 14 days after the end of study therapy including oral study therapy (safety follow-up period) Safety was assessed by statistical and/or clinical review of all safety parameters, including adverse experiences (AE), physical examination, vital signs, and laboratory results	0.74% 1/135 • Adverse experiences were recorded during parenteral therapy and for 14 days after the end of study therapy including oral study therapy (safety follow-up period) Safety was assessed by statistical and/or clinical review of all safety parameters, including adverse experiences (AE), physical examination, vital signs, and laboratory results
General disorders Oedema	0.00% 0/132 • Adverse experiences were recorded during parenteral therapy and for 14 days after the end of study therapy including oral study therapy (safety follow-up period) Safety was assessed by statistical and/or clinical review of all safety parameters, including adverse experiences (AE), physical examination, vital signs, and laboratory results	1.5% 2/135 • Adverse experiences were recorded during parenteral therapy and for 14 days after the end of study therapy including oral study therapy (safety follow-up period) Safety was assessed by statistical and/or clinical review of all safety parameters, including adverse experiences (AE), physical examination, vital signs, and laboratory results
General disorders Oedema peripheral	0.76% 1/132 • Adverse experiences were recorded during parenteral therapy and for 14 days after the end of study therapy including oral study therapy (safety follow-up period) Safety was assessed by statistical and/or clinical review of all safety parameters, including adverse experiences (AE), physical examination, vital signs, and laboratory results	0.74% 1/135 • Adverse experiences were recorded during parenteral therapy and for 14 days after the end of study therapy including oral study therapy (safety follow-up period) Safety was assessed by statistical and/or clinical review of all safety parameters, including adverse experiences (AE), physical examination, vital signs, and laboratory results
General disorders Pain	0.76% 1/132 • Adverse experiences were recorded during parenteral therapy and for 14 days after the end of study therapy including oral study therapy (safety follow-up period) Safety was assessed by statistical and/or clinical review of all safety parameters, including adverse experiences (AE), physical examination, vital signs, and laboratory results	0.74% 1/135 • Adverse experiences were recorded during parenteral therapy and for 14 days after the end of study therapy including oral study therapy (safety follow-up period) Safety was assessed by statistical and/or clinical review of all safety parameters, including adverse experiences (AE), physical examination, vital signs, and laboratory results
General disorders Asthenia	0.76% 1/132 • Adverse experiences were recorded during parenteral therapy and for 14 days after the end of study therapy including oral study therapy (safety follow-up period) Safety was assessed by statistical and/or clinical review of all safety parameters, including adverse experiences (AE), physical examination, vital signs, and laboratory results	0.00% 0/135 • Adverse experiences were recorded during parenteral therapy and for 14 days after the end of study therapy including oral study therapy (safety follow-up period) Safety was assessed by statistical and/or clinical review of all safety parameters, including adverse experiences (AE), physical examination, vital signs, and laboratory results
General disorders Chills	0.76% 1/132 • Adverse experiences were recorded during parenteral therapy and for 14 days after the end of study therapy including oral study therapy (safety follow-up period) Safety was assessed by statistical and/or clinical review of all safety parameters, including adverse experiences (AE), physical examination, vital signs, and laboratory results	0.00% 0/135 • Adverse experiences were recorded during parenteral therapy and for 14 days after the end of study therapy including oral study therapy (safety follow-up period) Safety was assessed by statistical and/or clinical review of all safety parameters, including adverse experiences (AE), physical examination, vital signs, and laboratory results
General disorders Feeling hot	0.76% 1/132 • Adverse experiences were recorded during parenteral therapy and for 14 days after the end of study therapy including oral study therapy (safety follow-up period) Safety was assessed by statistical and/or clinical review of all safety parameters, including adverse experiences (AE), physical examination, vital signs, and laboratory results	0.00% 0/135 • Adverse experiences were recorded during parenteral therapy and for 14 days after the end of study therapy including oral study therapy (safety follow-up period) Safety was assessed by statistical and/or clinical review of all safety parameters, including adverse experiences (AE), physical examination, vital signs, and laboratory results
General disorders Injection site erythema	0.00% 0/132 • Adverse experiences were recorded during parenteral therapy and for 14 days after the end of study therapy including oral study therapy (safety follow-up period) Safety was assessed by statistical and/or clinical review of all safety parameters, including adverse experiences (AE), physical examination, vital signs, and laboratory results	0.74% 1/135 • Adverse experiences were recorded during parenteral therapy and for 14 days after the end of study therapy including oral study therapy (safety follow-up period) Safety was assessed by statistical and/or clinical review of all safety parameters, including adverse experiences (AE), physical examination, vital signs, and laboratory results
General disorders Injection site pain	0.00% 0/132 • Adverse experiences were recorded during parenteral therapy and for 14 days after the end of study therapy including oral study therapy (safety follow-up period) Safety was assessed by statistical and/or clinical review of all safety parameters, including adverse experiences (AE), physical examination, vital signs, and laboratory results	0.74% 1/135 • Adverse experiences were recorded during parenteral therapy and for 14 days after the end of study therapy including oral study therapy (safety follow-up period) Safety was assessed by statistical and/or clinical review of all safety parameters, including adverse experiences (AE), physical examination, vital signs, and laboratory results
General disorders Injection site phlebitis	0.00% 0/132 • Adverse experiences were recorded during parenteral therapy and for 14 days after the end of study therapy including oral study therapy (safety follow-up period) Safety was assessed by statistical and/or clinical review of all safety parameters, including adverse experiences (AE), physical examination, vital signs, and laboratory results	0.74% 1/135 • Adverse experiences were recorded during parenteral therapy and for 14 days after the end of study therapy including oral study therapy (safety follow-up period) Safety was assessed by statistical and/or clinical review of all safety parameters, including adverse experiences (AE), physical examination, vital signs, and laboratory results
General disorders Tenderness	0.00% 0/132 • Adverse experiences were recorded during parenteral therapy and for 14 days after the end of study therapy including oral study therapy (safety follow-up period) Safety was assessed by statistical and/or clinical review of all safety parameters, including adverse experiences (AE), physical examination, vital signs, and laboratory results	0.74% 1/135 • Adverse experiences were recorded during parenteral therapy and for 14 days after the end of study therapy including oral study therapy (safety follow-up period) Safety was assessed by statistical and/or clinical review of all safety parameters, including adverse experiences (AE), physical examination, vital signs, and laboratory results
Infections and infestations Upper respiratory tract infection	1.5% 2/132 • Adverse experiences were recorded during parenteral therapy and for 14 days after the end of study therapy including oral study therapy (safety follow-up period) Safety was assessed by statistical and/or clinical review of all safety parameters, including adverse experiences (AE), physical examination, vital signs, and laboratory results	2.2% 3/135 • Adverse experiences were recorded during parenteral therapy and for 14 days after the end of study therapy including oral study therapy (safety follow-up period) Safety was assessed by statistical and/or clinical review of all safety parameters, including adverse experiences (AE), physical examination, vital signs, and laboratory results
Infections and infestations Herpes simplex	2.3% 3/132 • Adverse experiences were recorded during parenteral therapy and for 14 days after the end of study therapy including oral study therapy (safety follow-up period) Safety was assessed by statistical and/or clinical review of all safety parameters, including adverse experiences (AE), physical examination, vital signs, and laboratory results	0.74% 1/135 • Adverse experiences were recorded during parenteral therapy and for 14 days after the end of study therapy including oral study therapy (safety follow-up period) Safety was assessed by statistical and/or clinical review of all safety parameters, including adverse experiences (AE), physical examination, vital signs, and laboratory results
Infections and infestations Pyelonephritis acute	0.76% 1/132 • Adverse experiences were recorded during parenteral therapy and for 14 days after the end of study therapy including oral study therapy (safety follow-up period) Safety was assessed by statistical and/or clinical review of all safety parameters, including adverse experiences (AE), physical examination, vital signs, and laboratory results	0.00% 0/135 • Adverse experiences were recorded during parenteral therapy and for 14 days after the end of study therapy including oral study therapy (safety follow-up period) Safety was assessed by statistical and/or clinical review of all safety parameters, including adverse experiences (AE), physical examination, vital signs, and laboratory results
Infections and infestations Nasopharyngitis	0.76% 1/132 • Adverse experiences were recorded during parenteral therapy and for 14 days after the end of study therapy including oral study therapy (safety follow-up period) Safety was assessed by statistical and/or clinical review of all safety parameters, including adverse experiences (AE), physical examination, vital signs, and laboratory results	0.74% 1/135 • Adverse experiences were recorded during parenteral therapy and for 14 days after the end of study therapy including oral study therapy (safety follow-up period) Safety was assessed by statistical and/or clinical review of all safety parameters, including adverse experiences (AE), physical examination, vital signs, and laboratory results
Infections and infestations Tuberculosis	0.00% 0/132 • Adverse experiences were recorded during parenteral therapy and for 14 days after the end of study therapy including oral study therapy (safety follow-up period) Safety was assessed by statistical and/or clinical review of all safety parameters, including adverse experiences (AE), physical examination, vital signs, and laboratory results	0.74% 1/135 • Adverse experiences were recorded during parenteral therapy and for 14 days after the end of study therapy including oral study therapy (safety follow-up period) Safety was assessed by statistical and/or clinical review of all safety parameters, including adverse experiences (AE), physical examination, vital signs, and laboratory results
Infections and infestations Actinomycosis	0.76% 1/132 • Adverse experiences were recorded during parenteral therapy and for 14 days after the end of study therapy including oral study therapy (safety follow-up period) Safety was assessed by statistical and/or clinical review of all safety parameters, including adverse experiences (AE), physical examination, vital signs, and laboratory results	0.00% 0/135 • Adverse experiences were recorded during parenteral therapy and for 14 days after the end of study therapy including oral study therapy (safety follow-up period) Safety was assessed by statistical and/or clinical review of all safety parameters, including adverse experiences (AE), physical examination, vital signs, and laboratory results
Infections and infestations Herpes zoster	0.00% 0/132 • Adverse experiences were recorded during parenteral therapy and for 14 days after the end of study therapy including oral study therapy (safety follow-up period) Safety was assessed by statistical and/or clinical review of all safety parameters, including adverse experiences (AE), physical examination, vital signs, and laboratory results	0.74% 1/135 • Adverse experiences were recorded during parenteral therapy and for 14 days after the end of study therapy including oral study therapy (safety follow-up period) Safety was assessed by statistical and/or clinical review of all safety parameters, including adverse experiences (AE), physical examination, vital signs, and laboratory results
Infections and infestations Liver abscess	0.00% 0/132 • Adverse experiences were recorded during parenteral therapy and for 14 days after the end of study therapy including oral study therapy (safety follow-up period) Safety was assessed by statistical and/or clinical review of all safety parameters, including adverse experiences (AE), physical examination, vital signs, and laboratory results	0.74% 1/135 • Adverse experiences were recorded during parenteral therapy and for 14 days after the end of study therapy including oral study therapy (safety follow-up period) Safety was assessed by statistical and/or clinical review of all safety parameters, including adverse experiences (AE), physical examination, vital signs, and laboratory results
Infections and infestations Oral candidiasis	0.00% 0/132 • Adverse experiences were recorded during parenteral therapy and for 14 days after the end of study therapy including oral study therapy (safety follow-up period) Safety was assessed by statistical and/or clinical review of all safety parameters, including adverse experiences (AE), physical examination, vital signs, and laboratory results	0.74% 1/135 • Adverse experiences were recorded during parenteral therapy and for 14 days after the end of study therapy including oral study therapy (safety follow-up period) Safety was assessed by statistical and/or clinical review of all safety parameters, including adverse experiences (AE), physical examination, vital signs, and laboratory results
Infections and infestations Pelvic inflammatory disease	0.76% 1/132 • Adverse experiences were recorded during parenteral therapy and for 14 days after the end of study therapy including oral study therapy (safety follow-up period) Safety was assessed by statistical and/or clinical review of all safety parameters, including adverse experiences (AE), physical examination, vital signs, and laboratory results	0.00% 0/135 • Adverse experiences were recorded during parenteral therapy and for 14 days after the end of study therapy including oral study therapy (safety follow-up period) Safety was assessed by statistical and/or clinical review of all safety parameters, including adverse experiences (AE), physical examination, vital signs, and laboratory results
Infections and infestations Pyelonephritis	0.76% 1/132 • Adverse experiences were recorded during parenteral therapy and for 14 days after the end of study therapy including oral study therapy (safety follow-up period) Safety was assessed by statistical and/or clinical review of all safety parameters, including adverse experiences (AE), physical examination, vital signs, and laboratory results	0.00% 0/135 • Adverse experiences were recorded during parenteral therapy and for 14 days after the end of study therapy including oral study therapy (safety follow-up period) Safety was assessed by statistical and/or clinical review of all safety parameters, including adverse experiences (AE), physical examination, vital signs, and laboratory results
Infections and infestations Tinea cruris	0.00% 0/132 • Adverse experiences were recorded during parenteral therapy and for 14 days after the end of study therapy including oral study therapy (safety follow-up period) Safety was assessed by statistical and/or clinical review of all safety parameters, including adverse experiences (AE), physical examination, vital signs, and laboratory results	0.74% 1/135 • Adverse experiences were recorded during parenteral therapy and for 14 days after the end of study therapy including oral study therapy (safety follow-up period) Safety was assessed by statistical and/or clinical review of all safety parameters, including adverse experiences (AE), physical examination, vital signs, and laboratory results
Infections and infestations Urogenital trichomoniasis	0.76% 1/132 • Adverse experiences were recorded during parenteral therapy and for 14 days after the end of study therapy including oral study therapy (safety follow-up period) Safety was assessed by statistical and/or clinical review of all safety parameters, including adverse experiences (AE), physical examination, vital signs, and laboratory results	0.00% 0/135 • Adverse experiences were recorded during parenteral therapy and for 14 days after the end of study therapy including oral study therapy (safety follow-up period) Safety was assessed by statistical and/or clinical review of all safety parameters, including adverse experiences (AE), physical examination, vital signs, and laboratory results
Psychiatric disorders Insomnia	7.6% 10/132 • Adverse experiences were recorded during parenteral therapy and for 14 days after the end of study therapy including oral study therapy (safety follow-up period) Safety was assessed by statistical and/or clinical review of all safety parameters, including adverse experiences (AE), physical examination, vital signs, and laboratory results	5.9% 8/135 • Adverse experiences were recorded during parenteral therapy and for 14 days after the end of study therapy including oral study therapy (safety follow-up period) Safety was assessed by statistical and/or clinical review of all safety parameters, including adverse experiences (AE), physical examination, vital signs, and laboratory results
Psychiatric disorders Anxiety	0.00% 0/132 • Adverse experiences were recorded during parenteral therapy and for 14 days after the end of study therapy including oral study therapy (safety follow-up period) Safety was assessed by statistical and/or clinical review of all safety parameters, including adverse experiences (AE), physical examination, vital signs, and laboratory results	0.74% 1/135 • Adverse experiences were recorded during parenteral therapy and for 14 days after the end of study therapy including oral study therapy (safety follow-up period) Safety was assessed by statistical and/or clinical review of all safety parameters, including adverse experiences (AE), physical examination, vital signs, and laboratory results
Psychiatric disorders Confusional state	0.76% 1/132 • Adverse experiences were recorded during parenteral therapy and for 14 days after the end of study therapy including oral study therapy (safety follow-up period) Safety was assessed by statistical and/or clinical review of all safety parameters, including adverse experiences (AE), physical examination, vital signs, and laboratory results	0.00% 0/135 • Adverse experiences were recorded during parenteral therapy and for 14 days after the end of study therapy including oral study therapy (safety follow-up period) Safety was assessed by statistical and/or clinical review of all safety parameters, including adverse experiences (AE), physical examination, vital signs, and laboratory results
Psychiatric disorders Delirium	0.76% 1/132 • Adverse experiences were recorded during parenteral therapy and for 14 days after the end of study therapy including oral study therapy (safety follow-up period) Safety was assessed by statistical and/or clinical review of all safety parameters, including adverse experiences (AE), physical examination, vital signs, and laboratory results	0.00% 0/135 • Adverse experiences were recorded during parenteral therapy and for 14 days after the end of study therapy including oral study therapy (safety follow-up period) Safety was assessed by statistical and/or clinical review of all safety parameters, including adverse experiences (AE), physical examination, vital signs, and laboratory results
Psychiatric disorders Major depression	0.00% 0/132 • Adverse experiences were recorded during parenteral therapy and for 14 days after the end of study therapy including oral study therapy (safety follow-up period) Safety was assessed by statistical and/or clinical review of all safety parameters, including adverse experiences (AE), physical examination, vital signs, and laboratory results	0.74% 1/135 • Adverse experiences were recorded during parenteral therapy and for 14 days after the end of study therapy including oral study therapy (safety follow-up period) Safety was assessed by statistical and/or clinical review of all safety parameters, including adverse experiences (AE), physical examination, vital signs, and laboratory results
Psychiatric disorders Psychotic disorder	0.00% 0/132 • Adverse experiences were recorded during parenteral therapy and for 14 days after the end of study therapy including oral study therapy (safety follow-up period) Safety was assessed by statistical and/or clinical review of all safety parameters, including adverse experiences (AE), physical examination, vital signs, and laboratory results	0.74% 1/135 • Adverse experiences were recorded during parenteral therapy and for 14 days after the end of study therapy including oral study therapy (safety follow-up period) Safety was assessed by statistical and/or clinical review of all safety parameters, including adverse experiences (AE), physical examination, vital signs, and laboratory results
Skin and subcutaneous tissue disorders Pruritus	1.5% 2/132 • Adverse experiences were recorded during parenteral therapy and for 14 days after the end of study therapy including oral study therapy (safety follow-up period) Safety was assessed by statistical and/or clinical review of all safety parameters, including adverse experiences (AE), physical examination, vital signs, and laboratory results	2.2% 3/135 • Adverse experiences were recorded during parenteral therapy and for 14 days after the end of study therapy including oral study therapy (safety follow-up period) Safety was assessed by statistical and/or clinical review of all safety parameters, including adverse experiences (AE), physical examination, vital signs, and laboratory results
Skin and subcutaneous tissue disorders Cold sweat	1.5% 2/132 • Adverse experiences were recorded during parenteral therapy and for 14 days after the end of study therapy including oral study therapy (safety follow-up period) Safety was assessed by statistical and/or clinical review of all safety parameters, including adverse experiences (AE), physical examination, vital signs, and laboratory results	0.74% 1/135 • Adverse experiences were recorded during parenteral therapy and for 14 days after the end of study therapy including oral study therapy (safety follow-up period) Safety was assessed by statistical and/or clinical review of all safety parameters, including adverse experiences (AE), physical examination, vital signs, and laboratory results
Skin and subcutaneous tissue disorders Erythema	0.00% 0/132 • Adverse experiences were recorded during parenteral therapy and for 14 days after the end of study therapy including oral study therapy (safety follow-up period) Safety was assessed by statistical and/or clinical review of all safety parameters, including adverse experiences (AE), physical examination, vital signs, and laboratory results	2.2% 3/135 • Adverse experiences were recorded during parenteral therapy and for 14 days after the end of study therapy including oral study therapy (safety follow-up period) Safety was assessed by statistical and/or clinical review of all safety parameters, including adverse experiences (AE), physical examination, vital signs, and laboratory results
Skin and subcutaneous tissue disorders Rash	0.76% 1/132 • Adverse experiences were recorded during parenteral therapy and for 14 days after the end of study therapy including oral study therapy (safety follow-up period) Safety was assessed by statistical and/or clinical review of all safety parameters, including adverse experiences (AE), physical examination, vital signs, and laboratory results	1.5% 2/135 • Adverse experiences were recorded during parenteral therapy and for 14 days after the end of study therapy including oral study therapy (safety follow-up period) Safety was assessed by statistical and/or clinical review of all safety parameters, including adverse experiences (AE), physical examination, vital signs, and laboratory results
Skin and subcutaneous tissue disorders Blister	0.00% 0/132 • Adverse experiences were recorded during parenteral therapy and for 14 days after the end of study therapy including oral study therapy (safety follow-up period) Safety was assessed by statistical and/or clinical review of all safety parameters, including adverse experiences (AE), physical examination, vital signs, and laboratory results	1.5% 2/135 • Adverse experiences were recorded during parenteral therapy and for 14 days after the end of study therapy including oral study therapy (safety follow-up period) Safety was assessed by statistical and/or clinical review of all safety parameters, including adverse experiences (AE), physical examination, vital signs, and laboratory results
Skin and subcutaneous tissue disorders Pruritus generalised	0.76% 1/132 • Adverse experiences were recorded during parenteral therapy and for 14 days after the end of study therapy including oral study therapy (safety follow-up period) Safety was assessed by statistical and/or clinical review of all safety parameters, including adverse experiences (AE), physical examination, vital signs, and laboratory results	0.74% 1/135 • Adverse experiences were recorded during parenteral therapy and for 14 days after the end of study therapy including oral study therapy (safety follow-up period) Safety was assessed by statistical and/or clinical review of all safety parameters, including adverse experiences (AE), physical examination, vital signs, and laboratory results
Skin and subcutaneous tissue disorders Rash generalised	0.76% 1/132 • Adverse experiences were recorded during parenteral therapy and for 14 days after the end of study therapy including oral study therapy (safety follow-up period) Safety was assessed by statistical and/or clinical review of all safety parameters, including adverse experiences (AE), physical examination, vital signs, and laboratory results	0.74% 1/135 • Adverse experiences were recorded during parenteral therapy and for 14 days after the end of study therapy including oral study therapy (safety follow-up period) Safety was assessed by statistical and/or clinical review of all safety parameters, including adverse experiences (AE), physical examination, vital signs, and laboratory results
Skin and subcutaneous tissue disorders Ecchymosis	0.76% 1/132 • Adverse experiences were recorded during parenteral therapy and for 14 days after the end of study therapy including oral study therapy (safety follow-up period) Safety was assessed by statistical and/or clinical review of all safety parameters, including adverse experiences (AE), physical examination, vital signs, and laboratory results	0.00% 0/135 • Adverse experiences were recorded during parenteral therapy and for 14 days after the end of study therapy including oral study therapy (safety follow-up period) Safety was assessed by statistical and/or clinical review of all safety parameters, including adverse experiences (AE), physical examination, vital signs, and laboratory results
Skin and subcutaneous tissue disorders Eczema	0.76% 1/132 • Adverse experiences were recorded during parenteral therapy and for 14 days after the end of study therapy including oral study therapy (safety follow-up period) Safety was assessed by statistical and/or clinical review of all safety parameters, including adverse experiences (AE), physical examination, vital signs, and laboratory results	0.00% 0/135 • Adverse experiences were recorded during parenteral therapy and for 14 days after the end of study therapy including oral study therapy (safety follow-up period) Safety was assessed by statistical and/or clinical review of all safety parameters, including adverse experiences (AE), physical examination, vital signs, and laboratory results
Skin and subcutaneous tissue disorders Swelling face	0.76% 1/132 • Adverse experiences were recorded during parenteral therapy and for 14 days after the end of study therapy including oral study therapy (safety follow-up period) Safety was assessed by statistical and/or clinical review of all safety parameters, including adverse experiences (AE), physical examination, vital signs, and laboratory results	0.00% 0/135 • Adverse experiences were recorded during parenteral therapy and for 14 days after the end of study therapy including oral study therapy (safety follow-up period) Safety was assessed by statistical and/or clinical review of all safety parameters, including adverse experiences (AE), physical examination, vital signs, and laboratory results
Investigations Blood pressure	0.00% 0/132 • Adverse experiences were recorded during parenteral therapy and for 14 days after the end of study therapy including oral study therapy (safety follow-up period) Safety was assessed by statistical and/or clinical review of all safety parameters, including adverse experiences (AE), physical examination, vital signs, and laboratory results	0.74% 1/135 • Adverse experiences were recorded during parenteral therapy and for 14 days after the end of study therapy including oral study therapy (safety follow-up period) Safety was assessed by statistical and/or clinical review of all safety parameters, including adverse experiences (AE), physical examination, vital signs, and laboratory results
Metabolism and nutrition disorders Anorexia	1.5% 2/132 • Adverse experiences were recorded during parenteral therapy and for 14 days after the end of study therapy including oral study therapy (safety follow-up period) Safety was assessed by statistical and/or clinical review of all safety parameters, including adverse experiences (AE), physical examination, vital signs, and laboratory results	0.74% 1/135 • Adverse experiences were recorded during parenteral therapy and for 14 days after the end of study therapy including oral study therapy (safety follow-up period) Safety was assessed by statistical and/or clinical review of all safety parameters, including adverse experiences (AE), physical examination, vital signs, and laboratory results
Metabolism and nutrition disorders Diabetes mellitus	1.5% 2/132 • Adverse experiences were recorded during parenteral therapy and for 14 days after the end of study therapy including oral study therapy (safety follow-up period) Safety was assessed by statistical and/or clinical review of all safety parameters, including adverse experiences (AE), physical examination, vital signs, and laboratory results	0.00% 0/135 • Adverse experiences were recorded during parenteral therapy and for 14 days after the end of study therapy including oral study therapy (safety follow-up period) Safety was assessed by statistical and/or clinical review of all safety parameters, including adverse experiences (AE), physical examination, vital signs, and laboratory results
Metabolism and nutrition disorders Acidosis	0.00% 0/132 • Adverse experiences were recorded during parenteral therapy and for 14 days after the end of study therapy including oral study therapy (safety follow-up period) Safety was assessed by statistical and/or clinical review of all safety parameters, including adverse experiences (AE), physical examination, vital signs, and laboratory results	0.74% 1/135 • Adverse experiences were recorded during parenteral therapy and for 14 days after the end of study therapy including oral study therapy (safety follow-up period) Safety was assessed by statistical and/or clinical review of all safety parameters, including adverse experiences (AE), physical examination, vital signs, and laboratory results
Metabolism and nutrition disorders Metabolic alkalosis	0.76% 1/132 • Adverse experiences were recorded during parenteral therapy and for 14 days after the end of study therapy including oral study therapy (safety follow-up period) Safety was assessed by statistical and/or clinical review of all safety parameters, including adverse experiences (AE), physical examination, vital signs, and laboratory results	0.00% 0/135 • Adverse experiences were recorded during parenteral therapy and for 14 days after the end of study therapy including oral study therapy (safety follow-up period) Safety was assessed by statistical and/or clinical review of all safety parameters, including adverse experiences (AE), physical examination, vital signs, and laboratory results
Musculoskeletal and connective tissue disorders Neck pain	0.00% 0/132 • Adverse experiences were recorded during parenteral therapy and for 14 days after the end of study therapy including oral study therapy (safety follow-up period) Safety was assessed by statistical and/or clinical review of all safety parameters, including adverse experiences (AE), physical examination, vital signs, and laboratory results	2.2% 3/135 • Adverse experiences were recorded during parenteral therapy and for 14 days after the end of study therapy including oral study therapy (safety follow-up period) Safety was assessed by statistical and/or clinical review of all safety parameters, including adverse experiences (AE), physical examination, vital signs, and laboratory results
Musculoskeletal and connective tissue disorders Back pain	0.76% 1/132 • Adverse experiences were recorded during parenteral therapy and for 14 days after the end of study therapy including oral study therapy (safety follow-up period) Safety was assessed by statistical and/or clinical review of all safety parameters, including adverse experiences (AE), physical examination, vital signs, and laboratory results	0.74% 1/135 • Adverse experiences were recorded during parenteral therapy and for 14 days after the end of study therapy including oral study therapy (safety follow-up period) Safety was assessed by statistical and/or clinical review of all safety parameters, including adverse experiences (AE), physical examination, vital signs, and laboratory results
Musculoskeletal and connective tissue disorders Musculoskeletal pain	0.00% 0/132 • Adverse experiences were recorded during parenteral therapy and for 14 days after the end of study therapy including oral study therapy (safety follow-up period) Safety was assessed by statistical and/or clinical review of all safety parameters, including adverse experiences (AE), physical examination, vital signs, and laboratory results	1.5% 2/135 • Adverse experiences were recorded during parenteral therapy and for 14 days after the end of study therapy including oral study therapy (safety follow-up period) Safety was assessed by statistical and/or clinical review of all safety parameters, including adverse experiences (AE), physical examination, vital signs, and laboratory results
Musculoskeletal and connective tissue disorders Osteoporosis	0.76% 1/132 • Adverse experiences were recorded during parenteral therapy and for 14 days after the end of study therapy including oral study therapy (safety follow-up period) Safety was assessed by statistical and/or clinical review of all safety parameters, including adverse experiences (AE), physical examination, vital signs, and laboratory results	0.74% 1/135 • Adverse experiences were recorded during parenteral therapy and for 14 days after the end of study therapy including oral study therapy (safety follow-up period) Safety was assessed by statistical and/or clinical review of all safety parameters, including adverse experiences (AE), physical examination, vital signs, and laboratory results
Musculoskeletal and connective tissue disorders Arthralgia	0.76% 1/132 • Adverse experiences were recorded during parenteral therapy and for 14 days after the end of study therapy including oral study therapy (safety follow-up period) Safety was assessed by statistical and/or clinical review of all safety parameters, including adverse experiences (AE), physical examination, vital signs, and laboratory results	0.00% 0/135 • Adverse experiences were recorded during parenteral therapy and for 14 days after the end of study therapy including oral study therapy (safety follow-up period) Safety was assessed by statistical and/or clinical review of all safety parameters, including adverse experiences (AE), physical examination, vital signs, and laboratory results
Musculoskeletal and connective tissue disorders Muscular weakness	0.00% 0/132 • Adverse experiences were recorded during parenteral therapy and for 14 days after the end of study therapy including oral study therapy (safety follow-up period) Safety was assessed by statistical and/or clinical review of all safety parameters, including adverse experiences (AE), physical examination, vital signs, and laboratory results	0.74% 1/135 • Adverse experiences were recorded during parenteral therapy and for 14 days after the end of study therapy including oral study therapy (safety follow-up period) Safety was assessed by statistical and/or clinical review of all safety parameters, including adverse experiences (AE), physical examination, vital signs, and laboratory results
Musculoskeletal and connective tissue disorders Musculoskeletal chest pain	0.00% 0/132 • Adverse experiences were recorded during parenteral therapy and for 14 days after the end of study therapy including oral study therapy (safety follow-up period) Safety was assessed by statistical and/or clinical review of all safety parameters, including adverse experiences (AE), physical examination, vital signs, and laboratory results	0.74% 1/135 • Adverse experiences were recorded during parenteral therapy and for 14 days after the end of study therapy including oral study therapy (safety follow-up period) Safety was assessed by statistical and/or clinical review of all safety parameters, including adverse experiences (AE), physical examination, vital signs, and laboratory results
Musculoskeletal and connective tissue disorders Musculoskeletal discomfort	0.00% 0/132 • Adverse experiences were recorded during parenteral therapy and for 14 days after the end of study therapy including oral study therapy (safety follow-up period) Safety was assessed by statistical and/or clinical review of all safety parameters, including adverse experiences (AE), physical examination, vital signs, and laboratory results	0.74% 1/135 • Adverse experiences were recorded during parenteral therapy and for 14 days after the end of study therapy including oral study therapy (safety follow-up period) Safety was assessed by statistical and/or clinical review of all safety parameters, including adverse experiences (AE), physical examination, vital signs, and laboratory results
Musculoskeletal and connective tissue disorders Myofascial pain syndrome	0.00% 0/132 • Adverse experiences were recorded during parenteral therapy and for 14 days after the end of study therapy including oral study therapy (safety follow-up period) Safety was assessed by statistical and/or clinical review of all safety parameters, including adverse experiences (AE), physical examination, vital signs, and laboratory results	0.74% 1/135 • Adverse experiences were recorded during parenteral therapy and for 14 days after the end of study therapy including oral study therapy (safety follow-up period) Safety was assessed by statistical and/or clinical review of all safety parameters, including adverse experiences (AE), physical examination, vital signs, and laboratory results
Vascular disorders Hypotension	0.76% 1/132 • Adverse experiences were recorded during parenteral therapy and for 14 days after the end of study therapy including oral study therapy (safety follow-up period) Safety was assessed by statistical and/or clinical review of all safety parameters, including adverse experiences (AE), physical examination, vital signs, and laboratory results	1.5% 2/135 • Adverse experiences were recorded during parenteral therapy and for 14 days after the end of study therapy including oral study therapy (safety follow-up period) Safety was assessed by statistical and/or clinical review of all safety parameters, including adverse experiences (AE), physical examination, vital signs, and laboratory results
Vascular disorders Hypertension	0.76% 1/132 • Adverse experiences were recorded during parenteral therapy and for 14 days after the end of study therapy including oral study therapy (safety follow-up period) Safety was assessed by statistical and/or clinical review of all safety parameters, including adverse experiences (AE), physical examination, vital signs, and laboratory results	2.2% 3/135 • Adverse experiences were recorded during parenteral therapy and for 14 days after the end of study therapy including oral study therapy (safety follow-up period) Safety was assessed by statistical and/or clinical review of all safety parameters, including adverse experiences (AE), physical examination, vital signs, and laboratory results
Vascular disorders Phlebitis	0.76% 1/132 • Adverse experiences were recorded during parenteral therapy and for 14 days after the end of study therapy including oral study therapy (safety follow-up period) Safety was assessed by statistical and/or clinical review of all safety parameters, including adverse experiences (AE), physical examination, vital signs, and laboratory results	0.74% 1/135 • Adverse experiences were recorded during parenteral therapy and for 14 days after the end of study therapy including oral study therapy (safety follow-up period) Safety was assessed by statistical and/or clinical review of all safety parameters, including adverse experiences (AE), physical examination, vital signs, and laboratory results
Vascular disorders Aortic dissection	0.76% 1/132 • Adverse experiences were recorded during parenteral therapy and for 14 days after the end of study therapy including oral study therapy (safety follow-up period) Safety was assessed by statistical and/or clinical review of all safety parameters, including adverse experiences (AE), physical examination, vital signs, and laboratory results	0.00% 0/135 • Adverse experiences were recorded during parenteral therapy and for 14 days after the end of study therapy including oral study therapy (safety follow-up period) Safety was assessed by statistical and/or clinical review of all safety parameters, including adverse experiences (AE), physical examination, vital signs, and laboratory results
Vascular disorders Flushing	0.76% 1/132 • Adverse experiences were recorded during parenteral therapy and for 14 days after the end of study therapy including oral study therapy (safety follow-up period) Safety was assessed by statistical and/or clinical review of all safety parameters, including adverse experiences (AE), physical examination, vital signs, and laboratory results	0.00% 0/135 • Adverse experiences were recorded during parenteral therapy and for 14 days after the end of study therapy including oral study therapy (safety follow-up period) Safety was assessed by statistical and/or clinical review of all safety parameters, including adverse experiences (AE), physical examination, vital signs, and laboratory results
Renal and urinary disorders Hydronephrosis	0.76% 1/132 • Adverse experiences were recorded during parenteral therapy and for 14 days after the end of study therapy including oral study therapy (safety follow-up period) Safety was assessed by statistical and/or clinical review of all safety parameters, including adverse experiences (AE), physical examination, vital signs, and laboratory results	0.00% 0/135 • Adverse experiences were recorded during parenteral therapy and for 14 days after the end of study therapy including oral study therapy (safety follow-up period) Safety was assessed by statistical and/or clinical review of all safety parameters, including adverse experiences (AE), physical examination, vital signs, and laboratory results
Renal and urinary disorders Renal cyst	0.76% 1/132 • Adverse experiences were recorded during parenteral therapy and for 14 days after the end of study therapy including oral study therapy (safety follow-up period) Safety was assessed by statistical and/or clinical review of all safety parameters, including adverse experiences (AE), physical examination, vital signs, and laboratory results	0.74% 1/135 • Adverse experiences were recorded during parenteral therapy and for 14 days after the end of study therapy including oral study therapy (safety follow-up period) Safety was assessed by statistical and/or clinical review of all safety parameters, including adverse experiences (AE), physical examination, vital signs, and laboratory results
Renal and urinary disorders Calculus urinary	0.76% 1/132 • Adverse experiences were recorded during parenteral therapy and for 14 days after the end of study therapy including oral study therapy (safety follow-up period) Safety was assessed by statistical and/or clinical review of all safety parameters, including adverse experiences (AE), physical examination, vital signs, and laboratory results	0.00% 0/135 • Adverse experiences were recorded during parenteral therapy and for 14 days after the end of study therapy including oral study therapy (safety follow-up period) Safety was assessed by statistical and/or clinical review of all safety parameters, including adverse experiences (AE), physical examination, vital signs, and laboratory results
Renal and urinary disorders Hydroureter	0.76% 1/132 • Adverse experiences were recorded during parenteral therapy and for 14 days after the end of study therapy including oral study therapy (safety follow-up period) Safety was assessed by statistical and/or clinical review of all safety parameters, including adverse experiences (AE), physical examination, vital signs, and laboratory results	0.00% 0/135 • Adverse experiences were recorded during parenteral therapy and for 14 days after the end of study therapy including oral study therapy (safety follow-up period) Safety was assessed by statistical and/or clinical review of all safety parameters, including adverse experiences (AE), physical examination, vital signs, and laboratory results
Renal and urinary disorders Nephrolithiasis	0.76% 1/132 • Adverse experiences were recorded during parenteral therapy and for 14 days after the end of study therapy including oral study therapy (safety follow-up period) Safety was assessed by statistical and/or clinical review of all safety parameters, including adverse experiences (AE), physical examination, vital signs, and laboratory results	0.00% 0/135 • Adverse experiences were recorded during parenteral therapy and for 14 days after the end of study therapy including oral study therapy (safety follow-up period) Safety was assessed by statistical and/or clinical review of all safety parameters, including adverse experiences (AE), physical examination, vital signs, and laboratory results
Renal and urinary disorders Nocturia	0.76% 1/132 • Adverse experiences were recorded during parenteral therapy and for 14 days after the end of study therapy including oral study therapy (safety follow-up period) Safety was assessed by statistical and/or clinical review of all safety parameters, including adverse experiences (AE), physical examination, vital signs, and laboratory results	0.00% 0/135 • Adverse experiences were recorded during parenteral therapy and for 14 days after the end of study therapy including oral study therapy (safety follow-up period) Safety was assessed by statistical and/or clinical review of all safety parameters, including adverse experiences (AE), physical examination, vital signs, and laboratory results
Renal and urinary disorders Urethral pain	0.00% 0/132 • Adverse experiences were recorded during parenteral therapy and for 14 days after the end of study therapy including oral study therapy (safety follow-up period) Safety was assessed by statistical and/or clinical review of all safety parameters, including adverse experiences (AE), physical examination, vital signs, and laboratory results	0.74% 1/135 • Adverse experiences were recorded during parenteral therapy and for 14 days after the end of study therapy including oral study therapy (safety follow-up period) Safety was assessed by statistical and/or clinical review of all safety parameters, including adverse experiences (AE), physical examination, vital signs, and laboratory results
Hepatobiliary disorders Cholelithiasis	0.00% 0/132 • Adverse experiences were recorded during parenteral therapy and for 14 days after the end of study therapy including oral study therapy (safety follow-up period) Safety was assessed by statistical and/or clinical review of all safety parameters, including adverse experiences (AE), physical examination, vital signs, and laboratory results	1.5% 2/135 • Adverse experiences were recorded during parenteral therapy and for 14 days after the end of study therapy including oral study therapy (safety follow-up period) Safety was assessed by statistical and/or clinical review of all safety parameters, including adverse experiences (AE), physical examination, vital signs, and laboratory results
Hepatobiliary disorders Gallbladder polyp	0.76% 1/132 • Adverse experiences were recorded during parenteral therapy and for 14 days after the end of study therapy including oral study therapy (safety follow-up period) Safety was assessed by statistical and/or clinical review of all safety parameters, including adverse experiences (AE), physical examination, vital signs, and laboratory results	0.74% 1/135 • Adverse experiences were recorded during parenteral therapy and for 14 days after the end of study therapy including oral study therapy (safety follow-up period) Safety was assessed by statistical and/or clinical review of all safety parameters, including adverse experiences (AE), physical examination, vital signs, and laboratory results
Hepatobiliary disorders Hepatic cyst	0.76% 1/132 • Adverse experiences were recorded during parenteral therapy and for 14 days after the end of study therapy including oral study therapy (safety follow-up period) Safety was assessed by statistical and/or clinical review of all safety parameters, including adverse experiences (AE), physical examination, vital signs, and laboratory results	0.74% 1/135 • Adverse experiences were recorded during parenteral therapy and for 14 days after the end of study therapy including oral study therapy (safety follow-up period) Safety was assessed by statistical and/or clinical review of all safety parameters, including adverse experiences (AE), physical examination, vital signs, and laboratory results
Hepatobiliary disorders Hepatic steatosis	0.00% 0/132 • Adverse experiences were recorded during parenteral therapy and for 14 days after the end of study therapy including oral study therapy (safety follow-up period) Safety was assessed by statistical and/or clinical review of all safety parameters, including adverse experiences (AE), physical examination, vital signs, and laboratory results	0.74% 1/135 • Adverse experiences were recorded during parenteral therapy and for 14 days after the end of study therapy including oral study therapy (safety follow-up period) Safety was assessed by statistical and/or clinical review of all safety parameters, including adverse experiences (AE), physical examination, vital signs, and laboratory results
Blood and lymphatic system disorders Neutropenia	0.00% 0/132 • Adverse experiences were recorded during parenteral therapy and for 14 days after the end of study therapy including oral study therapy (safety follow-up period) Safety was assessed by statistical and/or clinical review of all safety parameters, including adverse experiences (AE), physical examination, vital signs, and laboratory results	0.74% 1/135 • Adverse experiences were recorded during parenteral therapy and for 14 days after the end of study therapy including oral study therapy (safety follow-up period) Safety was assessed by statistical and/or clinical review of all safety parameters, including adverse experiences (AE), physical examination, vital signs, and laboratory results
Blood and lymphatic system disorders Anaemia	0.76% 1/132 • Adverse experiences were recorded during parenteral therapy and for 14 days after the end of study therapy including oral study therapy (safety follow-up period) Safety was assessed by statistical and/or clinical review of all safety parameters, including adverse experiences (AE), physical examination, vital signs, and laboratory results	0.00% 0/135 • Adverse experiences were recorded during parenteral therapy and for 14 days after the end of study therapy including oral study therapy (safety follow-up period) Safety was assessed by statistical and/or clinical review of all safety parameters, including adverse experiences (AE), physical examination, vital signs, and laboratory results
Blood and lymphatic system disorders Iron deficiency anaemia	0.76% 1/132 • Adverse experiences were recorded during parenteral therapy and for 14 days after the end of study therapy including oral study therapy (safety follow-up period) Safety was assessed by statistical and/or clinical review of all safety parameters, including adverse experiences (AE), physical examination, vital signs, and laboratory results	0.00% 0/135 • Adverse experiences were recorded during parenteral therapy and for 14 days after the end of study therapy including oral study therapy (safety follow-up period) Safety was assessed by statistical and/or clinical review of all safety parameters, including adverse experiences (AE), physical examination, vital signs, and laboratory results
Cardiac disorders Mitral valve incompetence	0.00% 0/132 • Adverse experiences were recorded during parenteral therapy and for 14 days after the end of study therapy including oral study therapy (safety follow-up period) Safety was assessed by statistical and/or clinical review of all safety parameters, including adverse experiences (AE), physical examination, vital signs, and laboratory results	0.74% 1/135 • Adverse experiences were recorded during parenteral therapy and for 14 days after the end of study therapy including oral study therapy (safety follow-up period) Safety was assessed by statistical and/or clinical review of all safety parameters, including adverse experiences (AE), physical examination, vital signs, and laboratory results
Cardiac disorders Tachyarrhythmia	0.00% 0/132 • Adverse experiences were recorded during parenteral therapy and for 14 days after the end of study therapy including oral study therapy (safety follow-up period) Safety was assessed by statistical and/or clinical review of all safety parameters, including adverse experiences (AE), physical examination, vital signs, and laboratory results	0.74% 1/135 • Adverse experiences were recorded during parenteral therapy and for 14 days after the end of study therapy including oral study therapy (safety follow-up period) Safety was assessed by statistical and/or clinical review of all safety parameters, including adverse experiences (AE), physical examination, vital signs, and laboratory results
Cardiac disorders Tricuspid valve incompetence	0.00% 0/132 • Adverse experiences were recorded during parenteral therapy and for 14 days after the end of study therapy including oral study therapy (safety follow-up period) Safety was assessed by statistical and/or clinical review of all safety parameters, including adverse experiences (AE), physical examination, vital signs, and laboratory results	0.74% 1/135 • Adverse experiences were recorded during parenteral therapy and for 14 days after the end of study therapy including oral study therapy (safety follow-up period) Safety was assessed by statistical and/or clinical review of all safety parameters, including adverse experiences (AE), physical examination, vital signs, and laboratory results
Injury, poisoning and procedural complications Excoriation	2.3% 3/132 • Adverse experiences were recorded during parenteral therapy and for 14 days after the end of study therapy including oral study therapy (safety follow-up period) Safety was assessed by statistical and/or clinical review of all safety parameters, including adverse experiences (AE), physical examination, vital signs, and laboratory results	0.00% 0/135 • Adverse experiences were recorded during parenteral therapy and for 14 days after the end of study therapy including oral study therapy (safety follow-up period) Safety was assessed by statistical and/or clinical review of all safety parameters, including adverse experiences (AE), physical examination, vital signs, and laboratory results
Reproductive system and breast disorders Adnexa uteri cyst	0.00% 0/132 • Adverse experiences were recorded during parenteral therapy and for 14 days after the end of study therapy including oral study therapy (safety follow-up period) Safety was assessed by statistical and/or clinical review of all safety parameters, including adverse experiences (AE), physical examination, vital signs, and laboratory results	0.74% 1/135 • Adverse experiences were recorded during parenteral therapy and for 14 days after the end of study therapy including oral study therapy (safety follow-up period) Safety was assessed by statistical and/or clinical review of all safety parameters, including adverse experiences (AE), physical examination, vital signs, and laboratory results
Reproductive system and breast disorders Atrophic vulvovaginitis	0.00% 0/132 • Adverse experiences were recorded during parenteral therapy and for 14 days after the end of study therapy including oral study therapy (safety follow-up period) Safety was assessed by statistical and/or clinical review of all safety parameters, including adverse experiences (AE), physical examination, vital signs, and laboratory results	0.74% 1/135 • Adverse experiences were recorded during parenteral therapy and for 14 days after the end of study therapy including oral study therapy (safety follow-up period) Safety was assessed by statistical and/or clinical review of all safety parameters, including adverse experiences (AE), physical examination, vital signs, and laboratory results
Reproductive system and breast disorders Prostatitis	0.00% 0/132 • Adverse experiences were recorded during parenteral therapy and for 14 days after the end of study therapy including oral study therapy (safety follow-up period) Safety was assessed by statistical and/or clinical review of all safety parameters, including adverse experiences (AE), physical examination, vital signs, and laboratory results	0.74% 1/135 • Adverse experiences were recorded during parenteral therapy and for 14 days after the end of study therapy including oral study therapy (safety follow-up period) Safety was assessed by statistical and/or clinical review of all safety parameters, including adverse experiences (AE), physical examination, vital signs, and laboratory results
Reproductive system and breast disorders Vaginal discharge	0.76% 1/132 • Adverse experiences were recorded during parenteral therapy and for 14 days after the end of study therapy including oral study therapy (safety follow-up period) Safety was assessed by statistical and/or clinical review of all safety parameters, including adverse experiences (AE), physical examination, vital signs, and laboratory results	0.00% 0/135 • Adverse experiences were recorded during parenteral therapy and for 14 days after the end of study therapy including oral study therapy (safety follow-up period) Safety was assessed by statistical and/or clinical review of all safety parameters, including adverse experiences (AE), physical examination, vital signs, and laboratory results
Eye disorders Abnormal sensation in eye	0.00% 0/132 • Adverse experiences were recorded during parenteral therapy and for 14 days after the end of study therapy including oral study therapy (safety follow-up period) Safety was assessed by statistical and/or clinical review of all safety parameters, including adverse experiences (AE), physical examination, vital signs, and laboratory results	0.74% 1/135 • Adverse experiences were recorded during parenteral therapy and for 14 days after the end of study therapy including oral study therapy (safety follow-up period) Safety was assessed by statistical and/or clinical review of all safety parameters, including adverse experiences (AE), physical examination, vital signs, and laboratory results
Eye disorders Conjunctivochalasis	0.76% 1/132 • Adverse experiences were recorded during parenteral therapy and for 14 days after the end of study therapy including oral study therapy (safety follow-up period) Safety was assessed by statistical and/or clinical review of all safety parameters, including adverse experiences (AE), physical examination, vital signs, and laboratory results	0.00% 0/135 • Adverse experiences were recorded during parenteral therapy and for 14 days after the end of study therapy including oral study therapy (safety follow-up period) Safety was assessed by statistical and/or clinical review of all safety parameters, including adverse experiences (AE), physical examination, vital signs, and laboratory results
Eye disorders Diabetic retinopathy	0.00% 0/132 • Adverse experiences were recorded during parenteral therapy and for 14 days after the end of study therapy including oral study therapy (safety follow-up period) Safety was assessed by statistical and/or clinical review of all safety parameters, including adverse experiences (AE), physical examination, vital signs, and laboratory results	0.74% 1/135 • Adverse experiences were recorded during parenteral therapy and for 14 days after the end of study therapy including oral study therapy (safety follow-up period) Safety was assessed by statistical and/or clinical review of all safety parameters, including adverse experiences (AE), physical examination, vital signs, and laboratory results
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Haemangioma of liver	0.76% 1/132 • Adverse experiences were recorded during parenteral therapy and for 14 days after the end of study therapy including oral study therapy (safety follow-up period) Safety was assessed by statistical and/or clinical review of all safety parameters, including adverse experiences (AE), physical examination, vital signs, and laboratory results	0.00% 0/135 • Adverse experiences were recorded during parenteral therapy and for 14 days after the end of study therapy including oral study therapy (safety follow-up period) Safety was assessed by statistical and/or clinical review of all safety parameters, including adverse experiences (AE), physical examination, vital signs, and laboratory results
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Uterine leiomyoma	0.76% 1/132 • Adverse experiences were recorded during parenteral therapy and for 14 days after the end of study therapy including oral study therapy (safety follow-up period) Safety was assessed by statistical and/or clinical review of all safety parameters, including adverse experiences (AE), physical examination, vital signs, and laboratory results	0.00% 0/135 • Adverse experiences were recorded during parenteral therapy and for 14 days after the end of study therapy including oral study therapy (safety follow-up period) Safety was assessed by statistical and/or clinical review of all safety parameters, including adverse experiences (AE), physical examination, vital signs, and laboratory results
Endocrine disorders Adrenal insufficiency	0.00% 0/132 • Adverse experiences were recorded during parenteral therapy and for 14 days after the end of study therapy including oral study therapy (safety follow-up period) Safety was assessed by statistical and/or clinical review of all safety parameters, including adverse experiences (AE), physical examination, vital signs, and laboratory results	0.74% 1/135 • Adverse experiences were recorded during parenteral therapy and for 14 days after the end of study therapy including oral study therapy (safety follow-up period) Safety was assessed by statistical and/or clinical review of all safety parameters, including adverse experiences (AE), physical examination, vital signs, and laboratory results
Endocrine disorders Hypothyroidism	0.76% 1/132 • Adverse experiences were recorded during parenteral therapy and for 14 days after the end of study therapy including oral study therapy (safety follow-up period) Safety was assessed by statistical and/or clinical review of all safety parameters, including adverse experiences (AE), physical examination, vital signs, and laboratory results	0.00% 0/135 • Adverse experiences were recorded during parenteral therapy and for 14 days after the end of study therapy including oral study therapy (safety follow-up period) Safety was assessed by statistical and/or clinical review of all safety parameters, including adverse experiences (AE), physical examination, vital signs, and laboratory results
Investigations Alanine aminotransferase increased	1.5% 2/132 • Adverse experiences were recorded during parenteral therapy and for 14 days after the end of study therapy including oral study therapy (safety follow-up period) Safety was assessed by statistical and/or clinical review of all safety parameters, including adverse experiences (AE), physical examination, vital signs, and laboratory results	3.7% 5/135 • Adverse experiences were recorded during parenteral therapy and for 14 days after the end of study therapy including oral study therapy (safety follow-up period) Safety was assessed by statistical and/or clinical review of all safety parameters, including adverse experiences (AE), physical examination, vital signs, and laboratory results
Investigations Aspartate aminotransferase increased	2.3% 3/132 • Adverse experiences were recorded during parenteral therapy and for 14 days after the end of study therapy including oral study therapy (safety follow-up period) Safety was assessed by statistical and/or clinical review of all safety parameters, including adverse experiences (AE), physical examination, vital signs, and laboratory results	3.0% 4/135 • Adverse experiences were recorded during parenteral therapy and for 14 days after the end of study therapy including oral study therapy (safety follow-up period) Safety was assessed by statistical and/or clinical review of all safety parameters, including adverse experiences (AE), physical examination, vital signs, and laboratory results
Investigations Blood albumin decreased	0.76% 1/132 • Adverse experiences were recorded during parenteral therapy and for 14 days after the end of study therapy including oral study therapy (safety follow-up period) Safety was assessed by statistical and/or clinical review of all safety parameters, including adverse experiences (AE), physical examination, vital signs, and laboratory results	0.74% 1/135 • Adverse experiences were recorded during parenteral therapy and for 14 days after the end of study therapy including oral study therapy (safety follow-up period) Safety was assessed by statistical and/or clinical review of all safety parameters, including adverse experiences (AE), physical examination, vital signs, and laboratory results
Investigations Blood potassium decreased	0.76% 1/132 • Adverse experiences were recorded during parenteral therapy and for 14 days after the end of study therapy including oral study therapy (safety follow-up period) Safety was assessed by statistical and/or clinical review of all safety parameters, including adverse experiences (AE), physical examination, vital signs, and laboratory results	0.74% 1/135 • Adverse experiences were recorded during parenteral therapy and for 14 days after the end of study therapy including oral study therapy (safety follow-up period) Safety was assessed by statistical and/or clinical review of all safety parameters, including adverse experiences (AE), physical examination, vital signs, and laboratory results
Investigations Platelet count decreased	1.5% 2/132 • Adverse experiences were recorded during parenteral therapy and for 14 days after the end of study therapy including oral study therapy (safety follow-up period) Safety was assessed by statistical and/or clinical review of all safety parameters, including adverse experiences (AE), physical examination, vital signs, and laboratory results	0.00% 0/135 • Adverse experiences were recorded during parenteral therapy and for 14 days after the end of study therapy including oral study therapy (safety follow-up period) Safety was assessed by statistical and/or clinical review of all safety parameters, including adverse experiences (AE), physical examination, vital signs, and laboratory results
Investigations Blood urea increased	0.76% 1/132 • Adverse experiences were recorded during parenteral therapy and for 14 days after the end of study therapy including oral study therapy (safety follow-up period) Safety was assessed by statistical and/or clinical review of all safety parameters, including adverse experiences (AE), physical examination, vital signs, and laboratory results	0.00% 0/135 • Adverse experiences were recorded during parenteral therapy and for 14 days after the end of study therapy including oral study therapy (safety follow-up period) Safety was assessed by statistical and/or clinical review of all safety parameters, including adverse experiences (AE), physical examination, vital signs, and laboratory results
Investigations Gamma-glutamyltransferase increased	0.76% 1/132 • Adverse experiences were recorded during parenteral therapy and for 14 days after the end of study therapy including oral study therapy (safety follow-up period) Safety was assessed by statistical and/or clinical review of all safety parameters, including adverse experiences (AE), physical examination, vital signs, and laboratory results	0.00% 0/135 • Adverse experiences were recorded during parenteral therapy and for 14 days after the end of study therapy including oral study therapy (safety follow-up period) Safety was assessed by statistical and/or clinical review of all safety parameters, including adverse experiences (AE), physical examination, vital signs, and laboratory results
Investigations Haemoglobin decreased	0.00% 0/132 • Adverse experiences were recorded during parenteral therapy and for 14 days after the end of study therapy including oral study therapy (safety follow-up period) Safety was assessed by statistical and/or clinical review of all safety parameters, including adverse experiences (AE), physical examination, vital signs, and laboratory results	0.74% 1/135 • Adverse experiences were recorded during parenteral therapy and for 14 days after the end of study therapy including oral study therapy (safety follow-up period) Safety was assessed by statistical and/or clinical review of all safety parameters, including adverse experiences (AE), physical examination, vital signs, and laboratory results
Investigations Platelet count increased	0.00% 0/132 • Adverse experiences were recorded during parenteral therapy and for 14 days after the end of study therapy including oral study therapy (safety follow-up period) Safety was assessed by statistical and/or clinical review of all safety parameters, including adverse experiences (AE), physical examination, vital signs, and laboratory results	0.74% 1/135 • Adverse experiences were recorded during parenteral therapy and for 14 days after the end of study therapy including oral study therapy (safety follow-up period) Safety was assessed by statistical and/or clinical review of all safety parameters, including adverse experiences (AE), physical examination, vital signs, and laboratory results
Investigations Red blood cells urine positive	0.00% 0/132 • Adverse experiences were recorded during parenteral therapy and for 14 days after the end of study therapy including oral study therapy (safety follow-up period) Safety was assessed by statistical and/or clinical review of all safety parameters, including adverse experiences (AE), physical examination, vital signs, and laboratory results	0.74% 1/135 • Adverse experiences were recorded during parenteral therapy and for 14 days after the end of study therapy including oral study therapy (safety follow-up period) Safety was assessed by statistical and/or clinical review of all safety parameters, including adverse experiences (AE), physical examination, vital signs, and laboratory results
Metabolism and nutrition disorders Hypokalaemia	0.00% 0/132 • Adverse experiences were recorded during parenteral therapy and for 14 days after the end of study therapy including oral study therapy (safety follow-up period) Safety was assessed by statistical and/or clinical review of all safety parameters, including adverse experiences (AE), physical examination, vital signs, and laboratory results	1.5% 2/135 • Adverse experiences were recorded during parenteral therapy and for 14 days after the end of study therapy including oral study therapy (safety follow-up period) Safety was assessed by statistical and/or clinical review of all safety parameters, including adverse experiences (AE), physical examination, vital signs, and laboratory results
Metabolism and nutrition disorders Hypoalbuminaemia	1.5% 2/132 • Adverse experiences were recorded during parenteral therapy and for 14 days after the end of study therapy including oral study therapy (safety follow-up period) Safety was assessed by statistical and/or clinical review of all safety parameters, including adverse experiences (AE), physical examination, vital signs, and laboratory results	0.00% 0/135 • Adverse experiences were recorded during parenteral therapy and for 14 days after the end of study therapy including oral study therapy (safety follow-up period) Safety was assessed by statistical and/or clinical review of all safety parameters, including adverse experiences (AE), physical examination, vital signs, and laboratory results
Metabolism and nutrition disorders Hypoglycaemia	0.00% 0/132 • Adverse experiences were recorded during parenteral therapy and for 14 days after the end of study therapy including oral study therapy (safety follow-up period) Safety was assessed by statistical and/or clinical review of all safety parameters, including adverse experiences (AE), physical examination, vital signs, and laboratory results	0.74% 1/135 • Adverse experiences were recorded during parenteral therapy and for 14 days after the end of study therapy including oral study therapy (safety follow-up period) Safety was assessed by statistical and/or clinical review of all safety parameters, including adverse experiences (AE), physical examination, vital signs, and laboratory results

Additional Information

Senior Vice President, Global Clinical Development

Merck Sharp & Dohme Corp

Phone: 1-800-672-6372

Results disclosure agreements

• Principal investigator is a sponsor employee Merck agreements may vary with individual investigators, but will not prohibit any investigator from publishing. Merck 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