TABLE 4.

Clinical PD observations from trials NC-002, NC-005, NC-006, and NC-008 used to validate the model^a

Trial	Arm	Dosing	Time	Participants	Primary outcome	Ref.
NC-002	Arm 1: PaMZ in DS-TB	Arm 1: Pa 100 mg, M 400 mg, Z 1,500 mg daily	8 weeks	14	Sputum count CFU/mL from days 0 to 56	NCT01691534
	Arm 2: PaMZ in DS-TB	Arm 2: Pa 100 mg, M 400 mg, Z 1,500 mg daily
NC-005	Arm 1: BPaZ in DS-TB	Arm 1: B 400 mg daily for 14 days followed by 200 mg three times a week. Pa 200 mg and Z 1,500 mg daily	8 weeks	148	Sputum count CFU/mL from days 0 to 56	NCT01498419
	Arm 2: BPaZ in DS-TB	Arm 2: B 200 mg daily. Pa 200 mg and Z 1,500 mg are dosed daily
	Arm 3: BPaMZ in MDR-TB	Arm 3: B 200 mg, Pa 200 mg, M 400 mg, and Z 1,500 mg daily
NC-006 (STAND-TB)	Arm 1: PaMZ in DS-TB	Arm 1: Pa 100 mg, M 400 mg, Z 1,500 mg daily	17 weeks	179	Culture negative status at 4 months and relapse at month 12	NCT02193776
	Arm 2: PaMZ in DS-TB	Arm 2: Pa 200 mg, M 400 mg, Z 1,500 mg daily
NC-008 (SimpliciTB)	Arm 1: BPaMZ in DS-TB	B 200 mg (first 8 weeks) followed by 100 mg (9–17 weeks). Pa 200mg, M 400 mg, Z 1,500 mg daily	Arm 1: 17 weeks; Arm 3: 26 weeks	203	Relapse at month 12	NCT02342886

^a DS-TB, drug sensitive TB; MDR-TB, multidrug-resistant TB.