Table 3.
Associations of participant characteristics with serious adverse drug reactions
Characteristics | N (%) with Adverse Drug Reactions, n=125 | Incidence Ratea | Unadjusted Model | Adjusted Model | |||||
---|---|---|---|---|---|---|---|---|---|
Incidence Rate | [95% Confidence Interval] | Hazard Ratio | [95% Confidence Interval] | P Value | Hazard Ratio | [95% Confidence Interval] | P Value | ||
Age, yr | 0.15 | 0.32 | |||||||
<60 | 26 (4) | 2.4 | [0.9 to 6.9] | Reference | Reference | ||||
60–75 | 52 (4) | 2.4 | [1.1 to 5.1] | 1.02 | [0.64 to 1.63] | 0.71 | [0.44 to 1.17] | ||
≥75 | 47 (5) | 3.4 | [1.6 to 7.5] | 1.45 | [0.90 to 2.34] | 0.91 | [0.54 to 1.51] | ||
Sex | 0.91 | 0.74 | |||||||
Men | 82 (4) | 2.7 | [1.5 to 4.8] | Reference | Reference | ||||
Women | 43 (4) | 2.8 | [1.3 to 6.0] | 0.98 | [0.68 to 1.42] | 1.06 | [0.73 to 1.55] | ||
eGFR, ml/min per 1.73 m2 | <0.001 | 0.01 | |||||||
≥30 | 49 (3) | 1.8 | [0.9 to 3.4] | Reference | Reference | ||||
<30 | 76 (6) | 4.0 | [2.4 to 6.8] | 2.17 | [1.51 to 3.11] | 1.82 | [1.25 to 2.63] | ||
BMI, kg/m2 | 0.05 | 0.46 | |||||||
<30 | 70 (4) | 2.4 | [1.3 to 4.5] | Reference | Reference | ||||
≥30 | 55 (5) | 3.3 | [1.6 to 6.8] | 1.42 | [0.99 to 2.04] | 1.16 | [0.79 to 1.70] | ||
Anemiab | 0.001 | 0.15 | |||||||
Without anemia | 60 (3) | 2.0 | [1.0 to 4.1] | Reference | Reference | ||||
With anemia | 65 (5) | 3.9 | [2.0 to 7.5] | 1.77 | [1.25 to 2.52] | 1.31 | [0.91 to 1.89] | ||
Diabetes | 0.03 | 0.89 | |||||||
Without diabetes | 60 (3) | 2.3 | [1.2 to 4.3] | Reference | Reference | ||||
With diabetes | 65 (5) | 3.3 | [1.8 to 6.1] | 1.47 | [1.03 to 2.09] | 0.97 | [0.65 to 1.44] | ||
AKI history | 0.01 | 0.12 | |||||||
Without AKI history | 84 (4) | 2.3 | [1.3 to 4.2] | Reference | Reference | ||||
With AKI history | 41 (6) | 4.0 | [1.8 to 9.3] | 1.67 | [1.12 to 2.49] | 1.37 | [0.92 to 2.05] | ||
Cardiovascular history | <0.001 | 0.01 | |||||||
Without cardiovascular history | 35 (2) | 1.5 | [0.7 to 3.4] | Reference | Reference | ||||
With cardiovascular history | 90 (6) | 3.9 | [2.4 to 6.3] | 2.45 | [1.65 to 3.63] | 1.93 | [1.25 to 2.98] | ||
Baseline no. of drugs per patients | <0.001 | 0.05 | |||||||
<5 | 10 (2) | 1.1 | [0.2 to 4.6] | Reference | Reference | ||||
5–10 | 62 (4) | 2.4 | [1.3 to 4.3] | 2.29 | [1.17 to 4.46] | 1.53 | [0.76 to 3.10] | ||
>10 | 53 (3) | 5.0 | [2.7 to 9.4] | 4.70 | [2.39 to 9.23] | 2.31 | [1.07 to 5.01] | ||
Adherence to medication | 0.01 | 0.03 | |||||||
Good | 30 (3) | 1.8 | [0.8 to 4.3] | Reference | Reference | ||||
Poor | 95 (5) | 3.3 | [2.0 to 5.4] | 1.95 | [1.29 to 2.94] | 1.59 | [1.05 to 2.42] |
P values used the Wald chi-squared test for global variable effect. BMI, body mass index.
Incidence rates are expressed per 100 person-years.
Anemia is defined by the 1968 World Health Organization (51) definition: <12 g/dl for women and <13 g/dl for men.