Trial Outcomes & Findings for The BEST Trial: Biomarkers for Evaluating Spine Treatments (NCT NCT05396014)
NCT ID: NCT05396014
Last Updated: 2025-07-23
Results Overview
Patient-reported pain intensity and interference is measured by the Pain, Enjoyment of Life, and General Activity (PEG) scale. The PEG is a series of 3 questions. Results range from -10 to 10, with higher scores indicating increased pain intensity and interference at 24 Weeks compared to Baseline.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
1014 participants
Primary outcome timeframe
Baseline, 24 Weeks
Results posted on
2025-07-23
Participant Flow
While 1014 participants in total were enrolled in the trial, 805 were randomized. This was due to participant withdrawal or participant ineligibility during the run-in period between the enrollment visit and randomization.
Participant milestones
| Measure |
Acceptance and Commitment Therapy (ACT) Alone
This arm included both participants who had a strong response to Acceptance and Commitment Therapy (ACT) in Period 1 and participants who were not assessed for response at the end of Period 1. In Period 1, participants randomized to ACT took part in 12 therapy sessions over the course of 12 weeks. Each participant was scheduled for a combination of 4 remote face-to-face visits and 8 therapist-supported online sessions, which included a self-directed module combined with personalized provider coaching delivered via an online messaging system. In Period 2, strong responders were encouraged to continue to practice ACT skills at home without therapist supervision and were given access to an additional 11 ACT audio modules.
|
ACT Plus Duloxetine, Moderate Treatment Response
This arm included participants who had a moderate response to ACT in Period 1 and started Duloxetine in Period 2 while continuing ACT treatment.
|
ACT Plus Evidence Based Exercise and Manual Therapy (EBEM), Moderate Period 1 Treatment Response
This arm included participants who had a moderate response to ACT in Period 1 and started Evidence Based Exercise and Manual Therapy (EBEM) treatment in Period 2 while continuing ACT.
|
ACT Plus Enhanced Self-Care Therapy (ESC), Moderate Period 1 Treatment Response
This arm included participants who had a moderate response to ACT in Period 1 and started Enhanced Self-Care Therapy (ESC) treatment in Period 2 while continuing ACT.
|
ACT Plus Duloxetine, Low Period 1 Treatment Response
This arm included participants who had a low response to ACT in Period 1 and started Duloxetine treatment in Period 2 while continuing ACT.
|
ACT Plus Evidence Based Exercise and Manual Therapy (EBEM), Low Period 1 Treatment Response
This arm included participants who had a low response to ACT in Period 1 and started EBEM treatment in Period 2 while continuing ACT.
|
ACT Plus Enhanced Self-Care Therapy (ESC), Low Period 1 Treatment Response
This arm included participants who had a low response to ACT in Period 1 and started ESC treatment in Period 2 while continuing ACT.
|
ACT Followed by Duloxetine, Low Period 1 Treatment Response
This arm included participants who had a low response to ACT in Period 1 and started Duloxetine treatment in Period 2. ACT treatment was discontinued.
|
ACT Followed by Evidence Based Exercise and Manual Therapy (EBEM), Low Period 1 Treatment Response
This arm included participants who had a low response to ACT in Period 1 and started EBEM treatment in Period 2. ACT treatment was discontinued.
|
ACT Followed by Enhanced Self-Care Therapy (ESC), Low Period 1 Treatment Response
This arm included participants who had a low response to ACT in Period 1 and started ESC treatment in Period 2. ACT treatment was discontinued.
|
ACT Followed by Duloxetine, Poor Period 1 Treatment Response
This arm included participants who had a poor response to ACT in Period 1 and started Duloxetine treatment in Period 2. ACT treatment was discontinued.
|
ACT Followed by Evidence Based Exercise and Manual Therapy (EBEM), Poor Period 1 Treatment Response
This arm included participants who had a poor response to ACT in Period 1 and started EBEM treatment in Period 2. ACT treatment was discontinued.
|
ACT Followed by Enhanced Self-Care Therapy (ESC), Poor Period 1 Treatment Response
This arm included participants who had a poor response to ACT in Period 1 and started ESC treatment in Period 2. ACT treatment was discontinued.
|
Duloxetine Alone
This arm included both participants who had a strong response to Duloxetine in Period 1 and participants who were not assessed for response at the end of Period 1.
|
Duloxetine Plus Acceptance and Commitment Therapy (ACT), Moderate Period 1 Treatment Response
This arm included participants who had a moderate response to Duloxetine in Period 1 and started ACT treatment in Period 2 while continuing Duloxetine.
|
Duloxetine Plus Evidence Based Exercise & Manual Therapy(EBEM), Moderate Period 1 Treatment Response
This arm included participants who had a moderate response to Duloxetine in Period 1 and started EBEM treatment in Period 2 while continuing Duloxetine.
|
Duloxetine Plus Enhanced Self-Care Therapy (ESC), Moderate Period 1 Treatment Response
This arm included participants who had a moderate response to Duloxetine in Period 1 and started ESC treatment in Period 2 while continuing Duloxetine.
|
Duloxetine Plus Acceptance and Commitment Therapy (ACT), Low Period 1 Treatment Response
This arm included participants who had a low response to Duloxetine in Period 1 and started ACT treatment in Period 2 while continuing Duloxetine.
|
Duloxetine Plus Evidence Based Exercise and Manual Therapy (EBEM), Low Period 1 Treatment Response
This arm included participants who had a low response to Duloxetine in Period 1 and started EBEM treatment in Period 2 while continuing Duloxetine.
|
Duloxetine Plus Enhanced Self-Care Therapy (ESC), Low Period 1 Treatment Response
This arm included participants who had a low response to Duloxetine in Period 1 and started ESC treatment in Period 2 while continuing Duloxetine.
|
Duloxetine Followed by Acceptance and Commitment Therapy (ACT), Low Period 1 Treatment Response
This arm included participants who had a low response to Duloxetine in Period 1 and started ACT treatment in Period 2. Duloxetine treatment was discontinued.
|
Duloxetine Followed by Evidence Based Exercise and Manual Therapy(EBEM), Low Period 1 Trt Response
This arm included participants who had a low response to Duloxetine in Period 1 and started EBEM treatment in Period 2. Duloxetine treatment was discontinued.
|
Duloxetine Followed by Enhanced Self-Care Therapy (ESC), Low Period 1 Treatment Response
This arm included participants who had a low response to Duloxetine in Period 1 and started ESC treatment in Period 2. Duloxetine treatment was discontinued.
|
Duloxetine Followed by Acceptance and Commitment Therapy (ACT), Poor Period 1 Treatment Response
This arm included participants who had a poor response to Duloxetine in Period 1 and started ACT treatment in Period 2. Duloxetine treatment was discontinued.
|
Duloxetine Followed by Evidence Based Exercise and Manual Therapy (EBEM), Poor Period 1 Trt Response
This arm included participants who had a poor response to Duloxetine in Period 1 and started EBEM treatment in Period 2. Duloxetine treatment was discontinued.
|
Duloxetine Followed by Enhanced Self-Care Therapy (ESC), Poor Period 1 Treatment Response
This arm included participants who had a poor response to Duloxetine in Period 1 and started ESC treatment in Period 2. Duloxetine treatment was discontinued.
|
Evidence Based Exercise and Manual Therapy (EBEM) Alone
This arm included both participants who had a strong response to EBEM in Period 1 and participants who were not assessed for response at the end of Period 1.
|
EBEM Plus Duloxetine, Moderate Period 1 Treatment Response
This arm included participants who had a moderate response to EBEM in Period 1 and started Duloxetine treatment in Period 2 while continuing EBEM.
|
EBEM Plus Acceptance and Commitment Therapy (ACT), Moderate Period 1 Treatment Response
This arm included participants who had a moderate response to EBEM in Period 1 and started ACT treatment in Period 2 while continuing EBEM.
|
EBEM Plus Enhanced Self-Care Therapy (ESC), Moderate Period 1 Treatment Response
This arm included participants who had a moderate response to EBEM in Period 1 and started ESC treatment in Period 2 while continuing EBEM.
|
EBEM Plus Duloxetine, Low Period 1 Treatment Response
This arm included participants who had a low response to EBEM in Period 1 and started Duloxetine treatment in Period 2 while continuing EBEM.
|
EBEM Plus Acceptance and Commitment Therapy (ACT), Low Period 1 Treatment Response
This arm included participants who had a low response to EBEM in Period 1 and started ACT treatment in Period 2 while continuing EBEM.
|
EBEM Plus Enhanced Self-Care Therapy (ESC), Low Period 1 Treatment Response
This arm included participants who had a low response to EBEM in Period 1 and started ESC treatment in Period 2 while continuing EBEM.
|
EBEM Followed by Duloxetine, Low Period 1 Treatment Response
This arm included participants who had a low response to EBEM in Period 1 and started Duloxetine treatment in Period 2. EBEM treatment was discontinued.
|
EBEM Followed by Acceptance and Commitment Therapy (ACT), Low Period 1 Treatment Response
This arm included participants who had a low response to EBEM in Period 1 and started ACT treatment in Period 2. EBEM treatment was discontinued.
|
EBEM Followed by Enhanced Self-Care Therapy (ESC), Low Period 1 Treatment Response
This arm included participants who had a low response to ESC in Period 1 and started Duloxetine treatment in Period 2. EBEM treatment was discontinued.
|
EBEM Followed by Duloxetine, Poor Period 1 Treatment Response
This arm included participants who had a poor response to EBEM in Period 1 and started Duloxetine treatment in Period 2. EBEM treatment was discontinued.
|
EBEM Followed by Acceptance and Commitment Therapy (ACT), Poor Period 1 Treatment Response
This arm included participants who had a poor response to EBEM in Period 1 and started ACT treatment in Period 2. EBEM treatment was discontinued.
|
EBEM Followed by Enhanced Self-Care Therapy (ESC), Poor Period 1 Treatment Response
This arm included participants who had a poor response to EBEM in Period 1 and started ESC treatment in Period 2. EBEM treatment was discontinued.
|
Enhanced Self-Care Therapy (ESC) Alone
This arm included both participants who had a strong response to ESC in Period 1 and participants who were not assessed for response at the end of Period 1.
|
ESC Plus Duloxetine, Moderate to Low Period 1 Treatment Response
This arm included participants who had a moderate to poor response to ESC in Period 1 and started Duloxetine treatment in Period 2. ESC treatment was discontinued.
|
ESC Plus Acceptance and Commitment Therapy (ACT), Moderate to Low Period 1 Treatment Response
This arm included participants who had a moderate to poor response to ESC in Period 1 and started ACT treatment in Period 2. ESC treatment was discontinued.
|
ESC Plus Evidence Based Exercise and Manual Therapy (EBEM), Moderate to Low Period 1 Trt Response
This arm included participants who had a moderate to poor response to ESC in Period 1 and started EBEM treatment in Period 2. ESC treatment was discontinued.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Stage 1 Intervention (Weeks 0-12)
STARTED
|
63
|
8
|
8
|
5
|
12
|
21
|
20
|
12
|
22
|
28
|
2
|
1
|
1
|
71
|
9
|
4
|
4
|
4
|
8
|
9
|
25
|
26
|
26
|
4
|
3
|
5
|
97
|
5
|
15
|
12
|
6
|
9
|
14
|
13
|
12
|
7
|
4
|
1
|
4
|
46
|
41
|
59
|
59
|
|
Stage 1 Intervention (Weeks 0-12)
COMPLETED
|
28
|
8
|
8
|
5
|
12
|
21
|
20
|
12
|
22
|
28
|
2
|
1
|
1
|
48
|
9
|
4
|
4
|
4
|
8
|
9
|
25
|
26
|
26
|
4
|
3
|
5
|
71
|
5
|
15
|
12
|
6
|
9
|
14
|
13
|
12
|
7
|
4
|
1
|
4
|
16
|
41
|
59
|
59
|
|
Stage 1 Intervention (Weeks 0-12)
NOT COMPLETED
|
35
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
23
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
26
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
30
|
0
|
0
|
0
|
|
Stage 2 Screening (Week 12 Pre-Rand.)
STARTED
|
28
|
8
|
8
|
5
|
12
|
21
|
20
|
12
|
22
|
28
|
2
|
1
|
1
|
48
|
9
|
4
|
4
|
4
|
8
|
9
|
25
|
26
|
26
|
4
|
3
|
5
|
71
|
5
|
15
|
12
|
6
|
9
|
14
|
13
|
12
|
7
|
4
|
1
|
4
|
16
|
41
|
59
|
59
|
|
Stage 2 Screening (Week 12 Pre-Rand.)
COMPLETED
|
26
|
8
|
8
|
5
|
12
|
21
|
20
|
12
|
22
|
28
|
2
|
1
|
1
|
45
|
9
|
4
|
4
|
4
|
8
|
9
|
25
|
26
|
26
|
4
|
3
|
5
|
70
|
5
|
15
|
12
|
6
|
9
|
14
|
13
|
12
|
7
|
4
|
1
|
4
|
14
|
41
|
59
|
59
|
|
Stage 2 Screening (Week 12 Pre-Rand.)
NOT COMPLETED
|
2
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
3
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
2
|
0
|
0
|
0
|
|
Stage 2 Intervention (Weeks 12-24)
STARTED
|
26
|
8
|
8
|
5
|
12
|
21
|
20
|
12
|
22
|
28
|
2
|
1
|
1
|
45
|
9
|
4
|
4
|
4
|
8
|
9
|
25
|
26
|
26
|
4
|
3
|
5
|
70
|
5
|
15
|
12
|
6
|
9
|
14
|
13
|
12
|
7
|
4
|
1
|
4
|
14
|
41
|
59
|
59
|
|
Stage 2 Intervention (Weeks 12-24)
COMPLETED
|
26
|
8
|
8
|
3
|
12
|
20
|
18
|
12
|
18
|
27
|
2
|
1
|
1
|
43
|
9
|
3
|
3
|
3
|
7
|
9
|
25
|
25
|
23
|
3
|
1
|
2
|
67
|
4
|
15
|
12
|
5
|
7
|
13
|
13
|
9
|
5
|
4
|
1
|
4
|
14
|
37
|
54
|
56
|
|
Stage 2 Intervention (Weeks 12-24)
NOT COMPLETED
|
0
|
0
|
0
|
2
|
0
|
1
|
2
|
0
|
4
|
1
|
0
|
0
|
0
|
2
|
0
|
1
|
1
|
1
|
1
|
0
|
0
|
1
|
3
|
1
|
2
|
3
|
3
|
1
|
0
|
0
|
1
|
2
|
1
|
0
|
3
|
2
|
0
|
0
|
0
|
0
|
4
|
5
|
3
|
Reasons for withdrawal
| Measure |
Acceptance and Commitment Therapy (ACT) Alone
This arm included both participants who had a strong response to Acceptance and Commitment Therapy (ACT) in Period 1 and participants who were not assessed for response at the end of Period 1. In Period 1, participants randomized to ACT took part in 12 therapy sessions over the course of 12 weeks. Each participant was scheduled for a combination of 4 remote face-to-face visits and 8 therapist-supported online sessions, which included a self-directed module combined with personalized provider coaching delivered via an online messaging system. In Period 2, strong responders were encouraged to continue to practice ACT skills at home without therapist supervision and were given access to an additional 11 ACT audio modules.
|
ACT Plus Duloxetine, Moderate Treatment Response
This arm included participants who had a moderate response to ACT in Period 1 and started Duloxetine in Period 2 while continuing ACT treatment.
|
ACT Plus Evidence Based Exercise and Manual Therapy (EBEM), Moderate Period 1 Treatment Response
This arm included participants who had a moderate response to ACT in Period 1 and started Evidence Based Exercise and Manual Therapy (EBEM) treatment in Period 2 while continuing ACT.
|
ACT Plus Enhanced Self-Care Therapy (ESC), Moderate Period 1 Treatment Response
This arm included participants who had a moderate response to ACT in Period 1 and started Enhanced Self-Care Therapy (ESC) treatment in Period 2 while continuing ACT.
|
ACT Plus Duloxetine, Low Period 1 Treatment Response
This arm included participants who had a low response to ACT in Period 1 and started Duloxetine treatment in Period 2 while continuing ACT.
|
ACT Plus Evidence Based Exercise and Manual Therapy (EBEM), Low Period 1 Treatment Response
This arm included participants who had a low response to ACT in Period 1 and started EBEM treatment in Period 2 while continuing ACT.
|
ACT Plus Enhanced Self-Care Therapy (ESC), Low Period 1 Treatment Response
This arm included participants who had a low response to ACT in Period 1 and started ESC treatment in Period 2 while continuing ACT.
|
ACT Followed by Duloxetine, Low Period 1 Treatment Response
This arm included participants who had a low response to ACT in Period 1 and started Duloxetine treatment in Period 2. ACT treatment was discontinued.
|
ACT Followed by Evidence Based Exercise and Manual Therapy (EBEM), Low Period 1 Treatment Response
This arm included participants who had a low response to ACT in Period 1 and started EBEM treatment in Period 2. ACT treatment was discontinued.
|
ACT Followed by Enhanced Self-Care Therapy (ESC), Low Period 1 Treatment Response
This arm included participants who had a low response to ACT in Period 1 and started ESC treatment in Period 2. ACT treatment was discontinued.
|
ACT Followed by Duloxetine, Poor Period 1 Treatment Response
This arm included participants who had a poor response to ACT in Period 1 and started Duloxetine treatment in Period 2. ACT treatment was discontinued.
|
ACT Followed by Evidence Based Exercise and Manual Therapy (EBEM), Poor Period 1 Treatment Response
This arm included participants who had a poor response to ACT in Period 1 and started EBEM treatment in Period 2. ACT treatment was discontinued.
|
ACT Followed by Enhanced Self-Care Therapy (ESC), Poor Period 1 Treatment Response
This arm included participants who had a poor response to ACT in Period 1 and started ESC treatment in Period 2. ACT treatment was discontinued.
|
Duloxetine Alone
This arm included both participants who had a strong response to Duloxetine in Period 1 and participants who were not assessed for response at the end of Period 1.
|
Duloxetine Plus Acceptance and Commitment Therapy (ACT), Moderate Period 1 Treatment Response
This arm included participants who had a moderate response to Duloxetine in Period 1 and started ACT treatment in Period 2 while continuing Duloxetine.
|
Duloxetine Plus Evidence Based Exercise & Manual Therapy(EBEM), Moderate Period 1 Treatment Response
This arm included participants who had a moderate response to Duloxetine in Period 1 and started EBEM treatment in Period 2 while continuing Duloxetine.
|
Duloxetine Plus Enhanced Self-Care Therapy (ESC), Moderate Period 1 Treatment Response
This arm included participants who had a moderate response to Duloxetine in Period 1 and started ESC treatment in Period 2 while continuing Duloxetine.
|
Duloxetine Plus Acceptance and Commitment Therapy (ACT), Low Period 1 Treatment Response
This arm included participants who had a low response to Duloxetine in Period 1 and started ACT treatment in Period 2 while continuing Duloxetine.
|
Duloxetine Plus Evidence Based Exercise and Manual Therapy (EBEM), Low Period 1 Treatment Response
This arm included participants who had a low response to Duloxetine in Period 1 and started EBEM treatment in Period 2 while continuing Duloxetine.
|
Duloxetine Plus Enhanced Self-Care Therapy (ESC), Low Period 1 Treatment Response
This arm included participants who had a low response to Duloxetine in Period 1 and started ESC treatment in Period 2 while continuing Duloxetine.
|
Duloxetine Followed by Acceptance and Commitment Therapy (ACT), Low Period 1 Treatment Response
This arm included participants who had a low response to Duloxetine in Period 1 and started ACT treatment in Period 2. Duloxetine treatment was discontinued.
|
Duloxetine Followed by Evidence Based Exercise and Manual Therapy(EBEM), Low Period 1 Trt Response
This arm included participants who had a low response to Duloxetine in Period 1 and started EBEM treatment in Period 2. Duloxetine treatment was discontinued.
|
Duloxetine Followed by Enhanced Self-Care Therapy (ESC), Low Period 1 Treatment Response
This arm included participants who had a low response to Duloxetine in Period 1 and started ESC treatment in Period 2. Duloxetine treatment was discontinued.
|
Duloxetine Followed by Acceptance and Commitment Therapy (ACT), Poor Period 1 Treatment Response
This arm included participants who had a poor response to Duloxetine in Period 1 and started ACT treatment in Period 2. Duloxetine treatment was discontinued.
|
Duloxetine Followed by Evidence Based Exercise and Manual Therapy (EBEM), Poor Period 1 Trt Response
This arm included participants who had a poor response to Duloxetine in Period 1 and started EBEM treatment in Period 2. Duloxetine treatment was discontinued.
|
Duloxetine Followed by Enhanced Self-Care Therapy (ESC), Poor Period 1 Treatment Response
This arm included participants who had a poor response to Duloxetine in Period 1 and started ESC treatment in Period 2. Duloxetine treatment was discontinued.
|
Evidence Based Exercise and Manual Therapy (EBEM) Alone
This arm included both participants who had a strong response to EBEM in Period 1 and participants who were not assessed for response at the end of Period 1.
|
EBEM Plus Duloxetine, Moderate Period 1 Treatment Response
This arm included participants who had a moderate response to EBEM in Period 1 and started Duloxetine treatment in Period 2 while continuing EBEM.
|
EBEM Plus Acceptance and Commitment Therapy (ACT), Moderate Period 1 Treatment Response
This arm included participants who had a moderate response to EBEM in Period 1 and started ACT treatment in Period 2 while continuing EBEM.
|
EBEM Plus Enhanced Self-Care Therapy (ESC), Moderate Period 1 Treatment Response
This arm included participants who had a moderate response to EBEM in Period 1 and started ESC treatment in Period 2 while continuing EBEM.
|
EBEM Plus Duloxetine, Low Period 1 Treatment Response
This arm included participants who had a low response to EBEM in Period 1 and started Duloxetine treatment in Period 2 while continuing EBEM.
|
EBEM Plus Acceptance and Commitment Therapy (ACT), Low Period 1 Treatment Response
This arm included participants who had a low response to EBEM in Period 1 and started ACT treatment in Period 2 while continuing EBEM.
|
EBEM Plus Enhanced Self-Care Therapy (ESC), Low Period 1 Treatment Response
This arm included participants who had a low response to EBEM in Period 1 and started ESC treatment in Period 2 while continuing EBEM.
|
EBEM Followed by Duloxetine, Low Period 1 Treatment Response
This arm included participants who had a low response to EBEM in Period 1 and started Duloxetine treatment in Period 2. EBEM treatment was discontinued.
|
EBEM Followed by Acceptance and Commitment Therapy (ACT), Low Period 1 Treatment Response
This arm included participants who had a low response to EBEM in Period 1 and started ACT treatment in Period 2. EBEM treatment was discontinued.
|
EBEM Followed by Enhanced Self-Care Therapy (ESC), Low Period 1 Treatment Response
This arm included participants who had a low response to ESC in Period 1 and started Duloxetine treatment in Period 2. EBEM treatment was discontinued.
|
EBEM Followed by Duloxetine, Poor Period 1 Treatment Response
This arm included participants who had a poor response to EBEM in Period 1 and started Duloxetine treatment in Period 2. EBEM treatment was discontinued.
|
EBEM Followed by Acceptance and Commitment Therapy (ACT), Poor Period 1 Treatment Response
This arm included participants who had a poor response to EBEM in Period 1 and started ACT treatment in Period 2. EBEM treatment was discontinued.
|
EBEM Followed by Enhanced Self-Care Therapy (ESC), Poor Period 1 Treatment Response
This arm included participants who had a poor response to EBEM in Period 1 and started ESC treatment in Period 2. EBEM treatment was discontinued.
|
Enhanced Self-Care Therapy (ESC) Alone
This arm included both participants who had a strong response to ESC in Period 1 and participants who were not assessed for response at the end of Period 1.
|
ESC Plus Duloxetine, Moderate to Low Period 1 Treatment Response
This arm included participants who had a moderate to poor response to ESC in Period 1 and started Duloxetine treatment in Period 2. ESC treatment was discontinued.
|
ESC Plus Acceptance and Commitment Therapy (ACT), Moderate to Low Period 1 Treatment Response
This arm included participants who had a moderate to poor response to ESC in Period 1 and started ACT treatment in Period 2. ESC treatment was discontinued.
|
ESC Plus Evidence Based Exercise and Manual Therapy (EBEM), Moderate to Low Period 1 Trt Response
This arm included participants who had a moderate to poor response to ESC in Period 1 and started EBEM treatment in Period 2. ESC treatment was discontinued.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Stage 1 Intervention (Weeks 0-12)
Withdrawal by Subject
|
18
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
13
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
14
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
14
|
0
|
0
|
0
|
|
Stage 1 Intervention (Weeks 0-12)
Lost to Follow-up
|
15
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
8
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
8
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
14
|
0
|
0
|
0
|
|
Stage 1 Intervention (Weeks 0-12)
Adverse Event
|
2
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
2
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
2
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
|
Stage 1 Intervention (Weeks 0-12)
Protocol Violation
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
|
Stage 1 Intervention (Weeks 0-12)
Physician Decision
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Stage 2 Screening (Week 12 Pre-Rand.)
Withdrawal by Subject
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Stage 2 Screening (Week 12 Pre-Rand.)
Lost to Follow-up
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
2
|
0
|
0
|
0
|
|
Stage 2 Screening (Week 12 Pre-Rand.)
Physician Decision
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Stage 2 Screening (Week 12 Pre-Rand.)
Adverse Event
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Stage 2 Intervention (Weeks 12-24)
Lost to Follow-up
|
0
|
0
|
0
|
2
|
0
|
1
|
1
|
0
|
2
|
1
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
1
|
1
|
2
|
0
|
0
|
0
|
0
|
1
|
1
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
3
|
2
|
1
|
|
Stage 2 Intervention (Weeks 12-24)
Withdrawal by Subject
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
2
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
1
|
1
|
1
|
0
|
0
|
1
|
2
|
0
|
1
|
1
|
1
|
1
|
0
|
0
|
0
|
1
|
1
|
0
|
1
|
2
|
0
|
0
|
0
|
0
|
1
|
3
|
1
|
|
Stage 2 Intervention (Weeks 12-24)
Adverse Event
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
|
Stage 2 Intervention (Weeks 12-24)
Protocol Violation
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
Baseline Characteristics
The number of participants analyzed are participants who had a low back operation.
Baseline characteristics by cohort
| Measure |
Stage 1: Acceptance and Commitment Therapy (ACT)
n=203 Participants
ACT is a form of cognitive behavioral therapy that is well established for the treatment of chronic pain. The goal of ACT is to build psychological flexibility thereby interrupting pain avoidance behavior patterns. Participants randomized to ACT will take part in 12 sessions over the course of 12 weeks. Sessions will be delivered as a combination of 4 remote face-to-face visits with a therapist and 8 therapist-supported online sessions (self-directed online modules supported by provider coaching). Online sessions will focus on helping participants accept pain, connect with negative thoughts and emotions, develop mindfulness and identify and commit to values and goals that are important to them. During face-to-face sessions with the therapist, participants will be encouraged to share their experience of skills practice and mastery, provide examples of skill use at home, and describe what barriers they encountered.
|
Stage 1: Duloxetine
n=198 Participants
Duloxetine is a serotonin norepinephrine reuptake inhibitor (SNRI) that is FDA-approved for use in Chronic Low-Back Pain, and, as such, is included as a recommended therapy in nearly all current treatment guidelines for low back pain. Study participants will be treated with duloxetine for 12 weeks during the active treatment phase. At the time of randomization, the approved drug pharmacy at each study site will dispense between 185 and 192 duloxetine 30 mg capsules and provide to participants. This will ensure enough capsules to maintain up to a 60 mg dosage through the 12-week intervention phase and to taper the dose in the 13th week if needed.
|
Stage 1: Evidence Based Exercise and Manual Therapy (EBEM)
n=199 Participants
Licensed physical therapists (PTs) or Doctors of Chiropractic (DCs) will rely on evidence-based guidance to direct decision-making on the particular type of manual and exercise therapy that may be best suited to an individual study participant. Special attention will be paid to the clinician's choice of language in regard to the purpose and expected outcomes of manual therapy in order to avoid enhancing catastrophizing ideations or preference for passive interventions. A total of 10 sessions will be provided over an 8-week treatment period. Two sessions per week are provided in the first two weeks followed by weekly sessions over the next 6 weeks. Treatment sessions will last approximately 60 minutes each.
|
Stage 1: Enhanced Self-Care Therapy (ESC)
n=205 Participants
The Enhanced Self-Care intervention will be comprised of educational modules on evidence-based cognitive-behavioral self-management skills for pain. These modules will be provided digitally for self-administration over a period of 12 weeks. There will be no therapist associated with the delivery of these educational materials; however, after the first four modules, email or text messages will be used to make personalized recommendations for accessing additional modules based upon identified problems from the baseline assessment. Additionally, the walking program module will utilize Fitbit step tracking to allow participants to monitor their walking progress.
|
Total
n=805 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=203 Participants
|
0 Participants
n=198 Participants
|
0 Participants
n=199 Participants
|
0 Participants
n=205 Participants
|
0 Participants
n=805 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
166 Participants
n=203 Participants
|
160 Participants
n=198 Participants
|
161 Participants
n=199 Participants
|
164 Participants
n=205 Participants
|
651 Participants
n=805 Participants
|
|
Age, Categorical
>=65 years
|
37 Participants
n=203 Participants
|
38 Participants
n=198 Participants
|
38 Participants
n=199 Participants
|
41 Participants
n=205 Participants
|
154 Participants
n=805 Participants
|
|
Age, Continuous
|
49.4 years
STANDARD_DEVIATION 16.5 • n=203 Participants
|
51.6 years
STANDARD_DEVIATION 15.4 • n=198 Participants
|
49.5 years
STANDARD_DEVIATION 16.3 • n=199 Participants
|
51.2 years
STANDARD_DEVIATION 16.1 • n=205 Participants
|
50.4 years
STANDARD_DEVIATION 16.1 • n=805 Participants
|
|
Sex: Female, Male
Female
|
116 Participants
n=203 Participants
|
115 Participants
n=198 Participants
|
131 Participants
n=199 Participants
|
134 Participants
n=205 Participants
|
496 Participants
n=805 Participants
|
|
Sex: Female, Male
Male
|
87 Participants
n=203 Participants
|
83 Participants
n=198 Participants
|
68 Participants
n=199 Participants
|
71 Participants
n=205 Participants
|
309 Participants
n=805 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
24 Participants
n=203 Participants
|
13 Participants
n=198 Participants
|
17 Participants
n=199 Participants
|
18 Participants
n=205 Participants
|
72 Participants
n=805 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
172 Participants
n=203 Participants
|
182 Participants
n=198 Participants
|
178 Participants
n=199 Participants
|
187 Participants
n=205 Participants
|
719 Participants
n=805 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
7 Participants
n=203 Participants
|
3 Participants
n=198 Participants
|
4 Participants
n=199 Participants
|
0 Participants
n=205 Participants
|
14 Participants
n=805 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=203 Participants
|
1 Participants
n=198 Participants
|
1 Participants
n=199 Participants
|
1 Participants
n=205 Participants
|
3 Participants
n=805 Participants
|
|
Race (NIH/OMB)
Asian
|
23 Participants
n=203 Participants
|
21 Participants
n=198 Participants
|
17 Participants
n=199 Participants
|
19 Participants
n=205 Participants
|
80 Participants
n=805 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=203 Participants
|
0 Participants
n=198 Participants
|
0 Participants
n=199 Participants
|
2 Participants
n=205 Participants
|
3 Participants
n=805 Participants
|
|
Race (NIH/OMB)
Black or African American
|
21 Participants
n=203 Participants
|
19 Participants
n=198 Participants
|
21 Participants
n=199 Participants
|
29 Participants
n=205 Participants
|
90 Participants
n=805 Participants
|
|
Race (NIH/OMB)
White
|
142 Participants
n=203 Participants
|
144 Participants
n=198 Participants
|
144 Participants
n=199 Participants
|
142 Participants
n=205 Participants
|
572 Participants
n=805 Participants
|
|
Race (NIH/OMB)
More than one race
|
6 Participants
n=203 Participants
|
6 Participants
n=198 Participants
|
7 Participants
n=199 Participants
|
8 Participants
n=205 Participants
|
27 Participants
n=805 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
10 Participants
n=203 Participants
|
7 Participants
n=198 Participants
|
9 Participants
n=199 Participants
|
4 Participants
n=205 Participants
|
30 Participants
n=805 Participants
|
|
Region of Enrollment
United States
|
203 Participants
n=203 Participants
|
198 Participants
n=198 Participants
|
199 Participants
n=199 Participants
|
205 Participants
n=205 Participants
|
805 Participants
n=805 Participants
|
|
Highest Level of Education Completed
Did not complete Secondary School or High School
|
6 Participants
n=203 Participants
|
6 Participants
n=198 Participants
|
8 Participants
n=199 Participants
|
8 Participants
n=205 Participants
|
28 Participants
n=805 Participants
|
|
Highest Level of Education Completed
High School or Secondary School Degree Complete
|
31 Participants
n=203 Participants
|
24 Participants
n=198 Participants
|
33 Participants
n=199 Participants
|
41 Participants
n=205 Participants
|
129 Participants
n=805 Participants
|
|
Highest Level of Education Completed
Associate's or Technical Degree Complete
|
33 Participants
n=203 Participants
|
27 Participants
n=198 Participants
|
36 Participants
n=199 Participants
|
35 Participants
n=205 Participants
|
131 Participants
n=805 Participants
|
|
Highest Level of Education Completed
College or Baccalaureate Degree Complete
|
75 Participants
n=203 Participants
|
85 Participants
n=198 Participants
|
65 Participants
n=199 Participants
|
69 Participants
n=205 Participants
|
294 Participants
n=805 Participants
|
|
Highest Level of Education Completed
Doctoral or Postgraduate Education
|
56 Participants
n=203 Participants
|
56 Participants
n=198 Participants
|
57 Participants
n=199 Participants
|
51 Participants
n=205 Participants
|
220 Participants
n=805 Participants
|
|
Highest Level of Education Completed
Missing
|
2 Participants
n=203 Participants
|
0 Participants
n=198 Participants
|
0 Participants
n=199 Participants
|
1 Participants
n=205 Participants
|
3 Participants
n=805 Participants
|
|
Current Employment Status
Full-time employment
|
102 Participants
n=203 Participants
|
101 Participants
n=198 Participants
|
112 Participants
n=199 Participants
|
84 Participants
n=205 Participants
|
399 Participants
n=805 Participants
|
|
Current Employment Status
Not employed
|
64 Participants
n=203 Participants
|
72 Participants
n=198 Participants
|
60 Participants
n=199 Participants
|
83 Participants
n=205 Participants
|
279 Participants
n=805 Participants
|
|
Current Employment Status
Part-time employment
|
35 Participants
n=203 Participants
|
25 Participants
n=198 Participants
|
27 Participants
n=199 Participants
|
37 Participants
n=205 Participants
|
124 Participants
n=805 Participants
|
|
Current Employment Status
Missing
|
2 Participants
n=203 Participants
|
0 Participants
n=198 Participants
|
0 Participants
n=199 Participants
|
1 Participants
n=205 Participants
|
3 Participants
n=805 Participants
|
|
Current Relationship Status
Married
|
97 Participants
n=203 Participants
|
117 Participants
n=198 Participants
|
94 Participants
n=199 Participants
|
99 Participants
n=205 Participants
|
407 Participants
n=805 Participants
|
|
Current Relationship Status
Never Married
|
53 Participants
n=203 Participants
|
37 Participants
n=198 Participants
|
49 Participants
n=199 Participants
|
46 Participants
n=205 Participants
|
185 Participants
n=805 Participants
|
|
Current Relationship Status
Domestic Partner
|
13 Participants
n=203 Participants
|
12 Participants
n=198 Participants
|
17 Participants
n=199 Participants
|
10 Participants
n=205 Participants
|
52 Participants
n=805 Participants
|
|
Current Relationship Status
Widowed
|
6 Participants
n=203 Participants
|
11 Participants
n=198 Participants
|
6 Participants
n=199 Participants
|
7 Participants
n=205 Participants
|
30 Participants
n=805 Participants
|
|
Current Relationship Status
Divorced or Separated
|
32 Participants
n=203 Participants
|
21 Participants
n=198 Participants
|
33 Participants
n=199 Participants
|
42 Participants
n=205 Participants
|
128 Participants
n=805 Participants
|
|
Current Relationship Status
Missing
|
2 Participants
n=203 Participants
|
0 Participants
n=198 Participants
|
0 Participants
n=199 Participants
|
1 Participants
n=205 Participants
|
3 Participants
n=805 Participants
|
|
Number of People Living in Household
1
|
50 Participants
n=203 Participants
|
43 Participants
n=198 Participants
|
53 Participants
n=199 Participants
|
58 Participants
n=205 Participants
|
204 Participants
n=805 Participants
|
|
Number of People Living in Household
2
|
85 Participants
n=203 Participants
|
88 Participants
n=198 Participants
|
62 Participants
n=199 Participants
|
87 Participants
n=205 Participants
|
322 Participants
n=805 Participants
|
|
Number of People Living in Household
3
|
30 Participants
n=203 Participants
|
25 Participants
n=198 Participants
|
40 Participants
n=199 Participants
|
19 Participants
n=205 Participants
|
114 Participants
n=805 Participants
|
|
Number of People Living in Household
4
|
25 Participants
n=203 Participants
|
29 Participants
n=198 Participants
|
29 Participants
n=199 Participants
|
23 Participants
n=205 Participants
|
106 Participants
n=805 Participants
|
|
Number of People Living in Household
5
|
8 Participants
n=203 Participants
|
9 Participants
n=198 Participants
|
8 Participants
n=199 Participants
|
13 Participants
n=205 Participants
|
38 Participants
n=805 Participants
|
|
Number of People Living in Household
6
|
3 Participants
n=203 Participants
|
3 Participants
n=198 Participants
|
7 Participants
n=199 Participants
|
1 Participants
n=205 Participants
|
14 Participants
n=805 Participants
|
|
Number of People Living in Household
7
|
0 Participants
n=203 Participants
|
1 Participants
n=198 Participants
|
0 Participants
n=199 Participants
|
1 Participants
n=205 Participants
|
2 Participants
n=805 Participants
|
|
Number of People Living in Household
8
|
0 Participants
n=203 Participants
|
0 Participants
n=198 Participants
|
0 Participants
n=199 Participants
|
2 Participants
n=205 Participants
|
2 Participants
n=805 Participants
|
|
Number of People Living in Household
Missing
|
2 Participants
n=203 Participants
|
0 Participants
n=198 Participants
|
0 Participants
n=199 Participants
|
1 Participants
n=205 Participants
|
3 Participants
n=805 Participants
|
|
Annual household income from all sources
Less than $10,000
|
11 Participants
n=203 Participants
|
4 Participants
n=198 Participants
|
9 Participants
n=199 Participants
|
12 Participants
n=205 Participants
|
36 Participants
n=805 Participants
|
|
Annual household income from all sources
$10,000 to $24,999
|
20 Participants
n=203 Participants
|
14 Participants
n=198 Participants
|
16 Participants
n=199 Participants
|
23 Participants
n=205 Participants
|
73 Participants
n=805 Participants
|
|
Annual household income from all sources
$25,000 to $34,999
|
15 Participants
n=203 Participants
|
11 Participants
n=198 Participants
|
15 Participants
n=199 Participants
|
16 Participants
n=205 Participants
|
57 Participants
n=805 Participants
|
|
Annual household income from all sources
$35,000 to $49,999
|
15 Participants
n=203 Participants
|
15 Participants
n=198 Participants
|
21 Participants
n=199 Participants
|
13 Participants
n=205 Participants
|
64 Participants
n=805 Participants
|
|
Annual household income from all sources
$50,000 to $74,999
|
24 Participants
n=203 Participants
|
21 Participants
n=198 Participants
|
25 Participants
n=199 Participants
|
20 Participants
n=205 Participants
|
90 Participants
n=805 Participants
|
|
Annual household income from all sources
$75,000 to $99,999
|
21 Participants
n=203 Participants
|
19 Participants
n=198 Participants
|
22 Participants
n=199 Participants
|
28 Participants
n=205 Participants
|
90 Participants
n=805 Participants
|
|
Annual household income from all sources
$100,000 to $149,999
|
31 Participants
n=203 Participants
|
24 Participants
n=198 Participants
|
34 Participants
n=199 Participants
|
39 Participants
n=205 Participants
|
128 Participants
n=805 Participants
|
|
Annual household income from all sources
$150,000 to $199,999
|
17 Participants
n=203 Participants
|
21 Participants
n=198 Participants
|
14 Participants
n=199 Participants
|
6 Participants
n=205 Participants
|
58 Participants
n=805 Participants
|
|
Annual household income from all sources
$200,000 or more
|
22 Participants
n=203 Participants
|
39 Participants
n=198 Participants
|
20 Participants
n=199 Participants
|
20 Participants
n=205 Participants
|
101 Participants
n=805 Participants
|
|
Annual household income from all sources
Prefer not to answer
|
0 Participants
n=203 Participants
|
0 Participants
n=198 Participants
|
0 Participants
n=199 Participants
|
0 Participants
n=205 Participants
|
0 Participants
n=805 Participants
|
|
Annual household income from all sources
Missing
|
27 Participants
n=203 Participants
|
30 Participants
n=198 Participants
|
23 Participants
n=199 Participants
|
28 Participants
n=205 Participants
|
108 Participants
n=805 Participants
|
|
Pain, Enjoyment of Life, General Activity (PEG) score
|
5.4 units on a scale
STANDARD_DEVIATION 2.0 • n=203 Participants
|
5.1 units on a scale
STANDARD_DEVIATION 1.9 • n=198 Participants
|
5.3 units on a scale
STANDARD_DEVIATION 1.8 • n=199 Participants
|
5.5 units on a scale
STANDARD_DEVIATION 1.9 • n=205 Participants
|
5.3 units on a scale
STANDARD_DEVIATION 1.9 • n=805 Participants
|
|
Pain, Enjoyment of Life, General Activity (PEG) score, median (range)
|
5.3 units on a scale
n=203 Participants
|
5.0 units on a scale
n=198 Participants
|
5.3 units on a scale
n=199 Participants
|
5.3 units on a scale
n=205 Participants
|
5.3 units on a scale
n=805 Participants
|
|
Self-reported low back pain duration (months)
|
163.4 months
STANDARD_DEVIATION 150.0 • n=203 Participants
|
156.7 months
STANDARD_DEVIATION 151.0 • n=198 Participants
|
156.4 months
STANDARD_DEVIATION 139.8 • n=199 Participants
|
154.7 months
STANDARD_DEVIATION 123.4 • n=205 Participants
|
157.8 months
STANDARD_DEVIATION 141.2 • n=805 Participants
|
|
Self-reported low back pain duration
<1 year
|
12 Participants
n=203 Participants
|
14 Participants
n=198 Participants
|
9 Participants
n=199 Participants
|
15 Participants
n=205 Participants
|
50 Participants
n=805 Participants
|
|
Self-reported low back pain duration
1-5 years
|
70 Participants
n=203 Participants
|
66 Participants
n=198 Participants
|
71 Participants
n=199 Participants
|
67 Participants
n=205 Participants
|
274 Participants
n=805 Participants
|
|
Self-reported low back pain duration
>5 years
|
121 Participants
n=203 Participants
|
118 Participants
n=198 Participants
|
119 Participants
n=199 Participants
|
123 Participants
n=205 Participants
|
481 Participants
n=805 Participants
|
|
Self-reported low back pain duration
Missing
|
0 Participants
n=203 Participants
|
0 Participants
n=198 Participants
|
0 Participants
n=199 Participants
|
0 Participants
n=205 Participants
|
0 Participants
n=805 Participants
|
|
Low Back Pain Frequency in the past 6 months
Every day or nearly every day
|
181 Participants
n=203 Participants
|
163 Participants
n=198 Participants
|
160 Participants
n=199 Participants
|
169 Participants
n=205 Participants
|
673 Participants
n=805 Participants
|
|
Low Back Pain Frequency in the past 6 months
At least half the days
|
22 Participants
n=203 Participants
|
35 Participants
n=198 Participants
|
39 Participants
n=199 Participants
|
36 Participants
n=205 Participants
|
132 Participants
n=805 Participants
|
|
Low Back Pain Specific Pain Intensity
|
5.6 units on a scale
STANDARD_DEVIATION 1.9 • n=203 Participants
|
5.4 units on a scale
STANDARD_DEVIATION 1.8 • n=198 Participants
|
5.6 units on a scale
STANDARD_DEVIATION 1.7 • n=199 Participants
|
5.8 units on a scale
STANDARD_DEVIATION 1.7 • n=205 Participants
|
5.6 units on a scale
STANDARD_DEVIATION 1.8 • n=805 Participants
|
|
Low Back Pain Specific Pain Intensity, median (range)
|
5.0 units on a scale
n=203 Participants
|
6.0 units on a scale
n=198 Participants
|
6.0 units on a scale
n=199 Participants
|
6.0 units on a scale
n=205 Participants
|
6.0 units on a scale
n=805 Participants
|
|
Ever had low back operation
No
|
176 Participants
n=203 Participants
|
174 Participants
n=198 Participants
|
177 Participants
n=199 Participants
|
171 Participants
n=205 Participants
|
698 Participants
n=805 Participants
|
|
Ever had low back operation
Yes, at least one
|
25 Participants
n=203 Participants
|
24 Participants
n=198 Participants
|
22 Participants
n=199 Participants
|
33 Participants
n=205 Participants
|
104 Participants
n=805 Participants
|
|
Ever had low back operation
Missing
|
2 Participants
n=203 Participants
|
0 Participants
n=198 Participants
|
0 Participants
n=199 Participants
|
1 Participants
n=205 Participants
|
3 Participants
n=805 Participants
|
|
When was last back operation
Less than 6 months ago
|
20 Participants
n=25 Participants • The number of participants analyzed are participants who had a low back operation.
|
18 Participants
n=24 Participants • The number of participants analyzed are participants who had a low back operation.
|
15 Participants
n=22 Participants • The number of participants analyzed are participants who had a low back operation.
|
21 Participants
n=33 Participants • The number of participants analyzed are participants who had a low back operation.
|
74 Participants
n=104 Participants • The number of participants analyzed are participants who had a low back operation.
|
|
When was last back operation
More than 6 months ago but less than 1 year ago
|
5 Participants
n=25 Participants • The number of participants analyzed are participants who had a low back operation.
|
6 Participants
n=24 Participants • The number of participants analyzed are participants who had a low back operation.
|
7 Participants
n=22 Participants • The number of participants analyzed are participants who had a low back operation.
|
12 Participants
n=33 Participants • The number of participants analyzed are participants who had a low back operation.
|
30 Participants
n=104 Participants • The number of participants analyzed are participants who had a low back operation.
|
|
When was last back operation
Between 1 and 2 years ago
|
0 Participants
n=25 Participants • The number of participants analyzed are participants who had a low back operation.
|
0 Participants
n=24 Participants • The number of participants analyzed are participants who had a low back operation.
|
0 Participants
n=22 Participants • The number of participants analyzed are participants who had a low back operation.
|
0 Participants
n=33 Participants • The number of participants analyzed are participants who had a low back operation.
|
0 Participants
n=104 Participants • The number of participants analyzed are participants who had a low back operation.
|
|
When was last back operation
More than 2 years ago
|
0 Participants
n=25 Participants • The number of participants analyzed are participants who had a low back operation.
|
0 Participants
n=24 Participants • The number of participants analyzed are participants who had a low back operation.
|
0 Participants
n=22 Participants • The number of participants analyzed are participants who had a low back operation.
|
0 Participants
n=33 Participants • The number of participants analyzed are participants who had a low back operation.
|
0 Participants
n=104 Participants • The number of participants analyzed are participants who had a low back operation.
|
|
Any back operations involve a spinal fusion
No
|
15 Participants
n=25 Participants • The number of participants analyzed are those who had a low back operation.
|
13 Participants
n=24 Participants • The number of participants analyzed are those who had a low back operation.
|
13 Participants
n=22 Participants • The number of participants analyzed are those who had a low back operation.
|
20 Participants
n=33 Participants • The number of participants analyzed are those who had a low back operation.
|
61 Participants
n=104 Participants • The number of participants analyzed are those who had a low back operation.
|
|
Any back operations involve a spinal fusion
Yes
|
7 Participants
n=25 Participants • The number of participants analyzed are those who had a low back operation.
|
9 Participants
n=24 Participants • The number of participants analyzed are those who had a low back operation.
|
7 Participants
n=22 Participants • The number of participants analyzed are those who had a low back operation.
|
10 Participants
n=33 Participants • The number of participants analyzed are those who had a low back operation.
|
33 Participants
n=104 Participants • The number of participants analyzed are those who had a low back operation.
|
|
Any back operations involve a spinal fusion
Not Sure
|
3 Participants
n=25 Participants • The number of participants analyzed are those who had a low back operation.
|
2 Participants
n=24 Participants • The number of participants analyzed are those who had a low back operation.
|
2 Participants
n=22 Participants • The number of participants analyzed are those who had a low back operation.
|
3 Participants
n=33 Participants • The number of participants analyzed are those who had a low back operation.
|
10 Participants
n=104 Participants • The number of participants analyzed are those who had a low back operation.
|
|
Ever unemployed for 1 or more months due to low back pain
No
|
145 Participants
n=203 Participants
|
151 Participants
n=198 Participants
|
142 Participants
n=199 Participants
|
134 Participants
n=205 Participants
|
572 Participants
n=805 Participants
|
|
Ever unemployed for 1 or more months due to low back pain
Yes
|
40 Participants
n=203 Participants
|
27 Participants
n=198 Participants
|
36 Participants
n=199 Participants
|
43 Participants
n=205 Participants
|
146 Participants
n=805 Participants
|
|
Ever unemployed for 1 or more months due to low back pain
Does not apply
|
16 Participants
n=203 Participants
|
20 Participants
n=198 Participants
|
21 Participants
n=199 Participants
|
27 Participants
n=205 Participants
|
84 Participants
n=805 Participants
|
|
Ever unemployed for 1 or more months due to low back pain
Missing
|
2 Participants
n=203 Participants
|
0 Participants
n=198 Participants
|
0 Participants
n=199 Participants
|
1 Participants
n=205 Participants
|
3 Participants
n=805 Participants
|
|
Ever filed or awarded worker's compensation claim related to back problem
No
|
179 Participants
n=203 Participants
|
176 Participants
n=198 Participants
|
175 Participants
n=199 Participants
|
174 Participants
n=205 Participants
|
704 Participants
n=805 Participants
|
|
Ever filed or awarded worker's compensation claim related to back problem
Yes
|
6 Participants
n=203 Participants
|
9 Participants
n=198 Participants
|
7 Participants
n=199 Participants
|
7 Participants
n=205 Participants
|
29 Participants
n=805 Participants
|
|
Ever filed or awarded worker's compensation claim related to back problem
Does not apply
|
16 Participants
n=203 Participants
|
13 Participants
n=198 Participants
|
17 Participants
n=199 Participants
|
23 Participants
n=205 Participants
|
69 Participants
n=805 Participants
|
|
Ever filed or awarded worker's compensation claim related to back problem
Missing
|
2 Participants
n=203 Participants
|
0 Participants
n=198 Participants
|
0 Participants
n=199 Participants
|
1 Participants
n=205 Participants
|
3 Participants
n=805 Participants
|
|
Involved in a lawsuit or legal claim related to back problem
No
|
199 Participants
n=203 Participants
|
196 Participants
n=198 Participants
|
198 Participants
n=199 Participants
|
201 Participants
n=205 Participants
|
794 Participants
n=805 Participants
|
|
Involved in a lawsuit or legal claim related to back problem
Yes
|
0 Participants
n=203 Participants
|
1 Participants
n=198 Participants
|
0 Participants
n=199 Participants
|
1 Participants
n=205 Participants
|
2 Participants
n=805 Participants
|
|
Involved in a lawsuit or legal claim related to back problem
Not sure
|
2 Participants
n=203 Participants
|
1 Participants
n=198 Participants
|
1 Participants
n=199 Participants
|
2 Participants
n=205 Participants
|
6 Participants
n=805 Participants
|
|
Involved in a lawsuit or legal claim related to back problem
Missing
|
2 Participants
n=203 Participants
|
0 Participants
n=198 Participants
|
0 Participants
n=199 Participants
|
1 Participants
n=205 Participants
|
3 Participants
n=805 Participants
|
|
Ever applied for, or received, disability insurance for pain condition
No
|
180 Participants
n=203 Participants
|
185 Participants
n=198 Participants
|
183 Participants
n=199 Participants
|
170 Participants
n=205 Participants
|
718 Participants
n=805 Participants
|
|
Ever applied for, or received, disability insurance for pain condition
Yes
|
21 Participants
n=203 Participants
|
13 Participants
n=198 Participants
|
16 Participants
n=199 Participants
|
34 Participants
n=205 Participants
|
84 Participants
n=805 Participants
|
|
Ever applied for, or received, disability insurance for pain condition
Missing
|
2 Participants
n=203 Participants
|
0 Participants
n=198 Participants
|
0 Participants
n=199 Participants
|
1 Participants
n=205 Participants
|
3 Participants
n=805 Participants
|
|
BMI
|
28.8 kg/m^2
STANDARD_DEVIATION 6.3 • n=203 Participants
|
29.3 kg/m^2
STANDARD_DEVIATION 7.2 • n=198 Participants
|
29.0 kg/m^2
STANDARD_DEVIATION 6.3 • n=199 Participants
|
29.4 kg/m^2
STANDARD_DEVIATION 6.9 • n=205 Participants
|
29.1 kg/m^2
STANDARD_DEVIATION 6.7 • n=805 Participants
|
|
Systolic Blood Pressure (mmHg)
|
125.8 mmHg
STANDARD_DEVIATION 15.5 • n=203 Participants
|
129.5 mmHg
STANDARD_DEVIATION 17.2 • n=198 Participants
|
124.2 mmHg
STANDARD_DEVIATION 14.3 • n=199 Participants
|
125.6 mmHg
STANDARD_DEVIATION 13.6 • n=205 Participants
|
126.3 mmHg
STANDARD_DEVIATION 15.3 • n=805 Participants
|
|
Diastolic Blood Pressure (mmHg)
|
78.5 mmHg
STANDARD_DEVIATION 10.5 • n=203 Participants
|
78.7 mmHg
STANDARD_DEVIATION 10.2 • n=198 Participants
|
76.7 mmHg
STANDARD_DEVIATION 9.6 • n=199 Participants
|
77.7 mmHg
STANDARD_DEVIATION 10.1 • n=205 Participants
|
77.9 mmHg
STANDARD_DEVIATION 10.1 • n=805 Participants
|
|
Heart Rate (bpm)
|
71.7 bpm
STANDARD_DEVIATION 12.9 • n=203 Participants
|
70.9 bpm
STANDARD_DEVIATION 11.6 • n=198 Participants
|
73.2 bpm
STANDARD_DEVIATION 12.0 • n=199 Participants
|
72.8 bpm
STANDARD_DEVIATION 12.3 • n=205 Participants
|
72.2 bpm
STANDARD_DEVIATION 12.2 • n=805 Participants
|
|
Ever Hip Replacement Surgery
Yes
|
7 Participants
n=203 Participants
|
7 Participants
n=198 Participants
|
9 Participants
n=199 Participants
|
9 Participants
n=205 Participants
|
32 Participants
n=805 Participants
|
|
Ever Hip Replacement Surgery
No
|
196 Participants
n=203 Participants
|
191 Participants
n=198 Participants
|
190 Participants
n=199 Participants
|
196 Participants
n=205 Participants
|
773 Participants
n=805 Participants
|
|
Ever Hip Replacement Surgery
Missing
|
0 Participants
n=203 Participants
|
0 Participants
n=198 Participants
|
0 Participants
n=199 Participants
|
0 Participants
n=205 Participants
|
0 Participants
n=805 Participants
|
|
Ever Knee Replacement Surgery
Yes
|
13 Participants
n=203 Participants
|
13 Participants
n=198 Participants
|
15 Participants
n=199 Participants
|
9 Participants
n=205 Participants
|
50 Participants
n=805 Participants
|
|
Ever Knee Replacement Surgery
No
|
190 Participants
n=203 Participants
|
185 Participants
n=198 Participants
|
184 Participants
n=199 Participants
|
196 Participants
n=205 Participants
|
755 Participants
n=805 Participants
|
|
Ever Knee Replacement Surgery
Missing
|
0 Participants
n=203 Participants
|
0 Participants
n=198 Participants
|
0 Participants
n=199 Participants
|
0 Participants
n=205 Participants
|
0 Participants
n=805 Participants
|
|
Observed Gait
Normal
|
179 Participants
n=203 Participants
|
164 Participants
n=198 Participants
|
172 Participants
n=199 Participants
|
169 Participants
n=205 Participants
|
684 Participants
n=805 Participants
|
|
Observed Gait
Antalgic
|
24 Participants
n=203 Participants
|
34 Participants
n=198 Participants
|
27 Participants
n=199 Participants
|
36 Participants
n=205 Participants
|
121 Participants
n=805 Participants
|
|
Observed Gait
Missing
|
0 Participants
n=203 Participants
|
0 Participants
n=198 Participants
|
0 Participants
n=199 Participants
|
0 Participants
n=205 Participants
|
0 Participants
n=805 Participants
|
|
TAPS Tobacco Use
Daily or Almost Daily
|
14 Participants
n=203 Participants
|
15 Participants
n=198 Participants
|
14 Participants
n=199 Participants
|
25 Participants
n=205 Participants
|
68 Participants
n=805 Participants
|
|
TAPS Tobacco Use
Less Than Daily
|
18 Participants
n=203 Participants
|
17 Participants
n=198 Participants
|
17 Participants
n=199 Participants
|
20 Participants
n=205 Participants
|
72 Participants
n=805 Participants
|
|
TAPS Tobacco Use
Never
|
169 Participants
n=203 Participants
|
166 Participants
n=198 Participants
|
168 Participants
n=199 Participants
|
159 Participants
n=205 Participants
|
662 Participants
n=805 Participants
|
|
TAPS Tobacco Use
Missing
|
2 Participants
n=203 Participants
|
0 Participants
n=198 Participants
|
0 Participants
n=199 Participants
|
1 Participants
n=205 Participants
|
3 Participants
n=805 Participants
|
|
TAPS Alcohol Use
At Least Weekly
|
15 Participants
n=203 Participants
|
12 Participants
n=198 Participants
|
13 Participants
n=199 Participants
|
11 Participants
n=205 Participants
|
51 Participants
n=805 Participants
|
|
TAPS Alcohol Use
Monthly
|
8 Participants
n=203 Participants
|
15 Participants
n=198 Participants
|
12 Participants
n=199 Participants
|
25 Participants
n=205 Participants
|
60 Participants
n=805 Participants
|
|
TAPS Alcohol Use
Less Than Monthly
|
52 Participants
n=203 Participants
|
52 Participants
n=198 Participants
|
52 Participants
n=199 Participants
|
46 Participants
n=205 Participants
|
202 Participants
n=805 Participants
|
|
TAPS Alcohol Use
Never
|
125 Participants
n=203 Participants
|
118 Participants
n=198 Participants
|
122 Participants
n=199 Participants
|
122 Participants
n=205 Participants
|
487 Participants
n=805 Participants
|
|
TAPS Alcohol Use
Missing
|
3 Participants
n=203 Participants
|
1 Participants
n=198 Participants
|
0 Participants
n=199 Participants
|
1 Participants
n=205 Participants
|
5 Participants
n=805 Participants
|
|
TAPS Drug Use
Daily or Almost Daily
|
11 Participants
n=203 Participants
|
5 Participants
n=198 Participants
|
8 Participants
n=199 Participants
|
11 Participants
n=205 Participants
|
35 Participants
n=805 Participants
|
|
TAPS Drug Use
Between Monthly to Weekly
|
14 Participants
n=203 Participants
|
8 Participants
n=198 Participants
|
11 Participants
n=199 Participants
|
13 Participants
n=205 Participants
|
46 Participants
n=805 Participants
|
|
TAPS Drug Use
Less Than Monthly
|
11 Participants
n=203 Participants
|
17 Participants
n=198 Participants
|
13 Participants
n=199 Participants
|
22 Participants
n=205 Participants
|
63 Participants
n=805 Participants
|
|
TAPS Drug Use
Never
|
165 Participants
n=203 Participants
|
168 Participants
n=198 Participants
|
167 Participants
n=199 Participants
|
158 Participants
n=205 Participants
|
658 Participants
n=805 Participants
|
|
TAPS Drug Use
Missing
|
2 Participants
n=203 Participants
|
0 Participants
n=198 Participants
|
0 Participants
n=199 Participants
|
1 Participants
n=205 Participants
|
3 Participants
n=805 Participants
|
|
TAPS Prescription Drug Used Not as Intended
At Least Once
|
13 Participants
n=203 Participants
|
16 Participants
n=198 Participants
|
12 Participants
n=199 Participants
|
19 Participants
n=205 Participants
|
60 Participants
n=805 Participants
|
|
TAPS Prescription Drug Used Not as Intended
Never
|
188 Participants
n=203 Participants
|
182 Participants
n=198 Participants
|
187 Participants
n=199 Participants
|
185 Participants
n=205 Participants
|
742 Participants
n=805 Participants
|
|
TAPS Prescription Drug Used Not as Intended
Missing
|
2 Participants
n=203 Participants
|
0 Participants
n=198 Participants
|
0 Participants
n=199 Participants
|
1 Participants
n=205 Participants
|
3 Participants
n=805 Participants
|
|
Currently Taking Opioid Medication (daily)
Yes
|
11 Participants
n=203 Participants
|
8 Participants
n=198 Participants
|
9 Participants
n=199 Participants
|
13 Participants
n=205 Participants
|
41 Participants
n=805 Participants
|
|
Currently Taking Opioid Medication (daily)
No
|
192 Participants
n=203 Participants
|
190 Participants
n=198 Participants
|
190 Participants
n=199 Participants
|
192 Participants
n=205 Participants
|
764 Participants
n=805 Participants
|
|
Currently Taking Opioid Medication (daily)
Not Sure
|
0 Participants
n=203 Participants
|
0 Participants
n=198 Participants
|
0 Participants
n=199 Participants
|
0 Participants
n=205 Participants
|
0 Participants
n=805 Participants
|
|
Previously Diagnosed with Coronavirus Disease 2019 (COVID-19)
Yes
|
112 Participants
n=203 Participants
|
98 Participants
n=198 Participants
|
107 Participants
n=199 Participants
|
104 Participants
n=205 Participants
|
421 Participants
n=805 Participants
|
|
Previously Diagnosed with Coronavirus Disease 2019 (COVID-19)
No
|
84 Participants
n=203 Participants
|
95 Participants
n=198 Participants
|
85 Participants
n=199 Participants
|
98 Participants
n=205 Participants
|
362 Participants
n=805 Participants
|
|
Previously Diagnosed with Coronavirus Disease 2019 (COVID-19)
Not Sure
|
4 Participants
n=203 Participants
|
5 Participants
n=198 Participants
|
5 Participants
n=199 Participants
|
1 Participants
n=205 Participants
|
15 Participants
n=805 Participants
|
|
Previously Diagnosed with Coronavirus Disease 2019 (COVID-19)
Prefer not to answer
|
3 Participants
n=203 Participants
|
0 Participants
n=198 Participants
|
2 Participants
n=199 Participants
|
2 Participants
n=205 Participants
|
7 Participants
n=805 Participants
|
|
Previously Diagnosed with Coronavirus Disease 2019 (COVID-19)
Missing
|
0 Participants
n=203 Participants
|
0 Participants
n=198 Participants
|
0 Participants
n=199 Participants
|
0 Participants
n=205 Participants
|
0 Participants
n=805 Participants
|
|
Long COVID
Yes
|
20 Participants
n=203 Participants
|
18 Participants
n=198 Participants
|
21 Participants
n=199 Participants
|
23 Participants
n=205 Participants
|
82 Participants
n=805 Participants
|
|
Long COVID
No
|
79 Participants
n=203 Participants
|
74 Participants
n=198 Participants
|
81 Participants
n=199 Participants
|
74 Participants
n=205 Participants
|
308 Participants
n=805 Participants
|
|
Long COVID
Not Sure
|
13 Participants
n=203 Participants
|
6 Participants
n=198 Participants
|
5 Participants
n=199 Participants
|
7 Participants
n=205 Participants
|
31 Participants
n=805 Participants
|
|
Long COVID
Prefer not to answer
|
0 Participants
n=203 Participants
|
0 Participants
n=198 Participants
|
0 Participants
n=199 Participants
|
0 Participants
n=205 Participants
|
0 Participants
n=805 Participants
|
|
Long COVID
No self-reported COVID-19 diagnosis
|
91 Participants
n=203 Participants
|
100 Participants
n=198 Participants
|
92 Participants
n=199 Participants
|
101 Participants
n=205 Participants
|
384 Participants
n=805 Participants
|
|
COVID-19 Vaccine
Yes
|
186 Participants
n=203 Participants
|
188 Participants
n=198 Participants
|
182 Participants
n=199 Participants
|
189 Participants
n=205 Participants
|
745 Participants
n=805 Participants
|
|
COVID-19 Vaccine
No
|
15 Participants
n=203 Participants
|
8 Participants
n=198 Participants
|
17 Participants
n=199 Participants
|
14 Participants
n=205 Participants
|
54 Participants
n=805 Participants
|
|
COVID-19 Vaccine
Not Sure
|
0 Participants
n=203 Participants
|
0 Participants
n=198 Participants
|
0 Participants
n=199 Participants
|
0 Participants
n=205 Participants
|
0 Participants
n=805 Participants
|
|
COVID-19 Vaccine
Prefer Not to Answer
|
2 Participants
n=203 Participants
|
2 Participants
n=198 Participants
|
0 Participants
n=199 Participants
|
2 Participants
n=205 Participants
|
6 Participants
n=805 Participants
|
|
Fear-Avoidance Beliefs - Physical Activity (FABQ-PA) Score
|
13.7 units on a scale
STANDARD_DEVIATION 5.1 • n=203 Participants
|
12.3 units on a scale
STANDARD_DEVIATION 5.4 • n=198 Participants
|
13.3 units on a scale
STANDARD_DEVIATION 5.2 • n=199 Participants
|
13.4 units on a scale
STANDARD_DEVIATION 5.6 • n=205 Participants
|
13.2 units on a scale
STANDARD_DEVIATION 5.3 • n=805 Participants
|
|
Generalized Anxiety Disorder (GAD-2) Raw Score
|
1.7 units on a scale
STANDARD_DEVIATION 1.8 • n=203 Participants
|
1.1 units on a scale
STANDARD_DEVIATION 1.2 • n=198 Participants
|
1.5 units on a scale
STANDARD_DEVIATION 1.7 • n=199 Participants
|
1.4 units on a scale
STANDARD_DEVIATION 1.6 • n=205 Participants
|
1.4 units on a scale
STANDARD_DEVIATION 1.6 • n=805 Participants
|
|
Keele STarT Back Screening Tool Risk
Low Risk
|
72 Participants
n=203 Participants
|
92 Participants
n=198 Participants
|
73 Participants
n=199 Participants
|
79 Participants
n=205 Participants
|
316 Participants
n=805 Participants
|
|
Keele STarT Back Screening Tool Risk
Medium Risk
|
100 Participants
n=203 Participants
|
79 Participants
n=198 Participants
|
80 Participants
n=199 Participants
|
86 Participants
n=205 Participants
|
345 Participants
n=805 Participants
|
|
Keele STarT Back Screening Tool Risk
High Risk
|
31 Participants
n=203 Participants
|
27 Participants
n=198 Participants
|
44 Participants
n=199 Participants
|
40 Participants
n=205 Participants
|
142 Participants
n=805 Participants
|
|
Keele STarT Back Screening Tool Risk
Missing
|
0 Participants
n=203 Participants
|
0 Participants
n=198 Participants
|
2 Participants
n=199 Participants
|
0 Participants
n=205 Participants
|
2 Participants
n=805 Participants
|
|
Oswestry Disability Index (ODI) Percentage
|
29.4 units on a scale
STANDARD_DEVIATION 13.5 • n=203 Participants
|
27.7 units on a scale
STANDARD_DEVIATION 12.0 • n=198 Participants
|
30.7 units on a scale
STANDARD_DEVIATION 14.1 • n=199 Participants
|
31.1 units on a scale
STANDARD_DEVIATION 14.3 • n=205 Participants
|
29.8 units on a scale
STANDARD_DEVIATION 13.6 • n=805 Participants
|
|
Oswestry Disability Index (ODI) Percentage, median (range)
|
28.0 units on a scale
n=203 Participants
|
26.7 units on a scale
n=198 Participants
|
28.0 units on a scale
n=199 Participants
|
28.9 units on a scale
n=205 Participants
|
28.0 units on a scale
n=805 Participants
|
|
Pain Catastrophizing Scale - Short Form 6 (PCS-SF6)
|
11.6 units on a scale
STANDARD_DEVIATION 5.3 • n=203 Participants
|
10.4 units on a scale
STANDARD_DEVIATION 4.5 • n=198 Participants
|
10.9 units on a scale
STANDARD_DEVIATION 4.9 • n=199 Participants
|
11.7 units on a scale
STANDARD_DEVIATION 5.0 • n=205 Participants
|
11.1 units on a scale
STANDARD_DEVIATION 5.0 • n=805 Participants
|
|
Pain Detect Neuropathic Pain Questionnaire (painDETECT) Raw Score
Nociceptive Pain
|
136 Participants
n=203 Participants
|
154 Participants
n=198 Participants
|
142 Participants
n=199 Participants
|
147 Participants
n=205 Participants
|
579 Participants
n=805 Participants
|
|
Pain Detect Neuropathic Pain Questionnaire (painDETECT) Raw Score
Possible Neuropathic Pain
|
38 Participants
n=203 Participants
|
33 Participants
n=198 Participants
|
35 Participants
n=199 Participants
|
36 Participants
n=205 Participants
|
142 Participants
n=805 Participants
|
|
Pain Detect Neuropathic Pain Questionnaire (painDETECT) Raw Score
Neuropathic Pain
|
28 Participants
n=203 Participants
|
11 Participants
n=198 Participants
|
20 Participants
n=199 Participants
|
20 Participants
n=205 Participants
|
79 Participants
n=805 Participants
|
|
Pain Detect Neuropathic Pain Questionnaire (painDETECT) Raw Score
Missing
|
1 Participants
n=203 Participants
|
0 Participants
n=198 Participants
|
2 Participants
n=199 Participants
|
2 Participants
n=205 Participants
|
5 Participants
n=805 Participants
|
|
Patient Health Questionnaire-2 (PHQ-2): Raw Score
|
1.6 units on a scale
STANDARD_DEVIATION 1.6 • n=203 Participants
|
1.2 units on a scale
STANDARD_DEVIATION 1.2 • n=198 Participants
|
1.4 units on a scale
STANDARD_DEVIATION 1.6 • n=199 Participants
|
1.6 units on a scale
STANDARD_DEVIATION 1.6 • n=205 Participants
|
1.5 units on a scale
STANDARD_DEVIATION 1.5 • n=805 Participants
|
|
Healing Encounters and Attitudes Lists (HEAL) Positive Outlook: Raw Score
|
21.6 units on a scale
STANDARD_DEVIATION 5.6 • n=203 Participants
|
23.0 units on a scale
STANDARD_DEVIATION 4.9 • n=198 Participants
|
21.6 units on a scale
STANDARD_DEVIATION 5.8 • n=199 Participants
|
21.2 units on a scale
STANDARD_DEVIATION 5.4 • n=205 Participants
|
21.8 units on a scale
STANDARD_DEVIATION 5.4 • n=805 Participants
|
|
PROMIS Cognitive Function and Abilities - Short Form 2a Raw Score
|
7.2 units on a scale
STANDARD_DEVIATION 1.8 • n=203 Participants
|
7.5 units on a scale
STANDARD_DEVIATION 1.6 • n=198 Participants
|
7.1 units on a scale
STANDARD_DEVIATION 1.8 • n=199 Participants
|
7.2 units on a scale
STANDARD_DEVIATION 1.8 • n=205 Participants
|
7.3 units on a scale
STANDARD_DEVIATION 1.8 • n=805 Participants
|
|
General Sensory Sensitivity Score (GSS) - External
|
0.9 units on a scale
STANDARD_DEVIATION 1.4 • n=203 Participants
|
0.7 units on a scale
STANDARD_DEVIATION 1.2 • n=198 Participants
|
1.1 units on a scale
STANDARD_DEVIATION 1.5 • n=199 Participants
|
0.9 units on a scale
STANDARD_DEVIATION 1.3 • n=205 Participants
|
0.9 units on a scale
STANDARD_DEVIATION 1.3 • n=805 Participants
|
|
General Sensory Sensitivity (GSS) Score - Interoception
|
0.6 units on a scale
STANDARD_DEVIATION 0.8 • n=203 Participants
|
0.4 units on a scale
STANDARD_DEVIATION 0.7 • n=198 Participants
|
0.6 units on a scale
STANDARD_DEVIATION 0.8 • n=199 Participants
|
0.6 units on a scale
STANDARD_DEVIATION 0.8 • n=205 Participants
|
0.6 units on a scale
STANDARD_DEVIATION 0.8 • n=805 Participants
|
|
General Sensory Sensitivity (GSS) Score - Total
|
1.5 units on a scale
STANDARD_DEVIATION 1.8 • n=203 Participants
|
1.1 units on a scale
STANDARD_DEVIATION 1.6 • n=198 Participants
|
1.7 units on a scale
STANDARD_DEVIATION 2.0 • n=199 Participants
|
1.5 units on a scale
STANDARD_DEVIATION 1.8 • n=205 Participants
|
1.5 units on a scale
STANDARD_DEVIATION 1.8 • n=805 Participants
|
|
Self-reported Sleep Duration in the Past Month (hours)
|
6.6 hours
STANDARD_DEVIATION 1.2 • n=203 Participants
|
6.7 hours
STANDARD_DEVIATION 1.5 • n=198 Participants
|
6.5 hours
STANDARD_DEVIATION 1.2 • n=199 Participants
|
6.6 hours
STANDARD_DEVIATION 1.6 • n=205 Participants
|
6.6 hours
STANDARD_DEVIATION 1.4 • n=805 Participants
|
|
Symptom Severity Index
|
5.5 units on a scale
STANDARD_DEVIATION 2.9 • n=203 Participants
|
4.8 units on a scale
STANDARD_DEVIATION 2.4 • n=198 Participants
|
5.5 units on a scale
STANDARD_DEVIATION 2.9 • n=199 Participants
|
5.9 units on a scale
STANDARD_DEVIATION 2.7 • n=205 Participants
|
5.5 units on a scale
STANDARD_DEVIATION 2.8 • n=805 Participants
|
|
Widespread Pain Inventory: Raw Score
|
2.3 units on a scale
STANDARD_DEVIATION 1.8 • n=203 Participants
|
2.1 units on a scale
STANDARD_DEVIATION 1.8 • n=198 Participants
|
2.4 units on a scale
STANDARD_DEVIATION 1.9 • n=199 Participants
|
2.5 units on a scale
STANDARD_DEVIATION 1.7 • n=205 Participants
|
2.3 units on a scale
STANDARD_DEVIATION 1.8 • n=805 Participants
|
|
Stomach Pain in the Past 4 Weeks
Not bothered at all
|
111 Participants
n=203 Participants
|
120 Participants
n=198 Participants
|
106 Participants
n=199 Participants
|
109 Participants
n=205 Participants
|
446 Participants
n=805 Participants
|
|
Stomach Pain in the Past 4 Weeks
Bothered a little
|
71 Participants
n=203 Participants
|
66 Participants
n=198 Participants
|
78 Participants
n=199 Participants
|
77 Participants
n=205 Participants
|
292 Participants
n=805 Participants
|
|
Stomach Pain in the Past 4 Weeks
Bothered a lot
|
19 Participants
n=203 Participants
|
12 Participants
n=198 Participants
|
15 Participants
n=199 Participants
|
18 Participants
n=205 Participants
|
64 Participants
n=805 Participants
|
|
Stomach Pain in the Past 4 Weeks
Missing
|
2 Participants
n=203 Participants
|
0 Participants
n=198 Participants
|
0 Participants
n=199 Participants
|
1 Participants
n=205 Participants
|
3 Participants
n=805 Participants
|
|
Headaches in the Past 4 Weeks
Not bothered at all
|
86 Participants
n=203 Participants
|
90 Participants
n=198 Participants
|
85 Participants
n=199 Participants
|
77 Participants
n=205 Participants
|
338 Participants
n=805 Participants
|
|
Headaches in the Past 4 Weeks
Bothered a little
|
95 Participants
n=203 Participants
|
96 Participants
n=198 Participants
|
92 Participants
n=199 Participants
|
103 Participants
n=205 Participants
|
386 Participants
n=805 Participants
|
|
Headaches in the Past 4 Weeks
Bothered a lot
|
20 Participants
n=203 Participants
|
12 Participants
n=198 Participants
|
22 Participants
n=199 Participants
|
24 Participants
n=205 Participants
|
78 Participants
n=805 Participants
|
|
Headaches in the Past 4 Weeks
Missing
|
2 Participants
n=203 Participants
|
0 Participants
n=198 Participants
|
0 Participants
n=199 Participants
|
1 Participants
n=205 Participants
|
3 Participants
n=805 Participants
|
|
Radiating Pain to Buttock/Thigh, Past 2 Weeks
Yes
|
117 Participants
n=203 Participants
|
101 Participants
n=198 Participants
|
121 Participants
n=199 Participants
|
132 Participants
n=205 Participants
|
471 Participants
n=805 Participants
|
|
Radiating Pain to Buttock/Thigh, Past 2 Weeks
No
|
65 Participants
n=203 Participants
|
77 Participants
n=198 Participants
|
66 Participants
n=199 Participants
|
62 Participants
n=205 Participants
|
270 Participants
n=805 Participants
|
|
Radiating Pain to Buttock/Thigh, Past 2 Weeks
Not Sure
|
19 Participants
n=203 Participants
|
20 Participants
n=198 Participants
|
12 Participants
n=199 Participants
|
10 Participants
n=205 Participants
|
61 Participants
n=805 Participants
|
|
Radiating Pain to Buttock/Thigh, Past 2 Weeks
Missing
|
2 Participants
n=203 Participants
|
0 Participants
n=198 Participants
|
0 Participants
n=199 Participants
|
1 Participants
n=205 Participants
|
3 Participants
n=805 Participants
|
|
Radiating Pain to Below Knee, Past 2 Weeks
Yes
|
53 Participants
n=203 Participants
|
40 Participants
n=198 Participants
|
52 Participants
n=199 Participants
|
56 Participants
n=205 Participants
|
201 Participants
n=805 Participants
|
|
Radiating Pain to Below Knee, Past 2 Weeks
No
|
126 Participants
n=203 Participants
|
143 Participants
n=198 Participants
|
136 Participants
n=199 Participants
|
132 Participants
n=205 Participants
|
537 Participants
n=805 Participants
|
|
Radiating Pain to Below Knee, Past 2 Weeks
Not Sure
|
22 Participants
n=203 Participants
|
15 Participants
n=198 Participants
|
11 Participants
n=199 Participants
|
16 Participants
n=205 Participants
|
64 Participants
n=805 Participants
|
|
Radiating Pain to Below Knee, Past 2 Weeks
Missing
|
2 Participants
n=203 Participants
|
0 Participants
n=198 Participants
|
0 Participants
n=199 Participants
|
1 Participants
n=205 Participants
|
3 Participants
n=805 Participants
|
|
Social Determinants of Health (SDOH): Transportation Needs
Yes
|
17 Participants
n=203 Participants
|
13 Participants
n=198 Participants
|
14 Participants
n=199 Participants
|
18 Participants
n=205 Participants
|
62 Participants
n=805 Participants
|
|
Social Determinants of Health (SDOH): Transportation Needs
No
|
184 Participants
n=203 Participants
|
185 Participants
n=198 Participants
|
185 Participants
n=199 Participants
|
186 Participants
n=205 Participants
|
740 Participants
n=805 Participants
|
|
Social Determinants of Health (SDOH): Transportation Needs
Missing
|
2 Participants
n=203 Participants
|
0 Participants
n=198 Participants
|
0 Participants
n=199 Participants
|
1 Participants
n=205 Participants
|
3 Participants
n=805 Participants
|
|
Social Determinants of Health (SDOH): Healthcare Needs
Yes
|
33 Participants
n=203 Participants
|
28 Participants
n=198 Participants
|
37 Participants
n=199 Participants
|
31 Participants
n=205 Participants
|
129 Participants
n=805 Participants
|
|
Social Determinants of Health (SDOH): Healthcare Needs
No
|
168 Participants
n=203 Participants
|
170 Participants
n=198 Participants
|
162 Participants
n=199 Participants
|
173 Participants
n=205 Participants
|
673 Participants
n=805 Participants
|
|
Social Determinants of Health (SDOH): Healthcare Needs
Missing
|
2 Participants
n=203 Participants
|
0 Participants
n=198 Participants
|
0 Participants
n=199 Participants
|
1 Participants
n=205 Participants
|
3 Participants
n=805 Participants
|
|
Social Determinants of Health: Food Insecurity
Often True
|
7 Participants
n=203 Participants
|
3 Participants
n=198 Participants
|
7 Participants
n=199 Participants
|
7 Participants
n=205 Participants
|
24 Participants
n=805 Participants
|
|
Social Determinants of Health: Food Insecurity
Sometimes True
|
27 Participants
n=203 Participants
|
17 Participants
n=198 Participants
|
24 Participants
n=199 Participants
|
32 Participants
n=205 Participants
|
100 Participants
n=805 Participants
|
|
Social Determinants of Health: Food Insecurity
Never True
|
167 Participants
n=203 Participants
|
178 Participants
n=198 Participants
|
168 Participants
n=199 Participants
|
165 Participants
n=205 Participants
|
678 Participants
n=805 Participants
|
|
Social Determinants of Health: Food Insecurity
Missing
|
2 Participants
n=203 Participants
|
0 Participants
n=198 Participants
|
0 Participants
n=199 Participants
|
1 Participants
n=205 Participants
|
3 Participants
n=805 Participants
|
|
Social Determinants of Health (SDOH): Food Money
Often True
|
5 Participants
n=203 Participants
|
4 Participants
n=198 Participants
|
7 Participants
n=199 Participants
|
6 Participants
n=205 Participants
|
22 Participants
n=805 Participants
|
|
Social Determinants of Health (SDOH): Food Money
Sometimes True
|
20 Participants
n=203 Participants
|
9 Participants
n=198 Participants
|
21 Participants
n=199 Participants
|
22 Participants
n=205 Participants
|
72 Participants
n=805 Participants
|
|
Social Determinants of Health (SDOH): Food Money
Never True
|
176 Participants
n=203 Participants
|
185 Participants
n=198 Participants
|
171 Participants
n=199 Participants
|
176 Participants
n=205 Participants
|
708 Participants
n=805 Participants
|
|
Social Determinants of Health (SDOH): Food Money
Missing
|
2 Participants
n=203 Participants
|
0 Participants
n=198 Participants
|
0 Participants
n=199 Participants
|
1 Participants
n=205 Participants
|
3 Participants
n=805 Participants
|
|
Social Determinants of Health (SDOH): Utilities
Yes
|
5 Participants
n=203 Participants
|
9 Participants
n=198 Participants
|
6 Participants
n=199 Participants
|
11 Participants
n=205 Participants
|
31 Participants
n=805 Participants
|
|
Social Determinants of Health (SDOH): Utilities
No
|
196 Participants
n=203 Participants
|
189 Participants
n=198 Participants
|
193 Participants
n=199 Participants
|
193 Participants
n=205 Participants
|
771 Participants
n=805 Participants
|
|
Social Determinants of Health (SDOH): Utilities
Missing
|
2 Participants
n=203 Participants
|
0 Participants
n=198 Participants
|
0 Participants
n=199 Participants
|
1 Participants
n=205 Participants
|
3 Participants
n=805 Participants
|
|
Social Determinants of Health (SDOH): Stable Housing
Yes
|
14 Participants
n=203 Participants
|
6 Participants
n=198 Participants
|
12 Participants
n=199 Participants
|
16 Participants
n=205 Participants
|
48 Participants
n=805 Participants
|
|
Social Determinants of Health (SDOH): Stable Housing
No
|
187 Participants
n=203 Participants
|
192 Participants
n=198 Participants
|
187 Participants
n=199 Participants
|
188 Participants
n=205 Participants
|
754 Participants
n=805 Participants
|
|
Social Determinants of Health (SDOH): Stable Housing
Missing
|
2 Participants
n=203 Participants
|
0 Participants
n=198 Participants
|
0 Participants
n=199 Participants
|
1 Participants
n=205 Participants
|
3 Participants
n=805 Participants
|
|
Social Determinants of Health (SDOH): Emotional Support
Yes
|
185 Participants
n=203 Participants
|
180 Participants
n=198 Participants
|
184 Participants
n=199 Participants
|
187 Participants
n=205 Participants
|
736 Participants
n=805 Participants
|
|
Social Determinants of Health (SDOH): Emotional Support
No
|
16 Participants
n=203 Participants
|
17 Participants
n=198 Participants
|
15 Participants
n=199 Participants
|
17 Participants
n=205 Participants
|
65 Participants
n=805 Participants
|
|
Social Determinants of Health (SDOH): Emotional Support
Missing
|
2 Participants
n=203 Participants
|
1 Participants
n=198 Participants
|
0 Participants
n=199 Participants
|
1 Participants
n=205 Participants
|
4 Participants
n=805 Participants
|
|
Social Determinants of Health (SDOH): Number of Close Friends
0
|
1 Participants
n=203 Participants
|
8 Participants
n=198 Participants
|
6 Participants
n=199 Participants
|
2 Participants
n=205 Participants
|
17 Participants
n=805 Participants
|
|
Social Determinants of Health (SDOH): Number of Close Friends
1-2
|
46 Participants
n=203 Participants
|
41 Participants
n=198 Participants
|
46 Participants
n=199 Participants
|
49 Participants
n=205 Participants
|
182 Participants
n=805 Participants
|
|
Social Determinants of Health (SDOH): Number of Close Friends
3-5
|
99 Participants
n=203 Participants
|
89 Participants
n=198 Participants
|
90 Participants
n=199 Participants
|
94 Participants
n=205 Participants
|
372 Participants
n=805 Participants
|
|
Social Determinants of Health (SDOH): Number of Close Friends
6-10
|
36 Participants
n=203 Participants
|
40 Participants
n=198 Participants
|
40 Participants
n=199 Participants
|
48 Participants
n=205 Participants
|
164 Participants
n=805 Participants
|
|
Social Determinants of Health (SDOH): Number of Close Friends
More than 10
|
19 Participants
n=203 Participants
|
20 Participants
n=198 Participants
|
17 Participants
n=199 Participants
|
11 Participants
n=205 Participants
|
67 Participants
n=805 Participants
|
|
Social Determinants of Health (SDOH): Number of Close Friends
Missing
|
2 Participants
n=203 Participants
|
0 Participants
n=198 Participants
|
0 Participants
n=199 Participants
|
1 Participants
n=205 Participants
|
3 Participants
n=805 Participants
|
|
Perceived Discrimination: Race/Ethnicity
Never
|
113 Participants
n=203 Participants
|
120 Participants
n=198 Participants
|
115 Participants
n=199 Participants
|
126 Participants
n=205 Participants
|
474 Participants
n=805 Participants
|
|
Perceived Discrimination: Race/Ethnicity
Rarely
|
47 Participants
n=203 Participants
|
42 Participants
n=198 Participants
|
45 Participants
n=199 Participants
|
40 Participants
n=205 Participants
|
174 Participants
n=805 Participants
|
|
Perceived Discrimination: Race/Ethnicity
Sometimes
|
40 Participants
n=203 Participants
|
36 Participants
n=198 Participants
|
39 Participants
n=199 Participants
|
38 Participants
n=205 Participants
|
153 Participants
n=805 Participants
|
|
Perceived Discrimination: Race/Ethnicity
Often to Almost Always
|
0 Participants
n=203 Participants
|
0 Participants
n=198 Participants
|
0 Participants
n=199 Participants
|
0 Participants
n=205 Participants
|
0 Participants
n=805 Participants
|
|
Perceived Discrimination: Race/Ethnicity
Not sure
|
0 Participants
n=203 Participants
|
0 Participants
n=198 Participants
|
0 Participants
n=199 Participants
|
0 Participants
n=205 Participants
|
0 Participants
n=805 Participants
|
|
Perceived Discrimination: Race/Ethnicity
Missing
|
3 Participants
n=203 Participants
|
0 Participants
n=198 Participants
|
0 Participants
n=199 Participants
|
1 Participants
n=205 Participants
|
4 Participants
n=805 Participants
|
|
Perceived Discrimination: Orientation/Gender Identity
Never
|
161 Participants
n=203 Participants
|
172 Participants
n=198 Participants
|
159 Participants
n=199 Participants
|
166 Participants
n=205 Participants
|
658 Participants
n=805 Participants
|
|
Perceived Discrimination: Orientation/Gender Identity
Rarely
|
24 Participants
n=203 Participants
|
16 Participants
n=198 Participants
|
20 Participants
n=199 Participants
|
19 Participants
n=205 Participants
|
79 Participants
n=805 Participants
|
|
Perceived Discrimination: Orientation/Gender Identity
Sometimes
|
16 Participants
n=203 Participants
|
10 Participants
n=198 Participants
|
20 Participants
n=199 Participants
|
19 Participants
n=205 Participants
|
65 Participants
n=805 Participants
|
|
Perceived Discrimination: Orientation/Gender Identity
Often to Almost Always
|
0 Participants
n=203 Participants
|
0 Participants
n=198 Participants
|
0 Participants
n=199 Participants
|
0 Participants
n=205 Participants
|
0 Participants
n=805 Participants
|
|
Perceived Discrimination: Orientation/Gender Identity
Not sure
|
0 Participants
n=203 Participants
|
0 Participants
n=198 Participants
|
0 Participants
n=199 Participants
|
0 Participants
n=205 Participants
|
0 Participants
n=805 Participants
|
|
Perceived Discrimination: Orientation/Gender Identity
Missing
|
2 Participants
n=203 Participants
|
0 Participants
n=198 Participants
|
0 Participants
n=199 Participants
|
1 Participants
n=205 Participants
|
3 Participants
n=805 Participants
|
PRIMARY outcome
Timeframe: Baseline, 24 WeeksPopulation: The analysis population is the all-randomized population to Stage 1 interventions.
Patient-reported pain intensity and interference is measured by the Pain, Enjoyment of Life, and General Activity (PEG) scale. The PEG is a series of 3 questions. Results range from -10 to 10, with higher scores indicating increased pain intensity and interference at 24 Weeks compared to Baseline.
Outcome measures
| Measure |
Stage 1: Acceptance and Commitment Therapy (ACT)
n=203 Participants
ACT is a form of cognitive behavioral therapy that is well established for the treatment of chronic pain. The goal of ACT is to build psychological flexibility thereby interrupting pain avoidance behavior patterns. Participants randomized to ACT will take part in 12 sessions over the course of 12 weeks. Sessions will be delivered as a combination of 4 remote face-to-face visits with a therapist and 8 therapist-supported online sessions (self-directed online modules supported by provider coaching). Online sessions will focus on helping participants accept pain, connect with negative thoughts and emotions, develop mindfulness and identify and commit to values and goals that are important to them. During face-to-face sessions with the therapist, participants will be encouraged to share their experience of skills practice and mastery, provide examples of skill use at home, and describe what barriers they encountered.
|
Stage 1: Duloxetine
n=198 Participants
Duloxetine is a serotonin norepinephrine reuptake inhibitor (SNRI) that is FDA-approved for use in Chronic Low-Back Pain, and, as such, is included as a recommended therapy in nearly all current treatment guidelines for low back pain. Study participants will be treated with duloxetine for 12 weeks during the active treatment phase. At the time of randomization, the approved drug pharmacy at each study site will dispense between 185 and 192 duloxetine 30 mg capsules and provide to participants. This will ensure enough capsules to maintain up to a 60 mg dosage through the 12-week intervention phase and to taper the dose in the 13th week if needed.
|
Stage 1: Evidence Based Exercise and Manual Therapy (EBEM)
n=199 Participants
Licensed physical therapists (PTs) or Doctors of Chiropractic (DCs) will rely on evidence-based guidance to direct decision-making on the particular type of manual and exercise therapy that may be best suited to an individual study participant. Special attention will be paid to the clinician's choice of language in regard to the purpose and expected outcomes of manual therapy in order to avoid enhancing catastrophizing ideations or preference for passive interventions. A total of 10 sessions will be provided over an 8-week treatment period. Two sessions per week are provided in the first two weeks followed by weekly sessions over the next 6 weeks. Treatment sessions will last approximately 60 minutes each.
|
Stage 1: Enhanced Self-Care Therapy (ESC)
n=205 Participants
The Enhanced Self-Care intervention will be comprised of educational modules on evidence-based cognitive-behavioral self-management skills for pain. These modules will be provided digitally for self-administration over a period of 12 weeks. There will be no therapist associated with the delivery of these educational materials; however, after the first four modules, email or text messages will be used to make personalized recommendations for accessing additional modules based upon identified problems from the baseline assessment. Additionally, the walking program module will utilize Fitbit step tracking to allow participants to monitor their walking progress.
|
|---|---|---|---|---|
|
Patient-Reported Pain Intensity and Interference Score
|
4.16 score on a scale
Interval 3.74 to 4.58
|
3.86 score on a scale
Interval 3.43 to 4.28
|
3.57 score on a scale
Interval 3.15 to 3.99
|
4.72 score on a scale
Interval 4.3 to 5.14
|
SECONDARY outcome
Timeframe: Baseline, 24 WeeksPopulation: The analysis population is the all-randomized population to Stage 1 interventions.
Pain interference is measured by the 4-item PROMIS (Patient-Reported Outcomes Measurement Information System) Pain Interference scale (PROMIS-PI, 4a). The PROMIS-PI, 4a is a series of 4 questions, and measures self-reported consequences of pain on relevant aspects of one's life. Results range from -34 to 34 (t-scores range from 41.6 to 75.6). For each t-score, 50 indicates the population mean with a standard deviation of 10. Lower scores indicate lower pain interference and a better outcome. PROMIS measures are not used for clinical decision making but to describe participant symptoms.
Outcome measures
| Measure |
Stage 1: Acceptance and Commitment Therapy (ACT)
n=203 Participants
ACT is a form of cognitive behavioral therapy that is well established for the treatment of chronic pain. The goal of ACT is to build psychological flexibility thereby interrupting pain avoidance behavior patterns. Participants randomized to ACT will take part in 12 sessions over the course of 12 weeks. Sessions will be delivered as a combination of 4 remote face-to-face visits with a therapist and 8 therapist-supported online sessions (self-directed online modules supported by provider coaching). Online sessions will focus on helping participants accept pain, connect with negative thoughts and emotions, develop mindfulness and identify and commit to values and goals that are important to them. During face-to-face sessions with the therapist, participants will be encouraged to share their experience of skills practice and mastery, provide examples of skill use at home, and describe what barriers they encountered.
|
Stage 1: Duloxetine
n=198 Participants
Duloxetine is a serotonin norepinephrine reuptake inhibitor (SNRI) that is FDA-approved for use in Chronic Low-Back Pain, and, as such, is included as a recommended therapy in nearly all current treatment guidelines for low back pain. Study participants will be treated with duloxetine for 12 weeks during the active treatment phase. At the time of randomization, the approved drug pharmacy at each study site will dispense between 185 and 192 duloxetine 30 mg capsules and provide to participants. This will ensure enough capsules to maintain up to a 60 mg dosage through the 12-week intervention phase and to taper the dose in the 13th week if needed.
|
Stage 1: Evidence Based Exercise and Manual Therapy (EBEM)
n=199 Participants
Licensed physical therapists (PTs) or Doctors of Chiropractic (DCs) will rely on evidence-based guidance to direct decision-making on the particular type of manual and exercise therapy that may be best suited to an individual study participant. Special attention will be paid to the clinician's choice of language in regard to the purpose and expected outcomes of manual therapy in order to avoid enhancing catastrophizing ideations or preference for passive interventions. A total of 10 sessions will be provided over an 8-week treatment period. Two sessions per week are provided in the first two weeks followed by weekly sessions over the next 6 weeks. Treatment sessions will last approximately 60 minutes each.
|
Stage 1: Enhanced Self-Care Therapy (ESC)
n=205 Participants
The Enhanced Self-Care intervention will be comprised of educational modules on evidence-based cognitive-behavioral self-management skills for pain. These modules will be provided digitally for self-administration over a period of 12 weeks. There will be no therapist associated with the delivery of these educational materials; however, after the first four modules, email or text messages will be used to make personalized recommendations for accessing additional modules based upon identified problems from the baseline assessment. Additionally, the walking program module will utilize Fitbit step tracking to allow participants to monitor their walking progress.
|
|---|---|---|---|---|
|
Patient-Reported Outcomes Measurement Information System-Pain Interference
|
59.03 t-scores
Interval 57.67 to 60.39
|
58.48 t-scores
Interval 57.12 to 59.84
|
57.61 t-scores
Interval 56.25 to 58.97
|
60.13 t-scores
Interval 58.77 to 61.49
|
SECONDARY outcome
Timeframe: 24 WeeksPopulation: The analysis population is the all-randomized population to Stage 1 interventions.
The number of participants self-reporting taking opioids ("Yes" response) is measured by a single question, "Are you currently taking any opioid pain medication on a daily basis?".
Outcome measures
| Measure |
Stage 1: Acceptance and Commitment Therapy (ACT)
n=203 Participants
ACT is a form of cognitive behavioral therapy that is well established for the treatment of chronic pain. The goal of ACT is to build psychological flexibility thereby interrupting pain avoidance behavior patterns. Participants randomized to ACT will take part in 12 sessions over the course of 12 weeks. Sessions will be delivered as a combination of 4 remote face-to-face visits with a therapist and 8 therapist-supported online sessions (self-directed online modules supported by provider coaching). Online sessions will focus on helping participants accept pain, connect with negative thoughts and emotions, develop mindfulness and identify and commit to values and goals that are important to them. During face-to-face sessions with the therapist, participants will be encouraged to share their experience of skills practice and mastery, provide examples of skill use at home, and describe what barriers they encountered.
|
Stage 1: Duloxetine
n=198 Participants
Duloxetine is a serotonin norepinephrine reuptake inhibitor (SNRI) that is FDA-approved for use in Chronic Low-Back Pain, and, as such, is included as a recommended therapy in nearly all current treatment guidelines for low back pain. Study participants will be treated with duloxetine for 12 weeks during the active treatment phase. At the time of randomization, the approved drug pharmacy at each study site will dispense between 185 and 192 duloxetine 30 mg capsules and provide to participants. This will ensure enough capsules to maintain up to a 60 mg dosage through the 12-week intervention phase and to taper the dose in the 13th week if needed.
|
Stage 1: Evidence Based Exercise and Manual Therapy (EBEM)
n=199 Participants
Licensed physical therapists (PTs) or Doctors of Chiropractic (DCs) will rely on evidence-based guidance to direct decision-making on the particular type of manual and exercise therapy that may be best suited to an individual study participant. Special attention will be paid to the clinician's choice of language in regard to the purpose and expected outcomes of manual therapy in order to avoid enhancing catastrophizing ideations or preference for passive interventions. A total of 10 sessions will be provided over an 8-week treatment period. Two sessions per week are provided in the first two weeks followed by weekly sessions over the next 6 weeks. Treatment sessions will last approximately 60 minutes each.
|
Stage 1: Enhanced Self-Care Therapy (ESC)
n=205 Participants
The Enhanced Self-Care intervention will be comprised of educational modules on evidence-based cognitive-behavioral self-management skills for pain. These modules will be provided digitally for self-administration over a period of 12 weeks. There will be no therapist associated with the delivery of these educational materials; however, after the first four modules, email or text messages will be used to make personalized recommendations for accessing additional modules based upon identified problems from the baseline assessment. Additionally, the walking program module will utilize Fitbit step tracking to allow participants to monitor their walking progress.
|
|---|---|---|---|---|
|
Number of Participants Self-Reporting Taking Opioids
|
8 Participants
|
6 Participants
|
8 Participants
|
9 Participants
|
SECONDARY outcome
Timeframe: Baseline, 24 WeeksPopulation: The analysis population is the all-randomized population to Stage 1 interventions.
Physical function is measured by the Patient-Reported Outcomes Measurement Information System-Physical Function (PROMIS-PF) Short Form 6b. The PROMIS-PF Short Form 6b is a series of 6 questions. T-scores range from 21.6 to 58.7 and for each t-score, 50 indicates the population mean with a standard deviation of 10. Results range from -37.1 to 37.1, with higher physical function scores indicating a better outcome and increased physical functioning at 24 Weeks compared to Baseline. A higher physical function is the better outcome. PROMIS measures are not used for clinical decision making but to describe participant symptoms.
Outcome measures
| Measure |
Stage 1: Acceptance and Commitment Therapy (ACT)
n=203 Participants
ACT is a form of cognitive behavioral therapy that is well established for the treatment of chronic pain. The goal of ACT is to build psychological flexibility thereby interrupting pain avoidance behavior patterns. Participants randomized to ACT will take part in 12 sessions over the course of 12 weeks. Sessions will be delivered as a combination of 4 remote face-to-face visits with a therapist and 8 therapist-supported online sessions (self-directed online modules supported by provider coaching). Online sessions will focus on helping participants accept pain, connect with negative thoughts and emotions, develop mindfulness and identify and commit to values and goals that are important to them. During face-to-face sessions with the therapist, participants will be encouraged to share their experience of skills practice and mastery, provide examples of skill use at home, and describe what barriers they encountered.
|
Stage 1: Duloxetine
n=198 Participants
Duloxetine is a serotonin norepinephrine reuptake inhibitor (SNRI) that is FDA-approved for use in Chronic Low-Back Pain, and, as such, is included as a recommended therapy in nearly all current treatment guidelines for low back pain. Study participants will be treated with duloxetine for 12 weeks during the active treatment phase. At the time of randomization, the approved drug pharmacy at each study site will dispense between 185 and 192 duloxetine 30 mg capsules and provide to participants. This will ensure enough capsules to maintain up to a 60 mg dosage through the 12-week intervention phase and to taper the dose in the 13th week if needed.
|
Stage 1: Evidence Based Exercise and Manual Therapy (EBEM)
n=199 Participants
Licensed physical therapists (PTs) or Doctors of Chiropractic (DCs) will rely on evidence-based guidance to direct decision-making on the particular type of manual and exercise therapy that may be best suited to an individual study participant. Special attention will be paid to the clinician's choice of language in regard to the purpose and expected outcomes of manual therapy in order to avoid enhancing catastrophizing ideations or preference for passive interventions. A total of 10 sessions will be provided over an 8-week treatment period. Two sessions per week are provided in the first two weeks followed by weekly sessions over the next 6 weeks. Treatment sessions will last approximately 60 minutes each.
|
Stage 1: Enhanced Self-Care Therapy (ESC)
n=205 Participants
The Enhanced Self-Care intervention will be comprised of educational modules on evidence-based cognitive-behavioral self-management skills for pain. These modules will be provided digitally for self-administration over a period of 12 weeks. There will be no therapist associated with the delivery of these educational materials; however, after the first four modules, email or text messages will be used to make personalized recommendations for accessing additional modules based upon identified problems from the baseline assessment. Additionally, the walking program module will utilize Fitbit step tracking to allow participants to monitor their walking progress.
|
|---|---|---|---|---|
|
Patient-Reported Outcomes Measurement Information System- Physical Function
|
42.14 t-scores
Interval 40.81 to 43.46
|
43.32 t-scores
Interval 41.99 to 44.64
|
43.11 t-scores
Interval 41.78 to 44.43
|
41.18 t-scores
Interval 39.86 to 42.5
|
SECONDARY outcome
Timeframe: Baseline, 24 WeeksPopulation: The analysis population is the all-randomized population to Stage 1 interventions.
Depression score is measured by the Patient-Reported Outcomes Measurement Information System (PROMIS) 4-item depression scale from the PROMIS 29 profile. The PROMIS 4-item depression scale from the PROMIS 29 profile is a series of 4 questions. T-scores range from 41.0 to 79.4), and for each t-score, 50 indicates the population mean with a standard deviation of 10. Results range from -38.4 to 38.4, with higher scores indicating increased depression at 24 Weeks compared to Baseline. A lower depression score is the better outcome. PROMIS measures are not used for clinical decision making but to describe participant symptoms.
Outcome measures
| Measure |
Stage 1: Acceptance and Commitment Therapy (ACT)
n=203 Participants
ACT is a form of cognitive behavioral therapy that is well established for the treatment of chronic pain. The goal of ACT is to build psychological flexibility thereby interrupting pain avoidance behavior patterns. Participants randomized to ACT will take part in 12 sessions over the course of 12 weeks. Sessions will be delivered as a combination of 4 remote face-to-face visits with a therapist and 8 therapist-supported online sessions (self-directed online modules supported by provider coaching). Online sessions will focus on helping participants accept pain, connect with negative thoughts and emotions, develop mindfulness and identify and commit to values and goals that are important to them. During face-to-face sessions with the therapist, participants will be encouraged to share their experience of skills practice and mastery, provide examples of skill use at home, and describe what barriers they encountered.
|
Stage 1: Duloxetine
n=198 Participants
Duloxetine is a serotonin norepinephrine reuptake inhibitor (SNRI) that is FDA-approved for use in Chronic Low-Back Pain, and, as such, is included as a recommended therapy in nearly all current treatment guidelines for low back pain. Study participants will be treated with duloxetine for 12 weeks during the active treatment phase. At the time of randomization, the approved drug pharmacy at each study site will dispense between 185 and 192 duloxetine 30 mg capsules and provide to participants. This will ensure enough capsules to maintain up to a 60 mg dosage through the 12-week intervention phase and to taper the dose in the 13th week if needed.
|
Stage 1: Evidence Based Exercise and Manual Therapy (EBEM)
n=199 Participants
Licensed physical therapists (PTs) or Doctors of Chiropractic (DCs) will rely on evidence-based guidance to direct decision-making on the particular type of manual and exercise therapy that may be best suited to an individual study participant. Special attention will be paid to the clinician's choice of language in regard to the purpose and expected outcomes of manual therapy in order to avoid enhancing catastrophizing ideations or preference for passive interventions. A total of 10 sessions will be provided over an 8-week treatment period. Two sessions per week are provided in the first two weeks followed by weekly sessions over the next 6 weeks. Treatment sessions will last approximately 60 minutes each.
|
Stage 1: Enhanced Self-Care Therapy (ESC)
n=205 Participants
The Enhanced Self-Care intervention will be comprised of educational modules on evidence-based cognitive-behavioral self-management skills for pain. These modules will be provided digitally for self-administration over a period of 12 weeks. There will be no therapist associated with the delivery of these educational materials; however, after the first four modules, email or text messages will be used to make personalized recommendations for accessing additional modules based upon identified problems from the baseline assessment. Additionally, the walking program module will utilize Fitbit step tracking to allow participants to monitor their walking progress.
|
|---|---|---|---|---|
|
Patient-Reported Outcomes Measurement Information System (PROMIS) - Depression Score
|
49.22 t-scores
Interval 47.71 to 50.74
|
47.83 t-scores
Interval 46.32 to 49.35
|
49.03 t-scores
Interval 47.51 to 50.54
|
50.19 t-scores
Interval 48.68 to 51.71
|
SECONDARY outcome
Timeframe: Baseline, 24 WeeksPopulation: The analysis population is the all-randomized population to Stage 1 interventions.
Anxiety score is measured by the Patient-Reported Outcomes Measurement Information System-Emotional Distress-Anxiety (PROMIS-EDA) scale 4a. The PROMIS-EDA 4a is a series of 4 questions. T-scores range from 40.3 to 81.6, and for each t-score, 50 indicates the population mean with a standard deviation of 10. Results range from -41.3 to 41.3, with higher scores indicating increased anxiety at 24 Weeks compared to Baseline. A lower anxiety score is the better outcome. PROMIS measures are not used for clinical decision making but to describe participant symptoms.
Outcome measures
| Measure |
Stage 1: Acceptance and Commitment Therapy (ACT)
n=203 Participants
ACT is a form of cognitive behavioral therapy that is well established for the treatment of chronic pain. The goal of ACT is to build psychological flexibility thereby interrupting pain avoidance behavior patterns. Participants randomized to ACT will take part in 12 sessions over the course of 12 weeks. Sessions will be delivered as a combination of 4 remote face-to-face visits with a therapist and 8 therapist-supported online sessions (self-directed online modules supported by provider coaching). Online sessions will focus on helping participants accept pain, connect with negative thoughts and emotions, develop mindfulness and identify and commit to values and goals that are important to them. During face-to-face sessions with the therapist, participants will be encouraged to share their experience of skills practice and mastery, provide examples of skill use at home, and describe what barriers they encountered.
|
Stage 1: Duloxetine
n=198 Participants
Duloxetine is a serotonin norepinephrine reuptake inhibitor (SNRI) that is FDA-approved for use in Chronic Low-Back Pain, and, as such, is included as a recommended therapy in nearly all current treatment guidelines for low back pain. Study participants will be treated with duloxetine for 12 weeks during the active treatment phase. At the time of randomization, the approved drug pharmacy at each study site will dispense between 185 and 192 duloxetine 30 mg capsules and provide to participants. This will ensure enough capsules to maintain up to a 60 mg dosage through the 12-week intervention phase and to taper the dose in the 13th week if needed.
|
Stage 1: Evidence Based Exercise and Manual Therapy (EBEM)
n=199 Participants
Licensed physical therapists (PTs) or Doctors of Chiropractic (DCs) will rely on evidence-based guidance to direct decision-making on the particular type of manual and exercise therapy that may be best suited to an individual study participant. Special attention will be paid to the clinician's choice of language in regard to the purpose and expected outcomes of manual therapy in order to avoid enhancing catastrophizing ideations or preference for passive interventions. A total of 10 sessions will be provided over an 8-week treatment period. Two sessions per week are provided in the first two weeks followed by weekly sessions over the next 6 weeks. Treatment sessions will last approximately 60 minutes each.
|
Stage 1: Enhanced Self-Care Therapy (ESC)
n=205 Participants
The Enhanced Self-Care intervention will be comprised of educational modules on evidence-based cognitive-behavioral self-management skills for pain. These modules will be provided digitally for self-administration over a period of 12 weeks. There will be no therapist associated with the delivery of these educational materials; however, after the first four modules, email or text messages will be used to make personalized recommendations for accessing additional modules based upon identified problems from the baseline assessment. Additionally, the walking program module will utilize Fitbit step tracking to allow participants to monitor their walking progress.
|
|---|---|---|---|---|
|
Patient-Reported Outcomes Measurement Information System-Emotional Distress-Anxiety
|
49.73 t-scores
Interval 48.1 to 51.35
|
48.15 t-scores
Interval 46.52 to 49.77
|
49.14 t-scores
Interval 47.52 to 50.77
|
50.43 t-scores
Interval 48.8 to 52.05
|
SECONDARY outcome
Timeframe: Baseline, 24 WeeksPopulation: The analysis population is the all-randomized population to Stage 1 interventions.
Sleep disturbance is measured by the Patient-Reported Outcomes Measurement Information System (PROMIS) short form 6a. The PROMIS short form 6a is a series of 6 questions. T-scores range from 31.7 to 76.1 and for each t-score, 50 indicates the population mean with a standard deviation of 10). Results range from -44.4 to 44.4, with higher scores indicating increased sleep disturbance at 24 Weeks compared to Baseline. A lower sleep disturbance score is the better outcome. PPROMIS measures are not used for clinical decision making but to describe participant symptoms.
Outcome measures
| Measure |
Stage 1: Acceptance and Commitment Therapy (ACT)
n=203 Participants
ACT is a form of cognitive behavioral therapy that is well established for the treatment of chronic pain. The goal of ACT is to build psychological flexibility thereby interrupting pain avoidance behavior patterns. Participants randomized to ACT will take part in 12 sessions over the course of 12 weeks. Sessions will be delivered as a combination of 4 remote face-to-face visits with a therapist and 8 therapist-supported online sessions (self-directed online modules supported by provider coaching). Online sessions will focus on helping participants accept pain, connect with negative thoughts and emotions, develop mindfulness and identify and commit to values and goals that are important to them. During face-to-face sessions with the therapist, participants will be encouraged to share their experience of skills practice and mastery, provide examples of skill use at home, and describe what barriers they encountered.
|
Stage 1: Duloxetine
n=198 Participants
Duloxetine is a serotonin norepinephrine reuptake inhibitor (SNRI) that is FDA-approved for use in Chronic Low-Back Pain, and, as such, is included as a recommended therapy in nearly all current treatment guidelines for low back pain. Study participants will be treated with duloxetine for 12 weeks during the active treatment phase. At the time of randomization, the approved drug pharmacy at each study site will dispense between 185 and 192 duloxetine 30 mg capsules and provide to participants. This will ensure enough capsules to maintain up to a 60 mg dosage through the 12-week intervention phase and to taper the dose in the 13th week if needed.
|
Stage 1: Evidence Based Exercise and Manual Therapy (EBEM)
n=199 Participants
Licensed physical therapists (PTs) or Doctors of Chiropractic (DCs) will rely on evidence-based guidance to direct decision-making on the particular type of manual and exercise therapy that may be best suited to an individual study participant. Special attention will be paid to the clinician's choice of language in regard to the purpose and expected outcomes of manual therapy in order to avoid enhancing catastrophizing ideations or preference for passive interventions. A total of 10 sessions will be provided over an 8-week treatment period. Two sessions per week are provided in the first two weeks followed by weekly sessions over the next 6 weeks. Treatment sessions will last approximately 60 minutes each.
|
Stage 1: Enhanced Self-Care Therapy (ESC)
n=205 Participants
The Enhanced Self-Care intervention will be comprised of educational modules on evidence-based cognitive-behavioral self-management skills for pain. These modules will be provided digitally for self-administration over a period of 12 weeks. There will be no therapist associated with the delivery of these educational materials; however, after the first four modules, email or text messages will be used to make personalized recommendations for accessing additional modules based upon identified problems from the baseline assessment. Additionally, the walking program module will utilize Fitbit step tracking to allow participants to monitor their walking progress.
|
|---|---|---|---|---|
|
Patient-Reported Outcomes Measurement Information System - Sleep Disturbance
|
52.61 t-scores
Interval 50.98 to 54.25
|
51.45 t-scores
Interval 49.82 to 53.09
|
51.91 t-scores
Interval 50.28 to 53.54
|
53.21 t-scores
Interval 51.58 to 54.84
|
SECONDARY outcome
Timeframe: Baseline, 24 WeeksPopulation: The analysis population is the all-randomized population to Stage 1 interventions.
Sleep duration is measured by the Back Pain Consortium (BACPAC) sleep duration question, "During the past month, how many hours and minutes of actual sleep did you get at night? (This may be different than the number of hours and minutes you spent in bed)." Participants respond with a number of hours and minutes. Results range from -24 to 24 hours, with higher number of hours indicating increased sleep duration at 24 Weeks compared to Baseline.
Outcome measures
| Measure |
Stage 1: Acceptance and Commitment Therapy (ACT)
n=203 Participants
ACT is a form of cognitive behavioral therapy that is well established for the treatment of chronic pain. The goal of ACT is to build psychological flexibility thereby interrupting pain avoidance behavior patterns. Participants randomized to ACT will take part in 12 sessions over the course of 12 weeks. Sessions will be delivered as a combination of 4 remote face-to-face visits with a therapist and 8 therapist-supported online sessions (self-directed online modules supported by provider coaching). Online sessions will focus on helping participants accept pain, connect with negative thoughts and emotions, develop mindfulness and identify and commit to values and goals that are important to them. During face-to-face sessions with the therapist, participants will be encouraged to share their experience of skills practice and mastery, provide examples of skill use at home, and describe what barriers they encountered.
|
Stage 1: Duloxetine
n=198 Participants
Duloxetine is a serotonin norepinephrine reuptake inhibitor (SNRI) that is FDA-approved for use in Chronic Low-Back Pain, and, as such, is included as a recommended therapy in nearly all current treatment guidelines for low back pain. Study participants will be treated with duloxetine for 12 weeks during the active treatment phase. At the time of randomization, the approved drug pharmacy at each study site will dispense between 185 and 192 duloxetine 30 mg capsules and provide to participants. This will ensure enough capsules to maintain up to a 60 mg dosage through the 12-week intervention phase and to taper the dose in the 13th week if needed.
|
Stage 1: Evidence Based Exercise and Manual Therapy (EBEM)
n=199 Participants
Licensed physical therapists (PTs) or Doctors of Chiropractic (DCs) will rely on evidence-based guidance to direct decision-making on the particular type of manual and exercise therapy that may be best suited to an individual study participant. Special attention will be paid to the clinician's choice of language in regard to the purpose and expected outcomes of manual therapy in order to avoid enhancing catastrophizing ideations or preference for passive interventions. A total of 10 sessions will be provided over an 8-week treatment period. Two sessions per week are provided in the first two weeks followed by weekly sessions over the next 6 weeks. Treatment sessions will last approximately 60 minutes each.
|
Stage 1: Enhanced Self-Care Therapy (ESC)
n=205 Participants
The Enhanced Self-Care intervention will be comprised of educational modules on evidence-based cognitive-behavioral self-management skills for pain. These modules will be provided digitally for self-administration over a period of 12 weeks. There will be no therapist associated with the delivery of these educational materials; however, after the first four modules, email or text messages will be used to make personalized recommendations for accessing additional modules based upon identified problems from the baseline assessment. Additionally, the walking program module will utilize Fitbit step tracking to allow participants to monitor their walking progress.
|
|---|---|---|---|---|
|
Sleep Duration
|
6.82 units on a scale
Interval 6.58 to 7.06
|
6.74 units on a scale
Interval 6.49 to 6.98
|
6.73 units on a scale
Interval 6.49 to 6.97
|
6.67 units on a scale
Interval 6.43 to 6.91
|
Adverse Events
Stage 1: Acceptance and Commitment Therapy (ACT)
Serious events: 4 serious events
Other events: 2 other events
Deaths: 0 deaths
Stage 1: Duloxetine
Serious events: 1 serious events
Other events: 92 other events
Deaths: 0 deaths
Stage 1: Evidence Based Exercise and Manual Therapy (EBEM)
Serious events: 6 serious events
Other events: 7 other events
Deaths: 0 deaths
Stage 1: Enhanced Self-Care Therapy (ESC)
Serious events: 2 serious events
Other events: 4 other events
Deaths: 0 deaths
Stage 2: Acceptance and Commitment Therapy (ACT)
Serious events: 4 serious events
Other events: 1 other events
Deaths: 0 deaths
Stage 2: Duloxetine
Serious events: 0 serious events
Other events: 29 other events
Deaths: 0 deaths
Stage 2: Evidence Based Exercise and Manual Therapy (EBEM)
Serious events: 3 serious events
Other events: 3 other events
Deaths: 0 deaths
Stage 2: Enhanced Self-Care Therapy (ESC)
Serious events: 2 serious events
Other events: 0 other events
Deaths: 0 deaths
Stage 2: ACT and Duloxetine
Serious events: 1 serious events
Other events: 12 other events
Deaths: 0 deaths
Stage 2: ACT and EBEM
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Stage 2: ACT and ESC
Serious events: 4 serious events
Other events: 2 other events
Deaths: 0 deaths
Stage 2: Duloxetine and EBEM
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Stage 2: Duloxetine and ESC
Serious events: 1 serious events
Other events: 18 other events
Deaths: 0 deaths
Stage 2: EBEM and ESC
Serious events: 4 serious events
Other events: 5 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Stage 1: Acceptance and Commitment Therapy (ACT)
n=191 participants at risk
ACT is a form of cognitive behavioral therapy that is well established for the treatment of chronic pain. The goal of ACT is to build psychological flexibility thereby interrupting pain avoidance behavior patterns. Participants randomized to ACT will take part in 12 sessions over the course of 12 weeks. Sessions will be delivered as a combination of 4 remote face-to-face visits with a therapist and 8 therapist-supported online sessions (self-directed online modules supported by provider coaching). Online sessions will focus on helping participants accept pain, connect with negative thoughts and emotions, develop mindfulness and identify and commit to values and goals that are important to them. During face-to-face sessions with the therapist, participants will be encouraged to share their experience of skills practice and mastery, provide examples of skill use at home, and describe what barriers they encountered.
|
Stage 1: Duloxetine
n=172 participants at risk
Duloxetine is a serotonin norepinephrine reuptake inhibitor (SNRI) that is FDA-approved for use in Chronic Low-Back Pain, and, as such, is included as a recommended therapy in nearly all current treatment guidelines for low back pain. Study participants will be treated with duloxetine for 12 weeks during the active treatment phase. At the time of randomization, the approved drug pharmacy at each study site will dispense between 185 and 192 duloxetine 30 mg capsules and provide to participants. This will ensure enough capsules to maintain up to a 60 mg dosage through the 12-week intervention phase and to taper the dose in the 13th week if needed.
|
Stage 1: Evidence Based Exercise and Manual Therapy (EBEM)
n=184 participants at risk
Licensed physical therapists (PTs) or Doctors of Chiropractic (DCs) will rely on evidence-based guidance to direct decision-making on the particular type of manual and exercise therapy that may be best suited to an individual study participant. Special attention will be paid to the clinician's choice of language in regard to the purpose and expected outcomes of manual therapy in order to avoid enhancing catastrophizing ideations or preference for passive interventions. A total of 10 sessions will be provided over an 8-week treatment period. Two sessions per week are provided in the first two weeks followed by weekly sessions over the next 6 weeks. Treatment sessions will last approximately 60 minutes each.
|
Stage 1: Enhanced Self-Care Therapy (ESC)
n=205 participants at risk
The Enhanced Self-Care intervention will be comprised of educational modules on evidence-based cognitive-behavioral self-management skills for pain. These modules will be provided digitally for self-administration over a period of 12 weeks. There will be no therapist associated with the delivery of these educational materials; however, after the first four modules, email or text messages will be used to make personalized recommendations for accessing additional modules based upon identified problems from the baseline assessment. Additionally, the walking program module will utilize Fitbit step tracking to allow participants to monitor their walking progress.
|
Stage 2: Acceptance and Commitment Therapy (ACT)
n=65 participants at risk
Participants newly randomized to ACT in Stage 2 will take part in 12 sessions over the course of 12 weeks. Sessions will be delivered as a combination of 4 remote face-to-face visits with a therapist and 8 therapist-supported online sessions (self-directed online modules supported by provider coaching). Participants assigned to maintain ACT will be encouraged to continue at-home skills and will have access to all previously viewed online content. In addition, participants will have access to 11 additional online ACT audio modules, but without the communications with the therapist.
|
Stage 2: Duloxetine
n=71 participants at risk
Study participants will be treated with duloxetine for 12 weeks during the active treatment phase. All participants will be assessed at the midpoint of the intervention treatment period (Week 18) for tolerance, adverse events, and response. At the midpoint phone call:
Participants tolerating the medication with no side effects will be instructed to increase to 60mg/day (if currently taking 30mg/day) or remain on their current dosage (if currently taking 60mg/day).
|
Stage 2: Evidence Based Exercise and Manual Therapy (EBEM)
n=110 participants at risk
Participants newly randomized to EBEM in stage 2 will take part in a total of 10 sessions over an 8-week treatment period. Two sessions per week are provided in the first two weeks followed by weekly sessions over the next 6 weeks. Treatment sessions will last approximately 60 minutes each. Participants assigned to maintain EBEM will receive 4 additional in-person EBEM sessions during weeks 1-4 of this period. If visits are missed and/or need to be rescheduled, visits may be scheduled up to 5 weeks from the date of the first augmenting/maintenance visit.
|
Stage 2: Enhanced Self-Care Therapy (ESC)
n=85 participants at risk
Participants newly randomized to ESC in stage 2 will be provided modules digitally for self-administration over a period of 12 weeks. There will be no therapist associated with the delivery of these educational materials; however, after the first four modules, email or text messages will be used to make personalized recommendations for accessing additional modules based upon identified problems from the baseline assessment. Additionally, the walking program module will utilize Fitbit step tracking to allow participants to monitor their walking progress. Participants assigned to maintain ESC in the second period intervention will receive personalized recommendations based on the most recently completed PROMIS 29+2.
|
Stage 2: ACT and Duloxetine
n=33 participants at risk
Participants received both ACT and duloxetine in Stage 2. Participants who received augmented Stage 2 treatments always continued their stage 1 treatment. The continued intervention matches the dose of those maintaining Stage 1 treatment alone, and the added intervention is as if they were newly randomized.
|
Stage 2: ACT and EBEM
n=52 participants at risk
Participants received both ACT and EBEM in Stage 2. Participants who received augmented Stage 2 treatments always continued their stage 1 treatment. The continued intervention matches the dose of those maintaining Stage 1 treatment alone, and the added intervention is as if they were newly randomized.
|
Stage 2: ACT and ESC
n=84 participants at risk
Participants received both ACT and ESC in Stage 2. Participants who received augmented Stage 2 treatments always continued their stage 1 treatment. The continued intervention matches the dose of those maintaining Stage 1 treatment alone, and the added intervention is as if they were newly randomized.
|
Stage 2: Duloxetine and EBEM
n=22 participants at risk
Participants received both duloxetine and EBEM in Stage 2. Participants who received augmented Stage 2 treatments always continued their stage 1 treatment. The continued intervention matches the dose of those maintaining Stage 1 treatment alone, and the added intervention is as if they were newly randomized.
|
Stage 2: Duloxetine and ESC
n=54 participants at risk
Participants received both duloxetine and ESC in Stage 2. Participants who received augmented Stage 2 treatments always continued their stage 1 treatment. The continued intervention matches the dose of those maintaining Stage 1 treatment alone, and the added intervention is as if they were newly randomized.
|
Stage 2: EBEM and ESC
n=85 participants at risk
Participants received both EBEM and ESC in Stage 2. Participants who received augmented Stage 2 treatments always continued their stage 1 treatment. The continued intervention matches the dose of those maintaining Stage 1 treatment alone, and the added intervention is as if they were newly randomized.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Reproductive system and breast disorders
Prostate cancer
|
0.00%
0/191 • All adverse events were recorded between the time the participant provided informed consent at Week -2 (Run-in Period: Weeks -2 to 0) through 4 weeks after their last treatment (Stage 1 intervention period: Weeks 0 to 12; Stage 2 intervention period: Weeks 12 to 24), up to 30 weeks.
|
0.00%
0/172 • All adverse events were recorded between the time the participant provided informed consent at Week -2 (Run-in Period: Weeks -2 to 0) through 4 weeks after their last treatment (Stage 1 intervention period: Weeks 0 to 12; Stage 2 intervention period: Weeks 12 to 24), up to 30 weeks.
|
0.00%
0/184 • All adverse events were recorded between the time the participant provided informed consent at Week -2 (Run-in Period: Weeks -2 to 0) through 4 weeks after their last treatment (Stage 1 intervention period: Weeks 0 to 12; Stage 2 intervention period: Weeks 12 to 24), up to 30 weeks.
|
0.00%
0/205 • All adverse events were recorded between the time the participant provided informed consent at Week -2 (Run-in Period: Weeks -2 to 0) through 4 weeks after their last treatment (Stage 1 intervention period: Weeks 0 to 12; Stage 2 intervention period: Weeks 12 to 24), up to 30 weeks.
|
0.00%
0/65 • All adverse events were recorded between the time the participant provided informed consent at Week -2 (Run-in Period: Weeks -2 to 0) through 4 weeks after their last treatment (Stage 1 intervention period: Weeks 0 to 12; Stage 2 intervention period: Weeks 12 to 24), up to 30 weeks.
|
0.00%
0/71 • All adverse events were recorded between the time the participant provided informed consent at Week -2 (Run-in Period: Weeks -2 to 0) through 4 weeks after their last treatment (Stage 1 intervention period: Weeks 0 to 12; Stage 2 intervention period: Weeks 12 to 24), up to 30 weeks.
|
0.00%
0/110 • All adverse events were recorded between the time the participant provided informed consent at Week -2 (Run-in Period: Weeks -2 to 0) through 4 weeks after their last treatment (Stage 1 intervention period: Weeks 0 to 12; Stage 2 intervention period: Weeks 12 to 24), up to 30 weeks.
|
1.2%
1/85 • Number of events 1 • All adverse events were recorded between the time the participant provided informed consent at Week -2 (Run-in Period: Weeks -2 to 0) through 4 weeks after their last treatment (Stage 1 intervention period: Weeks 0 to 12; Stage 2 intervention period: Weeks 12 to 24), up to 30 weeks.
|
0.00%
0/33 • All adverse events were recorded between the time the participant provided informed consent at Week -2 (Run-in Period: Weeks -2 to 0) through 4 weeks after their last treatment (Stage 1 intervention period: Weeks 0 to 12; Stage 2 intervention period: Weeks 12 to 24), up to 30 weeks.
|
0.00%
0/52 • All adverse events were recorded between the time the participant provided informed consent at Week -2 (Run-in Period: Weeks -2 to 0) through 4 weeks after their last treatment (Stage 1 intervention period: Weeks 0 to 12; Stage 2 intervention period: Weeks 12 to 24), up to 30 weeks.
|
0.00%
0/84 • All adverse events were recorded between the time the participant provided informed consent at Week -2 (Run-in Period: Weeks -2 to 0) through 4 weeks after their last treatment (Stage 1 intervention period: Weeks 0 to 12; Stage 2 intervention period: Weeks 12 to 24), up to 30 weeks.
|
0.00%
0/22 • All adverse events were recorded between the time the participant provided informed consent at Week -2 (Run-in Period: Weeks -2 to 0) through 4 weeks after their last treatment (Stage 1 intervention period: Weeks 0 to 12; Stage 2 intervention period: Weeks 12 to 24), up to 30 weeks.
|
0.00%
0/54 • All adverse events were recorded between the time the participant provided informed consent at Week -2 (Run-in Period: Weeks -2 to 0) through 4 weeks after their last treatment (Stage 1 intervention period: Weeks 0 to 12; Stage 2 intervention period: Weeks 12 to 24), up to 30 weeks.
|
0.00%
0/85 • All adverse events were recorded between the time the participant provided informed consent at Week -2 (Run-in Period: Weeks -2 to 0) through 4 weeks after their last treatment (Stage 1 intervention period: Weeks 0 to 12; Stage 2 intervention period: Weeks 12 to 24), up to 30 weeks.
|
|
Cardiac disorders
Atrial Fibrillation
|
0.00%
0/191 • All adverse events were recorded between the time the participant provided informed consent at Week -2 (Run-in Period: Weeks -2 to 0) through 4 weeks after their last treatment (Stage 1 intervention period: Weeks 0 to 12; Stage 2 intervention period: Weeks 12 to 24), up to 30 weeks.
|
0.00%
0/172 • All adverse events were recorded between the time the participant provided informed consent at Week -2 (Run-in Period: Weeks -2 to 0) through 4 weeks after their last treatment (Stage 1 intervention period: Weeks 0 to 12; Stage 2 intervention period: Weeks 12 to 24), up to 30 weeks.
|
0.00%
0/184 • All adverse events were recorded between the time the participant provided informed consent at Week -2 (Run-in Period: Weeks -2 to 0) through 4 weeks after their last treatment (Stage 1 intervention period: Weeks 0 to 12; Stage 2 intervention period: Weeks 12 to 24), up to 30 weeks.
|
0.00%
0/205 • All adverse events were recorded between the time the participant provided informed consent at Week -2 (Run-in Period: Weeks -2 to 0) through 4 weeks after their last treatment (Stage 1 intervention period: Weeks 0 to 12; Stage 2 intervention period: Weeks 12 to 24), up to 30 weeks.
|
0.00%
0/65 • All adverse events were recorded between the time the participant provided informed consent at Week -2 (Run-in Period: Weeks -2 to 0) through 4 weeks after their last treatment (Stage 1 intervention period: Weeks 0 to 12; Stage 2 intervention period: Weeks 12 to 24), up to 30 weeks.
|
0.00%
0/71 • All adverse events were recorded between the time the participant provided informed consent at Week -2 (Run-in Period: Weeks -2 to 0) through 4 weeks after their last treatment (Stage 1 intervention period: Weeks 0 to 12; Stage 2 intervention period: Weeks 12 to 24), up to 30 weeks.
|
0.00%
0/110 • All adverse events were recorded between the time the participant provided informed consent at Week -2 (Run-in Period: Weeks -2 to 0) through 4 weeks after their last treatment (Stage 1 intervention period: Weeks 0 to 12; Stage 2 intervention period: Weeks 12 to 24), up to 30 weeks.
|
0.00%
0/85 • All adverse events were recorded between the time the participant provided informed consent at Week -2 (Run-in Period: Weeks -2 to 0) through 4 weeks after their last treatment (Stage 1 intervention period: Weeks 0 to 12; Stage 2 intervention period: Weeks 12 to 24), up to 30 weeks.
|
0.00%
0/33 • All adverse events were recorded between the time the participant provided informed consent at Week -2 (Run-in Period: Weeks -2 to 0) through 4 weeks after their last treatment (Stage 1 intervention period: Weeks 0 to 12; Stage 2 intervention period: Weeks 12 to 24), up to 30 weeks.
|
0.00%
0/52 • All adverse events were recorded between the time the participant provided informed consent at Week -2 (Run-in Period: Weeks -2 to 0) through 4 weeks after their last treatment (Stage 1 intervention period: Weeks 0 to 12; Stage 2 intervention period: Weeks 12 to 24), up to 30 weeks.
|
0.00%
0/84 • All adverse events were recorded between the time the participant provided informed consent at Week -2 (Run-in Period: Weeks -2 to 0) through 4 weeks after their last treatment (Stage 1 intervention period: Weeks 0 to 12; Stage 2 intervention period: Weeks 12 to 24), up to 30 weeks.
|
0.00%
0/22 • All adverse events were recorded between the time the participant provided informed consent at Week -2 (Run-in Period: Weeks -2 to 0) through 4 weeks after their last treatment (Stage 1 intervention period: Weeks 0 to 12; Stage 2 intervention period: Weeks 12 to 24), up to 30 weeks.
|
0.00%
0/54 • All adverse events were recorded between the time the participant provided informed consent at Week -2 (Run-in Period: Weeks -2 to 0) through 4 weeks after their last treatment (Stage 1 intervention period: Weeks 0 to 12; Stage 2 intervention period: Weeks 12 to 24), up to 30 weeks.
|
1.2%
1/85 • Number of events 1 • All adverse events were recorded between the time the participant provided informed consent at Week -2 (Run-in Period: Weeks -2 to 0) through 4 weeks after their last treatment (Stage 1 intervention period: Weeks 0 to 12; Stage 2 intervention period: Weeks 12 to 24), up to 30 weeks.
|
|
Cardiac disorders
Chest pain
|
0.00%
0/191 • All adverse events were recorded between the time the participant provided informed consent at Week -2 (Run-in Period: Weeks -2 to 0) through 4 weeks after their last treatment (Stage 1 intervention period: Weeks 0 to 12; Stage 2 intervention period: Weeks 12 to 24), up to 30 weeks.
|
0.00%
0/172 • All adverse events were recorded between the time the participant provided informed consent at Week -2 (Run-in Period: Weeks -2 to 0) through 4 weeks after their last treatment (Stage 1 intervention period: Weeks 0 to 12; Stage 2 intervention period: Weeks 12 to 24), up to 30 weeks.
|
0.00%
0/184 • All adverse events were recorded between the time the participant provided informed consent at Week -2 (Run-in Period: Weeks -2 to 0) through 4 weeks after their last treatment (Stage 1 intervention period: Weeks 0 to 12; Stage 2 intervention period: Weeks 12 to 24), up to 30 weeks.
|
0.00%
0/205 • All adverse events were recorded between the time the participant provided informed consent at Week -2 (Run-in Period: Weeks -2 to 0) through 4 weeks after their last treatment (Stage 1 intervention period: Weeks 0 to 12; Stage 2 intervention period: Weeks 12 to 24), up to 30 weeks.
|
0.00%
0/65 • All adverse events were recorded between the time the participant provided informed consent at Week -2 (Run-in Period: Weeks -2 to 0) through 4 weeks after their last treatment (Stage 1 intervention period: Weeks 0 to 12; Stage 2 intervention period: Weeks 12 to 24), up to 30 weeks.
|
0.00%
0/71 • All adverse events were recorded between the time the participant provided informed consent at Week -2 (Run-in Period: Weeks -2 to 0) through 4 weeks after their last treatment (Stage 1 intervention period: Weeks 0 to 12; Stage 2 intervention period: Weeks 12 to 24), up to 30 weeks.
|
0.00%
0/110 • All adverse events were recorded between the time the participant provided informed consent at Week -2 (Run-in Period: Weeks -2 to 0) through 4 weeks after their last treatment (Stage 1 intervention period: Weeks 0 to 12; Stage 2 intervention period: Weeks 12 to 24), up to 30 weeks.
|
0.00%
0/85 • All adverse events were recorded between the time the participant provided informed consent at Week -2 (Run-in Period: Weeks -2 to 0) through 4 weeks after their last treatment (Stage 1 intervention period: Weeks 0 to 12; Stage 2 intervention period: Weeks 12 to 24), up to 30 weeks.
|
0.00%
0/33 • All adverse events were recorded between the time the participant provided informed consent at Week -2 (Run-in Period: Weeks -2 to 0) through 4 weeks after their last treatment (Stage 1 intervention period: Weeks 0 to 12; Stage 2 intervention period: Weeks 12 to 24), up to 30 weeks.
|
0.00%
0/52 • All adverse events were recorded between the time the participant provided informed consent at Week -2 (Run-in Period: Weeks -2 to 0) through 4 weeks after their last treatment (Stage 1 intervention period: Weeks 0 to 12; Stage 2 intervention period: Weeks 12 to 24), up to 30 weeks.
|
0.00%
0/84 • All adverse events were recorded between the time the participant provided informed consent at Week -2 (Run-in Period: Weeks -2 to 0) through 4 weeks after their last treatment (Stage 1 intervention period: Weeks 0 to 12; Stage 2 intervention period: Weeks 12 to 24), up to 30 weeks.
|
0.00%
0/22 • All adverse events were recorded between the time the participant provided informed consent at Week -2 (Run-in Period: Weeks -2 to 0) through 4 weeks after their last treatment (Stage 1 intervention period: Weeks 0 to 12; Stage 2 intervention period: Weeks 12 to 24), up to 30 weeks.
|
0.00%
0/54 • All adverse events were recorded between the time the participant provided informed consent at Week -2 (Run-in Period: Weeks -2 to 0) through 4 weeks after their last treatment (Stage 1 intervention period: Weeks 0 to 12; Stage 2 intervention period: Weeks 12 to 24), up to 30 weeks.
|
1.2%
1/85 • Number of events 1 • All adverse events were recorded between the time the participant provided informed consent at Week -2 (Run-in Period: Weeks -2 to 0) through 4 weeks after their last treatment (Stage 1 intervention period: Weeks 0 to 12; Stage 2 intervention period: Weeks 12 to 24), up to 30 weeks.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/191 • All adverse events were recorded between the time the participant provided informed consent at Week -2 (Run-in Period: Weeks -2 to 0) through 4 weeks after their last treatment (Stage 1 intervention period: Weeks 0 to 12; Stage 2 intervention period: Weeks 12 to 24), up to 30 weeks.
|
0.00%
0/172 • All adverse events were recorded between the time the participant provided informed consent at Week -2 (Run-in Period: Weeks -2 to 0) through 4 weeks after their last treatment (Stage 1 intervention period: Weeks 0 to 12; Stage 2 intervention period: Weeks 12 to 24), up to 30 weeks.
|
0.54%
1/184 • Number of events 1 • All adverse events were recorded between the time the participant provided informed consent at Week -2 (Run-in Period: Weeks -2 to 0) through 4 weeks after their last treatment (Stage 1 intervention period: Weeks 0 to 12; Stage 2 intervention period: Weeks 12 to 24), up to 30 weeks.
|
0.00%
0/205 • All adverse events were recorded between the time the participant provided informed consent at Week -2 (Run-in Period: Weeks -2 to 0) through 4 weeks after their last treatment (Stage 1 intervention period: Weeks 0 to 12; Stage 2 intervention period: Weeks 12 to 24), up to 30 weeks.
|
0.00%
0/65 • All adverse events were recorded between the time the participant provided informed consent at Week -2 (Run-in Period: Weeks -2 to 0) through 4 weeks after their last treatment (Stage 1 intervention period: Weeks 0 to 12; Stage 2 intervention period: Weeks 12 to 24), up to 30 weeks.
|
0.00%
0/71 • All adverse events were recorded between the time the participant provided informed consent at Week -2 (Run-in Period: Weeks -2 to 0) through 4 weeks after their last treatment (Stage 1 intervention period: Weeks 0 to 12; Stage 2 intervention period: Weeks 12 to 24), up to 30 weeks.
|
0.00%
0/110 • All adverse events were recorded between the time the participant provided informed consent at Week -2 (Run-in Period: Weeks -2 to 0) through 4 weeks after their last treatment (Stage 1 intervention period: Weeks 0 to 12; Stage 2 intervention period: Weeks 12 to 24), up to 30 weeks.
|
0.00%
0/85 • All adverse events were recorded between the time the participant provided informed consent at Week -2 (Run-in Period: Weeks -2 to 0) through 4 weeks after their last treatment (Stage 1 intervention period: Weeks 0 to 12; Stage 2 intervention period: Weeks 12 to 24), up to 30 weeks.
|
0.00%
0/33 • All adverse events were recorded between the time the participant provided informed consent at Week -2 (Run-in Period: Weeks -2 to 0) through 4 weeks after their last treatment (Stage 1 intervention period: Weeks 0 to 12; Stage 2 intervention period: Weeks 12 to 24), up to 30 weeks.
|
0.00%
0/52 • All adverse events were recorded between the time the participant provided informed consent at Week -2 (Run-in Period: Weeks -2 to 0) through 4 weeks after their last treatment (Stage 1 intervention period: Weeks 0 to 12; Stage 2 intervention period: Weeks 12 to 24), up to 30 weeks.
|
0.00%
0/84 • All adverse events were recorded between the time the participant provided informed consent at Week -2 (Run-in Period: Weeks -2 to 0) through 4 weeks after their last treatment (Stage 1 intervention period: Weeks 0 to 12; Stage 2 intervention period: Weeks 12 to 24), up to 30 weeks.
|
0.00%
0/22 • All adverse events were recorded between the time the participant provided informed consent at Week -2 (Run-in Period: Weeks -2 to 0) through 4 weeks after their last treatment (Stage 1 intervention period: Weeks 0 to 12; Stage 2 intervention period: Weeks 12 to 24), up to 30 weeks.
|
0.00%
0/54 • All adverse events were recorded between the time the participant provided informed consent at Week -2 (Run-in Period: Weeks -2 to 0) through 4 weeks after their last treatment (Stage 1 intervention period: Weeks 0 to 12; Stage 2 intervention period: Weeks 12 to 24), up to 30 weeks.
|
0.00%
0/85 • All adverse events were recorded between the time the participant provided informed consent at Week -2 (Run-in Period: Weeks -2 to 0) through 4 weeks after their last treatment (Stage 1 intervention period: Weeks 0 to 12; Stage 2 intervention period: Weeks 12 to 24), up to 30 weeks.
|
|
Gastrointestinal disorders
Appendicitis
|
0.52%
1/191 • Number of events 1 • All adverse events were recorded between the time the participant provided informed consent at Week -2 (Run-in Period: Weeks -2 to 0) through 4 weeks after their last treatment (Stage 1 intervention period: Weeks 0 to 12; Stage 2 intervention period: Weeks 12 to 24), up to 30 weeks.
|
0.00%
0/172 • All adverse events were recorded between the time the participant provided informed consent at Week -2 (Run-in Period: Weeks -2 to 0) through 4 weeks after their last treatment (Stage 1 intervention period: Weeks 0 to 12; Stage 2 intervention period: Weeks 12 to 24), up to 30 weeks.
|
0.00%
0/184 • All adverse events were recorded between the time the participant provided informed consent at Week -2 (Run-in Period: Weeks -2 to 0) through 4 weeks after their last treatment (Stage 1 intervention period: Weeks 0 to 12; Stage 2 intervention period: Weeks 12 to 24), up to 30 weeks.
|
0.00%
0/205 • All adverse events were recorded between the time the participant provided informed consent at Week -2 (Run-in Period: Weeks -2 to 0) through 4 weeks after their last treatment (Stage 1 intervention period: Weeks 0 to 12; Stage 2 intervention period: Weeks 12 to 24), up to 30 weeks.
|
0.00%
0/65 • All adverse events were recorded between the time the participant provided informed consent at Week -2 (Run-in Period: Weeks -2 to 0) through 4 weeks after their last treatment (Stage 1 intervention period: Weeks 0 to 12; Stage 2 intervention period: Weeks 12 to 24), up to 30 weeks.
|
0.00%
0/71 • All adverse events were recorded between the time the participant provided informed consent at Week -2 (Run-in Period: Weeks -2 to 0) through 4 weeks after their last treatment (Stage 1 intervention period: Weeks 0 to 12; Stage 2 intervention period: Weeks 12 to 24), up to 30 weeks.
|
0.00%
0/110 • All adverse events were recorded between the time the participant provided informed consent at Week -2 (Run-in Period: Weeks -2 to 0) through 4 weeks after their last treatment (Stage 1 intervention period: Weeks 0 to 12; Stage 2 intervention period: Weeks 12 to 24), up to 30 weeks.
|
0.00%
0/85 • All adverse events were recorded between the time the participant provided informed consent at Week -2 (Run-in Period: Weeks -2 to 0) through 4 weeks after their last treatment (Stage 1 intervention period: Weeks 0 to 12; Stage 2 intervention period: Weeks 12 to 24), up to 30 weeks.
|
0.00%
0/33 • All adverse events were recorded between the time the participant provided informed consent at Week -2 (Run-in Period: Weeks -2 to 0) through 4 weeks after their last treatment (Stage 1 intervention period: Weeks 0 to 12; Stage 2 intervention period: Weeks 12 to 24), up to 30 weeks.
|
0.00%
0/52 • All adverse events were recorded between the time the participant provided informed consent at Week -2 (Run-in Period: Weeks -2 to 0) through 4 weeks after their last treatment (Stage 1 intervention period: Weeks 0 to 12; Stage 2 intervention period: Weeks 12 to 24), up to 30 weeks.
|
0.00%
0/84 • All adverse events were recorded between the time the participant provided informed consent at Week -2 (Run-in Period: Weeks -2 to 0) through 4 weeks after their last treatment (Stage 1 intervention period: Weeks 0 to 12; Stage 2 intervention period: Weeks 12 to 24), up to 30 weeks.
|
0.00%
0/22 • All adverse events were recorded between the time the participant provided informed consent at Week -2 (Run-in Period: Weeks -2 to 0) through 4 weeks after their last treatment (Stage 1 intervention period: Weeks 0 to 12; Stage 2 intervention period: Weeks 12 to 24), up to 30 weeks.
|
0.00%
0/54 • All adverse events were recorded between the time the participant provided informed consent at Week -2 (Run-in Period: Weeks -2 to 0) through 4 weeks after their last treatment (Stage 1 intervention period: Weeks 0 to 12; Stage 2 intervention period: Weeks 12 to 24), up to 30 weeks.
|
0.00%
0/85 • All adverse events were recorded between the time the participant provided informed consent at Week -2 (Run-in Period: Weeks -2 to 0) through 4 weeks after their last treatment (Stage 1 intervention period: Weeks 0 to 12; Stage 2 intervention period: Weeks 12 to 24), up to 30 weeks.
|
|
Gastrointestinal disorders
Colitis ulcerative
|
0.00%
0/191 • All adverse events were recorded between the time the participant provided informed consent at Week -2 (Run-in Period: Weeks -2 to 0) through 4 weeks after their last treatment (Stage 1 intervention period: Weeks 0 to 12; Stage 2 intervention period: Weeks 12 to 24), up to 30 weeks.
|
0.00%
0/172 • All adverse events were recorded between the time the participant provided informed consent at Week -2 (Run-in Period: Weeks -2 to 0) through 4 weeks after their last treatment (Stage 1 intervention period: Weeks 0 to 12; Stage 2 intervention period: Weeks 12 to 24), up to 30 weeks.
|
0.00%
0/184 • All adverse events were recorded between the time the participant provided informed consent at Week -2 (Run-in Period: Weeks -2 to 0) through 4 weeks after their last treatment (Stage 1 intervention period: Weeks 0 to 12; Stage 2 intervention period: Weeks 12 to 24), up to 30 weeks.
|
0.00%
0/205 • All adverse events were recorded between the time the participant provided informed consent at Week -2 (Run-in Period: Weeks -2 to 0) through 4 weeks after their last treatment (Stage 1 intervention period: Weeks 0 to 12; Stage 2 intervention period: Weeks 12 to 24), up to 30 weeks.
|
0.00%
0/65 • All adverse events were recorded between the time the participant provided informed consent at Week -2 (Run-in Period: Weeks -2 to 0) through 4 weeks after their last treatment (Stage 1 intervention period: Weeks 0 to 12; Stage 2 intervention period: Weeks 12 to 24), up to 30 weeks.
|
0.00%
0/71 • All adverse events were recorded between the time the participant provided informed consent at Week -2 (Run-in Period: Weeks -2 to 0) through 4 weeks after their last treatment (Stage 1 intervention period: Weeks 0 to 12; Stage 2 intervention period: Weeks 12 to 24), up to 30 weeks.
|
0.91%
1/110 • Number of events 1 • All adverse events were recorded between the time the participant provided informed consent at Week -2 (Run-in Period: Weeks -2 to 0) through 4 weeks after their last treatment (Stage 1 intervention period: Weeks 0 to 12; Stage 2 intervention period: Weeks 12 to 24), up to 30 weeks.
|
0.00%
0/85 • All adverse events were recorded between the time the participant provided informed consent at Week -2 (Run-in Period: Weeks -2 to 0) through 4 weeks after their last treatment (Stage 1 intervention period: Weeks 0 to 12; Stage 2 intervention period: Weeks 12 to 24), up to 30 weeks.
|
0.00%
0/33 • All adverse events were recorded between the time the participant provided informed consent at Week -2 (Run-in Period: Weeks -2 to 0) through 4 weeks after their last treatment (Stage 1 intervention period: Weeks 0 to 12; Stage 2 intervention period: Weeks 12 to 24), up to 30 weeks.
|
0.00%
0/52 • All adverse events were recorded between the time the participant provided informed consent at Week -2 (Run-in Period: Weeks -2 to 0) through 4 weeks after their last treatment (Stage 1 intervention period: Weeks 0 to 12; Stage 2 intervention period: Weeks 12 to 24), up to 30 weeks.
|
0.00%
0/84 • All adverse events were recorded between the time the participant provided informed consent at Week -2 (Run-in Period: Weeks -2 to 0) through 4 weeks after their last treatment (Stage 1 intervention period: Weeks 0 to 12; Stage 2 intervention period: Weeks 12 to 24), up to 30 weeks.
|
0.00%
0/22 • All adverse events were recorded between the time the participant provided informed consent at Week -2 (Run-in Period: Weeks -2 to 0) through 4 weeks after their last treatment (Stage 1 intervention period: Weeks 0 to 12; Stage 2 intervention period: Weeks 12 to 24), up to 30 weeks.
|
0.00%
0/54 • All adverse events were recorded between the time the participant provided informed consent at Week -2 (Run-in Period: Weeks -2 to 0) through 4 weeks after their last treatment (Stage 1 intervention period: Weeks 0 to 12; Stage 2 intervention period: Weeks 12 to 24), up to 30 weeks.
|
0.00%
0/85 • All adverse events were recorded between the time the participant provided informed consent at Week -2 (Run-in Period: Weeks -2 to 0) through 4 weeks after their last treatment (Stage 1 intervention period: Weeks 0 to 12; Stage 2 intervention period: Weeks 12 to 24), up to 30 weeks.
|
|
Gastrointestinal disorders
Gastroenteritis
|
0.00%
0/191 • All adverse events were recorded between the time the participant provided informed consent at Week -2 (Run-in Period: Weeks -2 to 0) through 4 weeks after their last treatment (Stage 1 intervention period: Weeks 0 to 12; Stage 2 intervention period: Weeks 12 to 24), up to 30 weeks.
|
0.00%
0/172 • All adverse events were recorded between the time the participant provided informed consent at Week -2 (Run-in Period: Weeks -2 to 0) through 4 weeks after their last treatment (Stage 1 intervention period: Weeks 0 to 12; Stage 2 intervention period: Weeks 12 to 24), up to 30 weeks.
|
0.00%
0/184 • All adverse events were recorded between the time the participant provided informed consent at Week -2 (Run-in Period: Weeks -2 to 0) through 4 weeks after their last treatment (Stage 1 intervention period: Weeks 0 to 12; Stage 2 intervention period: Weeks 12 to 24), up to 30 weeks.
|
0.00%
0/205 • All adverse events were recorded between the time the participant provided informed consent at Week -2 (Run-in Period: Weeks -2 to 0) through 4 weeks after their last treatment (Stage 1 intervention period: Weeks 0 to 12; Stage 2 intervention period: Weeks 12 to 24), up to 30 weeks.
|
1.5%
1/65 • Number of events 1 • All adverse events were recorded between the time the participant provided informed consent at Week -2 (Run-in Period: Weeks -2 to 0) through 4 weeks after their last treatment (Stage 1 intervention period: Weeks 0 to 12; Stage 2 intervention period: Weeks 12 to 24), up to 30 weeks.
|
0.00%
0/71 • All adverse events were recorded between the time the participant provided informed consent at Week -2 (Run-in Period: Weeks -2 to 0) through 4 weeks after their last treatment (Stage 1 intervention period: Weeks 0 to 12; Stage 2 intervention period: Weeks 12 to 24), up to 30 weeks.
|
0.00%
0/110 • All adverse events were recorded between the time the participant provided informed consent at Week -2 (Run-in Period: Weeks -2 to 0) through 4 weeks after their last treatment (Stage 1 intervention period: Weeks 0 to 12; Stage 2 intervention period: Weeks 12 to 24), up to 30 weeks.
|
0.00%
0/85 • All adverse events were recorded between the time the participant provided informed consent at Week -2 (Run-in Period: Weeks -2 to 0) through 4 weeks after their last treatment (Stage 1 intervention period: Weeks 0 to 12; Stage 2 intervention period: Weeks 12 to 24), up to 30 weeks.
|
0.00%
0/33 • All adverse events were recorded between the time the participant provided informed consent at Week -2 (Run-in Period: Weeks -2 to 0) through 4 weeks after their last treatment (Stage 1 intervention period: Weeks 0 to 12; Stage 2 intervention period: Weeks 12 to 24), up to 30 weeks.
|
0.00%
0/52 • All adverse events were recorded between the time the participant provided informed consent at Week -2 (Run-in Period: Weeks -2 to 0) through 4 weeks after their last treatment (Stage 1 intervention period: Weeks 0 to 12; Stage 2 intervention period: Weeks 12 to 24), up to 30 weeks.
|
0.00%
0/84 • All adverse events were recorded between the time the participant provided informed consent at Week -2 (Run-in Period: Weeks -2 to 0) through 4 weeks after their last treatment (Stage 1 intervention period: Weeks 0 to 12; Stage 2 intervention period: Weeks 12 to 24), up to 30 weeks.
|
0.00%
0/22 • All adverse events were recorded between the time the participant provided informed consent at Week -2 (Run-in Period: Weeks -2 to 0) through 4 weeks after their last treatment (Stage 1 intervention period: Weeks 0 to 12; Stage 2 intervention period: Weeks 12 to 24), up to 30 weeks.
|
0.00%
0/54 • All adverse events were recorded between the time the participant provided informed consent at Week -2 (Run-in Period: Weeks -2 to 0) through 4 weeks after their last treatment (Stage 1 intervention period: Weeks 0 to 12; Stage 2 intervention period: Weeks 12 to 24), up to 30 weeks.
|
0.00%
0/85 • All adverse events were recorded between the time the participant provided informed consent at Week -2 (Run-in Period: Weeks -2 to 0) through 4 weeks after their last treatment (Stage 1 intervention period: Weeks 0 to 12; Stage 2 intervention period: Weeks 12 to 24), up to 30 weeks.
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.00%
0/191 • All adverse events were recorded between the time the participant provided informed consent at Week -2 (Run-in Period: Weeks -2 to 0) through 4 weeks after their last treatment (Stage 1 intervention period: Weeks 0 to 12; Stage 2 intervention period: Weeks 12 to 24), up to 30 weeks.
|
0.00%
0/172 • All adverse events were recorded between the time the participant provided informed consent at Week -2 (Run-in Period: Weeks -2 to 0) through 4 weeks after their last treatment (Stage 1 intervention period: Weeks 0 to 12; Stage 2 intervention period: Weeks 12 to 24), up to 30 weeks.
|
0.00%
0/184 • All adverse events were recorded between the time the participant provided informed consent at Week -2 (Run-in Period: Weeks -2 to 0) through 4 weeks after their last treatment (Stage 1 intervention period: Weeks 0 to 12; Stage 2 intervention period: Weeks 12 to 24), up to 30 weeks.
|
0.00%
0/205 • All adverse events were recorded between the time the participant provided informed consent at Week -2 (Run-in Period: Weeks -2 to 0) through 4 weeks after their last treatment (Stage 1 intervention period: Weeks 0 to 12; Stage 2 intervention period: Weeks 12 to 24), up to 30 weeks.
|
0.00%
0/65 • All adverse events were recorded between the time the participant provided informed consent at Week -2 (Run-in Period: Weeks -2 to 0) through 4 weeks after their last treatment (Stage 1 intervention period: Weeks 0 to 12; Stage 2 intervention period: Weeks 12 to 24), up to 30 weeks.
|
0.00%
0/71 • All adverse events were recorded between the time the participant provided informed consent at Week -2 (Run-in Period: Weeks -2 to 0) through 4 weeks after their last treatment (Stage 1 intervention period: Weeks 0 to 12; Stage 2 intervention period: Weeks 12 to 24), up to 30 weeks.
|
0.00%
0/110 • All adverse events were recorded between the time the participant provided informed consent at Week -2 (Run-in Period: Weeks -2 to 0) through 4 weeks after their last treatment (Stage 1 intervention period: Weeks 0 to 12; Stage 2 intervention period: Weeks 12 to 24), up to 30 weeks.
|
0.00%
0/85 • All adverse events were recorded between the time the participant provided informed consent at Week -2 (Run-in Period: Weeks -2 to 0) through 4 weeks after their last treatment (Stage 1 intervention period: Weeks 0 to 12; Stage 2 intervention period: Weeks 12 to 24), up to 30 weeks.
|
3.0%
1/33 • Number of events 1 • All adverse events were recorded between the time the participant provided informed consent at Week -2 (Run-in Period: Weeks -2 to 0) through 4 weeks after their last treatment (Stage 1 intervention period: Weeks 0 to 12; Stage 2 intervention period: Weeks 12 to 24), up to 30 weeks.
|
0.00%
0/52 • All adverse events were recorded between the time the participant provided informed consent at Week -2 (Run-in Period: Weeks -2 to 0) through 4 weeks after their last treatment (Stage 1 intervention period: Weeks 0 to 12; Stage 2 intervention period: Weeks 12 to 24), up to 30 weeks.
|
0.00%
0/84 • All adverse events were recorded between the time the participant provided informed consent at Week -2 (Run-in Period: Weeks -2 to 0) through 4 weeks after their last treatment (Stage 1 intervention period: Weeks 0 to 12; Stage 2 intervention period: Weeks 12 to 24), up to 30 weeks.
|
0.00%
0/22 • All adverse events were recorded between the time the participant provided informed consent at Week -2 (Run-in Period: Weeks -2 to 0) through 4 weeks after their last treatment (Stage 1 intervention period: Weeks 0 to 12; Stage 2 intervention period: Weeks 12 to 24), up to 30 weeks.
|
0.00%
0/54 • All adverse events were recorded between the time the participant provided informed consent at Week -2 (Run-in Period: Weeks -2 to 0) through 4 weeks after their last treatment (Stage 1 intervention period: Weeks 0 to 12; Stage 2 intervention period: Weeks 12 to 24), up to 30 weeks.
|
0.00%
0/85 • All adverse events were recorded between the time the participant provided informed consent at Week -2 (Run-in Period: Weeks -2 to 0) through 4 weeks after their last treatment (Stage 1 intervention period: Weeks 0 to 12; Stage 2 intervention period: Weeks 12 to 24), up to 30 weeks.
|
|
Gastrointestinal disorders
Incisional hernia
|
0.00%
0/191 • All adverse events were recorded between the time the participant provided informed consent at Week -2 (Run-in Period: Weeks -2 to 0) through 4 weeks after their last treatment (Stage 1 intervention period: Weeks 0 to 12; Stage 2 intervention period: Weeks 12 to 24), up to 30 weeks.
|
0.00%
0/172 • All adverse events were recorded between the time the participant provided informed consent at Week -2 (Run-in Period: Weeks -2 to 0) through 4 weeks after their last treatment (Stage 1 intervention period: Weeks 0 to 12; Stage 2 intervention period: Weeks 12 to 24), up to 30 weeks.
|
0.00%
0/184 • All adverse events were recorded between the time the participant provided informed consent at Week -2 (Run-in Period: Weeks -2 to 0) through 4 weeks after their last treatment (Stage 1 intervention period: Weeks 0 to 12; Stage 2 intervention period: Weeks 12 to 24), up to 30 weeks.
|
0.00%
0/205 • All adverse events were recorded between the time the participant provided informed consent at Week -2 (Run-in Period: Weeks -2 to 0) through 4 weeks after their last treatment (Stage 1 intervention period: Weeks 0 to 12; Stage 2 intervention period: Weeks 12 to 24), up to 30 weeks.
|
1.5%
1/65 • Number of events 1 • All adverse events were recorded between the time the participant provided informed consent at Week -2 (Run-in Period: Weeks -2 to 0) through 4 weeks after their last treatment (Stage 1 intervention period: Weeks 0 to 12; Stage 2 intervention period: Weeks 12 to 24), up to 30 weeks.
|
0.00%
0/71 • All adverse events were recorded between the time the participant provided informed consent at Week -2 (Run-in Period: Weeks -2 to 0) through 4 weeks after their last treatment (Stage 1 intervention period: Weeks 0 to 12; Stage 2 intervention period: Weeks 12 to 24), up to 30 weeks.
|
0.00%
0/110 • All adverse events were recorded between the time the participant provided informed consent at Week -2 (Run-in Period: Weeks -2 to 0) through 4 weeks after their last treatment (Stage 1 intervention period: Weeks 0 to 12; Stage 2 intervention period: Weeks 12 to 24), up to 30 weeks.
|
0.00%
0/85 • All adverse events were recorded between the time the participant provided informed consent at Week -2 (Run-in Period: Weeks -2 to 0) through 4 weeks after their last treatment (Stage 1 intervention period: Weeks 0 to 12; Stage 2 intervention period: Weeks 12 to 24), up to 30 weeks.
|
0.00%
0/33 • All adverse events were recorded between the time the participant provided informed consent at Week -2 (Run-in Period: Weeks -2 to 0) through 4 weeks after their last treatment (Stage 1 intervention period: Weeks 0 to 12; Stage 2 intervention period: Weeks 12 to 24), up to 30 weeks.
|
0.00%
0/52 • All adverse events were recorded between the time the participant provided informed consent at Week -2 (Run-in Period: Weeks -2 to 0) through 4 weeks after their last treatment (Stage 1 intervention period: Weeks 0 to 12; Stage 2 intervention period: Weeks 12 to 24), up to 30 weeks.
|
0.00%
0/84 • All adverse events were recorded between the time the participant provided informed consent at Week -2 (Run-in Period: Weeks -2 to 0) through 4 weeks after their last treatment (Stage 1 intervention period: Weeks 0 to 12; Stage 2 intervention period: Weeks 12 to 24), up to 30 weeks.
|
0.00%
0/22 • All adverse events were recorded between the time the participant provided informed consent at Week -2 (Run-in Period: Weeks -2 to 0) through 4 weeks after their last treatment (Stage 1 intervention period: Weeks 0 to 12; Stage 2 intervention period: Weeks 12 to 24), up to 30 weeks.
|
0.00%
0/54 • All adverse events were recorded between the time the participant provided informed consent at Week -2 (Run-in Period: Weeks -2 to 0) through 4 weeks after their last treatment (Stage 1 intervention period: Weeks 0 to 12; Stage 2 intervention period: Weeks 12 to 24), up to 30 weeks.
|
0.00%
0/85 • All adverse events were recorded between the time the participant provided informed consent at Week -2 (Run-in Period: Weeks -2 to 0) through 4 weeks after their last treatment (Stage 1 intervention period: Weeks 0 to 12; Stage 2 intervention period: Weeks 12 to 24), up to 30 weeks.
|
|
Gastrointestinal disorders
Intestinal mass
|
0.00%
0/191 • All adverse events were recorded between the time the participant provided informed consent at Week -2 (Run-in Period: Weeks -2 to 0) through 4 weeks after their last treatment (Stage 1 intervention period: Weeks 0 to 12; Stage 2 intervention period: Weeks 12 to 24), up to 30 weeks.
|
0.00%
0/172 • All adverse events were recorded between the time the participant provided informed consent at Week -2 (Run-in Period: Weeks -2 to 0) through 4 weeks after their last treatment (Stage 1 intervention period: Weeks 0 to 12; Stage 2 intervention period: Weeks 12 to 24), up to 30 weeks.
|
0.54%
1/184 • Number of events 1 • All adverse events were recorded between the time the participant provided informed consent at Week -2 (Run-in Period: Weeks -2 to 0) through 4 weeks after their last treatment (Stage 1 intervention period: Weeks 0 to 12; Stage 2 intervention period: Weeks 12 to 24), up to 30 weeks.
|
0.00%
0/205 • All adverse events were recorded between the time the participant provided informed consent at Week -2 (Run-in Period: Weeks -2 to 0) through 4 weeks after their last treatment (Stage 1 intervention period: Weeks 0 to 12; Stage 2 intervention period: Weeks 12 to 24), up to 30 weeks.
|
0.00%
0/65 • All adverse events were recorded between the time the participant provided informed consent at Week -2 (Run-in Period: Weeks -2 to 0) through 4 weeks after their last treatment (Stage 1 intervention period: Weeks 0 to 12; Stage 2 intervention period: Weeks 12 to 24), up to 30 weeks.
|
0.00%
0/71 • All adverse events were recorded between the time the participant provided informed consent at Week -2 (Run-in Period: Weeks -2 to 0) through 4 weeks after their last treatment (Stage 1 intervention period: Weeks 0 to 12; Stage 2 intervention period: Weeks 12 to 24), up to 30 weeks.
|
0.00%
0/110 • All adverse events were recorded between the time the participant provided informed consent at Week -2 (Run-in Period: Weeks -2 to 0) through 4 weeks after their last treatment (Stage 1 intervention period: Weeks 0 to 12; Stage 2 intervention period: Weeks 12 to 24), up to 30 weeks.
|
0.00%
0/85 • All adverse events were recorded between the time the participant provided informed consent at Week -2 (Run-in Period: Weeks -2 to 0) through 4 weeks after their last treatment (Stage 1 intervention period: Weeks 0 to 12; Stage 2 intervention period: Weeks 12 to 24), up to 30 weeks.
|
0.00%
0/33 • All adverse events were recorded between the time the participant provided informed consent at Week -2 (Run-in Period: Weeks -2 to 0) through 4 weeks after their last treatment (Stage 1 intervention period: Weeks 0 to 12; Stage 2 intervention period: Weeks 12 to 24), up to 30 weeks.
|
0.00%
0/52 • All adverse events were recorded between the time the participant provided informed consent at Week -2 (Run-in Period: Weeks -2 to 0) through 4 weeks after their last treatment (Stage 1 intervention period: Weeks 0 to 12; Stage 2 intervention period: Weeks 12 to 24), up to 30 weeks.
|
0.00%
0/84 • All adverse events were recorded between the time the participant provided informed consent at Week -2 (Run-in Period: Weeks -2 to 0) through 4 weeks after their last treatment (Stage 1 intervention period: Weeks 0 to 12; Stage 2 intervention period: Weeks 12 to 24), up to 30 weeks.
|
0.00%
0/22 • All adverse events were recorded between the time the participant provided informed consent at Week -2 (Run-in Period: Weeks -2 to 0) through 4 weeks after their last treatment (Stage 1 intervention period: Weeks 0 to 12; Stage 2 intervention period: Weeks 12 to 24), up to 30 weeks.
|
0.00%
0/54 • All adverse events were recorded between the time the participant provided informed consent at Week -2 (Run-in Period: Weeks -2 to 0) through 4 weeks after their last treatment (Stage 1 intervention period: Weeks 0 to 12; Stage 2 intervention period: Weeks 12 to 24), up to 30 weeks.
|
0.00%
0/85 • All adverse events were recorded between the time the participant provided informed consent at Week -2 (Run-in Period: Weeks -2 to 0) through 4 weeks after their last treatment (Stage 1 intervention period: Weeks 0 to 12; Stage 2 intervention period: Weeks 12 to 24), up to 30 weeks.
|
|
General disorders
Ulcer
|
0.00%
0/191 • All adverse events were recorded between the time the participant provided informed consent at Week -2 (Run-in Period: Weeks -2 to 0) through 4 weeks after their last treatment (Stage 1 intervention period: Weeks 0 to 12; Stage 2 intervention period: Weeks 12 to 24), up to 30 weeks.
|
0.00%
0/172 • All adverse events were recorded between the time the participant provided informed consent at Week -2 (Run-in Period: Weeks -2 to 0) through 4 weeks after their last treatment (Stage 1 intervention period: Weeks 0 to 12; Stage 2 intervention period: Weeks 12 to 24), up to 30 weeks.
|
0.00%
0/184 • All adverse events were recorded between the time the participant provided informed consent at Week -2 (Run-in Period: Weeks -2 to 0) through 4 weeks after their last treatment (Stage 1 intervention period: Weeks 0 to 12; Stage 2 intervention period: Weeks 12 to 24), up to 30 weeks.
|
0.00%
0/205 • All adverse events were recorded between the time the participant provided informed consent at Week -2 (Run-in Period: Weeks -2 to 0) through 4 weeks after their last treatment (Stage 1 intervention period: Weeks 0 to 12; Stage 2 intervention period: Weeks 12 to 24), up to 30 weeks.
|
0.00%
0/65 • All adverse events were recorded between the time the participant provided informed consent at Week -2 (Run-in Period: Weeks -2 to 0) through 4 weeks after their last treatment (Stage 1 intervention period: Weeks 0 to 12; Stage 2 intervention period: Weeks 12 to 24), up to 30 weeks.
|
0.00%
0/71 • All adverse events were recorded between the time the participant provided informed consent at Week -2 (Run-in Period: Weeks -2 to 0) through 4 weeks after their last treatment (Stage 1 intervention period: Weeks 0 to 12; Stage 2 intervention period: Weeks 12 to 24), up to 30 weeks.
|
0.00%
0/110 • All adverse events were recorded between the time the participant provided informed consent at Week -2 (Run-in Period: Weeks -2 to 0) through 4 weeks after their last treatment (Stage 1 intervention period: Weeks 0 to 12; Stage 2 intervention period: Weeks 12 to 24), up to 30 weeks.
|
0.00%
0/85 • All adverse events were recorded between the time the participant provided informed consent at Week -2 (Run-in Period: Weeks -2 to 0) through 4 weeks after their last treatment (Stage 1 intervention period: Weeks 0 to 12; Stage 2 intervention period: Weeks 12 to 24), up to 30 weeks.
|
0.00%
0/33 • All adverse events were recorded between the time the participant provided informed consent at Week -2 (Run-in Period: Weeks -2 to 0) through 4 weeks after their last treatment (Stage 1 intervention period: Weeks 0 to 12; Stage 2 intervention period: Weeks 12 to 24), up to 30 weeks.
|
0.00%
0/52 • All adverse events were recorded between the time the participant provided informed consent at Week -2 (Run-in Period: Weeks -2 to 0) through 4 weeks after their last treatment (Stage 1 intervention period: Weeks 0 to 12; Stage 2 intervention period: Weeks 12 to 24), up to 30 weeks.
|
0.00%
0/84 • All adverse events were recorded between the time the participant provided informed consent at Week -2 (Run-in Period: Weeks -2 to 0) through 4 weeks after their last treatment (Stage 1 intervention period: Weeks 0 to 12; Stage 2 intervention period: Weeks 12 to 24), up to 30 weeks.
|
0.00%
0/22 • All adverse events were recorded between the time the participant provided informed consent at Week -2 (Run-in Period: Weeks -2 to 0) through 4 weeks after their last treatment (Stage 1 intervention period: Weeks 0 to 12; Stage 2 intervention period: Weeks 12 to 24), up to 30 weeks.
|
0.00%
0/54 • All adverse events were recorded between the time the participant provided informed consent at Week -2 (Run-in Period: Weeks -2 to 0) through 4 weeks after their last treatment (Stage 1 intervention period: Weeks 0 to 12; Stage 2 intervention period: Weeks 12 to 24), up to 30 weeks.
|
1.2%
1/85 • Number of events 1 • All adverse events were recorded between the time the participant provided informed consent at Week -2 (Run-in Period: Weeks -2 to 0) through 4 weeks after their last treatment (Stage 1 intervention period: Weeks 0 to 12; Stage 2 intervention period: Weeks 12 to 24), up to 30 weeks.
|
|
Infections and infestations
Cat scratch disease
|
0.00%
0/191 • All adverse events were recorded between the time the participant provided informed consent at Week -2 (Run-in Period: Weeks -2 to 0) through 4 weeks after their last treatment (Stage 1 intervention period: Weeks 0 to 12; Stage 2 intervention period: Weeks 12 to 24), up to 30 weeks.
|
0.00%
0/172 • All adverse events were recorded between the time the participant provided informed consent at Week -2 (Run-in Period: Weeks -2 to 0) through 4 weeks after their last treatment (Stage 1 intervention period: Weeks 0 to 12; Stage 2 intervention period: Weeks 12 to 24), up to 30 weeks.
|
0.00%
0/184 • All adverse events were recorded between the time the participant provided informed consent at Week -2 (Run-in Period: Weeks -2 to 0) through 4 weeks after their last treatment (Stage 1 intervention period: Weeks 0 to 12; Stage 2 intervention period: Weeks 12 to 24), up to 30 weeks.
|
0.00%
0/205 • All adverse events were recorded between the time the participant provided informed consent at Week -2 (Run-in Period: Weeks -2 to 0) through 4 weeks after their last treatment (Stage 1 intervention period: Weeks 0 to 12; Stage 2 intervention period: Weeks 12 to 24), up to 30 weeks.
|
0.00%
0/65 • All adverse events were recorded between the time the participant provided informed consent at Week -2 (Run-in Period: Weeks -2 to 0) through 4 weeks after their last treatment (Stage 1 intervention period: Weeks 0 to 12; Stage 2 intervention period: Weeks 12 to 24), up to 30 weeks.
|
0.00%
0/71 • All adverse events were recorded between the time the participant provided informed consent at Week -2 (Run-in Period: Weeks -2 to 0) through 4 weeks after their last treatment (Stage 1 intervention period: Weeks 0 to 12; Stage 2 intervention period: Weeks 12 to 24), up to 30 weeks.
|
0.00%
0/110 • All adverse events were recorded between the time the participant provided informed consent at Week -2 (Run-in Period: Weeks -2 to 0) through 4 weeks after their last treatment (Stage 1 intervention period: Weeks 0 to 12; Stage 2 intervention period: Weeks 12 to 24), up to 30 weeks.
|
0.00%
0/85 • All adverse events were recorded between the time the participant provided informed consent at Week -2 (Run-in Period: Weeks -2 to 0) through 4 weeks after their last treatment (Stage 1 intervention period: Weeks 0 to 12; Stage 2 intervention period: Weeks 12 to 24), up to 30 weeks.
|
0.00%
0/33 • All adverse events were recorded between the time the participant provided informed consent at Week -2 (Run-in Period: Weeks -2 to 0) through 4 weeks after their last treatment (Stage 1 intervention period: Weeks 0 to 12; Stage 2 intervention period: Weeks 12 to 24), up to 30 weeks.
|
0.00%
0/52 • All adverse events were recorded between the time the participant provided informed consent at Week -2 (Run-in Period: Weeks -2 to 0) through 4 weeks after their last treatment (Stage 1 intervention period: Weeks 0 to 12; Stage 2 intervention period: Weeks 12 to 24), up to 30 weeks.
|
1.2%
1/84 • Number of events 1 • All adverse events were recorded between the time the participant provided informed consent at Week -2 (Run-in Period: Weeks -2 to 0) through 4 weeks after their last treatment (Stage 1 intervention period: Weeks 0 to 12; Stage 2 intervention period: Weeks 12 to 24), up to 30 weeks.
|
0.00%
0/22 • All adverse events were recorded between the time the participant provided informed consent at Week -2 (Run-in Period: Weeks -2 to 0) through 4 weeks after their last treatment (Stage 1 intervention period: Weeks 0 to 12; Stage 2 intervention period: Weeks 12 to 24), up to 30 weeks.
|
0.00%
0/54 • All adverse events were recorded between the time the participant provided informed consent at Week -2 (Run-in Period: Weeks -2 to 0) through 4 weeks after their last treatment (Stage 1 intervention period: Weeks 0 to 12; Stage 2 intervention period: Weeks 12 to 24), up to 30 weeks.
|
0.00%
0/85 • All adverse events were recorded between the time the participant provided informed consent at Week -2 (Run-in Period: Weeks -2 to 0) through 4 weeks after their last treatment (Stage 1 intervention period: Weeks 0 to 12; Stage 2 intervention period: Weeks 12 to 24), up to 30 weeks.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/191 • All adverse events were recorded between the time the participant provided informed consent at Week -2 (Run-in Period: Weeks -2 to 0) through 4 weeks after their last treatment (Stage 1 intervention period: Weeks 0 to 12; Stage 2 intervention period: Weeks 12 to 24), up to 30 weeks.
|
0.00%
0/172 • All adverse events were recorded between the time the participant provided informed consent at Week -2 (Run-in Period: Weeks -2 to 0) through 4 weeks after their last treatment (Stage 1 intervention period: Weeks 0 to 12; Stage 2 intervention period: Weeks 12 to 24), up to 30 weeks.
|
0.00%
0/184 • All adverse events were recorded between the time the participant provided informed consent at Week -2 (Run-in Period: Weeks -2 to 0) through 4 weeks after their last treatment (Stage 1 intervention period: Weeks 0 to 12; Stage 2 intervention period: Weeks 12 to 24), up to 30 weeks.
|
0.00%
0/205 • All adverse events were recorded between the time the participant provided informed consent at Week -2 (Run-in Period: Weeks -2 to 0) through 4 weeks after their last treatment (Stage 1 intervention period: Weeks 0 to 12; Stage 2 intervention period: Weeks 12 to 24), up to 30 weeks.
|
0.00%
0/65 • All adverse events were recorded between the time the participant provided informed consent at Week -2 (Run-in Period: Weeks -2 to 0) through 4 weeks after their last treatment (Stage 1 intervention period: Weeks 0 to 12; Stage 2 intervention period: Weeks 12 to 24), up to 30 weeks.
|
0.00%
0/71 • All adverse events were recorded between the time the participant provided informed consent at Week -2 (Run-in Period: Weeks -2 to 0) through 4 weeks after their last treatment (Stage 1 intervention period: Weeks 0 to 12; Stage 2 intervention period: Weeks 12 to 24), up to 30 weeks.
|
0.00%
0/110 • All adverse events were recorded between the time the participant provided informed consent at Week -2 (Run-in Period: Weeks -2 to 0) through 4 weeks after their last treatment (Stage 1 intervention period: Weeks 0 to 12; Stage 2 intervention period: Weeks 12 to 24), up to 30 weeks.
|
0.00%
0/85 • All adverse events were recorded between the time the participant provided informed consent at Week -2 (Run-in Period: Weeks -2 to 0) through 4 weeks after their last treatment (Stage 1 intervention period: Weeks 0 to 12; Stage 2 intervention period: Weeks 12 to 24), up to 30 weeks.
|
0.00%
0/33 • All adverse events were recorded between the time the participant provided informed consent at Week -2 (Run-in Period: Weeks -2 to 0) through 4 weeks after their last treatment (Stage 1 intervention period: Weeks 0 to 12; Stage 2 intervention period: Weeks 12 to 24), up to 30 weeks.
|
0.00%
0/52 • All adverse events were recorded between the time the participant provided informed consent at Week -2 (Run-in Period: Weeks -2 to 0) through 4 weeks after their last treatment (Stage 1 intervention period: Weeks 0 to 12; Stage 2 intervention period: Weeks 12 to 24), up to 30 weeks.
|
1.2%
1/84 • Number of events 1 • All adverse events were recorded between the time the participant provided informed consent at Week -2 (Run-in Period: Weeks -2 to 0) through 4 weeks after their last treatment (Stage 1 intervention period: Weeks 0 to 12; Stage 2 intervention period: Weeks 12 to 24), up to 30 weeks.
|
0.00%
0/22 • All adverse events were recorded between the time the participant provided informed consent at Week -2 (Run-in Period: Weeks -2 to 0) through 4 weeks after their last treatment (Stage 1 intervention period: Weeks 0 to 12; Stage 2 intervention period: Weeks 12 to 24), up to 30 weeks.
|
0.00%
0/54 • All adverse events were recorded between the time the participant provided informed consent at Week -2 (Run-in Period: Weeks -2 to 0) through 4 weeks after their last treatment (Stage 1 intervention period: Weeks 0 to 12; Stage 2 intervention period: Weeks 12 to 24), up to 30 weeks.
|
0.00%
0/85 • All adverse events were recorded between the time the participant provided informed consent at Week -2 (Run-in Period: Weeks -2 to 0) through 4 weeks after their last treatment (Stage 1 intervention period: Weeks 0 to 12; Stage 2 intervention period: Weeks 12 to 24), up to 30 weeks.
|
|
Injury, poisoning and procedural complications
Accident
|
0.00%
0/191 • All adverse events were recorded between the time the participant provided informed consent at Week -2 (Run-in Period: Weeks -2 to 0) through 4 weeks after their last treatment (Stage 1 intervention period: Weeks 0 to 12; Stage 2 intervention period: Weeks 12 to 24), up to 30 weeks.
|
0.00%
0/172 • All adverse events were recorded between the time the participant provided informed consent at Week -2 (Run-in Period: Weeks -2 to 0) through 4 weeks after their last treatment (Stage 1 intervention period: Weeks 0 to 12; Stage 2 intervention period: Weeks 12 to 24), up to 30 weeks.
|
0.00%
0/184 • All adverse events were recorded between the time the participant provided informed consent at Week -2 (Run-in Period: Weeks -2 to 0) through 4 weeks after their last treatment (Stage 1 intervention period: Weeks 0 to 12; Stage 2 intervention period: Weeks 12 to 24), up to 30 weeks.
|
0.00%
0/205 • All adverse events were recorded between the time the participant provided informed consent at Week -2 (Run-in Period: Weeks -2 to 0) through 4 weeks after their last treatment (Stage 1 intervention period: Weeks 0 to 12; Stage 2 intervention period: Weeks 12 to 24), up to 30 weeks.
|
0.00%
0/65 • All adverse events were recorded between the time the participant provided informed consent at Week -2 (Run-in Period: Weeks -2 to 0) through 4 weeks after their last treatment (Stage 1 intervention period: Weeks 0 to 12; Stage 2 intervention period: Weeks 12 to 24), up to 30 weeks.
|
0.00%
0/71 • All adverse events were recorded between the time the participant provided informed consent at Week -2 (Run-in Period: Weeks -2 to 0) through 4 weeks after their last treatment (Stage 1 intervention period: Weeks 0 to 12; Stage 2 intervention period: Weeks 12 to 24), up to 30 weeks.
|
0.00%
0/110 • All adverse events were recorded between the time the participant provided informed consent at Week -2 (Run-in Period: Weeks -2 to 0) through 4 weeks after their last treatment (Stage 1 intervention period: Weeks 0 to 12; Stage 2 intervention period: Weeks 12 to 24), up to 30 weeks.
|
0.00%
0/85 • All adverse events were recorded between the time the participant provided informed consent at Week -2 (Run-in Period: Weeks -2 to 0) through 4 weeks after their last treatment (Stage 1 intervention period: Weeks 0 to 12; Stage 2 intervention period: Weeks 12 to 24), up to 30 weeks.
|
0.00%
0/33 • All adverse events were recorded between the time the participant provided informed consent at Week -2 (Run-in Period: Weeks -2 to 0) through 4 weeks after their last treatment (Stage 1 intervention period: Weeks 0 to 12; Stage 2 intervention period: Weeks 12 to 24), up to 30 weeks.
|
0.00%
0/52 • All adverse events were recorded between the time the participant provided informed consent at Week -2 (Run-in Period: Weeks -2 to 0) through 4 weeks after their last treatment (Stage 1 intervention period: Weeks 0 to 12; Stage 2 intervention period: Weeks 12 to 24), up to 30 weeks.
|
0.00%
0/84 • All adverse events were recorded between the time the participant provided informed consent at Week -2 (Run-in Period: Weeks -2 to 0) through 4 weeks after their last treatment (Stage 1 intervention period: Weeks 0 to 12; Stage 2 intervention period: Weeks 12 to 24), up to 30 weeks.
|
0.00%
0/22 • All adverse events were recorded between the time the participant provided informed consent at Week -2 (Run-in Period: Weeks -2 to 0) through 4 weeks after their last treatment (Stage 1 intervention period: Weeks 0 to 12; Stage 2 intervention period: Weeks 12 to 24), up to 30 weeks.
|
0.00%
0/54 • All adverse events were recorded between the time the participant provided informed consent at Week -2 (Run-in Period: Weeks -2 to 0) through 4 weeks after their last treatment (Stage 1 intervention period: Weeks 0 to 12; Stage 2 intervention period: Weeks 12 to 24), up to 30 weeks.
|
1.2%
1/85 • Number of events 1 • All adverse events were recorded between the time the participant provided informed consent at Week -2 (Run-in Period: Weeks -2 to 0) through 4 weeks after their last treatment (Stage 1 intervention period: Weeks 0 to 12; Stage 2 intervention period: Weeks 12 to 24), up to 30 weeks.
|
|
Injury, poisoning and procedural complications
Cervical vertebral fracture
|
0.52%
1/191 • Number of events 1 • All adverse events were recorded between the time the participant provided informed consent at Week -2 (Run-in Period: Weeks -2 to 0) through 4 weeks after their last treatment (Stage 1 intervention period: Weeks 0 to 12; Stage 2 intervention period: Weeks 12 to 24), up to 30 weeks.
|
0.00%
0/172 • All adverse events were recorded between the time the participant provided informed consent at Week -2 (Run-in Period: Weeks -2 to 0) through 4 weeks after their last treatment (Stage 1 intervention period: Weeks 0 to 12; Stage 2 intervention period: Weeks 12 to 24), up to 30 weeks.
|
0.00%
0/184 • All adverse events were recorded between the time the participant provided informed consent at Week -2 (Run-in Period: Weeks -2 to 0) through 4 weeks after their last treatment (Stage 1 intervention period: Weeks 0 to 12; Stage 2 intervention period: Weeks 12 to 24), up to 30 weeks.
|
0.00%
0/205 • All adverse events were recorded between the time the participant provided informed consent at Week -2 (Run-in Period: Weeks -2 to 0) through 4 weeks after their last treatment (Stage 1 intervention period: Weeks 0 to 12; Stage 2 intervention period: Weeks 12 to 24), up to 30 weeks.
|
0.00%
0/65 • All adverse events were recorded between the time the participant provided informed consent at Week -2 (Run-in Period: Weeks -2 to 0) through 4 weeks after their last treatment (Stage 1 intervention period: Weeks 0 to 12; Stage 2 intervention period: Weeks 12 to 24), up to 30 weeks.
|
0.00%
0/71 • All adverse events were recorded between the time the participant provided informed consent at Week -2 (Run-in Period: Weeks -2 to 0) through 4 weeks after their last treatment (Stage 1 intervention period: Weeks 0 to 12; Stage 2 intervention period: Weeks 12 to 24), up to 30 weeks.
|
0.00%
0/110 • All adverse events were recorded between the time the participant provided informed consent at Week -2 (Run-in Period: Weeks -2 to 0) through 4 weeks after their last treatment (Stage 1 intervention period: Weeks 0 to 12; Stage 2 intervention period: Weeks 12 to 24), up to 30 weeks.
|
0.00%
0/85 • All adverse events were recorded between the time the participant provided informed consent at Week -2 (Run-in Period: Weeks -2 to 0) through 4 weeks after their last treatment (Stage 1 intervention period: Weeks 0 to 12; Stage 2 intervention period: Weeks 12 to 24), up to 30 weeks.
|
0.00%
0/33 • All adverse events were recorded between the time the participant provided informed consent at Week -2 (Run-in Period: Weeks -2 to 0) through 4 weeks after their last treatment (Stage 1 intervention period: Weeks 0 to 12; Stage 2 intervention period: Weeks 12 to 24), up to 30 weeks.
|
0.00%
0/52 • All adverse events were recorded between the time the participant provided informed consent at Week -2 (Run-in Period: Weeks -2 to 0) through 4 weeks after their last treatment (Stage 1 intervention period: Weeks 0 to 12; Stage 2 intervention period: Weeks 12 to 24), up to 30 weeks.
|
0.00%
0/84 • All adverse events were recorded between the time the participant provided informed consent at Week -2 (Run-in Period: Weeks -2 to 0) through 4 weeks after their last treatment (Stage 1 intervention period: Weeks 0 to 12; Stage 2 intervention period: Weeks 12 to 24), up to 30 weeks.
|
0.00%
0/22 • All adverse events were recorded between the time the participant provided informed consent at Week -2 (Run-in Period: Weeks -2 to 0) through 4 weeks after their last treatment (Stage 1 intervention period: Weeks 0 to 12; Stage 2 intervention period: Weeks 12 to 24), up to 30 weeks.
|
0.00%
0/54 • All adverse events were recorded between the time the participant provided informed consent at Week -2 (Run-in Period: Weeks -2 to 0) through 4 weeks after their last treatment (Stage 1 intervention period: Weeks 0 to 12; Stage 2 intervention period: Weeks 12 to 24), up to 30 weeks.
|
0.00%
0/85 • All adverse events were recorded between the time the participant provided informed consent at Week -2 (Run-in Period: Weeks -2 to 0) through 4 weeks after their last treatment (Stage 1 intervention period: Weeks 0 to 12; Stage 2 intervention period: Weeks 12 to 24), up to 30 weeks.
|
|
Injury, poisoning and procedural complications
Fall
|
0.52%
1/191 • Number of events 1 • All adverse events were recorded between the time the participant provided informed consent at Week -2 (Run-in Period: Weeks -2 to 0) through 4 weeks after their last treatment (Stage 1 intervention period: Weeks 0 to 12; Stage 2 intervention period: Weeks 12 to 24), up to 30 weeks.
|
0.00%
0/172 • All adverse events were recorded between the time the participant provided informed consent at Week -2 (Run-in Period: Weeks -2 to 0) through 4 weeks after their last treatment (Stage 1 intervention period: Weeks 0 to 12; Stage 2 intervention period: Weeks 12 to 24), up to 30 weeks.
|
0.00%
0/184 • All adverse events were recorded between the time the participant provided informed consent at Week -2 (Run-in Period: Weeks -2 to 0) through 4 weeks after their last treatment (Stage 1 intervention period: Weeks 0 to 12; Stage 2 intervention period: Weeks 12 to 24), up to 30 weeks.
|
0.00%
0/205 • All adverse events were recorded between the time the participant provided informed consent at Week -2 (Run-in Period: Weeks -2 to 0) through 4 weeks after their last treatment (Stage 1 intervention period: Weeks 0 to 12; Stage 2 intervention period: Weeks 12 to 24), up to 30 weeks.
|
0.00%
0/65 • All adverse events were recorded between the time the participant provided informed consent at Week -2 (Run-in Period: Weeks -2 to 0) through 4 weeks after their last treatment (Stage 1 intervention period: Weeks 0 to 12; Stage 2 intervention period: Weeks 12 to 24), up to 30 weeks.
|
0.00%
0/71 • All adverse events were recorded between the time the participant provided informed consent at Week -2 (Run-in Period: Weeks -2 to 0) through 4 weeks after their last treatment (Stage 1 intervention period: Weeks 0 to 12; Stage 2 intervention period: Weeks 12 to 24), up to 30 weeks.
|
0.00%
0/110 • All adverse events were recorded between the time the participant provided informed consent at Week -2 (Run-in Period: Weeks -2 to 0) through 4 weeks after their last treatment (Stage 1 intervention period: Weeks 0 to 12; Stage 2 intervention period: Weeks 12 to 24), up to 30 weeks.
|
0.00%
0/85 • All adverse events were recorded between the time the participant provided informed consent at Week -2 (Run-in Period: Weeks -2 to 0) through 4 weeks after their last treatment (Stage 1 intervention period: Weeks 0 to 12; Stage 2 intervention period: Weeks 12 to 24), up to 30 weeks.
|
0.00%
0/33 • All adverse events were recorded between the time the participant provided informed consent at Week -2 (Run-in Period: Weeks -2 to 0) through 4 weeks after their last treatment (Stage 1 intervention period: Weeks 0 to 12; Stage 2 intervention period: Weeks 12 to 24), up to 30 weeks.
|
0.00%
0/52 • All adverse events were recorded between the time the participant provided informed consent at Week -2 (Run-in Period: Weeks -2 to 0) through 4 weeks after their last treatment (Stage 1 intervention period: Weeks 0 to 12; Stage 2 intervention period: Weeks 12 to 24), up to 30 weeks.
|
0.00%
0/84 • All adverse events were recorded between the time the participant provided informed consent at Week -2 (Run-in Period: Weeks -2 to 0) through 4 weeks after their last treatment (Stage 1 intervention period: Weeks 0 to 12; Stage 2 intervention period: Weeks 12 to 24), up to 30 weeks.
|
0.00%
0/22 • All adverse events were recorded between the time the participant provided informed consent at Week -2 (Run-in Period: Weeks -2 to 0) through 4 weeks after their last treatment (Stage 1 intervention period: Weeks 0 to 12; Stage 2 intervention period: Weeks 12 to 24), up to 30 weeks.
|
1.9%
1/54 • Number of events 1 • All adverse events were recorded between the time the participant provided informed consent at Week -2 (Run-in Period: Weeks -2 to 0) through 4 weeks after their last treatment (Stage 1 intervention period: Weeks 0 to 12; Stage 2 intervention period: Weeks 12 to 24), up to 30 weeks.
|
0.00%
0/85 • All adverse events were recorded between the time the participant provided informed consent at Week -2 (Run-in Period: Weeks -2 to 0) through 4 weeks after their last treatment (Stage 1 intervention period: Weeks 0 to 12; Stage 2 intervention period: Weeks 12 to 24), up to 30 weeks.
|
|
Injury, poisoning and procedural complications
Ligament rupture
|
0.00%
0/191 • All adverse events were recorded between the time the participant provided informed consent at Week -2 (Run-in Period: Weeks -2 to 0) through 4 weeks after their last treatment (Stage 1 intervention period: Weeks 0 to 12; Stage 2 intervention period: Weeks 12 to 24), up to 30 weeks.
|
0.00%
0/172 • All adverse events were recorded between the time the participant provided informed consent at Week -2 (Run-in Period: Weeks -2 to 0) through 4 weeks after their last treatment (Stage 1 intervention period: Weeks 0 to 12; Stage 2 intervention period: Weeks 12 to 24), up to 30 weeks.
|
0.54%
1/184 • Number of events 1 • All adverse events were recorded between the time the participant provided informed consent at Week -2 (Run-in Period: Weeks -2 to 0) through 4 weeks after their last treatment (Stage 1 intervention period: Weeks 0 to 12; Stage 2 intervention period: Weeks 12 to 24), up to 30 weeks.
|
0.00%
0/205 • All adverse events were recorded between the time the participant provided informed consent at Week -2 (Run-in Period: Weeks -2 to 0) through 4 weeks after their last treatment (Stage 1 intervention period: Weeks 0 to 12; Stage 2 intervention period: Weeks 12 to 24), up to 30 weeks.
|
0.00%
0/65 • All adverse events were recorded between the time the participant provided informed consent at Week -2 (Run-in Period: Weeks -2 to 0) through 4 weeks after their last treatment (Stage 1 intervention period: Weeks 0 to 12; Stage 2 intervention period: Weeks 12 to 24), up to 30 weeks.
|
0.00%
0/71 • All adverse events were recorded between the time the participant provided informed consent at Week -2 (Run-in Period: Weeks -2 to 0) through 4 weeks after their last treatment (Stage 1 intervention period: Weeks 0 to 12; Stage 2 intervention period: Weeks 12 to 24), up to 30 weeks.
|
0.00%
0/110 • All adverse events were recorded between the time the participant provided informed consent at Week -2 (Run-in Period: Weeks -2 to 0) through 4 weeks after their last treatment (Stage 1 intervention period: Weeks 0 to 12; Stage 2 intervention period: Weeks 12 to 24), up to 30 weeks.
|
0.00%
0/85 • All adverse events were recorded between the time the participant provided informed consent at Week -2 (Run-in Period: Weeks -2 to 0) through 4 weeks after their last treatment (Stage 1 intervention period: Weeks 0 to 12; Stage 2 intervention period: Weeks 12 to 24), up to 30 weeks.
|
0.00%
0/33 • All adverse events were recorded between the time the participant provided informed consent at Week -2 (Run-in Period: Weeks -2 to 0) through 4 weeks after their last treatment (Stage 1 intervention period: Weeks 0 to 12; Stage 2 intervention period: Weeks 12 to 24), up to 30 weeks.
|
0.00%
0/52 • All adverse events were recorded between the time the participant provided informed consent at Week -2 (Run-in Period: Weeks -2 to 0) through 4 weeks after their last treatment (Stage 1 intervention period: Weeks 0 to 12; Stage 2 intervention period: Weeks 12 to 24), up to 30 weeks.
|
0.00%
0/84 • All adverse events were recorded between the time the participant provided informed consent at Week -2 (Run-in Period: Weeks -2 to 0) through 4 weeks after their last treatment (Stage 1 intervention period: Weeks 0 to 12; Stage 2 intervention period: Weeks 12 to 24), up to 30 weeks.
|
0.00%
0/22 • All adverse events were recorded between the time the participant provided informed consent at Week -2 (Run-in Period: Weeks -2 to 0) through 4 weeks after their last treatment (Stage 1 intervention period: Weeks 0 to 12; Stage 2 intervention period: Weeks 12 to 24), up to 30 weeks.
|
0.00%
0/54 • All adverse events were recorded between the time the participant provided informed consent at Week -2 (Run-in Period: Weeks -2 to 0) through 4 weeks after their last treatment (Stage 1 intervention period: Weeks 0 to 12; Stage 2 intervention period: Weeks 12 to 24), up to 30 weeks.
|
0.00%
0/85 • All adverse events were recorded between the time the participant provided informed consent at Week -2 (Run-in Period: Weeks -2 to 0) through 4 weeks after their last treatment (Stage 1 intervention period: Weeks 0 to 12; Stage 2 intervention period: Weeks 12 to 24), up to 30 weeks.
|
|
Investigations
Magnetic resonance imaging abnormal
|
0.00%
0/191 • All adverse events were recorded between the time the participant provided informed consent at Week -2 (Run-in Period: Weeks -2 to 0) through 4 weeks after their last treatment (Stage 1 intervention period: Weeks 0 to 12; Stage 2 intervention period: Weeks 12 to 24), up to 30 weeks.
|
0.00%
0/172 • All adverse events were recorded between the time the participant provided informed consent at Week -2 (Run-in Period: Weeks -2 to 0) through 4 weeks after their last treatment (Stage 1 intervention period: Weeks 0 to 12; Stage 2 intervention period: Weeks 12 to 24), up to 30 weeks.
|
0.54%
1/184 • Number of events 1 • All adverse events were recorded between the time the participant provided informed consent at Week -2 (Run-in Period: Weeks -2 to 0) through 4 weeks after their last treatment (Stage 1 intervention period: Weeks 0 to 12; Stage 2 intervention period: Weeks 12 to 24), up to 30 weeks.
|
0.00%
0/205 • All adverse events were recorded between the time the participant provided informed consent at Week -2 (Run-in Period: Weeks -2 to 0) through 4 weeks after their last treatment (Stage 1 intervention period: Weeks 0 to 12; Stage 2 intervention period: Weeks 12 to 24), up to 30 weeks.
|
0.00%
0/65 • All adverse events were recorded between the time the participant provided informed consent at Week -2 (Run-in Period: Weeks -2 to 0) through 4 weeks after their last treatment (Stage 1 intervention period: Weeks 0 to 12; Stage 2 intervention period: Weeks 12 to 24), up to 30 weeks.
|
0.00%
0/71 • All adverse events were recorded between the time the participant provided informed consent at Week -2 (Run-in Period: Weeks -2 to 0) through 4 weeks after their last treatment (Stage 1 intervention period: Weeks 0 to 12; Stage 2 intervention period: Weeks 12 to 24), up to 30 weeks.
|
0.00%
0/110 • All adverse events were recorded between the time the participant provided informed consent at Week -2 (Run-in Period: Weeks -2 to 0) through 4 weeks after their last treatment (Stage 1 intervention period: Weeks 0 to 12; Stage 2 intervention period: Weeks 12 to 24), up to 30 weeks.
|
0.00%
0/85 • All adverse events were recorded between the time the participant provided informed consent at Week -2 (Run-in Period: Weeks -2 to 0) through 4 weeks after their last treatment (Stage 1 intervention period: Weeks 0 to 12; Stage 2 intervention period: Weeks 12 to 24), up to 30 weeks.
|
0.00%
0/33 • All adverse events were recorded between the time the participant provided informed consent at Week -2 (Run-in Period: Weeks -2 to 0) through 4 weeks after their last treatment (Stage 1 intervention period: Weeks 0 to 12; Stage 2 intervention period: Weeks 12 to 24), up to 30 weeks.
|
0.00%
0/52 • All adverse events were recorded between the time the participant provided informed consent at Week -2 (Run-in Period: Weeks -2 to 0) through 4 weeks after their last treatment (Stage 1 intervention period: Weeks 0 to 12; Stage 2 intervention period: Weeks 12 to 24), up to 30 weeks.
|
0.00%
0/84 • All adverse events were recorded between the time the participant provided informed consent at Week -2 (Run-in Period: Weeks -2 to 0) through 4 weeks after their last treatment (Stage 1 intervention period: Weeks 0 to 12; Stage 2 intervention period: Weeks 12 to 24), up to 30 weeks.
|
0.00%
0/22 • All adverse events were recorded between the time the participant provided informed consent at Week -2 (Run-in Period: Weeks -2 to 0) through 4 weeks after their last treatment (Stage 1 intervention period: Weeks 0 to 12; Stage 2 intervention period: Weeks 12 to 24), up to 30 weeks.
|
0.00%
0/54 • All adverse events were recorded between the time the participant provided informed consent at Week -2 (Run-in Period: Weeks -2 to 0) through 4 weeks after their last treatment (Stage 1 intervention period: Weeks 0 to 12; Stage 2 intervention period: Weeks 12 to 24), up to 30 weeks.
|
0.00%
0/85 • All adverse events were recorded between the time the participant provided informed consent at Week -2 (Run-in Period: Weeks -2 to 0) through 4 weeks after their last treatment (Stage 1 intervention period: Weeks 0 to 12; Stage 2 intervention period: Weeks 12 to 24), up to 30 weeks.
|
|
Metabolism and nutrition disorders
Ketoacidosis
|
0.00%
0/191 • All adverse events were recorded between the time the participant provided informed consent at Week -2 (Run-in Period: Weeks -2 to 0) through 4 weeks after their last treatment (Stage 1 intervention period: Weeks 0 to 12; Stage 2 intervention period: Weeks 12 to 24), up to 30 weeks.
|
0.00%
0/172 • All adverse events were recorded between the time the participant provided informed consent at Week -2 (Run-in Period: Weeks -2 to 0) through 4 weeks after their last treatment (Stage 1 intervention period: Weeks 0 to 12; Stage 2 intervention period: Weeks 12 to 24), up to 30 weeks.
|
0.00%
0/184 • All adverse events were recorded between the time the participant provided informed consent at Week -2 (Run-in Period: Weeks -2 to 0) through 4 weeks after their last treatment (Stage 1 intervention period: Weeks 0 to 12; Stage 2 intervention period: Weeks 12 to 24), up to 30 weeks.
|
0.00%
0/205 • All adverse events were recorded between the time the participant provided informed consent at Week -2 (Run-in Period: Weeks -2 to 0) through 4 weeks after their last treatment (Stage 1 intervention period: Weeks 0 to 12; Stage 2 intervention period: Weeks 12 to 24), up to 30 weeks.
|
0.00%
0/65 • All adverse events were recorded between the time the participant provided informed consent at Week -2 (Run-in Period: Weeks -2 to 0) through 4 weeks after their last treatment (Stage 1 intervention period: Weeks 0 to 12; Stage 2 intervention period: Weeks 12 to 24), up to 30 weeks.
|
0.00%
0/71 • All adverse events were recorded between the time the participant provided informed consent at Week -2 (Run-in Period: Weeks -2 to 0) through 4 weeks after their last treatment (Stage 1 intervention period: Weeks 0 to 12; Stage 2 intervention period: Weeks 12 to 24), up to 30 weeks.
|
0.91%
1/110 • Number of events 1 • All adverse events were recorded between the time the participant provided informed consent at Week -2 (Run-in Period: Weeks -2 to 0) through 4 weeks after their last treatment (Stage 1 intervention period: Weeks 0 to 12; Stage 2 intervention period: Weeks 12 to 24), up to 30 weeks.
|
0.00%
0/85 • All adverse events were recorded between the time the participant provided informed consent at Week -2 (Run-in Period: Weeks -2 to 0) through 4 weeks after their last treatment (Stage 1 intervention period: Weeks 0 to 12; Stage 2 intervention period: Weeks 12 to 24), up to 30 weeks.
|
0.00%
0/33 • All adverse events were recorded between the time the participant provided informed consent at Week -2 (Run-in Period: Weeks -2 to 0) through 4 weeks after their last treatment (Stage 1 intervention period: Weeks 0 to 12; Stage 2 intervention period: Weeks 12 to 24), up to 30 weeks.
|
0.00%
0/52 • All adverse events were recorded between the time the participant provided informed consent at Week -2 (Run-in Period: Weeks -2 to 0) through 4 weeks after their last treatment (Stage 1 intervention period: Weeks 0 to 12; Stage 2 intervention period: Weeks 12 to 24), up to 30 weeks.
|
0.00%
0/84 • All adverse events were recorded between the time the participant provided informed consent at Week -2 (Run-in Period: Weeks -2 to 0) through 4 weeks after their last treatment (Stage 1 intervention period: Weeks 0 to 12; Stage 2 intervention period: Weeks 12 to 24), up to 30 weeks.
|
0.00%
0/22 • All adverse events were recorded between the time the participant provided informed consent at Week -2 (Run-in Period: Weeks -2 to 0) through 4 weeks after their last treatment (Stage 1 intervention period: Weeks 0 to 12; Stage 2 intervention period: Weeks 12 to 24), up to 30 weeks.
|
0.00%
0/54 • All adverse events were recorded between the time the participant provided informed consent at Week -2 (Run-in Period: Weeks -2 to 0) through 4 weeks after their last treatment (Stage 1 intervention period: Weeks 0 to 12; Stage 2 intervention period: Weeks 12 to 24), up to 30 weeks.
|
0.00%
0/85 • All adverse events were recorded between the time the participant provided informed consent at Week -2 (Run-in Period: Weeks -2 to 0) through 4 weeks after their last treatment (Stage 1 intervention period: Weeks 0 to 12; Stage 2 intervention period: Weeks 12 to 24), up to 30 weeks.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Uterine polyp
|
0.52%
1/191 • Number of events 1 • All adverse events were recorded between the time the participant provided informed consent at Week -2 (Run-in Period: Weeks -2 to 0) through 4 weeks after their last treatment (Stage 1 intervention period: Weeks 0 to 12; Stage 2 intervention period: Weeks 12 to 24), up to 30 weeks.
|
0.00%
0/172 • All adverse events were recorded between the time the participant provided informed consent at Week -2 (Run-in Period: Weeks -2 to 0) through 4 weeks after their last treatment (Stage 1 intervention period: Weeks 0 to 12; Stage 2 intervention period: Weeks 12 to 24), up to 30 weeks.
|
0.00%
0/184 • All adverse events were recorded between the time the participant provided informed consent at Week -2 (Run-in Period: Weeks -2 to 0) through 4 weeks after their last treatment (Stage 1 intervention period: Weeks 0 to 12; Stage 2 intervention period: Weeks 12 to 24), up to 30 weeks.
|
0.00%
0/205 • All adverse events were recorded between the time the participant provided informed consent at Week -2 (Run-in Period: Weeks -2 to 0) through 4 weeks after their last treatment (Stage 1 intervention period: Weeks 0 to 12; Stage 2 intervention period: Weeks 12 to 24), up to 30 weeks.
|
0.00%
0/65 • All adverse events were recorded between the time the participant provided informed consent at Week -2 (Run-in Period: Weeks -2 to 0) through 4 weeks after their last treatment (Stage 1 intervention period: Weeks 0 to 12; Stage 2 intervention period: Weeks 12 to 24), up to 30 weeks.
|
0.00%
0/71 • All adverse events were recorded between the time the participant provided informed consent at Week -2 (Run-in Period: Weeks -2 to 0) through 4 weeks after their last treatment (Stage 1 intervention period: Weeks 0 to 12; Stage 2 intervention period: Weeks 12 to 24), up to 30 weeks.
|
0.00%
0/110 • All adverse events were recorded between the time the participant provided informed consent at Week -2 (Run-in Period: Weeks -2 to 0) through 4 weeks after their last treatment (Stage 1 intervention period: Weeks 0 to 12; Stage 2 intervention period: Weeks 12 to 24), up to 30 weeks.
|
0.00%
0/85 • All adverse events were recorded between the time the participant provided informed consent at Week -2 (Run-in Period: Weeks -2 to 0) through 4 weeks after their last treatment (Stage 1 intervention period: Weeks 0 to 12; Stage 2 intervention period: Weeks 12 to 24), up to 30 weeks.
|
0.00%
0/33 • All adverse events were recorded between the time the participant provided informed consent at Week -2 (Run-in Period: Weeks -2 to 0) through 4 weeks after their last treatment (Stage 1 intervention period: Weeks 0 to 12; Stage 2 intervention period: Weeks 12 to 24), up to 30 weeks.
|
0.00%
0/52 • All adverse events were recorded between the time the participant provided informed consent at Week -2 (Run-in Period: Weeks -2 to 0) through 4 weeks after their last treatment (Stage 1 intervention period: Weeks 0 to 12; Stage 2 intervention period: Weeks 12 to 24), up to 30 weeks.
|
0.00%
0/84 • All adverse events were recorded between the time the participant provided informed consent at Week -2 (Run-in Period: Weeks -2 to 0) through 4 weeks after their last treatment (Stage 1 intervention period: Weeks 0 to 12; Stage 2 intervention period: Weeks 12 to 24), up to 30 weeks.
|
0.00%
0/22 • All adverse events were recorded between the time the participant provided informed consent at Week -2 (Run-in Period: Weeks -2 to 0) through 4 weeks after their last treatment (Stage 1 intervention period: Weeks 0 to 12; Stage 2 intervention period: Weeks 12 to 24), up to 30 weeks.
|
0.00%
0/54 • All adverse events were recorded between the time the participant provided informed consent at Week -2 (Run-in Period: Weeks -2 to 0) through 4 weeks after their last treatment (Stage 1 intervention period: Weeks 0 to 12; Stage 2 intervention period: Weeks 12 to 24), up to 30 weeks.
|
0.00%
0/85 • All adverse events were recorded between the time the participant provided informed consent at Week -2 (Run-in Period: Weeks -2 to 0) through 4 weeks after their last treatment (Stage 1 intervention period: Weeks 0 to 12; Stage 2 intervention period: Weeks 12 to 24), up to 30 weeks.
|
|
Nervous system disorders
Headache
|
0.00%
0/191 • All adverse events were recorded between the time the participant provided informed consent at Week -2 (Run-in Period: Weeks -2 to 0) through 4 weeks after their last treatment (Stage 1 intervention period: Weeks 0 to 12; Stage 2 intervention period: Weeks 12 to 24), up to 30 weeks.
|
0.00%
0/172 • All adverse events were recorded between the time the participant provided informed consent at Week -2 (Run-in Period: Weeks -2 to 0) through 4 weeks after their last treatment (Stage 1 intervention period: Weeks 0 to 12; Stage 2 intervention period: Weeks 12 to 24), up to 30 weeks.
|
0.54%
1/184 • Number of events 1 • All adverse events were recorded between the time the participant provided informed consent at Week -2 (Run-in Period: Weeks -2 to 0) through 4 weeks after their last treatment (Stage 1 intervention period: Weeks 0 to 12; Stage 2 intervention period: Weeks 12 to 24), up to 30 weeks.
|
0.00%
0/205 • All adverse events were recorded between the time the participant provided informed consent at Week -2 (Run-in Period: Weeks -2 to 0) through 4 weeks after their last treatment (Stage 1 intervention period: Weeks 0 to 12; Stage 2 intervention period: Weeks 12 to 24), up to 30 weeks.
|
0.00%
0/65 • All adverse events were recorded between the time the participant provided informed consent at Week -2 (Run-in Period: Weeks -2 to 0) through 4 weeks after their last treatment (Stage 1 intervention period: Weeks 0 to 12; Stage 2 intervention period: Weeks 12 to 24), up to 30 weeks.
|
0.00%
0/71 • All adverse events were recorded between the time the participant provided informed consent at Week -2 (Run-in Period: Weeks -2 to 0) through 4 weeks after their last treatment (Stage 1 intervention period: Weeks 0 to 12; Stage 2 intervention period: Weeks 12 to 24), up to 30 weeks.
|
0.00%
0/110 • All adverse events were recorded between the time the participant provided informed consent at Week -2 (Run-in Period: Weeks -2 to 0) through 4 weeks after their last treatment (Stage 1 intervention period: Weeks 0 to 12; Stage 2 intervention period: Weeks 12 to 24), up to 30 weeks.
|
0.00%
0/85 • All adverse events were recorded between the time the participant provided informed consent at Week -2 (Run-in Period: Weeks -2 to 0) through 4 weeks after their last treatment (Stage 1 intervention period: Weeks 0 to 12; Stage 2 intervention period: Weeks 12 to 24), up to 30 weeks.
|
0.00%
0/33 • All adverse events were recorded between the time the participant provided informed consent at Week -2 (Run-in Period: Weeks -2 to 0) through 4 weeks after their last treatment (Stage 1 intervention period: Weeks 0 to 12; Stage 2 intervention period: Weeks 12 to 24), up to 30 weeks.
|
0.00%
0/52 • All adverse events were recorded between the time the participant provided informed consent at Week -2 (Run-in Period: Weeks -2 to 0) through 4 weeks after their last treatment (Stage 1 intervention period: Weeks 0 to 12; Stage 2 intervention period: Weeks 12 to 24), up to 30 weeks.
|
0.00%
0/84 • All adverse events were recorded between the time the participant provided informed consent at Week -2 (Run-in Period: Weeks -2 to 0) through 4 weeks after their last treatment (Stage 1 intervention period: Weeks 0 to 12; Stage 2 intervention period: Weeks 12 to 24), up to 30 weeks.
|
0.00%
0/22 • All adverse events were recorded between the time the participant provided informed consent at Week -2 (Run-in Period: Weeks -2 to 0) through 4 weeks after their last treatment (Stage 1 intervention period: Weeks 0 to 12; Stage 2 intervention period: Weeks 12 to 24), up to 30 weeks.
|
0.00%
0/54 • All adverse events were recorded between the time the participant provided informed consent at Week -2 (Run-in Period: Weeks -2 to 0) through 4 weeks after their last treatment (Stage 1 intervention period: Weeks 0 to 12; Stage 2 intervention period: Weeks 12 to 24), up to 30 weeks.
|
0.00%
0/85 • All adverse events were recorded between the time the participant provided informed consent at Week -2 (Run-in Period: Weeks -2 to 0) through 4 weeks after their last treatment (Stage 1 intervention period: Weeks 0 to 12; Stage 2 intervention period: Weeks 12 to 24), up to 30 weeks.
|
|
Nervous system disorders
Migraine
|
0.00%
0/191 • All adverse events were recorded between the time the participant provided informed consent at Week -2 (Run-in Period: Weeks -2 to 0) through 4 weeks after their last treatment (Stage 1 intervention period: Weeks 0 to 12; Stage 2 intervention period: Weeks 12 to 24), up to 30 weeks.
|
0.58%
1/172 • Number of events 1 • All adverse events were recorded between the time the participant provided informed consent at Week -2 (Run-in Period: Weeks -2 to 0) through 4 weeks after their last treatment (Stage 1 intervention period: Weeks 0 to 12; Stage 2 intervention period: Weeks 12 to 24), up to 30 weeks.
|
0.00%
0/184 • All adverse events were recorded between the time the participant provided informed consent at Week -2 (Run-in Period: Weeks -2 to 0) through 4 weeks after their last treatment (Stage 1 intervention period: Weeks 0 to 12; Stage 2 intervention period: Weeks 12 to 24), up to 30 weeks.
|
0.00%
0/205 • All adverse events were recorded between the time the participant provided informed consent at Week -2 (Run-in Period: Weeks -2 to 0) through 4 weeks after their last treatment (Stage 1 intervention period: Weeks 0 to 12; Stage 2 intervention period: Weeks 12 to 24), up to 30 weeks.
|
0.00%
0/65 • All adverse events were recorded between the time the participant provided informed consent at Week -2 (Run-in Period: Weeks -2 to 0) through 4 weeks after their last treatment (Stage 1 intervention period: Weeks 0 to 12; Stage 2 intervention period: Weeks 12 to 24), up to 30 weeks.
|
0.00%
0/71 • All adverse events were recorded between the time the participant provided informed consent at Week -2 (Run-in Period: Weeks -2 to 0) through 4 weeks after their last treatment (Stage 1 intervention period: Weeks 0 to 12; Stage 2 intervention period: Weeks 12 to 24), up to 30 weeks.
|
0.00%
0/110 • All adverse events were recorded between the time the participant provided informed consent at Week -2 (Run-in Period: Weeks -2 to 0) through 4 weeks after their last treatment (Stage 1 intervention period: Weeks 0 to 12; Stage 2 intervention period: Weeks 12 to 24), up to 30 weeks.
|
0.00%
0/85 • All adverse events were recorded between the time the participant provided informed consent at Week -2 (Run-in Period: Weeks -2 to 0) through 4 weeks after their last treatment (Stage 1 intervention period: Weeks 0 to 12; Stage 2 intervention period: Weeks 12 to 24), up to 30 weeks.
|
0.00%
0/33 • All adverse events were recorded between the time the participant provided informed consent at Week -2 (Run-in Period: Weeks -2 to 0) through 4 weeks after their last treatment (Stage 1 intervention period: Weeks 0 to 12; Stage 2 intervention period: Weeks 12 to 24), up to 30 weeks.
|
0.00%
0/52 • All adverse events were recorded between the time the participant provided informed consent at Week -2 (Run-in Period: Weeks -2 to 0) through 4 weeks after their last treatment (Stage 1 intervention period: Weeks 0 to 12; Stage 2 intervention period: Weeks 12 to 24), up to 30 weeks.
|
0.00%
0/84 • All adverse events were recorded between the time the participant provided informed consent at Week -2 (Run-in Period: Weeks -2 to 0) through 4 weeks after their last treatment (Stage 1 intervention period: Weeks 0 to 12; Stage 2 intervention period: Weeks 12 to 24), up to 30 weeks.
|
0.00%
0/22 • All adverse events were recorded between the time the participant provided informed consent at Week -2 (Run-in Period: Weeks -2 to 0) through 4 weeks after their last treatment (Stage 1 intervention period: Weeks 0 to 12; Stage 2 intervention period: Weeks 12 to 24), up to 30 weeks.
|
0.00%
0/54 • All adverse events were recorded between the time the participant provided informed consent at Week -2 (Run-in Period: Weeks -2 to 0) through 4 weeks after their last treatment (Stage 1 intervention period: Weeks 0 to 12; Stage 2 intervention period: Weeks 12 to 24), up to 30 weeks.
|
0.00%
0/85 • All adverse events were recorded between the time the participant provided informed consent at Week -2 (Run-in Period: Weeks -2 to 0) through 4 weeks after their last treatment (Stage 1 intervention period: Weeks 0 to 12; Stage 2 intervention period: Weeks 12 to 24), up to 30 weeks.
|
|
Renal and urinary disorders
Urinary tract infection
|
0.00%
0/191 • All adverse events were recorded between the time the participant provided informed consent at Week -2 (Run-in Period: Weeks -2 to 0) through 4 weeks after their last treatment (Stage 1 intervention period: Weeks 0 to 12; Stage 2 intervention period: Weeks 12 to 24), up to 30 weeks.
|
0.00%
0/172 • All adverse events were recorded between the time the participant provided informed consent at Week -2 (Run-in Period: Weeks -2 to 0) through 4 weeks after their last treatment (Stage 1 intervention period: Weeks 0 to 12; Stage 2 intervention period: Weeks 12 to 24), up to 30 weeks.
|
0.54%
1/184 • Number of events 1 • All adverse events were recorded between the time the participant provided informed consent at Week -2 (Run-in Period: Weeks -2 to 0) through 4 weeks after their last treatment (Stage 1 intervention period: Weeks 0 to 12; Stage 2 intervention period: Weeks 12 to 24), up to 30 weeks.
|
0.00%
0/205 • All adverse events were recorded between the time the participant provided informed consent at Week -2 (Run-in Period: Weeks -2 to 0) through 4 weeks after their last treatment (Stage 1 intervention period: Weeks 0 to 12; Stage 2 intervention period: Weeks 12 to 24), up to 30 weeks.
|
0.00%
0/65 • All adverse events were recorded between the time the participant provided informed consent at Week -2 (Run-in Period: Weeks -2 to 0) through 4 weeks after their last treatment (Stage 1 intervention period: Weeks 0 to 12; Stage 2 intervention period: Weeks 12 to 24), up to 30 weeks.
|
0.00%
0/71 • All adverse events were recorded between the time the participant provided informed consent at Week -2 (Run-in Period: Weeks -2 to 0) through 4 weeks after their last treatment (Stage 1 intervention period: Weeks 0 to 12; Stage 2 intervention period: Weeks 12 to 24), up to 30 weeks.
|
0.00%
0/110 • All adverse events were recorded between the time the participant provided informed consent at Week -2 (Run-in Period: Weeks -2 to 0) through 4 weeks after their last treatment (Stage 1 intervention period: Weeks 0 to 12; Stage 2 intervention period: Weeks 12 to 24), up to 30 weeks.
|
0.00%
0/85 • All adverse events were recorded between the time the participant provided informed consent at Week -2 (Run-in Period: Weeks -2 to 0) through 4 weeks after their last treatment (Stage 1 intervention period: Weeks 0 to 12; Stage 2 intervention period: Weeks 12 to 24), up to 30 weeks.
|
0.00%
0/33 • All adverse events were recorded between the time the participant provided informed consent at Week -2 (Run-in Period: Weeks -2 to 0) through 4 weeks after their last treatment (Stage 1 intervention period: Weeks 0 to 12; Stage 2 intervention period: Weeks 12 to 24), up to 30 weeks.
|
0.00%
0/52 • All adverse events were recorded between the time the participant provided informed consent at Week -2 (Run-in Period: Weeks -2 to 0) through 4 weeks after their last treatment (Stage 1 intervention period: Weeks 0 to 12; Stage 2 intervention period: Weeks 12 to 24), up to 30 weeks.
|
0.00%
0/84 • All adverse events were recorded between the time the participant provided informed consent at Week -2 (Run-in Period: Weeks -2 to 0) through 4 weeks after their last treatment (Stage 1 intervention period: Weeks 0 to 12; Stage 2 intervention period: Weeks 12 to 24), up to 30 weeks.
|
0.00%
0/22 • All adverse events were recorded between the time the participant provided informed consent at Week -2 (Run-in Period: Weeks -2 to 0) through 4 weeks after their last treatment (Stage 1 intervention period: Weeks 0 to 12; Stage 2 intervention period: Weeks 12 to 24), up to 30 weeks.
|
0.00%
0/54 • All adverse events were recorded between the time the participant provided informed consent at Week -2 (Run-in Period: Weeks -2 to 0) through 4 weeks after their last treatment (Stage 1 intervention period: Weeks 0 to 12; Stage 2 intervention period: Weeks 12 to 24), up to 30 weeks.
|
0.00%
0/85 • All adverse events were recorded between the time the participant provided informed consent at Week -2 (Run-in Period: Weeks -2 to 0) through 4 weeks after their last treatment (Stage 1 intervention period: Weeks 0 to 12; Stage 2 intervention period: Weeks 12 to 24), up to 30 weeks.
|
|
Reproductive system and breast disorders
Testis cancer
|
0.00%
0/191 • All adverse events were recorded between the time the participant provided informed consent at Week -2 (Run-in Period: Weeks -2 to 0) through 4 weeks after their last treatment (Stage 1 intervention period: Weeks 0 to 12; Stage 2 intervention period: Weeks 12 to 24), up to 30 weeks.
|
0.00%
0/172 • All adverse events were recorded between the time the participant provided informed consent at Week -2 (Run-in Period: Weeks -2 to 0) through 4 weeks after their last treatment (Stage 1 intervention period: Weeks 0 to 12; Stage 2 intervention period: Weeks 12 to 24), up to 30 weeks.
|
0.00%
0/184 • All adverse events were recorded between the time the participant provided informed consent at Week -2 (Run-in Period: Weeks -2 to 0) through 4 weeks after their last treatment (Stage 1 intervention period: Weeks 0 to 12; Stage 2 intervention period: Weeks 12 to 24), up to 30 weeks.
|
0.00%
0/205 • All adverse events were recorded between the time the participant provided informed consent at Week -2 (Run-in Period: Weeks -2 to 0) through 4 weeks after their last treatment (Stage 1 intervention period: Weeks 0 to 12; Stage 2 intervention period: Weeks 12 to 24), up to 30 weeks.
|
0.00%
0/65 • All adverse events were recorded between the time the participant provided informed consent at Week -2 (Run-in Period: Weeks -2 to 0) through 4 weeks after their last treatment (Stage 1 intervention period: Weeks 0 to 12; Stage 2 intervention period: Weeks 12 to 24), up to 30 weeks.
|
0.00%
0/71 • All adverse events were recorded between the time the participant provided informed consent at Week -2 (Run-in Period: Weeks -2 to 0) through 4 weeks after their last treatment (Stage 1 intervention period: Weeks 0 to 12; Stage 2 intervention period: Weeks 12 to 24), up to 30 weeks.
|
0.91%
1/110 • Number of events 1 • All adverse events were recorded between the time the participant provided informed consent at Week -2 (Run-in Period: Weeks -2 to 0) through 4 weeks after their last treatment (Stage 1 intervention period: Weeks 0 to 12; Stage 2 intervention period: Weeks 12 to 24), up to 30 weeks.
|
0.00%
0/85 • All adverse events were recorded between the time the participant provided informed consent at Week -2 (Run-in Period: Weeks -2 to 0) through 4 weeks after their last treatment (Stage 1 intervention period: Weeks 0 to 12; Stage 2 intervention period: Weeks 12 to 24), up to 30 weeks.
|
0.00%
0/33 • All adverse events were recorded between the time the participant provided informed consent at Week -2 (Run-in Period: Weeks -2 to 0) through 4 weeks after their last treatment (Stage 1 intervention period: Weeks 0 to 12; Stage 2 intervention period: Weeks 12 to 24), up to 30 weeks.
|
0.00%
0/52 • All adverse events were recorded between the time the participant provided informed consent at Week -2 (Run-in Period: Weeks -2 to 0) through 4 weeks after their last treatment (Stage 1 intervention period: Weeks 0 to 12; Stage 2 intervention period: Weeks 12 to 24), up to 30 weeks.
|
0.00%
0/84 • All adverse events were recorded between the time the participant provided informed consent at Week -2 (Run-in Period: Weeks -2 to 0) through 4 weeks after their last treatment (Stage 1 intervention period: Weeks 0 to 12; Stage 2 intervention period: Weeks 12 to 24), up to 30 weeks.
|
0.00%
0/22 • All adverse events were recorded between the time the participant provided informed consent at Week -2 (Run-in Period: Weeks -2 to 0) through 4 weeks after their last treatment (Stage 1 intervention period: Weeks 0 to 12; Stage 2 intervention period: Weeks 12 to 24), up to 30 weeks.
|
0.00%
0/54 • All adverse events were recorded between the time the participant provided informed consent at Week -2 (Run-in Period: Weeks -2 to 0) through 4 weeks after their last treatment (Stage 1 intervention period: Weeks 0 to 12; Stage 2 intervention period: Weeks 12 to 24), up to 30 weeks.
|
0.00%
0/85 • All adverse events were recorded between the time the participant provided informed consent at Week -2 (Run-in Period: Weeks -2 to 0) through 4 weeks after their last treatment (Stage 1 intervention period: Weeks 0 to 12; Stage 2 intervention period: Weeks 12 to 24), up to 30 weeks.
|
|
Social circumstances
Physical assault
|
0.00%
0/191 • All adverse events were recorded between the time the participant provided informed consent at Week -2 (Run-in Period: Weeks -2 to 0) through 4 weeks after their last treatment (Stage 1 intervention period: Weeks 0 to 12; Stage 2 intervention period: Weeks 12 to 24), up to 30 weeks.
|
0.00%
0/172 • All adverse events were recorded between the time the participant provided informed consent at Week -2 (Run-in Period: Weeks -2 to 0) through 4 weeks after their last treatment (Stage 1 intervention period: Weeks 0 to 12; Stage 2 intervention period: Weeks 12 to 24), up to 30 weeks.
|
0.00%
0/184 • All adverse events were recorded between the time the participant provided informed consent at Week -2 (Run-in Period: Weeks -2 to 0) through 4 weeks after their last treatment (Stage 1 intervention period: Weeks 0 to 12; Stage 2 intervention period: Weeks 12 to 24), up to 30 weeks.
|
0.00%
0/205 • All adverse events were recorded between the time the participant provided informed consent at Week -2 (Run-in Period: Weeks -2 to 0) through 4 weeks after their last treatment (Stage 1 intervention period: Weeks 0 to 12; Stage 2 intervention period: Weeks 12 to 24), up to 30 weeks.
|
0.00%
0/65 • All adverse events were recorded between the time the participant provided informed consent at Week -2 (Run-in Period: Weeks -2 to 0) through 4 weeks after their last treatment (Stage 1 intervention period: Weeks 0 to 12; Stage 2 intervention period: Weeks 12 to 24), up to 30 weeks.
|
0.00%
0/71 • All adverse events were recorded between the time the participant provided informed consent at Week -2 (Run-in Period: Weeks -2 to 0) through 4 weeks after their last treatment (Stage 1 intervention period: Weeks 0 to 12; Stage 2 intervention period: Weeks 12 to 24), up to 30 weeks.
|
0.00%
0/110 • All adverse events were recorded between the time the participant provided informed consent at Week -2 (Run-in Period: Weeks -2 to 0) through 4 weeks after their last treatment (Stage 1 intervention period: Weeks 0 to 12; Stage 2 intervention period: Weeks 12 to 24), up to 30 weeks.
|
0.00%
0/85 • All adverse events were recorded between the time the participant provided informed consent at Week -2 (Run-in Period: Weeks -2 to 0) through 4 weeks after their last treatment (Stage 1 intervention period: Weeks 0 to 12; Stage 2 intervention period: Weeks 12 to 24), up to 30 weeks.
|
0.00%
0/33 • All adverse events were recorded between the time the participant provided informed consent at Week -2 (Run-in Period: Weeks -2 to 0) through 4 weeks after their last treatment (Stage 1 intervention period: Weeks 0 to 12; Stage 2 intervention period: Weeks 12 to 24), up to 30 weeks.
|
0.00%
0/52 • All adverse events were recorded between the time the participant provided informed consent at Week -2 (Run-in Period: Weeks -2 to 0) through 4 weeks after their last treatment (Stage 1 intervention period: Weeks 0 to 12; Stage 2 intervention period: Weeks 12 to 24), up to 30 weeks.
|
1.2%
1/84 • Number of events 1 • All adverse events were recorded between the time the participant provided informed consent at Week -2 (Run-in Period: Weeks -2 to 0) through 4 weeks after their last treatment (Stage 1 intervention period: Weeks 0 to 12; Stage 2 intervention period: Weeks 12 to 24), up to 30 weeks.
|
0.00%
0/22 • All adverse events were recorded between the time the participant provided informed consent at Week -2 (Run-in Period: Weeks -2 to 0) through 4 weeks after their last treatment (Stage 1 intervention period: Weeks 0 to 12; Stage 2 intervention period: Weeks 12 to 24), up to 30 weeks.
|
0.00%
0/54 • All adverse events were recorded between the time the participant provided informed consent at Week -2 (Run-in Period: Weeks -2 to 0) through 4 weeks after their last treatment (Stage 1 intervention period: Weeks 0 to 12; Stage 2 intervention period: Weeks 12 to 24), up to 30 weeks.
|
0.00%
0/85 • All adverse events were recorded between the time the participant provided informed consent at Week -2 (Run-in Period: Weeks -2 to 0) through 4 weeks after their last treatment (Stage 1 intervention period: Weeks 0 to 12; Stage 2 intervention period: Weeks 12 to 24), up to 30 weeks.
|
|
Surgical and medical procedures
Knee arthroplasty
|
0.00%
0/191 • All adverse events were recorded between the time the participant provided informed consent at Week -2 (Run-in Period: Weeks -2 to 0) through 4 weeks after their last treatment (Stage 1 intervention period: Weeks 0 to 12; Stage 2 intervention period: Weeks 12 to 24), up to 30 weeks.
|
0.00%
0/172 • All adverse events were recorded between the time the participant provided informed consent at Week -2 (Run-in Period: Weeks -2 to 0) through 4 weeks after their last treatment (Stage 1 intervention period: Weeks 0 to 12; Stage 2 intervention period: Weeks 12 to 24), up to 30 weeks.
|
0.00%
0/184 • All adverse events were recorded between the time the participant provided informed consent at Week -2 (Run-in Period: Weeks -2 to 0) through 4 weeks after their last treatment (Stage 1 intervention period: Weeks 0 to 12; Stage 2 intervention period: Weeks 12 to 24), up to 30 weeks.
|
0.00%
0/205 • All adverse events were recorded between the time the participant provided informed consent at Week -2 (Run-in Period: Weeks -2 to 0) through 4 weeks after their last treatment (Stage 1 intervention period: Weeks 0 to 12; Stage 2 intervention period: Weeks 12 to 24), up to 30 weeks.
|
1.5%
1/65 • Number of events 1 • All adverse events were recorded between the time the participant provided informed consent at Week -2 (Run-in Period: Weeks -2 to 0) through 4 weeks after their last treatment (Stage 1 intervention period: Weeks 0 to 12; Stage 2 intervention period: Weeks 12 to 24), up to 30 weeks.
|
0.00%
0/71 • All adverse events were recorded between the time the participant provided informed consent at Week -2 (Run-in Period: Weeks -2 to 0) through 4 weeks after their last treatment (Stage 1 intervention period: Weeks 0 to 12; Stage 2 intervention period: Weeks 12 to 24), up to 30 weeks.
|
0.00%
0/110 • All adverse events were recorded between the time the participant provided informed consent at Week -2 (Run-in Period: Weeks -2 to 0) through 4 weeks after their last treatment (Stage 1 intervention period: Weeks 0 to 12; Stage 2 intervention period: Weeks 12 to 24), up to 30 weeks.
|
1.2%
1/85 • Number of events 1 • All adverse events were recorded between the time the participant provided informed consent at Week -2 (Run-in Period: Weeks -2 to 0) through 4 weeks after their last treatment (Stage 1 intervention period: Weeks 0 to 12; Stage 2 intervention period: Weeks 12 to 24), up to 30 weeks.
|
0.00%
0/33 • All adverse events were recorded between the time the participant provided informed consent at Week -2 (Run-in Period: Weeks -2 to 0) through 4 weeks after their last treatment (Stage 1 intervention period: Weeks 0 to 12; Stage 2 intervention period: Weeks 12 to 24), up to 30 weeks.
|
0.00%
0/52 • All adverse events were recorded between the time the participant provided informed consent at Week -2 (Run-in Period: Weeks -2 to 0) through 4 weeks after their last treatment (Stage 1 intervention period: Weeks 0 to 12; Stage 2 intervention period: Weeks 12 to 24), up to 30 weeks.
|
1.2%
1/84 • Number of events 1 • All adverse events were recorded between the time the participant provided informed consent at Week -2 (Run-in Period: Weeks -2 to 0) through 4 weeks after their last treatment (Stage 1 intervention period: Weeks 0 to 12; Stage 2 intervention period: Weeks 12 to 24), up to 30 weeks.
|
0.00%
0/22 • All adverse events were recorded between the time the participant provided informed consent at Week -2 (Run-in Period: Weeks -2 to 0) through 4 weeks after their last treatment (Stage 1 intervention period: Weeks 0 to 12; Stage 2 intervention period: Weeks 12 to 24), up to 30 weeks.
|
0.00%
0/54 • All adverse events were recorded between the time the participant provided informed consent at Week -2 (Run-in Period: Weeks -2 to 0) through 4 weeks after their last treatment (Stage 1 intervention period: Weeks 0 to 12; Stage 2 intervention period: Weeks 12 to 24), up to 30 weeks.
|
0.00%
0/85 • All adverse events were recorded between the time the participant provided informed consent at Week -2 (Run-in Period: Weeks -2 to 0) through 4 weeks after their last treatment (Stage 1 intervention period: Weeks 0 to 12; Stage 2 intervention period: Weeks 12 to 24), up to 30 weeks.
|
|
Surgical and medical procedures
Metabolic surgery
|
0.00%
0/191 • All adverse events were recorded between the time the participant provided informed consent at Week -2 (Run-in Period: Weeks -2 to 0) through 4 weeks after their last treatment (Stage 1 intervention period: Weeks 0 to 12; Stage 2 intervention period: Weeks 12 to 24), up to 30 weeks.
|
0.00%
0/172 • All adverse events were recorded between the time the participant provided informed consent at Week -2 (Run-in Period: Weeks -2 to 0) through 4 weeks after their last treatment (Stage 1 intervention period: Weeks 0 to 12; Stage 2 intervention period: Weeks 12 to 24), up to 30 weeks.
|
0.00%
0/184 • All adverse events were recorded between the time the participant provided informed consent at Week -2 (Run-in Period: Weeks -2 to 0) through 4 weeks after their last treatment (Stage 1 intervention period: Weeks 0 to 12; Stage 2 intervention period: Weeks 12 to 24), up to 30 weeks.
|
0.00%
0/205 • All adverse events were recorded between the time the participant provided informed consent at Week -2 (Run-in Period: Weeks -2 to 0) through 4 weeks after their last treatment (Stage 1 intervention period: Weeks 0 to 12; Stage 2 intervention period: Weeks 12 to 24), up to 30 weeks.
|
1.5%
1/65 • Number of events 1 • All adverse events were recorded between the time the participant provided informed consent at Week -2 (Run-in Period: Weeks -2 to 0) through 4 weeks after their last treatment (Stage 1 intervention period: Weeks 0 to 12; Stage 2 intervention period: Weeks 12 to 24), up to 30 weeks.
|
0.00%
0/71 • All adverse events were recorded between the time the participant provided informed consent at Week -2 (Run-in Period: Weeks -2 to 0) through 4 weeks after their last treatment (Stage 1 intervention period: Weeks 0 to 12; Stage 2 intervention period: Weeks 12 to 24), up to 30 weeks.
|
0.00%
0/110 • All adverse events were recorded between the time the participant provided informed consent at Week -2 (Run-in Period: Weeks -2 to 0) through 4 weeks after their last treatment (Stage 1 intervention period: Weeks 0 to 12; Stage 2 intervention period: Weeks 12 to 24), up to 30 weeks.
|
0.00%
0/85 • All adverse events were recorded between the time the participant provided informed consent at Week -2 (Run-in Period: Weeks -2 to 0) through 4 weeks after their last treatment (Stage 1 intervention period: Weeks 0 to 12; Stage 2 intervention period: Weeks 12 to 24), up to 30 weeks.
|
0.00%
0/33 • All adverse events were recorded between the time the participant provided informed consent at Week -2 (Run-in Period: Weeks -2 to 0) through 4 weeks after their last treatment (Stage 1 intervention period: Weeks 0 to 12; Stage 2 intervention period: Weeks 12 to 24), up to 30 weeks.
|
0.00%
0/52 • All adverse events were recorded between the time the participant provided informed consent at Week -2 (Run-in Period: Weeks -2 to 0) through 4 weeks after their last treatment (Stage 1 intervention period: Weeks 0 to 12; Stage 2 intervention period: Weeks 12 to 24), up to 30 weeks.
|
0.00%
0/84 • All adverse events were recorded between the time the participant provided informed consent at Week -2 (Run-in Period: Weeks -2 to 0) through 4 weeks after their last treatment (Stage 1 intervention period: Weeks 0 to 12; Stage 2 intervention period: Weeks 12 to 24), up to 30 weeks.
|
0.00%
0/22 • All adverse events were recorded between the time the participant provided informed consent at Week -2 (Run-in Period: Weeks -2 to 0) through 4 weeks after their last treatment (Stage 1 intervention period: Weeks 0 to 12; Stage 2 intervention period: Weeks 12 to 24), up to 30 weeks.
|
0.00%
0/54 • All adverse events were recorded between the time the participant provided informed consent at Week -2 (Run-in Period: Weeks -2 to 0) through 4 weeks after their last treatment (Stage 1 intervention period: Weeks 0 to 12; Stage 2 intervention period: Weeks 12 to 24), up to 30 weeks.
|
0.00%
0/85 • All adverse events were recorded between the time the participant provided informed consent at Week -2 (Run-in Period: Weeks -2 to 0) through 4 weeks after their last treatment (Stage 1 intervention period: Weeks 0 to 12; Stage 2 intervention period: Weeks 12 to 24), up to 30 weeks.
|
|
Surgical and medical procedures
Psychiatric care
|
0.00%
0/191 • All adverse events were recorded between the time the participant provided informed consent at Week -2 (Run-in Period: Weeks -2 to 0) through 4 weeks after their last treatment (Stage 1 intervention period: Weeks 0 to 12; Stage 2 intervention period: Weeks 12 to 24), up to 30 weeks.
|
0.00%
0/172 • All adverse events were recorded between the time the participant provided informed consent at Week -2 (Run-in Period: Weeks -2 to 0) through 4 weeks after their last treatment (Stage 1 intervention period: Weeks 0 to 12; Stage 2 intervention period: Weeks 12 to 24), up to 30 weeks.
|
0.00%
0/184 • All adverse events were recorded between the time the participant provided informed consent at Week -2 (Run-in Period: Weeks -2 to 0) through 4 weeks after their last treatment (Stage 1 intervention period: Weeks 0 to 12; Stage 2 intervention period: Weeks 12 to 24), up to 30 weeks.
|
0.49%
1/205 • Number of events 1 • All adverse events were recorded between the time the participant provided informed consent at Week -2 (Run-in Period: Weeks -2 to 0) through 4 weeks after their last treatment (Stage 1 intervention period: Weeks 0 to 12; Stage 2 intervention period: Weeks 12 to 24), up to 30 weeks.
|
0.00%
0/65 • All adverse events were recorded between the time the participant provided informed consent at Week -2 (Run-in Period: Weeks -2 to 0) through 4 weeks after their last treatment (Stage 1 intervention period: Weeks 0 to 12; Stage 2 intervention period: Weeks 12 to 24), up to 30 weeks.
|
0.00%
0/71 • All adverse events were recorded between the time the participant provided informed consent at Week -2 (Run-in Period: Weeks -2 to 0) through 4 weeks after their last treatment (Stage 1 intervention period: Weeks 0 to 12; Stage 2 intervention period: Weeks 12 to 24), up to 30 weeks.
|
0.00%
0/110 • All adverse events were recorded between the time the participant provided informed consent at Week -2 (Run-in Period: Weeks -2 to 0) through 4 weeks after their last treatment (Stage 1 intervention period: Weeks 0 to 12; Stage 2 intervention period: Weeks 12 to 24), up to 30 weeks.
|
0.00%
0/85 • All adverse events were recorded between the time the participant provided informed consent at Week -2 (Run-in Period: Weeks -2 to 0) through 4 weeks after their last treatment (Stage 1 intervention period: Weeks 0 to 12; Stage 2 intervention period: Weeks 12 to 24), up to 30 weeks.
|
0.00%
0/33 • All adverse events were recorded between the time the participant provided informed consent at Week -2 (Run-in Period: Weeks -2 to 0) through 4 weeks after their last treatment (Stage 1 intervention period: Weeks 0 to 12; Stage 2 intervention period: Weeks 12 to 24), up to 30 weeks.
|
0.00%
0/52 • All adverse events were recorded between the time the participant provided informed consent at Week -2 (Run-in Period: Weeks -2 to 0) through 4 weeks after their last treatment (Stage 1 intervention period: Weeks 0 to 12; Stage 2 intervention period: Weeks 12 to 24), up to 30 weeks.
|
0.00%
0/84 • All adverse events were recorded between the time the participant provided informed consent at Week -2 (Run-in Period: Weeks -2 to 0) through 4 weeks after their last treatment (Stage 1 intervention period: Weeks 0 to 12; Stage 2 intervention period: Weeks 12 to 24), up to 30 weeks.
|
0.00%
0/22 • All adverse events were recorded between the time the participant provided informed consent at Week -2 (Run-in Period: Weeks -2 to 0) through 4 weeks after their last treatment (Stage 1 intervention period: Weeks 0 to 12; Stage 2 intervention period: Weeks 12 to 24), up to 30 weeks.
|
0.00%
0/54 • All adverse events were recorded between the time the participant provided informed consent at Week -2 (Run-in Period: Weeks -2 to 0) through 4 weeks after their last treatment (Stage 1 intervention period: Weeks 0 to 12; Stage 2 intervention period: Weeks 12 to 24), up to 30 weeks.
|
0.00%
0/85 • All adverse events were recorded between the time the participant provided informed consent at Week -2 (Run-in Period: Weeks -2 to 0) through 4 weeks after their last treatment (Stage 1 intervention period: Weeks 0 to 12; Stage 2 intervention period: Weeks 12 to 24), up to 30 weeks.
|
|
Vascular disorders
Angina pectoris
|
0.00%
0/191 • All adverse events were recorded between the time the participant provided informed consent at Week -2 (Run-in Period: Weeks -2 to 0) through 4 weeks after their last treatment (Stage 1 intervention period: Weeks 0 to 12; Stage 2 intervention period: Weeks 12 to 24), up to 30 weeks.
|
0.00%
0/172 • All adverse events were recorded between the time the participant provided informed consent at Week -2 (Run-in Period: Weeks -2 to 0) through 4 weeks after their last treatment (Stage 1 intervention period: Weeks 0 to 12; Stage 2 intervention period: Weeks 12 to 24), up to 30 weeks.
|
0.00%
0/184 • All adverse events were recorded between the time the participant provided informed consent at Week -2 (Run-in Period: Weeks -2 to 0) through 4 weeks after their last treatment (Stage 1 intervention period: Weeks 0 to 12; Stage 2 intervention period: Weeks 12 to 24), up to 30 weeks.
|
0.49%
1/205 • Number of events 1 • All adverse events were recorded between the time the participant provided informed consent at Week -2 (Run-in Period: Weeks -2 to 0) through 4 weeks after their last treatment (Stage 1 intervention period: Weeks 0 to 12; Stage 2 intervention period: Weeks 12 to 24), up to 30 weeks.
|
0.00%
0/65 • All adverse events were recorded between the time the participant provided informed consent at Week -2 (Run-in Period: Weeks -2 to 0) through 4 weeks after their last treatment (Stage 1 intervention period: Weeks 0 to 12; Stage 2 intervention period: Weeks 12 to 24), up to 30 weeks.
|
0.00%
0/71 • All adverse events were recorded between the time the participant provided informed consent at Week -2 (Run-in Period: Weeks -2 to 0) through 4 weeks after their last treatment (Stage 1 intervention period: Weeks 0 to 12; Stage 2 intervention period: Weeks 12 to 24), up to 30 weeks.
|
0.00%
0/110 • All adverse events were recorded between the time the participant provided informed consent at Week -2 (Run-in Period: Weeks -2 to 0) through 4 weeks after their last treatment (Stage 1 intervention period: Weeks 0 to 12; Stage 2 intervention period: Weeks 12 to 24), up to 30 weeks.
|
0.00%
0/85 • All adverse events were recorded between the time the participant provided informed consent at Week -2 (Run-in Period: Weeks -2 to 0) through 4 weeks after their last treatment (Stage 1 intervention period: Weeks 0 to 12; Stage 2 intervention period: Weeks 12 to 24), up to 30 weeks.
|
0.00%
0/33 • All adverse events were recorded between the time the participant provided informed consent at Week -2 (Run-in Period: Weeks -2 to 0) through 4 weeks after their last treatment (Stage 1 intervention period: Weeks 0 to 12; Stage 2 intervention period: Weeks 12 to 24), up to 30 weeks.
|
0.00%
0/52 • All adverse events were recorded between the time the participant provided informed consent at Week -2 (Run-in Period: Weeks -2 to 0) through 4 weeks after their last treatment (Stage 1 intervention period: Weeks 0 to 12; Stage 2 intervention period: Weeks 12 to 24), up to 30 weeks.
|
0.00%
0/84 • All adverse events were recorded between the time the participant provided informed consent at Week -2 (Run-in Period: Weeks -2 to 0) through 4 weeks after their last treatment (Stage 1 intervention period: Weeks 0 to 12; Stage 2 intervention period: Weeks 12 to 24), up to 30 weeks.
|
0.00%
0/22 • All adverse events were recorded between the time the participant provided informed consent at Week -2 (Run-in Period: Weeks -2 to 0) through 4 weeks after their last treatment (Stage 1 intervention period: Weeks 0 to 12; Stage 2 intervention period: Weeks 12 to 24), up to 30 weeks.
|
0.00%
0/54 • All adverse events were recorded between the time the participant provided informed consent at Week -2 (Run-in Period: Weeks -2 to 0) through 4 weeks after their last treatment (Stage 1 intervention period: Weeks 0 to 12; Stage 2 intervention period: Weeks 12 to 24), up to 30 weeks.
|
0.00%
0/85 • All adverse events were recorded between the time the participant provided informed consent at Week -2 (Run-in Period: Weeks -2 to 0) through 4 weeks after their last treatment (Stage 1 intervention period: Weeks 0 to 12; Stage 2 intervention period: Weeks 12 to 24), up to 30 weeks.
|
Other adverse events
| Measure |
Stage 1: Acceptance and Commitment Therapy (ACT)
n=191 participants at risk
ACT is a form of cognitive behavioral therapy that is well established for the treatment of chronic pain. The goal of ACT is to build psychological flexibility thereby interrupting pain avoidance behavior patterns. Participants randomized to ACT will take part in 12 sessions over the course of 12 weeks. Sessions will be delivered as a combination of 4 remote face-to-face visits with a therapist and 8 therapist-supported online sessions (self-directed online modules supported by provider coaching). Online sessions will focus on helping participants accept pain, connect with negative thoughts and emotions, develop mindfulness and identify and commit to values and goals that are important to them. During face-to-face sessions with the therapist, participants will be encouraged to share their experience of skills practice and mastery, provide examples of skill use at home, and describe what barriers they encountered.
|
Stage 1: Duloxetine
n=172 participants at risk
Duloxetine is a serotonin norepinephrine reuptake inhibitor (SNRI) that is FDA-approved for use in Chronic Low-Back Pain, and, as such, is included as a recommended therapy in nearly all current treatment guidelines for low back pain. Study participants will be treated with duloxetine for 12 weeks during the active treatment phase. At the time of randomization, the approved drug pharmacy at each study site will dispense between 185 and 192 duloxetine 30 mg capsules and provide to participants. This will ensure enough capsules to maintain up to a 60 mg dosage through the 12-week intervention phase and to taper the dose in the 13th week if needed.
|
Stage 1: Evidence Based Exercise and Manual Therapy (EBEM)
n=184 participants at risk
Licensed physical therapists (PTs) or Doctors of Chiropractic (DCs) will rely on evidence-based guidance to direct decision-making on the particular type of manual and exercise therapy that may be best suited to an individual study participant. Special attention will be paid to the clinician's choice of language in regard to the purpose and expected outcomes of manual therapy in order to avoid enhancing catastrophizing ideations or preference for passive interventions. A total of 10 sessions will be provided over an 8-week treatment period. Two sessions per week are provided in the first two weeks followed by weekly sessions over the next 6 weeks. Treatment sessions will last approximately 60 minutes each.
|
Stage 1: Enhanced Self-Care Therapy (ESC)
n=205 participants at risk
The Enhanced Self-Care intervention will be comprised of educational modules on evidence-based cognitive-behavioral self-management skills for pain. These modules will be provided digitally for self-administration over a period of 12 weeks. There will be no therapist associated with the delivery of these educational materials; however, after the first four modules, email or text messages will be used to make personalized recommendations for accessing additional modules based upon identified problems from the baseline assessment. Additionally, the walking program module will utilize Fitbit step tracking to allow participants to monitor their walking progress.
|
Stage 2: Acceptance and Commitment Therapy (ACT)
n=65 participants at risk
Participants newly randomized to ACT in Stage 2 will take part in 12 sessions over the course of 12 weeks. Sessions will be delivered as a combination of 4 remote face-to-face visits with a therapist and 8 therapist-supported online sessions (self-directed online modules supported by provider coaching). Participants assigned to maintain ACT will be encouraged to continue at-home skills and will have access to all previously viewed online content. In addition, participants will have access to 11 additional online ACT audio modules, but without the communications with the therapist.
|
Stage 2: Duloxetine
n=71 participants at risk
Study participants will be treated with duloxetine for 12 weeks during the active treatment phase. All participants will be assessed at the midpoint of the intervention treatment period (Week 18) for tolerance, adverse events, and response. At the midpoint phone call:
Participants tolerating the medication with no side effects will be instructed to increase to 60mg/day (if currently taking 30mg/day) or remain on their current dosage (if currently taking 60mg/day).
|
Stage 2: Evidence Based Exercise and Manual Therapy (EBEM)
n=110 participants at risk
Participants newly randomized to EBEM in stage 2 will take part in a total of 10 sessions over an 8-week treatment period. Two sessions per week are provided in the first two weeks followed by weekly sessions over the next 6 weeks. Treatment sessions will last approximately 60 minutes each. Participants assigned to maintain EBEM will receive 4 additional in-person EBEM sessions during weeks 1-4 of this period. If visits are missed and/or need to be rescheduled, visits may be scheduled up to 5 weeks from the date of the first augmenting/maintenance visit.
|
Stage 2: Enhanced Self-Care Therapy (ESC)
n=85 participants at risk
Participants newly randomized to ESC in stage 2 will be provided modules digitally for self-administration over a period of 12 weeks. There will be no therapist associated with the delivery of these educational materials; however, after the first four modules, email or text messages will be used to make personalized recommendations for accessing additional modules based upon identified problems from the baseline assessment. Additionally, the walking program module will utilize Fitbit step tracking to allow participants to monitor their walking progress. Participants assigned to maintain ESC in the second period intervention will receive personalized recommendations based on the most recently completed PROMIS 29+2.
|
Stage 2: ACT and Duloxetine
n=33 participants at risk
Participants received both ACT and duloxetine in Stage 2. Participants who received augmented Stage 2 treatments always continued their stage 1 treatment. The continued intervention matches the dose of those maintaining Stage 1 treatment alone, and the added intervention is as if they were newly randomized.
|
Stage 2: ACT and EBEM
n=52 participants at risk
Participants received both ACT and EBEM in Stage 2. Participants who received augmented Stage 2 treatments always continued their stage 1 treatment. The continued intervention matches the dose of those maintaining Stage 1 treatment alone, and the added intervention is as if they were newly randomized.
|
Stage 2: ACT and ESC
n=84 participants at risk
Participants received both ACT and ESC in Stage 2. Participants who received augmented Stage 2 treatments always continued their stage 1 treatment. The continued intervention matches the dose of those maintaining Stage 1 treatment alone, and the added intervention is as if they were newly randomized.
|
Stage 2: Duloxetine and EBEM
n=22 participants at risk
Participants received both duloxetine and EBEM in Stage 2. Participants who received augmented Stage 2 treatments always continued their stage 1 treatment. The continued intervention matches the dose of those maintaining Stage 1 treatment alone, and the added intervention is as if they were newly randomized.
|
Stage 2: Duloxetine and ESC
n=54 participants at risk
Participants received both duloxetine and ESC in Stage 2. Participants who received augmented Stage 2 treatments always continued their stage 1 treatment. The continued intervention matches the dose of those maintaining Stage 1 treatment alone, and the added intervention is as if they were newly randomized.
|
Stage 2: EBEM and ESC
n=85 participants at risk
Participants received both EBEM and ESC in Stage 2. Participants who received augmented Stage 2 treatments always continued their stage 1 treatment. The continued intervention matches the dose of those maintaining Stage 1 treatment alone, and the added intervention is as if they were newly randomized.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/191 • All adverse events were recorded between the time the participant provided informed consent at Week -2 (Run-in Period: Weeks -2 to 0) through 4 weeks after their last treatment (Stage 1 intervention period: Weeks 0 to 12; Stage 2 intervention period: Weeks 12 to 24), up to 30 weeks.
|
9.9%
17/172 • Number of events 18 • All adverse events were recorded between the time the participant provided informed consent at Week -2 (Run-in Period: Weeks -2 to 0) through 4 weeks after their last treatment (Stage 1 intervention period: Weeks 0 to 12; Stage 2 intervention period: Weeks 12 to 24), up to 30 weeks.
|
0.00%
0/184 • All adverse events were recorded between the time the participant provided informed consent at Week -2 (Run-in Period: Weeks -2 to 0) through 4 weeks after their last treatment (Stage 1 intervention period: Weeks 0 to 12; Stage 2 intervention period: Weeks 12 to 24), up to 30 weeks.
|
0.00%
0/205 • All adverse events were recorded between the time the participant provided informed consent at Week -2 (Run-in Period: Weeks -2 to 0) through 4 weeks after their last treatment (Stage 1 intervention period: Weeks 0 to 12; Stage 2 intervention period: Weeks 12 to 24), up to 30 weeks.
|
0.00%
0/65 • All adverse events were recorded between the time the participant provided informed consent at Week -2 (Run-in Period: Weeks -2 to 0) through 4 weeks after their last treatment (Stage 1 intervention period: Weeks 0 to 12; Stage 2 intervention period: Weeks 12 to 24), up to 30 weeks.
|
2.8%
2/71 • Number of events 2 • All adverse events were recorded between the time the participant provided informed consent at Week -2 (Run-in Period: Weeks -2 to 0) through 4 weeks after their last treatment (Stage 1 intervention period: Weeks 0 to 12; Stage 2 intervention period: Weeks 12 to 24), up to 30 weeks.
|
0.00%
0/110 • All adverse events were recorded between the time the participant provided informed consent at Week -2 (Run-in Period: Weeks -2 to 0) through 4 weeks after their last treatment (Stage 1 intervention period: Weeks 0 to 12; Stage 2 intervention period: Weeks 12 to 24), up to 30 weeks.
|
0.00%
0/85 • All adverse events were recorded between the time the participant provided informed consent at Week -2 (Run-in Period: Weeks -2 to 0) through 4 weeks after their last treatment (Stage 1 intervention period: Weeks 0 to 12; Stage 2 intervention period: Weeks 12 to 24), up to 30 weeks.
|
0.00%
0/33 • All adverse events were recorded between the time the participant provided informed consent at Week -2 (Run-in Period: Weeks -2 to 0) through 4 weeks after their last treatment (Stage 1 intervention period: Weeks 0 to 12; Stage 2 intervention period: Weeks 12 to 24), up to 30 weeks.
|
0.00%
0/52 • All adverse events were recorded between the time the participant provided informed consent at Week -2 (Run-in Period: Weeks -2 to 0) through 4 weeks after their last treatment (Stage 1 intervention period: Weeks 0 to 12; Stage 2 intervention period: Weeks 12 to 24), up to 30 weeks.
|
0.00%
0/84 • All adverse events were recorded between the time the participant provided informed consent at Week -2 (Run-in Period: Weeks -2 to 0) through 4 weeks after their last treatment (Stage 1 intervention period: Weeks 0 to 12; Stage 2 intervention period: Weeks 12 to 24), up to 30 weeks.
|
0.00%
0/22 • All adverse events were recorded between the time the participant provided informed consent at Week -2 (Run-in Period: Weeks -2 to 0) through 4 weeks after their last treatment (Stage 1 intervention period: Weeks 0 to 12; Stage 2 intervention period: Weeks 12 to 24), up to 30 weeks.
|
1.9%
1/54 • Number of events 1 • All adverse events were recorded between the time the participant provided informed consent at Week -2 (Run-in Period: Weeks -2 to 0) through 4 weeks after their last treatment (Stage 1 intervention period: Weeks 0 to 12; Stage 2 intervention period: Weeks 12 to 24), up to 30 weeks.
|
0.00%
0/85 • All adverse events were recorded between the time the participant provided informed consent at Week -2 (Run-in Period: Weeks -2 to 0) through 4 weeks after their last treatment (Stage 1 intervention period: Weeks 0 to 12; Stage 2 intervention period: Weeks 12 to 24), up to 30 weeks.
|
|
Gastrointestinal disorders
Diarrhea
|
0.00%
0/191 • All adverse events were recorded between the time the participant provided informed consent at Week -2 (Run-in Period: Weeks -2 to 0) through 4 weeks after their last treatment (Stage 1 intervention period: Weeks 0 to 12; Stage 2 intervention period: Weeks 12 to 24), up to 30 weeks.
|
4.7%
8/172 • Number of events 8 • All adverse events were recorded between the time the participant provided informed consent at Week -2 (Run-in Period: Weeks -2 to 0) through 4 weeks after their last treatment (Stage 1 intervention period: Weeks 0 to 12; Stage 2 intervention period: Weeks 12 to 24), up to 30 weeks.
|
0.00%
0/184 • All adverse events were recorded between the time the participant provided informed consent at Week -2 (Run-in Period: Weeks -2 to 0) through 4 weeks after their last treatment (Stage 1 intervention period: Weeks 0 to 12; Stage 2 intervention period: Weeks 12 to 24), up to 30 weeks.
|
0.00%
0/205 • All adverse events were recorded between the time the participant provided informed consent at Week -2 (Run-in Period: Weeks -2 to 0) through 4 weeks after their last treatment (Stage 1 intervention period: Weeks 0 to 12; Stage 2 intervention period: Weeks 12 to 24), up to 30 weeks.
|
0.00%
0/65 • All adverse events were recorded between the time the participant provided informed consent at Week -2 (Run-in Period: Weeks -2 to 0) through 4 weeks after their last treatment (Stage 1 intervention period: Weeks 0 to 12; Stage 2 intervention period: Weeks 12 to 24), up to 30 weeks.
|
4.2%
3/71 • Number of events 3 • All adverse events were recorded between the time the participant provided informed consent at Week -2 (Run-in Period: Weeks -2 to 0) through 4 weeks after their last treatment (Stage 1 intervention period: Weeks 0 to 12; Stage 2 intervention period: Weeks 12 to 24), up to 30 weeks.
|
0.00%
0/110 • All adverse events were recorded between the time the participant provided informed consent at Week -2 (Run-in Period: Weeks -2 to 0) through 4 weeks after their last treatment (Stage 1 intervention period: Weeks 0 to 12; Stage 2 intervention period: Weeks 12 to 24), up to 30 weeks.
|
0.00%
0/85 • All adverse events were recorded between the time the participant provided informed consent at Week -2 (Run-in Period: Weeks -2 to 0) through 4 weeks after their last treatment (Stage 1 intervention period: Weeks 0 to 12; Stage 2 intervention period: Weeks 12 to 24), up to 30 weeks.
|
0.00%
0/33 • All adverse events were recorded between the time the participant provided informed consent at Week -2 (Run-in Period: Weeks -2 to 0) through 4 weeks after their last treatment (Stage 1 intervention period: Weeks 0 to 12; Stage 2 intervention period: Weeks 12 to 24), up to 30 weeks.
|
0.00%
0/52 • All adverse events were recorded between the time the participant provided informed consent at Week -2 (Run-in Period: Weeks -2 to 0) through 4 weeks after their last treatment (Stage 1 intervention period: Weeks 0 to 12; Stage 2 intervention period: Weeks 12 to 24), up to 30 weeks.
|
0.00%
0/84 • All adverse events were recorded between the time the participant provided informed consent at Week -2 (Run-in Period: Weeks -2 to 0) through 4 weeks after their last treatment (Stage 1 intervention period: Weeks 0 to 12; Stage 2 intervention period: Weeks 12 to 24), up to 30 weeks.
|
0.00%
0/22 • All adverse events were recorded between the time the participant provided informed consent at Week -2 (Run-in Period: Weeks -2 to 0) through 4 weeks after their last treatment (Stage 1 intervention period: Weeks 0 to 12; Stage 2 intervention period: Weeks 12 to 24), up to 30 weeks.
|
9.3%
5/54 • Number of events 5 • All adverse events were recorded between the time the participant provided informed consent at Week -2 (Run-in Period: Weeks -2 to 0) through 4 weeks after their last treatment (Stage 1 intervention period: Weeks 0 to 12; Stage 2 intervention period: Weeks 12 to 24), up to 30 weeks.
|
0.00%
0/85 • All adverse events were recorded between the time the participant provided informed consent at Week -2 (Run-in Period: Weeks -2 to 0) through 4 weeks after their last treatment (Stage 1 intervention period: Weeks 0 to 12; Stage 2 intervention period: Weeks 12 to 24), up to 30 weeks.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/191 • All adverse events were recorded between the time the participant provided informed consent at Week -2 (Run-in Period: Weeks -2 to 0) through 4 weeks after their last treatment (Stage 1 intervention period: Weeks 0 to 12; Stage 2 intervention period: Weeks 12 to 24), up to 30 weeks.
|
19.2%
33/172 • Number of events 34 • All adverse events were recorded between the time the participant provided informed consent at Week -2 (Run-in Period: Weeks -2 to 0) through 4 weeks after their last treatment (Stage 1 intervention period: Weeks 0 to 12; Stage 2 intervention period: Weeks 12 to 24), up to 30 weeks.
|
0.00%
0/184 • All adverse events were recorded between the time the participant provided informed consent at Week -2 (Run-in Period: Weeks -2 to 0) through 4 weeks after their last treatment (Stage 1 intervention period: Weeks 0 to 12; Stage 2 intervention period: Weeks 12 to 24), up to 30 weeks.
|
0.00%
0/205 • All adverse events were recorded between the time the participant provided informed consent at Week -2 (Run-in Period: Weeks -2 to 0) through 4 weeks after their last treatment (Stage 1 intervention period: Weeks 0 to 12; Stage 2 intervention period: Weeks 12 to 24), up to 30 weeks.
|
0.00%
0/65 • All adverse events were recorded between the time the participant provided informed consent at Week -2 (Run-in Period: Weeks -2 to 0) through 4 weeks after their last treatment (Stage 1 intervention period: Weeks 0 to 12; Stage 2 intervention period: Weeks 12 to 24), up to 30 weeks.
|
19.7%
14/71 • Number of events 14 • All adverse events were recorded between the time the participant provided informed consent at Week -2 (Run-in Period: Weeks -2 to 0) through 4 weeks after their last treatment (Stage 1 intervention period: Weeks 0 to 12; Stage 2 intervention period: Weeks 12 to 24), up to 30 weeks.
|
0.00%
0/110 • All adverse events were recorded between the time the participant provided informed consent at Week -2 (Run-in Period: Weeks -2 to 0) through 4 weeks after their last treatment (Stage 1 intervention period: Weeks 0 to 12; Stage 2 intervention period: Weeks 12 to 24), up to 30 weeks.
|
0.00%
0/85 • All adverse events were recorded between the time the participant provided informed consent at Week -2 (Run-in Period: Weeks -2 to 0) through 4 weeks after their last treatment (Stage 1 intervention period: Weeks 0 to 12; Stage 2 intervention period: Weeks 12 to 24), up to 30 weeks.
|
21.2%
7/33 • Number of events 7 • All adverse events were recorded between the time the participant provided informed consent at Week -2 (Run-in Period: Weeks -2 to 0) through 4 weeks after their last treatment (Stage 1 intervention period: Weeks 0 to 12; Stage 2 intervention period: Weeks 12 to 24), up to 30 weeks.
|
0.00%
0/52 • All adverse events were recorded between the time the participant provided informed consent at Week -2 (Run-in Period: Weeks -2 to 0) through 4 weeks after their last treatment (Stage 1 intervention period: Weeks 0 to 12; Stage 2 intervention period: Weeks 12 to 24), up to 30 weeks.
|
0.00%
0/84 • All adverse events were recorded between the time the participant provided informed consent at Week -2 (Run-in Period: Weeks -2 to 0) through 4 weeks after their last treatment (Stage 1 intervention period: Weeks 0 to 12; Stage 2 intervention period: Weeks 12 to 24), up to 30 weeks.
|
9.1%
2/22 • Number of events 2 • All adverse events were recorded between the time the participant provided informed consent at Week -2 (Run-in Period: Weeks -2 to 0) through 4 weeks after their last treatment (Stage 1 intervention period: Weeks 0 to 12; Stage 2 intervention period: Weeks 12 to 24), up to 30 weeks.
|
16.7%
9/54 • Number of events 9 • All adverse events were recorded between the time the participant provided informed consent at Week -2 (Run-in Period: Weeks -2 to 0) through 4 weeks after their last treatment (Stage 1 intervention period: Weeks 0 to 12; Stage 2 intervention period: Weeks 12 to 24), up to 30 weeks.
|
0.00%
0/85 • All adverse events were recorded between the time the participant provided informed consent at Week -2 (Run-in Period: Weeks -2 to 0) through 4 weeks after their last treatment (Stage 1 intervention period: Weeks 0 to 12; Stage 2 intervention period: Weeks 12 to 24), up to 30 weeks.
|
|
General disorders
Fatigue
|
0.00%
0/191 • All adverse events were recorded between the time the participant provided informed consent at Week -2 (Run-in Period: Weeks -2 to 0) through 4 weeks after their last treatment (Stage 1 intervention period: Weeks 0 to 12; Stage 2 intervention period: Weeks 12 to 24), up to 30 weeks.
|
12.2%
21/172 • Number of events 21 • All adverse events were recorded between the time the participant provided informed consent at Week -2 (Run-in Period: Weeks -2 to 0) through 4 weeks after their last treatment (Stage 1 intervention period: Weeks 0 to 12; Stage 2 intervention period: Weeks 12 to 24), up to 30 weeks.
|
1.1%
2/184 • Number of events 2 • All adverse events were recorded between the time the participant provided informed consent at Week -2 (Run-in Period: Weeks -2 to 0) through 4 weeks after their last treatment (Stage 1 intervention period: Weeks 0 to 12; Stage 2 intervention period: Weeks 12 to 24), up to 30 weeks.
|
0.49%
1/205 • Number of events 1 • All adverse events were recorded between the time the participant provided informed consent at Week -2 (Run-in Period: Weeks -2 to 0) through 4 weeks after their last treatment (Stage 1 intervention period: Weeks 0 to 12; Stage 2 intervention period: Weeks 12 to 24), up to 30 weeks.
|
0.00%
0/65 • All adverse events were recorded between the time the participant provided informed consent at Week -2 (Run-in Period: Weeks -2 to 0) through 4 weeks after their last treatment (Stage 1 intervention period: Weeks 0 to 12; Stage 2 intervention period: Weeks 12 to 24), up to 30 weeks.
|
7.0%
5/71 • Number of events 5 • All adverse events were recorded between the time the participant provided informed consent at Week -2 (Run-in Period: Weeks -2 to 0) through 4 weeks after their last treatment (Stage 1 intervention period: Weeks 0 to 12; Stage 2 intervention period: Weeks 12 to 24), up to 30 weeks.
|
0.00%
0/110 • All adverse events were recorded between the time the participant provided informed consent at Week -2 (Run-in Period: Weeks -2 to 0) through 4 weeks after their last treatment (Stage 1 intervention period: Weeks 0 to 12; Stage 2 intervention period: Weeks 12 to 24), up to 30 weeks.
|
0.00%
0/85 • All adverse events were recorded between the time the participant provided informed consent at Week -2 (Run-in Period: Weeks -2 to 0) through 4 weeks after their last treatment (Stage 1 intervention period: Weeks 0 to 12; Stage 2 intervention period: Weeks 12 to 24), up to 30 weeks.
|
6.1%
2/33 • Number of events 2 • All adverse events were recorded between the time the participant provided informed consent at Week -2 (Run-in Period: Weeks -2 to 0) through 4 weeks after their last treatment (Stage 1 intervention period: Weeks 0 to 12; Stage 2 intervention period: Weeks 12 to 24), up to 30 weeks.
|
0.00%
0/52 • All adverse events were recorded between the time the participant provided informed consent at Week -2 (Run-in Period: Weeks -2 to 0) through 4 weeks after their last treatment (Stage 1 intervention period: Weeks 0 to 12; Stage 2 intervention period: Weeks 12 to 24), up to 30 weeks.
|
0.00%
0/84 • All adverse events were recorded between the time the participant provided informed consent at Week -2 (Run-in Period: Weeks -2 to 0) through 4 weeks after their last treatment (Stage 1 intervention period: Weeks 0 to 12; Stage 2 intervention period: Weeks 12 to 24), up to 30 weeks.
|
4.5%
1/22 • Number of events 1 • All adverse events were recorded between the time the participant provided informed consent at Week -2 (Run-in Period: Weeks -2 to 0) through 4 weeks after their last treatment (Stage 1 intervention period: Weeks 0 to 12; Stage 2 intervention period: Weeks 12 to 24), up to 30 weeks.
|
11.1%
6/54 • Number of events 6 • All adverse events were recorded between the time the participant provided informed consent at Week -2 (Run-in Period: Weeks -2 to 0) through 4 weeks after their last treatment (Stage 1 intervention period: Weeks 0 to 12; Stage 2 intervention period: Weeks 12 to 24), up to 30 weeks.
|
1.2%
1/85 • Number of events 1 • All adverse events were recorded between the time the participant provided informed consent at Week -2 (Run-in Period: Weeks -2 to 0) through 4 weeks after their last treatment (Stage 1 intervention period: Weeks 0 to 12; Stage 2 intervention period: Weeks 12 to 24), up to 30 weeks.
|
|
General disorders
Irritability
|
0.00%
0/191 • All adverse events were recorded between the time the participant provided informed consent at Week -2 (Run-in Period: Weeks -2 to 0) through 4 weeks after their last treatment (Stage 1 intervention period: Weeks 0 to 12; Stage 2 intervention period: Weeks 12 to 24), up to 30 weeks.
|
0.00%
0/172 • All adverse events were recorded between the time the participant provided informed consent at Week -2 (Run-in Period: Weeks -2 to 0) through 4 weeks after their last treatment (Stage 1 intervention period: Weeks 0 to 12; Stage 2 intervention period: Weeks 12 to 24), up to 30 weeks.
|
0.00%
0/184 • All adverse events were recorded between the time the participant provided informed consent at Week -2 (Run-in Period: Weeks -2 to 0) through 4 weeks after their last treatment (Stage 1 intervention period: Weeks 0 to 12; Stage 2 intervention period: Weeks 12 to 24), up to 30 weeks.
|
0.00%
0/205 • All adverse events were recorded between the time the participant provided informed consent at Week -2 (Run-in Period: Weeks -2 to 0) through 4 weeks after their last treatment (Stage 1 intervention period: Weeks 0 to 12; Stage 2 intervention period: Weeks 12 to 24), up to 30 weeks.
|
0.00%
0/65 • All adverse events were recorded between the time the participant provided informed consent at Week -2 (Run-in Period: Weeks -2 to 0) through 4 weeks after their last treatment (Stage 1 intervention period: Weeks 0 to 12; Stage 2 intervention period: Weeks 12 to 24), up to 30 weeks.
|
0.00%
0/71 • All adverse events were recorded between the time the participant provided informed consent at Week -2 (Run-in Period: Weeks -2 to 0) through 4 weeks after their last treatment (Stage 1 intervention period: Weeks 0 to 12; Stage 2 intervention period: Weeks 12 to 24), up to 30 weeks.
|
0.00%
0/110 • All adverse events were recorded between the time the participant provided informed consent at Week -2 (Run-in Period: Weeks -2 to 0) through 4 weeks after their last treatment (Stage 1 intervention period: Weeks 0 to 12; Stage 2 intervention period: Weeks 12 to 24), up to 30 weeks.
|
0.00%
0/85 • All adverse events were recorded between the time the participant provided informed consent at Week -2 (Run-in Period: Weeks -2 to 0) through 4 weeks after their last treatment (Stage 1 intervention period: Weeks 0 to 12; Stage 2 intervention period: Weeks 12 to 24), up to 30 weeks.
|
6.1%
2/33 • Number of events 2 • All adverse events were recorded between the time the participant provided informed consent at Week -2 (Run-in Period: Weeks -2 to 0) through 4 weeks after their last treatment (Stage 1 intervention period: Weeks 0 to 12; Stage 2 intervention period: Weeks 12 to 24), up to 30 weeks.
|
0.00%
0/52 • All adverse events were recorded between the time the participant provided informed consent at Week -2 (Run-in Period: Weeks -2 to 0) through 4 weeks after their last treatment (Stage 1 intervention period: Weeks 0 to 12; Stage 2 intervention period: Weeks 12 to 24), up to 30 weeks.
|
0.00%
0/84 • All adverse events were recorded between the time the participant provided informed consent at Week -2 (Run-in Period: Weeks -2 to 0) through 4 weeks after their last treatment (Stage 1 intervention period: Weeks 0 to 12; Stage 2 intervention period: Weeks 12 to 24), up to 30 weeks.
|
0.00%
0/22 • All adverse events were recorded between the time the participant provided informed consent at Week -2 (Run-in Period: Weeks -2 to 0) through 4 weeks after their last treatment (Stage 1 intervention period: Weeks 0 to 12; Stage 2 intervention period: Weeks 12 to 24), up to 30 weeks.
|
0.00%
0/54 • All adverse events were recorded between the time the participant provided informed consent at Week -2 (Run-in Period: Weeks -2 to 0) through 4 weeks after their last treatment (Stage 1 intervention period: Weeks 0 to 12; Stage 2 intervention period: Weeks 12 to 24), up to 30 weeks.
|
0.00%
0/85 • All adverse events were recorded between the time the participant provided informed consent at Week -2 (Run-in Period: Weeks -2 to 0) through 4 weeks after their last treatment (Stage 1 intervention period: Weeks 0 to 12; Stage 2 intervention period: Weeks 12 to 24), up to 30 weeks.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
1.0%
2/191 • Number of events 2 • All adverse events were recorded between the time the participant provided informed consent at Week -2 (Run-in Period: Weeks -2 to 0) through 4 weeks after their last treatment (Stage 1 intervention period: Weeks 0 to 12; Stage 2 intervention period: Weeks 12 to 24), up to 30 weeks.
|
0.58%
1/172 • Number of events 1 • All adverse events were recorded between the time the participant provided informed consent at Week -2 (Run-in Period: Weeks -2 to 0) through 4 weeks after their last treatment (Stage 1 intervention period: Weeks 0 to 12; Stage 2 intervention period: Weeks 12 to 24), up to 30 weeks.
|
2.2%
4/184 • Number of events 4 • All adverse events were recorded between the time the participant provided informed consent at Week -2 (Run-in Period: Weeks -2 to 0) through 4 weeks after their last treatment (Stage 1 intervention period: Weeks 0 to 12; Stage 2 intervention period: Weeks 12 to 24), up to 30 weeks.
|
0.49%
1/205 • Number of events 1 • All adverse events were recorded between the time the participant provided informed consent at Week -2 (Run-in Period: Weeks -2 to 0) through 4 weeks after their last treatment (Stage 1 intervention period: Weeks 0 to 12; Stage 2 intervention period: Weeks 12 to 24), up to 30 weeks.
|
1.5%
1/65 • Number of events 1 • All adverse events were recorded between the time the participant provided informed consent at Week -2 (Run-in Period: Weeks -2 to 0) through 4 weeks after their last treatment (Stage 1 intervention period: Weeks 0 to 12; Stage 2 intervention period: Weeks 12 to 24), up to 30 weeks.
|
4.2%
3/71 • Number of events 3 • All adverse events were recorded between the time the participant provided informed consent at Week -2 (Run-in Period: Weeks -2 to 0) through 4 weeks after their last treatment (Stage 1 intervention period: Weeks 0 to 12; Stage 2 intervention period: Weeks 12 to 24), up to 30 weeks.
|
1.8%
2/110 • Number of events 2 • All adverse events were recorded between the time the participant provided informed consent at Week -2 (Run-in Period: Weeks -2 to 0) through 4 weeks after their last treatment (Stage 1 intervention period: Weeks 0 to 12; Stage 2 intervention period: Weeks 12 to 24), up to 30 weeks.
|
0.00%
0/85 • All adverse events were recorded between the time the participant provided informed consent at Week -2 (Run-in Period: Weeks -2 to 0) through 4 weeks after their last treatment (Stage 1 intervention period: Weeks 0 to 12; Stage 2 intervention period: Weeks 12 to 24), up to 30 weeks.
|
3.0%
1/33 • Number of events 1 • All adverse events were recorded between the time the participant provided informed consent at Week -2 (Run-in Period: Weeks -2 to 0) through 4 weeks after their last treatment (Stage 1 intervention period: Weeks 0 to 12; Stage 2 intervention period: Weeks 12 to 24), up to 30 weeks.
|
5.8%
3/52 • Number of events 3 • All adverse events were recorded between the time the participant provided informed consent at Week -2 (Run-in Period: Weeks -2 to 0) through 4 weeks after their last treatment (Stage 1 intervention period: Weeks 0 to 12; Stage 2 intervention period: Weeks 12 to 24), up to 30 weeks.
|
0.00%
0/84 • All adverse events were recorded between the time the participant provided informed consent at Week -2 (Run-in Period: Weeks -2 to 0) through 4 weeks after their last treatment (Stage 1 intervention period: Weeks 0 to 12; Stage 2 intervention period: Weeks 12 to 24), up to 30 weeks.
|
0.00%
0/22 • All adverse events were recorded between the time the participant provided informed consent at Week -2 (Run-in Period: Weeks -2 to 0) through 4 weeks after their last treatment (Stage 1 intervention period: Weeks 0 to 12; Stage 2 intervention period: Weeks 12 to 24), up to 30 weeks.
|
0.00%
0/54 • All adverse events were recorded between the time the participant provided informed consent at Week -2 (Run-in Period: Weeks -2 to 0) through 4 weeks after their last treatment (Stage 1 intervention period: Weeks 0 to 12; Stage 2 intervention period: Weeks 12 to 24), up to 30 weeks.
|
4.7%
4/85 • Number of events 4 • All adverse events were recorded between the time the participant provided informed consent at Week -2 (Run-in Period: Weeks -2 to 0) through 4 weeks after their last treatment (Stage 1 intervention period: Weeks 0 to 12; Stage 2 intervention period: Weeks 12 to 24), up to 30 weeks.
|
|
Nervous system disorders
Headache
|
0.00%
0/191 • All adverse events were recorded between the time the participant provided informed consent at Week -2 (Run-in Period: Weeks -2 to 0) through 4 weeks after their last treatment (Stage 1 intervention period: Weeks 0 to 12; Stage 2 intervention period: Weeks 12 to 24), up to 30 weeks.
|
7.0%
12/172 • Number of events 12 • All adverse events were recorded between the time the participant provided informed consent at Week -2 (Run-in Period: Weeks -2 to 0) through 4 weeks after their last treatment (Stage 1 intervention period: Weeks 0 to 12; Stage 2 intervention period: Weeks 12 to 24), up to 30 weeks.
|
0.54%
1/184 • Number of events 1 • All adverse events were recorded between the time the participant provided informed consent at Week -2 (Run-in Period: Weeks -2 to 0) through 4 weeks after their last treatment (Stage 1 intervention period: Weeks 0 to 12; Stage 2 intervention period: Weeks 12 to 24), up to 30 weeks.
|
0.00%
0/205 • All adverse events were recorded between the time the participant provided informed consent at Week -2 (Run-in Period: Weeks -2 to 0) through 4 weeks after their last treatment (Stage 1 intervention period: Weeks 0 to 12; Stage 2 intervention period: Weeks 12 to 24), up to 30 weeks.
|
0.00%
0/65 • All adverse events were recorded between the time the participant provided informed consent at Week -2 (Run-in Period: Weeks -2 to 0) through 4 weeks after their last treatment (Stage 1 intervention period: Weeks 0 to 12; Stage 2 intervention period: Weeks 12 to 24), up to 30 weeks.
|
7.0%
5/71 • Number of events 6 • All adverse events were recorded between the time the participant provided informed consent at Week -2 (Run-in Period: Weeks -2 to 0) through 4 weeks after their last treatment (Stage 1 intervention period: Weeks 0 to 12; Stage 2 intervention period: Weeks 12 to 24), up to 30 weeks.
|
0.00%
0/110 • All adverse events were recorded between the time the participant provided informed consent at Week -2 (Run-in Period: Weeks -2 to 0) through 4 weeks after their last treatment (Stage 1 intervention period: Weeks 0 to 12; Stage 2 intervention period: Weeks 12 to 24), up to 30 weeks.
|
0.00%
0/85 • All adverse events were recorded between the time the participant provided informed consent at Week -2 (Run-in Period: Weeks -2 to 0) through 4 weeks after their last treatment (Stage 1 intervention period: Weeks 0 to 12; Stage 2 intervention period: Weeks 12 to 24), up to 30 weeks.
|
0.00%
0/33 • All adverse events were recorded between the time the participant provided informed consent at Week -2 (Run-in Period: Weeks -2 to 0) through 4 weeks after their last treatment (Stage 1 intervention period: Weeks 0 to 12; Stage 2 intervention period: Weeks 12 to 24), up to 30 weeks.
|
0.00%
0/52 • All adverse events were recorded between the time the participant provided informed consent at Week -2 (Run-in Period: Weeks -2 to 0) through 4 weeks after their last treatment (Stage 1 intervention period: Weeks 0 to 12; Stage 2 intervention period: Weeks 12 to 24), up to 30 weeks.
|
1.2%
1/84 • Number of events 1 • All adverse events were recorded between the time the participant provided informed consent at Week -2 (Run-in Period: Weeks -2 to 0) through 4 weeks after their last treatment (Stage 1 intervention period: Weeks 0 to 12; Stage 2 intervention period: Weeks 12 to 24), up to 30 weeks.
|
9.1%
2/22 • Number of events 2 • All adverse events were recorded between the time the participant provided informed consent at Week -2 (Run-in Period: Weeks -2 to 0) through 4 weeks after their last treatment (Stage 1 intervention period: Weeks 0 to 12; Stage 2 intervention period: Weeks 12 to 24), up to 30 weeks.
|
7.4%
4/54 • Number of events 4 • All adverse events were recorded between the time the participant provided informed consent at Week -2 (Run-in Period: Weeks -2 to 0) through 4 weeks after their last treatment (Stage 1 intervention period: Weeks 0 to 12; Stage 2 intervention period: Weeks 12 to 24), up to 30 weeks.
|
0.00%
0/85 • All adverse events were recorded between the time the participant provided informed consent at Week -2 (Run-in Period: Weeks -2 to 0) through 4 weeks after their last treatment (Stage 1 intervention period: Weeks 0 to 12; Stage 2 intervention period: Weeks 12 to 24), up to 30 weeks.
|
|
Nervous system disorders
Insomnia
|
0.00%
0/191 • All adverse events were recorded between the time the participant provided informed consent at Week -2 (Run-in Period: Weeks -2 to 0) through 4 weeks after their last treatment (Stage 1 intervention period: Weeks 0 to 12; Stage 2 intervention period: Weeks 12 to 24), up to 30 weeks.
|
6.4%
11/172 • Number of events 11 • All adverse events were recorded between the time the participant provided informed consent at Week -2 (Run-in Period: Weeks -2 to 0) through 4 weeks after their last treatment (Stage 1 intervention period: Weeks 0 to 12; Stage 2 intervention period: Weeks 12 to 24), up to 30 weeks.
|
0.00%
0/184 • All adverse events were recorded between the time the participant provided informed consent at Week -2 (Run-in Period: Weeks -2 to 0) through 4 weeks after their last treatment (Stage 1 intervention period: Weeks 0 to 12; Stage 2 intervention period: Weeks 12 to 24), up to 30 weeks.
|
0.00%
0/205 • All adverse events were recorded between the time the participant provided informed consent at Week -2 (Run-in Period: Weeks -2 to 0) through 4 weeks after their last treatment (Stage 1 intervention period: Weeks 0 to 12; Stage 2 intervention period: Weeks 12 to 24), up to 30 weeks.
|
0.00%
0/65 • All adverse events were recorded between the time the participant provided informed consent at Week -2 (Run-in Period: Weeks -2 to 0) through 4 weeks after their last treatment (Stage 1 intervention period: Weeks 0 to 12; Stage 2 intervention period: Weeks 12 to 24), up to 30 weeks.
|
2.8%
2/71 • Number of events 2 • All adverse events were recorded between the time the participant provided informed consent at Week -2 (Run-in Period: Weeks -2 to 0) through 4 weeks after their last treatment (Stage 1 intervention period: Weeks 0 to 12; Stage 2 intervention period: Weeks 12 to 24), up to 30 weeks.
|
0.00%
0/110 • All adverse events were recorded between the time the participant provided informed consent at Week -2 (Run-in Period: Weeks -2 to 0) through 4 weeks after their last treatment (Stage 1 intervention period: Weeks 0 to 12; Stage 2 intervention period: Weeks 12 to 24), up to 30 weeks.
|
0.00%
0/85 • All adverse events were recorded between the time the participant provided informed consent at Week -2 (Run-in Period: Weeks -2 to 0) through 4 weeks after their last treatment (Stage 1 intervention period: Weeks 0 to 12; Stage 2 intervention period: Weeks 12 to 24), up to 30 weeks.
|
3.0%
1/33 • Number of events 1 • All adverse events were recorded between the time the participant provided informed consent at Week -2 (Run-in Period: Weeks -2 to 0) through 4 weeks after their last treatment (Stage 1 intervention period: Weeks 0 to 12; Stage 2 intervention period: Weeks 12 to 24), up to 30 weeks.
|
0.00%
0/52 • All adverse events were recorded between the time the participant provided informed consent at Week -2 (Run-in Period: Weeks -2 to 0) through 4 weeks after their last treatment (Stage 1 intervention period: Weeks 0 to 12; Stage 2 intervention period: Weeks 12 to 24), up to 30 weeks.
|
0.00%
0/84 • All adverse events were recorded between the time the participant provided informed consent at Week -2 (Run-in Period: Weeks -2 to 0) through 4 weeks after their last treatment (Stage 1 intervention period: Weeks 0 to 12; Stage 2 intervention period: Weeks 12 to 24), up to 30 weeks.
|
4.5%
1/22 • Number of events 1 • All adverse events were recorded between the time the participant provided informed consent at Week -2 (Run-in Period: Weeks -2 to 0) through 4 weeks after their last treatment (Stage 1 intervention period: Weeks 0 to 12; Stage 2 intervention period: Weeks 12 to 24), up to 30 weeks.
|
5.6%
3/54 • Number of events 3 • All adverse events were recorded between the time the participant provided informed consent at Week -2 (Run-in Period: Weeks -2 to 0) through 4 weeks after their last treatment (Stage 1 intervention period: Weeks 0 to 12; Stage 2 intervention period: Weeks 12 to 24), up to 30 weeks.
|
0.00%
0/85 • All adverse events were recorded between the time the participant provided informed consent at Week -2 (Run-in Period: Weeks -2 to 0) through 4 weeks after their last treatment (Stage 1 intervention period: Weeks 0 to 12; Stage 2 intervention period: Weeks 12 to 24), up to 30 weeks.
|
|
Nervous system disorders
Somnolence
|
0.00%
0/191 • All adverse events were recorded between the time the participant provided informed consent at Week -2 (Run-in Period: Weeks -2 to 0) through 4 weeks after their last treatment (Stage 1 intervention period: Weeks 0 to 12; Stage 2 intervention period: Weeks 12 to 24), up to 30 weeks.
|
9.3%
16/172 • Number of events 17 • All adverse events were recorded between the time the participant provided informed consent at Week -2 (Run-in Period: Weeks -2 to 0) through 4 weeks after their last treatment (Stage 1 intervention period: Weeks 0 to 12; Stage 2 intervention period: Weeks 12 to 24), up to 30 weeks.
|
0.00%
0/184 • All adverse events were recorded between the time the participant provided informed consent at Week -2 (Run-in Period: Weeks -2 to 0) through 4 weeks after their last treatment (Stage 1 intervention period: Weeks 0 to 12; Stage 2 intervention period: Weeks 12 to 24), up to 30 weeks.
|
0.00%
0/205 • All adverse events were recorded between the time the participant provided informed consent at Week -2 (Run-in Period: Weeks -2 to 0) through 4 weeks after their last treatment (Stage 1 intervention period: Weeks 0 to 12; Stage 2 intervention period: Weeks 12 to 24), up to 30 weeks.
|
0.00%
0/65 • All adverse events were recorded between the time the participant provided informed consent at Week -2 (Run-in Period: Weeks -2 to 0) through 4 weeks after their last treatment (Stage 1 intervention period: Weeks 0 to 12; Stage 2 intervention period: Weeks 12 to 24), up to 30 weeks.
|
1.4%
1/71 • Number of events 1 • All adverse events were recorded between the time the participant provided informed consent at Week -2 (Run-in Period: Weeks -2 to 0) through 4 weeks after their last treatment (Stage 1 intervention period: Weeks 0 to 12; Stage 2 intervention period: Weeks 12 to 24), up to 30 weeks.
|
0.00%
0/110 • All adverse events were recorded between the time the participant provided informed consent at Week -2 (Run-in Period: Weeks -2 to 0) through 4 weeks after their last treatment (Stage 1 intervention period: Weeks 0 to 12; Stage 2 intervention period: Weeks 12 to 24), up to 30 weeks.
|
0.00%
0/85 • All adverse events were recorded between the time the participant provided informed consent at Week -2 (Run-in Period: Weeks -2 to 0) through 4 weeks after their last treatment (Stage 1 intervention period: Weeks 0 to 12; Stage 2 intervention period: Weeks 12 to 24), up to 30 weeks.
|
3.0%
1/33 • Number of events 1 • All adverse events were recorded between the time the participant provided informed consent at Week -2 (Run-in Period: Weeks -2 to 0) through 4 weeks after their last treatment (Stage 1 intervention period: Weeks 0 to 12; Stage 2 intervention period: Weeks 12 to 24), up to 30 weeks.
|
0.00%
0/52 • All adverse events were recorded between the time the participant provided informed consent at Week -2 (Run-in Period: Weeks -2 to 0) through 4 weeks after their last treatment (Stage 1 intervention period: Weeks 0 to 12; Stage 2 intervention period: Weeks 12 to 24), up to 30 weeks.
|
0.00%
0/84 • All adverse events were recorded between the time the participant provided informed consent at Week -2 (Run-in Period: Weeks -2 to 0) through 4 weeks after their last treatment (Stage 1 intervention period: Weeks 0 to 12; Stage 2 intervention period: Weeks 12 to 24), up to 30 weeks.
|
0.00%
0/22 • All adverse events were recorded between the time the participant provided informed consent at Week -2 (Run-in Period: Weeks -2 to 0) through 4 weeks after their last treatment (Stage 1 intervention period: Weeks 0 to 12; Stage 2 intervention period: Weeks 12 to 24), up to 30 weeks.
|
1.9%
1/54 • Number of events 1 • All adverse events were recorded between the time the participant provided informed consent at Week -2 (Run-in Period: Weeks -2 to 0) through 4 weeks after their last treatment (Stage 1 intervention period: Weeks 0 to 12; Stage 2 intervention period: Weeks 12 to 24), up to 30 weeks.
|
0.00%
0/85 • All adverse events were recorded between the time the participant provided informed consent at Week -2 (Run-in Period: Weeks -2 to 0) through 4 weeks after their last treatment (Stage 1 intervention period: Weeks 0 to 12; Stage 2 intervention period: Weeks 12 to 24), up to 30 weeks.
|
|
Vascular disorders
Dizziness
|
0.00%
0/191 • All adverse events were recorded between the time the participant provided informed consent at Week -2 (Run-in Period: Weeks -2 to 0) through 4 weeks after their last treatment (Stage 1 intervention period: Weeks 0 to 12; Stage 2 intervention period: Weeks 12 to 24), up to 30 weeks.
|
7.0%
12/172 • Number of events 12 • All adverse events were recorded between the time the participant provided informed consent at Week -2 (Run-in Period: Weeks -2 to 0) through 4 weeks after their last treatment (Stage 1 intervention period: Weeks 0 to 12; Stage 2 intervention period: Weeks 12 to 24), up to 30 weeks.
|
0.00%
0/184 • All adverse events were recorded between the time the participant provided informed consent at Week -2 (Run-in Period: Weeks -2 to 0) through 4 weeks after their last treatment (Stage 1 intervention period: Weeks 0 to 12; Stage 2 intervention period: Weeks 12 to 24), up to 30 weeks.
|
0.98%
2/205 • Number of events 2 • All adverse events were recorded between the time the participant provided informed consent at Week -2 (Run-in Period: Weeks -2 to 0) through 4 weeks after their last treatment (Stage 1 intervention period: Weeks 0 to 12; Stage 2 intervention period: Weeks 12 to 24), up to 30 weeks.
|
0.00%
0/65 • All adverse events were recorded between the time the participant provided informed consent at Week -2 (Run-in Period: Weeks -2 to 0) through 4 weeks after their last treatment (Stage 1 intervention period: Weeks 0 to 12; Stage 2 intervention period: Weeks 12 to 24), up to 30 weeks.
|
11.3%
8/71 • Number of events 8 • All adverse events were recorded between the time the participant provided informed consent at Week -2 (Run-in Period: Weeks -2 to 0) through 4 weeks after their last treatment (Stage 1 intervention period: Weeks 0 to 12; Stage 2 intervention period: Weeks 12 to 24), up to 30 weeks.
|
0.91%
1/110 • Number of events 1 • All adverse events were recorded between the time the participant provided informed consent at Week -2 (Run-in Period: Weeks -2 to 0) through 4 weeks after their last treatment (Stage 1 intervention period: Weeks 0 to 12; Stage 2 intervention period: Weeks 12 to 24), up to 30 weeks.
|
0.00%
0/85 • All adverse events were recorded between the time the participant provided informed consent at Week -2 (Run-in Period: Weeks -2 to 0) through 4 weeks after their last treatment (Stage 1 intervention period: Weeks 0 to 12; Stage 2 intervention period: Weeks 12 to 24), up to 30 weeks.
|
6.1%
2/33 • Number of events 2 • All adverse events were recorded between the time the participant provided informed consent at Week -2 (Run-in Period: Weeks -2 to 0) through 4 weeks after their last treatment (Stage 1 intervention period: Weeks 0 to 12; Stage 2 intervention period: Weeks 12 to 24), up to 30 weeks.
|
0.00%
0/52 • All adverse events were recorded between the time the participant provided informed consent at Week -2 (Run-in Period: Weeks -2 to 0) through 4 weeks after their last treatment (Stage 1 intervention period: Weeks 0 to 12; Stage 2 intervention period: Weeks 12 to 24), up to 30 weeks.
|
1.2%
1/84 • Number of events 1 • All adverse events were recorded between the time the participant provided informed consent at Week -2 (Run-in Period: Weeks -2 to 0) through 4 weeks after their last treatment (Stage 1 intervention period: Weeks 0 to 12; Stage 2 intervention period: Weeks 12 to 24), up to 30 weeks.
|
9.1%
2/22 • Number of events 3 • All adverse events were recorded between the time the participant provided informed consent at Week -2 (Run-in Period: Weeks -2 to 0) through 4 weeks after their last treatment (Stage 1 intervention period: Weeks 0 to 12; Stage 2 intervention period: Weeks 12 to 24), up to 30 weeks.
|
5.6%
3/54 • Number of events 3 • All adverse events were recorded between the time the participant provided informed consent at Week -2 (Run-in Period: Weeks -2 to 0) through 4 weeks after their last treatment (Stage 1 intervention period: Weeks 0 to 12; Stage 2 intervention period: Weeks 12 to 24), up to 30 weeks.
|
0.00%
0/85 • All adverse events were recorded between the time the participant provided informed consent at Week -2 (Run-in Period: Weeks -2 to 0) through 4 weeks after their last treatment (Stage 1 intervention period: Weeks 0 to 12; Stage 2 intervention period: Weeks 12 to 24), up to 30 weeks.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place