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NCT02348216 · OUTCOME

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

GroupSource count
Phase 2 (Safety Management Study): Cohort 338
Phase 2 (Safety Management Study): Cohort 439
Phase 2 (Safety Management Study): Cohort 547
Phase 2 (Safety Management Study): Cohort 634

Reported measurements

Baseline: Mobility

Analysis denominator · Participants

GroupSource count
Phase 2 (Safety Management Study): Cohort 338
Phase 2 (Safety Management Study): Cohort 439
Phase 2 (Safety Management Study): Cohort 547
Phase 2 (Safety Management Study): Cohort 634

No problem

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Phase 2 (Safety Management Study): Cohort 330Not reportedNot reportedNot reportedNot reported
Phase 2 (Safety Management Study): Cohort 425Not reportedNot reportedNot reportedNot reported
Phase 2 (Safety Management Study): Cohort 533Not reportedNot reportedNot reportedNot reported
Phase 2 (Safety Management Study): Cohort 626Not reportedNot reportedNot reportedNot reported

Slight problem

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Phase 2 (Safety Management Study): Cohort 37Not reportedNot reportedNot reportedNot reported
Phase 2 (Safety Management Study): Cohort 49Not reportedNot reportedNot reportedNot reported
Phase 2 (Safety Management Study): Cohort 55Not reportedNot reportedNot reportedNot reported
Phase 2 (Safety Management Study): Cohort 64Not reportedNot reportedNot reportedNot reported

Moderate problem

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Phase 2 (Safety Management Study): Cohort 31Not reportedNot reportedNot reportedNot reported
Phase 2 (Safety Management Study): Cohort 45Not reportedNot reportedNot reportedNot reported
Phase 2 (Safety Management Study): Cohort 57Not reportedNot reportedNot reportedNot reported
Phase 2 (Safety Management Study): Cohort 63Not reportedNot reportedNot reportedNot reported

Severe problem

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Phase 2 (Safety Management Study): Cohort 30Not reportedNot reportedNot reportedNot reported
Phase 2 (Safety Management Study): Cohort 40Not reportedNot reportedNot reportedNot reported
Phase 2 (Safety Management Study): Cohort 51Not reportedNot reportedNot reportedNot reported
Phase 2 (Safety Management Study): Cohort 61Not reportedNot reportedNot reportedNot reported

Unable to perform

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Phase 2 (Safety Management Study): Cohort 30Not reportedNot reportedNot reportedNot reported
Phase 2 (Safety Management Study): Cohort 40Not reportedNot reportedNot reportedNot reported
Phase 2 (Safety Management Study): Cohort 51Not reportedNot reportedNot reportedNot reported
Phase 2 (Safety Management Study): Cohort 60Not reportedNot reportedNot reportedNot reported
Week 4: Mobility

Analysis denominator · Participants

GroupSource count
Phase 2 (Safety Management Study): Cohort 332
Phase 2 (Safety Management Study): Cohort 437
Phase 2 (Safety Management Study): Cohort 538
Phase 2 (Safety Management Study): Cohort 629

No problem

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Phase 2 (Safety Management Study): Cohort 316Not reportedNot reportedNot reportedNot reported
Phase 2 (Safety Management Study): Cohort 421Not reportedNot reportedNot reportedNot reported
Phase 2 (Safety Management Study): Cohort 523Not reportedNot reportedNot reportedNot reported
Phase 2 (Safety Management Study): Cohort 620Not reportedNot reportedNot reportedNot reported

Slight problem

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Phase 2 (Safety Management Study): Cohort 311Not reportedNot reportedNot reportedNot reported
Phase 2 (Safety Management Study): Cohort 47Not reportedNot reportedNot reportedNot reported
Phase 2 (Safety Management Study): Cohort 59Not reportedNot reportedNot reportedNot reported
Phase 2 (Safety Management Study): Cohort 65Not reportedNot reportedNot reportedNot reported

Moderate problem

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Phase 2 (Safety Management Study): Cohort 34Not reportedNot reportedNot reportedNot reported
Phase 2 (Safety Management Study): Cohort 45Not reportedNot reportedNot reportedNot reported
Phase 2 (Safety Management Study): Cohort 54Not reportedNot reportedNot reportedNot reported
Phase 2 (Safety Management Study): Cohort 64Not reportedNot reportedNot reportedNot reported

Severe problem

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Phase 2 (Safety Management Study): Cohort 30Not reportedNot reportedNot reportedNot reported
Phase 2 (Safety Management Study): Cohort 43Not reportedNot reportedNot reportedNot reported
Phase 2 (Safety Management Study): Cohort 51Not reportedNot reportedNot reportedNot reported
Phase 2 (Safety Management Study): Cohort 60Not reportedNot reportedNot reportedNot reported

Unable to perform

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Phase 2 (Safety Management Study): Cohort 31Not reportedNot reportedNot reportedNot reported
Phase 2 (Safety Management Study): Cohort 41Not reportedNot reportedNot reportedNot reported
Phase 2 (Safety Management Study): Cohort 51Not reportedNot reportedNot reportedNot reported
Phase 2 (Safety Management Study): Cohort 60Not reportedNot reportedNot reportedNot reported
Month 3: Mobility

Analysis denominator · Participants

GroupSource count
Phase 2 (Safety Management Study): Cohort 323
Phase 2 (Safety Management Study): Cohort 431
Phase 2 (Safety Management Study): Cohort 533
Phase 2 (Safety Management Study): Cohort 629

No problem

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Phase 2 (Safety Management Study): Cohort 314Not reportedNot reportedNot reportedNot reported
Phase 2 (Safety Management Study): Cohort 420Not reportedNot reportedNot reportedNot reported
Phase 2 (Safety Management Study): Cohort 521Not reportedNot reportedNot reportedNot reported
Phase 2 (Safety Management Study): Cohort 622Not reportedNot reportedNot reportedNot reported

Slight problem

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Phase 2 (Safety Management Study): Cohort 36Not reportedNot reportedNot reportedNot reported
Phase 2 (Safety Management Study): Cohort 48Not reportedNot reportedNot reportedNot reported
Phase 2 (Safety Management Study): Cohort 56Not reportedNot reportedNot reportedNot reported
Phase 2 (Safety Management Study): Cohort 63Not reportedNot reportedNot reportedNot reported

Moderate problem

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Phase 2 (Safety Management Study): Cohort 32Not reportedNot reportedNot reportedNot reported
Phase 2 (Safety Management Study): Cohort 42Not reportedNot reportedNot reportedNot reported
Phase 2 (Safety Management Study): Cohort 56Not reportedNot reportedNot reportedNot reported
Phase 2 (Safety Management Study): Cohort 63Not reportedNot reportedNot reportedNot reported

Severe problem

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Phase 2 (Safety Management Study): Cohort 31Not reportedNot reportedNot reportedNot reported
Phase 2 (Safety Management Study): Cohort 41Not reportedNot reportedNot reportedNot reported
Phase 2 (Safety Management Study): Cohort 50Not reportedNot reportedNot reportedNot reported
Phase 2 (Safety Management Study): Cohort 61Not reportedNot reportedNot reportedNot reported

Unable to perform

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Phase 2 (Safety Management Study): Cohort 30Not reportedNot reportedNot reportedNot reported
Phase 2 (Safety Management Study): Cohort 40Not reportedNot reportedNot reportedNot reported
Phase 2 (Safety Management Study): Cohort 50Not reportedNot reportedNot reportedNot reported
Phase 2 (Safety Management Study): Cohort 60Not reportedNot reportedNot reportedNot reported
Month 6: Mobility

Analysis denominator · Participants

GroupSource count
Phase 2 (Safety Management Study): Cohort 318
Phase 2 (Safety Management Study): Cohort 425
Phase 2 (Safety Management Study): Cohort 517
Phase 2 (Safety Management Study): Cohort 627

No problem

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Phase 2 (Safety Management Study): Cohort 310Not reportedNot reportedNot reportedNot reported
Phase 2 (Safety Management Study): Cohort 419Not reportedNot reportedNot reportedNot reported
Phase 2 (Safety Management Study): Cohort 511Not reportedNot reportedNot reportedNot reported
Phase 2 (Safety Management Study): Cohort 615Not reportedNot reportedNot reportedNot reported

Slight problem

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Phase 2 (Safety Management Study): Cohort 36Not reportedNot reportedNot reportedNot reported
Phase 2 (Safety Management Study): Cohort 44Not reportedNot reportedNot reportedNot reported
Phase 2 (Safety Management Study): Cohort 52Not reportedNot reportedNot reportedNot reported
Phase 2 (Safety Management Study): Cohort 68Not reportedNot reportedNot reportedNot reported

Moderate problem

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Phase 2 (Safety Management Study): Cohort 32Not reportedNot reportedNot reportedNot reported
Phase 2 (Safety Management Study): Cohort 42Not reportedNot reportedNot reportedNot reported
Phase 2 (Safety Management Study): Cohort 54Not reportedNot reportedNot reportedNot reported
Phase 2 (Safety Management Study): Cohort 63Not reportedNot reportedNot reportedNot reported

Severe problem

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Phase 2 (Safety Management Study): Cohort 30Not reportedNot reportedNot reportedNot reported
Phase 2 (Safety Management Study): Cohort 40Not reportedNot reportedNot reportedNot reported
Phase 2 (Safety Management Study): Cohort 50Not reportedNot reportedNot reportedNot reported
Phase 2 (Safety Management Study): Cohort 61Not reportedNot reportedNot reportedNot reported

Unable to perform

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Phase 2 (Safety Management Study): Cohort 30Not reportedNot reportedNot reportedNot reported
Phase 2 (Safety Management Study): Cohort 40Not reportedNot reportedNot reportedNot reported
Phase 2 (Safety Management Study): Cohort 50Not reportedNot reportedNot reportedNot reported
Phase 2 (Safety Management Study): Cohort 60Not reportedNot reportedNot reportedNot reported
Baseline: Self-care

Analysis denominator · Participants

GroupSource count
Phase 2 (Safety Management Study): Cohort 338
Phase 2 (Safety Management Study): Cohort 439
Phase 2 (Safety Management Study): Cohort 547
Phase 2 (Safety Management Study): Cohort 634

No problem

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Phase 2 (Safety Management Study): Cohort 337Not reportedNot reportedNot reportedNot reported
Phase 2 (Safety Management Study): Cohort 438Not reportedNot reportedNot reportedNot reported
Phase 2 (Safety Management Study): Cohort 544Not reportedNot reportedNot reportedNot reported
Phase 2 (Safety Management Study): Cohort 632Not reportedNot reportedNot reportedNot reported

Slight problem

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Phase 2 (Safety Management Study): Cohort 31Not reportedNot reportedNot reportedNot reported
Phase 2 (Safety Management Study): Cohort 41Not reportedNot reportedNot reportedNot reported
Phase 2 (Safety Management Study): Cohort 53Not reportedNot reportedNot reportedNot reported
Phase 2 (Safety Management Study): Cohort 61Not reportedNot reportedNot reportedNot reported

Moderate problem

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Phase 2 (Safety Management Study): Cohort 30Not reportedNot reportedNot reportedNot reported
Phase 2 (Safety Management Study): Cohort 40Not reportedNot reportedNot reportedNot reported
Phase 2 (Safety Management Study): Cohort 50Not reportedNot reportedNot reportedNot reported
Phase 2 (Safety Management Study): Cohort 61Not reportedNot reportedNot reportedNot reported

Severe problem

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Phase 2 (Safety Management Study): Cohort 30Not reportedNot reportedNot reportedNot reported
Phase 2 (Safety Management Study): Cohort 40Not reportedNot reportedNot reportedNot reported
Phase 2 (Safety Management Study): Cohort 50Not reportedNot reportedNot reportedNot reported
Phase 2 (Safety Management Study): Cohort 60Not reportedNot reportedNot reportedNot reported

Unable to perform

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Phase 2 (Safety Management Study): Cohort 30Not reportedNot reportedNot reportedNot reported
Phase 2 (Safety Management Study): Cohort 40Not reportedNot reportedNot reportedNot reported
Phase 2 (Safety Management Study): Cohort 50Not reportedNot reportedNot reportedNot reported
Phase 2 (Safety Management Study): Cohort 60Not reportedNot reportedNot reportedNot reported
Week 4: Self-care

Analysis denominator · Participants

GroupSource count
Phase 2 (Safety Management Study): Cohort 332
Phase 2 (Safety Management Study): Cohort 437
Phase 2 (Safety Management Study): Cohort 538
Phase 2 (Safety Management Study): Cohort 629

No problem

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Phase 2 (Safety Management Study): Cohort 325Not reportedNot reportedNot reportedNot reported
Phase 2 (Safety Management Study): Cohort 433Not reportedNot reportedNot reportedNot reported
Phase 2 (Safety Management Study): Cohort 531Not reportedNot reportedNot reportedNot reported
Phase 2 (Safety Management Study): Cohort 624Not reportedNot reportedNot reportedNot reported

Slight problem

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Phase 2 (Safety Management Study): Cohort 35Not reportedNot reportedNot reportedNot reported
Phase 2 (Safety Management Study): Cohort 43Not reportedNot reportedNot reportedNot reported
Phase 2 (Safety Management Study): Cohort 56Not reportedNot reportedNot reportedNot reported
Phase 2 (Safety Management Study): Cohort 63Not reportedNot reportedNot reportedNot reported

Moderate problem

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Phase 2 (Safety Management Study): Cohort 31Not reportedNot reportedNot reportedNot reported
Phase 2 (Safety Management Study): Cohort 40Not reportedNot reportedNot reportedNot reported
Phase 2 (Safety Management Study): Cohort 51Not reportedNot reportedNot reportedNot reported
Phase 2 (Safety Management Study): Cohort 61Not reportedNot reportedNot reportedNot reported

Severe problem

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Phase 2 (Safety Management Study): Cohort 30Not reportedNot reportedNot reportedNot reported
Phase 2 (Safety Management Study): Cohort 41Not reportedNot reportedNot reportedNot reported
Phase 2 (Safety Management Study): Cohort 50Not reportedNot reportedNot reportedNot reported
Phase 2 (Safety Management Study): Cohort 61Not reportedNot reportedNot reportedNot reported

Unable to perform

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Phase 2 (Safety Management Study): Cohort 31Not reportedNot reportedNot reportedNot reported
Phase 2 (Safety Management Study): Cohort 40Not reportedNot reportedNot reportedNot reported
Phase 2 (Safety Management Study): Cohort 50Not reportedNot reportedNot reportedNot reported
Phase 2 (Safety Management Study): Cohort 60Not reportedNot reportedNot reportedNot reported
Month 3: Self-care

Analysis denominator · Participants

GroupSource count
Phase 2 (Safety Management Study): Cohort 323
Phase 2 (Safety Management Study): Cohort 431
Phase 2 (Safety Management Study): Cohort 533
Phase 2 (Safety Management Study): Cohort 629

No problem

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Phase 2 (Safety Management Study): Cohort 319Not reportedNot reportedNot reportedNot reported
Phase 2 (Safety Management Study): Cohort 429Not reportedNot reportedNot reportedNot reported
Phase 2 (Safety Management Study): Cohort 532Not reportedNot reportedNot reportedNot reported
Phase 2 (Safety Management Study): Cohort 625Not reportedNot reportedNot reportedNot reported

Slight problem

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Phase 2 (Safety Management Study): Cohort 34Not reportedNot reportedNot reportedNot reported
Phase 2 (Safety Management Study): Cohort 42Not reportedNot reportedNot reportedNot reported
Phase 2 (Safety Management Study): Cohort 51Not reportedNot reportedNot reportedNot reported
Phase 2 (Safety Management Study): Cohort 64Not reportedNot reportedNot reportedNot reported

Moderate problem

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Phase 2 (Safety Management Study): Cohort 30Not reportedNot reportedNot reportedNot reported
Phase 2 (Safety Management Study): Cohort 40Not reportedNot reportedNot reportedNot reported
Phase 2 (Safety Management Study): Cohort 50Not reportedNot reportedNot reportedNot reported
Phase 2 (Safety Management Study): Cohort 60Not reportedNot reportedNot reportedNot reported

Severe problem

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Phase 2 (Safety Management Study): Cohort 30Not reportedNot reportedNot reportedNot reported
Phase 2 (Safety Management Study): Cohort 40Not reportedNot reportedNot reportedNot reported
Phase 2 (Safety Management Study): Cohort 50Not reportedNot reportedNot reportedNot reported
Phase 2 (Safety Management Study): Cohort 60Not reportedNot reportedNot reportedNot reported

Unable to perform

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Phase 2 (Safety Management Study): Cohort 30Not reportedNot reportedNot reportedNot reported
Phase 2 (Safety Management Study): Cohort 40Not reportedNot reportedNot reportedNot reported
Phase 2 (Safety Management Study): Cohort 50Not reportedNot reportedNot reportedNot reported
Phase 2 (Safety Management Study): Cohort 60Not reportedNot reportedNot reportedNot reported
Month 6: Self-care

Analysis denominator · Participants

GroupSource count
Phase 2 (Safety Management Study): Cohort 318
Phase 2 (Safety Management Study): Cohort 425
Phase 2 (Safety Management Study): Cohort 517
Phase 2 (Safety Management Study): Cohort 627

No problem

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Phase 2 (Safety Management Study): Cohort 317Not reportedNot reportedNot reportedNot reported
Phase 2 (Safety Management Study): Cohort 425Not reportedNot reportedNot reportedNot reported
Phase 2 (Safety Management Study): Cohort 516Not reportedNot reportedNot reportedNot reported
Phase 2 (Safety Management Study): Cohort 620Not reportedNot reportedNot reportedNot reported

Slight problem

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Phase 2 (Safety Management Study): Cohort 31Not reportedNot reportedNot reportedNot reported
Phase 2 (Safety Management Study): Cohort 40Not reportedNot reportedNot reportedNot reported
Phase 2 (Safety Management Study): Cohort 51Not reportedNot reportedNot reportedNot reported
Phase 2 (Safety Management Study): Cohort 67Not reportedNot reportedNot reportedNot reported

Moderate problem

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Phase 2 (Safety Management Study): Cohort 30Not reportedNot reportedNot reportedNot reported
Phase 2 (Safety Management Study): Cohort 40Not reportedNot reportedNot reportedNot reported
Phase 2 (Safety Management Study): Cohort 50Not reportedNot reportedNot reportedNot reported
Phase 2 (Safety Management Study): Cohort 60Not reportedNot reportedNot reportedNot reported

Severe problem

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Phase 2 (Safety Management Study): Cohort 30Not reportedNot reportedNot reportedNot reported
Phase 2 (Safety Management Study): Cohort 40Not reportedNot reportedNot reportedNot reported
Phase 2 (Safety Management Study): Cohort 50Not reportedNot reportedNot reportedNot reported
Phase 2 (Safety Management Study): Cohort 60Not reportedNot reportedNot reportedNot reported

Unable to perform

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Phase 2 (Safety Management Study): Cohort 30Not reportedNot reportedNot reportedNot reported
Phase 2 (Safety Management Study): Cohort 40Not reportedNot reportedNot reportedNot reported
Phase 2 (Safety Management Study): Cohort 50Not reportedNot reportedNot reportedNot reported
Phase 2 (Safety Management Study): Cohort 60Not reportedNot reportedNot reportedNot reported
Baseline: Usual activities

Analysis denominator · Participants

GroupSource count
Phase 2 (Safety Management Study): Cohort 338
Phase 2 (Safety Management Study): Cohort 439
Phase 2 (Safety Management Study): Cohort 547
Phase 2 (Safety Management Study): Cohort 634

No problem

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Phase 2 (Safety Management Study): Cohort 322Not reportedNot reportedNot reportedNot reported
Phase 2 (Safety Management Study): Cohort 422Not reportedNot reportedNot reportedNot reported
Phase 2 (Safety Management Study): Cohort 524Not reportedNot reportedNot reportedNot reported
Phase 2 (Safety Management Study): Cohort 616Not reportedNot reportedNot reportedNot reported

Slight problem

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Phase 2 (Safety Management Study): Cohort 310Not reportedNot reportedNot reportedNot reported
Phase 2 (Safety Management Study): Cohort 46Not reportedNot reportedNot reportedNot reported
Phase 2 (Safety Management Study): Cohort 513Not reportedNot reportedNot reportedNot reported
Phase 2 (Safety Management Study): Cohort 614Not reportedNot reportedNot reportedNot reported

Moderate problem

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Phase 2 (Safety Management Study): Cohort 34Not reportedNot reportedNot reportedNot reported
Phase 2 (Safety Management Study): Cohort 48Not reportedNot reportedNot reportedNot reported
Phase 2 (Safety Management Study): Cohort 58Not reportedNot reportedNot reportedNot reported
Phase 2 (Safety Management Study): Cohort 62Not reportedNot reportedNot reportedNot reported

Severe problem

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Phase 2 (Safety Management Study): Cohort 32Not reportedNot reportedNot reportedNot reported
Phase 2 (Safety Management Study): Cohort 41Not reportedNot reportedNot reportedNot reported
Phase 2 (Safety Management Study): Cohort 51Not reportedNot reportedNot reportedNot reported
Phase 2 (Safety Management Study): Cohort 62Not reportedNot reportedNot reportedNot reported

Unable to perform

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Phase 2 (Safety Management Study): Cohort 30Not reportedNot reportedNot reportedNot reported
Phase 2 (Safety Management Study): Cohort 42Not reportedNot reportedNot reportedNot reported
Phase 2 (Safety Management Study): Cohort 51Not reportedNot reportedNot reportedNot reported
Phase 2 (Safety Management Study): Cohort 60Not reportedNot reportedNot reportedNot reported
Week 4: Usual activities

Analysis denominator · Participants

GroupSource count
Phase 2 (Safety Management Study): Cohort 332
Phase 2 (Safety Management Study): Cohort 437
Phase 2 (Safety Management Study): Cohort 537
Phase 2 (Safety Management Study): Cohort 629

No problem

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Phase 2 (Safety Management Study): Cohort 36Not reportedNot reportedNot reportedNot reported
Phase 2 (Safety Management Study): Cohort 412Not reportedNot reportedNot reportedNot reported
Phase 2 (Safety Management Study): Cohort 512Not reportedNot reportedNot reportedNot reported
Phase 2 (Safety Management Study): Cohort 612Not reportedNot reportedNot reportedNot reported

Slight problem

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Phase 2 (Safety Management Study): Cohort 313Not reportedNot reportedNot reportedNot reported
Phase 2 (Safety Management Study): Cohort 411Not reportedNot reportedNot reportedNot reported
Phase 2 (Safety Management Study): Cohort 513Not reportedNot reportedNot reportedNot reported
Phase 2 (Safety Management Study): Cohort 611Not reportedNot reportedNot reportedNot reported

Moderate problem

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Phase 2 (Safety Management Study): Cohort 311Not reportedNot reportedNot reportedNot reported
Phase 2 (Safety Management Study): Cohort 48Not reportedNot reportedNot reportedNot reported
Phase 2 (Safety Management Study): Cohort 58Not reportedNot reportedNot reportedNot reported
Phase 2 (Safety Management Study): Cohort 64Not reportedNot reportedNot reportedNot reported

Severe problem

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Phase 2 (Safety Management Study): Cohort 30Not reportedNot reportedNot reportedNot reported
Phase 2 (Safety Management Study): Cohort 43Not reportedNot reportedNot reportedNot reported
Phase 2 (Safety Management Study): Cohort 52Not reportedNot reportedNot reportedNot reported
Phase 2 (Safety Management Study): Cohort 61Not reportedNot reportedNot reportedNot reported

Unable to perform

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Phase 2 (Safety Management Study): Cohort 32Not reportedNot reportedNot reportedNot reported
Phase 2 (Safety Management Study): Cohort 43Not reportedNot reportedNot reportedNot reported
Phase 2 (Safety Management Study): Cohort 52Not reportedNot reportedNot reportedNot reported
Phase 2 (Safety Management Study): Cohort 61Not reportedNot reportedNot reportedNot reported
Month 3: Usual activities

Analysis denominator · Participants

GroupSource count
Phase 2 (Safety Management Study): Cohort 323
Phase 2 (Safety Management Study): Cohort 431
Phase 2 (Safety Management Study): Cohort 533
Phase 2 (Safety Management Study): Cohort 629

No problem

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Phase 2 (Safety Management Study): Cohort 38Not reportedNot reportedNot reportedNot reported
Phase 2 (Safety Management Study): Cohort 416Not reportedNot reportedNot reportedNot reported
Phase 2 (Safety Management Study): Cohort 519Not reportedNot reportedNot reportedNot reported
Phase 2 (Safety Management Study): Cohort 612Not reportedNot reportedNot reportedNot reported

Slight problem

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Phase 2 (Safety Management Study): Cohort 39Not reportedNot reportedNot reportedNot reported
Phase 2 (Safety Management Study): Cohort 49Not reportedNot reportedNot reportedNot reported
Phase 2 (Safety Management Study): Cohort 510Not reportedNot reportedNot reportedNot reported
Phase 2 (Safety Management Study): Cohort 614Not reportedNot reportedNot reportedNot reported

Moderate problem

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Phase 2 (Safety Management Study): Cohort 35Not reportedNot reportedNot reportedNot reported
Phase 2 (Safety Management Study): Cohort 45Not reportedNot reportedNot reportedNot reported
Phase 2 (Safety Management Study): Cohort 52Not reportedNot reportedNot reportedNot reported
Phase 2 (Safety Management Study): Cohort 62Not reportedNot reportedNot reportedNot reported

Severe problem

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Phase 2 (Safety Management Study): Cohort 31Not reportedNot reportedNot reportedNot reported
Phase 2 (Safety Management Study): Cohort 41Not reportedNot reportedNot reportedNot reported
Phase 2 (Safety Management Study): Cohort 51Not reportedNot reportedNot reportedNot reported
Phase 2 (Safety Management Study): Cohort 61Not reportedNot reportedNot reportedNot reported

Unable to perform

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Phase 2 (Safety Management Study): Cohort 30Not reportedNot reportedNot reportedNot reported
Phase 2 (Safety Management Study): Cohort 40Not reportedNot reportedNot reportedNot reported
Phase 2 (Safety Management Study): Cohort 51Not reportedNot reportedNot reportedNot reported
Phase 2 (Safety Management Study): Cohort 60Not reportedNot reportedNot reportedNot reported
Month 6: Usual activities

Analysis denominator · Participants

GroupSource count
Phase 2 (Safety Management Study): Cohort 318
Phase 2 (Safety Management Study): Cohort 425
Phase 2 (Safety Management Study): Cohort 517
Phase 2 (Safety Management Study): Cohort 627

No problem

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Phase 2 (Safety Management Study): Cohort 39Not reportedNot reportedNot reportedNot reported
Phase 2 (Safety Management Study): Cohort 415Not reportedNot reportedNot reportedNot reported
Phase 2 (Safety Management Study): Cohort 510Not reportedNot reportedNot reportedNot reported
Phase 2 (Safety Management Study): Cohort 611Not reportedNot reportedNot reportedNot reported

Slight problem

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Phase 2 (Safety Management Study): Cohort 35Not reportedNot reportedNot reportedNot reported
Phase 2 (Safety Management Study): Cohort 47Not reportedNot reportedNot reportedNot reported
Phase 2 (Safety Management Study): Cohort 54Not reportedNot reportedNot reportedNot reported
Phase 2 (Safety Management Study): Cohort 612Not reportedNot reportedNot reportedNot reported

Moderate problem

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Phase 2 (Safety Management Study): Cohort 33Not reportedNot reportedNot reportedNot reported
Phase 2 (Safety Management Study): Cohort 43Not reportedNot reportedNot reportedNot reported
Phase 2 (Safety Management Study): Cohort 52Not reportedNot reportedNot reportedNot reported
Phase 2 (Safety Management Study): Cohort 63Not reportedNot reportedNot reportedNot reported

Severe problem

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Phase 2 (Safety Management Study): Cohort 31Not reportedNot reportedNot reportedNot reported
Phase 2 (Safety Management Study): Cohort 40Not reportedNot reportedNot reportedNot reported
Phase 2 (Safety Management Study): Cohort 51Not reportedNot reportedNot reportedNot reported
Phase 2 (Safety Management Study): Cohort 60Not reportedNot reportedNot reportedNot reported

Unable to perform

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Phase 2 (Safety Management Study): Cohort 30Not reportedNot reportedNot reportedNot reported
Phase 2 (Safety Management Study): Cohort 40Not reportedNot reportedNot reportedNot reported
Phase 2 (Safety Management Study): Cohort 50Not reportedNot reportedNot reportedNot reported
Phase 2 (Safety Management Study): Cohort 61Not reportedNot reportedNot reportedNot reported
Baseline: Pain/Discomfort

Analysis denominator · Participants

GroupSource count
Phase 2 (Safety Management Study): Cohort 338
Phase 2 (Safety Management Study): Cohort 439
Phase 2 (Safety Management Study): Cohort 547
Phase 2 (Safety Management Study): Cohort 634

No problem

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Phase 2 (Safety Management Study): Cohort 318Not reportedNot reportedNot reportedNot reported
Phase 2 (Safety Management Study): Cohort 417Not reportedNot reportedNot reportedNot reported
Phase 2 (Safety Management Study): Cohort 516Not reportedNot reportedNot reportedNot reported
Phase 2 (Safety Management Study): Cohort 615Not reportedNot reportedNot reportedNot reported

Slight problem

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Phase 2 (Safety Management Study): Cohort 39Not reportedNot reportedNot reportedNot reported
Phase 2 (Safety Management Study): Cohort 417Not reportedNot reportedNot reportedNot reported
Phase 2 (Safety Management Study): Cohort 518Not reportedNot reportedNot reportedNot reported
Phase 2 (Safety Management Study): Cohort 614Not reportedNot reportedNot reportedNot reported

Moderate problem

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Phase 2 (Safety Management Study): Cohort 38Not reportedNot reportedNot reportedNot reported
Phase 2 (Safety Management Study): Cohort 45Not reportedNot reportedNot reportedNot reported
Phase 2 (Safety Management Study): Cohort 57Not reportedNot reportedNot reportedNot reported
Phase 2 (Safety Management Study): Cohort 64Not reportedNot reportedNot reportedNot reported

Severe problem

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Phase 2 (Safety Management Study): Cohort 31Not reportedNot reportedNot reportedNot reported
Phase 2 (Safety Management Study): Cohort 40Not reportedNot reportedNot reportedNot reported
Phase 2 (Safety Management Study): Cohort 55Not reportedNot reportedNot reportedNot reported
Phase 2 (Safety Management Study): Cohort 61Not reportedNot reportedNot reportedNot reported

Unable to perform

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Phase 2 (Safety Management Study): Cohort 32Not reportedNot reportedNot reportedNot reported
Phase 2 (Safety Management Study): Cohort 40Not reportedNot reportedNot reportedNot reported
Phase 2 (Safety Management Study): Cohort 51Not reportedNot reportedNot reportedNot reported
Phase 2 (Safety Management Study): Cohort 60Not reportedNot reportedNot reportedNot reported
Week 4: Pain/Discomfort

Analysis denominator · Participants

GroupSource count
Phase 2 (Safety Management Study): Cohort 332
Phase 2 (Safety Management Study): Cohort 437
Phase 2 (Safety Management Study): Cohort 537
Phase 2 (Safety Management Study): Cohort 629

No problem

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Phase 2 (Safety Management Study): Cohort 312Not reportedNot reportedNot reportedNot reported
Phase 2 (Safety Management Study): Cohort 419Not reportedNot reportedNot reportedNot reported
Phase 2 (Safety Management Study): Cohort 520Not reportedNot reportedNot reportedNot reported
Phase 2 (Safety Management Study): Cohort 617Not reportedNot reportedNot reportedNot reported

Slight problem

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Phase 2 (Safety Management Study): Cohort 312Not reportedNot reportedNot reportedNot reported
Phase 2 (Safety Management Study): Cohort 413Not reportedNot reportedNot reportedNot reported
Phase 2 (Safety Management Study): Cohort 510Not reportedNot reportedNot reportedNot reported
Phase 2 (Safety Management Study): Cohort 69Not reportedNot reportedNot reportedNot reported

Moderate problem

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Phase 2 (Safety Management Study): Cohort 37Not reportedNot reportedNot reportedNot reported
Phase 2 (Safety Management Study): Cohort 42Not reportedNot reportedNot reportedNot reported
Phase 2 (Safety Management Study): Cohort 55Not reportedNot reportedNot reportedNot reported
Phase 2 (Safety Management Study): Cohort 63Not reportedNot reportedNot reportedNot reported

Severe problem

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Phase 2 (Safety Management Study): Cohort 31Not reportedNot reportedNot reportedNot reported
Phase 2 (Safety Management Study): Cohort 43Not reportedNot reportedNot reportedNot reported
Phase 2 (Safety Management Study): Cohort 52Not reportedNot reportedNot reportedNot reported
Phase 2 (Safety Management Study): Cohort 60Not reportedNot reportedNot reportedNot reported

Unable to perform

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Phase 2 (Safety Management Study): Cohort 30Not reportedNot reportedNot reportedNot reported
Phase 2 (Safety Management Study): Cohort 40Not reportedNot reportedNot reportedNot reported
Phase 2 (Safety Management Study): Cohort 50Not reportedNot reportedNot reportedNot reported
Phase 2 (Safety Management Study): Cohort 60Not reportedNot reportedNot reportedNot reported
Month 3: Pain/Discomfort

Analysis denominator · Participants

GroupSource count
Phase 2 (Safety Management Study): Cohort 323
Phase 2 (Safety Management Study): Cohort 431
Phase 2 (Safety Management Study): Cohort 533
Phase 2 (Safety Management Study): Cohort 629

No problem

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Phase 2 (Safety Management Study): Cohort 39Not reportedNot reportedNot reportedNot reported
Phase 2 (Safety Management Study): Cohort 410Not reportedNot reportedNot reportedNot reported
Phase 2 (Safety Management Study): Cohort 518Not reportedNot reportedNot reportedNot reported
Phase 2 (Safety Management Study): Cohort 616Not reportedNot reportedNot reportedNot reported

Slight problem

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Phase 2 (Safety Management Study): Cohort 35Not reportedNot reportedNot reportedNot reported
Phase 2 (Safety Management Study): Cohort 414Not reportedNot reportedNot reportedNot reported
Phase 2 (Safety Management Study): Cohort 59Not reportedNot reportedNot reportedNot reported
Phase 2 (Safety Management Study): Cohort 65Not reportedNot reportedNot reportedNot reported

Moderate problem

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Phase 2 (Safety Management Study): Cohort 39Not reportedNot reportedNot reportedNot reported
Phase 2 (Safety Management Study): Cohort 46Not reportedNot reportedNot reportedNot reported
Phase 2 (Safety Management Study): Cohort 56Not reportedNot reportedNot reportedNot reported
Phase 2 (Safety Management Study): Cohort 65Not reportedNot reportedNot reportedNot reported

Severe problem

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Phase 2 (Safety Management Study): Cohort 30Not reportedNot reportedNot reportedNot reported
Phase 2 (Safety Management Study): Cohort 41Not reportedNot reportedNot reportedNot reported
Phase 2 (Safety Management Study): Cohort 50Not reportedNot reportedNot reportedNot reported
Phase 2 (Safety Management Study): Cohort 63Not reportedNot reportedNot reportedNot reported

Unable to perform

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Phase 2 (Safety Management Study): Cohort 30Not reportedNot reportedNot reportedNot reported
Phase 2 (Safety Management Study): Cohort 40Not reportedNot reportedNot reportedNot reported
Phase 2 (Safety Management Study): Cohort 50Not reportedNot reportedNot reportedNot reported
Phase 2 (Safety Management Study): Cohort 60Not reportedNot reportedNot reportedNot reported
Month 6: Pain/Discomfort

Analysis denominator · Participants

GroupSource count
Phase 2 (Safety Management Study): Cohort 317
Phase 2 (Safety Management Study): Cohort 425
Phase 2 (Safety Management Study): Cohort 517
Phase 2 (Safety Management Study): Cohort 627

No problem

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Phase 2 (Safety Management Study): Cohort 38Not reportedNot reportedNot reportedNot reported
Phase 2 (Safety Management Study): Cohort 49Not reportedNot reportedNot reportedNot reported
Phase 2 (Safety Management Study): Cohort 56Not reportedNot reportedNot reportedNot reported
Phase 2 (Safety Management Study): Cohort 612Not reportedNot reportedNot reportedNot reported

Slight problem

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Phase 2 (Safety Management Study): Cohort 34Not reportedNot reportedNot reportedNot reported
Phase 2 (Safety Management Study): Cohort 414Not reportedNot reportedNot reportedNot reported
Phase 2 (Safety Management Study): Cohort 58Not reportedNot reportedNot reportedNot reported
Phase 2 (Safety Management Study): Cohort 68Not reportedNot reportedNot reportedNot reported

Moderate problem

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Phase 2 (Safety Management Study): Cohort 35Not reportedNot reportedNot reportedNot reported
Phase 2 (Safety Management Study): Cohort 41Not reportedNot reportedNot reportedNot reported
Phase 2 (Safety Management Study): Cohort 53Not reportedNot reportedNot reportedNot reported
Phase 2 (Safety Management Study): Cohort 64Not reportedNot reportedNot reportedNot reported

Severe problem

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Phase 2 (Safety Management Study): Cohort 30Not reportedNot reportedNot reportedNot reported
Phase 2 (Safety Management Study): Cohort 41Not reportedNot reportedNot reportedNot reported
Phase 2 (Safety Management Study): Cohort 50Not reportedNot reportedNot reportedNot reported
Phase 2 (Safety Management Study): Cohort 63Not reportedNot reportedNot reportedNot reported

Unable to perform

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Phase 2 (Safety Management Study): Cohort 30Not reportedNot reportedNot reportedNot reported
Phase 2 (Safety Management Study): Cohort 40Not reportedNot reportedNot reportedNot reported
Phase 2 (Safety Management Study): Cohort 50Not reportedNot reportedNot reportedNot reported
Phase 2 (Safety Management Study): Cohort 60Not reportedNot reportedNot reportedNot reported
Baseline: Anxiety/Depression

Analysis denominator · Participants

GroupSource count
Phase 2 (Safety Management Study): Cohort 338
Phase 2 (Safety Management Study): Cohort 439
Phase 2 (Safety Management Study): Cohort 547
Phase 2 (Safety Management Study): Cohort 634

No problem

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Phase 2 (Safety Management Study): Cohort 316Not reportedNot reportedNot reportedNot reported
Phase 2 (Safety Management Study): Cohort 423Not reportedNot reportedNot reportedNot reported
Phase 2 (Safety Management Study): Cohort 518Not reportedNot reportedNot reportedNot reported
Phase 2 (Safety Management Study): Cohort 621Not reportedNot reportedNot reportedNot reported

Slight problem

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Phase 2 (Safety Management Study): Cohort 316Not reportedNot reportedNot reportedNot reported
Phase 2 (Safety Management Study): Cohort 413Not reportedNot reportedNot reportedNot reported
Phase 2 (Safety Management Study): Cohort 517Not reportedNot reportedNot reportedNot reported
Phase 2 (Safety Management Study): Cohort 69Not reportedNot reportedNot reportedNot reported

Moderate problem

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Phase 2 (Safety Management Study): Cohort 33Not reportedNot reportedNot reportedNot reported
Phase 2 (Safety Management Study): Cohort 43Not reportedNot reportedNot reportedNot reported
Phase 2 (Safety Management Study): Cohort 510Not reportedNot reportedNot reportedNot reported
Phase 2 (Safety Management Study): Cohort 63Not reportedNot reportedNot reportedNot reported

Severe problem

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Phase 2 (Safety Management Study): Cohort 31Not reportedNot reportedNot reportedNot reported
Phase 2 (Safety Management Study): Cohort 40Not reportedNot reportedNot reportedNot reported
Phase 2 (Safety Management Study): Cohort 51Not reportedNot reportedNot reportedNot reported
Phase 2 (Safety Management Study): Cohort 61Not reportedNot reportedNot reportedNot reported

Unable to perform

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Phase 2 (Safety Management Study): Cohort 32Not reportedNot reportedNot reportedNot reported
Phase 2 (Safety Management Study): Cohort 40Not reportedNot reportedNot reportedNot reported
Phase 2 (Safety Management Study): Cohort 51Not reportedNot reportedNot reportedNot reported
Phase 2 (Safety Management Study): Cohort 60Not reportedNot reportedNot reportedNot reported
Week 4: Anxiety/Depression

Analysis denominator · Participants

GroupSource count
Phase 2 (Safety Management Study): Cohort 332
Phase 2 (Safety Management Study): Cohort 437
Phase 2 (Safety Management Study): Cohort 538
Phase 2 (Safety Management Study): Cohort 629

No problem

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Phase 2 (Safety Management Study): Cohort 39Not reportedNot reportedNot reportedNot reported
Phase 2 (Safety Management Study): Cohort 425Not reportedNot reportedNot reportedNot reported
Phase 2 (Safety Management Study): Cohort 521Not reportedNot reportedNot reportedNot reported
Phase 2 (Safety Management Study): Cohort 623Not reportedNot reportedNot reportedNot reported

Slight problem

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Phase 2 (Safety Management Study): Cohort 315Not reportedNot reportedNot reportedNot reported
Phase 2 (Safety Management Study): Cohort 48Not reportedNot reportedNot reportedNot reported
Phase 2 (Safety Management Study): Cohort 512Not reportedNot reportedNot reportedNot reported
Phase 2 (Safety Management Study): Cohort 63Not reportedNot reportedNot reportedNot reported

Moderate problem

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Phase 2 (Safety Management Study): Cohort 37Not reportedNot reportedNot reportedNot reported
Phase 2 (Safety Management Study): Cohort 43Not reportedNot reportedNot reportedNot reported
Phase 2 (Safety Management Study): Cohort 55Not reportedNot reportedNot reportedNot reported
Phase 2 (Safety Management Study): Cohort 63Not reportedNot reportedNot reportedNot reported

Severe problem

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Phase 2 (Safety Management Study): Cohort 31Not reportedNot reportedNot reportedNot reported
Phase 2 (Safety Management Study): Cohort 41Not reportedNot reportedNot reportedNot reported
Phase 2 (Safety Management Study): Cohort 50Not reportedNot reportedNot reportedNot reported
Phase 2 (Safety Management Study): Cohort 60Not reportedNot reportedNot reportedNot reported

Unable to perform

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Phase 2 (Safety Management Study): Cohort 30Not reportedNot reportedNot reportedNot reported
Phase 2 (Safety Management Study): Cohort 40Not reportedNot reportedNot reportedNot reported
Phase 2 (Safety Management Study): Cohort 50Not reportedNot reportedNot reportedNot reported
Phase 2 (Safety Management Study): Cohort 60Not reportedNot reportedNot reportedNot reported
Month 3: Anxiety/Depression

Analysis denominator · Participants

GroupSource count
Phase 2 (Safety Management Study): Cohort 323
Phase 2 (Safety Management Study): Cohort 431
Phase 2 (Safety Management Study): Cohort 533
Phase 2 (Safety Management Study): Cohort 629

No problem

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Phase 2 (Safety Management Study): Cohort 311Not reportedNot reportedNot reportedNot reported
Phase 2 (Safety Management Study): Cohort 419Not reportedNot reportedNot reportedNot reported
Phase 2 (Safety Management Study): Cohort 516Not reportedNot reportedNot reportedNot reported
Phase 2 (Safety Management Study): Cohort 619Not reportedNot reportedNot reportedNot reported

Slight problem

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Phase 2 (Safety Management Study): Cohort 35Not reportedNot reportedNot reportedNot reported
Phase 2 (Safety Management Study): Cohort 48Not reportedNot reportedNot reportedNot reported
Phase 2 (Safety Management Study): Cohort 512Not reportedNot reportedNot reportedNot reported
Phase 2 (Safety Management Study): Cohort 67Not reportedNot reportedNot reportedNot reported

Moderate problem

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Phase 2 (Safety Management Study): Cohort 36Not reportedNot reportedNot reportedNot reported
Phase 2 (Safety Management Study): Cohort 44Not reportedNot reportedNot reportedNot reported
Phase 2 (Safety Management Study): Cohort 54Not reportedNot reportedNot reportedNot reported
Phase 2 (Safety Management Study): Cohort 62Not reportedNot reportedNot reportedNot reported

Severe problem

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Phase 2 (Safety Management Study): Cohort 31Not reportedNot reportedNot reportedNot reported
Phase 2 (Safety Management Study): Cohort 40Not reportedNot reportedNot reportedNot reported
Phase 2 (Safety Management Study): Cohort 51Not reportedNot reportedNot reportedNot reported
Phase 2 (Safety Management Study): Cohort 61Not reportedNot reportedNot reportedNot reported

Unable to perform

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Phase 2 (Safety Management Study): Cohort 30Not reportedNot reportedNot reportedNot reported
Phase 2 (Safety Management Study): Cohort 40Not reportedNot reportedNot reportedNot reported
Phase 2 (Safety Management Study): Cohort 50Not reportedNot reportedNot reportedNot reported
Phase 2 (Safety Management Study): Cohort 60Not reportedNot reportedNot reportedNot reported
Month 6: Anxiety/Depression

Analysis denominator · Participants

GroupSource count
Phase 2 (Safety Management Study): Cohort 318
Phase 2 (Safety Management Study): Cohort 425
Phase 2 (Safety Management Study): Cohort 517
Phase 2 (Safety Management Study): Cohort 626

No problem

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Phase 2 (Safety Management Study): Cohort 39Not reportedNot reportedNot reportedNot reported
Phase 2 (Safety Management Study): Cohort 414Not reportedNot reportedNot reportedNot reported
Phase 2 (Safety Management Study): Cohort 57Not reportedNot reportedNot reportedNot reported
Phase 2 (Safety Management Study): Cohort 618Not reportedNot reportedNot reportedNot reported

Slight problem

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Phase 2 (Safety Management Study): Cohort 35Not reportedNot reportedNot reportedNot reported
Phase 2 (Safety Management Study): Cohort 410Not reportedNot reportedNot reportedNot reported
Phase 2 (Safety Management Study): Cohort 58Not reportedNot reportedNot reportedNot reported
Phase 2 (Safety Management Study): Cohort 65Not reportedNot reportedNot reportedNot reported

Moderate problem

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Phase 2 (Safety Management Study): Cohort 33Not reportedNot reportedNot reportedNot reported
Phase 2 (Safety Management Study): Cohort 40Not reportedNot reportedNot reportedNot reported
Phase 2 (Safety Management Study): Cohort 51Not reportedNot reportedNot reportedNot reported
Phase 2 (Safety Management Study): Cohort 63Not reportedNot reportedNot reportedNot reported

Severe problem

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Phase 2 (Safety Management Study): Cohort 30Not reportedNot reportedNot reportedNot reported
Phase 2 (Safety Management Study): Cohort 41Not reportedNot reportedNot reportedNot reported
Phase 2 (Safety Management Study): Cohort 51Not reportedNot reportedNot reportedNot reported
Phase 2 (Safety Management Study): Cohort 60Not reportedNot reportedNot reportedNot reported

Unable to perform

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Phase 2 (Safety Management Study): Cohort 31Not reportedNot reportedNot reportedNot reported
Phase 2 (Safety Management Study): Cohort 40Not reportedNot reportedNot reportedNot reported
Phase 2 (Safety Management Study): Cohort 50Not reportedNot reportedNot reportedNot reported
Phase 2 (Safety Management Study): Cohort 60Not reportedNot reportedNot reportedNot reported
Complete source fields
calculate Pct
false
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        30
      2. group Id
        OG001
        value
        25
      3. group Id
        OG002
        value
        33
      4. group Id
        OG003
        value
        26
      title
      No problem
    2. measurements
      1. group Id
        OG000
        value
        7
      2. group Id
        OG001
        value
        9
      3. group Id
        OG002
        value
        5
      4. group Id
        OG003
        value
        4
      title
      Slight problem
    3. measurements
      1. group Id
        OG000
        value
        1
      2. group Id
        OG001
        value
        5
      3. group Id
        OG002
        value
        7
      4. group Id
        OG003
        value
        3
      title
      Moderate problem
    4. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        1
      4. group Id
        OG003
        value
        1
      title
      Severe problem
    5. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        1
      4. group Id
        OG003
        value
        0
      title
      Unable to perform
    denoms
    1. counts
      1. group Id
        OG000
        value
        38
      2. group Id
        OG001
        value
        39
      3. group Id
        OG002
        value
        47
      4. group Id
        OG003
        value
        34
      units
      Participants
    title
    Baseline: Mobility
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        16
      2. group Id
        OG001
        value
        21
      3. group Id
        OG002
        value
        23
      4. group Id
        OG003
        value
        20
      title
      No problem
    2. measurements
      1. group Id
        OG000
        value
        11
      2. group Id
        OG001
        value
        7
      3. group Id
        OG002
        value
        9
      4. group Id
        OG003
        value
        5
      title
      Slight problem
    3. measurements
      1. group Id
        OG000
        value
        4
      2. group Id
        OG001
        value
        5
      3. group Id
        OG002
        value
        4
      4. group Id
        OG003
        value
        4
      title
      Moderate problem
    4. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        3
      3. group Id
        OG002
        value
        1
      4. group Id
        OG003
        value
        0
      title
      Severe problem
    5. measurements
      1. group Id
        OG000
        value
        1
      2. group Id
        OG001
        value
        1
      3. group Id
        OG002
        value
        1
      4. group Id
        OG003
        value
        0
      title
      Unable to perform
    denoms
    1. counts
      1. group Id
        OG000
        value
        32
      2. group Id
        OG001
        value
        37
      3. group Id
        OG002
        value
        38
      4. group Id
        OG003
        value
        29
      units
      Participants
    title
    Week 4: Mobility
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        14
      2. group Id
        OG001
        value
        20
      3. group Id
        OG002
        value
        21
      4. group Id
        OG003
        value
        22
      title
      No problem
    2. measurements
      1. group Id
        OG000
        value
        6
      2. group Id
        OG001
        value
        8
      3. group Id
        OG002
        value
        6
      4. group Id
        OG003
        value
        3
      title
      Slight problem
    3. measurements
      1. group Id
        OG000
        value
        2
      2. group Id
        OG001
        value
        2
      3. group Id
        OG002
        value
        6
      4. group Id
        OG003
        value
        3
      title
      Moderate problem
    4. measurements
      1. group Id
        OG000
        value
        1
      2. group Id
        OG001
        value
        1
      3. group Id
        OG002
        value
        0
      4. group Id
        OG003
        value
        1
      title
      Severe problem
    5. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        0
      4. group Id
        OG003
        value
        0
      title
      Unable to perform
    denoms
    1. counts
      1. group Id
        OG000
        value
        23
      2. group Id
        OG001
        value
        31
      3. group Id
        OG002
        value
        33
      4. group Id
        OG003
        value
        29
      units
      Participants
    title
    Month 3: Mobility
  4. categories
    1. measurements
      1. group Id
        OG000
        value
        10
      2. group Id
        OG001
        value
        19
      3. group Id
        OG002
        value
        11
      4. group Id
        OG003
        value
        15
      title
      No problem
    2. measurements
      1. group Id
        OG000
        value
        6
      2. group Id
        OG001
        value
        4
      3. group Id
        OG002
        value
        2
      4. group Id
        OG003
        value
        8
      title
      Slight problem
    3. measurements
      1. group Id
        OG000
        value
        2
      2. group Id
        OG001
        value
        2
      3. group Id
        OG002
        value
        4
      4. group Id
        OG003
        value
        3
      title
      Moderate problem
    4. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        0
      4. group Id
        OG003
        value
        1
      title
      Severe problem
    5. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        0
      4. group Id
        OG003
        value
        0
      title
      Unable to perform
    denoms
    1. counts
      1. group Id
        OG000
        value
        18
      2. group Id
        OG001
        value
        25
      3. group Id
        OG002
        value
        17
      4. group Id
        OG003
        value
        27
      units
      Participants
    title
    Month 6: Mobility
  5. categories
    1. measurements
      1. group Id
        OG000
        value
        37
      2. group Id
        OG001
        value
        38
      3. group Id
        OG002
        value
        44
      4. group Id
        OG003
        value
        32
      title
      No problem
    2. measurements
      1. group Id
        OG000
        value
        1
      2. group Id
        OG001
        value
        1
      3. group Id
        OG002
        value
        3
      4. group Id
        OG003
        value
        1
      title
      Slight problem
    3. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        0
      4. group Id
        OG003
        value
        1
      title
      Moderate problem
    4. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        0
      4. group Id
        OG003
        value
        0
      title
      Severe problem
    5. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        0
      4. group Id
        OG003
        value
        0
      title
      Unable to perform
    denoms
    1. counts
      1. group Id
        OG000
        value
        38
      2. group Id
        OG001
        value
        39
      3. group Id
        OG002
        value
        47
      4. group Id
        OG003
        value
        34
      units
      Participants
    title
    Baseline: Self-care
  6. categories
    1. measurements
      1. group Id
        OG000
        value
        25
      2. group Id
        OG001
        value
        33
      3. group Id
        OG002
        value
        31
      4. group Id
        OG003
        value
        24
      title
      No problem
    2. measurements
      1. group Id
        OG000
        value
        5
      2. group Id
        OG001
        value
        3
      3. group Id
        OG002
        value
        6
      4. group Id
        OG003
        value
        3
      title
      Slight problem
    3. measurements
      1. group Id
        OG000
        value
        1
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        1
      4. group Id
        OG003
        value
        1
      title
      Moderate problem
    4. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        1
      3. group Id
        OG002
        value
        0
      4. group Id
        OG003
        value
        1
      title
      Severe problem
    5. measurements
      1. group Id
        OG000
        value
        1
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        0
      4. group Id
        OG003
        value
        0
      title
      Unable to perform
    denoms
    1. counts
      1. group Id
        OG000
        value
        32
      2. group Id
        OG001
        value
        37
      3. group Id
        OG002
        value
        38
      4. group Id
        OG003
        value
        29
      units
      Participants
    title
    Week 4: Self-care
  7. categories
    1. measurements
      1. group Id
        OG000
        value
        19
      2. group Id
        OG001
        value
        29
      3. group Id
        OG002
        value
        32
      4. group Id
        OG003
        value
        25
      title
      No problem
    2. measurements
      1. group Id
        OG000
        value
        4
      2. group Id
        OG001
        value
        2
      3. group Id
        OG002
        value
        1
      4. group Id
        OG003
        value
        4
      title
      Slight problem
    3. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        0
      4. group Id
        OG003
        value
        0
      title
      Moderate problem
    4. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        0
      4. group Id
        OG003
        value
        0
      title
      Severe problem
    5. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        0
      4. group Id
        OG003
        value
        0
      title
      Unable to perform
    denoms
    1. counts
      1. group Id
        OG000
        value
        23
      2. group Id
        OG001
        value
        31
      3. group Id
        OG002
        value
        33
      4. group Id
        OG003
        value
        29
      units
      Participants
    title
    Month 3: Self-care
  8. categories
    1. measurements
      1. group Id
        OG000
        value
        17
      2. group Id
        OG001
        value
        25
      3. group Id
        OG002
        value
        16
      4. group Id
        OG003
        value
        20
      title
      No problem
    2. measurements
      1. group Id
        OG000
        value
        1
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        1
      4. group Id
        OG003
        value
        7
      title
      Slight problem
    3. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        0
      4. group Id
        OG003
        value
        0
      title
      Moderate problem
    4. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        0
      4. group Id
        OG003
        value
        0
      title
      Severe problem
    5. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        0
      4. group Id
        OG003
        value
        0
      title
      Unable to perform
    denoms
    1. counts
      1. group Id
        OG000
        value
        18
      2. group Id
        OG001
        value
        25
      3. group Id
        OG002
        value
        17
      4. group Id
        OG003
        value
        27
      units
      Participants
    title
    Month 6: Self-care
  9. categories
    1. measurements
      1. group Id
        OG000
        value
        22
      2. group Id
        OG001
        value
        22
      3. group Id
        OG002
        value
        24
      4. group Id
        OG003
        value
        16
      title
      No problem
    2. measurements
      1. group Id
        OG000
        value
        10
      2. group Id
        OG001
        value
        6
      3. group Id
        OG002
        value
        13
      4. group Id
        OG003
        value
        14
      title
      Slight problem
    3. measurements
      1. group Id
        OG000
        value
        4
      2. group Id
        OG001
        value
        8
      3. group Id
        OG002
        value
        8
      4. group Id
        OG003
        value
        2
      title
      Moderate problem
    4. measurements
      1. group Id
        OG000
        value
        2
      2. group Id
        OG001
        value
        1
      3. group Id
        OG002
        value
        1
      4. group Id
        OG003
        value
        2
      title
      Severe problem
    5. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        2
      3. group Id
        OG002
        value
        1
      4. group Id
        OG003
        value
        0
      title
      Unable to perform
    denoms
    1. counts
      1. group Id
        OG000
        value
        38
      2. group Id
        OG001
        value
        39
      3. group Id
        OG002
        value
        47
      4. group Id
        OG003
        value
        34
      units
      Participants
    title
    Baseline: Usual activities
  10. categories
    1. measurements
      1. group Id
        OG000
        value
        6
      2. group Id
        OG001
        value
        12
      3. group Id
        OG002
        value
        12
      4. group Id
        OG003
        value
        12
      title
      No problem
    2. measurements
      1. group Id
        OG000
        value
        13
      2. group Id
        OG001
        value
        11
      3. group Id
        OG002
        value
        13
      4. group Id
        OG003
        value
        11
      title
      Slight problem
    3. measurements
      1. group Id
        OG000
        value
        11
      2. group Id
        OG001
        value
        8
      3. group Id
        OG002
        value
        8
      4. group Id
        OG003
        value
        4
      title
      Moderate problem
    4. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        3
      3. group Id
        OG002
        value
        2
      4. group Id
        OG003
        value
        1
      title
      Severe problem
    5. measurements
      1. group Id
        OG000
        value
        2
      2. group Id
        OG001
        value
        3
      3. group Id
        OG002
        value
        2
      4. group Id
        OG003
        value
        1
      title
      Unable to perform
    denoms
    1. counts
      1. group Id
        OG000
        value
        32
      2. group Id
        OG001
        value
        37
      3. group Id
        OG002
        value
        37
      4. group Id
        OG003
        value
        29
      units
      Participants
    title
    Week 4: Usual activities
  11. categories
    1. measurements
      1. group Id
        OG000
        value
        8
      2. group Id
        OG001
        value
        16
      3. group Id
        OG002
        value
        19
      4. group Id
        OG003
        value
        12
      title
      No problem
    2. measurements
      1. group Id
        OG000
        value
        9
      2. group Id
        OG001
        value
        9
      3. group Id
        OG002
        value
        10
      4. group Id
        OG003
        value
        14
      title
      Slight problem
    3. measurements
      1. group Id
        OG000
        value
        5
      2. group Id
        OG001
        value
        5
      3. group Id
        OG002
        value
        2
      4. group Id
        OG003
        value
        2
      title
      Moderate problem
    4. measurements
      1. group Id
        OG000
        value
        1
      2. group Id
        OG001
        value
        1
      3. group Id
        OG002
        value
        1
      4. group Id
        OG003
        value
        1
      title
      Severe problem
    5. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        1
      4. group Id
        OG003
        value
        0
      title
      Unable to perform
    denoms
    1. counts
      1. group Id
        OG000
        value
        23
      2. group Id
        OG001
        value
        31
      3. group Id
        OG002
        value
        33
      4. group Id
        OG003
        value
        29
      units
      Participants
    title
    Month 3: Usual activities
  12. categories
    1. measurements
      1. group Id
        OG000
        value
        9
      2. group Id
        OG001
        value
        15
      3. group Id
        OG002
        value
        10
      4. group Id
        OG003
        value
        11
      title
      No problem
    2. measurements
      1. group Id
        OG000
        value
        5
      2. group Id
        OG001
        value
        7
      3. group Id
        OG002
        value
        4
      4. group Id
        OG003
        value
        12
      title
      Slight problem
    3. measurements
      1. group Id
        OG000
        value
        3
      2. group Id
        OG001
        value
        3
      3. group Id
        OG002
        value
        2
      4. group Id
        OG003
        value
        3
      title
      Moderate problem
    4. measurements
      1. group Id
        OG000
        value
        1
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        1
      4. group Id
        OG003
        value
        0
      title
      Severe problem
    5. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        0
      4. group Id
        OG003
        value
        1
      title
      Unable to perform
    denoms
    1. counts
      1. group Id
        OG000
        value
        18
      2. group Id
        OG001
        value
        25
      3. group Id
        OG002
        value
        17
      4. group Id
        OG003
        value
        27
      units
      Participants
    title
    Month 6: Usual activities
denoms
  1. counts
    1. group Id
      OG000
      value
      38
    2. group Id
      OG001
      value
      39
    3. group Id
      OG002
      value
      47
    4. 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
  1. 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
  2. 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
  3. 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
  4. 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
type
SECONDARY
unit Of Measure
Participants

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