Trial Outcomes & Findings for Safety and Efficacy Evaluation of 4-month Regimen of OPC-167832, Delamanid and Bedaquiline in Participants With Drug-Susceptible Pulmonary TB (NCT NCT05221502)

Last Updated: 2026-08-12

Results Overview

An adverse event (AE) was defined as any untoward medical occurrence in a clinical trial participant administered an investigational medicinal product or trial treatment and which does not necessarily have a causal relationship with this treatment. TEAEs are AEs with an onset date on or after the start of treatment. Serious AE are AEs that leads to death, is life threatening, requires or prolongs hospitalization, significant disability, congenital anomaly or birth defect, and other medically important serious advent. AEs were graded on a severity 3-point scale as follows: Mild: Discomfort noticed, but no disruption to daily activity.; Moderate: Discomfort sufficient to reduce or affect normal daily activity.;Severe: Inability to work or perform normal daily activity. As pre-specified in statistical analysis plan (SAP),Division of AIDS (DAIDS v2.1) criteria was used and AEs graded as follows:Grade 1-Mild;Grade 2-Moderate;Grade 3-Severe;Grade 4-Life Threatening;Grade 5-Death.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

122 participants

Primary outcome timeframe

From first dose of study drug up to end of follow up period (up to Week 52)

Results posted on

2026-08-12

Participant Flow

Participants took part in the study at 8 clinical sites in South Africa from 12 April 2022 to 19 May 2024.

A total of 306 participants were screened, of which 122 participants were randomized into the treatment arms of delamanid + bedaquiline + OPC-167832 (10 mg, 30 mg, or 90 mg) or rifampin, isoniazid, ethambutol, and pyrazinamide (RHEZ) in a ratio of 1:2:2:1.

Participant milestones

Participant milestones
Measure	Delamanid + Bedaquiline + OPC-167832 10 mg Participants received a combination regimen of delamanid, 300 mg, oral tablets, once daily (QD), bedaquiline, 400 mg, oral tablets, QD for 2 weeks, then 200 mg, thrice weekly (TIW) and OPC-167832, 10 mg, oral tablets, QD for a total of 17 weeks.	Delamanid + Bedaquiline + OPC-167832 30 mg Participants received a combination regimen of delamanid, 300 mg, oral tablets, QD, bedaquiline, 400 mg, oral tablets, QD for 2 weeks, then 200 mg, TIW and OPC-167832, 30 mg, oral tablets, QD for a total of 17 weeks.	Delamanid + Bedaquiline + OPC-167832 90 mg Participants received a combination regimen of delamanid, 300 mg, oral tablets, QD, bedaquiline, 400 mg, oral tablets, QD for 2 weeks, then 200 mg, TIW and OPC-167832, 90 mg, oral tablets, QD for a total of 17 weeks.	RHEZ Participants received RHEZ, orally, QD for 8 weeks followed by 18 weeks of rifampin and isoniazid for a total of 26 weeks.
Overall Study STARTED	20	42	39	21
Overall Study Safety Analysis Set	20	42	38	21
Overall Study Modified Intent-to-treat (mITT) Analysis Set	20	42	38	21
Overall Study COMPLETED	20	39	38	21
Overall Study NOT COMPLETED	0	3	1	0

Reasons for withdrawal

Reasons for withdrawal
Measure	Delamanid + Bedaquiline + OPC-167832 30 mg Participants received a combination regimen of delamanid, 300 mg, oral tablets, QD, bedaquiline, 400 mg, oral tablets, QD for 2 weeks, then 200 mg, TIW and OPC-167832, 30 mg, oral tablets, QD for a total of 17 weeks.	Delamanid + Bedaquiline + OPC-167832 90 mg Participants received a combination regimen of delamanid, 300 mg, oral tablets, QD, bedaquiline, 400 mg, oral tablets, QD for 2 weeks, then 200 mg, TIW and OPC-167832, 90 mg, oral tablets, QD for a total of 17 weeks.
Overall Study Death	1	0
Overall Study Physician Decision	0	1
Overall Study Randomized by Mistake With Trial Treatment	1	0
Overall Study Other	1	0

Baseline Characteristics

Safety and Efficacy Evaluation of 4-month Regimen of OPC-167832, Delamanid and Bedaquiline in Participants With Drug-Susceptible Pulmonary TB

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Delamanid + Bedaquiline + OPC-167832 10 mg n=20 Participants Participants received a combination regimen of delamanid, 300 mg, oral tablets, QD, bedaquiline, 400 mg, oral tablets, QD for 2 weeks, then 200 mg, TIW and OPC-167832, 10 mg, oral tablets, QD for a total of 17 weeks.	Delamanid + Bedaquiline + OPC-167832 30 mg n=42 Participants Participants received a combination regimen of delamanid, 300 mg, oral tablets, QD, bedaquiline, 400 mg, oral tablets, QD for 2 weeks, then 200 mg, TIW and OPC-167832, 30 mg, oral tablets, QD for a total of 17 weeks.	Delamanid + Bedaquiline + OPC-167832 90 mg n=39 Participants Participants received a combination regimen of delamanid, 300 mg, oral tablets, QD, bedaquiline, 400 mg, oral tablets, QD for 2 weeks, then 200 mg, TIW and OPC-167832, 90 mg, oral tablets, QD for a total of 17 weeks.	RHEZ n=21 Participants Participants received RHEZ, orally, QD for 8 weeks followed by 18 weeks of rifampin and isoniazid for a total of 26 weeks.	Total n=122 Participants Total of all reporting groups
Age, Continuous	37.7 years STANDARD_DEVIATION 11.90 • n=1 Participants	32.8 years STANDARD_DEVIATION 11.92 • n=1 Participants	33.2 years STANDARD_DEVIATION 12.13 • n=1 Participants	32.7 years STANDARD_DEVIATION 9.91 • n=2 Participants	33.7 years STANDARD_DEVIATION 11.66
Sex: Female, Male Female	6 Participants n=1 Participants	15 Participants n=1 Participants	13 Participants n=1 Participants	9 Participants n=2 Participants	43 Participants
Sex: Female, Male Male	14 Participants n=1 Participants	27 Participants n=1 Participants	26 Participants n=1 Participants	12 Participants n=2 Participants	79 Participants
Race/Ethnicity, Customized Race · Black or African American	13 Participants n=1 Participants	27 Participants n=1 Participants	29 Participants n=1 Participants	14 Participants n=2 Participants	83 Participants
Race/Ethnicity, Customized Race · Other	7 Participants n=1 Participants	15 Participants n=1 Participants	10 Participants n=1 Participants	7 Participants n=2 Participants	39 Participants
Race/Ethnicity, Customized Ethnicity · Hispanic or Latino	0 Participants n=1 Participants	0 Participants n=1 Participants	0 Participants n=1 Participants	0 Participants n=2 Participants	0 Participants
Race/Ethnicity, Customized Ethnicity · Not Hispanic or Latino	20 Participants n=1 Participants	42 Participants n=1 Participants	39 Participants n=1 Participants	21 Participants n=2 Participants	122 Participants

PRIMARY outcome

Timeframe: From first dose of study drug up to end of follow up period (up to Week 52)

Population: Safety analysis set included all randomized participants who took any dose of the study treatment.

Outcome measures

Outcome measures
Measure	Delamanid + Bedaquiline + OPC-167832 10 mg n=20 Participants Participants received a combination regimen of delamanid, 300 mg, oral tablets, QD, bedaquiline, 400 mg, oral tablets, QD for 2 weeks, then 200 mg, TIW and OPC-167832, 10 mg, oral tablets, QD for a total of 17 weeks.	Delamanid + Bedaquiline + OPC-167832 30 mg n=42 Participants Participants received a combination regimen of delamanid, 300 mg, oral tablets, QD, bedaquiline, 400 mg, oral tablets, QD for 2 weeks, then 200 mg, TIW and OPC-167832, 30 mg, oral tablets, QD for a total of 17 weeks.	Delamanid + Bedaquiline + OPC-167832 90 mg n=38 Participants Participants received a combination regimen of delamanid, 300 mg, oral tablets, QD, bedaquiline, 400 mg, oral tablets, QD for 2 weeks, then 200 mg, TIW and OPC-167832, 90 mg, oral tablets, QD for a total of 17 weeks.	RHEZ n=21 Participants Participants received RHEZ, orally, QD for 8 weeks followed by 18 weeks of rifampin and isoniazid for a total of 26 weeks.
Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs, Severe TEAEs, TEAEs Related to Study Drug, TEAEs Leading to Study Discontinuation, TEAEs Leading to Death, and All Grade TEAEs Based on DAIDS Criteria TEAE Related to Study Drug	4 Participants	8 Participants	5 Participants	6 Participants
Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs, Severe TEAEs, TEAEs Related to Study Drug, TEAEs Leading to Study Discontinuation, TEAEs Leading to Death, and All Grade TEAEs Based on DAIDS Criteria TEAE Leading to Study Discontinuation	0 Participants	1 Participants	0 Participants	0 Participants
Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs, Severe TEAEs, TEAEs Related to Study Drug, TEAEs Leading to Study Discontinuation, TEAEs Leading to Death, and All Grade TEAEs Based on DAIDS Criteria TEAE Leading to Death	0 Participants	1 Participants	0 Participants	0 Participants
Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs, Severe TEAEs, TEAEs Related to Study Drug, TEAEs Leading to Study Discontinuation, TEAEs Leading to Death, and All Grade TEAEs Based on DAIDS Criteria DAIDS Grade 1 TEAE	4 Participants	12 Participants	9 Participants	8 Participants
Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs, Severe TEAEs, TEAEs Related to Study Drug, TEAEs Leading to Study Discontinuation, TEAEs Leading to Death, and All Grade TEAEs Based on DAIDS Criteria DAIDS Grade 2 TEAE	9 Participants	19 Participants	17 Participants	12 Participants
Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs, Severe TEAEs, TEAEs Related to Study Drug, TEAEs Leading to Study Discontinuation, TEAEs Leading to Death, and All Grade TEAEs Based on DAIDS Criteria DAIDS Grade 3 TEAE	4 Participants	4 Participants	4 Participants	1 Participants
Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs, Severe TEAEs, TEAEs Related to Study Drug, TEAEs Leading to Study Discontinuation, TEAEs Leading to Death, and All Grade TEAEs Based on DAIDS Criteria DAIDS Grade 4 TEAE	0 Participants	1 Participants	0 Participants	0 Participants
Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs, Severe TEAEs, TEAEs Related to Study Drug, TEAEs Leading to Study Discontinuation, TEAEs Leading to Death, and All Grade TEAEs Based on DAIDS Criteria DAIDS Grade 5 TEAE	0 Participants	1 Participants	0 Participants	0 Participants
Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs, Severe TEAEs, TEAEs Related to Study Drug, TEAEs Leading to Study Discontinuation, TEAEs Leading to Death, and All Grade TEAEs Based on DAIDS Criteria TEAE	17 Participants	37 Participants	30 Participants	21 Participants
Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs, Severe TEAEs, TEAEs Related to Study Drug, TEAEs Leading to Study Discontinuation, TEAEs Leading to Death, and All Grade TEAEs Based on DAIDS Criteria Serious TEAE	2 Participants	3 Participants	0 Participants	0 Participants
Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs, Severe TEAEs, TEAEs Related to Study Drug, TEAEs Leading to Study Discontinuation, TEAEs Leading to Death, and All Grade TEAEs Based on DAIDS Criteria Severe TEAE	3 Participants	5 Participants	2 Participants	1 Participants

PRIMARY outcome

Timeframe: Baseline up to end of follow up period (up to Week 52)

Population: Safety Analysis Set included all randomized participants who took any dose of the study treatment. "Number analyzed" indicates the number of participants evaluable for the specific category.

Laboratory assessments included clinical chemistry (Albumin, Alkaline Phosphatase, Aspartate Aminotransferase, Total Bilirubin, Calcium, Creatinine, estimated Glomerular Filtration Rate (eGFR), Glucose, Fasting and Non-Fasting, Cholesterol, Inorganic Phosphorus, Magnesium, Potassium, Sodium, Triglycerides and Uric Acid), hematology (Activated Partial Thromboplastin Time, Prothrombin Time, Partial Thromboplastin Time, International Normalized Ratio (INR), Absolute CD4+ Count, Absolute Lymphocytes, Absolute Neutrophil Count, Hemoglobin, Platelet Count, White Blood Cell), and urinalysis (Urine Glucose, Blood and Protein). As pre-specified in statistical analysis plan (SAP), Division of AIDS (DAIDS) criteria was used and abnormalities were graded as follows:Grade 1 - Mild; Grade 2 - Moderate; Grade 3 - Severe; Grade 4 - Life Threatening; Grade 5 - Death. Laboratory values with DAIDS Grade ≥3 were considered as potentially clinically relevant abnormalities and are reported here.

Outcome measures

Outcome measures
Measure	Delamanid + Bedaquiline + OPC-167832 10 mg n=20 Participants Participants received a combination regimen of delamanid, 300 mg, oral tablets, QD, bedaquiline, 400 mg, oral tablets, QD for 2 weeks, then 200 mg, TIW and OPC-167832, 10 mg, oral tablets, QD for a total of 17 weeks.	Delamanid + Bedaquiline + OPC-167832 30 mg n=42 Participants Participants received a combination regimen of delamanid, 300 mg, oral tablets, QD, bedaquiline, 400 mg, oral tablets, QD for 2 weeks, then 200 mg, TIW and OPC-167832, 30 mg, oral tablets, QD for a total of 17 weeks.	Delamanid + Bedaquiline + OPC-167832 90 mg n=38 Participants Participants received a combination regimen of delamanid, 300 mg, oral tablets, QD, bedaquiline, 400 mg, oral tablets, QD for 2 weeks, then 200 mg, TIW and OPC-167832, 90 mg, oral tablets, QD for a total of 17 weeks.	RHEZ n=21 Participants Participants received RHEZ, orally, QD for 8 weeks followed by 18 weeks of rifampin and isoniazid for a total of 26 weeks.
Number of Participants With Potentially Clinically Relevant Laboratory Test Abnormalities Aspartate Aminotransferase (U/L): High: Grade 3	0 Participants	1 Participants	2 Participants	1 Participants
Number of Participants With Potentially Clinically Relevant Laboratory Test Abnormalities Aspartate Aminotransferase (U/L): High: Grade 4	1 Participants	0 Participants	1 Participants	0 Participants
Number of Participants With Potentially Clinically Relevant Laboratory Test Abnormalities Alanine Aminotransferase (U/L): High: Grade 3	0 Participants	0 Participants	0 Participants	1 Participants
Number of Participants With Potentially Clinically Relevant Laboratory Test Abnormalities Bilirubin (umol/L): High: Grade 3	0 Participants	0 Participants	1 Participants	0 Participants
Number of Participants With Potentially Clinically Relevant Laboratory Test Abnormalities Bilirubin (umol/L): High: Grade 4	1 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Potentially Clinically Relevant Laboratory Test Abnormalities Cholesterol (Total) (mmol/L): High: Grade 3	0 Participants	0 Participants	1 Participants	0 Participants
Number of Participants With Potentially Clinically Relevant Laboratory Test Abnormalities Creatinine (umol/L): High: Grade 3	3 Participants	3 Participants	5 Participants	1 Participants
Number of Participants With Potentially Clinically Relevant Laboratory Test Abnormalities eGFR (mL/min): Low: Grade 3	2 Participants	6 Participants	8 Participants	0 Participants
Number of Participants With Potentially Clinically Relevant Laboratory Test Abnormalities Glucose (Non-Fasting) (mmol/L): High: Grade 3	0 Participants	3 Participants	1 Participants	0 Participants
Number of Participants With Potentially Clinically Relevant Laboratory Test Abnormalities Glucose (Non-Fasting) (mmol/L): High: Grade 4	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Potentially Clinically Relevant Laboratory Test Abnormalities Potassium (mmol/L): High: Grade 4	0 Participants	1 Participants	0 Participants	0 Participants
Number of Participants With Potentially Clinically Relevant Laboratory Test Abnormalities Sodium (mmol/L): High: Grade 3	0 Participants	1 Participants	0 Participants	0 Participants
Number of Participants With Potentially Clinically Relevant Laboratory Test Abnormalities Triglycerides (mmol/L): High Grade 3	0 Participants	0 Participants	1 Participants	0 Participants
Number of Participants With Potentially Clinically Relevant Laboratory Test Abnormalities Hemoglobin (g/dL): All (Males or Females): Low: Grade 3	1 Participants	2 Participants	2 Participants	0 Participants
Number of Participants With Potentially Clinically Relevant Laboratory Test Abnormalities Hemoglobin (g/dL): All (Males or Females): Low: Grade 4	0 Participants	1 Participants	0 Participants	0 Participants
Number of Participants With Potentially Clinically Relevant Laboratory Test Abnormalities Lymphocytes (x10^9/L): Low: Grade 3	0 Participants	0 Participants	1 Participants	0 Participants
Number of Participants With Potentially Clinically Relevant Laboratory Test Abnormalities Prothrombin Time (sec): High: Grade 3	0 Participants	1 Participants	0 Participants	0 Participants
Number of Participants With Potentially Clinically Relevant Laboratory Test Abnormalities Urine Protein: Grade 3	0 Participants	2 Participants	0 Participants	0 Participants

PRIMARY outcome

Timeframe: Baseline up to end of follow up period (up to Week 52)

Population: Safety analysis set included all randomized participants who took any dose of the study treatment.

Vital signs measurements included systolic blood pressure (SBP), diastolic blood pressure (DBP), heart rate, body weight, and body temperature. Blood pressure (i.e., SBP, DBP) and heart rate were measured in the supine and sitting positions after the participant had been in each position for at least 3 minutes. The participants were categorized based on the clinically relevant vital sign values as per DAIDS criteria pre-specified in SAP. Each vital sign parameter was graded using the DAIDS criteria as follows: Grade 1 - Mild; Grade 2 - Moderate; Grade 3 - Severe; Grade 4 - Potentially Life Threatening; Grade 5 - Death. The categories with at least one participant with clinically significant value of any grade for vital signs are reported here.

Outcome measures

Outcome measures
Measure	Delamanid + Bedaquiline + OPC-167832 10 mg n=20 Participants Participants received a combination regimen of delamanid, 300 mg, oral tablets, QD, bedaquiline, 400 mg, oral tablets, QD for 2 weeks, then 200 mg, TIW and OPC-167832, 10 mg, oral tablets, QD for a total of 17 weeks.	Delamanid + Bedaquiline + OPC-167832 30 mg n=42 Participants Participants received a combination regimen of delamanid, 300 mg, oral tablets, QD, bedaquiline, 400 mg, oral tablets, QD for 2 weeks, then 200 mg, TIW and OPC-167832, 30 mg, oral tablets, QD for a total of 17 weeks.	Delamanid + Bedaquiline + OPC-167832 90 mg n=38 Participants Participants received a combination regimen of delamanid, 300 mg, oral tablets, QD, bedaquiline, 400 mg, oral tablets, QD for 2 weeks, then 200 mg, TIW and OPC-167832, 90 mg, oral tablets, QD for a total of 17 weeks.	RHEZ n=21 Participants Participants received RHEZ, orally, QD for 8 weeks followed by 18 weeks of rifampin and isoniazid for a total of 26 weeks.
Number of Participants With Potentially Clinically Relevant Abnormalities in the Vital Signs Hypertension- DBP: Grade 1	8 Participants	8 Participants	13 Participants	8 Participants
Number of Participants With Potentially Clinically Relevant Abnormalities in the Vital Signs Hypertension- DBP: Grade 2	2 Participants	4 Participants	3 Participants	1 Participants
Number of Participants With Potentially Clinically Relevant Abnormalities in the Vital Signs Hypertension- DBP: Grade 3	1 Participants	2 Participants	1 Participants	1 Participants
Number of Participants With Potentially Clinically Relevant Abnormalities in the Vital Signs Hypertension- SBP: Grade 1	8 Participants	10 Participants	16 Participants	8 Participants
Number of Participants With Potentially Clinically Relevant Abnormalities in the Vital Signs Hypertension- SBP: Grade 2	3 Participants	2 Participants	2 Participants	2 Participants
Number of Participants With Potentially Clinically Relevant Abnormalities in the Vital Signs Hypertension- SBP: Grade 3	1 Participants	0 Participants	1 Participants	0 Participants
Number of Participants With Potentially Clinically Relevant Abnormalities in the Vital Signs Body Temperature Increased: Grade 1	1 Participants	3 Participants	2 Participants	2 Participants
Number of Participants With Potentially Clinically Relevant Abnormalities in the Vital Signs Body Temperature Increased: Grade 2	0 Participants	3 Participants	3 Participants	2 Participants
Number of Participants With Potentially Clinically Relevant Abnormalities in the Vital Signs Body Temperature Increased: Grade 3	0 Participants	0 Participants	0 Participants	1 Participants
Number of Participants With Potentially Clinically Relevant Abnormalities in the Vital Signs Body Temperature Increased: Grade 4	0 Participants	0 Participants	1 Participants	0 Participants
Number of Participants With Potentially Clinically Relevant Abnormalities in the Vital Signs Body Weight Decreased: Grade 2 weight loss from baseline	4 Participants	5 Participants	4 Participants	1 Participants
Number of Participants With Potentially Clinically Relevant Abnormalities in the Vital Signs Body Weight Decreased: Grade 3 body weight loss from baseline	1 Participants	0 Participants	0 Participants	1 Participants

PRIMARY outcome

Timeframe: Baseline up to end of follow up period (up to Week 52)

Population: Safety analysis set included all randomized participants who took any dose of the study treatment.

3 ECGs were performed at baseline (Day -1) spaced 5 to 10 minutes apart, and 3 ECGs at all subsequent visits during the treatment and follow-up periods. The categories with at least one participant with clinically relevant ECG abnormalities are reported here.

Outcome measures

Outcome measures
Measure	Delamanid + Bedaquiline + OPC-167832 10 mg n=20 Participants Participants received a combination regimen of delamanid, 300 mg, oral tablets, QD, bedaquiline, 400 mg, oral tablets, QD for 2 weeks, then 200 mg, TIW and OPC-167832, 10 mg, oral tablets, QD for a total of 17 weeks.	Delamanid + Bedaquiline + OPC-167832 30 mg n=42 Participants Participants received a combination regimen of delamanid, 300 mg, oral tablets, QD, bedaquiline, 400 mg, oral tablets, QD for 2 weeks, then 200 mg, TIW and OPC-167832, 30 mg, oral tablets, QD for a total of 17 weeks.	Delamanid + Bedaquiline + OPC-167832 90 mg n=38 Participants Participants received a combination regimen of delamanid, 300 mg, oral tablets, QD, bedaquiline, 400 mg, oral tablets, QD for 2 weeks, then 200 mg, TIW and OPC-167832, 90 mg, oral tablets, QD for a total of 17 weeks.	RHEZ n=21 Participants Participants received RHEZ, orally, QD for 8 weeks followed by 18 weeks of rifampin and isoniazid for a total of 26 weeks.
Number of Participants With Potentially Clinically Relevant Electrocardiogram (ECG) Abnormalities Increase in QT: >480 msec	2 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Potentially Clinically Relevant Electrocardiogram (ECG) Abnormalities Increase in QTcB: >450 msec	5 Participants	15 Participants	7 Participants	3 Participants
Number of Participants With Potentially Clinically Relevant Electrocardiogram (ECG) Abnormalities Increase in QTcB: >480 msec	2 Participants	4 Participants	0 Participants	0 Participants
Number of Participants With Potentially Clinically Relevant Electrocardiogram (ECG) Abnormalities First Degree AV Block: > 200 msec	1 Participants	6 Participants	3 Participants	0 Participants
Number of Participants With Potentially Clinically Relevant Electrocardiogram (ECG) Abnormalities Increase in QT: >450 msec	4 Participants	7 Participants	3 Participants	2 Participants
Number of Participants With Potentially Clinically Relevant Electrocardiogram (ECG) Abnormalities Increase in QTcB: >60 Increase from baseline	0 Participants	2 Participants	1 Participants	0 Participants
Number of Participants With Potentially Clinically Relevant Electrocardiogram (ECG) Abnormalities Increase in QTcB: >=30 to <=60 Increase from baseline	6 Participants	20 Participants	13 Participants	5 Participants
Number of Participants With Potentially Clinically Relevant Electrocardiogram (ECG) Abnormalities Increase in QTcF: >450 msec	5 Participants	8 Participants	4 Participants	1 Participants
Number of Participants With Potentially Clinically Relevant Electrocardiogram (ECG) Abnormalities Increase in QTcF: >60 Increase from baseline	0 Participants	5 Participants	2 Participants	1 Participants
Number of Participants With Potentially Clinically Relevant Electrocardiogram (ECG) Abnormalities Increase in QTcF: >=30 to <=60 Increase from baseline	13 Participants	28 Participants	27 Participants	11 Participants
Number of Participants With Potentially Clinically Relevant Electrocardiogram (ECG) Abnormalities RR High: > 1200 msec	6 Participants	7 Participants	6 Participants	3 Participants
Number of Participants With Potentially Clinically Relevant Electrocardiogram (ECG) Abnormalities RR Low: < 600 msec	1 Participants	4 Participants	5 Participants	6 Participants
Number of Participants With Potentially Clinically Relevant Electrocardiogram (ECG) Abnormalities Sinus Bradycardia: Heart Rate {HR} _Mean < 41 beats per minute {bpm}	0 Participants	1 Participants	0 Participants	0 Participants
Number of Participants With Potentially Clinically Relevant Electrocardiogram (ECG) Abnormalities Sinus Bradycardia: HR_Mean < 50 bpm	5 Participants	7 Participants	5 Participants	3 Participants
Number of Participants With Potentially Clinically Relevant Electrocardiogram (ECG) Abnormalities Sinus Tachycardia: HR_Mean > 100 bpm	4 Participants	4 Participants	5 Participants	6 Participants

PRIMARY outcome

Timeframe: From first dose of study drug up to end of follow up period (up to approximately Week 52)

Population: Safety analysis set included all randomized participants who took any dose of the study treatment.

An AE was defined as any untoward medical occurrence in a clinical trial participant administered a treatment that does not necessarily have a causal relationship with the treatment. All AEs were graded on a 5-point scale according to DAIDS Table for Grading the Severity of Adult and Pediatric AEs as follows: Grade 1 - Mild; Grade 2 - Moderate; Grade 3 - Severe; Grade 4 - Life Threatening; Grade 5 - Death.

Outcome measures

Outcome measures
Measure	Delamanid + Bedaquiline + OPC-167832 10 mg n=20 Participants Participants received a combination regimen of delamanid, 300 mg, oral tablets, QD, bedaquiline, 400 mg, oral tablets, QD for 2 weeks, then 200 mg, TIW and OPC-167832, 10 mg, oral tablets, QD for a total of 17 weeks.	Delamanid + Bedaquiline + OPC-167832 30 mg n=42 Participants Participants received a combination regimen of delamanid, 300 mg, oral tablets, QD, bedaquiline, 400 mg, oral tablets, QD for 2 weeks, then 200 mg, TIW and OPC-167832, 30 mg, oral tablets, QD for a total of 17 weeks.	Delamanid + Bedaquiline + OPC-167832 90 mg n=38 Participants Participants received a combination regimen of delamanid, 300 mg, oral tablets, QD, bedaquiline, 400 mg, oral tablets, QD for 2 weeks, then 200 mg, TIW and OPC-167832, 90 mg, oral tablets, QD for a total of 17 weeks.	RHEZ n=21 Participants Participants received RHEZ, orally, QD for 8 weeks followed by 18 weeks of rifampin and isoniazid for a total of 26 weeks.
Number of Participants With an AE Reported as DAIDS Grade 3 or Higher	4 Participants	6 Participants	4 Participants	1 Participants

PRIMARY outcome

Timeframe: From first dose of the study drug up to end of follow up period (up to approximately Week 52)

Population: Safety analysis set included all randomized participants who took any dose of the study treatment.

An AE was defined as any untoward medical occurrence in a clinical trial participant administered an investigational medicinal product or trial treatment and which does not necessarily have a causal relationship with this treatment. TEAEs are AEs with an onset date on or after the start of treatment.

Outcome measures

Outcome measures
Measure	Delamanid + Bedaquiline + OPC-167832 10 mg n=20 Participants Participants received a combination regimen of delamanid, 300 mg, oral tablets, QD, bedaquiline, 400 mg, oral tablets, QD for 2 weeks, then 200 mg, TIW and OPC-167832, 10 mg, oral tablets, QD for a total of 17 weeks.	Delamanid + Bedaquiline + OPC-167832 30 mg n=42 Participants Participants received a combination regimen of delamanid, 300 mg, oral tablets, QD, bedaquiline, 400 mg, oral tablets, QD for 2 weeks, then 200 mg, TIW and OPC-167832, 30 mg, oral tablets, QD for a total of 17 weeks.	Delamanid + Bedaquiline + OPC-167832 90 mg n=38 Participants Participants received a combination regimen of delamanid, 300 mg, oral tablets, QD, bedaquiline, 400 mg, oral tablets, QD for 2 weeks, then 200 mg, TIW and OPC-167832, 90 mg, oral tablets, QD for a total of 17 weeks.	RHEZ n=21 Participants Participants received RHEZ, orally, QD for 8 weeks followed by 18 weeks of rifampin and isoniazid for a total of 26 weeks.
Number of Participants With TEAEs Leading to Discontinuation of Treatment	0 Participants	1 Participants	0 Participants	0 Participants

PRIMARY outcome

Timeframe: Week 17

Population: mITT analysis set included all randomized participants that took at least 1 dose of study medication or RHEZ, had at least 1 postbaseline culture result, demonstrated positive culture results by Week 1, and demonstrated susceptibility to rifampin and isoniazid (from the screening specimen). Percentages are rounded off to the nearest decimal point. The data for Delamanid+Bedaquiline+OPC-167832 10, 30 and 90 mg arm groups is reported in this outcome measure.

A participant was classified as having achieved SCC if the participant achieved first 2 consecutive sputum cultures negative for growth of mycobacterium tuberculosis at least 1 week apart (±4 days) after his/her last sputum culture that was positive for growth, and did not have a positive sputum culture result in between, and by the end of the treatment. Efficacy was assessed by using the MGIT liquid culture system. 95% confidence interval (CI) was calculated using Clopper Pearson (exact) confidence interval model.

Outcome measures

Outcome measures
Measure	Delamanid + Bedaquiline + OPC-167832 10 mg n=20 Participants Participants received a combination regimen of delamanid, 300 mg, oral tablets, QD, bedaquiline, 400 mg, oral tablets, QD for 2 weeks, then 200 mg, TIW and OPC-167832, 10 mg, oral tablets, QD for a total of 17 weeks.	Delamanid + Bedaquiline + OPC-167832 30 mg n=42 Participants Participants received a combination regimen of delamanid, 300 mg, oral tablets, QD, bedaquiline, 400 mg, oral tablets, QD for 2 weeks, then 200 mg, TIW and OPC-167832, 30 mg, oral tablets, QD for a total of 17 weeks.	Delamanid + Bedaquiline + OPC-167832 90 mg n=38 Participants Participants received a combination regimen of delamanid, 300 mg, oral tablets, QD, bedaquiline, 400 mg, oral tablets, QD for 2 weeks, then 200 mg, TIW and OPC-167832, 90 mg, oral tablets, QD for a total of 17 weeks.	RHEZ Participants received RHEZ, orally, QD for 8 weeks followed by 18 weeks of rifampin and isoniazid for a total of 26 weeks.
Percentage of Participants Who Achieved Sputum Culture Conversion (SCC) in Mycobacteria Growth Indicator Tube® (MGIT) by End of Treatment (Week 17)	100.0 percentage of participants Interval 83.2 to 100.0	92.9 percentage of participants Interval 80.5 to 98.5	97.4 percentage of participants Interval 86.2 to 99.9	—

PRIMARY outcome

Timeframe: Week 26

Population: mITT analysis set included all randomized participants that took at least 1 dose of study medication or RHEZ, had at least 1 postbaseline culture result, demonstrated positive culture results by Week 1, and demonstrated susceptibility to rifampin and isoniazid (from the screening specimen). Percentages are rounded off to the nearest decimal point. The data for RHEZ arm group is reported in this outcome measure.

A participant was classified as having achieved SCC if the participant achieved first 2 consecutive sputum cultures negative for growth of mycobacterium tuberculosis at least 1 week apart (±4 days) after his/her last sputum culture that was positive for growth, and did not have a positive sputum culture result in between, and by the end of the treatment. Efficacy was assessed by using the MGIT liquid culture system. 95% CI is calculated using Clopper Pearson (exact) confidence interval model.

Outcome measures

Outcome measures
Measure	Delamanid + Bedaquiline + OPC-167832 10 mg n=21 Participants Participants received a combination regimen of delamanid, 300 mg, oral tablets, QD, bedaquiline, 400 mg, oral tablets, QD for 2 weeks, then 200 mg, TIW and OPC-167832, 10 mg, oral tablets, QD for a total of 17 weeks.	Delamanid + Bedaquiline + OPC-167832 30 mg Participants received a combination regimen of delamanid, 300 mg, oral tablets, QD, bedaquiline, 400 mg, oral tablets, QD for 2 weeks, then 200 mg, TIW and OPC-167832, 30 mg, oral tablets, QD for a total of 17 weeks.	Delamanid + Bedaquiline + OPC-167832 90 mg Participants received a combination regimen of delamanid, 300 mg, oral tablets, QD, bedaquiline, 400 mg, oral tablets, QD for 2 weeks, then 200 mg, TIW and OPC-167832, 90 mg, oral tablets, QD for a total of 17 weeks.	RHEZ Participants received RHEZ, orally, QD for 8 weeks followed by 18 weeks of rifampin and isoniazid for a total of 26 weeks.
Percentage of Participants Who Achieved SCC in MGIT by End of Treatment (Week 26)	100.0 percentage of participants Interval 83.9 to 100.0	—	—	—

SECONDARY outcome

Timeframe: Week 8

A participant was classified as having achieved SCC if he/she achieved first 2 consecutive sputum cultures negative for growth of mycobacterium tuberculosis at least 1 week apart (±4 days) after his/her last sputum culture that was positive for growth, and did not have a positive sputum culture result in between, and by the end of the 8 weeks of treatment. Efficacy was assessed by using the MGIT liquid culture system. 95% CI is calculated using Clopper Pearson (exact) confidence interval model.

Outcome measures

Outcome measures
Measure	Delamanid + Bedaquiline + OPC-167832 10 mg n=20 Participants Participants received a combination regimen of delamanid, 300 mg, oral tablets, QD, bedaquiline, 400 mg, oral tablets, QD for 2 weeks, then 200 mg, TIW and OPC-167832, 10 mg, oral tablets, QD for a total of 17 weeks.	Delamanid + Bedaquiline + OPC-167832 30 mg n=42 Participants Participants received a combination regimen of delamanid, 300 mg, oral tablets, QD, bedaquiline, 400 mg, oral tablets, QD for 2 weeks, then 200 mg, TIW and OPC-167832, 30 mg, oral tablets, QD for a total of 17 weeks.	Delamanid + Bedaquiline + OPC-167832 90 mg n=38 Participants Participants received a combination regimen of delamanid, 300 mg, oral tablets, QD, bedaquiline, 400 mg, oral tablets, QD for 2 weeks, then 200 mg, TIW and OPC-167832, 90 mg, oral tablets, QD for a total of 17 weeks.	RHEZ n=21 Participants Participants received RHEZ, orally, QD for 8 weeks followed by 18 weeks of rifampin and isoniazid for a total of 26 weeks.
Percentage of Participants Who Achieved SCC in MGIT by the End of 8 Weeks of Treatment	40.0 percentage of participants Interval 19.1 to 63.9	57.1 percentage of participants Interval 41.0 to 72.3	50.0 percentage of participants Interval 33.4 to 66.6	52.4 percentage of participants Interval 29.8 to 74.3

SECONDARY outcome

Timeframe: Baseline up to Week 52

Population: mITT analysis set included all randomized participants that took at least 1 dose of study medication or RHEZ, had at least 1 postbaseline culture result, demonstrated positive culture results by Week 1, and demonstrated susceptibility to rifampin and isoniazid (from the screening specimen). 'Number analyzed' indicates the number of participants evaluable for this outcome measure at the specific timepoint.

Time to detection of MGIT cultures was the time assessed, in days, when a sputum culture result was positive using the MGIT system during the routine 42-day incubation period. A longer time to detection represented a lower burden of mycobacterium tuberculosis (MTB) organisms present in the sputum.

Outcome measures

Outcome measures
Measure	Delamanid + Bedaquiline + OPC-167832 10 mg n=20 Participants Participants received a combination regimen of delamanid, 300 mg, oral tablets, QD, bedaquiline, 400 mg, oral tablets, QD for 2 weeks, then 200 mg, TIW and OPC-167832, 10 mg, oral tablets, QD for a total of 17 weeks.	Delamanid + Bedaquiline + OPC-167832 30 mg n=42 Participants Participants received a combination regimen of delamanid, 300 mg, oral tablets, QD, bedaquiline, 400 mg, oral tablets, QD for 2 weeks, then 200 mg, TIW and OPC-167832, 30 mg, oral tablets, QD for a total of 17 weeks.	Delamanid + Bedaquiline + OPC-167832 90 mg n=38 Participants Participants received a combination regimen of delamanid, 300 mg, oral tablets, QD, bedaquiline, 400 mg, oral tablets, QD for 2 weeks, then 200 mg, TIW and OPC-167832, 90 mg, oral tablets, QD for a total of 17 weeks.	RHEZ n=21 Participants Participants received RHEZ, orally, QD for 8 weeks followed by 18 weeks of rifampin and isoniazid for a total of 26 weeks.
Time to Detection of MGIT Cultures Week 4	12.6 days Interval 8.0 to 42.0	14.4 days Interval 4.0 to 42.0	18.1 days Interval 6.0 to 42.0	15.9 days Interval 9.0 to 42.0
Time to Detection of MGIT Cultures Baseline	5.7 days Interval 4.0 to 15.0	5.1 days Interval 3.0 to 42.0	5.3 days Interval 2.0 to 29.0	5.5 days Interval 4.0 to 12.0
Time to Detection of MGIT Cultures Week 1	8.5 days Interval 3.0 to 42.0	8.8 days Interval 5.0 to 16.0	10.4 days Interval 4.0 to 42.0	9.3 days Interval 6.0 to 17.0
Time to Detection of MGIT Cultures Week 2	9.9 days Interval 7.0 to 42.0	10.5 days Interval 5.0 to 42.0	11.9 days Interval 4.0 to 42.0	12.0 days Interval 6.0 to 42.0
Time to Detection of MGIT Cultures Week 3	12.6 days Interval 8.0 to 42.0	12.6 days Interval 5.0 to 42.0	15.5 days Interval 9.0 to 42.0	14.0 days Interval 8.0 to 42.0
Time to Detection of MGIT Cultures Week 5	19.3 days Interval 9.0 to 42.0	18.6 days Interval 9.0 to 42.0	21.9 days Interval 6.0 to 42.0	21.7 days Interval 11.0 to 42.0
Time to Detection of MGIT Cultures Week 6	19.0 days Interval 11.0 to 42.0	23.0 days Interval 9.0 to 42.0	22.9 days Interval 11.0 to 42.0	23.6 days Interval 11.0 to 42.0
Time to Detection of MGIT Cultures Week 7	20.1 days Interval 8.0 to 42.0	28.6 days Interval 11.0 to 42.0	32.6 days Interval 12.0 to 42.0	30.6 days Interval 13.0 to 42.0
Time to Detection of MGIT Cultures Week 8	35.2 days Interval 10.0 to 42.0	42.0 days Interval 11.0 to 42.0	42.0 days Interval 11.0 to 42.0	42.0 days Interval 7.0 to 42.0
Time to Detection of MGIT Cultures Week 10	42.0 days Interval 13.0 to 42.0	42.0 days Interval 12.0 to 42.0	42.0 days Interval 4.0 to 42.0	42.0 days Interval 17.0 to 42.0
Time to Detection of MGIT Cultures Week 12	42.0 days Interval 17.0 to 42.0	42.0 days Interval 16.0 to 42.0	42.0 days Interval 8.0 to 42.0	42.0 days Interval 24.0 to 42.0
Time to Detection of MGIT Cultures Week 13	42.0 days Interval 42.0 to 42.0	42.0 days Interval 14.0 to 42.0	42.0 days Interval 18.0 to 42.0	42.0 days Interval 30.0 to 42.0
Time to Detection of MGIT Cultures Week 15	42.0 days Interval 11.0 to 42.0	42.0 days Interval 15.0 to 42.0	42.0 days Interval 18.0 to 42.0	42.0 days Interval 36.0 to 42.0
Time to Detection of MGIT Cultures Week 17	42.0 days Interval 42.0 to 42.0	42.0 days Interval 29.0 to 42.0	42.0 days Interval 17.0 to 42.0	42.0 days Interval 42.0 to 42.0
Time to Detection of MGIT Cultures Week 19	42.0 days Interval 4.0 to 42.0	42.0 days Interval 42.0 to 42.0	42.0 days Interval 24.0 to 42.0	42.0 days Interval 42.0 to 42.0
Time to Detection of MGIT Cultures Week 21	42.0 days Interval 42.0 to 42.0	42.0 days Interval 42.0 to 42.0	42.0 days Interval 42.0 to 42.0	42.0 days Interval 42.0 to 42.0
Time to Detection of MGIT Cultures Week 23	42.0 days Interval 18.0 to 42.0	42.0 days Interval 42.0 to 42.0	42.0 days Interval 28.0 to 42.0	42.0 days Interval 42.0 to 42.0
Time to Detection of MGIT Cultures Week 26	42.0 days Interval 9.0 to 42.0	42.0 days Interval 42.0 to 42.0	42.0 days Interval 6.0 to 42.0	42.0 days Interval 42.0 to 42.0
Time to Detection of MGIT Cultures Week 28	42.0 days Interval 14.0 to 42.0	42.0 days Interval 42.0 to 42.0	42.0 days Interval 42.0 to 42.0	42.0 days Interval 42.0 to 42.0
Time to Detection of MGIT Cultures Week 30	42.0 days Interval 23.0 to 42.0	42.0 days Interval 42.0 to 42.0	42.0 days Interval 42.0 to 42.0	42.0 days Interval 42.0 to 42.0
Time to Detection of MGIT Cultures Week 34	42.0 days Interval 42.0 to 42.0	42.0 days Interval 12.0 to 42.0	42.0 days Interval 19.0 to 42.0	42.0 days Interval 16.0 to 42.0
Time to Detection of MGIT Cultures Week 39	42.0 days Interval 42.0 to 42.0	42.0 days Interval 7.0 to 42.0	42.0 days Interval 14.0 to 42.0	42.0 days Interval 3.0 to 42.0
Time to Detection of MGIT Cultures Week 43	42.0 days Interval 7.0 to 42.0	42.0 days Interval 4.0 to 42.0	42.0 days Interval 7.0 to 42.0	42.0 days Interval 19.0 to 42.0
Time to Detection of MGIT Cultures Week 47	42.0 days Interval 7.0 to 42.0	42.0 days Interval 4.0 to 42.0	42.0 days Interval 16.0 to 42.0	42.0 days Interval 10.0 to 42.0
Time to Detection of MGIT Cultures Week 52	42.0 days Interval 13.0 to 42.0	42.0 days Interval 13.0 to 42.0	42.0 days Interval 18.0 to 42.0	42.0 days Interval 42.0 to 42.0
Time to Detection of MGIT Cultures Early Termination	—	11.0 days Interval 11.0 to 11.0	—	—

SECONDARY outcome

Timeframe: Week 8, and End of Treatment Period - Week 17 (for OPC-167832 arms) and Week 26 (for RHEZ arm)

Sputum LAM concentrations were measured on up to 3 samples collected at baseline and postbaseline at Week 8 and at end of treatment. A participant was classified as having achieved negative sputum conversion in LAM if the participant has the first of 2 visits of at least 1 week apart with sputum LAM negative (below the lower limit of quantification) and without a positive sputum LAM result in between. Numeric sputum LAM concentration data was converted to a binary variable using the rule: if the sputum LAM concentration was less than 10 picograms per milliliter (pg/mL) then it was interpreted as a negative result. If the sputum LAM concentration was greater than or equal to 10 pg/mL then it was interpreted as positive result. SCC for LAM was considered to have been achieved if there were negative results at two consecutive visits with non-missing results. 95% CI was calculated using Clopper Pearson (exact) confidence interval model.

Outcome measures

Outcome measures
Measure	Delamanid + Bedaquiline + OPC-167832 10 mg n=20 Participants Participants received a combination regimen of delamanid, 300 mg, oral tablets, QD, bedaquiline, 400 mg, oral tablets, QD for 2 weeks, then 200 mg, TIW and OPC-167832, 10 mg, oral tablets, QD for a total of 17 weeks.	Delamanid + Bedaquiline + OPC-167832 30 mg n=42 Participants Participants received a combination regimen of delamanid, 300 mg, oral tablets, QD, bedaquiline, 400 mg, oral tablets, QD for 2 weeks, then 200 mg, TIW and OPC-167832, 30 mg, oral tablets, QD for a total of 17 weeks.	Delamanid + Bedaquiline + OPC-167832 90 mg n=38 Participants Participants received a combination regimen of delamanid, 300 mg, oral tablets, QD, bedaquiline, 400 mg, oral tablets, QD for 2 weeks, then 200 mg, TIW and OPC-167832, 90 mg, oral tablets, QD for a total of 17 weeks.	RHEZ n=21 Participants Participants received RHEZ, orally, QD for 8 weeks followed by 18 weeks of rifampin and isoniazid for a total of 26 weeks.
Percentage of Participants Achieving Negative Sputum Lipoarabinomannan (LAM) by 8 Weeks of Treatment and by End of Treatment At Week 8	0 percentage of participants Interval 0.0 to 0.0	2.4 percentage of participants Interval 0.1 to 12.6	0 percentage of participants Interval 0.0 to 0.0	14.3 percentage of participants Interval 3.0 to 36.3
Percentage of Participants Achieving Negative Sputum Lipoarabinomannan (LAM) by 8 Weeks of Treatment and by End of Treatment At End of Treatment - Week 17 and Week 26	15.0 percentage of participants Interval 3.2 to 37.9	14.3 percentage of participants Interval 5.4 to 28.5	23.7 percentage of participants Interval 11.4 to 40.2	23.8 percentage of participants Interval 8.2 to 47.2

SECONDARY outcome

Timeframe: Baseline up to Week 52

Acquired resistance was defined as a post-baseline resistant result at any timepoint after a baseline susceptible result. Baseline was defined as Day -1, if Day -1 was missing then Day 1 was used, if day 1 was missing then Week 1 was used. Resistance data was collected for streptomycin, isoniazid, rifampicin, ethambutol, pyrazinamide, bedaquiline and delamanid. Susceptibility testing (DST) for anti-TB medications was performed on positive M tuberculosis isolates from Day -1 or Day 1 cultures, and on the end of treatment sputum specimen. Percentage of participants who were susceptible at baseline and developed resistance to the indicated drug (class) at any post-baseline visits was summarized.

Outcome measures

Outcome measures
Measure	Delamanid + Bedaquiline + OPC-167832 10 mg n=20 Participants Participants received a combination regimen of delamanid, 300 mg, oral tablets, QD, bedaquiline, 400 mg, oral tablets, QD for 2 weeks, then 200 mg, TIW and OPC-167832, 10 mg, oral tablets, QD for a total of 17 weeks.	Delamanid + Bedaquiline + OPC-167832 30 mg n=42 Participants Participants received a combination regimen of delamanid, 300 mg, oral tablets, QD, bedaquiline, 400 mg, oral tablets, QD for 2 weeks, then 200 mg, TIW and OPC-167832, 30 mg, oral tablets, QD for a total of 17 weeks.	Delamanid + Bedaquiline + OPC-167832 90 mg n=38 Participants Participants received a combination regimen of delamanid, 300 mg, oral tablets, QD, bedaquiline, 400 mg, oral tablets, QD for 2 weeks, then 200 mg, TIW and OPC-167832, 90 mg, oral tablets, QD for a total of 17 weeks.	RHEZ n=21 Participants Participants received RHEZ, orally, QD for 8 weeks followed by 18 weeks of rifampin and isoniazid for a total of 26 weeks.
Percentage of Participants With Acquired Drug Resistance	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants

SECONDARY outcome

Timeframe: From the first dose of the study up to the end of the follow-up period (up to Week 52)

Sputum culture conversion occurs when a participant has the first of 2 consecutive visits of at least 7 days apart with sputum cultures negative and without a positive sputum culture result in between, as well as no positive sputum culture after the negative results. If a participant had a positive MGIT culture result throughout the study period, then the participant was considered as not having achieved SCC within the period under consideration. The time to SCC in this case was censored. Time to SCC was calculated from date of first dose using MGIT cultures without the mitigation method measures.

Outcome measures

Outcome measures
Measure	Delamanid + Bedaquiline + OPC-167832 10 mg n=20 Participants Participants received a combination regimen of delamanid, 300 mg, oral tablets, QD, bedaquiline, 400 mg, oral tablets, QD for 2 weeks, then 200 mg, TIW and OPC-167832, 10 mg, oral tablets, QD for a total of 17 weeks.	Delamanid + Bedaquiline + OPC-167832 30 mg n=42 Participants Participants received a combination regimen of delamanid, 300 mg, oral tablets, QD, bedaquiline, 400 mg, oral tablets, QD for 2 weeks, then 200 mg, TIW and OPC-167832, 30 mg, oral tablets, QD for a total of 17 weeks.	Delamanid + Bedaquiline + OPC-167832 90 mg n=38 Participants Participants received a combination regimen of delamanid, 300 mg, oral tablets, QD, bedaquiline, 400 mg, oral tablets, QD for 2 weeks, then 200 mg, TIW and OPC-167832, 90 mg, oral tablets, QD for a total of 17 weeks.	RHEZ n=21 Participants Participants received RHEZ, orally, QD for 8 weeks followed by 18 weeks of rifampin and isoniazid for a total of 26 weeks.
Time to Sputum Culture Conversion (SCC)	70.0 days Interval 51.0 to 84.5	56.0 days Interval 49.0 to 84.0	69.5 days Interval 49.0 to 84.0	56.0 days Interval 48.0 to 71.0

Adverse Events

Delamanid + Bedaquiline + OPC-167832 10 mg

Serious events: 2 serious events

Other events: 17 other events

Deaths: 0 deaths

Delamanid + Bedaquiline + OPC-167832 30 mg

Serious events: 3 serious events

Other events: 31 other events

Deaths: 1 deaths

Delamanid + Bedaquiline + OPC-167832 90 mg

Serious events: 0 serious events

Other events: 25 other events

Deaths: 0 deaths

RHEZ

Serious events: 0 serious events

Other events: 20 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Delamanid + Bedaquiline + OPC-167832 10 mg n=20 participants at risk Participants received a combination regimen of delamanid, 300 mg, oral tablets, QD, bedaquiline, 400 mg, oral tablets, QD for 2 weeks, then 200 mg, TIW and OPC-167832, 10 mg, oral tablets, QD for a total of 17 weeks.	Delamanid + Bedaquiline + OPC-167832 30 mg n=42 participants at risk Participants received a combination regimen of delamanid, 300 mg, oral tablets, QD, bedaquiline, 400 mg, oral tablets, QD for 2 weeks, then 200 mg, TIW and OPC-167832, 30 mg, oral tablets, QD for a total of 17 weeks.	Delamanid + Bedaquiline + OPC-167832 90 mg n=38 participants at risk Participants received a combination regimen of delamanid, 300 mg, oral tablets, QD, bedaquiline, 400 mg, oral tablets, QD for 2 weeks, then 200 mg, TIW and OPC-167832, 90 mg, oral tablets, QD for a total of 17 weeks.	RHEZ n=21 participants at risk Participants received RHEZ, orally, QD for 8 weeks followed by 18 weeks of rifampin and isoniazid for a total of 26 weeks.
Infections and infestations Appendicitis perforated	5.0% 1/20 • From first dose of the study drug up to end of follow up period (up to Week 52) Safety analysis set included all randomized participants who took any dose of the study drug.	0.00% 0/42 • From first dose of the study drug up to end of follow up period (up to Week 52) Safety analysis set included all randomized participants who took any dose of the study drug.	0.00% 0/38 • From first dose of the study drug up to end of follow up period (up to Week 52) Safety analysis set included all randomized participants who took any dose of the study drug.	0.00% 0/21 • From first dose of the study drug up to end of follow up period (up to Week 52) Safety analysis set included all randomized participants who took any dose of the study drug.
Infections and infestations Localised infection	5.0% 1/20 • From first dose of the study drug up to end of follow up period (up to Week 52) Safety analysis set included all randomized participants who took any dose of the study drug.	0.00% 0/42 • From first dose of the study drug up to end of follow up period (up to Week 52) Safety analysis set included all randomized participants who took any dose of the study drug.	0.00% 0/38 • From first dose of the study drug up to end of follow up period (up to Week 52) Safety analysis set included all randomized participants who took any dose of the study drug.	0.00% 0/21 • From first dose of the study drug up to end of follow up period (up to Week 52) Safety analysis set included all randomized participants who took any dose of the study drug.
Infections and infestations Pneumonia	0.00% 0/20 • From first dose of the study drug up to end of follow up period (up to Week 52) Safety analysis set included all randomized participants who took any dose of the study drug.	2.4% 1/42 • From first dose of the study drug up to end of follow up period (up to Week 52) Safety analysis set included all randomized participants who took any dose of the study drug.	0.00% 0/38 • From first dose of the study drug up to end of follow up period (up to Week 52) Safety analysis set included all randomized participants who took any dose of the study drug.	0.00% 0/21 • From first dose of the study drug up to end of follow up period (up to Week 52) Safety analysis set included all randomized participants who took any dose of the study drug.
Infections and infestations Tuberculosis	0.00% 0/20 • From first dose of the study drug up to end of follow up period (up to Week 52) Safety analysis set included all randomized participants who took any dose of the study drug.	2.4% 1/42 • From first dose of the study drug up to end of follow up period (up to Week 52) Safety analysis set included all randomized participants who took any dose of the study drug.	0.00% 0/38 • From first dose of the study drug up to end of follow up period (up to Week 52) Safety analysis set included all randomized participants who took any dose of the study drug.	0.00% 0/21 • From first dose of the study drug up to end of follow up period (up to Week 52) Safety analysis set included all randomized participants who took any dose of the study drug.
Metabolism and nutrition disorders Hyperkalaemia	0.00% 0/20 • From first dose of the study drug up to end of follow up period (up to Week 52) Safety analysis set included all randomized participants who took any dose of the study drug.	2.4% 1/42 • From first dose of the study drug up to end of follow up period (up to Week 52) Safety analysis set included all randomized participants who took any dose of the study drug.	0.00% 0/38 • From first dose of the study drug up to end of follow up period (up to Week 52) Safety analysis set included all randomized participants who took any dose of the study drug.	0.00% 0/21 • From first dose of the study drug up to end of follow up period (up to Week 52) Safety analysis set included all randomized participants who took any dose of the study drug.
Nervous system disorders Myelopathy	0.00% 0/20 • From first dose of the study drug up to end of follow up period (up to Week 52) Safety analysis set included all randomized participants who took any dose of the study drug.	2.4% 1/42 • From first dose of the study drug up to end of follow up period (up to Week 52) Safety analysis set included all randomized participants who took any dose of the study drug.	0.00% 0/38 • From first dose of the study drug up to end of follow up period (up to Week 52) Safety analysis set included all randomized participants who took any dose of the study drug.	0.00% 0/21 • From first dose of the study drug up to end of follow up period (up to Week 52) Safety analysis set included all randomized participants who took any dose of the study drug.
Respiratory, thoracic and mediastinal disorders Haemoptysis	0.00% 0/20 • From first dose of the study drug up to end of follow up period (up to Week 52) Safety analysis set included all randomized participants who took any dose of the study drug.	2.4% 1/42 • From first dose of the study drug up to end of follow up period (up to Week 52) Safety analysis set included all randomized participants who took any dose of the study drug.	0.00% 0/38 • From first dose of the study drug up to end of follow up period (up to Week 52) Safety analysis set included all randomized participants who took any dose of the study drug.	0.00% 0/21 • From first dose of the study drug up to end of follow up period (up to Week 52) Safety analysis set included all randomized participants who took any dose of the study drug.

Other adverse events

Additional Information

Clinical Transparency

Otsuka Pharmaceutical Development & Commercialization, Inc.

Phone: 08446878522

Email: [email protected]

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Principal investigator is a sponsor employee
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