Appendix Table 2.
Estimates of Long Term Adverse Health Events Following Treatment with Continuous (C) vs. Intermittent (I) Androgen Deprivation Therapy for Patients on S9346, Excluding Intermittent Arm Patients with No Evidence of Receipt of Any Consolidation Therapy
| Logistic Regression Results | Cumulative Incidence Results | ||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall | C | I | 5-Year | 10-Year | |||||||||||
| Adverse Health Event | N | % | N | % | N | % | OR (95% CI) | p-value | Total | C | I | C | I | HR* | p-value |
| ISCHEMIC AND THROMBOTIC EVENTS |
146 | 24 | 64 | 20 | 82 | 28 | 0.67 (0.46–0.98) | .04 | 31 | 16 | 23 | 23 | 33 | 0.67 | .02 |
| Acute MI | 47 | 8 | 23 | 7 | 24 | 8 | 0.89 (0.49–1.62) | .70 | 10 | 5 | 6 | 8 | 9 | 0.86 | .60 |
| Ischemic Heart Disease | 49 | 8 | 18 | 6 | 31 | 11 | 0.5 (0.27–0.93) | .03 | 10 | 5 | 9 | 7 | 13 | 0.50 | .02 |
| Thrombosis (severe) | 82 | 14 | 37 | 12 | 45 | 15 | 0.76 (0.47–1.21) | .25 | 18 | 9 | 12 | 14 | 18 | 0.75 | .20 |
| ENDOCRINE | 259 | 43 | 138 | 44 | 121 | 41 | 1.15 (0.83–1.6) | .41 | 52 | 44 | 41 | 51 | 48 | 1.03 | .81 |
| Diabetes | 117 | 19 | 62 | 20 | 55 | 19 | 1.13 (0.75–1.72) | .55 | 24 | 18 | 18 | 23 | 22 | 1.09 | .67 |
| Diabetes with Sequelae | 52 | 9 | 26 | 8 | 26 | 9 | 0.97 (0.54–1.72) | .91 | 12 | 7 | 8 | 9 | 10 | 0.95 | .84 |
| Hypercholesterolemia | 194 | 32 | 99 | 32 | 95 | 32 | 0.97 (0.69–1.37) | .89 | 40 | 30 | 31 | 37 | 38 | .94 | .66 |
| Obesity | 42 | 7 | 25 | 8 | 17 | 6 | 1.44 (0.76–2.73) | .27 | 9 | 7 | 5 | 9 | 7 | 1.35 | .34 |
| Osteoporosis | 130 | 21 | 73 | 23 | 57 | 19 | 1.25 (0.84–1.85) | .28 | 26 | 21 | 18 | 26 | 23 | 1.13 | .49 |
| Skeletal related event and fracture |
96 | 16 | 53 | 17 | 43 | 15 | 1.18 (0.76–1.85) | .45 | 20 | 12 | 11 | 20 | 18 | 1.12 | .58 |
| All Bone | 176 | 29 | 97 | 31 | 79 | 27 | 1.22 (0.85–1.75) | .28 | 35 | 27 | 24 | 36 | 32 | 1.11 | .52 |
| SEXUAL DYSFUNCTION | |||||||||||||||
| Organic | 35 | 6 | 20 | 6 | 15 | 5 | 1.29 (0.65–2.58) | .47 | 7 | 6 | 5 | 8 | 6 | 1.25 | .52 |
| MISCELLANEOUS | |||||||||||||||
| Depression Acute Kidney Injury |
83 117 |
14 19 |
43 60 |
14 19 |
40 57 |
14 19 |
0.99 (0.62–1.58) 1.01 (0.67–1.52) |
.97 .97 |
18 31 |
11 13 |
12 14 |
15 21 |
15 21 |
0.97 0.98 |
.87 .90 |
Regression analyses were conducted separately for each adverse event type in multivariable regression models, adjusting for demographic and stratification factors as covariates as specified in the Methods. In addition to the events listed in the table, patients on the continuous ADT arm had higher observed rates of dementia (overall percent = 5%; OR = 2.65, p=.02; overall cumulative incidence = 7%, hazard ratio = 2.51, p=.03).
Represents the subdistribution hazard ratios based on competing risk regression analyses.