Table 1.
Exposure and reporting rate of deaths and SAEs by 6-month reporting period (November 2012–November 2015)
| Reporting interval | Interval 1 06 Nov 2012–05 May 2013 |
Interval 2 06 May 2013–05 Nov 2013 |
Interval 3 06 Nov 2013–05 May 2014 |
Interval 4 06 May 2014–05 Nov 2014 |
Interval 5 06 Nov 2014–05 May 2015 |
Interval 6 06 May 2015–05 Nov 2015 |
Overall |
|---|---|---|---|---|---|---|---|
| Patient-years of exposurea | 709 | 2623 | 4511 | 6719 | 8888 | 10,733 | 34,223 |
| Number of cases reported | 368 | 1000 | 1131 | 1575 | 2026 | 3196 | 9291 |
| Number of AEs (RR)b | 957 (135.0) | 2720 (103.7) | 2918 (64.7) | 4221 (62.8) | 6236 (70.2) | 8365 (77.6) | 25,417 (74.3) |
| Number of SAEs (RR)b | 176 (24.8) | 446 (17.0) | 517 (11.6) | 714 (10.6) | 1137 (12.8) | 1137 (12.8) | 4352 (12.7) |
| Number of fatal cases (RR)b | 3 (0.42) | 10 (0.38) | 12 (0.27) | 16 (0.24) | 24 (0.27) | 37 (0.34) | 102 (0.30) |
| Number of SAEs and reporting rate per 100 patient-years by SOCb | |||||||
| Infections | 38 (5.36) | 103 (3.93) | 100 (2.22) | 148 (2.20) | 217 (2.44) | 273 (2.53) | 879 (2.57) |
| GI disorders | 13 (1.83) | 34 (1.30) | 50 (1.11) | 54 (0.80) | 73 (0.82) | 87 (0.81) | 311 (0.91) |
| Cardiac disorders | 11 (1.55) | 23 (0.88) | 26 (0.58) | 24 (0.36) | 32 (0.36) | 31 (0.29) | 147 (0.43) |
| Respiratory disorders | 11 (1.55) | 31 (1.18) | 36 (0.80) | 32 (0.48) | 33 (0.37) | 64 (0.59) | 207 (0.60) |
| Neoplasms | 1 (0.14) | 18 (0.69) | 17 (0.38) | 31 (0.46) | 40 (0.45) | 47 (0.44) | 154 (0.45) |
| Hepatobiliary disorders | 1 (0.14) | 3 (0.11) | 2 (0.04) | 9 (0.13) | 13 (0.15) | 13 (0.12) | 41 (0.12) |
AE adverse event, BID twice daily, GI gastrointestinal, MedDRA Medical Dictionary for Regulatory Activities, Nov November, RR reporting rate per 100 patient-years, SAE serious adverse event, SOC system organ class
aEstimated based on marketing sales and an estimated daily regimen of tofacitinib 5 mg BID
bReporting rate (different from incidence rate) is calculated by dividing the number of SAEs per MedDRA SOC or deaths by the estimated patient-years of exposure (per 100 patient-years). Note, multiple events can be reported within the same case report