Table 7. Risk of NPAEs associated with the use of pranlukast in the previous 7 days, stratified analysis according to age group, gender and season.
Variables | Exposed in hazard period | Exposed in control period | Crude | Adjusted | P value for interaction* | ||||
N/N | (%) | N/N | (%) | OR (95% CI)† | OR (95% CI)‡ | ||||
Total | 3 568/64 800 | (5.51) | 13 633/259 200 | (0.05) | 1.07 | (1.02 to 1.12) | 1.26 | (1.21 to 1.32) | |
Age group (years) | 0.5798 | ||||||||
0–2 | 422/3285 | (12.85) | 1655/13 140 | (12.60) | 1.03 | (0.90 to 1.17) | 1.18 | (1.03 to 1.34) | |
3–5 | 940/12 976 | (7.24) | 3644/51 904 | (7.02) | 1.05 | (0.96 to 1.14) | 1.21 | (1.11 to 1.33) | |
6–9 | 1076/22 671 | (4.75) | 4253/90 684 | (4.69) | 1.02 | (0.94 to 1.10) | 1.17 | (1.08 to 1.28) | |
10–12 | 226/5948 | (3.80) | 889/23 792 | (3.74) | 1.02 | (0.86 to 1.22) | 1.25 | (1.05 to 1.50) | |
13–19 | 904/19 920 | (4.54) | 3192/79 680 | (4.01) | 1.19 | (1.09 to 1.30) | 1.44 | (1.32 to 1.58) | |
Gender | 0.9691 | ||||||||
Male | 2294/39 257 | (5.84) | 8782/157 028 | (5.59) | 1.07 | (1.01 to 1.13) | 1.25 | (1.18 to 1.32) | |
Female | 1274/25 543 | (4.99) | 4851/102 172 | (4.75) | 1.07 | (1.00 to 1.15) | 1.28 | (1.19 to 1.38) | |
Season | <0.0001 | ||||||||
Spring | 903/14 256 | (6.33) | 3038/57 024 | (5.33) | 1.29 | (1.18 to 1.42) | 1.47 | (1.34 to 1.61) | |
Summer | 733/17 573 | (4.17) | 3233/70 292 | (4.60) | 0.87 | (0.79 to 0.96) | 1.08 | (0.98 to 1.19) | |
Autumn | 1206/19 111 | (6.31) | 3996/76 444 | (5.23) | 1.31 | (1.21 to 1.42) | 1.53 | (1.41 to 1.65) | |
Winter | 726/13 860 | (5.24) | 3366/55 440 | (6.07) | 0.81 | (0.74 to 0.89) | 0.96 | (0.88 to 1.06) |
Joint test for exposure and strata variable interaction, indicating whether montelukast affects NPAEDs differently depending on age group, gender, and season.
Calculated by conditional logistic regression.
Calculated by conditional logistic regression adjusted for concomitant medications.
NPAEsneuropsychiatric adverse events