Trial Outcomes & Findings for To Evaluate the Safety, Tolerability, and Efficacy of TMC207 as Part of an Individualized Multi-drug Resistant Tuberculosis (MDR-TB) Treatment Regimen in Participants With Sputum Smear-positive Pulmonary MDR-TB. (NCT NCT00910871)

Last Updated: 2015-04-24

Results Overview

The table below shows the median time in days to culture conversion for the modified intent-to-treat (mITT) population up to Week 24. Sputum culture conversion is defined as 2 consecutive sputum cultures negative for multi-drug resistant tuberculosis (MDR-TB) taken at least 25 days apart. Participants who discontinued during the 24-week period were considered non-responders (based on Mycobacteria Growth Indicator Tube \[MGIT\]).

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

241 participants

Primary outcome timeframe

Up to Week 24

Results posted on

2015-04-24

Participant Flow

A Phase II open label trial with TMC207 as part of multi-drug resistant mycobacterium tuberculosis (MDR-TB) treatment regimen in participants with sputum smear-positive pulmonary infection with MDR-TB.

A total of 241 participants were enrolled in the study; 8 participants were withdrawn from the study before study drug administration and 233 started treatment with study drug.

Participant milestones

Participant milestones
Measure	TMC207 Participants will receive 400 milligram (mg) TMC207 tablets orally 2 times a day along with background regimen from Day 1 to Week 2 followed by 200 mg TMC207 tablets orally 3 times a day from Week 3 to Week 24 along with background regimen, then background therapy from Week 25 to end of study (Week 120).
Overall Study STARTED	233
Overall Study COMPLETED	179
Overall Study NOT COMPLETED	54

Reasons for withdrawal

Reasons for withdrawal
Measure	TMC207 Participants will receive 400 milligram (mg) TMC207 tablets orally 2 times a day along with background regimen from Day 1 to Week 2 followed by 200 mg TMC207 tablets orally 3 times a day from Week 3 to Week 24 along with background regimen, then background therapy from Week 25 to end of study (Week 120).
Overall Study Adverse Event	5
Overall Study Death	12
Overall Study Lost to Follow-up	8
Overall Study Protocol Violation	11
Overall Study Withdrawal by Subject	12
Overall Study Subject didn't meet eligibility criteria	5
Overall Study Undefined	1

Baseline Characteristics

To Evaluate the Safety, Tolerability, and Efficacy of TMC207 as Part of an Individualized Multi-drug Resistant Tuberculosis (MDR-TB) Treatment Regimen in Participants With Sputum Smear-positive Pulmonary MDR-TB.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	TMC207 n=233 Participants Participants will receive 400 milligram (mg) TMC207 tablets orally 2 times a day along with background regimen from Day 1 to Week 2 followed by 200 mg TMC207 tablets orally 3 times a day from Week 3 to Week 24 along with background regimen, then background therapy from Week 25 to end of study (Week 120).
Age, Continuous	34.6 years STANDARD_DEVIATION 12.1 • n=5 Participants
Sex: Female, Male Female	83 Participants n=5 Participants
Sex: Female, Male Male	150 Participants n=5 Participants

PRIMARY outcome

Timeframe: Up to Week 24

Population: The modified intent-to-treat (mITT) population used for all efficacy analyses included all randomized participants who received at least 1 dose of TMC207 excluding participants with drug-susceptible tuberculosis (DS-TB) or participants that were not evaluable for efficacy.

Outcome measures

Outcome measures
Measure	TMC207 n=205 Participants Participants will receive 400 milligram (mg) TMC207 tablets orally 2 times a day along with background regimen from Day 1 to Week 2 followed by 200 mg TMC207 tablets orally 3 times a day from Week 3 to Week 24 along with background regimen, then background therapy from Week 25 to end of study (Week 120).
The Median Time to Sputum Culture Conversion	57 Days Interval 56.0 to 83.0

SECONDARY outcome

Timeframe: Week 120

The table below shows the percentage of participants who were responders to treatment. Sputum culture conversion is defined as 2 consecutive sputum cultures negative for multi-drug resistant tuberculosis (MDR-TB) taken at least 25 days apart. Participants who discontinued or died during the trial were considered non-responders.

Outcome measures

Outcome measures
Measure	TMC207 n=205 Participants Participants will receive 400 milligram (mg) TMC207 tablets orally 2 times a day along with background regimen from Day 1 to Week 2 followed by 200 mg TMC207 tablets orally 3 times a day from Week 3 to Week 24 along with background regimen, then background therapy from Week 25 to end of study (Week 120).
The Percentage of Participants With Sputum Culture Conversion	72.2 Percentage of Participants

Adverse Events

TMC207

Serious events: 47 serious events

Other events: 179 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	TMC207 n=233 participants at risk Participants will receive 400 milligram (mg) TMC207 tablets orally 2 times a day along with background regimen from Day 1 to Week 2 followed by 200 mg TMC207 tablets orally 3 times a day from Week 3 to Week 24 along with background regimen, then background therapy from Week 25 to end of study (Week 120).
Cardiac disorders Cardiac failure	0.43% 1/233 • Baseline up to Week 120 Only participants who had at least one of the treatment emergent adverse events (TEAEs) listed in the other (non-serious) adverse events table are included in the total number of participants with non-serious adverse events.
Cardiac disorders Cardiac failure congestive	0.86% 2/233 • Baseline up to Week 120 Only participants who had at least one of the treatment emergent adverse events (TEAEs) listed in the other (non-serious) adverse events table are included in the total number of participants with non-serious adverse events.
Cardiac disorders Cor pulmonale	0.43% 1/233 • Baseline up to Week 120 Only participants who had at least one of the treatment emergent adverse events (TEAEs) listed in the other (non-serious) adverse events table are included in the total number of participants with non-serious adverse events.
Gastrointestinal disorders Ileus paralytic	0.43% 1/233 • Baseline up to Week 120 Only participants who had at least one of the treatment emergent adverse events (TEAEs) listed in the other (non-serious) adverse events table are included in the total number of participants with non-serious adverse events.
Gastrointestinal disorders Vomiting	0.43% 1/233 • Baseline up to Week 120 Only participants who had at least one of the treatment emergent adverse events (TEAEs) listed in the other (non-serious) adverse events table are included in the total number of participants with non-serious adverse events.
General disorders Treatment failure	0.86% 2/233 • Baseline up to Week 120 Only participants who had at least one of the treatment emergent adverse events (TEAEs) listed in the other (non-serious) adverse events table are included in the total number of participants with non-serious adverse events.
Hepatobiliary disorders Cholelithiasis	0.43% 1/233 • Baseline up to Week 120 Only participants who had at least one of the treatment emergent adverse events (TEAEs) listed in the other (non-serious) adverse events table are included in the total number of participants with non-serious adverse events.
Hepatobiliary disorders Liver disorder	0.43% 1/233 • Baseline up to Week 120 Only participants who had at least one of the treatment emergent adverse events (TEAEs) listed in the other (non-serious) adverse events table are included in the total number of participants with non-serious adverse events.
Infections and infestations Gastroenteritis	0.43% 1/233 • Baseline up to Week 120 Only participants who had at least one of the treatment emergent adverse events (TEAEs) listed in the other (non-serious) adverse events table are included in the total number of participants with non-serious adverse events.
Infections and infestations Lung infection	0.86% 2/233 • Baseline up to Week 120 Only participants who had at least one of the treatment emergent adverse events (TEAEs) listed in the other (non-serious) adverse events table are included in the total number of participants with non-serious adverse events.
Infections and infestations Pneumonia	1.3% 3/233 • Baseline up to Week 120 Only participants who had at least one of the treatment emergent adverse events (TEAEs) listed in the other (non-serious) adverse events table are included in the total number of participants with non-serious adverse events.
Infections and infestations Tuberculosis	2.6% 6/233 • Baseline up to Week 120 Only participants who had at least one of the treatment emergent adverse events (TEAEs) listed in the other (non-serious) adverse events table are included in the total number of participants with non-serious adverse events.
Investigations Blood glucose fluctuation	0.43% 1/233 • Baseline up to Week 120 Only participants who had at least one of the treatment emergent adverse events (TEAEs) listed in the other (non-serious) adverse events table are included in the total number of participants with non-serious adverse events.
Investigations Electrocardiogram qt prolonged	0.43% 1/233 • Baseline up to Week 120 Only participants who had at least one of the treatment emergent adverse events (TEAEs) listed in the other (non-serious) adverse events table are included in the total number of participants with non-serious adverse events.
Metabolism and nutrition disorders Decreased appetite	0.43% 1/233 • Baseline up to Week 120 Only participants who had at least one of the treatment emergent adverse events (TEAEs) listed in the other (non-serious) adverse events table are included in the total number of participants with non-serious adverse events.
Metabolism and nutrition disorders Dehydration	0.43% 1/233 • Baseline up to Week 120 Only participants who had at least one of the treatment emergent adverse events (TEAEs) listed in the other (non-serious) adverse events table are included in the total number of participants with non-serious adverse events.
Metabolism and nutrition disorders Diabetes mellitus inadequate control	0.43% 1/233 • Baseline up to Week 120 Only participants who had at least one of the treatment emergent adverse events (TEAEs) listed in the other (non-serious) adverse events table are included in the total number of participants with non-serious adverse events.
Metabolism and nutrition disorders Hyponatraemia	0.43% 1/233 • Baseline up to Week 120 Only participants who had at least one of the treatment emergent adverse events (TEAEs) listed in the other (non-serious) adverse events table are included in the total number of participants with non-serious adverse events.
Musculoskeletal and connective tissue disorders Pain in extremity	0.43% 1/233 • Baseline up to Week 120 Only participants who had at least one of the treatment emergent adverse events (TEAEs) listed in the other (non-serious) adverse events table are included in the total number of participants with non-serious adverse events.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Basal cell carcinoma	0.43% 1/233 • Baseline up to Week 120 Only participants who had at least one of the treatment emergent adverse events (TEAEs) listed in the other (non-serious) adverse events table are included in the total number of participants with non-serious adverse events.
Psychiatric disorders Emotional disorder	0.43% 1/233 • Baseline up to Week 120 Only participants who had at least one of the treatment emergent adverse events (TEAEs) listed in the other (non-serious) adverse events table are included in the total number of participants with non-serious adverse events.
Psychiatric disorders Hallucination	0.43% 1/233 • Baseline up to Week 120 Only participants who had at least one of the treatment emergent adverse events (TEAEs) listed in the other (non-serious) adverse events table are included in the total number of participants with non-serious adverse events.
Renal and urinary disorders Renal impairment	0.43% 1/233 • Baseline up to Week 120 Only participants who had at least one of the treatment emergent adverse events (TEAEs) listed in the other (non-serious) adverse events table are included in the total number of participants with non-serious adverse events.
Renal and urinary disorders Ureteric stenosis	0.43% 1/233 • Baseline up to Week 120 Only participants who had at least one of the treatment emergent adverse events (TEAEs) listed in the other (non-serious) adverse events table are included in the total number of participants with non-serious adverse events.
Respiratory, thoracic and mediastinal disorders Chronic obstructive pulmonary disease	0.43% 1/233 • Baseline up to Week 120 Only participants who had at least one of the treatment emergent adverse events (TEAEs) listed in the other (non-serious) adverse events table are included in the total number of participants with non-serious adverse events.
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.86% 2/233 • Baseline up to Week 120 Only participants who had at least one of the treatment emergent adverse events (TEAEs) listed in the other (non-serious) adverse events table are included in the total number of participants with non-serious adverse events.
Respiratory, thoracic and mediastinal disorders Hydropneumothorax	0.86% 2/233 • Baseline up to Week 120 Only participants who had at least one of the treatment emergent adverse events (TEAEs) listed in the other (non-serious) adverse events table are included in the total number of participants with non-serious adverse events.
Respiratory, thoracic and mediastinal disorders Pneumothorax	2.1% 5/233 • Baseline up to Week 120 Only participants who had at least one of the treatment emergent adverse events (TEAEs) listed in the other (non-serious) adverse events table are included in the total number of participants with non-serious adverse events.
Surgical and medical procedures Surgery	0.43% 1/233 • Baseline up to Week 120 Only participants who had at least one of the treatment emergent adverse events (TEAEs) listed in the other (non-serious) adverse events table are included in the total number of participants with non-serious adverse events.
Blood and lymphatic system disorders Anaemia	0.86% 2/233 • Baseline up to Week 120 Only participants who had at least one of the treatment emergent adverse events (TEAEs) listed in the other (non-serious) adverse events table are included in the total number of participants with non-serious adverse events.
Ear and labyrinth disorders Deafness	0.43% 1/233 • Baseline up to Week 120 Only participants who had at least one of the treatment emergent adverse events (TEAEs) listed in the other (non-serious) adverse events table are included in the total number of participants with non-serious adverse events.
Gastrointestinal disorders Alcoholic pancreatitis	0.43% 1/233 • Baseline up to Week 120 Only participants who had at least one of the treatment emergent adverse events (TEAEs) listed in the other (non-serious) adverse events table are included in the total number of participants with non-serious adverse events.
Gastrointestinal disorders Gastritis	0.43% 1/233 • Baseline up to Week 120 Only participants who had at least one of the treatment emergent adverse events (TEAEs) listed in the other (non-serious) adverse events table are included in the total number of participants with non-serious adverse events.
Gastrointestinal disorders Inguinal hernia	0.43% 1/233 • Baseline up to Week 120 Only participants who had at least one of the treatment emergent adverse events (TEAEs) listed in the other (non-serious) adverse events table are included in the total number of participants with non-serious adverse events.
Hepatobiliary disorders Hepatitis	0.43% 1/233 • Baseline up to Week 120 Only participants who had at least one of the treatment emergent adverse events (TEAEs) listed in the other (non-serious) adverse events table are included in the total number of participants with non-serious adverse events.
Infections and infestations Hepatitis a	0.43% 1/233 • Baseline up to Week 120 Only participants who had at least one of the treatment emergent adverse events (TEAEs) listed in the other (non-serious) adverse events table are included in the total number of participants with non-serious adverse events.
Infections and infestations Lung abscess	0.43% 1/233 • Baseline up to Week 120 Only participants who had at least one of the treatment emergent adverse events (TEAEs) listed in the other (non-serious) adverse events table are included in the total number of participants with non-serious adverse events.
Infections and infestations Lymph node tuberculosis	0.43% 1/233 • Baseline up to Week 120 Only participants who had at least one of the treatment emergent adverse events (TEAEs) listed in the other (non-serious) adverse events table are included in the total number of participants with non-serious adverse events.
Infections and infestations Pyopneumothorax	0.43% 1/233 • Baseline up to Week 120 Only participants who had at least one of the treatment emergent adverse events (TEAEs) listed in the other (non-serious) adverse events table are included in the total number of participants with non-serious adverse events.
Injury, poisoning and procedural complications Concussion	0.43% 1/233 • Baseline up to Week 120 Only participants who had at least one of the treatment emergent adverse events (TEAEs) listed in the other (non-serious) adverse events table are included in the total number of participants with non-serious adverse events.
Injury, poisoning and procedural complications Contusion	0.43% 1/233 • Baseline up to Week 120 Only participants who had at least one of the treatment emergent adverse events (TEAEs) listed in the other (non-serious) adverse events table are included in the total number of participants with non-serious adverse events.
Musculoskeletal and connective tissue disorders Fistula	0.43% 1/233 • Baseline up to Week 120 Only participants who had at least one of the treatment emergent adverse events (TEAEs) listed in the other (non-serious) adverse events table are included in the total number of participants with non-serious adverse events.
Nervous system disorders Cerebral haemorrhage	0.43% 1/233 • Baseline up to Week 120 Only participants who had at least one of the treatment emergent adverse events (TEAEs) listed in the other (non-serious) adverse events table are included in the total number of participants with non-serious adverse events.
Nervous system disorders Ischaemic cerebral infarction	0.43% 1/233 • Baseline up to Week 120 Only participants who had at least one of the treatment emergent adverse events (TEAEs) listed in the other (non-serious) adverse events table are included in the total number of participants with non-serious adverse events.
Nervous system disorders Neurotoxicity	0.43% 1/233 • Baseline up to Week 120 Only participants who had at least one of the treatment emergent adverse events (TEAEs) listed in the other (non-serious) adverse events table are included in the total number of participants with non-serious adverse events.
Psychiatric disorders Psychiatric symptom	0.43% 1/233 • Baseline up to Week 120 Only participants who had at least one of the treatment emergent adverse events (TEAEs) listed in the other (non-serious) adverse events table are included in the total number of participants with non-serious adverse events.
Respiratory, thoracic and mediastinal disorders Cough	0.43% 1/233 • Baseline up to Week 120 Only participants who had at least one of the treatment emergent adverse events (TEAEs) listed in the other (non-serious) adverse events table are included in the total number of participants with non-serious adverse events.
Respiratory, thoracic and mediastinal disorders Haemoptysis	1.7% 4/233 • Baseline up to Week 120 Only participants who had at least one of the treatment emergent adverse events (TEAEs) listed in the other (non-serious) adverse events table are included in the total number of participants with non-serious adverse events.
Respiratory, thoracic and mediastinal disorders Pulmonary bulla	0.43% 1/233 • Baseline up to Week 120 Only participants who had at least one of the treatment emergent adverse events (TEAEs) listed in the other (non-serious) adverse events table are included in the total number of participants with non-serious adverse events.
Respiratory, thoracic and mediastinal disorders Pulmonary haemorrhage	0.43% 1/233 • Baseline up to Week 120 Only participants who had at least one of the treatment emergent adverse events (TEAEs) listed in the other (non-serious) adverse events table are included in the total number of participants with non-serious adverse events.
Respiratory, thoracic and mediastinal disorders Respiratory failure	0.43% 1/233 • Baseline up to Week 120 Only participants who had at least one of the treatment emergent adverse events (TEAEs) listed in the other (non-serious) adverse events table are included in the total number of participants with non-serious adverse events.
Surgical and medical procedures Lung operation	0.43% 1/233 • Baseline up to Week 120 Only participants who had at least one of the treatment emergent adverse events (TEAEs) listed in the other (non-serious) adverse events table are included in the total number of participants with non-serious adverse events.
Vascular disorders Hypertension	0.43% 1/233 • Baseline up to Week 120 Only participants who had at least one of the treatment emergent adverse events (TEAEs) listed in the other (non-serious) adverse events table are included in the total number of participants with non-serious adverse events.
Vascular disorders Hypovolaemic shock	0.43% 1/233 • Baseline up to Week 120 Only participants who had at least one of the treatment emergent adverse events (TEAEs) listed in the other (non-serious) adverse events table are included in the total number of participants with non-serious adverse events.

Other adverse events

Other adverse events
Measure	TMC207 n=233 participants at risk Participants will receive 400 milligram (mg) TMC207 tablets orally 2 times a day along with background regimen from Day 1 to Week 2 followed by 200 mg TMC207 tablets orally 3 times a day from Week 3 to Week 24 along with background regimen, then background therapy from Week 25 to end of study (Week 120).
Ear and labyrinth disorders Tinnitus	7.7% 18/233 • Baseline up to Week 120 Only participants who had at least one of the treatment emergent adverse events (TEAEs) listed in the other (non-serious) adverse events table are included in the total number of participants with non-serious adverse events.
Gastrointestinal disorders Diarrhoea	11.6% 27/233 • Baseline up to Week 120 Only participants who had at least one of the treatment emergent adverse events (TEAEs) listed in the other (non-serious) adverse events table are included in the total number of participants with non-serious adverse events.
Gastrointestinal disorders Nausea	15.0% 35/233 • Baseline up to Week 120 Only participants who had at least one of the treatment emergent adverse events (TEAEs) listed in the other (non-serious) adverse events table are included in the total number of participants with non-serious adverse events.
Gastrointestinal disorders Vomiting	11.2% 26/233 • Baseline up to Week 120 Only participants who had at least one of the treatment emergent adverse events (TEAEs) listed in the other (non-serious) adverse events table are included in the total number of participants with non-serious adverse events.
General disorders Injection site pain	6.4% 15/233 • Baseline up to Week 120 Only participants who had at least one of the treatment emergent adverse events (TEAEs) listed in the other (non-serious) adverse events table are included in the total number of participants with non-serious adverse events.
Infections and infestations Nasopharyngitis	7.3% 17/233 • Baseline up to Week 120 Only participants who had at least one of the treatment emergent adverse events (TEAEs) listed in the other (non-serious) adverse events table are included in the total number of participants with non-serious adverse events.
Investigations Blood uric acid increased	8.6% 20/233 • Baseline up to Week 120 Only participants who had at least one of the treatment emergent adverse events (TEAEs) listed in the other (non-serious) adverse events table are included in the total number of participants with non-serious adverse events.
Metabolism and nutrition disorders Hyperuricaemia	15.5% 36/233 • Baseline up to Week 120 Only participants who had at least one of the treatment emergent adverse events (TEAEs) listed in the other (non-serious) adverse events table are included in the total number of participants with non-serious adverse events.
Metabolism and nutrition disorders Hypokalaemia	8.2% 19/233 • Baseline up to Week 120 Only participants who had at least one of the treatment emergent adverse events (TEAEs) listed in the other (non-serious) adverse events table are included in the total number of participants with non-serious adverse events.
Musculoskeletal and connective tissue disorders Arthralgia	15.0% 35/233 • Baseline up to Week 120 Only participants who had at least one of the treatment emergent adverse events (TEAEs) listed in the other (non-serious) adverse events table are included in the total number of participants with non-serious adverse events.
Nervous system disorders Dizziness	5.6% 13/233 • Baseline up to Week 120 Only participants who had at least one of the treatment emergent adverse events (TEAEs) listed in the other (non-serious) adverse events table are included in the total number of participants with non-serious adverse events.
Nervous system disorders Headache	13.3% 31/233 • Baseline up to Week 120 Only participants who had at least one of the treatment emergent adverse events (TEAEs) listed in the other (non-serious) adverse events table are included in the total number of participants with non-serious adverse events.
Psychiatric disorders Insomnia	7.7% 18/233 • Baseline up to Week 120 Only participants who had at least one of the treatment emergent adverse events (TEAEs) listed in the other (non-serious) adverse events table are included in the total number of participants with non-serious adverse events.
Respiratory, thoracic and mediastinal disorders Haemoptysis	7.3% 17/233 • Baseline up to Week 120 Only participants who had at least one of the treatment emergent adverse events (TEAEs) listed in the other (non-serious) adverse events table are included in the total number of participants with non-serious adverse events.
Skin and subcutaneous tissue disorders Pruritus	7.7% 18/233 • Baseline up to Week 120 Only participants who had at least one of the treatment emergent adverse events (TEAEs) listed in the other (non-serious) adverse events table are included in the total number of participants with non-serious adverse events.
Blood and lymphatic system disorders Anaemia	5.6% 13/233 • Baseline up to Week 120 Only participants who had at least one of the treatment emergent adverse events (TEAEs) listed in the other (non-serious) adverse events table are included in the total number of participants with non-serious adverse events.
Gastrointestinal disorders Abdominal pain	6.0% 14/233 • Baseline up to Week 120 Only participants who had at least one of the treatment emergent adverse events (TEAEs) listed in the other (non-serious) adverse events table are included in the total number of participants with non-serious adverse events.
Gastrointestinal disorders Dyspepsia	6.0% 14/233 • Baseline up to Week 120 Only participants who had at least one of the treatment emergent adverse events (TEAEs) listed in the other (non-serious) adverse events table are included in the total number of participants with non-serious adverse events.
General disorders Chest pain	7.3% 17/233 • Baseline up to Week 120 Only participants who had at least one of the treatment emergent adverse events (TEAEs) listed in the other (non-serious) adverse events table are included in the total number of participants with non-serious adverse events.
Infections and infestations Upper respiratory tract infection	5.6% 13/233 • Baseline up to Week 120 Only participants who had at least one of the treatment emergent adverse events (TEAEs) listed in the other (non-serious) adverse events table are included in the total number of participants with non-serious adverse events.
Investigations Alanine aminotransferase increased	5.2% 12/233 • Baseline up to Week 120 Only participants who had at least one of the treatment emergent adverse events (TEAEs) listed in the other (non-serious) adverse events table are included in the total number of participants with non-serious adverse events.
Investigations Aspartate aminotransferase increased	6.0% 14/233 • Baseline up to Week 120 Only participants who had at least one of the treatment emergent adverse events (TEAEs) listed in the other (non-serious) adverse events table are included in the total number of participants with non-serious adverse events.
Investigations Hepatic enzyme increased	5.2% 12/233 • Baseline up to Week 120 Only participants who had at least one of the treatment emergent adverse events (TEAEs) listed in the other (non-serious) adverse events table are included in the total number of participants with non-serious adverse events.
Metabolism and nutrition disorders Decreased appetite	5.2% 12/233 • Baseline up to Week 120 Only participants who had at least one of the treatment emergent adverse events (TEAEs) listed in the other (non-serious) adverse events table are included in the total number of participants with non-serious adverse events.
Musculoskeletal and connective tissue disorders Pain in extremity	6.9% 16/233 • Baseline up to Week 120 Only participants who had at least one of the treatment emergent adverse events (TEAEs) listed in the other (non-serious) adverse events table are included in the total number of participants with non-serious adverse events.
Skin and subcutaneous tissue disorders Rash	5.6% 13/233 • Baseline up to Week 120 Only participants who had at least one of the treatment emergent adverse events (TEAEs) listed in the other (non-serious) adverse events table are included in the total number of participants with non-serious adverse events.

Additional Information

Medical Leader

Janssen Infectious Diseases - Diagnostics BVBA

Phone: 1 609 730-7768

Results disclosure agreements

Principal investigator is a sponsor employee 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.
Publication restrictions are in place

Restriction type: OTHER