Table 2.
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.