Table 3.

Summary of sensitivity (PPA) and specificity (NPA) by expert clinical diagnosis—on-site institutional reads—ITD population (N=726)

Response	Expert clinical diagnosis
	PS; SDDD		DLB; SDDD		Total
	Sensitivity	Specificity	Sensitivity	Specificity	Sensitivity	Specificity
	(%, 95% CI)	(%, 95% CI)	(%, 95% CI)	(%, 95% CI)	(%, 95% CI)	(%, 95% CI)
Pooled studies*	93.1 (89.5 to 95.8)	91.1 (84.6 to 95.5)	88.3 (80.0 to 94.0)	77.4 (69.7 to 83.9)	91.9 (88.7 to 94.5)	83.6 (78.7 to 87.9)
Study PDT301—month 12			89.9 (81.7 to 95.3)	81.6 (73.7 to 88.0)
Study PDT304—month 18	81.4 (70.3 to 89.7)	90.3 (74.2 to 98.0)
Study PDT304—month 36	83.8 (72.9 to 91.6)	86.2 (68.3 to 96.1)
Mean results†	89.6 (86.3 to 92.4)	90.2 (84.9 to 94.1)	89.9 (81.7 to 95.3)	81.6 (73.7 to 88.0)	89.7 (86.7 to 92.2)	86.7 (82.4 to 90.3)

Sensitivity/specificity for DLB is calculated based on probable DLB versus non-DLB.

Sensitivity/specificity for total is calculated based on SDDD versus non-SDDD.

*Pooled studies include on-site ioflupane (¹²³I) reads for DP008-003, PDT304 (at baseline), PDT301 (baseline reference clinical diagnosis) and PDT408.

†Summary results calculated across all studies and time points. For PDT301, the month 12 reference clinical diagnosis was used.

DLB, dementia with Lewy bodies; ITD, intent to diagnose; NPA, negative per cent agreement; PPA, positive per cent agreement; PS, parkinsonian syndrome; SDDD, striatal dopaminergic deficit disorder.