Trial Outcomes & Findings for A Study Evaluating Efficacy and Safety of Gepotidacin Compared With Ceftriaxone Plus Azithromycin in the Treatment of Uncomplicated Urogenital Gonorrhea (NCT NCT04010539)
NCT ID: NCT04010539
Last Updated: 2024-05-30
Results Overview
Urogenital specimens were obtained for bacteriological culture at the Baseline (Day 1) and TOC (Day 4 to 8) visits and were compared to determine microbiological outcome. Microbiological success was defined as culture-confirmed elimination of baseline pathogen (NG) from a bacteriology sample taken at the TOC visit without the participant receiving other systemic antimicrobials before this visit. Microbiological failure was categorized as "Bacterial Persistence (BP)" and "Unable to Determine (UTD)" outcomes. Bacterial persistence was defined as culture-confirmed persistence of baseline NG pathogen from a bacteriology sample taken at the TOC visit without the participant receiving other systemic antimicrobials before this visit. UTD was defined as inability to determine the TOC NG pathogen outcome (e.g., no bacteriological sample taken for culture, sample lost, visit did not occur etc.) or the participant received other systemic antimicrobials before the TOC visit.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
628 participants
Primary outcome timeframe
Baseline (Day 1) and TOC visit (Day 4 to 8)
Results posted on
2024-05-30
Participant Flow
Participant milestones
| Measure |
Gepotidacin
Participants with uncomplicated urogenital gonorrhea (GC) were randomized to receive first dose of 3000 milligram (mg) (4\*750 mg, tablets) gepotidacin orally on Day 1. Participants self-administered second dose of 3000 mg (4\*750 mg, tablets) gepotidacin orally 10-12 hours after first dose. All doses were to be administered after food consumption and with water.
|
Ceftriaxone Plus Azithromycin
Participants with uncomplicated urogenital gonorrhea (GC) were randomized to receive single dose of 500 mg Ceftriaxone as intramuscular sterile powder reconstituted with appropriate diluent plus single oral dose of 1 gram (g) Azithromycin (2\*500 mg, tablets) on Day 1. Azithromycin was to be administered after food consumption and with water.
|
|---|---|---|
|
Overall Study
STARTED
|
314
|
314
|
|
Overall Study
Safety Population
|
309
|
313
|
|
Overall Study
Microbiological ITT (Micro-ITT) Population
|
202
|
204
|
|
Overall Study
Micro-ITT Rectal Population
|
26
|
15
|
|
Overall Study
Micro-ITT Pharyngeal Population
|
18
|
17
|
|
Overall Study
COMPLETED
|
294
|
295
|
|
Overall Study
NOT COMPLETED
|
20
|
19
|
Reasons for withdrawal
| Measure |
Gepotidacin
Participants with uncomplicated urogenital gonorrhea (GC) were randomized to receive first dose of 3000 milligram (mg) (4\*750 mg, tablets) gepotidacin orally on Day 1. Participants self-administered second dose of 3000 mg (4\*750 mg, tablets) gepotidacin orally 10-12 hours after first dose. All doses were to be administered after food consumption and with water.
|
Ceftriaxone Plus Azithromycin
Participants with uncomplicated urogenital gonorrhea (GC) were randomized to receive single dose of 500 mg Ceftriaxone as intramuscular sterile powder reconstituted with appropriate diluent plus single oral dose of 1 gram (g) Azithromycin (2\*500 mg, tablets) on Day 1. Azithromycin was to be administered after food consumption and with water.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
4
|
1
|
|
Overall Study
Physician Decision
|
0
|
2
|
|
Overall Study
Lost to Follow-up
|
10
|
14
|
|
Overall Study
Adverse Event
|
3
|
0
|
|
Overall Study
Participant Did Not Receive IP
|
0
|
1
|
|
Overall Study
Protocol Deviation
|
0
|
1
|
|
Overall Study
Randomized in Error/ Mistake
|
2
|
0
|
|
Overall Study
Eligibility Criteria Unable to Evaluate
|
1
|
0
|
Baseline Characteristics
A Study Evaluating Efficacy and Safety of Gepotidacin Compared With Ceftriaxone Plus Azithromycin in the Treatment of Uncomplicated Urogenital Gonorrhea
Baseline characteristics by cohort
| Measure |
Gepotidacin
n=314 Participants
Participants with uncomplicated urogenital gonorrhea (GC) were randomized to receive first dose of 3000 milligram (mg) (4\*750 mg, tablets) gepotidacin orally on Day 1. Participants self-administered second dose of 3000 mg (4\*750 mg, tablets) gepotidacin orally 10-12 hours after first dose. All doses were to be administered after food consumption and with water.
|
Ceftriaxone Plus Azithromycin
n=314 Participants
Participants with uncomplicated urogenital gonorrhea (GC) were randomized to receive single dose of 500 mg Ceftriaxone as intramuscular sterile powder reconstituted with appropriate diluent plus single oral dose of 1 gram (g) Azithromycin (2\*500 mg, tablets) on Day 1. Azithromycin was to be administered after food consumption and with water.
|
Total
n=628 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
33.9 Years
STANDARD_DEVIATION 10.42 • n=99 Participants
|
33.7 Years
STANDARD_DEVIATION 10.70 • n=107 Participants
|
33.8 Years
STANDARD_DEVIATION 10.56 • n=206 Participants
|
|
Sex: Female, Male
Female
|
35 Participants
n=99 Participants
|
34 Participants
n=107 Participants
|
69 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
279 Participants
n=99 Participants
|
280 Participants
n=107 Participants
|
559 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
9 Participants
n=99 Participants
|
10 Participants
n=107 Participants
|
19 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
12 Participants
n=99 Participants
|
17 Participants
n=107 Participants
|
29 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
7 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
9 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
49 Participants
n=99 Participants
|
39 Participants
n=107 Participants
|
88 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
231 Participants
n=99 Participants
|
241 Participants
n=107 Participants
|
472 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
6 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
11 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Baseline (Day 1) and TOC visit (Day 4 to 8)Population: Microbiological intent-to-treat (Micro-ITT) population included all participants randomly assigned to study treatment who received at least 1 dose of study treatment and have confirmed NG isolated that is ceftriaxone-susceptible (based on CLSI breakpoints) from baseline culture of their urogenital specimen.
Urogenital specimens were obtained for bacteriological culture at the Baseline (Day 1) and TOC (Day 4 to 8) visits and were compared to determine microbiological outcome. Microbiological success was defined as culture-confirmed elimination of baseline pathogen (NG) from a bacteriology sample taken at the TOC visit without the participant receiving other systemic antimicrobials before this visit. Microbiological failure was categorized as "Bacterial Persistence (BP)" and "Unable to Determine (UTD)" outcomes. Bacterial persistence was defined as culture-confirmed persistence of baseline NG pathogen from a bacteriology sample taken at the TOC visit without the participant receiving other systemic antimicrobials before this visit. UTD was defined as inability to determine the TOC NG pathogen outcome (e.g., no bacteriological sample taken for culture, sample lost, visit did not occur etc.) or the participant received other systemic antimicrobials before the TOC visit.
Outcome measures
| Measure |
Ceftriaxone Plus Azithromycin
n=204 Participants
Participants with uncomplicated urogenital gonorrhea (GC) were randomized to receive single dose of 500 mg Ceftriaxone as intramuscular sterile powder reconstituted with appropriate diluent plus single oral dose of 1 gram (g) Azithromycin (2\*500 mg, tablets) on Day 1. Azithromycin was to be administered after food consumption and with water.
|
Gepotidacin
n=202 Participants
Participants with uncomplicated urogenital gonorrhea (GC) were randomized to receive first dose of 3000 milligram (mg) (4\*750 mg, tablets) gepotidacin orally on Day 1. Participants self-administered second dose of 3000 mg (4\*750 mg, tablets) gepotidacin orally 10-12 hours after first dose. All doses were to be administered after food consumption and with water.
|
|---|---|---|
|
Number of Participants With Culture-Confirmed Bacterial Eradication of Neisseria Gonorrhoeae (NG) From the Urogenital Site at the Test-Of-Cure (TOC) Visit (Day 4 to 8)
Microbiological success
|
186 Participants
|
187 Participants
|
|
Number of Participants With Culture-Confirmed Bacterial Eradication of Neisseria Gonorrhoeae (NG) From the Urogenital Site at the Test-Of-Cure (TOC) Visit (Day 4 to 8)
Microbiological failure, UTD
|
18 Participants
|
15 Participants
|
|
Number of Participants With Culture-Confirmed Bacterial Eradication of Neisseria Gonorrhoeae (NG) From the Urogenital Site at the Test-Of-Cure (TOC) Visit (Day 4 to 8)
Microbiological failure, BP
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Baseline (Day 1) and TOC visit (Day 4 to 8)Population: Micro-ITT Rectal population included all participants who met the definition of the Micro-ITT Population and have confirmed NG isolated that is ceftriaxone susceptible from baseline culture of their rectal specimen.
Rectal specimens were obtained for bacteriological culture at the Baseline (Day 1) and TOC (Day 4 to 8) visits and were compared to determine microbiological outcome. Microbiological success was defined as culture-confirmed elimination of baseline pathogen (NG) from a bacteriology sample taken at the TOC visit without the participant receiving other systemic antimicrobials before this visit. Microbiological failure was categorized as "Bacterial Persistence (BP)" and "Unable to Determine (UTD)" outcomes. Bacterial persistence was defined as culture-confirmed persistence of baseline NG pathogen from a bacteriology sample taken at the TOC visit without the participant receiving other systemic antimicrobials before this visit. UTD was defined as inability to determine the TOC NG pathogen outcome (e.g., no bacteriological sample taken for culture, sample lost, visit did not occur etc.) or the participant received other systemic antimicrobials before the TOC visit.
Outcome measures
| Measure |
Ceftriaxone Plus Azithromycin
n=15 Participants
Participants with uncomplicated urogenital gonorrhea (GC) were randomized to receive single dose of 500 mg Ceftriaxone as intramuscular sterile powder reconstituted with appropriate diluent plus single oral dose of 1 gram (g) Azithromycin (2\*500 mg, tablets) on Day 1. Azithromycin was to be administered after food consumption and with water.
|
Gepotidacin
n=26 Participants
Participants with uncomplicated urogenital gonorrhea (GC) were randomized to receive first dose of 3000 milligram (mg) (4\*750 mg, tablets) gepotidacin orally on Day 1. Participants self-administered second dose of 3000 mg (4\*750 mg, tablets) gepotidacin orally 10-12 hours after first dose. All doses were to be administered after food consumption and with water.
|
|---|---|---|
|
Number of Participants With Culture-Confirmed Bacterial Eradication of NG From the Rectal Site at the TOC Visit
Microbiological success
|
12 Participants
|
26 Participants
|
|
Number of Participants With Culture-Confirmed Bacterial Eradication of NG From the Rectal Site at the TOC Visit
Microbiological failure, BP
|
0 Participants
|
0 Participants
|
|
Number of Participants With Culture-Confirmed Bacterial Eradication of NG From the Rectal Site at the TOC Visit
Microbiological failure, UTD
|
3 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Baseline (Day 1) and TOC visit (Day 4 to 8)Population: Micro-ITT Pharyngeal population included all participants who met the definition of the Micro-ITT Population and have confirmed NG isolated that is ceftriaxone susceptible from baseline culture of their pharyngeal specimen.
Pharyngeal specimens were obtained for bacteriological culture at the Baseline (Day 1) and TOC (Day 4 to 8) visits and were compared to determine microbiological outcome. Microbiological success was defined as culture-confirmed elimination of baseline pathogen (NG) from a bacteriology sample taken at the TOC visit without the participant receiving other systemic antimicrobials before this visit. Microbiological failure was categorized as "Bacterial Persistence (BP)" and "Unable to Determine (UTD)" outcomes. Bacterial persistence was defined as culture-confirmed persistence of baseline NG pathogen from a bacteriology sample taken at the TOC visit without the participant receiving other systemic antimicrobials before this visit. UTD was defined as inability to determine the TOC NG pathogen outcome (e.g., no bacteriological sample taken for culture, sample lost, visit did not occur etc.) or the participant received other systemic antimicrobials before the TOC visit.
Outcome measures
| Measure |
Ceftriaxone Plus Azithromycin
n=17 Participants
Participants with uncomplicated urogenital gonorrhea (GC) were randomized to receive single dose of 500 mg Ceftriaxone as intramuscular sterile powder reconstituted with appropriate diluent plus single oral dose of 1 gram (g) Azithromycin (2\*500 mg, tablets) on Day 1. Azithromycin was to be administered after food consumption and with water.
|
Gepotidacin
n=18 Participants
Participants with uncomplicated urogenital gonorrhea (GC) were randomized to receive first dose of 3000 milligram (mg) (4\*750 mg, tablets) gepotidacin orally on Day 1. Participants self-administered second dose of 3000 mg (4\*750 mg, tablets) gepotidacin orally 10-12 hours after first dose. All doses were to be administered after food consumption and with water.
|
|---|---|---|
|
Number of Participants With Culture-Confirmed Bacterial Eradication of NG From the Pharyngeal Site at the TOC Visit
Microbiological success
|
16 Participants
|
14 Participants
|
|
Number of Participants With Culture-Confirmed Bacterial Eradication of NG From the Pharyngeal Site at the TOC Visit
Microbiological failure, BP
|
0 Participants
|
2 Participants
|
|
Number of Participants With Culture-Confirmed Bacterial Eradication of NG From the Pharyngeal Site at the TOC Visit
Microbiological failure, UTD
|
1 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: Up to 21 daysPopulation: Safety population included all participants who received at least 1 dose of study treatment.
An adverse event (AE) is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. A TEAE is an event that emerges during treatment having been absent pretreatment or worsens relative to the pretreatment state. An SAE is defined as any untoward medical occurrence that, at any dose, results in death; was life threatening; required hospitalization or prolongation of existing hospitalization; resulted in disability/incapacity; was a congenital anomaly/birth defect.
Outcome measures
| Measure |
Ceftriaxone Plus Azithromycin
n=313 Participants
Participants with uncomplicated urogenital gonorrhea (GC) were randomized to receive single dose of 500 mg Ceftriaxone as intramuscular sterile powder reconstituted with appropriate diluent plus single oral dose of 1 gram (g) Azithromycin (2\*500 mg, tablets) on Day 1. Azithromycin was to be administered after food consumption and with water.
|
Gepotidacin
n=309 Participants
Participants with uncomplicated urogenital gonorrhea (GC) were randomized to receive first dose of 3000 milligram (mg) (4\*750 mg, tablets) gepotidacin orally on Day 1. Participants self-administered second dose of 3000 mg (4\*750 mg, tablets) gepotidacin orally 10-12 hours after first dose. All doses were to be administered after food consumption and with water.
|
|---|---|---|
|
Number of Participants With Any Treatment-emergent Adverse Events (TEAEs) and Any Serious Adverse Events (SAEs)
Any TEAEs
|
104 Participants
|
230 Participants
|
|
Number of Participants With Any Treatment-emergent Adverse Events (TEAEs) and Any Serious Adverse Events (SAEs)
Any SAEs
|
0 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Baseline (Day 1) and TOC visit (Day 4 to 8)Population: Safety population. Only those participants with data available at specified time points have been analyzed.
Blood samples were collected for the assessment of change from baseline in hematology parameters: basophils, eosinophil, leukocytes, neutrophils, platelets, lymphocytes, monocytes, neutrophils and nucleated erythrocytes. Baseline (Day 1) was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits.
Outcome measures
| Measure |
Ceftriaxone Plus Azithromycin
n=293 Participants
Participants with uncomplicated urogenital gonorrhea (GC) were randomized to receive single dose of 500 mg Ceftriaxone as intramuscular sterile powder reconstituted with appropriate diluent plus single oral dose of 1 gram (g) Azithromycin (2\*500 mg, tablets) on Day 1. Azithromycin was to be administered after food consumption and with water.
|
Gepotidacin
n=284 Participants
Participants with uncomplicated urogenital gonorrhea (GC) were randomized to receive first dose of 3000 milligram (mg) (4\*750 mg, tablets) gepotidacin orally on Day 1. Participants self-administered second dose of 3000 mg (4\*750 mg, tablets) gepotidacin orally 10-12 hours after first dose. All doses were to be administered after food consumption and with water.
|
|---|---|---|
|
Change From Baseline (CFB) in Hematology Parameters: Basophils, Eosinophil, Leukocytes, Neutrophils, Platelets, Lymphocytes, Monocytes, Neutrophils and Nucleated Erythrocytes
Nucleated Erythrocytes, CFB to TOC
|
0.001 Giga cells per liter (10^9 cells/L)
Standard Deviation 0.0059
|
0.000 Giga cells per liter (10^9 cells/L)
Standard Deviation 0.0070
|
|
Change From Baseline (CFB) in Hematology Parameters: Basophils, Eosinophil, Leukocytes, Neutrophils, Platelets, Lymphocytes, Monocytes, Neutrophils and Nucleated Erythrocytes
Basophils, Baseline (Day 1)
|
0.045 Giga cells per liter (10^9 cells/L)
Standard Deviation 0.0222
|
0.044 Giga cells per liter (10^9 cells/L)
Standard Deviation 0.0196
|
|
Change From Baseline (CFB) in Hematology Parameters: Basophils, Eosinophil, Leukocytes, Neutrophils, Platelets, Lymphocytes, Monocytes, Neutrophils and Nucleated Erythrocytes
Basophils, CFB to TOC
|
0.000 Giga cells per liter (10^9 cells/L)
Standard Deviation 0.0152
|
0.001 Giga cells per liter (10^9 cells/L)
Standard Deviation 0.0167
|
|
Change From Baseline (CFB) in Hematology Parameters: Basophils, Eosinophil, Leukocytes, Neutrophils, Platelets, Lymphocytes, Monocytes, Neutrophils and Nucleated Erythrocytes
Eosinophils, Baseline (Day 1)
|
0.160 Giga cells per liter (10^9 cells/L)
Standard Deviation 0.1384
|
0.154 Giga cells per liter (10^9 cells/L)
Standard Deviation 0.2117
|
|
Change From Baseline (CFB) in Hematology Parameters: Basophils, Eosinophil, Leukocytes, Neutrophils, Platelets, Lymphocytes, Monocytes, Neutrophils and Nucleated Erythrocytes
Eosinophils, CFB to TOC
|
0.018 Giga cells per liter (10^9 cells/L)
Standard Deviation 0.0827
|
0.009 Giga cells per liter (10^9 cells/L)
Standard Deviation 0.1289
|
|
Change From Baseline (CFB) in Hematology Parameters: Basophils, Eosinophil, Leukocytes, Neutrophils, Platelets, Lymphocytes, Monocytes, Neutrophils and Nucleated Erythrocytes
Leukocytes, Baseline (Day 1)
|
7.507 Giga cells per liter (10^9 cells/L)
Standard Deviation 2.2045
|
7.143 Giga cells per liter (10^9 cells/L)
Standard Deviation 2.2808
|
|
Change From Baseline (CFB) in Hematology Parameters: Basophils, Eosinophil, Leukocytes, Neutrophils, Platelets, Lymphocytes, Monocytes, Neutrophils and Nucleated Erythrocytes
Leukocytes, CFB to TOC
|
-1.267 Giga cells per liter (10^9 cells/L)
Standard Deviation 1.9362
|
-0.811 Giga cells per liter (10^9 cells/L)
Standard Deviation 1.8536
|
|
Change From Baseline (CFB) in Hematology Parameters: Basophils, Eosinophil, Leukocytes, Neutrophils, Platelets, Lymphocytes, Monocytes, Neutrophils and Nucleated Erythrocytes
Neutrophils, Baseline (Day 1)
|
4.774 Giga cells per liter (10^9 cells/L)
Standard Deviation 1.9355
|
4.443 Giga cells per liter (10^9 cells/L)
Standard Deviation 1.9621
|
|
Change From Baseline (CFB) in Hematology Parameters: Basophils, Eosinophil, Leukocytes, Neutrophils, Platelets, Lymphocytes, Monocytes, Neutrophils and Nucleated Erythrocytes
Neutrophils, CFB to TOC
|
-1.473 Giga cells per liter (10^9 cells/L)
Standard Deviation 1.8860
|
-1.062 Giga cells per liter (10^9 cells/L)
Standard Deviation 1.7309
|
|
Change From Baseline (CFB) in Hematology Parameters: Basophils, Eosinophil, Leukocytes, Neutrophils, Platelets, Lymphocytes, Monocytes, Neutrophils and Nucleated Erythrocytes
Platelets, Baseline (Day 1)
|
268.4 Giga cells per liter (10^9 cells/L)
Standard Deviation 69.26
|
260.3 Giga cells per liter (10^9 cells/L)
Standard Deviation 61.79
|
|
Change From Baseline (CFB) in Hematology Parameters: Basophils, Eosinophil, Leukocytes, Neutrophils, Platelets, Lymphocytes, Monocytes, Neutrophils and Nucleated Erythrocytes
Platelets, CFB to TOC
|
9.7 Giga cells per liter (10^9 cells/L)
Standard Deviation 34.94
|
10.2 Giga cells per liter (10^9 cells/L)
Standard Deviation 32.14
|
|
Change From Baseline (CFB) in Hematology Parameters: Basophils, Eosinophil, Leukocytes, Neutrophils, Platelets, Lymphocytes, Monocytes, Neutrophils and Nucleated Erythrocytes
Lymphocytes, Baseline (Day 1)
|
1.948 Giga cells per liter (10^9 cells/L)
Standard Deviation 0.6321
|
1.934 Giga cells per liter (10^9 cells/L)
Standard Deviation 0.5941
|
|
Change From Baseline (CFB) in Hematology Parameters: Basophils, Eosinophil, Leukocytes, Neutrophils, Platelets, Lymphocytes, Monocytes, Neutrophils and Nucleated Erythrocytes
Lymphocytes, CFB to TOC
|
0.245 Giga cells per liter (10^9 cells/L)
Standard Deviation 0.5511
|
0.277 Giga cells per liter (10^9 cells/L)
Standard Deviation 0.5205
|
|
Change From Baseline (CFB) in Hematology Parameters: Basophils, Eosinophil, Leukocytes, Neutrophils, Platelets, Lymphocytes, Monocytes, Neutrophils and Nucleated Erythrocytes
Monocytes, Baseline (Day 1)
|
0.572 Giga cells per liter (10^9 cells/L)
Standard Deviation 0.1877
|
0.559 Giga cells per liter (10^9 cells/L)
Standard Deviation 0.2209
|
|
Change From Baseline (CFB) in Hematology Parameters: Basophils, Eosinophil, Leukocytes, Neutrophils, Platelets, Lymphocytes, Monocytes, Neutrophils and Nucleated Erythrocytes
Monocytes, CFB to TOC
|
-0.053 Giga cells per liter (10^9 cells/L)
Standard Deviation 0.1782
|
-0.034 Giga cells per liter (10^9 cells/L)
Standard Deviation 0.1917
|
|
Change From Baseline (CFB) in Hematology Parameters: Basophils, Eosinophil, Leukocytes, Neutrophils, Platelets, Lymphocytes, Monocytes, Neutrophils and Nucleated Erythrocytes
Nucleated Erythrocytes, Baseline (Day 1)
|
0.001 Giga cells per liter (10^9 cells/L)
Standard Deviation 0.0038
|
0.002 Giga cells per liter (10^9 cells/L)
Standard Deviation 0.0047
|
SECONDARY outcome
Timeframe: Baseline (Day 1) and TOC visit (Day 4 to 8)Population: Safety population. Only those participants with data available at specified time points have been analyzed.
Blood samples were collected for the assessment of change from baseline in hematology parameters: mean corpuscular hemoglobin concentration and hemoglobin. Baseline (Day 1) was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits.
Outcome measures
| Measure |
Ceftriaxone Plus Azithromycin
n=293 Participants
Participants with uncomplicated urogenital gonorrhea (GC) were randomized to receive single dose of 500 mg Ceftriaxone as intramuscular sterile powder reconstituted with appropriate diluent plus single oral dose of 1 gram (g) Azithromycin (2\*500 mg, tablets) on Day 1. Azithromycin was to be administered after food consumption and with water.
|
Gepotidacin
n=284 Participants
Participants with uncomplicated urogenital gonorrhea (GC) were randomized to receive first dose of 3000 milligram (mg) (4\*750 mg, tablets) gepotidacin orally on Day 1. Participants self-administered second dose of 3000 mg (4\*750 mg, tablets) gepotidacin orally 10-12 hours after first dose. All doses were to be administered after food consumption and with water.
|
|---|---|---|
|
Change From Baseline in Hematology Parameters: Mean Corpuscular Hemoglobin Concentration (MCHC) and Hemoglobin (Hb)
MCHC, Baseline (Day 1)
|
318.8 Grams per liter (g/L)
Standard Deviation 16.12
|
318.5 Grams per liter (g/L)
Standard Deviation 16.27
|
|
Change From Baseline in Hematology Parameters: Mean Corpuscular Hemoglobin Concentration (MCHC) and Hemoglobin (Hb)
MCHC, CFB to TOC
|
0.3 Grams per liter (g/L)
Standard Deviation 11.27
|
2.4 Grams per liter (g/L)
Standard Deviation 10.67
|
|
Change From Baseline in Hematology Parameters: Mean Corpuscular Hemoglobin Concentration (MCHC) and Hemoglobin (Hb)
Hb, Baseline (Day 1)
|
149.2 Grams per liter (g/L)
Standard Deviation 12.58
|
149.1 Grams per liter (g/L)
Standard Deviation 12.83
|
|
Change From Baseline in Hematology Parameters: Mean Corpuscular Hemoglobin Concentration (MCHC) and Hemoglobin (Hb)
Hb, CFB to TOC
|
0.6 Grams per liter (g/L)
Standard Deviation 6.92
|
0.00 Grams per liter (g/L)
Standard Deviation 6.70
|
SECONDARY outcome
Timeframe: Baseline (Day 1) and TOC visit (Day 4 to 8)Population: Safety population. Only those participants with data available at specified time points have been analyzed.
Blood samples were collected for the assessment of change from baseline in hematology parameter: hematocrit. Baseline (Day 1) was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits.
Outcome measures
| Measure |
Ceftriaxone Plus Azithromycin
n=293 Participants
Participants with uncomplicated urogenital gonorrhea (GC) were randomized to receive single dose of 500 mg Ceftriaxone as intramuscular sterile powder reconstituted with appropriate diluent plus single oral dose of 1 gram (g) Azithromycin (2\*500 mg, tablets) on Day 1. Azithromycin was to be administered after food consumption and with water.
|
Gepotidacin
n=284 Participants
Participants with uncomplicated urogenital gonorrhea (GC) were randomized to receive first dose of 3000 milligram (mg) (4\*750 mg, tablets) gepotidacin orally on Day 1. Participants self-administered second dose of 3000 mg (4\*750 mg, tablets) gepotidacin orally 10-12 hours after first dose. All doses were to be administered after food consumption and with water.
|
|---|---|---|
|
Change From Baseline in Hematology Parameter: Hematocrit
Baseline (Day 1)
|
0.4687 Percentage
Standard Deviation 0.04104
|
0.4691 Percentage
Standard Deviation 0.04205
|
|
Change From Baseline in Hematology Parameter: Hematocrit
CFB to TOC
|
0.0012 Percentage
Standard Deviation 0.02666
|
-0.0038 Percentage
Standard Deviation 0.02526
|
SECONDARY outcome
Timeframe: Baseline (Day 1) and TOC visit (Day 4 to 8)Population: Safety population. Only those participants with data available at specified time points have been analyzed.
Blood samples were collected for the assessment of change from baseline in hematology parameter: red blood cell (RBC) count. Baseline (Day 1) was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits.
Outcome measures
| Measure |
Ceftriaxone Plus Azithromycin
n=293 Participants
Participants with uncomplicated urogenital gonorrhea (GC) were randomized to receive single dose of 500 mg Ceftriaxone as intramuscular sterile powder reconstituted with appropriate diluent plus single oral dose of 1 gram (g) Azithromycin (2\*500 mg, tablets) on Day 1. Azithromycin was to be administered after food consumption and with water.
|
Gepotidacin
n=284 Participants
Participants with uncomplicated urogenital gonorrhea (GC) were randomized to receive first dose of 3000 milligram (mg) (4\*750 mg, tablets) gepotidacin orally on Day 1. Participants self-administered second dose of 3000 mg (4\*750 mg, tablets) gepotidacin orally 10-12 hours after first dose. All doses were to be administered after food consumption and with water.
|
|---|---|---|
|
Change From Baseline in Hematology Parameter: Erythrocytes
Baseline (Day 1)
|
4.926 Trillion cells per liter (10^12 cells/L)
Standard Deviation 0.4601
|
4.911 Trillion cells per liter (10^12 cells/L)
Standard Deviation 0.4722
|
|
Change From Baseline in Hematology Parameter: Erythrocytes
CFB to TOC
|
0.019 Trillion cells per liter (10^12 cells/L)
Standard Deviation 0.2332
|
0.003 Trillion cells per liter (10^12 cells/L)
Standard Deviation 0.2261
|
SECONDARY outcome
Timeframe: Baseline (Day 1) and TOC visit (Day 4 to 8)Population: Safety population. Only those participants with data available at specified time points have been analyzed.
Blood samples were collected for the assessment of change from baseline in hematology parameter: mean corpuscular hemoglobin (MCH). Baseline (Day 1) was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits.
Outcome measures
| Measure |
Ceftriaxone Plus Azithromycin
n=293 Participants
Participants with uncomplicated urogenital gonorrhea (GC) were randomized to receive single dose of 500 mg Ceftriaxone as intramuscular sterile powder reconstituted with appropriate diluent plus single oral dose of 1 gram (g) Azithromycin (2\*500 mg, tablets) on Day 1. Azithromycin was to be administered after food consumption and with water.
|
Gepotidacin
n=284 Participants
Participants with uncomplicated urogenital gonorrhea (GC) were randomized to receive first dose of 3000 milligram (mg) (4\*750 mg, tablets) gepotidacin orally on Day 1. Participants self-administered second dose of 3000 mg (4\*750 mg, tablets) gepotidacin orally 10-12 hours after first dose. All doses were to be administered after food consumption and with water.
|
|---|---|---|
|
Change From Baseline in Hematology Parameter: Mean Corpuscular Hemoglobin (MCH)
Baseline (Day 1)
|
30.38 Picograms (pg)
Standard Deviation 1.987
|
30.46 Picograms (pg)
Standard Deviation 1.978
|
|
Change From Baseline in Hematology Parameter: Mean Corpuscular Hemoglobin (MCH)
CFB to TOC
|
0.00 Picograms (pg)
Standard Deviation 0.594
|
-0.03 Picograms (pg)
Standard Deviation 0.451
|
SECONDARY outcome
Timeframe: Baseline (Day 1) and TOC visit (Day 4 to 8)Population: Safety population. Only those participants with data available at specified time points have been analyzed.
Blood samples were collected for the assessment of change from baseline in hematology parameter: mean corpuscular volume (MCV). Baseline (Day 1) was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits.
Outcome measures
| Measure |
Ceftriaxone Plus Azithromycin
n=293 Participants
Participants with uncomplicated urogenital gonorrhea (GC) were randomized to receive single dose of 500 mg Ceftriaxone as intramuscular sterile powder reconstituted with appropriate diluent plus single oral dose of 1 gram (g) Azithromycin (2\*500 mg, tablets) on Day 1. Azithromycin was to be administered after food consumption and with water.
|
Gepotidacin
n=284 Participants
Participants with uncomplicated urogenital gonorrhea (GC) were randomized to receive first dose of 3000 milligram (mg) (4\*750 mg, tablets) gepotidacin orally on Day 1. Participants self-administered second dose of 3000 mg (4\*750 mg, tablets) gepotidacin orally 10-12 hours after first dose. All doses were to be administered after food consumption and with water.
|
|---|---|---|
|
Change From Baseline in Hematology Parameter: Mean Corpuscular Volume (MCV)
Baseline (Day 1)
|
95.43 Femtoliters (fL)
Standard Deviation 6.760
|
95.79 Femtoliters (fL)
Standard Deviation 6.266
|
|
Change From Baseline in Hematology Parameter: Mean Corpuscular Volume (MCV)
CFB to TOC
|
-0.12 Femtoliters (fL)
Standard Deviation 3.084
|
-0.85 Femtoliters (fL)
Standard Deviation 3.104
|
SECONDARY outcome
Timeframe: Baseline (Day 1) and TOC visit (Day 4 to 8)Population: Safety population. Only those participants with data available at specified time points have been analyzed.
Blood samples were collected for the assessment of change from baseline in clinincal chemistry parameters: urea nitrogen (UN), glucose, calcium, chloride, sodium, magnesium and potassium. Baseline (Day 1) was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits.
Outcome measures
| Measure |
Ceftriaxone Plus Azithromycin
n=306 Participants
Participants with uncomplicated urogenital gonorrhea (GC) were randomized to receive single dose of 500 mg Ceftriaxone as intramuscular sterile powder reconstituted with appropriate diluent plus single oral dose of 1 gram (g) Azithromycin (2\*500 mg, tablets) on Day 1. Azithromycin was to be administered after food consumption and with water.
|
Gepotidacin
n=304 Participants
Participants with uncomplicated urogenital gonorrhea (GC) were randomized to receive first dose of 3000 milligram (mg) (4\*750 mg, tablets) gepotidacin orally on Day 1. Participants self-administered second dose of 3000 mg (4\*750 mg, tablets) gepotidacin orally 10-12 hours after first dose. All doses were to be administered after food consumption and with water.
|
|---|---|---|
|
Change From Baseline in Clinical Chemistry Parameters: Urea Nitrogen (UN), Glucose, Calcium, Chloride, Sodium, Magnesium and Potassium
UN, Baseline (Day 1)
|
4.800 Millimoles per liter (mmol/L)
Standard Deviation 1.4669
|
4.793 Millimoles per liter (mmol/L)
Standard Deviation 1.4293
|
|
Change From Baseline in Clinical Chemistry Parameters: Urea Nitrogen (UN), Glucose, Calcium, Chloride, Sodium, Magnesium and Potassium
UN, CFB to TOC
|
0.282 Millimoles per liter (mmol/L)
Standard Deviation 1.1920
|
0.190 Millimoles per liter (mmol/L)
Standard Deviation 1.1640
|
|
Change From Baseline in Clinical Chemistry Parameters: Urea Nitrogen (UN), Glucose, Calcium, Chloride, Sodium, Magnesium and Potassium
Glucose, Baseline
|
5.090 Millimoles per liter (mmol/L)
Standard Deviation 1.1183
|
5.049 Millimoles per liter (mmol/L)
Standard Deviation 1.0557
|
|
Change From Baseline in Clinical Chemistry Parameters: Urea Nitrogen (UN), Glucose, Calcium, Chloride, Sodium, Magnesium and Potassium
Glucose, CFB to TOC
|
0.064 Millimoles per liter (mmol/L)
Standard Deviation 0.9684
|
0.227 Millimoles per liter (mmol/L)
Standard Deviation 0.9425
|
|
Change From Baseline in Clinical Chemistry Parameters: Urea Nitrogen (UN), Glucose, Calcium, Chloride, Sodium, Magnesium and Potassium
Calcium, Baseline (Day 1)
|
2.387 Millimoles per liter (mmol/L)
Standard Deviation 0.0954
|
2.387 Millimoles per liter (mmol/L)
Standard Deviation 0.0986
|
|
Change From Baseline in Clinical Chemistry Parameters: Urea Nitrogen (UN), Glucose, Calcium, Chloride, Sodium, Magnesium and Potassium
Calcium, CFB to TOC
|
-0.015 Millimoles per liter (mmol/L)
Standard Deviation 0.0871
|
-0.009 Millimoles per liter (mmol/L)
Standard Deviation 0.0852
|
|
Change From Baseline in Clinical Chemistry Parameters: Urea Nitrogen (UN), Glucose, Calcium, Chloride, Sodium, Magnesium and Potassium
Chloride, Baseline (Day 1)
|
101.7 Millimoles per liter (mmol/L)
Standard Deviation 2.30
|
101.7 Millimoles per liter (mmol/L)
Standard Deviation 2.26
|
|
Change From Baseline in Clinical Chemistry Parameters: Urea Nitrogen (UN), Glucose, Calcium, Chloride, Sodium, Magnesium and Potassium
Chloride, CFB to TOC
|
0.5 Millimoles per liter (mmol/L)
Standard Deviation 2.40
|
0.7 Millimoles per liter (mmol/L)
Standard Deviation 2.57
|
|
Change From Baseline in Clinical Chemistry Parameters: Urea Nitrogen (UN), Glucose, Calcium, Chloride, Sodium, Magnesium and Potassium
Sodium, Baseline (Day 1)
|
139.6 Millimoles per liter (mmol/L)
Standard Deviation 2.02
|
139.6 Millimoles per liter (mmol/L)
Standard Deviation 2.11
|
|
Change From Baseline in Clinical Chemistry Parameters: Urea Nitrogen (UN), Glucose, Calcium, Chloride, Sodium, Magnesium and Potassium
Sodium, CFB to TOC
|
0.1 Millimoles per liter (mmol/L)
Standard Deviation 2.44
|
0.2 Millimoles per liter (mmol/L)
Standard Deviation 2.19
|
|
Change From Baseline in Clinical Chemistry Parameters: Urea Nitrogen (UN), Glucose, Calcium, Chloride, Sodium, Magnesium and Potassium
Magnesium, Baseline (Day 1)
|
0.855 Millimoles per liter (mmol/L)
Standard Deviation 0.0637
|
0.854 Millimoles per liter (mmol/L)
Standard Deviation 0.0612
|
|
Change From Baseline in Clinical Chemistry Parameters: Urea Nitrogen (UN), Glucose, Calcium, Chloride, Sodium, Magnesium and Potassium
Magnesium, CFB to TOC
|
-0.004 Millimoles per liter (mmol/L)
Standard Deviation 0.0584
|
-0.003 Millimoles per liter (mmol/L)
Standard Deviation 0.0604
|
|
Change From Baseline in Clinical Chemistry Parameters: Urea Nitrogen (UN), Glucose, Calcium, Chloride, Sodium, Magnesium and Potassium
Potassium, Baseline (Day 1)
|
4.30 Millimoles per liter (mmol/L)
Standard Deviation 0.332
|
4.29 Millimoles per liter (mmol/L)
Standard Deviation 0.323
|
|
Change From Baseline in Clinical Chemistry Parameters: Urea Nitrogen (UN), Glucose, Calcium, Chloride, Sodium, Magnesium and Potassium
Potassium, CFB to TOC
|
-0.03 Millimoles per liter (mmol/L)
Standard Deviation 0.345
|
-0.04 Millimoles per liter (mmol/L)
Standard Deviation 0.336
|
SECONDARY outcome
Timeframe: Baseline (Day 1) and TOC visit (Day 4 to 8)Population: Safety population. Only those participants with data available at specified time points have been analyzed.
Blood samples were collected for the assessment of change from baseline in clinical chemistry parameters: bilirubin, direct bilirubin and creatinine levels. Baseline (Day 1) was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits.
Outcome measures
| Measure |
Ceftriaxone Plus Azithromycin
n=305 Participants
Participants with uncomplicated urogenital gonorrhea (GC) were randomized to receive single dose of 500 mg Ceftriaxone as intramuscular sterile powder reconstituted with appropriate diluent plus single oral dose of 1 gram (g) Azithromycin (2\*500 mg, tablets) on Day 1. Azithromycin was to be administered after food consumption and with water.
|
Gepotidacin
n=303 Participants
Participants with uncomplicated urogenital gonorrhea (GC) were randomized to receive first dose of 3000 milligram (mg) (4\*750 mg, tablets) gepotidacin orally on Day 1. Participants self-administered second dose of 3000 mg (4\*750 mg, tablets) gepotidacin orally 10-12 hours after first dose. All doses were to be administered after food consumption and with water.
|
|---|---|---|
|
Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Direct Bilirubin and Creatinine
Bilirubin, Baseline (Day 1)
|
7.71 Micromoles per liter (umol/L)
Standard Deviation 4.806
|
8.54 Micromoles per liter (umol/L)
Standard Deviation 5.861
|
|
Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Direct Bilirubin and Creatinine
Bilirubin, CFB to TOC
|
-0.14 Micromoles per liter (umol/L)
Standard Deviation 3.914
|
-0.05 Micromoles per liter (umol/L)
Standard Deviation 5.025
|
|
Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Direct Bilirubin and Creatinine
Direct Bilirubin, Baseline (Day 1)
|
3.76 Micromoles per liter (umol/L)
Standard Deviation 1.210
|
3.83 Micromoles per liter (umol/L)
Standard Deviation 1.248
|
|
Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Direct Bilirubin and Creatinine
Direct Bilirubin, CFB to TOC
|
0.01 Micromoles per liter (umol/L)
Standard Deviation 0.876
|
-0.02 Micromoles per liter (umol/L)
Standard Deviation 0.897
|
|
Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Direct Bilirubin and Creatinine
Creatinine, Baseline (Day 1)
|
75.0 Micromoles per liter (umol/L)
Standard Deviation 20.63
|
75.9 Micromoles per liter (umol/L)
Standard Deviation 34.12
|
|
Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Direct Bilirubin and Creatinine
Creatinine, CFB to TOC
|
2.6 Micromoles per liter (umol/L)
Standard Deviation 9.52
|
-0.2 Micromoles per liter (umol/L)
Standard Deviation 34.08
|
SECONDARY outcome
Timeframe: Baseline (Day 1) and TOC visit (Day 4 to 8)Population: Safety population. Only those participants with data available at specified time points have been analyzed.
Blood samples were collected for the assessment of change from baseline in clinical chemistry parameters: albumin and protein. Baseline (Day 1) was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits.
Outcome measures
| Measure |
Ceftriaxone Plus Azithromycin
n=306 Participants
Participants with uncomplicated urogenital gonorrhea (GC) were randomized to receive single dose of 500 mg Ceftriaxone as intramuscular sterile powder reconstituted with appropriate diluent plus single oral dose of 1 gram (g) Azithromycin (2\*500 mg, tablets) on Day 1. Azithromycin was to be administered after food consumption and with water.
|
Gepotidacin
n=305 Participants
Participants with uncomplicated urogenital gonorrhea (GC) were randomized to receive first dose of 3000 milligram (mg) (4\*750 mg, tablets) gepotidacin orally on Day 1. Participants self-administered second dose of 3000 mg (4\*750 mg, tablets) gepotidacin orally 10-12 hours after first dose. All doses were to be administered after food consumption and with water.
|
|---|---|---|
|
Change From Baseline in Clinical Chemistry Parameters: Albumin and Protein
Albumin, CFB to TOC
|
-0.3 Grams per liter (g/L)
Standard Deviation 2.67
|
-0.3 Grams per liter (g/L)
Standard Deviation 2.35
|
|
Change From Baseline in Clinical Chemistry Parameters: Albumin and Protein
Albumin, Baseline (Day 1)
|
46.8 Grams per liter (g/L)
Standard Deviation 3.19
|
46.9 Grams per liter (g/L)
Standard Deviation 3.12
|
|
Change From Baseline in Clinical Chemistry Parameters: Albumin and Protein
Protein, Baseline (Day 1)
|
73.3 Grams per liter (g/L)
Standard Deviation 4.85
|
73.1 Grams per liter (g/L)
Standard Deviation 4.80
|
|
Change From Baseline in Clinical Chemistry Parameters: Albumin and Protein
Protein, CFB to TOC
|
-0.5 Grams per liter (g/L)
Standard Deviation 4.02
|
-0.5 Grams per liter (g/L)
Standard Deviation 3.86
|
SECONDARY outcome
Timeframe: Baseline (Day 1) and TOC visit (Day 4 to 8)Population: Safety population. Only those participants with data available at specified time points have been analyzed.
Blood samples were collected for the assessment of change from baseline in clinincal chemistry parameters: aspartate aminotransferase (AST), alanine aminotransferase (ALT) and alkaline phosphatase (ALP). Baseline (Day 1) was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits.
Outcome measures
| Measure |
Ceftriaxone Plus Azithromycin
n=305 Participants
Participants with uncomplicated urogenital gonorrhea (GC) were randomized to receive single dose of 500 mg Ceftriaxone as intramuscular sterile powder reconstituted with appropriate diluent plus single oral dose of 1 gram (g) Azithromycin (2\*500 mg, tablets) on Day 1. Azithromycin was to be administered after food consumption and with water.
|
Gepotidacin
n=303 Participants
Participants with uncomplicated urogenital gonorrhea (GC) were randomized to receive first dose of 3000 milligram (mg) (4\*750 mg, tablets) gepotidacin orally on Day 1. Participants self-administered second dose of 3000 mg (4\*750 mg, tablets) gepotidacin orally 10-12 hours after first dose. All doses were to be administered after food consumption and with water.
|
|---|---|---|
|
Change From Baseline in Clinical Chemistry Parameters: Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT) and Alkaline Phosphatase (ALP)
ALT, CFB to TOC
|
1.1 International units per Liter (IU/L)
Standard Deviation 7.64
|
1.4 International units per Liter (IU/L)
Standard Deviation 12.59
|
|
Change From Baseline in Clinical Chemistry Parameters: Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT) and Alkaline Phosphatase (ALP)
AST, Baseline (Day 1)
|
24.2 International units per Liter (IU/L)
Standard Deviation 16.29
|
24.4 International units per Liter (IU/L)
Standard Deviation 15.30
|
|
Change From Baseline in Clinical Chemistry Parameters: Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT) and Alkaline Phosphatase (ALP)
AST, CFB to TOC
|
0.9 International units per Liter (IU/L)
Standard Deviation 13.25
|
2.8 International units per Liter (IU/L)
Standard Deviation 19.51
|
|
Change From Baseline in Clinical Chemistry Parameters: Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT) and Alkaline Phosphatase (ALP)
ALT, Baseline (Day 1)
|
23.7 International units per Liter (IU/L)
Standard Deviation 14.35
|
23.7 International units per Liter (IU/L)
Standard Deviation 18.78
|
|
Change From Baseline in Clinical Chemistry Parameters: Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT) and Alkaline Phosphatase (ALP)
ALP, Baseline (Day 1)
|
77.1 International units per Liter (IU/L)
Standard Deviation 26.53
|
76.0 International units per Liter (IU/L)
Standard Deviation 20.86
|
|
Change From Baseline in Clinical Chemistry Parameters: Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT) and Alkaline Phosphatase (ALP)
ALP, CFB to TOC
|
-1.5 International units per Liter (IU/L)
Standard Deviation 7.80
|
-0.4 International units per Liter (IU/L)
Standard Deviation 7.73
|
SECONDARY outcome
Timeframe: Baseline (Day 1) and TOC visit (Day 4 to 8)Population: Safety population. Only those participants with data available at specified time points have been analyzed.
Urine samples were collected for urinalysis: Glucose, Protein, Occult Blood and Ketones. The dipstick test gives results in a semi-quantitative manner, and results can be read as Negative, Small, Moderate, Large, Positive, 5 milligram per deciliter (mg/dL), 20 mg/dL, 30 mg/dL 50 mg/dL, 100 mg/dL, 150 mg/dL and \>=500 mg/dL indicating concentrations in the urine sample. In the row title (Glucose, Baseline, Negative), Glucose indicates parameter, Baseline is the visit and Negative indicates the concentration in the urine sample. Baseline (Day 1) was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits.
Outcome measures
| Measure |
Ceftriaxone Plus Azithromycin
n=307 Participants
Participants with uncomplicated urogenital gonorrhea (GC) were randomized to receive single dose of 500 mg Ceftriaxone as intramuscular sterile powder reconstituted with appropriate diluent plus single oral dose of 1 gram (g) Azithromycin (2\*500 mg, tablets) on Day 1. Azithromycin was to be administered after food consumption and with water.
|
Gepotidacin
n=299 Participants
Participants with uncomplicated urogenital gonorrhea (GC) were randomized to receive first dose of 3000 milligram (mg) (4\*750 mg, tablets) gepotidacin orally on Day 1. Participants self-administered second dose of 3000 mg (4\*750 mg, tablets) gepotidacin orally 10-12 hours after first dose. All doses were to be administered after food consumption and with water.
|
|---|---|---|
|
Number of Participants With Urinalysis Dipstick Results
Glucose, Baseline (Day 1), Negative
|
305 Participants
|
296 Participants
|
|
Number of Participants With Urinalysis Dipstick Results
Glucose, Baseline (Day 1), 150 mg/dL
|
0 Participants
|
0 Participants
|
|
Number of Participants With Urinalysis Dipstick Results
Glucose, Baseline (Day 1), >=500 mg/dL
|
2 Participants
|
3 Participants
|
|
Number of Participants With Urinalysis Dipstick Results
Glucose, TOC, Negative
|
283 Participants
|
284 Participants
|
|
Number of Participants With Urinalysis Dipstick Results
Glucose, TOC, 150 mg/dL
|
1 Participants
|
1 Participants
|
|
Number of Participants With Urinalysis Dipstick Results
Glucose, TOC, >=500 mg/dL
|
1 Participants
|
2 Participants
|
|
Number of Participants With Urinalysis Dipstick Results
Ketones, Baseline (Day 1), Negative
|
300 Participants
|
288 Participants
|
|
Number of Participants With Urinalysis Dipstick Results
Ketones, Baseline (Day 1), 5 mg/dL
|
7 Participants
|
10 Participants
|
|
Number of Participants With Urinalysis Dipstick Results
Ketones, Baseline (Day 1), 20 mg/dL
|
0 Participants
|
1 Participants
|
|
Number of Participants With Urinalysis Dipstick Results
Ketones, TOC, Negative
|
279 Participants
|
279 Participants
|
|
Number of Participants With Urinalysis Dipstick Results
Ketones, TOC, 5 mg/dL
|
6 Participants
|
7 Participants
|
|
Number of Participants With Urinalysis Dipstick Results
Ketones, TOC, 20 mg/dL
|
0 Participants
|
1 Participants
|
|
Number of Participants With Urinalysis Dipstick Results
Occult Blood, Baseline (Day 1), Negative
|
192 Participants
|
202 Participants
|
|
Number of Participants With Urinalysis Dipstick Results
Occult Blood, Baseline (Day 1), Small
|
91 Participants
|
77 Participants
|
|
Number of Participants With Urinalysis Dipstick Results
Occult Blood, Baseline (Day 1), Moderate
|
19 Participants
|
18 Participants
|
|
Number of Participants With Urinalysis Dipstick Results
Occult Blood, Baseline (Day 1), Large
|
5 Participants
|
2 Participants
|
|
Number of Participants With Urinalysis Dipstick Results
Occult Blood, TOC, Negative
|
252 Participants
|
251 Participants
|
|
Number of Participants With Urinalysis Dipstick Results
Occult Blood, TOC, Small
|
24 Participants
|
30 Participants
|
|
Number of Participants With Urinalysis Dipstick Results
Occult Blood, TOC, Moderate
|
6 Participants
|
3 Participants
|
|
Number of Participants With Urinalysis Dipstick Results
Occult Blood, TOC, Large
|
3 Participants
|
3 Participants
|
|
Number of Participants With Urinalysis Dipstick Results
Protein, Baseline (Day 1), Negative
|
210 Participants
|
212 Participants
|
|
Number of Participants With Urinalysis Dipstick Results
Protein, Baseline (Day 1), 30 mg/dL
|
83 Participants
|
79 Participants
|
|
Number of Participants With Urinalysis Dipstick Results
Protein, Baseline (Day 1), 100 mg/dL
|
13 Participants
|
8 Participants
|
|
Number of Participants With Urinalysis Dipstick Results
Protein, Baseline (Day 1), >=500 mg/dL
|
1 Participants
|
0 Participants
|
|
Number of Participants With Urinalysis Dipstick Results
Protein, TOC, Negative
|
244 Participants
|
239 Participants
|
|
Number of Participants With Urinalysis Dipstick Results
Protein, TOC, 30 mg/dL
|
37 Participants
|
46 Participants
|
|
Number of Participants With Urinalysis Dipstick Results
Protein, TOC, 100 mg/dL
|
4 Participants
|
2 Participants
|
|
Number of Participants With Urinalysis Dipstick Results
Protein, TOC, >=500 mg/dL
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Baseline (Day 1) and TOC visit (Day 4 to 8)Population: Safety population. Only those participants with data available at specified time points have been analyzed.
Urine samples were collected from participants to assess urine specific gravity. Baseline (Day 1) was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits.
Outcome measures
| Measure |
Ceftriaxone Plus Azithromycin
n=307 Participants
Participants with uncomplicated urogenital gonorrhea (GC) were randomized to receive single dose of 500 mg Ceftriaxone as intramuscular sterile powder reconstituted with appropriate diluent plus single oral dose of 1 gram (g) Azithromycin (2\*500 mg, tablets) on Day 1. Azithromycin was to be administered after food consumption and with water.
|
Gepotidacin
n=299 Participants
Participants with uncomplicated urogenital gonorrhea (GC) were randomized to receive first dose of 3000 milligram (mg) (4\*750 mg, tablets) gepotidacin orally on Day 1. Participants self-administered second dose of 3000 mg (4\*750 mg, tablets) gepotidacin orally 10-12 hours after first dose. All doses were to be administered after food consumption and with water.
|
|---|---|---|
|
Absolute Values in Specific Gravity of Urine
Baseline (Day 1)
|
1.0207 Ratio
Standard Deviation 0.00747
|
1.0211 Ratio
Standard Deviation 0.00750
|
|
Absolute Values in Specific Gravity of Urine
TOC
|
1.0216 Ratio
Standard Deviation 0.00748
|
1.0211 Ratio
Standard Deviation 0.00720
|
SECONDARY outcome
Timeframe: Baseline (Day 1) and TOC visit (Day 4 to 8)Population: Safety population. Only those participants with data available at specified time points have been analyzed.
Urine samples were collected from participants to assess urine pH. Baseline (Day 1) was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits.
Outcome measures
| Measure |
Ceftriaxone Plus Azithromycin
n=307 Participants
Participants with uncomplicated urogenital gonorrhea (GC) were randomized to receive single dose of 500 mg Ceftriaxone as intramuscular sterile powder reconstituted with appropriate diluent plus single oral dose of 1 gram (g) Azithromycin (2\*500 mg, tablets) on Day 1. Azithromycin was to be administered after food consumption and with water.
|
Gepotidacin
n=299 Participants
Participants with uncomplicated urogenital gonorrhea (GC) were randomized to receive first dose of 3000 milligram (mg) (4\*750 mg, tablets) gepotidacin orally on Day 1. Participants self-administered second dose of 3000 mg (4\*750 mg, tablets) gepotidacin orally 10-12 hours after first dose. All doses were to be administered after food consumption and with water.
|
|---|---|---|
|
Absolute Values in Potential of Hydrogen (pH) of Urine
Baseline (Day 1)
|
5.6 pH
Standard Deviation 0.70
|
5.6 pH
Standard Deviation 0.69
|
|
Absolute Values in Potential of Hydrogen (pH) of Urine
TOC
|
5.4 pH
Standard Deviation 0.62
|
5.5 pH
Standard Deviation 0.64
|
SECONDARY outcome
Timeframe: Baseline (Day 1) and TOC visit (Day 4 to 8)Population: Safety population. Only those participants with data available at specified time points have been analyzed.
SBP and DBP were measured in a semi-supine position after 5 minutes rest. Baseline (Day 1) is the latest pre-dose assessment with a non-missing value, including those from unscheduled visits.
Outcome measures
| Measure |
Ceftriaxone Plus Azithromycin
n=313 Participants
Participants with uncomplicated urogenital gonorrhea (GC) were randomized to receive single dose of 500 mg Ceftriaxone as intramuscular sterile powder reconstituted with appropriate diluent plus single oral dose of 1 gram (g) Azithromycin (2\*500 mg, tablets) on Day 1. Azithromycin was to be administered after food consumption and with water.
|
Gepotidacin
n=307 Participants
Participants with uncomplicated urogenital gonorrhea (GC) were randomized to receive first dose of 3000 milligram (mg) (4\*750 mg, tablets) gepotidacin orally on Day 1. Participants self-administered second dose of 3000 mg (4\*750 mg, tablets) gepotidacin orally 10-12 hours after first dose. All doses were to be administered after food consumption and with water.
|
|---|---|---|
|
Change From Baseline in Vital Signs: Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)
SBP, Baseline (Day 1)
|
125.1 Millimeters of mercury (mmHg)
Standard Deviation 14.41
|
123.9 Millimeters of mercury (mmHg)
Standard Deviation 13.69
|
|
Change From Baseline in Vital Signs: Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)
SBP, CFB to TOC
|
-0.5 Millimeters of mercury (mmHg)
Standard Deviation 12.86
|
-0.4 Millimeters of mercury (mmHg)
Standard Deviation 12.61
|
|
Change From Baseline in Vital Signs: Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)
DBP, Baseline (Day 1)
|
77.2 Millimeters of mercury (mmHg)
Standard Deviation 10.50
|
76.7 Millimeters of mercury (mmHg)
Standard Deviation 10.77
|
|
Change From Baseline in Vital Signs: Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)
DBP, CFB to TOC
|
-0.9 Millimeters of mercury (mmHg)
Standard Deviation 9.54
|
0.1 Millimeters of mercury (mmHg)
Standard Deviation 9.10
|
SECONDARY outcome
Timeframe: Baseline (Day 1) and TOC visit (Day 4 to 8)Population: Safety population. Only those participants with data available at specified time points have been analyzed.
Pulse rate was measured in a semi-supine position after 5 minutes rest. Baseline (Day 1) is the latest pre-dose assessment with a non-missing value, including those from unscheduled visits.
Outcome measures
| Measure |
Ceftriaxone Plus Azithromycin
n=313 Participants
Participants with uncomplicated urogenital gonorrhea (GC) were randomized to receive single dose of 500 mg Ceftriaxone as intramuscular sterile powder reconstituted with appropriate diluent plus single oral dose of 1 gram (g) Azithromycin (2\*500 mg, tablets) on Day 1. Azithromycin was to be administered after food consumption and with water.
|
Gepotidacin
n=308 Participants
Participants with uncomplicated urogenital gonorrhea (GC) were randomized to receive first dose of 3000 milligram (mg) (4\*750 mg, tablets) gepotidacin orally on Day 1. Participants self-administered second dose of 3000 mg (4\*750 mg, tablets) gepotidacin orally 10-12 hours after first dose. All doses were to be administered after food consumption and with water.
|
|---|---|---|
|
Change From Baseline in Vital Sign: Pulse Rate
CFB to TOC
|
2.4 Beats per minute
Standard Deviation 12.33
|
2.2 Beats per minute
Standard Deviation 12.44
|
|
Change From Baseline in Vital Sign: Pulse Rate
Baseline (Day 1)
|
72.8 Beats per minute
Standard Deviation 12.20
|
73.0 Beats per minute
Standard Deviation 12.24
|
SECONDARY outcome
Timeframe: Baseline (Day 1) and TOC visit (Day 4 to 8)Population: Safety population. Only those participants with data available at specified time points have been analyzed.
Temperature was measured after 5 minutes rest. Baseline (Day 1) is the latest pre-dose assessment with a non-missing value, including those from unscheduled visits.
Outcome measures
| Measure |
Ceftriaxone Plus Azithromycin
n=313 Participants
Participants with uncomplicated urogenital gonorrhea (GC) were randomized to receive single dose of 500 mg Ceftriaxone as intramuscular sterile powder reconstituted with appropriate diluent plus single oral dose of 1 gram (g) Azithromycin (2\*500 mg, tablets) on Day 1. Azithromycin was to be administered after food consumption and with water.
|
Gepotidacin
n=306 Participants
Participants with uncomplicated urogenital gonorrhea (GC) were randomized to receive first dose of 3000 milligram (mg) (4\*750 mg, tablets) gepotidacin orally on Day 1. Participants self-administered second dose of 3000 mg (4\*750 mg, tablets) gepotidacin orally 10-12 hours after first dose. All doses were to be administered after food consumption and with water.
|
|---|---|---|
|
Change From Baseline in Vital Sign: Temperature
Baseline (Day 1)
|
36.44 Celsius (C)
Standard Deviation 0.457
|
36.45 Celsius (C)
Standard Deviation 0.395
|
|
Change From Baseline in Vital Sign: Temperature
CFB to TOC
|
-0.06 Celsius (C)
Standard Deviation 0.485
|
-0.03 Celsius (C)
Standard Deviation 0.381
|
Adverse Events
Gepotidacin
Serious events: 1 serious events
Other events: 230 other events
Deaths: 0 deaths
Ceftriaxone Plus Azithromycin
Serious events: 0 serious events
Other events: 81 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Gepotidacin
n=309 participants at risk
Participants with uncomplicated urogenital gonorrhea (GC) were randomized to receive first dose of 3000 milligram (mg) (4\*750 mg, tablets) gepotidacin orally on Day 1. Participants self-administered second dose of 3000 mg (4\*750 mg, tablets) gepotidacin orally 10-12 hours after first dose. All doses were to be administered after food consumption and with water.
|
Ceftriaxone Plus Azithromycin
n=313 participants at risk
Participants with uncomplicated urogenital gonorrhea (GC) were randomized to receive single dose of 500 mg Ceftriaxone as intramuscular sterile powder reconstituted with appropriate diluent plus single oral dose of 1 gram (g) Azithromycin (2\*500 mg, tablets) on Day 1. Azithromycin was to be administered after food consumption and with water.
|
|---|---|---|
|
Injury, poisoning and procedural complications
Lower limb fracture
|
0.32%
1/309 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 through the final follow-up visit (up to 21Days).
Safety population included all participants who received at least 1 dose of study treatment.
|
0.00%
0/313 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 through the final follow-up visit (up to 21Days).
Safety population included all participants who received at least 1 dose of study treatment.
|
Other adverse events
| Measure |
Gepotidacin
n=309 participants at risk
Participants with uncomplicated urogenital gonorrhea (GC) were randomized to receive first dose of 3000 milligram (mg) (4\*750 mg, tablets) gepotidacin orally on Day 1. Participants self-administered second dose of 3000 mg (4\*750 mg, tablets) gepotidacin orally 10-12 hours after first dose. All doses were to be administered after food consumption and with water.
|
Ceftriaxone Plus Azithromycin
n=313 participants at risk
Participants with uncomplicated urogenital gonorrhea (GC) were randomized to receive single dose of 500 mg Ceftriaxone as intramuscular sterile powder reconstituted with appropriate diluent plus single oral dose of 1 gram (g) Azithromycin (2\*500 mg, tablets) on Day 1. Azithromycin was to be administered after food consumption and with water.
|
|---|---|---|
|
Gastrointestinal disorders
Diarrhoea
|
48.9%
151/309 • Number of events 167 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 through the final follow-up visit (up to 21Days).
Safety population included all participants who received at least 1 dose of study treatment.
|
9.6%
30/313 • Number of events 30 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 through the final follow-up visit (up to 21Days).
Safety population included all participants who received at least 1 dose of study treatment.
|
|
Gastrointestinal disorders
Nausea
|
23.6%
73/309 • Number of events 80 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 through the final follow-up visit (up to 21Days).
Safety population included all participants who received at least 1 dose of study treatment.
|
2.9%
9/313 • Number of events 9 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 through the final follow-up visit (up to 21Days).
Safety population included all participants who received at least 1 dose of study treatment.
|
|
Gastrointestinal disorders
Vomiting
|
6.5%
20/309 • Number of events 21 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 through the final follow-up visit (up to 21Days).
Safety population included all participants who received at least 1 dose of study treatment.
|
0.64%
2/313 • Number of events 2 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 through the final follow-up visit (up to 21Days).
Safety population included all participants who received at least 1 dose of study treatment.
|
|
Gastrointestinal disorders
Flatulence
|
6.5%
20/309 • Number of events 20 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 through the final follow-up visit (up to 21Days).
Safety population included all participants who received at least 1 dose of study treatment.
|
0.32%
1/313 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 through the final follow-up visit (up to 21Days).
Safety population included all participants who received at least 1 dose of study treatment.
|
|
Gastrointestinal disorders
Abdominal Pain
|
5.2%
16/309 • Number of events 17 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 through the final follow-up visit (up to 21Days).
Safety population included all participants who received at least 1 dose of study treatment.
|
0.96%
3/313 • Number of events 4 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 through the final follow-up visit (up to 21Days).
Safety population included all participants who received at least 1 dose of study treatment.
|
|
Gastrointestinal disorders
Faeces soft
|
5.2%
16/309 • Number of events 16 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 through the final follow-up visit (up to 21Days).
Safety population included all participants who received at least 1 dose of study treatment.
|
0.32%
1/313 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 through the final follow-up visit (up to 21Days).
Safety population included all participants who received at least 1 dose of study treatment.
|
|
Gastrointestinal disorders
Abdominal distension
|
1.6%
5/309 • Number of events 5 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 through the final follow-up visit (up to 21Days).
Safety population included all participants who received at least 1 dose of study treatment.
|
0.64%
2/313 • Number of events 2 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 through the final follow-up visit (up to 21Days).
Safety population included all participants who received at least 1 dose of study treatment.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
1.9%
6/309 • Number of events 6 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 through the final follow-up visit (up to 21Days).
Safety population included all participants who received at least 1 dose of study treatment.
|
0.32%
1/313 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 through the final follow-up visit (up to 21Days).
Safety population included all participants who received at least 1 dose of study treatment.
|
|
Gastrointestinal disorders
Abdominal discomfort
|
1.3%
4/309 • Number of events 4 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 through the final follow-up visit (up to 21Days).
Safety population included all participants who received at least 1 dose of study treatment.
|
0.64%
2/313 • Number of events 2 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 through the final follow-up visit (up to 21Days).
Safety population included all participants who received at least 1 dose of study treatment.
|
|
Infections and infestations
Chlamydial infection
|
3.9%
12/309 • Number of events 12 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 through the final follow-up visit (up to 21Days).
Safety population included all participants who received at least 1 dose of study treatment.
|
3.2%
10/313 • Number of events 10 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 through the final follow-up visit (up to 21Days).
Safety population included all participants who received at least 1 dose of study treatment.
|
|
Infections and infestations
Urethritis chlamydial
|
1.9%
6/309 • Number of events 6 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 through the final follow-up visit (up to 21Days).
Safety population included all participants who received at least 1 dose of study treatment.
|
0.00%
0/313 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 through the final follow-up visit (up to 21Days).
Safety population included all participants who received at least 1 dose of study treatment.
|
|
Infections and infestations
Proctitis chlamydial
|
1.3%
4/309 • Number of events 4 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 through the final follow-up visit (up to 21Days).
Safety population included all participants who received at least 1 dose of study treatment.
|
0.32%
1/313 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 through the final follow-up visit (up to 21Days).
Safety population included all participants who received at least 1 dose of study treatment.
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/309 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 through the final follow-up visit (up to 21Days).
Safety population included all participants who received at least 1 dose of study treatment.
|
1.3%
4/313 • Number of events 4 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 through the final follow-up visit (up to 21Days).
Safety population included all participants who received at least 1 dose of study treatment.
|
|
Nervous system disorders
Dizziness
|
5.2%
16/309 • Number of events 19 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 through the final follow-up visit (up to 21Days).
Safety population included all participants who received at least 1 dose of study treatment.
|
0.64%
2/313 • Number of events 2 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 through the final follow-up visit (up to 21Days).
Safety population included all participants who received at least 1 dose of study treatment.
|
|
Nervous system disorders
Headache
|
3.2%
10/309 • Number of events 10 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 through the final follow-up visit (up to 21Days).
Safety population included all participants who received at least 1 dose of study treatment.
|
2.6%
8/313 • Number of events 8 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 through the final follow-up visit (up to 21Days).
Safety population included all participants who received at least 1 dose of study treatment.
|
|
General disorders
Fatigue
|
2.6%
8/309 • Number of events 9 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 through the final follow-up visit (up to 21Days).
Safety population included all participants who received at least 1 dose of study treatment.
|
0.00%
0/313 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 through the final follow-up visit (up to 21Days).
Safety population included all participants who received at least 1 dose of study treatment.
|
|
General disorders
Injection site pain
|
0.00%
0/309 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 through the final follow-up visit (up to 21Days).
Safety population included all participants who received at least 1 dose of study treatment.
|
1.6%
5/313 • Number of events 5 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 through the final follow-up visit (up to 21Days).
Safety population included all participants who received at least 1 dose of study treatment.
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
2.3%
7/309 • Number of events 8 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 through the final follow-up visit (up to 21Days).
Safety population included all participants who received at least 1 dose of study treatment.
|
0.00%
0/313 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 through the final follow-up visit (up to 21Days).
Safety population included all participants who received at least 1 dose of study treatment.
|
|
Eye disorders
Vision blurred
|
1.9%
6/309 • Number of events 6 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 through the final follow-up visit (up to 21Days).
Safety population included all participants who received at least 1 dose of study treatment.
|
0.00%
0/313 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 through the final follow-up visit (up to 21Days).
Safety population included all participants who received at least 1 dose of study treatment.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single site data not precede the primary publication of the entire clinical trial.
- Publication restrictions are in place
Restriction type: OTHER