Table 3.
Adverse Events Among Participants Included in the Safety Population
| 4RIF | 9INH | ||||
|---|---|---|---|---|---|
| Outcome | Participants Experiencing Event | Percent (95% CI) | Participants Experiencing Event | Percent (95% CI) | Percent (95% CI) Risk Difference (4RIF-9INH) |
| Total safety population | N = 3280 | N = 3205 | |||
| Any drug-related adverse event | 68 | 2.1 (1.6 to 2.6) | 131 | 4.1 (3.4 to 4.8) | −1.9 (−2.7 to −1.1) |
| Any drug-related grade 3–5 adverse event | 31 | 0.9 (.6 to 1.3) | 75 | 2.3 (1.8 to 2.9) | −1.3 (−1.9 to −.7) |
| Drug-related grade 1–4 rash or grade 3–4 hematologic | 31 | 0.9 (.6 to 1.3) | 13 | 0.4 (.2 to .7) | 0.5 (.1 to .9) |
| Drug-related grade 3–4 hepatotoxicity | 11 | 0.3 (.2 to .6) | 65 | 2.0 (1.6 to 2.6) | −1.6 (−2.1 to −1.1) |
| People living with human immunodeficiency virus | N = 130 | N = 138 | |||
| Any drug-related adverse event | 2 | 1.5 (.2 to 5.4) | 5 | 3.6 (1.2 to 8.3) | −2.1 (−5.9 to 1.6) |
| Any drug-related grade 3–5 adverse event | 1 | 0.8 (.0 to 4.2) | 5 | 3.6 (1.2 to 8.3) | −2.9 (−6.3 to .6) |
| Drug-related grade 1–4 rash or grade 3–4 hematologic | 0 | 0.0 (.0 to 2.8) | 0 | 0.0 (.0 to 2.6) | 0.0 (–) |
| Drug-related grade 3–4 hepatotoxicity | 0 | 0.0 (.0 to 2.8) | 5 | 3.6 (1.2 to 8.3) | −3.6 (−6.7 to −.5) |
| Renal failure or use of tumor necrosis factor-alpha inhibitors | N = 74 | N = 58 | |||
| Any drug-related adverse event | 8 | 10.8 (4.8 to 20.2) | 5 | 8.6 (2.9 to 19.0) | 2.1 (−7.2 to 11.3) |
| Any drug-related grade 3–5 adverse event | 2 | 2.7 (.3 to 9.4) | 3 | 5.2 (1.1 to 14.4) | −2.2 (−8.4 to 4.0) |
| Drug-related grade 1–4 rash or grade 3–4 hematologic | 3 | 4.1 (.8 to 11.4) | 0 | 0.0 (.0 to 6.2) | 4.0 (−.4 to 8.6) |
| Drug-related grade 3–4 hepatotoxicity | 1 | 1.4 (.0 to 7.3) | 3 | 5.2 (1.1 to 14.4) | −3.5 (−9.2 to 2.3) |
| Injection or nonprescription drug use or hepatitis | N = 54 | N = 51 | |||
| Any drug-related adverse event– | 1 | 1.9 (.0 to 9.9) | 2 | 3.9 (.5 to 13.5) | −1.9 (−8.1 to 4.2) |
| Any drug-related grade 3–5 adverse event | 1 | 1.9 (.0 to 9.9) | 1 | 2.0 (.0 to 10.4) | −0.1 (−5.1 to 4.9) |
| Drug-related grade 1–4 rash or grade 3–4 hematologic | 0 | 0.0 (.0 to 6.6) | 0 | 0.0 (.0 to 7.0) | 0.0 (–) |
| Drug-related grade 3–4 hepatotoxicity | 0 | 0.0 (.0 to 6.6) | 1 | 2.0 (.0 to 10.4) | −2.0 (−5.8 to 1.8) |
| Diabetes mellitus | N = 91 | N = 82 | |||
| Any drug-related adverse event | 3 | 3.3 (.7 to 9.3) | 6 | 7.3 (2.7 to 15.2) | −3.2 (−9.2 to 2.8) |
| Any drug-related grade 3–5 adverse event | 1 | 1.1 (.0 to 6.0) | 4 | 4.9 (1.3 to 12.0) | −3.2 (−7.8 to 1.3) |
| Drug-related grade 1–4 rash or grade 3–4 hematologic | 1 | 1.1 (.0 to 6.0) | 0 | 0.0 (.0 to 4.4) | 1.1 (−1 to 3.2) |
| Drug-related grade 3–4 hepatotoxicity | 0 | 0.0 (.0 to 4.0) | 4 | 4.9 (1.3 to 12.0) | −4.9 (−9.5 to −.2) |
| Alcohol use or smoking history | N = 747 | N = 740 | |||
| Any drug-related adverse event | 9 | 1.2 (.6 to 2.3) | 34 | 4.6 (3.2 to 6.4) | −3.1 (−4.7 to −1.5) |
| Any drug-related grade 3–5 adverse event | 4 | 0.5 (.1 to 1.4) | 22 | 3.0 (1.9 to 4.5) | −2.2 (−3.5 to −1.0) |
| Drug-related grade 1–4 rash or grade 3–4 hematologic | 5 | 0.7 (.2 to 1.6) | 2 | 0.3 (.0 to 1.0) | 0.4 (−.3 to 1.0) |
| Drug-related grade 3–4 hepatotoxicity | 2 | 0.3 (.0 to 1.0) | 21 | 2.8 (1.8 to 4.3) | −2.4 (−3.6 to −1.2) |
| No concomitant health condition of interest | N = 2184 | N = 2136 | |||
| Any drug-related adverse event | 45 | 2.1 (1.5 to 2.7) | 79 | 3.7 (2.9 to 4.6) | −1.5 (−2.5 to −.6) |
| Any drug-related grade 3–5 adverse event | 22 | 1.0 (.6 to 1.5) | 40 | 1.9 (1.3 to 2.5) | −0.8 (−1.5 to −.1) |
| Drug-related grade 1–4 rash or grade 3–4 hematologic | 22 | 1.0 (.6 to 1.5) | 11 | 0.5 (.3 to .9) | 0.5 (.0 to 1.0) |
| Drug-related grade 3–4 hepatotoxicity | 8 | 0.4 (.2 to .7) | 31 | 1.5 (1.0 to 2.1) | −1.0 (−1.6 to −.5) |
Drug-related events are those resulting in permanent discontinuation of treatment that were judged possibly or probably related to the study drug. Exact binomial CIs for proportions calculated using the Clopper-Pearson method. Risk differences and CIs calculated using generalized estimating equations with a binomial distribution and identity link, accounting for clustering at the household level. If no events occurred in 1 subgroup, CIs were estimated using exact binomial CIs.
Abbreviations: 4RIF, 4 months daily rifampin; 9INH, 9 months daily isoniazid; CI, confidence interval.