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| ID | Type | Description | Link |
|---|---|---|---|
| 20721 | Registry Identifier | DAIDS-ES Registry Number |
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| Name | Class |
|---|---|
| Otsuka Pharmaceutical Development & Commercialization, Inc. | INDUSTRY |
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This Phase I/II study evaluated the pharmacokinetics, safety, and tolerability of the anti-tuberculosis (TB) drug delamanid (DLM) in combination with an optimized multidrug background regimen (OBR) for multidrug-resistant tuberculosis (MDR-TB) in children with MDR-TB with and without HIV.
The purpose of this study was to evaluate the pharmacokinetics, safety, and tolerability of the anti-TB drug DLM in combination with OBR for MDR-TB in children with MDR-TB with and without HIV.
Participants were enrolled in one of four age cohorts: 12 to less than 18 years, 6 to less than 12 years, 3 to less than 6 years, or 0 to less than 3 years. All participants were to receive DLM doses according to their age group and weight for 24 weeks.
Study visits occurred at study entry; Weeks 2 and 4; every 4 weeks through Week 40; and at Weeks 48, 60, 72, and 96. Visits included physical examinations; blood, urine, and sputum collection; chest x-rays; electrocardiograms (ECGs); hearing tests; medical history reviews; adherence assessments; and acceptability questionnaires.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1 (>=12 to < 18 years) | Experimental | Participants received delamanid (DLM) twice daily for 24 weeks. Participants also received non-study prescribed OBR for MDR-TB. |
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| Cohort 2 (>=6 to < 12 years) | Experimental | Participants received delamanid (DLM) twice daily for 24 weeks. Participants also received non-study prescribed OBR for MDR-TB. |
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| Cohort 3 (>=3 to < 6 years) | Experimental | Participants received delamanid (DLM) twice daily for 24 weeks. Participants also received non-study prescribed OBR for MDR-TB. |
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| Cohort 4 (>=0 to < 3 years) | Experimental | Participants received delamanid (DLM) twice daily for 24 weeks. Participants also received non-study prescribed OBR for MDR-TB. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Delamanid | Drug | Administered orally; dosing based on participants' weight. ≥ 40 kg: 100 mg twice daily (adult formulation); 30 to < 40 kg: 50 mg twice daily (adult formulation); 15 to < 30 kg: 25 mg twice daily (pediatric formulation); < 15 kg: 15 mg twice daily (pediatric formulation) |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Adverse Events of ≥ Grade 3 Severity | At entry and follow-up, all lab results, signs and symptoms, and diagnoses were recorded. The core team reviewed and confirmed the sites assessment of event relatedness to study drug. An adverse event (AE) is any unfavorable and unintended sign, symptom, or diagnosis that occurs in a study participant during the conduct of the study REGARDLESS of the attribution. Adverse events are graded on a scale from 1-5: 1=mild, 2=moderate, 3=severe, 4= potentially life-threatening, 5=death. AE grading was per Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table V2.1). 95% CIconfidence interval (CI) computed using exact Clopper-Pearson method. | Measured from entry through Week 24 |
| Percentage of Participants With Adverse Events of ≥ Grade 3 Assessed by the Core Team to be at Least Possibly Related to the Study Drug | At entry and follow-up, all lab results, signs and symptoms, and diagnoses were recorded. The core team reviewed and confirmed the sites assessment of event relatedness to study drug. An adverse event (AE) is any unfavorable and unintended sign, symptom, or diagnosis that occurs in a study participant during the conduct of the study REGARDLESS of the attribution. Adverse events are graded on a scale from 1-5: 1=mild, 2=moderate, 3=severe, 4= potentially life-threatening, 5=death. AE grading was per Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table V2.1). 95% CI computed using exact Clopper-Pearson method. | Measured from entry through Week 24 |
| Percentage of Participants Who Were Terminated From Study Treatment Due to a Drug-related Adverse Event | At entry and follow-up, all lab results, signs and symptoms, and diagnoses were recorded. The core team reviewed and confirmed the sites assessment of event relatedness to study drug. An adverse event (AE) is any unfavorable and unintended sign, symptom, or diagnosis that occurs in a study participant during the conduct of the study REGARDLESS of the attribution. Adverse events are graded on a scale from 1-5: 1=mild, 2=moderate, 3=severe, 4= potentially life-threatening, 5=death. AE grading was per Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table V2.1. 95% CI computed using exact Clopper-Pearson method. |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Adverse Events ≥ Grade 3 Severity | At entry and follow-up, all lab results, signs and symptoms, and diagnoses were recorded. The core team reviewed and confirmed the sites assessment of event relatedness to study drug. An adverse event (AE) is any unfavorable and unintended sign, symptom, or diagnosis that occurs in a study participant during the conduct of the study REGARDLESS of the attribution. Adverse events are graded on a scale from 1-5: 1=mild, 2=moderate, 3=severe, 4= potentially life-threatening, 5=death. AE grading was per Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table V2.1). A higher grade indicates worse outcome. 95% CI computed using exact Clopper-Pearson method. |
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Inclusion Criteria:
- Parent (or legal guardian) willing and able to provide written informed consent for child study participation. Additionally, for children whose assent is required per site institutional review board/ethics committee (IRB/EC) policies and procedures, child willing and able to provide written assent for his or her study participation.
HIV status determined by testing requirements in the protocol (see the protocol for more information on this criterion)
If living with HIV: Initiated the standard of care antiretroviral therapy (ART) regimen at least two weeks prior to enrollment (note: regimens including efavirenz [EFV], nevirapine [NVP], a boosted protease inhibitor [PI], or integrase strand transfer inhibitor [INSTI] are allowed)
Confirmed or probable MDR-TB classified as follows:
Confirmed MDR-TB (or rifampicin mono-resistant TB [RMR-TB], pre-extensively drug-resistant [XDR] or XDR-TB):
*Intra-thoracic (pulmonary) TB based on chest radiograph consistent with TB, and/or any of the following forms of extrathoracic TB:
Peripheral TB lymphadenitis
Pleural effusion or fibrotic pleural lesions
Stage 1 TB meningitis
Miliary and abdominal TB
Other non-disseminated forms of TB disease (see also exclusion criterion below)
AND
AND
*Drug-resistance demonstrated by genotypic (molecular) or phenotypic methods, with any of the following resistance patterns:
*MDR-TB (resistance to both rifampicin and isoniazid (INH))
Probable MDR-TB (or RMR, pre-XDR or XDR-TB), with inclusion of intrathoracic and/or extrathoracic TB as listed below:
*A presumptive diagnosis of intrathoracic (pulmonary) TB based on well-documented clinical symptoms or signs of TB AND chest radiograph consistent with TB, and/or any of the following forms of extrathoracic TB:
Peripheral TB lymphadenitis
Pleural effusion or fibrotic pleural lesions
Stage 1 TB meningitis
Miliary and abdominal TB,
Other non-disseminated forms of TB disease (see also exclusion criterion below)
AND
AND
$Confirmed MDR-TB source cases defined as a case with intrathoracic TB with or without extrathoracic TB, with microbiological confirmation of Mycobacterium tuberculosis from any clinical specimen by either culture or molecular methods (including Xpert MTB/RIF), and with drug-resistance demonstrated by genotypic (molecular) or phenotypic methods, with any of the resistance patterns described above.
Albumin level greater than 2.8 g/dL within 30 days prior to enrollment
Potassium greater than or equal to 3.4 and less than 5.6 mmol/L; magnesium greater than 0.59 mmol/L within 30 days prior to enrollment. Note: Electrolytes can be repleted and a recheck may be performed to meet eligibility criteria. The latest result should be used for eligibility determination.
BMI Z-score greater than -3 for children greater than or equal to 5 years of age; weight for length/height Z-score greater than -3 for children less than 5 years of age (using latest World Health Organization scores), at screening
Weight greater than or equal to 3 kg, at screening
Has initiated an appropriate optimized background regimen (OBR) MDR-TB treatment regimen as per routine treatment decision, at least two weeks but not more than eight weeks prior to enrollment, and in the opinion of the site investigator, is tolerating the regimen well at enrollment. Note: An appropriate OBR MDR-TB treatment regimen is defined as including components based on the sensitivities of the infecting isolate, if known, and past treatment history, if known. This regimen should also follow the OBR MBR-TB treatment guidelines as described in the protocol.
If male and engaging in sexual activity that could lead to pregnancy of the female partner: Agrees to use a barrier method of contraception (i.e. male condom) throughout the first 28 weeks on study (i.e., until four weeks after discontinuation of DLM).
If female and of reproductive potential, defined as having reached menarche and not having undergone a documented sterilization procedure (hysterectomy, bilateral oophorectomy, or salpingectomy): Negative pregnancy test at screening within 14 days prior to enrollment.
If female, of reproductive potential (as defined in the protocol), and engaging in sexual activity that could lead to pregnancy: Agrees to avoid pregnancy and to use one of the following forms of birth control while receiving DLM and for one month after stopping DLM: condoms, diaphragm or cervical cap, intrauterine device (IUD), hormonal-based contraception. The selected method must be initiated prior to enrollment.
Exclusion Criteria:
Known allergy to any nitroimidazoles or nitroimidazole derivatives
Active use of prohibited medications listed in the protocol, within 3 days of enrollment
Participant has a history of any of the following, as determined by the site investigator or designee based on parent/guardian report and available medical records:
Abnormal electrocardiogram (ECG) (including QTcF [mean value of QT interval, corrected using Fredericia correction, on ECG performed in triplicate] greater than or equal to 450 ms, atrioventricular block, or prolonged QRS greater than or equal to 120 ms) at screening. Note: The value from centralized ECG read should be used to determine study eligibility.
Karnofsky score less than 30% for participants greater than or equal to 16 years of age or Lansky play score less than 30% for participants less than 16 years of age, at screening
Alcohol intake that in the opinion of the study investigator could potentially interfere with study participation and/or introduce safety concerns with use of DLM
Lactating with plans to breastfeed, at enrollment
Tuberculous meningitis (TBM) Stage 2 or 3, or osteo-articular TB at screening
Co-enrolled in any other trial involving pharmacologic regimens, at screening
If exposed to HIV and less than 2 years of age: Breastfeeding at enrollment
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| Name | Affiliation | Role |
|---|---|---|
| Anthony Garcia-Prats, MD | University of Wisconsin, Madison | Study Chair |
| Ethel Weld, MD | Johns Hopkins University | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Byramjee Jeejeebhoy Medical College (BJMC) CRS | Pune | Maharashtra | 411001 | India | ||
| Sizwe CRS |
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| Label | URL |
|---|---|
| IMPAACT Network Studies | View source |
| The DAIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Corrected Version 2.1, dated July 2017, will be used in this study | View source |
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Individual participant data that underlie results in the publication, after deidentification.
Beginning 3 months following publication and available throughout period of funding of the International Maternal Pediatric Adolescent AIDS Clinical Trial (IMPAACT) Network by NIH.
With whom?
* Researchers who provide a methodologically sound proposal for use of the data that is approved by the IMPAACT Network.
For what types of analyses?
* To achieve aims in the proposal approved by the IMPAACT Network.
By what mechanism will data be made available?
https://www.impaactnetwork.org/studies/submit-research-proposal
Researchers of approved proposals will need to sign an IMPAACT Data Use Agreement before receiving the data.
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The first enrollment to the study was in February 2019 and enrollment was completed in November 2024 with a total of 37 participants who initiated study drug. There enrollments were from three sites from South Africa - Desmond Tutu TB Center - Stellenbosch University, Sizwe CRS, and PHRU Matlosana CRS; one site from India - Byramjee Jeejeebhoy Govt. Med Ctr; and one site from Tanzania - Kilimanjaro Christian Medical Center.
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| ID | Title | Description |
|---|---|---|
| FG000 | Cohort 1 (>=12 to < 18 Years) | Participants received delamanid (DLM) twice daily for 24 weeks. Participants also received non-study prescribed OBR for MDR-TB. Delamanid: Administered orally; dosing based on participants' weight. ≥ 40 kg: 100 mg twice daily (adult formulation); 30 to < 40 kg: 50 mg twice daily (adult formulation); 15 to < 30 kg: 25 mg twice daily (pediatric formulation); < 15 kg: 15 mg twice daily (pediatric formulation) Optimized multidrug background regimen (OBR) for children with MDR-TB: Non-study prescribed OBR varied according to local, national, and/or international guidelines for treatment of children with MDR-TB. Administered in addition to DLM for 24 weeks. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_ICF | Yes | No | Yes | Study Protocol and Informed Consent Form: V 3.0 26JUL2021 | Jul 26, 2021 |
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| Optimized multidrug background regimen (OBR) for children with MDR-TB | Drug | Non-study prescribed OBR varied according to local, national, and/or international guidelines for treatment of children with MDR-TB. Administered in addition to DLM for 24 weeks. |
|
| Measured from entry through Week 24 |
| Percentage of Participants With Absolute Corrected QT Interval by Fridericia (QTcF) ≥ 500 Msec | Evaluation of the Electrocardiogram (ECG) QTcF was performed per protocol. ECGs conducted at these visits were performed in triplicate (if possible). Consultation with the protocol cardiologist was available and encouraged for any abnormal or equivocal ECG findings and/or questions related to cardiac toxicities and assessment. Participants were counted if they had QTcF ≥ 500 msec at any study visit from entry to Week 24. 95% CI computed using exact Clopper-Pearson method. | Entry, weeks 2, 8, 12, 16, 20, and 24 |
| Percentage of Participants Who Died Through Week 24 | Death due to all causes included. 95% CI computed using exact Clopper-Pearson method. | Measured from entry through Week 24 |
| Geometric Mean of Area Under the Concentration Versus Time Curve (AUC0-24h) DLM | PK parameter was determined from plasma concentration-time profiles, dosing information and participant covariates using the final population PK model The starting population PK model was developed on data from Otsuka study 232 and 233 (1). NONMEM was used when developing the final model for the population in this study.
| Approximately day 10 (Week 2) at pre-dose, and 2, 4, and hours post dose |
| Geometric Mean of Area Under the Concentration Versus Time Curve (AUC0-24h) DM-6705 | PK parameter determined from plasma concentration-time profiles, dosing information and participant covariates using the final population PK model The starting population PK model was developed on data from Otsuka study 232 and 233 (1). NONMEM was used when developing the final model for the population in this study.
| Approximately day 10 (Week 2) at pre-dose, and 2, 4, and hours post dose |
| Geometric Mean of Area of Maximal Concentration (Cmax) DLM | PK parameter determined from plasma concentration-time profiles, dosing information and participant covariates using the final population PK model | Approximately day 10 (Week 2) at pre-dose, and 2, 4, and hours post dose |
| Geometric Mean of Area of Maximal Concentration (Cmax) DM-6705 | PK parameter determined from plasma concentration-time profiles, dosing information and participant covariates using the final population PK model | Approximately day 10 (Week 2) at pre-dose, and 2, 4, and hours post dose |
| Median Time of Maximal Concentration (Tmax) DLM | PK parameter determined from plasma concentration-time profiles, dosing information and participant covariates using the final population PK model | Approximately day 10 (Week 2) at pre-dose, and 2, 4, and hours post dose |
| Median Time of Maximal Concentration (Tmax) DM-6705 | PK parameter determined from plasma concentration-time profiles, dosing information and participant covariates using the final population PK model | Approximately day 10 (Week 2) at pre-dose, and 2, 4, and hours post dose |
| Median Oral Clearance (Cl/F) DLM | PK parameter determined from plasma concentration-time profiles, dosing information and participant covariates using the final population PK model | Approximately day 10 (Week 2) at pre-dose, and 2, 4, and hours post dose |
| Median Oral Clearance (Cl/F) DM-6705 | PK parameter determined from plasma concentration-time profiles, dosing information and participant covariates using the final population PK model | Approximately day 10 (Week 2) at pre-dose, and 2, 4, and hours post dose |
| Median Volume of Distribution (Vd) DLM | PK parameter determined from plasma concentration-time profiles, dosing information and participant covariates using the final population PK model | Approximately day 10 (Week 2) at pre-dose, and 2, 4, and hours post dose |
| Median Volume of Distribution (Vd) DM-6705 | PK parameter determined from plasma concentration-time profiles, dosing information and participant covariates using the final population PK model | Approximately day 10 (Week 2) at pre-dose, and 2, 4, and hours post dose |
| Median Mean Absorption Time (MAT) DLM | PK parameter determined from plasma concentration-time profiles, dosing information and participant covariates using the final population PK model | Approximately day 10 (Week 2) at pre-dose, and 2, 4, and hours post dose |
| Median Terminal Half-life (t1/2) DLM | PK parameter determined from plasma concentration-time profiles, dosing information and participant covariates using the final population PK model | Approximately day 10 (Week 2) at pre-dose, and 2, 4, and hours post dose |
| Median Terminal Half-life (t1/2) DM-6705 | PK parameter determined from plasma concentration-time profiles, dosing information and participant covariates using the final population PK model | Approximately day 10 (Week 2) at pre-dose, and 2, 4, and hours post dose |
| Measured from entry through Week 72 post DLM |
| Percentage of Participants With Adverse Events ≥ Grade 3 Severity Assessed by the Core Team to be at Least Possibly Related to the Study Drug | At entry and follow-up, all lab results, signs and symptoms, and diagnoses were recorded. The core team reviewed and confirmed the sites assessment of event relatedness to study drug. An adverse event (AE) is any unfavorable and unintended sign, symptom, or diagnosis that occurs in a study participant during the conduct of the study REGARDLESS of the attribution. Adverse events are graded on a scale from 1-5: 1=mild, 2=moderate, 3=severe, 4= potentially life-threatening, 5=death. AE grading was per Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table V2.1). A higher grade indicates worse outcome. 95% CI computed using exact Clopper-Pearson method. | Measured from entry through Week 72 post DLM |
| Percentage of Participants With Absolute Corrected QT Interval by Fridericia (QTcF) ≥ 500 Msec | Evaluation of the Electrocardiogram (ECG) QTcF was performed per protocol. ECGs conducted at these visits should be performed in triplicate (if possible). Consultation with the protocol cardiologist was available and encouraged for any abnormal or equivocal ECG findings and/or questions related to cardiac toxicities and assessment. Participants were counted as having an outcome if they had QTcF ≥ 500 msec at any study visit from entry to Week 28. 95% CI computed using exact Clopper-Pearson method. | Screening, Entry, weeks 2, 8, 12, 16, 20, 24 and week 28 |
| Percentage of Participants Who Died Through Week 72 Post DLM | Death due to all causes included. 95% CI computed using exact Clopper-Pearson method. | Measured from entry through Week 72 post DLM |
| Percentage of Participants With Adverse Events ≥ Grade 2 Severity | At entry and follow-up, all lab results, signs and symptoms, and diagnoses were recorded. The core team reviewed and confirmed the sites assessment of event relatedness to study drug. An adverse event (AE) is any unfavorable and unintended sign, symptom, or diagnosis that occurs in a study participant during the conduct of the study REGARDLESS of the attribution. Adverse events are graded on a scale from 1-5: 1=mild, 2=moderate, 3=severe, 4= potentially life-threatening, 5=death. AE grading was per Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table V2.1). A higher grade indicates worse outcome. 95% CI computed using exact Clopper-Pearson method. | Measured from entry through Week 72 post DLM |
| Percentage of Participants With Adverse Events ≥ Grade 2 Severity Assessed by the Core Team to be at Least Possibly Related to the Study Drug. | At entry and follow-up, all lab results, signs and symptoms, and diagnoses were recorded. The core team reviewed and confirmed the sites assessment of event relatedness to study drug. An adverse event (AE) is any unfavorable and unintended sign, symptom, or diagnosis that occurs in a study participant during the conduct of the study REGARDLESS of the attribution. Adverse events are graded on a scale from 1-5: 1=mild, 2=moderate, 3=severe, 4= potentially life-threatening, 5=death. AE grading was per Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table V2.1). A higher grade indicates worse outcome. 95% CI computed using exact Clopper-Pearson method. | Measured from entry through Week 72 post DLM |
| Count of Participants With Change in QTcF Interval From Baseline of Greater Than 60 ms | Evaluation of the Electrocardiogram (ECG) QTcF was performed per protocol. ECGs conducted at these visits should be performed in triplicate (if possible). Consultation with the protocol cardiologist was available and encouraged for any abnormal or equivocal ECG findings and/or questions related to cardiac toxicities and assessment. Participants were counted if they had QTcF was greater than 60 msec at any study visit from entry to Week 28. | Entry, weeks 2, 8, 12, 16, 20, 24, and week 28 |
| Percentage of Participants (Overall) With TB Treatment Outcomes | Site investigator assessment of participant TB treatment outcomes through last study visit were entered into the eCRF. Treatment outcomes in children were defined as bacteriologic cure, probable cure, death, treatment failure, TB recurrence, and loss to follow-up as per protocol. | Measured from entry through Week 72 post DLM |
| Number of Participants Who Had Permanently Discontinued Study Drug Whilst on Study Due to Intolerance or Refusal to Take Medication | Participants were assessed for tolerability of the study drug during the study by their intolerance or refusal to take the medications | Measured from entry through Week 24 |
| Frequency of Cumulative Responses to Taste of Study Drug in an Acceptability Assessment | Acceptability assessments were assessed by Study Staff at study visits and by Participant Caregiver whilst at home. The participants had the option of taking the study drug either as dispersible tablet or tablet formulation. | Assessments conducted at weeks 2, 8 and 24 |
| Frequency of Cumulative Responses to Formulation of Study Drug in an Acceptability Assessment | Acceptability assessments were assessed by Study Staff at study visits and by Participant Caregiver whilst at home. The participants had the option of taking the study drug either as dispersible tablet or tablet formulation. At a visit, the participant could have been taking a dispersible tablet and at the next visit the same participant could have been taking a tablet formulation. | Assessments conducted at weeks 2, 8 and 24 |
| Frequency of Cumulative Responses to Taste of Dispersible Tablet Doses in an Acceptability Assessment | Acceptability assessments were assessed by Study Staff at study visits and by Participant Caregiver whilst at home. Participants' dose formulations were not restrictive as at each visit, the participant was given the option of taking the study drug as either a dispersible tablet or tablet formulation. At a visit, the participant could have been taking a dispersible tablet and at the next visit the same participant could have been taking a tablet formulation. | Assessments conducted at weeks 2, 8 and 24 |
| Frequency of Cumulative Responses to Administration of Dispersible Tablet Doses in an Acceptability Assessment | Acceptability assessments were assessed by Study Staff at study visits and by Participant Caregiver whilst at home. Participants' dose formulations were not restrictive as at each visit, the participant was given the option of taking the study drug as either a dispersible tablet or tablet formulation. At a visit, the participant could have been taking a dispersible tablet and at the next visit the same participant could have been taking a tablet formulation. | Assessments conducted at weeks 2, 8 and 24 |
| Frequency of Cumulative Responses to Taste of Tablet Doses in an Acceptability Assessment | Acceptability assessments were assessed by Study Staff at study visits and by Participant Caregiver whilst at home. Participants' dose formulations were not restrictive as at each visit, the participant was given the option of taking the study drug as either a dispersible tablet or tablet formulation. At a visit, the participant could have been taking a dispersible tablet and at the next visit the same participant could have been taking a tablet formulation. | Assessments conducted at weeks 2, 8 and 24 |
| Frequency of Cumulative Responses to Administration of Tablet Doses in an Acceptability Assessment | Acceptability assessments were assessed by Study Staff at study visits and by Participant Caregiver whilst at home. Participants' dose formulations were not restrictive as at each visit, the participant was given the option of taking the study drug as either a dispersible tablet or tablet formulation. At a visit, the participant could have been taking a dispersible tablet and at the next visit the same participant could have been taking a tablet formulation. | Assessments conducted at weeks 2, 8 and 24 |
| Age Effect on Bioavailability DLM | Plasma concentrations are used to determine age effect on bioavailability. The age covariate describes the fold change in bioavailability for each respective age group of 0-1 year and 1-2 years, with participants aged >2 to <18 years used as the reference group. Study arms were combined for the analysis of age effect. | Approximately Week 2 |
| Age Effect on Fraction Metabolised From Delaminid to DM-6705 | Plasma concentrations are used to determine age effect on bioavailability. The age covariate describes the fold change in bioavailability for each respective age group of 0-1 year and 1-2 years, with participants aged >2 to <18 years used as the reference group. Study arms were combined for the analysis of age effect. | Approximately Week 2 |
| Dose Effect on Bioavailability DLM | Plasma concentrations are used to determine dose effect on bioavailability. For doses > 50 mg the bioavailability is described by F=(dose/100)-0.66. The participants receiving the dose 100 mg are the reference group and the dose effect of doses 15-20mg, 25mg and 50mg on the bioavailability are compared to the reference group and the fold change is presented. Study arms were combined for the analysis of dose effect. | Approximately Week 2 |
| Johannesburg |
| Gauteng |
| South Africa |
| PHRU Matlosana CRS | Klerksdorp | North West | 2574 | South Africa |
| Desmond Tutu TB Centre - Stellenbosch University (DTTC-SU) CRS | Cape Town | Western Cape | 7505 | South Africa |
| Kilimanjaro Christian Medical Centre (KCMC) | Moshi | Tanzania |
| "Manual for Expedited Reporting of Adverse Events to DAIDS (DAIDS EAE Manual), Version 2.0, January 2010" |
| View source |
| FG001 | Cohort 2 (>=6 to < 12 Years) | Participants received delamanid (DLM) twice daily for 24 weeks. Participants also received non-study prescribed OBR for MDR-TB. Delamanid: Administered orally; dosing based on participants' weight. ≥ 40 kg: 100 mg twice daily (adult formulation); 30 to < 40 kg: 50 mg twice daily (adult formulation); 15 to < 30 kg: 25 mg twice daily (pediatric formulation); < 15 kg: 15 mg twice daily (pediatric formulation) Optimized multidrug background regimen (OBR) for children with MDR-TB: Non-study prescribed OBR varied according to local, national, and/or international guidelines for treatment of children with MDR-TB. Administered in addition to DLM for 24 weeks. |
| FG002 | Cohort 3 (>=3 to < 6 Years) | Participants received delamanid (DLM) twice daily for 24 weeks. Participants also received non-study prescribed OBR for MDR-TB. Delamanid: Administered orally; dosing based on participants' weight. ≥ 40 kg: 100 mg twice daily (adult formulation); 30 to < 40 kg: 50 mg twice daily (adult formulation); 15 to < 30 kg: 25 mg twice daily (pediatric formulation); < 15 kg: 15 mg twice daily (pediatric formulation) Optimized multidrug background regimen (OBR) for children with MDR-TB: Non-study prescribed OBR varied according to local, national, and/or international guidelines for treatment of children with MDR-TB. Administered in addition to DLM for 24 weeks. |
| FG003 | Cohort 4 (>=0 to < 3 Years) | Participants received delamanid (DLM) twice daily for 24 weeks. Participants also received non-study prescribed OBR for MDR-TB. Delamanid: Administered orally; dosing based on participants' weight. ≥ 40 kg: 100 mg twice daily (adult formulation); 30 to < 40 kg: 50 mg twice daily (adult formulation); 15 to < 30 kg: 25 mg twice daily (pediatric formulation); < 15 kg: 15 mg twice daily (pediatric formulation) Optimized multidrug background regimen (OBR) for children with MDR-TB: Non-study prescribed OBR varied according to local, national, and/or international guidelines for treatment of children with MDR-TB. Administered in addition to DLM for 24 weeks. |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Cohort 1 (>=12 to < 18 Years) | Participants received delamanid (DLM) twice daily for 24 weeks. Participants also received non-study prescribed OBR for MDR-TB. Delamanid: Administered orally; dosing based on participants' weight. ≥ 40 kg: 100 mg twice daily (adult formulation); 30 to < 40 kg: 50 mg twice daily (adult formulation); 15 to < 30 kg: 25 mg twice daily (pediatric formulation); < 15 kg: 15 mg twice daily (pediatric formulation) Optimized multidrug background regimen (OBR) for children with MDR-TB: Non-study prescribed OBR varied according to local, national, and/or international guidelines for treatment of children with MDR-TB. Administered in addition to DLM for 24 weeks. |
| BG001 | Cohort 2 (>=6 to < 12 Years) | Participants received delamanid (DLM) twice daily for 24 weeks. Participants also received non-study prescribed OBR for MDR-TB. Delamanid: Administered orally; dosing based on participants' weight. ≥ 40 kg: 100 mg twice daily (adult formulation); 30 to < 40 kg: 50 mg twice daily (adult formulation); 15 to < 30 kg: 25 mg twice daily (pediatric formulation); < 15 kg: 15 mg twice daily (pediatric formulation) Optimized multidrug background regimen (OBR) for children with MDR-TB: Non-study prescribed OBR varied according to local, national, and/or international guidelines for treatment of children with MDR-TB. Administered in addition to DLM for 24 weeks. |
| BG002 | Cohort 3 (>=3 to < 6 Years) | Participants received delamanid (DLM) twice daily for 24 weeks. Participants also received non-study prescribed OBR for MDR-TB. Delamanid: Administered orally; dosing based on participants' weight. ≥ 40 kg: 100 mg twice daily (adult formulation); 30 to < 40 kg: 50 mg twice daily (adult formulation); 15 to < 30 kg: 25 mg twice daily (pediatric formulation); < 15 kg: 15 mg twice daily (pediatric formulation) Optimized multidrug background regimen (OBR) for children with MDR-TB: Non-study prescribed OBR varied according to local, national, and/or international guidelines for treatment of children with MDR-TB. Administered in addition to DLM for 24 weeks. |
| BG003 | Cohort 4 (>=0 to < 3 Years) | Participants received delamanid (DLM) twice daily for 24 weeks. Participants also received non-study prescribed OBR for MDR-TB. Delamanid: Administered orally; dosing based on participants' weight. ≥ 40 kg: 100 mg twice daily (adult formulation); 30 to < 40 kg: 50 mg twice daily (adult formulation); 15 to < 30 kg: 25 mg twice daily (pediatric formulation); < 15 kg: 15 mg twice daily (pediatric formulation) Optimized multidrug background regimen (OBR) for children with MDR-TB: Non-study prescribed OBR varied according to local, national, and/or international guidelines for treatment of children with MDR-TB. Administered in addition to DLM for 24 weeks. |
| BG004 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median | Inter-Quartile Range | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Race/Ethnicity, Customized | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | Number | participants |
| ||||||||||||||||
| HIV-1 status | Count of Participants | Participants |
| ||||||||||||||||
| Weight | Median | Inter-Quartile Range | kilogram (kg) |
| |||||||||||||||
| Height | Median | Inter-Quartile Range | centimeter (cm) |
| |||||||||||||||
| TB disease spectrum | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percentage of Participants With Adverse Events of ≥ Grade 3 Severity | At entry and follow-up, all lab results, signs and symptoms, and diagnoses were recorded. The core team reviewed and confirmed the sites assessment of event relatedness to study drug. An adverse event (AE) is any unfavorable and unintended sign, symptom, or diagnosis that occurs in a study participant during the conduct of the study REGARDLESS of the attribution. Adverse events are graded on a scale from 1-5: 1=mild, 2=moderate, 3=severe, 4= potentially life-threatening, 5=death. AE grading was per Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table V2.1). 95% CIconfidence interval (CI) computed using exact Clopper-Pearson method. | All participants enrolled in the study | Posted | Number | 95% Confidence Interval | percentage of participants | Measured from entry through Week 24 |
|
|
| ||||||||||||||||||||||||||||||||||
| Primary | Percentage of Participants With Adverse Events of ≥ Grade 3 Assessed by the Core Team to be at Least Possibly Related to the Study Drug | At entry and follow-up, all lab results, signs and symptoms, and diagnoses were recorded. The core team reviewed and confirmed the sites assessment of event relatedness to study drug. An adverse event (AE) is any unfavorable and unintended sign, symptom, or diagnosis that occurs in a study participant during the conduct of the study REGARDLESS of the attribution. Adverse events are graded on a scale from 1-5: 1=mild, 2=moderate, 3=severe, 4= potentially life-threatening, 5=death. AE grading was per Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table V2.1). 95% CI computed using exact Clopper-Pearson method. | All participants enrolled in the study | Posted | Number | 95% Confidence Interval | percentage of participants | Measured from entry through Week 24 |
| ||||||||||||||||||||||||||||||||||||
| Primary | Percentage of Participants Who Were Terminated From Study Treatment Due to a Drug-related Adverse Event | At entry and follow-up, all lab results, signs and symptoms, and diagnoses were recorded. The core team reviewed and confirmed the sites assessment of event relatedness to study drug. An adverse event (AE) is any unfavorable and unintended sign, symptom, or diagnosis that occurs in a study participant during the conduct of the study REGARDLESS of the attribution. Adverse events are graded on a scale from 1-5: 1=mild, 2=moderate, 3=severe, 4= potentially life-threatening, 5=death. AE grading was per Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table V2.1. 95% CI computed using exact Clopper-Pearson method. | All participants enrolled in the study | Posted | Number | 95% Confidence Interval | percentage of participants | Measured from entry through Week 24 |
| ||||||||||||||||||||||||||||||||||||
| Primary | Percentage of Participants With Absolute Corrected QT Interval by Fridericia (QTcF) ≥ 500 Msec | Evaluation of the Electrocardiogram (ECG) QTcF was performed per protocol. ECGs conducted at these visits were performed in triplicate (if possible). Consultation with the protocol cardiologist was available and encouraged for any abnormal or equivocal ECG findings and/or questions related to cardiac toxicities and assessment. Participants were counted if they had QTcF ≥ 500 msec at any study visit from entry to Week 24. 95% CI computed using exact Clopper-Pearson method. | All participants enrolled in the study | Posted | Number | 95% Confidence Interval | percentage of participants | Entry, weeks 2, 8, 12, 16, 20, and 24 |
| ||||||||||||||||||||||||||||||||||||
| Primary | Percentage of Participants Who Died Through Week 24 | Death due to all causes included. 95% CI computed using exact Clopper-Pearson method. | All participants enrolled in the study | Posted | Number | 95% Confidence Interval | participants | Measured from entry through Week 24 |
| ||||||||||||||||||||||||||||||||||||
| Primary | Geometric Mean of Area Under the Concentration Versus Time Curve (AUC0-24h) DLM | PK parameter was determined from plasma concentration-time profiles, dosing information and participant covariates using the final population PK model The starting population PK model was developed on data from Otsuka study 232 and 233 (1). NONMEM was used when developing the final model for the population in this study.
| • Participants that have the week 2 semi-intensive PK sampling collection and have at least two samples with measurable DLM and DM-6705 concentrations | Posted | Geometric Mean | Geometric Coefficient of Variation | hour*ng/mL | Approximately day 10 (Week 2) at pre-dose, and 2, 4, and hours post dose |
| ||||||||||||||||||||||||||||||||||||
| Primary | Geometric Mean of Area Under the Concentration Versus Time Curve (AUC0-24h) DM-6705 | PK parameter determined from plasma concentration-time profiles, dosing information and participant covariates using the final population PK model The starting population PK model was developed on data from Otsuka study 232 and 233 (1). NONMEM was used when developing the final model for the population in this study.
| • Participants that have the week 2 semi-intensive PK sampling collection and have at least two samples with measurable DLM and DM-6705 concentrations | Posted | Geometric Mean | Geometric Coefficient of Variation | hour*ng/mL | Approximately day 10 (Week 2) at pre-dose, and 2, 4, and hours post dose |
| ||||||||||||||||||||||||||||||||||||
| Primary | Geometric Mean of Area of Maximal Concentration (Cmax) DLM | PK parameter determined from plasma concentration-time profiles, dosing information and participant covariates using the final population PK model | • Participants that have the week 2 semi-intensive PK sampling collection and have at least two samples with measurable DLM and DM-6705 concentrations | Posted | Geometric Mean | Geometric Coefficient of Variation | ng/mL | Approximately day 10 (Week 2) at pre-dose, and 2, 4, and hours post dose |
| ||||||||||||||||||||||||||||||||||||
| Primary | Geometric Mean of Area of Maximal Concentration (Cmax) DM-6705 | PK parameter determined from plasma concentration-time profiles, dosing information and participant covariates using the final population PK model | • Participants that have the week 2 semi-intensive PK sampling collection and have at least two samples with measurable DLM and DM-6705 concentrations | Posted | Geometric Mean | Geometric Coefficient of Variation | ng/mL | Approximately day 10 (Week 2) at pre-dose, and 2, 4, and hours post dose |
| ||||||||||||||||||||||||||||||||||||
| Primary | Median Time of Maximal Concentration (Tmax) DLM | PK parameter determined from plasma concentration-time profiles, dosing information and participant covariates using the final population PK model | • Participants that have the week 2 semi-intensive PK sampling collection and have at least two samples with measurable DLM and DM-6705 concentrations | Posted | Median | Full Range | h | Approximately day 10 (Week 2) at pre-dose, and 2, 4, and hours post dose |
| ||||||||||||||||||||||||||||||||||||
| Primary | Median Time of Maximal Concentration (Tmax) DM-6705 | PK parameter determined from plasma concentration-time profiles, dosing information and participant covariates using the final population PK model | • Participants that have the week 2 semi-intensive PK sampling collection and have at least two samples with measurable DLM and DM-6705 concentrations | Posted | Median | Full Range | h | Approximately day 10 (Week 2) at pre-dose, and 2, 4, and hours post dose |
| ||||||||||||||||||||||||||||||||||||
| Primary | Median Oral Clearance (Cl/F) DLM | PK parameter determined from plasma concentration-time profiles, dosing information and participant covariates using the final population PK model | • Participants that have the week 2 semi-intensive PK sampling collection and have at least two samples with measurable DLM and DM-6705 concentrations | Posted | Median | Full Range | L/h | Approximately day 10 (Week 2) at pre-dose, and 2, 4, and hours post dose |
| ||||||||||||||||||||||||||||||||||||
| Primary | Median Oral Clearance (Cl/F) DM-6705 | PK parameter determined from plasma concentration-time profiles, dosing information and participant covariates using the final population PK model | • Participants that have the week 2 semi-intensive PK sampling collection and have at least two samples with measurable DLM and DM-6705 concentrations | Posted | Median | Full Range | L/h | Approximately day 10 (Week 2) at pre-dose, and 2, 4, and hours post dose |
| ||||||||||||||||||||||||||||||||||||
| Primary | Median Volume of Distribution (Vd) DLM | PK parameter determined from plasma concentration-time profiles, dosing information and participant covariates using the final population PK model | • Participants that have the week 2 semi-intensive PK sampling collection and have at least two samples with measurable DLM and DM-6705 concentrations | Posted | Median | Full Range | L | Approximately day 10 (Week 2) at pre-dose, and 2, 4, and hours post dose |
| ||||||||||||||||||||||||||||||||||||
| Primary | Median Volume of Distribution (Vd) DM-6705 | PK parameter determined from plasma concentration-time profiles, dosing information and participant covariates using the final population PK model | • Participants that have the week 2 semi-intensive PK sampling collection and have at least two samples with measurable DLM and DM-6705 concentrations | Posted | Median | Full Range | L | Approximately day 10 (Week 2) at pre-dose, and 2, 4, and hours post dose |
| ||||||||||||||||||||||||||||||||||||
| Primary | Median Mean Absorption Time (MAT) DLM | PK parameter determined from plasma concentration-time profiles, dosing information and participant covariates using the final population PK model | • Participants that have the week 2 semi-intensive PK sampling collection and have at least two samples with measurable DLM and DM-6705 concentrations | Posted | Median | Full Range | h^-1 | Approximately day 10 (Week 2) at pre-dose, and 2, 4, and hours post dose |
| ||||||||||||||||||||||||||||||||||||
| Primary | Median Terminal Half-life (t1/2) DLM | PK parameter determined from plasma concentration-time profiles, dosing information and participant covariates using the final population PK model | • Participants that have the week 2 semi-intensive PK sampling collection and have at least two samples with measurable DLM and DM-6705 concentrations | Posted | Median | Full Range | h | Approximately day 10 (Week 2) at pre-dose, and 2, 4, and hours post dose |
| ||||||||||||||||||||||||||||||||||||
| Primary | Median Terminal Half-life (t1/2) DM-6705 | PK parameter determined from plasma concentration-time profiles, dosing information and participant covariates using the final population PK model | • Participants that have the week 2 semi-intensive PK sampling collection and have at least two samples with measurable DLM and DM-6705 concentrations | Posted | Median | Full Range | h | Approximately day 10 (Week 2) at pre-dose, and 2, 4, and hours post dose |
| ||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Adverse Events ≥ Grade 3 Severity | At entry and follow-up, all lab results, signs and symptoms, and diagnoses were recorded. The core team reviewed and confirmed the sites assessment of event relatedness to study drug. An adverse event (AE) is any unfavorable and unintended sign, symptom, or diagnosis that occurs in a study participant during the conduct of the study REGARDLESS of the attribution. Adverse events are graded on a scale from 1-5: 1=mild, 2=moderate, 3=severe, 4= potentially life-threatening, 5=death. AE grading was per Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table V2.1). A higher grade indicates worse outcome. 95% CI computed using exact Clopper-Pearson method. | All participants enrolled in the study | Posted | Number | 95% Confidence Interval | percentage of participants | Measured from entry through Week 72 post DLM |
| ||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Adverse Events ≥ Grade 3 Severity Assessed by the Core Team to be at Least Possibly Related to the Study Drug | At entry and follow-up, all lab results, signs and symptoms, and diagnoses were recorded. The core team reviewed and confirmed the sites assessment of event relatedness to study drug. An adverse event (AE) is any unfavorable and unintended sign, symptom, or diagnosis that occurs in a study participant during the conduct of the study REGARDLESS of the attribution. Adverse events are graded on a scale from 1-5: 1=mild, 2=moderate, 3=severe, 4= potentially life-threatening, 5=death. AE grading was per Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table V2.1). A higher grade indicates worse outcome. 95% CI computed using exact Clopper-Pearson method. | All participants enrolled in the study | Posted | Number | 95% Confidence Interval | percentage of participants | Measured from entry through Week 72 post DLM |
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| Secondary | Percentage of Participants With Absolute Corrected QT Interval by Fridericia (QTcF) ≥ 500 Msec | Evaluation of the Electrocardiogram (ECG) QTcF was performed per protocol. ECGs conducted at these visits should be performed in triplicate (if possible). Consultation with the protocol cardiologist was available and encouraged for any abnormal or equivocal ECG findings and/or questions related to cardiac toxicities and assessment. Participants were counted as having an outcome if they had QTcF ≥ 500 msec at any study visit from entry to Week 28. 95% CI computed using exact Clopper-Pearson method. | All participants enrolled in the study | Posted | Number | 95% Confidence Interval | percentage of participants | Screening, Entry, weeks 2, 8, 12, 16, 20, 24 and week 28 |
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| Secondary | Percentage of Participants Who Died Through Week 72 Post DLM | Death due to all causes included. 95% CI computed using exact Clopper-Pearson method. | All participants enrolled in the study | Posted | Number | 95% Confidence Interval | percentage of participants | Measured from entry through Week 72 post DLM |
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| Secondary | Percentage of Participants With Adverse Events ≥ Grade 2 Severity | At entry and follow-up, all lab results, signs and symptoms, and diagnoses were recorded. The core team reviewed and confirmed the sites assessment of event relatedness to study drug. An adverse event (AE) is any unfavorable and unintended sign, symptom, or diagnosis that occurs in a study participant during the conduct of the study REGARDLESS of the attribution. Adverse events are graded on a scale from 1-5: 1=mild, 2=moderate, 3=severe, 4= potentially life-threatening, 5=death. AE grading was per Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table V2.1). A higher grade indicates worse outcome. 95% CI computed using exact Clopper-Pearson method. | All participants enrolled in the study | Posted | Number | 95% Confidence Interval | percentage of participants | Measured from entry through Week 72 post DLM |
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| Secondary | Percentage of Participants With Adverse Events ≥ Grade 2 Severity Assessed by the Core Team to be at Least Possibly Related to the Study Drug. | At entry and follow-up, all lab results, signs and symptoms, and diagnoses were recorded. The core team reviewed and confirmed the sites assessment of event relatedness to study drug. An adverse event (AE) is any unfavorable and unintended sign, symptom, or diagnosis that occurs in a study participant during the conduct of the study REGARDLESS of the attribution. Adverse events are graded on a scale from 1-5: 1=mild, 2=moderate, 3=severe, 4= potentially life-threatening, 5=death. AE grading was per Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table V2.1). A higher grade indicates worse outcome. 95% CI computed using exact Clopper-Pearson method. | All participants enrolled in the study | Posted | Number | 95% Confidence Interval | percentage of participants | Measured from entry through Week 72 post DLM |
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| Secondary | Count of Participants With Change in QTcF Interval From Baseline of Greater Than 60 ms | Evaluation of the Electrocardiogram (ECG) QTcF was performed per protocol. ECGs conducted at these visits should be performed in triplicate (if possible). Consultation with the protocol cardiologist was available and encouraged for any abnormal or equivocal ECG findings and/or questions related to cardiac toxicities and assessment. Participants were counted if they had QTcF was greater than 60 msec at any study visit from entry to Week 28. | All participants enrolled in the study | Posted | Count of Participants | Participants | Entry, weeks 2, 8, 12, 16, 20, 24, and week 28 |
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| Secondary | Percentage of Participants (Overall) With TB Treatment Outcomes | Site investigator assessment of participant TB treatment outcomes through last study visit were entered into the eCRF. Treatment outcomes in children were defined as bacteriologic cure, probable cure, death, treatment failure, TB recurrence, and loss to follow-up as per protocol. | All participants who enrolled and completed study follow-up. Two participants missing TB outcome, one was eligibility failure at week 2 and one completed treatment after they were off study (unexpected study closure) | Posted | Number | 95% Confidence Interval | percentage of participants | Measured from entry through Week 72 post DLM |
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| Secondary | Number of Participants Who Had Permanently Discontinued Study Drug Whilst on Study Due to Intolerance or Refusal to Take Medication | Participants were assessed for tolerability of the study drug during the study by their intolerance or refusal to take the medications | All participants enrolled in the study | Posted | Count of Participants | Participants | Measured from entry through Week 24 |
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| Secondary | Frequency of Cumulative Responses to Taste of Study Drug in an Acceptability Assessment | Acceptability assessments were assessed by Study Staff at study visits and by Participant Caregiver whilst at home. The participants had the option of taking the study drug either as dispersible tablet or tablet formulation. | All participants that enrolled and were administered the acceptability assessment | Posted | Count of Participants | Participants | Assessments conducted at weeks 2, 8 and 24 |
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| Secondary | Frequency of Cumulative Responses to Formulation of Study Drug in an Acceptability Assessment | Acceptability assessments were assessed by Study Staff at study visits and by Participant Caregiver whilst at home. The participants had the option of taking the study drug either as dispersible tablet or tablet formulation. At a visit, the participant could have been taking a dispersible tablet and at the next visit the same participant could have been taking a tablet formulation. | Participants who took dispersible tablet and responded to the acceptability assessment of taste. The number of participants vary at each specific visit week because participants could have been taking a dispersible tablet at one visit and a tablet formulation at other visits, and not everyone who was on dispersible tablets responded to the assessment of taste. | Posted | Count of Participants | Participants | Assessments conducted at weeks 2, 8 and 24 |
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| Secondary | Frequency of Cumulative Responses to Taste of Dispersible Tablet Doses in an Acceptability Assessment | Acceptability assessments were assessed by Study Staff at study visits and by Participant Caregiver whilst at home. Participants' dose formulations were not restrictive as at each visit, the participant was given the option of taking the study drug as either a dispersible tablet or tablet formulation. At a visit, the participant could have been taking a dispersible tablet and at the next visit the same participant could have been taking a tablet formulation. | Participants who took dispersible tablet and responded to the acceptability assessment of taste. The number of participants vary at each specific visit week because participants could have been taking a dispersible tablet at one visit and a tablet formulation at other visits, and not everyone who was on dispersible tablets responded to the assessment of taste." | Posted | Count of Participants | Participants | Assessments conducted at weeks 2, 8 and 24 |
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| Secondary | Frequency of Cumulative Responses to Administration of Dispersible Tablet Doses in an Acceptability Assessment | Acceptability assessments were assessed by Study Staff at study visits and by Participant Caregiver whilst at home. Participants' dose formulations were not restrictive as at each visit, the participant was given the option of taking the study drug as either a dispersible tablet or tablet formulation. At a visit, the participant could have been taking a dispersible tablet and at the next visit the same participant could have been taking a tablet formulation. | Participants who took dispersible tablet and responded to the acceptability assessment of taste. The number of participants vary at each specific visit week because participants could have been taking a dispersible tablet at one visit and a tablet formulation at other visits, and not everyone who was on dispersible tablets responded to the assessment of taste. | Posted | Count of Participants | Participants | Assessments conducted at weeks 2, 8 and 24 |
| |||||||||||||||||||||||||||||||||||||
| Secondary | Frequency of Cumulative Responses to Taste of Tablet Doses in an Acceptability Assessment | Acceptability assessments were assessed by Study Staff at study visits and by Participant Caregiver whilst at home. Participants' dose formulations were not restrictive as at each visit, the participant was given the option of taking the study drug as either a dispersible tablet or tablet formulation. At a visit, the participant could have been taking a dispersible tablet and at the next visit the same participant could have been taking a tablet formulation. | Participants who took tablet formulation and responded to the acceptability assessment of taste. The number of participants vary at each specific visit week because participants could have been taking a dispersible tablet at one visit and a tablet formulation at other visits, and not everyone who was on dispersible tablets responded to the assessment of taste | Posted | Count of Participants | Participants | Assessments conducted at weeks 2, 8 and 24 |
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| Secondary | Frequency of Cumulative Responses to Administration of Tablet Doses in an Acceptability Assessment | Acceptability assessments were assessed by Study Staff at study visits and by Participant Caregiver whilst at home. Participants' dose formulations were not restrictive as at each visit, the participant was given the option of taking the study drug as either a dispersible tablet or tablet formulation. At a visit, the participant could have been taking a dispersible tablet and at the next visit the same participant could have been taking a tablet formulation. | Participants who took tablet formulation and responded to the acceptability assessment of taste. The number of participants vary at each specific visit week because participants could have been taking a dispersible tablet at one visit and a tablet formulation at other visits, and not everyone who was on dispersible tablets responded to the assessment of taste | Posted | Count of Participants | Participants | Assessments conducted at weeks 2, 8 and 24 |
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| Secondary | Age Effect on Bioavailability DLM | Plasma concentrations are used to determine age effect on bioavailability. The age covariate describes the fold change in bioavailability for each respective age group of 0-1 year and 1-2 years, with participants aged >2 to <18 years used as the reference group. Study arms were combined for the analysis of age effect. | Participants that have the week 2 semi-intensive PK sampling collection and have at least two samples with measurable DLM concentrations. | Posted | Median | Full Range | h | Approximately Week 2 |
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| Secondary | Age Effect on Fraction Metabolised From Delaminid to DM-6705 | Plasma concentrations are used to determine age effect on bioavailability. The age covariate describes the fold change in bioavailability for each respective age group of 0-1 year and 1-2 years, with participants aged >2 to <18 years used as the reference group. Study arms were combined for the analysis of age effect. | Participants that have the week 2 semi-intensive PK sampling collection and have at least two samples with measurable DM-6705 concentrations | Posted | Median | Full Range | h | Approximately Week 2 |
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| Secondary | Dose Effect on Bioavailability DLM | Plasma concentrations are used to determine dose effect on bioavailability. For doses > 50 mg the bioavailability is described by F=(dose/100)-0.66. The participants receiving the dose 100 mg are the reference group and the dose effect of doses 15-20mg, 25mg and 50mg on the bioavailability are compared to the reference group and the fold change is presented. Study arms were combined for the analysis of dose effect. | Participants that have the week 2 semi-intensive PK sampling collection and have at least two samples with measurable DM-6705 concentrations | Posted | Median | Full Range | h | Approximately Week 2 |
|
From entry through end of study, up to 96 weeks
An adverse event (AE) is any unfavorable and unintended sign, symptom, or diagnosis that occurs in a study participant during the conduct of the study REGARDLESS of the attribution. Adverse events are graded on a scale from 1-5: 1=mild, 2=moderate, 3=severe, 4= potentially life-threatening, 5=death. AE grading was per Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table V2.1.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Cohort 1 (>=12 to < 18 Years) | Participants received delamanid (DLM) twice daily for 24 weeks. Participants also received non-study prescribed OBR for MDR-TB. Delamanid: Administered orally; dosing based on participants' weight. ≥ 40 kg: 100 mg twice daily (adult formulation); 30 to < 40 kg: 50 mg twice daily (adult formulation); 15 to < 30 kg: 25 mg twice daily (pediatric formulation); < 15 kg: 15 mg twice daily (pediatric formulation) Optimized multidrug background regimen (OBR) for children with MDR-TB: Non-study prescribed OBR varied according to local, national, and/or international guidelines for treatment of children with MDR-TB. Administered in addition to DLM for 24 weeks. | 0 | 11 | 5 | 11 | 10 | 11 |
| EG001 | Cohort 2 (>=6 to < 12 Years) | Participants received delamanid (DLM) twice daily for 24 weeks. Participants also received non-study prescribed OBR for MDR-TB. Delamanid: Administered orally; dosing based on participants' weight. ≥ 40 kg: 100 mg twice daily (adult formulation); 30 to < 40 kg: 50 mg twice daily (adult formulation); 15 to < 30 kg: 25 mg twice daily (pediatric formulation); < 15 kg: 15 mg twice daily (pediatric formulation) Optimized multidrug background regimen (OBR) for children with MDR-TB: Non-study prescribed OBR varied according to local, national, and/or international guidelines for treatment of children with MDR-TB. Administered in addition to DLM for 24 weeks. | 0 | 8 | 1 | 8 | 8 | 8 |
| EG002 | Cohort 3 (>=3 to < 6 Years) | Participants received delamanid (DLM) twice daily for 24 weeks. Participants also received non-study prescribed OBR for MDR-TB. Delamanid: Administered orally; dosing based on participants' weight. ≥ 40 kg: 100 mg twice daily (adult formulation); 30 to < 40 kg: 50 mg twice daily (adult formulation); 15 to < 30 kg: 25 mg twice daily (pediatric formulation); < 15 kg: 15 mg twice daily (pediatric formulation) Optimized multidrug background regimen (OBR) for children with MDR-TB: Non-study prescribed OBR varied according to local, national, and/or international guidelines for treatment of children with MDR-TB. Administered in addition to DLM for 24 weeks. | 0 | 6 | 5 | 6 | 6 | 6 |
| EG003 | Cohort 4 (>=0 to < 3 Years | Participants received delamanid (DLM) twice daily for 24 weeks. Participants also received non-study prescribed OBR for MDR-TB. Delamanid: Administered orally; dosing based on participants' weight. ≥ 40 kg: 100 mg twice daily (adult formulation); 30 to < 40 kg: 50 mg twice daily (adult formulation); 15 to < 30 kg: 25 mg twice daily (pediatric formulation); < 15 kg: 15 mg twice daily (pediatric formulation) Optimized multidrug background regimen (OBR) for children with MDR-TB: Non-study prescribed OBR varied according to local, national, and/or international guidelines for treatment of children with MDR-TB. Administered in addition to DLM for 24 weeks. | 0 | 12 | 7 | 12 | 10 | 12 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Faecaloma | Gastrointestinal disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Treatment failure | General disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Gastroenteritis viral | Infections and infestations | MedDRA 28.0 | Systematic Assessment |
| |
| Rib fracture | Injury, poisoning and procedural complications | MedDRA 28.0 | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA 28.0 | Systematic Assessment |
| |
| Electrocardiogram QT prolonged | Investigations | MedDRA 28.0 | Systematic Assessment |
| |
| Malnutrition | Metabolism and nutrition disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Hypersomnia | Nervous system disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Abnormal behaviour | Psychiatric disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Abnormal dreams | Psychiatric disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Hallucination | Psychiatric disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Hallucination, auditory | Psychiatric disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Hallucination, visual | Psychiatric disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Hypnopompic hallucination | Psychiatric disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Mood swings | Psychiatric disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Nightmare | Psychiatric disorders | MedDRA 28.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Iron deficiency anaemia | Blood and lymphatic system disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Lymphadenopathy | Blood and lymphatic system disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Normochromic normocytic anaemia | Blood and lymphatic system disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Vernal keratoconjunctivitis | Eye disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Angular cheilitis | Gastrointestinal disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Dental caries | Gastrointestinal disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Faecaloma | Gastrointestinal disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Glossitis | Gastrointestinal disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Toothache | Gastrointestinal disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Chest pain | General disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Decreased activity | General disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Influenza like illness | General disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Swelling | General disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Hepatomegaly | Hepatobiliary disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Ocular icterus | Hepatobiliary disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Acute sinusitis | Infections and infestations | MedDRA 28.0 | Systematic Assessment |
| |
| Bronchiolitis | Infections and infestations | MedDRA 28.0 | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA 28.0 | Systematic Assessment |
| |
| Bronchitis viral | Infections and infestations | MedDRA 28.0 | Systematic Assessment |
| |
| Dysentery | Infections and infestations | MedDRA 28.0 | Systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA 28.0 | Systematic Assessment |
| |
| Helminthic infection | Infections and infestations | MedDRA 28.0 | Systematic Assessment |
| |
| Lower respiratory tract infection | Infections and infestations | MedDRA 28.0 | Systematic Assessment |
| |
| Oral herpes | Infections and infestations | MedDRA 28.0 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 28.0 | Systematic Assessment |
| |
| Scabies | Infections and infestations | MedDRA 28.0 | Systematic Assessment |
| |
| Tonsillitis | Infections and infestations | MedDRA 28.0 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 28.0 | Systematic Assessment |
| |
| Viral upper respiratory tract infection | Infections and infestations | MedDRA 28.0 | Systematic Assessment |
| |
| Animal bite | Injury, poisoning and procedural complications | MedDRA 28.0 | Systematic Assessment |
| |
| Thermal burn | Injury, poisoning and procedural complications | MedDRA 28.0 | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA 28.0 | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA 28.0 | Systematic Assessment |
| |
| Blood albumin decreased | Investigations | MedDRA 28.0 | Systematic Assessment |
| |
| Blood alkaline phosphatase increased | Investigations | MedDRA 28.0 | Systematic Assessment |
| |
| Blood bilirubin increased | Investigations | MedDRA 28.0 | Systematic Assessment |
| |
| Blood calcium decreased | Investigations | MedDRA 28.0 | Systematic Assessment |
| |
| Blood calcium increased | Investigations | MedDRA 28.0 | Systematic Assessment |
| |
| Blood creatinine increased | Investigations | MedDRA 28.0 | Systematic Assessment |
| |
| Blood magnesium decreased | Investigations | MedDRA 28.0 | Systematic Assessment |
| |
| Blood potassium increased | Investigations | MedDRA 28.0 | Systematic Assessment |
| |
| Blood pressure diastolic increased | Investigations | MedDRA 28.0 | Systematic Assessment |
| |
| Blood pressure systolic increased | Investigations | MedDRA 28.0 | Systematic Assessment |
| |
| Electrocardiogram abnormal | Investigations | MedDRA 28.0 | Systematic Assessment |
| |
| Haemoglobin decreased | Investigations | MedDRA 28.0 | Systematic Assessment |
| |
| Neutrophil count decreased | Investigations | MedDRA 28.0 | Systematic Assessment |
| |
| Platelet count decreased | Investigations | MedDRA 28.0 | Systematic Assessment |
| |
| Platelet count increased | Investigations | MedDRA 28.0 | Systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA 28.0 | Systematic Assessment |
| |
| White blood cell count decreased | Investigations | MedDRA 28.0 | Systematic Assessment |
| |
| Abnormal loss of weight | Metabolism and nutrition disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Malnutrition | Metabolism and nutrition disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Underweight | Metabolism and nutrition disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Tendonitis | Musculoskeletal and connective tissue disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Hypoaesthesia | Nervous system disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Lethargy | Nervous system disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Paraesthesia | Nervous system disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Somnolence | Nervous system disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Abnormal behaviour | Psychiatric disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Hallucination | Psychiatric disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Hallucinations, mixed | Psychiatric disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Irritability | Psychiatric disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Nightmare | Psychiatric disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Substance abuse | Psychiatric disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Dysuria | Renal and urinary disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Haematuria | Renal and urinary disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Productive cough | Respiratory, thoracic and mediastinal disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Throat irritation | Respiratory, thoracic and mediastinal disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Dermatitis atopic | Skin and subcutaneous tissue disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Dermatitis diaper | Skin and subcutaneous tissue disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Dry skin | Skin and subcutaneous tissue disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Eosinophilic pustular folliculitis | Skin and subcutaneous tissue disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Nail pigmentation | Skin and subcutaneous tissue disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Rash maculo-papular | Skin and subcutaneous tissue disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Skin hyperpigmentation | Skin and subcutaneous tissue disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Skin hypopigmentation | Skin and subcutaneous tissue disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Victim of sexual abuse | Social circumstances | MedDRA 28.0 | Systematic Assessment |
|
In accordance with the Clinical Trials Agreement between NIAID (DAIDS) and company collaborators, NIAID (DAIDS) provides companies with a copy of any abstract, press release, or manuscript prior to submission for publication with sufficient time for company review and comment. The publication/other disclosure can be delayed for up to 30 additional business days for manuscripts and five (5) business days for abstracts, to preserve U.S. or foreign patent or other intellectual property rights
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| ACTG Clinicaltrials.gov Coordinator | ACTG Network Coordinating Center, Social and Scientific Systems, a DHL Holdings Company | (301) 628-3348 | ACTGCT.gov@fstrf.org |
| Jan 9, 2026 |
| Prot_ICF_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan: PK analysis plan | Aug 5, 2025 | Apr 8, 2026 | SAP_001.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan: PK analysis plan | Feb 5, 2026 | Apr 8, 2026 | SAP_002.pdf |
Not provided
| ID | Term |
|---|---|
| D014376 | Tuberculosis |
| D015658 | HIV Infections |
| ID | Term |
|---|---|
| D009164 | Mycobacterium Infections |
| D000193 | Actinomycetales Infections |
| D016908 | Gram-Positive Bacterial Infections |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D015229 | Sexually Transmitted Diseases, Viral |
| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C516022 | OPC-67683 |
Not provided
Not provided
Not provided
| Male |
|
| Indian (Native of India) |
|
| Coloured |
|
| South Africa |
|
| India |
|
| living with HIV-1 |
|
| ExtraPulmonary TB (EPTB) |
|
| PTB and EPTB |
|
| OG001 | Cohort 2 (>=6 to < 12 Years) | Participants received delamanid (DLM) twice daily for 24 weeks. Participants also received non-study prescribed OBR for MDR-TB. Delamanid: Administered orally; dosing based on participants' weight. ≥ 40 kg: 100 mg twice daily (adult formulation); 30 to < 40 kg: 50 mg twice daily (adult formulation); 15 to < 30 kg: 25 mg twice daily (pediatric formulation); < 15 kg: 15 mg twice daily (pediatric formulation) Optimized multidrug background regimen (OBR) for children with MDR-TB: Non-study prescribed OBR varied according to local, national, and/or international guidelines for treatment of children with MDR-TB. Administered in addition to DLM for 24 weeks. |
| OG002 | Cohort 3 (>=3 to < 6 Years) | Participants received delamanid (DLM) twice daily for 24 weeks. Participants also received non-study prescribed OBR for MDR-TB. Delamanid: Administered orally; dosing based on participants' weight. ≥ 40 kg: 100 mg twice daily (adult formulation); 30 to < 40 kg: 50 mg twice daily (adult formulation); 15 to < 30 kg: 25 mg twice daily (pediatric formulation); < 15 kg: 15 mg twice daily (pediatric formulation) Optimized multidrug background regimen (OBR) for children with MDR-TB: Non-study prescribed OBR varied according to local, national, and/or international guidelines for treatment of children with MDR-TB. Administered in addition to DLM for 24 weeks. |
| OG003 | Cohort 4 (>=0 to < 3 Years) | Participants received delamanid (DLM) twice daily for 24 weeks. Participants also received non-study prescribed OBR for MDR-TB. Delamanid: Administered orally; dosing based on participants' weight. ≥ 40 kg: 100 mg twice daily (adult formulation); 30 to < 40 kg: 50 mg twice daily (adult formulation); 15 to < 30 kg: 25 mg twice daily (pediatric formulation); < 15 kg: 15 mg twice daily (pediatric formulation) Optimized multidrug background regimen (OBR) for children with MDR-TB: Non-study prescribed OBR varied according to local, national, and/or international guidelines for treatment of children with MDR-TB. Administered in addition to DLM for 24 weeks. |
|
|
| OG001 |
| Cohort 2 (>=6 to < 12 Years) |
Participants received delamanid (DLM) twice daily for 24 weeks. Participants also received non-study prescribed OBR for MDR-TB. Delamanid: Administered orally; dosing based on participants' weight. ≥ 40 kg: 100 mg twice daily (adult formulation); 30 to < 40 kg: 50 mg twice daily (adult formulation); 15 to < 30 kg: 25 mg twice daily (pediatric formulation); < 15 kg: 15 mg twice daily (pediatric formulation) Optimized multidrug background regimen (OBR) for children with MDR-TB: Non-study prescribed OBR varied according to local, national, and/or international guidelines for treatment of children with MDR-TB. Administered in addition to DLM for 24 weeks. |
| OG002 | Cohort 3 (>=3 to < 6 Years) | Participants received delamanid (DLM) twice daily for 24 weeks. Participants also received non-study prescribed OBR for MDR-TB. Delamanid: Administered orally; dosing based on participants' weight. ≥ 40 kg: 100 mg twice daily (adult formulation); 30 to < 40 kg: 50 mg twice daily (adult formulation); 15 to < 30 kg: 25 mg twice daily (pediatric formulation); < 15 kg: 15 mg twice daily (pediatric formulation) Optimized multidrug background regimen (OBR) for children with MDR-TB: Non-study prescribed OBR varied according to local, national, and/or international guidelines for treatment of children with MDR-TB. Administered in addition to DLM for 24 weeks. |
| OG003 | Cohort 4 (>=0 to < 3 Years) | Participants received delamanid (DLM) twice daily for 24 weeks. Participants also received non-study prescribed OBR for MDR-TB. Delamanid: Administered orally; dosing based on participants' weight. ≥ 40 kg: 100 mg twice daily (adult formulation); 30 to < 40 kg: 50 mg twice daily (adult formulation); 15 to < 30 kg: 25 mg twice daily (pediatric formulation); < 15 kg: 15 mg twice daily (pediatric formulation) Optimized multidrug background regimen (OBR) for children with MDR-TB: Non-study prescribed OBR varied according to local, national, and/or international guidelines for treatment of children with MDR-TB. Administered in addition to DLM for 24 weeks. |
|
|
Participants received delamanid (DLM) twice daily for 24 weeks. Participants also received non-study prescribed OBR for MDR-TB.
Delamanid: Administered orally; dosing based on participants' weight.
≥ 40 kg: 100 mg twice daily (adult formulation); 30 to < 40 kg: 50 mg twice daily (adult formulation); 15 to < 30 kg: 25 mg twice daily (pediatric formulation); < 15 kg: 15 mg twice daily (pediatric formulation)
Optimized multidrug background regimen (OBR) for children with MDR-TB: Non-study prescribed OBR varied according to local, national, and/or international guidelines for treatment of children with MDR-TB. Administered in addition to DLM for 24 weeks.
| OG002 | Cohort 3 (>=3 to < 6 Years) | Participants received delamanid (DLM) twice daily for 24 weeks. Participants also received non-study prescribed OBR for MDR-TB. Delamanid: Administered orally; dosing based on participants' weight. ≥ 40 kg: 100 mg twice daily (adult formulation); 30 to < 40 kg: 50 mg twice daily (adult formulation); 15 to < 30 kg: 25 mg twice daily (pediatric formulation); < 15 kg: 15 mg twice daily (pediatric formulation) Optimized multidrug background regimen (OBR) for children with MDR-TB: Non-study prescribed OBR varied according to local, national, and/or international guidelines for treatment of children with MDR-TB. Administered in addition to DLM for 24 weeks. |
| OG003 | Cohort 4 (>=0 to < 3 Years) | Participants received delamanid (DLM) twice daily for 24 weeks. Participants also received non-study prescribed OBR for MDR-TB. Delamanid: Administered orally; dosing based on participants' weight. ≥ 40 kg: 100 mg twice daily (adult formulation); 30 to < 40 kg: 50 mg twice daily (adult formulation); 15 to < 30 kg: 25 mg twice daily (pediatric formulation); < 15 kg: 15 mg twice daily (pediatric formulation) Optimized multidrug background regimen (OBR) for children with MDR-TB: Non-study prescribed OBR varied according to local, national, and/or international guidelines for treatment of children with MDR-TB. Administered in addition to DLM for 24 weeks. |
|
|
| OG002 | Cohort 3 (>=3 to < 6 Years) | Participants received delamanid (DLM) twice daily for 24 weeks. Participants also received non-study prescribed OBR for MDR-TB. Delamanid: Administered orally; dosing based on participants' weight. ≥ 40 kg: 100 mg twice daily (adult formulation); 30 to < 40 kg: 50 mg twice daily (adult formulation); 15 to < 30 kg: 25 mg twice daily (pediatric formulation); < 15 kg: 15 mg twice daily (pediatric formulation) Optimized multidrug background regimen (OBR) for children with MDR-TB: Non-study prescribed OBR varied according to local, national, and/or international guidelines for treatment of children with MDR-TB. Administered in addition to DLM for 24 weeks. |
| OG003 | Cohort 4 (>=0 to < 3 Years) | Participants received delamanid (DLM) twice daily for 24 weeks. Participants also received non-study prescribed OBR for MDR-TB. Delamanid: Administered orally; dosing based on participants' weight. ≥ 40 kg: 100 mg twice daily (adult formulation); 30 to < 40 kg: 50 mg twice daily (adult formulation); 15 to < 30 kg: 25 mg twice daily (pediatric formulation); < 15 kg: 15 mg twice daily (pediatric formulation) Optimized multidrug background regimen (OBR) for children with MDR-TB: Non-study prescribed OBR varied according to local, national, and/or international guidelines for treatment of children with MDR-TB. Administered in addition to DLM for 24 weeks. |
|
|
| OG001 |
| Cohort 2 (>=6 to < 12 Years) |
Participants received delamanid (DLM) twice daily for 24 weeks. Participants also received non-study prescribed OBR for MDR-TB. Delamanid: Administered orally; dosing based on participants' weight. ≥ 40 kg: 100 mg twice daily (adult formulation); 30 to < 40 kg: 50 mg twice daily (adult formulation); 15 to < 30 kg: 25 mg twice daily (pediatric formulation); < 15 kg: 15 mg twice daily (pediatric formulation) Optimized multidrug background regimen (OBR) for children with MDR-TB: Non-study prescribed OBR varied according to local, national, and/or international guidelines for treatment of children with MDR-TB. Administered in addition to DLM for 24 weeks. |
| OG002 | Cohort 3 (>=3 to < 6 Years) | Participants received delamanid (DLM) twice daily for 24 weeks. Participants also received non-study prescribed OBR for MDR-TB. Delamanid: Administered orally; dosing based on participants' weight. ≥ 40 kg: 100 mg twice daily (adult formulation); 30 to < 40 kg: 50 mg twice daily (adult formulation); 15 to < 30 kg: 25 mg twice daily (pediatric formulation); < 15 kg: 15 mg twice daily (pediatric formulation) Optimized multidrug background regimen (OBR) for children with MDR-TB: Non-study prescribed OBR varied according to local, national, and/or international guidelines for treatment of children with MDR-TB. Administered in addition to DLM for 24 weeks. |
| OG003 | Cohort 4 (>=0 to < 3 Years) | Participants received delamanid (DLM) twice daily for 24 weeks. Participants also received non-study prescribed OBR for MDR-TB. Delamanid: Administered orally; dosing based on participants' weight. ≥ 40 kg: 100 mg twice daily (adult formulation); 30 to < 40 kg: 50 mg twice daily (adult formulation); 15 to < 30 kg: 25 mg twice daily (pediatric formulation); < 15 kg: 15 mg twice daily (pediatric formulation) Optimized multidrug background regimen (OBR) for children with MDR-TB: Non-study prescribed OBR varied according to local, national, and/or international guidelines for treatment of children with MDR-TB. Administered in addition to DLM for 24 weeks. |
|
|
| OG001 |
| Cohort 2 (>=6 to < 12 Years) |
Participants received delamanid (DLM) twice daily for 24 weeks. Participants also received non-study prescribed OBR for MDR-TB. Delamanid: Administered orally; dosing based on participants' weight. ≥ 40 kg: 100 mg twice daily (adult formulation); 30 to < 40 kg: 50 mg twice daily (adult formulation); 15 to < 30 kg: 25 mg twice daily (pediatric formulation); < 15 kg: 15 mg twice daily (pediatric formulation) Optimized multidrug background regimen (OBR) for children with MDR-TB: Non-study prescribed OBR varied according to local, national, and/or international guidelines for treatment of children with MDR-TB. Administered in addition to DLM for 24 weeks. |
| OG002 | Cohort 3 (>=3 to < 6 Years) | Participants received delamanid (DLM) twice daily for 24 weeks. Participants also received non-study prescribed OBR for MDR-TB. Delamanid: Administered orally; dosing based on participants' weight. ≥ 40 kg: 100 mg twice daily (adult formulation); 30 to < 40 kg: 50 mg twice daily (adult formulation); 15 to < 30 kg: 25 mg twice daily (pediatric formulation); < 15 kg: 15 mg twice daily (pediatric formulation) Optimized multidrug background regimen (OBR) for children with MDR-TB: Non-study prescribed OBR varied according to local, national, and/or international guidelines for treatment of children with MDR-TB. Administered in addition to DLM for 24 weeks. |
| OG003 | Cohort 4 (>=0 to < 3 Years) | Participants received delamanid (DLM) twice daily for 24 weeks. Participants also received non-study prescribed OBR for MDR-TB. Delamanid: Administered orally; dosing based on participants' weight. ≥ 40 kg: 100 mg twice daily (adult formulation); 30 to < 40 kg: 50 mg twice daily (adult formulation); 15 to < 30 kg: 25 mg twice daily (pediatric formulation); < 15 kg: 15 mg twice daily (pediatric formulation) Optimized multidrug background regimen (OBR) for children with MDR-TB: Non-study prescribed OBR varied according to local, national, and/or international guidelines for treatment of children with MDR-TB. Administered in addition to DLM for 24 weeks. |
|
|
| OG002 | Cohort 3 (>=3 to < 6 Years) | Participants received delamanid (DLM) twice daily for 24 weeks. Participants also received non-study prescribed OBR for MDR-TB. Delamanid: Administered orally; dosing based on participants' weight. ≥ 40 kg: 100 mg twice daily (adult formulation); 30 to < 40 kg: 50 mg twice daily (adult formulation); 15 to < 30 kg: 25 mg twice daily (pediatric formulation); < 15 kg: 15 mg twice daily (pediatric formulation) Optimized multidrug background regimen (OBR) for children with MDR-TB: Non-study prescribed OBR varied according to local, national, and/or international guidelines for treatment of children with MDR-TB. Administered in addition to DLM for 24 weeks. |
| OG003 | Cohort 4 (>=0 to < 3 Years) | Participants received delamanid (DLM) twice daily for 24 weeks. Participants also received non-study prescribed OBR for MDR-TB. Delamanid: Administered orally; dosing based on participants' weight. ≥ 40 kg: 100 mg twice daily (adult formulation); 30 to < 40 kg: 50 mg twice daily (adult formulation); 15 to < 30 kg: 25 mg twice daily (pediatric formulation); < 15 kg: 15 mg twice daily (pediatric formulation) Optimized multidrug background regimen (OBR) for children with MDR-TB: Non-study prescribed OBR varied according to local, national, and/or international guidelines for treatment of children with MDR-TB. Administered in addition to DLM for 24 weeks. |
|
|
| OG002 | Cohort 3 (>=3 to < 6 Years) | Participants received delamanid (DLM) twice daily for 24 weeks. Participants also received non-study prescribed OBR for MDR-TB. Delamanid: Administered orally; dosing based on participants' weight. ≥ 40 kg: 100 mg twice daily (adult formulation); 30 to < 40 kg: 50 mg twice daily (adult formulation); 15 to < 30 kg: 25 mg twice daily (pediatric formulation); < 15 kg: 15 mg twice daily (pediatric formulation) Optimized multidrug background regimen (OBR) for children with MDR-TB: Non-study prescribed OBR varied according to local, national, and/or international guidelines for treatment of children with MDR-TB. Administered in addition to DLM for 24 weeks. |
| OG003 | Cohort 4 (>=0 to < 3 Years) | Participants received delamanid (DLM) twice daily for 24 weeks. Participants also received non-study prescribed OBR for MDR-TB. Delamanid: Administered orally; dosing based on participants' weight. ≥ 40 kg: 100 mg twice daily (adult formulation); 30 to < 40 kg: 50 mg twice daily (adult formulation); 15 to < 30 kg: 25 mg twice daily (pediatric formulation); < 15 kg: 15 mg twice daily (pediatric formulation) Optimized multidrug background regimen (OBR) for children with MDR-TB: Non-study prescribed OBR varied according to local, national, and/or international guidelines for treatment of children with MDR-TB. Administered in addition to DLM for 24 weeks. |
|
|
| OG002 | Cohort 3 (>=3 to < 6 Years) | Participants received delamanid (DLM) twice daily for 24 weeks. Participants also received non-study prescribed OBR for MDR-TB. Delamanid: Administered orally; dosing based on participants' weight. ≥ 40 kg: 100 mg twice daily (adult formulation); 30 to < 40 kg: 50 mg twice daily (adult formulation); 15 to < 30 kg: 25 mg twice daily (pediatric formulation); < 15 kg: 15 mg twice daily (pediatric formulation) Optimized multidrug background regimen (OBR) for children with MDR-TB: Non-study prescribed OBR varied according to local, national, and/or international guidelines for treatment of children with MDR-TB. Administered in addition to DLM for 24 weeks. |
| OG003 | Cohort 4 (>=0 to < 3 Years) | Participants received delamanid (DLM) twice daily for 24 weeks. Participants also received non-study prescribed OBR for MDR-TB. Delamanid: Administered orally; dosing based on participants' weight. ≥ 40 kg: 100 mg twice daily (adult formulation); 30 to < 40 kg: 50 mg twice daily (adult formulation); 15 to < 30 kg: 25 mg twice daily (pediatric formulation); < 15 kg: 15 mg twice daily (pediatric formulation) Optimized multidrug background regimen (OBR) for children with MDR-TB: Non-study prescribed OBR varied according to local, national, and/or international guidelines for treatment of children with MDR-TB. Administered in addition to DLM for 24 weeks. |
|
|
| OG002 | Cohort 3 (>=3 to < 6 Years) | Participants received delamanid (DLM) twice daily for 24 weeks. Participants also received non-study prescribed OBR for MDR-TB. Delamanid: Administered orally; dosing based on participants' weight. ≥ 40 kg: 100 mg twice daily (adult formulation); 30 to < 40 kg: 50 mg twice daily (adult formulation); 15 to < 30 kg: 25 mg twice daily (pediatric formulation); < 15 kg: 15 mg twice daily (pediatric formulation) Optimized multidrug background regimen (OBR) for children with MDR-TB: Non-study prescribed OBR varied according to local, national, and/or international guidelines for treatment of children with MDR-TB. Administered in addition to DLM for 24 weeks. |
| OG003 | Cohort 4 (>=0 to < 3 Years) | Participants received delamanid (DLM) twice daily for 24 weeks. Participants also received non-study prescribed OBR for MDR-TB. Delamanid: Administered orally; dosing based on participants' weight. ≥ 40 kg: 100 mg twice daily (adult formulation); 30 to < 40 kg: 50 mg twice daily (adult formulation); 15 to < 30 kg: 25 mg twice daily (pediatric formulation); < 15 kg: 15 mg twice daily (pediatric formulation) Optimized multidrug background regimen (OBR) for children with MDR-TB: Non-study prescribed OBR varied according to local, national, and/or international guidelines for treatment of children with MDR-TB. Administered in addition to DLM for 24 weeks. |
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|
| OG002 | Cohort 3 (>=3 to < 6 Years) | Participants received delamanid (DLM) twice daily for 24 weeks. Participants also received non-study prescribed OBR for MDR-TB. Delamanid: Administered orally; dosing based on participants' weight. ≥ 40 kg: 100 mg twice daily (adult formulation); 30 to < 40 kg: 50 mg twice daily (adult formulation); 15 to < 30 kg: 25 mg twice daily (pediatric formulation); < 15 kg: 15 mg twice daily (pediatric formulation) Optimized multidrug background regimen (OBR) for children with MDR-TB: Non-study prescribed OBR varied according to local, national, and/or international guidelines for treatment of children with MDR-TB. Administered in addition to DLM for 24 weeks. |
| OG003 | Cohort 4 (>=0 to < 3 Years) | Participants received delamanid (DLM) twice daily for 24 weeks. Participants also received non-study prescribed OBR for MDR-TB. Delamanid: Administered orally; dosing based on participants' weight. ≥ 40 kg: 100 mg twice daily (adult formulation); 30 to < 40 kg: 50 mg twice daily (adult formulation); 15 to < 30 kg: 25 mg twice daily (pediatric formulation); < 15 kg: 15 mg twice daily (pediatric formulation) Optimized multidrug background regimen (OBR) for children with MDR-TB: Non-study prescribed OBR varied according to local, national, and/or international guidelines for treatment of children with MDR-TB. Administered in addition to DLM for 24 weeks. |
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| OG002 | Cohort 3 (>=3 to < 6 Years) | Participants received delamanid (DLM) twice daily for 24 weeks. Participants also received non-study prescribed OBR for MDR-TB. Delamanid: Administered orally; dosing based on participants' weight. ≥ 40 kg: 100 mg twice daily (adult formulation); 30 to < 40 kg: 50 mg twice daily (adult formulation); 15 to < 30 kg: 25 mg twice daily (pediatric formulation); < 15 kg: 15 mg twice daily (pediatric formulation) Optimized multidrug background regimen (OBR) for children with MDR-TB: Non-study prescribed OBR varied according to local, national, and/or international guidelines for treatment of children with MDR-TB. Administered in addition to DLM for 24 weeks. |
| OG003 | Cohort 4 (>=0 to < 3 Years) | Participants received delamanid (DLM) twice daily for 24 weeks. Participants also received non-study prescribed OBR for MDR-TB. Delamanid: Administered orally; dosing based on participants' weight. ≥ 40 kg: 100 mg twice daily (adult formulation); 30 to < 40 kg: 50 mg twice daily (adult formulation); 15 to < 30 kg: 25 mg twice daily (pediatric formulation); < 15 kg: 15 mg twice daily (pediatric formulation) Optimized multidrug background regimen (OBR) for children with MDR-TB: Non-study prescribed OBR varied according to local, national, and/or international guidelines for treatment of children with MDR-TB. Administered in addition to DLM for 24 weeks. |
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| OG002 | Cohort 3 (>=3 to < 6 Years) | Participants received delamanid (DLM) twice daily for 24 weeks. Participants also received non-study prescribed OBR for MDR-TB. Delamanid: Administered orally; dosing based on participants' weight. ≥ 40 kg: 100 mg twice daily (adult formulation); 30 to < 40 kg: 50 mg twice daily (adult formulation); 15 to < 30 kg: 25 mg twice daily (pediatric formulation); < 15 kg: 15 mg twice daily (pediatric formulation) Optimized multidrug background regimen (OBR) for children with MDR-TB: Non-study prescribed OBR varied according to local, national, and/or international guidelines for treatment of children with MDR-TB. Administered in addition to DLM for 24 weeks. |
| OG003 | Cohort 4 (>=0 to < 3 Years) | Participants received delamanid (DLM) twice daily for 24 weeks. Participants also received non-study prescribed OBR for MDR-TB. Delamanid: Administered orally; dosing based on participants' weight. ≥ 40 kg: 100 mg twice daily (adult formulation); 30 to < 40 kg: 50 mg twice daily (adult formulation); 15 to < 30 kg: 25 mg twice daily (pediatric formulation); < 15 kg: 15 mg twice daily (pediatric formulation) Optimized multidrug background regimen (OBR) for children with MDR-TB: Non-study prescribed OBR varied according to local, national, and/or international guidelines for treatment of children with MDR-TB. Administered in addition to DLM for 24 weeks. |
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| OG002 | Cohort 3 (>=3 to < 6 Years) | Participants received delamanid (DLM) twice daily for 24 weeks. Participants also received non-study prescribed OBR for MDR-TB. Delamanid: Administered orally; dosing based on participants' weight. ≥ 40 kg: 100 mg twice daily (adult formulation); 30 to < 40 kg: 50 mg twice daily (adult formulation); 15 to < 30 kg: 25 mg twice daily (pediatric formulation); < 15 kg: 15 mg twice daily (pediatric formulation) Optimized multidrug background regimen (OBR) for children with MDR-TB: Non-study prescribed OBR varied according to local, national, and/or international guidelines for treatment of children with MDR-TB. Administered in addition to DLM for 24 weeks. |
| OG003 | Cohort 4 (>=0 to < 3 Years) | Participants received delamanid (DLM) twice daily for 24 weeks. Participants also received non-study prescribed OBR for MDR-TB. Delamanid: Administered orally; dosing based on participants' weight. ≥ 40 kg: 100 mg twice daily (adult formulation); 30 to < 40 kg: 50 mg twice daily (adult formulation); 15 to < 30 kg: 25 mg twice daily (pediatric formulation); < 15 kg: 15 mg twice daily (pediatric formulation) Optimized multidrug background regimen (OBR) for children with MDR-TB: Non-study prescribed OBR varied according to local, national, and/or international guidelines for treatment of children with MDR-TB. Administered in addition to DLM for 24 weeks. |
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| OG002 | Cohort 3 (>=3 to < 6 Years) | Participants received delamanid (DLM) twice daily for 24 weeks. Participants also received non-study prescribed OBR for MDR-TB. Delamanid: Administered orally; dosing based on participants' weight. ≥ 40 kg: 100 mg twice daily (adult formulation); 30 to < 40 kg: 50 mg twice daily (adult formulation); 15 to < 30 kg: 25 mg twice daily (pediatric formulation); < 15 kg: 15 mg twice daily (pediatric formulation) Optimized multidrug background regimen (OBR) for children with MDR-TB: Non-study prescribed OBR varied according to local, national, and/or international guidelines for treatment of children with MDR-TB. Administered in addition to DLM for 24 weeks. |
| OG003 | Cohort 4 (>=0 to < 3 Years) | Participants received delamanid (DLM) twice daily for 24 weeks. Participants also received non-study prescribed OBR for MDR-TB. Delamanid: Administered orally; dosing based on participants' weight. ≥ 40 kg: 100 mg twice daily (adult formulation); 30 to < 40 kg: 50 mg twice daily (adult formulation); 15 to < 30 kg: 25 mg twice daily (pediatric formulation); < 15 kg: 15 mg twice daily (pediatric formulation) Optimized multidrug background regimen (OBR) for children with MDR-TB: Non-study prescribed OBR varied according to local, national, and/or international guidelines for treatment of children with MDR-TB. Administered in addition to DLM for 24 weeks. |
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| OG002 | Cohort 3 (>=3 to < 6 Years) | Participants received delamanid (DLM) twice daily for 24 weeks. Participants also received non-study prescribed OBR for MDR-TB. Delamanid: Administered orally; dosing based on participants' weight. ≥ 40 kg: 100 mg twice daily (adult formulation); 30 to < 40 kg: 50 mg twice daily (adult formulation); 15 to < 30 kg: 25 mg twice daily (pediatric formulation); < 15 kg: 15 mg twice daily (pediatric formulation) Optimized multidrug background regimen (OBR) for children with MDR-TB: Non-study prescribed OBR varied according to local, national, and/or international guidelines for treatment of children with MDR-TB. Administered in addition to DLM for 24 weeks. |
| OG003 | Cohort 4 (>=0 to < 3 Years) | Participants received delamanid (DLM) twice daily for 24 weeks. Participants also received non-study prescribed OBR for MDR-TB. Delamanid: Administered orally; dosing based on participants' weight. ≥ 40 kg: 100 mg twice daily (adult formulation); 30 to < 40 kg: 50 mg twice daily (adult formulation); 15 to < 30 kg: 25 mg twice daily (pediatric formulation); < 15 kg: 15 mg twice daily (pediatric formulation) Optimized multidrug background regimen (OBR) for children with MDR-TB: Non-study prescribed OBR varied according to local, national, and/or international guidelines for treatment of children with MDR-TB. Administered in addition to DLM for 24 weeks. |
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| OG002 | Cohort 3 (>=3 to < 6 Years) | Participants received delamanid (DLM) twice daily for 24 weeks. Participants also received non-study prescribed OBR for MDR-TB. Delamanid: Administered orally; dosing based on participants' weight. ≥ 40 kg: 100 mg twice daily (adult formulation); 30 to < 40 kg: 50 mg twice daily (adult formulation); 15 to < 30 kg: 25 mg twice daily (pediatric formulation); < 15 kg: 15 mg twice daily (pediatric formulation) Optimized multidrug background regimen (OBR) for children with MDR-TB: Non-study prescribed OBR varied according to local, national, and/or international guidelines for treatment of children with MDR-TB. Administered in addition to DLM for 24 weeks. |
| OG003 | Cohort 4 (>=0 to < 3 Years) | Participants received delamanid (DLM) twice daily for 24 weeks. Participants also received non-study prescribed OBR for MDR-TB. Delamanid: Administered orally; dosing based on participants' weight. ≥ 40 kg: 100 mg twice daily (adult formulation); 30 to < 40 kg: 50 mg twice daily (adult formulation); 15 to < 30 kg: 25 mg twice daily (pediatric formulation); < 15 kg: 15 mg twice daily (pediatric formulation) Optimized multidrug background regimen (OBR) for children with MDR-TB: Non-study prescribed OBR varied according to local, national, and/or international guidelines for treatment of children with MDR-TB. Administered in addition to DLM for 24 weeks. |
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| OG001 | Cohort 2 (>=6 to < 12 Years) | Participants received delamanid (DLM) twice daily for 24 weeks. Participants also received non-study prescribed OBR for MDR-TB. Delamanid: Administered orally; dosing based on participants' weight. ≥ 40 kg: 100 mg twice daily (adult formulation); 30 to < 40 kg: 50 mg twice daily (adult formulation); 15 to < 30 kg: 25 mg twice daily (pediatric formulation); < 15 kg: 15 mg twice daily (pediatric formulation) Optimized multidrug background regimen (OBR) for children with MDR-TB: Non-study prescribed OBR varied according to local, national, and/or international guidelines for treatment of children with MDR-TB. Administered in addition to DLM for 24 weeks. |
| OG002 | Cohort 3 (>=3 to < 6 Years) | Participants received delamanid (DLM) twice daily for 24 weeks. Participants also received non-study prescribed OBR for MDR-TB. Delamanid: Administered orally; dosing based on participants' weight. ≥ 40 kg: 100 mg twice daily (adult formulation); 30 to < 40 kg: 50 mg twice daily (adult formulation); 15 to < 30 kg: 25 mg twice daily (pediatric formulation); < 15 kg: 15 mg twice daily (pediatric formulation) Optimized multidrug background regimen (OBR) for children with MDR-TB: Non-study prescribed OBR varied according to local, national, and/or international guidelines for treatment of children with MDR-TB. Administered in addition to DLM for 24 weeks. |
| OG003 | Cohort 4 (>=0 to < 3 Years) | Participants received delamanid (DLM) twice daily for 24 weeks. Participants also received non-study prescribed OBR for MDR-TB. Delamanid: Administered orally; dosing based on participants' weight. ≥ 40 kg: 100 mg twice daily (adult formulation); 30 to < 40 kg: 50 mg twice daily (adult formulation); 15 to < 30 kg: 25 mg twice daily (pediatric formulation); < 15 kg: 15 mg twice daily (pediatric formulation) Optimized multidrug background regimen (OBR) for children with MDR-TB: Non-study prescribed OBR varied according to local, national, and/or international guidelines for treatment of children with MDR-TB. Administered in addition to DLM for 24 weeks. |
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| OG001 | Cohort 2 (>=6 to < 12 Years) | Participants received delamanid (DLM) twice daily for 24 weeks. Participants also received non-study prescribed OBR for MDR-TB. Delamanid: Administered orally; dosing based on participants' weight. ≥ 40 kg: 100 mg twice daily (adult formulation); 30 to < 40 kg: 50 mg twice daily (adult formulation); 15 to < 30 kg: 25 mg twice daily (pediatric formulation); < 15 kg: 15 mg twice daily (pediatric formulation) Optimized multidrug background regimen (OBR) for children with MDR-TB: Non-study prescribed OBR varied according to local, national, and/or international guidelines for treatment of children with MDR-TB. Administered in addition to DLM for 24 weeks. |
| OG002 | Cohort 3 (>=3 to < 6 Years) | Participants received delamanid (DLM) twice daily for 24 weeks. Participants also received non-study prescribed OBR for MDR-TB. Delamanid: Administered orally; dosing based on participants' weight. ≥ 40 kg: 100 mg twice daily (adult formulation); 30 to < 40 kg: 50 mg twice daily (adult formulation); 15 to < 30 kg: 25 mg twice daily (pediatric formulation); < 15 kg: 15 mg twice daily (pediatric formulation) Optimized multidrug background regimen (OBR) for children with MDR-TB: Non-study prescribed OBR varied according to local, national, and/or international guidelines for treatment of children with MDR-TB. Administered in addition to DLM for 24 weeks. |
| OG003 | Cohort 4 (>=0 to < 3 Years) | Participants received delamanid (DLM) twice daily for 24 weeks. Participants also received non-study prescribed OBR for MDR-TB. Delamanid: Administered orally; dosing based on participants' weight. ≥ 40 kg: 100 mg twice daily (adult formulation); 30 to < 40 kg: 50 mg twice daily (adult formulation); 15 to < 30 kg: 25 mg twice daily (pediatric formulation); < 15 kg: 15 mg twice daily (pediatric formulation) Optimized multidrug background regimen (OBR) for children with MDR-TB: Non-study prescribed OBR varied according to local, national, and/or international guidelines for treatment of children with MDR-TB. Administered in addition to DLM for 24 weeks. |
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Participants received delamanid (DLM) twice daily for 24 weeks. Participants also received non-study prescribed OBR for MDR-TB. Delamanid: Administered orally; dosing based on participants' weight. ≥ 40 kg: 100 mg twice daily (adult formulation); 30 to < 40 kg: 50 mg twice daily (adult formulation); 15 to < 30 kg: 25 mg twice daily (pediatric formulation); < 15 kg: 15 mg twice daily (pediatric formulation) Optimized multidrug background regimen (OBR) for children with MDR-TB: Non-study prescribed OBR varied according to local, national, and/or international guidelines for treatment of children with MDR-TB. Administered in addition to DLM for 24 weeks. |
| OG002 | Cohort 3 (>=3 to < 6 Years) | Participants received delamanid (DLM) twice daily for 24 weeks. Participants also received non-study prescribed OBR for MDR-TB. Delamanid: Administered orally; dosing based on participants' weight. ≥ 40 kg: 100 mg twice daily (adult formulation); 30 to < 40 kg: 50 mg twice daily (adult formulation); 15 to < 30 kg: 25 mg twice daily (pediatric formulation); < 15 kg: 15 mg twice daily (pediatric formulation) Optimized multidrug background regimen (OBR) for children with MDR-TB: Non-study prescribed OBR varied according to local, national, and/or international guidelines for treatment of children with MDR-TB. Administered in addition to DLM for 24 weeks. |
| OG003 | Cohort 4 (>=0 to < 3 Years) | Participants received delamanid (DLM) twice daily for 24 weeks. Participants also received non-study prescribed OBR for MDR-TB. Delamanid: Administered orally; dosing based on participants' weight. ≥ 40 kg: 100 mg twice daily (adult formulation); 30 to < 40 kg: 50 mg twice daily (adult formulation); 15 to < 30 kg: 25 mg twice daily (pediatric formulation); < 15 kg: 15 mg twice daily (pediatric formulation) Optimized multidrug background regimen (OBR) for children with MDR-TB: Non-study prescribed OBR varied according to local, national, and/or international guidelines for treatment of children with MDR-TB. Administered in addition to DLM for 24 weeks. |
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| OG002 | Cohort 3 (>=3 to < 6 Years) | Participants received delamanid (DLM) twice daily for 24 weeks. Participants also received non-study prescribed OBR for MDR-TB. Delamanid: Administered orally; dosing based on participants' weight. ≥ 40 kg: 100 mg twice daily (adult formulation); 30 to < 40 kg: 50 mg twice daily (adult formulation); 15 to < 30 kg: 25 mg twice daily (pediatric formulation); < 15 kg: 15 mg twice daily (pediatric formulation) Optimized multidrug background regimen (OBR) for children with MDR-TB: Non-study prescribed OBR varied according to local, national, and/or international guidelines for treatment of children with MDR-TB. Administered in addition to DLM for 24 weeks. |
| OG003 | Cohort 4 (>=0 to < 3 Years) | Participants received delamanid (DLM) twice daily for 24 weeks. Participants also received non-study prescribed OBR for MDR-TB. Delamanid: Administered orally; dosing based on participants' weight. ≥ 40 kg: 100 mg twice daily (adult formulation); 30 to < 40 kg: 50 mg twice daily (adult formulation); 15 to < 30 kg: 25 mg twice daily (pediatric formulation); < 15 kg: 15 mg twice daily (pediatric formulation) Optimized multidrug background regimen (OBR) for children with MDR-TB: Non-study prescribed OBR varied according to local, national, and/or international guidelines for treatment of children with MDR-TB. Administered in addition to DLM for 24 weeks. |
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| OG001 | Cohort 2 (>=6 to < 12 Years) | Participants received delamanid (DLM) twice daily for 24 weeks. Participants also received non-study prescribed OBR for MDR-TB. Delamanid: Administered orally; dosing based on participants' weight. ≥ 40 kg: 100 mg twice daily (adult formulation); 30 to < 40 kg: 50 mg twice daily (adult formulation); 15 to < 30 kg: 25 mg twice daily (pediatric formulation); < 15 kg: 15 mg twice daily (pediatric formulation) Optimized multidrug background regimen (OBR) for children with MDR-TB: Non-study prescribed OBR varied according to local, national, and/or international guidelines for treatment of children with MDR-TB. Administered in addition to DLM for 24 weeks. |
| OG002 | Cohort 3 (>=3 to < 6 Years) | Participants received delamanid (DLM) twice daily for 24 weeks. Participants also received non-study prescribed OBR for MDR-TB. Delamanid: Administered orally; dosing based on participants' weight. ≥ 40 kg: 100 mg twice daily (adult formulation); 30 to < 40 kg: 50 mg twice daily (adult formulation); 15 to < 30 kg: 25 mg twice daily (pediatric formulation); < 15 kg: 15 mg twice daily (pediatric formulation) Optimized multidrug background regimen (OBR) for children with MDR-TB: Non-study prescribed OBR varied according to local, national, and/or international guidelines for treatment of children with MDR-TB. Administered in addition to DLM for 24 weeks. |
| OG003 | Cohort 4 (>=0 to < 3 Years) | Participants received delamanid (DLM) twice daily for 24 weeks. Participants also received non-study prescribed OBR for MDR-TB. Delamanid: Administered orally; dosing based on participants' weight. ≥ 40 kg: 100 mg twice daily (adult formulation); 30 to < 40 kg: 50 mg twice daily (adult formulation); 15 to < 30 kg: 25 mg twice daily (pediatric formulation); < 15 kg: 15 mg twice daily (pediatric formulation) Optimized multidrug background regimen (OBR) for children with MDR-TB: Non-study prescribed OBR varied according to local, national, and/or international guidelines for treatment of children with MDR-TB. Administered in addition to DLM for 24 weeks. |
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| OG001 | Cohort 2 (>=6 to < 12 Years) | Participants received delamanid (DLM) twice daily for 24 weeks. Participants also received non-study prescribed OBR for MDR-TB. Delamanid: Administered orally; dosing based on participants' weight. ≥ 40 kg: 100 mg twice daily (adult formulation); 30 to < 40 kg: 50 mg twice daily (adult formulation); 15 to < 30 kg: 25 mg twice daily (pediatric formulation); < 15 kg: 15 mg twice daily (pediatric formulation) Optimized multidrug background regimen (OBR) for children with MDR-TB: Non-study prescribed OBR varied according to local, national, and/or international guidelines for treatment of children with MDR-TB. Administered in addition to DLM for 24 weeks. |
| OG002 | Cohort 3 (>=3 to < 6 Years) | Participants received delamanid (DLM) twice daily for 24 weeks. Participants also received non-study prescribed OBR for MDR-TB. Delamanid: Administered orally; dosing based on participants' weight. ≥ 40 kg: 100 mg twice daily (adult formulation); 30 to < 40 kg: 50 mg twice daily (adult formulation); 15 to < 30 kg: 25 mg twice daily (pediatric formulation); < 15 kg: 15 mg twice daily (pediatric formulation) Optimized multidrug background regimen (OBR) for children with MDR-TB: Non-study prescribed OBR varied according to local, national, and/or international guidelines for treatment of children with MDR-TB. Administered in addition to DLM for 24 weeks. |
| OG003 | Cohort 4 (>=0 to < 3 Years) | Participants received delamanid (DLM) twice daily for 24 weeks. Participants also received non-study prescribed OBR for MDR-TB. Delamanid: Administered orally; dosing based on participants' weight. ≥ 40 kg: 100 mg twice daily (adult formulation); 30 to < 40 kg: 50 mg twice daily (adult formulation); 15 to < 30 kg: 25 mg twice daily (pediatric formulation); < 15 kg: 15 mg twice daily (pediatric formulation) Optimized multidrug background regimen (OBR) for children with MDR-TB: Non-study prescribed OBR varied according to local, national, and/or international guidelines for treatment of children with MDR-TB. Administered in addition to DLM for 24 weeks. |
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| OG002 | Cohort 3 (>=3 to < 6 Years) | Participants received delamanid (DLM) twice daily for 24 weeks. Participants also received non-study prescribed OBR for MDR-TB. Delamanid: Administered orally; dosing based on participants' weight. ≥ 40 kg: 100 mg twice daily (adult formulation); 30 to < 40 kg: 50 mg twice daily (adult formulation); 15 to < 30 kg: 25 mg twice daily (pediatric formulation); < 15 kg: 15 mg twice daily (pediatric formulation) Optimized multidrug background regimen (OBR) for children with MDR-TB: Non-study prescribed OBR varied according to local, national, and/or international guidelines for treatment of children with MDR-TB. Administered in addition to DLM for 24 weeks. |
| OG003 | Cohort 4 (>=0 to < 3 Years) | Participants received delamanid (DLM) twice daily for 24 weeks. Participants also received non-study prescribed OBR for MDR-TB. Delamanid: Administered orally; dosing based on participants' weight. ≥ 40 kg: 100 mg twice daily (adult formulation); 30 to < 40 kg: 50 mg twice daily (adult formulation); 15 to < 30 kg: 25 mg twice daily (pediatric formulation); < 15 kg: 15 mg twice daily (pediatric formulation) Optimized multidrug background regimen (OBR) for children with MDR-TB: Non-study prescribed OBR varied according to local, national, and/or international guidelines for treatment of children with MDR-TB. Administered in addition to DLM for 24 weeks. |
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| OG002 | Cohort 3 (>=3 to < 6 Years) | Participants received delamanid (DLM) twice daily for 24 weeks. Participants also received non-study prescribed OBR for MDR-TB. Delamanid: Administered orally; dosing based on participants' weight. ≥ 40 kg: 100 mg twice daily (adult formulation); 30 to < 40 kg: 50 mg twice daily (adult formulation); 15 to < 30 kg: 25 mg twice daily (pediatric formulation); < 15 kg: 15 mg twice daily (pediatric formulation) Optimized multidrug background regimen (OBR) for children with MDR-TB: Non-study prescribed OBR varied according to local, national, and/or international guidelines for treatment of children with MDR-TB. Administered in addition to DLM for 24 weeks. |
| OG003 | Cohort 4 (>=0 to < 3 Years) | Participants received delamanid (DLM) twice daily for 24 weeks. Participants also received non-study prescribed OBR for MDR-TB. Delamanid: Administered orally; dosing based on participants' weight. ≥ 40 kg: 100 mg twice daily (adult formulation); 30 to < 40 kg: 50 mg twice daily (adult formulation); 15 to < 30 kg: 25 mg twice daily (pediatric formulation); < 15 kg: 15 mg twice daily (pediatric formulation) Optimized multidrug background regimen (OBR) for children with MDR-TB: Non-study prescribed OBR varied according to local, national, and/or international guidelines for treatment of children with MDR-TB. Administered in addition to DLM for 24 weeks. |
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| OG002 | Cohort 3 (>=3 to < 6 Years) | Participants received delamanid (DLM) twice daily for 24 weeks. Participants also received non-study prescribed OBR for MDR-TB. Delamanid: Administered orally; dosing based on participants' weight. ≥ 40 kg: 100 mg twice daily (adult formulation); 30 to < 40 kg: 50 mg twice daily (adult formulation); 15 to < 30 kg: 25 mg twice daily (pediatric formulation); < 15 kg: 15 mg twice daily (pediatric formulation) Optimized multidrug background regimen (OBR) for children with MDR-TB: Non-study prescribed OBR varied according to local, national, and/or international guidelines for treatment of children with MDR-TB. Administered in addition to DLM for 24 weeks. |
| OG003 | Cohort 4 (>=0 to < 3 Years) | Participants received delamanid (DLM) twice daily for 24 weeks. Participants also received non-study prescribed OBR for MDR-TB. Delamanid: Administered orally; dosing based on participants' weight. ≥ 40 kg: 100 mg twice daily (adult formulation); 30 to < 40 kg: 50 mg twice daily (adult formulation); 15 to < 30 kg: 25 mg twice daily (pediatric formulation); < 15 kg: 15 mg twice daily (pediatric formulation) Optimized multidrug background regimen (OBR) for children with MDR-TB: Non-study prescribed OBR varied according to local, national, and/or international guidelines for treatment of children with MDR-TB. Administered in addition to DLM for 24 weeks. |
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| OG002 | Cohort 3 (>=3 to < 6 Years) | Participants received delamanid (DLM) twice daily for 24 weeks. Participants also received non-study prescribed OBR for MDR-TB. Delamanid: Administered orally; dosing based on participants' weight. ≥ 40 kg: 100 mg twice daily (adult formulation); 30 to < 40 kg: 50 mg twice daily (adult formulation); 15 to < 30 kg: 25 mg twice daily (pediatric formulation); < 15 kg: 15 mg twice daily (pediatric formulation) Optimized multidrug background regimen (OBR) for children with MDR-TB: Non-study prescribed OBR varied according to local, national, and/or international guidelines for treatment of children with MDR-TB. Administered in addition to DLM for 24 weeks. |
| OG003 | Cohort 4 (>=0 to < 3 Years) | Participants received delamanid (DLM) twice daily for 24 weeks. Participants also received non-study prescribed OBR for MDR-TB. Delamanid: Administered orally; dosing based on participants' weight. ≥ 40 kg: 100 mg twice daily (adult formulation); 30 to < 40 kg: 50 mg twice daily (adult formulation); 15 to < 30 kg: 25 mg twice daily (pediatric formulation); < 15 kg: 15 mg twice daily (pediatric formulation) Optimized multidrug background regimen (OBR) for children with MDR-TB: Non-study prescribed OBR varied according to local, national, and/or international guidelines for treatment of children with MDR-TB. Administered in addition to DLM for 24 weeks. |
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| OG001 | Cohort 2 (>=6 to < 12 Years) | Participants received delamanid (DLM) twice daily for 24 weeks. Participants also received non-study prescribed OBR for MDR-TB. Delamanid: Administered orally; dosing based on participants' weight. ≥ 40 kg: 100 mg twice daily (adult formulation); 30 to < 40 kg: 50 mg twice daily (adult formulation); 15 to < 30 kg: 25 mg twice daily (pediatric formulation); < 15 kg: 15 mg twice daily (pediatric formulation) Optimized multidrug background regimen (OBR) for children with MDR-TB: Non-study prescribed OBR varied according to local, national, and/or international guidelines for treatment of children with MDR-TB. Administered in addition to DLM for 24 weeks. |
| OG002 | Cohort 3 (>=3 to < 6 Years) | Participants received delamanid (DLM) twice daily for 24 weeks. Participants also received non-study prescribed OBR for MDR-TB. Delamanid: Administered orally; dosing based on participants' weight. ≥ 40 kg: 100 mg twice daily (adult formulation); 30 to < 40 kg: 50 mg twice daily (adult formulation); 15 to < 30 kg: 25 mg twice daily (pediatric formulation); < 15 kg: 15 mg twice daily (pediatric formulation) Optimized multidrug background regimen (OBR) for children with MDR-TB: Non-study prescribed OBR varied according to local, national, and/or international guidelines for treatment of children with MDR-TB. Administered in addition to DLM for 24 weeks. |
| OG003 | Cohort 4 (>=0 to < 3 Years) | Participants received delamanid (DLM) twice daily for 24 weeks. Participants also received non-study prescribed OBR for MDR-TB. Delamanid: Administered orally; dosing based on participants' weight. ≥ 40 kg: 100 mg twice daily (adult formulation); 30 to < 40 kg: 50 mg twice daily (adult formulation); 15 to < 30 kg: 25 mg twice daily (pediatric formulation); < 15 kg: 15 mg twice daily (pediatric formulation) Optimized multidrug background regimen (OBR) for children with MDR-TB: Non-study prescribed OBR varied according to local, national, and/or international guidelines for treatment of children with MDR-TB. Administered in addition to DLM for 24 weeks. |
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| OG001 | Cohort 2 (>=6 to < 12 Years) | Participants received delamanid (DLM) twice daily for 24 weeks. Participants also received non-study prescribed OBR for MDR-TB. Delamanid: Administered orally; dosing based on participants' weight. ≥ 40 kg: 100 mg twice daily (adult formulation); 30 to < 40 kg: 50 mg twice daily (adult formulation); 15 to < 30 kg: 25 mg twice daily (pediatric formulation); < 15 kg: 15 mg twice daily (pediatric formulation) Optimized multidrug background regimen (OBR) for children with MDR-TB: Non-study prescribed OBR varied according to local, national, and/or international guidelines for treatment of children with MDR-TB. Administered in addition to DLM for 24 weeks. |
| OG002 | Cohort 3 (>=3 to < 6 Years) | Participants received delamanid (DLM) twice daily for 24 weeks. Participants also received non-study prescribed OBR for MDR-TB. Delamanid: Administered orally; dosing based on participants' weight. ≥ 40 kg: 100 mg twice daily (adult formulation); 30 to < 40 kg: 50 mg twice daily (adult formulation); 15 to < 30 kg: 25 mg twice daily (pediatric formulation); < 15 kg: 15 mg twice daily (pediatric formulation) Optimized multidrug background regimen (OBR) for children with MDR-TB: Non-study prescribed OBR varied according to local, national, and/or international guidelines for treatment of children with MDR-TB. Administered in addition to DLM for 24 weeks. |
| OG003 | Cohort 4 (>=0 to < 3 Years) | Participants received delamanid (DLM) twice daily for 24 weeks. Participants also received non-study prescribed OBR for MDR-TB. Delamanid: Administered orally; dosing based on participants' weight. ≥ 40 kg: 100 mg twice daily (adult formulation); 30 to < 40 kg: 50 mg twice daily (adult formulation); 15 to < 30 kg: 25 mg twice daily (pediatric formulation); < 15 kg: 15 mg twice daily (pediatric formulation) Optimized multidrug background regimen (OBR) for children with MDR-TB: Non-study prescribed OBR varied according to local, national, and/or international guidelines for treatment of children with MDR-TB. Administered in addition to DLM for 24 weeks. |
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| OG001 | Cohort 2 (>=6 to < 12 Years) | Participants received delamanid (DLM) twice daily for 24 weeks. Participants also received non-study prescribed OBR for MDR-TB. Delamanid: Administered orally; dosing based on participants' weight. ≥ 40 kg: 100 mg twice daily (adult formulation); 30 to < 40 kg: 50 mg twice daily (adult formulation); 15 to < 30 kg: 25 mg twice daily (pediatric formulation); < 15 kg: 15 mg twice daily (pediatric formulation) Optimized multidrug background regimen (OBR) for children with MDR-TB: Non-study prescribed OBR varied according to local, national, and/or international guidelines for treatment of children with MDR-TB. Administered in addition to DLM for 24 weeks. |
| OG002 | Cohort 3 (>=3 to < 6 Years) | Participants received delamanid (DLM) twice daily for 24 weeks. Participants also received non-study prescribed OBR for MDR-TB. Delamanid: Administered orally; dosing based on participants' weight. ≥ 40 kg: 100 mg twice daily (adult formulation); 30 to < 40 kg: 50 mg twice daily (adult formulation); 15 to < 30 kg: 25 mg twice daily (pediatric formulation); < 15 kg: 15 mg twice daily (pediatric formulation) Optimized multidrug background regimen (OBR) for children with MDR-TB: Non-study prescribed OBR varied according to local, national, and/or international guidelines for treatment of children with MDR-TB. Administered in addition to DLM for 24 weeks. |
| OG003 | Cohort 4 (>=0 to < 3 Years) | Participants received delamanid (DLM) twice daily for 24 weeks. Participants also received non-study prescribed OBR for MDR-TB. Delamanid: Administered orally; dosing based on participants' weight. ≥ 40 kg: 100 mg twice daily (adult formulation); 30 to < 40 kg: 50 mg twice daily (adult formulation); 15 to < 30 kg: 25 mg twice daily (pediatric formulation); < 15 kg: 15 mg twice daily (pediatric formulation) Optimized multidrug background regimen (OBR) for children with MDR-TB: Non-study prescribed OBR varied according to local, national, and/or international guidelines for treatment of children with MDR-TB. Administered in addition to DLM for 24 weeks. |
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| OG001 | Cohort 2 (>=6 to < 12 Years) | Participants received delamanid (DLM) twice daily for 24 weeks. Participants also received non-study prescribed OBR for MDR-TB. Delamanid: Administered orally; dosing based on participants' weight. ≥ 40 kg: 100 mg twice daily (adult formulation); 30 to < 40 kg: 50 mg twice daily (adult formulation); 15 to < 30 kg: 25 mg twice daily (pediatric formulation); < 15 kg: 15 mg twice daily (pediatric formulation) Optimized multidrug background regimen (OBR) for children with MDR-TB: Non-study prescribed OBR varied according to local, national, and/or international guidelines for treatment of children with MDR-TB. Administered in addition to DLM for 24 weeks. |
| OG002 | Cohort 3 (>=3 to < 6 Years) | Participants received delamanid (DLM) twice daily for 24 weeks. Participants also received non-study prescribed OBR for MDR-TB. Delamanid: Administered orally; dosing based on participants' weight. ≥ 40 kg: 100 mg twice daily (adult formulation); 30 to < 40 kg: 50 mg twice daily (adult formulation); 15 to < 30 kg: 25 mg twice daily (pediatric formulation); < 15 kg: 15 mg twice daily (pediatric formulation) Optimized multidrug background regimen (OBR) for children with MDR-TB: Non-study prescribed OBR varied according to local, national, and/or international guidelines for treatment of children with MDR-TB. Administered in addition to DLM for 24 weeks. |
| OG003 | Cohort 4 (>=0 to < 3 Years) | Participants received delamanid (DLM) twice daily for 24 weeks. Participants also received non-study prescribed OBR for MDR-TB. Delamanid: Administered orally; dosing based on participants' weight. ≥ 40 kg: 100 mg twice daily (adult formulation); 30 to < 40 kg: 50 mg twice daily (adult formulation); 15 to < 30 kg: 25 mg twice daily (pediatric formulation); < 15 kg: 15 mg twice daily (pediatric formulation) Optimized multidrug background regimen (OBR) for children with MDR-TB: Non-study prescribed OBR varied according to local, national, and/or international guidelines for treatment of children with MDR-TB. Administered in addition to DLM for 24 weeks. |
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| OG001 | Cohort 2 (>=6 to < 12 Years) | Participants received delamanid (DLM) twice daily for 24 weeks. Participants also received non-study prescribed OBR for MDR-TB. Delamanid: Administered orally; dosing based on participants' weight. ≥ 40 kg: 100 mg twice daily (adult formulation); 30 to < 40 kg: 50 mg twice daily (adult formulation); 15 to < 30 kg: 25 mg twice daily (pediatric formulation); < 15 kg: 15 mg twice daily (pediatric formulation) Optimized multidrug background regimen (OBR) for children with MDR-TB: Non-study prescribed OBR varied according to local, national, and/or international guidelines for treatment of children with MDR-TB. Administered in addition to DLM for 24 weeks. |
| OG002 | Cohort 3 (>=3 to < 6 Years) | Participants received delamanid (DLM) twice daily for 24 weeks. Participants also received non-study prescribed OBR for MDR-TB. Delamanid: Administered orally; dosing based on participants' weight. ≥ 40 kg: 100 mg twice daily (adult formulation); 30 to < 40 kg: 50 mg twice daily (adult formulation); 15 to < 30 kg: 25 mg twice daily (pediatric formulation); < 15 kg: 15 mg twice daily (pediatric formulation) Optimized multidrug background regimen (OBR) for children with MDR-TB: Non-study prescribed OBR varied according to local, national, and/or international guidelines for treatment of children with MDR-TB. Administered in addition to DLM for 24 weeks. |
| OG003 | Cohort 4 (>=0 to < 3 Years) | Participants received delamanid (DLM) twice daily for 24 weeks. Participants also received non-study prescribed OBR for MDR-TB. Delamanid: Administered orally; dosing based on participants' weight. ≥ 40 kg: 100 mg twice daily (adult formulation); 30 to < 40 kg: 50 mg twice daily (adult formulation); 15 to < 30 kg: 25 mg twice daily (pediatric formulation); < 15 kg: 15 mg twice daily (pediatric formulation) Optimized multidrug background regimen (OBR) for children with MDR-TB: Non-study prescribed OBR varied according to local, national, and/or international guidelines for treatment of children with MDR-TB. Administered in addition to DLM for 24 weeks. |
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| OG002 | Cohort 3 (>=3 to < 6 Years) | Participants received delamanid (DLM) twice daily for 24 weeks. Participants also received non-study prescribed OBR for MDR-TB. Delamanid: Administered orally; dosing based on participants' weight. ≥ 40 kg: 100 mg twice daily (adult formulation); 30 to < 40 kg: 50 mg twice daily (adult formulation); 15 to < 30 kg: 25 mg twice daily (pediatric formulation); < 15 kg: 15 mg twice daily (pediatric formulation) Optimized multidrug background regimen (OBR) for children with MDR-TB: Non-study prescribed OBR varied according to local, national, and/or international guidelines for treatment of children with MDR-TB. Administered in addition to DLM for 24 weeks. |
| OG003 | Cohort 4 (>=0 to < 3 Years) | Participants received delamanid (DLM) twice daily for 24 weeks. Participants also received non-study prescribed OBR for MDR-TB. Delamanid: Administered orally; dosing based on participants' weight. ≥ 40 kg: 100 mg twice daily (adult formulation); 30 to < 40 kg: 50 mg twice daily (adult formulation); 15 to < 30 kg: 25 mg twice daily (pediatric formulation); < 15 kg: 15 mg twice daily (pediatric formulation) Optimized multidrug background regimen (OBR) for children with MDR-TB: Non-study prescribed OBR varied according to local, national, and/or international guidelines for treatment of children with MDR-TB. Administered in addition to DLM for 24 weeks. |
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| OG002 | Cohort 3 (>=3 to < 6 Years) | Participants received delamanid (DLM) twice daily for 24 weeks. Participants also received non-study prescribed OBR for MDR-TB. Delamanid: Administered orally; dosing based on participants' weight. ≥ 40 kg: 100 mg twice daily (adult formulation); 30 to < 40 kg: 50 mg twice daily (adult formulation); 15 to < 30 kg: 25 mg twice daily (pediatric formulation); < 15 kg: 15 mg twice daily (pediatric formulation) Optimized multidrug background regimen (OBR) for children with MDR-TB: Non-study prescribed OBR varied according to local, national, and/or international guidelines for treatment of children with MDR-TB. Administered in addition to DLM for 24 weeks. |
| OG003 | Cohort 4 (>=0 to < 3 Years) | Participants received delamanid (DLM) twice daily for 24 weeks. Participants also received non-study prescribed OBR for MDR-TB. Delamanid: Administered orally; dosing based on participants' weight. ≥ 40 kg: 100 mg twice daily (adult formulation); 30 to < 40 kg: 50 mg twice daily (adult formulation); 15 to < 30 kg: 25 mg twice daily (pediatric formulation); < 15 kg: 15 mg twice daily (pediatric formulation) Optimized multidrug background regimen (OBR) for children with MDR-TB: Non-study prescribed OBR varied according to local, national, and/or international guidelines for treatment of children with MDR-TB. Administered in addition to DLM for 24 weeks. |
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| OG002 | Cohort 3 (>=3 to < 6 Years) | Participants received delamanid (DLM) twice daily for 24 weeks. Participants also received non-study prescribed OBR for MDR-TB. Delamanid: Administered orally; dosing based on participants' weight. ≥ 40 kg: 100 mg twice daily (adult formulation); 30 to < 40 kg: 50 mg twice daily (adult formulation); 15 to < 30 kg: 25 mg twice daily (pediatric formulation); < 15 kg: 15 mg twice daily (pediatric formulation) Optimized multidrug background regimen (OBR) for children with MDR-TB: Non-study prescribed OBR varied according to local, national, and/or international guidelines for treatment of children with MDR-TB. Administered in addition to DLM for 24 weeks. |
| OG003 | Cohort 4 (>=0 to < 3 Years) | Participants received delamanid (DLM) twice daily for 24 weeks. Participants also received non-study prescribed OBR for MDR-TB. Delamanid: Administered orally; dosing based on participants' weight. ≥ 40 kg: 100 mg twice daily (adult formulation); 30 to < 40 kg: 50 mg twice daily (adult formulation); 15 to < 30 kg: 25 mg twice daily (pediatric formulation); < 15 kg: 15 mg twice daily (pediatric formulation) Optimized multidrug background regimen (OBR) for children with MDR-TB: Non-study prescribed OBR varied according to local, national, and/or international guidelines for treatment of children with MDR-TB. Administered in addition to DLM for 24 weeks. |
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