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. 2021 Jul 18;38(8):4480–4504. doi: 10.1007/s12325-021-01842-3

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]