(a) Area Under the Pain Curve (SD).

(b) Excludes 5 patients with missing baseline or extreme values; and all 40 patients who received 0.5 mCi Quadramet. Quadramet 0.5 mCi/kg can not be distinguished from placebo.

(c) Excludes 2 patients with missing baseline values.

(*) Statistically significant difference in change from baseline in comparison to placebo.

In the two clinical trials, the patient use of analgesics differed. In Study A, the patients did not receive specific instructions on analgesic reduction. In Study B, patients were encouraged to adjust their pain medication as needed. As shown in Table 4, the morphine equivalent analgesic use in study A generally increased from baseline in both the Quadramet and placebo treatment groups; however, the difference between the Quadramet and placebo group change from baseline is not statistically significant. In study B, the placebo treated patients increased their use of opioid analgesics, while the Quadramet treated patients decreased their use of opioid analgesics.

(a) Mean Analgesic Use (SD) is in morphine equivalent units; 0 = none.

(b) Excludes 5 patients with missing baseline or with extreme values; and all 40 patients who received 0.5 mCi Quadramet. Quadramet 0.5 mCi/kg can not be distinguished from placebo.

(c) Excludes 2 patients with missing baseline values.

(*) Statistically significant difference in change from baseline in comparison to placebo.

In both studies, the numbers of patients who experienced any decrease in AUPC score without any increase in analgesic use at weeks 3 and 4 were also evaluated. In study A, this occurred in 20/37 (54%) of the patients who received Quadramet 1.0 mCi/kg and 9/36 (25%) of the placebo treated patients. In study B, this occurred in 48/100 (48%) of the Quadramet treated patients and 11/51 (22%) of the placebo treated patients.

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