Trial Outcomes & Findings for A Trial to Evaluate Safety, Tolerability, and Efficacy of Orally Administered OPC-67683 (NCT NCT02573350)

NCT ID: NCT02573350

Last Updated: 2021-11-01

Results Overview

Vital signs included weight (kg), body temperature (degree Celsius), heart rate \[beats/minute (bpm)\], systolic and diastolic blood pressure \[millimetre of mercury (mm Hg)\]. The criteria for clinically significant abnormal value for: weight was decrease or increase of \>=5% in body weight, heart rate was \<=60 bpm and decrease of \>=15 bpm; \>=120 bpm and Increase of \>=15 bpm, systolic blood pressure (SBP) \<=90 mm Hg and decrease of \>=20 mm Hg; diastolic blood pressure (DBP) \<=50 mm Hg and decrease of \>=15 mm Hg, all vital signs relative to Baseline. Baseline is Study 204 completion visit (Day 84) for participants who complete the baseline visit within 7 days of completing Study 204. Only categories with data for potentially clinically significant abnormal vital sign parameter values are reported.

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 213 participants
• Primary outcome timeframe: From first dose of study drug up to Week 26
• Results posted on: 2021-11-01

Participant Flow

Participants took part in the study at 14 investigative sites in the Philippines, Latvia, Estonia, South Korea, Peru, China, and Japan from 26 March 2009 to 27 October 2011.

The study consisted of a Pre-treatment, Treatment, and Follow-up Period. The Pre-treatment Period consisted of a screening and baseline visit. This was followed by a 26-week Treatment Period. There was also a Follow-up Period (28 to 32 days) for the collection of Adverse events (AEs).

Participant milestones

Measure	Delamanid 100 mg BID + OBR Participants received Delamanid 100 milligrams (mg) (2x50 mg tablets), orally, twice daily (BID) along with at least 4 additional anti-TB medications per optimized background regimen (OBR) from Week 0 to Week 26. Participants were administered OBR as directed by the given investigator based on World Health Organization (WHO) guidelines and clinical judgment.	Delamanid 200 mg BID + OBR Participants received Delamanid 200 mg (4x50 mg tablets), orally, BID along with at least 4 additional anti-TB medications per OBR up to Week 26. Participants were administered OBR as directed by the given investigator based on WHO guidelines and clinical judgment. A participant might have been titrated to Delamanid 200 mg BID after an initial hospitalization of 2 weeks. Participants were grouped according to the longest duration of Delamanid dose administered during the study.
Overall Study STARTED	137	76
Overall Study Efficacy Analysis Population	132	73
Overall Study Safety Population	137	76
Overall Study COMPLETED	121	67
Overall Study NOT COMPLETED	16	9

Reasons for withdrawal

Measure	Delamanid 100 mg BID + OBR Participants received Delamanid 100 milligrams (mg) (2x50 mg tablets), orally, twice daily (BID) along with at least 4 additional anti-TB medications per optimized background regimen (OBR) from Week 0 to Week 26. Participants were administered OBR as directed by the given investigator based on World Health Organization (WHO) guidelines and clinical judgment.	Delamanid 200 mg BID + OBR Participants received Delamanid 200 mg (4x50 mg tablets), orally, BID along with at least 4 additional anti-TB medications per OBR up to Week 26. Participants were administered OBR as directed by the given investigator based on WHO guidelines and clinical judgment. A participant might have been titrated to Delamanid 200 mg BID after an initial hospitalization of 2 weeks. Participants were grouped according to the longest duration of Delamanid dose administered during the study.
Overall Study Lost to Follow-up	2	1
Overall Study Adverse Event	3	4
Overall Study Subject met Withdrawal Criteria	1	1
Overall Study Subject was Withdrawn from Participation by the Investigator	3	1
Overall Study Subject withdrew consent to participate	6	1
Overall Study Protocol Deviation	1	1

Baseline Characteristics

A Trial to Evaluate Safety, Tolerability, and Efficacy of Orally Administered OPC-67683

Baseline characteristics by cohort

Measure	Delamanid 100 mg BID + OBR n=137 Participants Participants received Delamanid 100 mg (2x50 mg tablets), orally, BID along with at least 4 additional anti-TB medications per OBR from Week 0 to Week 26. Participants were administered OBR as directed by the given investigator based on WHO guidelines and clinical judgment.	Delamanid 200 mg BID + OBR n=76 Participants Participants received Delamanid 200 mg (4x50 mg tablets), orally, BID along with at least 4 additional anti-TB medications per OBR up to Week 26. Participants were administered OBR as directed by the given investigator based on WHO guidelines and clinical judgment. A participant might have been titrated to Delamanid 200 mg BID after an initial hospitalization of 2 weeks. Participants were grouped according to the longest duration of Delamanid dose administered during the study.	Total n=213 Participants Total of all reporting groups
Age, Continuous	36.8 years STANDARD_DEVIATION 12.36 • n=5 Participants	37.1 years STANDARD_DEVIATION 10.98 • n=7 Participants	36.9 years STANDARD_DEVIATION 11.86 • n=5 Participants
Sex: Female, Male Female	41 Participants n=5 Participants	21 Participants n=7 Participants	62 Participants n=5 Participants
Sex: Female, Male Male	96 Participants n=5 Participants	55 Participants n=7 Participants	151 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	22 Participants n=5 Participants	17 Participants n=7 Participants	39 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	115 Participants n=5 Participants	59 Participants n=7 Participants	174 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race/Ethnicity, Customized Race · Asian	100 Participants n=5 Participants	24 Participants n=7 Participants	124 Participants n=5 Participants
Race/Ethnicity, Customized Race · White	16 Participants n=5 Participants	34 Participants n=7 Participants	50 Participants n=5 Participants
Race/Ethnicity, Customized Race · Other	21 Participants n=5 Participants	18 Participants n=7 Participants	39 Participants n=5 Participants

PRIMARY outcome

Timeframe: From first dose of study drug up to Week 26

Population: Safety Population included all participants treated with at least one dose of Delamanid in this study. Number analyzed is the number of participants with data available for analyses at the given time point.

Vital signs included weight (kg), body temperature (degree Celsius), heart rate [beats/minute (bpm)], systolic and diastolic blood pressure [millimetre of mercury (mm Hg)]. The criteria for clinically significant abnormal value for: weight was decrease or increase of >=5% in body weight, heart rate was <=60 bpm and decrease of >=15 bpm; >=120 bpm and Increase of >=15 bpm, systolic blood pressure (SBP) <=90 mm Hg and decrease of >=20 mm Hg; diastolic blood pressure (DBP) <=50 mm Hg and decrease of >=15 mm Hg, all vital signs relative to Baseline. Baseline is Study 204 completion visit (Day 84) for participants who complete the baseline visit within 7 days of completing Study 204. Only categories with data for potentially clinically significant abnormal vital sign parameter values are reported.

Outcome measures

Measure	Delamanid 100 mg BID + OBR n=137 Participants Participants received Delamanid 100 mg (2x50 mg tablets), orally, BID along with at least 4 additional anti-TB medications per OBR from Week 0 to Week 26. Participants were administered OBR as directed by the given investigator based on WHO guidelines and clinical judgment.	Delamanid 200 mg BID + OBR n=76 Participants Participants received Delamanid 200 mg (4x50 mg tablets), orally, BID along with at least 4 additional anti-TB medications per OBR up to Week 26. Participants were administered OBR as directed by the given investigator based on WHO guidelines and clinical judgment. A participant might have been titrated to Delamanid 200 mg BID after an initial hospitalization of 2 weeks. Participants were grouped according to the longest duration of Delamanid dose administered during the study.
Number of Participants With Clinically Significant Abnormality in Vital Signs Weight Decrease of >=5%	23 Participants	11 Participants
Number of Participants With Clinically Significant Abnormality in Vital Signs Weight Increase of >=5%	34 Participants	25 Participants
Number of Participants With Clinically Significant Abnormality in Vital Signs SBP: <=90 mm Hg and Decrease of >=20 mm Hg	16 Participants	2 Participants
Number of Participants With Clinically Significant Abnormality in Vital Signs SBP: >=160 mm Hg and Increase of >=20 mm Hg	3 Participants	0 Participants
Number of Participants With Clinically Significant Abnormality in Vital Signs Heart Rate: <=60 bpm and Decrease of >=15 bpm	10 Participants	11 Participants
Number of Participants With Clinically Significant Abnormality in Vital Signs Heart Rate: >=120 bpm and Increase of >=15 bpm	1 Participants	0 Participants
Number of Participants With Clinically Significant Abnormality in Vital Signs DBP: <=50 mm Hg and Decrease of >=15 mm Hg	1 Participants	2 Participants

PRIMARY outcome

Timeframe: From first dose of study drug up to Week 26

Population: Safety Population included all participants treated with at least one dose of Delamanid in this study.

The criteria for clinically significant abnormal ECG values were ventricular rate outlier (<50 bpm and decrease of >=25%, >100 bpm and increase of >=25%), PR outlier (increase of >=25% when PR >200 milliseconds (ms)), QRS outlier (increase of >=25% when QRS >100 ms), QT (new onset (in treatment period but not at Baseline) [>500 ms]), QT interval corrected by Bazett's formula (QTcB) (new onset [>450, >480, >500 ms], increase of >=30 ms and <= 60 ms or increase of >60 ms), QT interval corrected by Fridericia's formula (QTcF) (new onset [>450, >480, >500 ms], increase of >=30 ms and <= 60 ms or increase of >60 ms), new abnormal U waves, new ST segment changes, new T wave changes, new abnormal rhythm, new conduction abnormality were reported as categories. Only categories with data are reported.

Outcome measures

Measure	Delamanid 100 mg BID + OBR n=137 Participants Participants received Delamanid 100 mg (2x50 mg tablets), orally, BID along with at least 4 additional anti-TB medications per OBR from Week 0 to Week 26. Participants were administered OBR as directed by the given investigator based on WHO guidelines and clinical judgment.	Delamanid 200 mg BID + OBR n=76 Participants Participants received Delamanid 200 mg (4x50 mg tablets), orally, BID along with at least 4 additional anti-TB medications per OBR up to Week 26. Participants were administered OBR as directed by the given investigator based on WHO guidelines and clinical judgment. A participant might have been titrated to Delamanid 200 mg BID after an initial hospitalization of 2 weeks. Participants were grouped according to the longest duration of Delamanid dose administered during the study.
Number of Participants With Clinically Significant Abnormalities in Electrocardiogram (ECG) Values QT Interval, New Onset (>500 msec)	1 Participants	0 Participants
Number of Participants With Clinically Significant Abnormalities in Electrocardiogram (ECG) Values QTcB Interval, New Onset (>480 msec)	11 Participants	7 Participants
Number of Participants With Clinically Significant Abnormalities in Electrocardiogram (ECG) Values QTcB Interval, New Onset (>500 msec)	2 Participants	3 Participants
Number of Participants With Clinically Significant Abnormalities in Electrocardiogram (ECG) Values QTcB Interval, Increase from Baseline >=30 msec and <=60 msec	58 Participants	39 Participants
Number of Participants With Clinically Significant Abnormalities in Electrocardiogram (ECG) Values QTcB Interval, Increase from Baseline >60 msec	5 Participants	7 Participants
Number of Participants With Clinically Significant Abnormalities in Electrocardiogram (ECG) Values QTcF Interval, New Onset (>450 msec)	23 Participants	10 Participants
Number of Participants With Clinically Significant Abnormalities in Electrocardiogram (ECG) Values QTcF Interval, New Onset (>480 msec)	3 Participants	1 Participants
Number of Participants With Clinically Significant Abnormalities in Electrocardiogram (ECG) Values QTcF Interval, New Onset (>500 msec)	1 Participants	1 Participants
Number of Participants With Clinically Significant Abnormalities in Electrocardiogram (ECG) Values QTcF Interval, Increase from Baseline >=30 msec and <=60 msec	36 Participants	30 Participants
Number of Participants With Clinically Significant Abnormalities in Electrocardiogram (ECG) Values QTcF Interval, Increase from Baseline >60 msec	4 Participants	4 Participants
Number of Participants With Clinically Significant Abnormalities in Electrocardiogram (ECG) Values Ventricular Rate Notable Changes, <50 bpm and Decrease from Baseline of >=25%	1 Participants	2 Participants
Number of Participants With Clinically Significant Abnormalities in Electrocardiogram (ECG) Values Ventricular Rate Notable Changes, >100 bpm and Increase from Baseline of >=25%	16 Participants	8 Participants
Number of Participants With Clinically Significant Abnormalities in Electrocardiogram (ECG) Values New Abnormal U Waves	4 Participants	0 Participants
Number of Participants With Clinically Significant Abnormalities in Electrocardiogram (ECG) Values New ST Segment Changes	11 Participants	2 Participants
Number of Participants With Clinically Significant Abnormalities in Electrocardiogram (ECG) Values New T Waves Changes	27 Participants	14 Participants
Number of Participants With Clinically Significant Abnormalities in Electrocardiogram (ECG) Values New Abnormal Rhythm	44 Participants	22 Participants
Number of Participants With Clinically Significant Abnormalities in Electrocardiogram (ECG) Values New Conduction	10 Participants	4 Participants
Number of Participants With Clinically Significant Abnormalities in Electrocardiogram (ECG) Values QRS Outlier	2 Participants	0 Participants
Number of Participants With Clinically Significant Abnormalities in Electrocardiogram (ECG) Values QTcB Interval, New Onset (>450 msec)	62 Participants	37 Participants

PRIMARY outcome

Timeframe: From first dose of study drug up to Week 26

Population: Safety Population included all participants treated with at least one dose of Delamanid in this study. Number analyzed is the number of participants with at least one post-baseline result for the given test.

Laboratory assessments included parameters for serum chemistry (alkaline phosphatase, alanine aminotransferase, alanine transaminase, total bilirubin, cholesterol, gamma-glutamyl transferase, glucose, lactic dehydrogenase, potassium, sodium, triglycerides, uric acid), hematology (white blood cell count eosinophils, absolute, hematocrit, hemoglobin, lymphocytes, absolute, mean corpuscular volume, neutrophil, bands, neutrophils, neutrophils, absolute, platelet count, red blood cell (RBC) count, reticulocyte count) and urinalysis (blood, epithelial cast, granular cast, hyaline cast, RBCs per high power field (RBC/HPF)). The participants were categorized based on the clinically significant laboratory values as per predefined criteria. The categories with at least one participant with clinically significant value outside the normal range for laboratory assessments are reported.

Outcome measures

Measure	Delamanid 100 mg BID + OBR n=137 Participants Participants received Delamanid 100 mg (2x50 mg tablets), orally, BID along with at least 4 additional anti-TB medications per OBR from Week 0 to Week 26. Participants were administered OBR as directed by the given investigator based on WHO guidelines and clinical judgment.	Delamanid 200 mg BID + OBR n=76 Participants Participants received Delamanid 200 mg (4x50 mg tablets), orally, BID along with at least 4 additional anti-TB medications per OBR up to Week 26. Participants were administered OBR as directed by the given investigator based on WHO guidelines and clinical judgment. A participant might have been titrated to Delamanid 200 mg BID after an initial hospitalization of 2 weeks. Participants were grouped according to the longest duration of Delamanid dose administered during the study.
Number of Participants With Clinical Significant Abnormality in Laboratory Test Alkaline Phosphatase	0 Participants	1 Participants
Number of Participants With Clinical Significant Abnormality in Laboratory Test Alanine Aminotransferase (SGPT)	2 Participants	1 Participants
Number of Participants With Clinical Significant Abnormality in Laboratory Test Aspartate Aminotransferase (SGOT)	2 Participants	1 Participants
Number of Participants With Clinical Significant Abnormality in Laboratory Test Total Bilirubin	7 Participants	4 Participants
Number of Participants With Clinical Significant Abnormality in Laboratory Test Cholesterol	1 Participants	2 Participants
Number of Participants With Clinical Significant Abnormality in Laboratory Test GAMMA-Glutamyl Transferase	2 Participants	2 Participants
Number of Participants With Clinical Significant Abnormality in Laboratory Test Glucose	5 Participants	3 Participants
Number of Participants With Clinical Significant Abnormality in Laboratory Test Lactic Dehydrogenase	22 Participants	5 Participants
Number of Participants With Clinical Significant Abnormality in Laboratory Test Potassium	13 Participants	10 Participants
Number of Participants With Clinical Significant Abnormality in Laboratory Test Sodium	16 Participants	16 Participants
Number of Participants With Clinical Significant Abnormality in Laboratory Test Triglycerides	9 Participants	3 Participants
Number of Participants With Clinical Significant Abnormality in Laboratory Test Uric Acid	9 Participants	8 Participants
Number of Participants With Clinical Significant Abnormality in Laboratory Test Eosinophils, Absolute	10 Participants	3 Participants
Number of Participants With Clinical Significant Abnormality in Laboratory Test Hematocrit	2 Participants	4 Participants
Number of Participants With Clinical Significant Abnormality in Laboratory Test Hemoglobin	61 Participants	24 Participants
Number of Participants With Clinical Significant Abnormality in Laboratory Test Lymphocytes, Absolute	0 Participants	1 Participants
Number of Participants With Clinical Significant Abnormality in Laboratory Test Mean Corpuscular Volume	20 Participants	13 Participants
Number of Participants With Clinical Significant Abnormality in Laboratory Test Neutrophil, Bands	0 Participants	1 Participants
Number of Participants With Clinical Significant Abnormality in Laboratory Test Neutrophils	6 Participants	2 Participants
Number of Participants With Clinical Significant Abnormality in Laboratory Test Neutrophils, Absolute	17 Participants	10 Participants
Number of Participants With Clinical Significant Abnormality in Laboratory Test Platelet Count	5 Participants	3 Participants
Number of Participants With Clinical Significant Abnormality in Laboratory Test Red Blood Cell Count	15 Participants	14 Participants
Number of Participants With Clinical Significant Abnormality in Laboratory Test Reticulocyte Count	9 Participants	5 Participants
Number of Participants With Clinical Significant Abnormality in Laboratory Test White Blood Count	6 Participants	3 Participants
Number of Participants With Clinical Significant Abnormality in Laboratory Test Blood Urine Present	41 Participants	29 Participants
Number of Participants With Clinical Significant Abnormality in Laboratory Test Epithelial Cast in Urine	1 Participants	1 Participants
Number of Participants With Clinical Significant Abnormality in Laboratory Test Granular Cast in Urine	9 Participants	3 Participants
Number of Participants With Clinical Significant Abnormality in Laboratory Test Hyaline Cast in Urine	6 Participants	6 Participants
Number of Participants With Clinical Significant Abnormality in Laboratory Test RBC/HPF in Urine	13 Participants	5 Participants

PRIMARY outcome

Timeframe: Baseline

Population: Safety Population included all participants treated with at least one dose of Delamanid in this study.

Audiometry assessments were done at Baseline.

Outcome measures

Measure	Delamanid 100 mg BID + OBR n=137 Participants Participants received Delamanid 100 mg (2x50 mg tablets), orally, BID along with at least 4 additional anti-TB medications per OBR from Week 0 to Week 26. Participants were administered OBR as directed by the given investigator based on WHO guidelines and clinical judgment.	Delamanid 200 mg BID + OBR n=76 Participants Participants received Delamanid 200 mg (4x50 mg tablets), orally, BID along with at least 4 additional anti-TB medications per OBR up to Week 26. Participants were administered OBR as directed by the given investigator based on WHO guidelines and clinical judgment. A participant might have been titrated to Delamanid 200 mg BID after an initial hospitalization of 2 weeks. Participants were grouped according to the longest duration of Delamanid dose administered during the study.
Number of Participants With Abnormality in Audiometry at Baseline	90 Participants	34 Participants

PRIMARY outcome

Timeframe: From first dose of study drug up to Week 26

Population: Safety Population included all participants treated with at least one dose of Delamanid in this study.

Outcome measures

Measure	Delamanid 100 mg BID + OBR n=137 Participants Participants received Delamanid 100 mg (2x50 mg tablets), orally, BID along with at least 4 additional anti-TB medications per OBR from Week 0 to Week 26. Participants were administered OBR as directed by the given investigator based on WHO guidelines and clinical judgment.	Delamanid 200 mg BID + OBR n=76 Participants Participants received Delamanid 200 mg (4x50 mg tablets), orally, BID along with at least 4 additional anti-TB medications per OBR up to Week 26. Participants were administered OBR as directed by the given investigator based on WHO guidelines and clinical judgment. A participant might have been titrated to Delamanid 200 mg BID after an initial hospitalization of 2 weeks. Participants were grouped according to the longest duration of Delamanid dose administered during the study.
Number of Participants With Abnormality in Visual Acuity	45 Participants	35 Participants

PRIMARY outcome

Timeframe: From first dose through 28 days after last dose of study drug (up to approximately 30 weeks)

Population: Safety Population included all participants treated with at least one dose of Delamanid in this study.

Participants with abnormal neurological and psychiatric assessments were reported. An adverse event (AE) is any untoward medical occurrence in a participant/clinical investigation participant administered a pharmaceutical product and which does not necessarily have a causal relationship with treatment. A TEAE is any new AE or worsening of an existing condition after initiation of study drug.

Outcome measures

Measure	Delamanid 100 mg BID + OBR n=137 Participants Participants received Delamanid 100 mg (2x50 mg tablets), orally, BID along with at least 4 additional anti-TB medications per OBR from Week 0 to Week 26. Participants were administered OBR as directed by the given investigator based on WHO guidelines and clinical judgment.	Delamanid 200 mg BID + OBR n=76 Participants Participants received Delamanid 200 mg (4x50 mg tablets), orally, BID along with at least 4 additional anti-TB medications per OBR up to Week 26. Participants were administered OBR as directed by the given investigator based on WHO guidelines and clinical judgment. A participant might have been titrated to Delamanid 200 mg BID after an initial hospitalization of 2 weeks. Participants were grouped according to the longest duration of Delamanid dose administered during the study.
Number of Participants With Abnormality in Neurological and Psychiatric Assessment Reported as Treatment-emergent Adverse Event (TEAE) Neurological Disorders	63 Participants	25 Participants
Number of Participants With Abnormality in Neurological and Psychiatric Assessment Reported as Treatment-emergent Adverse Event (TEAE) Psychiatric Disorders	44 Participants	38 Participants

PRIMARY outcome

Timeframe: From first dose through 28 days after last dose of study drug (up to approximately 30 weeks)

Population: Safety Population included all participants treated with at least one dose of Delamanid in this study.

Participants with abnormal thyroid free T4 nanograms per deciliter (ng/dL) and thyroid-stimulating hormone (>=3 OR <=0.3 micro-international units per litre (uIU/mL). An AE is any untoward medical occurrence in a participant/clinical investigation participant administered a pharmaceutical product and which does not necessarily have a causal relationship with treatment. A TEAE is any new AE or worsening of an existing condition after initiation of study drug.

Outcome measures

Measure	Delamanid 100 mg BID + OBR n=137 Participants Participants received Delamanid 100 mg (2x50 mg tablets), orally, BID along with at least 4 additional anti-TB medications per OBR from Week 0 to Week 26. Participants were administered OBR as directed by the given investigator based on WHO guidelines and clinical judgment.	Delamanid 200 mg BID + OBR n=76 Participants Participants received Delamanid 200 mg (4x50 mg tablets), orally, BID along with at least 4 additional anti-TB medications per OBR up to Week 26. Participants were administered OBR as directed by the given investigator based on WHO guidelines and clinical judgment. A participant might have been titrated to Delamanid 200 mg BID after an initial hospitalization of 2 weeks. Participants were grouped according to the longest duration of Delamanid dose administered during the study.
Number of Participants With Clinical Significant Abnormality in Thyroid Function Test Reported as TEAE	0 Participants	1 Participants

PRIMARY outcome

Timeframe: From first dose of study drug up to Week 26

Population: Safety Population included all participants treated with at least one dose of Delamanid in this study.

Concomitant medications are defined as medications that started on or after the first day of study treatment or were started prior to study treatment but were ongoing on the first day of study treatment.

Outcome measures

Measure	Delamanid 100 mg BID + OBR n=137 Participants Participants received Delamanid 100 mg (2x50 mg tablets), orally, BID along with at least 4 additional anti-TB medications per OBR from Week 0 to Week 26. Participants were administered OBR as directed by the given investigator based on WHO guidelines and clinical judgment.	Delamanid 200 mg BID + OBR n=76 Participants Participants received Delamanid 200 mg (4x50 mg tablets), orally, BID along with at least 4 additional anti-TB medications per OBR up to Week 26. Participants were administered OBR as directed by the given investigator based on WHO guidelines and clinical judgment. A participant might have been titrated to Delamanid 200 mg BID after an initial hospitalization of 2 weeks. Participants were grouped according to the longest duration of Delamanid dose administered during the study.
Number of Participants With Any Concomitant Medication Usage	135 Participants	75 Participants

PRIMARY outcome

Timeframe: From first dose through 28 days after last dose of study drug (up to approximately 30 weeks)

Population: Safety Population included all participants treated with at least one dose of Delamanid in this study.

An adverse event (AE) is any untoward medical occurrence in a participant/clinical investigation participant administered a pharmaceutical product and which does not necessarily have a causal relationship with treatment. A TEAE is any new AE or worsening of an existing condition after initiation of study drug. An SAE is an AE that resulted in death, inpatient hospitalization/prolongation of existing hospitalization, persistent or significant disability or incapacity, life-threatening, a congenital anomaly/birth defect, or an important medical event.

Outcome measures

Measure	Delamanid 100 mg BID + OBR n=137 Participants Participants received Delamanid 100 mg (2x50 mg tablets), orally, BID along with at least 4 additional anti-TB medications per OBR from Week 0 to Week 26. Participants were administered OBR as directed by the given investigator based on WHO guidelines and clinical judgment.	Delamanid 200 mg BID + OBR n=76 Participants Participants received Delamanid 200 mg (4x50 mg tablets), orally, BID along with at least 4 additional anti-TB medications per OBR up to Week 26. Participants were administered OBR as directed by the given investigator based on WHO guidelines and clinical judgment. A participant might have been titrated to Delamanid 200 mg BID after an initial hospitalization of 2 weeks. Participants were grouped according to the longest duration of Delamanid dose administered during the study.
Percentage of Participants With At Least One TEAEs and Serious Adverse Events (SAEs) TEAEs	92.0 percentage of participants	97.4 percentage of participants
Percentage of Participants With At Least One TEAEs and Serious Adverse Events (SAEs) SAEs	13.9 percentage of participants	7.9 percentage of participants

PRIMARY outcome

Timeframe: From first dose through 28 days after last dose of study drug (up to approximately 30 weeks)

Population: Safety Population included all participants treated with at least one dose of Delamanid in this study. Number analyzed is the number of participants with at least one post-baseline result for the given test.

Participants with clinically significant abnormal coagulation (prothrombin time (PT) >17.5 seconds and activated partial thromboplastin time (aPTT) >45 seconds) were reported.

Outcome measures

Measure	Delamanid 100 mg BID + OBR n=137 Participants Participants received Delamanid 100 mg (2x50 mg tablets), orally, BID along with at least 4 additional anti-TB medications per OBR from Week 0 to Week 26. Participants were administered OBR as directed by the given investigator based on WHO guidelines and clinical judgment.	Delamanid 200 mg BID + OBR n=76 Participants Participants received Delamanid 200 mg (4x50 mg tablets), orally, BID along with at least 4 additional anti-TB medications per OBR up to Week 26. Participants were administered OBR as directed by the given investigator based on WHO guidelines and clinical judgment. A participant might have been titrated to Delamanid 200 mg BID after an initial hospitalization of 2 weeks. Participants were grouped according to the longest duration of Delamanid dose administered during the study.
Number of Participants With Clinical Significant Abnormality in Coagulation (PT and aPTT) Reported as TEAE Activated Partial Thromboplastin Time	12 Participants	8 Participants
Number of Participants With Clinical Significant Abnormality in Coagulation (PT and aPTT) Reported as TEAE Prothrombin Time	2 Participants	1 Participants

PRIMARY outcome

Timeframe: From first dose of study drug up to Week 26

Population: Safety Population included all participants treated with at least one dose of Delamanid in this study. Overall number of participants analyzed is the number of participants with at least one post-baseline result for the given test.

Participants with clinically significant cortisol >=26 micrograms/decilitre (ug/dL) were reported.

Outcome measures

Measure	Delamanid 100 mg BID + OBR n=136 Participants Participants received Delamanid 100 mg (2x50 mg tablets), orally, BID along with at least 4 additional anti-TB medications per OBR from Week 0 to Week 26. Participants were administered OBR as directed by the given investigator based on WHO guidelines and clinical judgment.	Delamanid 200 mg BID + OBR n=76 Participants Participants received Delamanid 200 mg (4x50 mg tablets), orally, BID along with at least 4 additional anti-TB medications per OBR up to Week 26. Participants were administered OBR as directed by the given investigator based on WHO guidelines and clinical judgment. A participant might have been titrated to Delamanid 200 mg BID after an initial hospitalization of 2 weeks. Participants were grouped according to the longest duration of Delamanid dose administered during the study.
Number of Participants With Clinical Significant Abnormality in Cortisol	44 Participants	19 Participants

SECONDARY outcome

Timeframe: Week 26

Population: Efficacy Analysis Population included all enrolled participants who had a baseline and a post-baseline measurement available for assessment of any efficacy endpoint.

Treatment Responder was defined as a participant classified as sustained converter or a new converter. Sustained Converter was defined as a participant with sputum culture conversion (SCC) at baseline and without any positive culture result during the 26-week trial period. New converter was defined as a participant without SCC at baseline who subsequently met the definition of SCC. A participant was classified as having achieved SCC if he/she achieved 2 consecutive sputum cultures negative for growth of mycobacterium tuberculosis (MTB) at least 28 days apart after his/her last sputum culture that was positive for growth. The total percentage of treatment responders was calculated as the number of sustained converters plus the number of new converters divided by the total number of participants in the analysis population. Efficacy was assessed by the MGIT sputum culture system (ie, sputum culture conversion).

Outcome measures

Measure	Delamanid 100 mg BID + OBR n=132 Participants Participants received Delamanid 100 mg (2x50 mg tablets), orally, BID along with at least 4 additional anti-TB medications per OBR from Week 0 to Week 26. Participants were administered OBR as directed by the given investigator based on WHO guidelines and clinical judgment.	Delamanid 200 mg BID + OBR n=73 Participants Participants received Delamanid 200 mg (4x50 mg tablets), orally, BID along with at least 4 additional anti-TB medications per OBR up to Week 26. Participants were administered OBR as directed by the given investigator based on WHO guidelines and clinical judgment. A participant might have been titrated to Delamanid 200 mg BID after an initial hospitalization of 2 weeks. Participants were grouped according to the longest duration of Delamanid dose administered during the study.
Percentage of Treatment Responders Using the Mycobacterial Growth Indicator Tube (MGIT) Culture System	79.5 percentage of participants Interval 71.7 to 86.1	75.3 percentage of participants Interval 63.9 to 84.7

SECONDARY outcome

Timeframe: Week 26

Population: Efficacy Analysis Population included all enrolled participants who had a baseline and a post-baseline measurement available for assessment of any efficacy endpoint.

Treatment Responder was defined as a participant classified as sustained converter or a new converter. Sustained Converter was defined as a participant with SCC at baseline and without any positive culture result during the 26-week trial period. New converter was defined as a participant without SCC at baseline who subsequently met the definition of SCC. A participant was classified as having achieved SCC if he/she achieved 2 consecutive sputum cultures negative for growth of MTB at least 28 days apart after his/her last sputum culture that was positive for growth. The total percentage of treatment responders was calculated as the number of sustained converters plus the number of new converters divided by the total number of participants in the analysis population. Efficacy was assessed by the solid culture medium (ie, sputum culture conversion)

Outcome measures

Measure	Delamanid 100 mg BID + OBR n=132 Participants Participants received Delamanid 100 mg (2x50 mg tablets), orally, BID along with at least 4 additional anti-TB medications per OBR from Week 0 to Week 26. Participants were administered OBR as directed by the given investigator based on WHO guidelines and clinical judgment.	Delamanid 200 mg BID + OBR n=73 Participants Participants received Delamanid 200 mg (4x50 mg tablets), orally, BID along with at least 4 additional anti-TB medications per OBR up to Week 26. Participants were administered OBR as directed by the given investigator based on WHO guidelines and clinical judgment. A participant might have been titrated to Delamanid 200 mg BID after an initial hospitalization of 2 weeks. Participants were grouped according to the longest duration of Delamanid dose administered during the study.
Percentage of Treatment Responders Using Solid Culture Medium	81.8 percentage of participants Interval 74.2 to 88.0	82.2 percentage of participants Interval 71.5 to 90.2

SECONDARY outcome

Timeframe: Week 26

Population: Efficacy Analysis Population included all enrolled participants who had a baseline and a post-baseline measurement available for assessment of any efficacy endpoint.

Non-responders were defined as participants classified as non-converter or reverter. Non-converters were defined as participants without SCC at baseline and who did not achieve SCC during the 26-week trial period whereas reverters were participants with SCC at baseline and at least one positive post-baseline result. The total percentage of treatment non-responders was calculated as the number of reverters plus the number of non-converters divided by the total number of participants in the analysis population. Efficacy was assessed by the MGIT sputum culture system (ie, sputum culture conversion)

Outcome measures

Measure	Delamanid 100 mg BID + OBR n=132 Participants Participants received Delamanid 100 mg (2x50 mg tablets), orally, BID along with at least 4 additional anti-TB medications per OBR from Week 0 to Week 26. Participants were administered OBR as directed by the given investigator based on WHO guidelines and clinical judgment.	Delamanid 200 mg BID + OBR n=73 Participants Participants received Delamanid 200 mg (4x50 mg tablets), orally, BID along with at least 4 additional anti-TB medications per OBR up to Week 26. Participants were administered OBR as directed by the given investigator based on WHO guidelines and clinical judgment. A participant might have been titrated to Delamanid 200 mg BID after an initial hospitalization of 2 weeks. Participants were grouped according to the longest duration of Delamanid dose administered during the study.
Percentage of Treatment Non-responders Using the MGIT Culture System	20.5 percentage of participants Interval 13.9 to 28.3	24.7 percentage of participants Interval 15.3 to 36.1

SECONDARY outcome

Timeframe: Week 26

Population: Efficacy Analysis Population included all enrolled participants who had a baseline and a post-baseline measurement available for assessment of any efficacy endpoint.

Non-responders were defined as participants classified as non-converter or reverter. Non-converters were defined as participants without SCC at baseline and who did not achieve SCC during the 26-week trial period whereas reverters were participants with SCC at baseline and at least one positive post-baseline result. Treatment Non-responders was calculated as the number of reverters plus the number of non-converters divided by the total number of participants in the analysis population. Efficacy was assessed by the Solid culture medium (ie, sputum culture conversion).

Outcome measures

Measure	Delamanid 100 mg BID + OBR n=132 Participants Participants received Delamanid 100 mg (2x50 mg tablets), orally, BID along with at least 4 additional anti-TB medications per OBR from Week 0 to Week 26. Participants were administered OBR as directed by the given investigator based on WHO guidelines and clinical judgment.	Delamanid 200 mg BID + OBR n=73 Participants Participants received Delamanid 200 mg (4x50 mg tablets), orally, BID along with at least 4 additional anti-TB medications per OBR up to Week 26. Participants were administered OBR as directed by the given investigator based on WHO guidelines and clinical judgment. A participant might have been titrated to Delamanid 200 mg BID after an initial hospitalization of 2 weeks. Participants were grouped according to the longest duration of Delamanid dose administered during the study.
Percentage of Treatment Non-responders Using Solid Culture Medium	18.2 percentage of participants Interval 12.0 to 25.8	17.8 percentage of participants Interval 9.8 to 28.5

SECONDARY outcome

Timeframe: Week 26

Population: Efficacy Analysis Population included all enrolled participants who had a baseline and a post-baseline measurement available for assessment of any efficacy endpoint.

The total percentage of sustained converters was defined as the percentage of participants in the analysis dataset who had SCC at baseline and non-positive sputum culture results for all post-baseline visits. Efficacy was assessed by the MGIT sputum culture system (ie, sputum culture conversion)

Outcome measures

Measure	Delamanid 100 mg BID + OBR n=132 Participants Participants received Delamanid 100 mg (2x50 mg tablets), orally, BID along with at least 4 additional anti-TB medications per OBR from Week 0 to Week 26. Participants were administered OBR as directed by the given investigator based on WHO guidelines and clinical judgment.	Delamanid 200 mg BID + OBR n=73 Participants Participants received Delamanid 200 mg (4x50 mg tablets), orally, BID along with at least 4 additional anti-TB medications per OBR up to Week 26. Participants were administered OBR as directed by the given investigator based on WHO guidelines and clinical judgment. A participant might have been titrated to Delamanid 200 mg BID after an initial hospitalization of 2 weeks. Participants were grouped according to the longest duration of Delamanid dose administered during the study.
Percentage of Sustained Converters Using the MGIT Culture System	69.7 percentage of participants Interval 61.1 to 77.4	69.9 percentage of participants Interval 58.0 to 80.1

SECONDARY outcome

Timeframe: Week 26

Population: Efficacy Analysis Population included all enrolled participants who had a baseline and a post-baseline measurement available for assessment of any efficacy endpoint.

The total percentage of sustained converters was defined as percentage of participants in the analysis dataset who had SCC at baseline and non-positive sputum culture results for all post-baseline visits. Determined by Solid culture medium. Efficacy was assessed by the solid culture medium (ie, sputum culture conversion)

Outcome measures

Measure	Delamanid 100 mg BID + OBR n=132 Participants Participants received Delamanid 100 mg (2x50 mg tablets), orally, BID along with at least 4 additional anti-TB medications per OBR from Week 0 to Week 26. Participants were administered OBR as directed by the given investigator based on WHO guidelines and clinical judgment.	Delamanid 200 mg BID + OBR n=73 Participants Participants received Delamanid 200 mg (4x50 mg tablets), orally, BID along with at least 4 additional anti-TB medications per OBR up to Week 26. Participants were administered OBR as directed by the given investigator based on WHO guidelines and clinical judgment. A participant might have been titrated to Delamanid 200 mg BID after an initial hospitalization of 2 weeks. Participants were grouped according to the longest duration of Delamanid dose administered during the study.
Percentage of Sustained Converters Using Solid Culture Medium	74.2 percentage of participants Interval 65.9 to 81.5	72.6 percentage of participants Interval 60.9 to 82.4

SECONDARY outcome

Timeframe: Week 26

Population: Efficacy Analysis Population included all enrolled participants who had a baseline and a post-baseline measurement available for assessment of any efficacy endpoint.

The total percentage of new converters was defined as the percentage of participants in the analysis dataset without SCC at baseline who achieved SCC during the 26-week trial period. Efficacy was assessed by the MGIT sputum culture system (ie, sputum culture conversion).

Outcome measures

Measure	Delamanid 100 mg BID + OBR n=132 Participants Participants received Delamanid 100 mg (2x50 mg tablets), orally, BID along with at least 4 additional anti-TB medications per OBR from Week 0 to Week 26. Participants were administered OBR as directed by the given investigator based on WHO guidelines and clinical judgment.	Delamanid 200 mg BID + OBR n=73 Participants Participants received Delamanid 200 mg (4x50 mg tablets), orally, BID along with at least 4 additional anti-TB medications per OBR up to Week 26. Participants were administered OBR as directed by the given investigator based on WHO guidelines and clinical judgment. A participant might have been titrated to Delamanid 200 mg BID after an initial hospitalization of 2 weeks. Participants were grouped according to the longest duration of Delamanid dose administered during the study.
Percentage of New Converters Using the MGIT Culture System	9.8 percentage of participants Interval 5.3 to 16.3	5.5 percentage of participants Interval 1.5 to 13.4

SECONDARY outcome

Timeframe: Week 26

Population: Efficacy Analysis Population included all enrolled participants who had a baseline and a post-baseline measurement available for assessment of any efficacy endpoint.

The total percentage of new converters was defined as the percentage of participants in the analysis dataset without SCC at baseline who achieved SCC during the 26-week trial period. Efficacy was assessed by the solid culture medium (ie, sputum culture conversion).

Outcome measures

Measure	Delamanid 100 mg BID + OBR n=132 Participants Participants received Delamanid 100 mg (2x50 mg tablets), orally, BID along with at least 4 additional anti-TB medications per OBR from Week 0 to Week 26. Participants were administered OBR as directed by the given investigator based on WHO guidelines and clinical judgment.	Delamanid 200 mg BID + OBR n=73 Participants Participants received Delamanid 200 mg (4x50 mg tablets), orally, BID along with at least 4 additional anti-TB medications per OBR up to Week 26. Participants were administered OBR as directed by the given investigator based on WHO guidelines and clinical judgment. A participant might have been titrated to Delamanid 200 mg BID after an initial hospitalization of 2 weeks. Participants were grouped according to the longest duration of Delamanid dose administered during the study.
Percentage of New Converters Using Solid Culture Medium	7.6 percentage of participants Interval 3.7 to 13.5	9.6 percentage of participants Interval 3.9 to 18.8

SECONDARY outcome

Timeframe: Week 26

Population: Efficacy Analysis Population included all enrolled participants who had a baseline and a post-baseline measurement available for assessment of any efficacy endpoint.

The total percentage of non-converters was defined as the percentage of participants in the analysis dataset without SCC at baseline and who did not achieve SCC during the 26-week trial period. Efficacy was assessed by the MGIT sputum culture system (ie, sputum culture conversion).

Outcome measures

Measure	Delamanid 100 mg BID + OBR n=132 Participants Participants received Delamanid 100 mg (2x50 mg tablets), orally, BID along with at least 4 additional anti-TB medications per OBR from Week 0 to Week 26. Participants were administered OBR as directed by the given investigator based on WHO guidelines and clinical judgment.	Delamanid 200 mg BID + OBR n=73 Participants Participants received Delamanid 200 mg (4x50 mg tablets), orally, BID along with at least 4 additional anti-TB medications per OBR up to Week 26. Participants were administered OBR as directed by the given investigator based on WHO guidelines and clinical judgment. A participant might have been titrated to Delamanid 200 mg BID after an initial hospitalization of 2 weeks. Participants were grouped according to the longest duration of Delamanid dose administered during the study.
Percentage of Non-converters Using the MGIT Culture System	8.3 percentage of participants Interval 4.2 to 14.4	13.7 percentage of participants Interval 6.8 to 23.8

SECONDARY outcome

Timeframe: Week 26

Population: Efficacy Analysis Population included all enrolled participants who had a baseline and a post-baseline measurement available for assessment of any efficacy endpoint.

The total percentage of non-converters was defined as the percentage of participants in the analysis dataset without SCC at baseline and who did not achieve SCC during the 26-week trial period. Efficacy was assessed by the solid culture medium (ie, sputum culture conversion).

Outcome measures

Measure	Delamanid 100 mg BID + OBR n=132 Participants Participants received Delamanid 100 mg (2x50 mg tablets), orally, BID along with at least 4 additional anti-TB medications per OBR from Week 0 to Week 26. Participants were administered OBR as directed by the given investigator based on WHO guidelines and clinical judgment.	Delamanid 200 mg BID + OBR n=73 Participants Participants received Delamanid 200 mg (4x50 mg tablets), orally, BID along with at least 4 additional anti-TB medications per OBR up to Week 26. Participants were administered OBR as directed by the given investigator based on WHO guidelines and clinical judgment. A participant might have been titrated to Delamanid 200 mg BID after an initial hospitalization of 2 weeks. Participants were grouped according to the longest duration of Delamanid dose administered during the study.
Percentage of Non-converters Using Solid Culture Medium	6.8 percentage of participants Interval 3.2 to 12.5	9.6 percentage of participants Interval 3.9 to 18.8

SECONDARY outcome

Timeframe: Week 26

Population: Efficacy Analysis Population included all enrolled participants who had a baseline and a post-baseline measurement available for assessment of any efficacy endpoint.

The total percentage of reverters was defined as the percentage of participants in the analysis dataset with SCC at baseline and at least one positive post-baseline result. Efficacy was assessed by the MGIT sputum culture system (ie, sputum culture conversion).

Outcome measures

Measure	Delamanid 100 mg BID + OBR n=132 Participants Participants received Delamanid 100 mg (2x50 mg tablets), orally, BID along with at least 4 additional anti-TB medications per OBR from Week 0 to Week 26. Participants were administered OBR as directed by the given investigator based on WHO guidelines and clinical judgment.	Delamanid 200 mg BID + OBR n=73 Participants Participants received Delamanid 200 mg (4x50 mg tablets), orally, BID along with at least 4 additional anti-TB medications per OBR up to Week 26. Participants were administered OBR as directed by the given investigator based on WHO guidelines and clinical judgment. A participant might have been titrated to Delamanid 200 mg BID after an initial hospitalization of 2 weeks. Participants were grouped according to the longest duration of Delamanid dose administered during the study.
Percentage of Reverters Using the MGIT Culture System	12.1 percentage of participants Interval 7.1 to 18.9	11.0 percentage of participants Interval 4.9 to 20.5

SECONDARY outcome

Timeframe: Week 26

Population: Efficacy Analysis Population included all enrolled participants who had a baseline and a post-baseline measurement available for assessment of any efficacy endpoint.

The total percentage of reverters was defined as the percentage of participants in the analysis dataset with SCC at baseline and at least one positive post-baseline result. Efficacy was assessed by the solid culture medium (ie, sputum culture conversion).

Outcome measures

Measure	Delamanid 100 mg BID + OBR n=132 Participants Participants received Delamanid 100 mg (2x50 mg tablets), orally, BID along with at least 4 additional anti-TB medications per OBR from Week 0 to Week 26. Participants were administered OBR as directed by the given investigator based on WHO guidelines and clinical judgment.	Delamanid 200 mg BID + OBR n=73 Participants Participants received Delamanid 200 mg (4x50 mg tablets), orally, BID along with at least 4 additional anti-TB medications per OBR up to Week 26. Participants were administered OBR as directed by the given investigator based on WHO guidelines and clinical judgment. A participant might have been titrated to Delamanid 200 mg BID after an initial hospitalization of 2 weeks. Participants were grouped according to the longest duration of Delamanid dose administered during the study.
Percentage of Reverters Using Solid Culture Medium	11.4 percentage of participants Interval 6.5 to 18.0	8.2 percentage of participants Interval 3.1 to 17.0

SECONDARY outcome

Timeframe: Up to Week 26

Population: Efficacy Analysis Population included all enrolled participants who had a baseline and a post-baseline measurement available for assessment of any efficacy endpoint.

Resistance was defined as mycobacterium tuberculosis (MTB) growth on the delamanid-containing medium of greater than 1% of that on the drug-free medium. The overall resistance to delamanid during the study was assessed.

Outcome measures

Measure	Delamanid 100 mg BID + OBR n=132 Participants Participants received Delamanid 100 mg (2x50 mg tablets), orally, BID along with at least 4 additional anti-TB medications per OBR from Week 0 to Week 26. Participants were administered OBR as directed by the given investigator based on WHO guidelines and clinical judgment.	Delamanid 200 mg BID + OBR n=73 Participants Participants received Delamanid 200 mg (4x50 mg tablets), orally, BID along with at least 4 additional anti-TB medications per OBR up to Week 26. Participants were administered OBR as directed by the given investigator based on WHO guidelines and clinical judgment. A participant might have been titrated to Delamanid 200 mg BID after an initial hospitalization of 2 weeks. Participants were grouped according to the longest duration of Delamanid dose administered during the study.
Percentage of Participants Who Developed Resistance to Delamanid While on Treatment	1.5 percentage of participants	2.7 percentage of participants

Adverse Events

Delamanid 100 mg BID + OBR

Serious events: 19 serious events

Other events: 126 other events

Deaths: 1 deaths

Delamanid 200 mg BID + OBR

Serious events: 6 serious events

Other events: 73 other events

Deaths: 0 deaths

Serious adverse events

Measure	Delamanid 100 mg BID + OBR n=137 participants at risk Participants received Delamanid 100 milligrams (mg) (2x50 mg tablets), orally, twice daily (BID) along with at least 4 additional anti-TB medications per optimized background regimen (OBR) from Week 0 to Week 26. Participants were administered OBR as directed by the given investigator based on WHO guidelines and clinical judgment.	Delamanid 200 mg BID + OBR n=76 participants at risk Participants received Delamanid 200 mg (4x50 mg tablets), orally, BID along with at least 4 additional anti-TB medications per OBR up to Week 26. Participants were administered OBR as directed by the given investigator based on WHO guidelines and clinical judgment. A participant might have been titrated to Delamanid 200 mg BID after an initial hospitalization of 2 weeks. Participants were grouped according to the longest duration of Delamanid dose administered during the study.
Cardiac disorders Right ventricular failure	0.73% 1/137 • From first dose through 28 days after last dose of study drug (up to approximately 30 weeks) Safety Population included all participants treated with at least one dose of Delamanid in this study.	0.00% 0/76 • From first dose through 28 days after last dose of study drug (up to approximately 30 weeks) Safety Population included all participants treated with at least one dose of Delamanid in this study.
Hepatobiliary disorders Hepatitis acute	0.00% 0/137 • From first dose through 28 days after last dose of study drug (up to approximately 30 weeks) Safety Population included all participants treated with at least one dose of Delamanid in this study.	1.3% 1/76 • From first dose through 28 days after last dose of study drug (up to approximately 30 weeks) Safety Population included all participants treated with at least one dose of Delamanid in this study.
Hepatobiliary disorders Hyperbilirubinaemia	1.5% 2/137 • From first dose through 28 days after last dose of study drug (up to approximately 30 weeks) Safety Population included all participants treated with at least one dose of Delamanid in this study.	1.3% 1/76 • From first dose through 28 days after last dose of study drug (up to approximately 30 weeks) Safety Population included all participants treated with at least one dose of Delamanid in this study.
Infections and infestations Appendicitis	0.73% 1/137 • From first dose through 28 days after last dose of study drug (up to approximately 30 weeks) Safety Population included all participants treated with at least one dose of Delamanid in this study.	0.00% 0/76 • From first dose through 28 days after last dose of study drug (up to approximately 30 weeks) Safety Population included all participants treated with at least one dose of Delamanid in this study.
Infections and infestations Lung infection	0.73% 1/137 • From first dose through 28 days after last dose of study drug (up to approximately 30 weeks) Safety Population included all participants treated with at least one dose of Delamanid in this study.	0.00% 0/76 • From first dose through 28 days after last dose of study drug (up to approximately 30 weeks) Safety Population included all participants treated with at least one dose of Delamanid in this study.
Infections and infestations Pulmonary tuberculoma	0.73% 1/137 • From first dose through 28 days after last dose of study drug (up to approximately 30 weeks) Safety Population included all participants treated with at least one dose of Delamanid in this study.	0.00% 0/76 • From first dose through 28 days after last dose of study drug (up to approximately 30 weeks) Safety Population included all participants treated with at least one dose of Delamanid in this study.
Infections and infestations Tuberculosis	1.5% 2/137 • From first dose through 28 days after last dose of study drug (up to approximately 30 weeks) Safety Population included all participants treated with at least one dose of Delamanid in this study.	1.3% 1/76 • From first dose through 28 days after last dose of study drug (up to approximately 30 weeks) Safety Population included all participants treated with at least one dose of Delamanid in this study.
Injury, poisoning and procedural complications Gun shot wound	0.73% 1/137 • From first dose through 28 days after last dose of study drug (up to approximately 30 weeks) Safety Population included all participants treated with at least one dose of Delamanid in this study.	0.00% 0/76 • From first dose through 28 days after last dose of study drug (up to approximately 30 weeks) Safety Population included all participants treated with at least one dose of Delamanid in this study.
Injury, poisoning and procedural complications Intentional overdose	0.00% 0/137 • From first dose through 28 days after last dose of study drug (up to approximately 30 weeks) Safety Population included all participants treated with at least one dose of Delamanid in this study.	1.3% 1/76 • From first dose through 28 days after last dose of study drug (up to approximately 30 weeks) Safety Population included all participants treated with at least one dose of Delamanid in this study.
Investigations Blood pressure increased	0.73% 1/137 • From first dose through 28 days after last dose of study drug (up to approximately 30 weeks) Safety Population included all participants treated with at least one dose of Delamanid in this study.	0.00% 0/76 • From first dose through 28 days after last dose of study drug (up to approximately 30 weeks) Safety Population included all participants treated with at least one dose of Delamanid in this study.
Investigations Electrocardiogram Qt prolonged	0.73% 1/137 • From first dose through 28 days after last dose of study drug (up to approximately 30 weeks) Safety Population included all participants treated with at least one dose of Delamanid in this study.	1.3% 1/76 • From first dose through 28 days after last dose of study drug (up to approximately 30 weeks) Safety Population included all participants treated with at least one dose of Delamanid in this study.
Metabolism and nutrition disorders Hypokalaemia	0.73% 1/137 • From first dose through 28 days after last dose of study drug (up to approximately 30 weeks) Safety Population included all participants treated with at least one dose of Delamanid in this study.	0.00% 0/76 • From first dose through 28 days after last dose of study drug (up to approximately 30 weeks) Safety Population included all participants treated with at least one dose of Delamanid in this study.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lip and/or oral cavity cancer	0.00% 0/137 • From first dose through 28 days after last dose of study drug (up to approximately 30 weeks) Safety Population included all participants treated with at least one dose of Delamanid in this study.	1.3% 1/76 • From first dose through 28 days after last dose of study drug (up to approximately 30 weeks) Safety Population included all participants treated with at least one dose of Delamanid in this study.
Nervous system disorders Headache	0.73% 1/137 • From first dose through 28 days after last dose of study drug (up to approximately 30 weeks) Safety Population included all participants treated with at least one dose of Delamanid in this study.	0.00% 0/76 • From first dose through 28 days after last dose of study drug (up to approximately 30 weeks) Safety Population included all participants treated with at least one dose of Delamanid in this study.
Nervous system disorders Polyneuropathy	0.73% 1/137 • From first dose through 28 days after last dose of study drug (up to approximately 30 weeks) Safety Population included all participants treated with at least one dose of Delamanid in this study.	0.00% 0/76 • From first dose through 28 days after last dose of study drug (up to approximately 30 weeks) Safety Population included all participants treated with at least one dose of Delamanid in this study.
Pregnancy, puerperium and perinatal conditions Abortion incomplete	0.73% 1/137 • From first dose through 28 days after last dose of study drug (up to approximately 30 weeks) Safety Population included all participants treated with at least one dose of Delamanid in this study.	0.00% 0/76 • From first dose through 28 days after last dose of study drug (up to approximately 30 weeks) Safety Population included all participants treated with at least one dose of Delamanid in this study.
Psychiatric disorders Suicidal ideation	0.73% 1/137 • From first dose through 28 days after last dose of study drug (up to approximately 30 weeks) Safety Population included all participants treated with at least one dose of Delamanid in this study.	0.00% 0/76 • From first dose through 28 days after last dose of study drug (up to approximately 30 weeks) Safety Population included all participants treated with at least one dose of Delamanid in this study.
Psychiatric disorders Suicide attempt	0.00% 0/137 • From first dose through 28 days after last dose of study drug (up to approximately 30 weeks) Safety Population included all participants treated with at least one dose of Delamanid in this study.	1.3% 1/76 • From first dose through 28 days after last dose of study drug (up to approximately 30 weeks) Safety Population included all participants treated with at least one dose of Delamanid in this study.
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.73% 1/137 • From first dose through 28 days after last dose of study drug (up to approximately 30 weeks) Safety Population included all participants treated with at least one dose of Delamanid in this study.	0.00% 0/76 • From first dose through 28 days after last dose of study drug (up to approximately 30 weeks) Safety Population included all participants treated with at least one dose of Delamanid in this study.
Respiratory, thoracic and mediastinal disorders Haemoptysis	1.5% 2/137 • From first dose through 28 days after last dose of study drug (up to approximately 30 weeks) Safety Population included all participants treated with at least one dose of Delamanid in this study.	0.00% 0/76 • From first dose through 28 days after last dose of study drug (up to approximately 30 weeks) Safety Population included all participants treated with at least one dose of Delamanid in this study.
Respiratory, thoracic and mediastinal disorders Hydropneumothorax	0.73% 1/137 • From first dose through 28 days after last dose of study drug (up to approximately 30 weeks) Safety Population included all participants treated with at least one dose of Delamanid in this study.	0.00% 0/76 • From first dose through 28 days after last dose of study drug (up to approximately 30 weeks) Safety Population included all participants treated with at least one dose of Delamanid in this study.
Respiratory, thoracic and mediastinal disorders Respiratory failure	0.73% 1/137 • From first dose through 28 days after last dose of study drug (up to approximately 30 weeks) Safety Population included all participants treated with at least one dose of Delamanid in this study.	0.00% 0/76 • From first dose through 28 days after last dose of study drug (up to approximately 30 weeks) Safety Population included all participants treated with at least one dose of Delamanid in this study.
Investigations Transaminases increased	0.73% 1/137 • From first dose through 28 days after last dose of study drug (up to approximately 30 weeks) Safety Population included all participants treated with at least one dose of Delamanid in this study.	0.00% 0/76 • From first dose through 28 days after last dose of study drug (up to approximately 30 weeks) Safety Population included all participants treated with at least one dose of Delamanid in this study.

Other adverse events

Measure	Delamanid 100 mg BID + OBR n=137 participants at risk Participants received Delamanid 100 milligrams (mg) (2x50 mg tablets), orally, twice daily (BID) along with at least 4 additional anti-TB medications per optimized background regimen (OBR) from Week 0 to Week 26. Participants were administered OBR as directed by the given investigator based on WHO guidelines and clinical judgment.	Delamanid 200 mg BID + OBR n=76 participants at risk Participants received Delamanid 200 mg (4x50 mg tablets), orally, BID along with at least 4 additional anti-TB medications per OBR up to Week 26. Participants were administered OBR as directed by the given investigator based on WHO guidelines and clinical judgment. A participant might have been titrated to Delamanid 200 mg BID after an initial hospitalization of 2 weeks. Participants were grouped according to the longest duration of Delamanid dose administered during the study.
Cardiac disorders Palpitations	13.1% 18/137 • From first dose through 28 days after last dose of study drug (up to approximately 30 weeks) Safety Population included all participants treated with at least one dose of Delamanid in this study.	0.00% 0/76 • From first dose through 28 days after last dose of study drug (up to approximately 30 weeks) Safety Population included all participants treated with at least one dose of Delamanid in this study.
Ear and labyrinth disorders Tinnitus	11.7% 16/137 • From first dose through 28 days after last dose of study drug (up to approximately 30 weeks) Safety Population included all participants treated with at least one dose of Delamanid in this study.	6.6% 5/76 • From first dose through 28 days after last dose of study drug (up to approximately 30 weeks) Safety Population included all participants treated with at least one dose of Delamanid in this study.
Gastrointestinal disorders Abdominal pain	5.8% 8/137 • From first dose through 28 days after last dose of study drug (up to approximately 30 weeks) Safety Population included all participants treated with at least one dose of Delamanid in this study.	1.3% 1/76 • From first dose through 28 days after last dose of study drug (up to approximately 30 weeks) Safety Population included all participants treated with at least one dose of Delamanid in this study.
Gastrointestinal disorders Abdominal pain lower	5.1% 7/137 • From first dose through 28 days after last dose of study drug (up to approximately 30 weeks) Safety Population included all participants treated with at least one dose of Delamanid in this study.	1.3% 1/76 • From first dose through 28 days after last dose of study drug (up to approximately 30 weeks) Safety Population included all participants treated with at least one dose of Delamanid in this study.
Gastrointestinal disorders Abdominal pain upper	13.9% 19/137 • From first dose through 28 days after last dose of study drug (up to approximately 30 weeks) Safety Population included all participants treated with at least one dose of Delamanid in this study.	7.9% 6/76 • From first dose through 28 days after last dose of study drug (up to approximately 30 weeks) Safety Population included all participants treated with at least one dose of Delamanid in this study.
Gastrointestinal disorders Diarrhoea	10.2% 14/137 • From first dose through 28 days after last dose of study drug (up to approximately 30 weeks) Safety Population included all participants treated with at least one dose of Delamanid in this study.	9.2% 7/76 • From first dose through 28 days after last dose of study drug (up to approximately 30 weeks) Safety Population included all participants treated with at least one dose of Delamanid in this study.
Gastrointestinal disorders Dyspepsia	5.1% 7/137 • From first dose through 28 days after last dose of study drug (up to approximately 30 weeks) Safety Population included all participants treated with at least one dose of Delamanid in this study.	7.9% 6/76 • From first dose through 28 days after last dose of study drug (up to approximately 30 weeks) Safety Population included all participants treated with at least one dose of Delamanid in this study.
Gastrointestinal disorders Gastritis	7.3% 10/137 • From first dose through 28 days after last dose of study drug (up to approximately 30 weeks) Safety Population included all participants treated with at least one dose of Delamanid in this study.	10.5% 8/76 • From first dose through 28 days after last dose of study drug (up to approximately 30 weeks) Safety Population included all participants treated with at least one dose of Delamanid in this study.
Gastrointestinal disorders Nausea	14.6% 20/137 • From first dose through 28 days after last dose of study drug (up to approximately 30 weeks) Safety Population included all participants treated with at least one dose of Delamanid in this study.	19.7% 15/76 • From first dose through 28 days after last dose of study drug (up to approximately 30 weeks) Safety Population included all participants treated with at least one dose of Delamanid in this study.
Gastrointestinal disorders Toothache	5.8% 8/137 • From first dose through 28 days after last dose of study drug (up to approximately 30 weeks) Safety Population included all participants treated with at least one dose of Delamanid in this study.	7.9% 6/76 • From first dose through 28 days after last dose of study drug (up to approximately 30 weeks) Safety Population included all participants treated with at least one dose of Delamanid in this study.
Gastrointestinal disorders Vomiting	17.5% 24/137 • From first dose through 28 days after last dose of study drug (up to approximately 30 weeks) Safety Population included all participants treated with at least one dose of Delamanid in this study.	6.6% 5/76 • From first dose through 28 days after last dose of study drug (up to approximately 30 weeks) Safety Population included all participants treated with at least one dose of Delamanid in this study.
General disorders Chest pain	8.8% 12/137 • From first dose through 28 days after last dose of study drug (up to approximately 30 weeks) Safety Population included all participants treated with at least one dose of Delamanid in this study.	7.9% 6/76 • From first dose through 28 days after last dose of study drug (up to approximately 30 weeks) Safety Population included all participants treated with at least one dose of Delamanid in this study.
Hepatobiliary disorders Hyperbilirubinaemia	5.8% 8/137 • From first dose through 28 days after last dose of study drug (up to approximately 30 weeks) Safety Population included all participants treated with at least one dose of Delamanid in this study.	1.3% 1/76 • From first dose through 28 days after last dose of study drug (up to approximately 30 weeks) Safety Population included all participants treated with at least one dose of Delamanid in this study.
Infections and infestations Folliculitis	0.73% 1/137 • From first dose through 28 days after last dose of study drug (up to approximately 30 weeks) Safety Population included all participants treated with at least one dose of Delamanid in this study.	5.3% 4/76 • From first dose through 28 days after last dose of study drug (up to approximately 30 weeks) Safety Population included all participants treated with at least one dose of Delamanid in this study.
Infections and infestations Lung infection	5.1% 7/137 • From first dose through 28 days after last dose of study drug (up to approximately 30 weeks) Safety Population included all participants treated with at least one dose of Delamanid in this study.	2.6% 2/76 • From first dose through 28 days after last dose of study drug (up to approximately 30 weeks) Safety Population included all participants treated with at least one dose of Delamanid in this study.
Infections and infestations Nasopharyngitis	8.8% 12/137 • From first dose through 28 days after last dose of study drug (up to approximately 30 weeks) Safety Population included all participants treated with at least one dose of Delamanid in this study.	15.8% 12/76 • From first dose through 28 days after last dose of study drug (up to approximately 30 weeks) Safety Population included all participants treated with at least one dose of Delamanid in this study.
Infections and infestations Pharyngitis	4.4% 6/137 • From first dose through 28 days after last dose of study drug (up to approximately 30 weeks) Safety Population included all participants treated with at least one dose of Delamanid in this study.	5.3% 4/76 • From first dose through 28 days after last dose of study drug (up to approximately 30 weeks) Safety Population included all participants treated with at least one dose of Delamanid in this study.
Infections and infestations Tracheobronchitis	1.5% 2/137 • From first dose through 28 days after last dose of study drug (up to approximately 30 weeks) Safety Population included all participants treated with at least one dose of Delamanid in this study.	5.3% 4/76 • From first dose through 28 days after last dose of study drug (up to approximately 30 weeks) Safety Population included all participants treated with at least one dose of Delamanid in this study.
Infections and infestations Upper respiratory tract infection	8.0% 11/137 • From first dose through 28 days after last dose of study drug (up to approximately 30 weeks) Safety Population included all participants treated with at least one dose of Delamanid in this study.	6.6% 5/76 • From first dose through 28 days after last dose of study drug (up to approximately 30 weeks) Safety Population included all participants treated with at least one dose of Delamanid in this study.
Investigations Blood cortisol increased	8.8% 12/137 • From first dose through 28 days after last dose of study drug (up to approximately 30 weeks) Safety Population included all participants treated with at least one dose of Delamanid in this study.	1.3% 1/76 • From first dose through 28 days after last dose of study drug (up to approximately 30 weeks) Safety Population included all participants treated with at least one dose of Delamanid in this study.
Metabolism and nutrition disorders Decreased appetite	8.0% 11/137 • From first dose through 28 days after last dose of study drug (up to approximately 30 weeks) Safety Population included all participants treated with at least one dose of Delamanid in this study.	3.9% 3/76 • From first dose through 28 days after last dose of study drug (up to approximately 30 weeks) Safety Population included all participants treated with at least one dose of Delamanid in this study.
Metabolism and nutrition disorders Hyperuricaemia	8.0% 11/137 • From first dose through 28 days after last dose of study drug (up to approximately 30 weeks) Safety Population included all participants treated with at least one dose of Delamanid in this study.	3.9% 3/76 • From first dose through 28 days after last dose of study drug (up to approximately 30 weeks) Safety Population included all participants treated with at least one dose of Delamanid in this study.
Metabolism and nutrition disorders Hypokalaemia	8.0% 11/137 • From first dose through 28 days after last dose of study drug (up to approximately 30 weeks) Safety Population included all participants treated with at least one dose of Delamanid in this study.	0.00% 0/76 • From first dose through 28 days after last dose of study drug (up to approximately 30 weeks) Safety Population included all participants treated with at least one dose of Delamanid in this study.
Musculoskeletal and connective tissue disorders Arthralgia	15.3% 21/137 • From first dose through 28 days after last dose of study drug (up to approximately 30 weeks) Safety Population included all participants treated with at least one dose of Delamanid in this study.	10.5% 8/76 • From first dose through 28 days after last dose of study drug (up to approximately 30 weeks) Safety Population included all participants treated with at least one dose of Delamanid in this study.
Musculoskeletal and connective tissue disorders Back pain	5.8% 8/137 • From first dose through 28 days after last dose of study drug (up to approximately 30 weeks) Safety Population included all participants treated with at least one dose of Delamanid in this study.	6.6% 5/76 • From first dose through 28 days after last dose of study drug (up to approximately 30 weeks) Safety Population included all participants treated with at least one dose of Delamanid in this study.
Musculoskeletal and connective tissue disorders Myalgia	10.9% 15/137 • From first dose through 28 days after last dose of study drug (up to approximately 30 weeks) Safety Population included all participants treated with at least one dose of Delamanid in this study.	2.6% 2/76 • From first dose through 28 days after last dose of study drug (up to approximately 30 weeks) Safety Population included all participants treated with at least one dose of Delamanid in this study.
Nervous system disorders Dizziness	13.9% 19/137 • From first dose through 28 days after last dose of study drug (up to approximately 30 weeks) Safety Population included all participants treated with at least one dose of Delamanid in this study.	3.9% 3/76 • From first dose through 28 days after last dose of study drug (up to approximately 30 weeks) Safety Population included all participants treated with at least one dose of Delamanid in this study.
Nervous system disorders Headache	30.7% 42/137 • From first dose through 28 days after last dose of study drug (up to approximately 30 weeks) Safety Population included all participants treated with at least one dose of Delamanid in this study.	15.8% 12/76 • From first dose through 28 days after last dose of study drug (up to approximately 30 weeks) Safety Population included all participants treated with at least one dose of Delamanid in this study.
Nervous system disorders Paraesthesia	5.8% 8/137 • From first dose through 28 days after last dose of study drug (up to approximately 30 weeks) Safety Population included all participants treated with at least one dose of Delamanid in this study.	6.6% 5/76 • From first dose through 28 days after last dose of study drug (up to approximately 30 weeks) Safety Population included all participants treated with at least one dose of Delamanid in this study.
Nervous system disorders Somnolence	10.2% 14/137 • From first dose through 28 days after last dose of study drug (up to approximately 30 weeks) Safety Population included all participants treated with at least one dose of Delamanid in this study.	5.3% 4/76 • From first dose through 28 days after last dose of study drug (up to approximately 30 weeks) Safety Population included all participants treated with at least one dose of Delamanid in this study.
Nervous system disorders Tremor	6.6% 9/137 • From first dose through 28 days after last dose of study drug (up to approximately 30 weeks) Safety Population included all participants treated with at least one dose of Delamanid in this study.	0.00% 0/76 • From first dose through 28 days after last dose of study drug (up to approximately 30 weeks) Safety Population included all participants treated with at least one dose of Delamanid in this study.
Psychiatric disorders Alcohol abuse	0.73% 1/137 • From first dose through 28 days after last dose of study drug (up to approximately 30 weeks) Safety Population included all participants treated with at least one dose of Delamanid in this study.	9.2% 7/76 • From first dose through 28 days after last dose of study drug (up to approximately 30 weeks) Safety Population included all participants treated with at least one dose of Delamanid in this study.
Psychiatric disorders Anxiety	4.4% 6/137 • From first dose through 28 days after last dose of study drug (up to approximately 30 weeks) Safety Population included all participants treated with at least one dose of Delamanid in this study.	9.2% 7/76 • From first dose through 28 days after last dose of study drug (up to approximately 30 weeks) Safety Population included all participants treated with at least one dose of Delamanid in this study.
Psychiatric disorders Depression	2.9% 4/137 • From first dose through 28 days after last dose of study drug (up to approximately 30 weeks) Safety Population included all participants treated with at least one dose of Delamanid in this study.	5.3% 4/76 • From first dose through 28 days after last dose of study drug (up to approximately 30 weeks) Safety Population included all participants treated with at least one dose of Delamanid in this study.
Psychiatric disorders Insomnia	21.9% 30/137 • From first dose through 28 days after last dose of study drug (up to approximately 30 weeks) Safety Population included all participants treated with at least one dose of Delamanid in this study.	26.3% 20/76 • From first dose through 28 days after last dose of study drug (up to approximately 30 weeks) Safety Population included all participants treated with at least one dose of Delamanid in this study.
Respiratory, thoracic and mediastinal disorders Cough	3.6% 5/137 • From first dose through 28 days after last dose of study drug (up to approximately 30 weeks) Safety Population included all participants treated with at least one dose of Delamanid in this study.	6.6% 5/76 • From first dose through 28 days after last dose of study drug (up to approximately 30 weeks) Safety Population included all participants treated with at least one dose of Delamanid in this study.
Respiratory, thoracic and mediastinal disorders Haemoptysis	5.8% 8/137 • From first dose through 28 days after last dose of study drug (up to approximately 30 weeks) Safety Population included all participants treated with at least one dose of Delamanid in this study.	3.9% 3/76 • From first dose through 28 days after last dose of study drug (up to approximately 30 weeks) Safety Population included all participants treated with at least one dose of Delamanid in this study.
Respiratory, thoracic and mediastinal disorders Throat irritation	6.6% 9/137 • From first dose through 28 days after last dose of study drug (up to approximately 30 weeks) Safety Population included all participants treated with at least one dose of Delamanid in this study.	1.3% 1/76 • From first dose through 28 days after last dose of study drug (up to approximately 30 weeks) Safety Population included all participants treated with at least one dose of Delamanid in this study.
Skin and subcutaneous tissue disorders Pruritus	10.2% 14/137 • From first dose through 28 days after last dose of study drug (up to approximately 30 weeks) Safety Population included all participants treated with at least one dose of Delamanid in this study.	5.3% 4/76 • From first dose through 28 days after last dose of study drug (up to approximately 30 weeks) Safety Population included all participants treated with at least one dose of Delamanid in this study.
Skin and subcutaneous tissue disorders Rash	5.8% 8/137 • From first dose through 28 days after last dose of study drug (up to approximately 30 weeks) Safety Population included all participants treated with at least one dose of Delamanid in this study.	2.6% 2/76 • From first dose through 28 days after last dose of study drug (up to approximately 30 weeks) Safety Population included all participants treated with at least one dose of Delamanid in this study.
Skin and subcutaneous tissue disorders Rash papular	8.0% 11/137 • From first dose through 28 days after last dose of study drug (up to approximately 30 weeks) Safety Population included all participants treated with at least one dose of Delamanid in this study.	2.6% 2/76 • From first dose through 28 days after last dose of study drug (up to approximately 30 weeks) Safety Population included all participants treated with at least one dose of Delamanid in this study.
Vascular disorders Hot flush	5.1% 7/137 • From first dose through 28 days after last dose of study drug (up to approximately 30 weeks) Safety Population included all participants treated with at least one dose of Delamanid in this study.	0.00% 0/76 • From first dose through 28 days after last dose of study drug (up to approximately 30 weeks) Safety Population included all participants treated with at least one dose of Delamanid in this study.

Additional Information

Global Clinical Development

Otsuka Pharmaceutical Development & Commercialization, Inc.

Phone: 1-609-524-6788

Email: clinicaltransparency@otsuka-us.com

Results disclosure agreements

• Principal investigator is a sponsor employee Sponsor reserves the right to review results publications prior to public release and can delay such publications for a period greater than 60 days but no more than 120 days from the date that the publication is submitted to the Sponsor for review. Sponsor can require changes to the publication to protect Sponsor's intellectual property rights and/or confidential information and reserves the right to limit publication timing and scope of data published based on the number of study locations.
• Publication restrictions are in place

Restriction type: OTHER