Table 3.
Associations With Failure in Week 48 Primary Endpoint
| Variable | Covariated | Simple Modela | Full Modelb | Final Modelc | |
|---|---|---|---|---|---|
| OR (95% CI) | OR (95% CI) | OR (95% CI) | P Value | ||
| Study arm | As-needed vs immediate | NA | 0.91 (0.45, 1.87) | 0.95 (0.47, 1.90) | .879 |
| Age (years) | ≥35 vs <35 | 0.92 (0.50, 1.71) | … | … | … |
| Sex | Female vs male | 0.49 (0.25, 0.97)* | 0.48 (0.21, 1.09) | 0.45 (0.21, 0.96) | .039 |
| Scr: CD4 cell count, stratification factor | <200 vs ≥200 (cells/mm3) | 0.75 (0.40, 1.39) | … | … | … |
| Scr: CD4 cell count | <50 vs ≥50 (cells/mm3) | 0.89 (0.41, 1.94) | … | … | … |
| W0: Human immunodeficiency virus RNA | ≥5.0 vs <5.0 (log10 copies/mL) | 0.87 (0.47, 1.63) | … | … | … |
| W0: Albumin grade | Grade ≥1 vs normal | 4.40 (2.16, 9.00)* | 3.98 (1.47, 10.81) | 4.48 (2.09, 9.58) | <.001 |
| W0: Absolute neutrophil count grade | Grade ≥1 vs normal | 0.37 (0.18, 0.76)* | 0.39 (0.17, 0.89) | 0.36 (0.16, 0.79) | .011 |
| W0: Hemoglobin grade | Grade ≥1 vs normal | 2.16 (0.89, 5.28) | 1.23 (0.34, 4.46) | … | … |
| Scr: Karnofsky score | <90 vs ≥90 | 2.24 (1.15, 4.34)* | 1.92 (0.88, 4.18) | 2.34 (1.12, 4.88) | .024 |
| Scr: X-ray result | Abnormal vs normal | 1.23 (0.61, 2.49) | … | … | … |
| W0: KS stage | T1 vs T0 | 2.18 (1.14, 4.15)* | 0.63 (0.06, 7.06) | … | … |
| W0: Total cutaneous lesion count | >50 vs ≤50 | 2.00 (1.07, 3.76)* | 1.03 (0.45, 2.35) | … | … |
| W0: Raised cutaneous lesions present | Yes vs no | 1.53 (0.78, 3.03) | … | … | … |
| W0: Oral KS present | Yes vs no | 1.67 (0.89, 3.14) | 1.03 (0.38, 2.81) | … | … |
| W0: Oral KS minimal | Beyond minimal vs minimal or no oral KS | 2.56 (0.66, 9.86) | 2.63 (0.27, 25.50) | … | … |
| W0: Edema present | Yes vs no | 2.34 (1.23, 4.44)* | 2.68 (0.25, 28.19) | … | … |
| W0: Edema interferes with function | Yes vs does not interfere or no edema | 4.06 (0.84, 19.48) | 1.97 (0.32, 12.24) | … | … |
| W0: Cutaneous KS only | Yes vs no | 0.38 (0.15, 0.93)* | 1.31 (0.29, 5.94) | … | … |
Abbreviations: CI, confidence interval; KS, Kaposi sarcoma; NA, not applicable; OR, odds ratio; Scr, screening; W0, baseline (study entry).
aEstimates are from simple logistic regression models, conducted separately for each covariate and including study arm only.
bEstimates are from a full model that included the study arm and all covariates that had P values < .20 in the simple models.
cEstimates are from a final, reduced model that included the study arm and all covariates that remained statistically significant (P < .05).
dThe latter group is the reference group.
* P < .05.