Safety and Efficacy of BAY1192631 in Japanese Patients Wi... | NCT01967225

Label	Type	Description	Intervention Names
Tedizolid Phosphate (Sivextro, BAY1192631)	Experimental	Participants received 200 mg BAY1192631 solution or tablet once daily (intravenous (I.V.) or oral (PO))	Drug: Tedizolid Phosphate (Sivextro, BAY1192631)
Linezolid	Active Comparator	Participants received 600 mg Linezolid solution or tablet twice daily, every 12 ± 3 hours (intravenous (I.V.) or oral (PO))	Drug: Linezolid

Name	Type	Description	Arm Group Labels	Other Names
Tedizolid Phosphate (Sivextro, BAY1192631)	Drug	BAY1192631 solution or tablet 200 mg, once daily, Intravenous (IV) or By Mouth (PO) for 7-14 days for skin and soft tissue infections (SSTI) or 7-21 days for bacteremia.

Measure	Description	Time Frame
Clinical Response at Test of Cure (TOC)	Clinical response was evaluated by the masked investigator as clinical cure, clinical failure and indeterminate on the basis of the clinical symptoms/findings, vital sign and laboratory data from screening period to each evaluation point. Measurements for the assessment of clinical response included body temperature, pulse/heart rate, respiration rate, and white blood cell or band cell count.	7-14 days after the end of treatment (EOT) for skin and soft tissue infections (SSTI) and 4-6 weeks after EOT for bacteremia
Microbiological Response at Test of Cure (TOC)	Microbiological response was assessed in accordance with the Guidance for the method of microbiological assessment by Japanese Chemotherapy Society.	7-14 days after the end of treatment (EOT) for skin and soft tissue infections (SSTI) and 4-6 weeks after EOT for bacteremia

Measure	Description	Time Frame
Clinical Response at End of Treatment Visit (EOT)	Clinical response was evaluated by the masked investigator as effective, ineffective and indeterminate on the basis of the clinical symptoms/findings, vital sign and laboratory data from screening period to each evaluation point. Measurements for the assessment of clinical response included body temperature, pulse/heart rate, respiration rate, and white blood cell or band cell count.

Name	Affiliation	Role
Bayer Study Director	Bayer	Study Director

ID	Title	Description
FG000	Tedizolid Phosphate (Sivextro, BAY1192631)	Participants received 200 mg BAY1192631 solution or tablet once daily (intravenous (I.V.) or oral (PO))
FG001	Linezolid	Participants received 600 mg Linezolid solution or tablet twice daily, every 12 +- 3 hours (intravenous (I.V.) or oral (PO))

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

Clinical Response at Test of Cure (TOC)

Clinical response was evaluated by the masked investigator as clinical cure, clinical failure and indeterminate on the basis of the clinical symptoms/findings, vital sign and laboratory data from screening period to each evaluation point. Measurements for the assessment of clinical response included body temperature, pulse/heart rate, respiration rate, and white blood cell or band cell count.

This outcome measure was analyzed based on the microbiological evaluable population-methicillin-resistant Staphylococcus aureus (ME-MRSA) analysis set. The ME-MRSA consisted of clinical evaluable population at test of Cure (CE-TOC) analysis population who had an MRSA isolated as pathogen at the baseline.

Posted

Number

Percentage of participants

7-14 days after the end of treatment (EOT) for skin and soft tissue infections (SSTI) and 4-6 weeks after EOT for bacteremia

ID	Title	Description
OG000	Tedizolid Phosphate (Sivextro, BAY1192631) - SSTI	Participants who had skin and soft tissue infections (SSTI) including deep skin and soft tissue infection, chronic pyoderma, infection secondary to wound, burn and surgical wound, infected ulcer at baseline received 200 mg BAY1192631 solution or tablet once daily (intravenous (I.V.) or oral (PO))
OG001	Linezoid - SSTI	Participants who had skin and soft tissue infections (SSTI) including deep skin and soft tissue infection, chronic pyoderma, infection secondary to wound, burn and surgical wound, infected ulcer at baseline received 600 mg Linezolid solution or tablet twice daily, every 12 ± 3 hours (intravenous (I.V.) or oral (PO))
OG002	Tedizolid Phosphate (Sivextro, BAY1192631) - Bacteremia	Participants who had SSTI-related bacteremia at baseline received 200 mg BAY1192631 solution or tablet once daily (intravenous (I.V.) or oral (PO))
OG003	Linezoid - Bacteremia	Participants who had SSTI-related bacteremia at baseline received 600 mg Linezolid solution or tablet twice daily, every 12 ± 3 hours (intravenous (I.V.) or oral (PO))

Units	Counts
Participants	OG00029 OG00110 OG0020 OG003

Title

Denominators

Categories

Clinical cure

Title	Measurements
	OG00086.2(75.7 to 99.1) OG00180.0 OG0030.0

Clinical failure

Primary

Microbiological Response at Test of Cure (TOC)

Microbiological response was assessed in accordance with the Guidance for the method of microbiological assessment by Japanese Chemotherapy Society.

Posted

Number

Percentage of participants

7-14 days after the end of treatment (EOT) for skin and soft tissue infections (SSTI) and 4-6 weeks after EOT for bacteremia

ID	Title	Description
OG000	Tedizolid Phosphate (Sivextro, BAY1192631) - SSTI	Participants who had skin and soft tissue infections (SSTI) including deep skin and soft tissue infection, chronic pyoderma, infection secondary to wound, burn and surgical wound, infected ulcer at baseline received 200 mg BAY1192631 solution or tablet once daily (intravenous (I.V.) or oral (PO))
OG001	Linezoid - SSTI	Participants who had skin and soft tissue infections (SSTI) including deep skin and soft tissue infection, chronic pyoderma, infection secondary to wound, burn and surgical wound, infected ulcer at baseline received 600 mg Linezolid solution or tablet twice daily, every 12 ± 3 hours (intravenous (I.V.) or oral (PO))

Secondary

Clinical Response at End of Treatment Visit (EOT)

Clinical response was evaluated by the masked investigator as effective, ineffective and indeterminate on the basis of the clinical symptoms/findings, vital sign and laboratory data from screening period to each evaluation point. Measurements for the assessment of clinical response included body temperature, pulse/heart rate, respiration rate, and white blood cell or band cell count.

Posted

Number

Percentage of participants

7-14 days for skin and soft tissue infections (SSTI) or 7-21 days for bacteremia from the study drug administration

ID	Title	Description
OG000	Tedizolid Phosphate (Sivextro, BAY1192631) - SSTI	Participants who had skin and soft tissue infections (SSTI) including deep skin and soft tissue infection, chronic pyoderma, infection secondary to wound, burn and surgical wound, infected ulcer at baseline received 200 mg BAY1192631 solution or tablet once daily (intravenous (I.V.) or oral (PO))
OG001	Linezoid - SSTI	Participants who had skin and soft tissue infections (SSTI) including deep skin and soft tissue infection, chronic pyoderma, infection secondary to wound, burn and surgical wound, infected ulcer at baseline received 600 mg Linezolid solution or tablet twice daily, every 12 ± 3 hours (intravenous (I.V.) or oral (PO))

Secondary

Microbiological Response at End of Treatment (EOT)

Microbiological response was assessed in accordance with the Guidance for the method of microbiological assessment by Japanese Chemotherapy Society.

Posted

Number

Percentage of participants

7-14 days for skin and soft tissue infections (SSTI) or 7-21 days for bacteremia from the study drug administration

ID	Title	Description
OG000	Tedizolid Phosphate (Sivextro, BAY1192631) - SSTI	Participants who had skin and soft tissue infections (SSTI) including deep skin and soft tissue infection, chronic pyoderma, infection secondary to wound, burn and surgical wound, infected ulcer at baseline received 200 mg BAY1192631 solution or tablet once daily (intravenous (I.V.) or oral (PO))
OG001	Linezoid - SSTI	Participants who had skin and soft tissue infections (SSTI) including deep skin and soft tissue infection, chronic pyoderma, infection secondary to wound, burn and surgical wound, infected ulcer at baseline received 600 mg Linezolid solution or tablet twice daily, every 12 ± 3 hours (intravenous (I.V.) or oral (PO))

Secondary

Change of the Lesion Size From the Screening Visit by Visit (Only Skin and Soft Tissue Infection [SSTI])

Lesion size was measured by the masked investigators of erythema, edema, or induration whichever is largest.

This outcome measure was analyzed based on the microbiological evaluable population-ME-MRSA analysis set. The ME-MRSA consisted of clinical evaluable population at test of Cure (CE-TOC) analysis population who had an MRSA isolated as pathogen at the baseline. Data of SSTI target participants were reported for this outcome measure.

Posted

Mean

Standard Deviation

cm^2

Multiple time points up to 7-14 days after the end of treatment

ID	Title	Description
OG000	Tedizolid Phosphate (Sivextro, BAY1192631) - SSTI	Participants who had skin and soft tissue infections (SSTI) including deep skin and soft tissue infection, chronic pyoderma, infection secondary to wound, burn and surgical wound, infected ulcer at baseline received 200 mg BAY1192631 solution or tablet once daily (intravenous (I.V.) or oral (PO))
OG001	Linezoid - SSTI	Participants who had skin and soft tissue infections (SSTI) including deep skin and soft tissue infection, chronic pyoderma, infection secondary to wound, burn and surgical wound, infected ulcer at baseline received 600 mg Linezolid solution or tablet twice daily, every 12 ± 3 hours (intravenous (I.V.) or oral (PO))

Secondary

Reduction Ratio of the Lesion Size From the Screening Visit to Day 3 to Day 4 Visit (Only Skin and Soft Tissue Infection [SSTI])

Lesion size was measured by the masked investigators of erythema, edema, or induration whichever is largest. Reduction ratio (%) = 100 * (the post baseline value - baseline value) / baseline value. Negative values represent reduction of lesion size compared to baseline.

Posted

Mean

Standard Deviation

Percentage

Baseline and Day 3/4, Day 5/13, EOT, TOC

ID	Title	Description
OG000	Tedizolid Phosphate (Sivextro, BAY1192631) - SSTI	Participants who had skin and soft tissue infections (SSTI) including deep skin and soft tissue infection, chronic pyoderma, infection secondary to wound, burn and surgical wound, infected ulcer at baseline received 200 mg BAY1192631 solution or tablet once daily (intravenous (I.V.) or oral (PO))
OG001	Linezoid - SSTI	Participants who had skin and soft tissue infections (SSTI) including deep skin and soft tissue infection, chronic pyoderma, infection secondary to wound, burn and surgical wound, infected ulcer at baseline received 600 mg Linezolid solution or tablet twice daily, every 12 ± 3 hours (intravenous (I.V.) or oral (PO))

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA (19.1)	Non-systematic Assessment	EG0001 events1 affected83 at risk EG0012 events2 affected41 at risk
Eosinophilia	Blood and lymphatic system disorders	MedDRA (19.1)	Non-systematic Assessment	EG0000 events0 affected83 at risk EG0011 events1 affected41 at risk
Pancytopenia	Blood and lymphatic system disorders	MedDRA (19.1)	Non-systematic Assessment	EG0000 events0 affected83 at risk EG0011 events1 affected41 at risk
Thrombocytopenia	Blood and lymphatic system disorders	MedDRA (19.1)	Non-systematic Assessment	EG0000 events0 affected83 at risk EG0012 events2 affected41 at risk
Bone marrow failure	Blood and lymphatic system disorders	MedDRA (19.1)	Non-systematic Assessment	EG0000 events0 affected83 at risk EG0011 events1 affected41 at risk
Bundle branch block right	Cardiac disorders	MedDRA (19.1)	Non-systematic Assessment	EG0001 events1 affected83 at risk EG0010 events0 affected41 at risk
Cardiac failure chronic	Cardiac disorders	MedDRA (19.1)	Non-systematic Assessment	EG0000 events0 affected83 at risk EG0011 events1 affected41 at risk
Cardiac failure congestive	Cardiac disorders	MedDRA (19.1)	Non-systematic Assessment	EG0000 events0 affected83 at risk EG0011 events1 affected41 at risk
Hypothyroidism	Endocrine disorders	MedDRA (19.1)	Non-systematic Assessment	EG0000 events0 affected83 at risk EG0011 events1 affected41 at risk
Cataract	Eye disorders	MedDRA (19.1)	Non-systematic Assessment	EG0000 events0 affected83 at risk EG0011 events1 affected41 at risk
Diabetic retinopathy	Eye disorders	MedDRA (19.1)	Non-systematic Assessment	EG0000 events0 affected83 at risk EG0012 events1 affected41 at risk
Abdominal discomfort	Gastrointestinal disorders	MedDRA (19.1)	Non-systematic Assessment	EG0003 events3 affected83 at risk EG0010 events0 affected41 at risk
Abdominal distension	Gastrointestinal disorders	MedDRA (19.1)	Non-systematic Assessment	EG0001 events1 affected83 at risk EG0011 events1 affected41 at risk
Constipation	Gastrointestinal disorders	MedDRA (19.1)	Non-systematic Assessment	EG0005 events4 affected83 at risk EG0015 events4 affected41 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA (19.1)	Non-systematic Assessment	EG0007 events4 affected83 at risk EG0014 events4 affected41 at risk
Gastric ulcer	Gastrointestinal disorders	MedDRA (19.1)	Non-systematic Assessment	EG0001 events1 affected83 at risk EG0010 events0 affected41 at risk
Lip swelling	Gastrointestinal disorders	MedDRA (19.1)	Non-systematic Assessment	EG0001 events1 affected83 at risk EG0010 events0 affected41 at risk
Nausea	Gastrointestinal disorders	MedDRA (19.1)	Non-systematic Assessment	EG0005 events5 affected83 at risk EG0015 events4 affected41 at risk
Stomatitis	Gastrointestinal disorders	MedDRA (19.1)	Non-systematic Assessment	EG0000 events0 affected83 at risk EG0011 events1 affected41 at risk
Vomiting	Gastrointestinal disorders	MedDRA (19.1)	Non-systematic Assessment	EG0007 events4 affected83 at risk EG0016 events4 affected41 at risk
Anal incontinence	Gastrointestinal disorders	MedDRA (19.1)	Non-systematic Assessment	EG0000 events0 affected83 at risk EG0012 events1 affected41 at risk
Decreased activity	General disorders	MedDRA (19.1)	Non-systematic Assessment	EG0000 events0 affected83 at risk EG0011 events1 affected41 at risk
Injection site dermatitis	General disorders	MedDRA (19.1)	Non-systematic Assessment	EG0001 events1 affected83 at risk EG0010 events0 affected41 at risk
Injection site erythema	General disorders	MedDRA (19.1)	Non-systematic Assessment	EG0005 events4 affected83 at risk EG0010 events0 affected41 at risk
Injection site hypersensitivity	General disorders	MedDRA (19.1)	Non-systematic Assessment	EG0002 events1 affected83 at risk EG0010 events0 affected41 at risk
Injection site induration	General disorders	MedDRA (19.1)	Non-systematic Assessment	EG0001 events1 affected83 at risk EG0010 events0 affected41 at risk
Injection site inflammation	General disorders	MedDRA (19.1)	Non-systematic Assessment	EG0000 events0 affected83 at risk EG0012 events1 affected41 at risk
Injection site pain	General disorders	MedDRA (19.1)	Non-systematic Assessment	EG0007 events5 affected83 at risk EG0014 events4 affected41 at risk
Injection site phlebitis	General disorders	MedDRA (19.1)	Non-systematic Assessment	EG0002 events2 affected83 at risk EG0010 events0 affected41 at risk
Injection site reaction	General disorders	MedDRA (19.1)	Non-systematic Assessment	EG0002 events2 affected83 at risk EG0010 events0 affected41 at risk
Instillation site pain	General disorders	MedDRA (19.1)	Non-systematic Assessment	EG0001 events1 affected83 at risk EG0010 events0 affected41 at risk
Pain	General disorders	MedDRA (19.1)	Non-systematic Assessment	EG0001 events1 affected83 at risk EG0010 events0 affected41 at risk
Pyrexia	General disorders	MedDRA (19.1)	Non-systematic Assessment	EG0003 events3 affected83 at risk EG0010 events0 affected41 at risk
Peripheral swelling	General disorders	MedDRA (19.1)	Non-systematic Assessment	EG0000 events0 affected83 at risk EG0012 events1 affected41 at risk
Injection site swelling	General disorders	MedDRA (19.1)	Non-systematic Assessment	EG0003 events3 affected83 at risk EG0011 events1 affected41 at risk
Infusion site extravasation	General disorders	MedDRA (19.1)	Non-systematic Assessment	EG0002 events2 affected83 at risk EG0010 events0 affected41 at risk
Puncture site pain	General disorders	MedDRA (19.1)	Non-systematic Assessment	EG0003 events3 affected83 at risk EG0010 events0 affected41 at risk
Hepatic function abnormal	Hepatobiliary disorders	MedDRA (19.1)	Non-systematic Assessment	EG0003 events3 affected83 at risk EG0013 events3 affected41 at risk
Drug-induced liver injury	Hepatobiliary disorders	MedDRA (19.1)	Non-systematic Assessment	EG0000 events0 affected83 at risk EG0011 events1 affected41 at risk
Angular cheilitis	Infections and infestations	MedDRA (19.1)	Non-systematic Assessment	EG0000 events0 affected83 at risk EG0011 events1 affected41 at risk
Cellulitis	Infections and infestations	MedDRA (19.1)	Non-systematic Assessment	EG0002 events2 affected83 at risk EG0011 events1 affected41 at risk
Folliculitis	Infections and infestations	MedDRA (19.1)	Non-systematic Assessment	EG0001 events1 affected83 at risk EG0010 events0 affected41 at risk
Furuncle	Infections and infestations	MedDRA (19.1)	Non-systematic Assessment	EG0001 events1 affected83 at risk EG0011 events1 affected41 at risk
Gangrene	Infections and infestations	MedDRA (19.1)	Non-systematic Assessment	EG0000 events0 affected83 at risk EG0011 events1 affected41 at risk
Herpes simplex	Infections and infestations	MedDRA (19.1)	Non-systematic Assessment	EG0000 events0 affected83 at risk EG0011 events1 affected41 at risk
Infected skin ulcer	Infections and infestations	MedDRA (19.1)	Non-systematic Assessment	EG0001 events1 affected83 at risk EG0011 events1 affected41 at risk
Infective myositis	Infections and infestations	MedDRA (19.1)	Non-systematic Assessment	EG0001 events1 affected83 at risk EG0010 events0 affected41 at risk
Injection site infection	Infections and infestations	MedDRA (19.1)	Non-systematic Assessment	EG0001 events1 affected83 at risk EG0010 events0 affected41 at risk
Nasopharyngitis	Infections and infestations	MedDRA (19.1)	Non-systematic Assessment	EG0004 events4 affected83 at risk EG0011 events1 affected41 at risk
Osteomyelitis	Infections and infestations	MedDRA (19.1)	Non-systematic Assessment	EG0001 events1 affected83 at risk EG0010 events0 affected41 at risk
Postoperative wound infection	Infections and infestations	MedDRA (19.1)	Non-systematic Assessment	EG0000 events0 affected83 at risk EG0011 events1 affected41 at risk
Tinea pedis	Infections and infestations	MedDRA (19.1)	Non-systematic Assessment	EG0001 events1 affected83 at risk EG0011 events1 affected41 at risk
Upper respiratory tract infection	Infections and infestations	MedDRA (19.1)	Non-systematic Assessment	EG0001 events1 affected83 at risk EG0010 events0 affected41 at risk
Urinary tract infection	Infections and infestations	MedDRA (19.1)	Non-systematic Assessment	EG0001 events1 affected83 at risk EG0010 events0 affected41 at risk
Wound infection	Infections and infestations	MedDRA (19.1)	Non-systematic Assessment	EG0000 events0 affected83 at risk EG0011 events1 affected41 at risk
Abscess limb	Infections and infestations	MedDRA (19.1)	Non-systematic Assessment	EG0001 events1 affected83 at risk EG0010 events0 affected41 at risk
Groin infection	Infections and infestations	MedDRA (19.1)	Non-systematic Assessment	EG0001 events1 affected83 at risk EG0010 events0 affected41 at risk
Psoas abscess	Infections and infestations	MedDRA (19.1)	Non-systematic Assessment	EG0000 events0 affected83 at risk EG0011 events1 affected41 at risk
Genital infection fungal	Infections and infestations	MedDRA (19.1)	Non-systematic Assessment	EG0000 events0 affected83 at risk EG0011 events1 affected41 at risk
Infective spondylitis	Infections and infestations	MedDRA (19.1)	Non-systematic Assessment	EG0001 events1 affected83 at risk EG0010 events0 affected41 at risk
Vulvovaginal mycotic infection	Infections and infestations	MedDRA (19.1)	Non-systematic Assessment	EG0000 events0 affected83 at risk EG0011 events1 affected41 at risk
Enterocolitis bacterial	Infections and infestations	MedDRA (19.1)	Non-systematic Assessment	EG0000 events0 affected83 at risk EG0011 events1 affected41 at risk
Subcutaneous haematoma	Injury, poisoning and procedural complications	MedDRA (19.1)	Non-systematic Assessment	EG0000 events0 affected83 at risk EG0012 events2 affected41 at risk
Subdural haematoma	Injury, poisoning and procedural complications	MedDRA (19.1)	Non-systematic Assessment	EG0000 events0 affected83 at risk EG0011 events1 affected41 at risk
Excoriation	Injury, poisoning and procedural complications	MedDRA (19.1)	Non-systematic Assessment	EG0001 events1 affected83 at risk EG0010 events0 affected41 at risk
Contusion	Injury, poisoning and procedural complications	MedDRA (19.1)	Non-systematic Assessment	EG0000 events0 affected83 at risk EG0014 events1 affected41 at risk
Traumatic haemorrhage	Injury, poisoning and procedural complications	MedDRA (19.1)	Non-systematic Assessment	EG0001 events1 affected83 at risk EG0010 events0 affected41 at risk
Skin abrasion	Injury, poisoning and procedural complications	MedDRA (19.1)	Non-systematic Assessment	EG0001 events1 affected83 at risk EG0010 events0 affected41 at risk
Activated partial thromboplastin time prolonged	Investigations	MedDRA (19.1)	Non-systematic Assessment	EG0000 events0 affected83 at risk EG0011 events1 affected41 at risk
Alanine aminotransferase increased	Investigations	MedDRA (19.1)	Non-systematic Assessment	EG0005 events5 affected83 at risk EG0012 events2 affected41 at risk
Aspartate aminotransferase increased	Investigations	MedDRA (19.1)	Non-systematic Assessment	EG0004 events4 affected83 at risk EG0011 events1 affected41 at risk
Blood creatinine increased	Investigations	MedDRA (19.1)	Non-systematic Assessment	EG0000 events0 affected83 at risk EG0012 events2 affected41 at risk
Blood potassium decreased	Investigations	MedDRA (19.1)	Non-systematic Assessment	EG0002 events1 affected83 at risk EG0010 events0 affected41 at risk
Blood pressure decreased	Investigations	MedDRA (19.1)	Non-systematic Assessment	EG0001 events1 affected83 at risk EG0012 events1 affected41 at risk
Blood urea increased	Investigations	MedDRA (19.1)	Non-systematic Assessment	EG0001 events1 affected83 at risk EG0010 events0 affected41 at risk
Blood uric acid increased	Investigations	MedDRA (19.1)	Non-systematic Assessment	EG0003 events3 affected83 at risk EG0012 events2 affected41 at risk
Body temperature increased	Investigations	MedDRA (19.1)	Non-systematic Assessment	EG0001 events1 affected83 at risk EG0010 events0 affected41 at risk
Eosinophil count increased	Investigations	MedDRA (19.1)	Non-systematic Assessment	EG0002 events2 affected83 at risk EG0010 events0 affected41 at risk
Gamma-glutamyltransferase increased	Investigations	MedDRA (19.1)	Non-systematic Assessment	EG0002 events2 affected83 at risk EG0011 events1 affected41 at risk
Neutrophil count decreased	Investigations	MedDRA (19.1)	Non-systematic Assessment	EG0000 events0 affected83 at risk EG0011 events1 affected41 at risk
Platelet count decreased	Investigations	MedDRA (19.1)	Non-systematic Assessment	EG0001 events1 affected83 at risk EG0011 events1 affected41 at risk
Band neutrophil percentage increased	Investigations	MedDRA (19.1)	Non-systematic Assessment	EG0001 events1 affected83 at risk EG0010 events0 affected41 at risk
Blood alkaline phosphatase increased	Investigations	MedDRA (19.1)	Non-systematic Assessment	EG0002 events2 affected83 at risk EG0010 events0 affected41 at risk
Hepatic enzyme increased	Investigations	MedDRA (19.1)	Non-systematic Assessment	EG0002 events2 affected83 at risk EG0012 events2 affected41 at risk
Liver function test increased	Investigations	MedDRA (19.1)	Non-systematic Assessment	EG0003 events3 affected83 at risk EG0010 events0 affected41 at risk
Electrolyte imbalance	Metabolism and nutrition disorders	MedDRA (19.1)	Non-systematic Assessment	EG0000 events0 affected83 at risk EG0011 events1 affected41 at risk
Gout	Metabolism and nutrition disorders	MedDRA (19.1)	Non-systematic Assessment	EG0001 events1 affected83 at risk EG0010 events0 affected41 at risk
Hyperglycaemia	Metabolism and nutrition disorders	MedDRA (19.1)	Non-systematic Assessment	EG0000 events0 affected83 at risk EG0011 events1 affected41 at risk
Hyperkalaemia	Metabolism and nutrition disorders	MedDRA (19.1)	Non-systematic Assessment	EG0001 events1 affected83 at risk EG0010 events0 affected41 at risk
Hyperuricaemia	Metabolism and nutrition disorders	MedDRA (19.1)	Non-systematic Assessment	EG0002 events2 affected83 at risk EG0011 events1 affected41 at risk
Hypoglycaemia	Metabolism and nutrition disorders	MedDRA (19.1)	Non-systematic Assessment	EG00011 events3 affected83 at risk EG0014 events2 affected41 at risk
Malnutrition	Metabolism and nutrition disorders	MedDRA (19.1)	Non-systematic Assessment	EG0000 events0 affected83 at risk EG0011 events1 affected41 at risk
Decreased appetite	Metabolism and nutrition disorders	MedDRA (19.1)	Non-systematic Assessment	EG0001 events1 affected83 at risk EG0012 events2 affected41 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA (19.1)	Non-systematic Assessment	EG0001 events1 affected83 at risk EG0011 events1 affected41 at risk
Chondrocalcinosis pyrophosphate	Musculoskeletal and connective tissue disorders	MedDRA (19.1)	Non-systematic Assessment	EG0001 events1 affected83 at risk EG0010 events0 affected41 at risk
Musculoskeletal pain	Musculoskeletal and connective tissue disorders	MedDRA (19.1)	Non-systematic Assessment	EG0002 events2 affected83 at risk EG0010 events0 affected41 at risk
Neck pain	Musculoskeletal and connective tissue disorders	MedDRA (19.1)	Non-systematic Assessment	EG0002 events2 affected83 at risk EG0010 events0 affected41 at risk
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA (19.1)	Non-systematic Assessment	EG0003 events3 affected83 at risk EG0010 events0 affected41 at risk
Periarthritis	Musculoskeletal and connective tissue disorders	MedDRA (19.1)	Non-systematic Assessment	EG0001 events1 affected83 at risk EG0010 events0 affected41 at risk
Intervertebral disc protrusion	Musculoskeletal and connective tissue disorders	MedDRA (19.1)	Non-systematic Assessment	EG0001 events1 affected83 at risk EG0010 events0 affected41 at risk
Musculoskeletal stiffness	Musculoskeletal and connective tissue disorders	MedDRA (19.1)	Non-systematic Assessment	EG0001 events1 affected83 at risk EG0010 events0 affected41 at risk
Limb discomfort	Musculoskeletal and connective tissue disorders	MedDRA (19.1)	Non-systematic Assessment	EG0002 events1 affected83 at risk EG0010 events0 affected41 at risk
Autonomic nervous system imbalance	Nervous system disorders	MedDRA (19.1)	Non-systematic Assessment	EG0001 events1 affected83 at risk EG0010 events0 affected41 at risk
Dizziness	Nervous system disorders	MedDRA (19.1)	Non-systematic Assessment	EG0002 events2 affected83 at risk EG0010 events0 affected41 at risk
Somnolence	Nervous system disorders	MedDRA (19.1)	Non-systematic Assessment	EG0001 events1 affected83 at risk EG0010 events0 affected41 at risk
Delirium tremens	Psychiatric disorders	MedDRA (19.1)	Non-systematic Assessment	EG0000 events0 affected83 at risk EG0011 events1 affected41 at risk
Initial insomnia	Psychiatric disorders	MedDRA (19.1)	Non-systematic Assessment	EG0000 events0 affected83 at risk EG0011 events1 affected41 at risk
Insomnia	Psychiatric disorders	MedDRA (19.1)	Non-systematic Assessment	EG0002 events2 affected83 at risk EG0010 events0 affected41 at risk
Pollakiuria	Renal and urinary disorders	MedDRA (19.1)	Non-systematic Assessment	EG0000 events0 affected83 at risk EG0011 events1 affected41 at risk
Renal impairment	Renal and urinary disorders	MedDRA (19.1)	Non-systematic Assessment	EG0001 events1 affected83 at risk EG0010 events0 affected41 at risk
Acute kidney injury	Renal and urinary disorders	MedDRA (19.1)	Non-systematic Assessment	EG0000 events0 affected83 at risk EG0011 events1 affected41 at risk
Genital erythema	Reproductive system and breast disorders	MedDRA (19.1)	Non-systematic Assessment	EG0000 events0 affected83 at risk EG0011 events1 affected41 at risk
Epistaxis	Respiratory, thoracic and mediastinal disorders	MedDRA (19.1)	Non-systematic Assessment	EG0001 events1 affected83 at risk EG0010 events0 affected41 at risk
Pleural effusion	Respiratory, thoracic and mediastinal disorders	MedDRA (19.1)	Non-systematic Assessment	EG0001 events1 affected83 at risk EG0010 events0 affected41 at risk
Acne	Skin and subcutaneous tissue disorders	MedDRA (19.1)	Non-systematic Assessment	EG0000 events0 affected83 at risk EG0011 events1 affected41 at risk
Blister	Skin and subcutaneous tissue disorders	MedDRA (19.1)	Non-systematic Assessment	EG0000 events0 affected83 at risk EG0011 events1 affected41 at risk
Decubitus ulcer	Skin and subcutaneous tissue disorders	MedDRA (19.1)	Non-systematic Assessment	EG0001 events1 affected83 at risk EG0010 events0 affected41 at risk
Dermatitis	Skin and subcutaneous tissue disorders	MedDRA (19.1)	Non-systematic Assessment	EG0002 events2 affected83 at risk EG0010 events0 affected41 at risk
Dermatitis contact	Skin and subcutaneous tissue disorders	MedDRA (19.1)	Non-systematic Assessment	EG0005 events5 affected83 at risk EG0016 events6 affected41 at risk
Eczema	Skin and subcutaneous tissue disorders	MedDRA (19.1)	Non-systematic Assessment	EG0002 events2 affected83 at risk EG0012 events2 affected41 at risk
Eczema asteatotic	Skin and subcutaneous tissue disorders	MedDRA (19.1)	Non-systematic Assessment	EG0000 events0 affected83 at risk EG0011 events1 affected41 at risk
Erythema	Skin and subcutaneous tissue disorders	MedDRA (19.1)	Non-systematic Assessment	EG0000 events0 affected83 at risk EG0012 events1 affected41 at risk
Haemorrhage subcutaneous	Skin and subcutaneous tissue disorders	MedDRA (19.1)	Non-systematic Assessment	EG0002 events1 affected83 at risk EG0011 events1 affected41 at risk
Pruritus	Skin and subcutaneous tissue disorders	MedDRA (19.1)	Non-systematic Assessment	EG0003 events3 affected83 at risk EG0011 events1 affected41 at risk
Rash pruritic	Skin and subcutaneous tissue disorders	MedDRA (19.1)	Non-systematic Assessment	EG0001 events1 affected83 at risk EG0010 events0 affected41 at risk
Skin erosion	Skin and subcutaneous tissue disorders	MedDRA (19.1)	Non-systematic Assessment	EG0001 events1 affected83 at risk EG0010 events0 affected41 at risk
Skin necrosis	Skin and subcutaneous tissue disorders	MedDRA (19.1)	Non-systematic Assessment	EG0001 events1 affected83 at risk EG0010 events0 affected41 at risk
Skin ulcer	Skin and subcutaneous tissue disorders	MedDRA (19.1)	Non-systematic Assessment	EG0002 events2 affected83 at risk EG0012 events1 affected41 at risk
Stasis dermatitis	Skin and subcutaneous tissue disorders	MedDRA (19.1)	Non-systematic Assessment	EG0001 events1 affected83 at risk EG0011 events1 affected41 at risk
Asteatosis	Skin and subcutaneous tissue disorders	MedDRA (19.1)	Non-systematic Assessment	EG0001 events1 affected83 at risk EG0011 events1 affected41 at risk
Hypertension	Vascular disorders	MedDRA (19.1)	Non-systematic Assessment	EG0001 events1 affected83 at risk EG0010 events0 affected41 at risk
Orthostatic hypotension	Vascular disorders	MedDRA (19.1)	Non-systematic Assessment	EG0003 events3 affected83 at risk EG0010 events0 affected41 at risk
Vascular pain	Vascular disorders	MedDRA (19.1)	Non-systematic Assessment	EG0002 events2 affected83 at risk EG0011 events1 affected41 at risk

Facility	Status	City	State	ZIP	Country	Contacts
		Nagakute	Aichi-ken	480-1195	Japan

ID	Term
D012874	Skin Diseases, Infectious
D018461	Soft Tissue Infections
D016470	Bacteremia

ID	Term
D007239	Infections
D012871	Skin Diseases
D017437	Skin and Connective Tissue Diseases
D001424	Bacterial Infections
D001423	Bacterial Infections and Mycoses
D018805	Sepsis
D018746	Systemic Inflammatory Response Syndrome
D007249	Inflammation
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms

ID	Term
D000081	Acetamides
D000577	Amides
D009930	Organic Chemicals
D000085	Acetates
D000144	Acids, Acyclic
D002264	Carboxylic Acids
D023303	Oxazolidinones
D010080	Oxazoles
D001393	Azoles
D006573	Heterocyclic Compounds, 1-Ring
D006571	Heterocyclic Compounds

ID	Title	Description
BG000	Tedizolid Phosphate (Sivextro, BAY1192631) - SSTI	Participants who had skin and soft tissue infections (SSTI) including deep skin and soft tissue infection, chronic pyoderma, infection secondary to wound, burn and surgical wound, infected ulcer at baseline received 200 mg BAY1192631 solution or tablet once daily (intravenous (I.V.) or oral (PO))
BG001	Linezoid - SSTI	Participants who had skin and soft tissue infections (SSTI) including deep skin and soft tissue infection, chronic pyoderma, infection secondary to wound, burn and surgical wound, infected ulcer at baseline received 600 mg Linezolid solution or tablet twice daily, every 12 ± 3 hours (intravenous (I.V.) or oral (PO))
BG002	Tedizolid Phosphate (Sivextro, BAY1192631) - Bacteremia	Participants who had SSTI-related bacteremia at baseline received 200 mg BAY1192631 solution or tablet once daily (intravenous (I.V.) or oral (PO))
BG003	Linezoid - Bacteremia	Participants who had SSTI-related bacteremia at baseline received 600 mg Linezolid solution or tablet twice daily, every 12 ± 3 hours (intravenous (I.V.) or oral (PO))
BG004	Total	Total of all reporting groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Tedizolid Phosphate (Sivextro, BAY1192631)	Participants received 200 mg BAY1192631 solution or tablet once daily (intravenous (I.V.) or oral (PO))			7	83	64	83
EG001	Linezolid	Participants received 600 mg Linezolid solution or tablet twice daily, every 12 +- 3 hours (intravenous (I.V.) or oral (PO))			4	41	31	41