Skin Infections, Bacterial
Conditions
Keywords
methicillin-resistant Staphylococcus aureus, linezolid, repeat dose, GSK1322322
Brief summary
This study will determine the safety, tolerability and efficacy of GSK1322322 verses Linezolid in subjects with Acute Bacterial Skin and Skin Structure Infection (ABSSSI).
Detailed description
This is a phase IIa, multicenter, randomized, parallel group, double-blind, double dummy study to assess the safety, tolerability, and efficacy of GSK1322322 when given as 1500mg twice daily over a 10-day period versus linezolid (600mg twice daily for 10 days) in adults with suspected Gram positive Acute Bacterial Skin and Skin Structure Infection who are not currently receiving antibacterial therapy. Subjects will be randomized (2:1) to GSK1322322 or linezolid. This study consists of a screening visit, a 10-day treatment period, and follow-up evaluations 7 and 28 days following the last dose.
Interventions
Sponsors
GlaxoSmithKline
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Male or female subject age 18 years or older at the time of signing the informed consent * Male subjects must agree to use one of the contraception methods listed * A female is eligible to enter and participate in this study if she is of non-childbearing potential * The subject has a diagnosis of ABSSSI defined as one of the following: wound infection with cellulitis that has developed within 30 days of surgery or trauma; abscess with cellulitis, or cellulitis that has developed in no more than 7 days before enrollment with worsening over the past 48 hours OR in the investigator's opinion the patient's condition warrants systemic oral antibiotic therapy * The subject has at least 2 additional signs and symptoms of skin infection: purulence, erythema with or without induration, fluctuation, heat/localized warmth, and pain/tenderness * The subject has at least 1 systemic marker of infection: Lymphadenopathy, Fever (\>38 degrees Celsius), White Blood Cell elevation, or Creatinine Reactive Protein (CRP) \>Upper Limit of Normal (ULN) * The subject has given written, informed, dated consent to participate in the study * QTcB or QTcF \< 450 msec; or QTc \< 480 msec in subjects with Bundle Branch Block * Aspartate aminotransferase (AST) and Alanine aminotransferase (ALT) \< 2xULN; and bilirubin \< 1.0xULN
Exclusion criteria
* Current or chronic history of liver disease, or known hepatic or biliary abnormalities * The subject has been diagnosed with Acquired immune deficiency syndrome (AIDS) * Body mass index (BMI) \>40 kg/m2 * The subject has demonstrated a previous hypersensitivity reaction to GSK1322322, or to oxazolidinones * The subject has a secondarily infected animal/human bite * The subject has a chronic ulcerative lesion that is likely to be polymicrobial or caused by anaerobic organisms and unlikely to have Staphylococcus aureus or Streptococcus pyogenes as the causative agent * The subject has an underlying skin disease, such as pre-existing eczematous dermatitis, with clinical evidence of secondary infection * The subject has an infection that would normally have a high cure rate after surgical incision alone * The subject has a bacterial skin infection which, due to the extent, depth or severity of clinical presentation, in the opinion of the investigator, cannot be appropriately treated by an oral antibiotic * The subject has received more than one dose of treatment with a systemic and/or topical antibacterial within 7 days * The subject is currently receiving vasopressors * The subject is currently receiving adrenergic agents * The subject is currently receiving serotonergic reuptake inhibitors * The subject is currently receiving monoamine oxidase inhibitors * The subject has a documented clinical history of pseudomembranous colitis * The subject has known, pre-existing myelosuppression, or a history of myelosuppression with prior linezolid use, or is currently receiving a medication that produces bone marrow suppression * The subject has a history of seizures * The subject has a history of severe renal failure and is undergoing dialysis * The subject has a serious underlying disease that could be imminently life-threatening * The subject has been previously enrolled in this study * The subject has participated in a clinical trial and has received an investigational product within the following time period prior to the first dosing day in the current study: 30 days, 5 half-lives or twice the duration of the biological effect of the investigational product * Subject is unable to discontinue the use of prescription drugs listed in the protocol or non-prescription drugs, including vitamins, herbal and dietary supplements prior to the first dose of study medication through the first follow up visit * Lactating females or pregnant females as determined by positive urine pregnancy test at screening or prior to dosing
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean Clinical Chemistry Parameter of High Sensitivity C-Reactive Protein at Indicated Time Points | Up to Follow-up (7 Day Follow-up, Day 19) | Blood samples were obtained for analysis of high sensitivity C-Reactive protein at Day 1, Day 2, Day 3, Day 4, Day 8, Day 11 and 7 Day Follow-up. Baseline value was defined as the assessment done on Day 1. |
| Mean Hematology Parameters of Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, White Blood Cells (WBC) and Platelet Count at Indicated Time Points | Up to Follow-up (28 Day Follow-up, Day 40) | Blood samples were obtained for analysis of basophils, eosinophils, lymphocytes, monocytes, total neutrophils, WBC and platelet count at Day 1, Day 4, Day 8, Day 11, 7 Day Follow-up and 28 Day Follow-up. Baseline value was defined as the assessment done on Day 1. |
| Mean Hematology Parameter of Mean Corpuscle Volume (MCV) at Indicated Time Points | Up to Follow-up (28 Day Follow-up, Day 40) | Blood samples were obtained for analysis of MCV at Day 1, Day 4, Day 8, Day 11, 7 Day Follow-up and 28 Day Follow-up. Baseline value was defined as the assessment done on Day 1. |
| Mean Hematology Parameter of Hemoglobin, Mean Corpuscle Hemoglobin Concentration (MCHC) at Indicated Time Points | Up to Follow-up (28 Day Follow-up, Day 40) | Blood samples were obtained for analysis of MCHC at Day 1, Day 4, Day 8, Day 11, 7 Day Follow-up and 28 Day Follow-up. Baseline value was defined as the assessment done on Day 1. |
| Mean Hematology Parameter of Mean Corpuscle Hemoglobin (MCH) at Indicated Time Points | Up to Follow-up (28 Day Follow-up, Day 40) | Blood samples were obtained for analysis of MCH at Day 1, Day 4, Day 8, Day 11, 7 Day Follow-up and 28 Day Follow-up. Baseline value was defined as the assessment done on Day 1. |
| Mean Hematology Parameter of Red Blood Cell (RBC) Count and Reticulocyte Count at Indicated Time Points | Up to Follow-up (28 Day Follow-up, Day 40) | Blood samples were obtained for analysis of RBC count and reticulocyte at Day 1, Day 4, Day 8, Day 11, 7 Day Follow-up and 28 Day Follow-up. Baseline value was defined as the assessment done on Day 1. |
| Mean Vital Sign Value of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Indicated Time Points | Up to Day 11 | Vital sign assessments were conducted at Day 1 (pre-dose), Day 2 (pre-dose), Day 3 (pre-dose), Day 4 (4-12 hours post-dose), Day 8 (pre-dose) and Day 11. The assessments were made with the participant in a semi-supine position, having rested in that position for at least 10 minutes beforehand. Three BP measurements were taken at pre-dose on Day 1. The mean value recorded at pre-dose was classified as Baseline. Single BP was obtained at all other time points during the study. |
| Mean Vital Sign Value of Heart Rate (HR) at Indicated Time Points | Up to Day 11 | Vital sign assessments were conducted at Day 1 (pre-dose), Day 2 (pre-dose), Day 3 (pre-dose), Day 4 (4-12 hours post-dose), Day 8 (pre-dose) and Day 11. The assessments were made with the participant in a semi-supine position, having rested in that position for at least 10 minutes beforehand. Three HR measurements were taken at pre-dose on Day 1. The mean value recorded at pre-dose was classified as Baseline. Single HR was obtained at all other time points during the study. |
| Mean Vital Sign Value of Respiratory Rate (RR) at Indicated Time Points | Up to Day 11 | Vital sign assessments were conducted at Day 1 (pre-dose), Day 2 (pre-dose), Day 3 (pre-dose), Day 4 (4-12 hours post-dose), Day 8 (pre-dose) and Day 11. The assessments were made with the participant in a semi-supine position, having rested in that position for at least 10 minutes beforehand. Three RR measurements were taken at pre-dose on Day 1. The mean value recorded at pre-dose was classified as Baseline. Single RR was obtained at all other time points during the study. |
| Mean Change From Baseline in SBP and DBP at Indicated Time Points | Day 1 (Baseline) up to Day 11 | Vital sign assessments were conducted at Day 1 (pre-dose), Day 2 (pre-dose), Day 3 (pre-dose), Day 4 (4-12 hours post-dose), Day 8 (pre-dose) and Day 11. The assessments were made with the participant in a semi-supine position, having rested in that position for at least 10 minutes beforehand. Three BP measurements were taken at pre-dose on Day 1. The mean value recorded at pre-dose was classified as Baseline. Single BP was obtained at all other time points during the study. The change from Baseline was calculated by subtracting the Baseline value from the individual post-Baseline (Day 2, Day 3, Day 4, Day 8 and Day 11) values. If either the Baseline or post-Baseline value was missing, the change from Baseline was set to missing as well. |
| Mean Change From Baseline in HR at Indicated Time Points | Day 1 (Baseline) up to Day 11 | Vital sign assessments were conducted at Day 1 (pre-dose), Day 2 (pre-dose), Day 3 (pre-dose), Day 4 (4-12 hours post-dose), Day 8 (pre-dose) and Day 11. The assessments were made with the participant in a semi-supine position, having rested in that position for at least 10 minutes beforehand. Three HR measurements were taken at pre-dose on Day 1. The mean value recorded at pre-dose was classified as Baseline. Single HR was obtained at all other time points during the study. The change from Baseline was calculated by subtracting the Baseline value from the individual post-Baseline (Day 2, Day 3, Day 4, Day 8 and Day 11) values. If either the Baseline or post-Baseline value was missing, the change from Baseline was set to missing as well. |
| Mean Change From Baseline in RR at Indicated Time Points | Day 1 (Baseline) up to Day 11 | Vital sign assessments were conducted at Day 1 (pre-dose), Day 2 (pre-dose), Day 3 (pre-dose), Day 4 (4-12 hours post-dose), Day 8 (pre-dose) and Day 11. The assessments were made with the participant in a semi-supine position, having rested in that position for at least 10 minutes beforehand. Three RR measurements were taken at pre-dose on Day 1. The mean value recorded at pre-dose was classified as Baseline. Single RR was obtained at all other time points during the study. The change from Baseline was calculated by subtracting the Baseline value from the individual post-Baseline (Day 2, Day 3, Day 4, Day 8 and Day 11) values. If either the Baseline or post-Baseline value was missing, the change from Baseline was set to missing as well. |
| Mean Electrocardiogram (ECG) Values at Indicated Time Points | Up to Day 11 | 12-lead ECGs were obtained during the study using an ECG machine that automatically calculated the heart rate and measured PR, QRS, RR, QT, and QTc intervals. It was performed with the participant in a semi-supine position having rested in that position for at least 10 minutes beforehand. Three measurements were taken at pre-dose on Day 1 at least 5 minutes apart. The mean PR interval, RR interval, QRS duration, uncorrected QT interval (UncQT) and QTcB (QT corrected by Bazett's formula) and QTcF (corrected by Friedericia's formula) was calculated from automated ECG readings. The assessments were done at Day 1 (pre-dose, 0.25-1.5 hours post-initial dose and 1.5-3 hours post-initial dose), Day 4 (4-12 hours post-morning dose), Day 8 (pre-morning dose) and Day 11 (0 hour). The mean value recorded pre-dose on Day 1 was classified as Baseline. |
| Mean Change From Baseline in ECG Values at Indicated Time Points | Day 1 (pre-dose, Baseline) up to Day 11 | 12-lead ECGs were obtained during the study using an ECG machine that automatically calculated the heart rate and measured PR, QRS, RR, QT, and QTc intervals. It was performed with the participant in a semi-supine position having rested in that position for at least 10 minutes beforehand. Three measurements were taken at pre-dose on Day 1 at least 5 minutes apart. The mean PR interval, RR interval, QRS duration, uncorrected QT interval (UncQT) and QTcB (QT corrected by Bazett's formula) and QTcF (corrected by Friedericia's formula) was calculated from automated ECG readings. The assessments were done at Day 1 (pre-dose, 0.25-1.5 hours post-initial dose and 1.5-3 hours post-initial dose), Day 4 (4-12 hours post-morning dose), Day 8 (pre-morning dose) and Day 11 (0 hour). Mean value recorded pre-dose on Day 1 was classified as Baseline. Change from Baseline was calculated by subtracting the Baseline value from individual post-Baseline (Day 1 post-dose, Day 4, Day 8 and Day 11) values. |
| Mean ECG Rhythms at Indicated Time Points | Up to Day 11 | 12-lead ECGs were obtained during the study using an ECG machine that automatically calculated the heart rhythm and measured PR, QRS, RR, QT, and QTc intervals. It was performed with the participant in a semi-supine position having rested in that position for at least 10 minutes beforehand. Three measurements were taken at pre-dose on Day 1 at least 5 minutes apart and the mean of the three measurements was calculated. The assessments were done at Day 1 (pre-dose, 0.25-1.5 hours post-initial dose and 1.5-3 hours post-initial dose), Day 4 (4-12 hours post-morning dose), Day 8 (pre-morning dose) and Day 11 (0 hour). |
| Mean Change From Baseline in ECG Rhythms at Indicated Time Points | Day 1 (pre-dose, Baseline) up to Day 11 | 12-lead ECGs were obtained during the study using an ECG machine that automatically calculated the heart rhythm and measured PR, QRS, RR, QT, and QTc intervals. It was performed with the participant in a semi-supine position having rested in that position for at least 10 minutes beforehand. Three measurements were taken at pre-dose on Day 1 at least 5 minutes apart and the mean of the three measurements was calculated. The assessments were done at Day 1 (pre-dose, 0.25-1.5 hours post-initial dose and 1.5-3 hours post-initial dose), Day 4 (4-12 hours post-morning dose), Day 8 (pre-morning dose) and Day 11 (0 hour). The value recorded pre-dose on Day 1 was the Baseline. The change from Baseline was calculated by subtracting the Baseline value from the individual post-Baseline (Day 1 post-dose, Day 4, Day 8 and Day 11) values. |
| Number of Participants With Abnormal Transition From Baseline in Clinical Chemistry Values Relative to Normal Range | Day 1 (pre-dose, Baseline) up Follow-up (28 Day Follow-up, Day 40) | The parameters of clinical chemistry included albumin, total protein, ALT, ALP, AST, GGT, LDH and creatine kinase, creatinine, uric acid, direct bilirubin, total bilirubin, glucose, sodium, calcium, potassium, chloride, CO2 content /bicarbonate and urea/BUN and high sensitivity C-Reactive protein. The assessments were done at Day 1, Day 4, Day 8, Day 11, 7 Day Follow-up and 28 Day Follow-up. Baseline was defined as the assessment done on Day 1 (pre-dose). Data is reported for number of participants with abnormal transition from Baseline 'to high' or 'to low' relative to normal range. Only those parameters for which at least one value of abnormal transition was reported are summarized. |
| Number of Participants With Abnormal Transition From Baseline in Hematology Values Relative to Normal Range | Day 1 (pre-dose, Baseline) up Follow-up (28 Day Follow-up, Day 40) | The parameters of clinical chemistry included basophils, eosinophils, lymphocytes, monocytes, total neutrophils, WBC count, platelet count, MCV, hemoglobin, MCHC, MCH, RBC count and reticulocyte count. The assessments were done at Day 1, Day 4, Day 8, Day 11, 7 Day Follow-up and 28 Day Follow-up. Baseline was defined as the assessment done on Day 1 (pre-dose). Data is reported for number of participants with abnormal transition from Baseline 'to high' or 'to low' relative to normal range. Only those parameters for which at least one value of abnormal transition was reported are summarized. |
| Number of Participants With Any Adverse Events (AE) and Serious Adverse Events (SAE) | Up to Follow-up (28 Day Follow-up, Day 40) | An AE is defined as any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or is a congenital anomaly/birth defect, may jeopardize the participant or may require medical or surgical intervention to prevent one of the other outcomes listed in this definition, associated with liver injury and impaired liver function defined as alanine aminotransferase (ALT) \>=3 x upper limit of normal (ULN), and total bilirubin \>=2 x ULN or international normalised ratio \>1.5. |
| Mean Clinical Chemistry Parameters of Albumin and Total Protein at Indicated Time Points | Up to Follow-up (28 Day Follow-up, Day 40) | Blood samples were obtained for analysis of albumin and total protein at Day 1, Day 4, Day 8, Day 11, 7 Day Follow-up and 28 Day Follow-up. Baseline value was defined as the assessment done on Day 1. |
| Mean Clinical Chemistry Parameters of ALT, Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Follicle Stimulating Hormone (FSH), Gamma Glutamyl Transferase (GGT), Lactate Dehydrogenase (LDH) and Creatine Kinase at Indicated Time Points | Up to Follow-up (28 Day Follow-up, Day 40) | Blood samples were obtained for analysis of ALT, ALP, AST, FSH, GGT, LDH and creatine kinase at Day 1, Day 4, Day 8, Day 11, 7 Day Follow-up and 28 Day Follow-up. Baseline value was defined as the assessment done on Day 1. |
| Mean Clinical Chemistry Parameters of Creatinine, Uric Acid, Direct Bilirubin and Total Bilirubin at Indicated Time Points | Up to Follow-up (28 Day Follow-up, Day 40) | Blood samples were obtained for analysis of creatinine, uric acid, direct bilirubin and total bilirubin at Day 1, Day 4, Day 8, Day 11, 7 Day Follow-up and 28 Day Follow-up. Baseline value was defined as the assessment done on Day 1. |
| Mean Clinical Chemistry Parameters of Glucose, Sodium, Calcium, Potassium, Chloride, Carbon Dioxide (CO2) Content /Bicarbonate and Urea/ Blood Urea Nitrogen (BUN) at Indicated Time Points | Up to Follow-up (28 Day Follow-up, Day 40) | Blood samples were obtained for analysis of glucose, sodium, calcium, potassium, chloride, CO2 content /bicarbonate and urea/BUN at Day 1, Day 4, Day 8, Day 11, 7 Day Follow-up and 28 Day Follow-up. Baseline value was defined as the assessment done on Day 1. |
| Mean Clinical Chemistry Parameter of Estradiol at Indicated Time Point | Day 1 | Blood samples were obtained for analysis of estradiol at Day 1. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mean Total SIS at Indicated Time Points | Up to Follow-up (28 Day Follow-up, Day 40) | The investigator evaluated the infection by grading the infected lesion according to SIS. The SIS consist of 7 items of exudate or pus, crusting, erythema or inflammation, tissue warmth, tissue edema, itching and pain. The items were rated on a 7-point scale ranging from 0 to 6, where 0 indicated absence of symptom and 6 indicated severe symptom. The total score ranged from 0 to 42, where 0 indicated absence of symptoms and higher score indicated more severe symptoms. Assessments were done at Day 1, Day 2, Day 3, Day 4, Day 8, Day 11, 7 Day Follow-up and 28 Day Follow-up. |
| Mean Exudate or Pus Sub-score of SIS at Indicated Time Points | Up to Follow-up (28 Day Follow-up, Day 40) | The SIS consist of 7 items of exudate or pus, crusting, erythema or inflammation, tissue warmth, tissue edema, itching and pain. The exudate or pus sub-score of SIS was rated on a 7-point scale ranging from 0 to 6, where 0 indicated absence of symptom and 6 indicated severe symptom. Assessments were done at Day 1, Day 2, Day 3, Day 4, Day 8, Day 11, 7 Day Follow-up and 28 Day Follow-up. |
| Mean Change From Baseline in Total SIS at Indicated Time Points | Day 1 (Baseline ) up to Follow-up (28 Day Follow-up, Day 40) | The investigator evaluated the infection by grading the infected lesion according to SIS. The SIS consist of 7 items of exudate or pus, crusting, erythema or inflammation, tissue warmth, tissue edema, itching and pain. The items were rated on a 7-point scale ranging from 0 to 6, where 0 indicated absence of symptom and 6 indicated severe symptom. The total score ranged from 0 to 42, where 0 indicated absence of symptoms and higher score indicated more severe symptoms. Baseline was defined as the assessment value done on Day 1. The change from Baseline was calculated by subtracting the Baseline value from the individual post-Baseline (Day 1, Day 2, Day 3, Day 4, Day 8, Day 11, 7 Day Follow-up and 28 Day Follow-up) values. If either the Baseline or post-Baseline value was missing, the change from Baseline was set to missing as well. |
| Mean Change From Baseline in Wound Area at Indicated Time Points | Day 1 (Baseline) up to Follow-up (28 Day Follow-up, Day 40) | The area of the infected lesion size was calculated as the product between the length (L) and width (W) of the lesion size. The wound was measured by the investigator in centimeters (cm), using a standard metric ruler. Baseline was defined as the assessment value done on Day 1. The change from Baseline was calculated by subtracting the Baseline value from the individual post-Baseline (Day 1, Day 2, Day 3, Day 4, Day 8, Day 11, 7 Day Follow-up and 28 Day Follow-up) values. If either the Baseline or post-Baseline value was missing, the change from Baseline was set to missing as well. |
| Percentage of Participants With Clinical Success at End of Therapy by Pathogen Isolated at Baseline | Up to Follow-up (28 Day Follow-up, Day 40) | Clinical success was defined as total resolution of all signs and symptoms of infection recorded at Baseline, or improvement to such an extent that no further antimicrobial therapy was necessary, including a pus/exudates SIS of 0. The pathogens isolated at Baseline included staphylococcus aureus (methicillin-resistant staphylococcus aureus \[MRSA\] and methicillin-susceptible staphylococcus aureus \[MSSA\] as defined by susceptibility to cefoxitin or oxacilin), streptococcus pyogenes, other streptococcus species, other Gram-positive pathogens and Gram-negative pathogens. Data is categorized for the percentage of participants with clinical success for each of the pathogens, all pathogens and no pathogens. |
| Population Pharmacokinetic Parameters of Apparent Total Clearance of GSK1322322 From Plasma After Oral Administration (CL/F) | Day 1 (0.25-1.5 hours post-initial dose, 1.5-3 hours post-initial dose), Day 4 (4-12 hours post-morning dose) and Day 8 (pre-morning dose) | Blood samples were planned to be collected on Day 1, 0.25-1.5 hours post-initial dose (corresponding to the safety laboratory and ECG timepoint), and 1.5-3 hours post-initial dose (corresponding to the safety laboratory and ECG timepoint), and Day 4, 4-12 hours post-morning dose (corresponding to the safety laboratory and ECG timepoint), and Day 8, pre-morning dose (corresponding to safety laboratory and ECG timepoint) during the outpatient visit. The data for this outcome measure was not collected and assessed. |
| Number of Participants With Clinical Success of Clinical Response | Up to Follow-up (28 Day Follow-up, Day 40) | The clinical response was evaluated by the investigator at end of therapy (within 3 days post therapy; Day 12-14) and Follow-up (7 day Follow-up; Day 16 to 19 and 28 day Follow-up; Day 37 to 40). Clinical response was determined after clinical evaluation of reviewing clinical signs and symptoms. Clinical success was defined as total resolution of all signs and symptoms of infection recorded at Baseline, or improvement to such an extent that no further antimicrobial therapy was necessary, including a pus/exudate skin infection score (SIS) of 0. |
| Percentage of Participants With Clinical Success of Clinical Outcome | Day 11 (end of therapy) and Follow-up (7 Day Follow-up, Day 19) | The clinical response was determined by the investigator after clinical evaluation of reviewing clinical signs and symptoms at end of therapy (within 3 days post therapy; visit window of Day 12-14) and 7 day Follow-up ( visit window of Day 16 to 19), and the resulting clinical outcome was assigned, for each participant. Clinical success was defined as total resolution of all signs and symptoms of infection recorded at Baseline, or improvement to such an extent that no further antimicrobial therapy was necessary, including a pus/exudates SIS of 0. |
| Percentage of Participants With Microbiological Success of Microbiological Outcome at End of Therapy | Day 11 (end of therapy) | The 'by pathogen' microbiological response was determined by comparing the Baseline (Day 1) culture results to the culture results at the end of therapy (visit window of Day 12-14), and the corresponding microbiological outcome (success or failure) by participant was then assigned. Microbiological success was defined as: elimination of Baseline pathogens (defined as microbiological eradication in microbiological response); clinical outcome was success such that no culture was obtained due to lack of culturable material, secondary to adequate clinical response, and was documented in the electronic case report form (eCRF) (defined as presumed microbiological eradication in microbiological response); new pathogen not previously identified, was identified at end of therapy in a participant who was a 'clinical success' (defined as colonization in microbiological response). |
| Percentage of Participants With Microbiological Success of Microbiological Outcome at Follow-up | Follow-up (7 Day Follow-up, Day 19) | The 'by pathogen' microbiological response was determined by comparing the Baseline (Day 1) culture results to culture results at Follow-up (Day 16-19), and corresponding microbiological outcome (success or failure) by participant was then assigned. Microbiological success was defined as: Baseline pathogen was eradicated or presumed eradicated at end of therapy, or Baseline pathogens were present at end of therapy and is absent at Follow-up (microbiological eradication in microbiological response); Baseline pathogen was eradicated or presumed eradicated at end of therapy, or the Baseline pathogens were present at end of therapy and, participant was a 'clinical success', such that no culture was obtained due to lack of culturable material, secondary to adequate clinical response, and was documented in the eCRF (microbiological eradication); a new pathogen, not previously identified at Baseline, was identified at Follow-up in a participant who was a 'clinical success' (colonization) |
| Percentage of Participants With Therapeutic Success of Therapeutic Outcome | Follow-up (7 day Follow-up, Day 19) | Therapeutic outcome was combined clinical and microbiological outcome. Therapeutic outcome was a measure of the overall efficacy response, and a therapeutic success referred to participants who had been deemed both a 'clinical success' and a 'microbiological success'. All other combinations (other than 'clinical success' + 'microbiological success') were deemed failures for therapeutic outcome. Therapeutic outcome was determined programmatically, obtained at 7 day Follow-up. |
| Mean Short Form McGill Pain Questionnaire-2 (SF-MPQ-2) Sub-score of Continuous Pain, Intermittent Pain, Neuropathic Pain and Affective Descriptors at Indicated Time Points | Up to Follow-up (7 Day Follow up, Day 19) | SF-MPQ-2 is composed of 22 items that describes different quantities of pain and related symptoms. Sub-score of continuous pain represents mean of throbbing pain, cramping pain, gnawing pain, aching pain, heavy pain and tender (mean of items 1, 5, 6, 8, 9 and 10). Sub-score of intermittent pain represents mean of shooting pain, stabbing pain, sharp pain, splitting pain, electric-shock pain and piercing (mean of items 2, 3, 4, 11, 16 and 18). Sub-score of neuropathic pain represents mean of hot-burning pain, cold-freezing pain, pain caused by light touch, itching, tingling or pins and needles, numbness (mean of items 7, 17, 19, 20, 21 and 22). Sub-score of affective descriptors represents mean of tiring-exhaustive, sickening, fearful, punishing-cruel (mean of items 12, 13, 14 and 15). Scores ranged from 0 to 10, where 0 indicated absence of symptom and higher score indicated more severe symptoms. Assessments were done at Day 1, Day 2, Day 3, Day 4, Day 8, Day 11 and 7 Day Follow-up. |
Countries
United States
Participant flow
Recruitment details
The study was planned on 75 male and female participants with Gram-positive acute bacterial skin and skin structure infection (ABSSSI) who were not receiving any antibacterial therapy, aged 18 years or older at eight study centers in the United States from 13 September 2010 to 20 December 2010.
Pre-assignment details
A total of 84 participants were enrolled in the study; of which, 57 participants were randomized in a ratio of 2:1 to receive GSK1322322 1500 milligram (mg) twice a day (BID) and 27 were randomized to receive linezolid 600 mg BID for 10 days.
Participants by arm
| Arm | Count |
|---|---|
| GSK1322322 1500 mg BID Participants received oral dose of GSK1322322 1500 mg as 3 tablets of 500 mg each, BID in the morning and evening for 10 days. Blinding was maintained by administration of matching placebo capsules to linezoid in the morning and evening. The study medication was taken with 240 mL of water or liquid. | 57 |
| Linezolid 600 mg BID Participants received oral dose of linezolid 600 mg tablet BID in the morning and evening for 10 days. Blinding was maintained by administration of matching placebo tablets to GSK1322322 in the morning and evening. The study medication was taken with 240 mL of water or liquid. | 27 |
| Total | 84 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 5 | 0 |
| Overall Study | Lost to Follow-up | 4 | 0 |
| Overall Study | Physician Decision | 5 | 2 |
| Overall Study | Withdrawal by Subject | 2 | 1 |
Baseline characteristics
| Characteristic | Linezolid 600 mg BID | Total | GSK1322322 1500 mg BID |
|---|---|---|---|
| Age, Continuous | 41.5 Years STANDARD_DEVIATION 11 | 43.5 Years STANDARD_DEVIATION 11.61 | 44.4 Years STANDARD_DEVIATION 11.87 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 2 Participants | 2 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 2 Participants | 6 Participants | 4 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 2 Participants | 2 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 2 Participants | 3 Participants | 1 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 23 Participants | 70 Participants | 47 Participants |
| Sex: Female, Male Female | 4 Participants | 18 Participants | 14 Participants |
| Sex: Female, Male Male | 23 Participants | 66 Participants | 43 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 57 | 0 / 27 |
| other Total, other adverse events | 38 / 57 | 16 / 27 |
| serious Total, serious adverse events | 1 / 57 | 1 / 27 |
Outcome results
Primary
Mean Change From Baseline in ECG Rhythms at Indicated Time Points
12-lead ECGs were obtained during the study using an ECG machine that automatically calculated the heart rhythm and measured PR, QRS, RR, QT, and QTc intervals. It was performed with the participant in a semi-supine position having rested in that position for at least 10 minutes beforehand. Three measurements were taken at pre-dose on Day 1 at least 5 minutes apart and the mean of the three measurements was calculated. The assessments were done at Day 1 (pre-dose, 0.25-1.5 hours post-initial dose and 1.5-3 hours post-initial dose), Day 4 (4-12 hours post-morning dose), Day 8 (pre-morning dose) and Day 11 (0 hour). The value recorded pre-dose on Day 1 was the Baseline. The change from Baseline was calculated by subtracting the Baseline value from the individual post-Baseline (Day 1 post-dose, Day 4, Day 8 and Day 11) values.
Time frame: Day 1 (pre-dose, Baseline) up to Day 11
Population: Safety Population. Only those participants available at the specified time points were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| GSK1322322 1500 mg BID | Mean Change From Baseline in ECG Rhythms at Indicated Time Points | Day 1, 1.5-3 h post-dose | 5.9 Beats per minute | Standard Deviation 9.23 |
| GSK1322322 1500 mg BID | Mean Change From Baseline in ECG Rhythms at Indicated Time Points | Day 8, pre morning dose | -5.2 Beats per minute | Standard Deviation 12.4 |
| GSK1322322 1500 mg BID | Mean Change From Baseline in ECG Rhythms at Indicated Time Points | Day 4, 4-12 h post-dose | -3.1 Beats per minute | Standard Deviation 11.37 |
| GSK1322322 1500 mg BID | Mean Change From Baseline in ECG Rhythms at Indicated Time Points | Day 11, 0 h | -3.2 Beats per minute | Standard Deviation 11.94 |
| GSK1322322 1500 mg BID | Mean Change From Baseline in ECG Rhythms at Indicated Time Points | Day 1, 0.25-1.5 h post-dose | 4.2 Beats per minute | Standard Deviation 8.69 |
| Linezolid 600 mg BID | Mean Change From Baseline in ECG Rhythms at Indicated Time Points | Day 11, 0 h | 1.1 Beats per minute | Standard Deviation 11.39 |
| Linezolid 600 mg BID | Mean Change From Baseline in ECG Rhythms at Indicated Time Points | Day 1, 0.25-1.5 h post-dose | -0.9 Beats per minute | Standard Deviation 6.29 |
| Linezolid 600 mg BID | Mean Change From Baseline in ECG Rhythms at Indicated Time Points | Day 1, 1.5-3 h post-dose | 2.9 Beats per minute | Standard Deviation 8.35 |
| Linezolid 600 mg BID | Mean Change From Baseline in ECG Rhythms at Indicated Time Points | Day 4, 4-12 h post-dose | 2.4 Beats per minute | Standard Deviation 16.48 |
| Linezolid 600 mg BID | Mean Change From Baseline in ECG Rhythms at Indicated Time Points | Day 8, pre morning dose | -3.5 Beats per minute | Standard Deviation 10.12 |
Primary
Mean Change From Baseline in ECG Values at Indicated Time Points
12-lead ECGs were obtained during the study using an ECG machine that automatically calculated the heart rate and measured PR, QRS, RR, QT, and QTc intervals. It was performed with the participant in a semi-supine position having rested in that position for at least 10 minutes beforehand. Three measurements were taken at pre-dose on Day 1 at least 5 minutes apart. The mean PR interval, RR interval, QRS duration, uncorrected QT interval (UncQT) and QTcB (QT corrected by Bazett's formula) and QTcF (corrected by Friedericia's formula) was calculated from automated ECG readings. The assessments were done at Day 1 (pre-dose, 0.25-1.5 hours post-initial dose and 1.5-3 hours post-initial dose), Day 4 (4-12 hours post-morning dose), Day 8 (pre-morning dose) and Day 11 (0 hour). Mean value recorded pre-dose on Day 1 was classified as Baseline. Change from Baseline was calculated by subtracting the Baseline value from individual post-Baseline (Day 1 post-dose, Day 4, Day 8 and Day 11) values.
Time frame: Day 1 (pre-dose, Baseline) up to Day 11
Population: Safety Population. Only those participants available at the specified time points were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| GSK1322322 1500 mg BID | Mean Change From Baseline in ECG Values at Indicated Time Points | QTcB interval, Day 1, 0.25-1.5 h post dose | 5.1 msec | Standard Deviation 18.67 |
| GSK1322322 1500 mg BID | Mean Change From Baseline in ECG Values at Indicated Time Points | QRS duration, Day 8, pre morning dose | 1.0 msec | Standard Deviation 6.54 |
| GSK1322322 1500 mg BID | Mean Change From Baseline in ECG Values at Indicated Time Points | QTcB interval, Day 1, 1.5-3 h post dose | 8.5 msec | Standard Deviation 16.86 |
| GSK1322322 1500 mg BID | Mean Change From Baseline in ECG Values at Indicated Time Points | PR interval, Day 1, 1.5-3 h post dose | 0.4 msec | Standard Deviation 12.09 |
| GSK1322322 1500 mg BID | Mean Change From Baseline in ECG Values at Indicated Time Points | QTcB interval, Day 4, 4-12 h post dose | 8.4 msec | Standard Deviation 21.55 |
| GSK1322322 1500 mg BID | Mean Change From Baseline in ECG Values at Indicated Time Points | QRS duration, Day 11, 0 h | 1.2 msec | Standard Deviation 7.19 |
| GSK1322322 1500 mg BID | Mean Change From Baseline in ECG Values at Indicated Time Points | QTcB interval, Day 8, pre morning dose | 5.4 msec | Standard Deviation 23.19 |
| GSK1322322 1500 mg BID | Mean Change From Baseline in ECG Values at Indicated Time Points | QRS duration, Day 1, 0.25-1.5 h post dose | -0.2 msec | Standard Deviation 6.32 |
| GSK1322322 1500 mg BID | Mean Change From Baseline in ECG Values at Indicated Time Points | QTcB interval, Day 11, 0 h | 0.0 msec | Standard Deviation 19.45 |
| GSK1322322 1500 mg BID | Mean Change From Baseline in ECG Values at Indicated Time Points | UncQT interval, Day 1, 0.25-1.5 h post dose | -6.0 msec | Standard Deviation 18.66 |
| GSK1322322 1500 mg BID | Mean Change From Baseline in ECG Values at Indicated Time Points | QTcF interval, Day 1, 0.25-1.5 h post dose | 1.1 msec | Standard Deviation 14.99 |
| GSK1322322 1500 mg BID | Mean Change From Baseline in ECG Values at Indicated Time Points | PR interval, Day 8, pre morning dose | 7.1 msec | Standard Deviation 12.08 |
| GSK1322322 1500 mg BID | Mean Change From Baseline in ECG Values at Indicated Time Points | QTcF interval, Day 1, 1.5-3 h post dose | 3.0 msec | Standard Deviation 13.39 |
| GSK1322322 1500 mg BID | Mean Change From Baseline in ECG Values at Indicated Time Points | UncQT interval, Day 1, 1.5-3 h post dose | -7.1 msec | Standard Deviation 19.33 |
| GSK1322322 1500 mg BID | Mean Change From Baseline in ECG Values at Indicated Time Points | QTcF interval, Day 4, 4-12 h post dose | 10.6 msec | Standard Deviation 16.68 |
| GSK1322322 1500 mg BID | Mean Change From Baseline in ECG Values at Indicated Time Points | QRS duration, Day 1, 1.5-3 h post dose | 1.6 msec | Standard Deviation 5.85 |
| GSK1322322 1500 mg BID | Mean Change From Baseline in ECG Values at Indicated Time Points | QTcF interval, Day 8, pre morning dose | 9.8 msec | Standard Deviation 19.31 |
| GSK1322322 1500 mg BID | Mean Change From Baseline in ECG Values at Indicated Time Points | UncQT interval, Day 4, 4-12 h post dose | 14.1 msec | Standard Deviation 24.16 |
| GSK1322322 1500 mg BID | Mean Change From Baseline in ECG Values at Indicated Time Points | QTcF interval, Day 11, 0 h | 2.9 msec | Standard Deviation 18.09 |
| GSK1322322 1500 mg BID | Mean Change From Baseline in ECG Values at Indicated Time Points | PR interval, Day 4, 4-12 h post dose | 6.3 msec | Standard Deviation 11.03 |
| GSK1322322 1500 mg BID | Mean Change From Baseline in ECG Values at Indicated Time Points | RR interval, Day 1, 0.25-1.5 h post dose | -49.2 msec | Standard Deviation 108.01 |
| GSK1322322 1500 mg BID | Mean Change From Baseline in ECG Values at Indicated Time Points | UncQT interval, Day 8, pre morning dose | 17.6 msec | Standard Deviation 29.12 |
| GSK1322322 1500 mg BID | Mean Change From Baseline in ECG Values at Indicated Time Points | RR interval, Day 1, 1.5-3 h post dose | -66.4 msec | Standard Deviation 104.58 |
| GSK1322322 1500 mg BID | Mean Change From Baseline in ECG Values at Indicated Time Points | QRS duration, Day 4, 4-12 h post dose | 1.6 msec | Standard Deviation 5.25 |
| GSK1322322 1500 mg BID | Mean Change From Baseline in ECG Values at Indicated Time Points | RR interval, Day 4, 4-12 h post dose | 23.7 msec | Standard Deviation 143.89 |
| GSK1322322 1500 mg BID | Mean Change From Baseline in ECG Values at Indicated Time Points | UncQT interval, Day 11, 0 h | 8.2 msec | Standard Deviation 30.04 |
| GSK1322322 1500 mg BID | Mean Change From Baseline in ECG Values at Indicated Time Points | RR interval, Day 8, pre morning dose | 51.6 msec | Standard Deviation 160.59 |
| GSK1322322 1500 mg BID | Mean Change From Baseline in ECG Values at Indicated Time Points | PR interval, Day 11, 0 h | -1.2 msec | Standard Deviation 13.86 |
| GSK1322322 1500 mg BID | Mean Change From Baseline in ECG Values at Indicated Time Points | RR interval, Day 11, 0 h | 33.9 msec | Standard Deviation 142.01 |
| GSK1322322 1500 mg BID | Mean Change From Baseline in ECG Values at Indicated Time Points | PR interval, Day 1, 0.25-1.5 h post dose | -1.0 msec | Standard Deviation 9.64 |
| Linezolid 600 mg BID | Mean Change From Baseline in ECG Values at Indicated Time Points | RR interval, Day 11, 0 h | -5.1 msec | Standard Deviation 153.97 |
| Linezolid 600 mg BID | Mean Change From Baseline in ECG Values at Indicated Time Points | PR interval, Day 1, 0.25-1.5 h post dose | 4.2 msec | Standard Deviation 12.88 |
| Linezolid 600 mg BID | Mean Change From Baseline in ECG Values at Indicated Time Points | PR interval, Day 1, 1.5-3 h post dose | 1.3 msec | Standard Deviation 11.79 |
| Linezolid 600 mg BID | Mean Change From Baseline in ECG Values at Indicated Time Points | PR interval, Day 4, 4-12 h post dose | 2.2 msec | Standard Deviation 11.75 |
| Linezolid 600 mg BID | Mean Change From Baseline in ECG Values at Indicated Time Points | PR interval, Day 8, pre morning dose | -0.0 msec | Standard Deviation 13.79 |
| Linezolid 600 mg BID | Mean Change From Baseline in ECG Values at Indicated Time Points | PR interval, Day 11, 0 h | 1.5 msec | Standard Deviation 14.27 |
| Linezolid 600 mg BID | Mean Change From Baseline in ECG Values at Indicated Time Points | QRS duration, Day 1, 0.25-1.5 h post dose | 1.2 msec | Standard Deviation 5.52 |
| Linezolid 600 mg BID | Mean Change From Baseline in ECG Values at Indicated Time Points | QRS duration, Day 1, 1.5-3 h post dose | 0.3 msec | Standard Deviation 6.84 |
| Linezolid 600 mg BID | Mean Change From Baseline in ECG Values at Indicated Time Points | QRS duration, Day 4, 4-12 h post dose | -2.2 msec | Standard Deviation 7.28 |
| Linezolid 600 mg BID | Mean Change From Baseline in ECG Values at Indicated Time Points | QRS duration, Day 8, pre morning dose | -0.2 msec | Standard Deviation 8.18 |
| Linezolid 600 mg BID | Mean Change From Baseline in ECG Values at Indicated Time Points | QRS duration, Day 11, 0 h | -0.2 msec | Standard Deviation 7.5 |
| Linezolid 600 mg BID | Mean Change From Baseline in ECG Values at Indicated Time Points | UncQT interval, Day 1, 0.25-1.5 h post dose | -3.1 msec | Standard Deviation 15.7 |
| Linezolid 600 mg BID | Mean Change From Baseline in ECG Values at Indicated Time Points | UncQT interval, Day 1, 1.5-3 h post dose | -7.2 msec | Standard Deviation 20.09 |
| Linezolid 600 mg BID | Mean Change From Baseline in ECG Values at Indicated Time Points | UncQT interval, Day 4, 4-12 h post dose | 0.5 msec | Standard Deviation 36.55 |
| Linezolid 600 mg BID | Mean Change From Baseline in ECG Values at Indicated Time Points | UncQT interval, Day 8, pre morning dose | 10.5 msec | Standard Deviation 26.68 |
| Linezolid 600 mg BID | Mean Change From Baseline in ECG Values at Indicated Time Points | UncQT interval, Day 11, 0 h | 1.5 msec | Standard Deviation 29.88 |
| Linezolid 600 mg BID | Mean Change From Baseline in ECG Values at Indicated Time Points | QTcB interval, Day 1, 0.25-1.5 h post dose | -3.8 msec | Standard Deviation 13.5 |
| Linezolid 600 mg BID | Mean Change From Baseline in ECG Values at Indicated Time Points | QTcB interval, Day 1, 1.5-3 h post dose | 1.9 msec | Standard Deviation 17.59 |
| Linezolid 600 mg BID | Mean Change From Baseline in ECG Values at Indicated Time Points | QTcB interval, Day 4, 4-12 h post dose | 7.3 msec | Standard Deviation 16.7 |
| Linezolid 600 mg BID | Mean Change From Baseline in ECG Values at Indicated Time Points | QTcB interval, Day 8, pre morning dose | 3.3 msec | Standard Deviation 21.13 |
| Linezolid 600 mg BID | Mean Change From Baseline in ECG Values at Indicated Time Points | QTcB interval, Day 11, 0 h | 3.0 msec | Standard Deviation 20.16 |
| Linezolid 600 mg BID | Mean Change From Baseline in ECG Values at Indicated Time Points | QTcF interval, Day 1, 0.25-1.5 h post dose | -3.4 msec | Standard Deviation 10.86 |
| Linezolid 600 mg BID | Mean Change From Baseline in ECG Values at Indicated Time Points | QTcF interval, Day 1, 1.5-3 h post dose | -1.2 msec | Standard Deviation 14.74 |
| Linezolid 600 mg BID | Mean Change From Baseline in ECG Values at Indicated Time Points | QTcF interval, Day 4, 4-12 h post dose | 4.9 msec | Standard Deviation 16.57 |
| Linezolid 600 mg BID | Mean Change From Baseline in ECG Values at Indicated Time Points | QTcF interval, Day 8, pre morning dose | 5.9 msec | Standard Deviation 17.99 |
| Linezolid 600 mg BID | Mean Change From Baseline in ECG Values at Indicated Time Points | QTcF interval, Day 11, 0 h | 2.3 msec | Standard Deviation 18.28 |
| Linezolid 600 mg BID | Mean Change From Baseline in ECG Values at Indicated Time Points | RR interval, Day 1, 0.25-1.5 h post dose | 0.4 msec | Standard Deviation 88.51 |
| Linezolid 600 mg BID | Mean Change From Baseline in ECG Values at Indicated Time Points | RR interval, Day 1, 1.5-3 h post dose | -43.0 msec | Standard Deviation 102.48 |
| Linezolid 600 mg BID | Mean Change From Baseline in ECG Values at Indicated Time Points | RR interval, Day 4, 4-12 h post dose | -12.2 msec | Standard Deviation 194.88 |
| Linezolid 600 mg BID | Mean Change From Baseline in ECG Values at Indicated Time Points | RR interval, Day 8, pre morning dose | 44.6 msec | Standard Deviation 146.43 |
Primary
Mean Change From Baseline in HR at Indicated Time Points
Vital sign assessments were conducted at Day 1 (pre-dose), Day 2 (pre-dose), Day 3 (pre-dose), Day 4 (4-12 hours post-dose), Day 8 (pre-dose) and Day 11. The assessments were made with the participant in a semi-supine position, having rested in that position for at least 10 minutes beforehand. Three HR measurements were taken at pre-dose on Day 1. The mean value recorded at pre-dose was classified as Baseline. Single HR was obtained at all other time points during the study. The change from Baseline was calculated by subtracting the Baseline value from the individual post-Baseline (Day 2, Day 3, Day 4, Day 8 and Day 11) values. If either the Baseline or post-Baseline value was missing, the change from Baseline was set to missing as well.
Time frame: Day 1 (Baseline) up to Day 11
Population: Safety Population. Only those participants available at the specified time points were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| GSK1322322 1500 mg BID | Mean Change From Baseline in HR at Indicated Time Points | Day 3 | 2.2 Beats per minute | Standard Deviation 11.47 |
| GSK1322322 1500 mg BID | Mean Change From Baseline in HR at Indicated Time Points | Day 8 | -3.0 Beats per minute | Standard Deviation 10.98 |
| GSK1322322 1500 mg BID | Mean Change From Baseline in HR at Indicated Time Points | Day 4 | -1.4 Beats per minute | Standard Deviation 10.28 |
| GSK1322322 1500 mg BID | Mean Change From Baseline in HR at Indicated Time Points | Day 11 | -2.5 Beats per minute | Standard Deviation 12.07 |
| GSK1322322 1500 mg BID | Mean Change From Baseline in HR at Indicated Time Points | Day 2 | 6.5 Beats per minute | Standard Deviation 13.74 |
| Linezolid 600 mg BID | Mean Change From Baseline in HR at Indicated Time Points | Day 11 | 1.7 Beats per minute | Standard Deviation 12.28 |
| Linezolid 600 mg BID | Mean Change From Baseline in HR at Indicated Time Points | Day 2 | 3.7 Beats per minute | Standard Deviation 11.93 |
| Linezolid 600 mg BID | Mean Change From Baseline in HR at Indicated Time Points | Day 3 | 4.0 Beats per minute | Standard Deviation 11.48 |
| Linezolid 600 mg BID | Mean Change From Baseline in HR at Indicated Time Points | Day 4 | 2.5 Beats per minute | Standard Deviation 19.57 |
| Linezolid 600 mg BID | Mean Change From Baseline in HR at Indicated Time Points | Day 8 | -2.7 Beats per minute | Standard Deviation 12.05 |
Primary
Mean Change From Baseline in RR at Indicated Time Points
Vital sign assessments were conducted at Day 1 (pre-dose), Day 2 (pre-dose), Day 3 (pre-dose), Day 4 (4-12 hours post-dose), Day 8 (pre-dose) and Day 11. The assessments were made with the participant in a semi-supine position, having rested in that position for at least 10 minutes beforehand. Three RR measurements were taken at pre-dose on Day 1. The mean value recorded at pre-dose was classified as Baseline. Single RR was obtained at all other time points during the study. The change from Baseline was calculated by subtracting the Baseline value from the individual post-Baseline (Day 2, Day 3, Day 4, Day 8 and Day 11) values. If either the Baseline or post-Baseline value was missing, the change from Baseline was set to missing as well.
Time frame: Day 1 (Baseline) up to Day 11
Population: Safety Population. Only those participants available at the specified time points were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| GSK1322322 1500 mg BID | Mean Change From Baseline in RR at Indicated Time Points | Day 3 | 0.5 Breaths per minute | Standard Deviation 2.41 |
| GSK1322322 1500 mg BID | Mean Change From Baseline in RR at Indicated Time Points | Day 8 | 0.2 Breaths per minute | Standard Deviation 1.98 |
| GSK1322322 1500 mg BID | Mean Change From Baseline in RR at Indicated Time Points | Day 4 | 0.4 Breaths per minute | Standard Deviation 2.35 |
| GSK1322322 1500 mg BID | Mean Change From Baseline in RR at Indicated Time Points | Day 11 | 0.6 Breaths per minute | Standard Deviation 2.11 |
| GSK1322322 1500 mg BID | Mean Change From Baseline in RR at Indicated Time Points | Day 2 | 0.4 Breaths per minute | Standard Deviation 1.8 |
| Linezolid 600 mg BID | Mean Change From Baseline in RR at Indicated Time Points | Day 11 | -1.2 Breaths per minute | Standard Deviation 1.89 |
| Linezolid 600 mg BID | Mean Change From Baseline in RR at Indicated Time Points | Day 2 | -0.7 Breaths per minute | Standard Deviation 2.07 |
| Linezolid 600 mg BID | Mean Change From Baseline in RR at Indicated Time Points | Day 3 | -0.7 Breaths per minute | Standard Deviation 1.43 |
| Linezolid 600 mg BID | Mean Change From Baseline in RR at Indicated Time Points | Day 4 | -0.6 Breaths per minute | Standard Deviation 2.14 |
| Linezolid 600 mg BID | Mean Change From Baseline in RR at Indicated Time Points | Day 8 | -0.8 Breaths per minute | Standard Deviation 1.75 |
Primary
Mean Change From Baseline in SBP and DBP at Indicated Time Points
Vital sign assessments were conducted at Day 1 (pre-dose), Day 2 (pre-dose), Day 3 (pre-dose), Day 4 (4-12 hours post-dose), Day 8 (pre-dose) and Day 11. The assessments were made with the participant in a semi-supine position, having rested in that position for at least 10 minutes beforehand. Three BP measurements were taken at pre-dose on Day 1. The mean value recorded at pre-dose was classified as Baseline. Single BP was obtained at all other time points during the study. The change from Baseline was calculated by subtracting the Baseline value from the individual post-Baseline (Day 2, Day 3, Day 4, Day 8 and Day 11) values. If either the Baseline or post-Baseline value was missing, the change from Baseline was set to missing as well.
Time frame: Day 1 (Baseline) up to Day 11
Population: Safety Population. Only those participants available at the specified time points were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| GSK1322322 1500 mg BID | Mean Change From Baseline in SBP and DBP at Indicated Time Points | SBP, Day 2 | -6.5 mmHg | Standard Deviation 12.23 |
| GSK1322322 1500 mg BID | Mean Change From Baseline in SBP and DBP at Indicated Time Points | SBP, Day 3 | -5.2 mmHg | Standard Deviation 11.24 |
| GSK1322322 1500 mg BID | Mean Change From Baseline in SBP and DBP at Indicated Time Points | SBP, Day 4 | -6.5 mmHg | Standard Deviation 11.31 |
| GSK1322322 1500 mg BID | Mean Change From Baseline in SBP and DBP at Indicated Time Points | SBP, Day 8 | -2.5 mmHg | Standard Deviation 12.23 |
| GSK1322322 1500 mg BID | Mean Change From Baseline in SBP and DBP at Indicated Time Points | SBP, Day 11 | -2.7 mmHg | Standard Deviation 12.7 |
| GSK1322322 1500 mg BID | Mean Change From Baseline in SBP and DBP at Indicated Time Points | DBP, Day 2 | -2.6 mmHg | Standard Deviation 8.64 |
| GSK1322322 1500 mg BID | Mean Change From Baseline in SBP and DBP at Indicated Time Points | DBP, Day 3 | -4.8 mmHg | Standard Deviation 8.64 |
| GSK1322322 1500 mg BID | Mean Change From Baseline in SBP and DBP at Indicated Time Points | DBP, Day 4 | -8.7 mmHg | Standard Deviation 9.02 |
| GSK1322322 1500 mg BID | Mean Change From Baseline in SBP and DBP at Indicated Time Points | DBP, Day 8 | -4.7 mmHg | Standard Deviation 9.92 |
| GSK1322322 1500 mg BID | Mean Change From Baseline in SBP and DBP at Indicated Time Points | DBP, Day 11 | -4.4 mmHg | Standard Deviation 7.61 |
| Linezolid 600 mg BID | Mean Change From Baseline in SBP and DBP at Indicated Time Points | DBP, Day 4 | 2.5 mmHg | Standard Deviation 12.1 |
| Linezolid 600 mg BID | Mean Change From Baseline in SBP and DBP at Indicated Time Points | SBP, Day 2 | 1.6 mmHg | Standard Deviation 15.35 |
| Linezolid 600 mg BID | Mean Change From Baseline in SBP and DBP at Indicated Time Points | DBP, Day 2 | 1.8 mmHg | Standard Deviation 6.46 |
| Linezolid 600 mg BID | Mean Change From Baseline in SBP and DBP at Indicated Time Points | SBP, Day 3 | 3.7 mmHg | Standard Deviation 18.64 |
| Linezolid 600 mg BID | Mean Change From Baseline in SBP and DBP at Indicated Time Points | DBP, Day 11 | -1.7 mmHg | Standard Deviation 9.53 |
| Linezolid 600 mg BID | Mean Change From Baseline in SBP and DBP at Indicated Time Points | SBP, Day 4 | 3.1 mmHg | Standard Deviation 15.21 |
| Linezolid 600 mg BID | Mean Change From Baseline in SBP and DBP at Indicated Time Points | DBP, Day 3 | 2.7 mmHg | Standard Deviation 13.59 |
| Linezolid 600 mg BID | Mean Change From Baseline in SBP and DBP at Indicated Time Points | SBP, Day 8 | -2.7 mmHg | Standard Deviation 13.95 |
| Linezolid 600 mg BID | Mean Change From Baseline in SBP and DBP at Indicated Time Points | DBP, Day 8 | -2.8 mmHg | Standard Deviation 11 |
| Linezolid 600 mg BID | Mean Change From Baseline in SBP and DBP at Indicated Time Points | SBP, Day 11 | -2.6 mmHg | Standard Deviation 15.44 |
Primary
Mean Clinical Chemistry Parameter of Estradiol at Indicated Time Point
Blood samples were obtained for analysis of estradiol at Day 1.
Time frame: Day 1
Population: Safety Population. Only those participants available at the specified time points were analyzed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| GSK1322322 1500 mg BID | Mean Clinical Chemistry Parameter of Estradiol at Indicated Time Point | 261.8 Picomole (pmol)/Liter | Standard Deviation 218.2 |
| Linezolid 600 mg BID | Mean Clinical Chemistry Parameter of Estradiol at Indicated Time Point | 61.3 Picomole (pmol)/Liter | Standard Deviation 22.37 |
Primary
Mean Clinical Chemistry Parameter of High Sensitivity C-Reactive Protein at Indicated Time Points
Blood samples were obtained for analysis of high sensitivity C-Reactive protein at Day 1, Day 2, Day 3, Day 4, Day 8, Day 11 and 7 Day Follow-up. Baseline value was defined as the assessment done on Day 1.
Time frame: Up to Follow-up (7 Day Follow-up, Day 19)
Population: Safety Population. Only those participants available at the specified time points were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| GSK1322322 1500 mg BID | Mean Clinical Chemistry Parameter of High Sensitivity C-Reactive Protein at Indicated Time Points | Day 3 | 27.13 mg/Liter | Standard Deviation 32.425 |
| GSK1322322 1500 mg BID | Mean Clinical Chemistry Parameter of High Sensitivity C-Reactive Protein at Indicated Time Points | Day 8 | 6.87 mg/Liter | Standard Deviation 7.561 |
| GSK1322322 1500 mg BID | Mean Clinical Chemistry Parameter of High Sensitivity C-Reactive Protein at Indicated Time Points | Day 2 | 33.76 mg/Liter | Standard Deviation 36.759 |
| GSK1322322 1500 mg BID | Mean Clinical Chemistry Parameter of High Sensitivity C-Reactive Protein at Indicated Time Points | Day 11 | 7.56 mg/Liter | Standard Deviation 9.711 |
| GSK1322322 1500 mg BID | Mean Clinical Chemistry Parameter of High Sensitivity C-Reactive Protein at Indicated Time Points | Day 4 | 15.71 mg/Liter | Standard Deviation 23.564 |
| GSK1322322 1500 mg BID | Mean Clinical Chemistry Parameter of High Sensitivity C-Reactive Protein at Indicated Time Points | 7 Day Follow-up | 10.25 mg/Liter | Standard Deviation 16.299 |
| GSK1322322 1500 mg BID | Mean Clinical Chemistry Parameter of High Sensitivity C-Reactive Protein at Indicated Time Points | Day 1 | 38.39 mg/Liter | Standard Deviation 35.968 |
| Linezolid 600 mg BID | Mean Clinical Chemistry Parameter of High Sensitivity C-Reactive Protein at Indicated Time Points | 7 Day Follow-up | 7.29 mg/Liter | Standard Deviation 8.377 |
| Linezolid 600 mg BID | Mean Clinical Chemistry Parameter of High Sensitivity C-Reactive Protein at Indicated Time Points | Day 1 | 43.97 mg/Liter | Standard Deviation 42.829 |
| Linezolid 600 mg BID | Mean Clinical Chemistry Parameter of High Sensitivity C-Reactive Protein at Indicated Time Points | Day 2 | 40.72 mg/Liter | Standard Deviation 43.485 |
| Linezolid 600 mg BID | Mean Clinical Chemistry Parameter of High Sensitivity C-Reactive Protein at Indicated Time Points | Day 3 | 30.99 mg/Liter | Standard Deviation 42.93 |
| Linezolid 600 mg BID | Mean Clinical Chemistry Parameter of High Sensitivity C-Reactive Protein at Indicated Time Points | Day 4 | 21.82 mg/Liter | Standard Deviation 34.947 |
| Linezolid 600 mg BID | Mean Clinical Chemistry Parameter of High Sensitivity C-Reactive Protein at Indicated Time Points | Day 8 | 6.02 mg/Liter | Standard Deviation 5.28 |
| Linezolid 600 mg BID | Mean Clinical Chemistry Parameter of High Sensitivity C-Reactive Protein at Indicated Time Points | Day 11 | 4.74 mg/Liter | Standard Deviation 4.658 |
Primary
Mean Clinical Chemistry Parameters of Albumin and Total Protein at Indicated Time Points
Blood samples were obtained for analysis of albumin and total protein at Day 1, Day 4, Day 8, Day 11, 7 Day Follow-up and 28 Day Follow-up. Baseline value was defined as the assessment done on Day 1.
Time frame: Up to Follow-up (28 Day Follow-up, Day 40)
Population: Safety Population. Only those participants available at the specified time points were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| GSK1322322 1500 mg BID | Mean Clinical Chemistry Parameters of Albumin and Total Protein at Indicated Time Points | Albumin, Day 4 | 40.0 Gram/Liter | Standard Deviation 3.7 |
| GSK1322322 1500 mg BID | Mean Clinical Chemistry Parameters of Albumin and Total Protein at Indicated Time Points | Total protein, Day 1 | 72.6 Gram/Liter | Standard Deviation 5.86 |
| GSK1322322 1500 mg BID | Mean Clinical Chemistry Parameters of Albumin and Total Protein at Indicated Time Points | Total protein, Day 4 | 72.0 Gram/Liter | Standard Deviation 5.98 |
| GSK1322322 1500 mg BID | Mean Clinical Chemistry Parameters of Albumin and Total Protein at Indicated Time Points | Albumin, Day 11 | 40.9 Gram/Liter | Standard Deviation 3.59 |
| GSK1322322 1500 mg BID | Mean Clinical Chemistry Parameters of Albumin and Total Protein at Indicated Time Points | Total protein, Day 8 | 72.8 Gram/Liter | Standard Deviation 5.94 |
| GSK1322322 1500 mg BID | Mean Clinical Chemistry Parameters of Albumin and Total Protein at Indicated Time Points | Albumin, Day 1 | 39.9 Gram/Liter | Standard Deviation 3.41 |
| GSK1322322 1500 mg BID | Mean Clinical Chemistry Parameters of Albumin and Total Protein at Indicated Time Points | Total protein, Day 11 | 73.2 Gram/Liter | Standard Deviation 6.19 |
| GSK1322322 1500 mg BID | Mean Clinical Chemistry Parameters of Albumin and Total Protein at Indicated Time Points | Albumin, 7 Day Follow-up | 41.4 Gram/Liter | Standard Deviation 4.03 |
| GSK1322322 1500 mg BID | Mean Clinical Chemistry Parameters of Albumin and Total Protein at Indicated Time Points | Total protein, 7 Day Follow-up | 73.5 Gram/Liter | Standard Deviation 5.79 |
| GSK1322322 1500 mg BID | Mean Clinical Chemistry Parameters of Albumin and Total Protein at Indicated Time Points | Albumin, Day 8 | 40.3 Gram/Liter | Standard Deviation 4.04 |
| GSK1322322 1500 mg BID | Mean Clinical Chemistry Parameters of Albumin and Total Protein at Indicated Time Points | Total protein, 28 Day Follow-up | 73.2 Gram/Liter | Standard Deviation 6.35 |
| GSK1322322 1500 mg BID | Mean Clinical Chemistry Parameters of Albumin and Total Protein at Indicated Time Points | Albumin, 28 Day Follow-up | 41.5 Gram/Liter | Standard Deviation 4.03 |
| Linezolid 600 mg BID | Mean Clinical Chemistry Parameters of Albumin and Total Protein at Indicated Time Points | Total protein, 28 Day Follow-up | 72.6 Gram/Liter | Standard Deviation 4.42 |
| Linezolid 600 mg BID | Mean Clinical Chemistry Parameters of Albumin and Total Protein at Indicated Time Points | Albumin, Day 1 | 40.3 Gram/Liter | Standard Deviation 3.47 |
| Linezolid 600 mg BID | Mean Clinical Chemistry Parameters of Albumin and Total Protein at Indicated Time Points | Albumin, Day 4 | 40.5 Gram/Liter | Standard Deviation 2.66 |
| Linezolid 600 mg BID | Mean Clinical Chemistry Parameters of Albumin and Total Protein at Indicated Time Points | Albumin, Day 8 | 40.4 Gram/Liter | Standard Deviation 3.35 |
| Linezolid 600 mg BID | Mean Clinical Chemistry Parameters of Albumin and Total Protein at Indicated Time Points | Albumin, Day 11 | 42.2 Gram/Liter | Standard Deviation 2.83 |
| Linezolid 600 mg BID | Mean Clinical Chemistry Parameters of Albumin and Total Protein at Indicated Time Points | Albumin, 7 Day Follow-up | 42.8 Gram/Liter | Standard Deviation 3.02 |
| Linezolid 600 mg BID | Mean Clinical Chemistry Parameters of Albumin and Total Protein at Indicated Time Points | Albumin, 28 Day Follow-up | 41.1 Gram/Liter | Standard Deviation 3.04 |
| Linezolid 600 mg BID | Mean Clinical Chemistry Parameters of Albumin and Total Protein at Indicated Time Points | Total protein, Day 4 | 72.4 Gram/Liter | Standard Deviation 6.8 |
| Linezolid 600 mg BID | Mean Clinical Chemistry Parameters of Albumin and Total Protein at Indicated Time Points | Total protein, Day 8 | 71.3 Gram/Liter | Standard Deviation 4.46 |
| Linezolid 600 mg BID | Mean Clinical Chemistry Parameters of Albumin and Total Protein at Indicated Time Points | Total protein, Day 11 | 73.4 Gram/Liter | Standard Deviation 4.58 |
| Linezolid 600 mg BID | Mean Clinical Chemistry Parameters of Albumin and Total Protein at Indicated Time Points | Total protein, 7 Day Follow-up | 74.3 Gram/Liter | Standard Deviation 6.44 |
| Linezolid 600 mg BID | Mean Clinical Chemistry Parameters of Albumin and Total Protein at Indicated Time Points | Total protein, Day 1 | 72.2 Gram/Liter | Standard Deviation 6.86 |
Primary
Mean Clinical Chemistry Parameters of ALT, Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Follicle Stimulating Hormone (FSH), Gamma Glutamyl Transferase (GGT), Lactate Dehydrogenase (LDH) and Creatine Kinase at Indicated Time Points
Blood samples were obtained for analysis of ALT, ALP, AST, FSH, GGT, LDH and creatine kinase at Day 1, Day 4, Day 8, Day 11, 7 Day Follow-up and 28 Day Follow-up. Baseline value was defined as the assessment done on Day 1.
Time frame: Up to Follow-up (28 Day Follow-up, Day 40)
Population: Safety Population. Only those participants available at the specified time points were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| GSK1322322 1500 mg BID | Mean Clinical Chemistry Parameters of ALT, Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Follicle Stimulating Hormone (FSH), Gamma Glutamyl Transferase (GGT), Lactate Dehydrogenase (LDH) and Creatine Kinase at Indicated Time Points | FSH, Day 1 | 21.47 International units (IU)/Liter | Standard Deviation 14.585 |
| GSK1322322 1500 mg BID | Mean Clinical Chemistry Parameters of ALT, Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Follicle Stimulating Hormone (FSH), Gamma Glutamyl Transferase (GGT), Lactate Dehydrogenase (LDH) and Creatine Kinase at Indicated Time Points | ALP, Day 4 | 95.0 International units (IU)/Liter | Standard Deviation 21.99 |
| GSK1322322 1500 mg BID | Mean Clinical Chemistry Parameters of ALT, Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Follicle Stimulating Hormone (FSH), Gamma Glutamyl Transferase (GGT), Lactate Dehydrogenase (LDH) and Creatine Kinase at Indicated Time Points | ALP, Day 8 | 94.8 International units (IU)/Liter | Standard Deviation 21.26 |
| GSK1322322 1500 mg BID | Mean Clinical Chemistry Parameters of ALT, Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Follicle Stimulating Hormone (FSH), Gamma Glutamyl Transferase (GGT), Lactate Dehydrogenase (LDH) and Creatine Kinase at Indicated Time Points | ALP, Day 11 | 95.4 International units (IU)/Liter | Standard Deviation 23.88 |
| GSK1322322 1500 mg BID | Mean Clinical Chemistry Parameters of ALT, Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Follicle Stimulating Hormone (FSH), Gamma Glutamyl Transferase (GGT), Lactate Dehydrogenase (LDH) and Creatine Kinase at Indicated Time Points | ALP, 7 Day Follow-up | 95.6 International units (IU)/Liter | Standard Deviation 27.45 |
| GSK1322322 1500 mg BID | Mean Clinical Chemistry Parameters of ALT, Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Follicle Stimulating Hormone (FSH), Gamma Glutamyl Transferase (GGT), Lactate Dehydrogenase (LDH) and Creatine Kinase at Indicated Time Points | ALP, 28 Day Follow-up | 95.2 International units (IU)/Liter | Standard Deviation 27.79 |
| GSK1322322 1500 mg BID | Mean Clinical Chemistry Parameters of ALT, Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Follicle Stimulating Hormone (FSH), Gamma Glutamyl Transferase (GGT), Lactate Dehydrogenase (LDH) and Creatine Kinase at Indicated Time Points | ALT, Day 1 | 26.5 International units (IU)/Liter | Standard Deviation 18.55 |
| GSK1322322 1500 mg BID | Mean Clinical Chemistry Parameters of ALT, Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Follicle Stimulating Hormone (FSH), Gamma Glutamyl Transferase (GGT), Lactate Dehydrogenase (LDH) and Creatine Kinase at Indicated Time Points | ALT, Day 4 | 30.1 International units (IU)/Liter | Standard Deviation 29.46 |
| GSK1322322 1500 mg BID | Mean Clinical Chemistry Parameters of ALT, Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Follicle Stimulating Hormone (FSH), Gamma Glutamyl Transferase (GGT), Lactate Dehydrogenase (LDH) and Creatine Kinase at Indicated Time Points | ALT, Day 8 | 34.3 International units (IU)/Liter | Standard Deviation 30.9 |
| GSK1322322 1500 mg BID | Mean Clinical Chemistry Parameters of ALT, Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Follicle Stimulating Hormone (FSH), Gamma Glutamyl Transferase (GGT), Lactate Dehydrogenase (LDH) and Creatine Kinase at Indicated Time Points | ALT, Day 11 | 39.4 International units (IU)/Liter | Standard Deviation 51.29 |
| GSK1322322 1500 mg BID | Mean Clinical Chemistry Parameters of ALT, Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Follicle Stimulating Hormone (FSH), Gamma Glutamyl Transferase (GGT), Lactate Dehydrogenase (LDH) and Creatine Kinase at Indicated Time Points | ALT, 7 Day Follow-up | 37.5 International units (IU)/Liter | Standard Deviation 35.13 |
| GSK1322322 1500 mg BID | Mean Clinical Chemistry Parameters of ALT, Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Follicle Stimulating Hormone (FSH), Gamma Glutamyl Transferase (GGT), Lactate Dehydrogenase (LDH) and Creatine Kinase at Indicated Time Points | ALT, 28 Day Follow-up | 28.4 International units (IU)/Liter | Standard Deviation 19.03 |
| GSK1322322 1500 mg BID | Mean Clinical Chemistry Parameters of ALT, Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Follicle Stimulating Hormone (FSH), Gamma Glutamyl Transferase (GGT), Lactate Dehydrogenase (LDH) and Creatine Kinase at Indicated Time Points | AST, Day 1 | 25.9 International units (IU)/Liter | Standard Deviation 14.49 |
| GSK1322322 1500 mg BID | Mean Clinical Chemistry Parameters of ALT, Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Follicle Stimulating Hormone (FSH), Gamma Glutamyl Transferase (GGT), Lactate Dehydrogenase (LDH) and Creatine Kinase at Indicated Time Points | AST, Day 4 | 27.3 International units (IU)/Liter | Standard Deviation 15.01 |
| GSK1322322 1500 mg BID | Mean Clinical Chemistry Parameters of ALT, Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Follicle Stimulating Hormone (FSH), Gamma Glutamyl Transferase (GGT), Lactate Dehydrogenase (LDH) and Creatine Kinase at Indicated Time Points | AST, Day 8 | 32.0 International units (IU)/Liter | Standard Deviation 25.19 |
| GSK1322322 1500 mg BID | Mean Clinical Chemistry Parameters of ALT, Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Follicle Stimulating Hormone (FSH), Gamma Glutamyl Transferase (GGT), Lactate Dehydrogenase (LDH) and Creatine Kinase at Indicated Time Points | AST, Day 11 | 34.6 International units (IU)/Liter | Standard Deviation 30.89 |
| GSK1322322 1500 mg BID | Mean Clinical Chemistry Parameters of ALT, Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Follicle Stimulating Hormone (FSH), Gamma Glutamyl Transferase (GGT), Lactate Dehydrogenase (LDH) and Creatine Kinase at Indicated Time Points | AST, 7 Day Follow-up | 35.5 International units (IU)/Liter | Standard Deviation 25.72 |
| GSK1322322 1500 mg BID | Mean Clinical Chemistry Parameters of ALT, Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Follicle Stimulating Hormone (FSH), Gamma Glutamyl Transferase (GGT), Lactate Dehydrogenase (LDH) and Creatine Kinase at Indicated Time Points | AST, 28 Day Follow-up | 30.2 International units (IU)/Liter | Standard Deviation 21.83 |
| GSK1322322 1500 mg BID | Mean Clinical Chemistry Parameters of ALT, Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Follicle Stimulating Hormone (FSH), Gamma Glutamyl Transferase (GGT), Lactate Dehydrogenase (LDH) and Creatine Kinase at Indicated Time Points | Creatine kinase, Day 1 | 118.1 International units (IU)/Liter | Standard Deviation 187.13 |
| GSK1322322 1500 mg BID | Mean Clinical Chemistry Parameters of ALT, Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Follicle Stimulating Hormone (FSH), Gamma Glutamyl Transferase (GGT), Lactate Dehydrogenase (LDH) and Creatine Kinase at Indicated Time Points | Creatine kinase, Day 4 | 135.2 International units (IU)/Liter | Standard Deviation 98.96 |
| GSK1322322 1500 mg BID | Mean Clinical Chemistry Parameters of ALT, Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Follicle Stimulating Hormone (FSH), Gamma Glutamyl Transferase (GGT), Lactate Dehydrogenase (LDH) and Creatine Kinase at Indicated Time Points | Creatine kinase, Day 8 | 117.3 International units (IU)/Liter | Standard Deviation 71.14 |
| GSK1322322 1500 mg BID | Mean Clinical Chemistry Parameters of ALT, Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Follicle Stimulating Hormone (FSH), Gamma Glutamyl Transferase (GGT), Lactate Dehydrogenase (LDH) and Creatine Kinase at Indicated Time Points | Creatine kinase, Day 11 | 135.8 International units (IU)/Liter | Standard Deviation 113.14 |
| GSK1322322 1500 mg BID | Mean Clinical Chemistry Parameters of ALT, Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Follicle Stimulating Hormone (FSH), Gamma Glutamyl Transferase (GGT), Lactate Dehydrogenase (LDH) and Creatine Kinase at Indicated Time Points | Creatine kinase, 7 Day Follow-up | 204.7 International units (IU)/Liter | Standard Deviation 561.92 |
| GSK1322322 1500 mg BID | Mean Clinical Chemistry Parameters of ALT, Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Follicle Stimulating Hormone (FSH), Gamma Glutamyl Transferase (GGT), Lactate Dehydrogenase (LDH) and Creatine Kinase at Indicated Time Points | Creatine kinase, 28 Day Follow-up | 155.3 International units (IU)/Liter | Standard Deviation 168.84 |
| GSK1322322 1500 mg BID | Mean Clinical Chemistry Parameters of ALT, Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Follicle Stimulating Hormone (FSH), Gamma Glutamyl Transferase (GGT), Lactate Dehydrogenase (LDH) and Creatine Kinase at Indicated Time Points | ALP, Day 1 | 102.5 International units (IU)/Liter | Standard Deviation 39.65 |
| GSK1322322 1500 mg BID | Mean Clinical Chemistry Parameters of ALT, Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Follicle Stimulating Hormone (FSH), Gamma Glutamyl Transferase (GGT), Lactate Dehydrogenase (LDH) and Creatine Kinase at Indicated Time Points | GGT, Day 1 | 52.9 International units (IU)/Liter | Standard Deviation 51.7 |
| GSK1322322 1500 mg BID | Mean Clinical Chemistry Parameters of ALT, Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Follicle Stimulating Hormone (FSH), Gamma Glutamyl Transferase (GGT), Lactate Dehydrogenase (LDH) and Creatine Kinase at Indicated Time Points | GGT, Day 4 | 55.3 International units (IU)/Liter | Standard Deviation 56.17 |
| GSK1322322 1500 mg BID | Mean Clinical Chemistry Parameters of ALT, Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Follicle Stimulating Hormone (FSH), Gamma Glutamyl Transferase (GGT), Lactate Dehydrogenase (LDH) and Creatine Kinase at Indicated Time Points | GGT, Day 8 | 57.7 International units (IU)/Liter | Standard Deviation 52.08 |
| GSK1322322 1500 mg BID | Mean Clinical Chemistry Parameters of ALT, Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Follicle Stimulating Hormone (FSH), Gamma Glutamyl Transferase (GGT), Lactate Dehydrogenase (LDH) and Creatine Kinase at Indicated Time Points | GGT, Day 11 | 55.7 International units (IU)/Liter | Standard Deviation 57.22 |
| GSK1322322 1500 mg BID | Mean Clinical Chemistry Parameters of ALT, Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Follicle Stimulating Hormone (FSH), Gamma Glutamyl Transferase (GGT), Lactate Dehydrogenase (LDH) and Creatine Kinase at Indicated Time Points | GGT, 7 Day Follow-up | 65.1 International units (IU)/Liter | Standard Deviation 70.73 |
| GSK1322322 1500 mg BID | Mean Clinical Chemistry Parameters of ALT, Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Follicle Stimulating Hormone (FSH), Gamma Glutamyl Transferase (GGT), Lactate Dehydrogenase (LDH) and Creatine Kinase at Indicated Time Points | GGT, 28 Day Follow-up | 50.1 International units (IU)/Liter | Standard Deviation 57.09 |
| GSK1322322 1500 mg BID | Mean Clinical Chemistry Parameters of ALT, Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Follicle Stimulating Hormone (FSH), Gamma Glutamyl Transferase (GGT), Lactate Dehydrogenase (LDH) and Creatine Kinase at Indicated Time Points | LDH, Day 1 | 172.0 International units (IU)/Liter | — |
| Linezolid 600 mg BID | Mean Clinical Chemistry Parameters of ALT, Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Follicle Stimulating Hormone (FSH), Gamma Glutamyl Transferase (GGT), Lactate Dehydrogenase (LDH) and Creatine Kinase at Indicated Time Points | ALP, Day 1 | 97.7 International units (IU)/Liter | Standard Deviation 34.73 |
| Linezolid 600 mg BID | Mean Clinical Chemistry Parameters of ALT, Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Follicle Stimulating Hormone (FSH), Gamma Glutamyl Transferase (GGT), Lactate Dehydrogenase (LDH) and Creatine Kinase at Indicated Time Points | Creatine kinase, 28 Day Follow-up | 117.5 International units (IU)/Liter | Standard Deviation 64.86 |
| Linezolid 600 mg BID | Mean Clinical Chemistry Parameters of ALT, Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Follicle Stimulating Hormone (FSH), Gamma Glutamyl Transferase (GGT), Lactate Dehydrogenase (LDH) and Creatine Kinase at Indicated Time Points | ALP, Day 4 | 92.4 International units (IU)/Liter | Standard Deviation 26.32 |
| Linezolid 600 mg BID | Mean Clinical Chemistry Parameters of ALT, Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Follicle Stimulating Hormone (FSH), Gamma Glutamyl Transferase (GGT), Lactate Dehydrogenase (LDH) and Creatine Kinase at Indicated Time Points | AST, 7 Day Follow-up | 28.7 International units (IU)/Liter | Standard Deviation 11.37 |
| Linezolid 600 mg BID | Mean Clinical Chemistry Parameters of ALT, Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Follicle Stimulating Hormone (FSH), Gamma Glutamyl Transferase (GGT), Lactate Dehydrogenase (LDH) and Creatine Kinase at Indicated Time Points | ALP, Day 8 | 88.2 International units (IU)/Liter | Standard Deviation 21.63 |
| Linezolid 600 mg BID | Mean Clinical Chemistry Parameters of ALT, Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Follicle Stimulating Hormone (FSH), Gamma Glutamyl Transferase (GGT), Lactate Dehydrogenase (LDH) and Creatine Kinase at Indicated Time Points | GGT, Day 8 | 57.7 International units (IU)/Liter | Standard Deviation 45.2 |
| Linezolid 600 mg BID | Mean Clinical Chemistry Parameters of ALT, Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Follicle Stimulating Hormone (FSH), Gamma Glutamyl Transferase (GGT), Lactate Dehydrogenase (LDH) and Creatine Kinase at Indicated Time Points | ALP, Day 11 | 89.3 International units (IU)/Liter | Standard Deviation 19.06 |
| Linezolid 600 mg BID | Mean Clinical Chemistry Parameters of ALT, Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Follicle Stimulating Hormone (FSH), Gamma Glutamyl Transferase (GGT), Lactate Dehydrogenase (LDH) and Creatine Kinase at Indicated Time Points | AST, 28 Day Follow-up | 24.0 International units (IU)/Liter | Standard Deviation 10.11 |
| Linezolid 600 mg BID | Mean Clinical Chemistry Parameters of ALT, Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Follicle Stimulating Hormone (FSH), Gamma Glutamyl Transferase (GGT), Lactate Dehydrogenase (LDH) and Creatine Kinase at Indicated Time Points | ALP, 7 Day Follow-up | 90.9 International units (IU)/Liter | Standard Deviation 22.18 |
| Linezolid 600 mg BID | Mean Clinical Chemistry Parameters of ALT, Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Follicle Stimulating Hormone (FSH), Gamma Glutamyl Transferase (GGT), Lactate Dehydrogenase (LDH) and Creatine Kinase at Indicated Time Points | FSH, Day 1 | 16.05 International units (IU)/Liter | Standard Deviation 24.955 |
| Linezolid 600 mg BID | Mean Clinical Chemistry Parameters of ALT, Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Follicle Stimulating Hormone (FSH), Gamma Glutamyl Transferase (GGT), Lactate Dehydrogenase (LDH) and Creatine Kinase at Indicated Time Points | ALP, 28 Day Follow-up | 92.9 International units (IU)/Liter | Standard Deviation 29.85 |
| Linezolid 600 mg BID | Mean Clinical Chemistry Parameters of ALT, Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Follicle Stimulating Hormone (FSH), Gamma Glutamyl Transferase (GGT), Lactate Dehydrogenase (LDH) and Creatine Kinase at Indicated Time Points | Creatine kinase, Day 1 | 191.1 International units (IU)/Liter | Standard Deviation 396.31 |
| Linezolid 600 mg BID | Mean Clinical Chemistry Parameters of ALT, Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Follicle Stimulating Hormone (FSH), Gamma Glutamyl Transferase (GGT), Lactate Dehydrogenase (LDH) and Creatine Kinase at Indicated Time Points | ALT, Day 1 | 27.3 International units (IU)/Liter | Standard Deviation 17.94 |
| Linezolid 600 mg BID | Mean Clinical Chemistry Parameters of ALT, Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Follicle Stimulating Hormone (FSH), Gamma Glutamyl Transferase (GGT), Lactate Dehydrogenase (LDH) and Creatine Kinase at Indicated Time Points | GGT, 7 Day Follow-up | 52.8 International units (IU)/Liter | Standard Deviation 39.12 |
| Linezolid 600 mg BID | Mean Clinical Chemistry Parameters of ALT, Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Follicle Stimulating Hormone (FSH), Gamma Glutamyl Transferase (GGT), Lactate Dehydrogenase (LDH) and Creatine Kinase at Indicated Time Points | ALT, Day 4 | 25.4 International units (IU)/Liter | Standard Deviation 12.11 |
| Linezolid 600 mg BID | Mean Clinical Chemistry Parameters of ALT, Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Follicle Stimulating Hormone (FSH), Gamma Glutamyl Transferase (GGT), Lactate Dehydrogenase (LDH) and Creatine Kinase at Indicated Time Points | Creatine kinase, Day 4 | 166.7 International units (IU)/Liter | Standard Deviation 209.06 |
| Linezolid 600 mg BID | Mean Clinical Chemistry Parameters of ALT, Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Follicle Stimulating Hormone (FSH), Gamma Glutamyl Transferase (GGT), Lactate Dehydrogenase (LDH) and Creatine Kinase at Indicated Time Points | ALT, Day 8 | 34.0 International units (IU)/Liter | Standard Deviation 35.2 |
| Linezolid 600 mg BID | Mean Clinical Chemistry Parameters of ALT, Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Follicle Stimulating Hormone (FSH), Gamma Glutamyl Transferase (GGT), Lactate Dehydrogenase (LDH) and Creatine Kinase at Indicated Time Points | GGT, Day 1 | 52.6 International units (IU)/Liter | Standard Deviation 52.17 |
| Linezolid 600 mg BID | Mean Clinical Chemistry Parameters of ALT, Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Follicle Stimulating Hormone (FSH), Gamma Glutamyl Transferase (GGT), Lactate Dehydrogenase (LDH) and Creatine Kinase at Indicated Time Points | ALT, Day 11 | 32.2 International units (IU)/Liter | Standard Deviation 30.22 |
| Linezolid 600 mg BID | Mean Clinical Chemistry Parameters of ALT, Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Follicle Stimulating Hormone (FSH), Gamma Glutamyl Transferase (GGT), Lactate Dehydrogenase (LDH) and Creatine Kinase at Indicated Time Points | Creatine kinase, Day 8 | 120.3 International units (IU)/Liter | Standard Deviation 69.81 |
| Linezolid 600 mg BID | Mean Clinical Chemistry Parameters of ALT, Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Follicle Stimulating Hormone (FSH), Gamma Glutamyl Transferase (GGT), Lactate Dehydrogenase (LDH) and Creatine Kinase at Indicated Time Points | ALT, 7 Day Follow-up | 32.6 International units (IU)/Liter | Standard Deviation 25.03 |
| Linezolid 600 mg BID | Mean Clinical Chemistry Parameters of ALT, Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Follicle Stimulating Hormone (FSH), Gamma Glutamyl Transferase (GGT), Lactate Dehydrogenase (LDH) and Creatine Kinase at Indicated Time Points | GGT, Day 11 | 53.5 International units (IU)/Liter | Standard Deviation 40.95 |
| Linezolid 600 mg BID | Mean Clinical Chemistry Parameters of ALT, Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Follicle Stimulating Hormone (FSH), Gamma Glutamyl Transferase (GGT), Lactate Dehydrogenase (LDH) and Creatine Kinase at Indicated Time Points | ALT, 28 Day Follow-up | 22.7 International units (IU)/Liter | Standard Deviation 10.66 |
| Linezolid 600 mg BID | Mean Clinical Chemistry Parameters of ALT, Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Follicle Stimulating Hormone (FSH), Gamma Glutamyl Transferase (GGT), Lactate Dehydrogenase (LDH) and Creatine Kinase at Indicated Time Points | Creatine kinase, Day 11 | 169.3 International units (IU)/Liter | Standard Deviation 200.9 |
| Linezolid 600 mg BID | Mean Clinical Chemistry Parameters of ALT, Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Follicle Stimulating Hormone (FSH), Gamma Glutamyl Transferase (GGT), Lactate Dehydrogenase (LDH) and Creatine Kinase at Indicated Time Points | AST, Day 1 | 26.3 International units (IU)/Liter | Standard Deviation 14.66 |
| Linezolid 600 mg BID | Mean Clinical Chemistry Parameters of ALT, Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Follicle Stimulating Hormone (FSH), Gamma Glutamyl Transferase (GGT), Lactate Dehydrogenase (LDH) and Creatine Kinase at Indicated Time Points | GGT, Day 4 | 53.4 International units (IU)/Liter | Standard Deviation 43.15 |
| Linezolid 600 mg BID | Mean Clinical Chemistry Parameters of ALT, Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Follicle Stimulating Hormone (FSH), Gamma Glutamyl Transferase (GGT), Lactate Dehydrogenase (LDH) and Creatine Kinase at Indicated Time Points | AST, Day 4 | 24.7 International units (IU)/Liter | Standard Deviation 7.69 |
| Linezolid 600 mg BID | Mean Clinical Chemistry Parameters of ALT, Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Follicle Stimulating Hormone (FSH), Gamma Glutamyl Transferase (GGT), Lactate Dehydrogenase (LDH) and Creatine Kinase at Indicated Time Points | Creatine kinase, 7 Day Follow-up | 189.1 International units (IU)/Liter | Standard Deviation 235.47 |
| Linezolid 600 mg BID | Mean Clinical Chemistry Parameters of ALT, Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Follicle Stimulating Hormone (FSH), Gamma Glutamyl Transferase (GGT), Lactate Dehydrogenase (LDH) and Creatine Kinase at Indicated Time Points | AST, Day 8 | 29.3 International units (IU)/Liter | Standard Deviation 18.97 |
| Linezolid 600 mg BID | Mean Clinical Chemistry Parameters of ALT, Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Follicle Stimulating Hormone (FSH), Gamma Glutamyl Transferase (GGT), Lactate Dehydrogenase (LDH) and Creatine Kinase at Indicated Time Points | GGT, 28 Day Follow-up | 42.1 International units (IU)/Liter | Standard Deviation 42.1 |
| Linezolid 600 mg BID | Mean Clinical Chemistry Parameters of ALT, Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Follicle Stimulating Hormone (FSH), Gamma Glutamyl Transferase (GGT), Lactate Dehydrogenase (LDH) and Creatine Kinase at Indicated Time Points | AST, Day 11 | 28.5 International units (IU)/Liter | Standard Deviation 15.97 |
Primary
Mean Clinical Chemistry Parameters of Creatinine, Uric Acid, Direct Bilirubin and Total Bilirubin at Indicated Time Points
Blood samples were obtained for analysis of creatinine, uric acid, direct bilirubin and total bilirubin at Day 1, Day 4, Day 8, Day 11, 7 Day Follow-up and 28 Day Follow-up. Baseline value was defined as the assessment done on Day 1.
Time frame: Up to Follow-up (28 Day Follow-up, Day 40)
Population: Safety Population. Only those participants available at the specified time points were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| GSK1322322 1500 mg BID | Mean Clinical Chemistry Parameters of Creatinine, Uric Acid, Direct Bilirubin and Total Bilirubin at Indicated Time Points | Creatinine, Day 4 | 71.48 Micromoles (µmol)/liter | Standard Deviation 14.307 |
| GSK1322322 1500 mg BID | Mean Clinical Chemistry Parameters of Creatinine, Uric Acid, Direct Bilirubin and Total Bilirubin at Indicated Time Points | Direct bilirubin, Day 1 | 2.3 Micromoles (µmol)/liter | Standard Deviation 1.36 |
| GSK1322322 1500 mg BID | Mean Clinical Chemistry Parameters of Creatinine, Uric Acid, Direct Bilirubin and Total Bilirubin at Indicated Time Points | Uric acid, Day 1 | 322.5 Micromoles (µmol)/liter | Standard Deviation 88.53 |
| GSK1322322 1500 mg BID | Mean Clinical Chemistry Parameters of Creatinine, Uric Acid, Direct Bilirubin and Total Bilirubin at Indicated Time Points | Direct bilirubin, Day 4 | 2.4 Micromoles (µmol)/liter | Standard Deviation 1.39 |
| GSK1322322 1500 mg BID | Mean Clinical Chemistry Parameters of Creatinine, Uric Acid, Direct Bilirubin and Total Bilirubin at Indicated Time Points | Creatinine, Day 11 | 74.19 Micromoles (µmol)/liter | Standard Deviation 16.223 |
| GSK1322322 1500 mg BID | Mean Clinical Chemistry Parameters of Creatinine, Uric Acid, Direct Bilirubin and Total Bilirubin at Indicated Time Points | Direct bilirubin, Day 8 | 2.4 Micromoles (µmol)/liter | Standard Deviation 1.24 |
| GSK1322322 1500 mg BID | Mean Clinical Chemistry Parameters of Creatinine, Uric Acid, Direct Bilirubin and Total Bilirubin at Indicated Time Points | Uric acid, Day 4 | 282.2 Micromoles (µmol)/liter | Standard Deviation 78.77 |
| GSK1322322 1500 mg BID | Mean Clinical Chemistry Parameters of Creatinine, Uric Acid, Direct Bilirubin and Total Bilirubin at Indicated Time Points | Direct bilirubin, Day 11 | 2.5 Micromoles (µmol)/liter | Standard Deviation 1.32 |
| GSK1322322 1500 mg BID | Mean Clinical Chemistry Parameters of Creatinine, Uric Acid, Direct Bilirubin and Total Bilirubin at Indicated Time Points | Creatinine, Day 1 | 68.73 Micromoles (µmol)/liter | Standard Deviation 18.911 |
| GSK1322322 1500 mg BID | Mean Clinical Chemistry Parameters of Creatinine, Uric Acid, Direct Bilirubin and Total Bilirubin at Indicated Time Points | Direct bilirubin, 7 Day Follow-up | 2.6 Micromoles (µmol)/liter | Standard Deviation 2.16 |
| GSK1322322 1500 mg BID | Mean Clinical Chemistry Parameters of Creatinine, Uric Acid, Direct Bilirubin and Total Bilirubin at Indicated Time Points | Uric acid, Day 8 | 323.2 Micromoles (µmol)/liter | Standard Deviation 73.92 |
| GSK1322322 1500 mg BID | Mean Clinical Chemistry Parameters of Creatinine, Uric Acid, Direct Bilirubin and Total Bilirubin at Indicated Time Points | Direct bilirubin, 28 Day Follow-up | 2.3 Micromoles (µmol)/liter | Standard Deviation 1.16 |
| GSK1322322 1500 mg BID | Mean Clinical Chemistry Parameters of Creatinine, Uric Acid, Direct Bilirubin and Total Bilirubin at Indicated Time Points | Creatinine, 7 Day Follow-up | 70.84 Micromoles (µmol)/liter | Standard Deviation 15.601 |
| GSK1322322 1500 mg BID | Mean Clinical Chemistry Parameters of Creatinine, Uric Acid, Direct Bilirubin and Total Bilirubin at Indicated Time Points | Uric acid, Day 11 | 370.5 Micromoles (µmol)/liter | Standard Deviation 88 |
| GSK1322322 1500 mg BID | Mean Clinical Chemistry Parameters of Creatinine, Uric Acid, Direct Bilirubin and Total Bilirubin at Indicated Time Points | Total bilirubin, Day 4 | 7.3 Micromoles (µmol)/liter | Standard Deviation 2.66 |
| GSK1322322 1500 mg BID | Mean Clinical Chemistry Parameters of Creatinine, Uric Acid, Direct Bilirubin and Total Bilirubin at Indicated Time Points | Creatinine, Day 8 | 74.85 Micromoles (µmol)/liter | Standard Deviation 16.204 |
| GSK1322322 1500 mg BID | Mean Clinical Chemistry Parameters of Creatinine, Uric Acid, Direct Bilirubin and Total Bilirubin at Indicated Time Points | Total bilirubin, Day 8 | 7.6 Micromoles (µmol)/liter | Standard Deviation 3.15 |
| GSK1322322 1500 mg BID | Mean Clinical Chemistry Parameters of Creatinine, Uric Acid, Direct Bilirubin and Total Bilirubin at Indicated Time Points | Uric acid, 7 Day Follow-up | 386.0 Micromoles (µmol)/liter | Standard Deviation 105.6 |
| GSK1322322 1500 mg BID | Mean Clinical Chemistry Parameters of Creatinine, Uric Acid, Direct Bilirubin and Total Bilirubin at Indicated Time Points | Total bilirubin, Day 11 | 8.1 Micromoles (µmol)/liter | Standard Deviation 3.07 |
| GSK1322322 1500 mg BID | Mean Clinical Chemistry Parameters of Creatinine, Uric Acid, Direct Bilirubin and Total Bilirubin at Indicated Time Points | Creatinine, 28 Day Follow-up | 72.77 Micromoles (µmol)/liter | Standard Deviation 20.98 |
| GSK1322322 1500 mg BID | Mean Clinical Chemistry Parameters of Creatinine, Uric Acid, Direct Bilirubin and Total Bilirubin at Indicated Time Points | Total bilirubin, 7 Day Follow-up | 8.1 Micromoles (µmol)/liter | Standard Deviation 4.13 |
| GSK1322322 1500 mg BID | Mean Clinical Chemistry Parameters of Creatinine, Uric Acid, Direct Bilirubin and Total Bilirubin at Indicated Time Points | Uric acid, 28 Day Follow-up | 358.3 Micromoles (µmol)/liter | Standard Deviation 89.3 |
| GSK1322322 1500 mg BID | Mean Clinical Chemistry Parameters of Creatinine, Uric Acid, Direct Bilirubin and Total Bilirubin at Indicated Time Points | Total bilirubin, 28 Day Follow-up | 8.5 Micromoles (µmol)/liter | Standard Deviation 3.81 |
| GSK1322322 1500 mg BID | Mean Clinical Chemistry Parameters of Creatinine, Uric Acid, Direct Bilirubin and Total Bilirubin at Indicated Time Points | Total bilirubin, Day 1 | 8.7 Micromoles (µmol)/liter | Standard Deviation 3.87 |
| Linezolid 600 mg BID | Mean Clinical Chemistry Parameters of Creatinine, Uric Acid, Direct Bilirubin and Total Bilirubin at Indicated Time Points | Total bilirubin, 28 Day Follow-up | 7.6 Micromoles (µmol)/liter | Standard Deviation 3.01 |
| Linezolid 600 mg BID | Mean Clinical Chemistry Parameters of Creatinine, Uric Acid, Direct Bilirubin and Total Bilirubin at Indicated Time Points | Creatinine, Day 1 | 66.99 Micromoles (µmol)/liter | Standard Deviation 13.567 |
| Linezolid 600 mg BID | Mean Clinical Chemistry Parameters of Creatinine, Uric Acid, Direct Bilirubin and Total Bilirubin at Indicated Time Points | Creatinine, Day 4 | 72.35 Micromoles (µmol)/liter | Standard Deviation 13.123 |
| Linezolid 600 mg BID | Mean Clinical Chemistry Parameters of Creatinine, Uric Acid, Direct Bilirubin and Total Bilirubin at Indicated Time Points | Creatinine, Day 8 | 73.42 Micromoles (µmol)/liter | Standard Deviation 13.159 |
| Linezolid 600 mg BID | Mean Clinical Chemistry Parameters of Creatinine, Uric Acid, Direct Bilirubin and Total Bilirubin at Indicated Time Points | Creatinine, Day 11 | 72.07 Micromoles (µmol)/liter | Standard Deviation 12.37 |
| Linezolid 600 mg BID | Mean Clinical Chemistry Parameters of Creatinine, Uric Acid, Direct Bilirubin and Total Bilirubin at Indicated Time Points | Creatinine, 7 Day Follow-up | 75.06 Micromoles (µmol)/liter | Standard Deviation 21.598 |
| Linezolid 600 mg BID | Mean Clinical Chemistry Parameters of Creatinine, Uric Acid, Direct Bilirubin and Total Bilirubin at Indicated Time Points | Creatinine, 28 Day Follow-up | 72.49 Micromoles (µmol)/liter | Standard Deviation 13.537 |
| Linezolid 600 mg BID | Mean Clinical Chemistry Parameters of Creatinine, Uric Acid, Direct Bilirubin and Total Bilirubin at Indicated Time Points | Uric acid, Day 1 | 293.3 Micromoles (µmol)/liter | Standard Deviation 84.03 |
| Linezolid 600 mg BID | Mean Clinical Chemistry Parameters of Creatinine, Uric Acid, Direct Bilirubin and Total Bilirubin at Indicated Time Points | Uric acid, Day 4 | 346.4 Micromoles (µmol)/liter | Standard Deviation 74.21 |
| Linezolid 600 mg BID | Mean Clinical Chemistry Parameters of Creatinine, Uric Acid, Direct Bilirubin and Total Bilirubin at Indicated Time Points | Uric acid, Day 8 | 360.4 Micromoles (µmol)/liter | Standard Deviation 71.96 |
| Linezolid 600 mg BID | Mean Clinical Chemistry Parameters of Creatinine, Uric Acid, Direct Bilirubin and Total Bilirubin at Indicated Time Points | Uric acid, Day 11 | 367.4 Micromoles (µmol)/liter | Standard Deviation 84.86 |
| Linezolid 600 mg BID | Mean Clinical Chemistry Parameters of Creatinine, Uric Acid, Direct Bilirubin and Total Bilirubin at Indicated Time Points | Uric acid, 7 Day Follow-up | 363.8 Micromoles (µmol)/liter | Standard Deviation 97.17 |
| Linezolid 600 mg BID | Mean Clinical Chemistry Parameters of Creatinine, Uric Acid, Direct Bilirubin and Total Bilirubin at Indicated Time Points | Uric acid, 28 Day Follow-up | 332.6 Micromoles (µmol)/liter | Standard Deviation 79.96 |
| Linezolid 600 mg BID | Mean Clinical Chemistry Parameters of Creatinine, Uric Acid, Direct Bilirubin and Total Bilirubin at Indicated Time Points | Direct bilirubin, Day 1 | 2.5 Micromoles (µmol)/liter | Standard Deviation 1.05 |
| Linezolid 600 mg BID | Mean Clinical Chemistry Parameters of Creatinine, Uric Acid, Direct Bilirubin and Total Bilirubin at Indicated Time Points | Direct bilirubin, Day 4 | 2.0 Micromoles (µmol)/liter | Standard Deviation 1 |
| Linezolid 600 mg BID | Mean Clinical Chemistry Parameters of Creatinine, Uric Acid, Direct Bilirubin and Total Bilirubin at Indicated Time Points | Direct bilirubin, Day 8 | 1.9 Micromoles (µmol)/liter | Standard Deviation 0.93 |
| Linezolid 600 mg BID | Mean Clinical Chemistry Parameters of Creatinine, Uric Acid, Direct Bilirubin and Total Bilirubin at Indicated Time Points | Direct bilirubin, Day 11 | 2.1 Micromoles (µmol)/liter | Standard Deviation 0.95 |
| Linezolid 600 mg BID | Mean Clinical Chemistry Parameters of Creatinine, Uric Acid, Direct Bilirubin and Total Bilirubin at Indicated Time Points | Direct bilirubin, 7 Day Follow-up | 3.0 Micromoles (µmol)/liter | Standard Deviation 1.18 |
| Linezolid 600 mg BID | Mean Clinical Chemistry Parameters of Creatinine, Uric Acid, Direct Bilirubin and Total Bilirubin at Indicated Time Points | Direct bilirubin, 28 Day Follow-up | 2.3 Micromoles (µmol)/liter | Standard Deviation 0.92 |
| Linezolid 600 mg BID | Mean Clinical Chemistry Parameters of Creatinine, Uric Acid, Direct Bilirubin and Total Bilirubin at Indicated Time Points | Total bilirubin, Day 1 | 8.4 Micromoles (µmol)/liter | Standard Deviation 4.31 |
| Linezolid 600 mg BID | Mean Clinical Chemistry Parameters of Creatinine, Uric Acid, Direct Bilirubin and Total Bilirubin at Indicated Time Points | Total bilirubin, Day 4 | 6.6 Micromoles (µmol)/liter | Standard Deviation 1.87 |
| Linezolid 600 mg BID | Mean Clinical Chemistry Parameters of Creatinine, Uric Acid, Direct Bilirubin and Total Bilirubin at Indicated Time Points | Total bilirubin, Day 8 | 6.6 Micromoles (µmol)/liter | Standard Deviation 1.91 |
| Linezolid 600 mg BID | Mean Clinical Chemistry Parameters of Creatinine, Uric Acid, Direct Bilirubin and Total Bilirubin at Indicated Time Points | Total bilirubin, Day 11 | 7.6 Micromoles (µmol)/liter | Standard Deviation 2.17 |
| Linezolid 600 mg BID | Mean Clinical Chemistry Parameters of Creatinine, Uric Acid, Direct Bilirubin and Total Bilirubin at Indicated Time Points | Total bilirubin, 7 Day Follow-up | 8.9 Micromoles (µmol)/liter | Standard Deviation 4.04 |
Primary
Mean Clinical Chemistry Parameters of Glucose, Sodium, Calcium, Potassium, Chloride, Carbon Dioxide (CO2) Content /Bicarbonate and Urea/ Blood Urea Nitrogen (BUN) at Indicated Time Points
Blood samples were obtained for analysis of glucose, sodium, calcium, potassium, chloride, CO2 content /bicarbonate and urea/BUN at Day 1, Day 4, Day 8, Day 11, 7 Day Follow-up and 28 Day Follow-up. Baseline value was defined as the assessment done on Day 1.
Time frame: Up to Follow-up (28 Day Follow-up, Day 40)
Population: Safety Population. Only those participants available at the specified time points were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| GSK1322322 1500 mg BID | Mean Clinical Chemistry Parameters of Glucose, Sodium, Calcium, Potassium, Chloride, Carbon Dioxide (CO2) Content /Bicarbonate and Urea/ Blood Urea Nitrogen (BUN) at Indicated Time Points | Sodium, 7 Day Follow-up | 139.2 Millimole (mmol)/Liter | Standard Deviation 2.27 |
| GSK1322322 1500 mg BID | Mean Clinical Chemistry Parameters of Glucose, Sodium, Calcium, Potassium, Chloride, Carbon Dioxide (CO2) Content /Bicarbonate and Urea/ Blood Urea Nitrogen (BUN) at Indicated Time Points | Glucose, Day 4 | 6.13 Millimole (mmol)/Liter | Standard Deviation 2.459 |
| GSK1322322 1500 mg BID | Mean Clinical Chemistry Parameters of Glucose, Sodium, Calcium, Potassium, Chloride, Carbon Dioxide (CO2) Content /Bicarbonate and Urea/ Blood Urea Nitrogen (BUN) at Indicated Time Points | Glucose, Day 8 | 5.94 Millimole (mmol)/Liter | Standard Deviation 1.473 |
| GSK1322322 1500 mg BID | Mean Clinical Chemistry Parameters of Glucose, Sodium, Calcium, Potassium, Chloride, Carbon Dioxide (CO2) Content /Bicarbonate and Urea/ Blood Urea Nitrogen (BUN) at Indicated Time Points | Glucose, Day 11 | 6.27 Millimole (mmol)/Liter | Standard Deviation 2.025 |
| GSK1322322 1500 mg BID | Mean Clinical Chemistry Parameters of Glucose, Sodium, Calcium, Potassium, Chloride, Carbon Dioxide (CO2) Content /Bicarbonate and Urea/ Blood Urea Nitrogen (BUN) at Indicated Time Points | Glucose, 7 Day Follow-up | 5.96 Millimole (mmol)/Liter | Standard Deviation 1.607 |
| GSK1322322 1500 mg BID | Mean Clinical Chemistry Parameters of Glucose, Sodium, Calcium, Potassium, Chloride, Carbon Dioxide (CO2) Content /Bicarbonate and Urea/ Blood Urea Nitrogen (BUN) at Indicated Time Points | Glucose, 28 Day Follow-up | 6.10 Millimole (mmol)/Liter | Standard Deviation 1.487 |
| GSK1322322 1500 mg BID | Mean Clinical Chemistry Parameters of Glucose, Sodium, Calcium, Potassium, Chloride, Carbon Dioxide (CO2) Content /Bicarbonate and Urea/ Blood Urea Nitrogen (BUN) at Indicated Time Points | Sodium, Day 1 | 138.3 Millimole (mmol)/Liter | Standard Deviation 2.49 |
| GSK1322322 1500 mg BID | Mean Clinical Chemistry Parameters of Glucose, Sodium, Calcium, Potassium, Chloride, Carbon Dioxide (CO2) Content /Bicarbonate and Urea/ Blood Urea Nitrogen (BUN) at Indicated Time Points | Sodium, Day 4 | 137.3 Millimole (mmol)/Liter | Standard Deviation 3.07 |
| GSK1322322 1500 mg BID | Mean Clinical Chemistry Parameters of Glucose, Sodium, Calcium, Potassium, Chloride, Carbon Dioxide (CO2) Content /Bicarbonate and Urea/ Blood Urea Nitrogen (BUN) at Indicated Time Points | Sodium, Day 8 | 137.8 Millimole (mmol)/Liter | Standard Deviation 1.99 |
| GSK1322322 1500 mg BID | Mean Clinical Chemistry Parameters of Glucose, Sodium, Calcium, Potassium, Chloride, Carbon Dioxide (CO2) Content /Bicarbonate and Urea/ Blood Urea Nitrogen (BUN) at Indicated Time Points | Sodium, Day 11 | 138.6 Millimole (mmol)/Liter | Standard Deviation 2.11 |
| GSK1322322 1500 mg BID | Mean Clinical Chemistry Parameters of Glucose, Sodium, Calcium, Potassium, Chloride, Carbon Dioxide (CO2) Content /Bicarbonate and Urea/ Blood Urea Nitrogen (BUN) at Indicated Time Points | Glucose, Day 1 | 6.21 Millimole (mmol)/Liter | Standard Deviation 2.385 |
| GSK1322322 1500 mg BID | Mean Clinical Chemistry Parameters of Glucose, Sodium, Calcium, Potassium, Chloride, Carbon Dioxide (CO2) Content /Bicarbonate and Urea/ Blood Urea Nitrogen (BUN) at Indicated Time Points | Sodium, 28 Day Follow-up | 138.8 Millimole (mmol)/Liter | Standard Deviation 1.93 |
| GSK1322322 1500 mg BID | Mean Clinical Chemistry Parameters of Glucose, Sodium, Calcium, Potassium, Chloride, Carbon Dioxide (CO2) Content /Bicarbonate and Urea/ Blood Urea Nitrogen (BUN) at Indicated Time Points | Calcium, Day 1 | 2.264 Millimole (mmol)/Liter | Standard Deviation 0.1523 |
| GSK1322322 1500 mg BID | Mean Clinical Chemistry Parameters of Glucose, Sodium, Calcium, Potassium, Chloride, Carbon Dioxide (CO2) Content /Bicarbonate and Urea/ Blood Urea Nitrogen (BUN) at Indicated Time Points | Calcium, Day 4 | 2.217 Millimole (mmol)/Liter | Standard Deviation 0.1094 |
| GSK1322322 1500 mg BID | Mean Clinical Chemistry Parameters of Glucose, Sodium, Calcium, Potassium, Chloride, Carbon Dioxide (CO2) Content /Bicarbonate and Urea/ Blood Urea Nitrogen (BUN) at Indicated Time Points | Calcium, Day 8 | 2.267 Millimole (mmol)/Liter | Standard Deviation 0.1055 |
| GSK1322322 1500 mg BID | Mean Clinical Chemistry Parameters of Glucose, Sodium, Calcium, Potassium, Chloride, Carbon Dioxide (CO2) Content /Bicarbonate and Urea/ Blood Urea Nitrogen (BUN) at Indicated Time Points | Calcium, Day 11 | 2.301 Millimole (mmol)/Liter | Standard Deviation 0.107 |
| GSK1322322 1500 mg BID | Mean Clinical Chemistry Parameters of Glucose, Sodium, Calcium, Potassium, Chloride, Carbon Dioxide (CO2) Content /Bicarbonate and Urea/ Blood Urea Nitrogen (BUN) at Indicated Time Points | Calcium, 7 Day Follow-up | 2.315 Millimole (mmol)/Liter | Standard Deviation 0.1082 |
| GSK1322322 1500 mg BID | Mean Clinical Chemistry Parameters of Glucose, Sodium, Calcium, Potassium, Chloride, Carbon Dioxide (CO2) Content /Bicarbonate and Urea/ Blood Urea Nitrogen (BUN) at Indicated Time Points | Calcium, 28 Day Follow-up | 2.306 Millimole (mmol)/Liter | Standard Deviation 0.1268 |
| GSK1322322 1500 mg BID | Mean Clinical Chemistry Parameters of Glucose, Sodium, Calcium, Potassium, Chloride, Carbon Dioxide (CO2) Content /Bicarbonate and Urea/ Blood Urea Nitrogen (BUN) at Indicated Time Points | Potassium, Day 1 | 4.18 Millimole (mmol)/Liter | Standard Deviation 0.373 |
| GSK1322322 1500 mg BID | Mean Clinical Chemistry Parameters of Glucose, Sodium, Calcium, Potassium, Chloride, Carbon Dioxide (CO2) Content /Bicarbonate and Urea/ Blood Urea Nitrogen (BUN) at Indicated Time Points | Potassium, Day 4 | 4.19 Millimole (mmol)/Liter | Standard Deviation 0.4 |
| GSK1322322 1500 mg BID | Mean Clinical Chemistry Parameters of Glucose, Sodium, Calcium, Potassium, Chloride, Carbon Dioxide (CO2) Content /Bicarbonate and Urea/ Blood Urea Nitrogen (BUN) at Indicated Time Points | Potassium, Day 8 | 4.18 Millimole (mmol)/Liter | Standard Deviation 0.288 |
| GSK1322322 1500 mg BID | Mean Clinical Chemistry Parameters of Glucose, Sodium, Calcium, Potassium, Chloride, Carbon Dioxide (CO2) Content /Bicarbonate and Urea/ Blood Urea Nitrogen (BUN) at Indicated Time Points | Potassium, Day 11 | 4.12 Millimole (mmol)/Liter | Standard Deviation 0.28 |
| GSK1322322 1500 mg BID | Mean Clinical Chemistry Parameters of Glucose, Sodium, Calcium, Potassium, Chloride, Carbon Dioxide (CO2) Content /Bicarbonate and Urea/ Blood Urea Nitrogen (BUN) at Indicated Time Points | Potassium, 7 Day Follow-up | 4.16 Millimole (mmol)/Liter | Standard Deviation 0.331 |
| GSK1322322 1500 mg BID | Mean Clinical Chemistry Parameters of Glucose, Sodium, Calcium, Potassium, Chloride, Carbon Dioxide (CO2) Content /Bicarbonate and Urea/ Blood Urea Nitrogen (BUN) at Indicated Time Points | Potassium, 28 Day Follow-up | 4.04 Millimole (mmol)/Liter | Standard Deviation 0.307 |
| GSK1322322 1500 mg BID | Mean Clinical Chemistry Parameters of Glucose, Sodium, Calcium, Potassium, Chloride, Carbon Dioxide (CO2) Content /Bicarbonate and Urea/ Blood Urea Nitrogen (BUN) at Indicated Time Points | Chloride, Day 1 | 102.3 Millimole (mmol)/Liter | Standard Deviation 3.12 |
| GSK1322322 1500 mg BID | Mean Clinical Chemistry Parameters of Glucose, Sodium, Calcium, Potassium, Chloride, Carbon Dioxide (CO2) Content /Bicarbonate and Urea/ Blood Urea Nitrogen (BUN) at Indicated Time Points | Chloride, Day 4 | 101.9 Millimole (mmol)/Liter | Standard Deviation 3.71 |
| GSK1322322 1500 mg BID | Mean Clinical Chemistry Parameters of Glucose, Sodium, Calcium, Potassium, Chloride, Carbon Dioxide (CO2) Content /Bicarbonate and Urea/ Blood Urea Nitrogen (BUN) at Indicated Time Points | Chloride, Day 8 | 102.9 Millimole (mmol)/Liter | Standard Deviation 2.57 |
| GSK1322322 1500 mg BID | Mean Clinical Chemistry Parameters of Glucose, Sodium, Calcium, Potassium, Chloride, Carbon Dioxide (CO2) Content /Bicarbonate and Urea/ Blood Urea Nitrogen (BUN) at Indicated Time Points | Chloride, Day 11 | 104.2 Millimole (mmol)/Liter | Standard Deviation 2.69 |
| GSK1322322 1500 mg BID | Mean Clinical Chemistry Parameters of Glucose, Sodium, Calcium, Potassium, Chloride, Carbon Dioxide (CO2) Content /Bicarbonate and Urea/ Blood Urea Nitrogen (BUN) at Indicated Time Points | Chloride, 7 Day Follow-up | 104.7 Millimole (mmol)/Liter | Standard Deviation 2.14 |
| GSK1322322 1500 mg BID | Mean Clinical Chemistry Parameters of Glucose, Sodium, Calcium, Potassium, Chloride, Carbon Dioxide (CO2) Content /Bicarbonate and Urea/ Blood Urea Nitrogen (BUN) at Indicated Time Points | Chloride, 28 Day Follow-up | 103.7 Millimole (mmol)/Liter | Standard Deviation 2.6 |
| GSK1322322 1500 mg BID | Mean Clinical Chemistry Parameters of Glucose, Sodium, Calcium, Potassium, Chloride, Carbon Dioxide (CO2) Content /Bicarbonate and Urea/ Blood Urea Nitrogen (BUN) at Indicated Time Points | CO2 content/bicarbonate, Day 1 | 21.7 Millimole (mmol)/Liter | Standard Deviation 2.68 |
| GSK1322322 1500 mg BID | Mean Clinical Chemistry Parameters of Glucose, Sodium, Calcium, Potassium, Chloride, Carbon Dioxide (CO2) Content /Bicarbonate and Urea/ Blood Urea Nitrogen (BUN) at Indicated Time Points | CO2 content/bicarbonate, Day 4 | 22.3 Millimole (mmol)/Liter | Standard Deviation 2.51 |
| GSK1322322 1500 mg BID | Mean Clinical Chemistry Parameters of Glucose, Sodium, Calcium, Potassium, Chloride, Carbon Dioxide (CO2) Content /Bicarbonate and Urea/ Blood Urea Nitrogen (BUN) at Indicated Time Points | CO2 content/bicarbonate, Day 8 | 22.2 Millimole (mmol)/Liter | Standard Deviation 2.16 |
| GSK1322322 1500 mg BID | Mean Clinical Chemistry Parameters of Glucose, Sodium, Calcium, Potassium, Chloride, Carbon Dioxide (CO2) Content /Bicarbonate and Urea/ Blood Urea Nitrogen (BUN) at Indicated Time Points | CO2 content/bicarbonate, Day 11 | 21.6 Millimole (mmol)/Liter | Standard Deviation 2.2 |
| GSK1322322 1500 mg BID | Mean Clinical Chemistry Parameters of Glucose, Sodium, Calcium, Potassium, Chloride, Carbon Dioxide (CO2) Content /Bicarbonate and Urea/ Blood Urea Nitrogen (BUN) at Indicated Time Points | CO2 content/bicarbonate, 7 Day Follow-up | 21.9 Millimole (mmol)/Liter | Standard Deviation 2.31 |
| GSK1322322 1500 mg BID | Mean Clinical Chemistry Parameters of Glucose, Sodium, Calcium, Potassium, Chloride, Carbon Dioxide (CO2) Content /Bicarbonate and Urea/ Blood Urea Nitrogen (BUN) at Indicated Time Points | CO2 content/bicarbonate, 28 Day Follow-up | 22.3 Millimole (mmol)/Liter | Standard Deviation 2.05 |
| GSK1322322 1500 mg BID | Mean Clinical Chemistry Parameters of Glucose, Sodium, Calcium, Potassium, Chloride, Carbon Dioxide (CO2) Content /Bicarbonate and Urea/ Blood Urea Nitrogen (BUN) at Indicated Time Points | Urea/BUN, Day 1 | 4.90 Millimole (mmol)/Liter | Standard Deviation 1.695 |
| GSK1322322 1500 mg BID | Mean Clinical Chemistry Parameters of Glucose, Sodium, Calcium, Potassium, Chloride, Carbon Dioxide (CO2) Content /Bicarbonate and Urea/ Blood Urea Nitrogen (BUN) at Indicated Time Points | Urea/BUN, Day 4 | 4.81 Millimole (mmol)/Liter | Standard Deviation 1.383 |
| GSK1322322 1500 mg BID | Mean Clinical Chemistry Parameters of Glucose, Sodium, Calcium, Potassium, Chloride, Carbon Dioxide (CO2) Content /Bicarbonate and Urea/ Blood Urea Nitrogen (BUN) at Indicated Time Points | Urea/BUN, Day 8 | 4.47 Millimole (mmol)/Liter | Standard Deviation 1.188 |
| GSK1322322 1500 mg BID | Mean Clinical Chemistry Parameters of Glucose, Sodium, Calcium, Potassium, Chloride, Carbon Dioxide (CO2) Content /Bicarbonate and Urea/ Blood Urea Nitrogen (BUN) at Indicated Time Points | Urea/BUN, Day 11 | 4.69 Millimole (mmol)/Liter | Standard Deviation 1.381 |
| GSK1322322 1500 mg BID | Mean Clinical Chemistry Parameters of Glucose, Sodium, Calcium, Potassium, Chloride, Carbon Dioxide (CO2) Content /Bicarbonate and Urea/ Blood Urea Nitrogen (BUN) at Indicated Time Points | Urea/BUN, 7 Day Follow-up | 4.84 Millimole (mmol)/Liter | Standard Deviation 1.665 |
| GSK1322322 1500 mg BID | Mean Clinical Chemistry Parameters of Glucose, Sodium, Calcium, Potassium, Chloride, Carbon Dioxide (CO2) Content /Bicarbonate and Urea/ Blood Urea Nitrogen (BUN) at Indicated Time Points | Urea/BUN, 28 Day Follow-up | 4.88 Millimole (mmol)/Liter | Standard Deviation 1.526 |
| Linezolid 600 mg BID | Mean Clinical Chemistry Parameters of Glucose, Sodium, Calcium, Potassium, Chloride, Carbon Dioxide (CO2) Content /Bicarbonate and Urea/ Blood Urea Nitrogen (BUN) at Indicated Time Points | CO2 content/bicarbonate, Day 4 | 23.0 Millimole (mmol)/Liter | Standard Deviation 2.44 |
| Linezolid 600 mg BID | Mean Clinical Chemistry Parameters of Glucose, Sodium, Calcium, Potassium, Chloride, Carbon Dioxide (CO2) Content /Bicarbonate and Urea/ Blood Urea Nitrogen (BUN) at Indicated Time Points | Glucose, Day 1 | 6.63 Millimole (mmol)/Liter | Standard Deviation 5.652 |
| Linezolid 600 mg BID | Mean Clinical Chemistry Parameters of Glucose, Sodium, Calcium, Potassium, Chloride, Carbon Dioxide (CO2) Content /Bicarbonate and Urea/ Blood Urea Nitrogen (BUN) at Indicated Time Points | Potassium, Day 11 | 4.04 Millimole (mmol)/Liter | Standard Deviation 0.301 |
| Linezolid 600 mg BID | Mean Clinical Chemistry Parameters of Glucose, Sodium, Calcium, Potassium, Chloride, Carbon Dioxide (CO2) Content /Bicarbonate and Urea/ Blood Urea Nitrogen (BUN) at Indicated Time Points | Glucose, Day 4 | 6.77 Millimole (mmol)/Liter | Standard Deviation 5.834 |
| Linezolid 600 mg BID | Mean Clinical Chemistry Parameters of Glucose, Sodium, Calcium, Potassium, Chloride, Carbon Dioxide (CO2) Content /Bicarbonate and Urea/ Blood Urea Nitrogen (BUN) at Indicated Time Points | Urea/BUN, Day 11 | 4.87 Millimole (mmol)/Liter | Standard Deviation 1.618 |
| Linezolid 600 mg BID | Mean Clinical Chemistry Parameters of Glucose, Sodium, Calcium, Potassium, Chloride, Carbon Dioxide (CO2) Content /Bicarbonate and Urea/ Blood Urea Nitrogen (BUN) at Indicated Time Points | Glucose, Day 8 | 5.77 Millimole (mmol)/Liter | Standard Deviation 1.618 |
| Linezolid 600 mg BID | Mean Clinical Chemistry Parameters of Glucose, Sodium, Calcium, Potassium, Chloride, Carbon Dioxide (CO2) Content /Bicarbonate and Urea/ Blood Urea Nitrogen (BUN) at Indicated Time Points | Potassium, 7 Day Follow-up | 4.06 Millimole (mmol)/Liter | Standard Deviation 0.357 |
| Linezolid 600 mg BID | Mean Clinical Chemistry Parameters of Glucose, Sodium, Calcium, Potassium, Chloride, Carbon Dioxide (CO2) Content /Bicarbonate and Urea/ Blood Urea Nitrogen (BUN) at Indicated Time Points | Glucose, Day 11 | 6.65 Millimole (mmol)/Liter | Standard Deviation 3.355 |
| Linezolid 600 mg BID | Mean Clinical Chemistry Parameters of Glucose, Sodium, Calcium, Potassium, Chloride, Carbon Dioxide (CO2) Content /Bicarbonate and Urea/ Blood Urea Nitrogen (BUN) at Indicated Time Points | CO2 content/bicarbonate, Day 8 | 22.5 Millimole (mmol)/Liter | Standard Deviation 2.08 |
| Linezolid 600 mg BID | Mean Clinical Chemistry Parameters of Glucose, Sodium, Calcium, Potassium, Chloride, Carbon Dioxide (CO2) Content /Bicarbonate and Urea/ Blood Urea Nitrogen (BUN) at Indicated Time Points | Glucose, 7 Day Follow-up | 6.40 Millimole (mmol)/Liter | Standard Deviation 2.212 |
| Linezolid 600 mg BID | Mean Clinical Chemistry Parameters of Glucose, Sodium, Calcium, Potassium, Chloride, Carbon Dioxide (CO2) Content /Bicarbonate and Urea/ Blood Urea Nitrogen (BUN) at Indicated Time Points | Potassium, 28 Day Follow-up | 4.13 Millimole (mmol)/Liter | Standard Deviation 0.293 |
| Linezolid 600 mg BID | Mean Clinical Chemistry Parameters of Glucose, Sodium, Calcium, Potassium, Chloride, Carbon Dioxide (CO2) Content /Bicarbonate and Urea/ Blood Urea Nitrogen (BUN) at Indicated Time Points | Glucose, 28 Day Follow-up | 6.76 Millimole (mmol)/Liter | Standard Deviation 3.068 |
| Linezolid 600 mg BID | Mean Clinical Chemistry Parameters of Glucose, Sodium, Calcium, Potassium, Chloride, Carbon Dioxide (CO2) Content /Bicarbonate and Urea/ Blood Urea Nitrogen (BUN) at Indicated Time Points | Urea/BUN, Day 4 | 4.48 Millimole (mmol)/Liter | Standard Deviation 1.475 |
| Linezolid 600 mg BID | Mean Clinical Chemistry Parameters of Glucose, Sodium, Calcium, Potassium, Chloride, Carbon Dioxide (CO2) Content /Bicarbonate and Urea/ Blood Urea Nitrogen (BUN) at Indicated Time Points | Sodium, Day 1 | 138.3 Millimole (mmol)/Liter | Standard Deviation 3.17 |
| Linezolid 600 mg BID | Mean Clinical Chemistry Parameters of Glucose, Sodium, Calcium, Potassium, Chloride, Carbon Dioxide (CO2) Content /Bicarbonate and Urea/ Blood Urea Nitrogen (BUN) at Indicated Time Points | Chloride, Day 1 | 102.4 Millimole (mmol)/Liter | Standard Deviation 3.55 |
| Linezolid 600 mg BID | Mean Clinical Chemistry Parameters of Glucose, Sodium, Calcium, Potassium, Chloride, Carbon Dioxide (CO2) Content /Bicarbonate and Urea/ Blood Urea Nitrogen (BUN) at Indicated Time Points | Sodium, Day 4 | 138.3 Millimole (mmol)/Liter | Standard Deviation 1.96 |
| Linezolid 600 mg BID | Mean Clinical Chemistry Parameters of Glucose, Sodium, Calcium, Potassium, Chloride, Carbon Dioxide (CO2) Content /Bicarbonate and Urea/ Blood Urea Nitrogen (BUN) at Indicated Time Points | CO2 content/bicarbonate, Day 11 | 22.8 Millimole (mmol)/Liter | Standard Deviation 2.77 |
| Linezolid 600 mg BID | Mean Clinical Chemistry Parameters of Glucose, Sodium, Calcium, Potassium, Chloride, Carbon Dioxide (CO2) Content /Bicarbonate and Urea/ Blood Urea Nitrogen (BUN) at Indicated Time Points | Sodium, Day 8 | 138.4 Millimole (mmol)/Liter | Standard Deviation 3.11 |
| Linezolid 600 mg BID | Mean Clinical Chemistry Parameters of Glucose, Sodium, Calcium, Potassium, Chloride, Carbon Dioxide (CO2) Content /Bicarbonate and Urea/ Blood Urea Nitrogen (BUN) at Indicated Time Points | Chloride, Day 4 | 103.0 Millimole (mmol)/Liter | Standard Deviation 3.01 |
| Linezolid 600 mg BID | Mean Clinical Chemistry Parameters of Glucose, Sodium, Calcium, Potassium, Chloride, Carbon Dioxide (CO2) Content /Bicarbonate and Urea/ Blood Urea Nitrogen (BUN) at Indicated Time Points | Sodium, Day 11 | 138.2 Millimole (mmol)/Liter | Standard Deviation 2.79 |
| Linezolid 600 mg BID | Mean Clinical Chemistry Parameters of Glucose, Sodium, Calcium, Potassium, Chloride, Carbon Dioxide (CO2) Content /Bicarbonate and Urea/ Blood Urea Nitrogen (BUN) at Indicated Time Points | Urea/BUN, 28 Day Follow-up | 4.85 Millimole (mmol)/Liter | Standard Deviation 0.947 |
| Linezolid 600 mg BID | Mean Clinical Chemistry Parameters of Glucose, Sodium, Calcium, Potassium, Chloride, Carbon Dioxide (CO2) Content /Bicarbonate and Urea/ Blood Urea Nitrogen (BUN) at Indicated Time Points | Sodium, 7 Day Follow-up | 138.5 Millimole (mmol)/Liter | Standard Deviation 2.26 |
| Linezolid 600 mg BID | Mean Clinical Chemistry Parameters of Glucose, Sodium, Calcium, Potassium, Chloride, Carbon Dioxide (CO2) Content /Bicarbonate and Urea/ Blood Urea Nitrogen (BUN) at Indicated Time Points | Chloride, Day 8 | 103.8 Millimole (mmol)/Liter | Standard Deviation 2.95 |
| Linezolid 600 mg BID | Mean Clinical Chemistry Parameters of Glucose, Sodium, Calcium, Potassium, Chloride, Carbon Dioxide (CO2) Content /Bicarbonate and Urea/ Blood Urea Nitrogen (BUN) at Indicated Time Points | Sodium, 28 Day Follow-up | 138.8 Millimole (mmol)/Liter | Standard Deviation 3.03 |
| Linezolid 600 mg BID | Mean Clinical Chemistry Parameters of Glucose, Sodium, Calcium, Potassium, Chloride, Carbon Dioxide (CO2) Content /Bicarbonate and Urea/ Blood Urea Nitrogen (BUN) at Indicated Time Points | CO2 content/bicarbonate, 7 Day Follow-up | 22.0 Millimole (mmol)/Liter | Standard Deviation 2.51 |
| Linezolid 600 mg BID | Mean Clinical Chemistry Parameters of Glucose, Sodium, Calcium, Potassium, Chloride, Carbon Dioxide (CO2) Content /Bicarbonate and Urea/ Blood Urea Nitrogen (BUN) at Indicated Time Points | Calcium, Day 1 | 2.251 Millimole (mmol)/Liter | Standard Deviation 0.1169 |
| Linezolid 600 mg BID | Mean Clinical Chemistry Parameters of Glucose, Sodium, Calcium, Potassium, Chloride, Carbon Dioxide (CO2) Content /Bicarbonate and Urea/ Blood Urea Nitrogen (BUN) at Indicated Time Points | Chloride, Day 11 | 102.7 Millimole (mmol)/Liter | Standard Deviation 4.05 |
| Linezolid 600 mg BID | Mean Clinical Chemistry Parameters of Glucose, Sodium, Calcium, Potassium, Chloride, Carbon Dioxide (CO2) Content /Bicarbonate and Urea/ Blood Urea Nitrogen (BUN) at Indicated Time Points | Calcium, Day 4 | 2.257 Millimole (mmol)/Liter | Standard Deviation 0.093 |
| Linezolid 600 mg BID | Mean Clinical Chemistry Parameters of Glucose, Sodium, Calcium, Potassium, Chloride, Carbon Dioxide (CO2) Content /Bicarbonate and Urea/ Blood Urea Nitrogen (BUN) at Indicated Time Points | Urea/BUN, Day 8 | 4.73 Millimole (mmol)/Liter | Standard Deviation 1.452 |
| Linezolid 600 mg BID | Mean Clinical Chemistry Parameters of Glucose, Sodium, Calcium, Potassium, Chloride, Carbon Dioxide (CO2) Content /Bicarbonate and Urea/ Blood Urea Nitrogen (BUN) at Indicated Time Points | Calcium, Day 8 | 2.273 Millimole (mmol)/Liter | Standard Deviation 0.0719 |
| Linezolid 600 mg BID | Mean Clinical Chemistry Parameters of Glucose, Sodium, Calcium, Potassium, Chloride, Carbon Dioxide (CO2) Content /Bicarbonate and Urea/ Blood Urea Nitrogen (BUN) at Indicated Time Points | Chloride, 7 Day Follow-up | 102.6 Millimole (mmol)/Liter | Standard Deviation 3.85 |
| Linezolid 600 mg BID | Mean Clinical Chemistry Parameters of Glucose, Sodium, Calcium, Potassium, Chloride, Carbon Dioxide (CO2) Content /Bicarbonate and Urea/ Blood Urea Nitrogen (BUN) at Indicated Time Points | Calcium, Day 11 | 2.282 Millimole (mmol)/Liter | Standard Deviation 0.0772 |
| Linezolid 600 mg BID | Mean Clinical Chemistry Parameters of Glucose, Sodium, Calcium, Potassium, Chloride, Carbon Dioxide (CO2) Content /Bicarbonate and Urea/ Blood Urea Nitrogen (BUN) at Indicated Time Points | CO2 content/bicarbonate, 28 Day Follow-up | 21.5 Millimole (mmol)/Liter | Standard Deviation 2.64 |
| Linezolid 600 mg BID | Mean Clinical Chemistry Parameters of Glucose, Sodium, Calcium, Potassium, Chloride, Carbon Dioxide (CO2) Content /Bicarbonate and Urea/ Blood Urea Nitrogen (BUN) at Indicated Time Points | Calcium, 7 Day Follow-up | 2.303 Millimole (mmol)/Liter | Standard Deviation 0.0959 |
| Linezolid 600 mg BID | Mean Clinical Chemistry Parameters of Glucose, Sodium, Calcium, Potassium, Chloride, Carbon Dioxide (CO2) Content /Bicarbonate and Urea/ Blood Urea Nitrogen (BUN) at Indicated Time Points | Chloride, 28 Day Follow-up | 103.7 Millimole (mmol)/Liter | Standard Deviation 3.97 |
| Linezolid 600 mg BID | Mean Clinical Chemistry Parameters of Glucose, Sodium, Calcium, Potassium, Chloride, Carbon Dioxide (CO2) Content /Bicarbonate and Urea/ Blood Urea Nitrogen (BUN) at Indicated Time Points | Calcium, 28 Day Follow-up | 2.263 Millimole (mmol)/Liter | Standard Deviation 0.0913 |
| Linezolid 600 mg BID | Mean Clinical Chemistry Parameters of Glucose, Sodium, Calcium, Potassium, Chloride, Carbon Dioxide (CO2) Content /Bicarbonate and Urea/ Blood Urea Nitrogen (BUN) at Indicated Time Points | Urea/BUN, 7 Day Follow-up | 5.00 Millimole (mmol)/Liter | Standard Deviation 1.836 |
| Linezolid 600 mg BID | Mean Clinical Chemistry Parameters of Glucose, Sodium, Calcium, Potassium, Chloride, Carbon Dioxide (CO2) Content /Bicarbonate and Urea/ Blood Urea Nitrogen (BUN) at Indicated Time Points | Potassium, Day 1 | 4.08 Millimole (mmol)/Liter | Standard Deviation 0.297 |
| Linezolid 600 mg BID | Mean Clinical Chemistry Parameters of Glucose, Sodium, Calcium, Potassium, Chloride, Carbon Dioxide (CO2) Content /Bicarbonate and Urea/ Blood Urea Nitrogen (BUN) at Indicated Time Points | CO2 content/bicarbonate, Day 1 | 21.1 Millimole (mmol)/Liter | Standard Deviation 2.43 |
| Linezolid 600 mg BID | Mean Clinical Chemistry Parameters of Glucose, Sodium, Calcium, Potassium, Chloride, Carbon Dioxide (CO2) Content /Bicarbonate and Urea/ Blood Urea Nitrogen (BUN) at Indicated Time Points | Potassium, Day 4 | 4.11 Millimole (mmol)/Liter | Standard Deviation 0.301 |
| Linezolid 600 mg BID | Mean Clinical Chemistry Parameters of Glucose, Sodium, Calcium, Potassium, Chloride, Carbon Dioxide (CO2) Content /Bicarbonate and Urea/ Blood Urea Nitrogen (BUN) at Indicated Time Points | Urea/BUN, Day 1 | 4.20 Millimole (mmol)/Liter | Standard Deviation 1.137 |
| Linezolid 600 mg BID | Mean Clinical Chemistry Parameters of Glucose, Sodium, Calcium, Potassium, Chloride, Carbon Dioxide (CO2) Content /Bicarbonate and Urea/ Blood Urea Nitrogen (BUN) at Indicated Time Points | Potassium, Day 8 | 4.13 Millimole (mmol)/Liter | Standard Deviation 0.303 |
Primary
Mean ECG Rhythms at Indicated Time Points
12-lead ECGs were obtained during the study using an ECG machine that automatically calculated the heart rhythm and measured PR, QRS, RR, QT, and QTc intervals. It was performed with the participant in a semi-supine position having rested in that position for at least 10 minutes beforehand. Three measurements were taken at pre-dose on Day 1 at least 5 minutes apart and the mean of the three measurements was calculated. The assessments were done at Day 1 (pre-dose, 0.25-1.5 hours post-initial dose and 1.5-3 hours post-initial dose), Day 4 (4-12 hours post-morning dose), Day 8 (pre-morning dose) and Day 11 (0 hour).
Time frame: Up to Day 11
Population: Safety Population. Only those participants available at the specified time points were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| GSK1322322 1500 mg BID | Mean ECG Rhythms at Indicated Time Points | Day 1, 0.25-1.5 h post-dose | 79.2 Beats per minute | Standard Deviation 14.34 |
| GSK1322322 1500 mg BID | Mean ECG Rhythms at Indicated Time Points | Day 4, 4-12 h post-dose | 70.6 Beats per minute | Standard Deviation 10.67 |
| GSK1322322 1500 mg BID | Mean ECG Rhythms at Indicated Time Points | Day 1, mean pre-dose | 75.0 Beats per minute | Standard Deviation 14.33 |
| GSK1322322 1500 mg BID | Mean ECG Rhythms at Indicated Time Points | Day 8, pre-morning dose | 68.2 Beats per minute | Standard Deviation 10.37 |
| GSK1322322 1500 mg BID | Mean ECG Rhythms at Indicated Time Points | Day 1,1.5-3 h post-dose | 80.4 Beats per minute | Standard Deviation 14.22 |
| GSK1322322 1500 mg BID | Mean ECG Rhythms at Indicated Time Points | Day 11, 0 h | 70.9 Beats per minute | Standard Deviation 13.15 |
| Linezolid 600 mg BID | Mean ECG Rhythms at Indicated Time Points | Day 11, 0 h | 72.0 Beats per minute | Standard Deviation 13.94 |
| Linezolid 600 mg BID | Mean ECG Rhythms at Indicated Time Points | Day 1, mean pre-dose | 72.8 Beats per minute | Standard Deviation 15.01 |
| Linezolid 600 mg BID | Mean ECG Rhythms at Indicated Time Points | Day 1, 0.25-1.5 h post-dose | 72.0 Beats per minute | Standard Deviation 13.04 |
| Linezolid 600 mg BID | Mean ECG Rhythms at Indicated Time Points | Day 1,1.5-3 h post-dose | 73.7 Beats per minute | Standard Deviation 9.19 |
| Linezolid 600 mg BID | Mean ECG Rhythms at Indicated Time Points | Day 4, 4-12 h post-dose | 73.0 Beats per minute | Standard Deviation 16.39 |
| Linezolid 600 mg BID | Mean ECG Rhythms at Indicated Time Points | Day 8, pre-morning dose | 67.2 Beats per minute | Standard Deviation 12.28 |
Primary
Mean Electrocardiogram (ECG) Values at Indicated Time Points
12-lead ECGs were obtained during the study using an ECG machine that automatically calculated the heart rate and measured PR, QRS, RR, QT, and QTc intervals. It was performed with the participant in a semi-supine position having rested in that position for at least 10 minutes beforehand. Three measurements were taken at pre-dose on Day 1 at least 5 minutes apart. The mean PR interval, RR interval, QRS duration, uncorrected QT interval (UncQT) and QTcB (QT corrected by Bazett's formula) and QTcF (corrected by Friedericia's formula) was calculated from automated ECG readings. The assessments were done at Day 1 (pre-dose, 0.25-1.5 hours post-initial dose and 1.5-3 hours post-initial dose), Day 4 (4-12 hours post-morning dose), Day 8 (pre-morning dose) and Day 11 (0 hour). The mean value recorded pre-dose on Day 1 was classified as Baseline.
Time frame: Up to Day 11
Population: Safety Population. Only those participants available at the specified time points were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| GSK1322322 1500 mg BID | Mean Electrocardiogram (ECG) Values at Indicated Time Points | PR interval, Day 1, 0.25-1.5 h post-dose | 157.0 Millisecond (msec) | Standard Deviation 15.8 |
| GSK1322322 1500 mg BID | Mean Electrocardiogram (ECG) Values at Indicated Time Points | QRS duration, Day 11, 0 h | 95.2 Millisecond (msec) | Standard Deviation 8.41 |
| GSK1322322 1500 mg BID | Mean Electrocardiogram (ECG) Values at Indicated Time Points | UncQT interval, Day 1, mean pre-dose | 376.7 Millisecond (msec) | Standard Deviation 36.76 |
| GSK1322322 1500 mg BID | Mean Electrocardiogram (ECG) Values at Indicated Time Points | UncQT interval, Day 1, 0.25-1.5 h post-dose | 370.8 Millisecond (msec) | Standard Deviation 35.79 |
| GSK1322322 1500 mg BID | Mean Electrocardiogram (ECG) Values at Indicated Time Points | UncQT interval, Day 1,1.5-3 h post-dose | 370.3 Millisecond (msec) | Standard Deviation 36.01 |
| GSK1322322 1500 mg BID | Mean Electrocardiogram (ECG) Values at Indicated Time Points | UncQT interval, Day 4, 4-12 h post-dose | 392.6 Millisecond (msec) | Standard Deviation 32.26 |
| GSK1322322 1500 mg BID | Mean Electrocardiogram (ECG) Values at Indicated Time Points | UncQT interval, Day 8, pre morning dose | 397.1 Millisecond (msec) | Standard Deviation 31.64 |
| GSK1322322 1500 mg BID | Mean Electrocardiogram (ECG) Values at Indicated Time Points | UncQT interval, Day 11, 0 h | 385.3 Millisecond (msec) | Standard Deviation 32.05 |
| GSK1322322 1500 mg BID | Mean Electrocardiogram (ECG) Values at Indicated Time Points | QTcB interval, Day 1, mean pre-dose | 416.0 Millisecond (msec) | Standard Deviation 26.09 |
| GSK1322322 1500 mg BID | Mean Electrocardiogram (ECG) Values at Indicated Time Points | QTcB interval, Day 1, 0.25-1.5 h post-dose | 421.1 Millisecond (msec) | Standard Deviation 22.91 |
| GSK1322322 1500 mg BID | Mean Electrocardiogram (ECG) Values at Indicated Time Points | QTcB interval, Day 1,1.5-3 h post-dose | 424.1 Millisecond (msec) | Standard Deviation 24.89 |
| GSK1322322 1500 mg BID | Mean Electrocardiogram (ECG) Values at Indicated Time Points | QTcB interval, Day 4, 4-12 h post-dose | 422.9 Millisecond (msec) | Standard Deviation 23.65 |
| GSK1322322 1500 mg BID | Mean Electrocardiogram (ECG) Values at Indicated Time Points | QTcB interval, Day 8, pre morning dose | 420.1 Millisecond (msec) | Standard Deviation 22.82 |
| GSK1322322 1500 mg BID | Mean Electrocardiogram (ECG) Values at Indicated Time Points | QTcB interval, Day 11, 0 h | 414.5 Millisecond (msec) | Standard Deviation 17.76 |
| GSK1322322 1500 mg BID | Mean Electrocardiogram (ECG) Values at Indicated Time Points | QTcF interval, Day 1, mean pre-dose | 402.0 Millisecond (msec) | Standard Deviation 24.04 |
| GSK1322322 1500 mg BID | Mean Electrocardiogram (ECG) Values at Indicated Time Points | QTcF interval, Day 1, 0.25-1.5 h post-dose | 403.1 Millisecond (msec) | Standard Deviation 22.51 |
| GSK1322322 1500 mg BID | Mean Electrocardiogram (ECG) Values at Indicated Time Points | QTcF interval, Day 1,1.5-3 h post-dose | 405.0 Millisecond (msec) | Standard Deviation 24.14 |
| GSK1322322 1500 mg BID | Mean Electrocardiogram (ECG) Values at Indicated Time Points | QTcF interval, Day 4, 4-12 h post-dose | 412.3 Millisecond (msec) | Standard Deviation 22.76 |
| GSK1322322 1500 mg BID | Mean Electrocardiogram (ECG) Values at Indicated Time Points | QTcF interval, Day 8, pre morning dose | 412.0 Millisecond (msec) | Standard Deviation 21.87 |
| GSK1322322 1500 mg BID | Mean Electrocardiogram (ECG) Values at Indicated Time Points | QTcF interval, Day 11, 0 h | 404.1 Millisecond (msec) | Standard Deviation 16.95 |
| GSK1322322 1500 mg BID | Mean Electrocardiogram (ECG) Values at Indicated Time Points | RR interval, Day 1, mean pre-dose | 832.9 Millisecond (msec) | Standard Deviation 173.04 |
| GSK1322322 1500 mg BID | Mean Electrocardiogram (ECG) Values at Indicated Time Points | RR interval, Day 1, 0.25-1.5 h post-dose | 783.8 Millisecond (msec) | Standard Deviation 148.25 |
| GSK1322322 1500 mg BID | Mean Electrocardiogram (ECG) Values at Indicated Time Points | RR interval, Day 1,1.5-3 h post-dose | 770.7 Millisecond (msec) | Standard Deviation 149.27 |
| GSK1322322 1500 mg BID | Mean Electrocardiogram (ECG) Values at Indicated Time Points | RR interval, Day 4, 4-12 h post-dose | 868.7 Millisecond (msec) | Standard Deviation 133.65 |
| GSK1322322 1500 mg BID | Mean Electrocardiogram (ECG) Values at Indicated Time Points | RR interval, Day 8, pre morning dose | 900.4 Millisecond (msec) | Standard Deviation 134.96 |
| GSK1322322 1500 mg BID | Mean Electrocardiogram (ECG) Values at Indicated Time Points | RR interval, Day 11, 0 h | 873.4 Millisecond (msec) | Standard Deviation 155.04 |
| GSK1322322 1500 mg BID | Mean Electrocardiogram (ECG) Values at Indicated Time Points | PR interval, Day 1, mean pre-dose | 158.0 Millisecond (msec) | Standard Deviation 15.88 |
| GSK1322322 1500 mg BID | Mean Electrocardiogram (ECG) Values at Indicated Time Points | PR interval, Day 1,1.5-3 h post-dose | 158.5 Millisecond (msec) | Standard Deviation 17.07 |
| GSK1322322 1500 mg BID | Mean Electrocardiogram (ECG) Values at Indicated Time Points | PR interval, Day 4, 4-12 h post-dose | 165.8 Millisecond (msec) | Standard Deviation 18.35 |
| GSK1322322 1500 mg BID | Mean Electrocardiogram (ECG) Values at Indicated Time Points | PR interval, Day 8, pre morning dose | 167.4 Millisecond (msec) | Standard Deviation 16.52 |
| GSK1322322 1500 mg BID | Mean Electrocardiogram (ECG) Values at Indicated Time Points | PR interval, Day 11, 0 h | 158.6 Millisecond (msec) | Standard Deviation 19.72 |
| GSK1322322 1500 mg BID | Mean Electrocardiogram (ECG) Values at Indicated Time Points | QRS duration, Day 1, mean pre-dose | 94.0 Millisecond (msec) | Standard Deviation 8.94 |
| GSK1322322 1500 mg BID | Mean Electrocardiogram (ECG) Values at Indicated Time Points | QRS duration, Day 1, 0.25-1.5 h post-dose | 93.9 Millisecond (msec) | Standard Deviation 9.19 |
| GSK1322322 1500 mg BID | Mean Electrocardiogram (ECG) Values at Indicated Time Points | QRS duration, Day 1,1.5-3 h post-dose | 95.7 Millisecond (msec) | Standard Deviation 8.76 |
| GSK1322322 1500 mg BID | Mean Electrocardiogram (ECG) Values at Indicated Time Points | QRS duration, Day 4, 4-12 h post-dose | 95.7 Millisecond (msec) | Standard Deviation 8.91 |
| GSK1322322 1500 mg BID | Mean Electrocardiogram (ECG) Values at Indicated Time Points | QRS duration, Day 8, pre morning dose | 95.5 Millisecond (msec) | Standard Deviation 10.07 |
| Linezolid 600 mg BID | Mean Electrocardiogram (ECG) Values at Indicated Time Points | QTcF interval, Day 4, 4-12 h post-dose | 400.9 Millisecond (msec) | Standard Deviation 21.28 |
| Linezolid 600 mg BID | Mean Electrocardiogram (ECG) Values at Indicated Time Points | PR interval, Day 1, mean pre-dose | 155.0 Millisecond (msec) | Standard Deviation 20.17 |
| Linezolid 600 mg BID | Mean Electrocardiogram (ECG) Values at Indicated Time Points | QRS duration, Day 8, pre morning dose | 95.3 Millisecond (msec) | Standard Deviation 8.81 |
| Linezolid 600 mg BID | Mean Electrocardiogram (ECG) Values at Indicated Time Points | PR interval, Day 1, 0.25-1.5 h post-dose | 159.2 Millisecond (msec) | Standard Deviation 22.72 |
| Linezolid 600 mg BID | Mean Electrocardiogram (ECG) Values at Indicated Time Points | QRS duration, Day 11, 0 h | 96.2 Millisecond (msec) | Standard Deviation 8.22 |
| Linezolid 600 mg BID | Mean Electrocardiogram (ECG) Values at Indicated Time Points | QTcF interval, Day 8, pre morning dose | 403.7 Millisecond (msec) | Standard Deviation 21.54 |
| Linezolid 600 mg BID | Mean Electrocardiogram (ECG) Values at Indicated Time Points | UncQT interval, Day 1, mean pre-dose | 378.2 Millisecond (msec) | Standard Deviation 39.5 |
| Linezolid 600 mg BID | Mean Electrocardiogram (ECG) Values at Indicated Time Points | QRS duration, Day 4, 4-12 h post-dose | 93.7 Millisecond (msec) | Standard Deviation 6.76 |
| Linezolid 600 mg BID | Mean Electrocardiogram (ECG) Values at Indicated Time Points | UncQT interval, Day 1, 0.25-1.5 h post-dose | 375.1 Millisecond (msec) | Standard Deviation 28.51 |
| Linezolid 600 mg BID | Mean Electrocardiogram (ECG) Values at Indicated Time Points | QTcF interval, Day 11, 0 h | 402.0 Millisecond (msec) | Standard Deviation 24.27 |
| Linezolid 600 mg BID | Mean Electrocardiogram (ECG) Values at Indicated Time Points | UncQT interval, Day 1,1.5-3 h post-dose | 374.0 Millisecond (msec) | Standard Deviation 25.42 |
| Linezolid 600 mg BID | Mean Electrocardiogram (ECG) Values at Indicated Time Points | PR interval, Day 1,1.5-3 h post-dose | 157.2 Millisecond (msec) | Standard Deviation 23.87 |
| Linezolid 600 mg BID | Mean Electrocardiogram (ECG) Values at Indicated Time Points | UncQT interval, Day 4, 4-12 h post-dose | 378.4 Millisecond (msec) | Standard Deviation 37.77 |
| Linezolid 600 mg BID | Mean Electrocardiogram (ECG) Values at Indicated Time Points | RR interval, Day 1, mean pre-dose | 854.6 Millisecond (msec) | Standard Deviation 150.7 |
| Linezolid 600 mg BID | Mean Electrocardiogram (ECG) Values at Indicated Time Points | UncQT interval, Day 8, pre morning dose | 390.3 Millisecond (msec) | Standard Deviation 27.18 |
| Linezolid 600 mg BID | Mean Electrocardiogram (ECG) Values at Indicated Time Points | QRS duration, Day 1, mean pre-dose | 95.9 Millisecond (msec) | Standard Deviation 6.67 |
| Linezolid 600 mg BID | Mean Electrocardiogram (ECG) Values at Indicated Time Points | UncQT interval, Day 11, 0 h | 382.2 Millisecond (msec) | Standard Deviation 41.47 |
| Linezolid 600 mg BID | Mean Electrocardiogram (ECG) Values at Indicated Time Points | RR interval, Day 1, 0.25-1.5 h post-dose | 855.0 Millisecond (msec) | Standard Deviation 126.77 |
| Linezolid 600 mg BID | Mean Electrocardiogram (ECG) Values at Indicated Time Points | QTcB interval, Day 1, mean pre-dose | 411.6 Millisecond (msec) | Standard Deviation 28.57 |
| Linezolid 600 mg BID | Mean Electrocardiogram (ECG) Values at Indicated Time Points | PR interval, Day 4, 4-12 h post-dose | 159.2 Millisecond (msec) | Standard Deviation 21.39 |
| Linezolid 600 mg BID | Mean Electrocardiogram (ECG) Values at Indicated Time Points | QTcB interval, Day 1, 0.25-1.5 h post-dose | 407.9 Millisecond (msec) | Standard Deviation 28.74 |
| Linezolid 600 mg BID | Mean Electrocardiogram (ECG) Values at Indicated Time Points | RR interval, Day 1,1.5-3 h post-dose | 825.8 Millisecond (msec) | Standard Deviation 101.01 |
| Linezolid 600 mg BID | Mean Electrocardiogram (ECG) Values at Indicated Time Points | QTcB interval, Day 1,1.5-3 h post-dose | 412.7 Millisecond (msec) | Standard Deviation 25.4 |
| Linezolid 600 mg BID | Mean Electrocardiogram (ECG) Values at Indicated Time Points | QRS duration, Day 1,1.5-3 h post-dose | 96.1 Millisecond (msec) | Standard Deviation 8.4 |
| Linezolid 600 mg BID | Mean Electrocardiogram (ECG) Values at Indicated Time Points | QTcB interval, Day 4, 4-12 h post-dose | 413.2 Millisecond (msec) | Standard Deviation 22.61 |
| Linezolid 600 mg BID | Mean Electrocardiogram (ECG) Values at Indicated Time Points | RR interval, Day 4, 4-12 h post-dose | 860.7 Millisecond (msec) | Standard Deviation 185.66 |
| Linezolid 600 mg BID | Mean Electrocardiogram (ECG) Values at Indicated Time Points | QTcB interval, Day 8, pre morning dose | 411.0 Millisecond (msec) | Standard Deviation 26.94 |
| Linezolid 600 mg BID | Mean Electrocardiogram (ECG) Values at Indicated Time Points | PR interval, Day 8, pre morning dose | 158.1 Millisecond (msec) | Standard Deviation 23.98 |
| Linezolid 600 mg BID | Mean Electrocardiogram (ECG) Values at Indicated Time Points | QTcB interval, Day 11, 0 h | 413.1 Millisecond (msec) | Standard Deviation 22.21 |
| Linezolid 600 mg BID | Mean Electrocardiogram (ECG) Values at Indicated Time Points | RR interval, Day 8, pre morning dose | 918.6 Millisecond (msec) | Standard Deviation 150 |
| Linezolid 600 mg BID | Mean Electrocardiogram (ECG) Values at Indicated Time Points | QTcF interval, Day 1, mean pre-dose | 399.7 Millisecond (msec) | Standard Deviation 28.2 |
| Linezolid 600 mg BID | Mean Electrocardiogram (ECG) Values at Indicated Time Points | QRS duration, Day 1, 0.25-1.5 h post-dose | 97.1 Millisecond (msec) | Standard Deviation 6.7 |
| Linezolid 600 mg BID | Mean Electrocardiogram (ECG) Values at Indicated Time Points | QTcF interval, Day 1, 0.25-1.5 h post-dose | 396.3 Millisecond (msec) | Standard Deviation 24.78 |
| Linezolid 600 mg BID | Mean Electrocardiogram (ECG) Values at Indicated Time Points | RR interval, Day 11, 0 h | 865.0 Millisecond (msec) | Standard Deviation 170.76 |
| Linezolid 600 mg BID | Mean Electrocardiogram (ECG) Values at Indicated Time Points | QTcF interval, Day 1,1.5-3 h post-dose | 399.2 Millisecond (msec) | Standard Deviation 22.47 |
| Linezolid 600 mg BID | Mean Electrocardiogram (ECG) Values at Indicated Time Points | PR interval, Day 11, 0 h | 159.3 Millisecond (msec) | Standard Deviation 19.37 |
Primary
Mean Hematology Parameter of Hemoglobin, Mean Corpuscle Hemoglobin Concentration (MCHC) at Indicated Time Points
Blood samples were obtained for analysis of MCHC at Day 1, Day 4, Day 8, Day 11, 7 Day Follow-up and 28 Day Follow-up. Baseline value was defined as the assessment done on Day 1.
Time frame: Up to Follow-up (28 Day Follow-up, Day 40)
Population: Safety Population. Only those participants available at the specified time points were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| GSK1322322 1500 mg BID | Mean Hematology Parameter of Hemoglobin, Mean Corpuscle Hemoglobin Concentration (MCHC) at Indicated Time Points | Hemoglobin, Day 1 | 136.7 Gram/Liter | Standard Deviation 15.67 |
| GSK1322322 1500 mg BID | Mean Hematology Parameter of Hemoglobin, Mean Corpuscle Hemoglobin Concentration (MCHC) at Indicated Time Points | Hemoglobin, Day 4 | 132.9 Gram/Liter | Standard Deviation 15.49 |
| GSK1322322 1500 mg BID | Mean Hematology Parameter of Hemoglobin, Mean Corpuscle Hemoglobin Concentration (MCHC) at Indicated Time Points | Hemoglobin, Day 8 | 135.8 Gram/Liter | Standard Deviation 16.47 |
| GSK1322322 1500 mg BID | Mean Hematology Parameter of Hemoglobin, Mean Corpuscle Hemoglobin Concentration (MCHC) at Indicated Time Points | Hemoglobin, Day 11 | 135.9 Gram/Liter | Standard Deviation 16.83 |
| GSK1322322 1500 mg BID | Mean Hematology Parameter of Hemoglobin, Mean Corpuscle Hemoglobin Concentration (MCHC) at Indicated Time Points | Hemoglobin, 7 Day Follow-up | 137.7 Gram/Liter | Standard Deviation 19.71 |
| GSK1322322 1500 mg BID | Mean Hematology Parameter of Hemoglobin, Mean Corpuscle Hemoglobin Concentration (MCHC) at Indicated Time Points | Hemoglobin, 28 Day Follow-up | 139.6 Gram/Liter | Standard Deviation 17.82 |
| GSK1322322 1500 mg BID | Mean Hematology Parameter of Hemoglobin, Mean Corpuscle Hemoglobin Concentration (MCHC) at Indicated Time Points | MCHC, Day 1 | 334.0 Gram/Liter | Standard Deviation 8.73 |
| GSK1322322 1500 mg BID | Mean Hematology Parameter of Hemoglobin, Mean Corpuscle Hemoglobin Concentration (MCHC) at Indicated Time Points | MCHC, Day 4 | 335.1 Gram/Liter | Standard Deviation 9.42 |
| GSK1322322 1500 mg BID | Mean Hematology Parameter of Hemoglobin, Mean Corpuscle Hemoglobin Concentration (MCHC) at Indicated Time Points | MCHC, Day 8 | 336.6 Gram/Liter | Standard Deviation 8.73 |
| GSK1322322 1500 mg BID | Mean Hematology Parameter of Hemoglobin, Mean Corpuscle Hemoglobin Concentration (MCHC) at Indicated Time Points | MCHC, Day 11 | 335.5 Gram/Liter | Standard Deviation 7.73 |
| GSK1322322 1500 mg BID | Mean Hematology Parameter of Hemoglobin, Mean Corpuscle Hemoglobin Concentration (MCHC) at Indicated Time Points | MCHC, 7 Day Follow-up | 337.8 Gram/Liter | Standard Deviation 7.39 |
| GSK1322322 1500 mg BID | Mean Hematology Parameter of Hemoglobin, Mean Corpuscle Hemoglobin Concentration (MCHC) at Indicated Time Points | MCHC, 28 Day Follow-up | 336.1 Gram/Liter | Standard Deviation 8.53 |
| Linezolid 600 mg BID | Mean Hematology Parameter of Hemoglobin, Mean Corpuscle Hemoglobin Concentration (MCHC) at Indicated Time Points | MCHC, 7 Day Follow-up | 335.4 Gram/Liter | Standard Deviation 10.67 |
| Linezolid 600 mg BID | Mean Hematology Parameter of Hemoglobin, Mean Corpuscle Hemoglobin Concentration (MCHC) at Indicated Time Points | Hemoglobin, Day 1 | 134.2 Gram/Liter | Standard Deviation 19.49 |
| Linezolid 600 mg BID | Mean Hematology Parameter of Hemoglobin, Mean Corpuscle Hemoglobin Concentration (MCHC) at Indicated Time Points | MCHC, Day 1 | 331.9 Gram/Liter | Standard Deviation 12.38 |
| Linezolid 600 mg BID | Mean Hematology Parameter of Hemoglobin, Mean Corpuscle Hemoglobin Concentration (MCHC) at Indicated Time Points | Hemoglobin, Day 4 | 133.5 Gram/Liter | Standard Deviation 18.44 |
| Linezolid 600 mg BID | Mean Hematology Parameter of Hemoglobin, Mean Corpuscle Hemoglobin Concentration (MCHC) at Indicated Time Points | MCHC, Day 11 | 336.4 Gram/Liter | Standard Deviation 14.24 |
| Linezolid 600 mg BID | Mean Hematology Parameter of Hemoglobin, Mean Corpuscle Hemoglobin Concentration (MCHC) at Indicated Time Points | Hemoglobin, Day 8 | 134.0 Gram/Liter | Standard Deviation 19.03 |
| Linezolid 600 mg BID | Mean Hematology Parameter of Hemoglobin, Mean Corpuscle Hemoglobin Concentration (MCHC) at Indicated Time Points | MCHC, Day 4 | 333.5 Gram/Liter | Standard Deviation 15.25 |
| Linezolid 600 mg BID | Mean Hematology Parameter of Hemoglobin, Mean Corpuscle Hemoglobin Concentration (MCHC) at Indicated Time Points | Hemoglobin, Day 11 | 136.4 Gram/Liter | Standard Deviation 19.04 |
| Linezolid 600 mg BID | Mean Hematology Parameter of Hemoglobin, Mean Corpuscle Hemoglobin Concentration (MCHC) at Indicated Time Points | MCHC, 28 Day Follow-up | 334.3 Gram/Liter | Standard Deviation 11.8 |
| Linezolid 600 mg BID | Mean Hematology Parameter of Hemoglobin, Mean Corpuscle Hemoglobin Concentration (MCHC) at Indicated Time Points | Hemoglobin, 7 Day Follow-up | 135.8 Gram/Liter | Standard Deviation 19.08 |
| Linezolid 600 mg BID | Mean Hematology Parameter of Hemoglobin, Mean Corpuscle Hemoglobin Concentration (MCHC) at Indicated Time Points | MCHC, Day 8 | 335.7 Gram/Liter | Standard Deviation 12.6 |
| Linezolid 600 mg BID | Mean Hematology Parameter of Hemoglobin, Mean Corpuscle Hemoglobin Concentration (MCHC) at Indicated Time Points | Hemoglobin, 28 Day Follow-up | 136.1 Gram/Liter | Standard Deviation 18.35 |
Primary
Mean Hematology Parameter of Mean Corpuscle Hemoglobin (MCH) at Indicated Time Points
Blood samples were obtained for analysis of MCH at Day 1, Day 4, Day 8, Day 11, 7 Day Follow-up and 28 Day Follow-up. Baseline value was defined as the assessment done on Day 1.
Time frame: Up to Follow-up (28 Day Follow-up, Day 40)
Population: Safety Population. Only those participants available at the specified time points were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| GSK1322322 1500 mg BID | Mean Hematology Parameter of Mean Corpuscle Hemoglobin (MCH) at Indicated Time Points | Day 1 | 30.22 Picogram | Standard Deviation 1.97 |
| GSK1322322 1500 mg BID | Mean Hematology Parameter of Mean Corpuscle Hemoglobin (MCH) at Indicated Time Points | Day 4 | 30.08 Picogram | Standard Deviation 2.169 |
| GSK1322322 1500 mg BID | Mean Hematology Parameter of Mean Corpuscle Hemoglobin (MCH) at Indicated Time Points | Day 8 | 30.10 Picogram | Standard Deviation 2.165 |
| GSK1322322 1500 mg BID | Mean Hematology Parameter of Mean Corpuscle Hemoglobin (MCH) at Indicated Time Points | Day 11 | 30.06 Picogram | Standard Deviation 2.107 |
| GSK1322322 1500 mg BID | Mean Hematology Parameter of Mean Corpuscle Hemoglobin (MCH) at Indicated Time Points | 7 Day Follow-up | 30.14 Picogram | Standard Deviation 2.021 |
| GSK1322322 1500 mg BID | Mean Hematology Parameter of Mean Corpuscle Hemoglobin (MCH) at Indicated Time Points | 28 Day Follow-up | 30.26 Picogram | Standard Deviation 2.07 |
| Linezolid 600 mg BID | Mean Hematology Parameter of Mean Corpuscle Hemoglobin (MCH) at Indicated Time Points | 7 Day Follow-up | 30.71 Picogram | Standard Deviation 2.845 |
| Linezolid 600 mg BID | Mean Hematology Parameter of Mean Corpuscle Hemoglobin (MCH) at Indicated Time Points | Day 1 | 30.24 Picogram | Standard Deviation 3.284 |
| Linezolid 600 mg BID | Mean Hematology Parameter of Mean Corpuscle Hemoglobin (MCH) at Indicated Time Points | Day 11 | 30.59 Picogram | Standard Deviation 3.014 |
| Linezolid 600 mg BID | Mean Hematology Parameter of Mean Corpuscle Hemoglobin (MCH) at Indicated Time Points | Day 4 | 30.58 Picogram | Standard Deviation 2.957 |
| Linezolid 600 mg BID | Mean Hematology Parameter of Mean Corpuscle Hemoglobin (MCH) at Indicated Time Points | 28 Day Follow-up | 30.56 Picogram | Standard Deviation 3.002 |
| Linezolid 600 mg BID | Mean Hematology Parameter of Mean Corpuscle Hemoglobin (MCH) at Indicated Time Points | Day 8 | 30.63 Picogram | Standard Deviation 2.97 |
Primary
Mean Hematology Parameter of Mean Corpuscle Volume (MCV) at Indicated Time Points
Blood samples were obtained for analysis of MCV at Day 1, Day 4, Day 8, Day 11, 7 Day Follow-up and 28 Day Follow-up. Baseline value was defined as the assessment done on Day 1.
Time frame: Up to Follow-up (28 Day Follow-up, Day 40)
Population: Safety Population. Only those participants available at the specified time points were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| GSK1322322 1500 mg BID | Mean Hematology Parameter of Mean Corpuscle Volume (MCV) at Indicated Time Points | Day 1 | 90.5 Femtoliter | Standard Deviation 5.24 |
| GSK1322322 1500 mg BID | Mean Hematology Parameter of Mean Corpuscle Volume (MCV) at Indicated Time Points | Day 4 | 89.8 Femtoliter | Standard Deviation 5.52 |
| GSK1322322 1500 mg BID | Mean Hematology Parameter of Mean Corpuscle Volume (MCV) at Indicated Time Points | Day 8 | 89.4 Femtoliter | Standard Deviation 5.88 |
| GSK1322322 1500 mg BID | Mean Hematology Parameter of Mean Corpuscle Volume (MCV) at Indicated Time Points | Day 11 | 89.7 Femtoliter | Standard Deviation 5.38 |
| GSK1322322 1500 mg BID | Mean Hematology Parameter of Mean Corpuscle Volume (MCV) at Indicated Time Points | 7 Day Follow-up | 89.1 Femtoliter | Standard Deviation 4.91 |
| GSK1322322 1500 mg BID | Mean Hematology Parameter of Mean Corpuscle Volume (MCV) at Indicated Time Points | 28 Day Follow-up | 90.1 Femtoliter | Standard Deviation 5.6 |
| Linezolid 600 mg BID | Mean Hematology Parameter of Mean Corpuscle Volume (MCV) at Indicated Time Points | 7 Day Follow-up | 91.5 Femtoliter | Standard Deviation 7 |
| Linezolid 600 mg BID | Mean Hematology Parameter of Mean Corpuscle Volume (MCV) at Indicated Time Points | Day 1 | 91.1 Femtoliter | Standard Deviation 8.53 |
| Linezolid 600 mg BID | Mean Hematology Parameter of Mean Corpuscle Volume (MCV) at Indicated Time Points | Day 11 | 90.7 Femtoliter | Standard Deviation 6.96 |
| Linezolid 600 mg BID | Mean Hematology Parameter of Mean Corpuscle Volume (MCV) at Indicated Time Points | Day 4 | 91.6 Femtoliter | Standard Deviation 7.13 |
| Linezolid 600 mg BID | Mean Hematology Parameter of Mean Corpuscle Volume (MCV) at Indicated Time Points | 28 Day Follow-up | 91.3 Femtoliter | Standard Deviation 7.63 |
| Linezolid 600 mg BID | Mean Hematology Parameter of Mean Corpuscle Volume (MCV) at Indicated Time Points | Day 8 | 91.2 Femtoliter | Standard Deviation 7.01 |
Primary
Mean Hematology Parameter of Red Blood Cell (RBC) Count and Reticulocyte Count at Indicated Time Points
Blood samples were obtained for analysis of RBC count and reticulocyte at Day 1, Day 4, Day 8, Day 11, 7 Day Follow-up and 28 Day Follow-up. Baseline value was defined as the assessment done on Day 1.
Time frame: Up to Follow-up (28 Day Follow-up, Day 40)
Population: Safety Population. Only those participants available at the specified time points were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| GSK1322322 1500 mg BID | Mean Hematology Parameter of Red Blood Cell (RBC) Count and Reticulocyte Count at Indicated Time Points | RBC count, Day 1 | 4.53 Trillion cells (TI)/Liter | Standard Deviation 0.413 |
| GSK1322322 1500 mg BID | Mean Hematology Parameter of Red Blood Cell (RBC) Count and Reticulocyte Count at Indicated Time Points | RBC count, Day 4 | 4.43 Trillion cells (TI)/Liter | Standard Deviation 0.37 |
| GSK1322322 1500 mg BID | Mean Hematology Parameter of Red Blood Cell (RBC) Count and Reticulocyte Count at Indicated Time Points | RBC count, Day 8 | 4.52 Trillion cells (TI)/Liter | Standard Deviation 0.43 |
| GSK1322322 1500 mg BID | Mean Hematology Parameter of Red Blood Cell (RBC) Count and Reticulocyte Count at Indicated Time Points | RBC count, Day 11 | 4.52 Trillion cells (TI)/Liter | Standard Deviation 0.41 |
| GSK1322322 1500 mg BID | Mean Hematology Parameter of Red Blood Cell (RBC) Count and Reticulocyte Count at Indicated Time Points | RBC count, 7 Day Follow-up | 4.56 Trillion cells (TI)/Liter | Standard Deviation 0.489 |
| GSK1322322 1500 mg BID | Mean Hematology Parameter of Red Blood Cell (RBC) Count and Reticulocyte Count at Indicated Time Points | RBC count, 28 Day Follow-up | 4.61 Trillion cells (TI)/Liter | Standard Deviation 0.43 |
| GSK1322322 1500 mg BID | Mean Hematology Parameter of Red Blood Cell (RBC) Count and Reticulocyte Count at Indicated Time Points | Reticulocytes, Day 1 | 0.07 Trillion cells (TI)/Liter | Standard Deviation 0.032 |
| GSK1322322 1500 mg BID | Mean Hematology Parameter of Red Blood Cell (RBC) Count and Reticulocyte Count at Indicated Time Points | Reticulocytes, Day 4 | 0.06 Trillion cells (TI)/Liter | Standard Deviation 0.024 |
| GSK1322322 1500 mg BID | Mean Hematology Parameter of Red Blood Cell (RBC) Count and Reticulocyte Count at Indicated Time Points | Reticulocytes, Day 8 | 0.07 Trillion cells (TI)/Liter | Standard Deviation 0.026 |
| GSK1322322 1500 mg BID | Mean Hematology Parameter of Red Blood Cell (RBC) Count and Reticulocyte Count at Indicated Time Points | Reticulocytes, Day 11 | 0.07 Trillion cells (TI)/Liter | Standard Deviation 0.031 |
| GSK1322322 1500 mg BID | Mean Hematology Parameter of Red Blood Cell (RBC) Count and Reticulocyte Count at Indicated Time Points | Reticulocytes, 7 Day Follow-up | 0.06 Trillion cells (TI)/Liter | Standard Deviation 0.029 |
| GSK1322322 1500 mg BID | Mean Hematology Parameter of Red Blood Cell (RBC) Count and Reticulocyte Count at Indicated Time Points | Reticulocytes, 28 Day Follow-up | 0.07 Trillion cells (TI)/Liter | Standard Deviation 0.031 |
| Linezolid 600 mg BID | Mean Hematology Parameter of Red Blood Cell (RBC) Count and Reticulocyte Count at Indicated Time Points | Reticulocytes, 7 Day Follow-up | 0.08 Trillion cells (TI)/Liter | Standard Deviation 0.027 |
| Linezolid 600 mg BID | Mean Hematology Parameter of Red Blood Cell (RBC) Count and Reticulocyte Count at Indicated Time Points | RBC count, Day 1 | 4.43 Trillion cells (TI)/Liter | Standard Deviation 0.397 |
| Linezolid 600 mg BID | Mean Hematology Parameter of Red Blood Cell (RBC) Count and Reticulocyte Count at Indicated Time Points | Reticulocytes, Day 1 | 0.06 Trillion cells (TI)/Liter | Standard Deviation 0.021 |
| Linezolid 600 mg BID | Mean Hematology Parameter of Red Blood Cell (RBC) Count and Reticulocyte Count at Indicated Time Points | RBC count, Day 4 | 4.36 Trillion cells (TI)/Liter | Standard Deviation 0.454 |
| Linezolid 600 mg BID | Mean Hematology Parameter of Red Blood Cell (RBC) Count and Reticulocyte Count at Indicated Time Points | Reticulocytes, Day 11 | 0.07 Trillion cells (TI)/Liter | Standard Deviation 0.025 |
| Linezolid 600 mg BID | Mean Hematology Parameter of Red Blood Cell (RBC) Count and Reticulocyte Count at Indicated Time Points | RBC count, Day 8 | 4.37 Trillion cells (TI)/Liter | Standard Deviation 0.389 |
| Linezolid 600 mg BID | Mean Hematology Parameter of Red Blood Cell (RBC) Count and Reticulocyte Count at Indicated Time Points | Reticulocytes, Day 4 | 0.05 Trillion cells (TI)/Liter | Standard Deviation 0.02 |
| Linezolid 600 mg BID | Mean Hematology Parameter of Red Blood Cell (RBC) Count and Reticulocyte Count at Indicated Time Points | RBC count, Day 11 | 4.46 Trillion cells (TI)/Liter | Standard Deviation 0.436 |
| Linezolid 600 mg BID | Mean Hematology Parameter of Red Blood Cell (RBC) Count and Reticulocyte Count at Indicated Time Points | Reticulocytes, 28 Day Follow-up | 0.06 Trillion cells (TI)/Liter | Standard Deviation 0.023 |
| Linezolid 600 mg BID | Mean Hematology Parameter of Red Blood Cell (RBC) Count and Reticulocyte Count at Indicated Time Points | RBC count, 7 Day Follow-up | 4.42 Trillion cells (TI)/Liter | Standard Deviation 0.457 |
| Linezolid 600 mg BID | Mean Hematology Parameter of Red Blood Cell (RBC) Count and Reticulocyte Count at Indicated Time Points | Reticulocytes, Day 8 | 0.05 Trillion cells (TI)/Liter | Standard Deviation 0.023 |
| Linezolid 600 mg BID | Mean Hematology Parameter of Red Blood Cell (RBC) Count and Reticulocyte Count at Indicated Time Points | RBC count, 28 Day Follow-up | 4.44 Trillion cells (TI)/Liter | Standard Deviation 0.376 |
Primary
Mean Hematology Parameters of Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, White Blood Cells (WBC) and Platelet Count at Indicated Time Points
Blood samples were obtained for analysis of basophils, eosinophils, lymphocytes, monocytes, total neutrophils, WBC and platelet count at Day 1, Day 4, Day 8, Day 11, 7 Day Follow-up and 28 Day Follow-up. Baseline value was defined as the assessment done on Day 1.
Time frame: Up to Follow-up (28 Day Follow-up, Day 40)
Population: Safety Population. Only those participants available at the specified time points were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| GSK1322322 1500 mg BID | Mean Hematology Parameters of Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, White Blood Cells (WBC) and Platelet Count at Indicated Time Points | Eosinophils, 7 Day Follow-up | 0.151 Giga cells/Liter | Standard Deviation 0.087 |
| GSK1322322 1500 mg BID | Mean Hematology Parameters of Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, White Blood Cells (WBC) and Platelet Count at Indicated Time Points | Basophils, Day 4 | 0.030 Giga cells/Liter | Standard Deviation 0.0179 |
| GSK1322322 1500 mg BID | Mean Hematology Parameters of Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, White Blood Cells (WBC) and Platelet Count at Indicated Time Points | Basophils, Day 8 | 0.027 Giga cells/Liter | Standard Deviation 0.0125 |
| GSK1322322 1500 mg BID | Mean Hematology Parameters of Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, White Blood Cells (WBC) and Platelet Count at Indicated Time Points | Basophils, Day 11 | 0.030 Giga cells/Liter | Standard Deviation 0.0234 |
| GSK1322322 1500 mg BID | Mean Hematology Parameters of Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, White Blood Cells (WBC) and Platelet Count at Indicated Time Points | Basophils, 7 Day Follow-up | 0.032 Giga cells/Liter | Standard Deviation 0.0162 |
| GSK1322322 1500 mg BID | Mean Hematology Parameters of Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, White Blood Cells (WBC) and Platelet Count at Indicated Time Points | Basophils, 28 Day Follow-up | 0.024 Giga cells/Liter | Standard Deviation 0.0144 |
| GSK1322322 1500 mg BID | Mean Hematology Parameters of Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, White Blood Cells (WBC) and Platelet Count at Indicated Time Points | Eosinophils, Day 1 | 0.149 Giga cells/Liter | Standard Deviation 0.1116 |
| GSK1322322 1500 mg BID | Mean Hematology Parameters of Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, White Blood Cells (WBC) and Platelet Count at Indicated Time Points | Eosinophils, Day 4 | 0.149 Giga cells/Liter | Standard Deviation 0.1708 |
| GSK1322322 1500 mg BID | Mean Hematology Parameters of Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, White Blood Cells (WBC) and Platelet Count at Indicated Time Points | Eosinophils, Day 8 | 0.165 Giga cells/Liter | Standard Deviation 0.1347 |
| GSK1322322 1500 mg BID | Mean Hematology Parameters of Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, White Blood Cells (WBC) and Platelet Count at Indicated Time Points | Eosinophils, Day 11 | 0.175 Giga cells/Liter | Standard Deviation 0.1534 |
| GSK1322322 1500 mg BID | Mean Hematology Parameters of Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, White Blood Cells (WBC) and Platelet Count at Indicated Time Points | Basophils, Day 1 | 0.027 Giga cells/Liter | Standard Deviation 0.0146 |
| GSK1322322 1500 mg BID | Mean Hematology Parameters of Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, White Blood Cells (WBC) and Platelet Count at Indicated Time Points | Eosinophils, 28 Day Follow-up | 0.141 Giga cells/Liter | Standard Deviation 0.106 |
| GSK1322322 1500 mg BID | Mean Hematology Parameters of Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, White Blood Cells (WBC) and Platelet Count at Indicated Time Points | Monocytes, Day 1 | 0.432 Giga cells/Liter | Standard Deviation 0.2097 |
| GSK1322322 1500 mg BID | Mean Hematology Parameters of Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, White Blood Cells (WBC) and Platelet Count at Indicated Time Points | Monocytes, Day 4 | 0.354 Giga cells/Liter | Standard Deviation 0.1352 |
| GSK1322322 1500 mg BID | Mean Hematology Parameters of Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, White Blood Cells (WBC) and Platelet Count at Indicated Time Points | Monocytes, Day 8 | 0.370 Giga cells/Liter | Standard Deviation 0.1265 |
| GSK1322322 1500 mg BID | Mean Hematology Parameters of Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, White Blood Cells (WBC) and Platelet Count at Indicated Time Points | Monocytes, Day 11 | 0.320 Giga cells/Liter | Standard Deviation 0.1475 |
| GSK1322322 1500 mg BID | Mean Hematology Parameters of Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, White Blood Cells (WBC) and Platelet Count at Indicated Time Points | Monocytes, 7 Day Follow-up | 0.345 Giga cells/Liter | Standard Deviation 0.1544 |
| GSK1322322 1500 mg BID | Mean Hematology Parameters of Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, White Blood Cells (WBC) and Platelet Count at Indicated Time Points | Monocytes, 28 Day Follow-up | 0.384 Giga cells/Liter | Standard Deviation 0.1502 |
| GSK1322322 1500 mg BID | Mean Hematology Parameters of Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, White Blood Cells (WBC) and Platelet Count at Indicated Time Points | Total neutrophils, Day 1 | 6.533 Giga cells/Liter | Standard Deviation 3.0198 |
| GSK1322322 1500 mg BID | Mean Hematology Parameters of Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, White Blood Cells (WBC) and Platelet Count at Indicated Time Points | Total neutrophils, Day 4 | 4.757 Giga cells/Liter | Standard Deviation 2.147 |
| GSK1322322 1500 mg BID | Mean Hematology Parameters of Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, White Blood Cells (WBC) and Platelet Count at Indicated Time Points | Total neutrophils, Day 8 | 4.371 Giga cells/Liter | Standard Deviation 1.6688 |
| GSK1322322 1500 mg BID | Mean Hematology Parameters of Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, White Blood Cells (WBC) and Platelet Count at Indicated Time Points | Total neutrophils, Day 11 | 4.495 Giga cells/Liter | Standard Deviation 2.0516 |
| GSK1322322 1500 mg BID | Mean Hematology Parameters of Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, White Blood Cells (WBC) and Platelet Count at Indicated Time Points | Total neutrophils, 7 Day Follow-up | 4.111 Giga cells/Liter | Standard Deviation 1.5873 |
| GSK1322322 1500 mg BID | Mean Hematology Parameters of Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, White Blood Cells (WBC) and Platelet Count at Indicated Time Points | Total neutrophils, 28 Day Follow-up | 4.709 Giga cells/Liter | Standard Deviation 1.947 |
| GSK1322322 1500 mg BID | Mean Hematology Parameters of Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, White Blood Cells (WBC) and Platelet Count at Indicated Time Points | WBC count, Day 1 | 9.15 Giga cells/Liter | Standard Deviation 3.42 |
| GSK1322322 1500 mg BID | Mean Hematology Parameters of Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, White Blood Cells (WBC) and Platelet Count at Indicated Time Points | WBC count, Day 4 | 7.35 Giga cells/Liter | Standard Deviation 2.551 |
| GSK1322322 1500 mg BID | Mean Hematology Parameters of Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, White Blood Cells (WBC) and Platelet Count at Indicated Time Points | WBC count, Day 8 | 6.82 Giga cells/Liter | Standard Deviation 1.997 |
| GSK1322322 1500 mg BID | Mean Hematology Parameters of Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, White Blood Cells (WBC) and Platelet Count at Indicated Time Points | WBC count, Day 11 | 6.77 Giga cells/Liter | Standard Deviation 2.209 |
| GSK1322322 1500 mg BID | Mean Hematology Parameters of Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, White Blood Cells (WBC) and Platelet Count at Indicated Time Points | WBC count, 7 Day Follow-up | 6.44 Giga cells/Liter | Standard Deviation 2.077 |
| GSK1322322 1500 mg BID | Mean Hematology Parameters of Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, White Blood Cells (WBC) and Platelet Count at Indicated Time Points | WBC count, 28 Day Follow-up | 7.16 Giga cells/Liter | Standard Deviation 2.415 |
| GSK1322322 1500 mg BID | Mean Hematology Parameters of Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, White Blood Cells (WBC) and Platelet Count at Indicated Time Points | Platelet count, Day 1 | 285.5 Giga cells/Liter | Standard Deviation 91.48 |
| GSK1322322 1500 mg BID | Mean Hematology Parameters of Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, White Blood Cells (WBC) and Platelet Count at Indicated Time Points | Platelet count, Day 4 | 296.5 Giga cells/Liter | Standard Deviation 93.96 |
| GSK1322322 1500 mg BID | Mean Hematology Parameters of Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, White Blood Cells (WBC) and Platelet Count at Indicated Time Points | Platelet count, Day 8 | 293.0 Giga cells/Liter | Standard Deviation 79.28 |
| GSK1322322 1500 mg BID | Mean Hematology Parameters of Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, White Blood Cells (WBC) and Platelet Count at Indicated Time Points | Platelet count, Day 11 | 280.2 Giga cells/Liter | Standard Deviation 78.24 |
| GSK1322322 1500 mg BID | Mean Hematology Parameters of Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, White Blood Cells (WBC) and Platelet Count at Indicated Time Points | Platelet count, 7 Day Follow-up | 264.0 Giga cells/Liter | Standard Deviation 71.4 |
| GSK1322322 1500 mg BID | Mean Hematology Parameters of Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, White Blood Cells (WBC) and Platelet Count at Indicated Time Points | Platelet count, 28 Day Follow-up | 279.3 Giga cells/Liter | Standard Deviation 74.61 |
| GSK1322322 1500 mg BID | Mean Hematology Parameters of Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, White Blood Cells (WBC) and Platelet Count at Indicated Time Points | Lymphocytes, Day 1 | 2.012 Giga cells/Liter | Standard Deviation 0.7487 |
| GSK1322322 1500 mg BID | Mean Hematology Parameters of Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, White Blood Cells (WBC) and Platelet Count at Indicated Time Points | Lymphocytes, Day 4 | 2.057 Giga cells/Liter | Standard Deviation 0.8168 |
| GSK1322322 1500 mg BID | Mean Hematology Parameters of Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, White Blood Cells (WBC) and Platelet Count at Indicated Time Points | Lymphocytes, Day 8 | 1.890 Giga cells/Liter | Standard Deviation 0.7039 |
| GSK1322322 1500 mg BID | Mean Hematology Parameters of Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, White Blood Cells (WBC) and Platelet Count at Indicated Time Points | Lymphocytes, Day 11 | 1.749 Giga cells/Liter | Standard Deviation 0.699 |
| GSK1322322 1500 mg BID | Mean Hematology Parameters of Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, White Blood Cells (WBC) and Platelet Count at Indicated Time Points | Lymphocytes, 7 Day Follow-up | 1.806 Giga cells/Liter | Standard Deviation 0.7018 |
| GSK1322322 1500 mg BID | Mean Hematology Parameters of Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, White Blood Cells (WBC) and Platelet Count at Indicated Time Points | Lymphocytes, 28 Day Follow-up | 1.907 Giga cells/Liter | Standard Deviation 0.7745 |
| Linezolid 600 mg BID | Mean Hematology Parameters of Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, White Blood Cells (WBC) and Platelet Count at Indicated Time Points | Platelet count, Day 4 | 273.2 Giga cells/Liter | Standard Deviation 74.68 |
| Linezolid 600 mg BID | Mean Hematology Parameters of Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, White Blood Cells (WBC) and Platelet Count at Indicated Time Points | Basophils, Day 1 | 0.035 Giga cells/Liter | Standard Deviation 0.0272 |
| Linezolid 600 mg BID | Mean Hematology Parameters of Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, White Blood Cells (WBC) and Platelet Count at Indicated Time Points | Total neutrophils, Day 11 | 4.524 Giga cells/Liter | Standard Deviation 1.7753 |
| Linezolid 600 mg BID | Mean Hematology Parameters of Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, White Blood Cells (WBC) and Platelet Count at Indicated Time Points | Basophils, Day 4 | 0.035 Giga cells/Liter | Standard Deviation 0.0247 |
| Linezolid 600 mg BID | Mean Hematology Parameters of Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, White Blood Cells (WBC) and Platelet Count at Indicated Time Points | Lymphocytes, Day 11 | 1.925 Giga cells/Liter | Standard Deviation 0.6202 |
| Linezolid 600 mg BID | Mean Hematology Parameters of Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, White Blood Cells (WBC) and Platelet Count at Indicated Time Points | Basophils, Day 8 | 0.035 Giga cells/Liter | Standard Deviation 0.0343 |
| Linezolid 600 mg BID | Mean Hematology Parameters of Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, White Blood Cells (WBC) and Platelet Count at Indicated Time Points | Total neutrophils, 7 Day Follow-up | 4.821 Giga cells/Liter | Standard Deviation 2.0453 |
| Linezolid 600 mg BID | Mean Hematology Parameters of Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, White Blood Cells (WBC) and Platelet Count at Indicated Time Points | Basophils, Day 11 | 0.020 Giga cells/Liter | Standard Deviation 0.0088 |
| Linezolid 600 mg BID | Mean Hematology Parameters of Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, White Blood Cells (WBC) and Platelet Count at Indicated Time Points | Platelet count, Day 8 | 268.3 Giga cells/Liter | Standard Deviation 56.9 |
| Linezolid 600 mg BID | Mean Hematology Parameters of Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, White Blood Cells (WBC) and Platelet Count at Indicated Time Points | Basophils, 7 Day Follow-up | 0.027 Giga cells/Liter | Standard Deviation 0.0199 |
| Linezolid 600 mg BID | Mean Hematology Parameters of Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, White Blood Cells (WBC) and Platelet Count at Indicated Time Points | Total neutrophils, 28 Day Follow-up | 5.496 Giga cells/Liter | Standard Deviation 2.9618 |
| Linezolid 600 mg BID | Mean Hematology Parameters of Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, White Blood Cells (WBC) and Platelet Count at Indicated Time Points | Basophils, 28 Day Follow-up | 0.031 Giga cells/Liter | Standard Deviation 0.0187 |
| Linezolid 600 mg BID | Mean Hematology Parameters of Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, White Blood Cells (WBC) and Platelet Count at Indicated Time Points | Lymphocytes, Day 4 | 1.968 Giga cells/Liter | Standard Deviation 0.6718 |
| Linezolid 600 mg BID | Mean Hematology Parameters of Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, White Blood Cells (WBC) and Platelet Count at Indicated Time Points | Eosinophils, Day 1 | 0.140 Giga cells/Liter | Standard Deviation 0.1022 |
| Linezolid 600 mg BID | Mean Hematology Parameters of Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, White Blood Cells (WBC) and Platelet Count at Indicated Time Points | WBC count, Day 1 | 9.87 Giga cells/Liter | Standard Deviation 2.673 |
| Linezolid 600 mg BID | Mean Hematology Parameters of Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, White Blood Cells (WBC) and Platelet Count at Indicated Time Points | Eosinophils, Day 4 | 0.145 Giga cells/Liter | Standard Deviation 0.1018 |
| Linezolid 600 mg BID | Mean Hematology Parameters of Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, White Blood Cells (WBC) and Platelet Count at Indicated Time Points | Platelet count, Day 11 | 253.9 Giga cells/Liter | Standard Deviation 62.44 |
| Linezolid 600 mg BID | Mean Hematology Parameters of Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, White Blood Cells (WBC) and Platelet Count at Indicated Time Points | Eosinophils, Day 8 | 0.155 Giga cells/Liter | Standard Deviation 0.1016 |
| Linezolid 600 mg BID | Mean Hematology Parameters of Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, White Blood Cells (WBC) and Platelet Count at Indicated Time Points | WBC count, Day 4 | 7.54 Giga cells/Liter | Standard Deviation 2.462 |
| Linezolid 600 mg BID | Mean Hematology Parameters of Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, White Blood Cells (WBC) and Platelet Count at Indicated Time Points | Eosinophils, Day 11 | 0.168 Giga cells/Liter | Standard Deviation 0.1155 |
| Linezolid 600 mg BID | Mean Hematology Parameters of Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, White Blood Cells (WBC) and Platelet Count at Indicated Time Points | Lymphocytes, 28 Day Follow-up | 1.955 Giga cells/Liter | Standard Deviation 0.4947 |
| Linezolid 600 mg BID | Mean Hematology Parameters of Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, White Blood Cells (WBC) and Platelet Count at Indicated Time Points | Eosinophils, 7 Day Follow-up | 0.128 Giga cells/Liter | Standard Deviation 0.0947 |
| Linezolid 600 mg BID | Mean Hematology Parameters of Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, White Blood Cells (WBC) and Platelet Count at Indicated Time Points | WBC count, Day 8 | 7.30 Giga cells/Liter | Standard Deviation 2.895 |
| Linezolid 600 mg BID | Mean Hematology Parameters of Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, White Blood Cells (WBC) and Platelet Count at Indicated Time Points | Eosinophils, 28 Day Follow-up | 0.150 Giga cells/Liter | Standard Deviation 0.0959 |
| Linezolid 600 mg BID | Mean Hematology Parameters of Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, White Blood Cells (WBC) and Platelet Count at Indicated Time Points | Platelet count, 7 Day Follow-up | 249.8 Giga cells/Liter | Standard Deviation 58.68 |
| Linezolid 600 mg BID | Mean Hematology Parameters of Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, White Blood Cells (WBC) and Platelet Count at Indicated Time Points | Monocytes, Day 1 | 0.517 Giga cells/Liter | Standard Deviation 0.2131 |
| Linezolid 600 mg BID | Mean Hematology Parameters of Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, White Blood Cells (WBC) and Platelet Count at Indicated Time Points | WBC count, Day 11 | 7.06 Giga cells/Liter | Standard Deviation 2.172 |
| Linezolid 600 mg BID | Mean Hematology Parameters of Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, White Blood Cells (WBC) and Platelet Count at Indicated Time Points | Monocytes, Day 4 | 0.408 Giga cells/Liter | Standard Deviation 0.2819 |
| Linezolid 600 mg BID | Mean Hematology Parameters of Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, White Blood Cells (WBC) and Platelet Count at Indicated Time Points | Lymphocytes, Day 8 | 1.941 Giga cells/Liter | Standard Deviation 0.7312 |
| Linezolid 600 mg BID | Mean Hematology Parameters of Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, White Blood Cells (WBC) and Platelet Count at Indicated Time Points | Monocytes, Day 8 | 0.388 Giga cells/Liter | Standard Deviation 0.1826 |
| Linezolid 600 mg BID | Mean Hematology Parameters of Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, White Blood Cells (WBC) and Platelet Count at Indicated Time Points | WBC count, 7 Day Follow-up | 7.48 Giga cells/Liter | Standard Deviation 2.432 |
| Linezolid 600 mg BID | Mean Hematology Parameters of Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, White Blood Cells (WBC) and Platelet Count at Indicated Time Points | Monocytes, Day 11 | 0.420 Giga cells/Liter | Standard Deviation 0.18 |
| Linezolid 600 mg BID | Mean Hematology Parameters of Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, White Blood Cells (WBC) and Platelet Count at Indicated Time Points | Platelet count, 28 Day Follow-up | 240.5 Giga cells/Liter | Standard Deviation 69.81 |
| Linezolid 600 mg BID | Mean Hematology Parameters of Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, White Blood Cells (WBC) and Platelet Count at Indicated Time Points | Monocytes, 7 Day Follow-up | 0.410 Giga cells/Liter | Standard Deviation 0.1677 |
| Linezolid 600 mg BID | Mean Hematology Parameters of Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, White Blood Cells (WBC) and Platelet Count at Indicated Time Points | WBC count, 28 Day Follow-up | 8.10 Giga cells/Liter | Standard Deviation 3.268 |
| Linezolid 600 mg BID | Mean Hematology Parameters of Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, White Blood Cells (WBC) and Platelet Count at Indicated Time Points | Monocytes, 28 Day Follow-up | 0.471 Giga cells/Liter | Standard Deviation 0.2175 |
| Linezolid 600 mg BID | Mean Hematology Parameters of Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, White Blood Cells (WBC) and Platelet Count at Indicated Time Points | Lymphocytes, 7 Day Follow-up | 2.091 Giga cells/Liter | Standard Deviation 0.8427 |
| Linezolid 600 mg BID | Mean Hematology Parameters of Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, White Blood Cells (WBC) and Platelet Count at Indicated Time Points | Total neutrophils, Day 1 | 7.231 Giga cells/Liter | Standard Deviation 2.4074 |
| Linezolid 600 mg BID | Mean Hematology Parameters of Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, White Blood Cells (WBC) and Platelet Count at Indicated Time Points | Platelet count, Day 1 | 255.0 Giga cells/Liter | Standard Deviation 72.48 |
| Linezolid 600 mg BID | Mean Hematology Parameters of Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, White Blood Cells (WBC) and Platelet Count at Indicated Time Points | Total neutrophils, Day 4 | 4.984 Giga cells/Liter | Standard Deviation 2.0237 |
| Linezolid 600 mg BID | Mean Hematology Parameters of Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, White Blood Cells (WBC) and Platelet Count at Indicated Time Points | Lymphocytes, Day 1 | 1.947 Giga cells/Liter | Standard Deviation 0.6455 |
| Linezolid 600 mg BID | Mean Hematology Parameters of Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, White Blood Cells (WBC) and Platelet Count at Indicated Time Points | Total neutrophils, Day 8 | 4.780 Giga cells/Liter | Standard Deviation 2.6362 |
Primary
Mean Vital Sign Value of Heart Rate (HR) at Indicated Time Points
Vital sign assessments were conducted at Day 1 (pre-dose), Day 2 (pre-dose), Day 3 (pre-dose), Day 4 (4-12 hours post-dose), Day 8 (pre-dose) and Day 11. The assessments were made with the participant in a semi-supine position, having rested in that position for at least 10 minutes beforehand. Three HR measurements were taken at pre-dose on Day 1. The mean value recorded at pre-dose was classified as Baseline. Single HR was obtained at all other time points during the study.
Time frame: Up to Day 11
Population: Safety Population. Only those participants available at the specified time points were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| GSK1322322 1500 mg BID | Mean Vital Sign Value of Heart Rate (HR) at Indicated Time Points | Day 1 | 74.9 Beats per minute | Standard Deviation 13.75 |
| GSK1322322 1500 mg BID | Mean Vital Sign Value of Heart Rate (HR) at Indicated Time Points | Day 2 | 81.2 Beats per minute | Standard Deviation 14.54 |
| GSK1322322 1500 mg BID | Mean Vital Sign Value of Heart Rate (HR) at Indicated Time Points | Day 3 | 77.6 Beats per minute | Standard Deviation 12.81 |
| GSK1322322 1500 mg BID | Mean Vital Sign Value of Heart Rate (HR) at Indicated Time Points | Day 4 | 71.9 Beats per minute | Standard Deviation 11.21 |
| GSK1322322 1500 mg BID | Mean Vital Sign Value of Heart Rate (HR) at Indicated Time Points | Day 8 | 69.9 Beats per minute | Standard Deviation 10.52 |
| GSK1322322 1500 mg BID | Mean Vital Sign Value of Heart Rate (HR) at Indicated Time Points | Day 11 | 70.9 Beats per minute | Standard Deviation 12.86 |
| Linezolid 600 mg BID | Mean Vital Sign Value of Heart Rate (HR) at Indicated Time Points | Day 8 | 69.2 Beats per minute | Standard Deviation 12.07 |
| Linezolid 600 mg BID | Mean Vital Sign Value of Heart Rate (HR) at Indicated Time Points | Day 1 | 73.9 Beats per minute | Standard Deviation 14.11 |
| Linezolid 600 mg BID | Mean Vital Sign Value of Heart Rate (HR) at Indicated Time Points | Day 4 | 74.6 Beats per minute | Standard Deviation 17.08 |
| Linezolid 600 mg BID | Mean Vital Sign Value of Heart Rate (HR) at Indicated Time Points | Day 2 | 76.2 Beats per minute | Standard Deviation 12.8 |
| Linezolid 600 mg BID | Mean Vital Sign Value of Heart Rate (HR) at Indicated Time Points | Day 11 | 74.0 Beats per minute | Standard Deviation 12.22 |
| Linezolid 600 mg BID | Mean Vital Sign Value of Heart Rate (HR) at Indicated Time Points | Day 3 | 76.1 Beats per minute | Standard Deviation 11.7 |
Primary
Mean Vital Sign Value of Respiratory Rate (RR) at Indicated Time Points
Vital sign assessments were conducted at Day 1 (pre-dose), Day 2 (pre-dose), Day 3 (pre-dose), Day 4 (4-12 hours post-dose), Day 8 (pre-dose) and Day 11. The assessments were made with the participant in a semi-supine position, having rested in that position for at least 10 minutes beforehand. Three RR measurements were taken at pre-dose on Day 1. The mean value recorded at pre-dose was classified as Baseline. Single RR was obtained at all other time points during the study.
Time frame: Up to Day 11
Population: Safety Population. Only those participants available at the specified time points were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| GSK1322322 1500 mg BID | Mean Vital Sign Value of Respiratory Rate (RR) at Indicated Time Points | Day 1 | 17.1 Breaths per minute | Standard Deviation 1.95 |
| GSK1322322 1500 mg BID | Mean Vital Sign Value of Respiratory Rate (RR) at Indicated Time Points | Day 2 | 17.3 Breaths per minute | Standard Deviation 1.78 |
| GSK1322322 1500 mg BID | Mean Vital Sign Value of Respiratory Rate (RR) at Indicated Time Points | Day 3 | 17.4 Breaths per minute | Standard Deviation 2.08 |
| GSK1322322 1500 mg BID | Mean Vital Sign Value of Respiratory Rate (RR) at Indicated Time Points | Day 4 | 17.3 Breaths per minute | Standard Deviation 1.92 |
| GSK1322322 1500 mg BID | Mean Vital Sign Value of Respiratory Rate (RR) at Indicated Time Points | Day 8 | 17.1 Breaths per minute | Standard Deviation 1.66 |
| GSK1322322 1500 mg BID | Mean Vital Sign Value of Respiratory Rate (RR) at Indicated Time Points | Day 11 | 17.6 Breaths per minute | Standard Deviation 2.2 |
| Linezolid 600 mg BID | Mean Vital Sign Value of Respiratory Rate (RR) at Indicated Time Points | Day 8 | 17.2 Breaths per minute | Standard Deviation 1.76 |
| Linezolid 600 mg BID | Mean Vital Sign Value of Respiratory Rate (RR) at Indicated Time Points | Day 1 | 17.9 Breaths per minute | Standard Deviation 1.7 |
| Linezolid 600 mg BID | Mean Vital Sign Value of Respiratory Rate (RR) at Indicated Time Points | Day 4 | 17.4 Breaths per minute | Standard Deviation 1.85 |
| Linezolid 600 mg BID | Mean Vital Sign Value of Respiratory Rate (RR) at Indicated Time Points | Day 2 | 17.4 Breaths per minute | Standard Deviation 1.98 |
| Linezolid 600 mg BID | Mean Vital Sign Value of Respiratory Rate (RR) at Indicated Time Points | Day 11 | 16.8 Breaths per minute | Standard Deviation 1.96 |
| Linezolid 600 mg BID | Mean Vital Sign Value of Respiratory Rate (RR) at Indicated Time Points | Day 3 | 17.3 Breaths per minute | Standard Deviation 1.85 |
Primary
Mean Vital Sign Value of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Indicated Time Points
Vital sign assessments were conducted at Day 1 (pre-dose), Day 2 (pre-dose), Day 3 (pre-dose), Day 4 (4-12 hours post-dose), Day 8 (pre-dose) and Day 11. The assessments were made with the participant in a semi-supine position, having rested in that position for at least 10 minutes beforehand. Three BP measurements were taken at pre-dose on Day 1. The mean value recorded at pre-dose was classified as Baseline. Single BP was obtained at all other time points during the study.
Time frame: Up to Day 11
Population: Safety Population. Only those participants available at the specified time points were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| GSK1322322 1500 mg BID | Mean Vital Sign Value of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Indicated Time Points | DBP, Day 1 | 78.1 Millimeters of mercury (mmHg) | Standard Deviation 10.39 |
| GSK1322322 1500 mg BID | Mean Vital Sign Value of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Indicated Time Points | DBP, Day 2 | 76.0 Millimeters of mercury (mmHg) | Standard Deviation 10.81 |
| GSK1322322 1500 mg BID | Mean Vital Sign Value of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Indicated Time Points | DBP, Day 3 | 73.6 Millimeters of mercury (mmHg) | Standard Deviation 10.92 |
| GSK1322322 1500 mg BID | Mean Vital Sign Value of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Indicated Time Points | DBP, Day 4 | 69.7 Millimeters of mercury (mmHg) | Standard Deviation 9.63 |
| GSK1322322 1500 mg BID | Mean Vital Sign Value of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Indicated Time Points | DBP, Day 8 | 73.5 Millimeters of mercury (mmHg) | Standard Deviation 10.77 |
| GSK1322322 1500 mg BID | Mean Vital Sign Value of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Indicated Time Points | DBP, Day 11 | 73.6 Millimeters of mercury (mmHg) | Standard Deviation 9.75 |
| GSK1322322 1500 mg BID | Mean Vital Sign Value of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Indicated Time Points | SBP, Day 1 | 125.6 Millimeters of mercury (mmHg) | Standard Deviation 14.21 |
| GSK1322322 1500 mg BID | Mean Vital Sign Value of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Indicated Time Points | SBP, Day 2 | 119.2 Millimeters of mercury (mmHg) | Standard Deviation 13.78 |
| GSK1322322 1500 mg BID | Mean Vital Sign Value of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Indicated Time Points | SBP, Day 3 | 120.0 Millimeters of mercury (mmHg) | Standard Deviation 14.52 |
| GSK1322322 1500 mg BID | Mean Vital Sign Value of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Indicated Time Points | SBP, Day 4 | 119.3 Millimeters of mercury (mmHg) | Standard Deviation 13.56 |
| GSK1322322 1500 mg BID | Mean Vital Sign Value of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Indicated Time Points | SBP, Day 8 | 122.7 Millimeters of mercury (mmHg) | Standard Deviation 14.78 |
| GSK1322322 1500 mg BID | Mean Vital Sign Value of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Indicated Time Points | SBP, Day 11 | 122.0 Millimeters of mercury (mmHg) | Standard Deviation 14.53 |
| Linezolid 600 mg BID | Mean Vital Sign Value of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Indicated Time Points | SBP, Day 8 | 121.2 Millimeters of mercury (mmHg) | Standard Deviation 16.02 |
| Linezolid 600 mg BID | Mean Vital Sign Value of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Indicated Time Points | DBP, Day 1 | 74.5 Millimeters of mercury (mmHg) | Standard Deviation 10.46 |
| Linezolid 600 mg BID | Mean Vital Sign Value of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Indicated Time Points | SBP, Day 1 | 123.1 Millimeters of mercury (mmHg) | Standard Deviation 12.72 |
| Linezolid 600 mg BID | Mean Vital Sign Value of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Indicated Time Points | DBP, Day 2 | 76.7 Millimeters of mercury (mmHg) | Standard Deviation 9.7 |
| Linezolid 600 mg BID | Mean Vital Sign Value of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Indicated Time Points | SBP, Day 4 | 126.1 Millimeters of mercury (mmHg) | Standard Deviation 14.83 |
| Linezolid 600 mg BID | Mean Vital Sign Value of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Indicated Time Points | DBP, Day 3 | 77.3 Millimeters of mercury (mmHg) | Standard Deviation 11.01 |
| Linezolid 600 mg BID | Mean Vital Sign Value of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Indicated Time Points | SBP, Day 2 | 125.1 Millimeters of mercury (mmHg) | Standard Deviation 12.74 |
| Linezolid 600 mg BID | Mean Vital Sign Value of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Indicated Time Points | DBP, Day 4 | 76.8 Millimeters of mercury (mmHg) | Standard Deviation 12.02 |
| Linezolid 600 mg BID | Mean Vital Sign Value of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Indicated Time Points | SBP, Day 11 | 120.4 Millimeters of mercury (mmHg) | Standard Deviation 13.25 |
| Linezolid 600 mg BID | Mean Vital Sign Value of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Indicated Time Points | DBP, Day 8 | 72.1 Millimeters of mercury (mmHg) | Standard Deviation 11.23 |
| Linezolid 600 mg BID | Mean Vital Sign Value of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Indicated Time Points | SBP, Day 3 | 126.9 Millimeters of mercury (mmHg) | Standard Deviation 15.96 |
| Linezolid 600 mg BID | Mean Vital Sign Value of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Indicated Time Points | DBP, Day 11 | 72.8 Millimeters of mercury (mmHg) | Standard Deviation 10.97 |
Primary
Number of Participants With Abnormal Transition From Baseline in Clinical Chemistry Values Relative to Normal Range
The parameters of clinical chemistry included albumin, total protein, ALT, ALP, AST, GGT, LDH and creatine kinase, creatinine, uric acid, direct bilirubin, total bilirubin, glucose, sodium, calcium, potassium, chloride, CO2 content /bicarbonate and urea/BUN and high sensitivity C-Reactive protein. The assessments were done at Day 1, Day 4, Day 8, Day 11, 7 Day Follow-up and 28 Day Follow-up. Baseline was defined as the assessment done on Day 1 (pre-dose). Data is reported for number of participants with abnormal transition from Baseline 'to high' or 'to low' relative to normal range. Only those parameters for which at least one value of abnormal transition was reported are summarized.
Time frame: Day 1 (pre-dose, Baseline) up Follow-up (28 Day Follow-up, Day 40)
Population: Safety Population. Only those participants available at the specified time points were analyzed.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| GSK1322322 1500 mg BID | Number of Participants With Abnormal Transition From Baseline in Clinical Chemistry Values Relative to Normal Range | Day 8, Sodium, to low | 1 Participants |
| GSK1322322 1500 mg BID | Number of Participants With Abnormal Transition From Baseline in Clinical Chemistry Values Relative to Normal Range | Day 8, Urea/BUN, to low | 2 Participants |
| GSK1322322 1500 mg BID | Number of Participants With Abnormal Transition From Baseline in Clinical Chemistry Values Relative to Normal Range | Day 8, Uric acid, to low | 2 Participants |
| GSK1322322 1500 mg BID | Number of Participants With Abnormal Transition From Baseline in Clinical Chemistry Values Relative to Normal Range | Day 11, ALT, to high | 3 Participants |
| GSK1322322 1500 mg BID | Number of Participants With Abnormal Transition From Baseline in Clinical Chemistry Values Relative to Normal Range | Day 11, AST, to high | 5 Participants |
| GSK1322322 1500 mg BID | Number of Participants With Abnormal Transition From Baseline in Clinical Chemistry Values Relative to Normal Range | Day 11, Calcium, to low | 1 Participants |
| GSK1322322 1500 mg BID | Number of Participants With Abnormal Transition From Baseline in Clinical Chemistry Values Relative to Normal Range | Day 11, CO2/bicarbonate, to low | 5 Participants |
| GSK1322322 1500 mg BID | Number of Participants With Abnormal Transition From Baseline in Clinical Chemistry Values Relative to Normal Range | Day 11, Chloride, to low | 0 Participants |
| GSK1322322 1500 mg BID | Number of Participants With Abnormal Transition From Baseline in Clinical Chemistry Values Relative to Normal Range | Day 11, Chloride, to high | 1 Participants |
| GSK1322322 1500 mg BID | Number of Participants With Abnormal Transition From Baseline in Clinical Chemistry Values Relative to Normal Range | Day 11, Creatine kinase, to high | 2 Participants |
| GSK1322322 1500 mg BID | Number of Participants With Abnormal Transition From Baseline in Clinical Chemistry Values Relative to Normal Range | Day 11, Creatinine, to low | 2 Participants |
| GSK1322322 1500 mg BID | Number of Participants With Abnormal Transition From Baseline in Clinical Chemistry Values Relative to Normal Range | Day 11, GGT, to high | 3 Participants |
| GSK1322322 1500 mg BID | Number of Participants With Abnormal Transition From Baseline in Clinical Chemistry Values Relative to Normal Range | Day 11, Glucose, to low | 3 Participants |
| GSK1322322 1500 mg BID | Number of Participants With Abnormal Transition From Baseline in Clinical Chemistry Values Relative to Normal Range | Day 11, Glucose, to high | 8 Participants |
| GSK1322322 1500 mg BID | Number of Participants With Abnormal Transition From Baseline in Clinical Chemistry Values Relative to Normal Range | Day 2, C-Reactive protein, to high | 1 Participants |
| GSK1322322 1500 mg BID | Number of Participants With Abnormal Transition From Baseline in Clinical Chemistry Values Relative to Normal Range | Day 3, C-Reactive protein, to high | 1 Participants |
| GSK1322322 1500 mg BID | Number of Participants With Abnormal Transition From Baseline in Clinical Chemistry Values Relative to Normal Range | Day 4, ALT, to high | 1 Participants |
| GSK1322322 1500 mg BID | Number of Participants With Abnormal Transition From Baseline in Clinical Chemistry Values Relative to Normal Range | Day 11, C-Reactive protein, to high | 1 Participants |
| GSK1322322 1500 mg BID | Number of Participants With Abnormal Transition From Baseline in Clinical Chemistry Values Relative to Normal Range | Day 4, ALP, to high | 1 Participants |
| GSK1322322 1500 mg BID | Number of Participants With Abnormal Transition From Baseline in Clinical Chemistry Values Relative to Normal Range | Day 4, AST, to high | 2 Participants |
| GSK1322322 1500 mg BID | Number of Participants With Abnormal Transition From Baseline in Clinical Chemistry Values Relative to Normal Range | Day 4, Calcium, to low | 6 Participants |
| GSK1322322 1500 mg BID | Number of Participants With Abnormal Transition From Baseline in Clinical Chemistry Values Relative to Normal Range | Day 4, CO2/bicarbonate, to low | 4 Participants |
| GSK1322322 1500 mg BID | Number of Participants With Abnormal Transition From Baseline in Clinical Chemistry Values Relative to Normal Range | Day 4, Chloride, to low | 1 Participants |
| GSK1322322 1500 mg BID | Number of Participants With Abnormal Transition From Baseline in Clinical Chemistry Values Relative to Normal Range | Day 4, Creatine kinase, to high | 5 Participants |
| GSK1322322 1500 mg BID | Number of Participants With Abnormal Transition From Baseline in Clinical Chemistry Values Relative to Normal Range | Day 4, Creatinine, to low | 2 Participants |
| GSK1322322 1500 mg BID | Number of Participants With Abnormal Transition From Baseline in Clinical Chemistry Values Relative to Normal Range | Day 4, GGT, to high | 3 Participants |
| GSK1322322 1500 mg BID | Number of Participants With Abnormal Transition From Baseline in Clinical Chemistry Values Relative to Normal Range | Day 4, Glucose, to low | 2 Participants |
| GSK1322322 1500 mg BID | Number of Participants With Abnormal Transition From Baseline in Clinical Chemistry Values Relative to Normal Range | Day 4, Glucose, to high | 7 Participants |
| GSK1322322 1500 mg BID | Number of Participants With Abnormal Transition From Baseline in Clinical Chemistry Values Relative to Normal Range | Day 4, Potassium, to low | 1 Participants |
| GSK1322322 1500 mg BID | Number of Participants With Abnormal Transition From Baseline in Clinical Chemistry Values Relative to Normal Range | Day 4, Sodium, to low | 6 Participants |
| GSK1322322 1500 mg BID | Number of Participants With Abnormal Transition From Baseline in Clinical Chemistry Values Relative to Normal Range | Day 4, Total protein, to low | 1 Participants |
| GSK1322322 1500 mg BID | Number of Participants With Abnormal Transition From Baseline in Clinical Chemistry Values Relative to Normal Range | Day 4, Urea/BUN, to low | 2 Participants |
| GSK1322322 1500 mg BID | Number of Participants With Abnormal Transition From Baseline in Clinical Chemistry Values Relative to Normal Range | Day 4, Urea/BUN, to high | 0 Participants |
| GSK1322322 1500 mg BID | Number of Participants With Abnormal Transition From Baseline in Clinical Chemistry Values Relative to Normal Range | Day 4, Uric acid, to low | 5 Participants |
| GSK1322322 1500 mg BID | Number of Participants With Abnormal Transition From Baseline in Clinical Chemistry Values Relative to Normal Range | Day 8, ALT, to high | 1 Participants |
| GSK1322322 1500 mg BID | Number of Participants With Abnormal Transition From Baseline in Clinical Chemistry Values Relative to Normal Range | Day 8, Albumin, to low | 1 Participants |
| GSK1322322 1500 mg BID | Number of Participants With Abnormal Transition From Baseline in Clinical Chemistry Values Relative to Normal Range | Day 8, AST, to high | 4 Participants |
| GSK1322322 1500 mg BID | Number of Participants With Abnormal Transition From Baseline in Clinical Chemistry Values Relative to Normal Range | Day 8, Calcium, to low | 3 Participants |
| GSK1322322 1500 mg BID | Number of Participants With Abnormal Transition From Baseline in Clinical Chemistry Values Relative to Normal Range | Day 8, Chloride, to high | 1 Participants |
| GSK1322322 1500 mg BID | Number of Participants With Abnormal Transition From Baseline in Clinical Chemistry Values Relative to Normal Range | Day 8, Creatine kinase, to high | 4 Participants |
| GSK1322322 1500 mg BID | Number of Participants With Abnormal Transition From Baseline in Clinical Chemistry Values Relative to Normal Range | Day 8, Creatinine, to low | 4 Participants |
| GSK1322322 1500 mg BID | Number of Participants With Abnormal Transition From Baseline in Clinical Chemistry Values Relative to Normal Range | Day 8, GGT, to high | 4 Participants |
| GSK1322322 1500 mg BID | Number of Participants With Abnormal Transition From Baseline in Clinical Chemistry Values Relative to Normal Range | Day 11, Potassium, to low | 0 Participants |
| GSK1322322 1500 mg BID | Number of Participants With Abnormal Transition From Baseline in Clinical Chemistry Values Relative to Normal Range | Day 8, Glucose, to low | 1 Participants |
| GSK1322322 1500 mg BID | Number of Participants With Abnormal Transition From Baseline in Clinical Chemistry Values Relative to Normal Range | Day 11, Sodium, to low | 0 Participants |
| GSK1322322 1500 mg BID | Number of Participants With Abnormal Transition From Baseline in Clinical Chemistry Values Relative to Normal Range | Day 8, Glucose, to high | 7 Participants |
| GSK1322322 1500 mg BID | Number of Participants With Abnormal Transition From Baseline in Clinical Chemistry Values Relative to Normal Range | Day 11, Total protein, to high | 1 Participants |
| GSK1322322 1500 mg BID | Number of Participants With Abnormal Transition From Baseline in Clinical Chemistry Values Relative to Normal Range | Day 11, Urea/BUN, to low | 2 Participants |
| GSK1322322 1500 mg BID | Number of Participants With Abnormal Transition From Baseline in Clinical Chemistry Values Relative to Normal Range | Day 11, Urea/BUN, to high | 0 Participants |
| GSK1322322 1500 mg BID | Number of Participants With Abnormal Transition From Baseline in Clinical Chemistry Values Relative to Normal Range | Day 11, Uric acid, to low | 0 Participants |
| GSK1322322 1500 mg BID | Number of Participants With Abnormal Transition From Baseline in Clinical Chemistry Values Relative to Normal Range | Day 11, Uric acid, to high | 2 Participants |
| GSK1322322 1500 mg BID | Number of Participants With Abnormal Transition From Baseline in Clinical Chemistry Values Relative to Normal Range | 7 Day Follow-up, ALT, to high | 6 Participants |
| GSK1322322 1500 mg BID | Number of Participants With Abnormal Transition From Baseline in Clinical Chemistry Values Relative to Normal Range | 7 Day Follow-up, AST, to high | 6 Participants |
| GSK1322322 1500 mg BID | Number of Participants With Abnormal Transition From Baseline in Clinical Chemistry Values Relative to Normal Range | 7 Day Follow-up, Calcium, to low | 1 Participants |
| GSK1322322 1500 mg BID | Number of Participants With Abnormal Transition From Baseline in Clinical Chemistry Values Relative to Normal Range | 7 Day Follow-up, Calcium, to high | 1 Participants |
| GSK1322322 1500 mg BID | Number of Participants With Abnormal Transition From Baseline in Clinical Chemistry Values Relative to Normal Range | 7 Day Follow-up, CO2/bicarbonate, to low | 4 Participants |
| GSK1322322 1500 mg BID | Number of Participants With Abnormal Transition From Baseline in Clinical Chemistry Values Relative to Normal Range | 7 Day Follow-up, Chloride, to low | 0 Participants |
| GSK1322322 1500 mg BID | Number of Participants With Abnormal Transition From Baseline in Clinical Chemistry Values Relative to Normal Range | 7 Day Follow-up, Chloride, to high | 1 Participants |
| GSK1322322 1500 mg BID | Number of Participants With Abnormal Transition From Baseline in Clinical Chemistry Values Relative to Normal Range | 7 Day Follow-up, Creatine kinase, to high | 4 Participants |
| GSK1322322 1500 mg BID | Number of Participants With Abnormal Transition From Baseline in Clinical Chemistry Values Relative to Normal Range | 7 Day Follow-up, Creatinine, to low | 4 Participants |
| GSK1322322 1500 mg BID | Number of Participants With Abnormal Transition From Baseline in Clinical Chemistry Values Relative to Normal Range | 7 Day Follow-up, Creatinine, to high | 0 Participants |
| GSK1322322 1500 mg BID | Number of Participants With Abnormal Transition From Baseline in Clinical Chemistry Values Relative to Normal Range | 7 Day Follow-up, Direct bilirubin, to high | 1 Participants |
| GSK1322322 1500 mg BID | Number of Participants With Abnormal Transition From Baseline in Clinical Chemistry Values Relative to Normal Range | 7 Day Follow-up, GGT, to high | 3 Participants |
| GSK1322322 1500 mg BID | Number of Participants With Abnormal Transition From Baseline in Clinical Chemistry Values Relative to Normal Range | 7 Day Follow-up, Glucose, to high | 4 Participants |
| GSK1322322 1500 mg BID | Number of Participants With Abnormal Transition From Baseline in Clinical Chemistry Values Relative to Normal Range | 7 Day Follow-up, C-Reactive protein, to high | 0 Participants |
| GSK1322322 1500 mg BID | Number of Participants With Abnormal Transition From Baseline in Clinical Chemistry Values Relative to Normal Range | 7 Day Follow-up, Potassium, to low | 1 Participants |
| GSK1322322 1500 mg BID | Number of Participants With Abnormal Transition From Baseline in Clinical Chemistry Values Relative to Normal Range | 7 Day Follow-up, Sodium, to low | 1 Participants |
| GSK1322322 1500 mg BID | Number of Participants With Abnormal Transition From Baseline in Clinical Chemistry Values Relative to Normal Range | 7 Day Follow-up, Total bilirubin, to high | 1 Participants |
| GSK1322322 1500 mg BID | Number of Participants With Abnormal Transition From Baseline in Clinical Chemistry Values Relative to Normal Range | 7 Day Follow-up, Total protein, to high | 1 Participants |
| GSK1322322 1500 mg BID | Number of Participants With Abnormal Transition From Baseline in Clinical Chemistry Values Relative to Normal Range | 7 Day Follow-up, Urea/BUN, to low | 1 Participants |
| GSK1322322 1500 mg BID | Number of Participants With Abnormal Transition From Baseline in Clinical Chemistry Values Relative to Normal Range | 7 Day Follow-up, Urea/BUN, to high | 1 Participants |
| GSK1322322 1500 mg BID | Number of Participants With Abnormal Transition From Baseline in Clinical Chemistry Values Relative to Normal Range | 7 Day Follow-up, Uric acid, to low | 1 Participants |
| GSK1322322 1500 mg BID | Number of Participants With Abnormal Transition From Baseline in Clinical Chemistry Values Relative to Normal Range | 7 Day Follow-up, Uric acid, to high | 5 Participants |
| GSK1322322 1500 mg BID | Number of Participants With Abnormal Transition From Baseline in Clinical Chemistry Values Relative to Normal Range | 28 Day Follow-up, ALT, to high | 2 Participants |
| GSK1322322 1500 mg BID | Number of Participants With Abnormal Transition From Baseline in Clinical Chemistry Values Relative to Normal Range | 28 Day Follow-up, ALP, to high | 0 Participants |
| GSK1322322 1500 mg BID | Number of Participants With Abnormal Transition From Baseline in Clinical Chemistry Values Relative to Normal Range | 28 Day Follow-up, AST, to high | 1 Participants |
| GSK1322322 1500 mg BID | Number of Participants With Abnormal Transition From Baseline in Clinical Chemistry Values Relative to Normal Range | 28 Day Follow-up, Calcium, to low | 3 Participants |
| GSK1322322 1500 mg BID | Number of Participants With Abnormal Transition From Baseline in Clinical Chemistry Values Relative to Normal Range | 28 Day Follow-up, Calcium, to high | 1 Participants |
| GSK1322322 1500 mg BID | Number of Participants With Abnormal Transition From Baseline in Clinical Chemistry Values Relative to Normal Range | 28 Day Follow-up, CO2/bicarbonate, to low | 1 Participants |
| GSK1322322 1500 mg BID | Number of Participants With Abnormal Transition From Baseline in Clinical Chemistry Values Relative to Normal Range | 28 Day Follow-up, Chloride, to low | 0 Participants |
| GSK1322322 1500 mg BID | Number of Participants With Abnormal Transition From Baseline in Clinical Chemistry Values Relative to Normal Range | 28 Day Follow-up, Chloride, to high | 2 Participants |
| GSK1322322 1500 mg BID | Number of Participants With Abnormal Transition From Baseline in Clinical Chemistry Values Relative to Normal Range | 28 Day Follow-up, Creatine kinase, to high | 5 Participants |
| GSK1322322 1500 mg BID | Number of Participants With Abnormal Transition From Baseline in Clinical Chemistry Values Relative to Normal Range | 28 Day Follow-up, Creatinine, to low | 2 Participants |
| GSK1322322 1500 mg BID | Number of Participants With Abnormal Transition From Baseline in Clinical Chemistry Values Relative to Normal Range | 28 Day Follow-up, Creatinine, to high | 1 Participants |
| GSK1322322 1500 mg BID | Number of Participants With Abnormal Transition From Baseline in Clinical Chemistry Values Relative to Normal Range | 28 Day Follow-up, GGT, to high | 1 Participants |
| GSK1322322 1500 mg BID | Number of Participants With Abnormal Transition From Baseline in Clinical Chemistry Values Relative to Normal Range | 28 Day Follow-up, Glucose, to high | 7 Participants |
| GSK1322322 1500 mg BID | Number of Participants With Abnormal Transition From Baseline in Clinical Chemistry Values Relative to Normal Range | 28 Day Follow-up, Potassium, to low | 2 Participants |
| GSK1322322 1500 mg BID | Number of Participants With Abnormal Transition From Baseline in Clinical Chemistry Values Relative to Normal Range | 28 Day Follow-up, Sodium, to low | 0 Participants |
| GSK1322322 1500 mg BID | Number of Participants With Abnormal Transition From Baseline in Clinical Chemistry Values Relative to Normal Range | 28 Day Follow-up, Total protein, to low | 2 Participants |
| GSK1322322 1500 mg BID | Number of Participants With Abnormal Transition From Baseline in Clinical Chemistry Values Relative to Normal Range | 28 Day Follow-up, Total protein, to high | 1 Participants |
| GSK1322322 1500 mg BID | Number of Participants With Abnormal Transition From Baseline in Clinical Chemistry Values Relative to Normal Range | 28 Day Follow-up, Urea/BUN, to low | 1 Participants |
| GSK1322322 1500 mg BID | Number of Participants With Abnormal Transition From Baseline in Clinical Chemistry Values Relative to Normal Range | 28 Day Follow-up, Uric acid, to low | 0 Participants |
| GSK1322322 1500 mg BID | Number of Participants With Abnormal Transition From Baseline in Clinical Chemistry Values Relative to Normal Range | 28 Day Follow-up, Uric acid, to high | 1 Participants |
| Linezolid 600 mg BID | Number of Participants With Abnormal Transition From Baseline in Clinical Chemistry Values Relative to Normal Range | Day 11, Total protein, to high | 0 Participants |
| Linezolid 600 mg BID | Number of Participants With Abnormal Transition From Baseline in Clinical Chemistry Values Relative to Normal Range | Day 8, Sodium, to low | 1 Participants |
| Linezolid 600 mg BID | Number of Participants With Abnormal Transition From Baseline in Clinical Chemistry Values Relative to Normal Range | 28 Day Follow-up, Creatine kinase, to high | 2 Participants |
| Linezolid 600 mg BID | Number of Participants With Abnormal Transition From Baseline in Clinical Chemistry Values Relative to Normal Range | Day 8, Urea/BUN, to low | 0 Participants |
| Linezolid 600 mg BID | Number of Participants With Abnormal Transition From Baseline in Clinical Chemistry Values Relative to Normal Range | Day 11, Urea/BUN, to low | 0 Participants |
| Linezolid 600 mg BID | Number of Participants With Abnormal Transition From Baseline in Clinical Chemistry Values Relative to Normal Range | Day 8, Uric acid, to low | 0 Participants |
| Linezolid 600 mg BID | Number of Participants With Abnormal Transition From Baseline in Clinical Chemistry Values Relative to Normal Range | 7 Day Follow-up, Urea/BUN, to high | 1 Participants |
| Linezolid 600 mg BID | Number of Participants With Abnormal Transition From Baseline in Clinical Chemistry Values Relative to Normal Range | Day 11, ALT, to high | 2 Participants |
| Linezolid 600 mg BID | Number of Participants With Abnormal Transition From Baseline in Clinical Chemistry Values Relative to Normal Range | Day 11, Urea/BUN, to high | 1 Participants |
| Linezolid 600 mg BID | Number of Participants With Abnormal Transition From Baseline in Clinical Chemistry Values Relative to Normal Range | Day 11, AST, to high | 2 Participants |
| Linezolid 600 mg BID | Number of Participants With Abnormal Transition From Baseline in Clinical Chemistry Values Relative to Normal Range | 28 Day Follow-up, Sodium, to low | 2 Participants |
| Linezolid 600 mg BID | Number of Participants With Abnormal Transition From Baseline in Clinical Chemistry Values Relative to Normal Range | Day 11, Calcium, to low | 0 Participants |
| Linezolid 600 mg BID | Number of Participants With Abnormal Transition From Baseline in Clinical Chemistry Values Relative to Normal Range | Day 11, Uric acid, to low | 1 Participants |
| Linezolid 600 mg BID | Number of Participants With Abnormal Transition From Baseline in Clinical Chemistry Values Relative to Normal Range | Day 11, CO2/bicarbonate, to low | 2 Participants |
| Linezolid 600 mg BID | Number of Participants With Abnormal Transition From Baseline in Clinical Chemistry Values Relative to Normal Range | 7 Day Follow-up, Uric acid, to low | 1 Participants |
| Linezolid 600 mg BID | Number of Participants With Abnormal Transition From Baseline in Clinical Chemistry Values Relative to Normal Range | Day 11, Chloride, to low | 1 Participants |
| Linezolid 600 mg BID | Number of Participants With Abnormal Transition From Baseline in Clinical Chemistry Values Relative to Normal Range | Day 11, Uric acid, to high | 0 Participants |
| Linezolid 600 mg BID | Number of Participants With Abnormal Transition From Baseline in Clinical Chemistry Values Relative to Normal Range | Day 11, Chloride, to high | 1 Participants |
| Linezolid 600 mg BID | Number of Participants With Abnormal Transition From Baseline in Clinical Chemistry Values Relative to Normal Range | 28 Day Follow-up, Creatinine, to low | 3 Participants |
| Linezolid 600 mg BID | Number of Participants With Abnormal Transition From Baseline in Clinical Chemistry Values Relative to Normal Range | Day 11, Creatine kinase, to high | 0 Participants |
| Linezolid 600 mg BID | Number of Participants With Abnormal Transition From Baseline in Clinical Chemistry Values Relative to Normal Range | 7 Day Follow-up, ALT, to high | 3 Participants |
| Linezolid 600 mg BID | Number of Participants With Abnormal Transition From Baseline in Clinical Chemistry Values Relative to Normal Range | Day 11, Creatinine, to low | 2 Participants |
| Linezolid 600 mg BID | Number of Participants With Abnormal Transition From Baseline in Clinical Chemistry Values Relative to Normal Range | 7 Day Follow-up, Uric acid, to high | 0 Participants |
| Linezolid 600 mg BID | Number of Participants With Abnormal Transition From Baseline in Clinical Chemistry Values Relative to Normal Range | Day 11, GGT, to high | 0 Participants |
| Linezolid 600 mg BID | Number of Participants With Abnormal Transition From Baseline in Clinical Chemistry Values Relative to Normal Range | 7 Day Follow-up, AST, to high | 0 Participants |
| Linezolid 600 mg BID | Number of Participants With Abnormal Transition From Baseline in Clinical Chemistry Values Relative to Normal Range | Day 11, Glucose, to low | 0 Participants |
| Linezolid 600 mg BID | Number of Participants With Abnormal Transition From Baseline in Clinical Chemistry Values Relative to Normal Range | 28 Day Follow-up, Urea/BUN, to low | 0 Participants |
| Linezolid 600 mg BID | Number of Participants With Abnormal Transition From Baseline in Clinical Chemistry Values Relative to Normal Range | Day 11, Glucose, to high | 2 Participants |
| Linezolid 600 mg BID | Number of Participants With Abnormal Transition From Baseline in Clinical Chemistry Values Relative to Normal Range | 7 Day Follow-up, Calcium, to low | 0 Participants |
| Linezolid 600 mg BID | Number of Participants With Abnormal Transition From Baseline in Clinical Chemistry Values Relative to Normal Range | Day 2, C-Reactive protein, to high | 0 Participants |
| Linezolid 600 mg BID | Number of Participants With Abnormal Transition From Baseline in Clinical Chemistry Values Relative to Normal Range | 28 Day Follow-up, ALT, to high | 0 Participants |
| Linezolid 600 mg BID | Number of Participants With Abnormal Transition From Baseline in Clinical Chemistry Values Relative to Normal Range | Day 3, C-Reactive protein, to high | 0 Participants |
| Linezolid 600 mg BID | Number of Participants With Abnormal Transition From Baseline in Clinical Chemistry Values Relative to Normal Range | 7 Day Follow-up, Calcium, to high | 0 Participants |
| Linezolid 600 mg BID | Number of Participants With Abnormal Transition From Baseline in Clinical Chemistry Values Relative to Normal Range | 28 Day Follow-up, Creatinine, to high | 0 Participants |
| Linezolid 600 mg BID | Number of Participants With Abnormal Transition From Baseline in Clinical Chemistry Values Relative to Normal Range | Day 11, C-Reactive protein, to high | 1 Participants |
| Linezolid 600 mg BID | Number of Participants With Abnormal Transition From Baseline in Clinical Chemistry Values Relative to Normal Range | Day 4, ALT, to high | 0 Participants |
| Linezolid 600 mg BID | Number of Participants With Abnormal Transition From Baseline in Clinical Chemistry Values Relative to Normal Range | 7 Day Follow-up, CO2/bicarbonate, to low | 2 Participants |
| Linezolid 600 mg BID | Number of Participants With Abnormal Transition From Baseline in Clinical Chemistry Values Relative to Normal Range | Day 4, ALP, to high | 0 Participants |
| Linezolid 600 mg BID | Number of Participants With Abnormal Transition From Baseline in Clinical Chemistry Values Relative to Normal Range | 28 Day Follow-up, ALP, to high | 1 Participants |
| Linezolid 600 mg BID | Number of Participants With Abnormal Transition From Baseline in Clinical Chemistry Values Relative to Normal Range | Day 4, AST, to high | 1 Participants |
| Linezolid 600 mg BID | Number of Participants With Abnormal Transition From Baseline in Clinical Chemistry Values Relative to Normal Range | 7 Day Follow-up, Chloride, to low | 1 Participants |
| Linezolid 600 mg BID | Number of Participants With Abnormal Transition From Baseline in Clinical Chemistry Values Relative to Normal Range | Day 4, Calcium, to low | 0 Participants |
| Linezolid 600 mg BID | Number of Participants With Abnormal Transition From Baseline in Clinical Chemistry Values Relative to Normal Range | 28 Day Follow-up, Total protein, to low | 0 Participants |
| Linezolid 600 mg BID | Number of Participants With Abnormal Transition From Baseline in Clinical Chemistry Values Relative to Normal Range | Day 4, CO2/bicarbonate, to low | 3 Participants |
| Linezolid 600 mg BID | Number of Participants With Abnormal Transition From Baseline in Clinical Chemistry Values Relative to Normal Range | 7 Day Follow-up, Chloride, to high | 1 Participants |
| Linezolid 600 mg BID | Number of Participants With Abnormal Transition From Baseline in Clinical Chemistry Values Relative to Normal Range | Day 4, Chloride, to low | 0 Participants |
| Linezolid 600 mg BID | Number of Participants With Abnormal Transition From Baseline in Clinical Chemistry Values Relative to Normal Range | 28 Day Follow-up, AST, to high | 1 Participants |
| Linezolid 600 mg BID | Number of Participants With Abnormal Transition From Baseline in Clinical Chemistry Values Relative to Normal Range | Day 4, Creatine kinase, to high | 3 Participants |
| Linezolid 600 mg BID | Number of Participants With Abnormal Transition From Baseline in Clinical Chemistry Values Relative to Normal Range | 7 Day Follow-up, Creatine kinase, to high | 3 Participants |
| Linezolid 600 mg BID | Number of Participants With Abnormal Transition From Baseline in Clinical Chemistry Values Relative to Normal Range | Day 4, Creatinine, to low | 2 Participants |
| Linezolid 600 mg BID | Number of Participants With Abnormal Transition From Baseline in Clinical Chemistry Values Relative to Normal Range | 28 Day Follow-up, GGT, to high | 1 Participants |
| Linezolid 600 mg BID | Number of Participants With Abnormal Transition From Baseline in Clinical Chemistry Values Relative to Normal Range | Day 4, GGT, to high | 1 Participants |
| Linezolid 600 mg BID | Number of Participants With Abnormal Transition From Baseline in Clinical Chemistry Values Relative to Normal Range | 7 Day Follow-up, Creatinine, to low | 3 Participants |
| Linezolid 600 mg BID | Number of Participants With Abnormal Transition From Baseline in Clinical Chemistry Values Relative to Normal Range | Day 4, Glucose, to low | 0 Participants |
| Linezolid 600 mg BID | Number of Participants With Abnormal Transition From Baseline in Clinical Chemistry Values Relative to Normal Range | 28 Day Follow-up, Calcium, to low | 0 Participants |
| Linezolid 600 mg BID | Number of Participants With Abnormal Transition From Baseline in Clinical Chemistry Values Relative to Normal Range | Day 4, Glucose, to high | 2 Participants |
| Linezolid 600 mg BID | Number of Participants With Abnormal Transition From Baseline in Clinical Chemistry Values Relative to Normal Range | 7 Day Follow-up, Creatinine, to high | 1 Participants |
| Linezolid 600 mg BID | Number of Participants With Abnormal Transition From Baseline in Clinical Chemistry Values Relative to Normal Range | Day 4, Potassium, to low | 0 Participants |
| Linezolid 600 mg BID | Number of Participants With Abnormal Transition From Baseline in Clinical Chemistry Values Relative to Normal Range | 28 Day Follow-up, Uric acid, to high | 0 Participants |
| Linezolid 600 mg BID | Number of Participants With Abnormal Transition From Baseline in Clinical Chemistry Values Relative to Normal Range | Day 4, Sodium, to low | 0 Participants |
| Linezolid 600 mg BID | Number of Participants With Abnormal Transition From Baseline in Clinical Chemistry Values Relative to Normal Range | 7 Day Follow-up, Direct bilirubin, to high | 0 Participants |
| Linezolid 600 mg BID | Number of Participants With Abnormal Transition From Baseline in Clinical Chemistry Values Relative to Normal Range | Day 4, Total protein, to low | 1 Participants |
| Linezolid 600 mg BID | Number of Participants With Abnormal Transition From Baseline in Clinical Chemistry Values Relative to Normal Range | 28 Day Follow-up, Calcium, to high | 0 Participants |
| Linezolid 600 mg BID | Number of Participants With Abnormal Transition From Baseline in Clinical Chemistry Values Relative to Normal Range | Day 4, Urea/BUN, to low | 0 Participants |
| Linezolid 600 mg BID | Number of Participants With Abnormal Transition From Baseline in Clinical Chemistry Values Relative to Normal Range | 7 Day Follow-up, GGT, to high | 0 Participants |
| Linezolid 600 mg BID | Number of Participants With Abnormal Transition From Baseline in Clinical Chemistry Values Relative to Normal Range | Day 4, Urea/BUN, to high | 1 Participants |
| Linezolid 600 mg BID | Number of Participants With Abnormal Transition From Baseline in Clinical Chemistry Values Relative to Normal Range | 28 Day Follow-up, Glucose, to high | 3 Participants |
| Linezolid 600 mg BID | Number of Participants With Abnormal Transition From Baseline in Clinical Chemistry Values Relative to Normal Range | Day 4, Uric acid, to low | 0 Participants |
| Linezolid 600 mg BID | Number of Participants With Abnormal Transition From Baseline in Clinical Chemistry Values Relative to Normal Range | 7 Day Follow-up, Glucose, to high | 2 Participants |
| Linezolid 600 mg BID | Number of Participants With Abnormal Transition From Baseline in Clinical Chemistry Values Relative to Normal Range | Day 8, ALT, to high | 2 Participants |
| Linezolid 600 mg BID | Number of Participants With Abnormal Transition From Baseline in Clinical Chemistry Values Relative to Normal Range | 28 Day Follow-up, CO2/bicarbonate, to low | 6 Participants |
| Linezolid 600 mg BID | Number of Participants With Abnormal Transition From Baseline in Clinical Chemistry Values Relative to Normal Range | Day 8, Albumin, to low | 0 Participants |
| Linezolid 600 mg BID | Number of Participants With Abnormal Transition From Baseline in Clinical Chemistry Values Relative to Normal Range | 7 Day Follow-up, C-Reactive protein, to high | 1 Participants |
| Linezolid 600 mg BID | Number of Participants With Abnormal Transition From Baseline in Clinical Chemistry Values Relative to Normal Range | Day 8, AST, to high | 2 Participants |
| Linezolid 600 mg BID | Number of Participants With Abnormal Transition From Baseline in Clinical Chemistry Values Relative to Normal Range | 28 Day Follow-up, Total protein, to high | 0 Participants |
| Linezolid 600 mg BID | Number of Participants With Abnormal Transition From Baseline in Clinical Chemistry Values Relative to Normal Range | Day 8, Calcium, to low | 0 Participants |
| Linezolid 600 mg BID | Number of Participants With Abnormal Transition From Baseline in Clinical Chemistry Values Relative to Normal Range | 7 Day Follow-up, Potassium, to low | 1 Participants |
| Linezolid 600 mg BID | Number of Participants With Abnormal Transition From Baseline in Clinical Chemistry Values Relative to Normal Range | Day 8, Chloride, to high | 0 Participants |
| Linezolid 600 mg BID | Number of Participants With Abnormal Transition From Baseline in Clinical Chemistry Values Relative to Normal Range | 28 Day Follow-up, Chloride, to low | 1 Participants |
| Linezolid 600 mg BID | Number of Participants With Abnormal Transition From Baseline in Clinical Chemistry Values Relative to Normal Range | Day 8, Creatine kinase, to high | 1 Participants |
| Linezolid 600 mg BID | Number of Participants With Abnormal Transition From Baseline in Clinical Chemistry Values Relative to Normal Range | 7 Day Follow-up, Sodium, to low | 0 Participants |
| Linezolid 600 mg BID | Number of Participants With Abnormal Transition From Baseline in Clinical Chemistry Values Relative to Normal Range | Day 8, Creatinine, to low | 1 Participants |
| Linezolid 600 mg BID | Number of Participants With Abnormal Transition From Baseline in Clinical Chemistry Values Relative to Normal Range | 28 Day Follow-up, Potassium, to low | 1 Participants |
| Linezolid 600 mg BID | Number of Participants With Abnormal Transition From Baseline in Clinical Chemistry Values Relative to Normal Range | Day 8, GGT, to high | 1 Participants |
| Linezolid 600 mg BID | Number of Participants With Abnormal Transition From Baseline in Clinical Chemistry Values Relative to Normal Range | 7 Day Follow-up, Total bilirubin, to high | 0 Participants |
| Linezolid 600 mg BID | Number of Participants With Abnormal Transition From Baseline in Clinical Chemistry Values Relative to Normal Range | 28 Day Follow-up, Chloride, to high | 3 Participants |
| Linezolid 600 mg BID | Number of Participants With Abnormal Transition From Baseline in Clinical Chemistry Values Relative to Normal Range | Day 11, Potassium, to low | 1 Participants |
| Linezolid 600 mg BID | Number of Participants With Abnormal Transition From Baseline in Clinical Chemistry Values Relative to Normal Range | 7 Day Follow-up, Total protein, to high | 1 Participants |
| Linezolid 600 mg BID | Number of Participants With Abnormal Transition From Baseline in Clinical Chemistry Values Relative to Normal Range | Day 11, Sodium, to low | 1 Participants |
| Linezolid 600 mg BID | Number of Participants With Abnormal Transition From Baseline in Clinical Chemistry Values Relative to Normal Range | Day 8, Glucose, to low | 1 Participants |
| Linezolid 600 mg BID | Number of Participants With Abnormal Transition From Baseline in Clinical Chemistry Values Relative to Normal Range | 28 Day Follow-up, Uric acid, to low | 2 Participants |
| Linezolid 600 mg BID | Number of Participants With Abnormal Transition From Baseline in Clinical Chemistry Values Relative to Normal Range | Day 8, Glucose, to high | 5 Participants |
| Linezolid 600 mg BID | Number of Participants With Abnormal Transition From Baseline in Clinical Chemistry Values Relative to Normal Range | 7 Day Follow-up, Urea/BUN, to low | 1 Participants |
Primary
Number of Participants With Abnormal Transition From Baseline in Hematology Values Relative to Normal Range
The parameters of clinical chemistry included basophils, eosinophils, lymphocytes, monocytes, total neutrophils, WBC count, platelet count, MCV, hemoglobin, MCHC, MCH, RBC count and reticulocyte count. The assessments were done at Day 1, Day 4, Day 8, Day 11, 7 Day Follow-up and 28 Day Follow-up. Baseline was defined as the assessment done on Day 1 (pre-dose). Data is reported for number of participants with abnormal transition from Baseline 'to high' or 'to low' relative to normal range. Only those parameters for which at least one value of abnormal transition was reported are summarized.
Time frame: Day 1 (pre-dose, Baseline) up Follow-up (28 Day Follow-up, Day 40)
Population: Safety Population. Only those participants available at the specified time points were analyzed.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| GSK1322322 1500 mg BID | Number of Participants With Abnormal Transition From Baseline in Hematology Values Relative to Normal Range | Day 4, Eosinophils, to low | 6 Participants |
| GSK1322322 1500 mg BID | Number of Participants With Abnormal Transition From Baseline in Hematology Values Relative to Normal Range | Day 4, Eosinophils, to high | 1 Participants |
| GSK1322322 1500 mg BID | Number of Participants With Abnormal Transition From Baseline in Hematology Values Relative to Normal Range | Day 4, Hemoglobin, to low | 3 Participants |
| GSK1322322 1500 mg BID | Number of Participants With Abnormal Transition From Baseline in Hematology Values Relative to Normal Range | Day 4, Lymphocytes, to low | 1 Participants |
| GSK1322322 1500 mg BID | Number of Participants With Abnormal Transition From Baseline in Hematology Values Relative to Normal Range | Day 4, MCHC, to low | 2 Participants |
| GSK1322322 1500 mg BID | Number of Participants With Abnormal Transition From Baseline in Hematology Values Relative to Normal Range | Day 4, Monocytes, to low | 3 Participants |
| GSK1322322 1500 mg BID | Number of Participants With Abnormal Transition From Baseline in Hematology Values Relative to Normal Range | Day 4, Monocytes, to high | 0 Participants |
| GSK1322322 1500 mg BID | Number of Participants With Abnormal Transition From Baseline in Hematology Values Relative to Normal Range | Day 4, Platelet count, to high | 2 Participants |
| GSK1322322 1500 mg BID | Number of Participants With Abnormal Transition From Baseline in Hematology Values Relative to Normal Range | Day 4, RBC count, to low | 2 Participants |
| GSK1322322 1500 mg BID | Number of Participants With Abnormal Transition From Baseline in Hematology Values Relative to Normal Range | Day 4, Reticulocytes, to low | 1 Participants |
| GSK1322322 1500 mg BID | Number of Participants With Abnormal Transition From Baseline in Hematology Values Relative to Normal Range | Day 4, Reticulocytes, to high | 2 Participants |
| GSK1322322 1500 mg BID | Number of Participants With Abnormal Transition From Baseline in Hematology Values Relative to Normal Range | Day 4, Total neutrophils, to low | 1 Participants |
| GSK1322322 1500 mg BID | Number of Participants With Abnormal Transition From Baseline in Hematology Values Relative to Normal Range | Day 4, Total neutrophils, to high | 1 Participants |
| GSK1322322 1500 mg BID | Number of Participants With Abnormal Transition From Baseline in Hematology Values Relative to Normal Range | Day 4, WBC count, to low | 2 Participants |
| GSK1322322 1500 mg BID | Number of Participants With Abnormal Transition From Baseline in Hematology Values Relative to Normal Range | Day 4, WBC count, to high | 1 Participants |
| GSK1322322 1500 mg BID | Number of Participants With Abnormal Transition From Baseline in Hematology Values Relative to Normal Range | Day 8, Eosinophils, to low | 3 Participants |
| GSK1322322 1500 mg BID | Number of Participants With Abnormal Transition From Baseline in Hematology Values Relative to Normal Range | Day 8, Hemoglobin, to low | 1 Participants |
| GSK1322322 1500 mg BID | Number of Participants With Abnormal Transition From Baseline in Hematology Values Relative to Normal Range | Day 8, Lymphocytes, to low | 1 Participants |
| GSK1322322 1500 mg BID | Number of Participants With Abnormal Transition From Baseline in Hematology Values Relative to Normal Range | Day 8, MCHC, to low | 1 Participants |
| GSK1322322 1500 mg BID | Number of Participants With Abnormal Transition From Baseline in Hematology Values Relative to Normal Range | Day 8, MCV, to high | 1 Participants |
| GSK1322322 1500 mg BID | Number of Participants With Abnormal Transition From Baseline in Hematology Values Relative to Normal Range | Day 8, Monocytes, to low | 3 Participants |
| GSK1322322 1500 mg BID | Number of Participants With Abnormal Transition From Baseline in Hematology Values Relative to Normal Range | Day 8, Platelet count, to high | 2 Participants |
| GSK1322322 1500 mg BID | Number of Participants With Abnormal Transition From Baseline in Hematology Values Relative to Normal Range | Day 8, RBC count, to low | 1 Participants |
| GSK1322322 1500 mg BID | Number of Participants With Abnormal Transition From Baseline in Hematology Values Relative to Normal Range | Day 8, Reticulocytes, to low | 0 Participants |
| GSK1322322 1500 mg BID | Number of Participants With Abnormal Transition From Baseline in Hematology Values Relative to Normal Range | Day 8, Reticulocytes, to high | 5 Participants |
| GSK1322322 1500 mg BID | Number of Participants With Abnormal Transition From Baseline in Hematology Values Relative to Normal Range | Day 8, Total neutrophils, to low | 3 Participants |
| GSK1322322 1500 mg BID | Number of Participants With Abnormal Transition From Baseline in Hematology Values Relative to Normal Range | Day 8, Total neutrophils, to high | 0 Participants |
| GSK1322322 1500 mg BID | Number of Participants With Abnormal Transition From Baseline in Hematology Values Relative to Normal Range | Day 8, WBC count, to low | 2 Participants |
| GSK1322322 1500 mg BID | Number of Participants With Abnormal Transition From Baseline in Hematology Values Relative to Normal Range | Day 11, Eosinophils, to low | 2 Participants |
| GSK1322322 1500 mg BID | Number of Participants With Abnormal Transition From Baseline in Hematology Values Relative to Normal Range | Day 11, Hemoglobin, to low | 2 Participants |
| GSK1322322 1500 mg BID | Number of Participants With Abnormal Transition From Baseline in Hematology Values Relative to Normal Range | Day 11, Hemoglobin, to high | 1 Participants |
| GSK1322322 1500 mg BID | Number of Participants With Abnormal Transition From Baseline in Hematology Values Relative to Normal Range | Day 11, Lymphocytes, to low | 3 Participants |
| GSK1322322 1500 mg BID | Number of Participants With Abnormal Transition From Baseline in Hematology Values Relative to Normal Range | Day 11, Monocytes, to low | 5 Participants |
| GSK1322322 1500 mg BID | Number of Participants With Abnormal Transition From Baseline in Hematology Values Relative to Normal Range | Day 11, Platelet count, to high | 1 Participants |
| GSK1322322 1500 mg BID | Number of Participants With Abnormal Transition From Baseline in Hematology Values Relative to Normal Range | Day 11, RBC count, to low | 2 Participants |
| GSK1322322 1500 mg BID | Number of Participants With Abnormal Transition From Baseline in Hematology Values Relative to Normal Range | Day 11, Reticulocytes, to low | 3 Participants |
| GSK1322322 1500 mg BID | Number of Participants With Abnormal Transition From Baseline in Hematology Values Relative to Normal Range | Day 11, Reticulocytes, to high | 3 Participants |
| GSK1322322 1500 mg BID | Number of Participants With Abnormal Transition From Baseline in Hematology Values Relative to Normal Range | Day 11, Total neutrophils, to low | 1 Participants |
| GSK1322322 1500 mg BID | Number of Participants With Abnormal Transition From Baseline in Hematology Values Relative to Normal Range | Day 11, Total neutrophils, to high | 1 Participants |
| GSK1322322 1500 mg BID | Number of Participants With Abnormal Transition From Baseline in Hematology Values Relative to Normal Range | Day 11, WBC count, to low | 2 Participants |
| GSK1322322 1500 mg BID | Number of Participants With Abnormal Transition From Baseline in Hematology Values Relative to Normal Range | Day 11, WBC count, to high | 1 Participants |
| GSK1322322 1500 mg BID | Number of Participants With Abnormal Transition From Baseline in Hematology Values Relative to Normal Range | 7 Day Follow-up, Eosinophils, to low | 0 Participants |
| GSK1322322 1500 mg BID | Number of Participants With Abnormal Transition From Baseline in Hematology Values Relative to Normal Range | 7 Day Follow-up, Hemoglobin, to low | 1 Participants |
| GSK1322322 1500 mg BID | Number of Participants With Abnormal Transition From Baseline in Hematology Values Relative to Normal Range | 7 Day Follow-up, Lymphocytes, to low | 1 Participants |
| GSK1322322 1500 mg BID | Number of Participants With Abnormal Transition From Baseline in Hematology Values Relative to Normal Range | 7 Day Follow-up, Monocytes, to low | 5 Participants |
| GSK1322322 1500 mg BID | Number of Participants With Abnormal Transition From Baseline in Hematology Values Relative to Normal Range | 7 Day Follow-up, Platelet count, to low | 1 Participants |
| GSK1322322 1500 mg BID | Number of Participants With Abnormal Transition From Baseline in Hematology Values Relative to Normal Range | 7 Day Follow-up, RBC count, to low | 2 Participants |
| GSK1322322 1500 mg BID | Number of Participants With Abnormal Transition From Baseline in Hematology Values Relative to Normal Range | 7 Day Follow-up, Reticulocytes, to low | 4 Participants |
| GSK1322322 1500 mg BID | Number of Participants With Abnormal Transition From Baseline in Hematology Values Relative to Normal Range | 7 Day Follow-up, Reticulocytes, to high | 1 Participants |
| GSK1322322 1500 mg BID | Number of Participants With Abnormal Transition From Baseline in Hematology Values Relative to Normal Range | 7 Day Follow-up, Total neutrophils, to low | 1 Participants |
| GSK1322322 1500 mg BID | Number of Participants With Abnormal Transition From Baseline in Hematology Values Relative to Normal Range | 7 Day Follow-up, Total neutrophils, to high | 1 Participants |
| GSK1322322 1500 mg BID | Number of Participants With Abnormal Transition From Baseline in Hematology Values Relative to Normal Range | 7 Day Follow-up, WBC count, to low | 1 Participants |
| GSK1322322 1500 mg BID | Number of Participants With Abnormal Transition From Baseline in Hematology Values Relative to Normal Range | 7 Day Follow-up, WBC count, to high | 1 Participants |
| GSK1322322 1500 mg BID | Number of Participants With Abnormal Transition From Baseline in Hematology Values Relative to Normal Range | 28 Day Follow-up, Eosinophils, to low | 1 Participants |
| GSK1322322 1500 mg BID | Number of Participants With Abnormal Transition From Baseline in Hematology Values Relative to Normal Range | 28 Day Follow-up, Hemoglobin, to low | 1 Participants |
| GSK1322322 1500 mg BID | Number of Participants With Abnormal Transition From Baseline in Hematology Values Relative to Normal Range | 28 Day Follow-up, Hemoglobin, to high | 1 Participants |
| GSK1322322 1500 mg BID | Number of Participants With Abnormal Transition From Baseline in Hematology Values Relative to Normal Range | 28 Day Follow-up, Lymphocytes, to low | 1 Participants |
| GSK1322322 1500 mg BID | Number of Participants With Abnormal Transition From Baseline in Hematology Values Relative to Normal Range | 28 Day Follow-up, Lymphocytes, to high | 1 Participants |
| GSK1322322 1500 mg BID | Number of Participants With Abnormal Transition From Baseline in Hematology Values Relative to Normal Range | 28 Day Follow-up, MCHC, to low | 1 Participants |
| GSK1322322 1500 mg BID | Number of Participants With Abnormal Transition From Baseline in Hematology Values Relative to Normal Range | 28 Day Follow-up, Monocytes, to low | 1 Participants |
| GSK1322322 1500 mg BID | Number of Participants With Abnormal Transition From Baseline in Hematology Values Relative to Normal Range | 28 Day Follow-up, Platelet count, to low | 0 Participants |
| GSK1322322 1500 mg BID | Number of Participants With Abnormal Transition From Baseline in Hematology Values Relative to Normal Range | 28 Day Follow-up, Platelet count, to high | 2 Participants |
| GSK1322322 1500 mg BID | Number of Participants With Abnormal Transition From Baseline in Hematology Values Relative to Normal Range | 28 Day Follow-up, RBC count, to low | 0 Participants |
| GSK1322322 1500 mg BID | Number of Participants With Abnormal Transition From Baseline in Hematology Values Relative to Normal Range | 28 Day Follow-up, Reticulocytes, to low | 0 Participants |
| GSK1322322 1500 mg BID | Number of Participants With Abnormal Transition From Baseline in Hematology Values Relative to Normal Range | 28 Day Follow-up, Reticulocytes, to high | 3 Participants |
| GSK1322322 1500 mg BID | Number of Participants With Abnormal Transition From Baseline in Hematology Values Relative to Normal Range | 28 Day Follow-up, Total neutrophils, to low | 1 Participants |
| GSK1322322 1500 mg BID | Number of Participants With Abnormal Transition From Baseline in Hematology Values Relative to Normal Range | 28 Day Follow-up, Total neutrophils, to high | 1 Participants |
| GSK1322322 1500 mg BID | Number of Participants With Abnormal Transition From Baseline in Hematology Values Relative to Normal Range | 28 Day Follow-up, WBC count, to low | 1 Participants |
| GSK1322322 1500 mg BID | Number of Participants With Abnormal Transition From Baseline in Hematology Values Relative to Normal Range | 28 Day Follow-up, WBC count, to high | 2 Participants |
| Linezolid 600 mg BID | Number of Participants With Abnormal Transition From Baseline in Hematology Values Relative to Normal Range | Day 11, RBC count, to low | 1 Participants |
| Linezolid 600 mg BID | Number of Participants With Abnormal Transition From Baseline in Hematology Values Relative to Normal Range | Day 4, Eosinophils, to low | 1 Participants |
| Linezolid 600 mg BID | Number of Participants With Abnormal Transition From Baseline in Hematology Values Relative to Normal Range | 28 Day Follow-up, Platelet count, to low | 1 Participants |
| Linezolid 600 mg BID | Number of Participants With Abnormal Transition From Baseline in Hematology Values Relative to Normal Range | Day 4, Eosinophils, to high | 0 Participants |
| Linezolid 600 mg BID | Number of Participants With Abnormal Transition From Baseline in Hematology Values Relative to Normal Range | Day 11, Reticulocytes, to low | 1 Participants |
| Linezolid 600 mg BID | Number of Participants With Abnormal Transition From Baseline in Hematology Values Relative to Normal Range | Day 4, Hemoglobin, to low | 3 Participants |
| Linezolid 600 mg BID | Number of Participants With Abnormal Transition From Baseline in Hematology Values Relative to Normal Range | 7 Day Follow-up, WBC count, to high | 1 Participants |
| Linezolid 600 mg BID | Number of Participants With Abnormal Transition From Baseline in Hematology Values Relative to Normal Range | Day 4, Lymphocytes, to low | 0 Participants |
| Linezolid 600 mg BID | Number of Participants With Abnormal Transition From Baseline in Hematology Values Relative to Normal Range | Day 11, Reticulocytes, to high | 4 Participants |
| Linezolid 600 mg BID | Number of Participants With Abnormal Transition From Baseline in Hematology Values Relative to Normal Range | Day 4, MCHC, to low | 0 Participants |
| Linezolid 600 mg BID | Number of Participants With Abnormal Transition From Baseline in Hematology Values Relative to Normal Range | 28 Day Follow-up, WBC count, to high | 1 Participants |
| Linezolid 600 mg BID | Number of Participants With Abnormal Transition From Baseline in Hematology Values Relative to Normal Range | Day 4, Monocytes, to low | 1 Participants |
| Linezolid 600 mg BID | Number of Participants With Abnormal Transition From Baseline in Hematology Values Relative to Normal Range | Day 11, Total neutrophils, to low | 1 Participants |
| Linezolid 600 mg BID | Number of Participants With Abnormal Transition From Baseline in Hematology Values Relative to Normal Range | Day 4, Monocytes, to high | 1 Participants |
| Linezolid 600 mg BID | Number of Participants With Abnormal Transition From Baseline in Hematology Values Relative to Normal Range | 28 Day Follow-up, Eosinophils, to low | 1 Participants |
| Linezolid 600 mg BID | Number of Participants With Abnormal Transition From Baseline in Hematology Values Relative to Normal Range | Day 4, Platelet count, to high | 1 Participants |
| Linezolid 600 mg BID | Number of Participants With Abnormal Transition From Baseline in Hematology Values Relative to Normal Range | Day 11, Total neutrophils, to high | 0 Participants |
| Linezolid 600 mg BID | Number of Participants With Abnormal Transition From Baseline in Hematology Values Relative to Normal Range | Day 4, RBC count, to low | 4 Participants |
| Linezolid 600 mg BID | Number of Participants With Abnormal Transition From Baseline in Hematology Values Relative to Normal Range | 28 Day Follow-up, Platelet count, to high | 0 Participants |
| Linezolid 600 mg BID | Number of Participants With Abnormal Transition From Baseline in Hematology Values Relative to Normal Range | Day 4, Reticulocytes, to low | 1 Participants |
| Linezolid 600 mg BID | Number of Participants With Abnormal Transition From Baseline in Hematology Values Relative to Normal Range | Day 11, WBC count, to low | 0 Participants |
| Linezolid 600 mg BID | Number of Participants With Abnormal Transition From Baseline in Hematology Values Relative to Normal Range | Day 4, Reticulocytes, to high | 1 Participants |
| Linezolid 600 mg BID | Number of Participants With Abnormal Transition From Baseline in Hematology Values Relative to Normal Range | 28 Day Follow-up, Hemoglobin, to low | 3 Participants |
| Linezolid 600 mg BID | Number of Participants With Abnormal Transition From Baseline in Hematology Values Relative to Normal Range | Day 4, Total neutrophils, to low | 0 Participants |
| Linezolid 600 mg BID | Number of Participants With Abnormal Transition From Baseline in Hematology Values Relative to Normal Range | Day 11, WBC count, to high | 0 Participants |
| Linezolid 600 mg BID | Number of Participants With Abnormal Transition From Baseline in Hematology Values Relative to Normal Range | Day 4, Total neutrophils, to high | 0 Participants |
| Linezolid 600 mg BID | Number of Participants With Abnormal Transition From Baseline in Hematology Values Relative to Normal Range | 28 Day Follow-up, Total neutrophils, to low | 0 Participants |
| Linezolid 600 mg BID | Number of Participants With Abnormal Transition From Baseline in Hematology Values Relative to Normal Range | Day 4, WBC count, to low | 1 Participants |
| Linezolid 600 mg BID | Number of Participants With Abnormal Transition From Baseline in Hematology Values Relative to Normal Range | 7 Day Follow-up, Eosinophils, to low | 3 Participants |
| Linezolid 600 mg BID | Number of Participants With Abnormal Transition From Baseline in Hematology Values Relative to Normal Range | Day 4, WBC count, to high | 0 Participants |
| Linezolid 600 mg BID | Number of Participants With Abnormal Transition From Baseline in Hematology Values Relative to Normal Range | 28 Day Follow-up, Hemoglobin, to high | 0 Participants |
| Linezolid 600 mg BID | Number of Participants With Abnormal Transition From Baseline in Hematology Values Relative to Normal Range | Day 8, Eosinophils, to low | 2 Participants |
| Linezolid 600 mg BID | Number of Participants With Abnormal Transition From Baseline in Hematology Values Relative to Normal Range | 7 Day Follow-up, Hemoglobin, to low | 1 Participants |
| Linezolid 600 mg BID | Number of Participants With Abnormal Transition From Baseline in Hematology Values Relative to Normal Range | Day 8, Hemoglobin, to low | 2 Participants |
| Linezolid 600 mg BID | Number of Participants With Abnormal Transition From Baseline in Hematology Values Relative to Normal Range | 28 Day Follow-up, RBC count, to low | 4 Participants |
| Linezolid 600 mg BID | Number of Participants With Abnormal Transition From Baseline in Hematology Values Relative to Normal Range | Day 8, Lymphocytes, to low | 0 Participants |
| Linezolid 600 mg BID | Number of Participants With Abnormal Transition From Baseline in Hematology Values Relative to Normal Range | 7 Day Follow-up, Lymphocytes, to low | 1 Participants |
| Linezolid 600 mg BID | Number of Participants With Abnormal Transition From Baseline in Hematology Values Relative to Normal Range | Day 8, MCHC, to low | 0 Participants |
| Linezolid 600 mg BID | Number of Participants With Abnormal Transition From Baseline in Hematology Values Relative to Normal Range | 28 Day Follow-up, Lymphocytes, to low | 0 Participants |
| Linezolid 600 mg BID | Number of Participants With Abnormal Transition From Baseline in Hematology Values Relative to Normal Range | Day 8, MCV, to high | 0 Participants |
| Linezolid 600 mg BID | Number of Participants With Abnormal Transition From Baseline in Hematology Values Relative to Normal Range | 7 Day Follow-up, Monocytes, to low | 1 Participants |
| Linezolid 600 mg BID | Number of Participants With Abnormal Transition From Baseline in Hematology Values Relative to Normal Range | Day 8, Monocytes, to low | 0 Participants |
| Linezolid 600 mg BID | Number of Participants With Abnormal Transition From Baseline in Hematology Values Relative to Normal Range | 28 Day Follow-up, WBC count, to low | 0 Participants |
| Linezolid 600 mg BID | Number of Participants With Abnormal Transition From Baseline in Hematology Values Relative to Normal Range | Day 8, Platelet count, to high | 0 Participants |
| Linezolid 600 mg BID | Number of Participants With Abnormal Transition From Baseline in Hematology Values Relative to Normal Range | 7 Day Follow-up, Platelet count, to low | 0 Participants |
| Linezolid 600 mg BID | Number of Participants With Abnormal Transition From Baseline in Hematology Values Relative to Normal Range | Day 8, RBC count, to low | 2 Participants |
| Linezolid 600 mg BID | Number of Participants With Abnormal Transition From Baseline in Hematology Values Relative to Normal Range | 28 Day Follow-up, Lymphocytes, to high | 0 Participants |
| Linezolid 600 mg BID | Number of Participants With Abnormal Transition From Baseline in Hematology Values Relative to Normal Range | Day 8, Reticulocytes, to low | 4 Participants |
| Linezolid 600 mg BID | Number of Participants With Abnormal Transition From Baseline in Hematology Values Relative to Normal Range | 7 Day Follow-up, RBC count, to low | 1 Participants |
| Linezolid 600 mg BID | Number of Participants With Abnormal Transition From Baseline in Hematology Values Relative to Normal Range | Day 8, Reticulocytes, to high | 2 Participants |
| Linezolid 600 mg BID | Number of Participants With Abnormal Transition From Baseline in Hematology Values Relative to Normal Range | 28 Day Follow-up, Reticulocytes, to low | 1 Participants |
| Linezolid 600 mg BID | Number of Participants With Abnormal Transition From Baseline in Hematology Values Relative to Normal Range | Day 8, Total neutrophils, to low | 0 Participants |
| Linezolid 600 mg BID | Number of Participants With Abnormal Transition From Baseline in Hematology Values Relative to Normal Range | 7 Day Follow-up, Reticulocytes, to low | 0 Participants |
| Linezolid 600 mg BID | Number of Participants With Abnormal Transition From Baseline in Hematology Values Relative to Normal Range | Day 8, Total neutrophils, to high | 1 Participants |
| Linezolid 600 mg BID | Number of Participants With Abnormal Transition From Baseline in Hematology Values Relative to Normal Range | 28 Day Follow-up, MCHC, to low | 0 Participants |
| Linezolid 600 mg BID | Number of Participants With Abnormal Transition From Baseline in Hematology Values Relative to Normal Range | Day 8, WBC count, to low | 0 Participants |
| Linezolid 600 mg BID | Number of Participants With Abnormal Transition From Baseline in Hematology Values Relative to Normal Range | 7 Day Follow-up, Reticulocytes, to high | 10 Participants |
| Linezolid 600 mg BID | Number of Participants With Abnormal Transition From Baseline in Hematology Values Relative to Normal Range | Day 11, Eosinophils, to low | 1 Participants |
| Linezolid 600 mg BID | Number of Participants With Abnormal Transition From Baseline in Hematology Values Relative to Normal Range | 28 Day Follow-up, Total neutrophils, to high | 1 Participants |
| Linezolid 600 mg BID | Number of Participants With Abnormal Transition From Baseline in Hematology Values Relative to Normal Range | Day 11, Hemoglobin, to low | 2 Participants |
| Linezolid 600 mg BID | Number of Participants With Abnormal Transition From Baseline in Hematology Values Relative to Normal Range | 7 Day Follow-up, Total neutrophils, to low | 0 Participants |
| Linezolid 600 mg BID | Number of Participants With Abnormal Transition From Baseline in Hematology Values Relative to Normal Range | Day 11, Hemoglobin, to high | 0 Participants |
| Linezolid 600 mg BID | Number of Participants With Abnormal Transition From Baseline in Hematology Values Relative to Normal Range | 28 Day Follow-up, Monocytes, to low | 0 Participants |
| Linezolid 600 mg BID | Number of Participants With Abnormal Transition From Baseline in Hematology Values Relative to Normal Range | Day 11, Lymphocytes, to low | 0 Participants |
| Linezolid 600 mg BID | Number of Participants With Abnormal Transition From Baseline in Hematology Values Relative to Normal Range | 7 Day Follow-up, Total neutrophils, to high | 1 Participants |
| Linezolid 600 mg BID | Number of Participants With Abnormal Transition From Baseline in Hematology Values Relative to Normal Range | Day 11, Monocytes, to low | 1 Participants |
| Linezolid 600 mg BID | Number of Participants With Abnormal Transition From Baseline in Hematology Values Relative to Normal Range | 28 Day Follow-up, Reticulocytes, to high | 4 Participants |
| Linezolid 600 mg BID | Number of Participants With Abnormal Transition From Baseline in Hematology Values Relative to Normal Range | Day 11, Platelet count, to high | 0 Participants |
| Linezolid 600 mg BID | Number of Participants With Abnormal Transition From Baseline in Hematology Values Relative to Normal Range | 7 Day Follow-up, WBC count, to low | 0 Participants |
Primary
Number of Participants With Any Adverse Events (AE) and Serious Adverse Events (SAE)
An AE is defined as any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or is a congenital anomaly/birth defect, may jeopardize the participant or may require medical or surgical intervention to prevent one of the other outcomes listed in this definition, associated with liver injury and impaired liver function defined as alanine aminotransferase (ALT) \>=3 x upper limit of normal (ULN), and total bilirubin \>=2 x ULN or international normalised ratio \>1.5.
Time frame: Up to Follow-up (28 Day Follow-up, Day 40)
Population: Safety Population was defined as all participants who received at least one dose of study medication.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| GSK1322322 1500 mg BID | Number of Participants With Any Adverse Events (AE) and Serious Adverse Events (SAE) | Any AE | 49 Participants |
| GSK1322322 1500 mg BID | Number of Participants With Any Adverse Events (AE) and Serious Adverse Events (SAE) | Any SAE | 1 Participants |
| Linezolid 600 mg BID | Number of Participants With Any Adverse Events (AE) and Serious Adverse Events (SAE) | Any AE | 20 Participants |
| Linezolid 600 mg BID | Number of Participants With Any Adverse Events (AE) and Serious Adverse Events (SAE) | Any SAE | 1 Participants |
Secondary
Mean Change From Baseline in Total SIS at Indicated Time Points
The investigator evaluated the infection by grading the infected lesion according to SIS. The SIS consist of 7 items of exudate or pus, crusting, erythema or inflammation, tissue warmth, tissue edema, itching and pain. The items were rated on a 7-point scale ranging from 0 to 6, where 0 indicated absence of symptom and 6 indicated severe symptom. The total score ranged from 0 to 42, where 0 indicated absence of symptoms and higher score indicated more severe symptoms. Baseline was defined as the assessment value done on Day 1. The change from Baseline was calculated by subtracting the Baseline value from the individual post-Baseline (Day 1, Day 2, Day 3, Day 4, Day 8, Day 11, 7 Day Follow-up and 28 Day Follow-up) values. If either the Baseline or post-Baseline value was missing, the change from Baseline was set to missing as well.
Time frame: Day 1 (Baseline ) up to Follow-up (28 Day Follow-up, Day 40)
Population: ITTC Population. Only those participants available at the specified time points were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| GSK1322322 1500 mg BID | Mean Change From Baseline in Total SIS at Indicated Time Points | Day 4 | -10.9 Scores on scale | Standard Deviation 6.98 |
| GSK1322322 1500 mg BID | Mean Change From Baseline in Total SIS at Indicated Time Points | Day 11 | -22.0 Scores on scale | Standard Deviation 6.06 |
| GSK1322322 1500 mg BID | Mean Change From Baseline in Total SIS at Indicated Time Points | Day 3 | -8.4 Scores on scale | Standard Deviation 6.39 |
| GSK1322322 1500 mg BID | Mean Change From Baseline in Total SIS at Indicated Time Points | 7 Day Follow-up | -23.0 Scores on scale | Standard Deviation 5.91 |
| GSK1322322 1500 mg BID | Mean Change From Baseline in Total SIS at Indicated Time Points | Day 8 | -16.8 Scores on scale | Standard Deviation 7.22 |
| GSK1322322 1500 mg BID | Mean Change From Baseline in Total SIS at Indicated Time Points | 28 Day Follow-up | -25.1 Scores on scale | Standard Deviation 5.54 |
| GSK1322322 1500 mg BID | Mean Change From Baseline in Total SIS at Indicated Time Points | Day 2 | -3.4 Scores on scale | Standard Deviation 4.83 |
| Linezolid 600 mg BID | Mean Change From Baseline in Total SIS at Indicated Time Points | 28 Day Follow-up | -26.1 Scores on scale | Standard Deviation 3.98 |
| Linezolid 600 mg BID | Mean Change From Baseline in Total SIS at Indicated Time Points | Day 2 | -3.1 Scores on scale | Standard Deviation 4.98 |
| Linezolid 600 mg BID | Mean Change From Baseline in Total SIS at Indicated Time Points | Day 3 | -8.0 Scores on scale | Standard Deviation 6.79 |
| Linezolid 600 mg BID | Mean Change From Baseline in Total SIS at Indicated Time Points | Day 4 | -11.9 Scores on scale | Standard Deviation 6.84 |
| Linezolid 600 mg BID | Mean Change From Baseline in Total SIS at Indicated Time Points | Day 8 | -19.0 Scores on scale | Standard Deviation 6.38 |
| Linezolid 600 mg BID | Mean Change From Baseline in Total SIS at Indicated Time Points | Day 11 | -23.6 Scores on scale | Standard Deviation 4.82 |
| Linezolid 600 mg BID | Mean Change From Baseline in Total SIS at Indicated Time Points | 7 Day Follow-up | -24.2 Scores on scale | Standard Deviation 4.75 |
Comparison: GSK1322322 1500 mg versus Linezolid 600 mg for Day 2 total SIS.95% CI: [-3.04, 1.33]Mixed Models Analysis
Comparison: GSK1322322 1500 mg versus Linezolid 600 mg for Day 3 total SIS.95% CI: [-2.94, 1.41]Mixed Models Analysis
Comparison: GSK1322322 1500 mg versus Linezolid 600 mg for Day 4 total SIS.95% CI: [-1.68, 2.75]Mixed Models Analysis
Comparison: GSK1322322 1500 mg versus Linezolid 600 mg for Day 8 total SIS.95% CI: [-0.46, 4.05]Mixed Models Analysis
Comparison: GSK1322322 1500 mg versus Linezolid 600 mg for Day 11 total SIS.95% CI: [-1.09, 3.47]Mixed Models Analysis
Comparison: GSK1322322 1500 mg versus Linezolid 600 mg for 7 Day Follow-up total SIS.95% CI: [-1.49, 2.98]Mixed Models Analysis
Comparison: GSK1322322 1500 mg versus Linezolid 600 mg for 28 Day Follow-up total SIS.95% CI: [-2.09, 2.52]Mixed Models Analysis
Secondary
Mean Change From Baseline in Wound Area at Indicated Time Points
The area of the infected lesion size was calculated as the product between the length (L) and width (W) of the lesion size. The wound was measured by the investigator in centimeters (cm), using a standard metric ruler. Baseline was defined as the assessment value done on Day 1. The change from Baseline was calculated by subtracting the Baseline value from the individual post-Baseline (Day 1, Day 2, Day 3, Day 4, Day 8, Day 11, 7 Day Follow-up and 28 Day Follow-up) values. If either the Baseline or post-Baseline value was missing, the change from Baseline was set to missing as well.
Time frame: Day 1 (Baseline) up to Follow-up (28 Day Follow-up, Day 40)
Population: ITTC Population. Only those participants available at the specified time points were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| GSK1322322 1500 mg BID | Mean Change From Baseline in Wound Area at Indicated Time Points | Day 4 | -119.96 cm^2 | Standard Deviation 86.544 |
| GSK1322322 1500 mg BID | Mean Change From Baseline in Wound Area at Indicated Time Points | Day 11 | -234.99 cm^2 | Standard Deviation 276.801 |
| GSK1322322 1500 mg BID | Mean Change From Baseline in Wound Area at Indicated Time Points | Day 3 | -67.69 cm^2 | Standard Deviation 93.511 |
| GSK1322322 1500 mg BID | Mean Change From Baseline in Wound Area at Indicated Time Points | 7 Day Follow-up | -231.32 cm^2 | Standard Deviation 273.285 |
| GSK1322322 1500 mg BID | Mean Change From Baseline in Wound Area at Indicated Time Points | Day 8 | -192.92 cm^2 | Standard Deviation 175.606 |
| GSK1322322 1500 mg BID | Mean Change From Baseline in Wound Area at Indicated Time Points | 28 Day Follow-up | -242.92 cm^2 | Standard Deviation 277.312 |
| GSK1322322 1500 mg BID | Mean Change From Baseline in Wound Area at Indicated Time Points | Day 2 | -23.22 cm^2 | Standard Deviation 52.486 |
| Linezolid 600 mg BID | Mean Change From Baseline in Wound Area at Indicated Time Points | 28 Day Follow-up | -344.99 cm^2 | Standard Deviation 383.444 |
| Linezolid 600 mg BID | Mean Change From Baseline in Wound Area at Indicated Time Points | Day 2 | -20.71 cm^2 | Standard Deviation 88.184 |
| Linezolid 600 mg BID | Mean Change From Baseline in Wound Area at Indicated Time Points | Day 3 | -124.27 cm^2 | Standard Deviation 188.568 |
| Linezolid 600 mg BID | Mean Change From Baseline in Wound Area at Indicated Time Points | Day 4 | -209.79 cm^2 | Standard Deviation 224.125 |
| Linezolid 600 mg BID | Mean Change From Baseline in Wound Area at Indicated Time Points | Day 8 | -291.86 cm^2 | Standard Deviation 338.675 |
| Linezolid 600 mg BID | Mean Change From Baseline in Wound Area at Indicated Time Points | Day 11 | -329.93 cm^2 | Standard Deviation 362.831 |
| Linezolid 600 mg BID | Mean Change From Baseline in Wound Area at Indicated Time Points | 7 Day Follow-up | -335.20 cm^2 | Standard Deviation 363.233 |
Comparison: GSK1322322 1500 mg versus Linezolid 600 mg for Day 2 wound area.95% CI: [-132.8, -4.95]Mixed Models Analysis
Comparison: GSK1322322 1500 mg versus Linezolid 600 mg for Day 3 wound area.95% CI: [-66.54, 60.43]Mixed Models Analysis
Comparison: GSK1322322 1500 mg versus Linezolid 600 mg for Day 4 wound area.95% CI: [-33.53, 96.47]Mixed Models Analysis
Comparison: GSK1322322 1500 mg versus Linezolid 600 mg for Day 8 wound area.95% CI: [-22.43, 110.31]Mixed Models Analysis
Comparison: GSK1322322 1500 mg versus Linezolid 600 mg for Day 11 wound area.95% CI: [-33.03, 101.45]Mixed Models Analysis
Comparison: GSK1322322 1500 mg versus Linezolid 600 mg for 7 Day Follow-up wound area.95% CI: [-28.25, 103.4]Mixed Models Analysis
Comparison: GSK1322322 1500 mg versus Linezolid 600 mg for 28 Day Follow-up wound area.95% CI: [-30.77, 105.56]Mixed Models Analysis
Secondary
Mean Exudate or Pus Sub-score of SIS at Indicated Time Points
The SIS consist of 7 items of exudate or pus, crusting, erythema or inflammation, tissue warmth, tissue edema, itching and pain. The exudate or pus sub-score of SIS was rated on a 7-point scale ranging from 0 to 6, where 0 indicated absence of symptom and 6 indicated severe symptom. Assessments were done at Day 1, Day 2, Day 3, Day 4, Day 8, Day 11, 7 Day Follow-up and 28 Day Follow-up.
Time frame: Up to Follow-up (28 Day Follow-up, Day 40)
Population: ITTC Population. Only those participants available at the specified time points were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| GSK1322322 1500 mg BID | Mean Exudate or Pus Sub-score of SIS at Indicated Time Points | Day 1 | 3.2 Scores on scale | Standard Deviation 2.23 |
| GSK1322322 1500 mg BID | Mean Exudate or Pus Sub-score of SIS at Indicated Time Points | Day 2 | 3.0 Scores on scale | Standard Deviation 1.81 |
| GSK1322322 1500 mg BID | Mean Exudate or Pus Sub-score of SIS at Indicated Time Points | Day 3 | 2.1 Scores on scale | Standard Deviation 1.56 |
| GSK1322322 1500 mg BID | Mean Exudate or Pus Sub-score of SIS at Indicated Time Points | Day 4 | 1.5 Scores on scale | Standard Deviation 1.6 |
| GSK1322322 1500 mg BID | Mean Exudate or Pus Sub-score of SIS at Indicated Time Points | Day 8 | 0.8 Scores on scale | Standard Deviation 1.29 |
| GSK1322322 1500 mg BID | Mean Exudate or Pus Sub-score of SIS at Indicated Time Points | Day 11 | 0.2 Scores on scale | Standard Deviation 0.7 |
| GSK1322322 1500 mg BID | Mean Exudate or Pus Sub-score of SIS at Indicated Time Points | 7 Day Follow-up | 0.1 Scores on scale | Standard Deviation 0.37 |
| GSK1322322 1500 mg BID | Mean Exudate or Pus Sub-score of SIS at Indicated Time Points | 28 Day Follow-up | 0.0 Scores on scale | Standard Deviation 0 |
| Linezolid 600 mg BID | Mean Exudate or Pus Sub-score of SIS at Indicated Time Points | 28 Day Follow-up | 0.0 Scores on scale | Standard Deviation 0 |
| Linezolid 600 mg BID | Mean Exudate or Pus Sub-score of SIS at Indicated Time Points | Day 1 | 3.2 Scores on scale | Standard Deviation 2.39 |
| Linezolid 600 mg BID | Mean Exudate or Pus Sub-score of SIS at Indicated Time Points | Day 8 | 0.4 Scores on scale | Standard Deviation 0.71 |
| Linezolid 600 mg BID | Mean Exudate or Pus Sub-score of SIS at Indicated Time Points | Day 2 | 2.8 Scores on scale | Standard Deviation 1.97 |
| Linezolid 600 mg BID | Mean Exudate or Pus Sub-score of SIS at Indicated Time Points | 7 Day Follow-up | 0.0 Scores on scale | Standard Deviation 0 |
| Linezolid 600 mg BID | Mean Exudate or Pus Sub-score of SIS at Indicated Time Points | Day 3 | 2.2 Scores on scale | Standard Deviation 1.86 |
| Linezolid 600 mg BID | Mean Exudate or Pus Sub-score of SIS at Indicated Time Points | Day 11 | 0.0 Scores on scale | Standard Deviation 0 |
| Linezolid 600 mg BID | Mean Exudate or Pus Sub-score of SIS at Indicated Time Points | Day 4 | 1.7 Scores on scale | Standard Deviation 1.51 |
Comparison: GSK1322322 1500 mg versus Linezolid 600 mg for Day 2 exudate or pus score.95% CI: [-0.41, 0.74]Mixed Models Analysis
Comparison: GSK1322322 1500 mg versus Linezolid 600 mg for Day 3 exudate or pus score.95% CI: [-0.7, 0.45]Mixed Models Analysis
Comparison: GSK1322322 1500 mg versus Linezolid 600 mg for Day 4 exudate or pus score.95% CI: [-0.74, 0.43]Mixed Models Analysis
Comparison: GSK1322322 1500 mg versus Linezolid 600 mg for Day 8 exudate or pus score.95% CI: [-0.25, 0.95]Mixed Models Analysis
Comparison: GSK1322322 1500 mg versus Linezolid 600 mg for Day 11 exudate or pus score.95% CI: [-0.49, 0.72]Mixed Models Analysis
Comparison: GSK1322322 1500 mg versus Linezolid 600 mg for 7 Day Follow- up exudate or pus score.95% CI: [-0.53, 0.66]Mixed Models Analysis
Comparison: GSK1322322 1500 mg versus Linezolid 600 mg for 28 Day Follow- up exudate or pus score.95% CI: [-0.65, 0.58]Mixed Models Analysis
Secondary
Mean Short Form McGill Pain Questionnaire-2 (SF-MPQ-2) Sub-score of Continuous Pain, Intermittent Pain, Neuropathic Pain and Affective Descriptors at Indicated Time Points
SF-MPQ-2 is composed of 22 items that describes different quantities of pain and related symptoms. Sub-score of continuous pain represents mean of throbbing pain, cramping pain, gnawing pain, aching pain, heavy pain and tender (mean of items 1, 5, 6, 8, 9 and 10). Sub-score of intermittent pain represents mean of shooting pain, stabbing pain, sharp pain, splitting pain, electric-shock pain and piercing (mean of items 2, 3, 4, 11, 16 and 18). Sub-score of neuropathic pain represents mean of hot-burning pain, cold-freezing pain, pain caused by light touch, itching, tingling or pins and needles, numbness (mean of items 7, 17, 19, 20, 21 and 22). Sub-score of affective descriptors represents mean of tiring-exhaustive, sickening, fearful, punishing-cruel (mean of items 12, 13, 14 and 15). Scores ranged from 0 to 10, where 0 indicated absence of symptom and higher score indicated more severe symptoms. Assessments were done at Day 1, Day 2, Day 3, Day 4, Day 8, Day 11 and 7 Day Follow-up.
Time frame: Up to Follow-up (7 Day Follow up, Day 19)
Population: ITTC Population. Only those participants available at the specified time points were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| GSK1322322 1500 mg BID | Mean Short Form McGill Pain Questionnaire-2 (SF-MPQ-2) Sub-score of Continuous Pain, Intermittent Pain, Neuropathic Pain and Affective Descriptors at Indicated Time Points | Intermittent Pain, Day 2 | 2.337 Scores on scale | Standard Deviation 2.4214 |
| GSK1322322 1500 mg BID | Mean Short Form McGill Pain Questionnaire-2 (SF-MPQ-2) Sub-score of Continuous Pain, Intermittent Pain, Neuropathic Pain and Affective Descriptors at Indicated Time Points | Neuropathic Pain, Day 3 | 2.327 Scores on scale | Standard Deviation 2.0089 |
| GSK1322322 1500 mg BID | Mean Short Form McGill Pain Questionnaire-2 (SF-MPQ-2) Sub-score of Continuous Pain, Intermittent Pain, Neuropathic Pain and Affective Descriptors at Indicated Time Points | Neuropathic Pain, Day 4 | 2.391 Scores on scale | Standard Deviation 2.3476 |
| GSK1322322 1500 mg BID | Mean Short Form McGill Pain Questionnaire-2 (SF-MPQ-2) Sub-score of Continuous Pain, Intermittent Pain, Neuropathic Pain and Affective Descriptors at Indicated Time Points | Neuropathic Pain, Day 8 | 1.508 Scores on scale | Standard Deviation 1.7878 |
| GSK1322322 1500 mg BID | Mean Short Form McGill Pain Questionnaire-2 (SF-MPQ-2) Sub-score of Continuous Pain, Intermittent Pain, Neuropathic Pain and Affective Descriptors at Indicated Time Points | Neuropathic Pain, Day 11 | 0.813 Scores on scale | Standard Deviation 1.1113 |
| GSK1322322 1500 mg BID | Mean Short Form McGill Pain Questionnaire-2 (SF-MPQ-2) Sub-score of Continuous Pain, Intermittent Pain, Neuropathic Pain and Affective Descriptors at Indicated Time Points | Neuropathic Pain, 7 Day Follow-up | 0.690 Scores on scale | Standard Deviation 1.1515 |
| GSK1322322 1500 mg BID | Mean Short Form McGill Pain Questionnaire-2 (SF-MPQ-2) Sub-score of Continuous Pain, Intermittent Pain, Neuropathic Pain and Affective Descriptors at Indicated Time Points | Affective Descriptors, Day 1 | 3.360 Scores on scale | Standard Deviation 3.0063 |
| GSK1322322 1500 mg BID | Mean Short Form McGill Pain Questionnaire-2 (SF-MPQ-2) Sub-score of Continuous Pain, Intermittent Pain, Neuropathic Pain and Affective Descriptors at Indicated Time Points | Affective Descriptors, Day 2 | 2.226 Scores on scale | Standard Deviation 2.5925 |
| GSK1322322 1500 mg BID | Mean Short Form McGill Pain Questionnaire-2 (SF-MPQ-2) Sub-score of Continuous Pain, Intermittent Pain, Neuropathic Pain and Affective Descriptors at Indicated Time Points | Affective Descriptors, Day 3 | 1.929 Scores on scale | Standard Deviation 2.4088 |
| GSK1322322 1500 mg BID | Mean Short Form McGill Pain Questionnaire-2 (SF-MPQ-2) Sub-score of Continuous Pain, Intermittent Pain, Neuropathic Pain and Affective Descriptors at Indicated Time Points | Affective Descriptors, Day 4 | 1.641 Scores on scale | Standard Deviation 2.4736 |
| GSK1322322 1500 mg BID | Mean Short Form McGill Pain Questionnaire-2 (SF-MPQ-2) Sub-score of Continuous Pain, Intermittent Pain, Neuropathic Pain and Affective Descriptors at Indicated Time Points | Affective Descriptors, Day 8 | 0.852 Scores on scale | Standard Deviation 1.597 |
| GSK1322322 1500 mg BID | Mean Short Form McGill Pain Questionnaire-2 (SF-MPQ-2) Sub-score of Continuous Pain, Intermittent Pain, Neuropathic Pain and Affective Descriptors at Indicated Time Points | Affective Descriptors, Day 11 | 0.640 Scores on scale | Standard Deviation 1.132 |
| GSK1322322 1500 mg BID | Mean Short Form McGill Pain Questionnaire-2 (SF-MPQ-2) Sub-score of Continuous Pain, Intermittent Pain, Neuropathic Pain and Affective Descriptors at Indicated Time Points | Affective Descriptors, 7 Day Follow-up | 0.483 Scores on scale | Standard Deviation 1.04 |
| GSK1322322 1500 mg BID | Mean Short Form McGill Pain Questionnaire-2 (SF-MPQ-2) Sub-score of Continuous Pain, Intermittent Pain, Neuropathic Pain and Affective Descriptors at Indicated Time Points | Continuous Pain, Day 1 | 4.459 Scores on scale | Standard Deviation 2.8567 |
| GSK1322322 1500 mg BID | Mean Short Form McGill Pain Questionnaire-2 (SF-MPQ-2) Sub-score of Continuous Pain, Intermittent Pain, Neuropathic Pain and Affective Descriptors at Indicated Time Points | Continuous Pain, Day 2 | 3.407 Scores on scale | Standard Deviation 2.4454 |
| GSK1322322 1500 mg BID | Mean Short Form McGill Pain Questionnaire-2 (SF-MPQ-2) Sub-score of Continuous Pain, Intermittent Pain, Neuropathic Pain and Affective Descriptors at Indicated Time Points | Continuous Pain, Day 3 | 2.826 Scores on scale | Standard Deviation 2.5509 |
| GSK1322322 1500 mg BID | Mean Short Form McGill Pain Questionnaire-2 (SF-MPQ-2) Sub-score of Continuous Pain, Intermittent Pain, Neuropathic Pain and Affective Descriptors at Indicated Time Points | Continuous Pain, Day 4 | 2.645 Scores on scale | Standard Deviation 2.7701 |
| GSK1322322 1500 mg BID | Mean Short Form McGill Pain Questionnaire-2 (SF-MPQ-2) Sub-score of Continuous Pain, Intermittent Pain, Neuropathic Pain and Affective Descriptors at Indicated Time Points | Continuous Pain, Day 8 | 1.420 Scores on scale | Standard Deviation 1.9653 |
| GSK1322322 1500 mg BID | Mean Short Form McGill Pain Questionnaire-2 (SF-MPQ-2) Sub-score of Continuous Pain, Intermittent Pain, Neuropathic Pain and Affective Descriptors at Indicated Time Points | Continuous Pain, Day 11 | 0.882 Scores on scale | Standard Deviation 1.3387 |
| GSK1322322 1500 mg BID | Mean Short Form McGill Pain Questionnaire-2 (SF-MPQ-2) Sub-score of Continuous Pain, Intermittent Pain, Neuropathic Pain and Affective Descriptors at Indicated Time Points | Continuous Pain, 7 Day Follow-up | 0.733 Scores on scale | Standard Deviation 1.3018 |
| GSK1322322 1500 mg BID | Mean Short Form McGill Pain Questionnaire-2 (SF-MPQ-2) Sub-score of Continuous Pain, Intermittent Pain, Neuropathic Pain and Affective Descriptors at Indicated Time Points | Intermittent Pain, Day 1 | 3.836 Scores on scale | Standard Deviation 3.1349 |
| GSK1322322 1500 mg BID | Mean Short Form McGill Pain Questionnaire-2 (SF-MPQ-2) Sub-score of Continuous Pain, Intermittent Pain, Neuropathic Pain and Affective Descriptors at Indicated Time Points | Intermittent Pain, Day 3 | 2.078 Scores on scale | Standard Deviation 2.4989 |
| GSK1322322 1500 mg BID | Mean Short Form McGill Pain Questionnaire-2 (SF-MPQ-2) Sub-score of Continuous Pain, Intermittent Pain, Neuropathic Pain and Affective Descriptors at Indicated Time Points | Intermittent Pain, Day 4 | 1.906 Scores on scale | Standard Deviation 2.6239 |
| GSK1322322 1500 mg BID | Mean Short Form McGill Pain Questionnaire-2 (SF-MPQ-2) Sub-score of Continuous Pain, Intermittent Pain, Neuropathic Pain and Affective Descriptors at Indicated Time Points | Intermittent Pain, Day 8 | 0.871 Scores on scale | Standard Deviation 1.804 |
| GSK1322322 1500 mg BID | Mean Short Form McGill Pain Questionnaire-2 (SF-MPQ-2) Sub-score of Continuous Pain, Intermittent Pain, Neuropathic Pain and Affective Descriptors at Indicated Time Points | Intermittent Pain, Day 11 | 0.504 Scores on scale | Standard Deviation 0.9927 |
| GSK1322322 1500 mg BID | Mean Short Form McGill Pain Questionnaire-2 (SF-MPQ-2) Sub-score of Continuous Pain, Intermittent Pain, Neuropathic Pain and Affective Descriptors at Indicated Time Points | Intermittent Pain, 7 Day Follow-up | 0.581 Scores on scale | Standard Deviation 1.3429 |
| GSK1322322 1500 mg BID | Mean Short Form McGill Pain Questionnaire-2 (SF-MPQ-2) Sub-score of Continuous Pain, Intermittent Pain, Neuropathic Pain and Affective Descriptors at Indicated Time Points | Neuropathic Pain, Day 1 | 3.520 Scores on scale | Standard Deviation 2.5554 |
| GSK1322322 1500 mg BID | Mean Short Form McGill Pain Questionnaire-2 (SF-MPQ-2) Sub-score of Continuous Pain, Intermittent Pain, Neuropathic Pain and Affective Descriptors at Indicated Time Points | Neuropathic Pain, Day 2 | 2.705 Scores on scale | Standard Deviation 2.0982 |
| Linezolid 600 mg BID | Mean Short Form McGill Pain Questionnaire-2 (SF-MPQ-2) Sub-score of Continuous Pain, Intermittent Pain, Neuropathic Pain and Affective Descriptors at Indicated Time Points | Continuous Pain, Day 2 | 3.533 Scores on scale | Standard Deviation 2.6745 |
| Linezolid 600 mg BID | Mean Short Form McGill Pain Questionnaire-2 (SF-MPQ-2) Sub-score of Continuous Pain, Intermittent Pain, Neuropathic Pain and Affective Descriptors at Indicated Time Points | Intermittent Pain, 7 Day Follow-up | 0.440 Scores on scale | Standard Deviation 1.1656 |
| Linezolid 600 mg BID | Mean Short Form McGill Pain Questionnaire-2 (SF-MPQ-2) Sub-score of Continuous Pain, Intermittent Pain, Neuropathic Pain and Affective Descriptors at Indicated Time Points | Neuropathic Pain, Day 3 | 2.026 Scores on scale | Standard Deviation 2.3526 |
| Linezolid 600 mg BID | Mean Short Form McGill Pain Questionnaire-2 (SF-MPQ-2) Sub-score of Continuous Pain, Intermittent Pain, Neuropathic Pain and Affective Descriptors at Indicated Time Points | Continuous Pain, Day 3 | 2.744 Scores on scale | Standard Deviation 2.8477 |
| Linezolid 600 mg BID | Mean Short Form McGill Pain Questionnaire-2 (SF-MPQ-2) Sub-score of Continuous Pain, Intermittent Pain, Neuropathic Pain and Affective Descriptors at Indicated Time Points | Neuropathic Pain, Day 4 | 1.613 Scores on scale | Standard Deviation 2.0473 |
| Linezolid 600 mg BID | Mean Short Form McGill Pain Questionnaire-2 (SF-MPQ-2) Sub-score of Continuous Pain, Intermittent Pain, Neuropathic Pain and Affective Descriptors at Indicated Time Points | Intermittent Pain, Day 3 | 2.244 Scores on scale | Standard Deviation 2.7913 |
| Linezolid 600 mg BID | Mean Short Form McGill Pain Questionnaire-2 (SF-MPQ-2) Sub-score of Continuous Pain, Intermittent Pain, Neuropathic Pain and Affective Descriptors at Indicated Time Points | Neuropathic Pain, Day 8 | 1.410 Scores on scale | Standard Deviation 2.0042 |
| Linezolid 600 mg BID | Mean Short Form McGill Pain Questionnaire-2 (SF-MPQ-2) Sub-score of Continuous Pain, Intermittent Pain, Neuropathic Pain and Affective Descriptors at Indicated Time Points | Continuous Pain, Day 4 | 2.067 Scores on scale | Standard Deviation 2.4462 |
| Linezolid 600 mg BID | Mean Short Form McGill Pain Questionnaire-2 (SF-MPQ-2) Sub-score of Continuous Pain, Intermittent Pain, Neuropathic Pain and Affective Descriptors at Indicated Time Points | Neuropathic Pain, Day 11 | 0.778 Scores on scale | Standard Deviation 1.245 |
| Linezolid 600 mg BID | Mean Short Form McGill Pain Questionnaire-2 (SF-MPQ-2) Sub-score of Continuous Pain, Intermittent Pain, Neuropathic Pain and Affective Descriptors at Indicated Time Points | Intermittent Pain, Day 11 | 0.688 Scores on scale | Standard Deviation 1.4902 |
| Linezolid 600 mg BID | Mean Short Form McGill Pain Questionnaire-2 (SF-MPQ-2) Sub-score of Continuous Pain, Intermittent Pain, Neuropathic Pain and Affective Descriptors at Indicated Time Points | Neuropathic Pain, 7 Day Follow-up | 0.593 Scores on scale | Standard Deviation 1.1707 |
| Linezolid 600 mg BID | Mean Short Form McGill Pain Questionnaire-2 (SF-MPQ-2) Sub-score of Continuous Pain, Intermittent Pain, Neuropathic Pain and Affective Descriptors at Indicated Time Points | Continuous Pain, Day 8 | 1.389 Scores on scale | Standard Deviation 2.0534 |
| Linezolid 600 mg BID | Mean Short Form McGill Pain Questionnaire-2 (SF-MPQ-2) Sub-score of Continuous Pain, Intermittent Pain, Neuropathic Pain and Affective Descriptors at Indicated Time Points | Affective Descriptors, Day 1 | 2.806 Scores on scale | Standard Deviation 2.9 |
| Linezolid 600 mg BID | Mean Short Form McGill Pain Questionnaire-2 (SF-MPQ-2) Sub-score of Continuous Pain, Intermittent Pain, Neuropathic Pain and Affective Descriptors at Indicated Time Points | Intermittent Pain, Day 4 | 1.620 Scores on scale | Standard Deviation 2.4188 |
| Linezolid 600 mg BID | Mean Short Form McGill Pain Questionnaire-2 (SF-MPQ-2) Sub-score of Continuous Pain, Intermittent Pain, Neuropathic Pain and Affective Descriptors at Indicated Time Points | Affective Descriptors, Day 2 | 2.500 Scores on scale | Standard Deviation 2.9244 |
| Linezolid 600 mg BID | Mean Short Form McGill Pain Questionnaire-2 (SF-MPQ-2) Sub-score of Continuous Pain, Intermittent Pain, Neuropathic Pain and Affective Descriptors at Indicated Time Points | Continuous Pain, Day 11 | 0.806 Scores on scale | Standard Deviation 1.3976 |
| Linezolid 600 mg BID | Mean Short Form McGill Pain Questionnaire-2 (SF-MPQ-2) Sub-score of Continuous Pain, Intermittent Pain, Neuropathic Pain and Affective Descriptors at Indicated Time Points | Affective Descriptors, Day 3 | 1.692 Scores on scale | Standard Deviation 2.6517 |
| Linezolid 600 mg BID | Mean Short Form McGill Pain Questionnaire-2 (SF-MPQ-2) Sub-score of Continuous Pain, Intermittent Pain, Neuropathic Pain and Affective Descriptors at Indicated Time Points | Neuropathic Pain, Day 1 | 3.846 Scores on scale | Standard Deviation 2.3705 |
| Linezolid 600 mg BID | Mean Short Form McGill Pain Questionnaire-2 (SF-MPQ-2) Sub-score of Continuous Pain, Intermittent Pain, Neuropathic Pain and Affective Descriptors at Indicated Time Points | Affective Descriptors, Day 4 | 1.330 Scores on scale | Standard Deviation 2.2287 |
| Linezolid 600 mg BID | Mean Short Form McGill Pain Questionnaire-2 (SF-MPQ-2) Sub-score of Continuous Pain, Intermittent Pain, Neuropathic Pain and Affective Descriptors at Indicated Time Points | Continuous Pain, 7 Day Follow-up | 0.533 Scores on scale | Standard Deviation 1.2342 |
| Linezolid 600 mg BID | Mean Short Form McGill Pain Questionnaire-2 (SF-MPQ-2) Sub-score of Continuous Pain, Intermittent Pain, Neuropathic Pain and Affective Descriptors at Indicated Time Points | Affective Descriptors, Day 8 | 1.021 Scores on scale | Standard Deviation 2.0811 |
| Linezolid 600 mg BID | Mean Short Form McGill Pain Questionnaire-2 (SF-MPQ-2) Sub-score of Continuous Pain, Intermittent Pain, Neuropathic Pain and Affective Descriptors at Indicated Time Points | Intermittent Pain, Day 8 | 1.236 Scores on scale | Standard Deviation 1.964 |
| Linezolid 600 mg BID | Mean Short Form McGill Pain Questionnaire-2 (SF-MPQ-2) Sub-score of Continuous Pain, Intermittent Pain, Neuropathic Pain and Affective Descriptors at Indicated Time Points | Affective Descriptors, Day 11 | 0.490 Scores on scale | Standard Deviation 1.2079 |
| Linezolid 600 mg BID | Mean Short Form McGill Pain Questionnaire-2 (SF-MPQ-2) Sub-score of Continuous Pain, Intermittent Pain, Neuropathic Pain and Affective Descriptors at Indicated Time Points | Intermittent Pain, Day 1 | 3.802 Scores on scale | Standard Deviation 2.9067 |
| Linezolid 600 mg BID | Mean Short Form McGill Pain Questionnaire-2 (SF-MPQ-2) Sub-score of Continuous Pain, Intermittent Pain, Neuropathic Pain and Affective Descriptors at Indicated Time Points | Affective Descriptors, 7 Day Follow-up | 0.430 Scores on scale | Standard Deviation 1.1099 |
| Linezolid 600 mg BID | Mean Short Form McGill Pain Questionnaire-2 (SF-MPQ-2) Sub-score of Continuous Pain, Intermittent Pain, Neuropathic Pain and Affective Descriptors at Indicated Time Points | Neuropathic Pain, Day 2 | 2.193 Scores on scale | Standard Deviation 2.2632 |
| Linezolid 600 mg BID | Mean Short Form McGill Pain Questionnaire-2 (SF-MPQ-2) Sub-score of Continuous Pain, Intermittent Pain, Neuropathic Pain and Affective Descriptors at Indicated Time Points | Continuous Pain, Day 1 | 4.889 Scores on scale | Standard Deviation 2.2773 |
| Linezolid 600 mg BID | Mean Short Form McGill Pain Questionnaire-2 (SF-MPQ-2) Sub-score of Continuous Pain, Intermittent Pain, Neuropathic Pain and Affective Descriptors at Indicated Time Points | Intermittent Pain, Day 2 | 2.693 Scores on scale | Standard Deviation 2.9867 |
Secondary
Mean Total SIS at Indicated Time Points
The investigator evaluated the infection by grading the infected lesion according to SIS. The SIS consist of 7 items of exudate or pus, crusting, erythema or inflammation, tissue warmth, tissue edema, itching and pain. The items were rated on a 7-point scale ranging from 0 to 6, where 0 indicated absence of symptom and 6 indicated severe symptom. The total score ranged from 0 to 42, where 0 indicated absence of symptoms and higher score indicated more severe symptoms. Assessments were done at Day 1, Day 2, Day 3, Day 4, Day 8, Day 11, 7 Day Follow-up and 28 Day Follow-up.
Time frame: Up to Follow-up (28 Day Follow-up, Day 40)
Population: ITTC Population. Only those participants available at the specified time points were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| GSK1322322 1500 mg BID | Mean Total SIS at Indicated Time Points | Day 1 | 25.7 Scores on scale | Standard Deviation 5.44 |
| GSK1322322 1500 mg BID | Mean Total SIS at Indicated Time Points | Day 2 | 22.2 Scores on scale | Standard Deviation 5.24 |
| GSK1322322 1500 mg BID | Mean Total SIS at Indicated Time Points | Day 3 | 17.2 Scores on scale | Standard Deviation 6.09 |
| GSK1322322 1500 mg BID | Mean Total SIS at Indicated Time Points | Day 4 | 14.6 Scores on scale | Standard Deviation 6.47 |
| GSK1322322 1500 mg BID | Mean Total SIS at Indicated Time Points | Day 8 | 8.8 Scores on scale | Standard Deviation 5.52 |
| GSK1322322 1500 mg BID | Mean Total SIS at Indicated Time Points | Day 11 | 3.7 Scores on scale | Standard Deviation 3.53 |
| GSK1322322 1500 mg BID | Mean Total SIS at Indicated Time Points | 7 Day Follow-up | 2.4 Scores on scale | Standard Deviation 2.55 |
| GSK1322322 1500 mg BID | Mean Total SIS at Indicated Time Points | 28 Day Follow-up | 0.3 Scores on scale | Standard Deviation 1.29 |
| Linezolid 600 mg BID | Mean Total SIS at Indicated Time Points | 28 Day Follow-up | 0.1 Scores on scale | Standard Deviation 0.34 |
| Linezolid 600 mg BID | Mean Total SIS at Indicated Time Points | Day 1 | 26.0 Scores on scale | Standard Deviation 4.39 |
| Linezolid 600 mg BID | Mean Total SIS at Indicated Time Points | Day 8 | 6.9 Scores on scale | Standard Deviation 4.17 |
| Linezolid 600 mg BID | Mean Total SIS at Indicated Time Points | Day 2 | 23.3 Scores on scale | Standard Deviation 5.01 |
| Linezolid 600 mg BID | Mean Total SIS at Indicated Time Points | 7 Day Follow-up | 1.8 Scores on scale | Standard Deviation 2.07 |
| Linezolid 600 mg BID | Mean Total SIS at Indicated Time Points | Day 3 | 18.1 Scores on scale | Standard Deviation 6.59 |
| Linezolid 600 mg BID | Mean Total SIS at Indicated Time Points | Day 11 | 2.3 Scores on scale | Standard Deviation 2.11 |
| Linezolid 600 mg BID | Mean Total SIS at Indicated Time Points | Day 4 | 14.1 Scores on scale | Standard Deviation 6.19 |
Comparison: GSK1322322 1500 mg versus Linezolid 600 mg for Day 2 total SIS.95% CI: [-3.04, 1.33]Mixed Models Analysis
Comparison: GSK1322322 1500 mg versus Linezolid 600 mg for Day 3 total SIS.95% CI: [-2.94, 1.41]Mixed Models Analysis
Comparison: GSK1322322 1500 mg versus Linezolid 600 mg for Day 4 total SIS.95% CI: [-1.68, 2.75]
Comparison: GSK1322322 1500 mg versus Linezolid 600 mg for Day 8 total SIS.95% CI: [-0.46, 4.05]Mixed Models Analysis
Comparison: GSK1322322 1500 mg versus Linezolid 600 mg for Day 11 total SIS.95% CI: [-1.09, 3.47]Mixed Models Analysis
Comparison: GSK1322322 1500 mg versus Linezolid 600 mg for 7 Day Follow-up total SIS.95% CI: [-1.49, 2.98]Mixed Models Analysis
Comparison: GSK1322322 1500 mg versus Linezolid 600 mg for 28 Day Follow-up total SIS.95% CI: [-2.09, 2.52]Mixed Models Analysis
Secondary
Number of Participants With Clinical Success of Clinical Response
The clinical response was evaluated by the investigator at end of therapy (within 3 days post therapy; Day 12-14) and Follow-up (7 day Follow-up; Day 16 to 19 and 28 day Follow-up; Day 37 to 40). Clinical response was determined after clinical evaluation of reviewing clinical signs and symptoms. Clinical success was defined as total resolution of all signs and symptoms of infection recorded at Baseline, or improvement to such an extent that no further antimicrobial therapy was necessary, including a pus/exudate skin infection score (SIS) of 0.
Time frame: Up to Follow-up (28 Day Follow-up, Day 40)
Population: Intent-to-Treat Clinical (ITTC) Population was defined as all randomized participants who received at least one dose of study medication. Only those participants available at the specified time points were analyzed.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| GSK1322322 1500 mg BID | Number of Participants With Clinical Success of Clinical Response | Day 11 | 38 Participants |
| GSK1322322 1500 mg BID | Number of Participants With Clinical Success of Clinical Response | 7 Day Follow-up | 38 Participants |
| GSK1322322 1500 mg BID | Number of Participants With Clinical Success of Clinical Response | 28 Day Follow-up | 37 Participants |
| Linezolid 600 mg BID | Number of Participants With Clinical Success of Clinical Response | Day 11 | 24 Participants |
| Linezolid 600 mg BID | Number of Participants With Clinical Success of Clinical Response | 7 Day Follow-up | 25 Participants |
| Linezolid 600 mg BID | Number of Participants With Clinical Success of Clinical Response | 28 Day Follow-up | 23 Participants |
Secondary
Percentage of Participants With Clinical Success at End of Therapy by Pathogen Isolated at Baseline
Clinical success was defined as total resolution of all signs and symptoms of infection recorded at Baseline, or improvement to such an extent that no further antimicrobial therapy was necessary, including a pus/exudates SIS of 0. The pathogens isolated at Baseline included staphylococcus aureus (methicillin-resistant staphylococcus aureus \[MRSA\] and methicillin-susceptible staphylococcus aureus \[MSSA\] as defined by susceptibility to cefoxitin or oxacilin), streptococcus pyogenes, other streptococcus species, other Gram-positive pathogens and Gram-negative pathogens. Data is categorized for the percentage of participants with clinical success for each of the pathogens, all pathogens and no pathogens.
Time frame: Up to Follow-up (28 Day Follow-up, Day 40)
Population: ITTC Population. Only those participants available at the specified time points were analyzed.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| GSK1322322 1500 mg BID | Percentage of Participants With Clinical Success at End of Therapy by Pathogen Isolated at Baseline | Streptococcus pyogenes | 33.3 Percentage of participants |
| GSK1322322 1500 mg BID | Percentage of Participants With Clinical Success at End of Therapy by Pathogen Isolated at Baseline | Gram-negative pathogens | 75.0 Percentage of participants |
| GSK1322322 1500 mg BID | Percentage of Participants With Clinical Success at End of Therapy by Pathogen Isolated at Baseline | MSSA | 71.4 Percentage of participants |
| GSK1322322 1500 mg BID | Percentage of Participants With Clinical Success at End of Therapy by Pathogen Isolated at Baseline | All pathogens | 58.1 Percentage of participants |
| GSK1322322 1500 mg BID | Percentage of Participants With Clinical Success at End of Therapy by Pathogen Isolated at Baseline | MRSA | 50.0 Percentage of participants |
| GSK1322322 1500 mg BID | Percentage of Participants With Clinical Success at End of Therapy by Pathogen Isolated at Baseline | No pathogens | 80.0 Percentage of participants |
| GSK1322322 1500 mg BID | Percentage of Participants With Clinical Success at End of Therapy by Pathogen Isolated at Baseline | Staphylococcus aureus (all) | 58.3 Percentage of participants |
| Linezolid 600 mg BID | Percentage of Participants With Clinical Success at End of Therapy by Pathogen Isolated at Baseline | Gram-negative pathogens | 100.0 Percentage of participants |
| Linezolid 600 mg BID | Percentage of Participants With Clinical Success at End of Therapy by Pathogen Isolated at Baseline | All pathogens | 95.7 Percentage of participants |
| Linezolid 600 mg BID | Percentage of Participants With Clinical Success at End of Therapy by Pathogen Isolated at Baseline | No pathogens | 77.8 Percentage of participants |
| Linezolid 600 mg BID | Percentage of Participants With Clinical Success at End of Therapy by Pathogen Isolated at Baseline | Staphylococcus aureus (all) | 93.8 Percentage of participants |
| Linezolid 600 mg BID | Percentage of Participants With Clinical Success at End of Therapy by Pathogen Isolated at Baseline | MRSA | 87.5 Percentage of participants |
| Linezolid 600 mg BID | Percentage of Participants With Clinical Success at End of Therapy by Pathogen Isolated at Baseline | MSSA | 100.0 Percentage of participants |
| Linezolid 600 mg BID | Percentage of Participants With Clinical Success at End of Therapy by Pathogen Isolated at Baseline | Streptococcus pyogenes | 100.0 Percentage of participants |
| Linezolid 600 mg BID | Percentage of Participants With Clinical Success at End of Therapy by Pathogen Isolated at Baseline | Other Streptococcus species | 100.0 Percentage of participants |
| Linezolid 600 mg BID | Percentage of Participants With Clinical Success at End of Therapy by Pathogen Isolated at Baseline | Other Gram-positive pathogens | 100.0 Percentage of participants |
Comparison: GSK1322322 1500 mg versus Linezolid 600 mg for Staphylococcus aureus (all).Regression, Logistic
Comparison: GSK1322322 1500 mg versus Linezolid 600 mg for MRSA.Regression, Logistic
Comparison: GSK1322322 1500 mg versus Linezolid 600 mg for MSSA.Regression, Logistic
Comparison: GSK1322322 1500 mg versus Linezolid 600 mg for Streptococcus pyogenes.Regression, Logistic
Comparison: GSK1322322 1500 mg versus Linezolid 600 mg for Gram-negative pathogens.Regression, Logistic
Comparison: GSK1322322 1500 mg versus Linezolid 600 mg for All pathogens.Regression, Logistic
Comparison: GSK1322322 1500 mg versus Linezolid 600 mg for No pathogens.Regression, Logistic
Secondary
Percentage of Participants With Clinical Success of Clinical Outcome
The clinical response was determined by the investigator after clinical evaluation of reviewing clinical signs and symptoms at end of therapy (within 3 days post therapy; visit window of Day 12-14) and 7 day Follow-up ( visit window of Day 16 to 19), and the resulting clinical outcome was assigned, for each participant. Clinical success was defined as total resolution of all signs and symptoms of infection recorded at Baseline, or improvement to such an extent that no further antimicrobial therapy was necessary, including a pus/exudates SIS of 0.
Time frame: Day 11 (end of therapy) and Follow-up (7 Day Follow-up, Day 19)
Population: ITTC Population.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| GSK1322322 1500 mg BID | Percentage of Participants With Clinical Success of Clinical Outcome | End of therapy | 66.7 Percentage of participants |
| GSK1322322 1500 mg BID | Percentage of Participants With Clinical Success of Clinical Outcome | Follow-up | 64.9 Percentage of participants |
| Linezolid 600 mg BID | Percentage of Participants With Clinical Success of Clinical Outcome | End of therapy | 88.9 Percentage of participants |
| Linezolid 600 mg BID | Percentage of Participants With Clinical Success of Clinical Outcome | Follow-up | 88.9 Percentage of participants |
Comparison: GSK1322322 1500 mg versus Linezolid 600 mg for end of therapy Clinical Success.Regression, Logistic
Comparison: GSK1322322 1500 mg versus Linezolid 600 mg for Follow-up Clinical Success.Regression, Logistic
Secondary
Percentage of Participants With Microbiological Success of Microbiological Outcome at End of Therapy
The 'by pathogen' microbiological response was determined by comparing the Baseline (Day 1) culture results to the culture results at the end of therapy (visit window of Day 12-14), and the corresponding microbiological outcome (success or failure) by participant was then assigned. Microbiological success was defined as: elimination of Baseline pathogens (defined as microbiological eradication in microbiological response); clinical outcome was success such that no culture was obtained due to lack of culturable material, secondary to adequate clinical response, and was documented in the electronic case report form (eCRF) (defined as presumed microbiological eradication in microbiological response); new pathogen not previously identified, was identified at end of therapy in a participant who was a 'clinical success' (defined as colonization in microbiological response).
Time frame: Day 11 (end of therapy)
Population: Intent-to-Treat Bacteriology (ITTB) Population was defined as all randomized participants who received at least one dose of study medication and who had a pathogen isolated at Baseline.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| GSK1322322 1500 mg BID | Percentage of Participants With Microbiological Success of Microbiological Outcome at End of Therapy | 59.5 Percentage of participants |
| Linezolid 600 mg BID | Percentage of Participants With Microbiological Success of Microbiological Outcome at End of Therapy | 94.4 Percentage of participants |
95% CI: [-60.6, -9.4]Regression, Logistic
Secondary
Percentage of Participants With Microbiological Success of Microbiological Outcome at Follow-up
The 'by pathogen' microbiological response was determined by comparing the Baseline (Day 1) culture results to culture results at Follow-up (Day 16-19), and corresponding microbiological outcome (success or failure) by participant was then assigned. Microbiological success was defined as: Baseline pathogen was eradicated or presumed eradicated at end of therapy, or Baseline pathogens were present at end of therapy and is absent at Follow-up (microbiological eradication in microbiological response); Baseline pathogen was eradicated or presumed eradicated at end of therapy, or the Baseline pathogens were present at end of therapy and, participant was a 'clinical success', such that no culture was obtained due to lack of culturable material, secondary to adequate clinical response, and was documented in the eCRF (microbiological eradication); a new pathogen, not previously identified at Baseline, was identified at Follow-up in a participant who was a 'clinical success' (colonization)
Time frame: Follow-up (7 Day Follow-up, Day 19)
Population: ITTB Population.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| GSK1322322 1500 mg BID | Percentage of Participants With Microbiological Success of Microbiological Outcome at Follow-up | 59.5 Percentage of participants |
| Linezolid 600 mg BID | Percentage of Participants With Microbiological Success of Microbiological Outcome at Follow-up | 94.4 Percentage of participants |
95% CI: [-60.6, -9.4]Regression, Logistic
Secondary
Percentage of Participants With Therapeutic Success of Therapeutic Outcome
Therapeutic outcome was combined clinical and microbiological outcome. Therapeutic outcome was a measure of the overall efficacy response, and a therapeutic success referred to participants who had been deemed both a 'clinical success' and a 'microbiological success'. All other combinations (other than 'clinical success' + 'microbiological success') were deemed failures for therapeutic outcome. Therapeutic outcome was determined programmatically, obtained at 7 day Follow-up.
Time frame: Follow-up (7 day Follow-up, Day 19)
Population: Per Protocol Bacteriology (PPB) Population was defined as ITTB participants who adhered to protocol-specific criteria (i.e., no protocol violation ): taking 80% of medications and/or not missing more than 48 h in a row of study drug, and have both end of therapy and 7 day Follow-up to be evaluable and a documented pathogen cultured at Baseline.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| GSK1322322 1500 mg BID | Percentage of Participants With Therapeutic Success of Therapeutic Outcome | 0.8636 Percentage of participants |
| Linezolid 600 mg BID | Percentage of Participants With Therapeutic Success of Therapeutic Outcome | 1.0000 Percentage of participants |
Secondary
Population Pharmacokinetic Parameters of Apparent Total Clearance of GSK1322322 From Plasma After Oral Administration (CL/F)
Blood samples were planned to be collected on Day 1, 0.25-1.5 hours post-initial dose (corresponding to the safety laboratory and ECG timepoint), and 1.5-3 hours post-initial dose (corresponding to the safety laboratory and ECG timepoint), and Day 4, 4-12 hours post-morning dose (corresponding to the safety laboratory and ECG timepoint), and Day 8, pre-morning dose (corresponding to safety laboratory and ECG timepoint) during the outpatient visit. The data for this outcome measure was not collected and assessed.
Time frame: Day 1 (0.25-1.5 hours post-initial dose, 1.5-3 hours post-initial dose), Day 4 (4-12 hours post-morning dose) and Day 8 (pre-morning dose)
Population: Pharmacokinetic (PK) Concentration Population defined all Participants in the Safety Population who underwent plasma PK sampling during the study and from whom a measurable plasma concentration above the assay's limit of quantification were obtained for one of the treatment regimens. No participants were analyzed for this outcome measure.