Table 3.
Incidence of ADRs by patient characteristics safety analysis set
| Factors | Categories | Patients, N | Patients with ADRs, n | Percentage of patients with ADRs, % | Odds ratio estimate | 95% CI for odds ratio | Chi-squared (X) or Fisher’s exact test (Y) |
|---|---|---|---|---|---|---|---|
| Total | – | 2292 | 565 | 24.65 | – | ||
| Age (1) (years)a | < 15 | 1 | 0 | 0.00 | 0.00 | 0.00 to > 999.999 | (X) p = 0.79 |
| > 15, < 65 | 2187 | 541 | 24.74 | 1 | – | ||
| ≥ 65 | 104 | 24 | 23.08 | 0.91 | 0.57 to 1.46 | ||
| Age (2) (years)b | < 50 | 1806 | 446 | 24.70 | 1 | – | (Y) p = 0.95 |
| ≥ 50 | 486 | 119 | 24.49 | 0.99 | 0.78 to 1.25 | ||
| Sex | Male | 2181 | 544 | 24.94 | 1 | – | (Y) p = 0.18 |
| Female | 111 | 21 | 18.92 | 0.70 | 0.43 to 1.14 | ||
| CDC classification at pretreatment | A | 1529 | 338 | 22.11 | 1 | – | (X) p < 0.001** |
| B | 125 | 58 | 46.40 | 3.05 | 2.10 to 4.42 | ||
| C | 538 | 151 | 28.07 | 1.37 | 1.10 to 1.72 | ||
| Unknown | 99 | 18 | 18.18 | ||||
| Comorbidities | Absent | 751 | 99 | 13.18 | 1 | – | (Y) p < 0.001** |
| Present | 1432 | 449 | 31.35 | 3.01 | 2.37 to 3.82 | ||
| Unknown | 109 | 17 | 15.60 | ||||
| Liver disorder | Absent | 1703 | 365 | 21.43 | 1 | – | (Y) p < 0.001** |
| Present | 449 | 156 | 34.74 | 1.95 | 1.56 to 2.45 | ||
| Unknown | 140 | 44 | 31.43 | ||||
| Renal disorder | Absent | 2055 | 504 | 24.53 | 1 | – | (Y) p = 0.004** |
| Present | 160 | 56 | 35.00 | 1.66 | 1.18 to 2.33 | ||
| Unknown | 77 | 5 | 6.49 | ||||
| Prescription history of ARV at baseline | ART-naïve | 1040 | 320 | 30.77 | 1 | – | (Y) p < 0.001** |
| ART-experienced | 1219 | 243 | 19.93 | 0.56 | 0.46 to 0.68 | ||
| Unknown | 33 | 2 | 6.06 |
ADR adverse drug reaction, ARV antiretroviral, CDC Centers for Disease Control and Prevention, Cl confidence interval, HIV human immunodeficiency virus
**p < 0.01
aIn age group (1), patients were classified into 3 categories: adolescent (< 15 years), adult (≥ 15, < 64), elderly (≥ 65)
bIn age group (2), patients were classified into 2 categories: non-older person (< 50 years), older person (≥ 50) in accordance with the Guidelines for the Use of Antiretroviral Agents in Adults and Adolescents Living with HIV [16]