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. 2021 Apr 19;22(10):2324–2336. doi: 10.1093/pm/pnab113

Table 2.

Reasons for discontinuation by responder category in STRIDE and PACE

Reason Total Responders* After First Application Responders* After Second Application Responders* After Third Application Others
STRIDE N = 306 n = 60 n = 33 n = 11 n = 202
 Adverse event 11 (3.6) 2 (3.3) 0 1 (9.1) 8 (4.0)
 Lack of efficacy 54 (17.6) 4 (6.7) 2 (6.1) 1 (9.1) 47 (23.3)
 Protocol violation 6 (2.0) 1 (1.7) 0 0 5 (2.5)
 Lost to follow-up 17 (5.6) 1 (1.7) 2 (6.1) 1 (9.1) 13 (6.4)
 Withdrawal of consent 33 (10.8) 3 (5.0) 1 (3.0) 0 29 (14.4)
 Other 9 (2.9) 0 0 0 9 (4.5)
PACE N = 313 n = 96 n = 68 n = 43 n = 106
 Adverse event 15 (4.8) 3 (3.1) 3 (4.4) 0 9 (8.5)
 Lack of efficacy 4 (1.3) 2 (2.1) 0 0 2 (1.9)
 Protocol violation 4 (1.3) 0 0 0 4 (3.8)
 Lost to follow-up 3 (1.0) 0 1 (1.5) 0 2 (1.9)
 Withdrawal of consent 25 (8.0) 4 (4.2) 2 (2.9) 0 19 (17.9)
 Other 2 (0.6) 2 (2.1) 0 0 0

All data are n (%).

*

Response was defined as ≥30% reduction from baseline in pain intensity, assessed with the BPI.

Includes nonresponders to first or second application who were not offered subsequent applications, as well as nonresponders to third application.