Infections, Bacterial
Conditions
Keywords
Dose ranging, Intravenous, Adaptive design, suspected or confirmed gram-positive acute bacterial skin and skin structure infection, Subjects, infection, Oral, GSK2140944
Brief summary
GSK2140944 belongs to a novel structural class of antibiotics - Bacterial Type II Topoisomerase Inhibitors (BTI). This is a Phase II, randomized, two-part, multicenter study designed to select the optimal dose by further characterizing the safety, tolerability and PK of GSK 2140944 and by evaluating efficacy in subjects requiring in-patient medical care to treat their suspected or confirmed Gram-positive acute bacterial skin and skin structure infections (ABSSSI). The selected dose will be used in future studies.
Interventions
DRUGGSK2140944 Lyophile
GSK2140944 Lyophile (pale yellow to grayish yellow cake) containing 750 mg of GSK2140944 (as free base) per vial for IV infusion.
DRUGGSK2140944 Capsules
GSK2140944 500 mg capsules will be supplied as pink hard gelatin capsule with no external markings filled with slightly agglomerated pale yellow to grayish yellow powder.
Sponsors
GlaxoSmithKline
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* The subject is an adult male at least 18 years of age or an adult female at least 18 years of age who meets one of the following criteria: A female of child-bearing potential who is either 1) sexually inactive by abstinence, 2) whose sole male partner has been sterilized, or 3) uses a contraceptive method with a failure rate of \< 1%. Females of child-bearing potential must not become pregnant during the study. A female of non child- bearing potential, which includes: Females who are surgically sterile with a documented hysterectomy and/or bilateral oophorectomy; Females with a documented tubal ligation. If the procedure was done hysteroscopically, the effectiveness of tubal occlusion must have been documented by hysterosalpingogram post procedure (typically 3 months after procedure); Females who are post-menopausal, defined as amenorrhoeic for greater than 1 year. For women whose menopausal status is in doubt, a documented previous confirmatory blood sample with follicle-stimulating hormone (FSH) \> 40 milli-international units per milliliter (MIU/mL) and estradiol \<40 picograms per milliliter (\<140 picomole per liter) would need to be confirmed or they will be required to use one of the contraception methods. * The subject has a diagnosis of ABSSSI suspected or documented to be caused by Gram-positive pathogens that requires of intravenous (IV) antibiotic treatment for which subjects is willing to receive treatment in an in-patient setting for at least 2 days.. ABSSSI is defined as one of the following: Wound infection (traumatic or post-surgical): an infection involving skin and subcutaneous tissue, characterized by purulent drainage from a wound with surrounding redness, edema, and/or induration of a minimum surface area of 75 square centimeter (cm\^2) (e.g., the shortest distance of redness, edema, and/or induration extending at least 5 centimeter (cm) from the peripheral margin of the wound); Major cutaneous abscess: an infection characterized by a collection of pus within the dermis or deeper that is accompanied by redness, edema, and/or induration of a minimum surface area of 75 cm\^2 (e.g., the shortest distance of redness, edema, and/or induration extending at least 5 cm from the peripheral margin of the abscess). Cellulitis: a diffuse skin infection characterized by a spreading area of redness, edema, and/or induration of a minimum surface area of 75 cm\^2 Note: For subjects with more than one type of eligible lesion/wound or with multiple lesions of the same type, the investigator must clearly identify the lesion to be evaluated for study purposes. The identified lesion must be consistently chosen for assessment (including digital imaging) throughout the study. Incision and drainage (I&D) of the lesion is permitted prior to the first dose of study medication and will be allowed, per protocol, up to 24 hours after the start of the first dose of study medication. * The subject has at least 1 additional sign or symptom of skin infection: fluctuation, heat/localized warmth, and pain/tenderness. * The subject has at least 1 systemic marker of infection at the time of screening: Lymphadenopathy (proximal to and within the drainage of the wound); Fever (\>=38 degrees Celsius); white blood cells (WBC) elevation (\>10000 /cubic millimetre \[mm\^3\] or \>10% immature neutrophils regardless of WBC count); C-reactive protein \> upper limit of normal (ULN). Note: Systemic markers of infection are not required for subjects \>70 years of age or for known or suspected (based on blood glucose levels) diabetics. * The subject has provided written, dated, informed consent and is willing and able to comply with the study protocol.
Exclusion criteria
* The subject is pregnant or nursing. * The subject has an immune-compromising illness; including known human immunodeficiency virus (HIV) infection or acquired immunodeficiency syndrome (AIDS), organ (including bone marrow) transplant recipients, hematological malignancy, and immunosuppressive therapy, including high-dose corticosteroids (e.g., greater than 40mg prednisone or equivalent per day for greater than two weeks). * Body mass index (BMI)\>= 40.0 kilogram per square meter. * The subject has a serious underlying disease that could be imminently life-threatening, or is unlikely to survive for the duration of the study period. * The subject has a medical condition or requires medication that may be aggravated by inhibition of acetylcholinesterase, such as: the subject has poorly controlled asthma or chronic obstructive pulmonary disease at baseline, and, in the opinion, of the investigator is not stable on current therapy; the subject has acute severe pain, uncontrolled with conventional medical management; the subject has active peptic ulcer disease; the subject has parkinson's disease; the subject has myasthenia gravis; the subject has history of seizure disorder requiring medications for control. this does not include a history of childhood febrile seizures; the subject has any evidence of mechanical obstruction of the urinary or digestive tracts. * The subject has had a diagnosis of C. difficile infection (CDI) within 90 days of screening * The subject has history of seizure disorder requiring medications for control. This does not include a history of childhood febrile seizures. * The subject is a chronic abuser of alcohol or illicit substances such that it jeopardizes ability to comply with the protocol * History of sensitivity to any of the study medications, or components thereof or a history of drug or other allergy that, in the opinion of the investigator or Medical Monitor, contraindicates their participation * The subject has a PR Interval \<120 or \>220 millisecond (msec) * Corrected QT interval (QTc) \>450msec or QTc \>480msec for subjects with bundle branch block. Note: The QTc is the QT interval corrected for heart rate according to either Bazett's formula (QTcB), Fridericia's formula (QTcF), or another method, machine or manual overread. The QTc should be based on single or averaged QTc values of triplicate ECGs obtained over a brief recording period. It is essential that the same method for calculating QTc that was used at a subjects baseline visit be used for that subject for all subsequent visits. * The subject has QRS duration \<70 or \>120 msec. * The subject has pre-existing grade II atrioventricular block or higher, history of significant vasovagal and/or syncopal episodes, episodes of symptomatic bradycardia. * The subject has recent acute major blood loss with signs of hemodynamic instability. * The subject has liver function tests: alanine aminotransferase (ALT) \>2x ULN; alkaline phosphatase and bilirubin \>=1.5xULN (isolated bilirubin \>1.5 x ULN is acceptable if bilirubin is fractionated and direct bilirubin \<35%). * The subject has a current or chronic history of liver disease, or known hepatic or biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones). Subjects with stable Hepatitis B and/or Hepatitis C will be eligible if they meet the liver function test criteria in criterion (ALT \>2 × ULN; alkaline phosphatase and bilirubin ≥1.5 × ULN). Note: All subjects will be screened for Hepatitis B surface antigen and Hepatitis C ribonucleic acid (RNA), but these results will not be used to determine subject eligibility or subject continuation in the study after enrollment. * The subject has any skin condition or skin infection listed below: Secondarily infected animal/human bite; Infected burn; Infections of chronic ulcerative lesions (including diabetic foot infections and peripheral vascular disease) that are likely to be polymicrobial in nature, or caused by Gram-negative or anaerobic organisms that are unlikely to have a Gram-positive pathogen as the causative agent, (Note: Subjects with diabetic foot infections or peripheral vascular disease are eligible if they have a qualifying ABSSSI but diabetic foot infections are not eligible lesions for investigation); An underlying skin disease, such as pre-existing eczematous dermatitis, with clinical evidence of secondary infection; Suspected or confirmed osteomyelitis; Suspected or confirmed septic arthritis; Uncomplicated ABSSSI such as simple abscess, impetiginous lesions, superficial cellulitis, furunculosis, carbunculosis, or folliculitis; Infected abdominal wounds unable to be surgically closed; Necrotizing fasciitis, rapidly necrotizing infections, gangrenous processes, or decubitus ulcer; An existing abscess that cannot be drained or a wound requiring significant surgical intervention that cannot be performed within 48 hours of initiation of study treatment; Skin infection known or suspected to be due to fungal, parasitic or viral pathogens; or known or suspected to be due to anaerobic bacterial pathogens or Pseudomonas aeruginosa (including ecthyma gangrenosum), or other Gram negative pathogens as the contributing pathogen; Skin infections complicated by the presence of prosthetic materials that are not to be removed such as central venous catheters, permanent cardiac pacemaker battery packs, or joint replacement prostheses. * The subject has received treatment with a systemic and/or topical antibacterial within 4 days of study entry; EXCEPT for any of following conditions: The subject received a single dose of a short-acting antibacterial (half-life less than 12 hours) drug prior to the first dose of study treatment; The subject has failed a previous ABSSSI regimen (i.e. at least 48 hours of treatment) and has documented lack of microbiological or clinical response to such therapy. A subject enrolled as a failure of a previous antibacterial treatment regimen must EITHER: Show worsening or lack of improvement or worsening in signs and symptoms of infection, including continued or worsening purulence, erythema with or without induration, fluctuation, heat/localized warmth, and pain/tenderness and/or continued or worsening systemic markers of infection OR show microbiological evidence of failure; The subject recently completed a treatment course with an antibacterial drug for an infection other than ABSSSI and the drug does not have antibacterial activity against bacterial pathogens that cause ABSSSI. (Note: topical antiseptics, chorhexidine, and alcohol and soaps for wound care are permitted). For the purposes of these criteria, the information may be obtained via a verbal interview with the subject or from the subject's medical records; information obtained via a verbal interview must be recorded in the subject's medical record. * The subject has known or suspected severe impairment of renal function, including a calculated creatinine clearance (as calculated using the Cockroft-Gault method) of less than 30 millilitre per minute; requirement for peritoneal dialysis, hemodialysis, or hemofiltration; or oliguria (less than 20 millilitre urine output per hour over 24 hours). * The subject has known or suspected chronic neutropenia due to suppression of neutrophil production, or is anticipated to develop neutropenia during the course of the study (ie. new chemotherapy subject), with absolute neutrophil count less than 1000 cells/mm\^3 (subjects with neutrophil counts as low as 500 cell/mm\^3 are eligible if the reduction is due entirely to the acute infectious process). * The subject has been previously enrolled in this study, or has previously been treated with GSK2140944. * The subject has participated in a clinical trial and has received an investigational product within 30 days or 5 half-lives, whichever is longer
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Composite of the Cure Rate as Measured by Clinical Response and Outcome at the Early Efficacy Visit Combined With Withdrawal Rate | Up to Day 3 | Cure rate and withdrawal rate data points was jointly assessed in a composite endpoint for all participants who received at least one dose of GSK2140944. Cure rate was defined as the percentage of participants exhibiting clinical improvement (=\>20% reduction in overall lesion area) at the early efficacy visit. Withdrawal rate was defined as the percentage of participants who withdrew from study treatment due to a drug-related adverse event (AE) at any point while on treatment. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Clinical Response and Outcome at the Post Therapy Visit (Day 12-18) | Day 12 to Day 18 | The assessment was used to determine whether to continue the participant in the study. Clinical response was assessed as either a clinical success or a clinical failure and the clinical outcome was subsequently determined programmatically, based on the clinical response. Clinical success was defined as a reduction in the total surface area of the lesion (as calculated by digital imaging) of \>=20% compared to Baseline and no administration of additional antibacterial therapy for the lesion under study. Clinical failure was defined as death of participant; increase or insufficient decrease (i.e., \<20%) in the area (as calculated by digital imaging) of the lesion or administration of non-trial antibacterial drug therapy for treatment of the lesion under study before the primary efficacy endpoint assessment. In addition when the participant refused to consent to clinical examination, the clinical outcome was assessed as unable to determine with subsequent response as failure. |
| Number of Participants With Clinical Response and Outcome at the Final Follow up Visit (Day 21-28) | Day 21 to Day 28 | The assessment was used to determine whether to continue the participant in the study. Clinical response was assessed as either a clinical success or a clinical failure and the clinical outcome was subsequently determined programmatically, based on the clinical response. Clinical success was defined as no increase in the total surface area of the lesion (as calculated by digital imaging) compared to post therapy visit and no further administration of antibacterial therapy for the lesion under study. Clinical recurrence was defined as death of participant; increase in the area of the lesion compared to post therapy visit or administration of additional antibacterial therapy for the lesion under study before the efficacy endpoint assessment for participants who were a clinical success at post therapy visit. In addition when the participant refused to consent to clinical examination, the clinical outcome was assessed as unable to determine with subsequent response as failure. |
| Number of Pathogens With Microbiological Response and Outcome at Early Efficacy Visit for Staphylococcus Aureus (SA) Pathogen in Lesion Sample | Up to Day 3 | The microbiological outcome was determined by comparing Baseline bacteriology lesion sample, to the culture results at early efficacy visit. The corresponding microbiological response (success or failure) by participant was then assigned. Microbiological eradication or persistence was defined as culture documented elimination or presence of Baseline pathogens from a bacteriology specimen taken at early efficacy visit respectively. Participant was considered to have outcome of presumed microbiological eradication or persistence when the participant was a clinical success or clinical failure and no bacteriological specimen was obtained at early efficacy visit respectively. When the determination of Baseline pathogen microbiological response could not be made, the outcome was considered as unable to determine. The data for SA in lesion sample has been presented. |
| Number of Pathogens With Microbiological Response and Outcome at Early Efficacy Visit for Methicillin-resistant Staphylococcus Aureus (MRSA) in Lesion Sample | Day 3 | The microbiological outcome was determined by comparing Baseline bacteriology lesion sample, to the culture results at early efficacy visit. The corresponding microbiological response (success or failure) by participant was then assigned. Microbiological eradication or persistence was defined as culture documented elimination or presence of Baseline pathogens from a bacteriology specimen taken at early efficacy visit respectively. Participant was considered to have outcome of presumed microbiological eradication or persistence when the participant was a clinical success or clinical failure and no bacteriological specimen was obtained at early efficacy visit respectively. When the determination of Baseline pathogen microbiological response could not be made, the outcome was considered as unable to determine. The data for MRSA in lesion sample has been presented. |
| Number of Pathogens With Microbiological Response and Outcome at Early Efficacy Visit for Methicillin-susceptible Staphylococcus Aureus (MSSA) in Lesion Sample | Up to Day 3 | The microbiological outcome was determined by comparing Baseline bacteriology lesion sample, to the culture results at early efficacy visit. The corresponding microbiological response (success or failure) by participant was then assigned. Microbiological eradication or persistence was defined as culture documented elimination or presence of Baseline pathogens from a bacteriology specimen taken at early efficacy visit respectively. Participant was considered to have outcome of presumed microbiological eradication or persistence when the participant was a clinical success or clinical failure and no bacteriological specimen was obtained at early efficacy visit respectively. When the determination of Baseline pathogen microbiological response could not be made, the outcome was considered as unable to determine. The data for MSSA in lesion sample has been presented. |
| Number of Pathogens With Microbiological Response and Outcome at Early Efficacy Visit for Other Gram-positive Aerobic Pathogens in Lesion Sample | Up to Day 3 | The microbiological outcome was determined by comparing Baseline bacteriology lesion sample, to the culture results at early efficacy visit. The corresponding microbiological response (success or failure) by participant was then assigned. Microbiological eradication or persistence was defined as culture documented elimination or presence of Baseline pathogens from a bacteriology specimen taken at early efficacy visit respectively. Participant was considered to have outcome of presumed microbiological eradication or persistence when the participant was a clinical success or clinical failure and no bacteriological specimen was obtained at early efficacy visit respectively. When the determination of Baseline pathogen microbiological response could not be made, the outcome was considered as unable to determine. The data for other Gram-positive aerobic pathogens in lesion sample has been presented. |
| Number of Pathogens With Microbiological Response and Outcome at Early Efficacy Visit for All Gram-positive Aerobic Pathogens in Lesion Sample | Up to Day 3 | The microbiological outcome was determined by comparing Baseline bacteriology lesion sample, to the culture results at early efficacy visit. The corresponding microbiological response (success or failure) by participant was then assigned. Microbiological eradication or persistence was defined as culture documented elimination or presence of Baseline pathogens from a bacteriology specimen taken at early efficacy visit respectively. Participant was considered to have outcome of presumed microbiological eradication or persistence when the participant was a clinical success or clinical failure and no bacteriological specimen was obtained at early efficacy visit respectively. When the determination of Baseline pathogen microbiological response could not be made, the outcome was considered as unable to determine. The data for all Gram-positive aerobic pathogens in lesion sample has been presented. |
| Change From Baseline in Respiratory Rate | Baseline (Day 1) up to Day 28 | Respiratory rate was measured with the participant in a supine or semi-supine position, having rested in that position for at least 10 minutes. Baseline was defined at Day 1. Change from Baseline was calculated by subtracting the post-Baseline value from Baseline value. |
| Number of Pathogens With Microbiological Response and Outcome at Early Efficacy Visit for SA, MRSA and All Gram-positive Aerobic Pathogens in Blood Sample | Up to Day 3 | The microbiological outcome was determined by comparing Baseline bacteriology blood culture, to the culture results at early efficacy visit. The corresponding microbiological response (success or failure) by participant was then assigned. Microbiological eradication or persistence was defined as culture documented elimination or presence of Baseline pathogens from a bacteriology specimen taken at early efficacy visit respectively. Participant was considered to have outcome of presumed microbiological eradication or persistence when the participant was a clinical success or clinical failure and no bacteriological specimen was obtained at early efficacy visit respectively. When the determination of Baseline pathogen microbiological response could not be made, the outcome was considered as unable to determine. The data for SA, MRSA and all Gram-positive aerobic pathogens in blood sample has been presented. |
| Number of Pathogens With Microbiological Response and Outcome at Post Therapy Visit for SA Pathogen in Lesion Sample | Day 12 to Day 18 | Microbiological outcome was determined by comparing Baseline lesion sample, to culture results at post therapy visit. Corresponding response (success or failure) was then assigned. Microbiological eradication or persistence was culture documented elimination or presence of Baseline pathogens from a specimen taken at post therapy visit respectively. Presence of pathogens which was presumed to be eradicated at early efficacy visit was microbiological recurrence. Presumed microbiological eradication or persistence was when there was a clinical success or failure and no bacteriological specimen was obtained at post therapy respectively. Presumed microbiological recurrence was when there was a clinical failure and no bacteriological specimen was obtained at post therapy visit for pathogens presumed eradicated at early efficacy visit. When the determination of Baseline pathogen response could not be made, the outcome was unable to determine. Data for SA in lesion sample has been presented. |
| Number of Pathogens With Microbiological Response and Outcome at Post Therapy Visit for MRSA in Lesion Sample | Day 12 to Day 18 | Microbiological outcome was determined by comparing Baseline lesion sample, to culture results at post therapy visit. Corresponding response (success or failure) was then assigned. Microbiological eradication or persistence was culture documented elimination or presence of Baseline pathogens from a specimen taken at post therapy visit respectively. Presence of pathogens which was presumed to be eradicated at early efficacy visit was microbiological recurrence. Presumed microbiological eradication or persistence was when there was a clinical success or failure and no bacteriological specimen was obtained post therapy respectively. Presumed microbiological recurrence was when there was a clinical failure and no bacteriological specimen was obtained at post therapy visit for pathogens presumed eradicated at early efficacy visit. When the determination of Baseline pathogen response could not be made, the outcome was unable to determine. Data for MRSA in lesion sample has been presented. |
| Number of Pathogens With Microbiological Response and Outcome at Post Therapy Visit for MSSA in Lesion Sample | Day 12 to Day 18 | Microbiological outcome was determined by comparing Baseline lesion sample, to culture results at post therapy visit. Corresponding response (success or failure) was then assigned. Microbiological eradication or persistence was culture documented elimination or presence of Baseline pathogens from a specimen taken at post therapy visit respectively. Presence of pathogens which was presumed to be eradicated at early efficacy visit was microbiological recurrence. Presumed microbiological eradication or persistence was when there was a clinical success or failure and no bacteriological specimen was obtained post therapy respectively. Presumed microbiological recurrence was when there was a clinical failure and no bacteriological specimen was obtained at post therapy visit for pathogens presumed eradicated at early efficacy visit. When the determination of Baseline pathogen response could not be made, the outcome was unable to determine. Data for MSSA in lesion sample has been presented. |
| Number of Pathogens With Microbiological Response and Outcome at Post Therapy Visit for Other Gram-positive Aerobic Pathogens in Lesion Sample | Day 12 to Day 18 | Microbiological outcome was determined by comparing Baseline lesion sample, to culture results at post therapy visit. Corresponding response (success or failure) was then assigned. Microbiological eradication or persistence was culture documented elimination or presence of Baseline pathogens from a specimen taken at post therapy visit respectively. Presence of pathogens which was presumed to be eradicated at early efficacy visit was microbiological recurrence. Presumed microbiological eradication or persistence was when there was a clinical success or failure and no bacteriological specimen was obtained post therapy respectively. Presumed microbiological recurrence was when there was a clinical failure and no bacteriological specimen was obtained at post therapy visit for pathogens presumed eradicated at early efficacy visit. When the determination of Baseline pathogen response could not be made, the outcome was unable to determine. |
| Number of Pathogens With Microbiological Response and Outcome at Post Therapy Visit for All Gram-positive Aerobic Pathogens in Lesion Sample | Day 12 to Day 18 | Microbiological outcome was determined by comparing Baseline lesion sample, to culture results at post therapy visit. Corresponding response (success or failure) was then assigned. Microbiological eradication or persistence was culture documented elimination or presence of Baseline pathogens from a specimen taken at post therapy visit respectively. Presence of pathogens which was presumed to be eradicated at early efficacy visit was microbiological recurrence. Presumed microbiological eradication or persistence was when there was a clinical success or failure and no bacteriological specimen was obtained post therapy respectively. Presumed microbiological recurrence was when there was a clinical failure and no bacteriological specimen was obtained at post therapy visit for pathogens presumed eradicated at early efficacy visit. When the determination of Baseline pathogen response could not be made, the outcome was unable to determine. |
| Number of Pathogens With Microbiological Response and Outcome at Post Therapy Visit for SA, MRSA and All Gram-positive Aerobic Pathogens in Blood Sample | Day 12 to Day 18 | Microbiological outcome was determined by comparing Baseline lesion sample, to culture results at post therapy visit. Corresponding response (success or failure) was then assigned. Microbiological eradication or persistence was culture documented elimination or presence of Baseline pathogens from a specimen taken at post therapy visit respectively. Presence of pathogens which was presumed to be eradicated at early efficacy visit was microbiological recurrence. Presumed microbiological eradication or persistence was when there was a clinical success or failure and no bacteriological specimen was obtained post therapy respectively. Presumed microbiological recurrence was when there was a clinical failure and no bacteriological specimen was obtained at post therapy visit for pathogens presumed eradicated at early efficacy visit. When the determination of Baseline pathogen response could not be made, the outcome was unable to determine. |
| Pharmacokinetic (PK) Parameters (From GSK2140944 Plasma Concentration-time Data): Maximum Observed Concentration (Cmax) on IV Therapy | Predose, 1, 2, 2.5, 3, 6, 12 hours post dose on Day 1 to 3 | Samples for assessment of PK parameter Cmax was done on at predose, 1, 2, 2.5, 3, 6, 12 hours post dose on Day 1 to 3. The first occurrence of the Cmax was determined directly from the raw concentration-time data. Data for participants while on IV therapy has been presented. |
| Number of Pathogens With Microbiological Response and Outcome at Follow up Visit for SA Pathogen in Lesion Sample | Day 21 to Day 28 | Microbiological outcome was determined by comparing Baseline lesion sample, to culture results at final follow up visit. Corresponding response (success or failure) was then assigned. Microbiological eradication was culture documented elimination of Baseline pathogens from a bacteriology specimen taken at final follow up visit. Presumed microbiological eradication was when there was a clinical success and no bacteriological specimen was obtained at final follow up visit. Culture documented presence of Baseline pathogens in a bacteriology specimen taken at final follow up visit was microbiological recurrence. Presumed microbiological recurrence was when there was a clinical failure and no bacteriological specimen was obtained at final follow up visit. When the determination of Baseline pathogen response could not be made, the outcome was unable to determine. Data for SA pathogen in lesion sample has been presented. |
| Number of Pathogens With Microbiological Response and Outcome at Follow up Visit for MRSA in Lesion Sample | Day 21 to Day 28 | Microbiological outcome was determined by comparing Baseline lesion sample, to culture results at final follow up visit. Corresponding response (success or failure) was then assigned. Microbiological eradication was culture documented elimination of Baseline pathogens from a bacteriology specimen taken at final follow up visit. Presumed microbiological eradication was when there was a clinical success and no bacteriological specimen was obtained at final follow up visit. Culture documented presence of Baseline pathogens in a bacteriology specimen taken at final follow up visit was microbiological recurrence. Presumed microbiological recurrence was when there was a clinical failure and no bacteriological specimen was obtained at final follow up visit. When the determination of Baseline pathogen response could not be made, the outcome was unable to determine. Data for MRSA pathogen in lesion sample has been presented. |
| Number of Pathogens With Microbiological Response and Outcome at Follow up Visit for MSSA in Lesion Sample | Day 21 to Day 28 | Microbiological outcome was determined by comparing Baseline lesion sample, to culture results at final follow up visit. Corresponding response (success or failure) was then assigned. Microbiological eradication was culture documented elimination of Baseline pathogens from a bacteriology specimen taken at final follow up visit. Presumed microbiological eradication was when there was a clinical success and no bacteriological specimen was obtained at final follow up visit. Culture documented presence of Baseline pathogens in a bacteriology specimen taken at final follow up visit was microbiological recurrence. Presumed microbiological recurrence was when there was a clinical failure and no bacteriological specimen was obtained at final follow up visit. When the determination of Baseline pathogen response could not be made, the outcome was unable to determine. Data for MSSA pathogen in lesion sample has been presented. |
| Number of Pathogens With Microbiological Response and Outcome at Follow up Visit for Other Gram-positive Aerobic Pathogens in Lesion Sample | Day 21 to Day 28 | Microbiological outcome was determined by comparing Baseline lesion sample, to culture results at final follow up visit. Corresponding response (success or failure) was then assigned. Microbiological eradication was culture documented elimination of Baseline pathogens from a bacteriology specimen taken at final follow up visit. Presumed microbiological eradication was when there was a clinical success and no bacteriological specimen was obtained at final follow up visit. Culture documented presence of Baseline pathogens in a bacteriology specimen taken at final follow up visit was microbiological recurrence. Presumed microbiological recurrence was when there was a clinical failure and no bacteriological specimen was obtained at final follow up visit. When the determination of Baseline pathogen response could not be made, the outcome was unable to determine. Data for other Gram-positive aerobic pathogens in lesion sample has been presented. |
| Number of Pathogens With Microbiological Response and Outcome at Follow up Visit for All Gram-positive Aerobic Pathogens in Lesion Sample | Day 21 to Day 28 | Microbiological outcome was determined by comparing Baseline lesion sample, to culture results at final follow up visit. Corresponding response (success or failure) was then assigned. Microbiological eradication was culture documented elimination of Baseline pathogens from a bacteriology specimen taken at final follow up visit. Presumed microbiological eradication was when there was a clinical success and no bacteriological specimen was obtained at final follow up visit. Culture documented presence of Baseline pathogens in a bacteriology specimen taken at final follow up visit was microbiological recurrence. Presumed microbiological recurrence was when there was a clinical failure and no bacteriological specimen was obtained at final follow up visit. When the determination of Baseline pathogen response could not be made, the outcome was unable to determine. Data for all Gram-positive aerobic pathogens in lesion sample has been presented. |
| Number of Pathogens With Microbiological Response and Outcome at Follow up Visit for SA, MRSA and All Gram-positive Aerobic Pathogens in Blood Sample | Day 21 to Day 28 | Microbiological outcome was determined by comparing Baseline blood culture, to culture results at final follow up visit. Corresponding response (success or failure) was then assigned. Microbiological eradication was culture documented elimination of Baseline pathogens from a bacteriology specimen taken at final follow up visit. Presumed microbiological eradication was when there was a clinical success and no bacteriological specimen was obtained at final follow up visit. Culture documented presence of Baseline pathogens in a bacteriology specimen taken at final follow up visit was microbiological recurrence. Presumed microbiological recurrence was when there was a clinical failure and no bacteriological specimen was obtained at final follow up visit. When the determination of Baseline pathogen response could not be made, the outcome was unable to determine. Data for SA, MRSA and all Gram-positive aerobic pathogens in lesion sample has been presented. |
| PK Parameters (From GSK2140944 Plasma Concentration-time Data): Cmax on Oral Dose Therapy | Predose, 1, 2, 3 hours after first orally administered drug and Day 7 to 10 (predose) | Samples for assessment of PK parameter Cmax was done at Predose, 1, 2, 3 hours after first orally administered drug and one predose time point anytime from Day 7 to 10. The first occurrence of the Cmax was determined directly from the raw concentration-time data. Data for participants while on oral dose therapy has been presented. |
| PK Parameters (From GSK2140944 Plasma Concentration-time Data): Time to Cmax (Tmax) on IV Therapy | Predose, 1, 2, 2.5, 3, 6, 12 hours post dose on Day 1 to 3 | Samples for assessment of PK parameter tmax was done at predose, 1, 2, 2.5, 3, 6, 12 hours post dose on Day 1 to 3. The time at which Cmax was observed was determined directly from the raw concentration-time data. Data for participants while on IV therapy has been presented. |
| PK Parameters (From GSK2140944 Plasma Concentration-time Data): Tmax on Oral Dose Therapy | Predose, 1, 2, 3 hours after first orally administered drug and Day 7 to 10 (predose) | Samples for assessment of PK parameter tmax was done at Predose, 1, 2, 3 hours after first orally administered drug and one predose time point anytime from Day 7 to 10. The time at which Cmax was observed was determined directly from the raw concentration-time data. Data for participants while on oral dose therapy has been presented. |
| PK Parameters (From GSK2140944 Plasma Concentration-time Data): Area Under the Concentration-time Curve From Time Zero (Pre-dose) to Time of the Last Quantifiable Concentration [AUC (0-t)] and AUC Over the Dosing Interval [AUC(0-tau)] on IV Therapy | Predose, 1, 2, 2.5, 3, 6, 12 hours post dose on Day 1 to 3 | Samples for assessment of PK parameters AUClast and AUC0-tau was done at predose, 1, 2, 2.5, 3, 6, 12 hours post dose on Day 1 to 3. The AUC 0-t and AUC0-tau was determined using the linear trapezoidal rule for increasing concentrations and the logarithmic trapezoidal rule for decreasing concentrations. Data for participants while on IV therapy has been presented. |
| PK Parameters (From GSK2140944 Plasma Concentration-time Data): AUC (0-t) and AUC(0-tau) on Oral Dose Therapy | Predose, 1, 2, 3 hours after first orally administered drug and Day 7 to 10 (predose) | Samples for assessment of PK parameters AUClast and AUC0-tau was done at predose, 1, 2, 3 hours after first orally administered drug and one predose time point anytime from Day 7 to 10. The AUC 0-t and AUC0-tau was determined using the linear trapezoidal rule for increasing concentrations and the logarithmic trapezoidal rule for decreasing concentrations. Data for participants while on oral dose therapy has been presented. |
| Number of Participants Demonstrating a Decrease in GSK2140944 Susceptibility When Comparing Isolates Recovered From Baseline With Those From Any Time Post-Baseline Skin Specimens | Up to Day 28 | Reduction in susceptibility was defined as a \>=4-fold increase in minimum inhibitory concentration (MIC) or \>=6 millimeter decrease in zone size between an isolate obtained at Baseline and the same pathogen at subsequent visits. |
| Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | Up to Day 28 | An AE is 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 AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. An SAE is 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, medically significant or all events of possible drug-induced liver injury with hyperbilirubinemia. |
| Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | Baseline (Day 1) up to Day 28 | SBP and DBP was measured with the participant in a supine or semi-supine position, having rested in that position for at least 10 minutes. Baseline was defined at Day 1. Change from Baseline was calculated by subtracting the post-Baseline value from Baseline value. |
| Change From Baseline in Pulse Rate | Baseline (Day 1) up to Day 28 | Pulse rate was measured with the participant in a supine or semi-supine position, having rested in that position for at least 10 minutes. Baseline was defined at Day 1. Change from Baseline was calculated by subtracting the post-Baseline value from Baseline value. |
| Change From Baseline in Vital Sign: Body Temperature | Baseline (Day 1) up to Day 28 | Body temperature was measured with the participant in a supine or semi-supine position, having rested in that position for at least 10 minutes. Baseline was defined at Day 1. Change from Baseline was calculated by subtracting the post-Baseline value from Baseline value. |
| Number of Participants With Maximum Post-Baseline Electrocardiogram (ECG) Readings | Up to Day 28 | The 12-lead ECGs was obtained at Day 1, Day 2, Day 7 to 10, Day 12 to 21 and Day 21 to Day 28 for corrected QT, using Fridericia formula (QTcF), corrected QT using Bazett's formula (QTcB) and QRS intervals. The number of participants with maximum post-baseline ECG value exceeding the following limits have been reported: QTcB/QTcF interval \> 450 and ≤ 480 millisecond (msec), QTcB/QTcF interval \> 480 and ≤ 500 msec, QTcB/QTcF interval \> 500 msec, QRS interval \< 70 msec and QRS interval \> 120 msec. |
| Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Follicle Stimulating Hormone (FSH) and Gamma Glutamyl Transferase (GGT) | Baseline (Day 1) up to Day 28 | Blood samples for assessment of clinical chemistry parameters of ALT, ALP, AST, FSH and GGT was collected at Baseline (Day 1), Day 2, Day 7 to 10, Day 12 to 21 and Day 21 to Day 28. Baseline was defined at Day 1. Change from Baseline was calculated by subtracting the post-Baseline value from Baseline value. |
| Change From Baseline in Clinical Chemistry Parameters: Albumin and Protein | Baseline (Day 1) up to Day 28 | Blood samples for assessment of clinical chemistry parameters of albumin and total protein was collected at Baseline (Day 1), Day 2, Day 7 to 10, Day 12 to 21 and Day 21 to Day 28. Baseline was defined at Day 1. Change from Baseline was calculated by subtracting the post-Baseline value from Baseline value. |
| Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Urate | Baseline (Day 1) up to Day 28 | Blood samples for assessment of clinical chemistry parameters of bilirubin, creatinine, direct bilirubin and urate was collected at Baseline (Day 1), Day 2, Day 7 to 10, Day 12 to 21 and Day 21 to Day 28. Baseline was defined at Day 1. Change from Baseline was calculated by subtracting the post-Baseline value from Baseline value. |
| Change From Baseline in Clinical Chemistry Parameters: Calcium, Carbon Dioxide, Chloride, Glucose, Magnesium, Potassium, Sodium and Urea | Baseline (Day 1) up to Day 28 | Blood samples for assessment of clinical chemistry parameters of calcium, carbon dioxide, chloride, glucose, magnesium, potassium, sodium and urea was collected at Baseline (Day 1), Day 2, Day 7 to 10, Day 12 to 21 and Day 21 to Day 28. Baseline was defined at Day 1. Change from Baseline was calculated by subtracting the post-Baseline value from Baseline value. |
| Change From Baseline in Clinical Chemistry Parameters: Creatinine Clearance, Estimated | Baseline (Day 1) up to Day 28 | Blood samples for assessment of clinical chemistry parameter of estimated creatinine clearance was collected at Baseline (Day 1), Day 2, Day 7 to 10, Day 12 to 21 and Day 21 to Day 28. Baseline was defined at Day 1. Change from Baseline was calculated by subtracting the post-Baseline value from Baseline value. |
| Estradiol Values at Baseline | Baseline (Day 1) | Blood samples for assessment of clinical chemistry parameter of estradiol was collected at Baseline (Day 1). No post-baseline values were reported. |
| Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets | Baseline (Day 1) up to Day 28 | Blood samples for assessment of hematology parameters of basophils, eosinophils, leukocytes, lymphocytes, monocytes, neutrophils and platelets was collected at Baseline (Day 1), Day 2, Day 7 to 10, Day 12 to 21 and Day 21 to Day 28. Baseline was defined at Day 1. Change from Baseline was calculated by subtracting the post-Baseline value from Baseline value. |
| Number of Participants With Clinical Response and Outcome at Early Efficacy Visit | Up to Day 3 | The assessment was used to determine whether to continue the participant in the study. Clinical response was assessed as either a clinical success or a clinical failure and the clinical outcome was subsequently determined programmatically, based on the clinical response. Clinical success was defined as a reduction in the total surface area of the lesion (as calculated by digital imaging) of \>=20% compared to Baseline and no administration of additional antibacterial therapy for the lesion under study. Clinical failure was defined as death of participant; increase or insufficient decrease (i.e., \<20%) in the area (as calculated by digital imaging) of the lesion or administration of non-trial antibacterial drug therapy for treatment of the lesion under study before the primary efficacy endpoint assessment. In addition when the participant refused to consent to clinical examination, the clinical outcome was assessed as unable to determine with subsequent response as failure. |
| Change From Baseline in Hematology Parameters: Erythrocyte Mean Corpuscular Hemoglobin (EMCH) | Baseline (Day 1) up to Day 28 | Blood samples for assessment of hematology parameter of EMCH was collected at Baseline (Day 1), Day 2, Day 7 to 10, Day 12 to 21 and Day 21 to Day 28. Baseline was defined at Day 1. Change from Baseline was calculated by subtracting the post-Baseline value from Baseline value. |
| Change From Baseline in Hematology Parameters: Erythrocyte Mean Corpuscular Volume (EMCV) | Baseline (Day 1) up to Day 28 | Blood samples for assessment of hematology parameter of EMCV was collected at Baseline (Day 1), Day 2, Day 7 to 10, Day 12 to 21 and Day 21 to Day 28. Baseline was defined at Day 1. Change from Baseline was calculated by subtracting the post-Baseline value from Baseline value. |
| Change From Baseline in Hematology Parameters: Erythrocytes | Baseline (Day 1) up to Day 28 | Blood samples for assessment of hematology parameter of erythrocyte was collected at Baseline (Day 1), Day 2, Day 7 to 10, Day 12 to 21 and Day 21 to Day 28. Baseline was defined at Day 1. Change from Baseline was calculated by subtracting the post-Baseline value from Baseline value. |
| Change From Baseline in Hematology Parameters: Hematocrit | Baseline (Day 1) up to Day 28 | Blood samples for assessment of hematology parameter of hematocrit was collected at Baseline (Day 1), Day 2, Day 7 to 10, Day 12 to 21 and Day 21 to Day 28. Baseline was defined at Day 1. Change from Baseline was calculated by subtracting the post-Baseline value from Baseline value. |
| Number of Participants With Abnormal Urinalysis Dipstick Results | Up to day 28 | Samples for urinalysis assessment was collected at Baseline (Day 1), Day 2, Day 7 to 10, Day 12 to 21 and Day 21 to Day 28 for Glucose, Ketones, Occult Blood, Protein and pH. Participants with abnormal urinalysis result was reported. |
| Change From Baseline in Hematology Parameters: Erythrocyte Mean Corpuscular Hemoglobin Concentration (EMCHC) and Hemoglobin | Baseline (Day 1) up to Day 28 | Blood samples for assessment of hematology parameters of EMCHC and hemoglobin was collected at Baseline (Day 1), Day 2, Day 7 to 10, Day 12 to 21 and Day 21 to Day 28. Baseline was defined at Day 1. Change from Baseline was calculated by subtracting the post-Baseline value from Baseline value. |
Countries
United States
Participant flow
Recruitment details
This study was conducted at 13 centers in the United States from 24 March 2014 to 22 July 2015.
Pre-assignment details
A total of 126 participants were randomly assigned to study treatment (all randomized population). A total of 122 participants, who received study treatment, were included in the Modified Intent-to-Treat population (mITT) and safety populations. The mITT population is used in overall study numbers and demographic information.
Participants by arm
| Arm | Count |
|---|---|
| Gepotidacin 750 mg q12h Participants received GSK2140944 750 mg IV every 12 hours (q12h; BID) on Day 1 and Day 2. Participants switched to oral GSK2140944 1500 mg q12h (BID) at investigator's discretion or continued to receive GSK2140944 750 mg IV q12h (BID) from Day 3 to Day 10. | 58 |
| Gepotidacin 1000 mg q12h Participants received GSK2140944 1000 mg IV q12h (BID) on Day 1 and Day 2. Participants switched to oral GSK2140944 2000 mg q12h (BID) at investigator's discretion or continued to receive GSK2140944 1000 mg IV q12h (BID) from Day 3 to Day 10. | 39 |
| Gepotidacin 1000 mg q8h Participants received GSK21409447 1000 mg IV q8h TID on Day 1 and Day 2. Participants switched to oral GSK2140944 2000 mg q12h TID at investigator's discretion or continued to receive GSK2140944 1000 mg IV q8h TID from Day 3 to Day 10. | 25 |
| Total | 122 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Adverse Event | 3 | 1 | 0 |
| Overall Study | Lack of Efficacy | 1 | 0 | 0 |
| Overall Study | Lost to Follow-up | 2 | 3 | 1 |
| Overall Study | Physician Decision | 0 | 1 | 0 |
| Overall Study | Withdrawal by Subject | 1 | 2 | 0 |
Baseline characteristics
| Characteristic | Gepotidacin 750 mg q12h | Gepotidacin 1000 mg q12h | Gepotidacin 1000 mg q8h | Total |
|---|---|---|---|---|
| Age, Continuous | 44.3 Years STANDARD_DEVIATION 11.35 | 44.6 Years STANDARD_DEVIATION 10.76 | 45.8 Years STANDARD_DEVIATION 12.64 | 44.7 Years STANDARD_DEVIATION 11.36 |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants | 1 Participants | 0 Participants | 2 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants | 2 Participants | 0 Participants | 3 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 1 Participants | 0 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 55 Participants | 36 Participants | 24 Participants | 115 Participants |
| Sex: Female, Male Female | 18 Participants | 12 Participants | 5 Participants | 35 Participants |
| Sex: Female, Male Male | 40 Participants | 27 Participants | 20 Participants | 87 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 58 | 1 / 39 | 0 / 25 |
| other Total, other adverse events | 30 / 58 | 20 / 39 | 14 / 25 |
| serious Total, serious adverse events | 1 / 58 | 1 / 39 | 0 / 25 |
Outcome results
Primary
Number of Participants With Composite of the Cure Rate as Measured by Clinical Response and Outcome at the Early Efficacy Visit Combined With Withdrawal Rate
Cure rate and withdrawal rate data points was jointly assessed in a composite endpoint for all participants who received at least one dose of GSK2140944. Cure rate was defined as the percentage of participants exhibiting clinical improvement (=\>20% reduction in overall lesion area) at the early efficacy visit. Withdrawal rate was defined as the percentage of participants who withdrew from study treatment due to a drug-related adverse event (AE) at any point while on treatment.
Time frame: Up to Day 3
Population: Modified Intent-to-Treat (MITT) population consisted of all randomized participants who received at least one dose of study medication.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Gepotidacin 750 mg q12h | Number of Participants With Composite of the Cure Rate as Measured by Clinical Response and Outcome at the Early Efficacy Visit Combined With Withdrawal Rate | Number Withdrawn | 1 Participants |
| Gepotidacin 750 mg q12h | Number of Participants With Composite of the Cure Rate as Measured by Clinical Response and Outcome at the Early Efficacy Visit Combined With Withdrawal Rate | Number Cured | 48 Participants |
| Gepotidacin 1000 mg q12h | Number of Participants With Composite of the Cure Rate as Measured by Clinical Response and Outcome at the Early Efficacy Visit Combined With Withdrawal Rate | Number Withdrawn | 0 Participants |
| Gepotidacin 1000 mg q12h | Number of Participants With Composite of the Cure Rate as Measured by Clinical Response and Outcome at the Early Efficacy Visit Combined With Withdrawal Rate | Number Cured | 28 Participants |
| Gepotidacin 1000 mg q8h | Number of Participants With Composite of the Cure Rate as Measured by Clinical Response and Outcome at the Early Efficacy Visit Combined With Withdrawal Rate | Number Withdrawn | 0 Participants |
| Gepotidacin 1000 mg q8h | Number of Participants With Composite of the Cure Rate as Measured by Clinical Response and Outcome at the Early Efficacy Visit Combined With Withdrawal Rate | Number Cured | 23 Participants |
Secondary
Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Follicle Stimulating Hormone (FSH) and Gamma Glutamyl Transferase (GGT)
Blood samples for assessment of clinical chemistry parameters of ALT, ALP, AST, FSH and GGT was collected at Baseline (Day 1), Day 2, Day 7 to 10, Day 12 to 21 and Day 21 to Day 28. Baseline was defined at Day 1. Change from Baseline was calculated by subtracting the post-Baseline value from Baseline value.
Time frame: Baseline (Day 1) up to Day 28
Population: Safety population. Data for only those participants available at the indicated time points were collected and analyzed. Data points with null value for participants analyzed indicate data not collected for respective category and treatment arm.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Gepotidacin 750 mg q12h | Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Follicle Stimulating Hormone (FSH) and Gamma Glutamyl Transferase (GGT) | ALT, ON IV TREATMENT/DAY 3 | 1.2 International units per liter | Standard Deviation 14.63 |
| Gepotidacin 750 mg q12h | Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Follicle Stimulating Hormone (FSH) and Gamma Glutamyl Transferase (GGT) | GGT, ON IV TREATMENT/DAY 7 | 25.5 International units per liter | Standard Deviation 0.71 |
| Gepotidacin 750 mg q12h | Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Follicle Stimulating Hormone (FSH) and Gamma Glutamyl Transferase (GGT) | ALP, ON IV TREATMENT/DAY 3 | 1.8 International units per liter | Standard Deviation 18.97 |
| Gepotidacin 750 mg q12h | Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Follicle Stimulating Hormone (FSH) and Gamma Glutamyl Transferase (GGT) | AST, POST DOSE DAY 3-10 | 9.0 International units per liter | — |
| Gepotidacin 750 mg q12h | Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Follicle Stimulating Hormone (FSH) and Gamma Glutamyl Transferase (GGT) | GGT, POST THERAPY DAY 12-18 | 3.0 International units per liter | Standard Deviation 15.6 |
| Gepotidacin 750 mg q12h | Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Follicle Stimulating Hormone (FSH) and Gamma Glutamyl Transferase (GGT) | ALT, ON IV TREATMENT/DAY 5 | 9.3 International units per liter | Standard Deviation 18.27 |
| Gepotidacin 750 mg q12h | Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Follicle Stimulating Hormone (FSH) and Gamma Glutamyl Transferase (GGT) | AST, FOLLOW UP DAY 21-28 | 16.2 International units per liter | Standard Deviation 22.15 |
| Gepotidacin 750 mg q12h | Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Follicle Stimulating Hormone (FSH) and Gamma Glutamyl Transferase (GGT) | ALP, ORAL - DAY 7-10 | 3.8 International units per liter | Standard Deviation 13.21 |
| Gepotidacin 750 mg q12h | Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Follicle Stimulating Hormone (FSH) and Gamma Glutamyl Transferase (GGT) | ALP, POST THERAPY DAY 12-18 | -0.8 International units per liter | Standard Deviation 15.97 |
| Gepotidacin 750 mg q12h | Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Follicle Stimulating Hormone (FSH) and Gamma Glutamyl Transferase (GGT) | GGT, ON IV TREATMENT/DAY 5 | 3.3 International units per liter | Standard Deviation 21.7 |
| Gepotidacin 750 mg q12h | Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Follicle Stimulating Hormone (FSH) and Gamma Glutamyl Transferase (GGT) | AST, POST THERAPY DAY 12-18 | 10.9 International units per liter | Standard Deviation 18.98 |
| Gepotidacin 750 mg q12h | Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Follicle Stimulating Hormone (FSH) and Gamma Glutamyl Transferase (GGT) | ALP, POST DOSE DAY 3-10 | 17.0 International units per liter | — |
| Gepotidacin 750 mg q12h | Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Follicle Stimulating Hormone (FSH) and Gamma Glutamyl Transferase (GGT) | ALT, ON IV TREATMENT/DAY 7 | 37.5 International units per liter | Standard Deviation 19.09 |
| Gepotidacin 750 mg q12h | Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Follicle Stimulating Hormone (FSH) and Gamma Glutamyl Transferase (GGT) | GGT, POST DOSE DAY 3-10 | 39.0 International units per liter | — |
| Gepotidacin 750 mg q12h | Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Follicle Stimulating Hormone (FSH) and Gamma Glutamyl Transferase (GGT) | ALP, ON IV TREATMENT/DAY 7 | 3.0 International units per liter | Standard Deviation 22.63 |
| Gepotidacin 750 mg q12h | Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Follicle Stimulating Hormone (FSH) and Gamma Glutamyl Transferase (GGT) | AST, ORAL - FIRST DAY | 4.3 International units per liter | Standard Deviation 13.34 |
| Gepotidacin 750 mg q12h | Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Follicle Stimulating Hormone (FSH) and Gamma Glutamyl Transferase (GGT) | ALT, ORAL - DAY 7-10 | 6.6 International units per liter | Standard Deviation 15.75 |
| Gepotidacin 750 mg q12h | Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Follicle Stimulating Hormone (FSH) and Gamma Glutamyl Transferase (GGT) | ALT, ORAL - FIRST DAY | 3.6 International units per liter | Standard Deviation 17.52 |
| Gepotidacin 750 mg q12h | Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Follicle Stimulating Hormone (FSH) and Gamma Glutamyl Transferase (GGT) | AST, ON IV TREATMENT/DAY 5 | 7.4 International units per liter | Standard Deviation 17.95 |
| Gepotidacin 750 mg q12h | Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Follicle Stimulating Hormone (FSH) and Gamma Glutamyl Transferase (GGT) | ALT, POST THERAPY DAY 12-18 | 12.8 International units per liter | Standard Deviation 35.54 |
| Gepotidacin 750 mg q12h | Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Follicle Stimulating Hormone (FSH) and Gamma Glutamyl Transferase (GGT) | ALP, ORAL - FIRST DAY | 5.1 International units per liter | Standard Deviation 19.3 |
| Gepotidacin 750 mg q12h | Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Follicle Stimulating Hormone (FSH) and Gamma Glutamyl Transferase (GGT) | ALT, POST DOSE DAY 3-10 | 22.0 International units per liter | — |
| Gepotidacin 750 mg q12h | Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Follicle Stimulating Hormone (FSH) and Gamma Glutamyl Transferase (GGT) | ALP, ON IV TREATMENT/DAY 2 | -1.4 International units per liter | Standard Deviation 11.52 |
| Gepotidacin 750 mg q12h | Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Follicle Stimulating Hormone (FSH) and Gamma Glutamyl Transferase (GGT) | GGT, ORAL - DAY 7-10 | 3.6 International units per liter | Standard Deviation 17.06 |
| Gepotidacin 750 mg q12h | Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Follicle Stimulating Hormone (FSH) and Gamma Glutamyl Transferase (GGT) | ALT, ON IV TREATMENT/DAY 2 | -1.9 International units per liter | Standard Deviation 5.4 |
| Gepotidacin 750 mg q12h | Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Follicle Stimulating Hormone (FSH) and Gamma Glutamyl Transferase (GGT) | GGT, ON IV TREATMENT/DAY 3 | 1.7 International units per liter | Standard Deviation 18.66 |
| Gepotidacin 750 mg q12h | Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Follicle Stimulating Hormone (FSH) and Gamma Glutamyl Transferase (GGT) | ALP, ON IV TREATMENT/DAY 5 | -0.3 International units per liter | Standard Deviation 13.01 |
| Gepotidacin 750 mg q12h | Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Follicle Stimulating Hormone (FSH) and Gamma Glutamyl Transferase (GGT) | ALP, FOLLOW UP DAY 21-28 | 4.6 International units per liter | Standard Deviation 19.49 |
| Gepotidacin 750 mg q12h | Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Follicle Stimulating Hormone (FSH) and Gamma Glutamyl Transferase (GGT) | ALT, FOLLOW UP DAY 21-28 | 36.2 International units per liter | Standard Deviation 53.78 |
| Gepotidacin 750 mg q12h | Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Follicle Stimulating Hormone (FSH) and Gamma Glutamyl Transferase (GGT) | AST, ON IV TREATMENT/DAY 2 | -1.1 International units per liter | Standard Deviation 6.58 |
| Gepotidacin 750 mg q12h | Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Follicle Stimulating Hormone (FSH) and Gamma Glutamyl Transferase (GGT) | AST, ON IV TREATMENT/DAY 3 | 1.6 International units per liter | Standard Deviation 12.47 |
| Gepotidacin 750 mg q12h | Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Follicle Stimulating Hormone (FSH) and Gamma Glutamyl Transferase (GGT) | AST, ON IV TREATMENT/DAY 7 | 23.0 International units per liter | — |
| Gepotidacin 750 mg q12h | Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Follicle Stimulating Hormone (FSH) and Gamma Glutamyl Transferase (GGT) | GGT, FOLLOW UP DAY 21-28 | 6.0 International units per liter | Standard Deviation 13.56 |
| Gepotidacin 750 mg q12h | Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Follicle Stimulating Hormone (FSH) and Gamma Glutamyl Transferase (GGT) | GGT, ON IV TREATMENT/DAY 2 | -1.5 International units per liter | Standard Deviation 7.68 |
| Gepotidacin 750 mg q12h | Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Follicle Stimulating Hormone (FSH) and Gamma Glutamyl Transferase (GGT) | AST, ORAL - DAY 7-10 | 6.7 International units per liter | Standard Deviation 12.08 |
| Gepotidacin 750 mg q12h | Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Follicle Stimulating Hormone (FSH) and Gamma Glutamyl Transferase (GGT) | GGT, ORAL - FIRST DAY | 3.3 International units per liter | Standard Deviation 20.16 |
| Gepotidacin 1000 mg q12h | Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Follicle Stimulating Hormone (FSH) and Gamma Glutamyl Transferase (GGT) | ALP, ORAL - DAY 7-10 | 2.2 International units per liter | Standard Deviation 19.16 |
| Gepotidacin 1000 mg q12h | Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Follicle Stimulating Hormone (FSH) and Gamma Glutamyl Transferase (GGT) | ALT, ON IV TREATMENT/DAY 2 | -1.0 International units per liter | Standard Deviation 4.67 |
| Gepotidacin 1000 mg q12h | Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Follicle Stimulating Hormone (FSH) and Gamma Glutamyl Transferase (GGT) | ALT, ON IV TREATMENT/DAY 3 | 1.4 International units per liter | Standard Deviation 9.71 |
| Gepotidacin 1000 mg q12h | Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Follicle Stimulating Hormone (FSH) and Gamma Glutamyl Transferase (GGT) | ALT, ON IV TREATMENT/DAY 4 | 14.0 International units per liter | — |
| Gepotidacin 1000 mg q12h | Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Follicle Stimulating Hormone (FSH) and Gamma Glutamyl Transferase (GGT) | ALT, ON IV TREATMENT/DAY 5 | 2.8 International units per liter | Standard Deviation 9.89 |
| Gepotidacin 1000 mg q12h | Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Follicle Stimulating Hormone (FSH) and Gamma Glutamyl Transferase (GGT) | ALT, FOLLOW UP DAY 21-28 | 27.8 International units per liter | Standard Deviation 39.03 |
| Gepotidacin 1000 mg q12h | Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Follicle Stimulating Hormone (FSH) and Gamma Glutamyl Transferase (GGT) | ALP, ON IV TREATMENT/DAY 2 | -1.3 International units per liter | Standard Deviation 12.27 |
| Gepotidacin 1000 mg q12h | Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Follicle Stimulating Hormone (FSH) and Gamma Glutamyl Transferase (GGT) | ALP, ON IV TREATMENT/DAY 3 | 5.7 International units per liter | Standard Deviation 14.17 |
| Gepotidacin 1000 mg q12h | Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Follicle Stimulating Hormone (FSH) and Gamma Glutamyl Transferase (GGT) | ALP, ON IV TREATMENT/DAY 4 | 15.0 International units per liter | — |
| Gepotidacin 1000 mg q12h | Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Follicle Stimulating Hormone (FSH) and Gamma Glutamyl Transferase (GGT) | ALP, ON IV TREATMENT/DAY 7 | 10.0 International units per liter | Standard Deviation 21.21 |
| Gepotidacin 1000 mg q12h | Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Follicle Stimulating Hormone (FSH) and Gamma Glutamyl Transferase (GGT) | ALP, ORAL - FIRST DAY | 4.0 International units per liter | Standard Deviation 17.38 |
| Gepotidacin 1000 mg q12h | Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Follicle Stimulating Hormone (FSH) and Gamma Glutamyl Transferase (GGT) | ALP, FOLLOW UP DAY 21-28 | 15.6 International units per liter | Standard Deviation 20.84 |
| Gepotidacin 1000 mg q12h | Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Follicle Stimulating Hormone (FSH) and Gamma Glutamyl Transferase (GGT) | AST, ORAL - FIRST DAY | 34 International units per liter | Standard Deviation 13.52 |
| Gepotidacin 1000 mg q12h | Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Follicle Stimulating Hormone (FSH) and Gamma Glutamyl Transferase (GGT) | AST, ORAL - DAY 7-10 | 6.8 International units per liter | Standard Deviation 13.93 |
| Gepotidacin 1000 mg q12h | Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Follicle Stimulating Hormone (FSH) and Gamma Glutamyl Transferase (GGT) | AST, FOLLOW UP DAY 21-28 | 22.6 International units per liter | Standard Deviation 29.9 |
| Gepotidacin 1000 mg q12h | Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Follicle Stimulating Hormone (FSH) and Gamma Glutamyl Transferase (GGT) | GGT, ON IV TREATMENT/DAY 4 | -4.0 International units per liter | — |
| Gepotidacin 1000 mg q12h | Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Follicle Stimulating Hormone (FSH) and Gamma Glutamyl Transferase (GGT) | GGT, ON IV TREATMENT/DAY 7 | -3.0 International units per liter | Standard Deviation 12.73 |
| Gepotidacin 1000 mg q12h | Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Follicle Stimulating Hormone (FSH) and Gamma Glutamyl Transferase (GGT) | GGT, POST THERAPY DAY 12-18 | 5.3 International units per liter | Standard Deviation 21.08 |
| Gepotidacin 1000 mg q12h | Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Follicle Stimulating Hormone (FSH) and Gamma Glutamyl Transferase (GGT) | ALP, POST THERAPY DAY 12-18 | 0.1 International units per liter | Standard Deviation 16.16 |
| Gepotidacin 1000 mg q12h | Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Follicle Stimulating Hormone (FSH) and Gamma Glutamyl Transferase (GGT) | ALT, ON IV TREATMENT/DAY 7 | 18.5 International units per liter | Standard Deviation 9.19 |
| Gepotidacin 1000 mg q12h | Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Follicle Stimulating Hormone (FSH) and Gamma Glutamyl Transferase (GGT) | ALT, ORAL - FIRST DAY | 4.1 International units per liter | Standard Deviation 11.58 |
| Gepotidacin 1000 mg q12h | Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Follicle Stimulating Hormone (FSH) and Gamma Glutamyl Transferase (GGT) | ALT, ORAL - DAY 7-10 | 7.3 International units per liter | Standard Deviation 17.74 |
| Gepotidacin 1000 mg q12h | Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Follicle Stimulating Hormone (FSH) and Gamma Glutamyl Transferase (GGT) | ALT, POST THERAPY DAY 12-18 | 8.3 International units per liter | Standard Deviation 21.9 |
| Gepotidacin 1000 mg q12h | Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Follicle Stimulating Hormone (FSH) and Gamma Glutamyl Transferase (GGT) | AST, ON IV TREATMENT/DAY 2 | 0.7 International units per liter | Standard Deviation 7.03 |
| Gepotidacin 1000 mg q12h | Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Follicle Stimulating Hormone (FSH) and Gamma Glutamyl Transferase (GGT) | AST, ON IV TREATMENT/DAY 3 | 6.2 International units per liter | Standard Deviation 22.3 |
| Gepotidacin 1000 mg q12h | Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Follicle Stimulating Hormone (FSH) and Gamma Glutamyl Transferase (GGT) | AST, ON IV TREATMENT/DAY 4 | 22.0 International units per liter | — |
| Gepotidacin 1000 mg q12h | Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Follicle Stimulating Hormone (FSH) and Gamma Glutamyl Transferase (GGT) | AST, ON IV TREATMENT/DAY 5 | 4.2 International units per liter | Standard Deviation 13.01 |
| Gepotidacin 1000 mg q12h | Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Follicle Stimulating Hormone (FSH) and Gamma Glutamyl Transferase (GGT) | AST, ON IV TREATMENT/DAY 7 | 22.0 International units per liter | Standard Deviation 0 |
| Gepotidacin 1000 mg q12h | Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Follicle Stimulating Hormone (FSH) and Gamma Glutamyl Transferase (GGT) | AST, POST THERAPY DAY 12-18 | 9.0 International units per liter | Standard Deviation 15.53 |
| Gepotidacin 1000 mg q12h | Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Follicle Stimulating Hormone (FSH) and Gamma Glutamyl Transferase (GGT) | ALP, ON IV TREATMENT/DAY 5 | 5.0 International units per liter | Standard Deviation 11.49 |
| Gepotidacin 1000 mg q12h | Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Follicle Stimulating Hormone (FSH) and Gamma Glutamyl Transferase (GGT) | GGT, ON IV TREATMENT/DAY 2 | -1.9 International units per liter | Standard Deviation 8.1 |
| Gepotidacin 1000 mg q12h | Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Follicle Stimulating Hormone (FSH) and Gamma Glutamyl Transferase (GGT) | GGT, ON IV TREATMENT/DAY 3 | 3.8 International units per liter | Standard Deviation 12.23 |
| Gepotidacin 1000 mg q12h | Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Follicle Stimulating Hormone (FSH) and Gamma Glutamyl Transferase (GGT) | GGT, ON IV TREATMENT/DAY 5 | -2.5 International units per liter | Standard Deviation 5.21 |
| Gepotidacin 1000 mg q12h | Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Follicle Stimulating Hormone (FSH) and Gamma Glutamyl Transferase (GGT) | GGT, ORAL - FIRST DAY | 4.5 International units per liter | Standard Deviation 16.25 |
| Gepotidacin 1000 mg q12h | Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Follicle Stimulating Hormone (FSH) and Gamma Glutamyl Transferase (GGT) | GGT, ORAL - DAY 7-10 | 7.5 International units per liter | Standard Deviation 19.89 |
| Gepotidacin 1000 mg q12h | Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Follicle Stimulating Hormone (FSH) and Gamma Glutamyl Transferase (GGT) | GGT, FOLLOW UP DAY 21-28 | 64.0 International units per liter | Standard Deviation 89.91 |
| Gepotidacin 1000 mg q8h | Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Follicle Stimulating Hormone (FSH) and Gamma Glutamyl Transferase (GGT) | GGT, POST THERAPY DAY 12-18 | -3.9 International units per liter | Standard Deviation 16.8 |
| Gepotidacin 1000 mg q8h | Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Follicle Stimulating Hormone (FSH) and Gamma Glutamyl Transferase (GGT) | AST, FOLLOW UP DAY 21-28 | 5.3 International units per liter | Standard Deviation 2.52 |
| Gepotidacin 1000 mg q8h | Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Follicle Stimulating Hormone (FSH) and Gamma Glutamyl Transferase (GGT) | GGT, ORAL - FIRST DAY | -1.1 International units per liter | Standard Deviation 10.95 |
| Gepotidacin 1000 mg q8h | Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Follicle Stimulating Hormone (FSH) and Gamma Glutamyl Transferase (GGT) | AST, ORAL - FIRST DAY | 6.3 International units per liter | Standard Deviation 17.83 |
| Gepotidacin 1000 mg q8h | Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Follicle Stimulating Hormone (FSH) and Gamma Glutamyl Transferase (GGT) | ALP, POST THERAPY DAY 12-18 | -1.8 International units per liter | Standard Deviation 11.72 |
| Gepotidacin 1000 mg q8h | Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Follicle Stimulating Hormone (FSH) and Gamma Glutamyl Transferase (GGT) | ALT, POST THERAPY DAY 12-18 | 4.2 International units per liter | Standard Deviation 16.02 |
| Gepotidacin 1000 mg q8h | Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Follicle Stimulating Hormone (FSH) and Gamma Glutamyl Transferase (GGT) | GGT, FOLLOW UP DAY 21-28 | 3.0 International units per liter | — |
| Gepotidacin 1000 mg q8h | Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Follicle Stimulating Hormone (FSH) and Gamma Glutamyl Transferase (GGT) | GGT, ON IV TREATMENT/DAY 2 | -1.4 International units per liter | Standard Deviation 10.15 |
| Gepotidacin 1000 mg q8h | Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Follicle Stimulating Hormone (FSH) and Gamma Glutamyl Transferase (GGT) | ALP, ORAL - FIRST DAY | -0.4 International units per liter | Standard Deviation 11.32 |
| Gepotidacin 1000 mg q8h | Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Follicle Stimulating Hormone (FSH) and Gamma Glutamyl Transferase (GGT) | ALP, ORAL - DAY 7-10 | -0.1 International units per liter | Standard Deviation 11.17 |
| Gepotidacin 1000 mg q8h | Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Follicle Stimulating Hormone (FSH) and Gamma Glutamyl Transferase (GGT) | GGT, ORAL - DAY 7-10 | -2.2 International units per liter | Standard Deviation 14.75 |
| Gepotidacin 1000 mg q8h | Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Follicle Stimulating Hormone (FSH) and Gamma Glutamyl Transferase (GGT) | GGT, ON IV TREATMENT/DAY 3 | 1.9 International units per liter | Standard Deviation 5.16 |
| Gepotidacin 1000 mg q8h | Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Follicle Stimulating Hormone (FSH) and Gamma Glutamyl Transferase (GGT) | AST, ON IV TREATMENT/DAY 2 | 2.0 International units per liter | Standard Deviation 10.85 |
| Gepotidacin 1000 mg q8h | Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Follicle Stimulating Hormone (FSH) and Gamma Glutamyl Transferase (GGT) | ALP, ON IV TREATMENT/DAY 3 | -0.4 International units per liter | Standard Deviation 6.17 |
| Gepotidacin 1000 mg q8h | Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Follicle Stimulating Hormone (FSH) and Gamma Glutamyl Transferase (GGT) | AST, ON IV TREATMENT/DAY 3 | 6.9 International units per liter | Standard Deviation 18.84 |
| Gepotidacin 1000 mg q8h | Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Follicle Stimulating Hormone (FSH) and Gamma Glutamyl Transferase (GGT) | ALT, ON IV TREATMENT/DAY 3 | 1.2 International units per liter | Standard Deviation 6.3 |
| Gepotidacin 1000 mg q8h | Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Follicle Stimulating Hormone (FSH) and Gamma Glutamyl Transferase (GGT) | ALT, ORAL - DAY 7-10 | 6.3 International units per liter | Standard Deviation 12.6 |
| Gepotidacin 1000 mg q8h | Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Follicle Stimulating Hormone (FSH) and Gamma Glutamyl Transferase (GGT) | ALP, ON IV TREATMENT/DAY 2 | -4.0 International units per liter | Standard Deviation 12.23 |
| Gepotidacin 1000 mg q8h | Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Follicle Stimulating Hormone (FSH) and Gamma Glutamyl Transferase (GGT) | ALT, FOLLOW UP DAY 21-28 | 9.3 International units per liter | Standard Deviation 4.62 |
| Gepotidacin 1000 mg q8h | Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Follicle Stimulating Hormone (FSH) and Gamma Glutamyl Transferase (GGT) | ALT, ORAL - FIRST DAY | 5.7 International units per liter | Standard Deviation 11.57 |
| Gepotidacin 1000 mg q8h | Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Follicle Stimulating Hormone (FSH) and Gamma Glutamyl Transferase (GGT) | AST, ORAL - DAY 7-10 | 2.3 International units per liter | Standard Deviation 17.44 |
| Gepotidacin 1000 mg q8h | Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Follicle Stimulating Hormone (FSH) and Gamma Glutamyl Transferase (GGT) | ALP, FOLLOW UP DAY 21-28 | -2.0 International units per liter | Standard Deviation 3.61 |
| Gepotidacin 1000 mg q8h | Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Follicle Stimulating Hormone (FSH) and Gamma Glutamyl Transferase (GGT) | ALT, ON IV TREATMENT/DAY 2 | 2.3 International units per liter | Standard Deviation 14.57 |
| Gepotidacin 1000 mg q8h | Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Follicle Stimulating Hormone (FSH) and Gamma Glutamyl Transferase (GGT) | AST, POST THERAPY DAY 12-18 | 0.8 International units per liter | Standard Deviation 19.05 |
Secondary
Change From Baseline in Clinical Chemistry Parameters: Albumin and Protein
Blood samples for assessment of clinical chemistry parameters of albumin and total protein was collected at Baseline (Day 1), Day 2, Day 7 to 10, Day 12 to 21 and Day 21 to Day 28. Baseline was defined at Day 1. Change from Baseline was calculated by subtracting the post-Baseline value from Baseline value.
Time frame: Baseline (Day 1) up to Day 28
Population: Safety population. Data for only those participants available at the indicated time points were collected and analyzed. Data points with null value for participants analyzed indicate data not collected for respective category and treatment arm.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Gepotidacin 750 mg q12h | Change From Baseline in Clinical Chemistry Parameters: Albumin and Protein | Albumin, ON IV TREATMENT/DAY 7 | 4.0 Gram per liter | Standard Deviation 8.49 |
| Gepotidacin 750 mg q12h | Change From Baseline in Clinical Chemistry Parameters: Albumin and Protein | Protein, ON IV TREATMENT/DAY 3 | -1.6 Gram per liter | Standard Deviation 7.04 |
| Gepotidacin 750 mg q12h | Change From Baseline in Clinical Chemistry Parameters: Albumin and Protein | Albumin, ON IV TREATMENT/DAY 2 | -2.4 Gram per liter | Standard Deviation 3.57 |
| Gepotidacin 750 mg q12h | Change From Baseline in Clinical Chemistry Parameters: Albumin and Protein | Albumin, ON IV TREATMENT/DAY 3 | -1.7 Gram per liter | Standard Deviation 4.09 |
| Gepotidacin 750 mg q12h | Change From Baseline in Clinical Chemistry Parameters: Albumin and Protein | Albumin, ON IV TREATMENT/DAY 5 | -1.1 Gram per liter | Standard Deviation 4.09 |
| Gepotidacin 750 mg q12h | Change From Baseline in Clinical Chemistry Parameters: Albumin and Protein | Albumin, ORAL - FIRST DAY | 0.0 Gram per liter | Standard Deviation 3.39 |
| Gepotidacin 750 mg q12h | Change From Baseline in Clinical Chemistry Parameters: Albumin and Protein | Albumin, ORAL - DAY 7-10 | 1.8 Gram per liter | Standard Deviation 3.58 |
| Gepotidacin 750 mg q12h | Change From Baseline in Clinical Chemistry Parameters: Albumin and Protein | Albumin, POST THERAPY DAY 12-18 | 2.1 Gram per liter | Standard Deviation 3.81 |
| Gepotidacin 750 mg q12h | Change From Baseline in Clinical Chemistry Parameters: Albumin and Protein | Albumin, FOLLOW UP DAY 21-28 | 2.8 Gram per liter | Standard Deviation 2.36 |
| Gepotidacin 750 mg q12h | Change From Baseline in Clinical Chemistry Parameters: Albumin and Protein | Albumin, POST DOSE DAY 3-10 | -4.0 Gram per liter | — |
| Gepotidacin 750 mg q12h | Change From Baseline in Clinical Chemistry Parameters: Albumin and Protein | Protein, ON IV TREATMENT/DAY 2 | -3.2 Gram per liter | Standard Deviation 6.36 |
| Gepotidacin 750 mg q12h | Change From Baseline in Clinical Chemistry Parameters: Albumin and Protein | Protein, ON IV TREATMENT/DAY 5 | -0.5 Gram per liter | Standard Deviation 8.22 |
| Gepotidacin 750 mg q12h | Change From Baseline in Clinical Chemistry Parameters: Albumin and Protein | Protein, ON IV TREATMENT/DAY 7 | 5.5 Gram per liter | Standard Deviation 13.44 |
| Gepotidacin 750 mg q12h | Change From Baseline in Clinical Chemistry Parameters: Albumin and Protein | Protein, ORAL - FIRST DAY | 1.4 Gram per liter | Standard Deviation 5.96 |
| Gepotidacin 750 mg q12h | Change From Baseline in Clinical Chemistry Parameters: Albumin and Protein | Protein, ORAL - DAY 7-10 | 3.1 Gram per liter | Standard Deviation 6.95 |
| Gepotidacin 750 mg q12h | Change From Baseline in Clinical Chemistry Parameters: Albumin and Protein | Protein, POST THERAPY DAY 12-18 | 2.9 Gram per liter | Standard Deviation 7.21 |
| Gepotidacin 750 mg q12h | Change From Baseline in Clinical Chemistry Parameters: Albumin and Protein | Protein, FOLLOW UP DAY 21-28 | 5.0 Gram per liter | Standard Deviation 5.29 |
| Gepotidacin 750 mg q12h | Change From Baseline in Clinical Chemistry Parameters: Albumin and Protein | Protein, POST DOSE DAY 3-10 | -3.0 Gram per liter | — |
| Gepotidacin 1000 mg q12h | Change From Baseline in Clinical Chemistry Parameters: Albumin and Protein | Albumin, ORAL - DAY 7-10 | 1.4 Gram per liter | Standard Deviation 3.04 |
| Gepotidacin 1000 mg q12h | Change From Baseline in Clinical Chemistry Parameters: Albumin and Protein | Protein, ON IV TREATMENT/DAY 3 | -0.3 Gram per liter | Standard Deviation 5.88 |
| Gepotidacin 1000 mg q12h | Change From Baseline in Clinical Chemistry Parameters: Albumin and Protein | Protein, ON IV TREATMENT/DAY 4 | 0.0 Gram per liter | — |
| Gepotidacin 1000 mg q12h | Change From Baseline in Clinical Chemistry Parameters: Albumin and Protein | Protein, FOLLOW UP DAY 21-28 | 0.8 Gram per liter | Standard Deviation 5.06 |
| Gepotidacin 1000 mg q12h | Change From Baseline in Clinical Chemistry Parameters: Albumin and Protein | Albumin, ON IV TREATMENT/DAY 2 | -1.1 Gram per liter | Standard Deviation 2.93 |
| Gepotidacin 1000 mg q12h | Change From Baseline in Clinical Chemistry Parameters: Albumin and Protein | Protein, ON IV TREATMENT/DAY 5 | -2.3 Gram per liter | Standard Deviation 7.34 |
| Gepotidacin 1000 mg q12h | Change From Baseline in Clinical Chemistry Parameters: Albumin and Protein | Albumin, ON IV TREATMENT/DAY 3 | -0.6 Gram per liter | Standard Deviation 3.52 |
| Gepotidacin 1000 mg q12h | Change From Baseline in Clinical Chemistry Parameters: Albumin and Protein | Albumin, ON IV TREATMENT/DAY 4 | 1.0 Gram per liter | — |
| Gepotidacin 1000 mg q12h | Change From Baseline in Clinical Chemistry Parameters: Albumin and Protein | Protein, POST THERAPY DAY 12-18 | 3.1 Gram per liter | Standard Deviation 9.14 |
| Gepotidacin 1000 mg q12h | Change From Baseline in Clinical Chemistry Parameters: Albumin and Protein | Albumin, ON IV TREATMENT/DAY 5 | -1.5 Gram per liter | Standard Deviation 3.62 |
| Gepotidacin 1000 mg q12h | Change From Baseline in Clinical Chemistry Parameters: Albumin and Protein | Albumin, ON IV TREATMENT/DAY 7 | -0.5 Gram per liter | Standard Deviation 0.71 |
| Gepotidacin 1000 mg q12h | Change From Baseline in Clinical Chemistry Parameters: Albumin and Protein | Protein, ON IV TREATMENT/DAY 7 | -1.0 Gram per liter | Standard Deviation 8.49 |
| Gepotidacin 1000 mg q12h | Change From Baseline in Clinical Chemistry Parameters: Albumin and Protein | Albumin, ORAL - FIRST DAY | -0.2 Gram per liter | Standard Deviation 3.37 |
| Gepotidacin 1000 mg q12h | Change From Baseline in Clinical Chemistry Parameters: Albumin and Protein | Protein, ORAL - FIRST DAY | -0.2 Gram per liter | Standard Deviation 6.82 |
| Gepotidacin 1000 mg q12h | Change From Baseline in Clinical Chemistry Parameters: Albumin and Protein | Albumin, POST THERAPY DAY 12-18 | 2.8 Gram per liter | Standard Deviation 4.41 |
| Gepotidacin 1000 mg q12h | Change From Baseline in Clinical Chemistry Parameters: Albumin and Protein | Albumin, FOLLOW UP DAY 21-28 | 0.3 Gram per liter | Standard Deviation 2.22 |
| Gepotidacin 1000 mg q12h | Change From Baseline in Clinical Chemistry Parameters: Albumin and Protein | Protein, ORAL - DAY 7-10 | 2.2 Gram per liter | Standard Deviation 5.88 |
| Gepotidacin 1000 mg q12h | Change From Baseline in Clinical Chemistry Parameters: Albumin and Protein | Protein, ON IV TREATMENT/DAY 2 | -1.9 Gram per liter | Standard Deviation 5.86 |
| Gepotidacin 1000 mg q8h | Change From Baseline in Clinical Chemistry Parameters: Albumin and Protein | Albumin, ORAL - DAY 7-10 | 1.2 Gram per liter | Standard Deviation 2.51 |
| Gepotidacin 1000 mg q8h | Change From Baseline in Clinical Chemistry Parameters: Albumin and Protein | Protein, ORAL - DAY 7-10 | 0.5 Gram per liter | Standard Deviation 3.59 |
| Gepotidacin 1000 mg q8h | Change From Baseline in Clinical Chemistry Parameters: Albumin and Protein | Albumin, ORAL - FIRST DAY | -0.9 Gram per liter | Standard Deviation 2.86 |
| Gepotidacin 1000 mg q8h | Change From Baseline in Clinical Chemistry Parameters: Albumin and Protein | Albumin, POST THERAPY DAY 12-18 | 0.8 Gram per liter | Standard Deviation 3.61 |
| Gepotidacin 1000 mg q8h | Change From Baseline in Clinical Chemistry Parameters: Albumin and Protein | Protein, ORAL - FIRST DAY | -1.2 Gram per liter | Standard Deviation 5.05 |
| Gepotidacin 1000 mg q8h | Change From Baseline in Clinical Chemistry Parameters: Albumin and Protein | Albumin, ON IV TREATMENT/DAY 3 | -2.0 Gram per liter | Standard Deviation 3.46 |
| Gepotidacin 1000 mg q8h | Change From Baseline in Clinical Chemistry Parameters: Albumin and Protein | Albumin, FOLLOW UP DAY 21-28 | 0.0 Gram per liter | — |
| Gepotidacin 1000 mg q8h | Change From Baseline in Clinical Chemistry Parameters: Albumin and Protein | Protein, FOLLOW UP DAY 21-28 | -7.0 Gram per liter | — |
| Gepotidacin 1000 mg q8h | Change From Baseline in Clinical Chemistry Parameters: Albumin and Protein | Protein, ON IV TREATMENT/DAY 2 | -5.2 Gram per liter | Standard Deviation 6.28 |
| Gepotidacin 1000 mg q8h | Change From Baseline in Clinical Chemistry Parameters: Albumin and Protein | Albumin, ON IV TREATMENT/DAY 2 | -2.9 Gram per liter | Standard Deviation 3.34 |
| Gepotidacin 1000 mg q8h | Change From Baseline in Clinical Chemistry Parameters: Albumin and Protein | Protein, POST THERAPY DAY 12-18 | -1.1 Gram per liter | Standard Deviation 5.93 |
| Gepotidacin 1000 mg q8h | Change From Baseline in Clinical Chemistry Parameters: Albumin and Protein | Protein, ON IV TREATMENT/DAY 3 | -4.8 Gram per liter | Standard Deviation 6.59 |
Secondary
Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Urate
Blood samples for assessment of clinical chemistry parameters of bilirubin, creatinine, direct bilirubin and urate was collected at Baseline (Day 1), Day 2, Day 7 to 10, Day 12 to 21 and Day 21 to Day 28. Baseline was defined at Day 1. Change from Baseline was calculated by subtracting the post-Baseline value from Baseline value.
Time frame: Baseline (Day 1) up to Day 28
Population: Safety population. Data for only those participants available at the indicated time points were collected and analyzed. Data points with null value for participants analyzed indicate data not collected for respective category and treatment arm.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Gepotidacin 750 mg q12h | Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Urate | Bilirubin, ON IV TREATMENT/DAY 2 | -1.9 Micromoles per liter | Standard Deviation 3.22 |
| Gepotidacin 750 mg q12h | Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Urate | Bilirubin, ON IV TREATMENT/DAY 3 | -2.8 Micromoles per liter | Standard Deviation 4.42 |
| Gepotidacin 750 mg q12h | Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Urate | Bilirubin, ON IV TREATMENT/DAY 5 | -2.8 Micromoles per liter | Standard Deviation 4.64 |
| Gepotidacin 750 mg q12h | Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Urate | Bilirubin, ON IV TREATMENT/DAY 7 | 0.0 Micromoles per liter | Standard Deviation 0 |
| Gepotidacin 750 mg q12h | Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Urate | Bilirubin, ORAL - FIRST DAY | -1.9 Micromoles per liter | Standard Deviation 3.87 |
| Gepotidacin 750 mg q12h | Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Urate | Bilirubin, ORAL - DAY 7-10 | -0.9 Micromoles per liter | Standard Deviation 4.17 |
| Gepotidacin 750 mg q12h | Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Urate | Bilirubin, POST THERAPY DAY 12-18 | -1.0 Micromoles per liter | Standard Deviation 4.35 |
| Gepotidacin 750 mg q12h | Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Urate | Bilirubin, FOLLOW UP DAY 21-28 | 0.0 Micromoles per liter | Standard Deviation 8.72 |
| Gepotidacin 750 mg q12h | Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Urate | Bilirubin, POST DOSE DAY 3-10 | -2.0 Micromoles per liter | — |
| Gepotidacin 750 mg q12h | Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Urate | Creatinine, ON IV TREATMENT/DAY 2 | 3.45 Micromoles per liter | Standard Deviation 11.885 |
| Gepotidacin 750 mg q12h | Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Urate | Creatinine, ON IV TREATMENT/DAY 3 | 1.30 Micromoles per liter | Standard Deviation 10.462 |
| Gepotidacin 750 mg q12h | Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Urate | Creatinine, ON IV TREATMENT/DAY 5 | -0.91 Micromoles per liter | Standard Deviation 10.541 |
| Gepotidacin 750 mg q12h | Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Urate | Creatinine, ON IV TREATMENT/DAY 7 | 8.40 Micromoles per liter | Standard Deviation 10.607 |
| Gepotidacin 750 mg q12h | Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Urate | Creatinine, ORAL - FIRST DAY | 4.22 Micromoles per liter | Standard Deviation 11.115 |
| Gepotidacin 750 mg q12h | Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Urate | Creatinine, ORAL - DAY 7-10 | 4.65 Micromoles per liter | Standard Deviation 9.93 |
| Gepotidacin 750 mg q12h | Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Urate | Creatinine, POST THERAPY DAY 12-18 | 3.82 Micromoles per liter | Standard Deviation 10.641 |
| Gepotidacin 750 mg q12h | Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Urate | Creatinine, FOLLOW UP DAY 21-28 | 9.92 Micromoles per liter | Standard Deviation 12.289 |
| Gepotidacin 750 mg q12h | Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Urate | Creatinine, POST DOSE DAY 3-10 | -2.70 Micromoles per liter | — |
| Gepotidacin 750 mg q12h | Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Urate | Direct Bilirubin, ON IV TREATMENT/DAY 2 | -0.3 Micromoles per liter | Standard Deviation 2.09 |
| Gepotidacin 750 mg q12h | Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Urate | Direct Bilirubin, ON IV TREATMENT/DAY 3 | -0.2 Micromoles per liter | Standard Deviation 2.33 |
| Gepotidacin 750 mg q12h | Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Urate | Direct Bilirubin, ON IV TREATMENT/DAY 5 | -1.0 Micromoles per liter | Standard Deviation 1.94 |
| Gepotidacin 750 mg q12h | Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Urate | Direct Bilirubin, ON IV TREATMENT/DAY 7 | -1.0 Micromoles per liter | Standard Deviation 1.41 |
| Gepotidacin 750 mg q12h | Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Urate | Direct Bilirubin, ORAL - FIRST DAY | -0.4 Micromoles per liter | Standard Deviation 2.15 |
| Gepotidacin 750 mg q12h | Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Urate | Direct Bilirubin, ORAL - DAY 7-10 | 0.0 Micromoles per liter | Standard Deviation 1.95 |
| Gepotidacin 750 mg q12h | Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Urate | Direct Bilirubin, POST THERAPY DAY 12-18 | -0.3 Micromoles per liter | Standard Deviation 2.02 |
| Gepotidacin 750 mg q12h | Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Urate | Direct Bilirubin, FOLLOW UP DAY 21-28 | 1.5 Micromoles per liter | Standard Deviation 5 |
| Gepotidacin 750 mg q12h | Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Urate | Direct Bilirubin, POST DOSE DAY 3-10 | 0.0 Micromoles per liter | — |
| Gepotidacin 750 mg q12h | Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Urate | Urate, ON IV TREATMENT/DAY 2 | 1.2 Micromoles per liter | Standard Deviation 44.16 |
| Gepotidacin 750 mg q12h | Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Urate | Urate, ON IV TREATMENT/DAY 3 | 4.2 Micromoles per liter | Standard Deviation 66.33 |
| Gepotidacin 750 mg q12h | Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Urate | Urate, ON IV TREATMENT/DAY 5 | 26.0 Micromoles per liter | Standard Deviation 89.47 |
| Gepotidacin 750 mg q12h | Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Urate | Urate, ON IV TREATMENT/DAY 7 | 10.0 Micromoles per liter | Standard Deviation 169.71 |
| Gepotidacin 750 mg q12h | Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Urate | Urate, ORAL - FIRST DAY | 16.3 Micromoles per liter | Standard Deviation 52.46 |
| Gepotidacin 750 mg q12h | Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Urate | Urate, ORAL - DAY 7-10 | 51.6 Micromoles per liter | Standard Deviation 55.31 |
| Gepotidacin 750 mg q12h | Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Urate | Urate, POST THERAPY DAY 12-18 | 60.8 Micromoles per liter | Standard Deviation 73.88 |
| Gepotidacin 750 mg q12h | Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Urate | Urate, FOLLOW UP DAY 21-28 | 7.5 Micromoles per liter | Standard Deviation 80.16 |
| Gepotidacin 750 mg q12h | Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Urate | Urate, POST DOSE DAY 3-10 | 70.0 Micromoles per liter | — |
| Gepotidacin 1000 mg q12h | Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Urate | Bilirubin, ORAL - FIRST DAY | -1.7 Micromoles per liter | Standard Deviation 3.12 |
| Gepotidacin 1000 mg q12h | Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Urate | Creatinine, ORAL - FIRST DAY | -3.78 Micromoles per liter | Standard Deviation 27.598 |
| Gepotidacin 1000 mg q12h | Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Urate | Urate, ORAL - FIRST DAY | 2.9 Micromoles per liter | Standard Deviation 67.26 |
| Gepotidacin 1000 mg q12h | Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Urate | Bilirubin, ORAL - DAY 7-10 | -0.7 Micromoles per liter | Standard Deviation 2.49 |
| Gepotidacin 1000 mg q12h | Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Urate | Urate, FOLLOW UP DAY 21-28 | 10.0 Micromoles per liter | Standard Deviation 102.31 |
| Gepotidacin 1000 mg q12h | Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Urate | Direct Bilirubin, POST THERAPY DAY 12-18 | 0.0 Micromoles per liter | Standard Deviation 1.68 |
| Gepotidacin 1000 mg q12h | Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Urate | Bilirubin, POST THERAPY DAY 12-18 | -0.5 Micromoles per liter | Standard Deviation 3.25 |
| Gepotidacin 1000 mg q12h | Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Urate | Direct Bilirubin, ON IV TREATMENT/DAY 3 | -0.7 Micromoles per liter | Standard Deviation 1.83 |
| Gepotidacin 1000 mg q12h | Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Urate | Creatinine, FOLLOW UP DAY 21-28 | -1.80 Micromoles per liter | Standard Deviation 2.846 |
| Gepotidacin 1000 mg q12h | Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Urate | Bilirubin, FOLLOW UP DAY 21-28 | 0.0 Micromoles per liter | Standard Deviation 4.69 |
| Gepotidacin 1000 mg q12h | Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Urate | Direct Bilirubin, ON IV TREATMENT/DAY 4 | -2.0 Micromoles per liter | — |
| Gepotidacin 1000 mg q12h | Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Urate | Urate, ON IV TREATMENT/DAY 5 | 46.7 Micromoles per liter | Standard Deviation 50.86 |
| Gepotidacin 1000 mg q12h | Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Urate | Direct Bilirubin, FOLLOW UP DAY 21-28 | 0.5 Micromoles per liter | Standard Deviation 1.91 |
| Gepotidacin 1000 mg q12h | Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Urate | Creatinine, ON IV TREATMENT/DAY 2 | -2.33 Micromoles per liter | Standard Deviation 19.886 |
| Gepotidacin 1000 mg q12h | Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Urate | Direct Bilirubin, ON IV TREATMENT/DAY 5 | -0.7 Micromoles per liter | Standard Deviation 2.73 |
| Gepotidacin 1000 mg q12h | Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Urate | Urate, POST THERAPY DAY 12-18 | 49.4 Micromoles per liter | Standard Deviation 83.24 |
| Gepotidacin 1000 mg q12h | Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Urate | Creatinine, ON IV TREATMENT/DAY 3 | -5.35 Micromoles per liter | Standard Deviation 28.787 |
| Gepotidacin 1000 mg q12h | Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Urate | Direct Bilirubin, ON IV TREATMENT/DAY 7 | -3.0 Micromoles per liter | Standard Deviation 1.41 |
| Gepotidacin 1000 mg q12h | Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Urate | Creatinine, ON IV TREATMENT/DAY 4 | -1.70 Micromoles per liter | — |
| Gepotidacin 1000 mg q12h | Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Urate | Urate, ON IV TREATMENT/DAY 7 | 90.0 Micromoles per liter | Standard Deviation 28.28 |
| Gepotidacin 1000 mg q12h | Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Urate | Creatinine, ON IV TREATMENT/DAY 5 | 7.37 Micromoles per liter | Standard Deviation 8.704 |
| Gepotidacin 1000 mg q12h | Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Urate | Urate, ORAL - DAY 7-10 | 67.0 Micromoles per liter | Standard Deviation 69.79 |
| Gepotidacin 1000 mg q12h | Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Urate | Creatinine, ON IV TREATMENT/DAY 7 | 6.65 Micromoles per liter | Standard Deviation 8.132 |
| Gepotidacin 1000 mg q12h | Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Urate | Urate, ON IV TREATMENT/DAY 2 | -11.7 Micromoles per liter | Standard Deviation 42.46 |
| Gepotidacin 1000 mg q12h | Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Urate | Direct Bilirubin, ORAL - FIRST DAY | -0.2 Micromoles per liter | Standard Deviation 2.19 |
| Gepotidacin 1000 mg q12h | Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Urate | Bilirubin, ON IV TREATMENT/DAY 5 | -4.0 Micromoles per liter | Standard Deviation 2.53 |
| Gepotidacin 1000 mg q12h | Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Urate | Bilirubin, ON IV TREATMENT/DAY 2 | -1.3 Micromoles per liter | Standard Deviation 2.87 |
| Gepotidacin 1000 mg q12h | Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Urate | Creatinine, POST THERAPY DAY 12-18 | 2.93 Micromoles per liter | Standard Deviation 26.419 |
| Gepotidacin 1000 mg q12h | Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Urate | Creatinine, ORAL - DAY 7-10 | 0.72 Micromoles per liter | Standard Deviation 30.659 |
| Gepotidacin 1000 mg q12h | Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Urate | Bilirubin, ON IV TREATMENT/DAY 3 | -1.0 Micromoles per liter | Standard Deviation 3.61 |
| Gepotidacin 1000 mg q12h | Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Urate | Urate, ON IV TREATMENT/DAY 4 | 60.0 Micromoles per liter | — |
| Gepotidacin 1000 mg q12h | Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Urate | Bilirubin, ON IV TREATMENT/DAY 4 | -4.0 Micromoles per liter | — |
| Gepotidacin 1000 mg q12h | Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Urate | Direct Bilirubin, ON IV TREATMENT/DAY 2 | -0.6 Micromoles per liter | Standard Deviation 1.79 |
| Gepotidacin 1000 mg q12h | Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Urate | Direct Bilirubin, ORAL - DAY 7-10 | 0.0 Micromoles per liter | Standard Deviation 2.1 |
| Gepotidacin 1000 mg q12h | Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Urate | Bilirubin, ON IV TREATMENT/DAY 7 | -4.0 Micromoles per liter | Standard Deviation 0 |
| Gepotidacin 1000 mg q12h | Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Urate | Urate, ON IV TREATMENT/DAY 3 | 5.7 Micromoles per liter | Standard Deviation 52.02 |
| Gepotidacin 1000 mg q8h | Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Urate | Bilirubin, ORAL - FIRST DAY | -2.4 Micromoles per liter | Standard Deviation 2.69 |
| Gepotidacin 1000 mg q8h | Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Urate | Creatinine, ORAL - FIRST DAY | 2.37 Micromoles per liter | Standard Deviation 10.268 |
| Gepotidacin 1000 mg q8h | Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Urate | Urate, ON IV TREATMENT/DAY 2 | -17.1 Micromoles per liter | Standard Deviation 50.43 |
| Gepotidacin 1000 mg q8h | Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Urate | Creatinine, ORAL - DAY 7-10 | 4.13 Micromoles per liter | Standard Deviation 9.518 |
| Gepotidacin 1000 mg q8h | Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Urate | Urate, ORAL - DAY 7-10 | 55.2 Micromoles per liter | Standard Deviation 65.32 |
| Gepotidacin 1000 mg q8h | Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Urate | Creatinine, POST THERAPY DAY 12-18 | 2.08 Micromoles per liter | Standard Deviation 9.293 |
| Gepotidacin 1000 mg q8h | Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Urate | Creatinine, FOLLOW UP DAY 21-28 | 2.70 Micromoles per liter | — |
| Gepotidacin 1000 mg q8h | Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Urate | Urate, ON IV TREATMENT/DAY 3 | -14.4 Micromoles per liter | Standard Deviation 97.1 |
| Gepotidacin 1000 mg q8h | Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Urate | Direct Bilirubin, ON IV TREATMENT/DAY 2 | -1.1 Micromoles per liter | Standard Deviation 2.28 |
| Gepotidacin 1000 mg q8h | Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Urate | Direct Bilirubin, ON IV TREATMENT/DAY 3 | -1.3 Micromoles per liter | Standard Deviation 2.24 |
| Gepotidacin 1000 mg q8h | Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Urate | Bilirubin, ON IV TREATMENT/DAY 2 | -2.4 Micromoles per liter | Standard Deviation 3.34 |
| Gepotidacin 1000 mg q8h | Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Urate | Direct Bilirubin, ORAL - FIRST DAY | -1.0 Micromoles per liter | Standard Deviation 2.08 |
| Gepotidacin 1000 mg q8h | Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Urate | Bilirubin, ON IV TREATMENT/DAY 3 | -2.2 Micromoles per liter | Standard Deviation 2.73 |
| Gepotidacin 1000 mg q8h | Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Urate | Urate, POST THERAPY DAY 12-18 | 45.3 Micromoles per liter | Standard Deviation 60.31 |
| Gepotidacin 1000 mg q8h | Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Urate | Direct Bilirubin, ORAL - DAY 7-10 | -1.0 Micromoles per liter | Standard Deviation 2.16 |
| Gepotidacin 1000 mg q8h | Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Urate | Bilirubin, ORAL - DAY 7-10 | -1.7 Micromoles per liter | Standard Deviation 2.55 |
| Gepotidacin 1000 mg q8h | Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Urate | Bilirubin, POST THERAPY DAY 12-18 | -1.4 Micromoles per liter | Standard Deviation 3.83 |
| Gepotidacin 1000 mg q8h | Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Urate | Direct Bilirubin, POST THERAPY DAY 12-18 | -1.2 Micromoles per liter | Standard Deviation 2.03 |
| Gepotidacin 1000 mg q8h | Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Urate | Bilirubin, FOLLOW UP DAY 21-28 | -1.3 Micromoles per liter | Standard Deviation 6.11 |
| Gepotidacin 1000 mg q8h | Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Urate | Urate, ORAL - FIRST DAY | -1.3 Micromoles per liter | Standard Deviation 67.71 |
| Gepotidacin 1000 mg q8h | Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Urate | Creatinine, ON IV TREATMENT/DAY 2 | 0.66 Micromoles per liter | Standard Deviation 8.711 |
| Gepotidacin 1000 mg q8h | Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Urate | Direct Bilirubin, FOLLOW UP DAY 21-28 | 0.0 Micromoles per liter | — |
| Gepotidacin 1000 mg q8h | Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Urate | Creatinine, ON IV TREATMENT/DAY 3 | -3.93 Micromoles per liter | Standard Deviation 12.123 |
| Gepotidacin 1000 mg q8h | Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Urate | Urate, FOLLOW UP DAY 21-28 | 140.0 Micromoles per liter | — |
Secondary
Change From Baseline in Clinical Chemistry Parameters: Calcium, Carbon Dioxide, Chloride, Glucose, Magnesium, Potassium, Sodium and Urea
Blood samples for assessment of clinical chemistry parameters of calcium, carbon dioxide, chloride, glucose, magnesium, potassium, sodium and urea was collected at Baseline (Day 1), Day 2, Day 7 to 10, Day 12 to 21 and Day 21 to Day 28. Baseline was defined at Day 1. Change from Baseline was calculated by subtracting the post-Baseline value from Baseline value.
Time frame: Baseline (Day 1) up to Day 28
Population: Safety population. Data for only those participants available at the indicated time points were collected and analyzed. Data points with null value for participants analyzed indicate data not collected for respective category and treatment arm.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Gepotidacin 750 mg q12h | Change From Baseline in Clinical Chemistry Parameters: Calcium, Carbon Dioxide, Chloride, Glucose, Magnesium, Potassium, Sodium and Urea | Urea, POST DOSE DAY 3-10 | 0.00 Millimole per liter | — |
| Gepotidacin 750 mg q12h | Change From Baseline in Clinical Chemistry Parameters: Calcium, Carbon Dioxide, Chloride, Glucose, Magnesium, Potassium, Sodium and Urea | Magnesium, ORAL - FIRST DAY | -0.009 Millimole per liter | Standard Deviation 0.0709 |
| Gepotidacin 750 mg q12h | Change From Baseline in Clinical Chemistry Parameters: Calcium, Carbon Dioxide, Chloride, Glucose, Magnesium, Potassium, Sodium and Urea | Magnesium, ORAL - DAY 7-10 | 0.006 Millimole per liter | Standard Deviation 0.081 |
| Gepotidacin 750 mg q12h | Change From Baseline in Clinical Chemistry Parameters: Calcium, Carbon Dioxide, Chloride, Glucose, Magnesium, Potassium, Sodium and Urea | Magnesium, POST THERAPY DAY 12-18 | -0.005 Millimole per liter | Standard Deviation 0.0864 |
| Gepotidacin 750 mg q12h | Change From Baseline in Clinical Chemistry Parameters: Calcium, Carbon Dioxide, Chloride, Glucose, Magnesium, Potassium, Sodium and Urea | Magnesium, FOLLOW UP DAY 21-28 | 0.000 Millimole per liter | Standard Deviation 0.1347 |
| Gepotidacin 750 mg q12h | Change From Baseline in Clinical Chemistry Parameters: Calcium, Carbon Dioxide, Chloride, Glucose, Magnesium, Potassium, Sodium and Urea | Magnesium, POST DOSE DAY 3-10 | -0.040 Millimole per liter | — |
| Gepotidacin 750 mg q12h | Change From Baseline in Clinical Chemistry Parameters: Calcium, Carbon Dioxide, Chloride, Glucose, Magnesium, Potassium, Sodium and Urea | Calcium, ON IV TREATMENT/DAY 2 | -0.041 Millimole per liter | Standard Deviation 0.1095 |
| Gepotidacin 750 mg q12h | Change From Baseline in Clinical Chemistry Parameters: Calcium, Carbon Dioxide, Chloride, Glucose, Magnesium, Potassium, Sodium and Urea | Calcium, ON IV TREATMENT/DAY 3 | -0.007 Millimole per liter | Standard Deviation 0.1732 |
| Gepotidacin 750 mg q12h | Change From Baseline in Clinical Chemistry Parameters: Calcium, Carbon Dioxide, Chloride, Glucose, Magnesium, Potassium, Sodium and Urea | Calcium, ON IV TREATMENT/DAY 5 | 0.024 Millimole per liter | Standard Deviation 0.1313 |
| Gepotidacin 750 mg q12h | Change From Baseline in Clinical Chemistry Parameters: Calcium, Carbon Dioxide, Chloride, Glucose, Magnesium, Potassium, Sodium and Urea | Calcium, ON IV TREATMENT/DAY 7 | 0.080 Millimole per liter | — |
| Gepotidacin 750 mg q12h | Change From Baseline in Clinical Chemistry Parameters: Calcium, Carbon Dioxide, Chloride, Glucose, Magnesium, Potassium, Sodium and Urea | Calcium, ORAL - FIRST DAY | 0.042 Millimole per liter | Standard Deviation 0.1152 |
| Gepotidacin 750 mg q12h | Change From Baseline in Clinical Chemistry Parameters: Calcium, Carbon Dioxide, Chloride, Glucose, Magnesium, Potassium, Sodium and Urea | Calcium, ORAL - DAY 7-10 | 0.093 Millimole per liter | Standard Deviation 0.1373 |
| Gepotidacin 750 mg q12h | Change From Baseline in Clinical Chemistry Parameters: Calcium, Carbon Dioxide, Chloride, Glucose, Magnesium, Potassium, Sodium and Urea | Calcium, POST THERAPY DAY 12-18 | 0.083 Millimole per liter | Standard Deviation 0.144 |
| Gepotidacin 750 mg q12h | Change From Baseline in Clinical Chemistry Parameters: Calcium, Carbon Dioxide, Chloride, Glucose, Magnesium, Potassium, Sodium and Urea | Calcium, FOLLOW UP DAY 21-28 | 0.090 Millimole per liter | Standard Deviation 0.1685 |
| Gepotidacin 750 mg q12h | Change From Baseline in Clinical Chemistry Parameters: Calcium, Carbon Dioxide, Chloride, Glucose, Magnesium, Potassium, Sodium and Urea | Calcium, POST DOSE DAY 3-10 | -0.040 Millimole per liter | — |
| Gepotidacin 750 mg q12h | Change From Baseline in Clinical Chemistry Parameters: Calcium, Carbon Dioxide, Chloride, Glucose, Magnesium, Potassium, Sodium and Urea | Carbon Dioxide, ON IV TREATMENT/DAY 2 | -0.5 Millimole per liter | Standard Deviation 2.87 |
| Gepotidacin 750 mg q12h | Change From Baseline in Clinical Chemistry Parameters: Calcium, Carbon Dioxide, Chloride, Glucose, Magnesium, Potassium, Sodium and Urea | Carbon Dioxide, ON IV TREATMENT/DAY 3 | -0.5 Millimole per liter | Standard Deviation 3.34 |
| Gepotidacin 750 mg q12h | Change From Baseline in Clinical Chemistry Parameters: Calcium, Carbon Dioxide, Chloride, Glucose, Magnesium, Potassium, Sodium and Urea | Carbon Dioxide, ON IV TREATMENT/DAY 5 | 0.1 Millimole per liter | Standard Deviation 4.28 |
| Gepotidacin 750 mg q12h | Change From Baseline in Clinical Chemistry Parameters: Calcium, Carbon Dioxide, Chloride, Glucose, Magnesium, Potassium, Sodium and Urea | Carbon Dioxide, ON IV TREATMENT/DAY 7 | 6.0 Millimole per liter | — |
| Gepotidacin 750 mg q12h | Change From Baseline in Clinical Chemistry Parameters: Calcium, Carbon Dioxide, Chloride, Glucose, Magnesium, Potassium, Sodium and Urea | Carbon Dioxide, ORAL - FIRST DAY | -0.5 Millimole per liter | Standard Deviation 3.14 |
| Gepotidacin 750 mg q12h | Change From Baseline in Clinical Chemistry Parameters: Calcium, Carbon Dioxide, Chloride, Glucose, Magnesium, Potassium, Sodium and Urea | Carbon Dioxide, ORAL - DAY 7-10 | -0.5 Millimole per liter | Standard Deviation 2.43 |
| Gepotidacin 750 mg q12h | Change From Baseline in Clinical Chemistry Parameters: Calcium, Carbon Dioxide, Chloride, Glucose, Magnesium, Potassium, Sodium and Urea | Carbon Dioxide, POST THERAPY DAY 12-18 | -0.3 Millimole per liter | Standard Deviation 2.83 |
| Gepotidacin 750 mg q12h | Change From Baseline in Clinical Chemistry Parameters: Calcium, Carbon Dioxide, Chloride, Glucose, Magnesium, Potassium, Sodium and Urea | Carbon Dioxide, FOLLOW UP DAY 21-28 | -1.5 Millimole per liter | Standard Deviation 3.32 |
| Gepotidacin 750 mg q12h | Change From Baseline in Clinical Chemistry Parameters: Calcium, Carbon Dioxide, Chloride, Glucose, Magnesium, Potassium, Sodium and Urea | Carbon Dioxide, POST DOSE DAY 3-10 | -4.0 Millimole per liter | — |
| Gepotidacin 750 mg q12h | Change From Baseline in Clinical Chemistry Parameters: Calcium, Carbon Dioxide, Chloride, Glucose, Magnesium, Potassium, Sodium and Urea | Chloride, ON IV TREATMENT/DAY 2 | 2.1 Millimole per liter | Standard Deviation 2.32 |
| Gepotidacin 750 mg q12h | Change From Baseline in Clinical Chemistry Parameters: Calcium, Carbon Dioxide, Chloride, Glucose, Magnesium, Potassium, Sodium and Urea | Chloride, ON IV TREATMENT/DAY 3 | 2.3 Millimole per liter | Standard Deviation 2.92 |
| Gepotidacin 750 mg q12h | Change From Baseline in Clinical Chemistry Parameters: Calcium, Carbon Dioxide, Chloride, Glucose, Magnesium, Potassium, Sodium and Urea | Chloride, ON IV TREATMENT/DAY 5 | 2.9 Millimole per liter | Standard Deviation 2.73 |
| Gepotidacin 750 mg q12h | Change From Baseline in Clinical Chemistry Parameters: Calcium, Carbon Dioxide, Chloride, Glucose, Magnesium, Potassium, Sodium and Urea | Chloride, ON IV TREATMENT/DAY 7 | -0.5 Millimole per liter | Standard Deviation 0.71 |
| Gepotidacin 750 mg q12h | Change From Baseline in Clinical Chemistry Parameters: Calcium, Carbon Dioxide, Chloride, Glucose, Magnesium, Potassium, Sodium and Urea | Chloride, ORAL - FIRST DAY | 1.4 Millimole per liter | Standard Deviation 2.52 |
| Gepotidacin 750 mg q12h | Change From Baseline in Clinical Chemistry Parameters: Calcium, Carbon Dioxide, Chloride, Glucose, Magnesium, Potassium, Sodium and Urea | Chloride, ORAL - DAY 7-10 | 0.8 Millimole per liter | Standard Deviation 3.63 |
| Gepotidacin 750 mg q12h | Change From Baseline in Clinical Chemistry Parameters: Calcium, Carbon Dioxide, Chloride, Glucose, Magnesium, Potassium, Sodium and Urea | Chloride, POST THERAPY DAY 12-18 | 1.7 Millimole per liter | Standard Deviation 2.75 |
| Gepotidacin 750 mg q12h | Change From Baseline in Clinical Chemistry Parameters: Calcium, Carbon Dioxide, Chloride, Glucose, Magnesium, Potassium, Sodium and Urea | Chloride, FOLLOW UP DAY 21-28 | 0.5 Millimole per liter | Standard Deviation 4.93 |
| Gepotidacin 750 mg q12h | Change From Baseline in Clinical Chemistry Parameters: Calcium, Carbon Dioxide, Chloride, Glucose, Magnesium, Potassium, Sodium and Urea | Chloride, POST DOSE DAY 3-10 | 4.0 Millimole per liter | — |
| Gepotidacin 750 mg q12h | Change From Baseline in Clinical Chemistry Parameters: Calcium, Carbon Dioxide, Chloride, Glucose, Magnesium, Potassium, Sodium and Urea | Glucose, ON IV TREATMENT/DAY 2 | 0.32 Millimole per liter | Standard Deviation 1.973 |
| Gepotidacin 750 mg q12h | Change From Baseline in Clinical Chemistry Parameters: Calcium, Carbon Dioxide, Chloride, Glucose, Magnesium, Potassium, Sodium and Urea | Glucose, ON IV TREATMENT/DAY 3 | 0.40 Millimole per liter | Standard Deviation 2.144 |
| Gepotidacin 750 mg q12h | Change From Baseline in Clinical Chemistry Parameters: Calcium, Carbon Dioxide, Chloride, Glucose, Magnesium, Potassium, Sodium and Urea | Glucose, ON IV TREATMENT/DAY 5 | -0.51 Millimole per liter | Standard Deviation 3.257 |
| Gepotidacin 750 mg q12h | Change From Baseline in Clinical Chemistry Parameters: Calcium, Carbon Dioxide, Chloride, Glucose, Magnesium, Potassium, Sodium and Urea | Glucose, ON IV TREATMENT/DAY 7 | -2.65 Millimole per liter | Standard Deviation 4.313 |
| Gepotidacin 750 mg q12h | Change From Baseline in Clinical Chemistry Parameters: Calcium, Carbon Dioxide, Chloride, Glucose, Magnesium, Potassium, Sodium and Urea | Glucose, ORAL - FIRST DAY | 0.11 Millimole per liter | Standard Deviation 2.115 |
| Gepotidacin 750 mg q12h | Change From Baseline in Clinical Chemistry Parameters: Calcium, Carbon Dioxide, Chloride, Glucose, Magnesium, Potassium, Sodium and Urea | Glucose, ORAL - DAY 7-10 | 0.14 Millimole per liter | Standard Deviation 1.698 |
| Gepotidacin 750 mg q12h | Change From Baseline in Clinical Chemistry Parameters: Calcium, Carbon Dioxide, Chloride, Glucose, Magnesium, Potassium, Sodium and Urea | Glucose, POST THERAPY DAY 12-18 | -0.19 Millimole per liter | Standard Deviation 1.774 |
| Gepotidacin 750 mg q12h | Change From Baseline in Clinical Chemistry Parameters: Calcium, Carbon Dioxide, Chloride, Glucose, Magnesium, Potassium, Sodium and Urea | Glucose, FOLLOW UP DAY 21-28 | -0.38 Millimole per liter | Standard Deviation 1.284 |
| Gepotidacin 750 mg q12h | Change From Baseline in Clinical Chemistry Parameters: Calcium, Carbon Dioxide, Chloride, Glucose, Magnesium, Potassium, Sodium and Urea | Glucose, POST DOSE DAY 3-10 | 0.30 Millimole per liter | — |
| Gepotidacin 750 mg q12h | Change From Baseline in Clinical Chemistry Parameters: Calcium, Carbon Dioxide, Chloride, Glucose, Magnesium, Potassium, Sodium and Urea | Magnesium, ON IV TREATMENT/DAY 2 | -0.013 Millimole per liter | Standard Deviation 0.0682 |
| Gepotidacin 750 mg q12h | Change From Baseline in Clinical Chemistry Parameters: Calcium, Carbon Dioxide, Chloride, Glucose, Magnesium, Potassium, Sodium and Urea | Magnesium, ON IV TREATMENT/DAY 3 | 0.007 Millimole per liter | Standard Deviation 0.0829 |
| Gepotidacin 750 mg q12h | Change From Baseline in Clinical Chemistry Parameters: Calcium, Carbon Dioxide, Chloride, Glucose, Magnesium, Potassium, Sodium and Urea | Magnesium, ON IV TREATMENT/DAY 5 | 0.044 Millimole per liter | Standard Deviation 0.0532 |
| Gepotidacin 750 mg q12h | Change From Baseline in Clinical Chemistry Parameters: Calcium, Carbon Dioxide, Chloride, Glucose, Magnesium, Potassium, Sodium and Urea | Magnesium, ON IV TREATMENT/DAY 7 | 0.140 Millimole per liter | Standard Deviation 0 |
| Gepotidacin 750 mg q12h | Change From Baseline in Clinical Chemistry Parameters: Calcium, Carbon Dioxide, Chloride, Glucose, Magnesium, Potassium, Sodium and Urea | Potassium, ON IV TREATMENT/DAY 2 | 0.15 Millimole per liter | Standard Deviation 0.398 |
| Gepotidacin 750 mg q12h | Change From Baseline in Clinical Chemistry Parameters: Calcium, Carbon Dioxide, Chloride, Glucose, Magnesium, Potassium, Sodium and Urea | Potassium, ON IV TREATMENT/DAY 3 | 0.24 Millimole per liter | Standard Deviation 0.353 |
| Gepotidacin 750 mg q12h | Change From Baseline in Clinical Chemistry Parameters: Calcium, Carbon Dioxide, Chloride, Glucose, Magnesium, Potassium, Sodium and Urea | Potassium, ON IV TREATMENT/DAY 5 | 0.28 Millimole per liter | Standard Deviation 0.559 |
| Gepotidacin 750 mg q12h | Change From Baseline in Clinical Chemistry Parameters: Calcium, Carbon Dioxide, Chloride, Glucose, Magnesium, Potassium, Sodium and Urea | Potassium, ORAL - FIRST DAY | 0.36 Millimole per liter | Standard Deviation 0.374 |
| Gepotidacin 750 mg q12h | Change From Baseline in Clinical Chemistry Parameters: Calcium, Carbon Dioxide, Chloride, Glucose, Magnesium, Potassium, Sodium and Urea | Potassium, ORAL - DAY 7-10 | 0.29 Millimole per liter | Standard Deviation 0.483 |
| Gepotidacin 750 mg q12h | Change From Baseline in Clinical Chemistry Parameters: Calcium, Carbon Dioxide, Chloride, Glucose, Magnesium, Potassium, Sodium and Urea | Potassium, POST THERAPY DAY 12-18 | 0.28 Millimole per liter | Standard Deviation 0.543 |
| Gepotidacin 750 mg q12h | Change From Baseline in Clinical Chemistry Parameters: Calcium, Carbon Dioxide, Chloride, Glucose, Magnesium, Potassium, Sodium and Urea | Potassium, FOLLOW UP DAY 21-28 | 1.03 Millimole per liter | Standard Deviation 0.877 |
| Gepotidacin 750 mg q12h | Change From Baseline in Clinical Chemistry Parameters: Calcium, Carbon Dioxide, Chloride, Glucose, Magnesium, Potassium, Sodium and Urea | Potassium, POST DOSE DAY 3-10 | -0.10 Millimole per liter | — |
| Gepotidacin 750 mg q12h | Change From Baseline in Clinical Chemistry Parameters: Calcium, Carbon Dioxide, Chloride, Glucose, Magnesium, Potassium, Sodium and Urea | Sodium, ON IV TREATMENT/DAY 2 | 1.1 Millimole per liter | Standard Deviation 2.34 |
| Gepotidacin 750 mg q12h | Change From Baseline in Clinical Chemistry Parameters: Calcium, Carbon Dioxide, Chloride, Glucose, Magnesium, Potassium, Sodium and Urea | Sodium, ON IV TREATMENT/DAY 3 | 1.2 Millimole per liter | Standard Deviation 2.59 |
| Gepotidacin 750 mg q12h | Change From Baseline in Clinical Chemistry Parameters: Calcium, Carbon Dioxide, Chloride, Glucose, Magnesium, Potassium, Sodium and Urea | Sodium, ON IV TREATMENT/DAY 5 | 2.8 Millimole per liter | Standard Deviation 2.78 |
| Gepotidacin 750 mg q12h | Change From Baseline in Clinical Chemistry Parameters: Calcium, Carbon Dioxide, Chloride, Glucose, Magnesium, Potassium, Sodium and Urea | Sodium, ON IV TREATMENT/DAY 7 | 2.0 Millimole per liter | Standard Deviation 2.83 |
| Gepotidacin 750 mg q12h | Change From Baseline in Clinical Chemistry Parameters: Calcium, Carbon Dioxide, Chloride, Glucose, Magnesium, Potassium, Sodium and Urea | Sodium, ORAL - FIRST DAY | 1.2 Millimole per liter | Standard Deviation 2.55 |
| Gepotidacin 750 mg q12h | Change From Baseline in Clinical Chemistry Parameters: Calcium, Carbon Dioxide, Chloride, Glucose, Magnesium, Potassium, Sodium and Urea | Sodium, ORAL - DAY 7-10 | 0.8 Millimole per liter | Standard Deviation 2.44 |
| Gepotidacin 750 mg q12h | Change From Baseline in Clinical Chemistry Parameters: Calcium, Carbon Dioxide, Chloride, Glucose, Magnesium, Potassium, Sodium and Urea | Sodium, POST THERAPY DAY 12-18 | 1.1 Millimole per liter | Standard Deviation 2.53 |
| Gepotidacin 750 mg q12h | Change From Baseline in Clinical Chemistry Parameters: Calcium, Carbon Dioxide, Chloride, Glucose, Magnesium, Potassium, Sodium and Urea | Sodium, FOLLOW UP DAY 21-28 | -3.0 Millimole per liter | Standard Deviation 2.71 |
| Gepotidacin 750 mg q12h | Change From Baseline in Clinical Chemistry Parameters: Calcium, Carbon Dioxide, Chloride, Glucose, Magnesium, Potassium, Sodium and Urea | Sodium, POST DOSE DAY 3-10 | 5.0 Millimole per liter | — |
| Gepotidacin 750 mg q12h | Change From Baseline in Clinical Chemistry Parameters: Calcium, Carbon Dioxide, Chloride, Glucose, Magnesium, Potassium, Sodium and Urea | Urea, ON IV TREATMENT/DAY 2 | -0.11 Millimole per liter | Standard Deviation 1.308 |
| Gepotidacin 750 mg q12h | Change From Baseline in Clinical Chemistry Parameters: Calcium, Carbon Dioxide, Chloride, Glucose, Magnesium, Potassium, Sodium and Urea | Urea, ON IV TREATMENT/DAY 3 | -0.12 Millimole per liter | Standard Deviation 1.484 |
| Gepotidacin 750 mg q12h | Change From Baseline in Clinical Chemistry Parameters: Calcium, Carbon Dioxide, Chloride, Glucose, Magnesium, Potassium, Sodium and Urea | Urea, ON IV TREATMENT/DAY 5 | -0.50 Millimole per liter | Standard Deviation 1.414 |
| Gepotidacin 750 mg q12h | Change From Baseline in Clinical Chemistry Parameters: Calcium, Carbon Dioxide, Chloride, Glucose, Magnesium, Potassium, Sodium and Urea | Urea, ON IV TREATMENT/DAY 7 | 1.00 Millimole per liter | Standard Deviation 2.121 |
| Gepotidacin 750 mg q12h | Change From Baseline in Clinical Chemistry Parameters: Calcium, Carbon Dioxide, Chloride, Glucose, Magnesium, Potassium, Sodium and Urea | Urea, ORAL - FIRST DAY | -0.13 Millimole per liter | Standard Deviation 1.36 |
| Gepotidacin 750 mg q12h | Change From Baseline in Clinical Chemistry Parameters: Calcium, Carbon Dioxide, Chloride, Glucose, Magnesium, Potassium, Sodium and Urea | Urea, ORAL - DAY 7-10 | 0.77 Millimole per liter | Standard Deviation 1.576 |
| Gepotidacin 750 mg q12h | Change From Baseline in Clinical Chemistry Parameters: Calcium, Carbon Dioxide, Chloride, Glucose, Magnesium, Potassium, Sodium and Urea | Urea, POST THERAPY DAY 12-18 | 0.60 Millimole per liter | Standard Deviation 1.563 |
| Gepotidacin 750 mg q12h | Change From Baseline in Clinical Chemistry Parameters: Calcium, Carbon Dioxide, Chloride, Glucose, Magnesium, Potassium, Sodium and Urea | Urea, FOLLOW UP DAY 21-28 | 1.63 Millimole per liter | Standard Deviation 2.016 |
| Gepotidacin 1000 mg q12h | Change From Baseline in Clinical Chemistry Parameters: Calcium, Carbon Dioxide, Chloride, Glucose, Magnesium, Potassium, Sodium and Urea | Carbon Dioxide, ON IV TREATMENT/DAY 2 | -0.3 Millimole per liter | Standard Deviation 2.46 |
| Gepotidacin 1000 mg q12h | Change From Baseline in Clinical Chemistry Parameters: Calcium, Carbon Dioxide, Chloride, Glucose, Magnesium, Potassium, Sodium and Urea | Sodium, ON IV TREATMENT/DAY 3 | 1.0 Millimole per liter | Standard Deviation 2.65 |
| Gepotidacin 1000 mg q12h | Change From Baseline in Clinical Chemistry Parameters: Calcium, Carbon Dioxide, Chloride, Glucose, Magnesium, Potassium, Sodium and Urea | Chloride, ON IV TREATMENT/DAY 7 | 0.5 Millimole per liter | Standard Deviation 0.71 |
| Gepotidacin 1000 mg q12h | Change From Baseline in Clinical Chemistry Parameters: Calcium, Carbon Dioxide, Chloride, Glucose, Magnesium, Potassium, Sodium and Urea | Magnesium, ON IV TREATMENT/DAY 2 | -0.017 Millimole per liter | Standard Deviation 0.0688 |
| Gepotidacin 1000 mg q12h | Change From Baseline in Clinical Chemistry Parameters: Calcium, Carbon Dioxide, Chloride, Glucose, Magnesium, Potassium, Sodium and Urea | Urea, FOLLOW UP DAY 21-28 | 0.25 Millimole per liter | Standard Deviation 1.041 |
| Gepotidacin 1000 mg q12h | Change From Baseline in Clinical Chemistry Parameters: Calcium, Carbon Dioxide, Chloride, Glucose, Magnesium, Potassium, Sodium and Urea | Magnesium, ON IV TREATMENT/DAY 3 | -0.012 Millimole per liter | Standard Deviation 0.0553 |
| Gepotidacin 1000 mg q12h | Change From Baseline in Clinical Chemistry Parameters: Calcium, Carbon Dioxide, Chloride, Glucose, Magnesium, Potassium, Sodium and Urea | Magnesium, ON IV TREATMENT/DAY 4 | 0.000 Millimole per liter | — |
| Gepotidacin 1000 mg q12h | Change From Baseline in Clinical Chemistry Parameters: Calcium, Carbon Dioxide, Chloride, Glucose, Magnesium, Potassium, Sodium and Urea | Sodium, FOLLOW UP DAY 21-28 | -2.3 Millimole per liter | Standard Deviation 2.87 |
| Gepotidacin 1000 mg q12h | Change From Baseline in Clinical Chemistry Parameters: Calcium, Carbon Dioxide, Chloride, Glucose, Magnesium, Potassium, Sodium and Urea | Magnesium, ON IV TREATMENT/DAY 5 | -0.040 Millimole per liter | Standard Deviation 0.0738 |
| Gepotidacin 1000 mg q12h | Change From Baseline in Clinical Chemistry Parameters: Calcium, Carbon Dioxide, Chloride, Glucose, Magnesium, Potassium, Sodium and Urea | Urea, ORAL - DAY 7-10 | 0.10 Millimole per liter | Standard Deviation 1.945 |
| Gepotidacin 1000 mg q12h | Change From Baseline in Clinical Chemistry Parameters: Calcium, Carbon Dioxide, Chloride, Glucose, Magnesium, Potassium, Sodium and Urea | Magnesium, ON IV TREATMENT/DAY 7 | -0.080 Millimole per liter | Standard Deviation 0.0283 |
| Gepotidacin 1000 mg q12h | Change From Baseline in Clinical Chemistry Parameters: Calcium, Carbon Dioxide, Chloride, Glucose, Magnesium, Potassium, Sodium and Urea | Potassium, ON IV TREATMENT/DAY 2 | 0.07 Millimole per liter | Standard Deviation 0.481 |
| Gepotidacin 1000 mg q12h | Change From Baseline in Clinical Chemistry Parameters: Calcium, Carbon Dioxide, Chloride, Glucose, Magnesium, Potassium, Sodium and Urea | Magnesium, ORAL - FIRST DAY | -0.016 Millimole per liter | Standard Deviation 0.0592 |
| Gepotidacin 1000 mg q12h | Change From Baseline in Clinical Chemistry Parameters: Calcium, Carbon Dioxide, Chloride, Glucose, Magnesium, Potassium, Sodium and Urea | Magnesium, ORAL - DAY 7-10 | -0.007 Millimole per liter | Standard Deviation 0.0708 |
| Gepotidacin 1000 mg q12h | Change From Baseline in Clinical Chemistry Parameters: Calcium, Carbon Dioxide, Chloride, Glucose, Magnesium, Potassium, Sodium and Urea | Magnesium, POST THERAPY DAY 12-18 | 0.006 Millimole per liter | Standard Deviation 0.087 |
| Gepotidacin 1000 mg q12h | Change From Baseline in Clinical Chemistry Parameters: Calcium, Carbon Dioxide, Chloride, Glucose, Magnesium, Potassium, Sodium and Urea | Potassium, ON IV TREATMENT/DAY 3 | 0.11 Millimole per liter | Standard Deviation 0.429 |
| Gepotidacin 1000 mg q12h | Change From Baseline in Clinical Chemistry Parameters: Calcium, Carbon Dioxide, Chloride, Glucose, Magnesium, Potassium, Sodium and Urea | Magnesium, FOLLOW UP DAY 21-28 | -0.040 Millimole per liter | Standard Deviation 0.0283 |
| Gepotidacin 1000 mg q12h | Change From Baseline in Clinical Chemistry Parameters: Calcium, Carbon Dioxide, Chloride, Glucose, Magnesium, Potassium, Sodium and Urea | Potassium, ON IV TREATMENT/DAY 4 | -0.10 Millimole per liter | — |
| Gepotidacin 1000 mg q12h | Change From Baseline in Clinical Chemistry Parameters: Calcium, Carbon Dioxide, Chloride, Glucose, Magnesium, Potassium, Sodium and Urea | Calcium, ON IV TREATMENT/DAY 2 | -0.018 Millimole per liter | Standard Deviation 0.1227 |
| Gepotidacin 1000 mg q12h | Change From Baseline in Clinical Chemistry Parameters: Calcium, Carbon Dioxide, Chloride, Glucose, Magnesium, Potassium, Sodium and Urea | Urea, ON IV TREATMENT/DAY 2 | -0.11 Millimole per liter | Standard Deviation 1.189 |
| Gepotidacin 1000 mg q12h | Change From Baseline in Clinical Chemistry Parameters: Calcium, Carbon Dioxide, Chloride, Glucose, Magnesium, Potassium, Sodium and Urea | Calcium, ON IV TREATMENT/DAY 3 | 0.019 Millimole per liter | Standard Deviation 0.1247 |
| Gepotidacin 1000 mg q12h | Change From Baseline in Clinical Chemistry Parameters: Calcium, Carbon Dioxide, Chloride, Glucose, Magnesium, Potassium, Sodium and Urea | Calcium, ON IV TREATMENT/DAY 4 | -0.180 Millimole per liter | — |
| Gepotidacin 1000 mg q12h | Change From Baseline in Clinical Chemistry Parameters: Calcium, Carbon Dioxide, Chloride, Glucose, Magnesium, Potassium, Sodium and Urea | Potassium, ON IV TREATMENT/DAY 5 | 0.02 Millimole per liter | Standard Deviation 0.183 |
| Gepotidacin 1000 mg q12h | Change From Baseline in Clinical Chemistry Parameters: Calcium, Carbon Dioxide, Chloride, Glucose, Magnesium, Potassium, Sodium and Urea | Calcium, ON IV TREATMENT/DAY 5 | -0.007 Millimole per liter | Standard Deviation 0.144 |
| Gepotidacin 1000 mg q12h | Change From Baseline in Clinical Chemistry Parameters: Calcium, Carbon Dioxide, Chloride, Glucose, Magnesium, Potassium, Sodium and Urea | Potassium, ON IV TREATMENT/DAY 7 | 0.55 Millimole per liter | Standard Deviation 0.495 |
| Gepotidacin 1000 mg q12h | Change From Baseline in Clinical Chemistry Parameters: Calcium, Carbon Dioxide, Chloride, Glucose, Magnesium, Potassium, Sodium and Urea | Calcium, ON IV TREATMENT/DAY 7 | 0.040 Millimole per liter | Standard Deviation 0.2263 |
| Gepotidacin 1000 mg q12h | Change From Baseline in Clinical Chemistry Parameters: Calcium, Carbon Dioxide, Chloride, Glucose, Magnesium, Potassium, Sodium and Urea | Calcium, ORAL - FIRST DAY | 0.022 Millimole per liter | Standard Deviation 0.1245 |
| Gepotidacin 1000 mg q12h | Change From Baseline in Clinical Chemistry Parameters: Calcium, Carbon Dioxide, Chloride, Glucose, Magnesium, Potassium, Sodium and Urea | Potassium, ORAL - FIRST DAY | 0.20 Millimole per liter | Standard Deviation 0.468 |
| Gepotidacin 1000 mg q12h | Change From Baseline in Clinical Chemistry Parameters: Calcium, Carbon Dioxide, Chloride, Glucose, Magnesium, Potassium, Sodium and Urea | Calcium, ORAL - DAY 7-10 | 0.064 Millimole per liter | Standard Deviation 0.1063 |
| Gepotidacin 1000 mg q12h | Change From Baseline in Clinical Chemistry Parameters: Calcium, Carbon Dioxide, Chloride, Glucose, Magnesium, Potassium, Sodium and Urea | Calcium, POST THERAPY DAY 12-18 | 0.087 Millimole per liter | Standard Deviation 0.1363 |
| Gepotidacin 1000 mg q12h | Change From Baseline in Clinical Chemistry Parameters: Calcium, Carbon Dioxide, Chloride, Glucose, Magnesium, Potassium, Sodium and Urea | Calcium, FOLLOW UP DAY 21-28 | 0.060 Millimole per liter | Standard Deviation 0.0673 |
| Gepotidacin 1000 mg q12h | Change From Baseline in Clinical Chemistry Parameters: Calcium, Carbon Dioxide, Chloride, Glucose, Magnesium, Potassium, Sodium and Urea | Potassium, ORAL - DAY 7-10 | 0.06 Millimole per liter | Standard Deviation 0.434 |
| Gepotidacin 1000 mg q12h | Change From Baseline in Clinical Chemistry Parameters: Calcium, Carbon Dioxide, Chloride, Glucose, Magnesium, Potassium, Sodium and Urea | Chloride, ON IV TREATMENT/DAY 5 | 0.5 Millimole per liter | Standard Deviation 1.05 |
| Gepotidacin 1000 mg q12h | Change From Baseline in Clinical Chemistry Parameters: Calcium, Carbon Dioxide, Chloride, Glucose, Magnesium, Potassium, Sodium and Urea | Urea, ON IV TREATMENT/DAY 3 | -0.24 Millimole per liter | Standard Deviation 1.715 |
| Gepotidacin 1000 mg q12h | Change From Baseline in Clinical Chemistry Parameters: Calcium, Carbon Dioxide, Chloride, Glucose, Magnesium, Potassium, Sodium and Urea | Carbon Dioxide, ON IV TREATMENT/DAY 3 | -0.6 Millimole per liter | Standard Deviation 2.71 |
| Gepotidacin 1000 mg q12h | Change From Baseline in Clinical Chemistry Parameters: Calcium, Carbon Dioxide, Chloride, Glucose, Magnesium, Potassium, Sodium and Urea | Carbon Dioxide, ON IV TREATMENT/DAY 4 | 1.0 Millimole per liter | — |
| Gepotidacin 1000 mg q12h | Change From Baseline in Clinical Chemistry Parameters: Calcium, Carbon Dioxide, Chloride, Glucose, Magnesium, Potassium, Sodium and Urea | Potassium, POST THERAPY DAY 12-18 | 0.06 Millimole per liter | Standard Deviation 0.573 |
| Gepotidacin 1000 mg q12h | Change From Baseline in Clinical Chemistry Parameters: Calcium, Carbon Dioxide, Chloride, Glucose, Magnesium, Potassium, Sodium and Urea | Carbon Dioxide, ON IV TREATMENT/DAY 5 | 0.7 Millimole per liter | Standard Deviation 3.39 |
| Gepotidacin 1000 mg q12h | Change From Baseline in Clinical Chemistry Parameters: Calcium, Carbon Dioxide, Chloride, Glucose, Magnesium, Potassium, Sodium and Urea | Carbon Dioxide, ON IV TREATMENT/DAY 7 | 2.5 Millimole per liter | Standard Deviation 2.12 |
| Gepotidacin 1000 mg q12h | Change From Baseline in Clinical Chemistry Parameters: Calcium, Carbon Dioxide, Chloride, Glucose, Magnesium, Potassium, Sodium and Urea | Carbon Dioxide, ORAL - FIRST DAY | 0.1 Millimole per liter | Standard Deviation 2.55 |
| Gepotidacin 1000 mg q12h | Change From Baseline in Clinical Chemistry Parameters: Calcium, Carbon Dioxide, Chloride, Glucose, Magnesium, Potassium, Sodium and Urea | Potassium, FOLLOW UP DAY 21-28 | -0.35 Millimole per liter | Standard Deviation 0.998 |
| Gepotidacin 1000 mg q12h | Change From Baseline in Clinical Chemistry Parameters: Calcium, Carbon Dioxide, Chloride, Glucose, Magnesium, Potassium, Sodium and Urea | Carbon Dioxide, ORAL - DAY 7-10 | 0.4 Millimole per liter | Standard Deviation 2.87 |
| Gepotidacin 1000 mg q12h | Change From Baseline in Clinical Chemistry Parameters: Calcium, Carbon Dioxide, Chloride, Glucose, Magnesium, Potassium, Sodium and Urea | Carbon Dioxide, POST THERAPY DAY 12-18 | -0.1 Millimole per liter | Standard Deviation 3.32 |
| Gepotidacin 1000 mg q12h | Change From Baseline in Clinical Chemistry Parameters: Calcium, Carbon Dioxide, Chloride, Glucose, Magnesium, Potassium, Sodium and Urea | Urea, ON IV TREATMENT/DAY 4 | -1.00 Millimole per liter | — |
| Gepotidacin 1000 mg q12h | Change From Baseline in Clinical Chemistry Parameters: Calcium, Carbon Dioxide, Chloride, Glucose, Magnesium, Potassium, Sodium and Urea | Carbon Dioxide, FOLLOW UP DAY 21-28 | 2.3 Millimole per liter | Standard Deviation 1.89 |
| Gepotidacin 1000 mg q12h | Change From Baseline in Clinical Chemistry Parameters: Calcium, Carbon Dioxide, Chloride, Glucose, Magnesium, Potassium, Sodium and Urea | Urea, POST THERAPY DAY 12-18 | 0.63 Millimole per liter | Standard Deviation 1.437 |
| Gepotidacin 1000 mg q12h | Change From Baseline in Clinical Chemistry Parameters: Calcium, Carbon Dioxide, Chloride, Glucose, Magnesium, Potassium, Sodium and Urea | Sodium, ON IV TREATMENT/DAY 2 | 0.9 Millimole per liter | Standard Deviation 2.67 |
| Gepotidacin 1000 mg q12h | Change From Baseline in Clinical Chemistry Parameters: Calcium, Carbon Dioxide, Chloride, Glucose, Magnesium, Potassium, Sodium and Urea | Chloride, ON IV TREATMENT/DAY 2 | 1.3 Millimole per liter | Standard Deviation 2.92 |
| Gepotidacin 1000 mg q12h | Change From Baseline in Clinical Chemistry Parameters: Calcium, Carbon Dioxide, Chloride, Glucose, Magnesium, Potassium, Sodium and Urea | Chloride, ON IV TREATMENT/DAY 3 | 1.4 Millimole per liter | Standard Deviation 2.78 |
| Gepotidacin 1000 mg q12h | Change From Baseline in Clinical Chemistry Parameters: Calcium, Carbon Dioxide, Chloride, Glucose, Magnesium, Potassium, Sodium and Urea | Chloride, ON IV TREATMENT/DAY 4 | -1.0 Millimole per liter | — |
| Gepotidacin 1000 mg q12h | Change From Baseline in Clinical Chemistry Parameters: Calcium, Carbon Dioxide, Chloride, Glucose, Magnesium, Potassium, Sodium and Urea | Urea, ON IV TREATMENT/DAY 5 | 0.42 Millimole per liter | Standard Deviation 1.32 |
| Gepotidacin 1000 mg q12h | Change From Baseline in Clinical Chemistry Parameters: Calcium, Carbon Dioxide, Chloride, Glucose, Magnesium, Potassium, Sodium and Urea | Chloride, ORAL - FIRST DAY | 0.4 Millimole per liter | Standard Deviation 2.7 |
| Gepotidacin 1000 mg q12h | Change From Baseline in Clinical Chemistry Parameters: Calcium, Carbon Dioxide, Chloride, Glucose, Magnesium, Potassium, Sodium and Urea | Sodium, ON IV TREATMENT/DAY 4 | -3.0 Millimole per liter | — |
| Gepotidacin 1000 mg q12h | Change From Baseline in Clinical Chemistry Parameters: Calcium, Carbon Dioxide, Chloride, Glucose, Magnesium, Potassium, Sodium and Urea | Chloride, ORAL - DAY 7-10 | 0.7 Millimole per liter | Standard Deviation 2.23 |
| Gepotidacin 1000 mg q12h | Change From Baseline in Clinical Chemistry Parameters: Calcium, Carbon Dioxide, Chloride, Glucose, Magnesium, Potassium, Sodium and Urea | Chloride, POST THERAPY DAY 12-18 | 1.6 Millimole per liter | Standard Deviation 3.21 |
| Gepotidacin 1000 mg q12h | Change From Baseline in Clinical Chemistry Parameters: Calcium, Carbon Dioxide, Chloride, Glucose, Magnesium, Potassium, Sodium and Urea | Sodium, ON IV TREATMENT/DAY 5 | 1.0 Millimole per liter | Standard Deviation 2.9 |
| Gepotidacin 1000 mg q12h | Change From Baseline in Clinical Chemistry Parameters: Calcium, Carbon Dioxide, Chloride, Glucose, Magnesium, Potassium, Sodium and Urea | Chloride, FOLLOW UP DAY 21-28 | -3.0 Millimole per liter | Standard Deviation 2.94 |
| Gepotidacin 1000 mg q12h | Change From Baseline in Clinical Chemistry Parameters: Calcium, Carbon Dioxide, Chloride, Glucose, Magnesium, Potassium, Sodium and Urea | Urea, ON IV TREATMENT/DAY 7 | -0.25 Millimole per liter | Standard Deviation 1.061 |
| Gepotidacin 1000 mg q12h | Change From Baseline in Clinical Chemistry Parameters: Calcium, Carbon Dioxide, Chloride, Glucose, Magnesium, Potassium, Sodium and Urea | Sodium, ON IV TREATMENT/DAY 7 | 0.0 Millimole per liter | Standard Deviation 8.49 |
| Gepotidacin 1000 mg q12h | Change From Baseline in Clinical Chemistry Parameters: Calcium, Carbon Dioxide, Chloride, Glucose, Magnesium, Potassium, Sodium and Urea | Glucose, ON IV TREATMENT/DAY 2 | -0.31 Millimole per liter | Standard Deviation 2.863 |
| Gepotidacin 1000 mg q12h | Change From Baseline in Clinical Chemistry Parameters: Calcium, Carbon Dioxide, Chloride, Glucose, Magnesium, Potassium, Sodium and Urea | Glucose, ON IV TREATMENT/DAY 3 | 0.48 Millimole per liter | Standard Deviation 3.087 |
| Gepotidacin 1000 mg q12h | Change From Baseline in Clinical Chemistry Parameters: Calcium, Carbon Dioxide, Chloride, Glucose, Magnesium, Potassium, Sodium and Urea | Glucose, ON IV TREATMENT/DAY 4 | 6.60 Millimole per liter | — |
| Gepotidacin 1000 mg q12h | Change From Baseline in Clinical Chemistry Parameters: Calcium, Carbon Dioxide, Chloride, Glucose, Magnesium, Potassium, Sodium and Urea | Sodium, ORAL - FIRST DAY | 0.3 Millimole per liter | Standard Deviation 3.05 |
| Gepotidacin 1000 mg q12h | Change From Baseline in Clinical Chemistry Parameters: Calcium, Carbon Dioxide, Chloride, Glucose, Magnesium, Potassium, Sodium and Urea | Glucose, ON IV TREATMENT/DAY 5 | 1.92 Millimole per liter | Standard Deviation 1.723 |
| Gepotidacin 1000 mg q12h | Change From Baseline in Clinical Chemistry Parameters: Calcium, Carbon Dioxide, Chloride, Glucose, Magnesium, Potassium, Sodium and Urea | Glucose, ON IV TREATMENT/DAY 7 | 3.70 Millimole per liter | Standard Deviation 2.687 |
| Gepotidacin 1000 mg q12h | Change From Baseline in Clinical Chemistry Parameters: Calcium, Carbon Dioxide, Chloride, Glucose, Magnesium, Potassium, Sodium and Urea | Urea, ORAL - FIRST DAY | -0.56 Millimole per liter | Standard Deviation 1.65 |
| Gepotidacin 1000 mg q12h | Change From Baseline in Clinical Chemistry Parameters: Calcium, Carbon Dioxide, Chloride, Glucose, Magnesium, Potassium, Sodium and Urea | Glucose, ORAL - FIRST DAY | 0.13 Millimole per liter | Standard Deviation 2.926 |
| Gepotidacin 1000 mg q12h | Change From Baseline in Clinical Chemistry Parameters: Calcium, Carbon Dioxide, Chloride, Glucose, Magnesium, Potassium, Sodium and Urea | Sodium, ORAL - DAY 7-10 | 0.5 Millimole per liter | Standard Deviation 2.9 |
| Gepotidacin 1000 mg q12h | Change From Baseline in Clinical Chemistry Parameters: Calcium, Carbon Dioxide, Chloride, Glucose, Magnesium, Potassium, Sodium and Urea | Glucose, ORAL - DAY 7-10 | 1.08 Millimole per liter | Standard Deviation 3.066 |
| Gepotidacin 1000 mg q12h | Change From Baseline in Clinical Chemistry Parameters: Calcium, Carbon Dioxide, Chloride, Glucose, Magnesium, Potassium, Sodium and Urea | Glucose, POST THERAPY DAY 12-18 | 0.34 Millimole per liter | Standard Deviation 2.719 |
| Gepotidacin 1000 mg q12h | Change From Baseline in Clinical Chemistry Parameters: Calcium, Carbon Dioxide, Chloride, Glucose, Magnesium, Potassium, Sodium and Urea | Glucose, FOLLOW UP DAY 21-28 | 1.95 Millimole per liter | Standard Deviation 3.45 |
| Gepotidacin 1000 mg q12h | Change From Baseline in Clinical Chemistry Parameters: Calcium, Carbon Dioxide, Chloride, Glucose, Magnesium, Potassium, Sodium and Urea | Sodium, POST THERAPY DAY 12-18 | 1.4 Millimole per liter | Standard Deviation 2.7 |
| Gepotidacin 1000 mg q8h | Change From Baseline in Clinical Chemistry Parameters: Calcium, Carbon Dioxide, Chloride, Glucose, Magnesium, Potassium, Sodium and Urea | Sodium, ON IV TREATMENT/DAY 3 | 1.4 Millimole per liter | Standard Deviation 4.16 |
| Gepotidacin 1000 mg q8h | Change From Baseline in Clinical Chemistry Parameters: Calcium, Carbon Dioxide, Chloride, Glucose, Magnesium, Potassium, Sodium and Urea | Calcium, ORAL - DAY 7-10 | 0.030 Millimole per liter | Standard Deviation 0.1231 |
| Gepotidacin 1000 mg q8h | Change From Baseline in Clinical Chemistry Parameters: Calcium, Carbon Dioxide, Chloride, Glucose, Magnesium, Potassium, Sodium and Urea | Chloride, ORAL - FIRST DAY | 1.1 Millimole per liter | Standard Deviation 3.13 |
| Gepotidacin 1000 mg q8h | Change From Baseline in Clinical Chemistry Parameters: Calcium, Carbon Dioxide, Chloride, Glucose, Magnesium, Potassium, Sodium and Urea | Potassium, ORAL - FIRST DAY | 0.27 Millimole per liter | Standard Deviation 0.365 |
| Gepotidacin 1000 mg q8h | Change From Baseline in Clinical Chemistry Parameters: Calcium, Carbon Dioxide, Chloride, Glucose, Magnesium, Potassium, Sodium and Urea | Magnesium, ORAL - FIRST DAY | 0.006 Millimole per liter | Standard Deviation 0.0613 |
| Gepotidacin 1000 mg q8h | Change From Baseline in Clinical Chemistry Parameters: Calcium, Carbon Dioxide, Chloride, Glucose, Magnesium, Potassium, Sodium and Urea | Chloride, ORAL - DAY 7-10 | 1.2 Millimole per liter | Standard Deviation 2.93 |
| Gepotidacin 1000 mg q8h | Change From Baseline in Clinical Chemistry Parameters: Calcium, Carbon Dioxide, Chloride, Glucose, Magnesium, Potassium, Sodium and Urea | Urea, POST THERAPY DAY 12-18 | -0.03 Millimole per liter | Standard Deviation 1.486 |
| Gepotidacin 1000 mg q8h | Change From Baseline in Clinical Chemistry Parameters: Calcium, Carbon Dioxide, Chloride, Glucose, Magnesium, Potassium, Sodium and Urea | Potassium, ON IV TREATMENT/DAY 2 | 0.22 Millimole per liter | Standard Deviation 0.458 |
| Gepotidacin 1000 mg q8h | Change From Baseline in Clinical Chemistry Parameters: Calcium, Carbon Dioxide, Chloride, Glucose, Magnesium, Potassium, Sodium and Urea | Chloride, POST THERAPY DAY 12-18 | 1.8 Millimole per liter | Standard Deviation 2.95 |
| Gepotidacin 1000 mg q8h | Change From Baseline in Clinical Chemistry Parameters: Calcium, Carbon Dioxide, Chloride, Glucose, Magnesium, Potassium, Sodium and Urea | Carbon Dioxide, POST THERAPY DAY 12-18 | 1.0 Millimole per liter | Standard Deviation 1.73 |
| Gepotidacin 1000 mg q8h | Change From Baseline in Clinical Chemistry Parameters: Calcium, Carbon Dioxide, Chloride, Glucose, Magnesium, Potassium, Sodium and Urea | Magnesium, ORAL - DAY 7-10 | 0.021 Millimole per liter | Standard Deviation 0.0659 |
| Gepotidacin 1000 mg q8h | Change From Baseline in Clinical Chemistry Parameters: Calcium, Carbon Dioxide, Chloride, Glucose, Magnesium, Potassium, Sodium and Urea | Chloride, FOLLOW UP DAY 21-28 | 3.0 Millimole per liter | — |
| Gepotidacin 1000 mg q8h | Change From Baseline in Clinical Chemistry Parameters: Calcium, Carbon Dioxide, Chloride, Glucose, Magnesium, Potassium, Sodium and Urea | Urea, ORAL - DAY 7-10 | 0.29 Millimole per liter | Standard Deviation 1.586 |
| Gepotidacin 1000 mg q8h | Change From Baseline in Clinical Chemistry Parameters: Calcium, Carbon Dioxide, Chloride, Glucose, Magnesium, Potassium, Sodium and Urea | Calcium, POST THERAPY DAY 12-18 | 0.047 Millimole per liter | Standard Deviation 0.1239 |
| Gepotidacin 1000 mg q8h | Change From Baseline in Clinical Chemistry Parameters: Calcium, Carbon Dioxide, Chloride, Glucose, Magnesium, Potassium, Sodium and Urea | Glucose, ON IV TREATMENT/DAY 2 | -0.88 Millimole per liter | Standard Deviation 2.462 |
| Gepotidacin 1000 mg q8h | Change From Baseline in Clinical Chemistry Parameters: Calcium, Carbon Dioxide, Chloride, Glucose, Magnesium, Potassium, Sodium and Urea | Magnesium, POST THERAPY DAY 12-18 | -0.008 Millimole per liter | Standard Deviation 0.0737 |
| Gepotidacin 1000 mg q8h | Change From Baseline in Clinical Chemistry Parameters: Calcium, Carbon Dioxide, Chloride, Glucose, Magnesium, Potassium, Sodium and Urea | Urea, FOLLOW UP DAY 21-28 | -1.00 Millimole per liter | — |
| Gepotidacin 1000 mg q8h | Change From Baseline in Clinical Chemistry Parameters: Calcium, Carbon Dioxide, Chloride, Glucose, Magnesium, Potassium, Sodium and Urea | Glucose, ON IV TREATMENT/DAY 3 | -0.37 Millimole per liter | Standard Deviation 2.384 |
| Gepotidacin 1000 mg q8h | Change From Baseline in Clinical Chemistry Parameters: Calcium, Carbon Dioxide, Chloride, Glucose, Magnesium, Potassium, Sodium and Urea | Urea, ON IV TREATMENT/DAY 3 | -0.61 Millimole per liter | Standard Deviation 2.088 |
| Gepotidacin 1000 mg q8h | Change From Baseline in Clinical Chemistry Parameters: Calcium, Carbon Dioxide, Chloride, Glucose, Magnesium, Potassium, Sodium and Urea | Magnesium, FOLLOW UP DAY 21-28 | 0.000 Millimole per liter | — |
| Gepotidacin 1000 mg q8h | Change From Baseline in Clinical Chemistry Parameters: Calcium, Carbon Dioxide, Chloride, Glucose, Magnesium, Potassium, Sodium and Urea | Potassium, ON IV TREATMENT/DAY 3 | 0.16 Millimole per liter | Standard Deviation 0.433 |
| Gepotidacin 1000 mg q8h | Change From Baseline in Clinical Chemistry Parameters: Calcium, Carbon Dioxide, Chloride, Glucose, Magnesium, Potassium, Sodium and Urea | Sodium, ORAL - FIRST DAY | 1.2 Millimole per liter | Standard Deviation 2.54 |
| Gepotidacin 1000 mg q8h | Change From Baseline in Clinical Chemistry Parameters: Calcium, Carbon Dioxide, Chloride, Glucose, Magnesium, Potassium, Sodium and Urea | Calcium, FOLLOW UP DAY 21-28 | 0.060 Millimole per liter | — |
| Gepotidacin 1000 mg q8h | Change From Baseline in Clinical Chemistry Parameters: Calcium, Carbon Dioxide, Chloride, Glucose, Magnesium, Potassium, Sodium and Urea | Sodium, ON IV TREATMENT/DAY 2 | 1.6 Millimole per liter | Standard Deviation 1.93 |
| Gepotidacin 1000 mg q8h | Change From Baseline in Clinical Chemistry Parameters: Calcium, Carbon Dioxide, Chloride, Glucose, Magnesium, Potassium, Sodium and Urea | Calcium, ON IV TREATMENT/DAY 2 | -0.048 Millimole per liter | Standard Deviation 0.1221 |
| Gepotidacin 1000 mg q8h | Change From Baseline in Clinical Chemistry Parameters: Calcium, Carbon Dioxide, Chloride, Glucose, Magnesium, Potassium, Sodium and Urea | Glucose, ORAL - FIRST DAY | -0.04 Millimole per liter | Standard Deviation 1.619 |
| Gepotidacin 1000 mg q8h | Change From Baseline in Clinical Chemistry Parameters: Calcium, Carbon Dioxide, Chloride, Glucose, Magnesium, Potassium, Sodium and Urea | Potassium, ORAL - DAY 7-10 | 0.05 Millimole per liter | Standard Deviation 0.533 |
| Gepotidacin 1000 mg q8h | Change From Baseline in Clinical Chemistry Parameters: Calcium, Carbon Dioxide, Chloride, Glucose, Magnesium, Potassium, Sodium and Urea | Carbon Dioxide, ORAL - FIRST DAY | -0.4 Millimole per liter | Standard Deviation 2.97 |
| Gepotidacin 1000 mg q8h | Change From Baseline in Clinical Chemistry Parameters: Calcium, Carbon Dioxide, Chloride, Glucose, Magnesium, Potassium, Sodium and Urea | Glucose, ORAL - DAY 7-10 | -0.46 Millimole per liter | Standard Deviation 1.741 |
| Gepotidacin 1000 mg q8h | Change From Baseline in Clinical Chemistry Parameters: Calcium, Carbon Dioxide, Chloride, Glucose, Magnesium, Potassium, Sodium and Urea | Sodium, ORAL - DAY 7-10 | 1.3 Millimole per liter | Standard Deviation 2.55 |
| Gepotidacin 1000 mg q8h | Change From Baseline in Clinical Chemistry Parameters: Calcium, Carbon Dioxide, Chloride, Glucose, Magnesium, Potassium, Sodium and Urea | Calcium, ON IV TREATMENT/DAY 3 | -0.009 Millimole per liter | Standard Deviation 0.1289 |
| Gepotidacin 1000 mg q8h | Change From Baseline in Clinical Chemistry Parameters: Calcium, Carbon Dioxide, Chloride, Glucose, Magnesium, Potassium, Sodium and Urea | Glucose, POST THERAPY DAY 12-18 | -0.84 Millimole per liter | Standard Deviation 2.068 |
| Gepotidacin 1000 mg q8h | Change From Baseline in Clinical Chemistry Parameters: Calcium, Carbon Dioxide, Chloride, Glucose, Magnesium, Potassium, Sodium and Urea | Urea, ORAL - FIRST DAY | -0.41 Millimole per liter | Standard Deviation 1.379 |
| Gepotidacin 1000 mg q8h | Change From Baseline in Clinical Chemistry Parameters: Calcium, Carbon Dioxide, Chloride, Glucose, Magnesium, Potassium, Sodium and Urea | Carbon Dioxide, ON IV TREATMENT/DAY 2 | 0.1 Millimole per liter | Standard Deviation 2.49 |
| Gepotidacin 1000 mg q8h | Change From Baseline in Clinical Chemistry Parameters: Calcium, Carbon Dioxide, Chloride, Glucose, Magnesium, Potassium, Sodium and Urea | Glucose, FOLLOW UP DAY 21-28 | -0.10 Millimole per liter | — |
| Gepotidacin 1000 mg q8h | Change From Baseline in Clinical Chemistry Parameters: Calcium, Carbon Dioxide, Chloride, Glucose, Magnesium, Potassium, Sodium and Urea | Chloride, ON IV TREATMENT/DAY 3 | 2.1 Millimole per liter | Standard Deviation 4.04 |
| Gepotidacin 1000 mg q8h | Change From Baseline in Clinical Chemistry Parameters: Calcium, Carbon Dioxide, Chloride, Glucose, Magnesium, Potassium, Sodium and Urea | Sodium, POST THERAPY DAY 12-18 | 1.8 Millimole per liter | Standard Deviation 2.93 |
| Gepotidacin 1000 mg q8h | Change From Baseline in Clinical Chemistry Parameters: Calcium, Carbon Dioxide, Chloride, Glucose, Magnesium, Potassium, Sodium and Urea | Carbon Dioxide, FOLLOW UP DAY 21-28 | 1.0 Millimole per liter | — |
| Gepotidacin 1000 mg q8h | Change From Baseline in Clinical Chemistry Parameters: Calcium, Carbon Dioxide, Chloride, Glucose, Magnesium, Potassium, Sodium and Urea | Magnesium, ON IV TREATMENT/DAY 2 | 0.004 Millimole per liter | Standard Deviation 0.0865 |
| Gepotidacin 1000 mg q8h | Change From Baseline in Clinical Chemistry Parameters: Calcium, Carbon Dioxide, Chloride, Glucose, Magnesium, Potassium, Sodium and Urea | Carbon Dioxide, ON IV TREATMENT/DAY 3 | 0.4 Millimole per liter | Standard Deviation 2.19 |
| Gepotidacin 1000 mg q8h | Change From Baseline in Clinical Chemistry Parameters: Calcium, Carbon Dioxide, Chloride, Glucose, Magnesium, Potassium, Sodium and Urea | Carbon Dioxide, ORAL - DAY 7-10 | -0.2 Millimole per liter | Standard Deviation 3.09 |
| Gepotidacin 1000 mg q8h | Change From Baseline in Clinical Chemistry Parameters: Calcium, Carbon Dioxide, Chloride, Glucose, Magnesium, Potassium, Sodium and Urea | Magnesium, ON IV TREATMENT/DAY 3 | 0.018 Millimole per liter | Standard Deviation 0.0689 |
| Gepotidacin 1000 mg q8h | Change From Baseline in Clinical Chemistry Parameters: Calcium, Carbon Dioxide, Chloride, Glucose, Magnesium, Potassium, Sodium and Urea | Urea, ON IV TREATMENT/DAY 2 | -0.58 Millimole per liter | Standard Deviation 1.11 |
| Gepotidacin 1000 mg q8h | Change From Baseline in Clinical Chemistry Parameters: Calcium, Carbon Dioxide, Chloride, Glucose, Magnesium, Potassium, Sodium and Urea | Potassium, FOLLOW UP DAY 21-28 | 0.60 Millimole per liter | — |
| Gepotidacin 1000 mg q8h | Change From Baseline in Clinical Chemistry Parameters: Calcium, Carbon Dioxide, Chloride, Glucose, Magnesium, Potassium, Sodium and Urea | Calcium, ORAL - FIRST DAY | 0.018 Millimole per liter | Standard Deviation 0.0908 |
| Gepotidacin 1000 mg q8h | Change From Baseline in Clinical Chemistry Parameters: Calcium, Carbon Dioxide, Chloride, Glucose, Magnesium, Potassium, Sodium and Urea | Sodium, FOLLOW UP DAY 21-28 | 1.0 Millimole per liter | — |
| Gepotidacin 1000 mg q8h | Change From Baseline in Clinical Chemistry Parameters: Calcium, Carbon Dioxide, Chloride, Glucose, Magnesium, Potassium, Sodium and Urea | Chloride, ON IV TREATMENT/DAY 2 | 2.4 Millimole per liter | Standard Deviation 2.98 |
| Gepotidacin 1000 mg q8h | Change From Baseline in Clinical Chemistry Parameters: Calcium, Carbon Dioxide, Chloride, Glucose, Magnesium, Potassium, Sodium and Urea | Potassium, POST THERAPY DAY 12-18 | 0.22 Millimole per liter | Standard Deviation 0.487 |
Secondary
Change From Baseline in Clinical Chemistry Parameters: Creatinine Clearance, Estimated
Blood samples for assessment of clinical chemistry parameter of estimated creatinine clearance was collected at Baseline (Day 1), Day 2, Day 7 to 10, Day 12 to 21 and Day 21 to Day 28. Baseline was defined at Day 1. Change from Baseline was calculated by subtracting the post-Baseline value from Baseline value.
Time frame: Baseline (Day 1) up to Day 28
Population: Safety Population. Data for only those participants available at the indicated time points were collected and analyzed. Data points with null value for participants analyzed indicate data not collected for respective category and treatment arm.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Gepotidacin 750 mg q12h | Change From Baseline in Clinical Chemistry Parameters: Creatinine Clearance, Estimated | POST DOSE DAY 3-10 | 6.0 Milliliter per minute | — |
| Gepotidacin 750 mg q12h | Change From Baseline in Clinical Chemistry Parameters: Creatinine Clearance, Estimated | ON IV TREATMENT/DAY 3 | -4.8 Milliliter per minute | Standard Deviation 32.17 |
| Gepotidacin 750 mg q12h | Change From Baseline in Clinical Chemistry Parameters: Creatinine Clearance, Estimated | ON IV TREATMENT/DAY 5 | -17.4 Milliliter per minute | Standard Deviation 59.39 |
| Gepotidacin 750 mg q12h | Change From Baseline in Clinical Chemistry Parameters: Creatinine Clearance, Estimated | ON IV TREATMENT/DAY 7 | -22.0 Milliliter per minute | Standard Deviation 29.7 |
| Gepotidacin 750 mg q12h | Change From Baseline in Clinical Chemistry Parameters: Creatinine Clearance, Estimated | ORAL - FIRST DAY | -12.6 Milliliter per minute | Standard Deviation 32.53 |
| Gepotidacin 750 mg q12h | Change From Baseline in Clinical Chemistry Parameters: Creatinine Clearance, Estimated | ORAL - DAY 7-10 | -13.2 Milliliter per minute | Standard Deviation 29.04 |
| Gepotidacin 750 mg q12h | Change From Baseline in Clinical Chemistry Parameters: Creatinine Clearance, Estimated | POST THERAPY DAY 12-18 | -8.8 Milliliter per minute | Standard Deviation 28.55 |
| Gepotidacin 750 mg q12h | Change From Baseline in Clinical Chemistry Parameters: Creatinine Clearance, Estimated | FOLLOW UP DAY 21-28 | -13.7 Milliliter per minute | Standard Deviation 25.54 |
| Gepotidacin 750 mg q12h | Change From Baseline in Clinical Chemistry Parameters: Creatinine Clearance, Estimated | ON IV TREATMENT/DAY 2 | -6.8 Milliliter per minute | Standard Deviation 22.65 |
| Gepotidacin 1000 mg q12h | Change From Baseline in Clinical Chemistry Parameters: Creatinine Clearance, Estimated | FOLLOW UP DAY 21-28 | 3.8 Milliliter per minute | Standard Deviation 5.74 |
| Gepotidacin 1000 mg q12h | Change From Baseline in Clinical Chemistry Parameters: Creatinine Clearance, Estimated | ON IV TREATMENT/DAY 7 | -9.5 Milliliter per minute | Standard Deviation 13.44 |
| Gepotidacin 1000 mg q12h | Change From Baseline in Clinical Chemistry Parameters: Creatinine Clearance, Estimated | POST THERAPY DAY 12-18 | -10.4 Milliliter per minute | Standard Deviation 24.61 |
| Gepotidacin 1000 mg q12h | Change From Baseline in Clinical Chemistry Parameters: Creatinine Clearance, Estimated | ORAL - FIRST DAY | -1.1 Milliliter per minute | Standard Deviation 31.43 |
| Gepotidacin 1000 mg q12h | Change From Baseline in Clinical Chemistry Parameters: Creatinine Clearance, Estimated | ON IV TREATMENT/DAY 2 | -1.8 Milliliter per minute | Standard Deviation 17.47 |
| Gepotidacin 1000 mg q12h | Change From Baseline in Clinical Chemistry Parameters: Creatinine Clearance, Estimated | ORAL - DAY 7-10 | -9.7 Milliliter per minute | Standard Deviation 36.67 |
| Gepotidacin 1000 mg q12h | Change From Baseline in Clinical Chemistry Parameters: Creatinine Clearance, Estimated | ON IV TREATMENT/DAY 3 | 1.7 Milliliter per minute | Standard Deviation 30.02 |
| Gepotidacin 1000 mg q12h | Change From Baseline in Clinical Chemistry Parameters: Creatinine Clearance, Estimated | ON IV TREATMENT/DAY 4 | 5.0 Milliliter per minute | — |
| Gepotidacin 1000 mg q12h | Change From Baseline in Clinical Chemistry Parameters: Creatinine Clearance, Estimated | ON IV TREATMENT/DAY 5 | -14.5 Milliliter per minute | Standard Deviation 14.92 |
| Gepotidacin 1000 mg q8h | Change From Baseline in Clinical Chemistry Parameters: Creatinine Clearance, Estimated | ORAL - FIRST DAY | -6.3 Milliliter per minute | Standard Deviation 16.45 |
| Gepotidacin 1000 mg q8h | Change From Baseline in Clinical Chemistry Parameters: Creatinine Clearance, Estimated | POST THERAPY DAY 12-18 | -5.6 Milliliter per minute | Standard Deviation 12.72 |
| Gepotidacin 1000 mg q8h | Change From Baseline in Clinical Chemistry Parameters: Creatinine Clearance, Estimated | ORAL - DAY 7-10 | -8.3 Milliliter per minute | Standard Deviation 16.53 |
| Gepotidacin 1000 mg q8h | Change From Baseline in Clinical Chemistry Parameters: Creatinine Clearance, Estimated | ON IV TREATMENT/DAY 2 | -1.7 Milliliter per minute | Standard Deviation 17.98 |
| Gepotidacin 1000 mg q8h | Change From Baseline in Clinical Chemistry Parameters: Creatinine Clearance, Estimated | ON IV TREATMENT/DAY 3 | 3.8 Milliliter per minute | Standard Deviation 19.7 |
Secondary
Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets
Blood samples for assessment of hematology parameters of basophils, eosinophils, leukocytes, lymphocytes, monocytes, neutrophils and platelets was collected at Baseline (Day 1), Day 2, Day 7 to 10, Day 12 to 21 and Day 21 to Day 28. Baseline was defined at Day 1. Change from Baseline was calculated by subtracting the post-Baseline value from Baseline value.
Time frame: Baseline (Day 1) up to Day 28
Population: Safety Population. Data for only those participants available at the indicated time points were collected and analyzed. Data points with null value for participants analyzed indicate data not collected for respective category and treatment arm.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Gepotidacin 750 mg q12h | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets | Platelets, POST DOSE DAY 3-10 | 148.0 Giga cells per liter | — |
| Gepotidacin 750 mg q12h | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets | Basophils, ON IV TREATMENT/DAY 2 | 0.000 Giga cells per liter | Standard Deviation 0.033 |
| Gepotidacin 750 mg q12h | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets | Basophils, ON IV TREATMENT/DAY 3 | -0.003 Giga cells per liter | Standard Deviation 0.0262 |
| Gepotidacin 750 mg q12h | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets | Basophils, ON IV TREATMENT/DAY 5 | 0.008 Giga cells per liter | Standard Deviation 0.0212 |
| Gepotidacin 750 mg q12h | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets | Basophils, ON IV TREATMENT/DAY 7 | 0.013 Giga cells per liter | Standard Deviation 0.0206 |
| Gepotidacin 750 mg q12h | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets | Basophils, ON IV TREATMENT/DAY 10 | -0.020 Giga cells per liter | — |
| Gepotidacin 750 mg q12h | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets | Basophils, ORAL - FIRST DAY | 0.000 Giga cells per liter | Standard Deviation 0.031 |
| Gepotidacin 750 mg q12h | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets | Basophils, ORAL - DAY 7-10 | 0.001 Giga cells per liter | Standard Deviation 0.0277 |
| Gepotidacin 750 mg q12h | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets | Basophils, POST THERAPY DAY 12-18 | 0.005 Giga cells per liter | Standard Deviation 0.0304 |
| Gepotidacin 750 mg q12h | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets | Basophils, FOLLOW UP DAY 21-28 | 0.016 Giga cells per liter | Standard Deviation 0.0114 |
| Gepotidacin 750 mg q12h | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets | Basophils, POST DOSE DAY 3-10 | 0.040 Giga cells per liter | — |
| Gepotidacin 750 mg q12h | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets | Eosinophils, ON IV TREATMENT/DAY 2 | 0.021 Giga cells per liter | Standard Deviation 0.1597 |
| Gepotidacin 750 mg q12h | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets | Eosinophils, ON IV TREATMENT/DAY 3 | 0.010 Giga cells per liter | Standard Deviation 0.1405 |
| Gepotidacin 750 mg q12h | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets | Eosinophils, ON IV TREATMENT/DAY 5 | 0.026 Giga cells per liter | Standard Deviation 0.0826 |
| Gepotidacin 750 mg q12h | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets | Eosinophils, ON IV TREATMENT/DAY 7 | 0.055 Giga cells per liter | Standard Deviation 0.1723 |
| Gepotidacin 750 mg q12h | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets | Eosinophils, ON IV TREATMENT/DAY 10 | 0.010 Giga cells per liter | — |
| Gepotidacin 750 mg q12h | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets | Eosinophils, ORAL - FIRST DAY | 0.013 Giga cells per liter | Standard Deviation 0.1443 |
| Gepotidacin 750 mg q12h | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets | Eosinophils, ORAL - DAY 7-10 | 0.014 Giga cells per liter | Standard Deviation 0.1492 |
| Gepotidacin 750 mg q12h | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets | Eosinophils, POST THERAPY DAY 12-18 | -0.017 Giga cells per liter | Standard Deviation 0.1168 |
| Gepotidacin 750 mg q12h | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets | Eosinophils, FOLLOW UP DAY 21-28 | -0.004 Giga cells per liter | Standard Deviation 0.0716 |
| Gepotidacin 750 mg q12h | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets | Eosinophils, POST DOSE DAY 3-10 | 0.360 Giga cells per liter | — |
| Gepotidacin 750 mg q12h | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets | Leukocytes, ON IV TREATMENT/DAY 2 | -1.39 Giga cells per liter | Standard Deviation 2.722 |
| Gepotidacin 750 mg q12h | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets | Leukocytes, ON IV TREATMENT/DAY 3 | -2.04 Giga cells per liter | Standard Deviation 3.091 |
| Gepotidacin 750 mg q12h | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets | Leukocytes, ON IV TREATMENT/DAY 5 | -2.49 Giga cells per liter | Standard Deviation 4.376 |
| Gepotidacin 750 mg q12h | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets | Leukocytes, ON IV TREATMENT/DAY 7 | -4.55 Giga cells per liter | Standard Deviation 5.108 |
| Gepotidacin 750 mg q12h | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets | Leukocytes, ON IV TREATMENT/DAY 10 | -11.20 Giga cells per liter | — |
| Gepotidacin 750 mg q12h | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets | Leukocytes, ORAL - FIRST DAY | -1.31 Giga cells per liter | Standard Deviation 2.959 |
| Gepotidacin 750 mg q12h | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets | Leukocytes, ORAL - DAY 7-10 | -1.08 Giga cells per liter | Standard Deviation 2.482 |
| Gepotidacin 750 mg q12h | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets | Leukocytes, POST THERAPY DAY 12-18 | -2.15 Giga cells per liter | Standard Deviation 3.053 |
| Gepotidacin 750 mg q12h | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets | Leukocytes, FOLLOW UP DAY 21-28 | -2.06 Giga cells per liter | Standard Deviation 2.428 |
| Gepotidacin 750 mg q12h | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets | Leukocytes, POST DOSE DAY 3-10 | -12.60 Giga cells per liter | — |
| Gepotidacin 750 mg q12h | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets | Lymphocytes, ON IV TREATMENT/DAY 2 | 0.019 Giga cells per liter | Standard Deviation 0.6137 |
| Gepotidacin 750 mg q12h | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets | Lymphocytes, ON IV TREATMENT/DAY 3 | 0.263 Giga cells per liter | Standard Deviation 0.5574 |
| Gepotidacin 750 mg q12h | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets | Lymphocytes, ON IV TREATMENT/DAY 5 | 0.288 Giga cells per liter | Standard Deviation 0.6918 |
| Gepotidacin 750 mg q12h | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets | Lymphocytes, ON IV TREATMENT/DAY 10 | 1.230 Giga cells per liter | — |
| Gepotidacin 750 mg q12h | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets | Lymphocytes, ORAL - FIRST DAY | 0.002 Giga cells per liter | Standard Deviation 0.6844 |
| Gepotidacin 750 mg q12h | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets | Lymphocytes, ORAL - DAY 7-10 | 0.222 Giga cells per liter | Standard Deviation 0.6592 |
| Gepotidacin 750 mg q12h | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets | Lymphocytes, POST-THERAPY DAY 12-18 | 0.179 Giga cells per liter | Standard Deviation 0.7122 |
| Gepotidacin 750 mg q12h | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets | Lymphocytes, FOLLOW UP DAY 21-28 | 0.326 Giga cells per liter | Standard Deviation 0.3564 |
| Gepotidacin 750 mg q12h | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets | Lymphocytes, POST DOSE DAY 3-10 | 0.850 Giga cells per liter | — |
| Gepotidacin 750 mg q12h | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets | Monocytes, ON IV TREATMENT/DAY 2 | -0.054 Giga cells per liter | Standard Deviation 0.1938 |
| Gepotidacin 750 mg q12h | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets | Monocytes, ON IV TREATMENT/DAY 3 | -0.002 Giga cells per liter | Standard Deviation 0.2326 |
| Gepotidacin 750 mg q12h | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets | Monocytes, ON IV TREATMENT/DAY 5 | -0.114 Giga cells per liter | Standard Deviation 0.2056 |
| Gepotidacin 750 mg q12h | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets | Monocytes, ON IV TREATMENT/DAY 7 | 0.022 Giga cells per liter | Standard Deviation 0.3231 |
| Gepotidacin 750 mg q12h | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets | Monocytes, ON IV TREATMENT/DAY 10 | -0.240 Giga cells per liter | — |
| Gepotidacin 750 mg q12h | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets | Monocytes, ORAL - FIRST DAY | -0.076 Giga cells per liter | Standard Deviation 0.2069 |
| Gepotidacin 750 mg q12h | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets | Monocytes, ORAL - DAY 7-10 | -0.014 Giga cells per liter | Standard Deviation 0.203 |
| Gepotidacin 750 mg q12h | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets | Monocytes, POST THERAPY DAY 12-18 | -0.077 Giga cells per liter | Standard Deviation 0.1442 |
| Gepotidacin 750 mg q12h | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets | Monocytes, FOLLOW UP DAY 21-28 | 0.018 Giga cells per liter | Standard Deviation 0.2969 |
| Gepotidacin 750 mg q12h | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets | Monocytes, POST DOSE DAY 3-10 | 0.280 Giga cells per liter | — |
| Gepotidacin 750 mg q12h | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets | Neutrophils, ON IV TREATMENT/DAY 2 | -1.373 Giga cells per liter | Standard Deviation 2.7464 |
| Gepotidacin 750 mg q12h | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets | Neutrophils, ON IV TREATMENT/DAY 3 | -2.324 Giga cells per liter | Standard Deviation 3.2252 |
| Gepotidacin 750 mg q12h | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets | Neutrophils, ON IV TREATMENT/DAY 5 | -2.712 Giga cells per liter | Standard Deviation 4.5024 |
| Gepotidacin 750 mg q12h | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets | Neutrophils, ON IV TREATMENT/DAY 7 | -5.403 Giga cells per liter | Standard Deviation 5.179 |
| Gepotidacin 750 mg q12h | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets | Neutrophils, ON IV TREATMENT/DAY 10 | -12.250 Giga cells per liter | — |
| Gepotidacin 750 mg q12h | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets | Neutrophils, ORAL - FIRST DAY | -1.244 Giga cells per liter | Standard Deviation 3.0855 |
| Gepotidacin 750 mg q12h | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets | Neutrophils, ORAL - DAY 7-10 | -1.363 Giga cells per liter | Standard Deviation 2.4532 |
| Gepotidacin 750 mg q12h | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets | Neutrophils, POST THERAPY DAY 12-18 | -2.243 Giga cells per liter | Standard Deviation 3.2754 |
| Gepotidacin 750 mg q12h | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets | Neutrophils, FOLLOW UP DAY 21-28 | -2.436 Giga cells per liter | Standard Deviation 2.5072 |
| Gepotidacin 750 mg q12h | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets | Neutrophils, POST DOSE DAY 3-10 | -14.050 Giga cells per liter | — |
| Gepotidacin 750 mg q12h | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets | Platelets, ON IV TREATMENT/DAY 2 | 5.6 Giga cells per liter | Standard Deviation 37.64 |
| Gepotidacin 750 mg q12h | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets | Platelets, ON IV TREATMENT/DAY 3 | 5.8 Giga cells per liter | Standard Deviation 44.94 |
| Gepotidacin 750 mg q12h | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets | Platelets, ON IV TREATMENT/DAY 5 | 43.7 Giga cells per liter | Standard Deviation 78.78 |
| Gepotidacin 750 mg q12h | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets | Platelets, ON IV TREATMENT/DAY 7 | 77.8 Giga cells per liter | Standard Deviation 107.48 |
| Gepotidacin 750 mg q12h | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets | Platelets, ON IV TREATMENT/DAY 10 | 159.0 Giga cells per liter | — |
| Gepotidacin 750 mg q12h | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets | Platelets, ORAL - FIRST DAY | 44.0 Giga cells per liter | Standard Deviation 74.12 |
| Gepotidacin 750 mg q12h | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets | Platelets, ORAL - DAY 7-10 | 22.7 Giga cells per liter | Standard Deviation 55.11 |
| Gepotidacin 750 mg q12h | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets | Platelets, POST THERAPY DAY 12-18 | 17.5 Giga cells per liter | Standard Deviation 76.72 |
| Gepotidacin 750 mg q12h | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets | Platelets, FOLLOW UP DAY 21-28 | 21.0 Giga cells per liter | Standard Deviation 26.44 |
| Gepotidacin 750 mg q12h | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets | Lymphocytes, ON IV TREATMENT/DAY 7 | 0.705 Giga cells per liter | Standard Deviation 0.5291 |
| Gepotidacin 1000 mg q12h | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets | Eosinophils, ON IV TREATMENT/DAY 2 | 0.055 Giga cells per liter | Standard Deviation 0.1414 |
| Gepotidacin 1000 mg q12h | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets | Lymphocytes, POST-THERAPY DAY 12-18 | 0.028 Giga cells per liter | Standard Deviation 0.6588 |
| Gepotidacin 1000 mg q12h | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets | Monocytes, ORAL - DAY 7-10 | -0.067 Giga cells per liter | Standard Deviation 0.169 |
| Gepotidacin 1000 mg q12h | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets | Eosinophils, ON IV TREATMENT/DAY 3 | 0.024 Giga cells per liter | Standard Deviation 0.1474 |
| Gepotidacin 1000 mg q12h | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets | Lymphocytes, ON IV TREATMENT/DAY 2 | 0.009 Giga cells per liter | Standard Deviation 0.5047 |
| Gepotidacin 1000 mg q12h | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets | Eosinophils, ON IV TREATMENT/DAY 4 | 0.250 Giga cells per liter | — |
| Gepotidacin 1000 mg q12h | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets | Neutrophils, ON IV TREATMENT/DAY 5 | -2.445 Giga cells per liter | Standard Deviation 0.937 |
| Gepotidacin 1000 mg q12h | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets | Eosinophils, ON IV TREATMENT/DAY 5 | 0.025 Giga cells per liter | Standard Deviation 0.1245 |
| Gepotidacin 1000 mg q12h | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets | Lymphocytes, FOLLOW UP DAY 21-28 | -0.020 Giga cells per liter | — |
| Gepotidacin 1000 mg q12h | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets | Eosinophils, ON IV TREATMENT/DAY 7 | 0.040 Giga cells per liter | — |
| Gepotidacin 1000 mg q12h | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets | Monocytes, POST THERAPY DAY 12-18 | -0.130 Giga cells per liter | Standard Deviation 0.224 |
| Gepotidacin 1000 mg q12h | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets | Platelets, FOLLOW UP DAY 21-28 | -92.0 Giga cells per liter | — |
| Gepotidacin 1000 mg q12h | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets | Eosinophils, ORAL - FIRST DAY | 0.051 Giga cells per liter | Standard Deviation 0.2001 |
| Gepotidacin 1000 mg q12h | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets | Lymphocytes, ON IV TREATMENT/DAY 3 | 0.094 Giga cells per liter | Standard Deviation 0.3504 |
| Gepotidacin 1000 mg q12h | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets | Platelets, ORAL - DAY 7-10 | 33.9 Giga cells per liter | Standard Deviation 95.63 |
| Gepotidacin 1000 mg q12h | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets | Eosinophils, ORAL - DAY 7-10 | 0.001 Giga cells per liter | Standard Deviation 0.1391 |
| Gepotidacin 1000 mg q12h | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets | Neutrophils, POST THERAPY DAY 12-18 | -2.111 Giga cells per liter | Standard Deviation 2.6465 |
| Gepotidacin 1000 mg q12h | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets | Monocytes, FOLLOW UP DAY 21-28 | 0.050 Giga cells per liter | — |
| Gepotidacin 1000 mg q12h | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets | Eosinophils, POST THERAPY DAY 12-18 | 0.011 Giga cells per liter | Standard Deviation 0.132 |
| Gepotidacin 1000 mg q12h | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets | Monocytes, ON IV TREATMENT/DAY 2 | -0.030 Giga cells per liter | Standard Deviation 0.216 |
| Gepotidacin 1000 mg q12h | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets | Leukocytes, FOLLOW UP DAY 21-28 | -5.70 Giga cells per liter | — |
| Gepotidacin 1000 mg q12h | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets | Eosinophils, FOLLOW UP DAY 21-28 | 0.000 Giga cells per liter | — |
| Gepotidacin 1000 mg q12h | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets | Lymphocytes, ON IV TREATMENT/DAY 4 | 0.790 Giga cells per liter | — |
| Gepotidacin 1000 mg q12h | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets | Platelets, ON IV TREATMENT/DAY 3 | 3.1 Giga cells per liter | Standard Deviation 41.89 |
| Gepotidacin 1000 mg q12h | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets | Monocytes, ON IV TREATMENT/DAY 3 | -0.133 Giga cells per liter | Standard Deviation 0.233 |
| Gepotidacin 1000 mg q12h | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets | Leukocytes, ON IV TREATMENT/DAY 2 | -1.35 Giga cells per liter | Standard Deviation 2.251 |
| Gepotidacin 1000 mg q12h | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets | Platelets, ON IV TREATMENT/DAY 2 | 6.3 Giga cells per liter | Standard Deviation 41.11 |
| Gepotidacin 1000 mg q12h | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets | Neutrophils, ON IV TREATMENT/DAY 2 | -1.395 Giga cells per liter | Standard Deviation 2.428 |
| Gepotidacin 1000 mg q12h | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets | Leukocytes, ON IV TREATMENT/DAY 3 | -1.80 Giga cells per liter | Standard Deviation 2.692 |
| Gepotidacin 1000 mg q12h | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets | Platelets, ON IV TREATMENT/DAY 7 | -9.0 Giga cells per liter | — |
| Gepotidacin 1000 mg q12h | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets | Leukocytes, ON IV TREATMENT/DAY 4 | -7.10 Giga cells per liter | — |
| Gepotidacin 1000 mg q12h | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets | Basophils, ON IV TREATMENT/DAY 2 | 0.003 Giga cells per liter | Standard Deviation 0.022 |
| Gepotidacin 1000 mg q12h | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets | Leukocytes, ON IV TREATMENT/DAY 5 | -2.57 Giga cells per liter | Standard Deviation 1.402 |
| Gepotidacin 1000 mg q12h | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets | Platelets, ON IV TREATMENT/DAY 4 | -30.0 Giga cells per liter | — |
| Gepotidacin 1000 mg q12h | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets | Leukocytes, ON IV TREATMENT/DAY 7 | -2.90 Giga cells per liter | — |
| Gepotidacin 1000 mg q12h | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets | Neutrophils, ON IV TREATMENT/DAY 3 | -1.789 Giga cells per liter | Standard Deviation 2.6403 |
| Gepotidacin 1000 mg q12h | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets | Lymphocytes, ON IV TREATMENT/DAY 5 | 0.075 Giga cells per liter | Standard Deviation 0.5417 |
| Gepotidacin 1000 mg q12h | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets | Leukocytes, ORAL - FIRST DAY | -2.32 Giga cells per liter | Standard Deviation 2.527 |
| Gepotidacin 1000 mg q12h | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets | Monocytes, ON IV TREATMENT/DAY 4 | -0.280 Giga cells per liter | — |
| Gepotidacin 1000 mg q12h | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets | Neutrophils, ON IV TREATMENT/DAY 4 | -7.880 Giga cells per liter | — |
| Gepotidacin 1000 mg q12h | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets | Leukocytes, ORAL - DAY 7-10 | -1.91 Giga cells per liter | Standard Deviation 2.299 |
| Gepotidacin 1000 mg q12h | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets | Basophils, ON IV TREATMENT/DAY 3 | 0.003 Giga cells per liter | Standard Deviation 0.0217 |
| Gepotidacin 1000 mg q12h | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets | Lymphocytes, ON IV TREATMENT/DAY 7 | 0.200 Giga cells per liter | — |
| Gepotidacin 1000 mg q12h | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets | Basophils, ON IV TREATMENT/DAY 4 | -0.020 Giga cells per liter | — |
| Gepotidacin 1000 mg q12h | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets | Platelets, ORAL - FIRST DAY | 0.1 Giga cells per liter | Standard Deviation 73.36 |
| Gepotidacin 1000 mg q12h | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets | Basophils, ON IV TREATMENT/DAY 5 | 0.007 Giga cells per liter | Standard Deviation 0.0437 |
| Gepotidacin 1000 mg q12h | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets | Monocytes, ON IV TREATMENT/DAY 5 | -0.243 Giga cells per liter | Standard Deviation 0.2448 |
| Gepotidacin 1000 mg q12h | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets | Basophils, ON IV TREATMENT/DAY 7 | 0.000 Giga cells per liter | — |
| Gepotidacin 1000 mg q12h | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets | Neutrophils, FOLLOW UP DAY 21-28 | -5.770 Giga cells per liter | — |
| Gepotidacin 1000 mg q12h | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets | Monocytes, ON IV TREATMENT/DAY 7 | -0.170 Giga cells per liter | — |
| Gepotidacin 1000 mg q12h | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets | Basophils, ORAL - FIRST DAY | 0.000 Giga cells per liter | Standard Deviation 0.0185 |
| Gepotidacin 1000 mg q12h | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets | Neutrophils, ORAL - FIRST DAY | -2.229 Giga cells per liter | Standard Deviation 2.6921 |
| Gepotidacin 1000 mg q12h | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets | Leukocytes, POST THERAPY DAY 12-18 | -2.20 Giga cells per liter | Standard Deviation 2.464 |
| Gepotidacin 1000 mg q12h | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets | Basophils, ORAL - DAY 7-10 | 0.007 Giga cells per liter | Standard Deviation 0.0258 |
| Gepotidacin 1000 mg q12h | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets | Lymphocytes, ORAL - FIRST DAY | -0.050 Giga cells per liter | Standard Deviation 0.7343 |
| Gepotidacin 1000 mg q12h | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets | Platelets, ON IV TREATMENT/DAY 5 | 21.3 Giga cells per liter | Standard Deviation 33.02 |
| Gepotidacin 1000 mg q12h | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets | Basophils, POST THERAPY DAY 12-18 | 0.001 Giga cells per liter | Standard Deviation 0.0217 |
| Gepotidacin 1000 mg q12h | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets | Platelets, POST THERAPY DAY 12-18 | 2.9 Giga cells per liter | Standard Deviation 88.15 |
| Gepotidacin 1000 mg q12h | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets | Monocytes, ORAL - FIRST DAY | -0.099 Giga cells per liter | Standard Deviation 0.2379 |
| Gepotidacin 1000 mg q12h | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets | Basophils, FOLLOW UP DAY 21-28 | -0.020 Giga cells per liter | — |
| Gepotidacin 1000 mg q12h | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets | Lymphocytes, ORAL - DAY 7-10 | 0.204 Giga cells per liter | Standard Deviation 0.7131 |
| Gepotidacin 1000 mg q12h | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets | Neutrophils, ON IV TREATMENT/DAY 7 | -2.910 Giga cells per liter | — |
| Gepotidacin 1000 mg q12h | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets | Neutrophils, ORAL - DAY 7-10 | -2.068 Giga cells per liter | Standard Deviation 2.3963 |
| Gepotidacin 1000 mg q8h | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets | Neutrophils, FOLLOW UP DAY 21-28 | -3.007 Giga cells per liter | Standard Deviation 5.4347 |
| Gepotidacin 1000 mg q8h | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets | Leukocytes, POST THERAPY DAY 12-18 | -2.25 Giga cells per liter | Standard Deviation 3.152 |
| Gepotidacin 1000 mg q8h | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets | Leukocytes, FOLLOW UP DAY 21-28 | -3.23 Giga cells per liter | Standard Deviation 5.877 |
| Gepotidacin 1000 mg q8h | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets | Lymphocytes, ON IV TREATMENT/DAY 2 | 0.358 Giga cells per liter | Standard Deviation 0.7229 |
| Gepotidacin 1000 mg q8h | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets | Lymphocytes, ON IV TREATMENT/DAY 3 | 0.129 Giga cells per liter | Standard Deviation 0.5742 |
| Gepotidacin 1000 mg q8h | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets | Neutrophils, ORAL - FIRST DAY | -1.802 Giga cells per liter | Standard Deviation 2.5066 |
| Gepotidacin 1000 mg q8h | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets | Lymphocytes, ORAL - FIRST DAY | 0.247 Giga cells per liter | Standard Deviation 0.8342 |
| Gepotidacin 1000 mg q8h | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets | Lymphocytes, ORAL - DAY 7-10 | 0.284 Giga cells per liter | Standard Deviation 0.6655 |
| Gepotidacin 1000 mg q8h | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets | Lymphocytes, POST-THERAPY DAY 12-18 | 0.184 Giga cells per liter | Standard Deviation 0.5295 |
| Gepotidacin 1000 mg q8h | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets | Neutrophils, ORAL - DAY 7-10 | -1.930 Giga cells per liter | Standard Deviation 2.7752 |
| Gepotidacin 1000 mg q8h | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets | Lymphocytes, FOLLOW UP DAY 21-28 | 0.097 Giga cells per liter | Standard Deviation 0.2743 |
| Gepotidacin 1000 mg q8h | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets | Platelets, POST THERAPY DAY 12-18 | 0.6 Giga cells per liter | Standard Deviation 56.26 |
| Gepotidacin 1000 mg q8h | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets | Monocytes, ON IV TREATMENT/DAY 2 | -0.011 Giga cells per liter | Standard Deviation 0.2524 |
| Gepotidacin 1000 mg q8h | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets | Neutrophils, POST THERAPY DAY 12-18 | -2.346 Giga cells per liter | Standard Deviation 3.047 |
| Gepotidacin 1000 mg q8h | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets | Monocytes, ON IV TREATMENT/DAY 3 | -0.219 Giga cells per liter | Standard Deviation 0.5008 |
| Gepotidacin 1000 mg q8h | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets | Basophils, ON IV TREATMENT/DAY 2 | 0.007 Giga cells per liter | Standard Deviation 0.0216 |
| Gepotidacin 1000 mg q8h | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets | Basophils, ON IV TREATMENT/DAY 3 | -0.014 Giga cells per liter | Standard Deviation 0.0305 |
| Gepotidacin 1000 mg q8h | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets | Basophils, ORAL - FIRST DAY | -0.004 Giga cells per liter | Standard Deviation 0.0171 |
| Gepotidacin 1000 mg q8h | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets | Platelets, ORAL - DAY 7-10 | 22.0 Giga cells per liter | Standard Deviation 63.18 |
| Gepotidacin 1000 mg q8h | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets | Basophils, ORAL - DAY 7-10 | 0.004 Giga cells per liter | Standard Deviation 0.0169 |
| Gepotidacin 1000 mg q8h | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets | Platelets, ORAL - FIRST DAY | 11.6 Giga cells per liter | Standard Deviation 52.46 |
| Gepotidacin 1000 mg q8h | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets | Basophils, POST THERAPY DAY 12-18 | 0.001 Giga cells per liter | Standard Deviation 0.019 |
| Gepotidacin 1000 mg q8h | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets | Basophils, FOLLOW UP DAY 21-28 | -0.007 Giga cells per liter | Standard Deviation 0.0404 |
| Gepotidacin 1000 mg q8h | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets | Monocytes, ORAL - FIRST DAY | -0.154 Giga cells per liter | Standard Deviation 0.2919 |
| Gepotidacin 1000 mg q8h | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets | Platelets, FOLLOW UP DAY 21-28 | -23.3 Giga cells per liter | Standard Deviation 62.93 |
| Gepotidacin 1000 mg q8h | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets | Eosinophils, ON IV TREATMENT/DAY 2 | 0.052 Giga cells per liter | Standard Deviation 0.0744 |
| Gepotidacin 1000 mg q8h | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets | Eosinophils, ON IV TREATMENT/DAY 3 | 0.016 Giga cells per liter | Standard Deviation 0.0995 |
| Gepotidacin 1000 mg q8h | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets | Monocytes, ORAL - DAY 7-10 | -0.070 Giga cells per liter | Standard Deviation 0.3348 |
| Gepotidacin 1000 mg q8h | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets | Platelets, ON IV TREATMENT/DAY 2 | -6.7 Giga cells per liter | Standard Deviation 57.38 |
| Gepotidacin 1000 mg q8h | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets | Monocytes, POST THERAPY DAY 12-18 | -0.133 Giga cells per liter | Standard Deviation 0.3065 |
| Gepotidacin 1000 mg q8h | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets | Eosinophils, ORAL - FIRST DAY | 0.027 Giga cells per liter | Standard Deviation 0.0927 |
| Gepotidacin 1000 mg q8h | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets | Eosinophils, ORAL - DAY 7-10 | 0.052 Giga cells per liter | Standard Deviation 0.1066 |
| Gepotidacin 1000 mg q8h | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets | Eosinophils, POST THERAPY DAY 12-18 | 0.050 Giga cells per liter | Standard Deviation 0.1298 |
| Gepotidacin 1000 mg q8h | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets | Monocytes, FOLLOW UP DAY 21-28 | -0.347 Giga cells per liter | Standard Deviation 0.705 |
| Gepotidacin 1000 mg q8h | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets | Eosinophils, FOLLOW UP DAY 21-28 | 0.060 Giga cells per liter | Standard Deviation 0.0436 |
| Gepotidacin 1000 mg q8h | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets | Platelets, ON IV TREATMENT/DAY 3 | -0.6 Giga cells per liter | Standard Deviation 19.64 |
| Gepotidacin 1000 mg q8h | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets | Leukocytes, ON IV TREATMENT/DAY 2 | -1.47 Giga cells per liter | Standard Deviation 2.086 |
| Gepotidacin 1000 mg q8h | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets | Leukocytes, ON IV TREATMENT/DAY 3 | -2.94 Giga cells per liter | Standard Deviation 4.222 |
| Gepotidacin 1000 mg q8h | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets | Neutrophils, ON IV TREATMENT/DAY 2 | -1.873 Giga cells per liter | Standard Deviation 2.0729 |
| Gepotidacin 1000 mg q8h | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets | Neutrophils, ON IV TREATMENT/DAY 3 | -2.854 Giga cells per liter | Standard Deviation 3.6332 |
| Gepotidacin 1000 mg q8h | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets | Leukocytes, ORAL - FIRST DAY | -1.69 Giga cells per liter | Standard Deviation 2.641 |
| Gepotidacin 1000 mg q8h | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets | Leukocytes, ORAL - DAY 7-10 | -1.67 Giga cells per liter | Standard Deviation 2.637 |
Secondary
Change From Baseline in Hematology Parameters: Erythrocyte Mean Corpuscular Hemoglobin Concentration (EMCHC) and Hemoglobin
Blood samples for assessment of hematology parameters of EMCHC and hemoglobin was collected at Baseline (Day 1), Day 2, Day 7 to 10, Day 12 to 21 and Day 21 to Day 28. Baseline was defined at Day 1. Change from Baseline was calculated by subtracting the post-Baseline value from Baseline value.
Time frame: Baseline (Day 1) up to Day 28
Population: Safety Population. Data for only those participants available at the indicated time points were collected and analyzed. Data points with null value for participants analyzed indicate data not collected for respective category and treatment arm.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Gepotidacin 750 mg q12h | Change From Baseline in Hematology Parameters: Erythrocyte Mean Corpuscular Hemoglobin Concentration (EMCHC) and Hemoglobin | Hemoglobin, POST DOSE DAY 3-10 | -1.0 Gram per liter | — |
| Gepotidacin 750 mg q12h | Change From Baseline in Hematology Parameters: Erythrocyte Mean Corpuscular Hemoglobin Concentration (EMCHC) and Hemoglobin | EMCHC, ON IV TREATMENT/DAY 2 | 1.2 Gram per liter | Standard Deviation 6.08 |
| Gepotidacin 750 mg q12h | Change From Baseline in Hematology Parameters: Erythrocyte Mean Corpuscular Hemoglobin Concentration (EMCHC) and Hemoglobin | EMCHC, ON IV TREATMENT/DAY 3 | -0.4 Gram per liter | Standard Deviation 6.64 |
| Gepotidacin 750 mg q12h | Change From Baseline in Hematology Parameters: Erythrocyte Mean Corpuscular Hemoglobin Concentration (EMCHC) and Hemoglobin | EMCHC, ON IV TREATMENT/DAY 5 | -4.3 Gram per liter | Standard Deviation 7.51 |
| Gepotidacin 750 mg q12h | Change From Baseline in Hematology Parameters: Erythrocyte Mean Corpuscular Hemoglobin Concentration (EMCHC) and Hemoglobin | EMCHC, ON IV TREATMENT/DAY 7 | 2.8 Gram per liter | Standard Deviation 9.6 |
| Gepotidacin 750 mg q12h | Change From Baseline in Hematology Parameters: Erythrocyte Mean Corpuscular Hemoglobin Concentration (EMCHC) and Hemoglobin | EMCHC, ON IV TREATMENT/DAY 10 | -6.0 Gram per liter | — |
| Gepotidacin 750 mg q12h | Change From Baseline in Hematology Parameters: Erythrocyte Mean Corpuscular Hemoglobin Concentration (EMCHC) and Hemoglobin | EMCHC, ORAL - FIRST DAY | 1.2 Gram per liter | Standard Deviation 8.08 |
| Gepotidacin 750 mg q12h | Change From Baseline in Hematology Parameters: Erythrocyte Mean Corpuscular Hemoglobin Concentration (EMCHC) and Hemoglobin | EMCHC, ORAL - DAY 7-10 | 2.8 Gram per liter | Standard Deviation 5.55 |
| Gepotidacin 750 mg q12h | Change From Baseline in Hematology Parameters: Erythrocyte Mean Corpuscular Hemoglobin Concentration (EMCHC) and Hemoglobin | EMCHC, POST THERAPY DAY 12-18 | 1.6 Gram per liter | Standard Deviation 6.49 |
| Gepotidacin 750 mg q12h | Change From Baseline in Hematology Parameters: Erythrocyte Mean Corpuscular Hemoglobin Concentration (EMCHC) and Hemoglobin | EMCHC, FOLLOW UP DAY 21-28 | 5.6 Gram per liter | Standard Deviation 10.81 |
| Gepotidacin 750 mg q12h | Change From Baseline in Hematology Parameters: Erythrocyte Mean Corpuscular Hemoglobin Concentration (EMCHC) and Hemoglobin | EMCHC, POST DOSE DAY 3-10 | 21.0 Gram per liter | — |
| Gepotidacin 750 mg q12h | Change From Baseline in Hematology Parameters: Erythrocyte Mean Corpuscular Hemoglobin Concentration (EMCHC) and Hemoglobin | Hemoglobin, ON IV TREATMENT/DAY 2 | -3.0 Gram per liter | Standard Deviation 9.04 |
| Gepotidacin 750 mg q12h | Change From Baseline in Hematology Parameters: Erythrocyte Mean Corpuscular Hemoglobin Concentration (EMCHC) and Hemoglobin | Hemoglobin, ON IV TREATMENT/DAY 3 | -2.2 Gram per liter | Standard Deviation 10.95 |
| Gepotidacin 750 mg q12h | Change From Baseline in Hematology Parameters: Erythrocyte Mean Corpuscular Hemoglobin Concentration (EMCHC) and Hemoglobin | Hemoglobin, ON IV TREATMENT/DAY 5 | -4.7 Gram per liter | Standard Deviation 10.27 |
| Gepotidacin 750 mg q12h | Change From Baseline in Hematology Parameters: Erythrocyte Mean Corpuscular Hemoglobin Concentration (EMCHC) and Hemoglobin | Hemoglobin, ON IV TREATMENT/DAY 10 | -24.0 Gram per liter | — |
| Gepotidacin 750 mg q12h | Change From Baseline in Hematology Parameters: Erythrocyte Mean Corpuscular Hemoglobin Concentration (EMCHC) and Hemoglobin | Hemoglobin, ORAL - FIRST DAY | 4.2 Gram per liter | Standard Deviation 9.42 |
| Gepotidacin 750 mg q12h | Change From Baseline in Hematology Parameters: Erythrocyte Mean Corpuscular Hemoglobin Concentration (EMCHC) and Hemoglobin | Hemoglobin, ORAL - DAY 7-10 | 3.9 Gram per liter | Standard Deviation 11.18 |
| Gepotidacin 750 mg q12h | Change From Baseline in Hematology Parameters: Erythrocyte Mean Corpuscular Hemoglobin Concentration (EMCHC) and Hemoglobin | Hemoglobin, POST THERAPY DAY 12-18 | 3.8 Gram per liter | Standard Deviation 10.18 |
| Gepotidacin 750 mg q12h | Change From Baseline in Hematology Parameters: Erythrocyte Mean Corpuscular Hemoglobin Concentration (EMCHC) and Hemoglobin | Hemoglobin, FOLLOW UP DAY 21-28 | 8.4 Gram per liter | Standard Deviation 5.5 |
| Gepotidacin 750 mg q12h | Change From Baseline in Hematology Parameters: Erythrocyte Mean Corpuscular Hemoglobin Concentration (EMCHC) and Hemoglobin | Hemoglobin, ON IV TREATMENT/DAY 7 | -9.8 Gram per liter | Standard Deviation 7.8 |
| Gepotidacin 1000 mg q12h | Change From Baseline in Hematology Parameters: Erythrocyte Mean Corpuscular Hemoglobin Concentration (EMCHC) and Hemoglobin | Hemoglobin, ORAL - FIRST DAY | -0.9 Gram per liter | Standard Deviation 12.2 |
| Gepotidacin 1000 mg q12h | Change From Baseline in Hematology Parameters: Erythrocyte Mean Corpuscular Hemoglobin Concentration (EMCHC) and Hemoglobin | Hemoglobin, ON IV TREATMENT/DAY 4 | -8.0 Gram per liter | — |
| Gepotidacin 1000 mg q12h | Change From Baseline in Hematology Parameters: Erythrocyte Mean Corpuscular Hemoglobin Concentration (EMCHC) and Hemoglobin | EMCHC, ON IV TREATMENT/DAY 3 | 2.9 Gram per liter | Standard Deviation 7.67 |
| Gepotidacin 1000 mg q12h | Change From Baseline in Hematology Parameters: Erythrocyte Mean Corpuscular Hemoglobin Concentration (EMCHC) and Hemoglobin | EMCHC, ON IV TREATMENT/DAY 4 | 0.0 Gram per liter | — |
| Gepotidacin 1000 mg q12h | Change From Baseline in Hematology Parameters: Erythrocyte Mean Corpuscular Hemoglobin Concentration (EMCHC) and Hemoglobin | Hemoglobin, FOLLOW UP DAY 21-28 | -7.0 Gram per liter | — |
| Gepotidacin 1000 mg q12h | Change From Baseline in Hematology Parameters: Erythrocyte Mean Corpuscular Hemoglobin Concentration (EMCHC) and Hemoglobin | EMCHC, ON IV TREATMENT/DAY 5 | 5.8 Gram per liter | Standard Deviation 10.85 |
| Gepotidacin 1000 mg q12h | Change From Baseline in Hematology Parameters: Erythrocyte Mean Corpuscular Hemoglobin Concentration (EMCHC) and Hemoglobin | Hemoglobin, ON IV TREATMENT/DAY 5 | -8.0 Gram per liter | Standard Deviation 13.93 |
| Gepotidacin 1000 mg q12h | Change From Baseline in Hematology Parameters: Erythrocyte Mean Corpuscular Hemoglobin Concentration (EMCHC) and Hemoglobin | EMCHC, ON IV TREATMENT/DAY 7 | 6.0 Gram per liter | — |
| Gepotidacin 1000 mg q12h | Change From Baseline in Hematology Parameters: Erythrocyte Mean Corpuscular Hemoglobin Concentration (EMCHC) and Hemoglobin | Hemoglobin, ON IV TREATMENT/DAY 7 | 3.0 Gram per liter | — |
| Gepotidacin 1000 mg q12h | Change From Baseline in Hematology Parameters: Erythrocyte Mean Corpuscular Hemoglobin Concentration (EMCHC) and Hemoglobin | Hemoglobin, POST THERAPY DAY 12-18 | 2.2 Gram per liter | Standard Deviation 9.02 |
| Gepotidacin 1000 mg q12h | Change From Baseline in Hematology Parameters: Erythrocyte Mean Corpuscular Hemoglobin Concentration (EMCHC) and Hemoglobin | EMCHC, ORAL - FIRST DAY | 0.9 Gram per liter | Standard Deviation 8.23 |
| Gepotidacin 1000 mg q12h | Change From Baseline in Hematology Parameters: Erythrocyte Mean Corpuscular Hemoglobin Concentration (EMCHC) and Hemoglobin | EMCHC, ORAL - DAY 7-10 | 2.1 Gram per liter | Standard Deviation 7.06 |
| Gepotidacin 1000 mg q12h | Change From Baseline in Hematology Parameters: Erythrocyte Mean Corpuscular Hemoglobin Concentration (EMCHC) and Hemoglobin | EMCHC, POST THERAPY DAY 12-18 | 2.1 Gram per liter | Standard Deviation 6.83 |
| Gepotidacin 1000 mg q12h | Change From Baseline in Hematology Parameters: Erythrocyte Mean Corpuscular Hemoglobin Concentration (EMCHC) and Hemoglobin | EMCHC, FOLLOW UP DAY 21-28 | 0.0 Gram per liter | — |
| Gepotidacin 1000 mg q12h | Change From Baseline in Hematology Parameters: Erythrocyte Mean Corpuscular Hemoglobin Concentration (EMCHC) and Hemoglobin | Hemoglobin, ORAL - DAY 7-10 | 1.8 Gram per liter | Standard Deviation 9.74 |
| Gepotidacin 1000 mg q12h | Change From Baseline in Hematology Parameters: Erythrocyte Mean Corpuscular Hemoglobin Concentration (EMCHC) and Hemoglobin | Hemoglobin, ON IV TREATMENT/DAY 2 | -1.2 Gram per liter | Standard Deviation 9.1 |
| Gepotidacin 1000 mg q12h | Change From Baseline in Hematology Parameters: Erythrocyte Mean Corpuscular Hemoglobin Concentration (EMCHC) and Hemoglobin | Hemoglobin, ON IV TREATMENT/DAY 3 | -2.2 Gram per liter | Standard Deviation 11.13 |
| Gepotidacin 1000 mg q12h | Change From Baseline in Hematology Parameters: Erythrocyte Mean Corpuscular Hemoglobin Concentration (EMCHC) and Hemoglobin | EMCHC, ON IV TREATMENT/DAY 2 | 2.0 Gram per liter | Standard Deviation 6.9 |
| Gepotidacin 1000 mg q8h | Change From Baseline in Hematology Parameters: Erythrocyte Mean Corpuscular Hemoglobin Concentration (EMCHC) and Hemoglobin | EMCHC, POST THERAPY DAY 12-18 | 0.6 Gram per liter | Standard Deviation 7.93 |
| Gepotidacin 1000 mg q8h | Change From Baseline in Hematology Parameters: Erythrocyte Mean Corpuscular Hemoglobin Concentration (EMCHC) and Hemoglobin | Hemoglobin, ORAL - FIRST DAY | -1.0 Gram per liter | Standard Deviation 8.2 |
| Gepotidacin 1000 mg q8h | Change From Baseline in Hematology Parameters: Erythrocyte Mean Corpuscular Hemoglobin Concentration (EMCHC) and Hemoglobin | EMCHC, ON IV TREATMENT/DAY 2 | 0.1 Gram per liter | Standard Deviation 6.94 |
| Gepotidacin 1000 mg q8h | Change From Baseline in Hematology Parameters: Erythrocyte Mean Corpuscular Hemoglobin Concentration (EMCHC) and Hemoglobin | EMCHC, FOLLOW UP DAY 21-28 | 8.3 Gram per liter | Standard Deviation 13.32 |
| Gepotidacin 1000 mg q8h | Change From Baseline in Hematology Parameters: Erythrocyte Mean Corpuscular Hemoglobin Concentration (EMCHC) and Hemoglobin | Hemoglobin, FOLLOW UP DAY 21-28 | 3.0 Gram per liter | Standard Deviation 15.87 |
| Gepotidacin 1000 mg q8h | Change From Baseline in Hematology Parameters: Erythrocyte Mean Corpuscular Hemoglobin Concentration (EMCHC) and Hemoglobin | EMCHC, ORAL - DAY 7-10 | 2.1 Gram per liter | Standard Deviation 8.46 |
| Gepotidacin 1000 mg q8h | Change From Baseline in Hematology Parameters: Erythrocyte Mean Corpuscular Hemoglobin Concentration (EMCHC) and Hemoglobin | EMCHC, ORAL - FIRST DAY | 1.1 Gram per liter | Standard Deviation 6.13 |
| Gepotidacin 1000 mg q8h | Change From Baseline in Hematology Parameters: Erythrocyte Mean Corpuscular Hemoglobin Concentration (EMCHC) and Hemoglobin | Hemoglobin, ON IV TREATMENT/DAY 2 | -4.0 Gram per liter | Standard Deviation 8.79 |
| Gepotidacin 1000 mg q8h | Change From Baseline in Hematology Parameters: Erythrocyte Mean Corpuscular Hemoglobin Concentration (EMCHC) and Hemoglobin | Hemoglobin, ORAL - DAY 7-10 | -0.6 Gram per liter | Standard Deviation 7.45 |
| Gepotidacin 1000 mg q8h | Change From Baseline in Hematology Parameters: Erythrocyte Mean Corpuscular Hemoglobin Concentration (EMCHC) and Hemoglobin | EMCHC, ON IV TREATMENT/DAY 3 | 2.9 Gram per liter | Standard Deviation 7.9 |
| Gepotidacin 1000 mg q8h | Change From Baseline in Hematology Parameters: Erythrocyte Mean Corpuscular Hemoglobin Concentration (EMCHC) and Hemoglobin | Hemoglobin, ON IV TREATMENT/DAY 3 | -1.6 Gram per liter | Standard Deviation 8.22 |
| Gepotidacin 1000 mg q8h | Change From Baseline in Hematology Parameters: Erythrocyte Mean Corpuscular Hemoglobin Concentration (EMCHC) and Hemoglobin | Hemoglobin, POST THERAPY DAY 12-18 | -0.1 Gram per liter | Standard Deviation 10.85 |
Secondary
Change From Baseline in Hematology Parameters: Erythrocyte Mean Corpuscular Hemoglobin (EMCH)
Blood samples for assessment of hematology parameter of EMCH was collected at Baseline (Day 1), Day 2, Day 7 to 10, Day 12 to 21 and Day 21 to Day 28. Baseline was defined at Day 1. Change from Baseline was calculated by subtracting the post-Baseline value from Baseline value.
Time frame: Baseline (Day 1) up to Day 28
Population: Safety Population. Data for only those participants available at the indicated time points were collected and analyzed. Data points with null value for participants analyzed indicate data not collected for respective category and treatment arm.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Gepotidacin 750 mg q12h | Change From Baseline in Hematology Parameters: Erythrocyte Mean Corpuscular Hemoglobin (EMCH) | POST DOSE DAY 3-10 | 0.10 Picograms | — |
| Gepotidacin 750 mg q12h | Change From Baseline in Hematology Parameters: Erythrocyte Mean Corpuscular Hemoglobin (EMCH) | ON IV TREATMENT/DAY 3 | 0.00 Picograms | Standard Deviation 0.278 |
| Gepotidacin 750 mg q12h | Change From Baseline in Hematology Parameters: Erythrocyte Mean Corpuscular Hemoglobin (EMCH) | ON IV TREATMENT/DAY 5 | -0.19 Picograms | Standard Deviation 0.325 |
| Gepotidacin 750 mg q12h | Change From Baseline in Hematology Parameters: Erythrocyte Mean Corpuscular Hemoglobin (EMCH) | ON IV TREATMENT/DAY 7 | 0.30 Picograms | Standard Deviation 0.294 |
| Gepotidacin 750 mg q12h | Change From Baseline in Hematology Parameters: Erythrocyte Mean Corpuscular Hemoglobin (EMCH) | ON IV TREATMENT/DAY 10 | -0.20 Picograms | — |
| Gepotidacin 750 mg q12h | Change From Baseline in Hematology Parameters: Erythrocyte Mean Corpuscular Hemoglobin (EMCH) | ORAL - FIRST DAY | 0.08 Picograms | Standard Deviation 0.408 |
| Gepotidacin 750 mg q12h | Change From Baseline in Hematology Parameters: Erythrocyte Mean Corpuscular Hemoglobin (EMCH) | ORAL - DAY 7-10 | 0.01 Picograms | Standard Deviation 0.29 |
| Gepotidacin 750 mg q12h | Change From Baseline in Hematology Parameters: Erythrocyte Mean Corpuscular Hemoglobin (EMCH) | POST THERAPY DAY 12-18 | -0.04 Picograms | Standard Deviation 0.389 |
| Gepotidacin 750 mg q12h | Change From Baseline in Hematology Parameters: Erythrocyte Mean Corpuscular Hemoglobin (EMCH) | FOLLOW UP DAY 21-28 | 0.06 Picograms | Standard Deviation 0.483 |
| Gepotidacin 750 mg q12h | Change From Baseline in Hematology Parameters: Erythrocyte Mean Corpuscular Hemoglobin (EMCH) | ON IV TREATMENT/DAY 2 | 0.11 Picograms | Standard Deviation 0.413 |
| Gepotidacin 1000 mg q12h | Change From Baseline in Hematology Parameters: Erythrocyte Mean Corpuscular Hemoglobin (EMCH) | ON IV TREATMENT/DAY 7 | 0.20 Picograms | — |
| Gepotidacin 1000 mg q12h | Change From Baseline in Hematology Parameters: Erythrocyte Mean Corpuscular Hemoglobin (EMCH) | POST THERAPY DAY 12-18 | 0.01 Picograms | Standard Deviation 0.366 |
| Gepotidacin 1000 mg q12h | Change From Baseline in Hematology Parameters: Erythrocyte Mean Corpuscular Hemoglobin (EMCH) | ON IV TREATMENT/DAY 2 | 0.04 Picograms | Standard Deviation 0.386 |
| Gepotidacin 1000 mg q12h | Change From Baseline in Hematology Parameters: Erythrocyte Mean Corpuscular Hemoglobin (EMCH) | ORAL - DAY 7-10 | -0.03 Picograms | Standard Deviation 0.39 |
| Gepotidacin 1000 mg q12h | Change From Baseline in Hematology Parameters: Erythrocyte Mean Corpuscular Hemoglobin (EMCH) | ON IV TREATMENT/DAY 3 | 0.05 Picograms | Standard Deviation 0.495 |
| Gepotidacin 1000 mg q12h | Change From Baseline in Hematology Parameters: Erythrocyte Mean Corpuscular Hemoglobin (EMCH) | ON IV TREATMENT/DAY 4 | -0.40 Picograms | — |
| Gepotidacin 1000 mg q12h | Change From Baseline in Hematology Parameters: Erythrocyte Mean Corpuscular Hemoglobin (EMCH) | ON IV TREATMENT/DAY 5 | 0.12 Picograms | Standard Deviation 0.319 |
| Gepotidacin 1000 mg q12h | Change From Baseline in Hematology Parameters: Erythrocyte Mean Corpuscular Hemoglobin (EMCH) | FOLLOW UP DAY 21-28 | -0.40 Picograms | — |
| Gepotidacin 1000 mg q12h | Change From Baseline in Hematology Parameters: Erythrocyte Mean Corpuscular Hemoglobin (EMCH) | ORAL - FIRST DAY | -0.01 Picograms | Standard Deviation 0.389 |
| Gepotidacin 1000 mg q8h | Change From Baseline in Hematology Parameters: Erythrocyte Mean Corpuscular Hemoglobin (EMCH) | POST THERAPY DAY 12-18 | -0.08 Picograms | Standard Deviation 0.709 |
| Gepotidacin 1000 mg q8h | Change From Baseline in Hematology Parameters: Erythrocyte Mean Corpuscular Hemoglobin (EMCH) | ON IV TREATMENT/DAY 3 | -0.03 Picograms | Standard Deviation 0.374 |
| Gepotidacin 1000 mg q8h | Change From Baseline in Hematology Parameters: Erythrocyte Mean Corpuscular Hemoglobin (EMCH) | ORAL - FIRST DAY | -0.14 Picograms | Standard Deviation 0.333 |
| Gepotidacin 1000 mg q8h | Change From Baseline in Hematology Parameters: Erythrocyte Mean Corpuscular Hemoglobin (EMCH) | FOLLOW UP DAY 21-28 | 1.20 Picograms | Standard Deviation 1.735 |
| Gepotidacin 1000 mg q8h | Change From Baseline in Hematology Parameters: Erythrocyte Mean Corpuscular Hemoglobin (EMCH) | ORAL - DAY 7-10 | -0.06 Picograms | Standard Deviation 0.438 |
| Gepotidacin 1000 mg q8h | Change From Baseline in Hematology Parameters: Erythrocyte Mean Corpuscular Hemoglobin (EMCH) | ON IV TREATMENT/DAY 2 | -0.07 Picograms | Standard Deviation 0.354 |
Secondary
Change From Baseline in Hematology Parameters: Erythrocyte Mean Corpuscular Volume (EMCV)
Blood samples for assessment of hematology parameter of EMCV was collected at Baseline (Day 1), Day 2, Day 7 to 10, Day 12 to 21 and Day 21 to Day 28. Baseline was defined at Day 1. Change from Baseline was calculated by subtracting the post-Baseline value from Baseline value.
Time frame: Baseline (Day 1) up to Day 28
Population: Safety Population. Data for only those participants available at the indicated time points were collected and analyzed. Data points with null value for participants analyzed indicate data not collected for respective category and treatment arm.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Gepotidacin 750 mg q12h | Change From Baseline in Hematology Parameters: Erythrocyte Mean Corpuscular Volume (EMCV) | POST DOSE DAY 3-10 | -7.0 Femtoliter | — |
| Gepotidacin 750 mg q12h | Change From Baseline in Hematology Parameters: Erythrocyte Mean Corpuscular Volume (EMCV) | ON IV TREATMENT/DAY 3 | 0.0 Femtoliter | Standard Deviation 1.61 |
| Gepotidacin 750 mg q12h | Change From Baseline in Hematology Parameters: Erythrocyte Mean Corpuscular Volume (EMCV) | ON IV TREATMENT/DAY 5 | 0.7 Femtoliter | Standard Deviation 2.06 |
| Gepotidacin 750 mg q12h | Change From Baseline in Hematology Parameters: Erythrocyte Mean Corpuscular Volume (EMCV) | ON IV TREATMENT/DAY 7 | 0.0 Femtoliter | Standard Deviation 3.65 |
| Gepotidacin 750 mg q12h | Change From Baseline in Hematology Parameters: Erythrocyte Mean Corpuscular Volume (EMCV) | ON IV TREATMENT/DAY 10 | 1.0 Femtoliter | — |
| Gepotidacin 750 mg q12h | Change From Baseline in Hematology Parameters: Erythrocyte Mean Corpuscular Volume (EMCV) | ORAL - FIRST DAY | 0.0 Femtoliter | Standard Deviation 1.96 |
| Gepotidacin 750 mg q12h | Change From Baseline in Hematology Parameters: Erythrocyte Mean Corpuscular Volume (EMCV) | ORAL - DAY 7-10 | -0.8 Femtoliter | Standard Deviation 1.52 |
| Gepotidacin 750 mg q12h | Change From Baseline in Hematology Parameters: Erythrocyte Mean Corpuscular Volume (EMCV) | POST THERAPY DAY 12-18 | -0.6 Femtoliter | Standard Deviation 1.76 |
| Gepotidacin 750 mg q12h | Change From Baseline in Hematology Parameters: Erythrocyte Mean Corpuscular Volume (EMCV) | FOLLOW UP DAY 21-28 | -1.6 Femtoliter | Standard Deviation 1.82 |
| Gepotidacin 750 mg q12h | Change From Baseline in Hematology Parameters: Erythrocyte Mean Corpuscular Volume (EMCV) | ON IV TREATMENT/DAY 2 | 0.0 Femtoliter | Standard Deviation 1.73 |
| Gepotidacin 1000 mg q12h | Change From Baseline in Hematology Parameters: Erythrocyte Mean Corpuscular Volume (EMCV) | ON IV TREATMENT/DAY 7 | -1.0 Femtoliter | — |
| Gepotidacin 1000 mg q12h | Change From Baseline in Hematology Parameters: Erythrocyte Mean Corpuscular Volume (EMCV) | POST THERAPY DAY 12-18 | -0.5 Femtoliter | Standard Deviation 1.59 |
| Gepotidacin 1000 mg q12h | Change From Baseline in Hematology Parameters: Erythrocyte Mean Corpuscular Volume (EMCV) | ON IV TREATMENT/DAY 2 | -0.4 Femtoliter | Standard Deviation 1.56 |
| Gepotidacin 1000 mg q12h | Change From Baseline in Hematology Parameters: Erythrocyte Mean Corpuscular Volume (EMCV) | ORAL - DAY 7-10 | -0.6 Femtoliter | Standard Deviation 1.5 |
| Gepotidacin 1000 mg q12h | Change From Baseline in Hematology Parameters: Erythrocyte Mean Corpuscular Volume (EMCV) | ON IV TREATMENT/DAY 3 | -0.6 Femtoliter | Standard Deviation 1.63 |
| Gepotidacin 1000 mg q12h | Change From Baseline in Hematology Parameters: Erythrocyte Mean Corpuscular Volume (EMCV) | ON IV TREATMENT/DAY 4 | -2.0 Femtoliter | — |
| Gepotidacin 1000 mg q12h | Change From Baseline in Hematology Parameters: Erythrocyte Mean Corpuscular Volume (EMCV) | ON IV TREATMENT/DAY 5 | -1.0 Femtoliter | Standard Deviation 2.68 |
| Gepotidacin 1000 mg q12h | Change From Baseline in Hematology Parameters: Erythrocyte Mean Corpuscular Volume (EMCV) | FOLLOW UP DAY 21-28 | -2.0 Femtoliter | — |
| Gepotidacin 1000 mg q12h | Change From Baseline in Hematology Parameters: Erythrocyte Mean Corpuscular Volume (EMCV) | ORAL - FIRST DAY | -0.3 Femtoliter | Standard Deviation 2.11 |
| Gepotidacin 1000 mg q8h | Change From Baseline in Hematology Parameters: Erythrocyte Mean Corpuscular Volume (EMCV) | POST THERAPY DAY 12-18 | -0.5 Femtoliter | Standard Deviation 1.68 |
| Gepotidacin 1000 mg q8h | Change From Baseline in Hematology Parameters: Erythrocyte Mean Corpuscular Volume (EMCV) | ON IV TREATMENT/DAY 3 | -0.9 Femtoliter | Standard Deviation 1.96 |
| Gepotidacin 1000 mg q8h | Change From Baseline in Hematology Parameters: Erythrocyte Mean Corpuscular Volume (EMCV) | ORAL - FIRST DAY | -0.7 Femtoliter | Standard Deviation 1.66 |
| Gepotidacin 1000 mg q8h | Change From Baseline in Hematology Parameters: Erythrocyte Mean Corpuscular Volume (EMCV) | FOLLOW UP DAY 21-28 | 2.3 Femtoliter | Standard Deviation 3.21 |
| Gepotidacin 1000 mg q8h | Change From Baseline in Hematology Parameters: Erythrocyte Mean Corpuscular Volume (EMCV) | ORAL - DAY 7-10 | -0.9 Femtoliter | Standard Deviation 1.77 |
| Gepotidacin 1000 mg q8h | Change From Baseline in Hematology Parameters: Erythrocyte Mean Corpuscular Volume (EMCV) | ON IV TREATMENT/DAY 2 | -0.1 Femtoliter | Standard Deviation 1.9 |
Secondary
Change From Baseline in Hematology Parameters: Erythrocytes
Blood samples for assessment of hematology parameter of erythrocyte was collected at Baseline (Day 1), Day 2, Day 7 to 10, Day 12 to 21 and Day 21 to Day 28. Baseline was defined at Day 1. Change from Baseline was calculated by subtracting the post-Baseline value from Baseline value.
Time frame: Baseline (Day 1) up to Day 28
Population: Safety Population. Data for only those participants available at the indicated time points were collected and analyzed. Data points with null value for participants analyzed indicate data not collected for respective category and treatment arm.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Gepotidacin 750 mg q12h | Change From Baseline in Hematology Parameters: Erythrocytes | POST DOSE DAY 3-10 | 0.00 Trillion cells per liter | — |
| Gepotidacin 750 mg q12h | Change From Baseline in Hematology Parameters: Erythrocytes | ON IV TREATMENT/DAY 3 | -0.09 Trillion cells per liter | Standard Deviation 0.43 |
| Gepotidacin 750 mg q12h | Change From Baseline in Hematology Parameters: Erythrocytes | ON IV TREATMENT/DAY 5 | -0.14 Trillion cells per liter | Standard Deviation 0.373 |
| Gepotidacin 750 mg q12h | Change From Baseline in Hematology Parameters: Erythrocytes | ON IV TREATMENT/DAY 7 | -0.35 Trillion cells per liter | Standard Deviation 0.238 |
| Gepotidacin 750 mg q12h | Change From Baseline in Hematology Parameters: Erythrocytes | ON IV TREATMENT/DAY 10 | -0.80 Trillion cells per liter | — |
| Gepotidacin 750 mg q12h | Change From Baseline in Hematology Parameters: Erythrocytes | ORAL - FIRST DAY | 0.12 Trillion cells per liter | Standard Deviation 0.362 |
| Gepotidacin 750 mg q12h | Change From Baseline in Hematology Parameters: Erythrocytes | ORAL - DAY 7-10 | 0.12 Trillion cells per liter | Standard Deviation 0.4 |
| Gepotidacin 750 mg q12h | Change From Baseline in Hematology Parameters: Erythrocytes | POST THERAPY DAY 12-18 | 0.13 Trillion cells per liter | Standard Deviation 0.36 |
| Gepotidacin 750 mg q12h | Change From Baseline in Hematology Parameters: Erythrocytes | FOLLOW UP DAY 21-28 | 0.26 Trillion cells per liter | Standard Deviation 0.182 |
| Gepotidacin 750 mg q12h | Change From Baseline in Hematology Parameters: Erythrocytes | ON IV TREATMENT/DAY 2 | -0.14 Trillion cells per liter | Standard Deviation 0.332 |
| Gepotidacin 1000 mg q12h | Change From Baseline in Hematology Parameters: Erythrocytes | ON IV TREATMENT/DAY 7 | 0.10 Trillion cells per liter | — |
| Gepotidacin 1000 mg q12h | Change From Baseline in Hematology Parameters: Erythrocytes | POST THERAPY DAY 12-18 | 0.07 Trillion cells per liter | Standard Deviation 0.346 |
| Gepotidacin 1000 mg q12h | Change From Baseline in Hematology Parameters: Erythrocytes | ON IV TREATMENT/DAY 2 | -0.04 Trillion cells per liter | Standard Deviation 0.34 |
| Gepotidacin 1000 mg q12h | Change From Baseline in Hematology Parameters: Erythrocytes | ORAL - DAY 7-10 | 0.07 Trillion cells per liter | Standard Deviation 0.383 |
| Gepotidacin 1000 mg q12h | Change From Baseline in Hematology Parameters: Erythrocytes | ON IV TREATMENT/DAY 3 | -0.06 Trillion cells per liter | Standard Deviation 0.43 |
| Gepotidacin 1000 mg q12h | Change From Baseline in Hematology Parameters: Erythrocytes | ON IV TREATMENT/DAY 4 | -0.30 Trillion cells per liter | — |
| Gepotidacin 1000 mg q12h | Change From Baseline in Hematology Parameters: Erythrocytes | ON IV TREATMENT/DAY 5 | -0.28 Trillion cells per liter | Standard Deviation 0.475 |
| Gepotidacin 1000 mg q12h | Change From Baseline in Hematology Parameters: Erythrocytes | FOLLOW UP DAY 21-28 | -0.20 Trillion cells per liter | — |
| Gepotidacin 1000 mg q12h | Change From Baseline in Hematology Parameters: Erythrocytes | ORAL - FIRST DAY | -0.01 Trillion cells per liter | Standard Deviation 0.42 |
| Gepotidacin 1000 mg q8h | Change From Baseline in Hematology Parameters: Erythrocytes | POST THERAPY DAY 12-18 | 0.02 Trillion cells per liter | Standard Deviation 0.416 |
| Gepotidacin 1000 mg q8h | Change From Baseline in Hematology Parameters: Erythrocytes | ON IV TREATMENT/DAY 3 | -0.07 Trillion cells per liter | Standard Deviation 0.32 |
| Gepotidacin 1000 mg q8h | Change From Baseline in Hematology Parameters: Erythrocytes | ORAL - FIRST DAY | -0.01 Trillion cells per liter | Standard Deviation 0.317 |
| Gepotidacin 1000 mg q8h | Change From Baseline in Hematology Parameters: Erythrocytes | FOLLOW UP DAY 21-28 | -0.03 Trillion cells per liter | Standard Deviation 0.351 |
| Gepotidacin 1000 mg q8h | Change From Baseline in Hematology Parameters: Erythrocytes | ORAL - DAY 7-10 | -0.01 Trillion cells per liter | Standard Deviation 0.284 |
| Gepotidacin 1000 mg q8h | Change From Baseline in Hematology Parameters: Erythrocytes | ON IV TREATMENT/DAY 2 | -0.12 Trillion cells per liter | Standard Deviation 0.345 |
Secondary
Change From Baseline in Hematology Parameters: Hematocrit
Blood samples for assessment of hematology parameter of hematocrit was collected at Baseline (Day 1), Day 2, Day 7 to 10, Day 12 to 21 and Day 21 to Day 28. Baseline was defined at Day 1. Change from Baseline was calculated by subtracting the post-Baseline value from Baseline value.
Time frame: Baseline (Day 1) up to Day 28
Population: Safety Population. Data for only those participants available at the indicated time points were collected and analyzed. Data points with null value for participants analyzed indicate data not collected for respective category and treatment arm.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Gepotidacin 750 mg q12h | Change From Baseline in Hematology Parameters: Hematocrit | POST DOSE DAY 3-10 | -0.0320 Ratio | — |
| Gepotidacin 750 mg q12h | Change From Baseline in Hematology Parameters: Hematocrit | ON IV TREATMENT/DAY 2 | -0.0111 Ratio | Standard Deviation 0.03004 |
| Gepotidacin 750 mg q12h | Change From Baseline in Hematology Parameters: Hematocrit | ON IV TREATMENT/DAY 3 | -0.0066 Ratio | Standard Deviation 0.03683 |
| Gepotidacin 750 mg q12h | Change From Baseline in Hematology Parameters: Hematocrit | ON IV TREATMENT/DAY 5 | -0.0101 Ratio | Standard Deviation 0.03166 |
| Gepotidacin 750 mg q12h | Change From Baseline in Hematology Parameters: Hematocrit | ON IV TREATMENT/DAY 7 | -0.0353 Ratio | Standard Deviation 0.01873 |
| Gepotidacin 750 mg q12h | Change From Baseline in Hematology Parameters: Hematocrit | ON IV TREATMENT/DAY 10 | -0.0690 Ratio | — |
| Gepotidacin 750 mg q12h | Change From Baseline in Hematology Parameters: Hematocrit | ORAL - FIRST DAY | 0.0112 Ratio | Standard Deviation 0.03422 |
| Gepotidacin 750 mg q12h | Change From Baseline in Hematology Parameters: Hematocrit | ORAL - DAY 7-10 | 0.0080 Ratio | Standard Deviation 0.03674 |
| Gepotidacin 750 mg q12h | Change From Baseline in Hematology Parameters: Hematocrit | POST THERAPY DAY 12-18 | 0.0100 Ratio | Standard Deviation 0.0334 |
| Gepotidacin 750 mg q12h | Change From Baseline in Hematology Parameters: Hematocrit | FOLLOW UP DAY 21-28 | 0.0178 Ratio | Standard Deviation 0.01699 |
| Gepotidacin 1000 mg q12h | Change From Baseline in Hematology Parameters: Hematocrit | ON IV TREATMENT/DAY 5 | -0.0322 Ratio | Standard Deviation 0.04462 |
| Gepotidacin 1000 mg q12h | Change From Baseline in Hematology Parameters: Hematocrit | ON IV TREATMENT/DAY 7 | 0.0020 Ratio | — |
| Gepotidacin 1000 mg q12h | Change From Baseline in Hematology Parameters: Hematocrit | FOLLOW UP DAY 21-28 | -0.0220 Ratio | — |
| Gepotidacin 1000 mg q12h | Change From Baseline in Hematology Parameters: Hematocrit | ON IV TREATMENT/DAY 2 | -0.0065 Ratio | Standard Deviation 0.03316 |
| Gepotidacin 1000 mg q12h | Change From Baseline in Hematology Parameters: Hematocrit | ORAL - DAY 7-10 | 0.0027 Ratio | Standard Deviation 0.03459 |
| Gepotidacin 1000 mg q12h | Change From Baseline in Hematology Parameters: Hematocrit | ON IV TREATMENT/DAY 3 | -0.0099 Ratio | Standard Deviation 0.03922 |
| Gepotidacin 1000 mg q12h | Change From Baseline in Hematology Parameters: Hematocrit | ON IV TREATMENT/DAY 4 | -0.0260 Ratio | — |
| Gepotidacin 1000 mg q12h | Change From Baseline in Hematology Parameters: Hematocrit | POST THERAPY DAY 12-18 | 0.0039 Ratio | Standard Deviation 0.02846 |
| Gepotidacin 1000 mg q12h | Change From Baseline in Hematology Parameters: Hematocrit | ORAL - FIRST DAY | -0.0041 Ratio | Standard Deviation 0.04091 |
| Gepotidacin 1000 mg q8h | Change From Baseline in Hematology Parameters: Hematocrit | POST THERAPY DAY 12-18 | -0.0006 Ratio | Standard Deviation 0.04085 |
| Gepotidacin 1000 mg q8h | Change From Baseline in Hematology Parameters: Hematocrit | ORAL - DAY 7-10 | -0.0040 Ratio | Standard Deviation 0.0284 |
| Gepotidacin 1000 mg q8h | Change From Baseline in Hematology Parameters: Hematocrit | ON IV TREATMENT/DAY 2 | -0.0125 Ratio | Standard Deviation 0.03152 |
| Gepotidacin 1000 mg q8h | Change From Baseline in Hematology Parameters: Hematocrit | ORAL - FIRST DAY | -0.0043 Ratio | Standard Deviation 0.02854 |
| Gepotidacin 1000 mg q8h | Change From Baseline in Hematology Parameters: Hematocrit | ON IV TREATMENT/DAY 3 | -0.0073 Ratio | Standard Deviation 0.02536 |
| Gepotidacin 1000 mg q8h | Change From Baseline in Hematology Parameters: Hematocrit | FOLLOW UP DAY 21-28 | 0.0033 Ratio | Standard Deviation 0.03988 |
Secondary
Change From Baseline in Pulse Rate
Pulse rate was measured with the participant in a supine or semi-supine position, having rested in that position for at least 10 minutes. Baseline was defined at Day 1. Change from Baseline was calculated by subtracting the post-Baseline value from Baseline value.
Time frame: Baseline (Day 1) up to Day 28
Population: Safety population. Data for only those participants available at the indicated time points were collected and analyzed. Data points with null value for participants analyzed indicate data not collected for respective category and treatment arm.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Gepotidacin 750 mg q12h | Change From Baseline in Pulse Rate | POST DOSE DAY 3-10 | -15.0 Beats per minute | — |
| Gepotidacin 750 mg q12h | Change From Baseline in Pulse Rate | ON IV TREATMENT/DAY 1 | -4.5 Beats per minute | Standard Deviation 11.38 |
| Gepotidacin 750 mg q12h | Change From Baseline in Pulse Rate | ON IV TREATMENT/DAY 2 | -6.3 Beats per minute | Standard Deviation 14.31 |
| Gepotidacin 750 mg q12h | Change From Baseline in Pulse Rate | ON IV TREATMENT/DAY 3 | -7.5 Beats per minute | Standard Deviation 14.08 |
| Gepotidacin 750 mg q12h | Change From Baseline in Pulse Rate | ON IV TREATMENT/DAY 4 | -11.3 Beats per minute | Standard Deviation 18.27 |
| Gepotidacin 750 mg q12h | Change From Baseline in Pulse Rate | ON IV TREATMENT/DAY 5 | -15.1 Beats per minute | Standard Deviation 22.36 |
| Gepotidacin 750 mg q12h | Change From Baseline in Pulse Rate | ON IV TREATMENT/DAY 6 | -16.9 Beats per minute | Standard Deviation 21.6 |
| Gepotidacin 750 mg q12h | Change From Baseline in Pulse Rate | ON IV TREATMENT/DAY 7 | -28.4 Beats per minute | Standard Deviation 33.57 |
| Gepotidacin 750 mg q12h | Change From Baseline in Pulse Rate | ON IV TREATMENT/DAY 8 | -32.3 Beats per minute | Standard Deviation 15.63 |
| Gepotidacin 750 mg q12h | Change From Baseline in Pulse Rate | ON IV TREATMENT/DAY 9 | -45.5 Beats per minute | Standard Deviation 31.82 |
| Gepotidacin 750 mg q12h | Change From Baseline in Pulse Rate | ON IV TREATMENT/DAY 10 | -68.0 Beats per minute | — |
| Gepotidacin 750 mg q12h | Change From Baseline in Pulse Rate | ORAL - FIRST DAY | -6.7 Beats per minute | Standard Deviation 15.43 |
| Gepotidacin 750 mg q12h | Change From Baseline in Pulse Rate | ORAL - DAY 7-10 | -1.6 Beats per minute | Standard Deviation 12.35 |
| Gepotidacin 750 mg q12h | Change From Baseline in Pulse Rate | POST THERAPY DAY 12-18 | -1.6 Beats per minute | Standard Deviation 15.02 |
| Gepotidacin 750 mg q12h | Change From Baseline in Pulse Rate | FOLLOW UP DAY 21-28 | -1.6 Beats per minute | Standard Deviation 13.59 |
| Gepotidacin 1000 mg q12h | Change From Baseline in Pulse Rate | ON IV TREATMENT/DAY 5 | -9.9 Beats per minute | Standard Deviation 13.5 |
| Gepotidacin 1000 mg q12h | Change From Baseline in Pulse Rate | ON IV TREATMENT/DAY 6 | -11.0 Beats per minute | Standard Deviation 10.22 |
| Gepotidacin 1000 mg q12h | Change From Baseline in Pulse Rate | ORAL - DAY 7-10 | -1.8 Beats per minute | Standard Deviation 10.53 |
| Gepotidacin 1000 mg q12h | Change From Baseline in Pulse Rate | ON IV TREATMENT/DAY 7 | -18.0 Beats per minute | Standard Deviation 16.75 |
| Gepotidacin 1000 mg q12h | Change From Baseline in Pulse Rate | FOLLOW UP DAY 21-28 | -1.1 Beats per minute | Standard Deviation 10.09 |
| Gepotidacin 1000 mg q12h | Change From Baseline in Pulse Rate | ON IV TREATMENT/DAY 1 | -3.8 Beats per minute | Standard Deviation 10.66 |
| Gepotidacin 1000 mg q12h | Change From Baseline in Pulse Rate | POST THERAPY DAY 12-18 | 2.7 Beats per minute | Standard Deviation 13.38 |
| Gepotidacin 1000 mg q12h | Change From Baseline in Pulse Rate | ON IV TREATMENT/DAY 2 | -1.2 Beats per minute | Standard Deviation 10.66 |
| Gepotidacin 1000 mg q12h | Change From Baseline in Pulse Rate | ON IV TREATMENT/DAY 3 | -6.6 Beats per minute | Standard Deviation 10.28 |
| Gepotidacin 1000 mg q12h | Change From Baseline in Pulse Rate | ORAL - FIRST DAY | -5.6 Beats per minute | Standard Deviation 13.47 |
| Gepotidacin 1000 mg q12h | Change From Baseline in Pulse Rate | ON IV TREATMENT/DAY 4 | -5.5 Beats per minute | Standard Deviation 10.37 |
| Gepotidacin 1000 mg q8h | Change From Baseline in Pulse Rate | POST THERAPY DAY 12-18 | -7.0 Beats per minute | Standard Deviation 16.34 |
| Gepotidacin 1000 mg q8h | Change From Baseline in Pulse Rate | ORAL - DAY 7-10 | -5.7 Beats per minute | Standard Deviation 15.33 |
| Gepotidacin 1000 mg q8h | Change From Baseline in Pulse Rate | ON IV TREATMENT/DAY 4 | -7.0 Beats per minute | Standard Deviation 12.73 |
| Gepotidacin 1000 mg q8h | Change From Baseline in Pulse Rate | ON IV TREATMENT/DAY 3 | -7.1 Beats per minute | Standard Deviation 12.62 |
| Gepotidacin 1000 mg q8h | Change From Baseline in Pulse Rate | ON IV TREATMENT/DAY 1 | -2.0 Beats per minute | Standard Deviation 10.39 |
| Gepotidacin 1000 mg q8h | Change From Baseline in Pulse Rate | ORAL - FIRST DAY | -7.0 Beats per minute | Standard Deviation 11.45 |
| Gepotidacin 1000 mg q8h | Change From Baseline in Pulse Rate | FOLLOW UP DAY 21-28 | -2.5 Beats per minute | Standard Deviation 17.1 |
| Gepotidacin 1000 mg q8h | Change From Baseline in Pulse Rate | ON IV TREATMENT/DAY 2 | -5.2 Beats per minute | Standard Deviation 10.78 |
Secondary
Change From Baseline in Respiratory Rate
Respiratory rate was measured with the participant in a supine or semi-supine position, having rested in that position for at least 10 minutes. Baseline was defined at Day 1. Change from Baseline was calculated by subtracting the post-Baseline value from Baseline value.
Time frame: Baseline (Day 1) up to Day 28
Population: Safety population. Data for only those participants available at the indicated time points were collected and analyzed. Data points with null value for participants analyzed indicate data not collected for respective category and treatment arm.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Gepotidacin 750 mg q12h | Change From Baseline in Respiratory Rate | ON IV TREATMENT/DAY 2 | 0.1 Breaths per minute | Standard Deviation 2.28 |
| Gepotidacin 750 mg q12h | Change From Baseline in Respiratory Rate | ON IV TREATMENT/DAY 7 | -1.2 Breaths per minute | Standard Deviation 2.68 |
| Gepotidacin 750 mg q12h | Change From Baseline in Respiratory Rate | ORAL - DAY 7-10 | -0.2 Breaths per minute | Standard Deviation 2.39 |
| Gepotidacin 750 mg q12h | Change From Baseline in Respiratory Rate | ON IV TREATMENT/DAY 8 | -1.3 Breaths per minute | Standard Deviation 4.16 |
| Gepotidacin 750 mg q12h | Change From Baseline in Respiratory Rate | ON IV TREATMENT/DAY 9 | -4.0 Breaths per minute | Standard Deviation 2.83 |
| Gepotidacin 750 mg q12h | Change From Baseline in Respiratory Rate | ON IV TREATMENT/DAY 10 | -6.0 Breaths per minute | — |
| Gepotidacin 750 mg q12h | Change From Baseline in Respiratory Rate | ORAL - FIRST DAY | 0.4 Breaths per minute | Standard Deviation 2.33 |
| Gepotidacin 750 mg q12h | Change From Baseline in Respiratory Rate | ON IV TREATMENT/DAY 1 | -0.4 Breaths per minute | Standard Deviation 2.66 |
| Gepotidacin 750 mg q12h | Change From Baseline in Respiratory Rate | FOLLOW UP DAY 21-28 | -0.6 Breaths per minute | Standard Deviation 2.81 |
| Gepotidacin 750 mg q12h | Change From Baseline in Respiratory Rate | ON IV TREATMENT/DAY 3 | 0.3 Breaths per minute | Standard Deviation 2.8 |
| Gepotidacin 750 mg q12h | Change From Baseline in Respiratory Rate | ON IV TREATMENT/DAY 4 | -0.1 Breaths per minute | Standard Deviation 1.78 |
| Gepotidacin 750 mg q12h | Change From Baseline in Respiratory Rate | POST THERAPY DAY 12-18 | 0.0 Breaths per minute | Standard Deviation 2.94 |
| Gepotidacin 750 mg q12h | Change From Baseline in Respiratory Rate | ON IV TREATMENT/DAY 5 | -0.4 Breaths per minute | Standard Deviation 2.22 |
| Gepotidacin 750 mg q12h | Change From Baseline in Respiratory Rate | POST DOSE DAY 3-10 | -2.0 Breaths per minute | — |
| Gepotidacin 750 mg q12h | Change From Baseline in Respiratory Rate | ON IV TREATMENT/DAY 6 | -0.1 Breaths per minute | Standard Deviation 2.33 |
| Gepotidacin 1000 mg q12h | Change From Baseline in Respiratory Rate | ON IV TREATMENT/DAY 7 | -1.0 Breaths per minute | Standard Deviation 1.15 |
| Gepotidacin 1000 mg q12h | Change From Baseline in Respiratory Rate | ON IV TREATMENT/DAY 4 | -1.0 Breaths per minute | Standard Deviation 1.94 |
| Gepotidacin 1000 mg q12h | Change From Baseline in Respiratory Rate | ON IV TREATMENT/DAY 1 | -0.1 Breaths per minute | Standard Deviation 1.64 |
| Gepotidacin 1000 mg q12h | Change From Baseline in Respiratory Rate | ON IV TREATMENT/DAY 2 | -0.3 Breaths per minute | Standard Deviation 2.37 |
| Gepotidacin 1000 mg q12h | Change From Baseline in Respiratory Rate | ON IV TREATMENT/DAY 3 | -0.6 Breaths per minute | Standard Deviation 1.58 |
| Gepotidacin 1000 mg q12h | Change From Baseline in Respiratory Rate | ON IV TREATMENT/DAY 5 | -0.7 Breaths per minute | Standard Deviation 1.25 |
| Gepotidacin 1000 mg q12h | Change From Baseline in Respiratory Rate | ON IV TREATMENT/DAY 6 | -0.8 Breaths per minute | Standard Deviation 1.47 |
| Gepotidacin 1000 mg q12h | Change From Baseline in Respiratory Rate | ORAL - FIRST DAY | 0.3 Breaths per minute | Standard Deviation 1.66 |
| Gepotidacin 1000 mg q12h | Change From Baseline in Respiratory Rate | ORAL - DAY 7-10 | -0.1 Breaths per minute | Standard Deviation 2.35 |
| Gepotidacin 1000 mg q12h | Change From Baseline in Respiratory Rate | POST THERAPY DAY 12-18 | -0.3 Breaths per minute | Standard Deviation 1.97 |
| Gepotidacin 1000 mg q12h | Change From Baseline in Respiratory Rate | FOLLOW UP DAY 21-28 | -0.3 Breaths per minute | Standard Deviation 2.04 |
| Gepotidacin 1000 mg q8h | Change From Baseline in Respiratory Rate | ORAL - DAY 7-10 | -0.2 Breaths per minute | Standard Deviation 2.04 |
| Gepotidacin 1000 mg q8h | Change From Baseline in Respiratory Rate | ON IV TREATMENT/DAY 4 | -1.0 Breaths per minute | Standard Deviation 1.41 |
| Gepotidacin 1000 mg q8h | Change From Baseline in Respiratory Rate | FOLLOW UP DAY 21-28 | -0.5 Breaths per minute | Standard Deviation 1.78 |
| Gepotidacin 1000 mg q8h | Change From Baseline in Respiratory Rate | POST THERAPY DAY 12-18 | -0.4 Breaths per minute | Standard Deviation 2.02 |
| Gepotidacin 1000 mg q8h | Change From Baseline in Respiratory Rate | ON IV TREATMENT/DAY 2 | -0.5 Breaths per minute | Standard Deviation 1.73 |
| Gepotidacin 1000 mg q8h | Change From Baseline in Respiratory Rate | ORAL - FIRST DAY | 0.2 Breaths per minute | Standard Deviation 1.92 |
| Gepotidacin 1000 mg q8h | Change From Baseline in Respiratory Rate | ON IV TREATMENT/DAY 3 | -0.3 Breaths per minute | Standard Deviation 2.17 |
| Gepotidacin 1000 mg q8h | Change From Baseline in Respiratory Rate | ON IV TREATMENT/DAY 1 | 0.7 Breaths per minute | Standard Deviation 2.9 |
Secondary
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)
SBP and DBP was measured with the participant in a supine or semi-supine position, having rested in that position for at least 10 minutes. Baseline was defined at Day 1. Change from Baseline was calculated by subtracting the post-Baseline value from Baseline value.
Time frame: Baseline (Day 1) up to Day 28
Population: Safety population. Data for only those participants available at the indicated time points were collected and analyzed. Data points with null value for participants analyzed indicate data not collected for respective category and treatment arm.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Gepotidacin 750 mg q12h | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP, ORAL - FIRST DAY | 1.6 Millimeters of mercury | Standard Deviation 13.36 |
| Gepotidacin 750 mg q12h | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP, POST DOSE DAY 3-10 | -5.0 Millimeters of mercury | — |
| Gepotidacin 750 mg q12h | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP, ON IV TREATMENT/DAY 10 | 8.0 Millimeters of mercury | — |
| Gepotidacin 750 mg q12h | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP, ORAL - DAY 7-10 | 2.8 Millimeters of mercury | Standard Deviation 9.14 |
| Gepotidacin 750 mg q12h | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP, ON IV TREATMENT/DAY 9 | 13.0 Millimeters of mercury | Standard Deviation 21.21 |
| Gepotidacin 750 mg q12h | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP, ON IV TREATMENT/DAY 4 | -1.9 Millimeters of mercury | Standard Deviation 12.19 |
| Gepotidacin 750 mg q12h | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP, POST THERAPY DAY 12-18 | -0.1 Millimeters of mercury | Standard Deviation 13.71 |
| Gepotidacin 750 mg q12h | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP, ON IV TREATMENT/DAY 8 | -0.3 Millimeters of mercury | Standard Deviation 18.5 |
| Gepotidacin 750 mg q12h | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP, FOLLOW UP DAY 21-28 | 2.5 Millimeters of mercury | Standard Deviation 12.87 |
| Gepotidacin 750 mg q12h | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP, ON IV TREATMENT/DAY 7 | -17.0 Millimeters of mercury | Standard Deviation 16.57 |
| Gepotidacin 750 mg q12h | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP, ON IV TREATMENT/DAY 3 | -4.5 Millimeters of mercury | Standard Deviation 10.98 |
| Gepotidacin 750 mg q12h | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP, POST DOSE DAY 3-10 | -23.0 Millimeters of mercury | — |
| Gepotidacin 750 mg q12h | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP, ON IV TREATMENT/DAY 1 | -3.1 Millimeters of mercury | Standard Deviation 10.28 |
| Gepotidacin 750 mg q12h | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP, ON IV TREATMENT/DAY 1 | -2.9 Millimeters of mercury | Standard Deviation 15.07 |
| Gepotidacin 750 mg q12h | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP, ON IV TREATMENT/DAY 2 | -3.5 Millimeters of mercury | Standard Deviation 10.84 |
| Gepotidacin 750 mg q12h | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP, FOLLOW UP DAY 21-28 | 2.3 Millimeters of mercury | Standard Deviation 11 |
| Gepotidacin 750 mg q12h | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP, ON IV TREATMENT/DAY 2 | -4.8 Millimeters of mercury | Standard Deviation 14.63 |
| Gepotidacin 750 mg q12h | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP, POST THERAPY DAY 12-18 | 2.2 Millimeters of mercury | Standard Deviation 9.18 |
| Gepotidacin 750 mg q12h | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP, ON IV TREATMENT/DAY 3 | -1.7 Millimeters of mercury | Standard Deviation 14.57 |
| Gepotidacin 750 mg q12h | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP, ON IV TREATMENT/DAY 5 | -0.9 Millimeters of mercury | Standard Deviation 13.66 |
| Gepotidacin 750 mg q12h | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP, ORAL - DAY 7-10 | -1.2 Millimeters of mercury | Standard Deviation 9.12 |
| Gepotidacin 750 mg q12h | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP, ON IV TREATMENT/DAY 4 | -3.2 Millimeters of mercury | Standard Deviation 14.25 |
| Gepotidacin 750 mg q12h | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP, ON IV TREATMENT/DAY 5 | -4.8 Millimeters of mercury | Standard Deviation 17.9 |
| Gepotidacin 750 mg q12h | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP, ORAL - FIRST DAY | 0.0 Millimeters of mercury | Standard Deviation 11.26 |
| Gepotidacin 750 mg q12h | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP, ON IV TREATMENT/DAY 6 | -8.0 Millimeters of mercury | Standard Deviation 14.6 |
| Gepotidacin 750 mg q12h | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP, ON IV TREATMENT/DAY 6 | -1.4 Millimeters of mercury | Standard Deviation 11.75 |
| Gepotidacin 750 mg q12h | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP, ON IV TREATMENT/DAY 7 | -1.6 Millimeters of mercury | Standard Deviation 23.37 |
| Gepotidacin 750 mg q12h | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP, ON IV TREATMENT/DAY 8 | -10.3 Millimeters of mercury | Standard Deviation 29.87 |
| Gepotidacin 750 mg q12h | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP, ON IV TREATMENT/DAY 9 | 12.0 Millimeters of mercury | Standard Deviation 1.41 |
| Gepotidacin 750 mg q12h | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP, ON IV TREATMENT/DAY 10 | 6.0 Millimeters of mercury | — |
| Gepotidacin 1000 mg q12h | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP, ORAL - DAY 7-10 | 1.9 Millimeters of mercury | Standard Deviation 10.55 |
| Gepotidacin 1000 mg q12h | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP, ON IV TREATMENT/DAY 5 | -1.6 Millimeters of mercury | Standard Deviation 31.01 |
| Gepotidacin 1000 mg q12h | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP, ON IV TREATMENT/DAY 5 | -2.0 Millimeters of mercury | Standard Deviation 14.83 |
| Gepotidacin 1000 mg q12h | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP, ON IV TREATMENT/DAY 7 | -13.8 Millimeters of mercury | Standard Deviation 19.09 |
| Gepotidacin 1000 mg q12h | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP, POST THERAPY DAY 12-18 | 2.3 Millimeters of mercury | Standard Deviation 8 |
| Gepotidacin 1000 mg q12h | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP, ON IV TREATMENT/DAY 1 | -1.7 Millimeters of mercury | Standard Deviation 13.9 |
| Gepotidacin 1000 mg q12h | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP, ON IV TREATMENT/DAY 2 | 0.3 Millimeters of mercury | Standard Deviation 13.55 |
| Gepotidacin 1000 mg q12h | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP, ON IV TREATMENT/DAY 3 | 1.6 Millimeters of mercury | Standard Deviation 11.25 |
| Gepotidacin 1000 mg q12h | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP, ON IV TREATMENT/DAY 4 | -1.2 Millimeters of mercury | Standard Deviation 17.11 |
| Gepotidacin 1000 mg q12h | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP, ON IV TREATMENT/DAY 6 | -2.7 Millimeters of mercury | Standard Deviation 14.83 |
| Gepotidacin 1000 mg q12h | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP, ON IV TREATMENT/DAY 7 | 2.3 Millimeters of mercury | Standard Deviation 32.39 |
| Gepotidacin 1000 mg q12h | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP, ORAL - FIRST DAY | 2.3 Millimeters of mercury | Standard Deviation 13.86 |
| Gepotidacin 1000 mg q12h | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP, POST THERAPY DAY 12-18 | 4.5 Millimeters of mercury | Standard Deviation 11.33 |
| Gepotidacin 1000 mg q12h | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP, FOLLOW UP DAY 21-28 | 2.1 Millimeters of mercury | Standard Deviation 12.24 |
| Gepotidacin 1000 mg q12h | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP, ON IV TREATMENT/DAY 1 | -2.9 Millimeters of mercury | Standard Deviation 10.97 |
| Gepotidacin 1000 mg q12h | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP, ON IV TREATMENT/DAY 2 | -0.9 Millimeters of mercury | Standard Deviation 9.26 |
| Gepotidacin 1000 mg q12h | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP, ON IV TREATMENT/DAY 3 | -0.9 Millimeters of mercury | Standard Deviation 9.93 |
| Gepotidacin 1000 mg q12h | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP, ON IV TREATMENT/DAY 4 | 0.6 Millimeters of mercury | Standard Deviation 11.19 |
| Gepotidacin 1000 mg q12h | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP, ON IV TREATMENT/DAY 6 | -9.2 Millimeters of mercury | Standard Deviation 15.38 |
| Gepotidacin 1000 mg q12h | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP, ORAL - FIRST DAY | -1.0 Millimeters of mercury | Standard Deviation 8.44 |
| Gepotidacin 1000 mg q12h | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP, ORAL - DAY 7-10 | 0.4 Millimeters of mercury | Standard Deviation 8.13 |
| Gepotidacin 1000 mg q12h | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP, FOLLOW UP DAY 21-28 | 0.0 Millimeters of mercury | Standard Deviation 9.94 |
| Gepotidacin 1000 mg q8h | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP, ON IV TREATMENT/DAY 4 | -12.5 Millimeters of mercury | Standard Deviation 30.41 |
| Gepotidacin 1000 mg q8h | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP, POST THERAPY DAY 12-18 | 4.1 Millimeters of mercury | Standard Deviation 11.09 |
| Gepotidacin 1000 mg q8h | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP, ON IV TREATMENT/DAY 1 | -2.4 Millimeters of mercury | Standard Deviation 9.43 |
| Gepotidacin 1000 mg q8h | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP, ORAL - FIRST DAY | -3.7 Millimeters of mercury | Standard Deviation 13.59 |
| Gepotidacin 1000 mg q8h | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP, ON IV TREATMENT/DAY 4 | -22.0 Millimeters of mercury | Standard Deviation 31.11 |
| Gepotidacin 1000 mg q8h | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP, ON IV TREATMENT/DAY 2 | -1.9 Millimeters of mercury | Standard Deviation 9.73 |
| Gepotidacin 1000 mg q8h | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP, ORAL - FIRST DAY | -3.4 Millimeters of mercury | Standard Deviation 12.84 |
| Gepotidacin 1000 mg q8h | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP, ON IV TREATMENT/DAY 3 | -2.1 Millimeters of mercury | Standard Deviation 13.88 |
| Gepotidacin 1000 mg q8h | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP, FOLLOW UP DAY 21-28 | 1.2 Millimeters of mercury | Standard Deviation 13.44 |
| Gepotidacin 1000 mg q8h | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP, ON IV TREATMENT/DAY 1 | -2.3 Millimeters of mercury | Standard Deviation 9.21 |
| Gepotidacin 1000 mg q8h | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP, ORAL - DAY 7-10 | 0.0 Millimeters of mercury | Standard Deviation 11.13 |
| Gepotidacin 1000 mg q8h | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP, FOLLOW UP DAY 21-28 | 1.7 Millimeters of mercury | Standard Deviation 15.6 |
| Gepotidacin 1000 mg q8h | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP, ON IV TREATMENT/DAY 2 | -2.1 Millimeters of mercury | Standard Deviation 9.77 |
| Gepotidacin 1000 mg q8h | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP, ON IV TREATMENT/DAY 3 | -3.5 Millimeters of mercury | Standard Deviation 14.74 |
| Gepotidacin 1000 mg q8h | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP, ORAL - DAY 7-10 | -0.9 Millimeters of mercury | Standard Deviation 17.91 |
| Gepotidacin 1000 mg q8h | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP, POST THERAPY DAY 12-18 | 3.5 Millimeters of mercury | Standard Deviation 12.23 |
Secondary
Change From Baseline in Vital Sign: Body Temperature
Body temperature was measured with the participant in a supine or semi-supine position, having rested in that position for at least 10 minutes. Baseline was defined at Day 1. Change from Baseline was calculated by subtracting the post-Baseline value from Baseline value.
Time frame: Baseline (Day 1) up to Day 28
Population: Safety population. Data for only those participants available at the indicated time points were collected and analyzed. Data points with null value for participants analyzed indicate data not collected for respective category and treatment arm.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Gepotidacin 750 mg q12h | Change From Baseline in Vital Sign: Body Temperature | ON IV TREATMENT/DAY 4 | -0.476 Celcius | Standard Deviation 0.7242 |
| Gepotidacin 750 mg q12h | Change From Baseline in Vital Sign: Body Temperature | FOLLOW UP DAY 21-28 | -0.441 Celcius | Standard Deviation 0.7579 |
| Gepotidacin 750 mg q12h | Change From Baseline in Vital Sign: Body Temperature | ON IV TREATMENT/DAY 9 | -0.800 Celcius | Standard Deviation 0.7071 |
| Gepotidacin 750 mg q12h | Change From Baseline in Vital Sign: Body Temperature | ON IV TREATMENT/DAY 5 | -0.662 Celcius | Standard Deviation 0.8412 |
| Gepotidacin 750 mg q12h | Change From Baseline in Vital Sign: Body Temperature | POST THERAPY DAY 12-18 | -0.485 Celcius | Standard Deviation 0.7579 |
| Gepotidacin 750 mg q12h | Change From Baseline in Vital Sign: Body Temperature | ON IV TREATMENT/DAY 6 | -1.080 Celcius | Standard Deviation 0.9589 |
| Gepotidacin 750 mg q12h | Change From Baseline in Vital Sign: Body Temperature | ON IV TREATMENT/DAY 1 | -0.126 Celcius | Standard Deviation 0.6632 |
| Gepotidacin 750 mg q12h | Change From Baseline in Vital Sign: Body Temperature | ON IV TREATMENT/DAY 7 | -1.400 Celcius | Standard Deviation 1.1726 |
| Gepotidacin 750 mg q12h | Change From Baseline in Vital Sign: Body Temperature | ORAL - DAY 7-10 | -0.498 Celcius | Standard Deviation 0.6496 |
| Gepotidacin 750 mg q12h | Change From Baseline in Vital Sign: Body Temperature | ON IV TREATMENT/DAY 2 | -0.195 Celcius | Standard Deviation 0.6058 |
| Gepotidacin 750 mg q12h | Change From Baseline in Vital Sign: Body Temperature | ON IV TREATMENT/DAY 8 | -0.533 Celcius | Standard Deviation 0.611 |
| Gepotidacin 750 mg q12h | Change From Baseline in Vital Sign: Body Temperature | ORAL - FIRST DAY | -0.398 Celcius | Standard Deviation 0.8149 |
| Gepotidacin 750 mg q12h | Change From Baseline in Vital Sign: Body Temperature | ON IV TREATMENT/DAY 3 | -0.393 Celcius | Standard Deviation 0.5986 |
| Gepotidacin 750 mg q12h | Change From Baseline in Vital Sign: Body Temperature | POST DOSE DAY 3-10 | -0.200 Celcius | — |
| Gepotidacin 750 mg q12h | Change From Baseline in Vital Sign: Body Temperature | ON IV TREATMENT/DAY 10 | -1.100 Celcius | — |
| Gepotidacin 1000 mg q12h | Change From Baseline in Vital Sign: Body Temperature | ON IV TREATMENT/DAY 6 | -0.842 Celcius | Standard Deviation 1.067 |
| Gepotidacin 1000 mg q12h | Change From Baseline in Vital Sign: Body Temperature | ON IV TREATMENT/DAY 1 | -0.053 Celcius | Standard Deviation 0.4114 |
| Gepotidacin 1000 mg q12h | Change From Baseline in Vital Sign: Body Temperature | ON IV TREATMENT/DAY 2 | -0.173 Celcius | Standard Deviation 0.4642 |
| Gepotidacin 1000 mg q12h | Change From Baseline in Vital Sign: Body Temperature | ON IV TREATMENT/DAY 3 | -0.308 Celcius | Standard Deviation 0.4216 |
| Gepotidacin 1000 mg q12h | Change From Baseline in Vital Sign: Body Temperature | ON IV TREATMENT/DAY 4 | -0.455 Celcius | Standard Deviation 0.561 |
| Gepotidacin 1000 mg q12h | Change From Baseline in Vital Sign: Body Temperature | ON IV TREATMENT/DAY 5 | -0.521 Celcius | Standard Deviation 0.6013 |
| Gepotidacin 1000 mg q12h | Change From Baseline in Vital Sign: Body Temperature | ON IV TREATMENT/DAY 7 | -0.738 Celcius | Standard Deviation 0.8901 |
| Gepotidacin 1000 mg q12h | Change From Baseline in Vital Sign: Body Temperature | ORAL - FIRST DAY | -0.304 Celcius | Standard Deviation 0.7005 |
| Gepotidacin 1000 mg q12h | Change From Baseline in Vital Sign: Body Temperature | ORAL - DAY 7-10 | -0.468 Celcius | Standard Deviation 0.6417 |
| Gepotidacin 1000 mg q12h | Change From Baseline in Vital Sign: Body Temperature | POST THERAPY DAY 12-18 | -0.439 Celcius | Standard Deviation 0.6764 |
| Gepotidacin 1000 mg q12h | Change From Baseline in Vital Sign: Body Temperature | FOLLOW UP DAY 21-28 | -0.375 Celcius | Standard Deviation 0.7255 |
| Gepotidacin 1000 mg q8h | Change From Baseline in Vital Sign: Body Temperature | ORAL - FIRST DAY | -0.608 Celcius | Standard Deviation 0.7593 |
| Gepotidacin 1000 mg q8h | Change From Baseline in Vital Sign: Body Temperature | ON IV TREATMENT/DAY 1 | -0.172 Celcius | Standard Deviation 0.4208 |
| Gepotidacin 1000 mg q8h | Change From Baseline in Vital Sign: Body Temperature | POST THERAPY DAY 12-18 | -0.645 Celcius | Standard Deviation 0.9379 |
| Gepotidacin 1000 mg q8h | Change From Baseline in Vital Sign: Body Temperature | ORAL - DAY 7-10 | -0.635 Celcius | Standard Deviation 0.8483 |
| Gepotidacin 1000 mg q8h | Change From Baseline in Vital Sign: Body Temperature | ON IV TREATMENT/DAY 4 | -0.550 Celcius | Standard Deviation 0.2121 |
| Gepotidacin 1000 mg q8h | Change From Baseline in Vital Sign: Body Temperature | ON IV TREATMENT/DAY 3 | -0.456 Celcius | Standard Deviation 0.7548 |
| Gepotidacin 1000 mg q8h | Change From Baseline in Vital Sign: Body Temperature | ON IV TREATMENT/DAY 2 | -0.400 Celcius | Standard Deviation 0.5672 |
| Gepotidacin 1000 mg q8h | Change From Baseline in Vital Sign: Body Temperature | FOLLOW UP DAY 21-28 | -0.604 Celcius | Standard Deviation 0.8891 |
Secondary
Estradiol Values at Baseline
Blood samples for assessment of clinical chemistry parameter of estradiol was collected at Baseline (Day 1). No post-baseline values were reported.
Time frame: Baseline (Day 1)
Population: Safety Population. Only those participants available at the indicated time points were analyzed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Gepotidacin 750 mg q12h | Estradiol Values at Baseline | 229.4 Picomole per liter | Standard Deviation 196.66 |
| Gepotidacin 1000 mg q12h | Estradiol Values at Baseline | 148.8 Picomole per liter | Standard Deviation 153.58 |
| Gepotidacin 1000 mg q8h | Estradiol Values at Baseline | 23.5 Picomole per liter | Standard Deviation 23.33 |
Secondary
Number of Participants Demonstrating a Decrease in GSK2140944 Susceptibility When Comparing Isolates Recovered From Baseline With Those From Any Time Post-Baseline Skin Specimens
Reduction in susceptibility was defined as a \>=4-fold increase in minimum inhibitory concentration (MIC) or \>=6 millimeter decrease in zone size between an isolate obtained at Baseline and the same pathogen at subsequent visits.
Time frame: Up to Day 28
Population: Modified MITT Population.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Gepotidacin 750 mg q12h | Number of Participants Demonstrating a Decrease in GSK2140944 Susceptibility When Comparing Isolates Recovered From Baseline With Those From Any Time Post-Baseline Skin Specimens | 0 Participants |
| Gepotidacin 1000 mg q12h | Number of Participants Demonstrating a Decrease in GSK2140944 Susceptibility When Comparing Isolates Recovered From Baseline With Those From Any Time Post-Baseline Skin Specimens | 0 Participants |
| Gepotidacin 1000 mg q8h | Number of Participants Demonstrating a Decrease in GSK2140944 Susceptibility When Comparing Isolates Recovered From Baseline With Those From Any Time Post-Baseline Skin Specimens | 0 Participants |
Secondary
Number of Participants With Abnormal Urinalysis Dipstick Results
Samples for urinalysis assessment was collected at Baseline (Day 1), Day 2, Day 7 to 10, Day 12 to 21 and Day 21 to Day 28 for Glucose, Ketones, Occult Blood, Protein and pH. Participants with abnormal urinalysis result was reported.
Time frame: Up to day 28
Population: Safety Population. Only those participants available at the indicated time points were analyzed.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Gepotidacin 750 mg q12h | Number of Participants With Abnormal Urinalysis Dipstick Results | Protein, ON IV TREATMENT/DAY 5, Trace | 2 Participants |
| Gepotidacin 750 mg q12h | Number of Participants With Abnormal Urinalysis Dipstick Results | Occult Blood, POST THERAPY DAY 12-18, 2+ | 1 Participants |
| Gepotidacin 750 mg q12h | Number of Participants With Abnormal Urinalysis Dipstick Results | Occult Blood, POST THERAPY DAY 12-18, 3+ | 1 Participants |
| Gepotidacin 750 mg q12h | Number of Participants With Abnormal Urinalysis Dipstick Results | Glucose, POST THERAPY DAY 12-18, Trace | 3 Participants |
| Gepotidacin 750 mg q12h | Number of Participants With Abnormal Urinalysis Dipstick Results | Protein, BASELINE/DAY 1, Trace | 7 Participants |
| Gepotidacin 750 mg q12h | Number of Participants With Abnormal Urinalysis Dipstick Results | Protein, BASELINE/DAY 1, 1+ | 6 Participants |
| Gepotidacin 750 mg q12h | Number of Participants With Abnormal Urinalysis Dipstick Results | Glucose, ON IV TREATMENT/DAY 2, 3+ | 3 Participants |
| Gepotidacin 750 mg q12h | Number of Participants With Abnormal Urinalysis Dipstick Results | Protein, BASELINE/DAY 1, 2+ | 1 Participants |
| Gepotidacin 750 mg q12h | Number of Participants With Abnormal Urinalysis Dipstick Results | Glucose, POST THERAPY DAY 12-18, 1+ | 0 Participants |
| Gepotidacin 750 mg q12h | Number of Participants With Abnormal Urinalysis Dipstick Results | Protein, BASELINE/DAY 1, 3+ | 1 Participants |
| Gepotidacin 750 mg q12h | Number of Participants With Abnormal Urinalysis Dipstick Results | Protein, ON IV TREATMENT/DAY 2, Trace | 4 Participants |
| Gepotidacin 750 mg q12h | Number of Participants With Abnormal Urinalysis Dipstick Results | Protein, ON IV TREATMENT/DAY 2, 1+ | 7 Participants |
| Gepotidacin 750 mg q12h | Number of Participants With Abnormal Urinalysis Dipstick Results | Glucose, POST THERAPY DAY 12-18, 3+ | 0 Participants |
| Gepotidacin 750 mg q12h | Number of Participants With Abnormal Urinalysis Dipstick Results | Protein, ON IV TREATMENT/DAY 3, Trace | 4 Participants |
| Gepotidacin 750 mg q12h | Number of Participants With Abnormal Urinalysis Dipstick Results | Protein, ON IV TREATMENT/DAY 3, 1+ | 3 Participants |
| Gepotidacin 750 mg q12h | Number of Participants With Abnormal Urinalysis Dipstick Results | Protein, ON IV TREATMENT/DAY 3, 2+ | 1 Participants |
| Gepotidacin 750 mg q12h | Number of Participants With Abnormal Urinalysis Dipstick Results | Ketones, BASELINE/DAY 1, Trace | 8 Participants |
| Gepotidacin 750 mg q12h | Number of Participants With Abnormal Urinalysis Dipstick Results | Occult Blood, POST THERAPY DAY 12-18, 1+ | 1 Participants |
| Gepotidacin 750 mg q12h | Number of Participants With Abnormal Urinalysis Dipstick Results | Protein, ON IV TREATMENT/DAY 5, 1+ | 0 Participants |
| Gepotidacin 750 mg q12h | Number of Participants With Abnormal Urinalysis Dipstick Results | Protein, ORAL - FIRST DAY, Trace | 2 Participants |
| Gepotidacin 750 mg q12h | Number of Participants With Abnormal Urinalysis Dipstick Results | Protein, ORAL - FIRST DAY, 1+ | 0 Participants |
| Gepotidacin 750 mg q12h | Number of Participants With Abnormal Urinalysis Dipstick Results | Glucose, ON IV TREATMENT/DAY 3, 2+ | 1 Participants |
| Gepotidacin 750 mg q12h | Number of Participants With Abnormal Urinalysis Dipstick Results | Protein, ORAL - FIRST DAY, 2+ | 1 Participants |
| Gepotidacin 750 mg q12h | Number of Participants With Abnormal Urinalysis Dipstick Results | Ketones, BASELINE/DAY 1, 1+ | 1 Participants |
| Gepotidacin 750 mg q12h | Number of Participants With Abnormal Urinalysis Dipstick Results | Protein, ORAL - DAY 7-10, Trace | 7 Participants |
| Gepotidacin 750 mg q12h | Number of Participants With Abnormal Urinalysis Dipstick Results | Protein, ORAL - DAY 7-10, 1+ | 6 Participants |
| Gepotidacin 750 mg q12h | Number of Participants With Abnormal Urinalysis Dipstick Results | Protein, ORAL - DAY 7-10, 2+ | 1 Participants |
| Gepotidacin 750 mg q12h | Number of Participants With Abnormal Urinalysis Dipstick Results | Ketones, BASELINE/DAY 1, 3+ | 0 Participants |
| Gepotidacin 750 mg q12h | Number of Participants With Abnormal Urinalysis Dipstick Results | Protein, POST THERAPY DAY 12-18, Trace | 8 Participants |
| Gepotidacin 750 mg q12h | Number of Participants With Abnormal Urinalysis Dipstick Results | Protein, POST THERAPY DAY 12-18, 1+ | 3 Participants |
| Gepotidacin 750 mg q12h | Number of Participants With Abnormal Urinalysis Dipstick Results | Glucose, BASELINE/DAY 1, 3+ | 1 Participants |
| Gepotidacin 750 mg q12h | Number of Participants With Abnormal Urinalysis Dipstick Results | Protein, POST THERAPY DAY 12-18, 2+ | 0 Participants |
| Gepotidacin 750 mg q12h | Number of Participants With Abnormal Urinalysis Dipstick Results | Ketones, ON IV TREATMENT/DAY 2, Trace | 4 Participants |
| Gepotidacin 750 mg q12h | Number of Participants With Abnormal Urinalysis Dipstick Results | pH, Post-Baseline Maximum, 8.5 | 1 Participants |
| Gepotidacin 750 mg q12h | Number of Participants With Abnormal Urinalysis Dipstick Results | Glucose, ON IV TREATMENT/DAY 3, 3+ | 1 Participants |
| Gepotidacin 750 mg q12h | Number of Participants With Abnormal Urinalysis Dipstick Results | Ketones, ON IV TREATMENT/DAY 2, 1+ | 2 Participants |
| Gepotidacin 750 mg q12h | Number of Participants With Abnormal Urinalysis Dipstick Results | Ketones, ON IV TREATMENT/DAY 2, 3+ | 0 Participants |
| Gepotidacin 750 mg q12h | Number of Participants With Abnormal Urinalysis Dipstick Results | Ketones, ON IV TREATMENT/DAY 3, Trace | 5 Participants |
| Gepotidacin 750 mg q12h | Number of Participants With Abnormal Urinalysis Dipstick Results | Glucose, ON IV TREATMENT/DAY 5, 2+ | 1 Participants |
| Gepotidacin 750 mg q12h | Number of Participants With Abnormal Urinalysis Dipstick Results | Ketones, ORAL - FIRST DAY, Trace | 3 Participants |
| Gepotidacin 750 mg q12h | Number of Participants With Abnormal Urinalysis Dipstick Results | Ketones, ORAL - FIRST DAY, 2+ | 1 Participants |
| Gepotidacin 750 mg q12h | Number of Participants With Abnormal Urinalysis Dipstick Results | Glucose, ON IV TREATMENT/DAY 7, 2+ | 1 Participants |
| Gepotidacin 750 mg q12h | Number of Participants With Abnormal Urinalysis Dipstick Results | Ketones, ORAL - DAY 7-10, Trace | 6 Participants |
| Gepotidacin 750 mg q12h | Number of Participants With Abnormal Urinalysis Dipstick Results | Ketones, POST THERAPY DAY 12-18, Trace | 8 Participants |
| Gepotidacin 750 mg q12h | Number of Participants With Abnormal Urinalysis Dipstick Results | Glucose, ORAL - FIRST DAY, Trace | 0 Participants |
| Gepotidacin 750 mg q12h | Number of Participants With Abnormal Urinalysis Dipstick Results | Occult Blood, BASELINE/DAY 1, Trace | 3 Participants |
| Gepotidacin 750 mg q12h | Number of Participants With Abnormal Urinalysis Dipstick Results | Occult Blood, BASELINE/DAY 1, 1+ | 4 Participants |
| Gepotidacin 750 mg q12h | Number of Participants With Abnormal Urinalysis Dipstick Results | Glucose, BASELINE/DAY 1, Trace | 1 Participants |
| Gepotidacin 750 mg q12h | Number of Participants With Abnormal Urinalysis Dipstick Results | Occult Blood, BASELINE/DAY 1, 2+ | 1 Participants |
| Gepotidacin 750 mg q12h | Number of Participants With Abnormal Urinalysis Dipstick Results | Glucose, ORAL - FIRST DAY, 1+ | 1 Participants |
| Gepotidacin 750 mg q12h | Number of Participants With Abnormal Urinalysis Dipstick Results | Occult Blood, BASELINE/DAY 1, 3+ | 4 Participants |
| Gepotidacin 750 mg q12h | Number of Participants With Abnormal Urinalysis Dipstick Results | Occult Blood, ON IV TREATMENT/DAY 2, Trace | 3 Participants |
| Gepotidacin 750 mg q12h | Number of Participants With Abnormal Urinalysis Dipstick Results | Glucose, ON IV TREATMENT/DAY 2, Trace | 1 Participants |
| Gepotidacin 750 mg q12h | Number of Participants With Abnormal Urinalysis Dipstick Results | Occult Blood, ON IV TREATMENT/DAY 2, 1+ | 1 Participants |
| Gepotidacin 750 mg q12h | Number of Participants With Abnormal Urinalysis Dipstick Results | Glucose, ORAL - FIRST DAY, 3+ | 1 Participants |
| Gepotidacin 750 mg q12h | Number of Participants With Abnormal Urinalysis Dipstick Results | Occult Blood, ON IV TREATMENT/DAY 2, 2+ | 0 Participants |
| Gepotidacin 750 mg q12h | Number of Participants With Abnormal Urinalysis Dipstick Results | Occult Blood, ON IV TREATMENT/DAY 2, 3+ | 1 Participants |
| Gepotidacin 750 mg q12h | Number of Participants With Abnormal Urinalysis Dipstick Results | Occult Blood, ON IV TREATMENT/DAY 3, Trace | 0 Participants |
| Gepotidacin 750 mg q12h | Number of Participants With Abnormal Urinalysis Dipstick Results | Glucose, ORAL - DAY 7-10, Trace | 1 Participants |
| Gepotidacin 750 mg q12h | Number of Participants With Abnormal Urinalysis Dipstick Results | Occult Blood, ON IV TREATMENT/DAY 3, 3+ | 0 Participants |
| Gepotidacin 750 mg q12h | Number of Participants With Abnormal Urinalysis Dipstick Results | Occult Blood, ON IV TREATMENT/DAY 5, Trace | 2 Participants |
| Gepotidacin 750 mg q12h | Number of Participants With Abnormal Urinalysis Dipstick Results | Occult Blood, ON IV TREATMENT/DAY 7, Trace | 1 Participants |
| Gepotidacin 750 mg q12h | Number of Participants With Abnormal Urinalysis Dipstick Results | Occult Blood, ORAL - FIRST DAY, Trace | 2 Participants |
| Gepotidacin 750 mg q12h | Number of Participants With Abnormal Urinalysis Dipstick Results | Glucose, BASELINE/DAY 1, 1+ | 1 Participants |
| Gepotidacin 750 mg q12h | Number of Participants With Abnormal Urinalysis Dipstick Results | Occult Blood, ORAL - FIRST DAY, 1+ | 3 Participants |
| Gepotidacin 750 mg q12h | Number of Participants With Abnormal Urinalysis Dipstick Results | Glucose, ORAL - DAY 7-10, 1+ | 0 Participants |
| Gepotidacin 750 mg q12h | Number of Participants With Abnormal Urinalysis Dipstick Results | Occult Blood, ORAL - FIRST DAY, 2+ | 1 Participants |
| Gepotidacin 750 mg q12h | Number of Participants With Abnormal Urinalysis Dipstick Results | Occult Blood, ORAL - FIRST DAY, 3+ | 0 Participants |
| Gepotidacin 750 mg q12h | Number of Participants With Abnormal Urinalysis Dipstick Results | Glucose, ON IV TREATMENT/DAY 2, 1+ | 0 Participants |
| Gepotidacin 750 mg q12h | Number of Participants With Abnormal Urinalysis Dipstick Results | Occult Blood, ORAL - DAY 7-10, Trace | 1 Participants |
| Gepotidacin 750 mg q12h | Number of Participants With Abnormal Urinalysis Dipstick Results | Glucose, ORAL - DAY 7-10, 2+ | 0 Participants |
| Gepotidacin 750 mg q12h | Number of Participants With Abnormal Urinalysis Dipstick Results | Occult Blood, ORAL - DAY 7-10, 2+ | 1 Participants |
| Gepotidacin 750 mg q12h | Number of Participants With Abnormal Urinalysis Dipstick Results | Occult Blood, ORAL - DAY 7-10, 3+ | 0 Participants |
| Gepotidacin 750 mg q12h | Number of Participants With Abnormal Urinalysis Dipstick Results | Occult Blood, POST THERAPY DAY 12-18, Trace | 1 Participants |
| Gepotidacin 750 mg q12h | Number of Participants With Abnormal Urinalysis Dipstick Results | Glucose, ORAL - DAY 7-10, 3+ | 0 Participants |
| Gepotidacin 1000 mg q12h | Number of Participants With Abnormal Urinalysis Dipstick Results | Ketones, ON IV TREATMENT/DAY 2, 3+ | 0 Participants |
| Gepotidacin 1000 mg q12h | Number of Participants With Abnormal Urinalysis Dipstick Results | Occult Blood, POST THERAPY DAY 12-18, 1+ | 1 Participants |
| Gepotidacin 1000 mg q12h | Number of Participants With Abnormal Urinalysis Dipstick Results | Glucose, ORAL - DAY 7-10, 3+ | 2 Participants |
| Gepotidacin 1000 mg q12h | Number of Participants With Abnormal Urinalysis Dipstick Results | Glucose, BASELINE/DAY 1, 3+ | 2 Participants |
| Gepotidacin 1000 mg q12h | Number of Participants With Abnormal Urinalysis Dipstick Results | Occult Blood, POST THERAPY DAY 12-18, 2+ | 1 Participants |
| Gepotidacin 1000 mg q12h | Number of Participants With Abnormal Urinalysis Dipstick Results | Glucose, BASELINE/DAY 1, 1+ | 1 Participants |
| Gepotidacin 1000 mg q12h | Number of Participants With Abnormal Urinalysis Dipstick Results | Glucose, ORAL - FIRST DAY, 3+ | 2 Participants |
| Gepotidacin 1000 mg q12h | Number of Participants With Abnormal Urinalysis Dipstick Results | Occult Blood, POST THERAPY DAY 12-18, 3+ | 0 Participants |
| Gepotidacin 1000 mg q12h | Number of Participants With Abnormal Urinalysis Dipstick Results | Ketones, ON IV TREATMENT/DAY 3, Trace | 0 Participants |
| Gepotidacin 1000 mg q12h | Number of Participants With Abnormal Urinalysis Dipstick Results | Occult Blood, ORAL - DAY 7-10, 3+ | 0 Participants |
| Gepotidacin 1000 mg q12h | Number of Participants With Abnormal Urinalysis Dipstick Results | Protein, BASELINE/DAY 1, Trace | 5 Participants |
| Gepotidacin 1000 mg q12h | Number of Participants With Abnormal Urinalysis Dipstick Results | Glucose, POST THERAPY DAY 12-18, Trace | 0 Participants |
| Gepotidacin 1000 mg q12h | Number of Participants With Abnormal Urinalysis Dipstick Results | Occult Blood, ON IV TREATMENT/DAY 2, 3+ | 1 Participants |
| Gepotidacin 1000 mg q12h | Number of Participants With Abnormal Urinalysis Dipstick Results | Protein, BASELINE/DAY 1, 1+ | 4 Participants |
| Gepotidacin 1000 mg q12h | Number of Participants With Abnormal Urinalysis Dipstick Results | Ketones, ORAL - FIRST DAY, Trace | 1 Participants |
| Gepotidacin 1000 mg q12h | Number of Participants With Abnormal Urinalysis Dipstick Results | Glucose, ON IV TREATMENT/DAY 5, 2+ | 0 Participants |
| Gepotidacin 1000 mg q12h | Number of Participants With Abnormal Urinalysis Dipstick Results | Protein, BASELINE/DAY 1, 2+ | 0 Participants |
| Gepotidacin 1000 mg q12h | Number of Participants With Abnormal Urinalysis Dipstick Results | Glucose, ON IV TREATMENT/DAY 2, Trace | 0 Participants |
| Gepotidacin 1000 mg q12h | Number of Participants With Abnormal Urinalysis Dipstick Results | Ketones, ORAL - FIRST DAY, 2+ | 0 Participants |
| Gepotidacin 1000 mg q12h | Number of Participants With Abnormal Urinalysis Dipstick Results | Protein, BASELINE/DAY 1, 3+ | 0 Participants |
| Gepotidacin 1000 mg q12h | Number of Participants With Abnormal Urinalysis Dipstick Results | Glucose, POST THERAPY DAY 12-18, 1+ | 1 Participants |
| Gepotidacin 1000 mg q12h | Number of Participants With Abnormal Urinalysis Dipstick Results | Glucose, ON IV TREATMENT/DAY 2, 1+ | 0 Participants |
| Gepotidacin 1000 mg q12h | Number of Participants With Abnormal Urinalysis Dipstick Results | Protein, ON IV TREATMENT/DAY 2, Trace | 6 Participants |
| Gepotidacin 1000 mg q12h | Number of Participants With Abnormal Urinalysis Dipstick Results | Glucose, ON IV TREATMENT/DAY 2, 3+ | 2 Participants |
| Gepotidacin 1000 mg q12h | Number of Participants With Abnormal Urinalysis Dipstick Results | Occult Blood, ON IV TREATMENT/DAY 3, Trace | 1 Participants |
| Gepotidacin 1000 mg q12h | Number of Participants With Abnormal Urinalysis Dipstick Results | Protein, ON IV TREATMENT/DAY 2, 1+ | 7 Participants |
| Gepotidacin 1000 mg q12h | Number of Participants With Abnormal Urinalysis Dipstick Results | Ketones, ORAL - DAY 7-10, Trace | 3 Participants |
| Gepotidacin 1000 mg q12h | Number of Participants With Abnormal Urinalysis Dipstick Results | Glucose, ON IV TREATMENT/DAY 7, 2+ | 0 Participants |
| Gepotidacin 1000 mg q12h | Number of Participants With Abnormal Urinalysis Dipstick Results | Protein, ON IV TREATMENT/DAY 3, Trace | 3 Participants |
| Gepotidacin 1000 mg q12h | Number of Participants With Abnormal Urinalysis Dipstick Results | Glucose, POST THERAPY DAY 12-18, 3+ | 3 Participants |
| Gepotidacin 1000 mg q12h | Number of Participants With Abnormal Urinalysis Dipstick Results | Occult Blood, ORAL - FIRST DAY, 2+ | 0 Participants |
| Gepotidacin 1000 mg q12h | Number of Participants With Abnormal Urinalysis Dipstick Results | Protein, ON IV TREATMENT/DAY 3, 1+ | 2 Participants |
| Gepotidacin 1000 mg q12h | Number of Participants With Abnormal Urinalysis Dipstick Results | Glucose, BASELINE/DAY 1, Trace | 2 Participants |
| Gepotidacin 1000 mg q12h | Number of Participants With Abnormal Urinalysis Dipstick Results | Ketones, POST THERAPY DAY 12-18, Trace | 6 Participants |
| Gepotidacin 1000 mg q12h | Number of Participants With Abnormal Urinalysis Dipstick Results | Protein, ON IV TREATMENT/DAY 3, 2+ | 0 Participants |
| Gepotidacin 1000 mg q12h | Number of Participants With Abnormal Urinalysis Dipstick Results | Glucose, ORAL - DAY 7-10, 1+ | 1 Participants |
| Gepotidacin 1000 mg q12h | Number of Participants With Abnormal Urinalysis Dipstick Results | Occult Blood, ON IV TREATMENT/DAY 3, 3+ | 0 Participants |
| Gepotidacin 1000 mg q12h | Number of Participants With Abnormal Urinalysis Dipstick Results | Protein, ON IV TREATMENT/DAY 5, Trace | 0 Participants |
| Gepotidacin 1000 mg q12h | Number of Participants With Abnormal Urinalysis Dipstick Results | Occult Blood, BASELINE/DAY 1, Trace | 1 Participants |
| Gepotidacin 1000 mg q12h | Number of Participants With Abnormal Urinalysis Dipstick Results | Protein, ON IV TREATMENT/DAY 5, 1+ | 1 Participants |
| Gepotidacin 1000 mg q12h | Number of Participants With Abnormal Urinalysis Dipstick Results | Glucose, ORAL - FIRST DAY, Trace | 1 Participants |
| Gepotidacin 1000 mg q12h | Number of Participants With Abnormal Urinalysis Dipstick Results | Protein, ORAL - FIRST DAY, Trace | 3 Participants |
| Gepotidacin 1000 mg q12h | Number of Participants With Abnormal Urinalysis Dipstick Results | Ketones, BASELINE/DAY 1, Trace | 3 Participants |
| Gepotidacin 1000 mg q12h | Number of Participants With Abnormal Urinalysis Dipstick Results | Glucose, ORAL - DAY 7-10, Trace | 0 Participants |
| Gepotidacin 1000 mg q12h | Number of Participants With Abnormal Urinalysis Dipstick Results | Protein, ORAL - FIRST DAY, 1+ | 4 Participants |
| Gepotidacin 1000 mg q12h | Number of Participants With Abnormal Urinalysis Dipstick Results | Occult Blood, BASELINE/DAY 1, 1+ | 0 Participants |
| Gepotidacin 1000 mg q12h | Number of Participants With Abnormal Urinalysis Dipstick Results | Occult Blood, ORAL - DAY 7-10, 2+ | 0 Participants |
| Gepotidacin 1000 mg q12h | Number of Participants With Abnormal Urinalysis Dipstick Results | Protein, ORAL - FIRST DAY, 2+ | 0 Participants |
| Gepotidacin 1000 mg q12h | Number of Participants With Abnormal Urinalysis Dipstick Results | Occult Blood, ON IV TREATMENT/DAY 5, Trace | 0 Participants |
| Gepotidacin 1000 mg q12h | Number of Participants With Abnormal Urinalysis Dipstick Results | Occult Blood, BASELINE/DAY 1, 2+ | 1 Participants |
| Gepotidacin 1000 mg q12h | Number of Participants With Abnormal Urinalysis Dipstick Results | Protein, ORAL - DAY 7-10, Trace | 4 Participants |
| Gepotidacin 1000 mg q12h | Number of Participants With Abnormal Urinalysis Dipstick Results | Ketones, BASELINE/DAY 1, 1+ | 1 Participants |
| Gepotidacin 1000 mg q12h | Number of Participants With Abnormal Urinalysis Dipstick Results | Occult Blood, ORAL - FIRST DAY, 3+ | 1 Participants |
| Gepotidacin 1000 mg q12h | Number of Participants With Abnormal Urinalysis Dipstick Results | Protein, ORAL - DAY 7-10, 1+ | 5 Participants |
| Gepotidacin 1000 mg q12h | Number of Participants With Abnormal Urinalysis Dipstick Results | Glucose, ON IV TREATMENT/DAY 3, 2+ | 1 Participants |
| Gepotidacin 1000 mg q12h | Number of Participants With Abnormal Urinalysis Dipstick Results | Occult Blood, ON IV TREATMENT/DAY 7, Trace | 0 Participants |
| Gepotidacin 1000 mg q12h | Number of Participants With Abnormal Urinalysis Dipstick Results | Protein, ORAL - DAY 7-10, 2+ | 1 Participants |
| Gepotidacin 1000 mg q12h | Number of Participants With Abnormal Urinalysis Dipstick Results | Occult Blood, BASELINE/DAY 1, 3+ | 0 Participants |
| Gepotidacin 1000 mg q12h | Number of Participants With Abnormal Urinalysis Dipstick Results | Glucose, ORAL - FIRST DAY, 1+ | 0 Participants |
| Gepotidacin 1000 mg q12h | Number of Participants With Abnormal Urinalysis Dipstick Results | Protein, POST THERAPY DAY 12-18, Trace | 6 Participants |
| Gepotidacin 1000 mg q12h | Number of Participants With Abnormal Urinalysis Dipstick Results | Ketones, BASELINE/DAY 1, 3+ | 2 Participants |
| Gepotidacin 1000 mg q12h | Number of Participants With Abnormal Urinalysis Dipstick Results | Glucose, ORAL - DAY 7-10, 2+ | 1 Participants |
| Gepotidacin 1000 mg q12h | Number of Participants With Abnormal Urinalysis Dipstick Results | Protein, POST THERAPY DAY 12-18, 1+ | 4 Participants |
| Gepotidacin 1000 mg q12h | Number of Participants With Abnormal Urinalysis Dipstick Results | Occult Blood, ON IV TREATMENT/DAY 2, Trace | 0 Participants |
| Gepotidacin 1000 mg q12h | Number of Participants With Abnormal Urinalysis Dipstick Results | Occult Blood, ORAL - FIRST DAY, Trace | 1 Participants |
| Gepotidacin 1000 mg q12h | Number of Participants With Abnormal Urinalysis Dipstick Results | Protein, POST THERAPY DAY 12-18, 2+ | 1 Participants |
| Gepotidacin 1000 mg q12h | Number of Participants With Abnormal Urinalysis Dipstick Results | Occult Blood, POST THERAPY DAY 12-18, Trace | 1 Participants |
| Gepotidacin 1000 mg q12h | Number of Participants With Abnormal Urinalysis Dipstick Results | Occult Blood, ON IV TREATMENT/DAY 2, 1+ | 0 Participants |
| Gepotidacin 1000 mg q12h | Number of Participants With Abnormal Urinalysis Dipstick Results | pH, Post-Baseline Maximum, 8.5 | 0 Participants |
| Gepotidacin 1000 mg q12h | Number of Participants With Abnormal Urinalysis Dipstick Results | Ketones, ON IV TREATMENT/DAY 2, Trace | 3 Participants |
| Gepotidacin 1000 mg q12h | Number of Participants With Abnormal Urinalysis Dipstick Results | Occult Blood, ORAL - DAY 7-10, Trace | 0 Participants |
| Gepotidacin 1000 mg q12h | Number of Participants With Abnormal Urinalysis Dipstick Results | Occult Blood, ORAL - FIRST DAY, 1+ | 1 Participants |
| Gepotidacin 1000 mg q12h | Number of Participants With Abnormal Urinalysis Dipstick Results | Ketones, ON IV TREATMENT/DAY 2, 1+ | 1 Participants |
| Gepotidacin 1000 mg q12h | Number of Participants With Abnormal Urinalysis Dipstick Results | Glucose, ON IV TREATMENT/DAY 3, 3+ | 1 Participants |
| Gepotidacin 1000 mg q12h | Number of Participants With Abnormal Urinalysis Dipstick Results | Occult Blood, ON IV TREATMENT/DAY 2, 2+ | 0 Participants |
| Gepotidacin 1000 mg q8h | Number of Participants With Abnormal Urinalysis Dipstick Results | pH, Post-Baseline Maximum, 8.5 | 0 Participants |
| Gepotidacin 1000 mg q8h | Number of Participants With Abnormal Urinalysis Dipstick Results | Glucose, BASELINE/DAY 1, Trace | 1 Participants |
| Gepotidacin 1000 mg q8h | Number of Participants With Abnormal Urinalysis Dipstick Results | Glucose, BASELINE/DAY 1, 1+ | 1 Participants |
| Gepotidacin 1000 mg q8h | Number of Participants With Abnormal Urinalysis Dipstick Results | Glucose, BASELINE/DAY 1, 3+ | 1 Participants |
| Gepotidacin 1000 mg q8h | Number of Participants With Abnormal Urinalysis Dipstick Results | Glucose, ON IV TREATMENT/DAY 2, Trace | 0 Participants |
| Gepotidacin 1000 mg q8h | Number of Participants With Abnormal Urinalysis Dipstick Results | Glucose, ON IV TREATMENT/DAY 2, 1+ | 2 Participants |
| Gepotidacin 1000 mg q8h | Number of Participants With Abnormal Urinalysis Dipstick Results | Glucose, ON IV TREATMENT/DAY 2, 3+ | 1 Participants |
| Gepotidacin 1000 mg q8h | Number of Participants With Abnormal Urinalysis Dipstick Results | Glucose, ON IV TREATMENT/DAY 3, 2+ | 0 Participants |
| Gepotidacin 1000 mg q8h | Number of Participants With Abnormal Urinalysis Dipstick Results | Glucose, ON IV TREATMENT/DAY 3, 3+ | 0 Participants |
| Gepotidacin 1000 mg q8h | Number of Participants With Abnormal Urinalysis Dipstick Results | Glucose, ORAL - FIRST DAY, Trace | 0 Participants |
| Gepotidacin 1000 mg q8h | Number of Participants With Abnormal Urinalysis Dipstick Results | Glucose, ORAL - FIRST DAY, 1+ | 0 Participants |
| Gepotidacin 1000 mg q8h | Number of Participants With Abnormal Urinalysis Dipstick Results | Glucose, ORAL - FIRST DAY, 3+ | 0 Participants |
| Gepotidacin 1000 mg q8h | Number of Participants With Abnormal Urinalysis Dipstick Results | Glucose, ORAL - DAY 7-10, Trace | 0 Participants |
| Gepotidacin 1000 mg q8h | Number of Participants With Abnormal Urinalysis Dipstick Results | Glucose, ORAL - DAY 7-10, 1+ | 0 Participants |
| Gepotidacin 1000 mg q8h | Number of Participants With Abnormal Urinalysis Dipstick Results | Glucose, ORAL - DAY 7-10, 2+ | 0 Participants |
| Gepotidacin 1000 mg q8h | Number of Participants With Abnormal Urinalysis Dipstick Results | Glucose, ORAL - DAY 7-10, 3+ | 0 Participants |
| Gepotidacin 1000 mg q8h | Number of Participants With Abnormal Urinalysis Dipstick Results | Glucose, POST THERAPY DAY 12-18, Trace | 0 Participants |
| Gepotidacin 1000 mg q8h | Number of Participants With Abnormal Urinalysis Dipstick Results | Glucose, POST THERAPY DAY 12-18, 1+ | 0 Participants |
| Gepotidacin 1000 mg q8h | Number of Participants With Abnormal Urinalysis Dipstick Results | Glucose, POST THERAPY DAY 12-18, 3+ | 0 Participants |
| Gepotidacin 1000 mg q8h | Number of Participants With Abnormal Urinalysis Dipstick Results | Ketones, BASELINE/DAY 1, Trace | 6 Participants |
| Gepotidacin 1000 mg q8h | Number of Participants With Abnormal Urinalysis Dipstick Results | Ketones, BASELINE/DAY 1, 1+ | 0 Participants |
| Gepotidacin 1000 mg q8h | Number of Participants With Abnormal Urinalysis Dipstick Results | Ketones, BASELINE/DAY 1, 3+ | 0 Participants |
| Gepotidacin 1000 mg q8h | Number of Participants With Abnormal Urinalysis Dipstick Results | Ketones, ON IV TREATMENT/DAY 2, Trace | 1 Participants |
| Gepotidacin 1000 mg q8h | Number of Participants With Abnormal Urinalysis Dipstick Results | Ketones, ON IV TREATMENT/DAY 2, 1+ | 0 Participants |
| Gepotidacin 1000 mg q8h | Number of Participants With Abnormal Urinalysis Dipstick Results | Ketones, ON IV TREATMENT/DAY 2, 3+ | 1 Participants |
| Gepotidacin 1000 mg q8h | Number of Participants With Abnormal Urinalysis Dipstick Results | Ketones, ON IV TREATMENT/DAY 3, Trace | 2 Participants |
| Gepotidacin 1000 mg q8h | Number of Participants With Abnormal Urinalysis Dipstick Results | Ketones, ORAL - FIRST DAY, Trace | 2 Participants |
| Gepotidacin 1000 mg q8h | Number of Participants With Abnormal Urinalysis Dipstick Results | Ketones, ORAL - FIRST DAY, 2+ | 0 Participants |
| Gepotidacin 1000 mg q8h | Number of Participants With Abnormal Urinalysis Dipstick Results | Ketones, ORAL - DAY 7-10, Trace | 3 Participants |
| Gepotidacin 1000 mg q8h | Number of Participants With Abnormal Urinalysis Dipstick Results | Ketones, POST THERAPY DAY 12-18, Trace | 2 Participants |
| Gepotidacin 1000 mg q8h | Number of Participants With Abnormal Urinalysis Dipstick Results | Occult Blood, BASELINE/DAY 1, Trace | 1 Participants |
| Gepotidacin 1000 mg q8h | Number of Participants With Abnormal Urinalysis Dipstick Results | Occult Blood, BASELINE/DAY 1, 1+ | 1 Participants |
| Gepotidacin 1000 mg q8h | Number of Participants With Abnormal Urinalysis Dipstick Results | Occult Blood, BASELINE/DAY 1, 2+ | 0 Participants |
| Gepotidacin 1000 mg q8h | Number of Participants With Abnormal Urinalysis Dipstick Results | Occult Blood, BASELINE/DAY 1, 3+ | 1 Participants |
| Gepotidacin 1000 mg q8h | Number of Participants With Abnormal Urinalysis Dipstick Results | Occult Blood, ON IV TREATMENT/DAY 2, Trace | 1 Participants |
| Gepotidacin 1000 mg q8h | Number of Participants With Abnormal Urinalysis Dipstick Results | Occult Blood, ON IV TREATMENT/DAY 2, 1+ | 0 Participants |
| Gepotidacin 1000 mg q8h | Number of Participants With Abnormal Urinalysis Dipstick Results | Occult Blood, ON IV TREATMENT/DAY 2, 2+ | 2 Participants |
| Gepotidacin 1000 mg q8h | Number of Participants With Abnormal Urinalysis Dipstick Results | Occult Blood, ON IV TREATMENT/DAY 2, 3+ | 0 Participants |
| Gepotidacin 1000 mg q8h | Number of Participants With Abnormal Urinalysis Dipstick Results | Occult Blood, ON IV TREATMENT/DAY 3, Trace | 0 Participants |
| Gepotidacin 1000 mg q8h | Number of Participants With Abnormal Urinalysis Dipstick Results | Occult Blood, ON IV TREATMENT/DAY 3, 3+ | 1 Participants |
| Gepotidacin 1000 mg q8h | Number of Participants With Abnormal Urinalysis Dipstick Results | Occult Blood, ORAL - FIRST DAY, Trace | 1 Participants |
| Gepotidacin 1000 mg q8h | Number of Participants With Abnormal Urinalysis Dipstick Results | Occult Blood, ORAL - FIRST DAY, 1+ | 0 Participants |
| Gepotidacin 1000 mg q8h | Number of Participants With Abnormal Urinalysis Dipstick Results | Occult Blood, ORAL - FIRST DAY, 2+ | 0 Participants |
| Gepotidacin 1000 mg q8h | Number of Participants With Abnormal Urinalysis Dipstick Results | Occult Blood, ORAL - FIRST DAY, 3+ | 0 Participants |
| Gepotidacin 1000 mg q8h | Number of Participants With Abnormal Urinalysis Dipstick Results | Occult Blood, ORAL - DAY 7-10, Trace | 1 Participants |
| Gepotidacin 1000 mg q8h | Number of Participants With Abnormal Urinalysis Dipstick Results | Occult Blood, ORAL - DAY 7-10, 2+ | 1 Participants |
| Gepotidacin 1000 mg q8h | Number of Participants With Abnormal Urinalysis Dipstick Results | Occult Blood, ORAL - DAY 7-10, 3+ | 1 Participants |
| Gepotidacin 1000 mg q8h | Number of Participants With Abnormal Urinalysis Dipstick Results | Occult Blood, POST THERAPY DAY 12-18, Trace | 1 Participants |
| Gepotidacin 1000 mg q8h | Number of Participants With Abnormal Urinalysis Dipstick Results | Occult Blood, POST THERAPY DAY 12-18, 1+ | 0 Participants |
| Gepotidacin 1000 mg q8h | Number of Participants With Abnormal Urinalysis Dipstick Results | Occult Blood, POST THERAPY DAY 12-18, 2+ | 0 Participants |
| Gepotidacin 1000 mg q8h | Number of Participants With Abnormal Urinalysis Dipstick Results | Occult Blood, POST THERAPY DAY 12-18, 3+ | 1 Participants |
| Gepotidacin 1000 mg q8h | Number of Participants With Abnormal Urinalysis Dipstick Results | Protein, BASELINE/DAY 1, Trace | 5 Participants |
| Gepotidacin 1000 mg q8h | Number of Participants With Abnormal Urinalysis Dipstick Results | Protein, BASELINE/DAY 1, 1+ | 5 Participants |
| Gepotidacin 1000 mg q8h | Number of Participants With Abnormal Urinalysis Dipstick Results | Protein, BASELINE/DAY 1, 2+ | 1 Participants |
| Gepotidacin 1000 mg q8h | Number of Participants With Abnormal Urinalysis Dipstick Results | Protein, BASELINE/DAY 1, 3+ | 0 Participants |
| Gepotidacin 1000 mg q8h | Number of Participants With Abnormal Urinalysis Dipstick Results | Protein, ON IV TREATMENT/DAY 2, Trace | 4 Participants |
| Gepotidacin 1000 mg q8h | Number of Participants With Abnormal Urinalysis Dipstick Results | Protein, ON IV TREATMENT/DAY 2, 1+ | 4 Participants |
| Gepotidacin 1000 mg q8h | Number of Participants With Abnormal Urinalysis Dipstick Results | Protein, ON IV TREATMENT/DAY 3, Trace | 0 Participants |
| Gepotidacin 1000 mg q8h | Number of Participants With Abnormal Urinalysis Dipstick Results | Protein, ON IV TREATMENT/DAY 3, 1+ | 3 Participants |
| Gepotidacin 1000 mg q8h | Number of Participants With Abnormal Urinalysis Dipstick Results | Protein, ON IV TREATMENT/DAY 3, 2+ | 0 Participants |
| Gepotidacin 1000 mg q8h | Number of Participants With Abnormal Urinalysis Dipstick Results | Protein, ORAL - FIRST DAY, Trace | 1 Participants |
| Gepotidacin 1000 mg q8h | Number of Participants With Abnormal Urinalysis Dipstick Results | Protein, ORAL - FIRST DAY, 1+ | 2 Participants |
| Gepotidacin 1000 mg q8h | Number of Participants With Abnormal Urinalysis Dipstick Results | Protein, ORAL - FIRST DAY, 2+ | 0 Participants |
| Gepotidacin 1000 mg q8h | Number of Participants With Abnormal Urinalysis Dipstick Results | Protein, ORAL - DAY 7-10, Trace | 6 Participants |
| Gepotidacin 1000 mg q8h | Number of Participants With Abnormal Urinalysis Dipstick Results | Protein, ORAL - DAY 7-10, 1+ | 4 Participants |
| Gepotidacin 1000 mg q8h | Number of Participants With Abnormal Urinalysis Dipstick Results | Protein, ORAL - DAY 7-10, 2+ | 1 Participants |
| Gepotidacin 1000 mg q8h | Number of Participants With Abnormal Urinalysis Dipstick Results | Protein, POST THERAPY DAY 12-18, Trace | 2 Participants |
| Gepotidacin 1000 mg q8h | Number of Participants With Abnormal Urinalysis Dipstick Results | Protein, POST THERAPY DAY 12-18, 1+ | 3 Participants |
| Gepotidacin 1000 mg q8h | Number of Participants With Abnormal Urinalysis Dipstick Results | Protein, POST THERAPY DAY 12-18, 2+ | 0 Participants |
Secondary
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
An AE is 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 AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. An SAE is 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, medically significant or all events of possible drug-induced liver injury with hyperbilirubinemia.
Time frame: Up to Day 28
Population: Safety population comprised the same set of participants from MITT population and received at least one dose of study medication.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Gepotidacin 750 mg q12h | Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | Any AEs | 41 Participants |
| Gepotidacin 750 mg q12h | Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | Any SAEs | 1 Participants |
| Gepotidacin 1000 mg q12h | Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | Any AEs | 25 Participants |
| Gepotidacin 1000 mg q12h | Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | Any SAEs | 1 Participants |
| Gepotidacin 1000 mg q8h | Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | Any AEs | 18 Participants |
| Gepotidacin 1000 mg q8h | Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | Any SAEs | 0 Participants |
Secondary
Number of Participants With Clinical Response and Outcome at Early Efficacy Visit
The assessment was used to determine whether to continue the participant in the study. Clinical response was assessed as either a clinical success or a clinical failure and the clinical outcome was subsequently determined programmatically, based on the clinical response. Clinical success was defined as a reduction in the total surface area of the lesion (as calculated by digital imaging) of \>=20% compared to Baseline and no administration of additional antibacterial therapy for the lesion under study. Clinical failure was defined as death of participant; increase or insufficient decrease (i.e., \<20%) in the area (as calculated by digital imaging) of the lesion or administration of non-trial antibacterial drug therapy for treatment of the lesion under study before the primary efficacy endpoint assessment. In addition when the participant refused to consent to clinical examination, the clinical outcome was assessed as unable to determine with subsequent response as failure.
Time frame: Up to Day 3
Population: MITT population.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Gepotidacin 750 mg q12h | Number of Participants With Clinical Response and Outcome at Early Efficacy Visit | Unable to Determine | 3 Participants |
| Gepotidacin 750 mg q12h | Number of Participants With Clinical Response and Outcome at Early Efficacy Visit | Clinical Failure | 7 Participants |
| Gepotidacin 750 mg q12h | Number of Participants With Clinical Response and Outcome at Early Efficacy Visit | Clinical Success | 48 Participants |
| Gepotidacin 1000 mg q12h | Number of Participants With Clinical Response and Outcome at Early Efficacy Visit | Unable to Determine | 4 Participants |
| Gepotidacin 1000 mg q12h | Number of Participants With Clinical Response and Outcome at Early Efficacy Visit | Clinical Failure | 7 Participants |
| Gepotidacin 1000 mg q12h | Number of Participants With Clinical Response and Outcome at Early Efficacy Visit | Clinical Success | 28 Participants |
| Gepotidacin 1000 mg q8h | Number of Participants With Clinical Response and Outcome at Early Efficacy Visit | Clinical Failure | 2 Participants |
| Gepotidacin 1000 mg q8h | Number of Participants With Clinical Response and Outcome at Early Efficacy Visit | Clinical Success | 23 Participants |
| Gepotidacin 1000 mg q8h | Number of Participants With Clinical Response and Outcome at Early Efficacy Visit | Unable to Determine | 0 Participants |
Secondary
Number of Participants With Clinical Response and Outcome at the Final Follow up Visit (Day 21-28)
The assessment was used to determine whether to continue the participant in the study. Clinical response was assessed as either a clinical success or a clinical failure and the clinical outcome was subsequently determined programmatically, based on the clinical response. Clinical success was defined as no increase in the total surface area of the lesion (as calculated by digital imaging) compared to post therapy visit and no further administration of antibacterial therapy for the lesion under study. Clinical recurrence was defined as death of participant; increase in the area of the lesion compared to post therapy visit or administration of additional antibacterial therapy for the lesion under study before the efficacy endpoint assessment for participants who were a clinical success at post therapy visit. In addition when the participant refused to consent to clinical examination, the clinical outcome was assessed as unable to determine with subsequent response as failure.
Time frame: Day 21 to Day 28
Population: MITT population.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Gepotidacin 750 mg q12h | Number of Participants With Clinical Response and Outcome at the Final Follow up Visit (Day 21-28) | Clinical Success | 50 Participants |
| Gepotidacin 750 mg q12h | Number of Participants With Clinical Response and Outcome at the Final Follow up Visit (Day 21-28) | Clinical Recurrence | 2 Participants |
| Gepotidacin 750 mg q12h | Number of Participants With Clinical Response and Outcome at the Final Follow up Visit (Day 21-28) | Unable to Determine | 5 Participants |
| Gepotidacin 750 mg q12h | Number of Participants With Clinical Response and Outcome at the Final Follow up Visit (Day 21-28) | Clinical Failure | 1 Participants |
| Gepotidacin 1000 mg q12h | Number of Participants With Clinical Response and Outcome at the Final Follow up Visit (Day 21-28) | Clinical Recurrence | 1 Participants |
| Gepotidacin 1000 mg q12h | Number of Participants With Clinical Response and Outcome at the Final Follow up Visit (Day 21-28) | Clinical Success | 28 Participants |
| Gepotidacin 1000 mg q12h | Number of Participants With Clinical Response and Outcome at the Final Follow up Visit (Day 21-28) | Clinical Failure | 1 Participants |
| Gepotidacin 1000 mg q12h | Number of Participants With Clinical Response and Outcome at the Final Follow up Visit (Day 21-28) | Unable to Determine | 9 Participants |
| Gepotidacin 1000 mg q8h | Number of Participants With Clinical Response and Outcome at the Final Follow up Visit (Day 21-28) | Clinical Success | 20 Participants |
| Gepotidacin 1000 mg q8h | Number of Participants With Clinical Response and Outcome at the Final Follow up Visit (Day 21-28) | Unable to Determine | 3 Participants |
| Gepotidacin 1000 mg q8h | Number of Participants With Clinical Response and Outcome at the Final Follow up Visit (Day 21-28) | Clinical Failure | 1 Participants |
| Gepotidacin 1000 mg q8h | Number of Participants With Clinical Response and Outcome at the Final Follow up Visit (Day 21-28) | Clinical Recurrence | 1 Participants |
Secondary
Number of Participants With Clinical Response and Outcome at the Post Therapy Visit (Day 12-18)
The assessment was used to determine whether to continue the participant in the study. Clinical response was assessed as either a clinical success or a clinical failure and the clinical outcome was subsequently determined programmatically, based on the clinical response. Clinical success was defined as a reduction in the total surface area of the lesion (as calculated by digital imaging) of \>=20% compared to Baseline and no administration of additional antibacterial therapy for the lesion under study. Clinical failure was defined as death of participant; increase or insufficient decrease (i.e., \<20%) in the area (as calculated by digital imaging) of the lesion or administration of non-trial antibacterial drug therapy for treatment of the lesion under study before the primary efficacy endpoint assessment. In addition when the participant refused to consent to clinical examination, the clinical outcome was assessed as unable to determine with subsequent response as failure.
Time frame: Day 12 to Day 18
Population: MITT population.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Gepotidacin 750 mg q12h | Number of Participants With Clinical Response and Outcome at the Post Therapy Visit (Day 12-18) | Clinical Failure | 1 Participants |
| Gepotidacin 750 mg q12h | Number of Participants With Clinical Response and Outcome at the Post Therapy Visit (Day 12-18) | Unable to Determine | 5 Participants |
| Gepotidacin 750 mg q12h | Number of Participants With Clinical Response and Outcome at the Post Therapy Visit (Day 12-18) | Clinical Success | 52 Participants |
| Gepotidacin 1000 mg q12h | Number of Participants With Clinical Response and Outcome at the Post Therapy Visit (Day 12-18) | Unable to Determine | 6 Participants |
| Gepotidacin 1000 mg q12h | Number of Participants With Clinical Response and Outcome at the Post Therapy Visit (Day 12-18) | Clinical Success | 32 Participants |
| Gepotidacin 1000 mg q12h | Number of Participants With Clinical Response and Outcome at the Post Therapy Visit (Day 12-18) | Clinical Failure | 1 Participants |
| Gepotidacin 1000 mg q8h | Number of Participants With Clinical Response and Outcome at the Post Therapy Visit (Day 12-18) | Unable to Determine | 3 Participants |
| Gepotidacin 1000 mg q8h | Number of Participants With Clinical Response and Outcome at the Post Therapy Visit (Day 12-18) | Clinical Success | 21 Participants |
| Gepotidacin 1000 mg q8h | Number of Participants With Clinical Response and Outcome at the Post Therapy Visit (Day 12-18) | Clinical Failure | 1 Participants |
Secondary
Number of Participants With Maximum Post-Baseline Electrocardiogram (ECG) Readings
The 12-lead ECGs was obtained at Day 1, Day 2, Day 7 to 10, Day 12 to 21 and Day 21 to Day 28 for corrected QT, using Fridericia formula (QTcF), corrected QT using Bazett's formula (QTcB) and QRS intervals. The number of participants with maximum post-baseline ECG value exceeding the following limits have been reported: QTcB/QTcF interval \> 450 and ≤ 480 millisecond (msec), QTcB/QTcF interval \> 480 and ≤ 500 msec, QTcB/QTcF interval \> 500 msec, QRS interval \< 70 msec and QRS interval \> 120 msec.
Time frame: Up to Day 28
Population: Safety Population. Only those participants available at the indicated time points were analyzed.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Gepotidacin 750 mg q12h | Number of Participants With Maximum Post-Baseline Electrocardiogram (ECG) Readings | QTcB, Maximum Post-Baseline, <=450 and <=480 | 28 Participants |
| Gepotidacin 750 mg q12h | Number of Participants With Maximum Post-Baseline Electrocardiogram (ECG) Readings | QTcF, Maximum Post-Baseline, <=450 | 47 Participants |
| Gepotidacin 750 mg q12h | Number of Participants With Maximum Post-Baseline Electrocardiogram (ECG) Readings | QTcB, Maximum Post-Baseline, >480 and <=500 | 3 Participants |
| Gepotidacin 750 mg q12h | Number of Participants With Maximum Post-Baseline Electrocardiogram (ECG) Readings | QTcF, Maximum Post-Baseline, <=450 and <=480 | 11 Participants |
| Gepotidacin 750 mg q12h | Number of Participants With Maximum Post-Baseline Electrocardiogram (ECG) Readings | QRS, Maximum Post-Baseline, >120 | 2 Participants |
| Gepotidacin 750 mg q12h | Number of Participants With Maximum Post-Baseline Electrocardiogram (ECG) Readings | QTcB, Maximum Post-Baseline, <=450 | 27 Participants |
| Gepotidacin 750 mg q12h | Number of Participants With Maximum Post-Baseline Electrocardiogram (ECG) Readings | QTcB, Maximum Post-Baseline, >500 | 0 Participants |
| Gepotidacin 750 mg q12h | Number of Participants With Maximum Post-Baseline Electrocardiogram (ECG) Readings | QRS, Maximum Post-Baseline, 70 - 120 | 56 Participants |
| Gepotidacin 1000 mg q12h | Number of Participants With Maximum Post-Baseline Electrocardiogram (ECG) Readings | QRS, Maximum Post-Baseline, >120 | 2 Participants |
| Gepotidacin 1000 mg q12h | Number of Participants With Maximum Post-Baseline Electrocardiogram (ECG) Readings | QTcB, Maximum Post-Baseline, >480 and <=500 | 4 Participants |
| Gepotidacin 1000 mg q12h | Number of Participants With Maximum Post-Baseline Electrocardiogram (ECG) Readings | QTcB, Maximum Post-Baseline, <=450 | 15 Participants |
| Gepotidacin 1000 mg q12h | Number of Participants With Maximum Post-Baseline Electrocardiogram (ECG) Readings | QTcB, Maximum Post-Baseline, <=450 and <=480 | 19 Participants |
| Gepotidacin 1000 mg q12h | Number of Participants With Maximum Post-Baseline Electrocardiogram (ECG) Readings | QTcB, Maximum Post-Baseline, >500 | 0 Participants |
| Gepotidacin 1000 mg q12h | Number of Participants With Maximum Post-Baseline Electrocardiogram (ECG) Readings | QTcF, Maximum Post-Baseline, <=450 | 28 Participants |
| Gepotidacin 1000 mg q12h | Number of Participants With Maximum Post-Baseline Electrocardiogram (ECG) Readings | QTcF, Maximum Post-Baseline, <=450 and <=480 | 10 Participants |
| Gepotidacin 1000 mg q12h | Number of Participants With Maximum Post-Baseline Electrocardiogram (ECG) Readings | QRS, Maximum Post-Baseline, 70 - 120 | 36 Participants |
| Gepotidacin 1000 mg q8h | Number of Participants With Maximum Post-Baseline Electrocardiogram (ECG) Readings | QTcB, Maximum Post-Baseline, >480 and <=500 | 3 Participants |
| Gepotidacin 1000 mg q8h | Number of Participants With Maximum Post-Baseline Electrocardiogram (ECG) Readings | QRS, Maximum Post-Baseline, >120 | 2 Participants |
| Gepotidacin 1000 mg q8h | Number of Participants With Maximum Post-Baseline Electrocardiogram (ECG) Readings | QTcF, Maximum Post-Baseline, <=450 and <=480 | 8 Participants |
| Gepotidacin 1000 mg q8h | Number of Participants With Maximum Post-Baseline Electrocardiogram (ECG) Readings | QTcB, Maximum Post-Baseline, <=450 | 9 Participants |
| Gepotidacin 1000 mg q8h | Number of Participants With Maximum Post-Baseline Electrocardiogram (ECG) Readings | QTcB, Maximum Post-Baseline, <=450 and <=480 | 11 Participants |
| Gepotidacin 1000 mg q8h | Number of Participants With Maximum Post-Baseline Electrocardiogram (ECG) Readings | QTcB, Maximum Post-Baseline, >500 | 2 Participants |
| Gepotidacin 1000 mg q8h | Number of Participants With Maximum Post-Baseline Electrocardiogram (ECG) Readings | QRS, Maximum Post-Baseline, 70 - 120 | 23 Participants |
| Gepotidacin 1000 mg q8h | Number of Participants With Maximum Post-Baseline Electrocardiogram (ECG) Readings | QTcF, Maximum Post-Baseline, <=450 | 17 Participants |
Secondary
Number of Pathogens With Microbiological Response and Outcome at Early Efficacy Visit for All Gram-positive Aerobic Pathogens in Lesion Sample
The microbiological outcome was determined by comparing Baseline bacteriology lesion sample, to the culture results at early efficacy visit. The corresponding microbiological response (success or failure) by participant was then assigned. Microbiological eradication or persistence was defined as culture documented elimination or presence of Baseline pathogens from a bacteriology specimen taken at early efficacy visit respectively. Participant was considered to have outcome of presumed microbiological eradication or persistence when the participant was a clinical success or clinical failure and no bacteriological specimen was obtained at early efficacy visit respectively. When the determination of Baseline pathogen microbiological response could not be made, the outcome was considered as unable to determine. The data for all Gram-positive aerobic pathogens in lesion sample has been presented.
Time frame: Up to Day 3
Population: Modified Microbiological ITT population.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Gepotidacin 750 mg q12h | Number of Pathogens With Microbiological Response and Outcome at Early Efficacy Visit for All Gram-positive Aerobic Pathogens in Lesion Sample | Microbiological Success, Presumed Eradication | 24 Number of pathogens |
| Gepotidacin 750 mg q12h | Number of Pathogens With Microbiological Response and Outcome at Early Efficacy Visit for All Gram-positive Aerobic Pathogens in Lesion Sample | Microbiological Failure, Persistence | 11 Number of pathogens |
| Gepotidacin 750 mg q12h | Number of Pathogens With Microbiological Response and Outcome at Early Efficacy Visit for All Gram-positive Aerobic Pathogens in Lesion Sample | Microbiological Failure, Presumed Persistence | 5 Number of pathogens |
| Gepotidacin 750 mg q12h | Number of Pathogens With Microbiological Response and Outcome at Early Efficacy Visit for All Gram-positive Aerobic Pathogens in Lesion Sample | Microbiological Failure, Unable to Determine | 1 Number of pathogens |
| Gepotidacin 750 mg q12h | Number of Pathogens With Microbiological Response and Outcome at Early Efficacy Visit for All Gram-positive Aerobic Pathogens in Lesion Sample | Microbiological Success, Eradication | 2 Number of pathogens |
| Gepotidacin 1000 mg q12h | Number of Pathogens With Microbiological Response and Outcome at Early Efficacy Visit for All Gram-positive Aerobic Pathogens in Lesion Sample | Microbiological Failure, Unable to Determine | 0 Number of pathogens |
| Gepotidacin 1000 mg q12h | Number of Pathogens With Microbiological Response and Outcome at Early Efficacy Visit for All Gram-positive Aerobic Pathogens in Lesion Sample | Microbiological Failure, Presumed Persistence | 7 Number of pathogens |
| Gepotidacin 1000 mg q12h | Number of Pathogens With Microbiological Response and Outcome at Early Efficacy Visit for All Gram-positive Aerobic Pathogens in Lesion Sample | Microbiological Success, Eradication | 4 Number of pathogens |
| Gepotidacin 1000 mg q12h | Number of Pathogens With Microbiological Response and Outcome at Early Efficacy Visit for All Gram-positive Aerobic Pathogens in Lesion Sample | Microbiological Success, Presumed Eradication | 18 Number of pathogens |
| Gepotidacin 1000 mg q12h | Number of Pathogens With Microbiological Response and Outcome at Early Efficacy Visit for All Gram-positive Aerobic Pathogens in Lesion Sample | Microbiological Failure, Persistence | 3 Number of pathogens |
| Gepotidacin 1000 mg q8h | Number of Pathogens With Microbiological Response and Outcome at Early Efficacy Visit for All Gram-positive Aerobic Pathogens in Lesion Sample | Microbiological Success, Presumed Eradication | 12 Number of pathogens |
| Gepotidacin 1000 mg q8h | Number of Pathogens With Microbiological Response and Outcome at Early Efficacy Visit for All Gram-positive Aerobic Pathogens in Lesion Sample | Microbiological Failure, Persistence | 2 Number of pathogens |
| Gepotidacin 1000 mg q8h | Number of Pathogens With Microbiological Response and Outcome at Early Efficacy Visit for All Gram-positive Aerobic Pathogens in Lesion Sample | Microbiological Failure, Unable to Determine | 0 Number of pathogens |
| Gepotidacin 1000 mg q8h | Number of Pathogens With Microbiological Response and Outcome at Early Efficacy Visit for All Gram-positive Aerobic Pathogens in Lesion Sample | Microbiological Success, Eradication | 0 Number of pathogens |
| Gepotidacin 1000 mg q8h | Number of Pathogens With Microbiological Response and Outcome at Early Efficacy Visit for All Gram-positive Aerobic Pathogens in Lesion Sample | Microbiological Failure, Presumed Persistence | 0 Number of pathogens |
Secondary
Number of Pathogens With Microbiological Response and Outcome at Early Efficacy Visit for Methicillin-resistant Staphylococcus Aureus (MRSA) in Lesion Sample
The microbiological outcome was determined by comparing Baseline bacteriology lesion sample, to the culture results at early efficacy visit. The corresponding microbiological response (success or failure) by participant was then assigned. Microbiological eradication or persistence was defined as culture documented elimination or presence of Baseline pathogens from a bacteriology specimen taken at early efficacy visit respectively. Participant was considered to have outcome of presumed microbiological eradication or persistence when the participant was a clinical success or clinical failure and no bacteriological specimen was obtained at early efficacy visit respectively. When the determination of Baseline pathogen microbiological response could not be made, the outcome was considered as unable to determine. The data for MRSA in lesion sample has been presented.
Time frame: Day 3
Population: Modified Microbiological ITT population.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Gepotidacin 750 mg q12h | Number of Pathogens With Microbiological Response and Outcome at Early Efficacy Visit for Methicillin-resistant Staphylococcus Aureus (MRSA) in Lesion Sample | Microbiological Success, Presumed Eradication | 18 Number of pathogens |
| Gepotidacin 750 mg q12h | Number of Pathogens With Microbiological Response and Outcome at Early Efficacy Visit for Methicillin-resistant Staphylococcus Aureus (MRSA) in Lesion Sample | Microbiological Failure, Presumed Persistence | 4 Number of pathogens |
| Gepotidacin 750 mg q12h | Number of Pathogens With Microbiological Response and Outcome at Early Efficacy Visit for Methicillin-resistant Staphylococcus Aureus (MRSA) in Lesion Sample | Microbiological Failure, Persistence | 7 Number of pathogens |
| Gepotidacin 750 mg q12h | Number of Pathogens With Microbiological Response and Outcome at Early Efficacy Visit for Methicillin-resistant Staphylococcus Aureus (MRSA) in Lesion Sample | Microbiological Success, Eradication | 0 Number of pathogens |
| Gepotidacin 1000 mg q12h | Number of Pathogens With Microbiological Response and Outcome at Early Efficacy Visit for Methicillin-resistant Staphylococcus Aureus (MRSA) in Lesion Sample | Microbiological Failure, Presumed Persistence | 5 Number of pathogens |
| Gepotidacin 1000 mg q12h | Number of Pathogens With Microbiological Response and Outcome at Early Efficacy Visit for Methicillin-resistant Staphylococcus Aureus (MRSA) in Lesion Sample | Microbiological Success, Presumed Eradication | 10 Number of pathogens |
| Gepotidacin 1000 mg q12h | Number of Pathogens With Microbiological Response and Outcome at Early Efficacy Visit for Methicillin-resistant Staphylococcus Aureus (MRSA) in Lesion Sample | Microbiological Failure, Persistence | 3 Number of pathogens |
| Gepotidacin 1000 mg q12h | Number of Pathogens With Microbiological Response and Outcome at Early Efficacy Visit for Methicillin-resistant Staphylococcus Aureus (MRSA) in Lesion Sample | Microbiological Success, Eradication | 2 Number of pathogens |
| Gepotidacin 1000 mg q8h | Number of Pathogens With Microbiological Response and Outcome at Early Efficacy Visit for Methicillin-resistant Staphylococcus Aureus (MRSA) in Lesion Sample | Microbiological Failure, Presumed Persistence | 0 Number of pathogens |
| Gepotidacin 1000 mg q8h | Number of Pathogens With Microbiological Response and Outcome at Early Efficacy Visit for Methicillin-resistant Staphylococcus Aureus (MRSA) in Lesion Sample | Microbiological Failure, Persistence | 1 Number of pathogens |
| Gepotidacin 1000 mg q8h | Number of Pathogens With Microbiological Response and Outcome at Early Efficacy Visit for Methicillin-resistant Staphylococcus Aureus (MRSA) in Lesion Sample | Microbiological Success, Presumed Eradication | 4 Number of pathogens |
| Gepotidacin 1000 mg q8h | Number of Pathogens With Microbiological Response and Outcome at Early Efficacy Visit for Methicillin-resistant Staphylococcus Aureus (MRSA) in Lesion Sample | Microbiological Success, Eradication | 0 Number of pathogens |
Secondary
Number of Pathogens With Microbiological Response and Outcome at Early Efficacy Visit for Methicillin-susceptible Staphylococcus Aureus (MSSA) in Lesion Sample
The microbiological outcome was determined by comparing Baseline bacteriology lesion sample, to the culture results at early efficacy visit. The corresponding microbiological response (success or failure) by participant was then assigned. Microbiological eradication or persistence was defined as culture documented elimination or presence of Baseline pathogens from a bacteriology specimen taken at early efficacy visit respectively. Participant was considered to have outcome of presumed microbiological eradication or persistence when the participant was a clinical success or clinical failure and no bacteriological specimen was obtained at early efficacy visit respectively. When the determination of Baseline pathogen microbiological response could not be made, the outcome was considered as unable to determine. The data for MSSA in lesion sample has been presented.
Time frame: Up to Day 3
Population: Modified Microbiological ITT population.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Gepotidacin 750 mg q12h | Number of Pathogens With Microbiological Response and Outcome at Early Efficacy Visit for Methicillin-susceptible Staphylococcus Aureus (MSSA) in Lesion Sample | Microbiological Failure, Presumed Persistence | 0 Number of pathogens |
| Gepotidacin 750 mg q12h | Number of Pathogens With Microbiological Response and Outcome at Early Efficacy Visit for Methicillin-susceptible Staphylococcus Aureus (MSSA) in Lesion Sample | Microbiological Success, Presumed Eradication | 6 Number of pathogens |
| Gepotidacin 750 mg q12h | Number of Pathogens With Microbiological Response and Outcome at Early Efficacy Visit for Methicillin-susceptible Staphylococcus Aureus (MSSA) in Lesion Sample | Microbiological Failure, Persistence | 4 Number of pathogens |
| Gepotidacin 1000 mg q12h | Number of Pathogens With Microbiological Response and Outcome at Early Efficacy Visit for Methicillin-susceptible Staphylococcus Aureus (MSSA) in Lesion Sample | Microbiological Failure, Presumed Persistence | 1 Number of pathogens |
| Gepotidacin 1000 mg q12h | Number of Pathogens With Microbiological Response and Outcome at Early Efficacy Visit for Methicillin-susceptible Staphylococcus Aureus (MSSA) in Lesion Sample | Microbiological Failure, Persistence | 0 Number of pathogens |
| Gepotidacin 1000 mg q12h | Number of Pathogens With Microbiological Response and Outcome at Early Efficacy Visit for Methicillin-susceptible Staphylococcus Aureus (MSSA) in Lesion Sample | Microbiological Success, Presumed Eradication | 7 Number of pathogens |
| Gepotidacin 1000 mg q8h | Number of Pathogens With Microbiological Response and Outcome at Early Efficacy Visit for Methicillin-susceptible Staphylococcus Aureus (MSSA) in Lesion Sample | Microbiological Success, Presumed Eradication | 5 Number of pathogens |
| Gepotidacin 1000 mg q8h | Number of Pathogens With Microbiological Response and Outcome at Early Efficacy Visit for Methicillin-susceptible Staphylococcus Aureus (MSSA) in Lesion Sample | Microbiological Failure, Persistence | 1 Number of pathogens |
| Gepotidacin 1000 mg q8h | Number of Pathogens With Microbiological Response and Outcome at Early Efficacy Visit for Methicillin-susceptible Staphylococcus Aureus (MSSA) in Lesion Sample | Microbiological Failure, Presumed Persistence | 0 Number of pathogens |
Secondary
Number of Pathogens With Microbiological Response and Outcome at Early Efficacy Visit for Other Gram-positive Aerobic Pathogens in Lesion Sample
The microbiological outcome was determined by comparing Baseline bacteriology lesion sample, to the culture results at early efficacy visit. The corresponding microbiological response (success or failure) by participant was then assigned. Microbiological eradication or persistence was defined as culture documented elimination or presence of Baseline pathogens from a bacteriology specimen taken at early efficacy visit respectively. Participant was considered to have outcome of presumed microbiological eradication or persistence when the participant was a clinical success or clinical failure and no bacteriological specimen was obtained at early efficacy visit respectively. When the determination of Baseline pathogen microbiological response could not be made, the outcome was considered as unable to determine. The data for other Gram-positive aerobic pathogens in lesion sample has been presented.
Time frame: Up to Day 3
Population: Modified Microbiological ITT population.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Gepotidacin 750 mg q12h | Number of Pathogens With Microbiological Response and Outcome at Early Efficacy Visit for Other Gram-positive Aerobic Pathogens in Lesion Sample | Microbiological Failure, Unable to Determine | 1 Number of pathogens |
| Gepotidacin 750 mg q12h | Number of Pathogens With Microbiological Response and Outcome at Early Efficacy Visit for Other Gram-positive Aerobic Pathogens in Lesion Sample | Microbiological Success, Presumed Eradication | 0 Number of pathogens |
| Gepotidacin 750 mg q12h | Number of Pathogens With Microbiological Response and Outcome at Early Efficacy Visit for Other Gram-positive Aerobic Pathogens in Lesion Sample | Microbiological Failure, Presumed Persistence | 1 Number of pathogens |
| Gepotidacin 750 mg q12h | Number of Pathogens With Microbiological Response and Outcome at Early Efficacy Visit for Other Gram-positive Aerobic Pathogens in Lesion Sample | Microbiological Success, Eradication | 2 Number of pathogens |
| Gepotidacin 1000 mg q12h | Number of Pathogens With Microbiological Response and Outcome at Early Efficacy Visit for Other Gram-positive Aerobic Pathogens in Lesion Sample | Microbiological Success, Eradication | 2 Number of pathogens |
| Gepotidacin 1000 mg q12h | Number of Pathogens With Microbiological Response and Outcome at Early Efficacy Visit for Other Gram-positive Aerobic Pathogens in Lesion Sample | Microbiological Failure, Unable to Determine | 0 Number of pathogens |
| Gepotidacin 1000 mg q12h | Number of Pathogens With Microbiological Response and Outcome at Early Efficacy Visit for Other Gram-positive Aerobic Pathogens in Lesion Sample | Microbiological Success, Presumed Eradication | 1 Number of pathogens |
| Gepotidacin 1000 mg q12h | Number of Pathogens With Microbiological Response and Outcome at Early Efficacy Visit for Other Gram-positive Aerobic Pathogens in Lesion Sample | Microbiological Failure, Presumed Persistence | 1 Number of pathogens |
| Gepotidacin 1000 mg q8h | Number of Pathogens With Microbiological Response and Outcome at Early Efficacy Visit for Other Gram-positive Aerobic Pathogens in Lesion Sample | Microbiological Failure, Presumed Persistence | 0 Number of pathogens |
| Gepotidacin 1000 mg q8h | Number of Pathogens With Microbiological Response and Outcome at Early Efficacy Visit for Other Gram-positive Aerobic Pathogens in Lesion Sample | Microbiological Success, Presumed Eradication | 3 Number of pathogens |
| Gepotidacin 1000 mg q8h | Number of Pathogens With Microbiological Response and Outcome at Early Efficacy Visit for Other Gram-positive Aerobic Pathogens in Lesion Sample | Microbiological Failure, Unable to Determine | 0 Number of pathogens |
| Gepotidacin 1000 mg q8h | Number of Pathogens With Microbiological Response and Outcome at Early Efficacy Visit for Other Gram-positive Aerobic Pathogens in Lesion Sample | Microbiological Success, Eradication | 0 Number of pathogens |
Secondary
Number of Pathogens With Microbiological Response and Outcome at Early Efficacy Visit for SA, MRSA and All Gram-positive Aerobic Pathogens in Blood Sample
The microbiological outcome was determined by comparing Baseline bacteriology blood culture, to the culture results at early efficacy visit. The corresponding microbiological response (success or failure) by participant was then assigned. Microbiological eradication or persistence was defined as culture documented elimination or presence of Baseline pathogens from a bacteriology specimen taken at early efficacy visit respectively. Participant was considered to have outcome of presumed microbiological eradication or persistence when the participant was a clinical success or clinical failure and no bacteriological specimen was obtained at early efficacy visit respectively. When the determination of Baseline pathogen microbiological response could not be made, the outcome was considered as unable to determine. The data for SA, MRSA and all Gram-positive aerobic pathogens in blood sample has been presented.
Time frame: Up to Day 3
Population: Modified Microbiological ITT population.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Gepotidacin 750 mg q12h | Number of Pathogens With Microbiological Response and Outcome at Early Efficacy Visit for SA, MRSA and All Gram-positive Aerobic Pathogens in Blood Sample | MRSA, Microbiological Success, Eradication | 2 Number of pathogens |
| Gepotidacin 750 mg q12h | Number of Pathogens With Microbiological Response and Outcome at Early Efficacy Visit for SA, MRSA and All Gram-positive Aerobic Pathogens in Blood Sample | SA, Microbiological Success, Eradication | 2 Number of pathogens |
| Gepotidacin 750 mg q12h | Number of Pathogens With Microbiological Response and Outcome at Early Efficacy Visit for SA, MRSA and All Gram-positive Aerobic Pathogens in Blood Sample | Aerobic, Microbiological Success, Eradication | 2 Number of pathogens |
Secondary
Number of Pathogens With Microbiological Response and Outcome at Early Efficacy Visit for Staphylococcus Aureus (SA) Pathogen in Lesion Sample
The microbiological outcome was determined by comparing Baseline bacteriology lesion sample, to the culture results at early efficacy visit. The corresponding microbiological response (success or failure) by participant was then assigned. Microbiological eradication or persistence was defined as culture documented elimination or presence of Baseline pathogens from a bacteriology specimen taken at early efficacy visit respectively. Participant was considered to have outcome of presumed microbiological eradication or persistence when the participant was a clinical success or clinical failure and no bacteriological specimen was obtained at early efficacy visit respectively. When the determination of Baseline pathogen microbiological response could not be made, the outcome was considered as unable to determine. The data for SA in lesion sample has been presented.
Time frame: Up to Day 3
Population: Modified Microbiological ITT consisted of all randomized participants who received at least one dose of study medication and had a Gram-positive pathogens identified from their Baseline bacteriology lesion sample.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Gepotidacin 750 mg q12h | Number of Pathogens With Microbiological Response and Outcome at Early Efficacy Visit for Staphylococcus Aureus (SA) Pathogen in Lesion Sample | Microbiological Failure, Persistence | 11 Number of pathogens |
| Gepotidacin 750 mg q12h | Number of Pathogens With Microbiological Response and Outcome at Early Efficacy Visit for Staphylococcus Aureus (SA) Pathogen in Lesion Sample | Microbiological Failure, Presumed Persistence | 4 Number of pathogens |
| Gepotidacin 750 mg q12h | Number of Pathogens With Microbiological Response and Outcome at Early Efficacy Visit for Staphylococcus Aureus (SA) Pathogen in Lesion Sample | Microbiological Success, Presumed Eradication | 24 Number of pathogens |
| Gepotidacin 750 mg q12h | Number of Pathogens With Microbiological Response and Outcome at Early Efficacy Visit for Staphylococcus Aureus (SA) Pathogen in Lesion Sample | Microbiological Success, Eradication | 0 Number of pathogens |
| Gepotidacin 1000 mg q12h | Number of Pathogens With Microbiological Response and Outcome at Early Efficacy Visit for Staphylococcus Aureus (SA) Pathogen in Lesion Sample | Microbiological Failure, Persistence | 3 Number of pathogens |
| Gepotidacin 1000 mg q12h | Number of Pathogens With Microbiological Response and Outcome at Early Efficacy Visit for Staphylococcus Aureus (SA) Pathogen in Lesion Sample | Microbiological Success, Presumed Eradication | 17 Number of pathogens |
| Gepotidacin 1000 mg q12h | Number of Pathogens With Microbiological Response and Outcome at Early Efficacy Visit for Staphylococcus Aureus (SA) Pathogen in Lesion Sample | Microbiological Failure, Presumed Persistence | 6 Number of pathogens |
| Gepotidacin 1000 mg q12h | Number of Pathogens With Microbiological Response and Outcome at Early Efficacy Visit for Staphylococcus Aureus (SA) Pathogen in Lesion Sample | Microbiological Success, Eradication | 2 Number of pathogens |
| Gepotidacin 1000 mg q8h | Number of Pathogens With Microbiological Response and Outcome at Early Efficacy Visit for Staphylococcus Aureus (SA) Pathogen in Lesion Sample | Microbiological Success, Presumed Eradication | 9 Number of pathogens |
| Gepotidacin 1000 mg q8h | Number of Pathogens With Microbiological Response and Outcome at Early Efficacy Visit for Staphylococcus Aureus (SA) Pathogen in Lesion Sample | Microbiological Success, Eradication | 0 Number of pathogens |
| Gepotidacin 1000 mg q8h | Number of Pathogens With Microbiological Response and Outcome at Early Efficacy Visit for Staphylococcus Aureus (SA) Pathogen in Lesion Sample | Microbiological Failure, Persistence | 2 Number of pathogens |
| Gepotidacin 1000 mg q8h | Number of Pathogens With Microbiological Response and Outcome at Early Efficacy Visit for Staphylococcus Aureus (SA) Pathogen in Lesion Sample | Microbiological Failure, Presumed Persistence | 0 Number of pathogens |
Secondary
Number of Pathogens With Microbiological Response and Outcome at Follow up Visit for All Gram-positive Aerobic Pathogens in Lesion Sample
Microbiological outcome was determined by comparing Baseline lesion sample, to culture results at final follow up visit. Corresponding response (success or failure) was then assigned. Microbiological eradication was culture documented elimination of Baseline pathogens from a bacteriology specimen taken at final follow up visit. Presumed microbiological eradication was when there was a clinical success and no bacteriological specimen was obtained at final follow up visit. Culture documented presence of Baseline pathogens in a bacteriology specimen taken at final follow up visit was microbiological recurrence. Presumed microbiological recurrence was when there was a clinical failure and no bacteriological specimen was obtained at final follow up visit. When the determination of Baseline pathogen response could not be made, the outcome was unable to determine. Data for all Gram-positive aerobic pathogens in lesion sample has been presented.
Time frame: Day 21 to Day 28
Population: Modified Microbiological ITT population.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Gepotidacin 750 mg q12h | Number of Pathogens With Microbiological Response and Outcome at Follow up Visit for All Gram-positive Aerobic Pathogens in Lesion Sample | Microbiological Failure, Unable to Determine | 5 Number of pathogens |
| Gepotidacin 750 mg q12h | Number of Pathogens With Microbiological Response and Outcome at Follow up Visit for All Gram-positive Aerobic Pathogens in Lesion Sample | Microbiological Success, Presumed Eradication | 36 Number of pathogens |
| Gepotidacin 750 mg q12h | Number of Pathogens With Microbiological Response and Outcome at Follow up Visit for All Gram-positive Aerobic Pathogens in Lesion Sample | Microbiological Success, Eradication | 1 Number of pathogens |
| Gepotidacin 750 mg q12h | Number of Pathogens With Microbiological Response and Outcome at Follow up Visit for All Gram-positive Aerobic Pathogens in Lesion Sample | Microbiological Failure, Presumed Recurrence | 1 Number of pathogens |
| Gepotidacin 1000 mg q12h | Number of Pathogens With Microbiological Response and Outcome at Follow up Visit for All Gram-positive Aerobic Pathogens in Lesion Sample | Microbiological Failure, Presumed Recurrence | 5 Number of pathogens |
| Gepotidacin 1000 mg q12h | Number of Pathogens With Microbiological Response and Outcome at Follow up Visit for All Gram-positive Aerobic Pathogens in Lesion Sample | Microbiological Success, Eradication | 0 Number of pathogens |
| Gepotidacin 1000 mg q12h | Number of Pathogens With Microbiological Response and Outcome at Follow up Visit for All Gram-positive Aerobic Pathogens in Lesion Sample | Microbiological Success, Presumed Eradication | 23 Number of pathogens |
| Gepotidacin 1000 mg q12h | Number of Pathogens With Microbiological Response and Outcome at Follow up Visit for All Gram-positive Aerobic Pathogens in Lesion Sample | Microbiological Failure, Unable to Determine | 4 Number of pathogens |
| Gepotidacin 1000 mg q8h | Number of Pathogens With Microbiological Response and Outcome at Follow up Visit for All Gram-positive Aerobic Pathogens in Lesion Sample | Microbiological Failure, Presumed Recurrence | 0 Number of pathogens |
| Gepotidacin 1000 mg q8h | Number of Pathogens With Microbiological Response and Outcome at Follow up Visit for All Gram-positive Aerobic Pathogens in Lesion Sample | Microbiological Failure, Unable to Determine | 4 Number of pathogens |
| Gepotidacin 1000 mg q8h | Number of Pathogens With Microbiological Response and Outcome at Follow up Visit for All Gram-positive Aerobic Pathogens in Lesion Sample | Microbiological Success, Presumed Eradication | 10 Number of pathogens |
| Gepotidacin 1000 mg q8h | Number of Pathogens With Microbiological Response and Outcome at Follow up Visit for All Gram-positive Aerobic Pathogens in Lesion Sample | Microbiological Success, Eradication | 0 Number of pathogens |
Secondary
Number of Pathogens With Microbiological Response and Outcome at Follow up Visit for MRSA in Lesion Sample
Microbiological outcome was determined by comparing Baseline lesion sample, to culture results at final follow up visit. Corresponding response (success or failure) was then assigned. Microbiological eradication was culture documented elimination of Baseline pathogens from a bacteriology specimen taken at final follow up visit. Presumed microbiological eradication was when there was a clinical success and no bacteriological specimen was obtained at final follow up visit. Culture documented presence of Baseline pathogens in a bacteriology specimen taken at final follow up visit was microbiological recurrence. Presumed microbiological recurrence was when there was a clinical failure and no bacteriological specimen was obtained at final follow up visit. When the determination of Baseline pathogen response could not be made, the outcome was unable to determine. Data for MRSA pathogen in lesion sample has been presented.
Time frame: Day 21 to Day 28
Population: Modified Microbiological ITT population.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Gepotidacin 750 mg q12h | Number of Pathogens With Microbiological Response and Outcome at Follow up Visit for MRSA in Lesion Sample | Microbiological Failure, Presumed Recurrence | 1 Number of pathogens |
| Gepotidacin 750 mg q12h | Number of Pathogens With Microbiological Response and Outcome at Follow up Visit for MRSA in Lesion Sample | Microbiological Success, Presumed Eradication | 23 Number of pathogens |
| Gepotidacin 750 mg q12h | Number of Pathogens With Microbiological Response and Outcome at Follow up Visit for MRSA in Lesion Sample | Microbiological Failure, Unable to Determine | 4 Number of pathogens |
| Gepotidacin 750 mg q12h | Number of Pathogens With Microbiological Response and Outcome at Follow up Visit for MRSA in Lesion Sample | Microbiological Success, Eradication | 1 Number of pathogens |
| Gepotidacin 1000 mg q12h | Number of Pathogens With Microbiological Response and Outcome at Follow up Visit for MRSA in Lesion Sample | Microbiological Success, Presumed Eradication | 14 Number of pathogens |
| Gepotidacin 1000 mg q12h | Number of Pathogens With Microbiological Response and Outcome at Follow up Visit for MRSA in Lesion Sample | Microbiological Failure, Unable to Determine | 3 Number of pathogens |
| Gepotidacin 1000 mg q12h | Number of Pathogens With Microbiological Response and Outcome at Follow up Visit for MRSA in Lesion Sample | Microbiological Success, Eradication | 0 Number of pathogens |
| Gepotidacin 1000 mg q12h | Number of Pathogens With Microbiological Response and Outcome at Follow up Visit for MRSA in Lesion Sample | Microbiological Failure, Presumed Recurrence | 3 Number of pathogens |
| Gepotidacin 1000 mg q8h | Number of Pathogens With Microbiological Response and Outcome at Follow up Visit for MRSA in Lesion Sample | Microbiological Success, Eradication | 0 Number of pathogens |
| Gepotidacin 1000 mg q8h | Number of Pathogens With Microbiological Response and Outcome at Follow up Visit for MRSA in Lesion Sample | Microbiological Failure, Unable to Determine | 1 Number of pathogens |
| Gepotidacin 1000 mg q8h | Number of Pathogens With Microbiological Response and Outcome at Follow up Visit for MRSA in Lesion Sample | Microbiological Failure, Presumed Recurrence | 0 Number of pathogens |
| Gepotidacin 1000 mg q8h | Number of Pathogens With Microbiological Response and Outcome at Follow up Visit for MRSA in Lesion Sample | Microbiological Success, Presumed Eradication | 4 Number of pathogens |
Secondary
Number of Pathogens With Microbiological Response and Outcome at Follow up Visit for MSSA in Lesion Sample
Microbiological outcome was determined by comparing Baseline lesion sample, to culture results at final follow up visit. Corresponding response (success or failure) was then assigned. Microbiological eradication was culture documented elimination of Baseline pathogens from a bacteriology specimen taken at final follow up visit. Presumed microbiological eradication was when there was a clinical success and no bacteriological specimen was obtained at final follow up visit. Culture documented presence of Baseline pathogens in a bacteriology specimen taken at final follow up visit was microbiological recurrence. Presumed microbiological recurrence was when there was a clinical failure and no bacteriological specimen was obtained at final follow up visit. When the determination of Baseline pathogen response could not be made, the outcome was unable to determine. Data for MSSA pathogen in lesion sample has been presented.
Time frame: Day 21 to Day 28
Population: Modified Microbiological ITT population.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Gepotidacin 750 mg q12h | Number of Pathogens With Microbiological Response and Outcome at Follow up Visit for MSSA in Lesion Sample | Microbiological Failure, Unable to Determine | 0 Number of pathogens |
| Gepotidacin 750 mg q12h | Number of Pathogens With Microbiological Response and Outcome at Follow up Visit for MSSA in Lesion Sample | Microbiological Failure, Presumed Recurrence | 0 Number of pathogens |
| Gepotidacin 750 mg q12h | Number of Pathogens With Microbiological Response and Outcome at Follow up Visit for MSSA in Lesion Sample | Microbiological Success, Presumed Eradication | 10 Number of pathogens |
| Gepotidacin 1000 mg q12h | Number of Pathogens With Microbiological Response and Outcome at Follow up Visit for MSSA in Lesion Sample | Microbiological Failure, Unable to Determine | 0 Number of pathogens |
| Gepotidacin 1000 mg q12h | Number of Pathogens With Microbiological Response and Outcome at Follow up Visit for MSSA in Lesion Sample | Microbiological Success, Presumed Eradication | 7 Number of pathogens |
| Gepotidacin 1000 mg q12h | Number of Pathogens With Microbiological Response and Outcome at Follow up Visit for MSSA in Lesion Sample | Microbiological Failure, Presumed Recurrence | 1 Number of pathogens |
| Gepotidacin 1000 mg q8h | Number of Pathogens With Microbiological Response and Outcome at Follow up Visit for MSSA in Lesion Sample | Microbiological Failure, Presumed Recurrence | 0 Number of pathogens |
| Gepotidacin 1000 mg q8h | Number of Pathogens With Microbiological Response and Outcome at Follow up Visit for MSSA in Lesion Sample | Microbiological Success, Presumed Eradication | 4 Number of pathogens |
| Gepotidacin 1000 mg q8h | Number of Pathogens With Microbiological Response and Outcome at Follow up Visit for MSSA in Lesion Sample | Microbiological Failure, Unable to Determine | 2 Number of pathogens |
Secondary
Number of Pathogens With Microbiological Response and Outcome at Follow up Visit for Other Gram-positive Aerobic Pathogens in Lesion Sample
Microbiological outcome was determined by comparing Baseline lesion sample, to culture results at final follow up visit. Corresponding response (success or failure) was then assigned. Microbiological eradication was culture documented elimination of Baseline pathogens from a bacteriology specimen taken at final follow up visit. Presumed microbiological eradication was when there was a clinical success and no bacteriological specimen was obtained at final follow up visit. Culture documented presence of Baseline pathogens in a bacteriology specimen taken at final follow up visit was microbiological recurrence. Presumed microbiological recurrence was when there was a clinical failure and no bacteriological specimen was obtained at final follow up visit. When the determination of Baseline pathogen response could not be made, the outcome was unable to determine. Data for other Gram-positive aerobic pathogens in lesion sample has been presented.
Time frame: Day 21 to Day 28
Population: Modified Microbiological ITT population.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Gepotidacin 750 mg q12h | Number of Pathogens With Microbiological Response and Outcome at Follow up Visit for Other Gram-positive Aerobic Pathogens in Lesion Sample | Microbiological Success, Presumed Eradication | 3 Number of pathogens |
| Gepotidacin 750 mg q12h | Number of Pathogens With Microbiological Response and Outcome at Follow up Visit for Other Gram-positive Aerobic Pathogens in Lesion Sample | Microbiological Failure, Presumed Recurrence | 0 Number of pathogens |
| Gepotidacin 750 mg q12h | Number of Pathogens With Microbiological Response and Outcome at Follow up Visit for Other Gram-positive Aerobic Pathogens in Lesion Sample | Microbiological Failure, Unable to Determine | 1 Number of pathogens |
| Gepotidacin 1000 mg q12h | Number of Pathogens With Microbiological Response and Outcome at Follow up Visit for Other Gram-positive Aerobic Pathogens in Lesion Sample | Microbiological Failure, Unable to Determine | 1 Number of pathogens |
| Gepotidacin 1000 mg q12h | Number of Pathogens With Microbiological Response and Outcome at Follow up Visit for Other Gram-positive Aerobic Pathogens in Lesion Sample | Microbiological Failure, Presumed Recurrence | 1 Number of pathogens |
| Gepotidacin 1000 mg q12h | Number of Pathogens With Microbiological Response and Outcome at Follow up Visit for Other Gram-positive Aerobic Pathogens in Lesion Sample | Microbiological Success, Presumed Eradication | 2 Number of pathogens |
| Gepotidacin 1000 mg q8h | Number of Pathogens With Microbiological Response and Outcome at Follow up Visit for Other Gram-positive Aerobic Pathogens in Lesion Sample | Microbiological Failure, Unable to Determine | 1 Number of pathogens |
| Gepotidacin 1000 mg q8h | Number of Pathogens With Microbiological Response and Outcome at Follow up Visit for Other Gram-positive Aerobic Pathogens in Lesion Sample | Microbiological Failure, Presumed Recurrence | 0 Number of pathogens |
| Gepotidacin 1000 mg q8h | Number of Pathogens With Microbiological Response and Outcome at Follow up Visit for Other Gram-positive Aerobic Pathogens in Lesion Sample | Microbiological Success, Presumed Eradication | 2 Number of pathogens |
Secondary
Number of Pathogens With Microbiological Response and Outcome at Follow up Visit for SA, MRSA and All Gram-positive Aerobic Pathogens in Blood Sample
Microbiological outcome was determined by comparing Baseline blood culture, to culture results at final follow up visit. Corresponding response (success or failure) was then assigned. Microbiological eradication was culture documented elimination of Baseline pathogens from a bacteriology specimen taken at final follow up visit. Presumed microbiological eradication was when there was a clinical success and no bacteriological specimen was obtained at final follow up visit. Culture documented presence of Baseline pathogens in a bacteriology specimen taken at final follow up visit was microbiological recurrence. Presumed microbiological recurrence was when there was a clinical failure and no bacteriological specimen was obtained at final follow up visit. When the determination of Baseline pathogen response could not be made, the outcome was unable to determine. Data for SA, MRSA and all Gram-positive aerobic pathogens in lesion sample has been presented.
Time frame: Day 21 to Day 28
Population: Modified Microbiological ITT population.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Gepotidacin 750 mg q12h | Number of Pathogens With Microbiological Response and Outcome at Follow up Visit for SA, MRSA and All Gram-positive Aerobic Pathogens in Blood Sample | SA, Microbiological Success, Presumed Eradication | 2 Number of pathogens |
| Gepotidacin 750 mg q12h | Number of Pathogens With Microbiological Response and Outcome at Follow up Visit for SA, MRSA and All Gram-positive Aerobic Pathogens in Blood Sample | MRSA,Microbiological Success,Presumed Eradication | 2 Number of pathogens |
| Gepotidacin 750 mg q12h | Number of Pathogens With Microbiological Response and Outcome at Follow up Visit for SA, MRSA and All Gram-positive Aerobic Pathogens in Blood Sample | Aerobic,MicrobiologicalSuccess,PresumedEradication | 2 Number of pathogens |
Secondary
Number of Pathogens With Microbiological Response and Outcome at Follow up Visit for SA Pathogen in Lesion Sample
Microbiological outcome was determined by comparing Baseline lesion sample, to culture results at final follow up visit. Corresponding response (success or failure) was then assigned. Microbiological eradication was culture documented elimination of Baseline pathogens from a bacteriology specimen taken at final follow up visit. Presumed microbiological eradication was when there was a clinical success and no bacteriological specimen was obtained at final follow up visit. Culture documented presence of Baseline pathogens in a bacteriology specimen taken at final follow up visit was microbiological recurrence. Presumed microbiological recurrence was when there was a clinical failure and no bacteriological specimen was obtained at final follow up visit. When the determination of Baseline pathogen response could not be made, the outcome was unable to determine. Data for SA pathogen in lesion sample has been presented.
Time frame: Day 21 to Day 28
Population: Modified Microbiological ITT.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Gepotidacin 750 mg q12h | Number of Pathogens With Microbiological Response and Outcome at Follow up Visit for SA Pathogen in Lesion Sample | Microbiological Success, Eradication | 1 Number of pathogens |
| Gepotidacin 750 mg q12h | Number of Pathogens With Microbiological Response and Outcome at Follow up Visit for SA Pathogen in Lesion Sample | Microbiological Success, Presumed Eradication | 33 Number of pathogens |
| Gepotidacin 750 mg q12h | Number of Pathogens With Microbiological Response and Outcome at Follow up Visit for SA Pathogen in Lesion Sample | Microbiological Failure, Presumed Recurrence | 1 Number of pathogens |
| Gepotidacin 750 mg q12h | Number of Pathogens With Microbiological Response and Outcome at Follow up Visit for SA Pathogen in Lesion Sample | Microbiological Failure, Unable to Determine | 4 Number of pathogens |
| Gepotidacin 1000 mg q12h | Number of Pathogens With Microbiological Response and Outcome at Follow up Visit for SA Pathogen in Lesion Sample | Microbiological Failure, Unable to Determine | 3 Number of pathogens |
| Gepotidacin 1000 mg q12h | Number of Pathogens With Microbiological Response and Outcome at Follow up Visit for SA Pathogen in Lesion Sample | Microbiological Success, Eradication | 0 Number of pathogens |
| Gepotidacin 1000 mg q12h | Number of Pathogens With Microbiological Response and Outcome at Follow up Visit for SA Pathogen in Lesion Sample | Microbiological Failure, Presumed Recurrence | 4 Number of pathogens |
| Gepotidacin 1000 mg q12h | Number of Pathogens With Microbiological Response and Outcome at Follow up Visit for SA Pathogen in Lesion Sample | Microbiological Success, Presumed Eradication | 21 Number of pathogens |
| Gepotidacin 1000 mg q8h | Number of Pathogens With Microbiological Response and Outcome at Follow up Visit for SA Pathogen in Lesion Sample | Microbiological Failure, Unable to Determine | 3 Number of pathogens |
| Gepotidacin 1000 mg q8h | Number of Pathogens With Microbiological Response and Outcome at Follow up Visit for SA Pathogen in Lesion Sample | Microbiological Success, Presumed Eradication | 8 Number of pathogens |
| Gepotidacin 1000 mg q8h | Number of Pathogens With Microbiological Response and Outcome at Follow up Visit for SA Pathogen in Lesion Sample | Microbiological Failure, Presumed Recurrence | 0 Number of pathogens |
| Gepotidacin 1000 mg q8h | Number of Pathogens With Microbiological Response and Outcome at Follow up Visit for SA Pathogen in Lesion Sample | Microbiological Success, Eradication | 0 Number of pathogens |
Secondary
Number of Pathogens With Microbiological Response and Outcome at Post Therapy Visit for All Gram-positive Aerobic Pathogens in Lesion Sample
Microbiological outcome was determined by comparing Baseline lesion sample, to culture results at post therapy visit. Corresponding response (success or failure) was then assigned. Microbiological eradication or persistence was culture documented elimination or presence of Baseline pathogens from a specimen taken at post therapy visit respectively. Presence of pathogens which was presumed to be eradicated at early efficacy visit was microbiological recurrence. Presumed microbiological eradication or persistence was when there was a clinical success or failure and no bacteriological specimen was obtained post therapy respectively. Presumed microbiological recurrence was when there was a clinical failure and no bacteriological specimen was obtained at post therapy visit for pathogens presumed eradicated at early efficacy visit. When the determination of Baseline pathogen response could not be made, the outcome was unable to determine.
Time frame: Day 12 to Day 18
Population: Modified Microbiological ITT population.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Gepotidacin 750 mg q12h | Number of Pathogens With Microbiological Response and Outcome at Post Therapy Visit for All Gram-positive Aerobic Pathogens in Lesion Sample | Microbiological Success, Eradication | 3 Number of pathogens |
| Gepotidacin 750 mg q12h | Number of Pathogens With Microbiological Response and Outcome at Post Therapy Visit for All Gram-positive Aerobic Pathogens in Lesion Sample | Microbiological Success, Presumed Eradication | 35 Number of pathogens |
| Gepotidacin 750 mg q12h | Number of Pathogens With Microbiological Response and Outcome at Post Therapy Visit for All Gram-positive Aerobic Pathogens in Lesion Sample | Microbiological Failure, Presumed Persistence | 3 Number of pathogens |
| Gepotidacin 750 mg q12h | Number of Pathogens With Microbiological Response and Outcome at Post Therapy Visit for All Gram-positive Aerobic Pathogens in Lesion Sample | Microbiological Failure, Presumed Recurrence | 2 Number of pathogens |
| Gepotidacin 1000 mg q12h | Number of Pathogens With Microbiological Response and Outcome at Post Therapy Visit for All Gram-positive Aerobic Pathogens in Lesion Sample | Microbiological Failure, Presumed Recurrence | 1 Number of pathogens |
| Gepotidacin 1000 mg q12h | Number of Pathogens With Microbiological Response and Outcome at Post Therapy Visit for All Gram-positive Aerobic Pathogens in Lesion Sample | Microbiological Success, Eradication | 1 Number of pathogens |
| Gepotidacin 1000 mg q12h | Number of Pathogens With Microbiological Response and Outcome at Post Therapy Visit for All Gram-positive Aerobic Pathogens in Lesion Sample | Microbiological Failure, Presumed Persistence | 3 Number of pathogens |
| Gepotidacin 1000 mg q12h | Number of Pathogens With Microbiological Response and Outcome at Post Therapy Visit for All Gram-positive Aerobic Pathogens in Lesion Sample | Microbiological Success, Presumed Eradication | 27 Number of pathogens |
| Gepotidacin 1000 mg q8h | Number of Pathogens With Microbiological Response and Outcome at Post Therapy Visit for All Gram-positive Aerobic Pathogens in Lesion Sample | Microbiological Failure, Presumed Recurrence | 3 Number of pathogens |
| Gepotidacin 1000 mg q8h | Number of Pathogens With Microbiological Response and Outcome at Post Therapy Visit for All Gram-positive Aerobic Pathogens in Lesion Sample | Microbiological Success, Presumed Eradication | 10 Number of pathogens |
| Gepotidacin 1000 mg q8h | Number of Pathogens With Microbiological Response and Outcome at Post Therapy Visit for All Gram-positive Aerobic Pathogens in Lesion Sample | Microbiological Failure, Presumed Persistence | 1 Number of pathogens |
| Gepotidacin 1000 mg q8h | Number of Pathogens With Microbiological Response and Outcome at Post Therapy Visit for All Gram-positive Aerobic Pathogens in Lesion Sample | Microbiological Success, Eradication | 0 Number of pathogens |
Secondary
Number of Pathogens With Microbiological Response and Outcome at Post Therapy Visit for MRSA in Lesion Sample
Microbiological outcome was determined by comparing Baseline lesion sample, to culture results at post therapy visit. Corresponding response (success or failure) was then assigned. Microbiological eradication or persistence was culture documented elimination or presence of Baseline pathogens from a specimen taken at post therapy visit respectively. Presence of pathogens which was presumed to be eradicated at early efficacy visit was microbiological recurrence. Presumed microbiological eradication or persistence was when there was a clinical success or failure and no bacteriological specimen was obtained post therapy respectively. Presumed microbiological recurrence was when there was a clinical failure and no bacteriological specimen was obtained at post therapy visit for pathogens presumed eradicated at early efficacy visit. When the determination of Baseline pathogen response could not be made, the outcome was unable to determine. Data for MRSA in lesion sample has been presented.
Time frame: Day 12 to Day 18
Population: Modified Microbiological ITT population.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Gepotidacin 750 mg q12h | Number of Pathogens With Microbiological Response and Outcome at Post Therapy Visit for MRSA in Lesion Sample | Microbiological Failure, Presumed Recurrence | 1 Number of pathogens |
| Gepotidacin 750 mg q12h | Number of Pathogens With Microbiological Response and Outcome at Post Therapy Visit for MRSA in Lesion Sample | Microbiological Success, Eradication | 3 Number of pathogens |
| Gepotidacin 750 mg q12h | Number of Pathogens With Microbiological Response and Outcome at Post Therapy Visit for MRSA in Lesion Sample | Microbiological Success, Presumed Eradication | 22 Number of pathogens |
| Gepotidacin 750 mg q12h | Number of Pathogens With Microbiological Response and Outcome at Post Therapy Visit for MRSA in Lesion Sample | Microbiological Failure, Presumed Persistence | 3 Number of pathogens |
| Gepotidacin 1000 mg q12h | Number of Pathogens With Microbiological Response and Outcome at Post Therapy Visit for MRSA in Lesion Sample | Microbiological Success, Presumed Eradication | 17 Number of pathogens |
| Gepotidacin 1000 mg q12h | Number of Pathogens With Microbiological Response and Outcome at Post Therapy Visit for MRSA in Lesion Sample | Microbiological Failure, Presumed Recurrence | 1 Number of pathogens |
| Gepotidacin 1000 mg q12h | Number of Pathogens With Microbiological Response and Outcome at Post Therapy Visit for MRSA in Lesion Sample | Microbiological Success, Eradication | 0 Number of pathogens |
| Gepotidacin 1000 mg q12h | Number of Pathogens With Microbiological Response and Outcome at Post Therapy Visit for MRSA in Lesion Sample | Microbiological Failure, Presumed Persistence | 2 Number of pathogens |
| Gepotidacin 1000 mg q8h | Number of Pathogens With Microbiological Response and Outcome at Post Therapy Visit for MRSA in Lesion Sample | Microbiological Failure, Presumed Recurrence | 1 Number of pathogens |
| Gepotidacin 1000 mg q8h | Number of Pathogens With Microbiological Response and Outcome at Post Therapy Visit for MRSA in Lesion Sample | Microbiological Success, Eradication | 0 Number of pathogens |
| Gepotidacin 1000 mg q8h | Number of Pathogens With Microbiological Response and Outcome at Post Therapy Visit for MRSA in Lesion Sample | Microbiological Success, Presumed Eradication | 4 Number of pathogens |
| Gepotidacin 1000 mg q8h | Number of Pathogens With Microbiological Response and Outcome at Post Therapy Visit for MRSA in Lesion Sample | Microbiological Failure, Presumed Persistence | 0 Number of pathogens |
Secondary
Number of Pathogens With Microbiological Response and Outcome at Post Therapy Visit for MSSA in Lesion Sample
Microbiological outcome was determined by comparing Baseline lesion sample, to culture results at post therapy visit. Corresponding response (success or failure) was then assigned. Microbiological eradication or persistence was culture documented elimination or presence of Baseline pathogens from a specimen taken at post therapy visit respectively. Presence of pathogens which was presumed to be eradicated at early efficacy visit was microbiological recurrence. Presumed microbiological eradication or persistence was when there was a clinical success or failure and no bacteriological specimen was obtained post therapy respectively. Presumed microbiological recurrence was when there was a clinical failure and no bacteriological specimen was obtained at post therapy visit for pathogens presumed eradicated at early efficacy visit. When the determination of Baseline pathogen response could not be made, the outcome was unable to determine. Data for MSSA in lesion sample has been presented.
Time frame: Day 12 to Day 18
Population: Modified Microbiological ITT population.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Gepotidacin 750 mg q12h | Number of Pathogens With Microbiological Response and Outcome at Post Therapy Visit for MSSA in Lesion Sample | Microbiological Success, Presumed Eradication | 10 Number of pathogens |
| Gepotidacin 750 mg q12h | Number of Pathogens With Microbiological Response and Outcome at Post Therapy Visit for MSSA in Lesion Sample | Microbiological Failure, Presumed Recurrence | 0 Number of pathogens |
| Gepotidacin 750 mg q12h | Number of Pathogens With Microbiological Response and Outcome at Post Therapy Visit for MSSA in Lesion Sample | Microbiological Failure, Presumed Persistence | 0 Number of pathogens |
| Gepotidacin 750 mg q12h | Number of Pathogens With Microbiological Response and Outcome at Post Therapy Visit for MSSA in Lesion Sample | Microbiological Success, Eradication | 0 Number of pathogens |
| Gepotidacin 1000 mg q12h | Number of Pathogens With Microbiological Response and Outcome at Post Therapy Visit for MSSA in Lesion Sample | Microbiological Failure, Presumed Recurrence | 0 Number of pathogens |
| Gepotidacin 1000 mg q12h | Number of Pathogens With Microbiological Response and Outcome at Post Therapy Visit for MSSA in Lesion Sample | Microbiological Success, Presumed Eradication | 7 Number of pathogens |
| Gepotidacin 1000 mg q12h | Number of Pathogens With Microbiological Response and Outcome at Post Therapy Visit for MSSA in Lesion Sample | Microbiological Success, Eradication | 1 Number of pathogens |
| Gepotidacin 1000 mg q12h | Number of Pathogens With Microbiological Response and Outcome at Post Therapy Visit for MSSA in Lesion Sample | Microbiological Failure, Presumed Persistence | 0 Number of pathogens |
| Gepotidacin 1000 mg q8h | Number of Pathogens With Microbiological Response and Outcome at Post Therapy Visit for MSSA in Lesion Sample | Microbiological Failure, Presumed Recurrence | 1 Number of pathogens |
| Gepotidacin 1000 mg q8h | Number of Pathogens With Microbiological Response and Outcome at Post Therapy Visit for MSSA in Lesion Sample | Microbiological Failure, Presumed Persistence | 1 Number of pathogens |
| Gepotidacin 1000 mg q8h | Number of Pathogens With Microbiological Response and Outcome at Post Therapy Visit for MSSA in Lesion Sample | Microbiological Success, Eradication | 0 Number of pathogens |
| Gepotidacin 1000 mg q8h | Number of Pathogens With Microbiological Response and Outcome at Post Therapy Visit for MSSA in Lesion Sample | Microbiological Success, Presumed Eradication | 4 Number of pathogens |
Secondary
Number of Pathogens With Microbiological Response and Outcome at Post Therapy Visit for Other Gram-positive Aerobic Pathogens in Lesion Sample
Microbiological outcome was determined by comparing Baseline lesion sample, to culture results at post therapy visit. Corresponding response (success or failure) was then assigned. Microbiological eradication or persistence was culture documented elimination or presence of Baseline pathogens from a specimen taken at post therapy visit respectively. Presence of pathogens which was presumed to be eradicated at early efficacy visit was microbiological recurrence. Presumed microbiological eradication or persistence was when there was a clinical success or failure and no bacteriological specimen was obtained post therapy respectively. Presumed microbiological recurrence was when there was a clinical failure and no bacteriological specimen was obtained at post therapy visit for pathogens presumed eradicated at early efficacy visit. When the determination of Baseline pathogen response could not be made, the outcome was unable to determine.
Time frame: Day 12 to Day 18
Population: Modified Microbiological ITT population.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Gepotidacin 750 mg q12h | Number of Pathogens With Microbiological Response and Outcome at Post Therapy Visit for Other Gram-positive Aerobic Pathogens in Lesion Sample | Microbiological Failure, Presumed Persistence | 0 Number of pathogens |
| Gepotidacin 750 mg q12h | Number of Pathogens With Microbiological Response and Outcome at Post Therapy Visit for Other Gram-positive Aerobic Pathogens in Lesion Sample | Microbiological Success, Presumed Eradication | 3 Number of pathogens |
| Gepotidacin 750 mg q12h | Number of Pathogens With Microbiological Response and Outcome at Post Therapy Visit for Other Gram-positive Aerobic Pathogens in Lesion Sample | Microbiological Failure, Presumed Recurrence | 1 Number of pathogens |
| Gepotidacin 1000 mg q12h | Number of Pathogens With Microbiological Response and Outcome at Post Therapy Visit for Other Gram-positive Aerobic Pathogens in Lesion Sample | Microbiological Failure, Presumed Persistence | 1 Number of pathogens |
| Gepotidacin 1000 mg q12h | Number of Pathogens With Microbiological Response and Outcome at Post Therapy Visit for Other Gram-positive Aerobic Pathogens in Lesion Sample | Microbiological Success, Presumed Eradication | 3 Number of pathogens |
| Gepotidacin 1000 mg q12h | Number of Pathogens With Microbiological Response and Outcome at Post Therapy Visit for Other Gram-positive Aerobic Pathogens in Lesion Sample | Microbiological Failure, Presumed Recurrence | 0 Number of pathogens |
| Gepotidacin 1000 mg q8h | Number of Pathogens With Microbiological Response and Outcome at Post Therapy Visit for Other Gram-positive Aerobic Pathogens in Lesion Sample | Microbiological Success, Presumed Eradication | 2 Number of pathogens |
| Gepotidacin 1000 mg q8h | Number of Pathogens With Microbiological Response and Outcome at Post Therapy Visit for Other Gram-positive Aerobic Pathogens in Lesion Sample | Microbiological Failure, Presumed Recurrence | 1 Number of pathogens |
| Gepotidacin 1000 mg q8h | Number of Pathogens With Microbiological Response and Outcome at Post Therapy Visit for Other Gram-positive Aerobic Pathogens in Lesion Sample | Microbiological Failure, Presumed Persistence | 0 Number of pathogens |
Secondary
Number of Pathogens With Microbiological Response and Outcome at Post Therapy Visit for SA, MRSA and All Gram-positive Aerobic Pathogens in Blood Sample
Microbiological outcome was determined by comparing Baseline lesion sample, to culture results at post therapy visit. Corresponding response (success or failure) was then assigned. Microbiological eradication or persistence was culture documented elimination or presence of Baseline pathogens from a specimen taken at post therapy visit respectively. Presence of pathogens which was presumed to be eradicated at early efficacy visit was microbiological recurrence. Presumed microbiological eradication or persistence was when there was a clinical success or failure and no bacteriological specimen was obtained post therapy respectively. Presumed microbiological recurrence was when there was a clinical failure and no bacteriological specimen was obtained at post therapy visit for pathogens presumed eradicated at early efficacy visit. When the determination of Baseline pathogen response could not be made, the outcome was unable to determine.
Time frame: Day 12 to Day 18
Population: Modified Microbiological ITT population.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Gepotidacin 750 mg q12h | Number of Pathogens With Microbiological Response and Outcome at Post Therapy Visit for SA, MRSA and All Gram-positive Aerobic Pathogens in Blood Sample | SA, Microbiological Success, Presumed Eradication | 2 Number of pathogens |
| Gepotidacin 750 mg q12h | Number of Pathogens With Microbiological Response and Outcome at Post Therapy Visit for SA, MRSA and All Gram-positive Aerobic Pathogens in Blood Sample | MRSA, Microbiological Success,Presumed Eradication | 2 Number of pathogens |
| Gepotidacin 750 mg q12h | Number of Pathogens With Microbiological Response and Outcome at Post Therapy Visit for SA, MRSA and All Gram-positive Aerobic Pathogens in Blood Sample | Aerobic,MicrobiologicalSuccess,PresumedEradication | 2 Number of pathogens |
Secondary
Number of Pathogens With Microbiological Response and Outcome at Post Therapy Visit for SA Pathogen in Lesion Sample
Microbiological outcome was determined by comparing Baseline lesion sample, to culture results at post therapy visit. Corresponding response (success or failure) was then assigned. Microbiological eradication or persistence was culture documented elimination or presence of Baseline pathogens from a specimen taken at post therapy visit respectively. Presence of pathogens which was presumed to be eradicated at early efficacy visit was microbiological recurrence. Presumed microbiological eradication or persistence was when there was a clinical success or failure and no bacteriological specimen was obtained at post therapy respectively. Presumed microbiological recurrence was when there was a clinical failure and no bacteriological specimen was obtained at post therapy visit for pathogens presumed eradicated at early efficacy visit. When the determination of Baseline pathogen response could not be made, the outcome was unable to determine. Data for SA in lesion sample has been presented.
Time frame: Day 12 to Day 18
Population: Modified Microbiological ITT population.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Gepotidacin 750 mg q12h | Number of Pathogens With Microbiological Response and Outcome at Post Therapy Visit for SA Pathogen in Lesion Sample | Microbiological Success, Eradication | 3 Number of pathogens |
| Gepotidacin 750 mg q12h | Number of Pathogens With Microbiological Response and Outcome at Post Therapy Visit for SA Pathogen in Lesion Sample | Microbiological Success, Presumed Eradication | 32 Number of pathogens |
| Gepotidacin 750 mg q12h | Number of Pathogens With Microbiological Response and Outcome at Post Therapy Visit for SA Pathogen in Lesion Sample | Microbiological Failure, Presumed Recurrence | 1 Number of pathogens |
| Gepotidacin 750 mg q12h | Number of Pathogens With Microbiological Response and Outcome at Post Therapy Visit for SA Pathogen in Lesion Sample | Microbiological Failure, Presumed Persistence | 3 Number of pathogens |
| Gepotidacin 1000 mg q12h | Number of Pathogens With Microbiological Response and Outcome at Post Therapy Visit for SA Pathogen in Lesion Sample | Microbiological Success, Eradication | 1 Number of pathogens |
| Gepotidacin 1000 mg q12h | Number of Pathogens With Microbiological Response and Outcome at Post Therapy Visit for SA Pathogen in Lesion Sample | Microbiological Success, Presumed Eradication | 24 Number of pathogens |
| Gepotidacin 1000 mg q12h | Number of Pathogens With Microbiological Response and Outcome at Post Therapy Visit for SA Pathogen in Lesion Sample | Microbiological Failure, Presumed Persistence | 2 Number of pathogens |
| Gepotidacin 1000 mg q12h | Number of Pathogens With Microbiological Response and Outcome at Post Therapy Visit for SA Pathogen in Lesion Sample | Microbiological Failure, Presumed Recurrence | 1 Number of pathogens |
| Gepotidacin 1000 mg q8h | Number of Pathogens With Microbiological Response and Outcome at Post Therapy Visit for SA Pathogen in Lesion Sample | Microbiological Success, Eradication | 0 Number of pathogens |
| Gepotidacin 1000 mg q8h | Number of Pathogens With Microbiological Response and Outcome at Post Therapy Visit for SA Pathogen in Lesion Sample | Microbiological Failure, Presumed Recurrence | 2 Number of pathogens |
| Gepotidacin 1000 mg q8h | Number of Pathogens With Microbiological Response and Outcome at Post Therapy Visit for SA Pathogen in Lesion Sample | Microbiological Success, Presumed Eradication | 8 Number of pathogens |
| Gepotidacin 1000 mg q8h | Number of Pathogens With Microbiological Response and Outcome at Post Therapy Visit for SA Pathogen in Lesion Sample | Microbiological Failure, Presumed Persistence | 1 Number of pathogens |
Secondary
Pharmacokinetic (PK) Parameters (From GSK2140944 Plasma Concentration-time Data): Maximum Observed Concentration (Cmax) on IV Therapy
Samples for assessment of PK parameter Cmax was done on at predose, 1, 2, 2.5, 3, 6, 12 hours post dose on Day 1 to 3. The first occurrence of the Cmax was determined directly from the raw concentration-time data. Data for participants while on IV therapy has been presented.
Time frame: Predose, 1, 2, 2.5, 3, 6, 12 hours post dose on Day 1 to 3
Population: PK Parameter Population consisted of all participants in the PK concentration population for whom valid and evaluable PK parameters were derived. Only those participants available at the indicated time points were analyzed.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Gepotidacin 750 mg q12h | Pharmacokinetic (PK) Parameters (From GSK2140944 Plasma Concentration-time Data): Maximum Observed Concentration (Cmax) on IV Therapy | 4590 Nanograms per milliliter | Geometric Coefficient of Variation 42.4 |
| Gepotidacin 1000 mg q12h | Pharmacokinetic (PK) Parameters (From GSK2140944 Plasma Concentration-time Data): Maximum Observed Concentration (Cmax) on IV Therapy | 6059 Nanograms per milliliter | Geometric Coefficient of Variation 29.8 |
| Gepotidacin 1000 mg q8h | Pharmacokinetic (PK) Parameters (From GSK2140944 Plasma Concentration-time Data): Maximum Observed Concentration (Cmax) on IV Therapy | 8848 Nanograms per milliliter | Geometric Coefficient of Variation 105.5 |
Secondary
PK Parameters (From GSK2140944 Plasma Concentration-time Data): Area Under the Concentration-time Curve From Time Zero (Pre-dose) to Time of the Last Quantifiable Concentration [AUC (0-t)] and AUC Over the Dosing Interval [AUC(0-tau)] on IV Therapy
Samples for assessment of PK parameters AUClast and AUC0-tau was done at predose, 1, 2, 2.5, 3, 6, 12 hours post dose on Day 1 to 3. The AUC 0-t and AUC0-tau was determined using the linear trapezoidal rule for increasing concentrations and the logarithmic trapezoidal rule for decreasing concentrations. Data for participants while on IV therapy has been presented.
Time frame: Predose, 1, 2, 2.5, 3, 6, 12 hours post dose on Day 1 to 3
Population: PK Parameter Population. Only those participants available at the indicated time points were analyzed.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| Gepotidacin 750 mg q12h | PK Parameters (From GSK2140944 Plasma Concentration-time Data): Area Under the Concentration-time Curve From Time Zero (Pre-dose) to Time of the Last Quantifiable Concentration [AUC (0-t)] and AUC Over the Dosing Interval [AUC(0-tau)] on IV Therapy | AUC0-tau | 16159 Hour nanograms per milliliter | Geometric Coefficient of Variation 36.3 |
| Gepotidacin 750 mg q12h | PK Parameters (From GSK2140944 Plasma Concentration-time Data): Area Under the Concentration-time Curve From Time Zero (Pre-dose) to Time of the Last Quantifiable Concentration [AUC (0-t)] and AUC Over the Dosing Interval [AUC(0-tau)] on IV Therapy | AUClast | 15992 Hour nanograms per milliliter | Geometric Coefficient of Variation 36.7 |
| Gepotidacin 1000 mg q12h | PK Parameters (From GSK2140944 Plasma Concentration-time Data): Area Under the Concentration-time Curve From Time Zero (Pre-dose) to Time of the Last Quantifiable Concentration [AUC (0-t)] and AUC Over the Dosing Interval [AUC(0-tau)] on IV Therapy | AUClast | 20904 Hour nanograms per milliliter | Geometric Coefficient of Variation 31.8 |
| Gepotidacin 1000 mg q12h | PK Parameters (From GSK2140944 Plasma Concentration-time Data): Area Under the Concentration-time Curve From Time Zero (Pre-dose) to Time of the Last Quantifiable Concentration [AUC (0-t)] and AUC Over the Dosing Interval [AUC(0-tau)] on IV Therapy | AUC0-tau | 20815 Hour nanograms per milliliter | Geometric Coefficient of Variation 31.7 |
| Gepotidacin 1000 mg q8h | PK Parameters (From GSK2140944 Plasma Concentration-time Data): Area Under the Concentration-time Curve From Time Zero (Pre-dose) to Time of the Last Quantifiable Concentration [AUC (0-t)] and AUC Over the Dosing Interval [AUC(0-tau)] on IV Therapy | AUClast | 20851 Hour nanograms per milliliter | Geometric Coefficient of Variation 64.8 |
| Gepotidacin 1000 mg q8h | PK Parameters (From GSK2140944 Plasma Concentration-time Data): Area Under the Concentration-time Curve From Time Zero (Pre-dose) to Time of the Last Quantifiable Concentration [AUC (0-t)] and AUC Over the Dosing Interval [AUC(0-tau)] on IV Therapy | AUC0-tau | 21499 Hour nanograms per milliliter | Geometric Coefficient of Variation 66.9 |
Secondary
PK Parameters (From GSK2140944 Plasma Concentration-time Data): AUC (0-t) and AUC(0-tau) on Oral Dose Therapy
Samples for assessment of PK parameters AUClast and AUC0-tau was done at predose, 1, 2, 3 hours after first orally administered drug and one predose time point anytime from Day 7 to 10. The AUC 0-t and AUC0-tau was determined using the linear trapezoidal rule for increasing concentrations and the logarithmic trapezoidal rule for decreasing concentrations. Data for participants while on oral dose therapy has been presented.
Time frame: Predose, 1, 2, 3 hours after first orally administered drug and Day 7 to 10 (predose)
Population: PK Parameter Population. Only those participants available at the indicated time points were analyzed.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| Gepotidacin 750 mg q12h | PK Parameters (From GSK2140944 Plasma Concentration-time Data): AUC (0-t) and AUC(0-tau) on Oral Dose Therapy | AUClast | 11965 Hour nanograms per milliliter | Geometric Coefficient of Variation 101.7 |
| Gepotidacin 750 mg q12h | PK Parameters (From GSK2140944 Plasma Concentration-time Data): AUC (0-t) and AUC(0-tau) on Oral Dose Therapy | AUC0-tau | 14404 Hour nanograms per milliliter | Geometric Coefficient of Variation 78.2 |
| Gepotidacin 1000 mg q12h | PK Parameters (From GSK2140944 Plasma Concentration-time Data): AUC (0-t) and AUC(0-tau) on Oral Dose Therapy | AUClast | 19308 Hour nanograms per milliliter | Geometric Coefficient of Variation 98.8 |
| Gepotidacin 1000 mg q12h | PK Parameters (From GSK2140944 Plasma Concentration-time Data): AUC (0-t) and AUC(0-tau) on Oral Dose Therapy | AUC0-tau | 24253 Hour nanograms per milliliter | Geometric Coefficient of Variation 65.4 |
| Gepotidacin 1000 mg q8h | PK Parameters (From GSK2140944 Plasma Concentration-time Data): AUC (0-t) and AUC(0-tau) on Oral Dose Therapy | AUC0-tau | 19300 Hour nanograms per milliliter | Geometric Coefficient of Variation 77.9 |
| Gepotidacin 1000 mg q8h | PK Parameters (From GSK2140944 Plasma Concentration-time Data): AUC (0-t) and AUC(0-tau) on Oral Dose Therapy | AUClast | 15923 Hour nanograms per milliliter | Geometric Coefficient of Variation 117.4 |
Secondary
PK Parameters (From GSK2140944 Plasma Concentration-time Data): Cmax on Oral Dose Therapy
Samples for assessment of PK parameter Cmax was done at Predose, 1, 2, 3 hours after first orally administered drug and one predose time point anytime from Day 7 to 10. The first occurrence of the Cmax was determined directly from the raw concentration-time data. Data for participants while on oral dose therapy has been presented.
Time frame: Predose, 1, 2, 3 hours after first orally administered drug and Day 7 to 10 (predose)
Population: PK Parameter Population. Only those participants available at the indicated time points were analyzed.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Gepotidacin 750 mg q12h | PK Parameters (From GSK2140944 Plasma Concentration-time Data): Cmax on Oral Dose Therapy | 2342 Nanograms per milliliter | Geometric Coefficient of Variation 84.7 |
| Gepotidacin 1000 mg q12h | PK Parameters (From GSK2140944 Plasma Concentration-time Data): Cmax on Oral Dose Therapy | 4329 Nanograms per milliliter | Geometric Coefficient of Variation 67.8 |
| Gepotidacin 1000 mg q8h | PK Parameters (From GSK2140944 Plasma Concentration-time Data): Cmax on Oral Dose Therapy | 3858 Nanograms per milliliter | Geometric Coefficient of Variation 94.1 |
Secondary
PK Parameters (From GSK2140944 Plasma Concentration-time Data): Time to Cmax (Tmax) on IV Therapy
Samples for assessment of PK parameter tmax was done at predose, 1, 2, 2.5, 3, 6, 12 hours post dose on Day 1 to 3. The time at which Cmax was observed was determined directly from the raw concentration-time data. Data for participants while on IV therapy has been presented.
Time frame: Predose, 1, 2, 2.5, 3, 6, 12 hours post dose on Day 1 to 3
Population: PK Parameter Population. Only those participants available at the indicated time points were analyzed.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Gepotidacin 750 mg q12h | PK Parameters (From GSK2140944 Plasma Concentration-time Data): Time to Cmax (Tmax) on IV Therapy | 1.95 Hours |
| Gepotidacin 1000 mg q12h | PK Parameters (From GSK2140944 Plasma Concentration-time Data): Time to Cmax (Tmax) on IV Therapy | 1.90 Hours |
| Gepotidacin 1000 mg q8h | PK Parameters (From GSK2140944 Plasma Concentration-time Data): Time to Cmax (Tmax) on IV Therapy | 1.93 Hours |
Secondary
PK Parameters (From GSK2140944 Plasma Concentration-time Data): Tmax on Oral Dose Therapy
Samples for assessment of PK parameter tmax was done at Predose, 1, 2, 3 hours after first orally administered drug and one predose time point anytime from Day 7 to 10. The time at which Cmax was observed was determined directly from the raw concentration-time data. Data for participants while on oral dose therapy has been presented.
Time frame: Predose, 1, 2, 3 hours after first orally administered drug and Day 7 to 10 (predose)
Population: PK Parameter Population. Only those participants available at the indicated time points were analyzed.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Gepotidacin 750 mg q12h | PK Parameters (From GSK2140944 Plasma Concentration-time Data): Tmax on Oral Dose Therapy | 3.00 Hours |
| Gepotidacin 1000 mg q12h | PK Parameters (From GSK2140944 Plasma Concentration-time Data): Tmax on Oral Dose Therapy | 2.92 Hours |
| Gepotidacin 1000 mg q8h | PK Parameters (From GSK2140944 Plasma Concentration-time Data): Tmax on Oral Dose Therapy | 2.98 Hours |