Heavy Menstrual Bleeding, Uterine Fibroid
Conditions
Keywords
Uterine Fibroid, Heavy Menstrual Bleeding, Menstrual Blood Volume
Brief summary
The purpose of this study was to determine the long-term efficacy and safety of relugolix 40 milligrams (mg) once daily co-administered with estradiol (E2) and norethindrone acetate (NETA) for 28 weeks on heavy menstrual bleeding associated with uterine fibroids in participants who previously completed a 24-week treatment period in one of the pivotal studies (MVT-601-3001 or MVT-601-3002).
Detailed description
This study is an international phase 3 open-label, single-arm, long-term efficacy and safety extension study that enrolled eligible participants who have completed their participation in one of the phase 3 randomized, double-blind, placebo-controlled pivotal studies, MVT-601-3001 (LIBERTY 1 - NCT03049735) or MVT-601-3002 (LIBERTY 2 - NCT 03103087). All participants received relugolix 40 mg orally once daily co-administered with E2 (1 mg) and NETA (0.5 mg) for 28 weeks. Approximately 600 women with heavy menstrual bleeding associated with uterine fibroids were to be enrolled, after having completed a 24-week treatment period in one of the pivotal studies. The objectives of the study were to evaluate long-term efficacy and safety through up to 52 weeks of treatment (including treatment during the pivotal study) of relugolix co-administered with E2/NETA. Screening and baseline procedures were to be done at the same visit for this extension study (referred to as the Week 24/Baseline Visit), which coincided with the Week 24 Visit from the pivotal study and was to be defined as the date of completion of the last Week 24 procedure in the pivotal study. Participants will have received their last dose of study drug in the pivotal study on the day prior to the Week 24/Baseline Visit and were to receive their first dose of study drug for this extension study in the clinic after the participant was determined to be eligible for this extension study and provided informed consent to participate. The administration of the first dose of study drug for MVT-601-3003 was to define enrollment into this study. Study participants were to then take the open-label study treatment orally once daily for 28 weeks.
Interventions
DRUGRelugolix
Relugolix 40-mg tablet administered orally once daily
Capsule containing co-formulated tablet of E2 (1 mg) and NETA (0.5 mg) administered orally once daily
Sponsors
Myovant Sciences GmbH
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Open-Label Extension
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 50 Years
Healthy volunteers
No
Inclusion criteria
Key Inclusion Criteria: 1\. Completed 24 weeks of study drug treatment and study participation in either pivotal study, MVT-601-3001 or MVT-601-3002 Key
Exclusion criteria
1. Has undergone myomectomy, ultrasound-guided laparoscopic radiofrequency ablation, or any other surgical procedure for fibroids, uterine artery embolization, magnetic resonance-guided focused ultrasound for fibroids, or endometrial ablation for abnormal uterine bleeding at any time during the pivotal study (MVT-601-3001 or MVT-601-3002) 2. Met a withdrawal criterion in the pivotal study (MVT-601-3001 or MVT-601-3002).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage Of Participants Who Achieved Or Maintained An MBL Volume Of <80 Milliliters (mL) And At Least A 50% Reduction From Baseline MBL Volume At Week 52/End Of Treatment | Week 52/End of Treatment | A responder was a participant who had MBL volume of \< 80 mL and at least a 50% reduction from baseline MBL volume over the last 35 days of treatment (up to Week 52). All returned feminine products collected at each clinical visit were analyzed by the alkaline hematin method to obtain the MBL volume. MBL volume was measured over the Week 52/early termination feminine product collection interval (up to 35 days prior to the last dose of treatment). The percentage of participants who were responders are presented. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Pivotal Study Baseline In MBL Volume At Week 52 | Week 52 | MBL volume was measured using the alkaline hematin method, which involves chemically measuring the blood content of used feminine products. The volume of MBL is measured in mL and a blood loss of 80 mL or more per cycle is considered diagnostic of heavy menstrual bleeding. The least squares (LS) mean was derived for each treatment group using a mixed-effects model with repeated measure with visit, region, and Baseline MBL as fixed effects. |
| Percentage Of Participants Who Achieved Or Maintained Amenorrhea Over The Last 35 Days Of Treatment | Week 24 up to last 35 days of treatment (up to Week 52) | Amenorrhea was defined as meeting 1 of the following criteria for 2 consecutive visits: * No feminine product returned due to reported amenorrhea; * No feminine product returned due to reports of spotting/negligible bleeding coupled with other data (participant's paper diary) indicating infrequent non-cyclic bleeding/spotting; and * Feminine product collection with a negligible observed MBL volume coupled with data (participant's paper diary) indicating infrequent non-cyclic bleeding/spotting. |
| Percentage Of Participants With A Hemoglobin Level ≤10.5 Gram/Deciliter (g/dL) At Pivotal Study Baseline Who Achieved An Increase Of >2 g/dL From Pivotal Study Baseline At Week 52 | Week 52 | Blood samples were collected from participants for hemoglobin measurements. Percentages are based on number of participants with hemoglobin ≤10.5 g/dL at pivotal study Baseline and reported at Week 52. |
| Number Of Participants With Hemoglobin Increase Of ≥1 g/dL From Pivotal Study Baseline At Week 52 Among Those With A Hemoglobin Concentration Below Lower Limit Of Normal At Pivotal Baseline | Week 52 | Blood samples were collected from participants for hemoglobin measurements. Percentages are based on number of participants with hemoglobin concentration below the lower limit of normal (11.6 g/dL) at pivotal study Baseline and reported at Week 52. |
| Change From Pivotal Study Baseline In Hemoglobin Concentration At Week 52 | Week 52 | Blood samples were collected from participants for hemoglobin measurements. The LS mean was derived for each treatment group using a mixed-effects model with repeated measure. |
| Change From Pivotal Study Baseline In The UFS-QoL Symptom Severity Scale At Week 52 | Week 52 | Transformed score ranges from 0 to 100 based on Likert scale (none of time, a little of time, some of the time, most of the time, and all of the time). Lower score indicates less distress and higher score indicates greater distress. A negative change from baseline indicates improvement. The LS mean was derived for each treatment group using a mixed-effects model with repeated measure. |
| Change From Pivotal Study Baseline In The UFS-QoL Score By Health-Related Quality of Life Total Score At Week 52 | Week 52 | Assessed using the UFS-QoL Questionnaire. The UFS-QoL total score was the sum of the subscales (concern, activities, revised activities, energy/mood, control, self-conscious, and sexual function). The raw scores were transformed to normalized scores. Transformed score ranges from 0 to 100. Higher scores are indicative of better health-related quality of life (high = good). The LS mean was derived for each treatment group using a mixed-effects model with repeated measure. |
| Change From Pivotal Study Baseline In The Uterine Fibroid Symptom Health-Related Quality of Life (UFS-QoL) Bleeding And Pelvic Discomfort (BPD) Scale At Week 52 | Week 52 | The BPD scale has been derived from the UFS-QoL symptom severity scale. The scale consists of the following 3 symptoms proximal to uterine fibroids that are experienced by most participants: heavy bleeding during the menstrual period (Question 1), passing blood clots during the menstrual period (Question 2), and feeling tightness or pressure in the pelvic area (Question 5). Raw scores were transformed to a normalized score, with a range of possible scores from 0 to 100 (none of time, a little of time, some of the time, most of the time, and all of the time), where higher scores values are indicative of greater distress and lower scores are indicative of minimal distress. The LS mean was derived for each treatment group using a mixed-effects model with repeated measure. |
| Change From Pivotal Study Baseline In Uterine Volume At Week 52 | Week 52 | Volume of the uterus was measured by transvaginal or transabdominal ultrasound. The LS mean was derived for each treatment group using a mixed-effects model with repeated measure. |
| Change From Pivotal Study Baseline In Uterine Fibroid Volume At Week 52 | Week 52 | Volume of the primary uterine fibroid was measured by transvaginal or transabdominal ultrasound. The LS mean was derived for each treatment group using a mixed-effects model with repeated measure. |
| Percent Change From Pivotal Study Baseline In Bone Mineral Density (BMD) At The Lumbar Spine (L1-L4), Femoral Neck, And Total Hip At Week 52 | Week 52 | Assessed by dual-energy X-ray absorptiometry (DXA) scan at the lumbar spine (L1-L4), total hip, and femoral neck at pivotal study Baseline and at Week 52. The scans were read by the central radiology laboratory in accordance with the imaging charter. The same DXA machine was used at the local imaging center at each site and operated in the same scan mode for all images procured for an individual participant. All images were submitted for central reading. The central radiology laboratory collected and evaluated all DXA scans for acceptability and measured BMD. The LS mean was derived for each treatment group using a mixed-effects model with repeated measure. |
| Change From Pivotal Study Baseline In Predose Serum E2 Concentrations At Week 52 | Week 52 | Blood samples were collected from participants at predose for E2 measurements. These were analyzed at a central laboratory. |
| Change From Pivotal Study Baseline In The UFS-QoL Score Health-Related Quality of Life Subscales Score At Week 52 | Week 52 | Assessed using the UFS-QoL questionnaire. The UFS-QoL subscale scores include items related to uterine fibroid-associated limitations/impairment in activities, revised activities, concern, energy/mood, control, self-consciousness, and sexual function. The scores were transformed to normalized scores. Transformed score ranges from 0 to 100. Higher scores are indicative of better health-related quality of life (high = good). The LS mean was derived for each treatment group using a mixed-effects model with repeated measure. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Change From Pivotal Study Baseline In European Quality Of Life Five Dimension Five Level (EQ-5D-5L) Scale At Week 52 | Week 52 | The EQ-5D-5L scale is a standardized instrument for use as a measure of health outcomes. Mobility, self-care, usual activities, pain/discomfort, and anxiety/depression were each assessed on 5-point categorical scales of no problems to unable to complete specified activity, or no pain/discomfort to extreme pain/discomfort, or not anxious/depressed to extremely anxious/depressed. The change from baseline is summarized by amount of improvement (1-4 categories), amount of deterioration (1-4 categories), or no change. |
Countries
Belgium, Brazil, Chile, Czechia, Hungary, Italy, Poland, South Africa, United States
Participant flow
Recruitment details
All participants who completed their participation in one of the pivotal studies (MVT-601-3001 or MVT-601-3002) were eligible to enroll in this study.
Pre-assignment details
The study results were presented by treatment group in the pivotal study but all the participants received relugolix plus Estradiol (E2)/Norethindrone Acetate (NETA) in open-label extension study.
Participants by arm
| Arm | Count |
|---|---|
| Relugolix Plus E2/NETA (Group A) Relugolix 40 mg once daily co-administered with E2 (1 mg) and NETA (0.5 mg) for 24 weeks in the pivotal study followed by 28 weeks of relugolix 40 mg once daily co-administered with E2 (1 mg) and NETA (0.5 mg) in this study. | 163 |
| Relugolix Plus Delayed E2/NETA (Group B) Relugolix 40 mg monotherapy (once daily) for 12 weeks followed by relugolix 40 mg once daily co-administered with E2 (1mg) and NETA (0.5 mg) for 12 weeks in the pivotal study followed by 28 weeks of relugolix 40 mg once daily co-administered with E2 (1 mg) and NETA (0.5 mg) in this study. | 149 |
| Placebo (Group C) Relugolix placebo co-administered with E2/NETA placebo for up to 24 weeks in the pivotal study followed by 28 weeks of relugolix 40 mg once daily co-administered with E2 (1 mg) and NETA (0.5 mg) in this study. | 164 |
| Total | 476 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Adverse Event | 5 | 5 | 9 |
| Overall Study | Lack of Efficacy | 2 | 7 | 5 |
| Overall Study | Lost to Follow-up | 7 | 10 | 10 |
| Overall Study | Other | 5 | 6 | 5 |
| Overall Study | Participants who did not receive any study drug | 0 | 1 | 0 |
| Overall Study | Protocol deviation | 2 | 1 | 2 |
| Overall Study | Withdrawal by Subject | 9 | 12 | 11 |
Baseline characteristics
| Characteristic | Relugolix Plus Delayed E2/NETA (Group B) | Total | Relugolix Plus E2/NETA (Group A) | Placebo (Group C) |
|---|---|---|---|---|
| Age, Continuous | 42.1 years STANDARD_DEVIATION 5.58 | 42.2 years STANDARD_DEVIATION 5.36 | 42.6 years STANDARD_DEVIATION 5.08 | 41.9 years STANDARD_DEVIATION 5.43 |
| Body Mass Index | 30.997 kg/m^2 STANDARD_DEVIATION 6.4 | 31.675 kg/m^2 STANDARD_DEVIATION 7.0162 | 31.384 kg/m^2 STANDARD_DEVIATION 7.047 | 32.577 kg/m^2 STANDARD_DEVIATION 7.4556 |
| Bone Mineral Density (BMD) Femoral Neck | 0.994 g/cm^2 STANDARD_DEVIATION 0.1657 | 0.982 g/cm^2 STANDARD_DEVIATION 0.163 | 0.960 g/cm^2 STANDARD_DEVIATION 0.1572 | 0.994 g/cm^2 STANDARD_DEVIATION 0.1648 |
| Bone Mineral Density (BMD) Lumbar Spine (L1-L4) | 1.225 g/cm^2 STANDARD_DEVIATION 0.173 | 1.217 g/cm^2 STANDARD_DEVIATION 0.1645 | 1.186 g/cm^2 STANDARD_DEVIATION 0.1599 | 1.239 g/cm^2 STANDARD_DEVIATION 0.1573 |
| Bone Mineral Density (BMD) Total Hip | 1.062 g/cm^2 STANDARD_DEVIATION 0.1463 | 1.058 g/cm^2 STANDARD_DEVIATION 0.1415 | 1.044 g/cm^2 STANDARD_DEVIATION 0.1382 | 1.069 g/cm^2 STANDARD_DEVIATION 0.1401 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 34 Participants | 108 Participants | 38 Participants | 36 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 113 Participants | 361 Participants | 122 Participants | 126 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 2 Participants | 7 Participants | 3 Participants | 2 Participants |
| Mean Menstrual Blood Loss (MBL) volume | 238.78 mL STANDARD_DEVIATION 155.332 | 234.33 mL STANDARD_DEVIATION 161.753 | 248.71 mL STANDARD_DEVIATION 196.694 | 216.01 mL STANDARD_DEVIATION 123.786 |
| Race/Ethnicity, Customized American Indian or Alaska Native | 7 Participants | 10 Participants | 2 Participants | 1 Participants |
| Race/Ethnicity, Customized Asian | 3 Participants | 3 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Black or African American | 81 Participants | 238 Participants | 69 Participants | 88 Participants |
| Race/Ethnicity, Customized Multiple | 2 Participants | 5 Participants | 2 Participants | 1 Participants |
| Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Not Reported | 2 Participants | 6 Participants | 3 Participants | 1 Participants |
| Race/Ethnicity, Customized Other | 3 Participants | 7 Participants | 2 Participants | 2 Participants |
| Race/Ethnicity, Customized White | 51 Participants | 207 Participants | 85 Participants | 71 Participants |
| Region of Enrollment Belgium | 3 participants | 4 participants | 0 participants | 1 participants |
| Region of Enrollment Brazil | 6 participants | 12 participants | 4 participants | 2 participants |
| Region of Enrollment Chile | 6 participants | 19 participants | 5 participants | 8 participants |
| Region of Enrollment Czechia | 2 participants | 8 participants | 4 participants | 2 participants |
| Region of Enrollment Hungary | 4 participants | 17 participants | 6 participants | 7 participants |
| Region of Enrollment Italy | 5 participants | 15 participants | 7 participants | 3 participants |
| Region of Enrollment Poland | 14 participants | 47 participants | 14 participants | 19 participants |
| Region of Enrollment South Africa | 5 participants | 20 participants | 10 participants | 5 participants |
| Region of Enrollment United States | 104 participants | 335 participants | 113 participants | 117 participants |
| Sex: Female, Male Female | 149 Participants | 476 Participants | 163 Participants | 164 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 163 | 0 / 149 | 0 / 164 |
| other Total, other adverse events | 22 / 163 | 12 / 149 | 38 / 164 |
| serious Total, serious adverse events | 1 / 163 | 5 / 149 | 11 / 164 |
Outcome results
Primary
Percentage Of Participants Who Achieved Or Maintained An MBL Volume Of <80 Milliliters (mL) And At Least A 50% Reduction From Baseline MBL Volume At Week 52/End Of Treatment
A responder was a participant who had MBL volume of \< 80 mL and at least a 50% reduction from baseline MBL volume over the last 35 days of treatment (up to Week 52). All returned feminine products collected at each clinical visit were analyzed by the alkaline hematin method to obtain the MBL volume. MBL volume was measured over the Week 52/early termination feminine product collection interval (up to 35 days prior to the last dose of treatment). The percentage of participants who were responders are presented.
Time frame: Week 52/End of Treatment
Population: Extension Study Population: all participants who enrolled and received any amount of open-label study drug in the open-label extension study.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Relugolix Plus E2/NETA (Group A) | Percentage Of Participants Who Achieved Or Maintained An MBL Volume Of <80 Milliliters (mL) And At Least A 50% Reduction From Baseline MBL Volume At Week 52/End Of Treatment | 86.50 percentage of participants |
| Relugolix Plus Delayed E2/NETA (Group B) | Percentage Of Participants Who Achieved Or Maintained An MBL Volume Of <80 Milliliters (mL) And At Least A 50% Reduction From Baseline MBL Volume At Week 52/End Of Treatment | 79.87 percentage of participants |
| Placebo (Group C) | Percentage Of Participants Who Achieved Or Maintained An MBL Volume Of <80 Milliliters (mL) And At Least A 50% Reduction From Baseline MBL Volume At Week 52/End Of Treatment | 75.00 percentage of participants |
Secondary
Change From Pivotal Study Baseline In Hemoglobin Concentration At Week 52
Blood samples were collected from participants for hemoglobin measurements. The LS mean was derived for each treatment group using a mixed-effects model with repeated measure.
Time frame: Week 52
Population: Extension Study Population with a hemoglobin level ≤10.5 g/dL at pivotal study baseline: all participants who enrolled and received any amount of open-label study drug in the open-label extension study and who had a hemoglobin level ≤10.5 g/dL at pivotal study baseline.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Relugolix Plus E2/NETA (Group A) | Change From Pivotal Study Baseline In Hemoglobin Concentration At Week 52 | 2.7 g/dL | Standard Error 0.24 |
| Relugolix Plus Delayed E2/NETA (Group B) | Change From Pivotal Study Baseline In Hemoglobin Concentration At Week 52 | 3.0 g/dL | Standard Error 0.23 |
| Placebo (Group C) | Change From Pivotal Study Baseline In Hemoglobin Concentration At Week 52 | 1.9 g/dL | Standard Error 0.22 |
Secondary
Change From Pivotal Study Baseline In MBL Volume At Week 52
MBL volume was measured using the alkaline hematin method, which involves chemically measuring the blood content of used feminine products. The volume of MBL is measured in mL and a blood loss of 80 mL or more per cycle is considered diagnostic of heavy menstrual bleeding. The least squares (LS) mean was derived for each treatment group using a mixed-effects model with repeated measure with visit, region, and Baseline MBL as fixed effects.
Time frame: Week 52
Population: Extension Study Population: all participants who enrolled and received any amount of open-label study drug in the open-label extension study.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Relugolix Plus E2/NETA (Group A) | Change From Pivotal Study Baseline In MBL Volume At Week 52 | -251.6 mL | Standard Error 16.38 |
| Relugolix Plus Delayed E2/NETA (Group B) | Change From Pivotal Study Baseline In MBL Volume At Week 52 | -219.1 mL | Standard Error 13.91 |
| Placebo (Group C) | Change From Pivotal Study Baseline In MBL Volume At Week 52 | -204.7 mL | Standard Error 13.31 |
Secondary
Change From Pivotal Study Baseline In Predose Serum E2 Concentrations At Week 52
Blood samples were collected from participants at predose for E2 measurements. These were analyzed at a central laboratory.
Time frame: Week 52
Population: Extension Safety Population: all enrolled participants who received any amount of open-label study drug in the open-label extension study.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Relugolix Plus E2/NETA (Group A) | Change From Pivotal Study Baseline In Predose Serum E2 Concentrations At Week 52 | -21.83 pg/mL | Standard Deviation 91.525 |
| Relugolix Plus Delayed E2/NETA (Group B) | Change From Pivotal Study Baseline In Predose Serum E2 Concentrations At Week 52 | -33.77 pg/mL | Standard Deviation 106.407 |
| Placebo (Group C) | Change From Pivotal Study Baseline In Predose Serum E2 Concentrations At Week 52 | -29.99 pg/mL | Standard Deviation 81.465 |
Secondary
Change From Pivotal Study Baseline In The UFS-QoL Score By Health-Related Quality of Life Total Score At Week 52
Assessed using the UFS-QoL Questionnaire. The UFS-QoL total score was the sum of the subscales (concern, activities, revised activities, energy/mood, control, self-conscious, and sexual function). The raw scores were transformed to normalized scores. Transformed score ranges from 0 to 100. Higher scores are indicative of better health-related quality of life (high = good). The LS mean was derived for each treatment group using a mixed-effects model with repeated measure.
Time frame: Week 52
Population: Extension Study Population: all participants who enrolled and received any amount of open-label study drug in the open-label extension study.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Relugolix Plus E2/NETA (Group A) | Change From Pivotal Study Baseline In The UFS-QoL Score By Health-Related Quality of Life Total Score At Week 52 | 40.4 score on a scale | Standard Error 2.5 |
| Relugolix Plus Delayed E2/NETA (Group B) | Change From Pivotal Study Baseline In The UFS-QoL Score By Health-Related Quality of Life Total Score At Week 52 | 41.7 score on a scale | Standard Error 2.68 |
| Placebo (Group C) | Change From Pivotal Study Baseline In The UFS-QoL Score By Health-Related Quality of Life Total Score At Week 52 | 39.0 score on a scale | Standard Error 2.63 |
Secondary
Change From Pivotal Study Baseline In The UFS-QoL Score Health-Related Quality of Life Subscales Score At Week 52
Assessed using the UFS-QoL questionnaire. The UFS-QoL subscale scores include items related to uterine fibroid-associated limitations/impairment in activities, revised activities, concern, energy/mood, control, self-consciousness, and sexual function. The scores were transformed to normalized scores. Transformed score ranges from 0 to 100. Higher scores are indicative of better health-related quality of life (high = good). The LS mean was derived for each treatment group using a mixed-effects model with repeated measure.
Time frame: Week 52
Population: Extension Study Population: all participants who enrolled and received any amount of open-label study drug in the open-label extension study.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Relugolix Plus E2/NETA (Group A) | Change From Pivotal Study Baseline In The UFS-QoL Score Health-Related Quality of Life Subscales Score At Week 52 | Activities | 47.8 score on a scale | Standard Error 2.72 |
| Relugolix Plus E2/NETA (Group A) | Change From Pivotal Study Baseline In The UFS-QoL Score Health-Related Quality of Life Subscales Score At Week 52 | Concern | 56.4 score on a scale | Standard Error 2.92 |
| Relugolix Plus E2/NETA (Group A) | Change From Pivotal Study Baseline In The UFS-QoL Score Health-Related Quality of Life Subscales Score At Week 52 | Revised activities | 49.2 score on a scale | Standard Error 2.78 |
| Relugolix Plus E2/NETA (Group A) | Change From Pivotal Study Baseline In The UFS-QoL Score Health-Related Quality of Life Subscales Score At Week 52 | Sexual function | 22.7 score on a scale | Standard Error 3.4 |
| Relugolix Plus E2/NETA (Group A) | Change From Pivotal Study Baseline In The UFS-QoL Score Health-Related Quality of Life Subscales Score At Week 52 | Self-conscious | 31.2 score on a scale | Standard Error 3.06 |
| Relugolix Plus E2/NETA (Group A) | Change From Pivotal Study Baseline In The UFS-QoL Score Health-Related Quality of Life Subscales Score At Week 52 | Energy/mood | 35.6 score on a scale | Standard Error 2.67 |
| Relugolix Plus E2/NETA (Group A) | Change From Pivotal Study Baseline In The UFS-QoL Score Health-Related Quality of Life Subscales Score At Week 52 | Control | 33.0 score on a scale | Standard Error 2.69 |
| Relugolix Plus Delayed E2/NETA (Group B) | Change From Pivotal Study Baseline In The UFS-QoL Score Health-Related Quality of Life Subscales Score At Week 52 | Revised activities | 48.0 score on a scale | Standard Error 2.97 |
| Relugolix Plus Delayed E2/NETA (Group B) | Change From Pivotal Study Baseline In The UFS-QoL Score Health-Related Quality of Life Subscales Score At Week 52 | Activities | 46.9 score on a scale | Standard Error 2.82 |
| Relugolix Plus Delayed E2/NETA (Group B) | Change From Pivotal Study Baseline In The UFS-QoL Score Health-Related Quality of Life Subscales Score At Week 52 | Concern | 56.4 score on a scale | Standard Error 3.1 |
| Relugolix Plus Delayed E2/NETA (Group B) | Change From Pivotal Study Baseline In The UFS-QoL Score Health-Related Quality of Life Subscales Score At Week 52 | Energy/mood | 38.6 score on a scale | Standard Error 2.88 |
| Relugolix Plus Delayed E2/NETA (Group B) | Change From Pivotal Study Baseline In The UFS-QoL Score Health-Related Quality of Life Subscales Score At Week 52 | Control | 36.4 score on a scale | Standard Error 2.82 |
| Relugolix Plus Delayed E2/NETA (Group B) | Change From Pivotal Study Baseline In The UFS-QoL Score Health-Related Quality of Life Subscales Score At Week 52 | Self-conscious | 35.4 score on a scale | Standard Error 3.4 |
| Relugolix Plus Delayed E2/NETA (Group B) | Change From Pivotal Study Baseline In The UFS-QoL Score Health-Related Quality of Life Subscales Score At Week 52 | Sexual function | 22.0 score on a scale | Standard Error 3.87 |
| Placebo (Group C) | Change From Pivotal Study Baseline In The UFS-QoL Score Health-Related Quality of Life Subscales Score At Week 52 | Concern | 51.2 score on a scale | Standard Error 3.1 |
| Placebo (Group C) | Change From Pivotal Study Baseline In The UFS-QoL Score Health-Related Quality of Life Subscales Score At Week 52 | Control | 32.2 score on a scale | Standard Error 2.91 |
| Placebo (Group C) | Change From Pivotal Study Baseline In The UFS-QoL Score Health-Related Quality of Life Subscales Score At Week 52 | Revised activities | 46.9 score on a scale | Standard Error 2.85 |
| Placebo (Group C) | Change From Pivotal Study Baseline In The UFS-QoL Score Health-Related Quality of Life Subscales Score At Week 52 | Activities | 45.2 score on a scale | Standard Error 2.81 |
| Placebo (Group C) | Change From Pivotal Study Baseline In The UFS-QoL Score Health-Related Quality of Life Subscales Score At Week 52 | Sexual function | 24.1 score on a scale | Standard Error 3.62 |
| Placebo (Group C) | Change From Pivotal Study Baseline In The UFS-QoL Score Health-Related Quality of Life Subscales Score At Week 52 | Energy/mood | 36.5 score on a scale | Standard Error 2.79 |
| Placebo (Group C) | Change From Pivotal Study Baseline In The UFS-QoL Score Health-Related Quality of Life Subscales Score At Week 52 | Self-conscious | 31.0 score on a scale | Standard Error 3.14 |
Secondary
Change From Pivotal Study Baseline In The UFS-QoL Symptom Severity Scale At Week 52
Transformed score ranges from 0 to 100 based on Likert scale (none of time, a little of time, some of the time, most of the time, and all of the time). Lower score indicates less distress and higher score indicates greater distress. A negative change from baseline indicates improvement. The LS mean was derived for each treatment group using a mixed-effects model with repeated measure.
Time frame: Week 52
Population: Extension Study Population: all participants who enrolled and received any amount of open-label study drug in the open-label extension study.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Relugolix Plus E2/NETA (Group A) | Change From Pivotal Study Baseline In The UFS-QoL Symptom Severity Scale At Week 52 | -37.3 score on a scale | Standard Error 2.47 |
| Relugolix Plus Delayed E2/NETA (Group B) | Change From Pivotal Study Baseline In The UFS-QoL Symptom Severity Scale At Week 52 | -38.2 score on a scale | Standard Error 2.77 |
| Placebo (Group C) | Change From Pivotal Study Baseline In The UFS-QoL Symptom Severity Scale At Week 52 | -35.0 score on a scale | Standard Error 2.48 |
Secondary
Change From Pivotal Study Baseline In The Uterine Fibroid Symptom Health-Related Quality of Life (UFS-QoL) Bleeding And Pelvic Discomfort (BPD) Scale At Week 52
The BPD scale has been derived from the UFS-QoL symptom severity scale. The scale consists of the following 3 symptoms proximal to uterine fibroids that are experienced by most participants: heavy bleeding during the menstrual period (Question 1), passing blood clots during the menstrual period (Question 2), and feeling tightness or pressure in the pelvic area (Question 5). Raw scores were transformed to a normalized score, with a range of possible scores from 0 to 100 (none of time, a little of time, some of the time, most of the time, and all of the time), where higher scores values are indicative of greater distress and lower scores are indicative of minimal distress. The LS mean was derived for each treatment group using a mixed-effects model with repeated measure.
Time frame: Week 52
Population: Extension Study Population: all participants who enrolled and received any amount of open-label study drug in the open-label extension study.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Relugolix Plus E2/NETA (Group A) | Change From Pivotal Study Baseline In The Uterine Fibroid Symptom Health-Related Quality of Life (UFS-QoL) Bleeding And Pelvic Discomfort (BPD) Scale At Week 52 | -51.3 score on a scale | Standard Error 2.66 |
| Relugolix Plus Delayed E2/NETA (Group B) | Change From Pivotal Study Baseline In The Uterine Fibroid Symptom Health-Related Quality of Life (UFS-QoL) Bleeding And Pelvic Discomfort (BPD) Scale At Week 52 | -51.6 score on a scale | Standard Error 3.11 |
| Placebo (Group C) | Change From Pivotal Study Baseline In The Uterine Fibroid Symptom Health-Related Quality of Life (UFS-QoL) Bleeding And Pelvic Discomfort (BPD) Scale At Week 52 | -48.6 score on a scale | Standard Error 2.76 |
Secondary
Change From Pivotal Study Baseline In Uterine Fibroid Volume At Week 52
Volume of the primary uterine fibroid was measured by transvaginal or transabdominal ultrasound. The LS mean was derived for each treatment group using a mixed-effects model with repeated measure.
Time frame: Week 52
Population: Extension Study Population: all participants who enrolled and received any amount of open-label study drug in the open-label extension study.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Relugolix Plus E2/NETA (Group A) | Change From Pivotal Study Baseline In Uterine Fibroid Volume At Week 52 | -31.84 cm^3 | Standard Error 5.353 |
| Relugolix Plus Delayed E2/NETA (Group B) | Change From Pivotal Study Baseline In Uterine Fibroid Volume At Week 52 | -28.18 cm^3 | Standard Error 5.523 |
| Placebo (Group C) | Change From Pivotal Study Baseline In Uterine Fibroid Volume At Week 52 | -17.07 cm^3 | Standard Error 5.726 |
Secondary
Change From Pivotal Study Baseline In Uterine Volume At Week 52
Volume of the uterus was measured by transvaginal or transabdominal ultrasound. The LS mean was derived for each treatment group using a mixed-effects model with repeated measure.
Time frame: Week 52
Population: Extension Study Population: all participants who enrolled and received any amount of open-label study drug in the open-label extension study.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Relugolix Plus E2/NETA (Group A) | Change From Pivotal Study Baseline In Uterine Volume At Week 52 | -73.31 cm^3 | Standard Error 14.471 |
| Relugolix Plus Delayed E2/NETA (Group B) | Change From Pivotal Study Baseline In Uterine Volume At Week 52 | -91.67 cm^3 | Standard Error 20.143 |
| Placebo (Group C) | Change From Pivotal Study Baseline In Uterine Volume At Week 52 | -37.62 cm^3 | Standard Error 14.541 |
Secondary
Number Of Participants With Hemoglobin Increase Of ≥1 g/dL From Pivotal Study Baseline At Week 52 Among Those With A Hemoglobin Concentration Below Lower Limit Of Normal At Pivotal Baseline
Blood samples were collected from participants for hemoglobin measurements. Percentages are based on number of participants with hemoglobin concentration below the lower limit of normal (11.6 g/dL) at pivotal study Baseline and reported at Week 52.
Time frame: Week 52
Population: Extension Study Population with a hemoglobin level below lower limit of normal at pivotal study baseline: all participants who enrolled and received any amount of open-label study drug in the open-label extension study and who had a hemoglobin level below lower limit of normal at pivotal study baseline.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Relugolix Plus E2/NETA (Group A) | Number Of Participants With Hemoglobin Increase Of ≥1 g/dL From Pivotal Study Baseline At Week 52 Among Those With A Hemoglobin Concentration Below Lower Limit Of Normal At Pivotal Baseline | 56 participants |
| Relugolix Plus Delayed E2/NETA (Group B) | Number Of Participants With Hemoglobin Increase Of ≥1 g/dL From Pivotal Study Baseline At Week 52 Among Those With A Hemoglobin Concentration Below Lower Limit Of Normal At Pivotal Baseline | 60 participants |
| Placebo (Group C) | Number Of Participants With Hemoglobin Increase Of ≥1 g/dL From Pivotal Study Baseline At Week 52 Among Those With A Hemoglobin Concentration Below Lower Limit Of Normal At Pivotal Baseline | 45 participants |
Secondary
Percentage Of Participants Who Achieved Or Maintained Amenorrhea Over The Last 35 Days Of Treatment
Amenorrhea was defined as meeting 1 of the following criteria for 2 consecutive visits: * No feminine product returned due to reported amenorrhea; * No feminine product returned due to reports of spotting/negligible bleeding coupled with other data (participant's paper diary) indicating infrequent non-cyclic bleeding/spotting; and * Feminine product collection with a negligible observed MBL volume coupled with data (participant's paper diary) indicating infrequent non-cyclic bleeding/spotting.
Time frame: Week 24 up to last 35 days of treatment (up to Week 52)
Population: Extension Study Population: all participants who enrolled and received any amount of open-label study drug in the open-label extension study.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Relugolix Plus E2/NETA (Group A) | Percentage Of Participants Who Achieved Or Maintained Amenorrhea Over The Last 35 Days Of Treatment | 70.55 percentage of participants |
| Relugolix Plus Delayed E2/NETA (Group B) | Percentage Of Participants Who Achieved Or Maintained Amenorrhea Over The Last 35 Days Of Treatment | 68.46 percentage of participants |
| Placebo (Group C) | Percentage Of Participants Who Achieved Or Maintained Amenorrhea Over The Last 35 Days Of Treatment | 57.93 percentage of participants |
Secondary
Percentage Of Participants With A Hemoglobin Level ≤10.5 Gram/Deciliter (g/dL) At Pivotal Study Baseline Who Achieved An Increase Of >2 g/dL From Pivotal Study Baseline At Week 52
Blood samples were collected from participants for hemoglobin measurements. Percentages are based on number of participants with hemoglobin ≤10.5 g/dL at pivotal study Baseline and reported at Week 52.
Time frame: Week 52
Population: Extension Study Population with a hemoglobin level ≤10.5 g/dL at pivotal study baseline: all participants who enrolled and received any amount of open-label study drug in the open-label extension study and who had a hemoglobin level ≤10.5 g/dL at pivotal study baseline.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Relugolix Plus E2/NETA (Group A) | Percentage Of Participants With A Hemoglobin Level ≤10.5 Gram/Deciliter (g/dL) At Pivotal Study Baseline Who Achieved An Increase Of >2 g/dL From Pivotal Study Baseline At Week 52 | 58.97 percentage of participants |
| Relugolix Plus Delayed E2/NETA (Group B) | Percentage Of Participants With A Hemoglobin Level ≤10.5 Gram/Deciliter (g/dL) At Pivotal Study Baseline Who Achieved An Increase Of >2 g/dL From Pivotal Study Baseline At Week 52 | 78.95 percentage of participants |
| Placebo (Group C) | Percentage Of Participants With A Hemoglobin Level ≤10.5 Gram/Deciliter (g/dL) At Pivotal Study Baseline Who Achieved An Increase Of >2 g/dL From Pivotal Study Baseline At Week 52 | 42.11 percentage of participants |
Secondary
Percent Change From Pivotal Study Baseline In Bone Mineral Density (BMD) At The Lumbar Spine (L1-L4), Femoral Neck, And Total Hip At Week 52
Assessed by dual-energy X-ray absorptiometry (DXA) scan at the lumbar spine (L1-L4), total hip, and femoral neck at pivotal study Baseline and at Week 52. The scans were read by the central radiology laboratory in accordance with the imaging charter. The same DXA machine was used at the local imaging center at each site and operated in the same scan mode for all images procured for an individual participant. All images were submitted for central reading. The central radiology laboratory collected and evaluated all DXA scans for acceptability and measured BMD. The LS mean was derived for each treatment group using a mixed-effects model with repeated measure.
Time frame: Week 52
Population: Extension Safety Population: all enrolled participants who received any amount of open-label study drug in the open-label extension study. The overall number of participants analyzed is then umber of patients at baseline. The number analyzed at each location is the number of patients included in summary statistics for that location and timepoint.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Relugolix Plus E2/NETA (Group A) | Percent Change From Pivotal Study Baseline In Bone Mineral Density (BMD) At The Lumbar Spine (L1-L4), Femoral Neck, And Total Hip At Week 52 | Femoral Neck | -0.575 percentage change | Standard Error 0.3208 |
| Relugolix Plus E2/NETA (Group A) | Percent Change From Pivotal Study Baseline In Bone Mineral Density (BMD) At The Lumbar Spine (L1-L4), Femoral Neck, And Total Hip At Week 52 | Total Hip | -0.153 percentage change | Standard Error 0.2337 |
| Relugolix Plus E2/NETA (Group A) | Percent Change From Pivotal Study Baseline In Bone Mineral Density (BMD) At The Lumbar Spine (L1-L4), Femoral Neck, And Total Hip At Week 52 | Lumbar Spine (L1-L4) | -0.804 percentage change | Standard Error 0.2803 |
| Relugolix Plus Delayed E2/NETA (Group B) | Percent Change From Pivotal Study Baseline In Bone Mineral Density (BMD) At The Lumbar Spine (L1-L4), Femoral Neck, And Total Hip At Week 52 | Femoral Neck | -0.513 percentage change | Standard Error 0.4503 |
| Relugolix Plus Delayed E2/NETA (Group B) | Percent Change From Pivotal Study Baseline In Bone Mineral Density (BMD) At The Lumbar Spine (L1-L4), Femoral Neck, And Total Hip At Week 52 | Lumbar Spine (L1-L4) | -2.045 percentage change | Standard Error 0.2679 |
| Relugolix Plus Delayed E2/NETA (Group B) | Percent Change From Pivotal Study Baseline In Bone Mineral Density (BMD) At The Lumbar Spine (L1-L4), Femoral Neck, And Total Hip At Week 52 | Total Hip | -0.842 percentage change | Standard Error 0.2308 |
| Placebo (Group C) | Percent Change From Pivotal Study Baseline In Bone Mineral Density (BMD) At The Lumbar Spine (L1-L4), Femoral Neck, And Total Hip At Week 52 | Femoral Neck | 0.004 percentage change | Standard Error 0.3886 |
| Placebo (Group C) | Percent Change From Pivotal Study Baseline In Bone Mineral Density (BMD) At The Lumbar Spine (L1-L4), Femoral Neck, And Total Hip At Week 52 | Total Hip | -0.065 percentage change | Standard Error 0.2086 |
| Placebo (Group C) | Percent Change From Pivotal Study Baseline In Bone Mineral Density (BMD) At The Lumbar Spine (L1-L4), Femoral Neck, And Total Hip At Week 52 | Lumbar Spine (L1-L4) | -0.775 percentage change | Standard Error 0.2781 |
Other Pre-specified
Change From Pivotal Study Baseline In European Quality Of Life Five Dimension Five Level (EQ-5D-5L) Scale At Week 52
The EQ-5D-5L scale is a standardized instrument for use as a measure of health outcomes. Mobility, self-care, usual activities, pain/discomfort, and anxiety/depression were each assessed on 5-point categorical scales of no problems to unable to complete specified activity, or no pain/discomfort to extreme pain/discomfort, or not anxious/depressed to extremely anxious/depressed. The change from baseline is summarized by amount of improvement (1-4 categories), amount of deterioration (1-4 categories), or no change.
Time frame: Week 52
Population: Extension Study Population: all participants who enrolled and received any amount of open-label study drug in the open-label extension study.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Relugolix Plus E2/NETA (Group A) | Change From Pivotal Study Baseline In European Quality Of Life Five Dimension Five Level (EQ-5D-5L) Scale At Week 52 | Anxiety/depression - 3 Category improvement | 0 Participants |
| Relugolix Plus E2/NETA (Group A) | Change From Pivotal Study Baseline In European Quality Of Life Five Dimension Five Level (EQ-5D-5L) Scale At Week 52 | Mobility - 3 Category improvement | 0 Participants |
| Relugolix Plus E2/NETA (Group A) | Change From Pivotal Study Baseline In European Quality Of Life Five Dimension Five Level (EQ-5D-5L) Scale At Week 52 | Mobility - 3 Category deterioration | 0 Participants |
| Relugolix Plus E2/NETA (Group A) | Change From Pivotal Study Baseline In European Quality Of Life Five Dimension Five Level (EQ-5D-5L) Scale At Week 52 | Self-care - 3 Category deterioration | 0 Participants |
| Relugolix Plus E2/NETA (Group A) | Change From Pivotal Study Baseline In European Quality Of Life Five Dimension Five Level (EQ-5D-5L) Scale At Week 52 | Mobility - 1 Category improvement | 15 Participants |
| Relugolix Plus E2/NETA (Group A) | Change From Pivotal Study Baseline In European Quality Of Life Five Dimension Five Level (EQ-5D-5L) Scale At Week 52 | Mobility - 2 Category improvement | 5 Participants |
| Relugolix Plus E2/NETA (Group A) | Change From Pivotal Study Baseline In European Quality Of Life Five Dimension Five Level (EQ-5D-5L) Scale At Week 52 | Self-care - No change | 122 Participants |
| Relugolix Plus E2/NETA (Group A) | Change From Pivotal Study Baseline In European Quality Of Life Five Dimension Five Level (EQ-5D-5L) Scale At Week 52 | Self care - 2 Category improvement | 1 Participants |
| Relugolix Plus E2/NETA (Group A) | Change From Pivotal Study Baseline In European Quality Of Life Five Dimension Five Level (EQ-5D-5L) Scale At Week 52 | Usual activities - 3 Category deterioration | 0 Participants |
| Relugolix Plus E2/NETA (Group A) | Change From Pivotal Study Baseline In European Quality Of Life Five Dimension Five Level (EQ-5D-5L) Scale At Week 52 | Usual activities - 1 Category improvement | 15 Participants |
| Relugolix Plus E2/NETA (Group A) | Change From Pivotal Study Baseline In European Quality Of Life Five Dimension Five Level (EQ-5D-5L) Scale At Week 52 | Usual activities - 3 Category improvement | 3 Participants |
| Relugolix Plus E2/NETA (Group A) | Change From Pivotal Study Baseline In European Quality Of Life Five Dimension Five Level (EQ-5D-5L) Scale At Week 52 | Anxiety/depression - 1 Category improvement | 24 Participants |
| Relugolix Plus E2/NETA (Group A) | Change From Pivotal Study Baseline In European Quality Of Life Five Dimension Five Level (EQ-5D-5L) Scale At Week 52 | Anxiety/depression - 4 Category improvement | 1 Participants |
| Relugolix Plus E2/NETA (Group A) | Change From Pivotal Study Baseline In European Quality Of Life Five Dimension Five Level (EQ-5D-5L) Scale At Week 52 | Mobility - 4 Category improvement | 0 Participants |
| Relugolix Plus E2/NETA (Group A) | Change From Pivotal Study Baseline In European Quality Of Life Five Dimension Five Level (EQ-5D-5L) Scale At Week 52 | Self-care - 4 Category deterioration | 0 Participants |
| Relugolix Plus E2/NETA (Group A) | Change From Pivotal Study Baseline In European Quality Of Life Five Dimension Five Level (EQ-5D-5L) Scale At Week 52 | Self-care - 2 Category deterioration | 0 Participants |
| Relugolix Plus E2/NETA (Group A) | Change From Pivotal Study Baseline In European Quality Of Life Five Dimension Five Level (EQ-5D-5L) Scale At Week 52 | Self-care - 1 Category deterioration | 1 Participants |
| Relugolix Plus E2/NETA (Group A) | Change From Pivotal Study Baseline In European Quality Of Life Five Dimension Five Level (EQ-5D-5L) Scale At Week 52 | Self care - 1 Category improvement | 3 Participants |
| Relugolix Plus E2/NETA (Group A) | Change From Pivotal Study Baseline In European Quality Of Life Five Dimension Five Level (EQ-5D-5L) Scale At Week 52 | Self care - 3 Category improvement | 0 Participants |
| Relugolix Plus E2/NETA (Group A) | Change From Pivotal Study Baseline In European Quality Of Life Five Dimension Five Level (EQ-5D-5L) Scale At Week 52 | Self care - 4 Category improvement | 0 Participants |
| Relugolix Plus E2/NETA (Group A) | Change From Pivotal Study Baseline In European Quality Of Life Five Dimension Five Level (EQ-5D-5L) Scale At Week 52 | Usual activities - 4 Category deterioration | 0 Participants |
| Relugolix Plus E2/NETA (Group A) | Change From Pivotal Study Baseline In European Quality Of Life Five Dimension Five Level (EQ-5D-5L) Scale At Week 52 | Usual activities - 2 Category deterioration | 3 Participants |
| Relugolix Plus E2/NETA (Group A) | Change From Pivotal Study Baseline In European Quality Of Life Five Dimension Five Level (EQ-5D-5L) Scale At Week 52 | Usual activities - 1 Category deterioration | 4 Participants |
| Relugolix Plus E2/NETA (Group A) | Change From Pivotal Study Baseline In European Quality Of Life Five Dimension Five Level (EQ-5D-5L) Scale At Week 52 | Usual activities - No change | 91 Participants |
| Relugolix Plus E2/NETA (Group A) | Change From Pivotal Study Baseline In European Quality Of Life Five Dimension Five Level (EQ-5D-5L) Scale At Week 52 | Usual activities - 2 Category improvement | 10 Participants |
| Relugolix Plus E2/NETA (Group A) | Change From Pivotal Study Baseline In European Quality Of Life Five Dimension Five Level (EQ-5D-5L) Scale At Week 52 | Usual activities - 4 Category improvement | 1 Participants |
| Relugolix Plus E2/NETA (Group A) | Change From Pivotal Study Baseline In European Quality Of Life Five Dimension Five Level (EQ-5D-5L) Scale At Week 52 | Pain/discomfort - 4 Category deterioration | 0 Participants |
| Relugolix Plus E2/NETA (Group A) | Change From Pivotal Study Baseline In European Quality Of Life Five Dimension Five Level (EQ-5D-5L) Scale At Week 52 | Pain/discomfort - 3 Category deterioration | 0 Participants |
| Relugolix Plus E2/NETA (Group A) | Change From Pivotal Study Baseline In European Quality Of Life Five Dimension Five Level (EQ-5D-5L) Scale At Week 52 | Pain/discomfort - 2 Category deterioration | 3 Participants |
| Relugolix Plus E2/NETA (Group A) | Change From Pivotal Study Baseline In European Quality Of Life Five Dimension Five Level (EQ-5D-5L) Scale At Week 52 | Pain/discomfort - 1 Category deterioration | 17 Participants |
| Relugolix Plus E2/NETA (Group A) | Change From Pivotal Study Baseline In European Quality Of Life Five Dimension Five Level (EQ-5D-5L) Scale At Week 52 | Pain/discomfort - No change | 46 Participants |
| Relugolix Plus E2/NETA (Group A) | Change From Pivotal Study Baseline In European Quality Of Life Five Dimension Five Level (EQ-5D-5L) Scale At Week 52 | Pain/discomfort - 1 Category improvement | 37 Participants |
| Relugolix Plus E2/NETA (Group A) | Change From Pivotal Study Baseline In European Quality Of Life Five Dimension Five Level (EQ-5D-5L) Scale At Week 52 | Pain/discomfort - 2 Category improvement | 16 Participants |
| Relugolix Plus E2/NETA (Group A) | Change From Pivotal Study Baseline In European Quality Of Life Five Dimension Five Level (EQ-5D-5L) Scale At Week 52 | Pain/discomfort - 3 Category improvement | 8 Participants |
| Relugolix Plus E2/NETA (Group A) | Change From Pivotal Study Baseline In European Quality Of Life Five Dimension Five Level (EQ-5D-5L) Scale At Week 52 | Pain/discomfort - 4 Category improvement | 0 Participants |
| Relugolix Plus E2/NETA (Group A) | Change From Pivotal Study Baseline In European Quality Of Life Five Dimension Five Level (EQ-5D-5L) Scale At Week 52 | Anxiety/depression - 4 Category deterioration | 0 Participants |
| Relugolix Plus E2/NETA (Group A) | Change From Pivotal Study Baseline In European Quality Of Life Five Dimension Five Level (EQ-5D-5L) Scale At Week 52 | Anxiety/depression - 3 Category deterioration | 0 Participants |
| Relugolix Plus E2/NETA (Group A) | Change From Pivotal Study Baseline In European Quality Of Life Five Dimension Five Level (EQ-5D-5L) Scale At Week 52 | Anxiety/depression - 2 Category deterioration | 4 Participants |
| Relugolix Plus E2/NETA (Group A) | Change From Pivotal Study Baseline In European Quality Of Life Five Dimension Five Level (EQ-5D-5L) Scale At Week 52 | Anxiety/depression - 1 Category deterioration | 11 Participants |
| Relugolix Plus E2/NETA (Group A) | Change From Pivotal Study Baseline In European Quality Of Life Five Dimension Five Level (EQ-5D-5L) Scale At Week 52 | Anxiety/depression - No change | 79 Participants |
| Relugolix Plus E2/NETA (Group A) | Change From Pivotal Study Baseline In European Quality Of Life Five Dimension Five Level (EQ-5D-5L) Scale At Week 52 | Anxiety/depression - 2 Category improvement | 8 Participants |
| Relugolix Plus E2/NETA (Group A) | Change From Pivotal Study Baseline In European Quality Of Life Five Dimension Five Level (EQ-5D-5L) Scale At Week 52 | Mobility - 4 Category deterioration | 0 Participants |
| Relugolix Plus E2/NETA (Group A) | Change From Pivotal Study Baseline In European Quality Of Life Five Dimension Five Level (EQ-5D-5L) Scale At Week 52 | Mobility - 2 Category deterioration | 2 Participants |
| Relugolix Plus E2/NETA (Group A) | Change From Pivotal Study Baseline In European Quality Of Life Five Dimension Five Level (EQ-5D-5L) Scale At Week 52 | Mobility - 1 Category deterioration | 3 Participants |
| Relugolix Plus E2/NETA (Group A) | Change From Pivotal Study Baseline In European Quality Of Life Five Dimension Five Level (EQ-5D-5L) Scale At Week 52 | Mobility - No change | 102 Participants |
| Relugolix Plus Delayed E2/NETA (Group B) | Change From Pivotal Study Baseline In European Quality Of Life Five Dimension Five Level (EQ-5D-5L) Scale At Week 52 | Usual activities - 2 Category deterioration | 0 Participants |
| Relugolix Plus Delayed E2/NETA (Group B) | Change From Pivotal Study Baseline In European Quality Of Life Five Dimension Five Level (EQ-5D-5L) Scale At Week 52 | Self-care - 1 Category deterioration | 1 Participants |
| Relugolix Plus Delayed E2/NETA (Group B) | Change From Pivotal Study Baseline In European Quality Of Life Five Dimension Five Level (EQ-5D-5L) Scale At Week 52 | Self-care - No change | 105 Participants |
| Relugolix Plus Delayed E2/NETA (Group B) | Change From Pivotal Study Baseline In European Quality Of Life Five Dimension Five Level (EQ-5D-5L) Scale At Week 52 | Self care - 1 Category improvement | 0 Participants |
| Relugolix Plus Delayed E2/NETA (Group B) | Change From Pivotal Study Baseline In European Quality Of Life Five Dimension Five Level (EQ-5D-5L) Scale At Week 52 | Self care - 2 Category improvement | 1 Participants |
| Relugolix Plus Delayed E2/NETA (Group B) | Change From Pivotal Study Baseline In European Quality Of Life Five Dimension Five Level (EQ-5D-5L) Scale At Week 52 | Self care - 3 Category improvement | 0 Participants |
| Relugolix Plus Delayed E2/NETA (Group B) | Change From Pivotal Study Baseline In European Quality Of Life Five Dimension Five Level (EQ-5D-5L) Scale At Week 52 | Anxiety/depression - 2 Category deterioration | 3 Participants |
| Relugolix Plus Delayed E2/NETA (Group B) | Change From Pivotal Study Baseline In European Quality Of Life Five Dimension Five Level (EQ-5D-5L) Scale At Week 52 | Self care - 4 Category improvement | 0 Participants |
| Relugolix Plus Delayed E2/NETA (Group B) | Change From Pivotal Study Baseline In European Quality Of Life Five Dimension Five Level (EQ-5D-5L) Scale At Week 52 | Usual activities - 4 Category deterioration | 0 Participants |
| Relugolix Plus Delayed E2/NETA (Group B) | Change From Pivotal Study Baseline In European Quality Of Life Five Dimension Five Level (EQ-5D-5L) Scale At Week 52 | Usual activities - 3 Category deterioration | 1 Participants |
| Relugolix Plus Delayed E2/NETA (Group B) | Change From Pivotal Study Baseline In European Quality Of Life Five Dimension Five Level (EQ-5D-5L) Scale At Week 52 | Anxiety/depression - 3 Category deterioration | 0 Participants |
| Relugolix Plus Delayed E2/NETA (Group B) | Change From Pivotal Study Baseline In European Quality Of Life Five Dimension Five Level (EQ-5D-5L) Scale At Week 52 | Anxiety/depression - 1 Category deterioration | 20 Participants |
| Relugolix Plus Delayed E2/NETA (Group B) | Change From Pivotal Study Baseline In European Quality Of Life Five Dimension Five Level (EQ-5D-5L) Scale At Week 52 | Usual activities - 1 Category deterioration | 2 Participants |
| Relugolix Plus Delayed E2/NETA (Group B) | Change From Pivotal Study Baseline In European Quality Of Life Five Dimension Five Level (EQ-5D-5L) Scale At Week 52 | Usual activities - No change | 71 Participants |
| Relugolix Plus Delayed E2/NETA (Group B) | Change From Pivotal Study Baseline In European Quality Of Life Five Dimension Five Level (EQ-5D-5L) Scale At Week 52 | Mobility - 1 Category deterioration | 5 Participants |
| Relugolix Plus Delayed E2/NETA (Group B) | Change From Pivotal Study Baseline In European Quality Of Life Five Dimension Five Level (EQ-5D-5L) Scale At Week 52 | Usual activities - 2 Category improvement | 10 Participants |
| Relugolix Plus Delayed E2/NETA (Group B) | Change From Pivotal Study Baseline In European Quality Of Life Five Dimension Five Level (EQ-5D-5L) Scale At Week 52 | Anxiety/depression - No change | 53 Participants |
| Relugolix Plus Delayed E2/NETA (Group B) | Change From Pivotal Study Baseline In European Quality Of Life Five Dimension Five Level (EQ-5D-5L) Scale At Week 52 | Usual activities - 4 Category improvement | 0 Participants |
| Relugolix Plus Delayed E2/NETA (Group B) | Change From Pivotal Study Baseline In European Quality Of Life Five Dimension Five Level (EQ-5D-5L) Scale At Week 52 | Pain/discomfort - 4 Category deterioration | 0 Participants |
| Relugolix Plus Delayed E2/NETA (Group B) | Change From Pivotal Study Baseline In European Quality Of Life Five Dimension Five Level (EQ-5D-5L) Scale At Week 52 | Anxiety/depression - 1 Category improvement | 25 Participants |
| Relugolix Plus Delayed E2/NETA (Group B) | Change From Pivotal Study Baseline In European Quality Of Life Five Dimension Five Level (EQ-5D-5L) Scale At Week 52 | Pain/discomfort - 3 Category deterioration | 1 Participants |
| Relugolix Plus Delayed E2/NETA (Group B) | Change From Pivotal Study Baseline In European Quality Of Life Five Dimension Five Level (EQ-5D-5L) Scale At Week 52 | Mobility - 2 Category improvement | 3 Participants |
| Relugolix Plus Delayed E2/NETA (Group B) | Change From Pivotal Study Baseline In European Quality Of Life Five Dimension Five Level (EQ-5D-5L) Scale At Week 52 | Anxiety/depression - 2 Category improvement | 7 Participants |
| Relugolix Plus Delayed E2/NETA (Group B) | Change From Pivotal Study Baseline In European Quality Of Life Five Dimension Five Level (EQ-5D-5L) Scale At Week 52 | Anxiety/depression - 3 Category improvement | 0 Participants |
| Relugolix Plus Delayed E2/NETA (Group B) | Change From Pivotal Study Baseline In European Quality Of Life Five Dimension Five Level (EQ-5D-5L) Scale At Week 52 | Pain/discomfort - No change | 45 Participants |
| Relugolix Plus Delayed E2/NETA (Group B) | Change From Pivotal Study Baseline In European Quality Of Life Five Dimension Five Level (EQ-5D-5L) Scale At Week 52 | Pain/discomfort - 1 Category improvement | 31 Participants |
| Relugolix Plus Delayed E2/NETA (Group B) | Change From Pivotal Study Baseline In European Quality Of Life Five Dimension Five Level (EQ-5D-5L) Scale At Week 52 | Mobility - 3 Category deterioration | 1 Participants |
| Relugolix Plus Delayed E2/NETA (Group B) | Change From Pivotal Study Baseline In European Quality Of Life Five Dimension Five Level (EQ-5D-5L) Scale At Week 52 | Mobility - 2 Category deterioration | 0 Participants |
| Relugolix Plus Delayed E2/NETA (Group B) | Change From Pivotal Study Baseline In European Quality Of Life Five Dimension Five Level (EQ-5D-5L) Scale At Week 52 | Pain/discomfort - 2 Category improvement | 14 Participants |
| Relugolix Plus Delayed E2/NETA (Group B) | Change From Pivotal Study Baseline In European Quality Of Life Five Dimension Five Level (EQ-5D-5L) Scale At Week 52 | Mobility - 1 Category improvement | 9 Participants |
| Relugolix Plus Delayed E2/NETA (Group B) | Change From Pivotal Study Baseline In European Quality Of Life Five Dimension Five Level (EQ-5D-5L) Scale At Week 52 | Mobility - 3 Category improvement | 1 Participants |
| Relugolix Plus Delayed E2/NETA (Group B) | Change From Pivotal Study Baseline In European Quality Of Life Five Dimension Five Level (EQ-5D-5L) Scale At Week 52 | Self-care - 3 Category deterioration | 0 Participants |
| Relugolix Plus Delayed E2/NETA (Group B) | Change From Pivotal Study Baseline In European Quality Of Life Five Dimension Five Level (EQ-5D-5L) Scale At Week 52 | Mobility - No change | 89 Participants |
| Relugolix Plus Delayed E2/NETA (Group B) | Change From Pivotal Study Baseline In European Quality Of Life Five Dimension Five Level (EQ-5D-5L) Scale At Week 52 | Pain/discomfort - 3 Category improvement | 6 Participants |
| Relugolix Plus Delayed E2/NETA (Group B) | Change From Pivotal Study Baseline In European Quality Of Life Five Dimension Five Level (EQ-5D-5L) Scale At Week 52 | Mobility - 4 Category deterioration | 0 Participants |
| Relugolix Plus Delayed E2/NETA (Group B) | Change From Pivotal Study Baseline In European Quality Of Life Five Dimension Five Level (EQ-5D-5L) Scale At Week 52 | Usual activities - 1 Category improvement | 22 Participants |
| Relugolix Plus Delayed E2/NETA (Group B) | Change From Pivotal Study Baseline In European Quality Of Life Five Dimension Five Level (EQ-5D-5L) Scale At Week 52 | Pain/discomfort - 4 Category improvement | 1 Participants |
| Relugolix Plus Delayed E2/NETA (Group B) | Change From Pivotal Study Baseline In European Quality Of Life Five Dimension Five Level (EQ-5D-5L) Scale At Week 52 | Usual activities - 3 Category improvement | 2 Participants |
| Relugolix Plus Delayed E2/NETA (Group B) | Change From Pivotal Study Baseline In European Quality Of Life Five Dimension Five Level (EQ-5D-5L) Scale At Week 52 | Pain/discomfort - 2 Category deterioration | 2 Participants |
| Relugolix Plus Delayed E2/NETA (Group B) | Change From Pivotal Study Baseline In European Quality Of Life Five Dimension Five Level (EQ-5D-5L) Scale At Week 52 | Pain/discomfort - 1 Category deterioration | 8 Participants |
| Relugolix Plus Delayed E2/NETA (Group B) | Change From Pivotal Study Baseline In European Quality Of Life Five Dimension Five Level (EQ-5D-5L) Scale At Week 52 | Anxiety/depression - 4 Category improvement | 0 Participants |
| Relugolix Plus Delayed E2/NETA (Group B) | Change From Pivotal Study Baseline In European Quality Of Life Five Dimension Five Level (EQ-5D-5L) Scale At Week 52 | Anxiety/depression - 4 Category deterioration | 0 Participants |
| Relugolix Plus Delayed E2/NETA (Group B) | Change From Pivotal Study Baseline In European Quality Of Life Five Dimension Five Level (EQ-5D-5L) Scale At Week 52 | Mobility - 4 Category improvement | 0 Participants |
| Relugolix Plus Delayed E2/NETA (Group B) | Change From Pivotal Study Baseline In European Quality Of Life Five Dimension Five Level (EQ-5D-5L) Scale At Week 52 | Self-care - 4 Category deterioration | 0 Participants |
| Relugolix Plus Delayed E2/NETA (Group B) | Change From Pivotal Study Baseline In European Quality Of Life Five Dimension Five Level (EQ-5D-5L) Scale At Week 52 | Self-care - 2 Category deterioration | 1 Participants |
| Placebo (Group C) | Change From Pivotal Study Baseline In European Quality Of Life Five Dimension Five Level (EQ-5D-5L) Scale At Week 52 | Pain/discomfort - 2 Category deterioration | 0 Participants |
| Placebo (Group C) | Change From Pivotal Study Baseline In European Quality Of Life Five Dimension Five Level (EQ-5D-5L) Scale At Week 52 | Anxiety/depression - 3 Category improvement | 1 Participants |
| Placebo (Group C) | Change From Pivotal Study Baseline In European Quality Of Life Five Dimension Five Level (EQ-5D-5L) Scale At Week 52 | Self-care - 1 Category deterioration | 2 Participants |
| Placebo (Group C) | Change From Pivotal Study Baseline In European Quality Of Life Five Dimension Five Level (EQ-5D-5L) Scale At Week 52 | Mobility - 4 Category deterioration | 0 Participants |
| Placebo (Group C) | Change From Pivotal Study Baseline In European Quality Of Life Five Dimension Five Level (EQ-5D-5L) Scale At Week 52 | Self-care - No change | 108 Participants |
| Placebo (Group C) | Change From Pivotal Study Baseline In European Quality Of Life Five Dimension Five Level (EQ-5D-5L) Scale At Week 52 | Anxiety/depression - 3 Category deterioration | 0 Participants |
| Placebo (Group C) | Change From Pivotal Study Baseline In European Quality Of Life Five Dimension Five Level (EQ-5D-5L) Scale At Week 52 | Anxiety/depression - 4 Category deterioration | 1 Participants |
| Placebo (Group C) | Change From Pivotal Study Baseline In European Quality Of Life Five Dimension Five Level (EQ-5D-5L) Scale At Week 52 | Self care - 1 Category improvement | 5 Participants |
| Placebo (Group C) | Change From Pivotal Study Baseline In European Quality Of Life Five Dimension Five Level (EQ-5D-5L) Scale At Week 52 | Pain/discomfort - 1 Category deterioration | 10 Participants |
| Placebo (Group C) | Change From Pivotal Study Baseline In European Quality Of Life Five Dimension Five Level (EQ-5D-5L) Scale At Week 52 | Self care - 2 Category improvement | 1 Participants |
| Placebo (Group C) | Change From Pivotal Study Baseline In European Quality Of Life Five Dimension Five Level (EQ-5D-5L) Scale At Week 52 | Mobility - 2 Category deterioration | 0 Participants |
| Placebo (Group C) | Change From Pivotal Study Baseline In European Quality Of Life Five Dimension Five Level (EQ-5D-5L) Scale At Week 52 | Pain/discomfort - No change | 45 Participants |
| Placebo (Group C) | Change From Pivotal Study Baseline In European Quality Of Life Five Dimension Five Level (EQ-5D-5L) Scale At Week 52 | Self care - 3 Category improvement | 0 Participants |
| Placebo (Group C) | Change From Pivotal Study Baseline In European Quality Of Life Five Dimension Five Level (EQ-5D-5L) Scale At Week 52 | Mobility - 1 Category deterioration | 4 Participants |
| Placebo (Group C) | Change From Pivotal Study Baseline In European Quality Of Life Five Dimension Five Level (EQ-5D-5L) Scale At Week 52 | Anxiety/depression - 4 Category improvement | 1 Participants |
| Placebo (Group C) | Change From Pivotal Study Baseline In European Quality Of Life Five Dimension Five Level (EQ-5D-5L) Scale At Week 52 | Self care - 4 Category improvement | 1 Participants |
| Placebo (Group C) | Change From Pivotal Study Baseline In European Quality Of Life Five Dimension Five Level (EQ-5D-5L) Scale At Week 52 | Anxiety/depression - 2 Category deterioration | 5 Participants |
| Placebo (Group C) | Change From Pivotal Study Baseline In European Quality Of Life Five Dimension Five Level (EQ-5D-5L) Scale At Week 52 | Pain/discomfort - 1 Category improvement | 37 Participants |
| Placebo (Group C) | Change From Pivotal Study Baseline In European Quality Of Life Five Dimension Five Level (EQ-5D-5L) Scale At Week 52 | Usual activities - 4 Category deterioration | 0 Participants |
| Placebo (Group C) | Change From Pivotal Study Baseline In European Quality Of Life Five Dimension Five Level (EQ-5D-5L) Scale At Week 52 | Pain/discomfort - 4 Category improvement | 0 Participants |
| Placebo (Group C) | Change From Pivotal Study Baseline In European Quality Of Life Five Dimension Five Level (EQ-5D-5L) Scale At Week 52 | Usual activities - 3 Category deterioration | 0 Participants |
| Placebo (Group C) | Change From Pivotal Study Baseline In European Quality Of Life Five Dimension Five Level (EQ-5D-5L) Scale At Week 52 | Mobility - 1 Category improvement | 10 Participants |
| Placebo (Group C) | Change From Pivotal Study Baseline In European Quality Of Life Five Dimension Five Level (EQ-5D-5L) Scale At Week 52 | Pain/discomfort - 2 Category improvement | 17 Participants |
| Placebo (Group C) | Change From Pivotal Study Baseline In European Quality Of Life Five Dimension Five Level (EQ-5D-5L) Scale At Week 52 | Usual activities - 2 Category deterioration | 2 Participants |
| Placebo (Group C) | Change From Pivotal Study Baseline In European Quality Of Life Five Dimension Five Level (EQ-5D-5L) Scale At Week 52 | Anxiety/depression - 1 Category improvement | 17 Participants |
| Placebo (Group C) | Change From Pivotal Study Baseline In European Quality Of Life Five Dimension Five Level (EQ-5D-5L) Scale At Week 52 | Anxiety/depression - 2 Category improvement | 11 Participants |
| Placebo (Group C) | Change From Pivotal Study Baseline In European Quality Of Life Five Dimension Five Level (EQ-5D-5L) Scale At Week 52 | Usual activities - 1 Category deterioration | 4 Participants |
| Placebo (Group C) | Change From Pivotal Study Baseline In European Quality Of Life Five Dimension Five Level (EQ-5D-5L) Scale At Week 52 | Anxiety/depression - 1 Category deterioration | 12 Participants |
| Placebo (Group C) | Change From Pivotal Study Baseline In European Quality Of Life Five Dimension Five Level (EQ-5D-5L) Scale At Week 52 | Self-care - 2 Category deterioration | 0 Participants |
| Placebo (Group C) | Change From Pivotal Study Baseline In European Quality Of Life Five Dimension Five Level (EQ-5D-5L) Scale At Week 52 | Usual activities - No change | 73 Participants |
| Placebo (Group C) | Change From Pivotal Study Baseline In European Quality Of Life Five Dimension Five Level (EQ-5D-5L) Scale At Week 52 | Usual activities - 1 Category improvement | 22 Participants |
| Placebo (Group C) | Change From Pivotal Study Baseline In European Quality Of Life Five Dimension Five Level (EQ-5D-5L) Scale At Week 52 | Mobility - 2 Category improvement | 4 Participants |
| Placebo (Group C) | Change From Pivotal Study Baseline In European Quality Of Life Five Dimension Five Level (EQ-5D-5L) Scale At Week 52 | Mobility - 3 Category deterioration | 0 Participants |
| Placebo (Group C) | Change From Pivotal Study Baseline In European Quality Of Life Five Dimension Five Level (EQ-5D-5L) Scale At Week 52 | Pain/discomfort - 3 Category improvement | 6 Participants |
| Placebo (Group C) | Change From Pivotal Study Baseline In European Quality Of Life Five Dimension Five Level (EQ-5D-5L) Scale At Week 52 | Mobility - No change | 99 Participants |
| Placebo (Group C) | Change From Pivotal Study Baseline In European Quality Of Life Five Dimension Five Level (EQ-5D-5L) Scale At Week 52 | Usual activities - 4 Category improvement | 1 Participants |
| Placebo (Group C) | Change From Pivotal Study Baseline In European Quality Of Life Five Dimension Five Level (EQ-5D-5L) Scale At Week 52 | Anxiety/depression - No change | 69 Participants |
| Placebo (Group C) | Change From Pivotal Study Baseline In European Quality Of Life Five Dimension Five Level (EQ-5D-5L) Scale At Week 52 | Mobility - 3 Category improvement | 0 Participants |
| Placebo (Group C) | Change From Pivotal Study Baseline In European Quality Of Life Five Dimension Five Level (EQ-5D-5L) Scale At Week 52 | Pain/discomfort - 4 Category deterioration | 0 Participants |
| Placebo (Group C) | Change From Pivotal Study Baseline In European Quality Of Life Five Dimension Five Level (EQ-5D-5L) Scale At Week 52 | Usual activities - 2 Category improvement | 12 Participants |
| Placebo (Group C) | Change From Pivotal Study Baseline In European Quality Of Life Five Dimension Five Level (EQ-5D-5L) Scale At Week 52 | Self-care - 4 Category deterioration | 0 Participants |
| Placebo (Group C) | Change From Pivotal Study Baseline In European Quality Of Life Five Dimension Five Level (EQ-5D-5L) Scale At Week 52 | Pain/discomfort - 3 Category deterioration | 2 Participants |
| Placebo (Group C) | Change From Pivotal Study Baseline In European Quality Of Life Five Dimension Five Level (EQ-5D-5L) Scale At Week 52 | Self-care - 3 Category deterioration | 0 Participants |
| Placebo (Group C) | Change From Pivotal Study Baseline In European Quality Of Life Five Dimension Five Level (EQ-5D-5L) Scale At Week 52 | Usual activities - 3 Category improvement | 3 Participants |
| Placebo (Group C) | Change From Pivotal Study Baseline In European Quality Of Life Five Dimension Five Level (EQ-5D-5L) Scale At Week 52 | Mobility - 4 Category improvement | 0 Participants |