TABLE 1

Baseline patient demographic and clinical characteristics

Safety (ITT) population
N=233
Efficacy (mITT) population
N=205
Male150 (64.4)132 (64.4)
Age years32 (18–68)32 (18–68)
Race
 American Indian#8 (3.4)6 (2.9)
 Asian89 (38.2)84 (41.0)
 Black or African American75 (32.2)67 (32.7)
 White61 (26.2)48 (23.4)
Bodyweight kg57 (30–113)57 (30–113)
Body mass index kg·m−219.9 (13–37)19.8 (13–37)
Lung cavitations
 None or <2 cm85 (36.5)70 (34.1)
 Cavitations ≥2 cm in one lung only120 (51.5)108 (52.7)
 Cavitations ≥2 cm in both lungs28 (12.0)27 (13.2)
Extent of resistance of M. tuberculosis strain
 Drug-susceptible TB3 (1.3)0
 MDR-TB148 (63.5)124 (60.5)
 Pre-XDR-TB44 (18.9)44 (21.5)
  Pre-XDR-TB fluoroquinolone resistant31 (13.3)31 (15.1)
  Pre-XDR-TB injectable resistant13 (5.6)13 (6.3)
 XDR-TB38 (16.3)37 (18.0)
Previous TB medications
 No previous anti-TB treatment12 (5.2)12 (5.9)
 Previous use of second-line TB drugs203 (87.1)177 (86.3)
 Previous treatment with
  Aminoglycosides156 (67.0)139 (67.8)
  Fluoroquinolones193 (82.8)167 (81.5)
  Macrolides33 (14.2)33 (16.1)
Pooled centres
 Asia (other)33 (14.2)31 (15.1)
 China51 (21.9)50 (24.4)
 Eastern Europe52 (22.3)41 (20.0)
 South Africa79 (33.9)70 (34.1)
 South America18 (7.7)13 (6.3)
HIV statusN=225N=198
 Positive9 (4.0)8 (4.0)
  • Data are presented as n (%) or median (range). n: number of patients with result; N: number of patients with data; ITT: intent-to-treat; mITT: modified intent-to-treat; TB: tuberculosis; M. tuberculosis: Mycobacterium tuberculosis; MDR-TB: multidrug-resistant TB; pre-XDR-TB: pre-extensively drug-resistant TB (MDR-TB and resistant to either any second-line injectable drug (amikacin, kanamycin and capreomycin) or any fluoroquinolone); XDR-TB: extensively drug-resistant TB (MDR-TB and resistant to any second-line injectable drug (amikacin, kanamycin and capreomycin) and any fluoroquinolone). #: race based on US Food and Drug Administration template (no patients from North America were randomised); : for 55 patients in the safety population (31 patients in the efficacy population), the extent of resistance of the M. tuberculosis strain could not be determined due to missing baseline central drug susceptibility test results (these patients were considered to have MDR-TB based on previous drug-susceptibility testing).