| ID | Type | Description | Link |
|---|---|---|---|
| TMC207-TIDP13-C208 | Other Identifier | Janssen Infectious Diseases BVBA | |
| 2007-004462-40 | EudraCT Number |
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The objective of this study is to demonstrate that the antibacterial activity of TMC207 is better than placebo when added to a standardized Background Regimen (BR) for treatment of multi-drug resistant TB. Also safety and tolerability will be evaluated.
The trial will be conducted in 2 consecutive stages, an exploratory (investigative) stage (Stage 1) and a proof of effectiveness stage (Stage 2). During Stage 1, a panel of 50 participants will be randomized (participants are assigned different treatments based on chance) to receive either TMC207 or placebo for 8 weeks on top of a BR. In Stage 2, another panel of 150 participants will be randomized to receive either TMC207 or placebo for 24 weeks on top of a BR. TMC207 will be dosed as 400 mg every day for the first 2 weeks, and as 200 mg 3 times/week for the following 6 or 22 weeks during Stages 1 and 2, respectively. When the participants in Stage 1 have completed 8 weeks double-blind (neither theparticipant nor the physician knows whether drug or placebo is being taken, or at what dosage) treatment with TMC207 or placebo (or have discontinued earlier), the primary Stage 1 analysis will be performed on all data of the first 8 weeks of treatment. Following this Stage 1 analysis, Stage 2 will be initiated and a panel of 150 new participants will be enrolled. After the double-blind treatment phase in both Stage 1 and Stage 2, participants will continue to receive MDR-TB treatment as per national treatment guidelines. They will be followed for safety, tolerability, pharmacokinetics, and microbiological efficacy for 96 weeks after receiving their last dose of TMC207 or placebo. The Data Safety Monitoring Board Committee will review these data on a regular basis. The DSMB/DSMC is a group of experts in tuberculosis and clinical trial conduct who have no commercial interests in the development of TMC207 and the company (Tibotec, BVBA) that is developing the new TB drug.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TMC207 Stage 1 | Experimental | TMC207 400mg (4 tablets) once daily for 14 days, 200mg (2 tablets) three times a week for 6 weeks in addition to Background Regimen (BR) for multi-drug resistant tuberculosis (MDR-TB). |
|
| Placebo Stage 1 | Placebo Comparator | Placebo 4 tablets once daily for 14 days, 2 tablets three times a week for 6 weeks in addition to BR for MDR-TB. |
|
| TMC207 Stage 2 | Experimental | TMC207 400mg (4 tablets) once daily for 14 days, 200mg (2 tablets) three times a week for 22 weeks in addition to BR for MDR-TB. |
|
| Placebo Stage 2 | Placebo Comparator | Placebo 4 tablets once daily for 14 days, 2 tablets three times a week for 22 weeks in addition to BR for MDR-TB. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TMC207 | Drug | TMC207 400mg (4 tablets) once daily for 14 days, 200mg (2 tablets) three times a week for 6 or 22 weeks. |
|
| Measure | Description | Time Frame |
|---|---|---|
| The Time to Sputum Culture Conversion at Week 8 (Stage 1) | The table below shows the time to sputum culture conversion. Sputum culture conversion is defined as as having 2 consecutive negative cultures at least 25 days apart, not followed by a confirmed positive during the considered time period. Participants who discontinue or die during the considered time period are considered as non-responders and censored at their last assessment. | Week 8, Stage 1 |
| The Time to Sputum Culture Conversion at Week 24 (Stage 2) | The table below shows the time to sputum culture conversion. Sputum culture conversion is defined as as having 2 consecutive negative cultures at least 25 days apart, not followed by a confirmed positive during the considered time period. Participants who discontinue or die during the considered time period are considered as non-responders and censored at their last assessment. | Week 24, Stage 2 |
| Measure | Description | Time Frame |
|---|---|---|
| The Time to Sputum Culture Conversion at Week 24 (Stage 1) | The table below shows the time to sputum culture conversion. Sputum culture conversion is defined as as having 2 consecutive negative cultures at least 25 days apart, not followed by a confirmed positive during the considered time period. Participants who discontinue or die during the considered time period are considered as non-responders and censored at their last assessment. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Janssen Infectious Diseases BVBA Clinical Trial | Janssen Infectious Diseases BVBA | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rio de Janeiro | Brazil | |||||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19494215 | Result | Diacon AH, Pym A, Grobusch M, Patientia R, Rustomjee R, Page-Shipp L, Pistorius C, Krause R, Bogoshi M, Churchyard G, Venter A, Allen J, Palomino JC, De Marez T, van Heeswijk RP, Lounis N, Meyvisch P, Verbeeck J, Parys W, de Beule K, Andries K, Mc Neeley DF. The diarylquinoline TMC207 for multidrug-resistant tuberculosis. N Engl J Med. 2009 Jun 4;360(23):2397-405. doi: 10.1056/NEJMoa0808427. | |
| 37035978 |
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A total of 208 participants were randomized and 207 (47 participants in Stage 1 and 160 participants in Stage 2) started treatment with placebo or TMC207 (1 participant did not receive study drug). One placebo participant in Stage 2 rolled-over to treatment with TMC207 after Week 24.
This trial consisted of an exploratory stage (Stage 1) and a proof-of-efficacy stage (Stage 2). Different participants were enrolled in each stage. Participants in Stage 2 who met protocol-specified criteria were offered open-label treatment with TMC207 after Week 24 (ie, rollover arm).
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| ID | Title | Description |
|---|---|---|
| FG000 | TMC207 / BR (Stage 1) | Weeks 1 and 2: 400 mg TMC207 once daily administered as 4 tablets, and Background Regimen (BR) for Multi-drug resistant tuberculosis (MDR-TB). Week 3 to 8: 200 mg TMC207 three times per week administered as 2 tablets, and BR. Only BR after Week 8. |
| FG001 | Placebo / BR (Stage 1) |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Placebo | Drug | Placebo 4 tablets once daily for 14 days, 2 tablets three times a week for 6 or 22 weeks. |
|
| Background regimen (BR) for MDR-TB (multi-drug resistant tuberculosis) | Drug | Background Regimen (BR) of antibacterial drugs used in the treatment of TB according to national TB program and selected at the baseline visit as speciified in the protocol for up to 96 weeks. |
|
| Week 24, Stage 1 |
| The Time to Sputum Culture Conversion at Week 72 (Stage 2) | The table below shows the time to sputum culture conversion. Sputum culture conversion is defined as as having 2 consecutive negative cultures at least 25 days apart, not followed by a confirmed positive during the considered time period. Participants who discontinue or die during the considered time period are considered as non-responders and censored at their last assessment. | Week 72, Stage 2 |
| The Percentage of Participants With Sputum Culture Conversion (Stage 1) | The table below shows the percentage of participants in Stage 1 who were responders to treatment. Sputum culture conversion is defined as as having 2 consecutive negative cultures at least 25 days apart, not followed by a confirmed positive during the considered time period. Participants who discontinue or die during the considered time period are considered as non-responders. | Week 8, 24, and 104 (Stage 1) |
| The Percentage of Participants With Sputum Culture Conversion (Stage 2) | The table below shows the percentage of participants in Stage 2 who were responders to treatment. Sputum culture conversion is defined as as having 2 consecutive negative cultures at least 25 days apart, not followed by a confirmed positive during the considered time period. Participants who discontinue or die during the considered time period are considered as non-responders. | Week 24, Week 72, and Week 120 (Stage 2) |
| Chennai |
| India |
| New Delhi | India |
| Stopinu Region | Latvia |
| Lima | Peru |
| Quezon City | Philippines |
| Moscow | Russia |
| Bethelsdorp | South Africa |
| Cape Town | South Africa |
| Durban | South Africa |
| George | South Africa |
| Klerksdorp | South Africa |
| Sandringham | South Africa |
| Chiang Mai | Thailand |
| Nakhon | Thailand |
| Nonthaburi | Thailand |
| Derived |
| Bolhuis MS, Akkerman OW, Sturkenboom MGG, van Boven JFM, Alffenaar JC, Stevens J. Bedaquiline exposure in people with drug-resistant TB treated for diabetes: analysis of two phase 2 trials. Int J Tuberc Lung Dis. 2023 Apr 1;27(4):335-337. doi: 10.5588/ijtld.22.0581. No abstract available. |
| 30024924 | Derived | Meyvisch P, Kambili C, Andries K, Lounis N, Theeuwes M, Dannemann B, Vandebosch A, Van der Elst W, Molenberghs G, Alonso A. Evaluation of six months sputum culture conversion as a surrogate endpoint in a multidrug resistant-tuberculosis trial. PLoS One. 2018 Jul 19;13(7):e0200539. doi: 10.1371/journal.pone.0200539. eCollection 2018. |
| 26647431 | Derived | Pym AS, Diacon AH, Tang SJ, Conradie F, Danilovits M, Chuchottaworn C, Vasilyeva I, Andries K, Bakare N, De Marez T, Haxaire-Theeuwes M, Lounis N, Meyvisch P, Van Baelen B, van Heeswijk RP, Dannemann B; TMC207-C209 Study Group. Bedaquiline in the treatment of multidrug- and extensively drug-resistant tuberculosis. Eur Respir J. 2016 Feb;47(2):564-74. doi: 10.1183/13993003.00724-2015. Epub 2015 Dec 2. |
| 25140958 | Derived | Diacon AH, Pym A, Grobusch MP, de los Rios JM, Gotuzzo E, Vasilyeva I, Leimane V, Andries K, Bakare N, De Marez T, Haxaire-Theeuwes M, Lounis N, Meyvisch P, De Paepe E, van Heeswijk RP, Dannemann B; TMC207-C208 Study Group. Multidrug-resistant tuberculosis and culture conversion with bedaquiline. N Engl J Med. 2014 Aug 21;371(8):723-32. doi: 10.1056/NEJMoa1313865. |
Weeks 1 and 2: Placebo once daily administered as 4 tablets, and Background Regimen (BR) for Multi-drug resistant tuberculosis (MDR-TB). Week 3 to 8: Placebo three times per week administered as 2 tablets, and BR. Only BR after Week 8. |
| FG002 | TMC207 / BR (Stage 2) | Weeks 1 and 2: 400 mg TMC207 once daily administered as 4 tablets, and Background Regimen (BR) for Multi-drug resistant tuberculosis (MDR-TB). Week 3 to 24: 200 mg TMC207 three times per week administered as 2 tablets, and BR. Only BR after Week 24. |
| FG003 | Placebo / BR (Stage 2) | Weeks 1 and 2: Placebo once daily administered as 4 tablets, and Background Regimen (BR) for Multi-drug resistant tuberculosis (MDR-TB). Week 3 to 24: Placebo three times per week administered as 2 tablets, and BR. Only BR after Week 24. |
| Rollover |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | TMC207 / BR (Stage 1) | Weeks 1 and 2: 400 mg TMC207 once daily administered as 4 tablets, and Background Regimen (BR) for Multi-drug resistant tuberculosis (MDR-TB). Week 3 to 8: 200 mg TMC207 three times per week administered as 2 tablets, and BR. Only BR after Week 8. |
| BG001 | Placebo / BR (Stage 1) | Weeks 1 and 2: Placebo once daily administered as 4 tablets, and Background Regimen (BR) for Multi-drug resistant tuberculosis (MDR-TB). Week 3 to 8: Placebo three times per week administered as 2 tablets, and BR. Only BR after Week 8. |
| BG002 | TMC207 / BR (Stage 2) | Weeks 1 and 2: 400 mg TMC207 once daily administered as 4 tablets, and Background Regimen (BR) for Multi-drug resistant tuberculosis (MDR-TB). Week 3 to 24: 200 mg TMC207 three times per week administered as 2 tablets, and BR. Only BR after Week 24. |
| BG003 | Placebo / BR (Stage 2) | Weeks 1 and 2: Placebo once daily administered as 4 tablets, and Background Regimen (BR) for Multi-drug resistant tuberculosis (MDR-TB). Week 3 to 24: Placebo three times per week administered as 2 tablets, and BR. Only BR after Week 24. |
| 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 | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | 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 | The Time to Sputum Culture Conversion at Week 8 (Stage 1) | The table below shows the time to sputum culture conversion. Sputum culture conversion is defined as as having 2 consecutive negative cultures at least 25 days apart, not followed by a confirmed positive during the considered time period. Participants who discontinue or die during the considered time period are considered as non-responders and censored at their last assessment. | The modified intent-to-treat (mITT) population used for all efficacy analyses included all randomized participants who received at least 1 dose of study drug and did not have extensively drug resistant tuberculosis (XDR-TB) or non-multi-drug resistant tuberculosis (non-MDR-TB) at the start of the trial and were evaluable for efficacy. | Posted | Median | 95% Confidence Interval | Days | Week 8, Stage 1 |
|
|
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Primary | The Time to Sputum Culture Conversion at Week 24 (Stage 2) | The table below shows the time to sputum culture conversion. Sputum culture conversion is defined as as having 2 consecutive negative cultures at least 25 days apart, not followed by a confirmed positive during the considered time period. Participants who discontinue or die during the considered time period are considered as non-responders and censored at their last assessment. | The modified intent-to-treat (mITT) population used for all efficacy analyses included all randomized participants who received at least 1 dose of study drug and did not have extensively drug resistant tuberculosis (XDR-TB) or non-multi-drug resistant tuberculosis (non-MDR-TB) at the start of the trial and were evaluable for efficacy. | Posted | Median | 95% Confidence Interval | Days | Week 24, Stage 2 |
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| Secondary | The Time to Sputum Culture Conversion at Week 24 (Stage 1) | The table below shows the time to sputum culture conversion. Sputum culture conversion is defined as as having 2 consecutive negative cultures at least 25 days apart, not followed by a confirmed positive during the considered time period. Participants who discontinue or die during the considered time period are considered as non-responders and censored at their last assessment. | The modified intent-to-treat (mITT) population used for all efficacy analyses included all randomized participants who received at least 1 dose of study drug and did not have extensively drug resistant tuberculosis (XDR-TB) or non-multi-drug resistant tuberculosis (non-MDR-TB) at the start of the trial and were evaluable for efficacy. | Posted | Median | 95% Confidence Interval | Days | Week 24, Stage 1 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | The Time to Sputum Culture Conversion at Week 72 (Stage 2) | The table below shows the time to sputum culture conversion. Sputum culture conversion is defined as as having 2 consecutive negative cultures at least 25 days apart, not followed by a confirmed positive during the considered time period. Participants who discontinue or die during the considered time period are considered as non-responders and censored at their last assessment. | The modified intent-to-treat (mITT) population used for all efficacy analyses included all randomized participants who received at least 1 dose of study drug and did not have extensively drug resistant tuberculosis (XDR-TB) or non-multi-drug resistant tuberculosis (non-MDR-TB) at the start of the trial and were evaluable for efficacy. | Posted | Median | 95% Confidence Interval | Days | Week 72, Stage 2 |
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| Secondary | The Percentage of Participants With Sputum Culture Conversion (Stage 1) | The table below shows the percentage of participants in Stage 1 who were responders to treatment. Sputum culture conversion is defined as as having 2 consecutive negative cultures at least 25 days apart, not followed by a confirmed positive during the considered time period. Participants who discontinue or die during the considered time period are considered as non-responders. | The modified intent-to-treat (mITT) population used for all efficacy analyses included all randomized participants who received at least 1 dose of study drug and did not have extensively drug resistant tuberculosis (XDR-TB) or non-multi-drug resistant tuberculosis (non-MDR-TB) at the start of the trial and were evaluable for efficacy. | Posted | Number | Percentage of Participants | Week 8, 24, and 104 (Stage 1) |
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| Secondary | The Percentage of Participants With Sputum Culture Conversion (Stage 2) | The table below shows the percentage of participants in Stage 2 who were responders to treatment. Sputum culture conversion is defined as as having 2 consecutive negative cultures at least 25 days apart, not followed by a confirmed positive during the considered time period. Participants who discontinue or die during the considered time period are considered as non-responders. | The modified intent-to-treat (mITT) population used for all efficacy analyses included all randomized participants who received at least 1 dose of study drug and did not have extensively drug resistant tuberculosis (XDR-TB) or non-multi-drug resistant tuberculosis (non-MDR-TB) at the start of the trial and were evaluable for efficacy. | Posted | Number | Percentage of Participants | Week 24, Week 72, and Week 120 (Stage 2) |
|
Stage 1: Adverse Events were collected from 05-Jun-2007 to 04-Dec-2009. Stage 2: Adverse events were collected from 23-Apr-2008 to 31-Jan-2012.
Treatment-Emergent Adverse Events (TEAE) from overall treatment phase are reported. Only patients who had at least one of the TEAEs are listed in the Other (non Serious) Adverse Event table are included in the total number of patients with Non-Serious Adverse Events.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | TMC207 / BR (Stage 1) | Weeks 1 and 2: 400 mg TMC207 once daily administered as 4 tablets, and Background Regimen (BR) for Multi-drug resistant tuberculosis (MDR-TB). Week 3 to 8: 200 mg TMC207 three times per week administered as 2 tablets, and BR. Only BR after Week 8. | 1 | 23 | 21 | 23 | ||
| EG001 | Placebo / BR (Stage 1) | Weeks 1 and 2: Placebo once daily administered as 4 tablets, and Background Regimen (BR) for Multi-drug resistant tuberculosis (MDR-TB). Week 3 to 8: Placebo three times per week administered as 2 tablets, and BR. Only BR after Week 8. | 1 | 24 | 23 | 24 | ||
| EG002 | TMC207 / BR (Stage 2) | Weeks 1 and 2: 400 mg TMC207 once daily administered as 4 tablets, and Background Regimen (BR) for Multi-drug resistant tuberculosis (MDR-TB). Week 3 to 24: 200 mg TMC207 three times per week administered as 2 tablets, and BR. Only BR after Week 24. | 18 | 79 | 75 | 79 | ||
| EG003 | Placebo / BR (Stage 2) | Weeks 1 and 2: Placebo once daily administered as 4 tablets, and Background Regimen (BR) for Multi-drug resistant tuberculosis (MDR-TB). Week 3 to 24: Placebo three times per week administered as 2 tablets, and BR. Only BR after Week 24. | 15 | 81 | 75 | 81 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 10.0 | Non-systematic Assessment |
| |
| Lymphadenopathy mediastinal | Blood and lymphatic system disorders | MedDRA 10.0 | Non-systematic Assessment |
| |
| Conductive deafness | Ear and labyrinth disorders | MedDRA 10.0 | Non-systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 10.0 | Non-systematic Assessment |
| |
| Pancreatitis acute | Gastrointestinal disorders | MedDRA 10.0 | Non-systematic Assessment |
| |
| Hypersensitivity | Immune system disorders | MedDRA 10.0 | Non-systematic Assessment |
| |
| Bronchiectasis | Infections and infestations | MedDRA 10.0 | Non-systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 10.0 | Non-systematic Assessment |
| |
| Pulmonary tuberculosis | Infections and infestations | MedDRA 10.0 | Non-systematic Assessment |
| |
| Pyothorax | Infections and infestations | MedDRA 10.0 | Non-systematic Assessment |
| |
| Tuberculosis | Infections and infestations | MedDRA 10.0 | Non-systematic Assessment |
| |
| Alcohol poisoning | Injury, poisoning and procedural complications | MedDRA 10.0 | Non-systematic Assessment |
| |
| Drug toxicity | Injury, poisoning and procedural complications | MedDRA 10.0 | Non-systematic Assessment |
| |
| Humerus fracture | Injury, poisoning and procedural complications | MedDRA 10.0 | Non-systematic Assessment |
| |
| Pelvic fracture | Injury, poisoning and procedural complications | MedDRA 10.0 | Non-systematic Assessment |
| |
| Soft tissue injury | Injury, poisoning and procedural complications | MedDRA 10.0 | Non-systematic Assessment |
| |
| Diabetic ketoacidosis | Metabolism and nutrition disorders | MedDRA 10.0 | Non-systematic Assessment |
| |
| Cerebrovascular accident | Nervous system disorders | MedDRA 10.0 | Non-systematic Assessment |
| |
| Hemiparesis | Nervous system disorders | MedDRA 10.0 | Non-systematic Assessment |
| |
| Abortion spontaneous | Pregnancy, puerperium and perinatal conditions | MedDRA 10.0 | Non-systematic Assessment |
| |
| Suicidal ideation | Psychiatric disorders | MedDRA 10.0 | Non-systematic Assessment |
| |
| Haemoptysis | Respiratory, thoracic and mediastinal disorders | MedDRA 10.0 | Non-systematic Assessment |
| |
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | MedDRA 10.0 | Non-systematic Assessment |
| |
| Pulmonary cavitation | Respiratory, thoracic and mediastinal disorders | MedDRA 10.0 | Non-systematic Assessment |
| |
| Surgery | Surgical and medical procedures | MedDRA 10.0 | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 10.0 | Non-systematic Assessment |
| |
| Deafness | Ear and labyrinth disorders | MedDRA 10.0 | Non-systematic Assessment |
| |
| Deafness bilateral | Ear and labyrinth disorders | MedDRA 10.0 | Non-systematic Assessment |
| |
| Deafness unilateral | Ear and labyrinth disorders | MedDRA 10.0 | Non-systematic Assessment |
| |
| Ear pain | Ear and labyrinth disorders | MedDRA 10.0 | Non-systematic Assessment |
| |
| Tinnitus | Ear and labyrinth disorders | MedDRA 10.0 | Non-systematic Assessment |
| |
| Visual acuity reduced | Eye disorders | MedDRA 10.0 | Non-systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 10.0 | Non-systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 10.0 | Non-systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 10.0 | Non-systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 10.0 | Non-systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA 10.0 | Non-systematic Assessment |
| |
| Gastritis | Gastrointestinal disorders | MedDRA 10.0 | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 10.0 | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 10.0 | Non-systematic Assessment |
| |
| Chest pain | General disorders | MedDRA 10.0 | Non-systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 10.0 | Non-systematic Assessment |
| |
| Injection site pain | General disorders | MedDRA 10.0 | Non-systematic Assessment |
| |
| Non-cardiac chest pain | General disorders | MedDRA 10.0 | Non-systematic Assessment |
| |
| Pain | General disorders | MedDRA 10.0 | Non-systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 10.0 | Non-systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA 10.0 | Non-systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA 10.0 | Non-systematic Assessment |
| |
| Pharyngitis | Infections and infestations | MedDRA 10.0 | Non-systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 10.0 | Non-systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA 10.0 | Non-systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA 10.0 | Non-systematic Assessment |
| |
| Blood uric acid increased | Investigations | MedDRA 10.0 | Non-systematic Assessment |
| |
| Transaminases increased | Investigations | MedDRA 10.0 | Non-systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA 10.0 | Non-systematic Assessment |
| |
| Anorexia | Metabolism and nutrition disorders | MedDRA 10.0 | Non-systematic Assessment |
| |
| Hyperuricaemia | Metabolism and nutrition disorders | MedDRA 10.0 | Non-systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 10.0 | Non-systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 10.0 | Non-systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 10.0 | Non-systematic Assessment |
| |
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA 10.0 | Non-systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 10.0 | Non-systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 10.0 | Non-systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 10.0 | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 10.0 | Non-systematic Assessment |
| |
| Neuropathy peripheral | Nervous system disorders | MedDRA 10.0 | Non-systematic Assessment |
| |
| Paraesthesia | Nervous system disorders | MedDRA 10.0 | Non-systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA 10.0 | Non-systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA 10.0 | Non-systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 10.0 | Non-systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 10.0 | Non-systematic Assessment |
| |
| Dyspnoea exertional | Respiratory, thoracic and mediastinal disorders | MedDRA 10.0 | Non-systematic Assessment |
| |
| Haemoptysis | Respiratory, thoracic and mediastinal disorders | MedDRA 10.0 | Non-systematic Assessment |
| |
| Pharyngolaryngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 10.0 | Non-systematic Assessment |
| |
| Pleuritic pain | Respiratory, thoracic and mediastinal disorders | MedDRA 10.0 | Non-systematic Assessment |
| |
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA 10.0 | Non-systematic Assessment |
| |
| Acne | Skin and subcutaneous tissue disorders | MedDRA 10.0 | Non-systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 10.0 | Non-systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA 10.0 | Non-systematic Assessment |
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In Participant Flow, deaths occurring during the trial are reported. In addition, 1 TMC207 and 2 placebo subjects in stage 1 and 4 TMC207 and 1 placebo subject in stage 2 died after discontinuation during long-term survival follow-up.
It is the policy of the sponsor not to allow the investigators to publish their results or findings prior to the sponsor's publication of the overall trial results.The investigator agrees that before he/she publishes any results of this trial, he/she shall provide the sponsor with at least 45 days for full review of the prepublication manuscript prior to submission of the manuscript to the publisher.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Medical Leader | Janssen Infectious Diseases - Diagnostics BVBA | 1 609 730-7768 |
| ID | Term |
|---|---|
| D014376 | Tuberculosis |
| D018088 | Tuberculosis, Multidrug-Resistant |
| ID | Term |
|---|---|
| D009164 | Mycobacterium Infections |
| D000193 | Actinomycetales Infections |
| D016908 | Gram-Positive Bacterial Infections |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
Not provided
Not provided
| ID | Term |
|---|---|
| C493870 | bedaquiline |
Not provided
Not provided
Not provided
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