Trial Outcomes & Findings for Safety and Efficacy Study of TG-873870 (Nemonoxacin) in Diabetic Foot Infections (NCT NCT00685698)

Last Updated: 2025-07-01

Results Overview

Clinical Success * Resolution is defined as total resolution of all pretreatment clinically significant signs and symptoms of infection and no development of any systemic evidence of infection. * Improvement is defined as resolution of more than two, but not all, pretreatment clinical signs and symptoms, or partial resolution of all clinical signs and symptoms relative to the baseline assessment, with no further need for antibiotic therapy, and no need for infection-related surgical interventions.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

40 participants

Primary outcome timeframe

Test of Cure Visit, 12±2 days after End of Treatment Visit/Early Termination

Results posted on

2025-07-01

Participant Flow

Patients were assessed during the 1- to 2-day screening phase (Visit 1) to determine their eligibility. Eligible patients demonstrating the presence of at least one Gram-positive organism on the basis of Gram-stain could begin treatment with study medication the same day (Day 1, Visit 1).

Participant milestones

Participant milestones
Measure	Nemonoxacin Nemonoxacin 750 mg,oral administration, single-arm, once daily 7±1 and 14±1 days. TG-873870 (Nemonoxacin): 750 mg
Overall Study STARTED	38
Overall Study COMPLETED	25
Overall Study NOT COMPLETED	13

Reasons for withdrawal

Reasons for withdrawal
Measure	Nemonoxacin Nemonoxacin 750 mg,oral administration, single-arm, once daily 7±1 and 14±1 days. TG-873870 (Nemonoxacin): 750 mg
Overall Study Withdrawal by Subject	1
Overall Study Protocol Violation	6
Overall Study Adverse Event	3
Overall Study CULTURE GRAM NEG SPECIES	1
Overall Study CULTURE RESULTS: GRAM-VE	1
Overall Study NO GRAM POSITIVE CULTURE GROWN	1

Baseline Characteristics

Safety and Efficacy Study of TG-873870 (Nemonoxacin) in Diabetic Foot Infections

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Nemonoxacin n=33 Participants Nemonoxacin 750 mg,oral administration, single-arm, once daily 7±1 and 14±1 days. TG-873870 (Nemonoxacin): 750 mg
Age, Continuous	57.0 years n=99 Participants
Age, Customized < 20 years	0 participants n=99 Participants
Age, Customized >= 20 and < 30 years	0 participants n=99 Participants
Age, Customized >= 30 and < 40 years	1 participants n=99 Participants
Age, Customized >= 40 and < 50 years	8 participants n=99 Participants
Age, Customized >= 50 and < 60 years	11 participants n=99 Participants
Age, Customized >= 60 and < 70 years	3 participants n=99 Participants
Age, Customized >= 70 and < 80 years	9 participants n=99 Participants
Age, Customized >= 80 years	1 participants n=99 Participants
Sex: Female, Male Female	11 Participants n=99 Participants
Sex: Female, Male Male	22 Participants n=99 Participants
Race/Ethnicity, Customized White	15 participants n=99 Participants
Race/Ethnicity, Customized Black	7 participants n=99 Participants
Race/Ethnicity, Customized Asian	5 participants n=99 Participants
Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander	0 participants n=99 Participants
Race/Ethnicity, Customized American Indian or Alaska Native	0 participants n=99 Participants
Race/Ethnicity, Customized Other	6 participants n=99 Participants
Type of Diabetes Type 1 (Juvenile Onset)	3 participants n=99 Participants
Type of Diabetes Type 2 (Adult Onset)	30 participants n=99 Participants
Time Since Diabetes Diagnosis	6.0 years n=99 Participants
Distribution of Time Since Diabetes Diagnosis < 5 years	12 participants n=99 Participants
Distribution of Time Since Diabetes Diagnosis >= 5 and < 10 years	8 participants n=99 Participants
Distribution of Time Since Diabetes Diagnosis >= 10 and < 20 years	9 participants n=99 Participants
Distribution of Time Since Diabetes Diagnosis >= 20 and < 30 years	2 participants n=99 Participants
Distribution of Time Since Diabetes Diagnosis >= 30 and < 40 years	0 participants n=99 Participants
Distribution of Time Since Diabetes Diagnosis >= 40 years	0 participants n=99 Participants
Distribution of Time Since Diabetes Diagnosis Missing	2 participants n=99 Participants
Most Recent HbA1c % Result < 6.5%	2 participants n=99 Participants
Most Recent HbA1c % Result >= 6.5% and < 7.0%	3 participants n=99 Participants
Most Recent HbA1c % Result >= 7.0% and < 9.0%	10 participants n=99 Participants
Most Recent HbA1c % Result >= 9.0% and < 10.0%	3 participants n=99 Participants
Most Recent HbA1c % Result >= 10.0% and < 11.0%	2 participants n=99 Participants
Most Recent HbA1c % Result >= 11.0% and < 12.0%	1 participants n=99 Participants
Most Recent HbA1c % Result >= 12.0%	0 participants n=99 Participants
Most Recent HbA1c % Result Missing	12 participants n=99 Participants
HbA1c % Result at Visit 1 < 6.5%	6 participants n=99 Participants
HbA1c % Result at Visit 1 >= 6.5% and < 7.0%	2 participants n=99 Participants
HbA1c % Result at Visit 1 >= 7.0% and < 9.0%	18 participants n=99 Participants
HbA1c % Result at Visit 1 >= 9.0% and < 10.0%	3 participants n=99 Participants
HbA1c % Result at Visit 1 >= 10.0% and < 11.0%	1 participants n=99 Participants
HbA1c % Result at Visit 1 >= 11.0% and < 12.0%	2 participants n=99 Participants
HbA1c % Result at Visit 1 >= 12.0%	1 participants n=99 Participants
Current treatment for Diabetes Diet and Exercise	20 participants n=99 Participants
Current treatment for Diabetes Oral Agent	25 participants n=99 Participants
Current treatment for Diabetes Insulin	16 participants n=99 Participants

PRIMARY outcome

Timeframe: Test of Cure Visit, 12±2 days after End of Treatment Visit/Early Termination

Population: All eligible patients who took at least one whole dose of study drug and had at least 1 gram-positive pathogen identified at the Baseline Visit (Visit 1).

Outcome measures

Outcome measures
Measure	Nemonoxacin n=33 Participants Nemonoxacin 750 mg,oral administration, single-arm, once daily 7±1 and 14±1 days. TG-873870 (Nemonoxacin): 750 mg	Nemonoxacin (PP Population at Test of Cure Visit) Nemonoxacin 750 mg,oral administration, single-arm, once daily 7±1 and 14±1 days. TG-873870 (Nemonoxacin): 750 mg	Nemonoxacin (Change From Baseline to Test of Cure Visit) Nemonoxacin 750 mg,oral administration, single-arm, once daily 7±1 and 14±1 days. TG-873870 (Nemonoxacin): 750 mg
Clinical Success (in ITT Population)	95.7 percentage of participants Interval 78.1 to 99.9	—	—

SECONDARY outcome

Timeframe: Test of Cure Visit, 12±2 days after End of Treatment Visit/Early Termination

Microbiological Success * Eradicated, defined as absence of the original pathogen(s) from a repeat culture of the original infection site performed at the TOC visit. * Presumed Eradicated, defined as meeting the definition for Clinical Success at the TOC visit, but tissue sample could be obtained for culture from the original infection site. * TOC=Test of Cure

Outcome measures

Outcome measures
Measure	Nemonoxacin n=33 Participants Nemonoxacin 750 mg,oral administration, single-arm, once daily 7±1 and 14±1 days. TG-873870 (Nemonoxacin): 750 mg	Nemonoxacin (PP Population at Test of Cure Visit) n=20 Participants Nemonoxacin 750 mg,oral administration, single-arm, once daily 7±1 and 14±1 days. TG-873870 (Nemonoxacin): 750 mg	Nemonoxacin (Change From Baseline to Test of Cure Visit) Nemonoxacin 750 mg,oral administration, single-arm, once daily 7±1 and 14±1 days. TG-873870 (Nemonoxacin): 750 mg
Microbiological Success Rate	82.6 percentage of participants Interval 61.2 to 95.0	89.5 percentage of participants Interval 66.9 to 98.7	—

SECONDARY outcome

Timeframe: Test of Cure Visit, 12±2 days after End of Treatment Visit/Early Termination

Population: All eligible patients who took at least one whole dose of study drug and had at least 1 gram-positive pathogen identified at the Baseline Visit (Visit 1), and adhered to the protocol without major protocol violations.

Outcome measures

Outcome measures
Measure	Nemonoxacin n=20 Participants Nemonoxacin 750 mg,oral administration, single-arm, once daily 7±1 and 14±1 days. TG-873870 (Nemonoxacin): 750 mg	Nemonoxacin (PP Population at Test of Cure Visit) Nemonoxacin 750 mg,oral administration, single-arm, once daily 7±1 and 14±1 days. TG-873870 (Nemonoxacin): 750 mg	Nemonoxacin (Change From Baseline to Test of Cure Visit) Nemonoxacin 750 mg,oral administration, single-arm, once daily 7±1 and 14±1 days. TG-873870 (Nemonoxacin): 750 mg
Clinical Success (in PP Population)	94.7 percentage of participants Interval 74.0 to 99.9	—	—

SECONDARY outcome

Timeframe: End of Treatment/Early Termination Visit; 7±1, 14±1, 21±1 or 28±1 days after Baseline (Day 1)

Outcome measures

Outcome measures
Measure	Nemonoxacin n=33 Participants Nemonoxacin 750 mg,oral administration, single-arm, once daily 7±1 and 14±1 days. TG-873870 (Nemonoxacin): 750 mg	Nemonoxacin (PP Population at Test of Cure Visit) n=24 Participants Nemonoxacin 750 mg,oral administration, single-arm, once daily 7±1 and 14±1 days. TG-873870 (Nemonoxacin): 750 mg	Nemonoxacin (Change From Baseline to Test of Cure Visit) Nemonoxacin 750 mg,oral administration, single-arm, once daily 7±1 and 14±1 days. TG-873870 (Nemonoxacin): 750 mg
Clinical Success (at End of Treatment/Early Termination)	100.0 percentage of participants Interval 87.7 to 100.0	100.0 percentage of participants Interval 85.2 to 100.0	—

SECONDARY outcome

Timeframe: Test of Cure Visit, 12±2 days after End of Treatment Visit/Early Termination

Clinical responses were assessed on a per-pathogen basis for the most frequently isolated pathogens at baseline (i.e., present in four or more patients), including MRSA. Clinical Responses were assessed at Test of Cure visit within each of the ITT and PP populations. Insufficient numbers prevented reporting Clinical Success rates for Streptococcus pyogenes in the PP population.

Outcome measures

Outcome measures
Measure	Nemonoxacin n=33 Participants Nemonoxacin 750 mg,oral administration, single-arm, once daily 7±1 and 14±1 days. TG-873870 (Nemonoxacin): 750 mg	Nemonoxacin (PP Population at Test of Cure Visit) n=20 Participants Nemonoxacin 750 mg,oral administration, single-arm, once daily 7±1 and 14±1 days. TG-873870 (Nemonoxacin): 750 mg	Nemonoxacin (Change From Baseline to Test of Cure Visit) Nemonoxacin 750 mg,oral administration, single-arm, once daily 7±1 and 14±1 days. TG-873870 (Nemonoxacin): 750 mg
Per-Pathogen Clinical Responses (at Test of Cure) Staphylococcus aureus	100.0 percentage of participants Interval 78.2 to 100.0	100.0 percentage of participants Interval 73.5 to 100.0	—
Per-Pathogen Clinical Responses (at Test of Cure) Escherichia coli (in ITT population)	100.0 percentage of participants Interval 54.1 to 100.0	100.0 percentage of participants Interval 39.8 to 100.0	—
Per-Pathogen Clinical Responses (at Test of Cure) Enterococcus faecalis (in ITT population)	100.0 percentage of participants Interval 39.8 to 100.0	100.0 percentage of participants Interval 39.8 to 100.0	—
Per-Pathogen Clinical Responses (at Test of Cure) Streptococcus agalactiae (in ITT population)	100.0 percentage of participants Interval 29.2 to 100.0	100.0 percentage of participants Interval 29.2 to 100.0	—
Per-Pathogen Clinical Responses (at Test of Cure) Streptococcus pyogenes (in ITT population)	100.0 percentage of participants Interval 39.8 to 100.0	NA percentage of participants Insufficient numbers prevented reporting Clinical Success rate for Streptococcus pyogenes in the PP population.	—

SECONDARY outcome

Timeframe: End of Treatment/Early Termination Visit; 7±1, 14±1, 21±1 or 28±1 days after Baseline (Day 1)

Clinical responses were assessed on a per-pathogen basis for the most frequently isolated pathogens at baseline (i.e., present in four or more patients), including MRSA. Clinical Responses were assessed at at End of Treatment/Early Termination within each of the ITT and PP populations. Insufficient numbers prevented reporting Clinical Success rates for Streptococcus pyogenes in the PP population.

Outcome measures

Outcome measures
Measure	Nemonoxacin n=33 Participants Nemonoxacin 750 mg,oral administration, single-arm, once daily 7±1 and 14±1 days. TG-873870 (Nemonoxacin): 750 mg	Nemonoxacin (PP Population at Test of Cure Visit) n=24 Participants Nemonoxacin 750 mg,oral administration, single-arm, once daily 7±1 and 14±1 days. TG-873870 (Nemonoxacin): 750 mg	Nemonoxacin (Change From Baseline to Test of Cure Visit) Nemonoxacin 750 mg,oral administration, single-arm, once daily 7±1 and 14±1 days. TG-873870 (Nemonoxacin): 750 mg
Per-Pathogen Clinical Response (at End of Treatment/Early Termination) Staphylococcus aureus (in ITT population)	100.0 percentage of participants Interval 81.5 to 100.0	100.0 percentage of participants Interval 78.2 to 100.0	—
Per-Pathogen Clinical Response (at End of Treatment/Early Termination) Escherichia coli (in ITT population)	100.0 percentage of participants Interval 54.1 to 100.0	100.0 percentage of participants Interval 39.8 to 100.0	—
Per-Pathogen Clinical Response (at End of Treatment/Early Termination) Enterococcus faecalis (in ITT population)	100.0 percentage of participants Interval 47.8 to 100.0	100.0 percentage of participants Interval 47.8 to 100.0	—
Per-Pathogen Clinical Response (at End of Treatment/Early Termination) Streptococcus agalactiae (in ITT population)	100.0 percentage of participants Interval 39.8 to 100.0	100.0 percentage of participants Interval 29.2 to 100.0	—
Per-Pathogen Clinical Response (at End of Treatment/Early Termination) Streptococcus pyogenes (in ITT population)	100.0 percentage of participants Interval 39.8 to 100.0	NA percentage of participants Insufficient numbers prevented reporting Clinical Success rate for Streptococcus pyogenes in the PP population.	—

SECONDARY outcome

Timeframe: Test of Cure Visit, 12±2 days after End of Treatment Visit/Early Termination

Microbiological responses were assessed on a per-pathogen basis for the most frequently isolated pathogens at baseline (i.e., present in four or more patients), including MRSA. Microbiological Responses were assessed at Test of Cure visit within each of the ITT and PP populations. Insufficient numbers prevented reporting Microbiological Success rates for Streptococcus pyogenes in the PP population.

Outcome measures

Outcome measures
Measure	Nemonoxacin n=33 Participants Nemonoxacin 750 mg,oral administration, single-arm, once daily 7±1 and 14±1 days. TG-873870 (Nemonoxacin): 750 mg	Nemonoxacin (PP Population at Test of Cure Visit) n=20 Participants Nemonoxacin 750 mg,oral administration, single-arm, once daily 7±1 and 14±1 days. TG-873870 (Nemonoxacin): 750 mg	Nemonoxacin (Change From Baseline to Test of Cure Visit) Nemonoxacin 750 mg,oral administration, single-arm, once daily 7±1 and 14±1 days. TG-873870 (Nemonoxacin): 750 mg
Per-Pathogen Microbiological Responses Staphylococcus aureus (in ITT population)	93.3 percentage of participants Interval 68.1 to 99.8	100.0 percentage of participants Interval 73.5 to 100.0	—
Per-Pathogen Microbiological Responses Escherichia coli (in ITT population)	66.7 percentage of participants Interval 22.3 to 95.7	75.0 percentage of participants Interval 19.4 to 99.4	—
Per-Pathogen Microbiological Responses Enterococcus faecalis (in ITT population)	75.0 percentage of participants Interval 19.4 to 99.4	75.0 percentage of participants Interval 19.4 to 99.4	—
Per-Pathogen Microbiological Responses Streptococcus agalactiae (in ITT population)	100.0 percentage of participants Interval 29.2 to 100.0	100.0 percentage of participants Interval 29.2 to 100.0	—
Per-Pathogen Microbiological Responses Streptococcus pyogenes (in ITT population)	100.0 percentage of participants Interval 39.8 to 100.0	NA percentage of participants Insufficient numbers prevented reporting Microbiological Success rate for Streptococcus pyogenes in the PP population.	—

SECONDARY outcome

Timeframe: Visit 1 (Baseline); Test of Cure Visit, 12±2 days after End of Treatment Visit/Early Termination

The Diabetic Foot Infection (DFI) Wound Scores will be used to evaluate the wound assessment at baseline and Test of Cure visits. The wound composite score was based on combining the general wound parameters (signs and symptoms of infection), and wound measurements (length, width, depth). Each wound parameter was assigned a score based on severity, with higher scores defining greater severity. For wound measurements and undermining, larger measurements received higher scores. The minimum and maximum score are 3 and 49, respectively.

Outcome measures

Outcome measures
Measure	Nemonoxacin n=33 Participants Nemonoxacin 750 mg,oral administration, single-arm, once daily 7±1 and 14±1 days. TG-873870 (Nemonoxacin): 750 mg	Nemonoxacin (PP Population at Test of Cure Visit) n=28 Participants Nemonoxacin 750 mg,oral administration, single-arm, once daily 7±1 and 14±1 days. TG-873870 (Nemonoxacin): 750 mg	Nemonoxacin (Change From Baseline to Test of Cure Visit) n=28 Participants Nemonoxacin 750 mg,oral administration, single-arm, once daily 7±1 and 14±1 days. TG-873870 (Nemonoxacin): 750 mg
Total Wound Score (at Test of Cure in ITT Population)	16.9 scores on a scale Standard Deviation 6.30	6.0 scores on a scale Standard Deviation 3.67	-11.2 scores on a scale Standard Deviation 6.91

SECONDARY outcome

Timeframe: Visit 1 (Baseline); Test of Cure Visit, 12±2 days after End of Treatment Visit/Early Termination

Outcome measures

Outcome measures
Measure	Nemonoxacin n=20 Participants Nemonoxacin 750 mg,oral administration, single-arm, once daily 7±1 and 14±1 days. TG-873870 (Nemonoxacin): 750 mg	Nemonoxacin (PP Population at Test of Cure Visit) n=19 Participants Nemonoxacin 750 mg,oral administration, single-arm, once daily 7±1 and 14±1 days. TG-873870 (Nemonoxacin): 750 mg	Nemonoxacin (Change From Baseline to Test of Cure Visit) n=19 Participants Nemonoxacin 750 mg,oral administration, single-arm, once daily 7±1 and 14±1 days. TG-873870 (Nemonoxacin): 750 mg
Total Wound Score (at Test of Cure in PP Population)	18.2 scores on a scale Standard Deviation 6.54	5.0 scores on a scale Standard Deviation 2.79	-12.9 scores on a scale Standard Deviation 7.10

SECONDARY outcome

Timeframe: Visit 1 (Baseline); End of Treatment/Early Termination Visit; 7±1, 14±1, 21±1 or 28±1 days after Baseline (Day 1)

The Diabetic Foot Infection (DFI) Wound Scores will be used to evaluate the wound assessment at baseline and End of Treatment/ Early Termination visits. The wound composite score was based on combining the general wound parameters (signs and symptoms of infection), and wound measurements (length, width, depth). Each wound parameter was assigned a score based on severity, with higher scores defining greater severity. For wound measurements and undermining, larger measurements received higher scores. The minimum and maximum score are 3 and 49, respectively.

Outcome measures

Outcome measures
Measure	Nemonoxacin n=33 Participants Nemonoxacin 750 mg,oral administration, single-arm, once daily 7±1 and 14±1 days. TG-873870 (Nemonoxacin): 750 mg	Nemonoxacin (PP Population at Test of Cure Visit) n=32 Participants Nemonoxacin 750 mg,oral administration, single-arm, once daily 7±1 and 14±1 days. TG-873870 (Nemonoxacin): 750 mg	Nemonoxacin (Change From Baseline to Test of Cure Visit) n=32 Participants Nemonoxacin 750 mg,oral administration, single-arm, once daily 7±1 and 14±1 days. TG-873870 (Nemonoxacin): 750 mg
Total Wound Score (at End of Treatment/ Early Termination in ITT Population)	16.9 scores on a scale Standard Deviation 6.30	7.2 scores on a scale Standard Deviation 4.65	-9.6 scores on a scale Standard Deviation 6.35

SECONDARY outcome

Timeframe: Visit 1 (Baseline); End of Treatment/Early Termination Visit; 7±1, 14±1, 21±1 or 28±1 days after Baseline (Day 1)

Outcome measures

Outcome measures
Measure	Nemonoxacin n=20 Participants Nemonoxacin 750 mg,oral administration, single-arm, once daily 7±1 and 14±1 days. TG-873870 (Nemonoxacin): 750 mg	Nemonoxacin (PP Population at Test of Cure Visit) n=20 Participants Nemonoxacin 750 mg,oral administration, single-arm, once daily 7±1 and 14±1 days. TG-873870 (Nemonoxacin): 750 mg	Nemonoxacin (Change From Baseline to Test of Cure Visit) n=20 Participants Nemonoxacin 750 mg,oral administration, single-arm, once daily 7±1 and 14±1 days. TG-873870 (Nemonoxacin): 750 mg
Total Wound Score (at End of Treatment/ Early Termination in PP Population)	18.2 scores on a scale Standard Deviation 6.54	6.2 scores on a scale Standard Deviation 4.31	-12.1 scores on a scale Standard Deviation 6.44

SECONDARY outcome

Timeframe: End of Treatment/Early Termination Visit; 7±1, 14±1, 21±1 or 28±1 days after Baseline (Day 1)

The number of patients within each of the PEDIS grading categories (uninfected, mild, moderate and severe) at baseline and End of Treatment/Early Termination.

Outcome measures

Outcome measures
Measure	Nemonoxacin n=33 Participants Nemonoxacin 750 mg,oral administration, single-arm, once daily 7±1 and 14±1 days. TG-873870 (Nemonoxacin): 750 mg	Nemonoxacin (PP Population at Test of Cure Visit) Nemonoxacin 750 mg,oral administration, single-arm, once daily 7±1 and 14±1 days. TG-873870 (Nemonoxacin): 750 mg	Nemonoxacin (Change From Baseline to Test of Cure Visit) Nemonoxacin 750 mg,oral administration, single-arm, once daily 7±1 and 14±1 days. TG-873870 (Nemonoxacin): 750 mg
Diabetic Foot Assessment (PEDIS) Shifts From Baseline at End of Treatment/Early Termination in ITT Population Uninfected to Uninfected	0 participants	—	—
Diabetic Foot Assessment (PEDIS) Shifts From Baseline at End of Treatment/Early Termination in ITT Population Uninfected to Mild	0 participants	—	—
Diabetic Foot Assessment (PEDIS) Shifts From Baseline at End of Treatment/Early Termination in ITT Population Uninfected to Moderate	0 participants	—	—
Diabetic Foot Assessment (PEDIS) Shifts From Baseline at End of Treatment/Early Termination in ITT Population Uninfected to Severe	0 participants	—	—
Diabetic Foot Assessment (PEDIS) Shifts From Baseline at End of Treatment/Early Termination in ITT Population Mild to Uninfected	8 participants	—	—
Diabetic Foot Assessment (PEDIS) Shifts From Baseline at End of Treatment/Early Termination in ITT Population Mild to Mild	4 participants	—	—
Diabetic Foot Assessment (PEDIS) Shifts From Baseline at End of Treatment/Early Termination in ITT Population Mild to Moderate	0 participants	—	—
Diabetic Foot Assessment (PEDIS) Shifts From Baseline at End of Treatment/Early Termination in ITT Population Mild to Severe	0 participants	—	—
Diabetic Foot Assessment (PEDIS) Shifts From Baseline at End of Treatment/Early Termination in ITT Population Severe to Uninfected	0 participants	—	—
Diabetic Foot Assessment (PEDIS) Shifts From Baseline at End of Treatment/Early Termination in ITT Population Severe to Mild	0 participants	—	—
Diabetic Foot Assessment (PEDIS) Shifts From Baseline at End of Treatment/Early Termination in ITT Population Severe to Moderate	0 participants	—	—
Diabetic Foot Assessment (PEDIS) Shifts From Baseline at End of Treatment/Early Termination in ITT Population Severe to Severe	0 participants	—	—
Diabetic Foot Assessment (PEDIS) Shifts From Baseline at End of Treatment/Early Termination in ITT Population Moderate to Uninfected	12 participants	—	—
Diabetic Foot Assessment (PEDIS) Shifts From Baseline at End of Treatment/Early Termination in ITT Population Moderate to Mild	5 participants	—	—
Diabetic Foot Assessment (PEDIS) Shifts From Baseline at End of Treatment/Early Termination in ITT Population Moderate to Moderate	3 participants	—	—
Diabetic Foot Assessment (PEDIS) Shifts From Baseline at End of Treatment/Early Termination in ITT Population Moderate to Severe	0 participants	—	—

SECONDARY outcome

Timeframe: Test of Cure Visit, 12±2 days after End of Treatment Visit/Early Termination

The number of patients within each of the PEDIS grading categories (uninfected, mild, moderate and severe) at baseline and Test of Cure.

Outcome measures

Outcome measures
Measure	Nemonoxacin n=33 Participants Nemonoxacin 750 mg,oral administration, single-arm, once daily 7±1 and 14±1 days. TG-873870 (Nemonoxacin): 750 mg	Nemonoxacin (PP Population at Test of Cure Visit) Nemonoxacin 750 mg,oral administration, single-arm, once daily 7±1 and 14±1 days. TG-873870 (Nemonoxacin): 750 mg	Nemonoxacin (Change From Baseline to Test of Cure Visit) Nemonoxacin 750 mg,oral administration, single-arm, once daily 7±1 and 14±1 days. TG-873870 (Nemonoxacin): 750 mg
Diabetic Foot Assessment (PEDIS) Shifts From Baseline at Test of Cure in ITT Population Uninfected to Uninfected	0 participants	—	—
Diabetic Foot Assessment (PEDIS) Shifts From Baseline at Test of Cure in ITT Population Uninfected to Mild	0 participants	—	—
Diabetic Foot Assessment (PEDIS) Shifts From Baseline at Test of Cure in ITT Population Uninfected to Moderate	0 participants	—	—
Diabetic Foot Assessment (PEDIS) Shifts From Baseline at Test of Cure in ITT Population Uninfected to Severe	0 participants	—	—
Diabetic Foot Assessment (PEDIS) Shifts From Baseline at Test of Cure in ITT Population Mild to Uninfected	8 participants	—	—
Diabetic Foot Assessment (PEDIS) Shifts From Baseline at Test of Cure in ITT Population Mild to Mild	2 participants	—	—
Diabetic Foot Assessment (PEDIS) Shifts From Baseline at Test of Cure in ITT Population Severe to Mild	0 participants	—	—
Diabetic Foot Assessment (PEDIS) Shifts From Baseline at Test of Cure in ITT Population Severe to Moderate	0 participants	—	—
Diabetic Foot Assessment (PEDIS) Shifts From Baseline at Test of Cure in ITT Population Severe to Severe	0 participants	—	—
Diabetic Foot Assessment (PEDIS) Shifts From Baseline at Test of Cure in ITT Population Mild to Moderate	0 participants	—	—
Diabetic Foot Assessment (PEDIS) Shifts From Baseline at Test of Cure in ITT Population Mild to Severe	0 participants	—	—
Diabetic Foot Assessment (PEDIS) Shifts From Baseline at Test of Cure in ITT Population Moderate to Uninfected	15 participants	—	—
Diabetic Foot Assessment (PEDIS) Shifts From Baseline at Test of Cure in ITT Population Moderate to Mild	3 participants	—	—
Diabetic Foot Assessment (PEDIS) Shifts From Baseline at Test of Cure in ITT Population Moderate to Moderate	0 participants	—	—
Diabetic Foot Assessment (PEDIS) Shifts From Baseline at Test of Cure in ITT Population Moderate to Severe	0 participants	—	—
Diabetic Foot Assessment (PEDIS) Shifts From Baseline at Test of Cure in ITT Population Severe to Uninfected	0 participants	—	—

SECONDARY outcome

Timeframe: End of Treatment/Early Termination Visit; 7±1, 14±1, 21±1 or 28±1 days after Baseline (Day 1)

The number of patients within each of the PEDIS grading categories (uninfected, mild, moderate and severe) at baseline and End of Treatment/Early Termination.

Outcome measures

Outcome measures
Measure	Nemonoxacin n=20 Participants Nemonoxacin 750 mg,oral administration, single-arm, once daily 7±1 and 14±1 days. TG-873870 (Nemonoxacin): 750 mg	Nemonoxacin (PP Population at Test of Cure Visit) Nemonoxacin 750 mg,oral administration, single-arm, once daily 7±1 and 14±1 days. TG-873870 (Nemonoxacin): 750 mg	Nemonoxacin (Change From Baseline to Test of Cure Visit) Nemonoxacin 750 mg,oral administration, single-arm, once daily 7±1 and 14±1 days. TG-873870 (Nemonoxacin): 750 mg
Diabetic Foot Assessment (PEDIS) Shifts From Baseline at End of Treatment/Early Termination in PP Population Uninfected to Uninfected	0 participants	—	—
Diabetic Foot Assessment (PEDIS) Shifts From Baseline at End of Treatment/Early Termination in PP Population Uninfected to Mild	0 participants	—	—
Diabetic Foot Assessment (PEDIS) Shifts From Baseline at End of Treatment/Early Termination in PP Population Uninfected to Moderate	0 participants	—	—
Diabetic Foot Assessment (PEDIS) Shifts From Baseline at End of Treatment/Early Termination in PP Population Uninfected to Severe	0 participants	—	—
Diabetic Foot Assessment (PEDIS) Shifts From Baseline at End of Treatment/Early Termination in PP Population Mild to Uninfected	6 participants	—	—
Diabetic Foot Assessment (PEDIS) Shifts From Baseline at End of Treatment/Early Termination in PP Population Mild to Mild	1 participants	—	—
Diabetic Foot Assessment (PEDIS) Shifts From Baseline at End of Treatment/Early Termination in PP Population Mild to Moderate	0 participants	—	—
Diabetic Foot Assessment (PEDIS) Shifts From Baseline at End of Treatment/Early Termination in PP Population Mild to Severe	0 participants	—	—
Diabetic Foot Assessment (PEDIS) Shifts From Baseline at End of Treatment/Early Termination in PP Population Moderate to Uninfected	9 participants	—	—
Diabetic Foot Assessment (PEDIS) Shifts From Baseline at End of Treatment/Early Termination in PP Population Moderate to Mild	2 participants	—	—
Diabetic Foot Assessment (PEDIS) Shifts From Baseline at End of Treatment/Early Termination in PP Population Moderate to Moderate	2 participants	—	—
Diabetic Foot Assessment (PEDIS) Shifts From Baseline at End of Treatment/Early Termination in PP Population Moderate to Severe	0 participants	—	—
Diabetic Foot Assessment (PEDIS) Shifts From Baseline at End of Treatment/Early Termination in PP Population Severe to Uninfected	0 participants	—	—
Diabetic Foot Assessment (PEDIS) Shifts From Baseline at End of Treatment/Early Termination in PP Population Severe to Mild	0 participants	—	—
Diabetic Foot Assessment (PEDIS) Shifts From Baseline at End of Treatment/Early Termination in PP Population Severe to Moderate	0 participants	—	—
Diabetic Foot Assessment (PEDIS) Shifts From Baseline at End of Treatment/Early Termination in PP Population Severe to Severe	0 participants	—	—

SECONDARY outcome

Timeframe: Test of Cure Visit, 12±2 days after End of Treatment Visit/Early Termination

The number of patients within each of the PEDIS grading categories (uninfected, mild, moderate and severe) at baseline and Test of Cure.

Outcome measures

Outcome measures
Measure	Nemonoxacin n=20 Participants Nemonoxacin 750 mg,oral administration, single-arm, once daily 7±1 and 14±1 days. TG-873870 (Nemonoxacin): 750 mg	Nemonoxacin (PP Population at Test of Cure Visit) Nemonoxacin 750 mg,oral administration, single-arm, once daily 7±1 and 14±1 days. TG-873870 (Nemonoxacin): 750 mg	Nemonoxacin (Change From Baseline to Test of Cure Visit) Nemonoxacin 750 mg,oral administration, single-arm, once daily 7±1 and 14±1 days. TG-873870 (Nemonoxacin): 750 mg
Diabetic Foot Assessment (PEDIS) Shifts From Baseline at Test of Cure in PP Population Uninfected to Uninfected	0 participants	—	—
Diabetic Foot Assessment (PEDIS) Shifts From Baseline at Test of Cure in PP Population Uninfected to Mild	0 participants	—	—
Diabetic Foot Assessment (PEDIS) Shifts From Baseline at Test of Cure in PP Population Uninfected to Moderate	0 participants	—	—
Diabetic Foot Assessment (PEDIS) Shifts From Baseline at Test of Cure in PP Population Uninfected to Severe	0 participants	—	—
Diabetic Foot Assessment (PEDIS) Shifts From Baseline at Test of Cure in PP Population Moderate to Uninfected	11 participants	—	—
Diabetic Foot Assessment (PEDIS) Shifts From Baseline at Test of Cure in PP Population Moderate to Mild	1 participants	—	—
Diabetic Foot Assessment (PEDIS) Shifts From Baseline at Test of Cure in PP Population Moderate to Moderate	0 participants	—	—
Diabetic Foot Assessment (PEDIS) Shifts From Baseline at Test of Cure in PP Population Moderate to Severe	0 participants	—	—
Diabetic Foot Assessment (PEDIS) Shifts From Baseline at Test of Cure in PP Population Severe to Uninfected	0 participants	—	—
Diabetic Foot Assessment (PEDIS) Shifts From Baseline at Test of Cure in PP Population Severe to Mild	0 participants	—	—
Diabetic Foot Assessment (PEDIS) Shifts From Baseline at Test of Cure in PP Population Severe to Moderate	0 participants	—	—
Diabetic Foot Assessment (PEDIS) Shifts From Baseline at Test of Cure in PP Population Mild to Uninfected	6 participants	—	—
Diabetic Foot Assessment (PEDIS) Shifts From Baseline at Test of Cure in PP Population Mild to Mild	1 participants	—	—
Diabetic Foot Assessment (PEDIS) Shifts From Baseline at Test of Cure in PP Population Mild to Moderate	0 participants	—	—
Diabetic Foot Assessment (PEDIS) Shifts From Baseline at Test of Cure in PP Population Mild to Severe	0 participants	—	—
Diabetic Foot Assessment (PEDIS) Shifts From Baseline at Test of Cure in PP Population Severe to Severe	0 participants	—	—

SECONDARY outcome

Timeframe: End of Treatment/Early Termination Visit; 7±1, 14±1, 21±1 or 28±1 days after Baseline (Day 1)

Population: Number at the End of Treatment/Early Termination Visit, ITT population

Results in relation to the need for surgery, hospitalization, new and/or additional non-study antibiotic therapy for failure of initial oral therapy at End of Treatment/Early Termination.

Outcome measures

Outcome measures
Measure	Nemonoxacin n=32 Participants Nemonoxacin 750 mg,oral administration, single-arm, once daily 7±1 and 14±1 days. TG-873870 (Nemonoxacin): 750 mg	Nemonoxacin (PP Population at Test of Cure Visit) Nemonoxacin 750 mg,oral administration, single-arm, once daily 7±1 and 14±1 days. TG-873870 (Nemonoxacin): 750 mg	Nemonoxacin (Change From Baseline to Test of Cure Visit) Nemonoxacin 750 mg,oral administration, single-arm, once daily 7±1 and 14±1 days. TG-873870 (Nemonoxacin): 750 mg
Need for Surgery, Hospitalisation and Non-Study Antibiotic Therapy for Diabetic Foot Infection During Study (in ITT Population) Surgery Required for DFI During Study	1 participants	—	—
Need for Surgery, Hospitalisation and Non-Study Antibiotic Therapy for Diabetic Foot Infection During Study (in ITT Population) Hospitalisation Required for DFI During Study	1 participants	—	—
Need for Surgery, Hospitalisation and Non-Study Antibiotic Therapy for Diabetic Foot Infection During Study (in ITT Population) New or Additional Antibiotic Therapy Required	3 participants	—	—

SECONDARY outcome

Timeframe: Test of Cure Visit, 12±2 days after End of Treatment Visit/Early Termination

Population: Number at Test of Cure Visit, ITT population

Results in relation to the need for surgery, hospitalization, new and/or additional non-study antibiotic therapy for failure of initial oral therapy at Test of Cure.

Outcome measures

Outcome measures
Measure	Nemonoxacin n=30 Participants Nemonoxacin 750 mg,oral administration, single-arm, once daily 7±1 and 14±1 days. TG-873870 (Nemonoxacin): 750 mg	Nemonoxacin (PP Population at Test of Cure Visit) Nemonoxacin 750 mg,oral administration, single-arm, once daily 7±1 and 14±1 days. TG-873870 (Nemonoxacin): 750 mg	Nemonoxacin (Change From Baseline to Test of Cure Visit) Nemonoxacin 750 mg,oral administration, single-arm, once daily 7±1 and 14±1 days. TG-873870 (Nemonoxacin): 750 mg
Need for Surgery, Hospitalisation and Non-Study Antibiotic Therapy for Diabetic Foot Infection During Study (in ITT Population) Surgery Required for DFI During Study	1 participants	—	—
Need for Surgery, Hospitalisation and Non-Study Antibiotic Therapy for Diabetic Foot Infection During Study (in ITT Population) Hospitalisation Required for DFI During Study	1 participants	—	—
Need for Surgery, Hospitalisation and Non-Study Antibiotic Therapy for Diabetic Foot Infection During Study (in ITT Population) New or Additional Antibiotic Therapy Required	3 participants	—	—

SECONDARY outcome

Timeframe: End of Treatment/Early Termination Visit; 7±1, 14±1, 21±1 or 28±1 days after Baseline (Day 1)

Results in relation to the need for surgery, hospitalization, new and/or additional non-study antibiotic therapy for failure of initial oral therapy at End of Treatment/Early Termination.

Outcome measures

Outcome measures
Measure	Nemonoxacin n=20 Participants Nemonoxacin 750 mg,oral administration, single-arm, once daily 7±1 and 14±1 days. TG-873870 (Nemonoxacin): 750 mg	Nemonoxacin (PP Population at Test of Cure Visit) Nemonoxacin 750 mg,oral administration, single-arm, once daily 7±1 and 14±1 days. TG-873870 (Nemonoxacin): 750 mg	Nemonoxacin (Change From Baseline to Test of Cure Visit) Nemonoxacin 750 mg,oral administration, single-arm, once daily 7±1 and 14±1 days. TG-873870 (Nemonoxacin): 750 mg
Need for Surgery, Hospitalisation and Non-Study Antibiotic Therapy for Diabetic Foot Infection During Study (in PP Population) Surgery Required for DFI During Study	0 participants	—	—
Need for Surgery, Hospitalisation and Non-Study Antibiotic Therapy for Diabetic Foot Infection During Study (in PP Population) Hospitalisation Required for DFI During Study	0 participants	—	—
Need for Surgery, Hospitalisation and Non-Study Antibiotic Therapy for Diabetic Foot Infection During Study (in PP Population) New or Additional Antibiotic Therapy Required	0 participants	—	—

SECONDARY outcome

Timeframe: Test of Cure Visit, 12±2 days after End of Treatment Visit/Early Termination

Results in relation to the need for surgery, hospitalization, new and/or additional non-study antibiotic therapy for failure of initial oral therapy at Test of Cure.

Outcome measures

Outcome measures
Measure	Nemonoxacin n=20 Participants Nemonoxacin 750 mg,oral administration, single-arm, once daily 7±1 and 14±1 days. TG-873870 (Nemonoxacin): 750 mg	Nemonoxacin (PP Population at Test of Cure Visit) Nemonoxacin 750 mg,oral administration, single-arm, once daily 7±1 and 14±1 days. TG-873870 (Nemonoxacin): 750 mg	Nemonoxacin (Change From Baseline to Test of Cure Visit) Nemonoxacin 750 mg,oral administration, single-arm, once daily 7±1 and 14±1 days. TG-873870 (Nemonoxacin): 750 mg
Need for Surgery, Hospitalisation and Non-Study Antibiotic Therapy for Diabetic Foot Infection During Study (in PP Population) Surgery Required for DFI During Study	0 participants	—	—
Need for Surgery, Hospitalisation and Non-Study Antibiotic Therapy for Diabetic Foot Infection During Study (in PP Population) Hospitalisation Required for DFI During Study	0 participants	—	—
Need for Surgery, Hospitalisation and Non-Study Antibiotic Therapy for Diabetic Foot Infection During Study (in PP Population) New or Additional Antibiotic Therapy Required	1 participants	—	—

Adverse Events

Nemonoxacin

Serious events: 5 serious events

Other events: 21 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Nemonoxacin n=38 participants at risk Nemonoxacin 750 mg,oral administration, single-arm, once daily 7±1 and 14±1 days. TG-873870 (Nemonoxacin): 750 mg
Infections and infestations GANGRENE	5.3% 2/38 • Study period (Visit 1 to Test of Cure) At each visit, the Investigator will determine whether any adverse events have occurred. The patients will be questioned in a general way and no specific symptoms will be suggested. None of the SAEs were considered related to study drug. No patient died during the study period.
Infections and infestations ABSCESS LIMB	2.6% 1/38 • Study period (Visit 1 to Test of Cure) At each visit, the Investigator will determine whether any adverse events have occurred. The patients will be questioned in a general way and no specific symptoms will be suggested. None of the SAEs were considered related to study drug. No patient died during the study period.
Infections and infestations OSTEOMYELITIS	2.6% 1/38 • Study period (Visit 1 to Test of Cure) At each visit, the Investigator will determine whether any adverse events have occurred. The patients will be questioned in a general way and no specific symptoms will be suggested. None of the SAEs were considered related to study drug. No patient died during the study period.
Investigations BLOOD GLUCOSE INCREASED	2.6% 1/38 • Study period (Visit 1 to Test of Cure) At each visit, the Investigator will determine whether any adverse events have occurred. The patients will be questioned in a general way and no specific symptoms will be suggested. None of the SAEs were considered related to study drug. No patient died during the study period.
Investigations BLOOD PRESSURE INCREASED	2.6% 1/38 • Study period (Visit 1 to Test of Cure) At each visit, the Investigator will determine whether any adverse events have occurred. The patients will be questioned in a general way and no specific symptoms will be suggested. None of the SAEs were considered related to study drug. No patient died during the study period.

Other adverse events

Other adverse events
Measure	Nemonoxacin n=38 participants at risk Nemonoxacin 750 mg,oral administration, single-arm, once daily 7±1 and 14±1 days. TG-873870 (Nemonoxacin): 750 mg
Infections and infestations OSTEOMYELITIS	7.9% 3/38 • Study period (Visit 1 to Test of Cure) At each visit, the Investigator will determine whether any adverse events have occurred. The patients will be questioned in a general way and no specific symptoms will be suggested. None of the SAEs were considered related to study drug. No patient died during the study period.
Infections and infestations CELLULITIS	5.3% 2/38 • Study period (Visit 1 to Test of Cure) At each visit, the Investigator will determine whether any adverse events have occurred. The patients will be questioned in a general way and no specific symptoms will be suggested. None of the SAEs were considered related to study drug. No patient died during the study period.
Infections and infestations GANGRENE	5.3% 2/38 • Study period (Visit 1 to Test of Cure) At each visit, the Investigator will determine whether any adverse events have occurred. The patients will be questioned in a general way and no specific symptoms will be suggested. None of the SAEs were considered related to study drug. No patient died during the study period.
Infections and infestations ABSCESS LIMB	2.6% 1/38 • Study period (Visit 1 to Test of Cure) At each visit, the Investigator will determine whether any adverse events have occurred. The patients will be questioned in a general way and no specific symptoms will be suggested. None of the SAEs were considered related to study drug. No patient died during the study period.
Infections and infestations INFECTION	2.6% 1/38 • Study period (Visit 1 to Test of Cure) At each visit, the Investigator will determine whether any adverse events have occurred. The patients will be questioned in a general way and no specific symptoms will be suggested. None of the SAEs were considered related to study drug. No patient died during the study period.
Gastrointestinal disorders CONSTIPATION	5.3% 2/38 • Study period (Visit 1 to Test of Cure) At each visit, the Investigator will determine whether any adverse events have occurred. The patients will be questioned in a general way and no specific symptoms will be suggested. None of the SAEs were considered related to study drug. No patient died during the study period.
Gastrointestinal disorders DIARRHOEA	5.3% 2/38 • Study period (Visit 1 to Test of Cure) At each visit, the Investigator will determine whether any adverse events have occurred. The patients will be questioned in a general way and no specific symptoms will be suggested. None of the SAEs were considered related to study drug. No patient died during the study period.
Gastrointestinal disorders VOMITING	2.6% 1/38 • Study period (Visit 1 to Test of Cure) At each visit, the Investigator will determine whether any adverse events have occurred. The patients will be questioned in a general way and no specific symptoms will be suggested. None of the SAEs were considered related to study drug. No patient died during the study period.
Investigations BLOOD GLUCOSE INCREASED	7.9% 3/38 • Study period (Visit 1 to Test of Cure) At each visit, the Investigator will determine whether any adverse events have occurred. The patients will be questioned in a general way and no specific symptoms will be suggested. None of the SAEs were considered related to study drug. No patient died during the study period.
Investigations BLOOD ALBUMIN DECREASED	2.6% 1/38 • Study period (Visit 1 to Test of Cure) At each visit, the Investigator will determine whether any adverse events have occurred. The patients will be questioned in a general way and no specific symptoms will be suggested. None of the SAEs were considered related to study drug. No patient died during the study period.
Investigations BLOOD PRESSURE INCREASED	2.6% 1/38 • Study period (Visit 1 to Test of Cure) At each visit, the Investigator will determine whether any adverse events have occurred. The patients will be questioned in a general way and no specific symptoms will be suggested. None of the SAEs were considered related to study drug. No patient died during the study period.
Investigations BLOOD UREA INCREASED	2.6% 1/38 • Study period (Visit 1 to Test of Cure) At each visit, the Investigator will determine whether any adverse events have occurred. The patients will be questioned in a general way and no specific symptoms will be suggested. None of the SAEs were considered related to study drug. No patient died during the study period.
Investigations CREATININE RENAL CLEARANCE DECREASED	2.6% 1/38 • Study period (Visit 1 to Test of Cure) At each visit, the Investigator will determine whether any adverse events have occurred. The patients will be questioned in a general way and no specific symptoms will be suggested. None of the SAEs were considered related to study drug. No patient died during the study period.
Investigations ELECTROCARDIOGRAM QT PROLONGED	2.6% 1/38 • Study period (Visit 1 to Test of Cure) At each visit, the Investigator will determine whether any adverse events have occurred. The patients will be questioned in a general way and no specific symptoms will be suggested. None of the SAEs were considered related to study drug. No patient died during the study period.
Musculoskeletal and connective tissue disorders PAIN IN EXTREMITY	5.3% 2/38 • Study period (Visit 1 to Test of Cure) At each visit, the Investigator will determine whether any adverse events have occurred. The patients will be questioned in a general way and no specific symptoms will be suggested. None of the SAEs were considered related to study drug. No patient died during the study period.
Musculoskeletal and connective tissue disorders MYALGIA	2.6% 1/38 • Study period (Visit 1 to Test of Cure) At each visit, the Investigator will determine whether any adverse events have occurred. The patients will be questioned in a general way and no specific symptoms will be suggested. None of the SAEs were considered related to study drug. No patient died during the study period.
Musculoskeletal and connective tissue disorders NECK PAIN	2.6% 1/38 • Study period (Visit 1 to Test of Cure) At each visit, the Investigator will determine whether any adverse events have occurred. The patients will be questioned in a general way and no specific symptoms will be suggested. None of the SAEs were considered related to study drug. No patient died during the study period.
Musculoskeletal and connective tissue disorders OSTEITIS	2.6% 1/38 • Study period (Visit 1 to Test of Cure) At each visit, the Investigator will determine whether any adverse events have occurred. The patients will be questioned in a general way and no specific symptoms will be suggested. None of the SAEs were considered related to study drug. No patient died during the study period.
Skin and subcutaneous tissue disorders SKIN ULCER	5.3% 2/38 • Study period (Visit 1 to Test of Cure) At each visit, the Investigator will determine whether any adverse events have occurred. The patients will be questioned in a general way and no specific symptoms will be suggested. None of the SAEs were considered related to study drug. No patient died during the study period.
Skin and subcutaneous tissue disorders PRURITUS GENERALISED	2.6% 1/38 • Study period (Visit 1 to Test of Cure) At each visit, the Investigator will determine whether any adverse events have occurred. The patients will be questioned in a general way and no specific symptoms will be suggested. None of the SAEs were considered related to study drug. No patient died during the study period.
Skin and subcutaneous tissue disorders RASH PRURITIC	2.6% 1/38 • Study period (Visit 1 to Test of Cure) At each visit, the Investigator will determine whether any adverse events have occurred. The patients will be questioned in a general way and no specific symptoms will be suggested. None of the SAEs were considered related to study drug. No patient died during the study period.
Skin and subcutaneous tissue disorders SKIN FISSURES	2.6% 1/38 • Study period (Visit 1 to Test of Cure) At each visit, the Investigator will determine whether any adverse events have occurred. The patients will be questioned in a general way and no specific symptoms will be suggested. None of the SAEs were considered related to study drug. No patient died during the study period.
Skin and subcutaneous tissue disorders SWELLING FACE	2.6% 1/38 • Study period (Visit 1 to Test of Cure) At each visit, the Investigator will determine whether any adverse events have occurred. The patients will be questioned in a general way and no specific symptoms will be suggested. None of the SAEs were considered related to study drug. No patient died during the study period.
Nervous system disorders HEADACHE	7.9% 3/38 • Study period (Visit 1 to Test of Cure) At each visit, the Investigator will determine whether any adverse events have occurred. The patients will be questioned in a general way and no specific symptoms will be suggested. None of the SAEs were considered related to study drug. No patient died during the study period.
Respiratory, thoracic and mediastinal disorders EPISTAXIS	2.6% 1/38 • Study period (Visit 1 to Test of Cure) At each visit, the Investigator will determine whether any adverse events have occurred. The patients will be questioned in a general way and no specific symptoms will be suggested. None of the SAEs were considered related to study drug. No patient died during the study period.
Respiratory, thoracic and mediastinal disorders INCREASED UPPER AIRWAY SECRETION	2.6% 1/38 • Study period (Visit 1 to Test of Cure) At each visit, the Investigator will determine whether any adverse events have occurred. The patients will be questioned in a general way and no specific symptoms will be suggested. None of the SAEs were considered related to study drug. No patient died during the study period.
Respiratory, thoracic and mediastinal disorders THROAT TIGHTNESS	2.6% 1/38 • Study period (Visit 1 to Test of Cure) At each visit, the Investigator will determine whether any adverse events have occurred. The patients will be questioned in a general way and no specific symptoms will be suggested. None of the SAEs were considered related to study drug. No patient died during the study period.
Eye disorders DIABETIC RETINOPATHY	2.6% 1/38 • Study period (Visit 1 to Test of Cure) At each visit, the Investigator will determine whether any adverse events have occurred. The patients will be questioned in a general way and no specific symptoms will be suggested. None of the SAEs were considered related to study drug. No patient died during the study period.
Eye disorders EYE PAIN	2.6% 1/38 • Study period (Visit 1 to Test of Cure) At each visit, the Investigator will determine whether any adverse events have occurred. The patients will be questioned in a general way and no specific symptoms will be suggested. None of the SAEs were considered related to study drug. No patient died during the study period.
Metabolism and nutrition disorders HYPERGLYCAEMIA	2.6% 1/38 • Study period (Visit 1 to Test of Cure) At each visit, the Investigator will determine whether any adverse events have occurred. The patients will be questioned in a general way and no specific symptoms will be suggested. None of the SAEs were considered related to study drug. No patient died during the study period.
Metabolism and nutrition disorders HYPOGLYCAEMIA	2.6% 1/38 • Study period (Visit 1 to Test of Cure) At each visit, the Investigator will determine whether any adverse events have occurred. The patients will be questioned in a general way and no specific symptoms will be suggested. None of the SAEs were considered related to study drug. No patient died during the study period.
Blood and lymphatic system disorders ANAEMIA	2.6% 1/38 • Study period (Visit 1 to Test of Cure) At each visit, the Investigator will determine whether any adverse events have occurred. The patients will be questioned in a general way and no specific symptoms will be suggested. None of the SAEs were considered related to study drug. No patient died during the study period.
Injury, poisoning and procedural complications FOOT FRACTURE	2.6% 1/38 • Study period (Visit 1 to Test of Cure) At each visit, the Investigator will determine whether any adverse events have occurred. The patients will be questioned in a general way and no specific symptoms will be suggested. None of the SAEs were considered related to study drug. No patient died during the study period.
Psychiatric disorders PERSONALITY CHANGE	2.6% 1/38 • Study period (Visit 1 to Test of Cure) At each visit, the Investigator will determine whether any adverse events have occurred. The patients will be questioned in a general way and no specific symptoms will be suggested. None of the SAEs were considered related to study drug. No patient died during the study period.

Additional Information

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

TaiGen Biotechnology Co., Ltd.

Phone: +886-2-8177-7072

Email: [email protected]

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