eTable 2. Overall cancer risk and liver cancer risk from use of potentially NDMA-contaminated valsartan drug products compared with uncontaminated valsartan, different lag times.
Hazard ratio [95% CI]* | Sample size/cancer cases | |
Cancer overall: valsartan prescription | ||
Lag time 6 months | ||
No exposure | 1.00 (ref) | 386 322/19 383 |
Exposure | 1.00 [0.99; 1.02] | 443 442/26 375 |
Lag time 12 months (main analysis) | ||
No exposure | 1.00 (ref) | 371 688/17 504 |
Exposure | 1.00 [0.98; 1.02] | 409 183/24 752 |
Lag time 24 months | ||
No exposure | 1.00 (ref) | 291 955/11 252 |
Exposure | 0.99 [0.97; 1.01] | 371 555/16 966 |
Liver cancer: valsartan prescription | ||
Lag time 6 months | ||
No exposure | 1.00 (ref) | 367 705/485 |
Exposure | 1.16 [1.04; 1.31] | 418 219/774 |
Lag time 12 months (main analysis) | ||
No exposure | 1.00 (ref) | 354 628/444 |
Exposure | 1.16 [1.03; 1.31] | 385 167/736 |
Lag time 24 months | ||
No exposure | 1.00 (ref) | 280 990/287 |
Exposure | 1.22 [1.05; 1.41] | 355 115/526 |
* Lag time 1 year, fully adjusted for sex; age; polypharmacy (defined as prescription of five or more different drugs); prescription of low-dose acetylsalicylic acid (ASA), non-ASA non-steroidal anti-inflammatory drugs, 5α-reductase inhibitors, statins, spironolactone, glucocorticoids for systemic use, selective serotonin reuptake inhibitors, and hormone replacement therapy; the comorbidities diabetes, chronic obstructive pulmonary disease, congestive heart failure, and alcohol-related diseases; the Charlson comorbidity index (score); and prevalent valsartan use
95% CI, 95% confidence interval