Table 2.
Univariate Analysis of Risk Factors for the Primary End Point.*
| Variable | 1-Month Group | 9-Month Group | Difference in Incidence Rate (95% CI)† | ||
|---|---|---|---|---|---|
| no. of events/person-yr | incidence rate/100 person-yr | no. of events/person-yr | incidence rate/100 person-yr | ||
| All patients | 32/4926 | 0.65 | 33/896 | 0.67 | −0.02 (−0.35 to 0.30) |
| Per-protocol analysis | 31/876 | 0.64 | 29/4718 | 0.61 | 0.02 (−0.30 to 0.34) |
| Status on tuberculin skin test or IGRA | |||||
| Positive | 10/1110 | 0.90 | 11/1137 | 0.97 | −0.07 (−0.87 to 0.73) |
| Negative or unknown | 22/3815 | 0.58 | 22/3759 | 0.59 | −0.01 (−0.35 to 0.34) |
| Receipt of antiretroviral therapy at entry | |||||
| Yes | 13/2381 | 0.55 | 15/2387 | 0.63 | −0.08 (−0.52 to 0.35) |
| No | 19/2545 | 0.75 | 18/2508 | 0.72 | 0.03 (−0.44 to 0.50) |
| Screening CD4+ count | |||||
| ≤250 cells/mm3 | 12/621 | 1.93 | 8/628 | 1.28 | 0.66 (−0.75 to 2.06) |
| >250 cells/mm3 | 20/4304 | 0.47 | 25/4268 | 0.59 | −0.12 (−0.43 to 0.19) |
| Sex | |||||
| Male | 11/2303 | 0.48 | 15/2293 | 0.65 | −0.18 (−0.61 to 0.26) |
| Female | 21/623 | 0.80 | 18/2603 | 0.69 | 0.11 (−0.36 to 0.58) |
*
The primary end point was a diagnosis of tuberculosis or death from tuberculosis or an unknown cause.
†
This difference is the incidence rate in the 1-month group minus the rate in the 9-month group, so negative values indicate a lower risk in the 1-month group.