Table 2.

Actual number of malignancy and lymphoma (Hodgkin’s and Non-Hodgkin’s) reports in clinical databases compared with the expected number of reports in the general population (based on SEER [57])

APPLES and PEER are the ongoing 10-year prospective registries (planned N = 8,000 for each) designed to assess the risk of malignancies in children

AD atopic dermatitis, AERS FDA’s adverse event reporting system, CI confidence interval, CTCL cutaneous T cell lymphoma, CT/BCL cutaneous T cell and B cell lymphoma, HL Hodgkin lymphoma, incl. includes, NA not available, NHL non-Hodgkin lymphoma, pts patients, PY patient-years, TCI topical calcineurin inhibitor, YO year olds, – not calculable

^aCalculated by dividing the total amount (g) of cream or ointment sold worldwide since launch by the average amount of drug dispensed per year per patient (g/year/patient)

^bEstimated based on age-adjusted incidences (per 100,000 PY) for 2009 (the most recent estimate available) in the SEER database [57]; estimates were rounded to the nearest whole number unless estimate was <10, then estimate was rounded to the nearest tenth; Lower limits of 95 % confidence intervals were rounded to the next lower whole number, upper limits were rounded to the next higher whole number)

^cEstimated by multiplying the approximate number of patients exposed by the factor (3,000,000 PY/1,700,000 patients) given in the Tacrolimus Ointment February 2005 PAC Briefing Book [64]

^dAge range not further specified

^eOnly incidence of overall lymphoma available

^fCalculated by adding the expected (95 % CI) number of reports for HL and NHL to obtain expected (95 % CI) number of reports for all lymphomas

^gBased on exposure data as of December 2009, the most recent estimate available

^hIncludes clinical trial (solicited), spontaneous, and literature reports

ⁱActual reports were in patients ranging in age from 11 months to 70 years

^jIncludes 13 unspecified lymphomas

^kIncludes 4 unspecified lymphomas in patients <20 YO

^lCalculated by multiplying the cumulative exposure (PY) by the proportion of prescriptions dispensed to <17 YO estimated using SDI Vector One^® data from 2004 to 2008 [65] (assuming that number and distribution of prescriptions were similar between 2002–2003 and 2004 and between 2009–2011 and 2008)