Table 4.
Summary of adverse events
| Control | RIF35HZE | RIFQHZ | RIF20QHZ | RIF20MHZ | Total | |
|---|---|---|---|---|---|---|
| Total in safety analysis | 123 | 63 | 59 | 57 | 63 | 365 |
| Patients with at least one AE | 92 (75%) | 53 (84%) | 49 (83%) | 42 (74%) | 49 (78%) | 285 (78%) |
| Patients with at least one grade 3, 4, or 5 AE | 13 (11%) | 9 (14%) | 7 (12%) | 7 (12%) | 9 (14%) | 45 (12%) |
| Patients with at least one grade 3, 4, or 5 AE considered probably related or related | 1 (1%) | 3 (5%) | 0 | 0 | 4 (6%) | 8 (2%) |
| Patients with at least one serious AE | 6 (5%) | 4 (6%) | 4 (7%) | 5 (9%) | 4 (6%) | 23 (6%) |
| Deaths | 0 | 1 | 0 | 0 | 0 | 1 |
| Total number of patients with treatment changed due to hepatic AE | 2 (2%) | 5 (8%) | 0 (0%) | 3 (5%) | 0 | 10 (3%) |
| Number of patients with treatment changed due to hepatic AE—symptomatic or meeting protocol criteria* | 2 (2%) | 3 (5%) | 0 (0%) | 3 (5%) | 0 | 8 (2%) |
| Treatment changed due to hepatic AE—not fulfilling protocol criteria and not being symptomatic* | 0 | 2 (3%) | 0 | 0 | 0 | (1%) |
AE=adverse event. AST=aspartate aminotransferase. ALT=alanine transaminase. RIF35HZE=rifampicin 35 mg/kg, isoniazid, pyrazinamide, ethambutol. RIFQHZ=rifampicin 10 mg/kg, isoniazid, pyrazinamide, SQ109 300 mg. RIF20QHZ=rifampicin 20 mg/kg, isoniazid, pyrazinamide, SQ109 300 mg. RIF20MHZ=rifampicin 20 mg/kg, isoniazid, pyrazinamide, moxifloxacin 400 mg. Doses of concomitant drugs are detailed in Procedures.
*
Protocol criteria for treatment interruption due to hepatic AE: elevation of AST or ALT more than three times, but less than five times the upper limit of normal, with associated symptoms or elevation of AST or ALT more than five times the upper limit of normal irrespective of the presence of symptoms.