Table 4.

Summary of sensitivity (PPA) and specificity (NPA) by expert clinical diagnosis—on-site institutional reads—PP population (N=622)

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*	91.8 (87.5 to 95.0)	90.3 (82.9 to 95.2)	87.5 (78.7 to 93.6)	77.1 (69.3 to 83.7)	90.6 (86.8 to 93.6)	82.6 (77.3 to 87.1)
Study PDT301—month 12			89.4 (80.8 to 95.0)	81.3 (73.3 to 87.8)
Study PDT304—month 18	80.9 (69.5 to 89.4)	90.3 (74.2 to 98.0)
Study PDT304—month 36	83.3 (72.1 to 91.4)	86.2 (68.3 to 96.1)
Mean results†	88.2 (84.5 to 91.3)	89.6 (83.8 to 93.8)	89.4 (80.8 to 95.0)	81.3 (73.3 to 87.8)	88.4 (85.1 to 91.2)	86.0 (81.4 to 89.8)

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 [¹²³I] FP-CIT 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; FP-CIT, fluoropropyl-carbomethoxy-3β-(4-iodophenyltropane); NPA, negative per cent agreement; PP, per protocol; PPA, positive per cent agreement; PS, parkinsonian syndrome; SDDD, striatal dopaminergic deficit disorder.