Phase 2 Safety Management Study: Number of Participants With the European Quality of Life Five Dimension Five Level Scale (EQ-5D) Score
Study Evaluating the Safety and Efficacy of KTE-C19 in Adult Participants With Refractory Aggressive Non-Hodgkin Lymphoma · Source last updated 2024-06-04
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
Measure
COUNT_OF_PARTICIPANTS
Unit
Participants
Interval / dispersion
Not reported
Time frame
Baseline, Week 4, Month 3, and Month 6
What was measured
EQ-5D is a self-reported questionnaire used for assessing the overall health status of a participant scoring 5 dimensions of health: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension was divided into 5 levels of severity: "No problem", "Slight problems", "Moderate problems", "Severe problems", and "Extreme problems (unable to perform)". EQ-5D health states, defined by the EQ-5D descriptive system, are converted into a single summary index by applying a formula that attaches values (also called QOL weights or QOL utilities) to each of the levels in each dimension. EQ-5D Summary Index values range from -0.11 (worst health state) to 1.00 (perfect health state).
Analysis population: Participants in Safety Analysis Set with available data were analyzed.
Groups in this outcome
Phase 2 (Safety Management Study): Cohort 3
Participants with relapsed or refractory transplant ineligible DLBCL, PMBCL, or TFL received conditioning chemotherapy (fludarabine 30 mg/m\^2 IV over 30 minutes and cyclophosphamide 500 mg/m\^2 IV over 60 minutes) on Days -5, -4, and -3; followed by a single infusion of axicabtagene ciloleucel CAR transduced autologous T cells administered IV at a target dose of 2 x 10\^6 anti-CD19 CAR T cells/kg of BW on Day 0. Participants also received a prophylactic regimen of levetiracetam (750 mg orally or IV twice daily (BID) starting on Day 0) and tocilizumab (8 mg/kg IV over 1 hour (not to exceed 800 mg)) on Day 2).
Phase 2 (Safety Management Study): Cohort 4
Participants with r/r DLBCL, PMBCL ,TFL, or high-grade B-cell lymphoma (HGBCL) after 2 systemic lines of therapy received optional bridging therapy (dexamethasone 20mg to 40mg,either orally or IV daily for 1 to 4 days or 1g/m\^2 of high-dose methylprednisolone(HDMP) for 3 days with rituximab at 375mg/m\^2 weekly for 3 weeks or bendamustine 90 mg/m\^2 on Days 1 and 2 and rituximab 375mg/m\^2 on Day 1), conditioning chemotherapy (fludarabine 30mg/m\^2 IV and cyclophosphamide 500mg/m\^2 IV)on Days -5,-4, and -3; followed by single infusion of axicabtagene ciloleucel CAR transduced autologous T cells IV at a target dose of 2 x 10\^6 anti-CD19 CAR T cells/kg of BW. Participants also received a prophylactic regimen of levetiracetam (750 mg orally or IV twice daily (BID) starting on Day 0). Participants received tocilizumab (initiated on persistent Grade 1 CRS for over 24 hours) and dexamethasone (persistent Grade 1 CRS for over 72 hours and at onset of Grade 1 neurologic toxicity).
Phase 2 (Safety Management Study): Cohort 5
Participants with r/r DLBCL, PMBCL ,TFL, or HGBCL after 2 systemic lines of therapy received debulking therapy (R-CHOP:rituximab 375mg/m\^2 D1,doxorubicin 50mg/m\^2 D1,prednisone 100mg D1 to D5,cyclophosphamide 750mg/m\^2 D1,vincristine 1.4 mg/m\^2 D1 or R-ICE:rituximab 375mg/ m\^2 D1,ifosfamide 5g/m\^2 24h-CI D2,carboplatin AUC5 D2 maximum dose 800mg,etoposide 100 mg/m\^2/day D1 to D3 or R-GEMOX:rituximab 375mg/m\^2 D1,gemcitabine 1000mg/m\^2 D2,oxaliplatin 100mg/m\^2 D2 or R-GDP:rituximab 375mg/m\^2 D1 or D8,gemcitabine 1g/m\^2 D1 \& D8,dexamethasone 40mg D1 to D4,cisplatin 75mg/m\^2 D1(or carboplatin AUC5 D1) or radiotherapy:20 to 30 Gy), conditioning chemotherapy (fludarabine 30mg/m\^2 IV and cyclophosphamide 500mg/m\^2 IV)on Days -5,-4, and -3; followed by single infusion of axicabtagene ciloleucel at a target dose of 2 x 10\^6 anti-CD19 CAR T cells/kg of BW on Day 0. Participants also received a prophylactic regimen of levetiracetam (750 mg orally or IV BID starting on D0).D=Day.
Phase 2 (Safety Management Study): Cohort 6
Participants with r/r DLBCL, PMBCL ,TFL, or HGBCL after 2 systemic lines of therapy may have received bridging therapy (dexamethasone 20mg to 40mg, either orally or IV daily for 1 to 4 days or 1g/m\^2 of high-dose methylprednisolone(HDMP) for 3 days with rituximab at 375mg/m\^2 weekly for 3 weeks or bendamustine 90 mg/m\^2 on Days 1 and 2 and rituximab 375mg/m\^2 on Day 1), conditioning chemotherapy (fludarabine 30mg/m\^2 IV and cyclophosphamide 500mg/m\^2 IV)on Days -5,-4, and -3; followed by single infusion of axicabtagene ciloleucel CAR transduced autologous T cells IV at a target dose of 2 x 10\^6 anti-CD19 CAR T cells/kg of BW on Day 0. Participants also received a prophylactic regimen of levetiracetam (750 mg orally or IV twice daily (BID) starting on Day 0) and corticosteroids (dexamethasone, 10 mg once daily on Days 0, 1, and 2). Participants received tocilizumab (initiated on persistent Grade 1 CRS for over 24 hours) and dexamethasone (persistent Grade 1 CRS for over 72 hours and at onset of Grade 1 neurologic toxicity).
Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.
Analysis denominator · Participants
Group
Source count
Phase 2 (Safety Management Study): Cohort 3
38
Phase 2 (Safety Management Study): Cohort 4
39
Phase 2 (Safety Management Study): Cohort 5
47
Phase 2 (Safety Management Study): Cohort 6
34
Reported measurements
Baseline: Mobility
Analysis denominator · Participants
Group
Source count
Phase 2 (Safety Management Study): Cohort 3
38
Phase 2 (Safety Management Study): Cohort 4
39
Phase 2 (Safety Management Study): Cohort 5
47
Phase 2 (Safety Management Study): Cohort 6
34
No problem
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Phase 2 (Safety Management Study): Cohort 3
30
Not reported
Not reported
Not reported
Not reported
Phase 2 (Safety Management Study): Cohort 4
25
Not reported
Not reported
Not reported
Not reported
Phase 2 (Safety Management Study): Cohort 5
33
Not reported
Not reported
Not reported
Not reported
Phase 2 (Safety Management Study): Cohort 6
26
Not reported
Not reported
Not reported
Not reported
Slight problem
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Phase 2 (Safety Management Study): Cohort 3
7
Not reported
Not reported
Not reported
Not reported
Phase 2 (Safety Management Study): Cohort 4
9
Not reported
Not reported
Not reported
Not reported
Phase 2 (Safety Management Study): Cohort 5
5
Not reported
Not reported
Not reported
Not reported
Phase 2 (Safety Management Study): Cohort 6
4
Not reported
Not reported
Not reported
Not reported
Moderate problem
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Phase 2 (Safety Management Study): Cohort 3
1
Not reported
Not reported
Not reported
Not reported
Phase 2 (Safety Management Study): Cohort 4
5
Not reported
Not reported
Not reported
Not reported
Phase 2 (Safety Management Study): Cohort 5
7
Not reported
Not reported
Not reported
Not reported
Phase 2 (Safety Management Study): Cohort 6
3
Not reported
Not reported
Not reported
Not reported
Severe problem
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Phase 2 (Safety Management Study): Cohort 3
0
Not reported
Not reported
Not reported
Not reported
Phase 2 (Safety Management Study): Cohort 4
0
Not reported
Not reported
Not reported
Not reported
Phase 2 (Safety Management Study): Cohort 5
1
Not reported
Not reported
Not reported
Not reported
Phase 2 (Safety Management Study): Cohort 6
1
Not reported
Not reported
Not reported
Not reported
Unable to perform
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Phase 2 (Safety Management Study): Cohort 3
0
Not reported
Not reported
Not reported
Not reported
Phase 2 (Safety Management Study): Cohort 4
0
Not reported
Not reported
Not reported
Not reported
Phase 2 (Safety Management Study): Cohort 5
1
Not reported
Not reported
Not reported
Not reported
Phase 2 (Safety Management Study): Cohort 6
0
Not reported
Not reported
Not reported
Not reported
Week 4: Mobility
Analysis denominator · Participants
Group
Source count
Phase 2 (Safety Management Study): Cohort 3
32
Phase 2 (Safety Management Study): Cohort 4
37
Phase 2 (Safety Management Study): Cohort 5
38
Phase 2 (Safety Management Study): Cohort 6
29
No problem
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Phase 2 (Safety Management Study): Cohort 3
16
Not reported
Not reported
Not reported
Not reported
Phase 2 (Safety Management Study): Cohort 4
21
Not reported
Not reported
Not reported
Not reported
Phase 2 (Safety Management Study): Cohort 5
23
Not reported
Not reported
Not reported
Not reported
Phase 2 (Safety Management Study): Cohort 6
20
Not reported
Not reported
Not reported
Not reported
Slight problem
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Phase 2 (Safety Management Study): Cohort 3
11
Not reported
Not reported
Not reported
Not reported
Phase 2 (Safety Management Study): Cohort 4
7
Not reported
Not reported
Not reported
Not reported
Phase 2 (Safety Management Study): Cohort 5
9
Not reported
Not reported
Not reported
Not reported
Phase 2 (Safety Management Study): Cohort 6
5
Not reported
Not reported
Not reported
Not reported
Moderate problem
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Phase 2 (Safety Management Study): Cohort 3
4
Not reported
Not reported
Not reported
Not reported
Phase 2 (Safety Management Study): Cohort 4
5
Not reported
Not reported
Not reported
Not reported
Phase 2 (Safety Management Study): Cohort 5
4
Not reported
Not reported
Not reported
Not reported
Phase 2 (Safety Management Study): Cohort 6
4
Not reported
Not reported
Not reported
Not reported
Severe problem
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Phase 2 (Safety Management Study): Cohort 3
0
Not reported
Not reported
Not reported
Not reported
Phase 2 (Safety Management Study): Cohort 4
3
Not reported
Not reported
Not reported
Not reported
Phase 2 (Safety Management Study): Cohort 5
1
Not reported
Not reported
Not reported
Not reported
Phase 2 (Safety Management Study): Cohort 6
0
Not reported
Not reported
Not reported
Not reported
Unable to perform
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Phase 2 (Safety Management Study): Cohort 3
1
Not reported
Not reported
Not reported
Not reported
Phase 2 (Safety Management Study): Cohort 4
1
Not reported
Not reported
Not reported
Not reported
Phase 2 (Safety Management Study): Cohort 5
1
Not reported
Not reported
Not reported
Not reported
Phase 2 (Safety Management Study): Cohort 6
0
Not reported
Not reported
Not reported
Not reported
Month 3: Mobility
Analysis denominator · Participants
Group
Source count
Phase 2 (Safety Management Study): Cohort 3
23
Phase 2 (Safety Management Study): Cohort 4
31
Phase 2 (Safety Management Study): Cohort 5
33
Phase 2 (Safety Management Study): Cohort 6
29
No problem
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Phase 2 (Safety Management Study): Cohort 3
14
Not reported
Not reported
Not reported
Not reported
Phase 2 (Safety Management Study): Cohort 4
20
Not reported
Not reported
Not reported
Not reported
Phase 2 (Safety Management Study): Cohort 5
21
Not reported
Not reported
Not reported
Not reported
Phase 2 (Safety Management Study): Cohort 6
22
Not reported
Not reported
Not reported
Not reported
Slight problem
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Phase 2 (Safety Management Study): Cohort 3
6
Not reported
Not reported
Not reported
Not reported
Phase 2 (Safety Management Study): Cohort 4
8
Not reported
Not reported
Not reported
Not reported
Phase 2 (Safety Management Study): Cohort 5
6
Not reported
Not reported
Not reported
Not reported
Phase 2 (Safety Management Study): Cohort 6
3
Not reported
Not reported
Not reported
Not reported
Moderate problem
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Phase 2 (Safety Management Study): Cohort 3
2
Not reported
Not reported
Not reported
Not reported
Phase 2 (Safety Management Study): Cohort 4
2
Not reported
Not reported
Not reported
Not reported
Phase 2 (Safety Management Study): Cohort 5
6
Not reported
Not reported
Not reported
Not reported
Phase 2 (Safety Management Study): Cohort 6
3
Not reported
Not reported
Not reported
Not reported
Severe problem
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Phase 2 (Safety Management Study): Cohort 3
1
Not reported
Not reported
Not reported
Not reported
Phase 2 (Safety Management Study): Cohort 4
1
Not reported
Not reported
Not reported
Not reported
Phase 2 (Safety Management Study): Cohort 5
0
Not reported
Not reported
Not reported
Not reported
Phase 2 (Safety Management Study): Cohort 6
1
Not reported
Not reported
Not reported
Not reported
Unable to perform
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Phase 2 (Safety Management Study): Cohort 3
0
Not reported
Not reported
Not reported
Not reported
Phase 2 (Safety Management Study): Cohort 4
0
Not reported
Not reported
Not reported
Not reported
Phase 2 (Safety Management Study): Cohort 5
0
Not reported
Not reported
Not reported
Not reported
Phase 2 (Safety Management Study): Cohort 6
0
Not reported
Not reported
Not reported
Not reported
Month 6: Mobility
Analysis denominator · Participants
Group
Source count
Phase 2 (Safety Management Study): Cohort 3
18
Phase 2 (Safety Management Study): Cohort 4
25
Phase 2 (Safety Management Study): Cohort 5
17
Phase 2 (Safety Management Study): Cohort 6
27
No problem
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Phase 2 (Safety Management Study): Cohort 3
10
Not reported
Not reported
Not reported
Not reported
Phase 2 (Safety Management Study): Cohort 4
19
Not reported
Not reported
Not reported
Not reported
Phase 2 (Safety Management Study): Cohort 5
11
Not reported
Not reported
Not reported
Not reported
Phase 2 (Safety Management Study): Cohort 6
15
Not reported
Not reported
Not reported
Not reported
Slight problem
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Phase 2 (Safety Management Study): Cohort 3
6
Not reported
Not reported
Not reported
Not reported
Phase 2 (Safety Management Study): Cohort 4
4
Not reported
Not reported
Not reported
Not reported
Phase 2 (Safety Management Study): Cohort 5
2
Not reported
Not reported
Not reported
Not reported
Phase 2 (Safety Management Study): Cohort 6
8
Not reported
Not reported
Not reported
Not reported
Moderate problem
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Phase 2 (Safety Management Study): Cohort 3
2
Not reported
Not reported
Not reported
Not reported
Phase 2 (Safety Management Study): Cohort 4
2
Not reported
Not reported
Not reported
Not reported
Phase 2 (Safety Management Study): Cohort 5
4
Not reported
Not reported
Not reported
Not reported
Phase 2 (Safety Management Study): Cohort 6
3
Not reported
Not reported
Not reported
Not reported
Severe problem
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Phase 2 (Safety Management Study): Cohort 3
0
Not reported
Not reported
Not reported
Not reported
Phase 2 (Safety Management Study): Cohort 4
0
Not reported
Not reported
Not reported
Not reported
Phase 2 (Safety Management Study): Cohort 5
0
Not reported
Not reported
Not reported
Not reported
Phase 2 (Safety Management Study): Cohort 6
1
Not reported
Not reported
Not reported
Not reported
Unable to perform
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Phase 2 (Safety Management Study): Cohort 3
0
Not reported
Not reported
Not reported
Not reported
Phase 2 (Safety Management Study): Cohort 4
0
Not reported
Not reported
Not reported
Not reported
Phase 2 (Safety Management Study): Cohort 5
0
Not reported
Not reported
Not reported
Not reported
Phase 2 (Safety Management Study): Cohort 6
0
Not reported
Not reported
Not reported
Not reported
Baseline: Self-care
Analysis denominator · Participants
Group
Source count
Phase 2 (Safety Management Study): Cohort 3
38
Phase 2 (Safety Management Study): Cohort 4
39
Phase 2 (Safety Management Study): Cohort 5
47
Phase 2 (Safety Management Study): Cohort 6
34
No problem
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Phase 2 (Safety Management Study): Cohort 3
37
Not reported
Not reported
Not reported
Not reported
Phase 2 (Safety Management Study): Cohort 4
38
Not reported
Not reported
Not reported
Not reported
Phase 2 (Safety Management Study): Cohort 5
44
Not reported
Not reported
Not reported
Not reported
Phase 2 (Safety Management Study): Cohort 6
32
Not reported
Not reported
Not reported
Not reported
Slight problem
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Phase 2 (Safety Management Study): Cohort 3
1
Not reported
Not reported
Not reported
Not reported
Phase 2 (Safety Management Study): Cohort 4
1
Not reported
Not reported
Not reported
Not reported
Phase 2 (Safety Management Study): Cohort 5
3
Not reported
Not reported
Not reported
Not reported
Phase 2 (Safety Management Study): Cohort 6
1
Not reported
Not reported
Not reported
Not reported
Moderate problem
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Phase 2 (Safety Management Study): Cohort 3
0
Not reported
Not reported
Not reported
Not reported
Phase 2 (Safety Management Study): Cohort 4
0
Not reported
Not reported
Not reported
Not reported
Phase 2 (Safety Management Study): Cohort 5
0
Not reported
Not reported
Not reported
Not reported
Phase 2 (Safety Management Study): Cohort 6
1
Not reported
Not reported
Not reported
Not reported
Severe problem
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Phase 2 (Safety Management Study): Cohort 3
0
Not reported
Not reported
Not reported
Not reported
Phase 2 (Safety Management Study): Cohort 4
0
Not reported
Not reported
Not reported
Not reported
Phase 2 (Safety Management Study): Cohort 5
0
Not reported
Not reported
Not reported
Not reported
Phase 2 (Safety Management Study): Cohort 6
0
Not reported
Not reported
Not reported
Not reported
Unable to perform
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Phase 2 (Safety Management Study): Cohort 3
0
Not reported
Not reported
Not reported
Not reported
Phase 2 (Safety Management Study): Cohort 4
0
Not reported
Not reported
Not reported
Not reported
Phase 2 (Safety Management Study): Cohort 5
0
Not reported
Not reported
Not reported
Not reported
Phase 2 (Safety Management Study): Cohort 6
0
Not reported
Not reported
Not reported
Not reported
Week 4: Self-care
Analysis denominator · Participants
Group
Source count
Phase 2 (Safety Management Study): Cohort 3
32
Phase 2 (Safety Management Study): Cohort 4
37
Phase 2 (Safety Management Study): Cohort 5
38
Phase 2 (Safety Management Study): Cohort 6
29
No problem
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Phase 2 (Safety Management Study): Cohort 3
25
Not reported
Not reported
Not reported
Not reported
Phase 2 (Safety Management Study): Cohort 4
33
Not reported
Not reported
Not reported
Not reported
Phase 2 (Safety Management Study): Cohort 5
31
Not reported
Not reported
Not reported
Not reported
Phase 2 (Safety Management Study): Cohort 6
24
Not reported
Not reported
Not reported
Not reported
Slight problem
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Phase 2 (Safety Management Study): Cohort 3
5
Not reported
Not reported
Not reported
Not reported
Phase 2 (Safety Management Study): Cohort 4
3
Not reported
Not reported
Not reported
Not reported
Phase 2 (Safety Management Study): Cohort 5
6
Not reported
Not reported
Not reported
Not reported
Phase 2 (Safety Management Study): Cohort 6
3
Not reported
Not reported
Not reported
Not reported
Moderate problem
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Phase 2 (Safety Management Study): Cohort 3
1
Not reported
Not reported
Not reported
Not reported
Phase 2 (Safety Management Study): Cohort 4
0
Not reported
Not reported
Not reported
Not reported
Phase 2 (Safety Management Study): Cohort 5
1
Not reported
Not reported
Not reported
Not reported
Phase 2 (Safety Management Study): Cohort 6
1
Not reported
Not reported
Not reported
Not reported
Severe problem
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Phase 2 (Safety Management Study): Cohort 3
0
Not reported
Not reported
Not reported
Not reported
Phase 2 (Safety Management Study): Cohort 4
1
Not reported
Not reported
Not reported
Not reported
Phase 2 (Safety Management Study): Cohort 5
0
Not reported
Not reported
Not reported
Not reported
Phase 2 (Safety Management Study): Cohort 6
1
Not reported
Not reported
Not reported
Not reported
Unable to perform
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Phase 2 (Safety Management Study): Cohort 3
1
Not reported
Not reported
Not reported
Not reported
Phase 2 (Safety Management Study): Cohort 4
0
Not reported
Not reported
Not reported
Not reported
Phase 2 (Safety Management Study): Cohort 5
0
Not reported
Not reported
Not reported
Not reported
Phase 2 (Safety Management Study): Cohort 6
0
Not reported
Not reported
Not reported
Not reported
Month 3: Self-care
Analysis denominator · Participants
Group
Source count
Phase 2 (Safety Management Study): Cohort 3
23
Phase 2 (Safety Management Study): Cohort 4
31
Phase 2 (Safety Management Study): Cohort 5
33
Phase 2 (Safety Management Study): Cohort 6
29
No problem
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Phase 2 (Safety Management Study): Cohort 3
19
Not reported
Not reported
Not reported
Not reported
Phase 2 (Safety Management Study): Cohort 4
29
Not reported
Not reported
Not reported
Not reported
Phase 2 (Safety Management Study): Cohort 5
32
Not reported
Not reported
Not reported
Not reported
Phase 2 (Safety Management Study): Cohort 6
25
Not reported
Not reported
Not reported
Not reported
Slight problem
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Phase 2 (Safety Management Study): Cohort 3
4
Not reported
Not reported
Not reported
Not reported
Phase 2 (Safety Management Study): Cohort 4
2
Not reported
Not reported
Not reported
Not reported
Phase 2 (Safety Management Study): Cohort 5
1
Not reported
Not reported
Not reported
Not reported
Phase 2 (Safety Management Study): Cohort 6
4
Not reported
Not reported
Not reported
Not reported
Moderate problem
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Phase 2 (Safety Management Study): Cohort 3
0
Not reported
Not reported
Not reported
Not reported
Phase 2 (Safety Management Study): Cohort 4
0
Not reported
Not reported
Not reported
Not reported
Phase 2 (Safety Management Study): Cohort 5
0
Not reported
Not reported
Not reported
Not reported
Phase 2 (Safety Management Study): Cohort 6
0
Not reported
Not reported
Not reported
Not reported
Severe problem
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Phase 2 (Safety Management Study): Cohort 3
0
Not reported
Not reported
Not reported
Not reported
Phase 2 (Safety Management Study): Cohort 4
0
Not reported
Not reported
Not reported
Not reported
Phase 2 (Safety Management Study): Cohort 5
0
Not reported
Not reported
Not reported
Not reported
Phase 2 (Safety Management Study): Cohort 6
0
Not reported
Not reported
Not reported
Not reported
Unable to perform
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Phase 2 (Safety Management Study): Cohort 3
0
Not reported
Not reported
Not reported
Not reported
Phase 2 (Safety Management Study): Cohort 4
0
Not reported
Not reported
Not reported
Not reported
Phase 2 (Safety Management Study): Cohort 5
0
Not reported
Not reported
Not reported
Not reported
Phase 2 (Safety Management Study): Cohort 6
0
Not reported
Not reported
Not reported
Not reported
Month 6: Self-care
Analysis denominator · Participants
Group
Source count
Phase 2 (Safety Management Study): Cohort 3
18
Phase 2 (Safety Management Study): Cohort 4
25
Phase 2 (Safety Management Study): Cohort 5
17
Phase 2 (Safety Management Study): Cohort 6
27
No problem
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Phase 2 (Safety Management Study): Cohort 3
17
Not reported
Not reported
Not reported
Not reported
Phase 2 (Safety Management Study): Cohort 4
25
Not reported
Not reported
Not reported
Not reported
Phase 2 (Safety Management Study): Cohort 5
16
Not reported
Not reported
Not reported
Not reported
Phase 2 (Safety Management Study): Cohort 6
20
Not reported
Not reported
Not reported
Not reported
Slight problem
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Phase 2 (Safety Management Study): Cohort 3
1
Not reported
Not reported
Not reported
Not reported
Phase 2 (Safety Management Study): Cohort 4
0
Not reported
Not reported
Not reported
Not reported
Phase 2 (Safety Management Study): Cohort 5
1
Not reported
Not reported
Not reported
Not reported
Phase 2 (Safety Management Study): Cohort 6
7
Not reported
Not reported
Not reported
Not reported
Moderate problem
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Phase 2 (Safety Management Study): Cohort 3
0
Not reported
Not reported
Not reported
Not reported
Phase 2 (Safety Management Study): Cohort 4
0
Not reported
Not reported
Not reported
Not reported
Phase 2 (Safety Management Study): Cohort 5
0
Not reported
Not reported
Not reported
Not reported
Phase 2 (Safety Management Study): Cohort 6
0
Not reported
Not reported
Not reported
Not reported
Severe problem
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Phase 2 (Safety Management Study): Cohort 3
0
Not reported
Not reported
Not reported
Not reported
Phase 2 (Safety Management Study): Cohort 4
0
Not reported
Not reported
Not reported
Not reported
Phase 2 (Safety Management Study): Cohort 5
0
Not reported
Not reported
Not reported
Not reported
Phase 2 (Safety Management Study): Cohort 6
0
Not reported
Not reported
Not reported
Not reported
Unable to perform
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Phase 2 (Safety Management Study): Cohort 3
0
Not reported
Not reported
Not reported
Not reported
Phase 2 (Safety Management Study): Cohort 4
0
Not reported
Not reported
Not reported
Not reported
Phase 2 (Safety Management Study): Cohort 5
0
Not reported
Not reported
Not reported
Not reported
Phase 2 (Safety Management Study): Cohort 6
0
Not reported
Not reported
Not reported
Not reported
Baseline: Usual activities
Analysis denominator · Participants
Group
Source count
Phase 2 (Safety Management Study): Cohort 3
38
Phase 2 (Safety Management Study): Cohort 4
39
Phase 2 (Safety Management Study): Cohort 5
47
Phase 2 (Safety Management Study): Cohort 6
34
No problem
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Phase 2 (Safety Management Study): Cohort 3
22
Not reported
Not reported
Not reported
Not reported
Phase 2 (Safety Management Study): Cohort 4
22
Not reported
Not reported
Not reported
Not reported
Phase 2 (Safety Management Study): Cohort 5
24
Not reported
Not reported
Not reported
Not reported
Phase 2 (Safety Management Study): Cohort 6
16
Not reported
Not reported
Not reported
Not reported
Slight problem
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Phase 2 (Safety Management Study): Cohort 3
10
Not reported
Not reported
Not reported
Not reported
Phase 2 (Safety Management Study): Cohort 4
6
Not reported
Not reported
Not reported
Not reported
Phase 2 (Safety Management Study): Cohort 5
13
Not reported
Not reported
Not reported
Not reported
Phase 2 (Safety Management Study): Cohort 6
14
Not reported
Not reported
Not reported
Not reported
Moderate problem
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Phase 2 (Safety Management Study): Cohort 3
4
Not reported
Not reported
Not reported
Not reported
Phase 2 (Safety Management Study): Cohort 4
8
Not reported
Not reported
Not reported
Not reported
Phase 2 (Safety Management Study): Cohort 5
8
Not reported
Not reported
Not reported
Not reported
Phase 2 (Safety Management Study): Cohort 6
2
Not reported
Not reported
Not reported
Not reported
Severe problem
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Phase 2 (Safety Management Study): Cohort 3
2
Not reported
Not reported
Not reported
Not reported
Phase 2 (Safety Management Study): Cohort 4
1
Not reported
Not reported
Not reported
Not reported
Phase 2 (Safety Management Study): Cohort 5
1
Not reported
Not reported
Not reported
Not reported
Phase 2 (Safety Management Study): Cohort 6
2
Not reported
Not reported
Not reported
Not reported
Unable to perform
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Phase 2 (Safety Management Study): Cohort 3
0
Not reported
Not reported
Not reported
Not reported
Phase 2 (Safety Management Study): Cohort 4
2
Not reported
Not reported
Not reported
Not reported
Phase 2 (Safety Management Study): Cohort 5
1
Not reported
Not reported
Not reported
Not reported
Phase 2 (Safety Management Study): Cohort 6
0
Not reported
Not reported
Not reported
Not reported
Week 4: Usual activities
Analysis denominator · Participants
Group
Source count
Phase 2 (Safety Management Study): Cohort 3
32
Phase 2 (Safety Management Study): Cohort 4
37
Phase 2 (Safety Management Study): Cohort 5
37
Phase 2 (Safety Management Study): Cohort 6
29
No problem
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Phase 2 (Safety Management Study): Cohort 3
6
Not reported
Not reported
Not reported
Not reported
Phase 2 (Safety Management Study): Cohort 4
12
Not reported
Not reported
Not reported
Not reported
Phase 2 (Safety Management Study): Cohort 5
12
Not reported
Not reported
Not reported
Not reported
Phase 2 (Safety Management Study): Cohort 6
12
Not reported
Not reported
Not reported
Not reported
Slight problem
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Phase 2 (Safety Management Study): Cohort 3
13
Not reported
Not reported
Not reported
Not reported
Phase 2 (Safety Management Study): Cohort 4
11
Not reported
Not reported
Not reported
Not reported
Phase 2 (Safety Management Study): Cohort 5
13
Not reported
Not reported
Not reported
Not reported
Phase 2 (Safety Management Study): Cohort 6
11
Not reported
Not reported
Not reported
Not reported
Moderate problem
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Phase 2 (Safety Management Study): Cohort 3
11
Not reported
Not reported
Not reported
Not reported
Phase 2 (Safety Management Study): Cohort 4
8
Not reported
Not reported
Not reported
Not reported
Phase 2 (Safety Management Study): Cohort 5
8
Not reported
Not reported
Not reported
Not reported
Phase 2 (Safety Management Study): Cohort 6
4
Not reported
Not reported
Not reported
Not reported
Severe problem
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Phase 2 (Safety Management Study): Cohort 3
0
Not reported
Not reported
Not reported
Not reported
Phase 2 (Safety Management Study): Cohort 4
3
Not reported
Not reported
Not reported
Not reported
Phase 2 (Safety Management Study): Cohort 5
2
Not reported
Not reported
Not reported
Not reported
Phase 2 (Safety Management Study): Cohort 6
1
Not reported
Not reported
Not reported
Not reported
Unable to perform
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Phase 2 (Safety Management Study): Cohort 3
2
Not reported
Not reported
Not reported
Not reported
Phase 2 (Safety Management Study): Cohort 4
3
Not reported
Not reported
Not reported
Not reported
Phase 2 (Safety Management Study): Cohort 5
2
Not reported
Not reported
Not reported
Not reported
Phase 2 (Safety Management Study): Cohort 6
1
Not reported
Not reported
Not reported
Not reported
Month 3: Usual activities
Analysis denominator · Participants
Group
Source count
Phase 2 (Safety Management Study): Cohort 3
23
Phase 2 (Safety Management Study): Cohort 4
31
Phase 2 (Safety Management Study): Cohort 5
33
Phase 2 (Safety Management Study): Cohort 6
29
No problem
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Phase 2 (Safety Management Study): Cohort 3
8
Not reported
Not reported
Not reported
Not reported
Phase 2 (Safety Management Study): Cohort 4
16
Not reported
Not reported
Not reported
Not reported
Phase 2 (Safety Management Study): Cohort 5
19
Not reported
Not reported
Not reported
Not reported
Phase 2 (Safety Management Study): Cohort 6
12
Not reported
Not reported
Not reported
Not reported
Slight problem
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Phase 2 (Safety Management Study): Cohort 3
9
Not reported
Not reported
Not reported
Not reported
Phase 2 (Safety Management Study): Cohort 4
9
Not reported
Not reported
Not reported
Not reported
Phase 2 (Safety Management Study): Cohort 5
10
Not reported
Not reported
Not reported
Not reported
Phase 2 (Safety Management Study): Cohort 6
14
Not reported
Not reported
Not reported
Not reported
Moderate problem
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Phase 2 (Safety Management Study): Cohort 3
5
Not reported
Not reported
Not reported
Not reported
Phase 2 (Safety Management Study): Cohort 4
5
Not reported
Not reported
Not reported
Not reported
Phase 2 (Safety Management Study): Cohort 5
2
Not reported
Not reported
Not reported
Not reported
Phase 2 (Safety Management Study): Cohort 6
2
Not reported
Not reported
Not reported
Not reported
Severe problem
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Phase 2 (Safety Management Study): Cohort 3
1
Not reported
Not reported
Not reported
Not reported
Phase 2 (Safety Management Study): Cohort 4
1
Not reported
Not reported
Not reported
Not reported
Phase 2 (Safety Management Study): Cohort 5
1
Not reported
Not reported
Not reported
Not reported
Phase 2 (Safety Management Study): Cohort 6
1
Not reported
Not reported
Not reported
Not reported
Unable to perform
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Phase 2 (Safety Management Study): Cohort 3
0
Not reported
Not reported
Not reported
Not reported
Phase 2 (Safety Management Study): Cohort 4
0
Not reported
Not reported
Not reported
Not reported
Phase 2 (Safety Management Study): Cohort 5
1
Not reported
Not reported
Not reported
Not reported
Phase 2 (Safety Management Study): Cohort 6
0
Not reported
Not reported
Not reported
Not reported
Month 6: Usual activities
Analysis denominator · Participants
Group
Source count
Phase 2 (Safety Management Study): Cohort 3
18
Phase 2 (Safety Management Study): Cohort 4
25
Phase 2 (Safety Management Study): Cohort 5
17
Phase 2 (Safety Management Study): Cohort 6
27
No problem
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Phase 2 (Safety Management Study): Cohort 3
9
Not reported
Not reported
Not reported
Not reported
Phase 2 (Safety Management Study): Cohort 4
15
Not reported
Not reported
Not reported
Not reported
Phase 2 (Safety Management Study): Cohort 5
10
Not reported
Not reported
Not reported
Not reported
Phase 2 (Safety Management Study): Cohort 6
11
Not reported
Not reported
Not reported
Not reported
Slight problem
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Phase 2 (Safety Management Study): Cohort 3
5
Not reported
Not reported
Not reported
Not reported
Phase 2 (Safety Management Study): Cohort 4
7
Not reported
Not reported
Not reported
Not reported
Phase 2 (Safety Management Study): Cohort 5
4
Not reported
Not reported
Not reported
Not reported
Phase 2 (Safety Management Study): Cohort 6
12
Not reported
Not reported
Not reported
Not reported
Moderate problem
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Phase 2 (Safety Management Study): Cohort 3
3
Not reported
Not reported
Not reported
Not reported
Phase 2 (Safety Management Study): Cohort 4
3
Not reported
Not reported
Not reported
Not reported
Phase 2 (Safety Management Study): Cohort 5
2
Not reported
Not reported
Not reported
Not reported
Phase 2 (Safety Management Study): Cohort 6
3
Not reported
Not reported
Not reported
Not reported
Severe problem
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Phase 2 (Safety Management Study): Cohort 3
1
Not reported
Not reported
Not reported
Not reported
Phase 2 (Safety Management Study): Cohort 4
0
Not reported
Not reported
Not reported
Not reported
Phase 2 (Safety Management Study): Cohort 5
1
Not reported
Not reported
Not reported
Not reported
Phase 2 (Safety Management Study): Cohort 6
0
Not reported
Not reported
Not reported
Not reported
Unable to perform
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Phase 2 (Safety Management Study): Cohort 3
0
Not reported
Not reported
Not reported
Not reported
Phase 2 (Safety Management Study): Cohort 4
0
Not reported
Not reported
Not reported
Not reported
Phase 2 (Safety Management Study): Cohort 5
0
Not reported
Not reported
Not reported
Not reported
Phase 2 (Safety Management Study): Cohort 6
1
Not reported
Not reported
Not reported
Not reported
Baseline: Pain/Discomfort
Analysis denominator · Participants
Group
Source count
Phase 2 (Safety Management Study): Cohort 3
38
Phase 2 (Safety Management Study): Cohort 4
39
Phase 2 (Safety Management Study): Cohort 5
47
Phase 2 (Safety Management Study): Cohort 6
34
No problem
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Phase 2 (Safety Management Study): Cohort 3
18
Not reported
Not reported
Not reported
Not reported
Phase 2 (Safety Management Study): Cohort 4
17
Not reported
Not reported
Not reported
Not reported
Phase 2 (Safety Management Study): Cohort 5
16
Not reported
Not reported
Not reported
Not reported
Phase 2 (Safety Management Study): Cohort 6
15
Not reported
Not reported
Not reported
Not reported
Slight problem
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Phase 2 (Safety Management Study): Cohort 3
9
Not reported
Not reported
Not reported
Not reported
Phase 2 (Safety Management Study): Cohort 4
17
Not reported
Not reported
Not reported
Not reported
Phase 2 (Safety Management Study): Cohort 5
18
Not reported
Not reported
Not reported
Not reported
Phase 2 (Safety Management Study): Cohort 6
14
Not reported
Not reported
Not reported
Not reported
Moderate problem
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Phase 2 (Safety Management Study): Cohort 3
8
Not reported
Not reported
Not reported
Not reported
Phase 2 (Safety Management Study): Cohort 4
5
Not reported
Not reported
Not reported
Not reported
Phase 2 (Safety Management Study): Cohort 5
7
Not reported
Not reported
Not reported
Not reported
Phase 2 (Safety Management Study): Cohort 6
4
Not reported
Not reported
Not reported
Not reported
Severe problem
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Phase 2 (Safety Management Study): Cohort 3
1
Not reported
Not reported
Not reported
Not reported
Phase 2 (Safety Management Study): Cohort 4
0
Not reported
Not reported
Not reported
Not reported
Phase 2 (Safety Management Study): Cohort 5
5
Not reported
Not reported
Not reported
Not reported
Phase 2 (Safety Management Study): Cohort 6
1
Not reported
Not reported
Not reported
Not reported
Unable to perform
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Phase 2 (Safety Management Study): Cohort 3
2
Not reported
Not reported
Not reported
Not reported
Phase 2 (Safety Management Study): Cohort 4
0
Not reported
Not reported
Not reported
Not reported
Phase 2 (Safety Management Study): Cohort 5
1
Not reported
Not reported
Not reported
Not reported
Phase 2 (Safety Management Study): Cohort 6
0
Not reported
Not reported
Not reported
Not reported
Week 4: Pain/Discomfort
Analysis denominator · Participants
Group
Source count
Phase 2 (Safety Management Study): Cohort 3
32
Phase 2 (Safety Management Study): Cohort 4
37
Phase 2 (Safety Management Study): Cohort 5
37
Phase 2 (Safety Management Study): Cohort 6
29
No problem
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Phase 2 (Safety Management Study): Cohort 3
12
Not reported
Not reported
Not reported
Not reported
Phase 2 (Safety Management Study): Cohort 4
19
Not reported
Not reported
Not reported
Not reported
Phase 2 (Safety Management Study): Cohort 5
20
Not reported
Not reported
Not reported
Not reported
Phase 2 (Safety Management Study): Cohort 6
17
Not reported
Not reported
Not reported
Not reported
Slight problem
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Phase 2 (Safety Management Study): Cohort 3
12
Not reported
Not reported
Not reported
Not reported
Phase 2 (Safety Management Study): Cohort 4
13
Not reported
Not reported
Not reported
Not reported
Phase 2 (Safety Management Study): Cohort 5
10
Not reported
Not reported
Not reported
Not reported
Phase 2 (Safety Management Study): Cohort 6
9
Not reported
Not reported
Not reported
Not reported
Moderate problem
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Phase 2 (Safety Management Study): Cohort 3
7
Not reported
Not reported
Not reported
Not reported
Phase 2 (Safety Management Study): Cohort 4
2
Not reported
Not reported
Not reported
Not reported
Phase 2 (Safety Management Study): Cohort 5
5
Not reported
Not reported
Not reported
Not reported
Phase 2 (Safety Management Study): Cohort 6
3
Not reported
Not reported
Not reported
Not reported
Severe problem
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Phase 2 (Safety Management Study): Cohort 3
1
Not reported
Not reported
Not reported
Not reported
Phase 2 (Safety Management Study): Cohort 4
3
Not reported
Not reported
Not reported
Not reported
Phase 2 (Safety Management Study): Cohort 5
2
Not reported
Not reported
Not reported
Not reported
Phase 2 (Safety Management Study): Cohort 6
0
Not reported
Not reported
Not reported
Not reported
Unable to perform
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Phase 2 (Safety Management Study): Cohort 3
0
Not reported
Not reported
Not reported
Not reported
Phase 2 (Safety Management Study): Cohort 4
0
Not reported
Not reported
Not reported
Not reported
Phase 2 (Safety Management Study): Cohort 5
0
Not reported
Not reported
Not reported
Not reported
Phase 2 (Safety Management Study): Cohort 6
0
Not reported
Not reported
Not reported
Not reported
Month 3: Pain/Discomfort
Analysis denominator · Participants
Group
Source count
Phase 2 (Safety Management Study): Cohort 3
23
Phase 2 (Safety Management Study): Cohort 4
31
Phase 2 (Safety Management Study): Cohort 5
33
Phase 2 (Safety Management Study): Cohort 6
29
No problem
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Phase 2 (Safety Management Study): Cohort 3
9
Not reported
Not reported
Not reported
Not reported
Phase 2 (Safety Management Study): Cohort 4
10
Not reported
Not reported
Not reported
Not reported
Phase 2 (Safety Management Study): Cohort 5
18
Not reported
Not reported
Not reported
Not reported
Phase 2 (Safety Management Study): Cohort 6
16
Not reported
Not reported
Not reported
Not reported
Slight problem
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Phase 2 (Safety Management Study): Cohort 3
5
Not reported
Not reported
Not reported
Not reported
Phase 2 (Safety Management Study): Cohort 4
14
Not reported
Not reported
Not reported
Not reported
Phase 2 (Safety Management Study): Cohort 5
9
Not reported
Not reported
Not reported
Not reported
Phase 2 (Safety Management Study): Cohort 6
5
Not reported
Not reported
Not reported
Not reported
Moderate problem
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Phase 2 (Safety Management Study): Cohort 3
9
Not reported
Not reported
Not reported
Not reported
Phase 2 (Safety Management Study): Cohort 4
6
Not reported
Not reported
Not reported
Not reported
Phase 2 (Safety Management Study): Cohort 5
6
Not reported
Not reported
Not reported
Not reported
Phase 2 (Safety Management Study): Cohort 6
5
Not reported
Not reported
Not reported
Not reported
Severe problem
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Phase 2 (Safety Management Study): Cohort 3
0
Not reported
Not reported
Not reported
Not reported
Phase 2 (Safety Management Study): Cohort 4
1
Not reported
Not reported
Not reported
Not reported
Phase 2 (Safety Management Study): Cohort 5
0
Not reported
Not reported
Not reported
Not reported
Phase 2 (Safety Management Study): Cohort 6
3
Not reported
Not reported
Not reported
Not reported
Unable to perform
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Phase 2 (Safety Management Study): Cohort 3
0
Not reported
Not reported
Not reported
Not reported
Phase 2 (Safety Management Study): Cohort 4
0
Not reported
Not reported
Not reported
Not reported
Phase 2 (Safety Management Study): Cohort 5
0
Not reported
Not reported
Not reported
Not reported
Phase 2 (Safety Management Study): Cohort 6
0
Not reported
Not reported
Not reported
Not reported
Month 6: Pain/Discomfort
Analysis denominator · Participants
Group
Source count
Phase 2 (Safety Management Study): Cohort 3
17
Phase 2 (Safety Management Study): Cohort 4
25
Phase 2 (Safety Management Study): Cohort 5
17
Phase 2 (Safety Management Study): Cohort 6
27
No problem
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Phase 2 (Safety Management Study): Cohort 3
8
Not reported
Not reported
Not reported
Not reported
Phase 2 (Safety Management Study): Cohort 4
9
Not reported
Not reported
Not reported
Not reported
Phase 2 (Safety Management Study): Cohort 5
6
Not reported
Not reported
Not reported
Not reported
Phase 2 (Safety Management Study): Cohort 6
12
Not reported
Not reported
Not reported
Not reported
Slight problem
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Phase 2 (Safety Management Study): Cohort 3
4
Not reported
Not reported
Not reported
Not reported
Phase 2 (Safety Management Study): Cohort 4
14
Not reported
Not reported
Not reported
Not reported
Phase 2 (Safety Management Study): Cohort 5
8
Not reported
Not reported
Not reported
Not reported
Phase 2 (Safety Management Study): Cohort 6
8
Not reported
Not reported
Not reported
Not reported
Moderate problem
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Phase 2 (Safety Management Study): Cohort 3
5
Not reported
Not reported
Not reported
Not reported
Phase 2 (Safety Management Study): Cohort 4
1
Not reported
Not reported
Not reported
Not reported
Phase 2 (Safety Management Study): Cohort 5
3
Not reported
Not reported
Not reported
Not reported
Phase 2 (Safety Management Study): Cohort 6
4
Not reported
Not reported
Not reported
Not reported
Severe problem
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Phase 2 (Safety Management Study): Cohort 3
0
Not reported
Not reported
Not reported
Not reported
Phase 2 (Safety Management Study): Cohort 4
1
Not reported
Not reported
Not reported
Not reported
Phase 2 (Safety Management Study): Cohort 5
0
Not reported
Not reported
Not reported
Not reported
Phase 2 (Safety Management Study): Cohort 6
3
Not reported
Not reported
Not reported
Not reported
Unable to perform
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Phase 2 (Safety Management Study): Cohort 3
0
Not reported
Not reported
Not reported
Not reported
Phase 2 (Safety Management Study): Cohort 4
0
Not reported
Not reported
Not reported
Not reported
Phase 2 (Safety Management Study): Cohort 5
0
Not reported
Not reported
Not reported
Not reported
Phase 2 (Safety Management Study): Cohort 6
0
Not reported
Not reported
Not reported
Not reported
Baseline: Anxiety/Depression
Analysis denominator · Participants
Group
Source count
Phase 2 (Safety Management Study): Cohort 3
38
Phase 2 (Safety Management Study): Cohort 4
39
Phase 2 (Safety Management Study): Cohort 5
47
Phase 2 (Safety Management Study): Cohort 6
34
No problem
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Phase 2 (Safety Management Study): Cohort 3
16
Not reported
Not reported
Not reported
Not reported
Phase 2 (Safety Management Study): Cohort 4
23
Not reported
Not reported
Not reported
Not reported
Phase 2 (Safety Management Study): Cohort 5
18
Not reported
Not reported
Not reported
Not reported
Phase 2 (Safety Management Study): Cohort 6
21
Not reported
Not reported
Not reported
Not reported
Slight problem
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Phase 2 (Safety Management Study): Cohort 3
16
Not reported
Not reported
Not reported
Not reported
Phase 2 (Safety Management Study): Cohort 4
13
Not reported
Not reported
Not reported
Not reported
Phase 2 (Safety Management Study): Cohort 5
17
Not reported
Not reported
Not reported
Not reported
Phase 2 (Safety Management Study): Cohort 6
9
Not reported
Not reported
Not reported
Not reported
Moderate problem
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Phase 2 (Safety Management Study): Cohort 3
3
Not reported
Not reported
Not reported
Not reported
Phase 2 (Safety Management Study): Cohort 4
3
Not reported
Not reported
Not reported
Not reported
Phase 2 (Safety Management Study): Cohort 5
10
Not reported
Not reported
Not reported
Not reported
Phase 2 (Safety Management Study): Cohort 6
3
Not reported
Not reported
Not reported
Not reported
Severe problem
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Phase 2 (Safety Management Study): Cohort 3
1
Not reported
Not reported
Not reported
Not reported
Phase 2 (Safety Management Study): Cohort 4
0
Not reported
Not reported
Not reported
Not reported
Phase 2 (Safety Management Study): Cohort 5
1
Not reported
Not reported
Not reported
Not reported
Phase 2 (Safety Management Study): Cohort 6
1
Not reported
Not reported
Not reported
Not reported
Unable to perform
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Phase 2 (Safety Management Study): Cohort 3
2
Not reported
Not reported
Not reported
Not reported
Phase 2 (Safety Management Study): Cohort 4
0
Not reported
Not reported
Not reported
Not reported
Phase 2 (Safety Management Study): Cohort 5
1
Not reported
Not reported
Not reported
Not reported
Phase 2 (Safety Management Study): Cohort 6
0
Not reported
Not reported
Not reported
Not reported
Week 4: Anxiety/Depression
Analysis denominator · Participants
Group
Source count
Phase 2 (Safety Management Study): Cohort 3
32
Phase 2 (Safety Management Study): Cohort 4
37
Phase 2 (Safety Management Study): Cohort 5
38
Phase 2 (Safety Management Study): Cohort 6
29
No problem
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Phase 2 (Safety Management Study): Cohort 3
9
Not reported
Not reported
Not reported
Not reported
Phase 2 (Safety Management Study): Cohort 4
25
Not reported
Not reported
Not reported
Not reported
Phase 2 (Safety Management Study): Cohort 5
21
Not reported
Not reported
Not reported
Not reported
Phase 2 (Safety Management Study): Cohort 6
23
Not reported
Not reported
Not reported
Not reported
Slight problem
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Phase 2 (Safety Management Study): Cohort 3
15
Not reported
Not reported
Not reported
Not reported
Phase 2 (Safety Management Study): Cohort 4
8
Not reported
Not reported
Not reported
Not reported
Phase 2 (Safety Management Study): Cohort 5
12
Not reported
Not reported
Not reported
Not reported
Phase 2 (Safety Management Study): Cohort 6
3
Not reported
Not reported
Not reported
Not reported
Moderate problem
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Phase 2 (Safety Management Study): Cohort 3
7
Not reported
Not reported
Not reported
Not reported
Phase 2 (Safety Management Study): Cohort 4
3
Not reported
Not reported
Not reported
Not reported
Phase 2 (Safety Management Study): Cohort 5
5
Not reported
Not reported
Not reported
Not reported
Phase 2 (Safety Management Study): Cohort 6
3
Not reported
Not reported
Not reported
Not reported
Severe problem
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Phase 2 (Safety Management Study): Cohort 3
1
Not reported
Not reported
Not reported
Not reported
Phase 2 (Safety Management Study): Cohort 4
1
Not reported
Not reported
Not reported
Not reported
Phase 2 (Safety Management Study): Cohort 5
0
Not reported
Not reported
Not reported
Not reported
Phase 2 (Safety Management Study): Cohort 6
0
Not reported
Not reported
Not reported
Not reported
Unable to perform
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Phase 2 (Safety Management Study): Cohort 3
0
Not reported
Not reported
Not reported
Not reported
Phase 2 (Safety Management Study): Cohort 4
0
Not reported
Not reported
Not reported
Not reported
Phase 2 (Safety Management Study): Cohort 5
0
Not reported
Not reported
Not reported
Not reported
Phase 2 (Safety Management Study): Cohort 6
0
Not reported
Not reported
Not reported
Not reported
Month 3: Anxiety/Depression
Analysis denominator · Participants
Group
Source count
Phase 2 (Safety Management Study): Cohort 3
23
Phase 2 (Safety Management Study): Cohort 4
31
Phase 2 (Safety Management Study): Cohort 5
33
Phase 2 (Safety Management Study): Cohort 6
29
No problem
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Phase 2 (Safety Management Study): Cohort 3
11
Not reported
Not reported
Not reported
Not reported
Phase 2 (Safety Management Study): Cohort 4
19
Not reported
Not reported
Not reported
Not reported
Phase 2 (Safety Management Study): Cohort 5
16
Not reported
Not reported
Not reported
Not reported
Phase 2 (Safety Management Study): Cohort 6
19
Not reported
Not reported
Not reported
Not reported
Slight problem
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Phase 2 (Safety Management Study): Cohort 3
5
Not reported
Not reported
Not reported
Not reported
Phase 2 (Safety Management Study): Cohort 4
8
Not reported
Not reported
Not reported
Not reported
Phase 2 (Safety Management Study): Cohort 5
12
Not reported
Not reported
Not reported
Not reported
Phase 2 (Safety Management Study): Cohort 6
7
Not reported
Not reported
Not reported
Not reported
Moderate problem
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Phase 2 (Safety Management Study): Cohort 3
6
Not reported
Not reported
Not reported
Not reported
Phase 2 (Safety Management Study): Cohort 4
4
Not reported
Not reported
Not reported
Not reported
Phase 2 (Safety Management Study): Cohort 5
4
Not reported
Not reported
Not reported
Not reported
Phase 2 (Safety Management Study): Cohort 6
2
Not reported
Not reported
Not reported
Not reported
Severe problem
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Phase 2 (Safety Management Study): Cohort 3
1
Not reported
Not reported
Not reported
Not reported
Phase 2 (Safety Management Study): Cohort 4
0
Not reported
Not reported
Not reported
Not reported
Phase 2 (Safety Management Study): Cohort 5
1
Not reported
Not reported
Not reported
Not reported
Phase 2 (Safety Management Study): Cohort 6
1
Not reported
Not reported
Not reported
Not reported
Unable to perform
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Phase 2 (Safety Management Study): Cohort 3
0
Not reported
Not reported
Not reported
Not reported
Phase 2 (Safety Management Study): Cohort 4
0
Not reported
Not reported
Not reported
Not reported
Phase 2 (Safety Management Study): Cohort 5
0
Not reported
Not reported
Not reported
Not reported
Phase 2 (Safety Management Study): Cohort 6
0
Not reported
Not reported
Not reported
Not reported
Month 6: Anxiety/Depression
Analysis denominator · Participants
Group
Source count
Phase 2 (Safety Management Study): Cohort 3
18
Phase 2 (Safety Management Study): Cohort 4
25
Phase 2 (Safety Management Study): Cohort 5
17
Phase 2 (Safety Management Study): Cohort 6
26
No problem
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Phase 2 (Safety Management Study): Cohort 3
9
Not reported
Not reported
Not reported
Not reported
Phase 2 (Safety Management Study): Cohort 4
14
Not reported
Not reported
Not reported
Not reported
Phase 2 (Safety Management Study): Cohort 5
7
Not reported
Not reported
Not reported
Not reported
Phase 2 (Safety Management Study): Cohort 6
18
Not reported
Not reported
Not reported
Not reported
Slight problem
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Phase 2 (Safety Management Study): Cohort 3
5
Not reported
Not reported
Not reported
Not reported
Phase 2 (Safety Management Study): Cohort 4
10
Not reported
Not reported
Not reported
Not reported
Phase 2 (Safety Management Study): Cohort 5
8
Not reported
Not reported
Not reported
Not reported
Phase 2 (Safety Management Study): Cohort 6
5
Not reported
Not reported
Not reported
Not reported
Moderate problem
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Phase 2 (Safety Management Study): Cohort 3
3
Not reported
Not reported
Not reported
Not reported
Phase 2 (Safety Management Study): Cohort 4
0
Not reported
Not reported
Not reported
Not reported
Phase 2 (Safety Management Study): Cohort 5
1
Not reported
Not reported
Not reported
Not reported
Phase 2 (Safety Management Study): Cohort 6
3
Not reported
Not reported
Not reported
Not reported
Severe problem
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Phase 2 (Safety Management Study): Cohort 3
0
Not reported
Not reported
Not reported
Not reported
Phase 2 (Safety Management Study): Cohort 4
1
Not reported
Not reported
Not reported
Not reported
Phase 2 (Safety Management Study): Cohort 5
1
Not reported
Not reported
Not reported
Not reported
Phase 2 (Safety Management Study): Cohort 6
0
Not reported
Not reported
Not reported
Not reported
Unable to perform
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Phase 2 (Safety Management Study): Cohort 3
1
Not reported
Not reported
Not reported
Not reported
Phase 2 (Safety Management Study): Cohort 4
0
Not reported
Not reported
Not reported
Not reported
Phase 2 (Safety Management Study): Cohort 5
0
Not reported
Not reported
Not reported
Not reported
Phase 2 (Safety Management Study): Cohort 6
0
Not reported
Not reported
Not reported
Not reported
Complete source fields
calculate Pct
false
classes
categories
measurements
group Id
OG000
value
30
group Id
OG001
value
25
group Id
OG002
value
33
group Id
OG003
value
26
title
No problem
measurements
group Id
OG000
value
7
group Id
OG001
value
9
group Id
OG002
value
5
group Id
OG003
value
4
title
Slight problem
measurements
group Id
OG000
value
1
group Id
OG001
value
5
group Id
OG002
value
7
group Id
OG003
value
3
title
Moderate problem
measurements
group Id
OG000
value
0
group Id
OG001
value
0
group Id
OG002
value
1
group Id
OG003
value
1
title
Severe problem
measurements
group Id
OG000
value
0
group Id
OG001
value
0
group Id
OG002
value
1
group Id
OG003
value
0
title
Unable to perform
denoms
counts
group Id
OG000
value
38
group Id
OG001
value
39
group Id
OG002
value
47
group Id
OG003
value
34
units
Participants
title
Baseline: Mobility
categories
measurements
group Id
OG000
value
16
group Id
OG001
value
21
group Id
OG002
value
23
group Id
OG003
value
20
title
No problem
measurements
group Id
OG000
value
11
group Id
OG001
value
7
group Id
OG002
value
9
group Id
OG003
value
5
title
Slight problem
measurements
group Id
OG000
value
4
group Id
OG001
value
5
group Id
OG002
value
4
group Id
OG003
value
4
title
Moderate problem
measurements
group Id
OG000
value
0
group Id
OG001
value
3
group Id
OG002
value
1
group Id
OG003
value
0
title
Severe problem
measurements
group Id
OG000
value
1
group Id
OG001
value
1
group Id
OG002
value
1
group Id
OG003
value
0
title
Unable to perform
denoms
counts
group Id
OG000
value
32
group Id
OG001
value
37
group Id
OG002
value
38
group Id
OG003
value
29
units
Participants
title
Week 4: Mobility
categories
measurements
group Id
OG000
value
14
group Id
OG001
value
20
group Id
OG002
value
21
group Id
OG003
value
22
title
No problem
measurements
group Id
OG000
value
6
group Id
OG001
value
8
group Id
OG002
value
6
group Id
OG003
value
3
title
Slight problem
measurements
group Id
OG000
value
2
group Id
OG001
value
2
group Id
OG002
value
6
group Id
OG003
value
3
title
Moderate problem
measurements
group Id
OG000
value
1
group Id
OG001
value
1
group Id
OG002
value
0
group Id
OG003
value
1
title
Severe problem
measurements
group Id
OG000
value
0
group Id
OG001
value
0
group Id
OG002
value
0
group Id
OG003
value
0
title
Unable to perform
denoms
counts
group Id
OG000
value
23
group Id
OG001
value
31
group Id
OG002
value
33
group Id
OG003
value
29
units
Participants
title
Month 3: Mobility
categories
measurements
group Id
OG000
value
10
group Id
OG001
value
19
group Id
OG002
value
11
group Id
OG003
value
15
title
No problem
measurements
group Id
OG000
value
6
group Id
OG001
value
4
group Id
OG002
value
2
group Id
OG003
value
8
title
Slight problem
measurements
group Id
OG000
value
2
group Id
OG001
value
2
group Id
OG002
value
4
group Id
OG003
value
3
title
Moderate problem
measurements
group Id
OG000
value
0
group Id
OG001
value
0
group Id
OG002
value
0
group Id
OG003
value
1
title
Severe problem
measurements
group Id
OG000
value
0
group Id
OG001
value
0
group Id
OG002
value
0
group Id
OG003
value
0
title
Unable to perform
denoms
counts
group Id
OG000
value
18
group Id
OG001
value
25
group Id
OG002
value
17
group Id
OG003
value
27
units
Participants
title
Month 6: Mobility
categories
measurements
group Id
OG000
value
37
group Id
OG001
value
38
group Id
OG002
value
44
group Id
OG003
value
32
title
No problem
measurements
group Id
OG000
value
1
group Id
OG001
value
1
group Id
OG002
value
3
group Id
OG003
value
1
title
Slight problem
measurements
group Id
OG000
value
0
group Id
OG001
value
0
group Id
OG002
value
0
group Id
OG003
value
1
title
Moderate problem
measurements
group Id
OG000
value
0
group Id
OG001
value
0
group Id
OG002
value
0
group Id
OG003
value
0
title
Severe problem
measurements
group Id
OG000
value
0
group Id
OG001
value
0
group Id
OG002
value
0
group Id
OG003
value
0
title
Unable to perform
denoms
counts
group Id
OG000
value
38
group Id
OG001
value
39
group Id
OG002
value
47
group Id
OG003
value
34
units
Participants
title
Baseline: Self-care
categories
measurements
group Id
OG000
value
25
group Id
OG001
value
33
group Id
OG002
value
31
group Id
OG003
value
24
title
No problem
measurements
group Id
OG000
value
5
group Id
OG001
value
3
group Id
OG002
value
6
group Id
OG003
value
3
title
Slight problem
measurements
group Id
OG000
value
1
group Id
OG001
value
0
group Id
OG002
value
1
group Id
OG003
value
1
title
Moderate problem
measurements
group Id
OG000
value
0
group Id
OG001
value
1
group Id
OG002
value
0
group Id
OG003
value
1
title
Severe problem
measurements
group Id
OG000
value
1
group Id
OG001
value
0
group Id
OG002
value
0
group Id
OG003
value
0
title
Unable to perform
denoms
counts
group Id
OG000
value
32
group Id
OG001
value
37
group Id
OG002
value
38
group Id
OG003
value
29
units
Participants
title
Week 4: Self-care
categories
measurements
group Id
OG000
value
19
group Id
OG001
value
29
group Id
OG002
value
32
group Id
OG003
value
25
title
No problem
measurements
group Id
OG000
value
4
group Id
OG001
value
2
group Id
OG002
value
1
group Id
OG003
value
4
title
Slight problem
measurements
group Id
OG000
value
0
group Id
OG001
value
0
group Id
OG002
value
0
group Id
OG003
value
0
title
Moderate problem
measurements
group Id
OG000
value
0
group Id
OG001
value
0
group Id
OG002
value
0
group Id
OG003
value
0
title
Severe problem
measurements
group Id
OG000
value
0
group Id
OG001
value
0
group Id
OG002
value
0
group Id
OG003
value
0
title
Unable to perform
denoms
counts
group Id
OG000
value
23
group Id
OG001
value
31
group Id
OG002
value
33
group Id
OG003
value
29
units
Participants
title
Month 3: Self-care
categories
measurements
group Id
OG000
value
17
group Id
OG001
value
25
group Id
OG002
value
16
group Id
OG003
value
20
title
No problem
measurements
group Id
OG000
value
1
group Id
OG001
value
0
group Id
OG002
value
1
group Id
OG003
value
7
title
Slight problem
measurements
group Id
OG000
value
0
group Id
OG001
value
0
group Id
OG002
value
0
group Id
OG003
value
0
title
Moderate problem
measurements
group Id
OG000
value
0
group Id
OG001
value
0
group Id
OG002
value
0
group Id
OG003
value
0
title
Severe problem
measurements
group Id
OG000
value
0
group Id
OG001
value
0
group Id
OG002
value
0
group Id
OG003
value
0
title
Unable to perform
denoms
counts
group Id
OG000
value
18
group Id
OG001
value
25
group Id
OG002
value
17
group Id
OG003
value
27
units
Participants
title
Month 6: Self-care
categories
measurements
group Id
OG000
value
22
group Id
OG001
value
22
group Id
OG002
value
24
group Id
OG003
value
16
title
No problem
measurements
group Id
OG000
value
10
group Id
OG001
value
6
group Id
OG002
value
13
group Id
OG003
value
14
title
Slight problem
measurements
group Id
OG000
value
4
group Id
OG001
value
8
group Id
OG002
value
8
group Id
OG003
value
2
title
Moderate problem
measurements
group Id
OG000
value
2
group Id
OG001
value
1
group Id
OG002
value
1
group Id
OG003
value
2
title
Severe problem
measurements
group Id
OG000
value
0
group Id
OG001
value
2
group Id
OG002
value
1
group Id
OG003
value
0
title
Unable to perform
denoms
counts
group Id
OG000
value
38
group Id
OG001
value
39
group Id
OG002
value
47
group Id
OG003
value
34
units
Participants
title
Baseline: Usual activities
categories
measurements
group Id
OG000
value
6
group Id
OG001
value
12
group Id
OG002
value
12
group Id
OG003
value
12
title
No problem
measurements
group Id
OG000
value
13
group Id
OG001
value
11
group Id
OG002
value
13
group Id
OG003
value
11
title
Slight problem
measurements
group Id
OG000
value
11
group Id
OG001
value
8
group Id
OG002
value
8
group Id
OG003
value
4
title
Moderate problem
measurements
group Id
OG000
value
0
group Id
OG001
value
3
group Id
OG002
value
2
group Id
OG003
value
1
title
Severe problem
measurements
group Id
OG000
value
2
group Id
OG001
value
3
group Id
OG002
value
2
group Id
OG003
value
1
title
Unable to perform
denoms
counts
group Id
OG000
value
32
group Id
OG001
value
37
group Id
OG002
value
37
group Id
OG003
value
29
units
Participants
title
Week 4: Usual activities
categories
measurements
group Id
OG000
value
8
group Id
OG001
value
16
group Id
OG002
value
19
group Id
OG003
value
12
title
No problem
measurements
group Id
OG000
value
9
group Id
OG001
value
9
group Id
OG002
value
10
group Id
OG003
value
14
title
Slight problem
measurements
group Id
OG000
value
5
group Id
OG001
value
5
group Id
OG002
value
2
group Id
OG003
value
2
title
Moderate problem
measurements
group Id
OG000
value
1
group Id
OG001
value
1
group Id
OG002
value
1
group Id
OG003
value
1
title
Severe problem
measurements
group Id
OG000
value
0
group Id
OG001
value
0
group Id
OG002
value
1
group Id
OG003
value
0
title
Unable to perform
denoms
counts
group Id
OG000
value
23
group Id
OG001
value
31
group Id
OG002
value
33
group Id
OG003
value
29
units
Participants
title
Month 3: Usual activities
categories
measurements
group Id
OG000
value
9
group Id
OG001
value
15
group Id
OG002
value
10
group Id
OG003
value
11
title
No problem
measurements
group Id
OG000
value
5
group Id
OG001
value
7
group Id
OG002
value
4
group Id
OG003
value
12
title
Slight problem
measurements
group Id
OG000
value
3
group Id
OG001
value
3
group Id
OG002
value
2
group Id
OG003
value
3
title
Moderate problem
measurements
group Id
OG000
value
1
group Id
OG001
value
0
group Id
OG002
value
1
group Id
OG003
value
0
title
Severe problem
measurements
group Id
OG000
value
0
group Id
OG001
value
0
group Id
OG002
value
0
group Id
OG003
value
1
title
Unable to perform
denoms
counts
group Id
OG000
value
18
group Id
OG001
value
25
group Id
OG002
value
17
group Id
OG003
value
27
units
Participants
title
Month 6: Usual activities
denoms
counts
group Id
OG000
value
38
group Id
OG001
value
39
group Id
OG002
value
47
group Id
OG003
value
34
units
Participants
description
EQ-5D is a self-reported questionnaire used for assessing the overall health status of a participant scoring 5 dimensions of health: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension was divided into 5 levels of severity: "No problem", "Slight problems", "Moderate problems", "Severe problems", and "Extreme problems (unable to perform)". EQ-5D health states, defined by the EQ-5D descriptive system, are converted into a single summary index by applying a formula that attaches values (also called QOL weights or QOL utilities) to each of the levels in each dimension. EQ-5D Summary Index values range from -0.11 (worst health state) to 1.00 (perfect health state).
groups
description
Participants with relapsed or refractory transplant ineligible DLBCL, PMBCL, or TFL received conditioning chemotherapy (fludarabine 30 mg/m\^2 IV over 30 minutes and cyclophosphamide 500 mg/m\^2 IV over 60 minutes) on Days -5, -4, and -3; followed by a single infusion of axicabtagene ciloleucel CAR transduced autologous T cells administered IV at a target dose of 2 x 10\^6 anti-CD19 CAR T cells/kg of BW on Day 0. Participants also received a prophylactic regimen of levetiracetam (750 mg orally or IV twice daily (BID) starting on Day 0) and tocilizumab (8 mg/kg IV over 1 hour (not to exceed 800 mg)) on Day 2).
id
OG000
title
Phase 2 (Safety Management Study): Cohort 3
description
Participants with r/r DLBCL, PMBCL ,TFL, or high-grade B-cell lymphoma (HGBCL) after 2 systemic lines of therapy received optional bridging therapy (dexamethasone 20mg to 40mg,either orally or IV daily for 1 to 4 days or 1g/m\^2 of high-dose methylprednisolone(HDMP) for 3 days with rituximab at 375mg/m\^2 weekly for 3 weeks or bendamustine 90 mg/m\^2 on Days 1 and 2 and rituximab 375mg/m\^2 on Day 1), conditioning chemotherapy (fludarabine 30mg/m\^2 IV and cyclophosphamide 500mg/m\^2 IV)on Days -5,-4, and -3; followed by single infusion of axicabtagene ciloleucel CAR transduced autologous T cells IV at a target dose of 2 x 10\^6 anti-CD19 CAR T cells/kg of BW. Participants also received a prophylactic regimen of levetiracetam (750 mg orally or IV twice daily (BID) starting on Day 0). Participants received tocilizumab (initiated on persistent Grade 1 CRS for over 24 hours) and dexamethasone (persistent Grade 1 CRS for over 72 hours and at onset of Grade 1 neurologic toxicity).
id
OG001
title
Phase 2 (Safety Management Study): Cohort 4
description
Participants with r/r DLBCL, PMBCL ,TFL, or HGBCL after 2 systemic lines of therapy received debulking therapy (R-CHOP:rituximab 375mg/m\^2 D1,doxorubicin 50mg/m\^2 D1,prednisone 100mg D1 to D5,cyclophosphamide 750mg/m\^2 D1,vincristine 1.4 mg/m\^2 D1 or R-ICE:rituximab 375mg/ m\^2 D1,ifosfamide 5g/m\^2 24h-CI D2,carboplatin AUC5 D2 maximum dose 800mg,etoposide 100 mg/m\^2/day D1 to D3 or R-GEMOX:rituximab 375mg/m\^2 D1,gemcitabine 1000mg/m\^2 D2,oxaliplatin 100mg/m\^2 D2 or R-GDP:rituximab 375mg/m\^2 D1 or D8,gemcitabine 1g/m\^2 D1 \& D8,dexamethasone 40mg D1 to D4,cisplatin 75mg/m\^2 D1(or carboplatin AUC5 D1) or radiotherapy:20 to 30 Gy), conditioning chemotherapy (fludarabine 30mg/m\^2 IV and cyclophosphamide 500mg/m\^2 IV)on Days -5,-4, and -3; followed by single infusion of axicabtagene ciloleucel at a target dose of 2 x 10\^6 anti-CD19 CAR T cells/kg of BW on Day 0. Participants also received a prophylactic regimen of levetiracetam (750 mg orally or IV BID starting on D0).D=Day.
id
OG002
title
Phase 2 (Safety Management Study): Cohort 5
description
Participants with r/r DLBCL, PMBCL ,TFL, or HGBCL after 2 systemic lines of therapy may have received bridging therapy (dexamethasone 20mg to 40mg, either orally or IV daily for 1 to 4 days or 1g/m\^2 of high-dose methylprednisolone(HDMP) for 3 days with rituximab at 375mg/m\^2 weekly for 3 weeks or bendamustine 90 mg/m\^2 on Days 1 and 2 and rituximab 375mg/m\^2 on Day 1), conditioning chemotherapy (fludarabine 30mg/m\^2 IV and cyclophosphamide 500mg/m\^2 IV)on Days -5,-4, and -3; followed by single infusion of axicabtagene ciloleucel CAR transduced autologous T cells IV at a target dose of 2 x 10\^6 anti-CD19 CAR T cells/kg of BW on Day 0. Participants also received a prophylactic regimen of levetiracetam (750 mg orally or IV twice daily (BID) starting on Day 0) and corticosteroids (dexamethasone, 10 mg once daily on Days 0, 1, and 2). Participants received tocilizumab (initiated on persistent Grade 1 CRS for over 24 hours) and dexamethasone (persistent Grade 1 CRS for over 72 hours and at onset of Grade 1 neurologic toxicity).
id
OG003
title
Phase 2 (Safety Management Study): Cohort 6
param Type
COUNT_OF_PARTICIPANTS
population Description
Participants in Safety Analysis Set with available data were analyzed.
reporting Status
POSTED
time Frame
Baseline, Week 4, Month 3, and Month 6
title
Phase 2 Safety Management Study: Number of Participants With the European Quality of Life Five Dimension Five Level Scale (EQ-5D) Score