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. 2015 Dec 7;10(12):e0144263. doi: 10.1371/journal.pone.0144263

Table 2. Comparison of the time periods from initial drug release of the original signal onset time with the time period of signal detection from initial drug release when the FDA report is assumed to occur 15 days after the onset of ADRs.

Signal index Original signal onset time (time period from release in USA) (months) Estimated signal onset time when the FDA report is assumed to occur within 15 days (time period from release in USA) (months) Decrease in time period of signal detection (months)
Known ADRs
Rhabdomyolysis with rosuvastatin PRR signal 2004 Q1 (5–7) 2003 Q3 (–1) 4–7
ROR signal 2004 Q1 (5–7) 2003 Q3 (–1) 4–7
IC signal 2004 Q2 (8–10) 2003 Q3 (–1) 7–10
Malignant syndrome with aripiprazole PRR signal 2003 Q2 (5–7) 2003 Q1 (2–4) 1–5
ROR signal 2003 Q1 (2–4) 2003 Q1 (2–4)
IC signal 2003 Q2 (5–7) 2003 Q1 (2–4) 1–5
Hypercalcemia with teriparatide PRR signal 2003 Q3 (7–9) 2003 Q2 (5–7) 0–4
ROR signal 2003 Q2 (5–7) 2003 Q1 (2–4) 1–5
IC signal 2003 Q2 (5–7) 2003 Q1 (2–4) 1–5
Unknown ADRs
Severe liver injury with telithromycin PRR signal 2006 Q1 (21–23) 2005 Q2 (9–11) 10–14
ROR signal 2005 Q4 (18–20) 2005 Q2 (9–11) 7–11
IC signal 2006 Q1 (21–23) 2005 Q2 (9–11) 10–14
Suicidal behavior with varenicline PRR signal 2007 Q4 (19–21) 2006 Q4 (7–9) 10–14
ROR signal 2007 Q4 (19–21) 2007 Q1 (10–12) 7–11
IC signal 2008 Q1 (22–24) 2007 Q1 (10–12) 10–14
Pancreatitis with excenatide PRR signal 2008 Q4 (42–44) 2005 Q3 (3–5) 37–41
ROR signal 2008 Q1 (33–35) 2005 Q2 (0–2) 31–35
IC signal 2008 Q2 (36–38) 2005 Q2 (0–2) 34–38