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| ID | Type | Description | Link |
|---|---|---|---|
| MK0826-055 | |||
| 2009_690 |
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The purpose of this study is to determine the efficacy of ertapenem sodium (Invanz) in treatment of complicated urinary tract infections with respect to the proportion of patients with a favorable microbiological response at 5-9 days post therapy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ertapenem sodium (MK0826) | Experimental | ertapenem sodium |
|
| ceftriaxone sodium | Active Comparator | ceftriaxone sodium |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ertapenem sodium (MK0826) | Drug | a single daily dose of ertapenem sodium 1.0g IV infused over 30 minutes, for 7-14 days (patients may be switched to oral ciprofloxacin after 3 doses of IV therapy if needed) |
| Measure | Description | Time Frame |
|---|---|---|
| Microbiological Response Assessment Profile | The difference in favorable microbiological response rates between the 2 treatment groups (MK0826 response rate minus ceftriaxone response rate) was assessed | 5 to 9 days post-therapy |
| 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 | 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. | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical Response Assessment Profile | The difference in favorable clinical response rates between the 2 treatment groups (MK0826 response rate minus ceftriaxone response rate) was assessed | 5 to 9 days post-therapy |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Monitor | Merck Sharp & Dohme LLC | Study Director |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22563210 | Result | Park DW, Peck KR, Chung MH, Lee JS, Park YS, Kim HY, Lee MS, Kim JY, Yeom JS, Kim MJ. Comparison of ertapenem and ceftriaxone therapy for acute pyelonephritis and other complicated urinary tract infections in Korean adults: a randomized, double-blind, multicenter trial. J Korean Med Sci. 2012 May;27(5):476-83. doi: 10.3346/jkms.2012.27.5.476. Epub 2012 Apr 25. |
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1 patient was excluded due to ineligibility. The patient had a positive at screening pregnancy test.
Patients were recruited from 9 Medical Centers of Korea between April 2008 and January 2009.
Last patient has visited on 27 Feb 2009.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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) |
| FG001 | 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) |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
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| ID | Title | Description |
|---|---|---|
| BG000 | 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) |
| BG001 | Ceftriaxone |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Microbiological Response Assessment Profile | The difference in favorable microbiological response rates between the 2 treatment groups (MK0826 response rate minus ceftriaxone response rate) was assessed | Primary efficacy analysis was done for 137 evaluable patients (66 patients from MK0826 and 71 patients from Ceftriaxone) | Posted | Number | Participants | 5 to 9 days post-therapy |
|
Adverse experiences were recorded during parenteral therapy and for 14 days after the end of study therapy including oral study therapy (safety follow-up period)
Safety was assessed by statistical and/or clinical review of all safety parameters, including adverse experiences (AE), physical examination, vital signs, and laboratory results
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | MK0826 | 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 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cerebral infarction | Nervous system disorders | MedDRA 12.0 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhea | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Senior Vice President, Global Clinical Development | Merck Sharp & Dohme Corp | 1-800-672-6372 |
Not provided
| ID | Term |
|---|---|
| D014552 | Urinary Tract Infections |
| ID | Term |
|---|---|
| D007239 | Infections |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
Not provided
Not provided
| ID | Term |
|---|---|
| D000077727 | Ertapenem |
| ID | Term |
|---|---|
| D015780 | Carbapenems |
| D047090 | beta-Lactams |
| D007769 | Lactams |
| D000577 | Amides |
| D009930 |
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|
| Comparator: ceftriaxone sodium | Drug | a single daily dose of ceftriaxone 2.0g IV infused over 30 minutes, for 7-14 days (patients may be switched to oral ciprofloxacin after 3 doses of IV therapy) |
|
| Laboratory adverse experience |
|
| Protocol Violation |
|
| Withdrawal by Subject |
|
| Clinical/microbiologic failure |
|
| Pathogen culture = no growth |
|
| Negative urine culture |
|
| Pathogen resistant |
|
| Physician Decision |
|
| Another antibiotic therapy required |
|
| Appendectomy |
|
| Inappropriate therapy duration, < 7 Days |
|
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)
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Stratum | Patients have enrolled who have complicated urinary tract infection with or without acute pyelonephritis | Number | participants |
|
| Duration of Symptoms(Days) | The duration of clinical symptoms prior to study entry | Mean | Standard Deviation | Days |
|
| OG001 | Ceftriaxone | 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. |
|
|
|
| Primary | 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 | 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. | 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) | Posted | Number | Participants | 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 |
|
|
|
| Secondary | Clinical Response Assessment Profile | The difference in favorable clinical response rates between the 2 treatment groups (MK0826 response rate minus ceftriaxone response rate) was assessed | Secondary efficacy analysis was done for 137 evaluable patients (66 patients from MK0826 and 71 patients from Ceftriaxone) | Posted | Number | Participants | 5 to 9 days post-therapy |
|
|
|
|
| 12 |
| 132 |
| 85 |
| 132 |
| EG001 | Ceftriaxone | 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 | 8 | 135 | 90 | 135 |
| Cerebrovascular accident | Nervous system disorders | MedDRA 12.0 | Systematic Assessment |
|
| Hydrocephalus | Nervous system disorders | MedDRA 12.0 | Systematic Assessment |
|
| Somnolence | Nervous system disorders | MedDRA 12.0 | Systematic Assessment |
|
| Sleep apnoea syndrome | Respiratory, thoracic and mediastinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Pyelonephritis acute | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
|
| Tuberculosis | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
|
| Renal abcess | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
|
| Sepsis | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
|
| Tonsillitis | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
|
| Viral infection | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
|
| Mental status changes | Psychiatric disorders | MedDRA 12.0 | Systematic Assessment |
|
| Dehydration | Metabolism and nutrition disorders | MedDRA 12.0 | Systematic Assessment |
|
| Ketoacidosis | Metabolism and nutrition disorders | MedDRA 12.0 | Systematic Assessment |
|
| Hypotension | Vascular disorders | MedDRA 12.0 | Systematic Assessment |
|
| Hydronephrosis | Renal and urinary disorders | MedDRA 12.0 | Systematic Assessment |
|
| Haematuria | Renal and urinary disorders | MedDRA 12.0 | Systematic Assessment |
|
| Renal and urinary disorders | Renal and urinary disorders | MedDRA 12.0 | Systematic Assessment |
|
| Neutropenia | Blood and lymphatic system disorders | MedDRA 12.0 | Systematic Assessment |
|
| Cardiac discomfort | Cardiac disorders | MedDRA 12.0 | Systematic Assessment |
|
| Myocardial infarction | Cardiac disorders | MedDRA 12.0 | Systematic Assessment |
|
| Pericarditis | Cardiac disorders | MedDRA 12.0 | Systematic Assessment |
|
| Accidental overdose | Injury, poisoning and procedural complications | MedDRA 12.0 | Systematic Assessment |
|
| Renal haematoma | Injury, poisoning and procedural complications | MedDRA 12.0 | Systematic Assessment |
|
| Metastatic neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 12.0 | Systematic Assessment |
|
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 12.0 | Systematic Assessment |
|
| Hypernatraemia | Metabolism and nutrition disorders | MedDRA 12.0 | Systematic Assessment |
|
| Azotaemia | Renal and urinary disorders | MedDRA 12.0 | Systematic Assessment |
|
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 12.0 | Systematic Assessment |
|
| Dyspepsia | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Abdominal discomfort | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Abdominal distension | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Epigastric discomfort | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Gastric ulcer | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Gastritis atrophic | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Dry mouth | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Mouth ulceration | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Colonic polyp | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Duodenal ulcer | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Faecal incontinence | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Gastritis | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Gastritis erosive | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Haemorrhoids | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Lip blister | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 12.0 | Systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA 12.0 | Systematic Assessment |
|
| Paraesthesia | Nervous system disorders | MedDRA 12.0 | Systematic Assessment |
|
| Burning sensation | Nervous system disorders | MedDRA 12.0 | Systematic Assessment |
|
| Convulsion | Nervous system disorders | MedDRA 12.0 | Systematic Assessment |
|
| Hypoaesthesia | Nervous system disorders | MedDRA 12.0 | Systematic Assessment |
|
| Syncope | Nervous system disorders | MedDRA 12.0 | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Productive cough | Respiratory, thoracic and mediastinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Dyspnoea exertional | Respiratory, thoracic and mediastinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Pulmonary congestion | Respiratory, thoracic and mediastinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Sputum discoloured | Respiratory, thoracic and mediastinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Chest discomfort | General disorders | MedDRA 12.0 | Systematic Assessment |
|
| Pyrexia | General disorders | MedDRA 12.0 | Systematic Assessment |
|
| Application site pain | General disorders | MedDRA 12.0 | Systematic Assessment |
|
| Chest pain | General disorders | MedDRA 12.0 | Systematic Assessment |
|
| Face oedema | General disorders | MedDRA 12.0 | Systematic Assessment |
|
| Fatigue | General disorders | MedDRA 12.0 | Systematic Assessment |
|
| Oedema | General disorders | MedDRA 12.0 | Systematic Assessment |
|
| Oedema peripheral | General disorders | MedDRA 12.0 | Systematic Assessment |
|
| Pain | General disorders | MedDRA 12.0 | Systematic Assessment |
|
| Asthenia | General disorders | MedDRA 12.0 | Systematic Assessment |
|
| Chills | General disorders | MedDRA 12.0 | Systematic Assessment |
|
| Feeling hot | General disorders | MedDRA 12.0 | Systematic Assessment |
|
| Injection site erythema | General disorders | MedDRA 12.0 | Systematic Assessment |
|
| Injection site pain | General disorders | MedDRA 12.0 | Systematic Assessment |
|
| Injection site phlebitis | General disorders | MedDRA 12.0 | Systematic Assessment |
|
| Tenderness | General disorders | MedDRA 12.0 | Systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
|
| Herpes simplex | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
|
| Pyelonephritis acute | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
|
| Tuberculosis | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
|
| Actinomycosis | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
|
| Herpes zoster | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
|
| Liver abscess | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
|
| Oral candidiasis | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
|
| Pelvic inflammatory disease | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
|
| Pyelonephritis | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
|
| Tinea cruris | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
|
| Urogenital trichomoniasis | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
|
| Insomnia | Psychiatric disorders | MedDRA 12.0 | Systematic Assessment |
|
| Anxiety | Psychiatric disorders | MedDRA 12.0 | Systematic Assessment |
|
| Confusional state | Psychiatric disorders | MedDRA 12.0 | Systematic Assessment |
|
| Delirium | Psychiatric disorders | MedDRA 12.0 | Systematic Assessment |
|
| Major depression | Psychiatric disorders | MedDRA 12.0 | Systematic Assessment |
|
| Psychotic disorder | Psychiatric disorders | MedDRA 12.0 | Systematic Assessment |
|
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 12.0 | Systematic Assessment |
|
| Cold sweat | Skin and subcutaneous tissue disorders | MedDRA 12.0 | Systematic Assessment |
|
| Erythema | Skin and subcutaneous tissue disorders | MedDRA 12.0 | Systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA 12.0 | Systematic Assessment |
|
| Blister | Skin and subcutaneous tissue disorders | MedDRA 12.0 | Systematic Assessment |
|
| Pruritus generalised | Skin and subcutaneous tissue disorders | MedDRA 12.0 | Systematic Assessment |
|
| Rash generalised | Skin and subcutaneous tissue disorders | MedDRA 12.0 | Systematic Assessment |
|
| Ecchymosis | Skin and subcutaneous tissue disorders | MedDRA 12.0 | Systematic Assessment |
|
| Eczema | Skin and subcutaneous tissue disorders | MedDRA 12.0 | Systematic Assessment |
|
| Swelling face | Skin and subcutaneous tissue disorders | MedDRA 12.0 | Systematic Assessment |
|
| Blood pressure | Investigations | MedDRA 12.0 | Systematic Assessment |
|
| Anorexia | Metabolism and nutrition disorders | MedDRA 12.0 | Systematic Assessment |
|
| Diabetes mellitus | Metabolism and nutrition disorders | MedDRA 12.0 | Systematic Assessment |
|
| Acidosis | Metabolism and nutrition disorders | MedDRA 12.0 | Systematic Assessment |
|
| Metabolic alkalosis | Metabolism and nutrition disorders | MedDRA 12.0 | Systematic Assessment |
|
| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA 12.0 | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 12.0 | Systematic Assessment |
|
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA 12.0 | Systematic Assessment |
|
| Osteoporosis | Musculoskeletal and connective tissue disorders | MedDRA 12.0 | Systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 12.0 | Systematic Assessment |
|
| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA 12.0 | Systematic Assessment |
|
| Musculoskeletal chest pain | Musculoskeletal and connective tissue disorders | MedDRA 12.0 | Systematic Assessment |
|
| Musculoskeletal discomfort | Musculoskeletal and connective tissue disorders | MedDRA 12.0 | Systematic Assessment |
|
| Myofascial pain syndrome | Musculoskeletal and connective tissue disorders | MedDRA 12.0 | Systematic Assessment |
|
| Hypotension | Vascular disorders | MedDRA 12.0 | Systematic Assessment |
|
| Hypertension | Vascular disorders | MedDRA 12.0 | Systematic Assessment |
|
| Phlebitis | Vascular disorders | MedDRA 12.0 | Systematic Assessment |
|
| Aortic dissection | Vascular disorders | MedDRA 12.0 | Systematic Assessment |
|
| Flushing | Vascular disorders | MedDRA 12.0 | Systematic Assessment |
|
| Hydronephrosis | Renal and urinary disorders | MedDRA 12.0 | Systematic Assessment |
|
| Renal cyst | Renal and urinary disorders | MedDRA 12.0 | Systematic Assessment |
|
| Calculus urinary | Renal and urinary disorders | MedDRA 12.0 | Systematic Assessment |
|
| Hydroureter | Renal and urinary disorders | MedDRA 12.0 | Systematic Assessment |
|
| Nephrolithiasis | Renal and urinary disorders | MedDRA 12.0 | Systematic Assessment |
|
| Nocturia | Renal and urinary disorders | MedDRA 12.0 | Systematic Assessment |
|
| Urethral pain | Renal and urinary disorders | MedDRA 12.0 | Systematic Assessment |
|
| Cholelithiasis | Hepatobiliary disorders | MedDRA 12.0 | Systematic Assessment |
|
| Gallbladder polyp | Hepatobiliary disorders | MedDRA 12.0 | Systematic Assessment |
|
| Hepatic cyst | Hepatobiliary disorders | MedDRA 12.0 | Systematic Assessment |
|
| Hepatic steatosis | Hepatobiliary disorders | MedDRA 12.0 | Systematic Assessment |
|
| Neutropenia | Blood and lymphatic system disorders | MedDRA 12.0 | Systematic Assessment |
|
| Anaemia | Blood and lymphatic system disorders | MedDRA 12.0 | Systematic Assessment |
|
| Iron deficiency anaemia | Blood and lymphatic system disorders | MedDRA 12.0 | Systematic Assessment |
|
| Mitral valve incompetence | Cardiac disorders | MedDRA 12.0 | Systematic Assessment |
|
| Tachyarrhythmia | Cardiac disorders | MedDRA 12.0 | Systematic Assessment |
|
| Tricuspid valve incompetence | Cardiac disorders | MedDRA 12.0 | Systematic Assessment |
|
| Excoriation | Injury, poisoning and procedural complications | MedDRA 12.0 | Systematic Assessment |
|
| Adnexa uteri cyst | Reproductive system and breast disorders | MedDRA 12.0 | Systematic Assessment |
|
| Atrophic vulvovaginitis | Reproductive system and breast disorders | MedDRA 12.0 | Systematic Assessment |
|
| Prostatitis | Reproductive system and breast disorders | MedDRA 12.0 | Systematic Assessment |
|
| Vaginal discharge | Reproductive system and breast disorders | MedDRA 12.0 | Systematic Assessment |
|
| Abnormal sensation in eye | Eye disorders | MedDRA 12.0 | Systematic Assessment |
|
| Conjunctivochalasis | Eye disorders | MedDRA 12.0 | Systematic Assessment |
|
| Diabetic retinopathy | Eye disorders | MedDRA 12.0 | Systematic Assessment |
|
| Haemangioma of liver | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 12.0 | Systematic Assessment |
|
| Uterine leiomyoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 12.0 | Systematic Assessment |
|
| Adrenal insufficiency | Endocrine disorders | MedDRA 12.0 | Systematic Assessment |
|
| Hypothyroidism | Endocrine disorders | MedDRA 12.0 | Systematic Assessment |
|
| Alanine aminotransferase increased | Investigations | MedDRA 12.0 | Systematic Assessment |
|
| Aspartate aminotransferase increased | Investigations | MedDRA 12.0 | Systematic Assessment |
|
| Blood albumin decreased | Investigations | MedDRA 12.0 | Systematic Assessment |
|
| Blood potassium decreased | Investigations | MedDRA 12.0 | Systematic Assessment |
|
| Platelet count decreased | Investigations | MedDRA 12.0 | Systematic Assessment |
|
| Blood urea increased | Investigations | MedDRA 12.0 | Systematic Assessment |
|
| Gamma-glutamyltransferase increased | Investigations | MedDRA 12.0 | Systematic Assessment |
|
| Haemoglobin decreased | Investigations | MedDRA 12.0 | Systematic Assessment |
|
| Platelet count increased | Investigations | MedDRA 12.0 | Systematic Assessment |
|
| Red blood cells urine positive | Investigations | MedDRA 12.0 | Systematic Assessment |
|
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 12.0 | Systematic Assessment |
|
| Hypoalbuminaemia | Metabolism and nutrition disorders | MedDRA 12.0 | Systematic Assessment |
|
| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA 12.0 | Systematic Assessment |
|
| Neutropenia | Blood and lymphatic system disorders | MedDRA 12.0 | Systematic Assessment |
|
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.
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| Organic Chemicals |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| Discontinued due to drug-related laboratory AEs |
|
| Serious drug-related Laboratory AEs |
|