Table 2.
Frequency and incidence of VTE during first continuous treatment episode, all follow-up time, and first continuous treatment episode censored at 90 days by age category.
| Ospemifene Cohort (N = 8977) | Comparator SERM Cohort (N = 12,621) | Untreated VVA Cohort (N = 242,488) | ||||
|---|---|---|---|---|---|---|
| Patients with outcome, N (%) | IR per 1,000 PY (95% CI) | Patients with outcome, N (%) | IR per 1000 PY (95% CI) | Patients with Outcome, N (%) | IR per 1000 PY (95% CI) | |
| Outcome | ||||||
| During First Continuous Treatment Episode | ||||||
| VTE (any type) | ||||||
| Age 54–72 | 9 (0.1) | 3.42 (1.57–6.50) |
55 (0.5) | 10.56 (7.95–13.74) |
1788 (0.8) | 9.11 (8.69–9.54) |
| Age ⩾ 73 | 0 (0.0) | 0.00 (0.00–96.88) |
15 (0.8) | 15.24 (8.53–25.14) |
625 (2.4) | 25.41 (23.45–27.48) |
| Deep vein thrombosis | ||||||
| Age 54–72 | 8 (0.09) | 3.04 (1.31–6.00) |
46 (0.4) | 8.83 (6.46–11.77) |
1464 (0.7) | 7.45 (7.07–7.84) |
| Age ⩾ 73 | 0 (0.0) | 0.00 (0.00–96.88) |
13 (0.7) | 13.21 (7.03–22.58) |
503 (2.0) | 20.38 (18.64–22.24) |
| Pulmonary embolism | ||||||
| Age 54–72 | 2 (0.02) | 0.76 (0.09–2.75) |
11 (0.1) | 2.11 (1.05–3.77) |
402 (0.2) | 2.04 (1.84–2.25) |
| Age ⩾ 73 | 0 (0.0) | 0.00 (0.00–96.88) |
5 (0.3) | 5.07 (1.65–11.83) |
140 (0.5) | 5.61 (4.72–6.62) |
| Retinal vein thrombosis | ||||||
| Age 54–72 | 0 (0.0) | 0.00 (0.00–1.14) |
2 (0.02) | 0.38 (0.05–1.38) |
49 (0.02) | 0.25 (0.18–0.33) |
| Age ⩾ 73 | 0 (0.0) | 0.00 (0.00–96.88) |
0 (0.0) | 0.00 (0.00–3.03) |
34 (0.1) | 1.36 (0.94–1.90) |
| During All Follow-up Time | ||||||
| VTE (any type) | ||||||
| Age 54–72 | 33 (0.4) | 4.54 (3.12–6.37) |
106 (1.0) | 10.50 (8.60–12.70) |
1,792 (0.8) | 9.11 (8.69–9.54) |
| Age ⩾ 73 | 1 (1.0) | 11.50 (0.29–64.08) |
34 (1.9) | 18.11 (12.54–25.31) |
627 (2.5) | 25.46 (23.51–27.53) |
| Deep vein thrombosis | ||||||
| Age 54–72 | 29 (0.3) | 3.99 (2.67–5.72) |
91 (0.8) | 9.01 (7.25–11.06) |
1,467 (0.7) | 7.45 (7.07–7.84) |
| Age ⩾ 73 | 1 (1.0) | 11.50 (0.29–64.08) |
27 (1.5) | 14.36 (9.46–20.89) |
504 (2.0) | 20.40 (18.66–22.26) |
| Pulmonary embolism | ||||||
| Age 54–72 | 9 (0.1) | 1.24 (0.56–2.35) |
26 (0.2) | 2.56 (1.67–3.76) |
403 (0.2) | 2.04 (1.84–2.25) |
| Age ⩾ 73 | 0 (0.0) | 0.00 (0.00–34.45) |
10 (0.5) | 5.28 (2.53–9.71) |
141 (0.6) | 5.65 (4.75–6.66) |
| Retinal vein thrombosis | ||||||
| Age 54–72 | 0 (0.0) | 0.00 (0.00–0.41) |
2 (0.02) | 0.20 (0.02–0.71) | 49 (0.02) | 0.25 (0.18–0.33) |
| Age ⩾ 73 | 0 (0.0) | 0.00 (0.00–34.45) |
2 (0.1) | 1.05 (0.13–3.81) | 34 (0.1) | 1.36 (0.94–1.90) |
| During First Continuous Treatment Episode Censored at 90 Days | ||||||
| VTE (any type) | ||||||
| Age 54–72 | 4 (0.05) | 2.63 (0.72–6.73) |
22 (0.2) | 10.23 (6.41–15.50) |
460 (0.2) | 8.93 (8.14–9.79) |
| Age ⩾73 | 0 (0.0) | 0.00 (0.00–169.45) |
2 (0.1) | 5.15 (0.62–18.60) |
162 (0.6) | 26.73 (22.77–31.17) |
| Deep vein thrombosis | ||||||
| Age 54–72 | 3 (0.03) | 1.97 (0.41–5.76) |
19 (0.2) | 8.84 (5.32–13.80) |
374 (0.2) | 7.26 (6.55–8.04) |
| Age ⩾73 | 0 (0.0) | 0.00 (0.00–169.45) |
2 (0.1) | 5.15 (0.62–18.60) |
131 (0.5) | 21.60 (18.06–25.63) |
| Pulmonary embolism | ||||||
| Age 54–72 | 2 (0.02) | 1.31 (0.16–4.75) |
3 (0.03) | 1.39 (0.29–4.08) |
102 (0.05) | 1.98 (1.61–2.40) |
| Age ⩾ 73 | 0 (0.0) | 0.00 (0.00–169.45) |
0 (0.0) | 0.00 (0.00–7.71) |
35 (0.1) | 5.76 (4.01–8.01) |
| Retinal vein thrombosis | ||||||
| Age 54–72 | 0 (0.0) | 0.00 (0.00–1.97) |
1 (0.009) | 0.46 (0.01–2.59) |
12 (0.006) | 0.23 (0.12–0.41) |
| Age ⩾ 73 | 0 (0.0) | 0.00 (0.00–169.45) |
0 (0.0) | 0.00 (0.00–7.71) |
6 (0.02) | 0.99 (0.36–2.15) |
Ages are in years
CIs calculated using the Poisson distribution
Patients eligible for outcome did not have outcome during baseline.
CI, confidence interval; IR, incidence rate; PY, person-years; SERM, selective estrogen receptor modulator; VTE, venous thromboembolism; VVA, vulvar and vaginal atrophy.