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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01944774
Recruitment Status : Completed
First Posted : September 18, 2013
Results First Posted : February 18, 2015
Last Update Posted : February 18, 2015
Sponsor:
Collaborators:
QPS-Qualitix
R&G Pharma Studies Co.,Ltd.
Information provided by (Responsible Party):
TaiGen Biotechnology Co., Ltd.

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Pneumonia
Interventions Drug: Nemonoxacin 500 mg
Drug: Nemonoxacin 650 mg
Drug: Moxifloxacin 400 mg
Enrollment 207
Recruitment Details 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.
Pre-assignment Details  
Arm/Group Title Nemonoxacin 500 mg Nemonoxacin 650 mg Moxifloxacin 400 mg
Hide Arm/Group Description

Nemonoxacin 500mg/250mL.

Nemonoxacin 500 mg: IV Infusion, once daily for 7~14 days

Nemonoxacin 650 mg/325mL

Nemonoxacin 650 mg: IV Infusion, once daily for 7~14 days

Moxifloxacin 400mg/250mL

Moxifloxacin 400 mg: IV Infusion, once daily for 7~14 days

Period Title: Overall Study
Started 69 68 70
Received Treatment 68 67 70
Completed 63 60 62
Not Completed 6 8 8
Reason Not Completed
Withdrawal by Subject             2             3             3
Adverse Event             3             2             3
Lack of Efficacy             1             2             2
Lost to Follow-up             0             1             0
Arm/Group Title Nemonoxacin 500 mg Nemonoxacin 650 mg Moxifloxacin 400 mg Total
Hide Arm/Group Description

Nemonoxacin 500mg/250mL.

Nemonoxacin 500 mg: IV Infusion, once daily for 7~14 days

Nemonoxacin 650 mg/325mL

Nemonoxacin 650 mg: IV Infusion, once daily for 7~14 days

Moxifloxacin 400mg/250mL

Moxifloxacin 400 mg: IV Infusion, once daily for 7~14 days

Total of all reporting groups
Overall Number of Baseline Participants 67 64 64 195
Hide Baseline Analysis Population Description
mITT population: Subjects who were screened and randomized, received at least one complete dose of the drug (Nemonoxacin or Moxifloxacin), met the minimal disease criteria (inclusion criteria 4, 5 and 7), and was evaluated at least once for clinical efficacy .
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 67 participants 64 participants 64 participants 195 participants
52.7  (15.33) 53.5  (14.21) 51.5  (16.00) 52.6  (15.14)
Age, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 67 participants 64 participants 64 participants 195 participants
≧18 and <30 years 6 4 10 20
≧30 and < 40 years 9 8 9 26
≧40 and < 50 years 10 12 8 30
≧50 and < 60 years 16 15 11 42
≧60 and < 70 years 16 17 17 50
≧70 and < 76 years 10 8 9 27
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 67 participants 64 participants 64 participants 195 participants
Female
25
  37.3%
23
  35.9%
23
  35.9%
71
  36.4%
Male
42
  62.7%
41
  64.1%
41
  64.1%
124
  63.6%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 67 participants 64 participants 64 participants 195 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Asian
67
 100.0%
64
 100.0%
64
 100.0%
195
 100.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
White
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Nationality  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 67 participants 64 participants 64 participants 195 participants
Han 62 61 61 184
Minority ethnic groups 3 2 1 6
Taiwan Aborigines 0 0 1 1
Unknown 2 1 1 4
Height  
Mean (Standard Deviation)
Unit of measure:  Cm
Number Analyzed 67 participants 64 participants 64 participants 195 participants
163.5  (7.08) 164.2  (8.65) 164.7  (8.68) 164.1  (8.13)
Weight  
Mean (Standard Deviation)
Unit of measure:  Kg
Number Analyzed 67 participants 64 participants 64 participants 195 participants
60.0  (8.45) 63.5  (12.94) 64.3  (11.81) 62.5  (11.29)
BMI  
Mean (Standard Deviation)
Unit of measure:  Kg/m^2
Number Analyzed 67 participants 64 participants 64 participants 195 participants
22.5  (3.01) 23.4  (3.44) 23.6  (3.29) 23.1  (3.27)
PORT/PSI score   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 67 participants 64 participants 64 participants 195 participants
Class II 31 33 30 94
Class III 34 28 29 91
Class IV 2 3 5 10
[1]
Measure Description: The pneumonia severity index PSI or PORT Score is a clinical prediction rule that medical practitioners use to calculate the probability of morbidity and mortality among patients with CAP. Point values are given for various parameters of demographics, comorbidity, physical exam fndings, lab and radiographic findings. The total PSI score places a given patient into one of 5 risk classes. Classes I, II, and III are at low risk for death, and may be considered for outpatient treatment. Risk classes IV and V should be hospitalized and even an intensive care should be considered.
Smoking status  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 67 participants 64 participants 64 participants 195 participants
Never smoked 45 32 43 120
Former smoker (abstinent for a minimum of 2 years) 8 8 4 20
Current smoker or smoked within the past 2 years 14 24 17 55
Drinking status  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 67 participants 64 participants 64 participants 195 participants
Lifetime abstainer 54 41 39 134
Former drinker 4 3 7 14
Current drinker 9 20 18 47
1.Primary Outcome
Title Difference in the Clinical Cure Rate of Two Doses of Intravenously Infused Nemonoxacin Malate Sodium Chloride Injection at Visit 4 in the mITT Population
Hide Description 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.
Time Frame Visit 1 (baseline, day -1~1) to Visit 4 (7-14 days after stopping the drug)
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Nemonoxacin 500 mg Nemonoxacin 650 mg Moxifloxacin 400 mg
Hide Arm/Group Description:
Nemonoxacin 500mg/250mL. Nemonoxacin 500 mg: IV Infusion, once daily for 7~14 days
Nemonoxacin 650 mg/325mL Nemonoxacin 650 mg: IV Infusion, once daily for 7~14 days
Moxifloxacin 400mg/250mL Moxifloxacin 400 mg: IV Infusion, once daily for 7~14 days
Overall Number of Participants Analyzed 67 64 64
Measure Type: Number
Unit of Measure: participants
Success 60 58 59
Fail 7 4 2
Not evaluable 0 2 3
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Nemonoxacin 500 mg, Moxifloxacin 400 mg
Comments [Not Specified]
Type of Statistical Test Non-Inferiority or Equivalence
Comments Clinical success rate was assumed for the experimental group (Nemonoxacin 500mg) and the control group (Moxifloxacin 400mg) were both 88%. The non-inferiority margin was defined as 15%, one-sided significance value was 0.05 (one-tailed α=0.05), power was 80%, and the assignment ratio was 1:1:1.
Statistical Test of Hypothesis P-Value 0.133
Comments Only P values less than 0.05 are considered statistically significant in this study.
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.291
Confidence Interval (2-Sided) 95%
0.058 to 1.457
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Nemonoxacin 650 mg, Moxifloxacin 400 mg
Comments [Not Specified]
Type of Statistical Test Non-Inferiority or Equivalence
Comments Clinical success rate was assumed for the experimental group (Nemonoxacin 650mg) and the control group (Moxifloxacin 400mg) were both 88%. The non-inferiority margin was defined as 15%, one-sided significance value was 0.05 (one-tailed α=0.05), power was 80%, and the assignment ratio was 1:1:1.
Statistical Test of Hypothesis P-Value 0.423
Comments Only P values less than 0.05 are considered statistically significant in this study.
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.492
Confidence Interval (2-Sided) 95%
0.087 to 2.788
Estimation Comments [Not Specified]
2.Secondary Outcome
Title 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
Hide Description 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.
Time Frame Visit 1 (baseline, day -1~1) to Visit 4 (7-14 days after stopping the drug)
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Nemonoxacin 500 mg Nemonoxacin 650 mg Moxifloxacin 400 mg
Hide Arm/Group Description:
Nemonoxacin 500mg/250mL. Nemonoxacin 500 mg: IV Infusion, once daily for 7~14 days
Nemonoxacin 650 mg/325mL Nemonoxacin 650 mg: IV Infusion, once daily for 7~14 days
Moxifloxacin 400mg/250mL Moxifloxacin 400 mg: IV Infusion, once daily for 7~14 days
Overall Number of Participants Analyzed 63 59 60
Measure Type: Number
Unit of Measure: participants
Success 56 56 58
Not evaluable 7 3 2
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Nemonoxacin 500 mg, Moxifloxacin 400 mg
Comments [Not Specified]
Type of Statistical Test Non-Inferiority or Equivalence
Comments Clinical success rate was assumed for the experimental group (Nemonoxacin 500mg) and the control group (Moxifloxacin 400mg) were both 88%. The non-inferiority margin was defined as 15%, one-sided significance value was 0.05 (one-tailed α=0.05), power was 80%, and the assignment ratio was 1:1:1.
Statistical Test of Hypothesis P-Value 0.118
Comments Only P values less than 0.05 are considered statistically significant in this study.
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.276
Confidence Interval (2-Sided) 95%
0.055 to 1.385
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Nemonoxacin 650 mg, Moxifloxacin 400 mg
Comments [Not Specified]
Type of Statistical Test Non-Inferiority or Equivalence
Comments Clinical success rate was assumed for the experimental group (Nemonoxacin 650mg) and the control group (Moxifloxacin 400mg) were both 88%. The non-inferiority margin was defined as 15%, one-sided significance value was 0.05 (one-tailed α=0.05), power was 80%, and the assignment ratio was 1:1:1.
Statistical Test of Hypothesis P-Value 0.636
Comments Only P values less than 0.05 are considered statistically significant in this study.
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.644
Confidence Interval (2-Sided) 95%
0.104 to 3.999
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Difference in the Clinical Cure Rate of Two Doses of Intravenously Infused Nemonoxacin Malate Sodium Chloride Injection at Visit 3 in the mITT Population
Hide Description 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.
Time Frame Visit 1 (baseline, day -1~1) to Visit 3 (Within 24 hours after stopping the drug)
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Nemonoxacin 500 mg Nemonoxacin 650 mg Moxifloxacin 400 mg
Hide Arm/Group Description:
Nemonoxacin 500mg/250mL. Nemonoxacin 500 mg: IV Infusion, once daily for 7~14 days
Nemonoxacin 650 mg/325mL Nemonoxacin 650 mg: IV Infusion, once daily for 7~14 days
Moxifloxacin 400mg/250mL Moxifloxacin 400 mg: IV Infusion, once daily for 7~14 days
Overall Number of Participants Analyzed 67 64 64
Measure Type: Number
Unit of Measure: participants
Success 61 60 59
Fail 4 4 2
Not evaluable 2 0 3
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Nemonoxacin 500 mg, Moxifloxacin 400 mg
Comments [Not Specified]
Type of Statistical Test Non-Inferiority or Equivalence
Comments Clinical success rate was assumed for the experimental group (Nemonoxacin 500mg) and the control group (Moxifloxacin 400mg) were both 88%. The non-inferiority margin was defined as 15%, one-sided significance value was 0.05 (one-tailed α=0.05), power was 80%, and the assignment ratio was 1:1:1.
Statistical Test of Hypothesis P-Value 0.456
Comments Only P values less than 0.05 are considered statistically significant in this study.
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.517
Confidence Interval (2-Sided) 95%
0.091 to 2.930
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Nemonoxacin 650 mg, Moxifloxacin 400 mg
Comments [Not Specified]
Type of Statistical Test Non-Inferiority or Equivalence
Comments Clinical success rate was assumed for the experimental group (Nemonoxacin 650mg) and the control group (Moxifloxacin 400mg) were both 88%. The non-inferiority margin was defined as 15%, one-sided significance value was 0.05 (one-tailed α=0.05), power was 80%, and the assignment ratio was 1:1:1.
Statistical Test of Hypothesis P-Value 0.445
Comments Only P values less than 0.05 are considered statistically significant in this study.
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.508
Confidence Interval (2-Sided) 95%
0.090 to 2.883
Estimation Comments [Not Specified]
4.Secondary Outcome
Title Difference in the Clinical Cure Rate of Two Doses of Intravenously Infused Nemonoxacin Malate Sodium Chloride Injection at Visit 3 in the CE Population
Hide Description 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.
Time Frame Visit 1 (baseline, day -1~1) to Visit 3 (Within 24 hours after stopping the drug)
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Nemonoxacin 500 mg Nemonoxacin 650 mg Moxifloxacin 400 mg
Hide Arm/Group Description:
Nemonoxacin 500mg/250mL. Nemonoxacin 500 mg: IV Infusion, once daily for 7~14 days
Nemonoxacin 650 mg/325mL Nemonoxacin 650 mg: IV Infusion, once daily for 7~14 days
Moxifloxacin 400mg/250mL Moxifloxacin 400 mg: IV Infusion, once daily for 7~14 days
Overall Number of Participants Analyzed 63 59 60
Measure Type: Number
Unit of Measure: participants
Success 58 56 56
Fail 4 3 2
Not evaluable 1 0 2
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Nemonoxacin 500 mg, Moxifloxacin 400 mg
Comments [Not Specified]
Type of Statistical Test Non-Inferiority or Equivalence
Comments Clinical success rate was assumed for the experimental group (Nemonoxacin 500mg) and the control group (Moxifloxacin 400mg) were both 88%. The non-inferiority margin was defined as 15%, one-sided significance value was 0.05 (one-tailed α=0.05), power was 80%, and the assignment ratio was 1:1:1.
Statistical Test of Hypothesis P-Value 0.458
Comments Only P values less than 0.05 are considered statistically significant in this study.
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.518
Confidence Interval (2-Sided) 95%
0.091 to 2.941
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Nemonoxacin 650 mg, Moxifloxacin 400 mg
Comments [Not Specified]
Type of Statistical Test Non-Inferiority or Equivalence
Comments Clinical success rate was assumed for the experimental group (Nemonoxacin 650mg) and the control group (Moxifloxacin 400mg) were both 88%. The non-inferiority margin was defined as 15%, one-sided significance value was 0.05 (one-tailed α=0.05), power was 80%, and the assignment ratio was 1:1:1.
Statistical Test of Hypothesis P-Value 0.664
Comments Only P values less than 0.05 are considered statistically significant in this study.
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.667
Confidence Interval (2-Sided) 95%
0.107 to 4.144
Estimation Comments [Not Specified]
5.Secondary Outcome
Title Subject Number for Microbiologically Cured and Failure at Visit 4 in b-mITT (Bacteriological mITT) Population
Hide Description

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.

Time Frame Visit 1 (baseline, day -1~1) to Visit 4 (7-14 days after stopping the drug)
Hide Outcome Measure Data
Hide Analysis Population Description
Subjects in the mITT population whose bacterial culture yielded at least one baseline bacterial isolate were enrolled into the b-mITT population.
Arm/Group Title Nemonoxacin 500 mg Nemonoxacin 650 mg Moxifloxacin 400 mg
Hide Arm/Group Description:

Nemonoxacin 500mg/250mL.

Nemonoxacin 500 mg: IV Infusion, once daily for 7~14 days

Nemonoxacin 650 mg/325mL

Nemonoxacin 650 mg: IV Infusion, once daily for 7~14 days

Moxifloxacin 400mg/250mL

Moxifloxacin 400 mg: IV Infusion, once daily for 7~14 days

Overall Number of Participants Analyzed 24 19 17
Measure Type: Number
Unit of Measure: participants
Success 21 17 16
Failure 3 1 0
Not evaluable 0 1 1
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Nemonoxacin 500 mg, Moxifloxacin 400 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.959
Comments Only P values less than 0.05 are considered statistically significant in this study.
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.000
Estimation Comments The 2-sided 95% confidence interval of OR is (<0.001, >999.999).
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Nemonoxacin 650 mg, Moxifloxacin 400 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.961
Comments Only P values less than 0.05 are considered statistically significant in this study.
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.000
Estimation Comments The 2-sided 95% confidence interval of OR is (<0.001, >999.999).
6.Secondary Outcome
Title Subject Number for Microbiologically Cured and Failure at Visit 4 in BE (Bacteriological Evaluable) Population
Hide Description

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.

Time Frame Visit 1 (baseline, day -1~1) to Visit 4 (7-14 days after stopping the drug)
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Nemonoxacin 500 mg Nemonoxacin 650 mg Moxifloxacin 400 mg
Hide Arm/Group Description:

Nemonoxacin 500mg/250mL.

Nemonoxacin 500 mg: IV Infusion, once daily for 7~14 days

Nemonoxacin 650 mg/325mL

Nemonoxacin 650 mg: IV Infusion, once daily for 7~14 days

Moxifloxacin 400mg/250mL

Moxifloxacin 400 mg: IV Infusion, once daily for 7~14 days

Overall Number of Participants Analyzed 23 19 16
Measure Type: Number
Unit of Measure: participants
Success 20 17 15
Failure 3 1 0
Not evaluable 0 1 1
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Nemonoxacin 500 mg, Moxifloxacin 400 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.960
Comments Only P values less than 0.05 are considered statistically significant in this study.
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.000
Estimation Comments The 2-sided 95% confidence interval of OR is (<0.001, >999.999).
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Nemonoxacin 650 mg, Moxifloxacin 400 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.962
Comments Only P values less than 0.05 are considered statistically significant in this study.
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.000
Estimation Comments The 2-sided 95% confidence interval of OR is (<0.001, >999.999).
7.Secondary Outcome
Title Subject Number for Microbiologically Cured and Failure at Visit 3 in b-mITT (Bacteriological mITT) Population
Hide Description

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.

Time Frame Visit 1 (baseline, day -1~1) to Visit 3 (Within 24 hours after stopping the drug)
Hide Outcome Measure Data
Hide Analysis Population Description
Subjects in the mITT population whose bacterial culture yielded at least one baseline bacterial isolate were enrolled into the b-mITT population.
Arm/Group Title Nemonoxacin 500 mg Nemonoxacin 650 mg Moxifloxacin 400 mg
Hide Arm/Group Description:

Nemonoxacin 500mg/250mL.

Nemonoxacin 500 mg: IV Infusion, once daily for 7~14 days

Nemonoxacin 650 mg/325mL

Nemonoxacin 650 mg: IV Infusion, once daily for 7~14 days

Moxifloxacin 400mg/250mL

Moxifloxacin 400 mg: IV Infusion, once daily for 7~14 days

Overall Number of Participants Analyzed 24 19 17
Measure Type: Number
Unit of Measure: participants
Success 22 18 16
Failure 2 1 0
Not evaluable 0 0 1
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Nemonoxacin 500 mg, Moxifloxacin 400 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.950
Comments Only P values less than 0.05 are considered statistically significant in this study.
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.000
Estimation Comments The 2-sided 95% confidence interval of OR is (<0.001, >999.999).
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Nemonoxacin 650 mg, Moxifloxacin 400 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.962
Comments Only P values less than 0.05 are considered statistically significant in this study.
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.000
Estimation Comments The 2-sided 95% confidence interval of OR is (<0.001, >999.999).
8.Secondary Outcome
Title Subject Number for Microbiologically Cured and Failure at Visit 3 in BE (Bacteriological Evaluable) Population
Hide Description

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.

Time Frame Visit 1 (baseline, day -1~1) to Visit 3 (Within 24 hours after stopping the drug)
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Nemonoxacin 500 mg Nemonoxacin 650 mg Moxifloxacin 400 mg
Hide Arm/Group Description:

Nemonoxacin 500mg/250mL.

Nemonoxacin 500 mg: IV Infusion, once daily for 7~14 days

Nemonoxacin 650 mg/325mL

Nemonoxacin 650 mg: IV Infusion, once daily for 7~14 days

Moxifloxacin 400mg/250mL

Moxifloxacin 400 mg: IV Infusion, once daily for 7~14 days

Overall Number of Participants Analyzed 23 19 16
Measure Type: Number
Unit of Measure: participants
Success 21 18 16
Failure 2 1 0
Not evaluable 0 0 0
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Nemonoxacin 500 mg, Moxifloxacin 400 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.949
Comments Only P values less than 0.05 are considered statistically significant in this study.
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.000
Estimation Comments The 2-sided 95% confidence interval of OR is (<0.001, >999.999).
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Nemonoxacin 650 mg, Moxifloxacin 400 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.962
Comments Only P values less than 0.05 are considered statistically significant in this study.
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.000
Estimation Comments The 2-sided 95% confidence interval of OR is (<0.001, >999.999).
9.Secondary Outcome
Title Subject Number of Success and Failure in Overall Efficacy at Visit 4 in b-mITT (Bacteriological mITT) Population
Hide Description 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.
Time Frame Visit 1 (baseline, day -1~1) to Visit 4 (7-14 days after stopping the drug)
Hide Outcome Measure Data
Hide Analysis Population Description
Subjects in the mITT population whose bacterial culture yielded at least one baseline bacterial isolate were enrolled into the b-mITT population.
Arm/Group Title Nemonoxacin 500 mg Nemonoxacin 650 mg Moxifloxacin 400 mg
Hide Arm/Group Description:

Nemonoxacin 500mg/250mL.

Nemonoxacin 500 mg: IV Infusion, once daily for 7~14 days

Nemonoxacin 650 mg/325mL

Nemonoxacin 650 mg: IV Infusion, once daily for 7~14 days

Moxifloxacin 400mg/250mL

Moxifloxacin 400 mg: IV Infusion, once daily for 7~14 days

Overall Number of Participants Analyzed 24 19 17
Measure Type: Number
Unit of Measure: participants
Success 21 17 16
Failure 3 2 1
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Nemonoxacin 500 mg, Moxifloxacin 400 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.491
Comments Only P values less than 0.05 are considered statistically significant in this study.
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.438
Confidence Interval (2-Sided) 95%
0.042 to 4.609
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Nemonoxacin 650 mg, Moxifloxacin 400 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.619
Comments Only P values less than 0.05 are considered statistically significant in this study.
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.531
Confidence Interval (2-Sided) 95%
0.044 to 6.444
Estimation Comments [Not Specified]
10.Secondary Outcome
Title Subject Number of Success and Failure in Overall Efficacy at Visit 4 in BE (Bacteriological Evaluable) Population
Hide Description 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.
Time Frame Visit 1 (baseline, day -1~1) to Visit 4 (7-14 days after stopping the drug)
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Nemonoxacin 500 mg Nemonoxacin 650 mg Moxifloxacin 400 mg
Hide Arm/Group Description:

Nemonoxacin 500mg/250mL.

Nemonoxacin 500 mg: IV Infusion, once daily for 7~14 days

Nemonoxacin 650 mg/325mL

Nemonoxacin 650 mg: IV Infusion, once daily for 7~14 days

Moxifloxacin 400mg/250mL

Moxifloxacin 400 mg: IV Infusion, once daily for 7~14 days

Overall Number of Participants Analyzed 23 19 16
Measure Type: Number
Unit of Measure: participants
Success 20 17 15
Failure 3 2 1
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Nemonoxacin 500 mg, Moxifloxacin 400 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.501
Comments Only P values less than 0.05 are considered statistically significant in this study.
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.444
Confidence Interval (2-Sided) 95%
0.042 to 4.708
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Nemonoxacin 650 mg, Moxifloxacin 400 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.656
Comments Only P values less than 0.05 are considered statistically significant in this study.
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.567
Confidence Interval (2-Sided) 95%
0.047 to 6.895
Estimation Comments [Not Specified]
11.Secondary Outcome
Title Subject Number of Success and Failure in Overall Efficacy at Visit 3 in b-mITT (Bacteriological mITT) Population
Hide Description 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.
Time Frame Visit 1 (baseline, day -1~1) to Visit 3 (Within 24 hours after stopping the drug)
Hide Outcome Measure Data
Hide Analysis Population Description
Subjects in the mITT population whose bacterial culture yielded at least one baseline bacterial isolate were enrolled into the b-mITT population.
Arm/Group Title Nemonoxacin 500 mg Nemonoxacin 650 mg Moxifloxacin 400 mg
Hide Arm/Group Description:

Nemonoxacin 500mg/250mL.

Nemonoxacin 500 mg: IV Infusion, once daily for 7~14 days

Nemonoxacin 650 mg/325mL

Nemonoxacin 650 mg: IV Infusion, once daily for 7~14 days

Moxifloxacin 400mg/250mL

Moxifloxacin 400 mg: IV Infusion, once daily for 7~14 days

Overall Number of Participants Analyzed 24 19 17
Measure Type: Number
Unit of Measure: participants
Success 22 17 15
Failure 2 2 1
Unevaluable 0 0 1
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Nemonoxacin 500 mg, Moxifloxacin 400 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.807
Comments Only P values less than 0.05 are considered statistically significant in this study.
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.733
Confidence Interval (2-Sided) 95%
0.061 to 8.832
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Nemonoxacin 650 mg, Moxifloxacin 400 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.656
Comments Only P values less than 0.05 are considered statistically significant in this study.
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.567
Confidence Interval (2-Sided) 95%
0.047 to 6.895
Estimation Comments [Not Specified]
12.Secondary Outcome
Title Subject Number of Success and Failure in Overall Efficacy at Visit 3 in BE (Bacteriological Evaluable) Population
Hide Description 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.
Time Frame Visit 1 (baseline, day -1~1) to Visit 3 (Within 24 hours after stopping the drug)
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Nemonoxacin 500 mg Nemonoxacin 650 mg Moxifloxacin 400 mg
Hide Arm/Group Description:

Nemonoxacin 500mg/250mL.

Nemonoxacin 500 mg: IV Infusion, once daily for 7~14 days

Nemonoxacin 650 mg/325mL

Nemonoxacin 650 mg: IV Infusion, once daily for 7~14 days

Moxifloxacin 400mg/250mL

Moxifloxacin 400 mg: IV Infusion, once daily for 7~14 days

Overall Number of Participants Analyzed 23 19 16
Measure Type: Number
Unit of Measure: participants
Success 21 17 15
Failure 2 2 1
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Nemonoxacin 500 mg, Moxifloxacin 400 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.779
Comments Only P values less than 0.05 are considered statistically significant in this study.
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.700
Confidence Interval (2-Sided) 95%
0.058 to 8.445
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Nemonoxacin 650 mg, Moxifloxacin 400 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.656
Comments Only P values less than 0.05 are considered statistically significant in this study.
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.567
Confidence Interval (2-Sided) 95%
0.047 to 6.895
Estimation Comments [Not Specified]
Time Frame The whole study period: from Screening Vsit (day -1~1) to Visit 4 (7-14 days after stopping the drug)
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Nemonoxacin 500 mg Nemonoxacin 650 mg Moxifloxacin 400 mg
Hide Arm/Group Description

Nemonoxacin 500mg/250mL.

Nemonoxacin 500 mg: IV Infusion, once daily for 7~14 days

Nemonoxacin 650 mg/325mL

Nemonoxacin 650 mg: IV Infusion, once daily for 7~14 days

Moxifloxacin 400mg/250mL

Moxifloxacin 400 mg: IV Infusion, once daily for 7~14 days

All-Cause Mortality
Nemonoxacin 500 mg Nemonoxacin 650 mg Moxifloxacin 400 mg
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Nemonoxacin 500 mg Nemonoxacin 650 mg Moxifloxacin 400 mg
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   3/68 (4.41%)      1/67 (1.49%)      1/70 (1.43%)    
Cardiac disorders       
Bradycardia  1 [1]  1/68 (1.47%)  1 0/67 (0.00%)  0 0/70 (0.00%)  0
Worsening of congestive heart failure  1 [2]  1/68 (1.47%)  1 0/67 (0.00%)  0 0/70 (0.00%)  0
Respiratory, thoracic and mediastinal disorders       
Respiratory failure  1 [3]  1/68 (1.47%)  1 1/67 (1.49%)  1 0/70 (0.00%)  0
Lung neoplasm malignant  1 [4]  0/68 (0.00%)  0 0/67 (0.00%)  0 1/70 (1.43%)  1
Vascular disorders       
Hypotension  1 [1]  1/68 (1.47%)  1 0/67 (0.00%)  0 0/70 (0.00%)  0
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 15.1
[1]
Possibly related to the study drug
[2]
Possibly unrelated to the study drug
[3]
Possibly unrelated to the study drug for SAE occurred in subjects in the Nemonoxacin 650mg study group and definitely unrelated to the study drug for for SAE occurred in subjects in the Nemonoxacin 500mg study group
[4]
Definitely unrelated to the study drug
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Nemonoxacin 500 mg Nemonoxacin 650 mg Moxifloxacin 400 mg
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   51/68 (75.00%)      41/67 (61.19%)      33/70 (47.14%)    
Blood and lymphatic system disorders       
Leukopenias NEC  1  0/68 (0.00%)  0 0/67 (0.00%)  0 1/70 (1.43%)  1
Cardiac disorders       
Bradycardia  1  2/68 (2.94%)  2 1/67 (1.49%)  1 0/70 (0.00%)  0
Sinus bradycardia  1  1/68 (1.47%)  1 1/67 (1.49%)  1 2/70 (2.86%)  2
Supraventricular arrhythmias  1  1/68 (1.47%)  1 1/67 (1.49%)  2 0/70 (0.00%)  0
Cardiac conduction disorders  1  1/68 (1.47%)  1 1/67 (1.49%)  1 0/70 (0.00%)  0
Palpitation  1  0/68 (0.00%)  0 0/67 (0.00%)  0 1/70 (1.43%)  3
Chest discomfort  1  0/68 (0.00%)  0 0/67 (0.00%)  0 1/70 (1.43%)  1
Ear and labyrinth disorders       
Hypoacusis  1  1/68 (1.47%)  1 0/67 (0.00%)  0 1/70 (1.43%)  1
Gastrointestinal disorders       
Diarrhoea  1  1/68 (1.47%)  1 0/67 (0.00%)  0 2/70 (2.86%)  2
Constipation  1  1/68 (1.47%)  1 1/67 (1.49%)  1 0/70 (0.00%)  0
Vomiting  1  1/68 (1.47%)  2 0/67 (0.00%)  0 1/70 (1.43%)  1
Gastritis  1  2/68 (2.94%)  2 0/67 (0.00%)  0 0/70 (0.00%)  0
Nausea  1  1/68 (1.47%)  2 0/67 (0.00%)  0 0/70 (0.00%)  0
Dry mouth  1  0/68 (0.00%)  0 0/67 (0.00%)  0 1/70 (1.43%)  1
Frequent bowel movements  1  0/68 (0.00%)  0 0/67 (0.00%)  0 1/70 (1.43%)  1
Abdominal discomfort  1  1/68 (1.47%)  1 0/67 (0.00%)  0 0/70 (0.00%)  0
Oesophagitis  1  1/68 (1.47%)  1 0/67 (0.00%)  0 0/70 (0.00%)  0
Hyperchlorhydria  1  0/68 (0.00%)  0 1/67 (1.49%)  1 0/70 (0.00%)  0
Mucous stools  1  0/68 (0.00%)  0 0/67 (0.00%)  0 1/70 (1.43%)  1
Haemorrhoidal haemorrhage  1  0/68 (0.00%)  0 0/67 (0.00%)  0 1/70 (1.43%)  2
General disorders       
Infusion site erythema  1  11/68 (16.18%)  20 11/67 (16.42%)  25 4/70 (5.71%)  5
Infusion site pruritus  1  8/68 (11.76%)  23 8/67 (11.94%)  25 3/70 (4.29%)  8
Infusion site pain  1  4/68 (5.88%)  11 3/67 (4.48%)  8 2/70 (2.86%)  10
Infusion site discomfort  1  4/68 (5.88%)  16 1/67 (1.49%)  1 0/70 (0.00%)  0
Infusion site rash  1  2/68 (2.94%)  2 2/67 (2.99%)  2 0/70 (0.00%)  0
Infusion site swelling  1  2/68 (2.94%)  5 1/67 (1.49%)  1 0/70 (0.00%)  0
Pyrexia  1  2/68 (2.94%)  2 0/67 (0.00%)  0 0/70 (0.00%)  0
Chest pain  1  0/68 (0.00%)  0 1/67 (1.49%)  1 1/70 (1.43%)  1
Flushing  1  0/68 (0.00%)  0 0/67 (0.00%)  0 1/70 (1.43%)  1
Infusion site erythema  1  1/68 (1.47%)  1 0/67 (0.00%)  0 0/70 (0.00%)  0
Hepatobiliary disorders       
Cholelithiasis  1  2/68 (2.94%)  2 0/67 (0.00%)  0 0/70 (0.00%)  0
Immune system disorders       
Rheumatoid arthritis  1  1/68 (1.47%)  1 0/67 (0.00%)  0 0/70 (0.00%)  0
Urticaria  1  0/68 (0.00%)  0 1/67 (1.49%)  1 0/70 (0.00%)  0
Infections and infestations       
Urinary tract infection  1  1/68 (1.47%)  1 1/67 (1.49%)  1 0/70 (0.00%)  0
Herpes zoster  1  1/68 (1.47%)  1 0/67 (0.00%)  0 0/70 (0.00%)  0
Oral herpes  1  0/68 (0.00%)  0 1/67 (1.49%)  1 0/70 (0.00%)  0
Upper respiratory tract infection  1  1/68 (1.47%)  1 0/67 (0.00%)  0 0/70 (0.00%)  0
Tinea manuum  1  1/68 (1.47%)  1 0/67 (0.00%)  0 0/70 (0.00%)  0
Pharyngitis  1  1/68 (1.47%)  1 0/67 (0.00%)  0 0/70 (0.00%)  0
Tinea pedis  1  1/68 (1.47%)  1 0/67 (0.00%)  0 0/70 (0.00%)  0
Injury, poisoning and procedural complications       
Contusion  1  1/68 (1.47%)  3 0/67 (0.00%)  0 0/70 (0.00%)  0
Investigations       
Alanine aminotransferase increased  1  4/68 (5.88%)  4 14/67 (20.90%)  14 5/70 (7.14%)  5
Aspartate aminotransferase increased  1  3/68 (4.41%)  3 11/67 (16.42%)  11 4/70 (5.71%)  4
White blood cell count decreased  1  3/68 (4.41%)  3 5/67 (7.46%)  6 4/70 (5.71%)  4
Gamma-glutamyltransferase increased  1  1/68 (1.47%)  1 5/67 (7.46%)  5 2/70 (2.86%)  2
Red blood cells urine positive  1  2/68 (2.94%)  2 3/67 (4.48%)  3 2/70 (2.86%)  2
Red blood cell count decreased  1  2/68 (2.94%)  2 3/67 (4.48%)  3 1/70 (1.43%)  1
Neutrophil count decreased  1  0/68 (0.00%)  0 3/67 (4.48%)  3 3/70 (4.29%)  3
Electrocardiogram QT prolonged  1  1/68 (1.47%)  1 3/67 (4.48%)  3 2/70 (2.86%)  3
Blood albumin decreased  1  3/68 (4.41%)  4 1/67 (1.49%)  1 2/70 (2.86%)  2
Blood potassium decreased  1  2/68 (2.94%)  2 3/67 (4.48%)  3 1/70 (1.43%)  1
Blood lactate dehydrogenase increased  1  3/68 (4.41%)  3 2/67 (2.99%)  2 1/70 (1.43%)  1
Haematocrit decreased  1  2/68 (2.94%)  2 2/67 (2.99%)  2 2/70 (2.86%)  2
Neutrophil percentage decreased  1  2/68 (2.94%)  2 2/67 (2.99%)  2 1/70 (1.43%)  1
Haemoglobin decreased  1  1/68 (1.47%)  1 2/67 (2.99%)  2 2/70 (2.86%)  2
White blood cell count increased  1  1/68 (1.47%)  1 3/67 (4.48%)  3 0/70 (0.00%)  0
Blood creatine phosphokinase increased  1  2/68 (2.94%)  2 1/67 (1.49%)  1 1/70 (1.43%)  1
Blood alkaline phosphatase increased  1  0/68 (0.00%)  0 3/67 (4.48%)  3 1/70 (1.43%)  1
Platelet count increased  1  1/68 (1.47%)  1 1/67 (1.49%)  1 2/70 (2.86%)  2
Protein total decreased  1  1/68 (1.47%)  1 2/67 (2.99%)  2 1/70 (1.43%)  1
Platelet count decreased  1  0/68 (0.00%)  0 3/67 (4.48%)  3 0/70 (0.00%)  0
C-reactive protein increased  1  0/68 (0.00%)  0 1/67 (1.49%)  1 1/70 (1.43%)  1
Neutrophil count increased  1  1/68 (1.47%)  1 1/67 (1.49%)  1 0/70 (0.00%)  0
Blood urea increased  1  1/68 (1.47%)  1 0/67 (0.00%)  0 1/70 (1.43%)  1
Blood uric acid increased  1  1/68 (1.47%)  1 1/67 (1.49%)  1 0/70 (0.00%)  0
Blood pressure increased  1  0/68 (0.00%)  0 1/67 (1.49%)  1 1/70 (1.43%)  1
Alpha hydroxybutyrate dehydrogenase increased  1  1/68 (1.47%)  1 0/67 (0.00%)  0 0/70 (0.00%)  0
Monocyte percentage increased  1  0/68 (0.00%)  0 0/67 (0.00%)  0 1/70 (1.43%)  1
Monocyte count increased  1  1/68 (1.47%)  1 0/67 (0.00%)  0 0/70 (0.00%)  0
Lymphocyte percentage increased  1  0/68 (0.00%)  0 1/67 (1.49%)  1 0/70 (0.00%)  0
Lymphocyte count increased  1  0/68 (0.00%)  0 0/67 (0.00%)  0 1/70 (1.43%)  1
Protein urine present  1  0/68 (0.00%)  0 0/67 (0.00%)  0 1/70 (1.43%)  1
Red blood cells urine positive  1  1/68 (1.47%)  1 0/67 (0.00%)  0 0/70 (0.00%)  0
Mean cell haemoglobin concentration decreased  1  0/68 (0.00%)  0 1/67 (1.49%)  1 0/70 (0.00%)  0
Mean cell haemoglobin concentration increased  1  0/68 (0.00%)  0 1/67 (1.49%)  1 0/70 (0.00%)  0
Prealbumin decreased  1  1/68 (1.47%)  1 0/67 (0.00%)  0 0/70 (0.00%)  0
Eosinophil percentage increased  1  0/68 (0.00%)  0 1/67 (1.49%)  1 0/70 (0.00%)  0
Eosinophil count increased  1  0/68 (0.00%)  0 0/67 (0.00%)  0 1/70 (1.43%)  1
Neutrophil percentage increased  1  0/68 (0.00%)  0 1/67 (1.49%)  1 0/70 (0.00%)  0
Electrocardiogram ST-T change  1  0/68 (0.00%)  0 0/67 (0.00%)  0 1/70 (1.43%)  1
Electrocardiogram T wave amplitude decreased  1  1/68 (1.47%)  1 0/67 (0.00%)  0 0/70 (0.00%)  0
Blood bilirubin increased  1  1/68 (1.47%)  1 0/67 (0.00%)  0 0/70 (0.00%)  0
Blood glucose decreased  1  1/68 (1.47%)  1 0/67 (0.00%)  0 0/70 (0.00%)  0
Total bile acids increased  1  0/68 (0.00%)  0 1/67 (1.49%)  1 0/70 (0.00%)  0
Metabolism and nutrition disorders       
Hypoproteinaemia  1  0/68 (0.00%)  0 0/67 (0.00%)  0 1/70 (1.43%)  1
Hepatic steatosis  1  1/68 (1.47%)  1 0/67 (0.00%)  0 0/70 (0.00%)  0
Musculoskeletal and connective tissue disorders       
Groin pain  1  1/68 (1.47%)  1 0/67 (0.00%)  0 0/70 (0.00%)  0
Musculoskeletal pain  1  0/68 (0.00%)  0 0/67 (0.00%)  0 1/70 (1.43%)  1
Arthralgia  1  1/68 (1.47%)  1 0/67 (0.00%)  0 0/70 (0.00%)  0
Spondyloarthropathy  1  0/68 (0.00%)  0 0/67 (0.00%)  0 1/70 (1.43%)  1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)       
Renal cyst  1  1/68 (1.47%)  1 0/67 (0.00%)  0 0/70 (0.00%)  0
Nervous system disorders       
Dizziness  1  1/68 (1.47%)  1 0/67 (0.00%)  0 3/70 (4.29%)  3
Gait disturbance  1  0/68 (0.00%)  0 0/67 (0.00%)  0 1/70 (1.43%)  1
Hypoaesthesia  1  0/68 (0.00%)  0 1/67 (1.49%)  1 0/70 (0.00%)  0
Dysphemia  1  0/68 (0.00%)  0 0/67 (0.00%)  0 1/70 (1.43%)  1
Altered visual depth perception  1  0/68 (0.00%)  0 0/67 (0.00%)  0 1/70 (1.43%)  1
Headache  1  1/68 (1.47%)  1 0/67 (0.00%)  0 0/70 (0.00%)  0
Renal and urinary disorders       
Bladder mass  1  1/68 (1.47%)  1 0/67 (0.00%)  0 0/70 (0.00%)  0
Respiratory, thoracic and mediastinal disorders       
Nasal obstruction  1  0/68 (0.00%)  0 0/67 (0.00%)  0 1/70 (1.43%)  1
Interstitial lung disease  1  1/68 (1.47%)  1 0/67 (0.00%)  0 0/70 (0.00%)  0
Chest pain  1  1/68 (1.47%)  1 0/67 (0.00%)  0 0/70 (0.00%)  0
Skin and subcutaneous tissue disorders       
Rash  1  2/68 (2.94%)  2 1/67 (1.49%)  4 1/70 (1.43%)  1
Eczema  1  0/68 (0.00%)  0 0/67 (0.00%)  0 1/70 (1.43%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 15.1
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
PI needs to inform sponsor and asks for permission before he/she discusses or publishes trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Chen-En Tsai, M.D., Ph.D.
Organization: TaiGen Biotechnology Co., Ltd.
Phone: +886-2-8177-7072 ext 1211
EMail: cetsai@taigenbiotech.com
Layout table for additonal information
Responsible Party: TaiGen Biotechnology Co., Ltd.
ClinicalTrials.gov Identifier: NCT01944774     History of Changes
Other Study ID Numbers: TG-873870-C-5
First Submitted: August 26, 2013
First Posted: September 18, 2013
Results First Submitted: January 8, 2015
Results First Posted: February 18, 2015
Last Update Posted: February 18, 2015