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Trial Outcomes & Findings for Study to Evaluate the Efficacy and Safety of Intravenous Infusion With Nemonoxacin Malate Sodium Chloride (NCT NCT01944774)

NCT ID: NCT01944774

Last Updated: 2025-07-01

Results Overview

The primary efficacy endpoint of this study was to evaluate whether the clinical cure rate of Nemonoxacin malate sodium chloride is non-inferior to that of Moxifloxacin at visit 4 in the mITT population. At visit 4, the Investigator would assess changes in the symptoms/signs/laboratory tests and chest X-rays/or CT scans associated with this infection, and determined the clinical efficacy in the subjects. The clinical efficacy of the study group and the control group was calculated according to the proportion and percentage of overall clinically cured and clinically ineffective patients in the treatment groups. If the lower limit of the 90% confidence interval for the difference in the clinical cure rate between the study drug and the control drug was larger than -15%, it would be established that the efficacy of Nemonoxacin malate sodium chloride injection was not inferior to that of Moxifloxacin Hydrochloride Sodium Chloride Injection in the treatment of moderate to severe adult CAP.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

207 participants

Primary outcome timeframe

Visit 1 (baseline, day -1~1) to Visit 4 (7-14 days after stopping the drug)

Results posted on

2025-07-01

Participant Flow

This study was conducted in 41 research centers in China and Taiwan. Among these, 11 research centers did not enroll participants. 207 subjects were randomly enrolled in the 30 research centers.

Participant milestones

Participant milestones
Measure
Nemonoxacin 500 mg
Nemonoxacin 500mg/250mL. Nemonoxacin 500 mg: IV Infusion, once daily for 7\~14 days
Nemonoxacin 650 mg
Nemonoxacin 650 mg/325mL Nemonoxacin 650 mg: IV Infusion, once daily for 7\~14 days
Moxifloxacin 400 mg
Moxifloxacin 400mg/250mL Moxifloxacin 400 mg: IV Infusion, once daily for 7\~14 days
Overall Study
STARTED
69
68
70
Overall Study
Received Treatment
68
67
70
Overall Study
COMPLETED
63
60
62
Overall Study
NOT COMPLETED
6
8
8

Reasons for withdrawal

Reasons for withdrawal
Measure
Nemonoxacin 500 mg
Nemonoxacin 500mg/250mL. Nemonoxacin 500 mg: IV Infusion, once daily for 7\~14 days
Nemonoxacin 650 mg
Nemonoxacin 650 mg/325mL Nemonoxacin 650 mg: IV Infusion, once daily for 7\~14 days
Moxifloxacin 400 mg
Moxifloxacin 400mg/250mL Moxifloxacin 400 mg: IV Infusion, once daily for 7\~14 days
Overall Study
Withdrawal by Subject
2
3
3
Overall Study
Adverse Event
3
2
3
Overall Study
Lack of Efficacy
1
2
2
Overall Study
Lost to Follow-up
0
1
0

Baseline Characteristics

Study to Evaluate the Efficacy and Safety of Intravenous Infusion With Nemonoxacin Malate Sodium Chloride

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Nemonoxacin 500 mg
n=67 Participants
Nemonoxacin 500mg/250mL. Nemonoxacin 500 mg: IV Infusion, once daily for 7\~14 days
Nemonoxacin 650 mg
n=64 Participants
Nemonoxacin 650 mg/325mL Nemonoxacin 650 mg: IV Infusion, once daily for 7\~14 days
Moxifloxacin 400 mg
n=64 Participants
Moxifloxacin 400mg/250mL Moxifloxacin 400 mg: IV Infusion, once daily for 7\~14 days
Total
n=195 Participants
Total of all reporting groups
Age, Continuous
52.7 years
STANDARD_DEVIATION 15.33 • n=99 Participants
53.5 years
STANDARD_DEVIATION 14.21 • n=107 Participants
51.5 years
STANDARD_DEVIATION 16.00 • n=206 Participants
52.6 years
STANDARD_DEVIATION 15.14 • n=7 Participants
Age, Customized
≧18 and <30 years
6 participants
n=99 Participants
4 participants
n=107 Participants
10 participants
n=206 Participants
20 participants
n=7 Participants
Age, Customized
≧30 and < 40 years
9 participants
n=99 Participants
8 participants
n=107 Participants
9 participants
n=206 Participants
26 participants
n=7 Participants
Age, Customized
≧40 and < 50 years
10 participants
n=99 Participants
12 participants
n=107 Participants
8 participants
n=206 Participants
30 participants
n=7 Participants
Age, Customized
≧50 and < 60 years
16 participants
n=99 Participants
15 participants
n=107 Participants
11 participants
n=206 Participants
42 participants
n=7 Participants
Age, Customized
≧60 and < 70 years
16 participants
n=99 Participants
17 participants
n=107 Participants
17 participants
n=206 Participants
50 participants
n=7 Participants
Age, Customized
≧70 and < 76 years
10 participants
n=99 Participants
8 participants
n=107 Participants
9 participants
n=206 Participants
27 participants
n=7 Participants
Sex: Female, Male
Female
25 Participants
n=99 Participants
23 Participants
n=107 Participants
23 Participants
n=206 Participants
71 Participants
n=7 Participants
Sex: Female, Male
Male
42 Participants
n=99 Participants
41 Participants
n=107 Participants
41 Participants
n=206 Participants
124 Participants
n=7 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants
n=99 Participants
0 Participants
n=107 Participants
0 Participants
n=206 Participants
0 Participants
n=7 Participants
Race (NIH/OMB)
Asian
67 Participants
n=99 Participants
64 Participants
n=107 Participants
64 Participants
n=206 Participants
195 Participants
n=7 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants
n=99 Participants
0 Participants
n=107 Participants
0 Participants
n=206 Participants
0 Participants
n=7 Participants
Race (NIH/OMB)
Black or African American
0 Participants
n=99 Participants
0 Participants
n=107 Participants
0 Participants
n=206 Participants
0 Participants
n=7 Participants
Race (NIH/OMB)
White
0 Participants
n=99 Participants
0 Participants
n=107 Participants
0 Participants
n=206 Participants
0 Participants
n=7 Participants
Race (NIH/OMB)
More than one race
0 Participants
n=99 Participants
0 Participants
n=107 Participants
0 Participants
n=206 Participants
0 Participants
n=7 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants
n=99 Participants
0 Participants
n=107 Participants
0 Participants
n=206 Participants
0 Participants
n=7 Participants
Nationality
Han
62 participants
n=99 Participants
61 participants
n=107 Participants
61 participants
n=206 Participants
184 participants
n=7 Participants
Nationality
Minority ethnic groups
3 participants
n=99 Participants
2 participants
n=107 Participants
1 participants
n=206 Participants
6 participants
n=7 Participants
Nationality
Taiwan Aborigines
0 participants
n=99 Participants
0 participants
n=107 Participants
1 participants
n=206 Participants
1 participants
n=7 Participants
Nationality
Unknown
2 participants
n=99 Participants
1 participants
n=107 Participants
1 participants
n=206 Participants
4 participants
n=7 Participants
Height
163.5 cm
STANDARD_DEVIATION 7.08 • n=99 Participants
164.2 cm
STANDARD_DEVIATION 8.65 • n=107 Participants
164.7 cm
STANDARD_DEVIATION 8.68 • n=206 Participants
164.1 cm
STANDARD_DEVIATION 8.13 • n=7 Participants
Weight
60.0 kg
STANDARD_DEVIATION 8.45 • n=99 Participants
63.5 kg
STANDARD_DEVIATION 12.94 • n=107 Participants
64.3 kg
STANDARD_DEVIATION 11.81 • n=206 Participants
62.5 kg
STANDARD_DEVIATION 11.29 • n=7 Participants
BMI
22.5 kg/m^2
STANDARD_DEVIATION 3.01 • n=99 Participants
23.4 kg/m^2
STANDARD_DEVIATION 3.44 • n=107 Participants
23.6 kg/m^2
STANDARD_DEVIATION 3.29 • n=206 Participants
23.1 kg/m^2
STANDARD_DEVIATION 3.27 • n=7 Participants
PORT/PSI score
Class II
31 participants
n=99 Participants
33 participants
n=107 Participants
30 participants
n=206 Participants
94 participants
n=7 Participants
PORT/PSI score
Class III
34 participants
n=99 Participants
28 participants
n=107 Participants
29 participants
n=206 Participants
91 participants
n=7 Participants
PORT/PSI score
Class IV
2 participants
n=99 Participants
3 participants
n=107 Participants
5 participants
n=206 Participants
10 participants
n=7 Participants
Smoking status
Never smoked
45 participants
n=99 Participants
32 participants
n=107 Participants
43 participants
n=206 Participants
120 participants
n=7 Participants
Smoking status
Former smoker (abstinent for a minimum of 2 years)
8 participants
n=99 Participants
8 participants
n=107 Participants
4 participants
n=206 Participants
20 participants
n=7 Participants
Smoking status
Current smoker or smoked within the past 2 years
14 participants
n=99 Participants
24 participants
n=107 Participants
17 participants
n=206 Participants
55 participants
n=7 Participants
Drinking status
Lifetime abstainer
54 participants
n=99 Participants
41 participants
n=107 Participants
39 participants
n=206 Participants
134 participants
n=7 Participants
Drinking status
Former drinker
4 participants
n=99 Participants
3 participants
n=107 Participants
7 participants
n=206 Participants
14 participants
n=7 Participants
Drinking status
Current drinker
9 participants
n=99 Participants
20 participants
n=107 Participants
18 participants
n=206 Participants
47 participants
n=7 Participants

PRIMARY outcome

Timeframe: Visit 1 (baseline, day -1~1) to Visit 4 (7-14 days after stopping the drug)

Population: Subjects in the ITT population that met the minimal disease criteria, and was evaluated for clinical efficacy at least once were enrolled into the mITT population.

The primary efficacy endpoint of this study was to evaluate whether the clinical cure rate of Nemonoxacin malate sodium chloride is non-inferior to that of Moxifloxacin at visit 4 in the mITT population. At visit 4, the Investigator would assess changes in the symptoms/signs/laboratory tests and chest X-rays/or CT scans associated with this infection, and determined the clinical efficacy in the subjects. The clinical efficacy of the study group and the control group was calculated according to the proportion and percentage of overall clinically cured and clinically ineffective patients in the treatment groups. If the lower limit of the 90% confidence interval for the difference in the clinical cure rate between the study drug and the control drug was larger than -15%, it would be established that the efficacy of Nemonoxacin malate sodium chloride injection was not inferior to that of Moxifloxacin Hydrochloride Sodium Chloride Injection in the treatment of moderate to severe adult CAP.

Outcome measures

Outcome measures
Measure
Nemonoxacin 500 mg
n=67 Participants
Nemonoxacin 500mg/250mL. Nemonoxacin 500 mg: IV Infusion, once daily for 7\~14 days
Nemonoxacin 650 mg
n=64 Participants
Nemonoxacin 650 mg/325mL Nemonoxacin 650 mg: IV Infusion, once daily for 7\~14 days
Moxifloxacin 400 mg
n=64 Participants
Moxifloxacin 400mg/250mL Moxifloxacin 400 mg: IV Infusion, once daily for 7\~14 days
Difference in the Clinical Cure Rate of Two Doses of Intravenously Infused Nemonoxacin Malate Sodium Chloride Injection at Visit 4 in the mITT Population
Success
60 participants
58 participants
59 participants
Difference in the Clinical Cure Rate of Two Doses of Intravenously Infused Nemonoxacin Malate Sodium Chloride Injection at Visit 4 in the mITT Population
Fail
7 participants
4 participants
2 participants
Difference in the Clinical Cure Rate of Two Doses of Intravenously Infused Nemonoxacin Malate Sodium Chloride Injection at Visit 4 in the mITT Population
Not evaluable
0 participants
2 participants
3 participants

SECONDARY outcome

Timeframe: Visit 1 (baseline, day -1~1) to Visit 4 (7-14 days after stopping the drug)

Population: Subjects in the mITT population that conformed to the protocol analysis plan with no major violation to the protocol were enrolled into the CE population.

The primary efficacy endpoint of this study was to evaluate whether the clinical cure rate of Nemonoxacin malate sodium chloride is non-inferior to that of Moxifloxacin at visit 4 in the CE population. At visit 4, the Investigator would assess changes in the symptoms/signs/laboratory tests and chest X-rays/or CT scans associated with this infection, and determined the clinical efficacy in the subjects. The clinical efficacy of the study group and the control group was calculated according to the proportion and percentage of overall clinically cured and clinically ineffective patients in the treatment groups. If the lower limit of the 90% confidence interval for the difference in the clinical cure rate between the study drug and the control drug was larger than -15%, it would be established that the efficacy of Nemonoxacin malate sodium chloride injection was not inferior to that of Moxifloxacin Hydrochloride Sodium Chloride Injection in the treatment of moderate to severe adult CAP.

Outcome measures

Outcome measures
Measure
Nemonoxacin 500 mg
n=63 Participants
Nemonoxacin 500mg/250mL. Nemonoxacin 500 mg: IV Infusion, once daily for 7\~14 days
Nemonoxacin 650 mg
n=59 Participants
Nemonoxacin 650 mg/325mL Nemonoxacin 650 mg: IV Infusion, once daily for 7\~14 days
Moxifloxacin 400 mg
n=60 Participants
Moxifloxacin 400mg/250mL Moxifloxacin 400 mg: IV Infusion, once daily for 7\~14 days
Difference in the Clinical Cure Rate of Two Doses of Intravenously Infused Nemonoxacin Malate Sodium Chloride Injection at Visit 4 in the Clinically Evaluable (CE) Population
Success
56 participants
56 participants
58 participants
Difference in the Clinical Cure Rate of Two Doses of Intravenously Infused Nemonoxacin Malate Sodium Chloride Injection at Visit 4 in the Clinically Evaluable (CE) Population
Not evaluable
7 participants
3 participants
2 participants

SECONDARY outcome

Timeframe: Visit 1 (baseline, day -1~1) to Visit 3 (Within 24 hours after stopping the drug)

Population: Subjects in the ITT population that met the minimal disease criteria, and was evaluated for clinical efficacy at least once were enrolled into the mITT population.

The primary efficacy endpoint of this study was to evaluate whether the clinical cure rate of Nemonoxacin malate sodium chloride is non-inferior to that of Moxifloxacin at visit 3 in the mITT population. At visit 3, the Investigator would assess changes in the symptoms/signs/laboratory tests and chest X-rays/or CT scans associated with this infection, and determined the clinical efficacy in the subjects. The clinical efficacy of the study group and the control group was calculated according to the proportion and percentage of overall clinically cured and clinically ineffective patients in the treatment groups. If the lower limit of the 90% confidence interval for the difference in the clinical cure rate between the study drug and the control drug was larger than -15%, it would be established that the efficacy of Nemonoxacin malate sodium chloride injection was not inferior to that of Moxifloxacin Hydrochloride Sodium Chloride Injection in the treatment of moderate to severe adult CAP.

Outcome measures

Outcome measures
Measure
Nemonoxacin 500 mg
n=67 Participants
Nemonoxacin 500mg/250mL. Nemonoxacin 500 mg: IV Infusion, once daily for 7\~14 days
Nemonoxacin 650 mg
n=64 Participants
Nemonoxacin 650 mg/325mL Nemonoxacin 650 mg: IV Infusion, once daily for 7\~14 days
Moxifloxacin 400 mg
n=64 Participants
Moxifloxacin 400mg/250mL Moxifloxacin 400 mg: IV Infusion, once daily for 7\~14 days
Difference in the Clinical Cure Rate of Two Doses of Intravenously Infused Nemonoxacin Malate Sodium Chloride Injection at Visit 3 in the mITT Population
Success
61 participants
60 participants
59 participants
Difference in the Clinical Cure Rate of Two Doses of Intravenously Infused Nemonoxacin Malate Sodium Chloride Injection at Visit 3 in the mITT Population
Fail
4 participants
4 participants
2 participants
Difference in the Clinical Cure Rate of Two Doses of Intravenously Infused Nemonoxacin Malate Sodium Chloride Injection at Visit 3 in the mITT Population
Not evaluable
2 participants
0 participants
3 participants

SECONDARY outcome

Timeframe: Visit 1 (baseline, day -1~1) to Visit 3 (Within 24 hours after stopping the drug)

Population: Subjects in the mITT population that conformed to the protocol analysis plan with no major violation to the protocol were enrolled into the CE population.

The primary efficacy endpoint of this study was to evaluate whether the clinical cure rate of Nemonoxacin malate sodium chloride is non-inferior to that of Moxifloxacin at visit 3 in the CE population. At visit 3, the Investigator would assess changes in the symptoms/signs/laboratory tests and chest X-rays/or CT scans associated with this infection, and determined the clinical efficacy in the subjects. The clinical efficacy of the study group and the control group was calculated according to the proportion and percentage of overall clinically cured and clinically ineffective patients in the treatment groups. If the lower limit of the 90% confidence interval for the difference in the clinical cure rate between the study drug and the control drug was larger than -15%, it would be established that the efficacy of Nemonoxacin malate sodium chloride injection was not inferior to that of Moxifloxacin Hydrochloride Sodium Chloride Injection in the treatment of moderate to severe adult CAP.

Outcome measures

Outcome measures
Measure
Nemonoxacin 500 mg
n=63 Participants
Nemonoxacin 500mg/250mL. Nemonoxacin 500 mg: IV Infusion, once daily for 7\~14 days
Nemonoxacin 650 mg
n=59 Participants
Nemonoxacin 650 mg/325mL Nemonoxacin 650 mg: IV Infusion, once daily for 7\~14 days
Moxifloxacin 400 mg
n=60 Participants
Moxifloxacin 400mg/250mL Moxifloxacin 400 mg: IV Infusion, once daily for 7\~14 days
Difference in the Clinical Cure Rate of Two Doses of Intravenously Infused Nemonoxacin Malate Sodium Chloride Injection at Visit 3 in the CE Population
Success
58 participants
56 participants
56 participants
Difference in the Clinical Cure Rate of Two Doses of Intravenously Infused Nemonoxacin Malate Sodium Chloride Injection at Visit 3 in the CE Population
Fail
4 participants
3 participants
2 participants
Difference in the Clinical Cure Rate of Two Doses of Intravenously Infused Nemonoxacin Malate Sodium Chloride Injection at Visit 3 in the CE Population
Not evaluable
1 participants
0 participants
2 participants

SECONDARY outcome

Timeframe: Visit 1 (baseline, day -1~1) to Visit 4 (7-14 days after stopping the drug)

Population: Subjects in the mITT population whose bacterial culture yielded at least one baseline bacterial isolate were enrolled into the b-mITT population.

Microbiological efficacy at visits 4 would be determined by assessing the identification results from the central laboratory. Subjects must satisfy at least one of the following in order to be evaluated for the microbiological efficacy: 1. Subjects whose respiratory culture from visit 1 was positive; 2. Subjects whose blood culture from visit 1 was positive. The microbiological efficacy at Visit 4 and treatment group (determined by each subject) was determined by the number and percentage of microbiological success subjects. The difference in bacteriological success between Nemonoxacin malate sodium chloride injection and Moxifloxacin Hydrochloride Sodium Chloride Injection was tested using the logistic regression model.

Outcome measures

Outcome measures
Measure
Nemonoxacin 500 mg
n=24 Participants
Nemonoxacin 500mg/250mL. Nemonoxacin 500 mg: IV Infusion, once daily for 7\~14 days
Nemonoxacin 650 mg
n=19 Participants
Nemonoxacin 650 mg/325mL Nemonoxacin 650 mg: IV Infusion, once daily for 7\~14 days
Moxifloxacin 400 mg
n=17 Participants
Moxifloxacin 400mg/250mL Moxifloxacin 400 mg: IV Infusion, once daily for 7\~14 days
Subject Number for Microbiologically Cured and Failure at Visit 4 in b-mITT (Bacteriological mITT) Population
Success
21 participants
17 participants
16 participants
Subject Number for Microbiologically Cured and Failure at Visit 4 in b-mITT (Bacteriological mITT) Population
Failure
3 participants
1 participants
0 participants
Subject Number for Microbiologically Cured and Failure at Visit 4 in b-mITT (Bacteriological mITT) Population
Not evaluable
0 participants
1 participants
1 participants

SECONDARY outcome

Timeframe: Visit 1 (baseline, day -1~1) to Visit 4 (7-14 days after stopping the drug)

Population: Subjects in the b-mITT population who conformed to the protocol analysis plan with no major violation to the protocol were enrolled into the BE population.

Microbiological efficacy at visits 4 would be determined by assessing the identification results from the central laboratory. Subjects must satisfy at least one of the following in order to be evaluated for the microbiological efficacy: 1. Subjects whose respiratory culture from visit 1 was positive; 2. Subjects whose blood culture from visit 1 was positive. The microbiological efficacy at Visit 4 and treatment group (determined by each subject) was determined by the number and percentage of microbiological success subjects. The difference in bacteriological success between Nemonoxacin malate sodium chloride injection and Moxifloxacin Hydrochloride Sodium Chloride Injection was tested using the logistic regression model.

Outcome measures

Outcome measures
Measure
Nemonoxacin 500 mg
n=23 Participants
Nemonoxacin 500mg/250mL. Nemonoxacin 500 mg: IV Infusion, once daily for 7\~14 days
Nemonoxacin 650 mg
n=19 Participants
Nemonoxacin 650 mg/325mL Nemonoxacin 650 mg: IV Infusion, once daily for 7\~14 days
Moxifloxacin 400 mg
n=16 Participants
Moxifloxacin 400mg/250mL Moxifloxacin 400 mg: IV Infusion, once daily for 7\~14 days
Subject Number for Microbiologically Cured and Failure at Visit 4 in BE (Bacteriological Evaluable) Population
Success
20 participants
17 participants
15 participants
Subject Number for Microbiologically Cured and Failure at Visit 4 in BE (Bacteriological Evaluable) Population
Failure
3 participants
1 participants
0 participants
Subject Number for Microbiologically Cured and Failure at Visit 4 in BE (Bacteriological Evaluable) Population
Not evaluable
0 participants
1 participants
1 participants

SECONDARY outcome

Timeframe: Visit 1 (baseline, day -1~1) to Visit 3 (Within 24 hours after stopping the drug)

Population: Subjects in the mITT population whose bacterial culture yielded at least one baseline bacterial isolate were enrolled into the b-mITT population.

Microbiological efficacy at visits 3 would be determined by assessing the identification results from the central laboratory. Subjects must satisfy at least one of the following in order to be evaluated for the microbiological efficacy: 1. Subjects whose respiratory culture from visit 1 was positive; 2. Subjects whose blood culture from visit 1 was positive. The microbiological efficacy at Visit 3 and treatment group (determined by each subject) was determined by the number and percentage of microbiological success subjects. The difference in bacteriological success between Nemonoxacin malate sodium chloride injection and Moxifloxacin Hydrochloride Sodium Chloride Injection was tested using the logistic regression model.

Outcome measures

Outcome measures
Measure
Nemonoxacin 500 mg
n=24 Participants
Nemonoxacin 500mg/250mL. Nemonoxacin 500 mg: IV Infusion, once daily for 7\~14 days
Nemonoxacin 650 mg
n=19 Participants
Nemonoxacin 650 mg/325mL Nemonoxacin 650 mg: IV Infusion, once daily for 7\~14 days
Moxifloxacin 400 mg
n=17 Participants
Moxifloxacin 400mg/250mL Moxifloxacin 400 mg: IV Infusion, once daily for 7\~14 days
Subject Number for Microbiologically Cured and Failure at Visit 3 in b-mITT (Bacteriological mITT) Population
Success
22 participants
18 participants
16 participants
Subject Number for Microbiologically Cured and Failure at Visit 3 in b-mITT (Bacteriological mITT) Population
Failure
2 participants
1 participants
0 participants
Subject Number for Microbiologically Cured and Failure at Visit 3 in b-mITT (Bacteriological mITT) Population
Not evaluable
0 participants
0 participants
1 participants

SECONDARY outcome

Timeframe: Visit 1 (baseline, day -1~1) to Visit 3 (Within 24 hours after stopping the drug)

Population: Subjects in the b-mITT population who conformed to the protocol analysis plan with no major violation to the protocol were enrolled into the BE population.

Microbiological efficacy at visits 3 would be determined by assessing the identification results from the central laboratory. Subjects must satisfy at least one of the following in order to be evaluated for the microbiological efficacy: 1. Subjects whose respiratory culture from visit 1 was positive; 2. Subjects whose blood culture from visit 1 was positive. The microbiological efficacy at Visit 3 and treatment group (determined by each subject) was determined by the number and percentage of microbiological success subjects. The difference in bacteriological success between Nemonoxacin malate sodium chloride injection and Moxifloxacin Hydrochloride Sodium Chloride Injection was tested using the logistic regression model.

Outcome measures

Outcome measures
Measure
Nemonoxacin 500 mg
n=23 Participants
Nemonoxacin 500mg/250mL. Nemonoxacin 500 mg: IV Infusion, once daily for 7\~14 days
Nemonoxacin 650 mg
n=19 Participants
Nemonoxacin 650 mg/325mL Nemonoxacin 650 mg: IV Infusion, once daily for 7\~14 days
Moxifloxacin 400 mg
n=16 Participants
Moxifloxacin 400mg/250mL Moxifloxacin 400 mg: IV Infusion, once daily for 7\~14 days
Subject Number for Microbiologically Cured and Failure at Visit 3 in BE (Bacteriological Evaluable) Population
Success
21 participants
18 participants
16 participants
Subject Number for Microbiologically Cured and Failure at Visit 3 in BE (Bacteriological Evaluable) Population
Failure
2 participants
1 participants
0 participants
Subject Number for Microbiologically Cured and Failure at Visit 3 in BE (Bacteriological Evaluable) Population
Not evaluable
0 participants
0 participants
0 participants

SECONDARY outcome

Timeframe: Visit 1 (baseline, day -1~1) to Visit 4 (7-14 days after stopping the drug)

Population: Subjects in the mITT population whose bacterial culture yielded at least one baseline bacterial isolate were enrolled into the b-mITT population.

Only subjects whose bacterial culture from visit 1 was positive would be evaluated for the overall efficacy. The overall efficacy (cured or ineffective) at Visit 4 and treatment group (determined by each subject) was determined by the number and percentage of subjects. The difference in bacteriological success between Nemonoxacin malate sodium chloride injection and Moxifloxacin Hydrochloride Sodium Chloride Injection was tested using the logistic regression model.

Outcome measures

Outcome measures
Measure
Nemonoxacin 500 mg
n=24 Participants
Nemonoxacin 500mg/250mL. Nemonoxacin 500 mg: IV Infusion, once daily for 7\~14 days
Nemonoxacin 650 mg
n=19 Participants
Nemonoxacin 650 mg/325mL Nemonoxacin 650 mg: IV Infusion, once daily for 7\~14 days
Moxifloxacin 400 mg
n=17 Participants
Moxifloxacin 400mg/250mL Moxifloxacin 400 mg: IV Infusion, once daily for 7\~14 days
Subject Number of Success and Failure in Overall Efficacy at Visit 4 in b-mITT (Bacteriological mITT) Population
Success
21 participants
17 participants
16 participants
Subject Number of Success and Failure in Overall Efficacy at Visit 4 in b-mITT (Bacteriological mITT) Population
Failure
3 participants
2 participants
1 participants

SECONDARY outcome

Timeframe: Visit 1 (baseline, day -1~1) to Visit 4 (7-14 days after stopping the drug)

Population: Subjects in the b-mITT population who conformed to the protocol analysis plan with no major violation to the protocol were enrolled into the BE population.

Only subjects whose bacterial culture from visit 1 was positive would be evaluated for the overall efficacy. The overall efficacy (cured or ineffective) at Visit 4 and treatment group (determined by each subject) was determined by the number and percentage of subjects. The difference in bacteriological success between Nemonoxacin malate sodium chloride injection and Moxifloxacin Hydrochloride Sodium Chloride Injection was tested using the logistic regression model.

Outcome measures

Outcome measures
Measure
Nemonoxacin 500 mg
n=23 Participants
Nemonoxacin 500mg/250mL. Nemonoxacin 500 mg: IV Infusion, once daily for 7\~14 days
Nemonoxacin 650 mg
n=19 Participants
Nemonoxacin 650 mg/325mL Nemonoxacin 650 mg: IV Infusion, once daily for 7\~14 days
Moxifloxacin 400 mg
n=16 Participants
Moxifloxacin 400mg/250mL Moxifloxacin 400 mg: IV Infusion, once daily for 7\~14 days
Subject Number of Success and Failure in Overall Efficacy at Visit 4 in BE (Bacteriological Evaluable) Population
Success
20 participants
17 participants
15 participants
Subject Number of Success and Failure in Overall Efficacy at Visit 4 in BE (Bacteriological Evaluable) Population
Failure
3 participants
2 participants
1 participants

SECONDARY outcome

Timeframe: Visit 1 (baseline, day -1~1) to Visit 3 (Within 24 hours after stopping the drug)

Population: Subjects in the mITT population whose bacterial culture yielded at least one baseline bacterial isolate were enrolled into the b-mITT population.

Only subjects whose bacterial culture from visit 1 was positive would be evaluated for the overall efficacy. The overall efficacy (cured or ineffective) at Visit 3 and treatment group (determined by each subject) was determined by the number and percentage of subjects. The difference in bacteriological success between Nemonoxacin malate sodium chloride injection and Moxifloxacin Hydrochloride Sodium Chloride Injection was tested using the logistic regression model.

Outcome measures

Outcome measures
Measure
Nemonoxacin 500 mg
n=24 Participants
Nemonoxacin 500mg/250mL. Nemonoxacin 500 mg: IV Infusion, once daily for 7\~14 days
Nemonoxacin 650 mg
n=19 Participants
Nemonoxacin 650 mg/325mL Nemonoxacin 650 mg: IV Infusion, once daily for 7\~14 days
Moxifloxacin 400 mg
n=17 Participants
Moxifloxacin 400mg/250mL Moxifloxacin 400 mg: IV Infusion, once daily for 7\~14 days
Subject Number of Success and Failure in Overall Efficacy at Visit 3 in b-mITT (Bacteriological mITT) Population
Success
22 participants
17 participants
15 participants
Subject Number of Success and Failure in Overall Efficacy at Visit 3 in b-mITT (Bacteriological mITT) Population
Failure
2 participants
2 participants
1 participants
Subject Number of Success and Failure in Overall Efficacy at Visit 3 in b-mITT (Bacteriological mITT) Population
Unevaluable
0 participants
0 participants
1 participants

SECONDARY outcome

Timeframe: Visit 1 (baseline, day -1~1) to Visit 3 (Within 24 hours after stopping the drug)

Population: Subjects in the b-mITT population who conformed to the protocol analysis plan with no major violation to the protocol were enrolled into the BE population.

Only subjects whose bacterial culture from visit 1 was positive would be evaluated for the overall efficacy. The overall efficacy (cured or ineffective) at Visit 3 and treatment group (determined by each subject) was determined by the number and percentage of subjects. The difference in bacteriological success between Nemonoxacin malate sodium chloride injection and Moxifloxacin Hydrochloride Sodium Chloride Injection was tested using the logistic regression model.

Outcome measures

Outcome measures
Measure
Nemonoxacin 500 mg
n=23 Participants
Nemonoxacin 500mg/250mL. Nemonoxacin 500 mg: IV Infusion, once daily for 7\~14 days
Nemonoxacin 650 mg
n=19 Participants
Nemonoxacin 650 mg/325mL Nemonoxacin 650 mg: IV Infusion, once daily for 7\~14 days
Moxifloxacin 400 mg
n=16 Participants
Moxifloxacin 400mg/250mL Moxifloxacin 400 mg: IV Infusion, once daily for 7\~14 days
Subject Number of Success and Failure in Overall Efficacy at Visit 3 in BE (Bacteriological Evaluable) Population
Success
21 participants
17 participants
15 participants
Subject Number of Success and Failure in Overall Efficacy at Visit 3 in BE (Bacteriological Evaluable) Population
Failure
2 participants
2 participants
1 participants

Adverse Events

Nemonoxacin 500 mg

Serious events: 3 serious events
Other events: 51 other events
Deaths: 0 deaths

Nemonoxacin 650 mg

Serious events: 1 serious events
Other events: 41 other events
Deaths: 0 deaths

Moxifloxacin 400 mg

Serious events: 1 serious events
Other events: 33 other events
Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure
Nemonoxacin 500 mg
n=68 participants at risk
Nemonoxacin 500mg/250mL. Nemonoxacin 500 mg: IV Infusion, once daily for 7\~14 days
Nemonoxacin 650 mg
n=67 participants at risk
Nemonoxacin 650 mg/325mL Nemonoxacin 650 mg: IV Infusion, once daily for 7\~14 days
Moxifloxacin 400 mg
n=70 participants at risk
Moxifloxacin 400mg/250mL Moxifloxacin 400 mg: IV Infusion, once daily for 7\~14 days
Cardiac disorders
Bradycardia
1.5%
1/68 • Number of events 1 • The whole study period: from Screening Vsit (day -1~1) to Visit 4 (7-14 days after stopping the drug)
0.00%
0/67 • The whole study period: from Screening Vsit (day -1~1) to Visit 4 (7-14 days after stopping the drug)
0.00%
0/70 • The whole study period: from Screening Vsit (day -1~1) to Visit 4 (7-14 days after stopping the drug)
Vascular disorders
Hypotension
1.5%
1/68 • Number of events 1 • The whole study period: from Screening Vsit (day -1~1) to Visit 4 (7-14 days after stopping the drug)
0.00%
0/67 • The whole study period: from Screening Vsit (day -1~1) to Visit 4 (7-14 days after stopping the drug)
0.00%
0/70 • The whole study period: from Screening Vsit (day -1~1) to Visit 4 (7-14 days after stopping the drug)
Cardiac disorders
Worsening of congestive heart failure
1.5%
1/68 • Number of events 1 • The whole study period: from Screening Vsit (day -1~1) to Visit 4 (7-14 days after stopping the drug)
0.00%
0/67 • The whole study period: from Screening Vsit (day -1~1) to Visit 4 (7-14 days after stopping the drug)
0.00%
0/70 • The whole study period: from Screening Vsit (day -1~1) to Visit 4 (7-14 days after stopping the drug)
Respiratory, thoracic and mediastinal disorders
Respiratory failure
1.5%
1/68 • Number of events 1 • The whole study period: from Screening Vsit (day -1~1) to Visit 4 (7-14 days after stopping the drug)
1.5%
1/67 • Number of events 1 • The whole study period: from Screening Vsit (day -1~1) to Visit 4 (7-14 days after stopping the drug)
0.00%
0/70 • The whole study period: from Screening Vsit (day -1~1) to Visit 4 (7-14 days after stopping the drug)
Respiratory, thoracic and mediastinal disorders
Lung neoplasm malignant
0.00%
0/68 • The whole study period: from Screening Vsit (day -1~1) to Visit 4 (7-14 days after stopping the drug)
0.00%
0/67 • The whole study period: from Screening Vsit (day -1~1) to Visit 4 (7-14 days after stopping the drug)
1.4%
1/70 • Number of events 1 • The whole study period: from Screening Vsit (day -1~1) to Visit 4 (7-14 days after stopping the drug)

Other adverse events

Other adverse events
Measure
Nemonoxacin 500 mg
n=68 participants at risk
Nemonoxacin 500mg/250mL. Nemonoxacin 500 mg: IV Infusion, once daily for 7\~14 days
Nemonoxacin 650 mg
n=67 participants at risk
Nemonoxacin 650 mg/325mL Nemonoxacin 650 mg: IV Infusion, once daily for 7\~14 days
Moxifloxacin 400 mg
n=70 participants at risk
Moxifloxacin 400mg/250mL Moxifloxacin 400 mg: IV Infusion, once daily for 7\~14 days
General disorders
Infusion site erythema
16.2%
11/68 • Number of events 20 • The whole study period: from Screening Vsit (day -1~1) to Visit 4 (7-14 days after stopping the drug)
0.00%
0/67 • The whole study period: from Screening Vsit (day -1~1) to Visit 4 (7-14 days after stopping the drug)
0.00%
0/70 • The whole study period: from Screening Vsit (day -1~1) to Visit 4 (7-14 days after stopping the drug)
General disorders
Infusion site pruritus
11.8%
8/68 • Number of events 23 • The whole study period: from Screening Vsit (day -1~1) to Visit 4 (7-14 days after stopping the drug)
11.9%
8/67 • Number of events 25 • The whole study period: from Screening Vsit (day -1~1) to Visit 4 (7-14 days after stopping the drug)
4.3%
3/70 • Number of events 8 • The whole study period: from Screening Vsit (day -1~1) to Visit 4 (7-14 days after stopping the drug)
General disorders
Infusion site pain
5.9%
4/68 • Number of events 11 • The whole study period: from Screening Vsit (day -1~1) to Visit 4 (7-14 days after stopping the drug)
4.5%
3/67 • Number of events 8 • The whole study period: from Screening Vsit (day -1~1) to Visit 4 (7-14 days after stopping the drug)
2.9%
2/70 • Number of events 10 • The whole study period: from Screening Vsit (day -1~1) to Visit 4 (7-14 days after stopping the drug)
General disorders
Infusion site discomfort
5.9%
4/68 • Number of events 16 • The whole study period: from Screening Vsit (day -1~1) to Visit 4 (7-14 days after stopping the drug)
1.5%
1/67 • Number of events 1 • The whole study period: from Screening Vsit (day -1~1) to Visit 4 (7-14 days after stopping the drug)
0.00%
0/70 • The whole study period: from Screening Vsit (day -1~1) to Visit 4 (7-14 days after stopping the drug)
General disorders
Infusion site rash
2.9%
2/68 • Number of events 2 • The whole study period: from Screening Vsit (day -1~1) to Visit 4 (7-14 days after stopping the drug)
3.0%
2/67 • Number of events 2 • The whole study period: from Screening Vsit (day -1~1) to Visit 4 (7-14 days after stopping the drug)
0.00%
0/70 • The whole study period: from Screening Vsit (day -1~1) to Visit 4 (7-14 days after stopping the drug)
General disorders
Infusion site swelling
2.9%
2/68 • Number of events 5 • The whole study period: from Screening Vsit (day -1~1) to Visit 4 (7-14 days after stopping the drug)
1.5%
1/67 • Number of events 1 • The whole study period: from Screening Vsit (day -1~1) to Visit 4 (7-14 days after stopping the drug)
0.00%
0/70 • The whole study period: from Screening Vsit (day -1~1) to Visit 4 (7-14 days after stopping the drug)
General disorders
Pyrexia
2.9%
2/68 • Number of events 2 • The whole study period: from Screening Vsit (day -1~1) to Visit 4 (7-14 days after stopping the drug)
0.00%
0/67 • The whole study period: from Screening Vsit (day -1~1) to Visit 4 (7-14 days after stopping the drug)
0.00%
0/70 • The whole study period: from Screening Vsit (day -1~1) to Visit 4 (7-14 days after stopping the drug)
General disorders
Chest pain
0.00%
0/68 • The whole study period: from Screening Vsit (day -1~1) to Visit 4 (7-14 days after stopping the drug)
1.5%
1/67 • Number of events 1 • The whole study period: from Screening Vsit (day -1~1) to Visit 4 (7-14 days after stopping the drug)
1.4%
1/70 • Number of events 1 • The whole study period: from Screening Vsit (day -1~1) to Visit 4 (7-14 days after stopping the drug)
General disorders
Flushing
0.00%
0/68 • The whole study period: from Screening Vsit (day -1~1) to Visit 4 (7-14 days after stopping the drug)
0.00%
0/67 • The whole study period: from Screening Vsit (day -1~1) to Visit 4 (7-14 days after stopping the drug)
1.4%
1/70 • Number of events 1 • The whole study period: from Screening Vsit (day -1~1) to Visit 4 (7-14 days after stopping the drug)
Gastrointestinal disorders
Diarrhoea
1.5%
1/68 • Number of events 1 • The whole study period: from Screening Vsit (day -1~1) to Visit 4 (7-14 days after stopping the drug)
0.00%
0/67 • The whole study period: from Screening Vsit (day -1~1) to Visit 4 (7-14 days after stopping the drug)
2.9%
2/70 • Number of events 2 • The whole study period: from Screening Vsit (day -1~1) to Visit 4 (7-14 days after stopping the drug)
Gastrointestinal disorders
Constipation
1.5%
1/68 • Number of events 1 • The whole study period: from Screening Vsit (day -1~1) to Visit 4 (7-14 days after stopping the drug)
1.5%
1/67 • Number of events 1 • The whole study period: from Screening Vsit (day -1~1) to Visit 4 (7-14 days after stopping the drug)
0.00%
0/70 • The whole study period: from Screening Vsit (day -1~1) to Visit 4 (7-14 days after stopping the drug)
Gastrointestinal disorders
Vomiting
1.5%
1/68 • Number of events 2 • The whole study period: from Screening Vsit (day -1~1) to Visit 4 (7-14 days after stopping the drug)
0.00%
0/67 • The whole study period: from Screening Vsit (day -1~1) to Visit 4 (7-14 days after stopping the drug)
1.4%
1/70 • Number of events 1 • The whole study period: from Screening Vsit (day -1~1) to Visit 4 (7-14 days after stopping the drug)
Gastrointestinal disorders
Gastritis
2.9%
2/68 • Number of events 2 • The whole study period: from Screening Vsit (day -1~1) to Visit 4 (7-14 days after stopping the drug)
0.00%
0/67 • The whole study period: from Screening Vsit (day -1~1) to Visit 4 (7-14 days after stopping the drug)
0.00%
0/70 • The whole study period: from Screening Vsit (day -1~1) to Visit 4 (7-14 days after stopping the drug)
Gastrointestinal disorders
Nausea
1.5%
1/68 • Number of events 2 • The whole study period: from Screening Vsit (day -1~1) to Visit 4 (7-14 days after stopping the drug)
0.00%
0/67 • The whole study period: from Screening Vsit (day -1~1) to Visit 4 (7-14 days after stopping the drug)
0.00%
0/70 • The whole study period: from Screening Vsit (day -1~1) to Visit 4 (7-14 days after stopping the drug)
Gastrointestinal disorders
Dry mouth
0.00%
0/68 • The whole study period: from Screening Vsit (day -1~1) to Visit 4 (7-14 days after stopping the drug)
0.00%
0/67 • The whole study period: from Screening Vsit (day -1~1) to Visit 4 (7-14 days after stopping the drug)
1.4%
1/70 • Number of events 1 • The whole study period: from Screening Vsit (day -1~1) to Visit 4 (7-14 days after stopping the drug)
Gastrointestinal disorders
Frequent bowel movements
0.00%
0/68 • The whole study period: from Screening Vsit (day -1~1) to Visit 4 (7-14 days after stopping the drug)
0.00%
0/67 • The whole study period: from Screening Vsit (day -1~1) to Visit 4 (7-14 days after stopping the drug)
1.4%
1/70 • Number of events 1 • The whole study period: from Screening Vsit (day -1~1) to Visit 4 (7-14 days after stopping the drug)
Gastrointestinal disorders
Abdominal discomfort
1.5%
1/68 • Number of events 1 • The whole study period: from Screening Vsit (day -1~1) to Visit 4 (7-14 days after stopping the drug)
0.00%
0/67 • The whole study period: from Screening Vsit (day -1~1) to Visit 4 (7-14 days after stopping the drug)
0.00%
0/70 • The whole study period: from Screening Vsit (day -1~1) to Visit 4 (7-14 days after stopping the drug)
Gastrointestinal disorders
Oesophagitis
1.5%
1/68 • Number of events 1 • The whole study period: from Screening Vsit (day -1~1) to Visit 4 (7-14 days after stopping the drug)
0.00%
0/67 • The whole study period: from Screening Vsit (day -1~1) to Visit 4 (7-14 days after stopping the drug)
0.00%
0/70 • The whole study period: from Screening Vsit (day -1~1) to Visit 4 (7-14 days after stopping the drug)
Gastrointestinal disorders
Hyperchlorhydria
0.00%
0/68 • The whole study period: from Screening Vsit (day -1~1) to Visit 4 (7-14 days after stopping the drug)
1.5%
1/67 • Number of events 1 • The whole study period: from Screening Vsit (day -1~1) to Visit 4 (7-14 days after stopping the drug)
0.00%
0/70 • The whole study period: from Screening Vsit (day -1~1) to Visit 4 (7-14 days after stopping the drug)
Gastrointestinal disorders
Mucous stools
0.00%
0/68 • The whole study period: from Screening Vsit (day -1~1) to Visit 4 (7-14 days after stopping the drug)
0.00%
0/67 • The whole study period: from Screening Vsit (day -1~1) to Visit 4 (7-14 days after stopping the drug)
1.4%
1/70 • Number of events 1 • The whole study period: from Screening Vsit (day -1~1) to Visit 4 (7-14 days after stopping the drug)
Gastrointestinal disorders
Haemorrhoidal haemorrhage
0.00%
0/68 • The whole study period: from Screening Vsit (day -1~1) to Visit 4 (7-14 days after stopping the drug)
0.00%
0/67 • The whole study period: from Screening Vsit (day -1~1) to Visit 4 (7-14 days after stopping the drug)
1.4%
1/70 • Number of events 2 • The whole study period: from Screening Vsit (day -1~1) to Visit 4 (7-14 days after stopping the drug)
Cardiac disorders
Bradycardia
2.9%
2/68 • Number of events 2 • The whole study period: from Screening Vsit (day -1~1) to Visit 4 (7-14 days after stopping the drug)
1.5%
1/67 • Number of events 1 • The whole study period: from Screening Vsit (day -1~1) to Visit 4 (7-14 days after stopping the drug)
0.00%
0/70 • The whole study period: from Screening Vsit (day -1~1) to Visit 4 (7-14 days after stopping the drug)
Cardiac disorders
Sinus bradycardia
1.5%
1/68 • Number of events 1 • The whole study period: from Screening Vsit (day -1~1) to Visit 4 (7-14 days after stopping the drug)
1.5%
1/67 • Number of events 1 • The whole study period: from Screening Vsit (day -1~1) to Visit 4 (7-14 days after stopping the drug)
2.9%
2/70 • Number of events 2 • The whole study period: from Screening Vsit (day -1~1) to Visit 4 (7-14 days after stopping the drug)
Cardiac disorders
Supraventricular arrhythmias
1.5%
1/68 • Number of events 1 • The whole study period: from Screening Vsit (day -1~1) to Visit 4 (7-14 days after stopping the drug)
1.5%
1/67 • Number of events 2 • The whole study period: from Screening Vsit (day -1~1) to Visit 4 (7-14 days after stopping the drug)
0.00%
0/70 • The whole study period: from Screening Vsit (day -1~1) to Visit 4 (7-14 days after stopping the drug)
Cardiac disorders
Cardiac conduction disorders
1.5%
1/68 • Number of events 1 • The whole study period: from Screening Vsit (day -1~1) to Visit 4 (7-14 days after stopping the drug)
1.5%
1/67 • Number of events 1 • The whole study period: from Screening Vsit (day -1~1) to Visit 4 (7-14 days after stopping the drug)
0.00%
0/70 • The whole study period: from Screening Vsit (day -1~1) to Visit 4 (7-14 days after stopping the drug)
Cardiac disorders
Palpitation
0.00%
0/68 • The whole study period: from Screening Vsit (day -1~1) to Visit 4 (7-14 days after stopping the drug)
0.00%
0/67 • The whole study period: from Screening Vsit (day -1~1) to Visit 4 (7-14 days after stopping the drug)
1.4%
1/70 • Number of events 3 • The whole study period: from Screening Vsit (day -1~1) to Visit 4 (7-14 days after stopping the drug)
Cardiac disorders
Chest discomfort
0.00%
0/68 • The whole study period: from Screening Vsit (day -1~1) to Visit 4 (7-14 days after stopping the drug)
0.00%
0/67 • The whole study period: from Screening Vsit (day -1~1) to Visit 4 (7-14 days after stopping the drug)
1.4%
1/70 • Number of events 1 • The whole study period: from Screening Vsit (day -1~1) to Visit 4 (7-14 days after stopping the drug)
Infections and infestations
Urinary tract infection
1.5%
1/68 • Number of events 1 • The whole study period: from Screening Vsit (day -1~1) to Visit 4 (7-14 days after stopping the drug)
1.5%
1/67 • Number of events 1 • The whole study period: from Screening Vsit (day -1~1) to Visit 4 (7-14 days after stopping the drug)
0.00%
0/70 • The whole study period: from Screening Vsit (day -1~1) to Visit 4 (7-14 days after stopping the drug)
Infections and infestations
Herpes zoster
1.5%
1/68 • Number of events 1 • The whole study period: from Screening Vsit (day -1~1) to Visit 4 (7-14 days after stopping the drug)
0.00%
0/67 • The whole study period: from Screening Vsit (day -1~1) to Visit 4 (7-14 days after stopping the drug)
0.00%
0/70 • The whole study period: from Screening Vsit (day -1~1) to Visit 4 (7-14 days after stopping the drug)
Infections and infestations
Oral herpes
0.00%
0/68 • The whole study period: from Screening Vsit (day -1~1) to Visit 4 (7-14 days after stopping the drug)
1.5%
1/67 • Number of events 1 • The whole study period: from Screening Vsit (day -1~1) to Visit 4 (7-14 days after stopping the drug)
0.00%
0/70 • The whole study period: from Screening Vsit (day -1~1) to Visit 4 (7-14 days after stopping the drug)
Infections and infestations
Upper respiratory tract infection
1.5%
1/68 • Number of events 1 • The whole study period: from Screening Vsit (day -1~1) to Visit 4 (7-14 days after stopping the drug)
0.00%
0/67 • The whole study period: from Screening Vsit (day -1~1) to Visit 4 (7-14 days after stopping the drug)
0.00%
0/70 • The whole study period: from Screening Vsit (day -1~1) to Visit 4 (7-14 days after stopping the drug)
Infections and infestations
Tinea manuum
1.5%
1/68 • Number of events 1 • The whole study period: from Screening Vsit (day -1~1) to Visit 4 (7-14 days after stopping the drug)
0.00%
0/67 • The whole study period: from Screening Vsit (day -1~1) to Visit 4 (7-14 days after stopping the drug)
0.00%
0/70 • The whole study period: from Screening Vsit (day -1~1) to Visit 4 (7-14 days after stopping the drug)
Infections and infestations
Pharyngitis
1.5%
1/68 • Number of events 1 • The whole study period: from Screening Vsit (day -1~1) to Visit 4 (7-14 days after stopping the drug)
0.00%
0/67 • The whole study period: from Screening Vsit (day -1~1) to Visit 4 (7-14 days after stopping the drug)
0.00%
0/70 • The whole study period: from Screening Vsit (day -1~1) to Visit 4 (7-14 days after stopping the drug)
Infections and infestations
Tinea pedis
1.5%
1/68 • Number of events 1 • The whole study period: from Screening Vsit (day -1~1) to Visit 4 (7-14 days after stopping the drug)
0.00%
0/67 • The whole study period: from Screening Vsit (day -1~1) to Visit 4 (7-14 days after stopping the drug)
0.00%
0/70 • The whole study period: from Screening Vsit (day -1~1) to Visit 4 (7-14 days after stopping the drug)
Nervous system disorders
Dizziness
1.5%
1/68 • Number of events 1 • The whole study period: from Screening Vsit (day -1~1) to Visit 4 (7-14 days after stopping the drug)
0.00%
0/67 • The whole study period: from Screening Vsit (day -1~1) to Visit 4 (7-14 days after stopping the drug)
4.3%
3/70 • Number of events 3 • The whole study period: from Screening Vsit (day -1~1) to Visit 4 (7-14 days after stopping the drug)
Nervous system disorders
Gait disturbance
0.00%
0/68 • The whole study period: from Screening Vsit (day -1~1) to Visit 4 (7-14 days after stopping the drug)
0.00%
0/67 • The whole study period: from Screening Vsit (day -1~1) to Visit 4 (7-14 days after stopping the drug)
1.4%
1/70 • Number of events 1 • The whole study period: from Screening Vsit (day -1~1) to Visit 4 (7-14 days after stopping the drug)
Nervous system disorders
Hypoaesthesia
0.00%
0/68 • The whole study period: from Screening Vsit (day -1~1) to Visit 4 (7-14 days after stopping the drug)
1.5%
1/67 • Number of events 1 • The whole study period: from Screening Vsit (day -1~1) to Visit 4 (7-14 days after stopping the drug)
0.00%
0/70 • The whole study period: from Screening Vsit (day -1~1) to Visit 4 (7-14 days after stopping the drug)
Nervous system disorders
Dysphemia
0.00%
0/68 • The whole study period: from Screening Vsit (day -1~1) to Visit 4 (7-14 days after stopping the drug)
0.00%
0/67 • The whole study period: from Screening Vsit (day -1~1) to Visit 4 (7-14 days after stopping the drug)
1.4%
1/70 • Number of events 1 • The whole study period: from Screening Vsit (day -1~1) to Visit 4 (7-14 days after stopping the drug)
Nervous system disorders
Altered visual depth perception
0.00%
0/68 • The whole study period: from Screening Vsit (day -1~1) to Visit 4 (7-14 days after stopping the drug)
0.00%
0/67 • The whole study period: from Screening Vsit (day -1~1) to Visit 4 (7-14 days after stopping the drug)
1.4%
1/70 • Number of events 1 • The whole study period: from Screening Vsit (day -1~1) to Visit 4 (7-14 days after stopping the drug)
Nervous system disorders
Headache
1.5%
1/68 • Number of events 1 • The whole study period: from Screening Vsit (day -1~1) to Visit 4 (7-14 days after stopping the drug)
0.00%
0/67 • The whole study period: from Screening Vsit (day -1~1) to Visit 4 (7-14 days after stopping the drug)
0.00%
0/70 • The whole study period: from Screening Vsit (day -1~1) to Visit 4 (7-14 days after stopping the drug)
Respiratory, thoracic and mediastinal disorders
Nasal obstruction
0.00%
0/68 • The whole study period: from Screening Vsit (day -1~1) to Visit 4 (7-14 days after stopping the drug)
0.00%
0/67 • The whole study period: from Screening Vsit (day -1~1) to Visit 4 (7-14 days after stopping the drug)
1.4%
1/70 • Number of events 1 • The whole study period: from Screening Vsit (day -1~1) to Visit 4 (7-14 days after stopping the drug)
Respiratory, thoracic and mediastinal disorders
Interstitial lung disease
1.5%
1/68 • Number of events 1 • The whole study period: from Screening Vsit (day -1~1) to Visit 4 (7-14 days after stopping the drug)
0.00%
0/67 • The whole study period: from Screening Vsit (day -1~1) to Visit 4 (7-14 days after stopping the drug)
0.00%
0/70 • The whole study period: from Screening Vsit (day -1~1) to Visit 4 (7-14 days after stopping the drug)
Respiratory, thoracic and mediastinal disorders
Chest pain
1.5%
1/68 • Number of events 1 • The whole study period: from Screening Vsit (day -1~1) to Visit 4 (7-14 days after stopping the drug)
0.00%
0/67 • The whole study period: from Screening Vsit (day -1~1) to Visit 4 (7-14 days after stopping the drug)
0.00%
0/70 • The whole study period: from Screening Vsit (day -1~1) to Visit 4 (7-14 days after stopping the drug)
Skin and subcutaneous tissue disorders
Rash
2.9%
2/68 • Number of events 2 • The whole study period: from Screening Vsit (day -1~1) to Visit 4 (7-14 days after stopping the drug)
1.5%
1/67 • Number of events 4 • The whole study period: from Screening Vsit (day -1~1) to Visit 4 (7-14 days after stopping the drug)
1.4%
1/70 • Number of events 1 • The whole study period: from Screening Vsit (day -1~1) to Visit 4 (7-14 days after stopping the drug)
Skin and subcutaneous tissue disorders
Eczema
0.00%
0/68 • The whole study period: from Screening Vsit (day -1~1) to Visit 4 (7-14 days after stopping the drug)
0.00%
0/67 • The whole study period: from Screening Vsit (day -1~1) to Visit 4 (7-14 days after stopping the drug)
1.4%
1/70 • Number of events 1 • The whole study period: from Screening Vsit (day -1~1) to Visit 4 (7-14 days after stopping the drug)
Musculoskeletal and connective tissue disorders
Groin pain
1.5%
1/68 • Number of events 1 • The whole study period: from Screening Vsit (day -1~1) to Visit 4 (7-14 days after stopping the drug)
0.00%
0/67 • The whole study period: from Screening Vsit (day -1~1) to Visit 4 (7-14 days after stopping the drug)
0.00%
0/70 • The whole study period: from Screening Vsit (day -1~1) to Visit 4 (7-14 days after stopping the drug)
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
0.00%
0/68 • The whole study period: from Screening Vsit (day -1~1) to Visit 4 (7-14 days after stopping the drug)
0.00%
0/67 • The whole study period: from Screening Vsit (day -1~1) to Visit 4 (7-14 days after stopping the drug)
1.4%
1/70 • Number of events 1 • The whole study period: from Screening Vsit (day -1~1) to Visit 4 (7-14 days after stopping the drug)
Musculoskeletal and connective tissue disorders
Arthralgia
1.5%
1/68 • Number of events 1 • The whole study period: from Screening Vsit (day -1~1) to Visit 4 (7-14 days after stopping the drug)
0.00%
0/67 • The whole study period: from Screening Vsit (day -1~1) to Visit 4 (7-14 days after stopping the drug)
0.00%
0/70 • The whole study period: from Screening Vsit (day -1~1) to Visit 4 (7-14 days after stopping the drug)
Musculoskeletal and connective tissue disorders
Spondyloarthropathy
0.00%
0/68 • The whole study period: from Screening Vsit (day -1~1) to Visit 4 (7-14 days after stopping the drug)
0.00%
0/67 • The whole study period: from Screening Vsit (day -1~1) to Visit 4 (7-14 days after stopping the drug)
1.4%
1/70 • Number of events 1 • The whole study period: from Screening Vsit (day -1~1) to Visit 4 (7-14 days after stopping the drug)
Metabolism and nutrition disorders
Hypoproteinaemia
0.00%
0/68 • The whole study period: from Screening Vsit (day -1~1) to Visit 4 (7-14 days after stopping the drug)
0.00%
0/67 • The whole study period: from Screening Vsit (day -1~1) to Visit 4 (7-14 days after stopping the drug)
1.4%
1/70 • Number of events 1 • The whole study period: from Screening Vsit (day -1~1) to Visit 4 (7-14 days after stopping the drug)
Metabolism and nutrition disorders
Hepatic steatosis
1.5%
1/68 • Number of events 1 • The whole study period: from Screening Vsit (day -1~1) to Visit 4 (7-14 days after stopping the drug)
0.00%
0/67 • The whole study period: from Screening Vsit (day -1~1) to Visit 4 (7-14 days after stopping the drug)
0.00%
0/70 • The whole study period: from Screening Vsit (day -1~1) to Visit 4 (7-14 days after stopping the drug)
Ear and labyrinth disorders
Hypoacusis
1.5%
1/68 • Number of events 1 • The whole study period: from Screening Vsit (day -1~1) to Visit 4 (7-14 days after stopping the drug)
0.00%
0/67 • The whole study period: from Screening Vsit (day -1~1) to Visit 4 (7-14 days after stopping the drug)
1.4%
1/70 • Number of events 1 • The whole study period: from Screening Vsit (day -1~1) to Visit 4 (7-14 days after stopping the drug)
Hepatobiliary disorders
Cholelithiasis
2.9%
2/68 • Number of events 2 • The whole study period: from Screening Vsit (day -1~1) to Visit 4 (7-14 days after stopping the drug)
0.00%
0/67 • The whole study period: from Screening Vsit (day -1~1) to Visit 4 (7-14 days after stopping the drug)
0.00%
0/70 • The whole study period: from Screening Vsit (day -1~1) to Visit 4 (7-14 days after stopping the drug)
Immune system disorders
Rheumatoid arthritis
1.5%
1/68 • Number of events 1 • The whole study period: from Screening Vsit (day -1~1) to Visit 4 (7-14 days after stopping the drug)
0.00%
0/67 • The whole study period: from Screening Vsit (day -1~1) to Visit 4 (7-14 days after stopping the drug)
0.00%
0/70 • The whole study period: from Screening Vsit (day -1~1) to Visit 4 (7-14 days after stopping the drug)
Immune system disorders
Urticaria
0.00%
0/68 • The whole study period: from Screening Vsit (day -1~1) to Visit 4 (7-14 days after stopping the drug)
1.5%
1/67 • Number of events 1 • The whole study period: from Screening Vsit (day -1~1) to Visit 4 (7-14 days after stopping the drug)
0.00%
0/70 • The whole study period: from Screening Vsit (day -1~1) to Visit 4 (7-14 days after stopping the drug)
Injury, poisoning and procedural complications
Contusion
1.5%
1/68 • Number of events 3 • The whole study period: from Screening Vsit (day -1~1) to Visit 4 (7-14 days after stopping the drug)
0.00%
0/67 • The whole study period: from Screening Vsit (day -1~1) to Visit 4 (7-14 days after stopping the drug)
0.00%
0/70 • The whole study period: from Screening Vsit (day -1~1) to Visit 4 (7-14 days after stopping the drug)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal cyst
1.5%
1/68 • Number of events 1 • The whole study period: from Screening Vsit (day -1~1) to Visit 4 (7-14 days after stopping the drug)
0.00%
0/67 • The whole study period: from Screening Vsit (day -1~1) to Visit 4 (7-14 days after stopping the drug)
0.00%
0/70 • The whole study period: from Screening Vsit (day -1~1) to Visit 4 (7-14 days after stopping the drug)
Renal and urinary disorders
Bladder mass
1.5%
1/68 • Number of events 1 • The whole study period: from Screening Vsit (day -1~1) to Visit 4 (7-14 days after stopping the drug)
0.00%
0/67 • The whole study period: from Screening Vsit (day -1~1) to Visit 4 (7-14 days after stopping the drug)
0.00%
0/70 • The whole study period: from Screening Vsit (day -1~1) to Visit 4 (7-14 days after stopping the drug)
Blood and lymphatic system disorders
Leukopenias NEC
0.00%
0/68 • The whole study period: from Screening Vsit (day -1~1) to Visit 4 (7-14 days after stopping the drug)
0.00%
0/67 • The whole study period: from Screening Vsit (day -1~1) to Visit 4 (7-14 days after stopping the drug)
1.4%
1/70 • Number of events 1 • The whole study period: from Screening Vsit (day -1~1) to Visit 4 (7-14 days after stopping the drug)
Investigations
Alanine aminotransferase increased
5.9%
4/68 • Number of events 4 • The whole study period: from Screening Vsit (day -1~1) to Visit 4 (7-14 days after stopping the drug)
20.9%
14/67 • Number of events 14 • The whole study period: from Screening Vsit (day -1~1) to Visit 4 (7-14 days after stopping the drug)
7.1%
5/70 • Number of events 5 • The whole study period: from Screening Vsit (day -1~1) to Visit 4 (7-14 days after stopping the drug)
Investigations
Aspartate aminotransferase increased
4.4%
3/68 • Number of events 3 • The whole study period: from Screening Vsit (day -1~1) to Visit 4 (7-14 days after stopping the drug)
16.4%
11/67 • Number of events 11 • The whole study period: from Screening Vsit (day -1~1) to Visit 4 (7-14 days after stopping the drug)
5.7%
4/70 • Number of events 4 • The whole study period: from Screening Vsit (day -1~1) to Visit 4 (7-14 days after stopping the drug)
Investigations
White blood cell count decreased
4.4%
3/68 • Number of events 3 • The whole study period: from Screening Vsit (day -1~1) to Visit 4 (7-14 days after stopping the drug)
7.5%
5/67 • Number of events 6 • The whole study period: from Screening Vsit (day -1~1) to Visit 4 (7-14 days after stopping the drug)
5.7%
4/70 • Number of events 4 • The whole study period: from Screening Vsit (day -1~1) to Visit 4 (7-14 days after stopping the drug)
Investigations
Gamma-glutamyltransferase increased
1.5%
1/68 • Number of events 1 • The whole study period: from Screening Vsit (day -1~1) to Visit 4 (7-14 days after stopping the drug)
7.5%
5/67 • Number of events 5 • The whole study period: from Screening Vsit (day -1~1) to Visit 4 (7-14 days after stopping the drug)
2.9%
2/70 • Number of events 2 • The whole study period: from Screening Vsit (day -1~1) to Visit 4 (7-14 days after stopping the drug)
Investigations
Red blood cells urine positive
1.5%
1/68 • Number of events 1 • The whole study period: from Screening Vsit (day -1~1) to Visit 4 (7-14 days after stopping the drug)
0.00%
0/67 • The whole study period: from Screening Vsit (day -1~1) to Visit 4 (7-14 days after stopping the drug)
0.00%
0/70 • The whole study period: from Screening Vsit (day -1~1) to Visit 4 (7-14 days after stopping the drug)
Investigations
Red blood cell count decreased
2.9%
2/68 • Number of events 2 • The whole study period: from Screening Vsit (day -1~1) to Visit 4 (7-14 days after stopping the drug)
4.5%
3/67 • Number of events 3 • The whole study period: from Screening Vsit (day -1~1) to Visit 4 (7-14 days after stopping the drug)
1.4%
1/70 • Number of events 1 • The whole study period: from Screening Vsit (day -1~1) to Visit 4 (7-14 days after stopping the drug)
Investigations
Neutrophil count decreased
0.00%
0/68 • The whole study period: from Screening Vsit (day -1~1) to Visit 4 (7-14 days after stopping the drug)
4.5%
3/67 • Number of events 3 • The whole study period: from Screening Vsit (day -1~1) to Visit 4 (7-14 days after stopping the drug)
4.3%
3/70 • Number of events 3 • The whole study period: from Screening Vsit (day -1~1) to Visit 4 (7-14 days after stopping the drug)
Investigations
Electrocardiogram QT prolonged
1.5%
1/68 • Number of events 1 • The whole study period: from Screening Vsit (day -1~1) to Visit 4 (7-14 days after stopping the drug)
4.5%
3/67 • Number of events 3 • The whole study period: from Screening Vsit (day -1~1) to Visit 4 (7-14 days after stopping the drug)
2.9%
2/70 • Number of events 3 • The whole study period: from Screening Vsit (day -1~1) to Visit 4 (7-14 days after stopping the drug)
Investigations
Blood albumin decreased
4.4%
3/68 • Number of events 4 • The whole study period: from Screening Vsit (day -1~1) to Visit 4 (7-14 days after stopping the drug)
1.5%
1/67 • Number of events 1 • The whole study period: from Screening Vsit (day -1~1) to Visit 4 (7-14 days after stopping the drug)
2.9%
2/70 • Number of events 2 • The whole study period: from Screening Vsit (day -1~1) to Visit 4 (7-14 days after stopping the drug)
Investigations
Blood potassium decreased
2.9%
2/68 • Number of events 2 • The whole study period: from Screening Vsit (day -1~1) to Visit 4 (7-14 days after stopping the drug)
4.5%
3/67 • Number of events 3 • The whole study period: from Screening Vsit (day -1~1) to Visit 4 (7-14 days after stopping the drug)
1.4%
1/70 • Number of events 1 • The whole study period: from Screening Vsit (day -1~1) to Visit 4 (7-14 days after stopping the drug)
Investigations
Blood lactate dehydrogenase increased
4.4%
3/68 • Number of events 3 • The whole study period: from Screening Vsit (day -1~1) to Visit 4 (7-14 days after stopping the drug)
3.0%
2/67 • Number of events 2 • The whole study period: from Screening Vsit (day -1~1) to Visit 4 (7-14 days after stopping the drug)
1.4%
1/70 • Number of events 1 • The whole study period: from Screening Vsit (day -1~1) to Visit 4 (7-14 days after stopping the drug)
Investigations
Haematocrit decreased
2.9%
2/68 • Number of events 2 • The whole study period: from Screening Vsit (day -1~1) to Visit 4 (7-14 days after stopping the drug)
3.0%
2/67 • Number of events 2 • The whole study period: from Screening Vsit (day -1~1) to Visit 4 (7-14 days after stopping the drug)
2.9%
2/70 • Number of events 2 • The whole study period: from Screening Vsit (day -1~1) to Visit 4 (7-14 days after stopping the drug)
Investigations
Neutrophil percentage decreased
2.9%
2/68 • Number of events 2 • The whole study period: from Screening Vsit (day -1~1) to Visit 4 (7-14 days after stopping the drug)
3.0%
2/67 • Number of events 2 • The whole study period: from Screening Vsit (day -1~1) to Visit 4 (7-14 days after stopping the drug)
1.4%
1/70 • Number of events 1 • The whole study period: from Screening Vsit (day -1~1) to Visit 4 (7-14 days after stopping the drug)
Investigations
Haemoglobin decreased
1.5%
1/68 • Number of events 1 • The whole study period: from Screening Vsit (day -1~1) to Visit 4 (7-14 days after stopping the drug)
3.0%
2/67 • Number of events 2 • The whole study period: from Screening Vsit (day -1~1) to Visit 4 (7-14 days after stopping the drug)
2.9%
2/70 • Number of events 2 • The whole study period: from Screening Vsit (day -1~1) to Visit 4 (7-14 days after stopping the drug)
Investigations
White blood cell count increased
1.5%
1/68 • Number of events 1 • The whole study period: from Screening Vsit (day -1~1) to Visit 4 (7-14 days after stopping the drug)
4.5%
3/67 • Number of events 3 • The whole study period: from Screening Vsit (day -1~1) to Visit 4 (7-14 days after stopping the drug)
0.00%
0/70 • The whole study period: from Screening Vsit (day -1~1) to Visit 4 (7-14 days after stopping the drug)
Investigations
Blood creatine phosphokinase increased
2.9%
2/68 • Number of events 2 • The whole study period: from Screening Vsit (day -1~1) to Visit 4 (7-14 days after stopping the drug)
1.5%
1/67 • Number of events 1 • The whole study period: from Screening Vsit (day -1~1) to Visit 4 (7-14 days after stopping the drug)
1.4%
1/70 • Number of events 1 • The whole study period: from Screening Vsit (day -1~1) to Visit 4 (7-14 days after stopping the drug)
Investigations
Blood alkaline phosphatase increased
0.00%
0/68 • The whole study period: from Screening Vsit (day -1~1) to Visit 4 (7-14 days after stopping the drug)
4.5%
3/67 • Number of events 3 • The whole study period: from Screening Vsit (day -1~1) to Visit 4 (7-14 days after stopping the drug)
1.4%
1/70 • Number of events 1 • The whole study period: from Screening Vsit (day -1~1) to Visit 4 (7-14 days after stopping the drug)
Investigations
Platelet count increased
1.5%
1/68 • Number of events 1 • The whole study period: from Screening Vsit (day -1~1) to Visit 4 (7-14 days after stopping the drug)
1.5%
1/67 • Number of events 1 • The whole study period: from Screening Vsit (day -1~1) to Visit 4 (7-14 days after stopping the drug)
2.9%
2/70 • Number of events 2 • The whole study period: from Screening Vsit (day -1~1) to Visit 4 (7-14 days after stopping the drug)
Investigations
Protein total decreased
1.5%
1/68 • Number of events 1 • The whole study period: from Screening Vsit (day -1~1) to Visit 4 (7-14 days after stopping the drug)
3.0%
2/67 • Number of events 2 • The whole study period: from Screening Vsit (day -1~1) to Visit 4 (7-14 days after stopping the drug)
1.4%
1/70 • Number of events 1 • The whole study period: from Screening Vsit (day -1~1) to Visit 4 (7-14 days after stopping the drug)
Investigations
Platelet count decreased
0.00%
0/68 • The whole study period: from Screening Vsit (day -1~1) to Visit 4 (7-14 days after stopping the drug)
4.5%
3/67 • Number of events 3 • The whole study period: from Screening Vsit (day -1~1) to Visit 4 (7-14 days after stopping the drug)
0.00%
0/70 • The whole study period: from Screening Vsit (day -1~1) to Visit 4 (7-14 days after stopping the drug)
Investigations
C-reactive protein increased
0.00%
0/68 • The whole study period: from Screening Vsit (day -1~1) to Visit 4 (7-14 days after stopping the drug)
1.5%
1/67 • Number of events 1 • The whole study period: from Screening Vsit (day -1~1) to Visit 4 (7-14 days after stopping the drug)
1.4%
1/70 • Number of events 1 • The whole study period: from Screening Vsit (day -1~1) to Visit 4 (7-14 days after stopping the drug)
Investigations
Neutrophil count increased
1.5%
1/68 • Number of events 1 • The whole study period: from Screening Vsit (day -1~1) to Visit 4 (7-14 days after stopping the drug)
1.5%
1/67 • Number of events 1 • The whole study period: from Screening Vsit (day -1~1) to Visit 4 (7-14 days after stopping the drug)
0.00%
0/70 • The whole study period: from Screening Vsit (day -1~1) to Visit 4 (7-14 days after stopping the drug)
Investigations
Blood urea increased
1.5%
1/68 • Number of events 1 • The whole study period: from Screening Vsit (day -1~1) to Visit 4 (7-14 days after stopping the drug)
0.00%
0/67 • The whole study period: from Screening Vsit (day -1~1) to Visit 4 (7-14 days after stopping the drug)
1.4%
1/70 • Number of events 1 • The whole study period: from Screening Vsit (day -1~1) to Visit 4 (7-14 days after stopping the drug)
Investigations
Blood uric acid increased
1.5%
1/68 • Number of events 1 • The whole study period: from Screening Vsit (day -1~1) to Visit 4 (7-14 days after stopping the drug)
1.5%
1/67 • Number of events 1 • The whole study period: from Screening Vsit (day -1~1) to Visit 4 (7-14 days after stopping the drug)
0.00%
0/70 • The whole study period: from Screening Vsit (day -1~1) to Visit 4 (7-14 days after stopping the drug)
Investigations
Blood pressure increased
0.00%
0/68 • The whole study period: from Screening Vsit (day -1~1) to Visit 4 (7-14 days after stopping the drug)
1.5%
1/67 • Number of events 1 • The whole study period: from Screening Vsit (day -1~1) to Visit 4 (7-14 days after stopping the drug)
1.4%
1/70 • Number of events 1 • The whole study period: from Screening Vsit (day -1~1) to Visit 4 (7-14 days after stopping the drug)
Investigations
Alpha hydroxybutyrate dehydrogenase increased
1.5%
1/68 • Number of events 1 • The whole study period: from Screening Vsit (day -1~1) to Visit 4 (7-14 days after stopping the drug)
0.00%
0/67 • The whole study period: from Screening Vsit (day -1~1) to Visit 4 (7-14 days after stopping the drug)
0.00%
0/70 • The whole study period: from Screening Vsit (day -1~1) to Visit 4 (7-14 days after stopping the drug)
Investigations
Monocyte percentage increased
0.00%
0/68 • The whole study period: from Screening Vsit (day -1~1) to Visit 4 (7-14 days after stopping the drug)
0.00%
0/67 • The whole study period: from Screening Vsit (day -1~1) to Visit 4 (7-14 days after stopping the drug)
1.4%
1/70 • Number of events 1 • The whole study period: from Screening Vsit (day -1~1) to Visit 4 (7-14 days after stopping the drug)
Investigations
Monocyte count increased
1.5%
1/68 • Number of events 1 • The whole study period: from Screening Vsit (day -1~1) to Visit 4 (7-14 days after stopping the drug)
0.00%
0/67 • The whole study period: from Screening Vsit (day -1~1) to Visit 4 (7-14 days after stopping the drug)
0.00%
0/70 • The whole study period: from Screening Vsit (day -1~1) to Visit 4 (7-14 days after stopping the drug)
Investigations
Lymphocyte percentage increased
0.00%
0/68 • The whole study period: from Screening Vsit (day -1~1) to Visit 4 (7-14 days after stopping the drug)
1.5%
1/67 • Number of events 1 • The whole study period: from Screening Vsit (day -1~1) to Visit 4 (7-14 days after stopping the drug)
0.00%
0/70 • The whole study period: from Screening Vsit (day -1~1) to Visit 4 (7-14 days after stopping the drug)
Investigations
Lymphocyte count increased
0.00%
0/68 • The whole study period: from Screening Vsit (day -1~1) to Visit 4 (7-14 days after stopping the drug)
0.00%
0/67 • The whole study period: from Screening Vsit (day -1~1) to Visit 4 (7-14 days after stopping the drug)
1.4%
1/70 • Number of events 1 • The whole study period: from Screening Vsit (day -1~1) to Visit 4 (7-14 days after stopping the drug)
Investigations
Protein urine present
0.00%
0/68 • The whole study period: from Screening Vsit (day -1~1) to Visit 4 (7-14 days after stopping the drug)
0.00%
0/67 • The whole study period: from Screening Vsit (day -1~1) to Visit 4 (7-14 days after stopping the drug)
1.4%
1/70 • Number of events 1 • The whole study period: from Screening Vsit (day -1~1) to Visit 4 (7-14 days after stopping the drug)
Investigations
Mean cell haemoglobin concentration decreased
0.00%
0/68 • The whole study period: from Screening Vsit (day -1~1) to Visit 4 (7-14 days after stopping the drug)
1.5%
1/67 • Number of events 1 • The whole study period: from Screening Vsit (day -1~1) to Visit 4 (7-14 days after stopping the drug)
0.00%
0/70 • The whole study period: from Screening Vsit (day -1~1) to Visit 4 (7-14 days after stopping the drug)
Investigations
Mean cell haemoglobin concentration increased
0.00%
0/68 • The whole study period: from Screening Vsit (day -1~1) to Visit 4 (7-14 days after stopping the drug)
1.5%
1/67 • Number of events 1 • The whole study period: from Screening Vsit (day -1~1) to Visit 4 (7-14 days after stopping the drug)
0.00%
0/70 • The whole study period: from Screening Vsit (day -1~1) to Visit 4 (7-14 days after stopping the drug)
Investigations
Prealbumin decreased
1.5%
1/68 • Number of events 1 • The whole study period: from Screening Vsit (day -1~1) to Visit 4 (7-14 days after stopping the drug)
0.00%
0/67 • The whole study period: from Screening Vsit (day -1~1) to Visit 4 (7-14 days after stopping the drug)
0.00%
0/70 • The whole study period: from Screening Vsit (day -1~1) to Visit 4 (7-14 days after stopping the drug)
Investigations
Eosinophil percentage increased
0.00%
0/68 • The whole study period: from Screening Vsit (day -1~1) to Visit 4 (7-14 days after stopping the drug)
1.5%
1/67 • Number of events 1 • The whole study period: from Screening Vsit (day -1~1) to Visit 4 (7-14 days after stopping the drug)
0.00%
0/70 • The whole study period: from Screening Vsit (day -1~1) to Visit 4 (7-14 days after stopping the drug)
Investigations
Eosinophil count increased
0.00%
0/68 • The whole study period: from Screening Vsit (day -1~1) to Visit 4 (7-14 days after stopping the drug)
0.00%
0/67 • The whole study period: from Screening Vsit (day -1~1) to Visit 4 (7-14 days after stopping the drug)
1.4%
1/70 • Number of events 1 • The whole study period: from Screening Vsit (day -1~1) to Visit 4 (7-14 days after stopping the drug)
Investigations
Neutrophil percentage increased
0.00%
0/68 • The whole study period: from Screening Vsit (day -1~1) to Visit 4 (7-14 days after stopping the drug)
1.5%
1/67 • Number of events 1 • The whole study period: from Screening Vsit (day -1~1) to Visit 4 (7-14 days after stopping the drug)
0.00%
0/70 • The whole study period: from Screening Vsit (day -1~1) to Visit 4 (7-14 days after stopping the drug)
Investigations
Electrocardiogram ST-T change
0.00%
0/68 • The whole study period: from Screening Vsit (day -1~1) to Visit 4 (7-14 days after stopping the drug)
0.00%
0/67 • The whole study period: from Screening Vsit (day -1~1) to Visit 4 (7-14 days after stopping the drug)
1.4%
1/70 • Number of events 1 • The whole study period: from Screening Vsit (day -1~1) to Visit 4 (7-14 days after stopping the drug)
Investigations
Electrocardiogram T wave amplitude decreased
1.5%
1/68 • Number of events 1 • The whole study period: from Screening Vsit (day -1~1) to Visit 4 (7-14 days after stopping the drug)
0.00%
0/67 • The whole study period: from Screening Vsit (day -1~1) to Visit 4 (7-14 days after stopping the drug)
0.00%
0/70 • The whole study period: from Screening Vsit (day -1~1) to Visit 4 (7-14 days after stopping the drug)
Investigations
Blood bilirubin increased
1.5%
1/68 • Number of events 1 • The whole study period: from Screening Vsit (day -1~1) to Visit 4 (7-14 days after stopping the drug)
0.00%
0/67 • The whole study period: from Screening Vsit (day -1~1) to Visit 4 (7-14 days after stopping the drug)
0.00%
0/70 • The whole study period: from Screening Vsit (day -1~1) to Visit 4 (7-14 days after stopping the drug)
Investigations
Blood glucose decreased
1.5%
1/68 • Number of events 1 • The whole study period: from Screening Vsit (day -1~1) to Visit 4 (7-14 days after stopping the drug)
0.00%
0/67 • The whole study period: from Screening Vsit (day -1~1) to Visit 4 (7-14 days after stopping the drug)
0.00%
0/70 • The whole study period: from Screening Vsit (day -1~1) to Visit 4 (7-14 days after stopping the drug)
Investigations
Total bile acids increased
0.00%
0/68 • The whole study period: from Screening Vsit (day -1~1) to Visit 4 (7-14 days after stopping the drug)
1.5%
1/67 • Number of events 1 • The whole study period: from Screening Vsit (day -1~1) to Visit 4 (7-14 days after stopping the drug)
0.00%
0/70 • The whole study period: from Screening Vsit (day -1~1) to Visit 4 (7-14 days after stopping the drug)

Additional Information

Chen-En Tsai, M.D., Ph.D.

TaiGen Biotechnology Co., Ltd.

Phone: +886-2-8177-7072

Results disclosure agreements

  • Principal investigator is a sponsor employee PI needs to inform sponsor and asks for permission before he/she discusses or publishes trial results after the trial is completed.
  • Publication restrictions are in place

Restriction type: OTHER