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. Author manuscript; available in PMC: 2014 May 1.
Published in final edited form as: Pharmacoepidemiol Drug Saf. 2013 Feb 12;22(5):488–495. doi: 10.1002/pds.3412

Table 2b.

Fracture sequential analysis by time of extract using maximized sequential probability ratio test (MaxSPRT)


Near Real-Time Data Extraction
1.5 Month Delay Data Extraction
Final Pull (Nov 2009)α
Observed Cumulative
Cumulative
Month Exposed Days Outcomes Expected RR LLRβ Exposed Days Outcomes Expected RR LLRβ RR (95% confidence interval) LLRβ




APR 2009 48,635 0 2.1 0 0 52,516 1 2.4 0.41 0
MAY 111,096 3 5.1 0.59 0 111,147 4 5.1 0.78 0
JUN 164,205 4 7.3 0.54 0 163,941 4 7.4 0.54 0
JUL 189,766 4 8.5 0.47 0 229,523 11 10.7 1.03 0.005
AUG 291,278 14 13.6 1.03 0.005 291,158 14 13.6 1.03 0.005
SEP 350,298 15 16.3 0.92 0 350,882 15 16.4 0.92 0
OCT 412,820 17 19.2 0.88 0 - - - - - 0.88 (0.46–1.31) 0

Note: RR - Relative Risk; LLR - Log-likelihood Ratio

α

Nonsequential analysis using final pull.

β

Signal criteria for .05 alpha level of significance is a log-likelihood ratio of 3.7.