Cold Agglutinin Disease
Conditions
Brief summary
The purpose of Part A was to determine whether sutimlimab administration resulted in a greater than or equal to (\>=)1.5 grams per deciliter (g/dL) increase in hemoglobin (Hgb) level and avoidance of transfusion in participants with primary cold agglutinin disease (CAD) without a recent history of blood transfusion. The purpose of Part B was to evaluate the long-term safety and tolerability of sutimlimab in participants with primary CAD.
Detailed description
The planned total study duration per participant was approximately 1.5 to 2.5 years.
Interventions
DRUGsutimlimab (BIVV009)
Pharmaceutical form: solution for injection Route of administration: intravenous (i.v.)
DRUGplacebo
Pharmaceutical form: solution for injection Route of administration: intravenous (i.v.)
Sponsors
Bioverativ, a Sanofi company
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Body weight of \>=39 kg at screening. * Confirmed diagnosis of primary CAD based on the following criteria: a) Chronic hemolysis, b) Polyspecific direct antiglobulin test (DAT) positive, c) Monospecific DAT strongly positive for C3d, d) Cold agglutinin titer \>= 64 at 4 degree Celsius, and e) Immunoglobulin G DAT less than or equal to (\<=) 1+, and, f) No overt malignant disease. * Hemoglobin level \<= 10.0 g/dL. * Bilirubin level above the normal reference range, including participants with Gilbert's Syndrome.
Exclusion criteria
* Cold agglutinin syndrome secondary to infection, rheumatologic disease, or active hematologic malignancy. * History of blood transfusion within 6 months of screening, or history of more than one blood transfusion within 12 months of screening. * Clinically relevant infection of any kind within the month preceding enrollment (example, active hepatitis C, pneumonia). * Clinical diagnosis of systemic lupus erythematosus; or other autoimmune disorders with anti-nuclear antibodies at screening. Anti-nuclear antibodies of long-standing duration without associated clinical symptoms would be adjudicated on a case-by-case basis during the confirmatory review of participant eligibility. * Positive hepatitis panel (including hepatitis B surface antigen and/or hepatitis C virus antibody) prior to or at screening. * Positive human immunodeficiency virus antibody at screening. * Treatment with rituximab monotherapy within 3 months or rituximab combination therapies (example, with bendamustine, fludarabine, ibrutinib, or cytotoxic drugs) within 6 months prior to enrollment. The above information was not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Part A: Percentage of Participants With Response to Treatment | From Week 5 through Week 26 | A participant was considered a responder: if he or she did not receive blood transfusion from Week 5 through Week 26 (end of treatment) and did not receive treatment for CAD beyond what was permitted per protocol. Additionally, participant's hemoglobin (Hgb) level must have increased to \>=1.5 grams per deciliter (g/dL) from baseline (defined as last Hgb value before administration of first dose of study drug) at treatment assessment timepoint (defined as average of values from the Week 23, 25, and 26 visits). Percentage of responders was calculated together with 95% exact Clopper-Pearson confidence interval (CI). |
| Part B: Number of Participants With Treatment-emergent Adverse Events (AEs) and Serious AEs (SAEs) | Part B, 6.5 g cohort: From first dose (Week 26) up to 149 weeks of treatment + 9 weeks of follow-up (i.e., up to Week 184); Part B, 7.5 g cohort: From first dose (Week 26) up to 137 weeks of treatment + 9 weeks of follow-up (i.e., up to Week 172) | Adverse Event (AE): any untoward medical occurrence in a participant who received study drug and did not necessarily have to have a causal relationship with the treatment. Treatment emergent serious adverse events (TESAEs) was defined as any untoward medical occurrence that at any dose: resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was congenital anomaly/birth defect, was medically important event. Treatment emergent adverse events (TEAEs): AEs that developed, worsened or became serious during the treatment-emergent (TE) period (from first investigational medicinal product \[IMP\] administration in Part B to last IMP administration + 9 weeks follow-up period). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Part A: Mean Change From Baseline in Total Bilirubin Levels at the Treatment Assessment Timepoint | Baseline (Week 0), treatment assessment timepoint (i.e., average of Week 23, 25 and 26) | Mean change from baseline (Week 0) in total bilirubin at the treatment assessment timepoint is reported in this outcome measure. Treatment assessment timepoint was defined as the average of the values from the Week 23, 25, and 26 visits. Baseline was defined as the last non-missing value prior to the first administration of study drug. |
| Part A: Mean Change From Baseline in Lactate Dehydrogenase (LDH) at the Treatment Assessment Timepoint | Baseline (Week 0), treatment assessment timepoint (i.e., average of Week 23, 25 and 26) | Mean change from baseline (Week 0) in LDH at the treatment assessment timepoint is reported in this outcome measure. Treatment assessment timepoint was defined as the average of the values from the Week 23, 25, and 26 visits. Baseline was defined as the last non-missing value prior to the first administration of study drug. |
| Part A: Percentage of Participants With Solicited Symptomatic Anemia at Week 26 | Week 26 | Symptomatic anemia was defined as having following symptoms: i. Fatigue; ii. Weakness; iii. Shortness of breath; iv. Palpitations, fast heartbeat; v. Light headedness and/or vi. Chest pain. Percentage of participants with solicited symptomatic anemia symptoms was reported in this outcome measure. |
| Part B: Change From Baseline in Hemoglobin (Hgb) Level at Each Specified Time Points | Baseline (Week 0), every 2 weeks starting from Week 27 till Week 175 and at ET/SFU visit (i.e., up to Week 184) | Change from baseline (Week 0) in Hgb levels at each specified time points (i.e., Week 27, 29, 31, 33, 35, 37, 39, 41, 43,45, 47, 49, 51, 53, 55, 57, 59, 61, 63, 65, 67, 69, 71, 73, 75, 77, 79, 81, 83,85,87, 89,91, 93, 95, 97, 99,101,103, 105, 107,109, 111,113,115,117,119, 121,123, 125, 127,129,131,133,135,137,139,141,143,145,147,149,151,153, 155,157,159,161,163,165,167,169,171,173,175 and ET/SFU Visit) is reported in this outcome measure. Baseline was defined as the last non-missing value prior to the first administration of study drug in Part A. Early Termination (ET) visit/safety follow up (SFU) visit was 9 weeks after administration of last dose (i.e., up to Week 184). Here, 0 in the number analyzed field signifies that none of participants were available for assessment at the specified timepoints. |
| Part B: Change From Baseline in Total Bilirubin Levels at Each Specified Time Points | Baseline (Week 0), every 2 weeks starting from Week 27 till Week 175 and at ET/SFU visit (i.e., up to Week 184) | Change from baseline (Week 0) in total bilirubin levels at each specified time points (i.e., Week 27, 29, 31, 33, 35, 37, 39, 41, 43, 45, 47, 49, 51, 53, 55, 57, 59, 61, 63, 65,67,69,71,73,75, 77, 79, 81,83, 85, 87, 89, 91, 93, 95, 97, 99,101,103, 105, 107,109, 111,113,115,117,119, 121, 123, 125, 127,129,131,133,135,137,139,141,143, 145,147,149,151,153,155,157,159, 161,163,165,167,169,171,173,175 and ET/SFU Visit) is reported in this outcome measure. Baseline was defined as the last non-missing value prior to the first administration of study drug in Part A. ET visit/SFU visit was 9 weeks after administration of last dose (i.e., up to Week 184). Here, 0 in the number analyzed field signifies that none of participants were available for assessment at the specified timepoints. |
| Part B: Change From Baseline in Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Scale Score (Quality of Life) at Each Specified Time Points | Baseline (Week 0), Weeks 39, 51, 63, 75, 87, 99, 111, 123, 135, 147, 159, 171 and ET Visit/SFU visit (i.e., up to Week 184) | FACIT-Fatigue scale consists of 13 questions assessed using a 5-point scale (0=not at all; 1 = a little bit, 2 = somewhat, 3 = quite a bit and 4 = very much). Responses to each question were added to obtain a total score. The Total score ranged from 0 to 52, with higher score indicating more fatigue. Baseline (Week 0) was defined as the last non-missing value prior to the first administration of study drug in Part A. ET visit/SFU visit was 9 weeks after administration of last dose (i.e., up to Week 184). |
| Part B: Change From Baseline in 12-Item Short-Form Survey (SF-12) Physical Component Summary (PCS) and Mental Component Summary (MCS) Scores at Each Specified Time Points | Baseline (Week 0), Weeks 39, 51, 63, 75, 87, 99, 111, 123, 135, 147, 159, 171 and ET Visit/SFU visit (i.e., up to Week 184) | SF-12: 12 item-questionnaire assessed health-related quality of life (HRQOL), contained 12 items, categorized into 8 domains (subscales) of functioning and well-being: physical functioning, role-physical, role emotional, mental health, bodily pain, general health, vitality and social functioning, with each domain score ranged from 0 (poor health) to 100 (better health). Higher scores = good health condition. These 8 domains were further summarized into 2 summary scores, PCS and MCS that ranged from 0 (poor health) to 100 (better health). Higher scores = better HRQOL. Baseline (Week 0): last non-missing value prior to first administration of study drug in Part A. ET visit/SFU visit: 9 weeks after administration of last dose (i.e., up to Week 184). |
| Part A: Mean Change From Baseline in Hemoglobin (Hgb) Level at the Treatment Assessment Timepoint | Baseline (Week 0), treatment assessment timepoint (i.e., average of Week 23, 25 and 26) | Mean change from baseline (Week 0) in Hemoglobin (Hgb) at the treatment assessment timepoint is reported in this outcome measure. Treatment assessment timepoint was defined as the average of the values from the Week 23, 25, and 26 visits. Least squares (LS) mean and 95 % confidence interval (CI) was assessed by Mixed Model for Repeated Measures (MMRM) approach using heterogeneous Toeplitz (TOEPH) covariance matrix with change from baseline as the dependent variable and baseline value and visits as independent variables. Baseline was defined as the last non-missing value prior to the first administration of study drug. |
| Part B: Number of Participants With Response to Participant's Global Impression of (Fatigue) Severity (PGIS) Questionnaire at Each Specified Time Points | Baseline (Week 0), Weeks 39, 51, 63, 75, 87, 99, 111, 123, 135, 147, 159, 171 and ET Visit/SFU visit (i.e., up to Week 184) | The PGIS is a self-reported scale. The PGIS is a 1-item questionnaire designed to assess participant's impression of disease severity using a 5-point scale ranging from 1 to 5, where 1=none, 2=mild, 3=moderate, 4=severe, 5=very severe. Higher scores indicated greater severity. ET visit/SFU visit was 9 weeks after administration of last dose (i.e., up to Week 184). |
| Part B: Number of Participants With Response to Participant's Global Impression of Change (PGIC) Questionnaire at Each Specified Time Points | Baseline (Week 0), Weeks 39, 51, 63, 75, 87, 99, 111, 123, 135, 147, 159, 171 and ET Visit/SFU visit (i.e., up to Week 184) | PGIC is a self-administered questionnaire to evaluate the improvement or worsening compared to the start of the study. PGIC was assessed on a 7-point Likert scale ranged from 1 (greatly improved) to 7 (greatly worsened). Categories were defined based on the PGIC scores as follows: 1=very much improved, 2=much improved, 3=minimally improved, 4=no change, 5=minimally worse, 6=much worse and 7=very much worsen. Higher scores indicated greater severity. ET visit/SFU visit was 9 weeks after administration of last dose (i.e., up to Week 184). |
| Part B: Mean Change From Baseline in Lactate Dehydrogenase (LDH) Level at Each Specified Time Points | Baseline (Week 0), every 2 weeks starting from Week 27 till Week 175 and at ET/SFU visit (i.e., up to Week 184) | Change from baseline (Week 0) in LDH levels at each specified time points (i.e., Week 27, 29, 31, 33, 35, 37, 39, 41, 43, 45, 47, 49, 51, 53, 55, 57, 59, 61, 63, 65, 67, 69, 71, 73, 75, 77, 79, 81, 83, 85, 87, 89, 91, 93, 95, 97, 99, 101, 103, 105, 107,109, 111, 113, 115, 117, 119, 121,123, 125, 127,129,131,133,135,137,139,141,143,145,147, 149, 151,153,155,157,159,161,163,165,167,169, 171, 173, 175 and ET/SFU Visit) is reported in this outcome measure. Baseline was defined as the last non-missing value prior to the first administration of study drug in Part A. ET/SFU visit was 9 weeks after administration of last dose (i.e., up to Week 184). |
| Part B: Number of Blood Transfusions Per Participant | From Week 27 up to 149 weeks of treatment (i.e., up to Week 176) | A participant was to receive a transfusion if his or her Hgb level met either of the following criteria: Hgb was \<9 g/dL and the participant had symptoms of anemia or Hgb was \<7 g/dL and the participant was asymptomatic. |
| Part B: Mean Change From Baseline in Haptoglobin Values at Each Specified Time Points | Baseline (Week 0), every 2 weeks starting from Week 27 till Week 175 and at ET/SFU visit (i.e., up to Week 184) | Change from baseline (Week 0) in haptoglobin values at each specified time points (i.e., Week 27, 29, 31, 33, 35, 37, 39, 41, 43, 45, 47, 49, 51, 53, 55, 57, 59, 61, 63, 65, 67, 69, 71, 73, 75, 77, 79, 81, 83, 85, 87, 89, 91, 93, 95, 97,99,101,103, 105, 107,109, 111,113,115,117,119, 121,123, 125, 127, 129,131,133,135,137,139,141,143, 145,147,149,151,153,155,157,159, 161,163,165,167,169,171,173,175 and ET/SFU Visit) is reported in this outcome measure. Baseline was defined as the last non-missing value prior to the first administration of study drug in Part A. ET/SFU visit was 9 weeks after administration of last dose (i.e., up to Week 184). Haptoglobin values \<0.2 were imputed as 0.2. |
| Part B: Number of Healthcare Visits by Type | From Week 27 up to 149 weeks of treatment (i.e., up to Week 176) | In this outcome measure, number of healthcare visits which included non-study healthcare resource utilization visit (consisted mainly of extra visits to the office of the study doctor, visit to a generalist doctor or visit to a specialist doctor), hospitalization visit and visit to hospital emergency is reported. |
| Part B: Change From Baseline in 5-level European Quality of Life 5- Dimensions 5-Level Questionnaire (EQ-5D-5L) Health State Utility Index and VAS Scores at Each Specified Time Points | Baseline (Week 0), Weeks 39, 51, 63, 75, 87, 99, 111, 123, 135, 147, 159, 171 and ET Visit/SFU visit (i.e., up to Week 184) | EQ-5D-5L included 2 components: health state utility index (descriptive system) and Visual Analog Scale (VAS). EQ-5D descriptive system comprises 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 response option: no problem, slight problem, moderate problem, severe problem and extreme problems measured with Likert scale. EQ-5D-5L responses converted into single index utility score between 0 to 1. Higher score=better health. EQ-5D-5L VAS rated participant's current health state on scale from 0 (worst imaginable health) to 100 (best imaginable health). Baseline (Week 0): last non-missing value prior to first administration of study drug in Part A. ET visit/SFU visit: 9 weeks after administration of last dose (i.e., up to Week 184). |
| Part A: Mean Change From Baseline in Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Scale Score at the Treatment Assessment Timepoint | Baseline (Week 0), treatment assessment timepoint (i.e., average of Week 23, 25 and 26) | FACIT-Fatigue scale consists of 13 questions assessed using a 5-point scale (0=not at all; 1 = a little bit, 2 = somewhat, 3 = quite a bit and 4 = very much). Responses to each question were added to obtain a total score. Total score ranged from 0 to 52, with higher score indicating more fatigue. Treatment assessment timepoint was defined as the average of the values from the Week 23, 25, and 26 visits. LS mean and 95% CI was assessed by MMRM approach using TOEPH covariance matrix with change from baseline (Week 0) as the dependent variable and baseline value and visits as independent variables. Baseline was defined as the last non-missing value prior to the first administration of study drug. |
Countries
Australia, Austria, Belgium, Canada, France, Germany, Israel, Italy, Japan, Netherlands, Norway, Spain, United Kingdom, United States
Participant flow
Recruitment details
The study was conducted at 27 sites in 13 countries. Out of 66 screened participants, a total of 42 participants were enrolled and randomized from 17 March 2018 to 30 March 2020. This study consisted of 2 Parts: Part A and Part B.
Pre-assignment details
Participants were stratified based on baseline body weight to receive BIVV009 6.5 grams (g) (if \<75 kg) or 7.5 g (if \>=75 kg). As planned, data presented as: 1) Dose-wise (2 dose cohorts: BIVV009 6.5 g & BIVV009 7.5 g) for safety outcome measures and adverse events (AEs). 2) combined population (BIVV009 at any dose) for efficacy outcome measures.
Participants by arm
| Arm | Count |
|---|---|
| BIVV009/BIVV009 Participants with primary CAD and without a recent history of blood transfusion during the last 6 months prior to enrollment in this study, received an IV infusion of BIVV009 6.5 g (for participants \<75 kg) or 7.5 g dose (for participants \>=75 kg) on Day 0 and Day 7 and every 14 days thereafter in Part A up to Week 25. Participants who completed Part A per protocol through the end of treatment visit (Week 26), received placebo on Week 26 and continued to receive BIVV009 6.5 or 7.5 g in Part B, every 2 weeks starting at Week 27 for up to an additional 149 weeks (for 6.5 g) or 121 weeks (for 7.5 g). All participants who completed Part A elected to continue in Part B. | 22 |
| Placebo/BIVV009 Participants with primary CAD and without a recent history of blood transfusion during the last 6 months prior to enrollment in this study, received an IV infusion of placebo matched to BIVV009 on Day 0 and Day 7 and every 14 days thereafter in Part A up to Week 25. Participants who completed Part A per protocol through the end of treatment visit (Week 26) received BIVV009 6.5 (if \<75 kg) or 7.5 g (if \>=75 kg) in Part B, on Week 26 and Week 27 and every 2 weeks thereafter for up to an additional 123 weeks (for 6.5 g) or 137 weeks (for 7.5 g). All participants who completed Part A elected to continue in Part B. | 20 |
| Total | 42 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Part A (26 Weeks) | Adverse Event | 3 | 0 |
| Part B (149 Weeks) | Adverse Event | 0 | 1 |
| Part B (149 Weeks) | Lack of Efficacy | 1 | 2 |
| Part B (149 Weeks) | Other | 1 | 0 |
| Part B (149 Weeks) | Withdrawal by Subject | 1 | 1 |
Baseline characteristics
| Characteristic | Placebo/BIVV009 | Total | BIVV009/BIVV009 |
|---|---|---|---|
| Age, Continuous | 68.2 years STANDARD_DEVIATION 10.1 | 66.7 years STANDARD_DEVIATION 10.5 | 65.3 years STANDARD_DEVIATION 10.9 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 2 Participants | 7 Participants | 5 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 14 Participants | 31 Participants | 17 Participants |
| Race (NIH/OMB) White | 4 Participants | 4 Participants | 0 Participants |
| Sex: Female, Male Female | 16 Participants | 33 Participants | 17 Participants |
| Sex: Female, Male Male | 4 Participants | 9 Participants | 5 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk |
|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 17 | 0 / 5 | 0 / 20 | 1 / 32 | 0 / 7 |
| other Total, other adverse events | 16 / 17 | 5 / 5 | 3 / 20 | 28 / 32 | 7 / 7 |
| serious Total, serious adverse events | 2 / 17 | 1 / 5 | 0 / 20 | 6 / 32 | 1 / 7 |
Outcome results
Primary
Part A: Percentage of Participants With Response to Treatment
A participant was considered a responder: if he or she did not receive blood transfusion from Week 5 through Week 26 (end of treatment) and did not receive treatment for CAD beyond what was permitted per protocol. Additionally, participant's hemoglobin (Hgb) level must have increased to \>=1.5 grams per deciliter (g/dL) from baseline (defined as last Hgb value before administration of first dose of study drug) at treatment assessment timepoint (defined as average of values from the Week 23, 25, and 26 visits). Percentage of responders was calculated together with 95% exact Clopper-Pearson confidence interval (CI).
Time frame: From Week 5 through Week 26
Population: Analysis was performed on Part A-full analysis set (FAS) which included all randomized participants who received at least 1 dose (including partial dose) of study drug (BIVV009 or placebo). Data for this outcome measure was planned to be collected and analyzed for combined population of BIVV009 (i.e., all participants who received BIVV009 \[either at 6.5 or 7.5 g\] and placebo in Part A.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| BIVV009 | Part A: Percentage of Participants With Response to Treatment | 72.7 percentage of participants |
| Placebo | Part A: Percentage of Participants With Response to Treatment | 15.0 percentage of participants |
Comparison: A hierarchical testing procedure was used to control the overall type I error. Testing was then performed sequentially in order the outcome measures were reported and continued when primary outcome measure was statistically significant at two-sided 0.05 level.p-value: <0.00195% CI: [2.88, 88.04]Cochran-Mantel-Haenszel
Primary
Part B: Number of Participants With Treatment-emergent Adverse Events (AEs) and Serious AEs (SAEs)
Adverse Event (AE): any untoward medical occurrence in a participant who received study drug and did not necessarily have to have a causal relationship with the treatment. Treatment emergent serious adverse events (TESAEs) was defined as any untoward medical occurrence that at any dose: resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was congenital anomaly/birth defect, was medically important event. Treatment emergent adverse events (TEAEs): AEs that developed, worsened or became serious during the treatment-emergent (TE) period (from first investigational medicinal product \[IMP\] administration in Part B to last IMP administration + 9 weeks follow-up period).
Time frame: Part B, 6.5 g cohort: From first dose (Week 26) up to 149 weeks of treatment + 9 weeks of follow-up (i.e., up to Week 184); Part B, 7.5 g cohort: From first dose (Week 26) up to 137 weeks of treatment + 9 weeks of follow-up (i.e., up to Week 172)
Population: Analyzed on Part B safety analysis set (SAS) which included all participants who received at least 1 dose (including partial dose) of study drug in Part B. Data for this outcome measures was planned to be collected and analyzed separately for each dose of BIVV009 (6.5 g and 7.5 g).
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| BIVV009 | Part B: Number of Participants With Treatment-emergent Adverse Events (AEs) and Serious AEs (SAEs) | TEAEs | 29 Participants |
| BIVV009 | Part B: Number of Participants With Treatment-emergent Adverse Events (AEs) and Serious AEs (SAEs) | TESAEs | 6 Participants |
| Placebo | Part B: Number of Participants With Treatment-emergent Adverse Events (AEs) and Serious AEs (SAEs) | TEAEs | 7 Participants |
| Placebo | Part B: Number of Participants With Treatment-emergent Adverse Events (AEs) and Serious AEs (SAEs) | TESAEs | 1 Participants |
Secondary
Part A: Mean Change From Baseline in Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Scale Score at the Treatment Assessment Timepoint
FACIT-Fatigue scale consists of 13 questions assessed using a 5-point scale (0=not at all; 1 = a little bit, 2 = somewhat, 3 = quite a bit and 4 = very much). Responses to each question were added to obtain a total score. Total score ranged from 0 to 52, with higher score indicating more fatigue. Treatment assessment timepoint was defined as the average of the values from the Week 23, 25, and 26 visits. LS mean and 95% CI was assessed by MMRM approach using TOEPH covariance matrix with change from baseline (Week 0) as the dependent variable and baseline value and visits as independent variables. Baseline was defined as the last non-missing value prior to the first administration of study drug.
Time frame: Baseline (Week 0), treatment assessment timepoint (i.e., average of Week 23, 25 and 26)
Population: Analysis was performed on Part A-FAS. Data for this outcome measure was planned to be collected and analyzed for combined population of BIVV009 (i.e., all participants who received BIVV009 \[either 6.5 g or 7.5 g\]) and placebo in Part A.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| BIVV009 | Part A: Mean Change From Baseline in Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Scale Score at the Treatment Assessment Timepoint | 10.83 score on a scale |
| Placebo | Part A: Mean Change From Baseline in Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Scale Score at the Treatment Assessment Timepoint | 1.91 score on a scale |
Comparison: A hierarchical testing procedure was used to control the overall type I error. Testing was then performed sequentially in order the outcome measures were reported and continued when previous outcome measure was statistically significant at two-sided 0.05 level.p-value: <0.00195% CI: [4, 13.85]Mixed model for repeated measures
Secondary
Part A: Mean Change From Baseline in Hemoglobin (Hgb) Level at the Treatment Assessment Timepoint
Mean change from baseline (Week 0) in Hemoglobin (Hgb) at the treatment assessment timepoint is reported in this outcome measure. Treatment assessment timepoint was defined as the average of the values from the Week 23, 25, and 26 visits. Least squares (LS) mean and 95 % confidence interval (CI) was assessed by Mixed Model for Repeated Measures (MMRM) approach using heterogeneous Toeplitz (TOEPH) covariance matrix with change from baseline as the dependent variable and baseline value and visits as independent variables. Baseline was defined as the last non-missing value prior to the first administration of study drug.
Time frame: Baseline (Week 0), treatment assessment timepoint (i.e., average of Week 23, 25 and 26)
Population: Analysis was performed on Part A-FAS. Data for this outcome measure was planned to be collected and analyzed for combined population of BIVV009 (i.e., all participants who received BIVV009 \[either at 6.5 or 7.5 g\] and placebo in Part A.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| BIVV009 | Part A: Mean Change From Baseline in Hemoglobin (Hgb) Level at the Treatment Assessment Timepoint | 2.66 grams per deciliter |
| Placebo | Part A: Mean Change From Baseline in Hemoglobin (Hgb) Level at the Treatment Assessment Timepoint | 0.09 grams per deciliter |
Comparison: A hierarchical testing procedure was used to control the overall type I error. Testing was then performed sequentially in order the outcome measures were reported and continued when previous outcome measure was statistically significant at two-sided 0.05 level.p-value: <0.00195% CI: [1.75, 3.38]Mixed model for repeated measures
Secondary
Part A: Mean Change From Baseline in Lactate Dehydrogenase (LDH) at the Treatment Assessment Timepoint
Mean change from baseline (Week 0) in LDH at the treatment assessment timepoint is reported in this outcome measure. Treatment assessment timepoint was defined as the average of the values from the Week 23, 25, and 26 visits. Baseline was defined as the last non-missing value prior to the first administration of study drug.
Time frame: Baseline (Week 0), treatment assessment timepoint (i.e., average of Week 23, 25 and 26)
Population: Analysis was performed on Part A-FAS. Here, 'overall number of participants analyzed' = participants with available data for this outcome measure. Data for this outcome measure was planned to be collected and analyzed for combined population of BIVV009 (i.e., all participants who received BIVV009 \[either 6.5 g or 7.5 g\]) and placebo in Part A.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| BIVV009 | Part A: Mean Change From Baseline in Lactate Dehydrogenase (LDH) at the Treatment Assessment Timepoint | -150.833 units per liter | Standard Deviation 160.824 |
| Placebo | Part A: Mean Change From Baseline in Lactate Dehydrogenase (LDH) at the Treatment Assessment Timepoint | 7.600 units per liter | Standard Deviation 212.69 |
Secondary
Part A: Mean Change From Baseline in Total Bilirubin Levels at the Treatment Assessment Timepoint
Mean change from baseline (Week 0) in total bilirubin at the treatment assessment timepoint is reported in this outcome measure. Treatment assessment timepoint was defined as the average of the values from the Week 23, 25, and 26 visits. Baseline was defined as the last non-missing value prior to the first administration of study drug.
Time frame: Baseline (Week 0), treatment assessment timepoint (i.e., average of Week 23, 25 and 26)
Population: Analysis was performed on Part A-FAS. Here, 'overall number of participants analyzed' = participants with available data for this outcome measure. Data for this outcome measure was planned to be collected and analyzed for combined population of BIVV009 (i.e., all participants who received BIVV009 \[either at 6.5 or 7.5 g\] and placebo in Part A.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| BIVV009 | Part A: Mean Change From Baseline in Total Bilirubin Levels at the Treatment Assessment Timepoint | -22.881 micromoles per liter | Standard Deviation 10.401 |
| Placebo | Part A: Mean Change From Baseline in Total Bilirubin Levels at the Treatment Assessment Timepoint | -1.388 micromoles per liter | Standard Deviation 13.901 |
Secondary
Part A: Percentage of Participants With Solicited Symptomatic Anemia at Week 26
Symptomatic anemia was defined as having following symptoms: i. Fatigue; ii. Weakness; iii. Shortness of breath; iv. Palpitations, fast heartbeat; v. Light headedness and/or vi. Chest pain. Percentage of participants with solicited symptomatic anemia symptoms was reported in this outcome measure.
Time frame: Week 26
Population: Analysis was performed on Part A-FAS. Here, 'overall number of participants analyzed' = participants with available data for this outcome measure. Data for this outcome measure was planned to be collected and analyzed for combined population of BIVV009 (i.e., all participants who received BIVV009 \[either 6.5 g or 7.5 g\]) and placebo in Part A.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| BIVV009 | Part A: Percentage of Participants With Solicited Symptomatic Anemia at Week 26 | Fatigue | 31.6 percentage of participants |
| BIVV009 | Part A: Percentage of Participants With Solicited Symptomatic Anemia at Week 26 | Weakness | 5.3 percentage of participants |
| BIVV009 | Part A: Percentage of Participants With Solicited Symptomatic Anemia at Week 26 | Shortness of breath | 5.3 percentage of participants |
| BIVV009 | Part A: Percentage of Participants With Solicited Symptomatic Anemia at Week 26 | Palpitations | 0 percentage of participants |
| BIVV009 | Part A: Percentage of Participants With Solicited Symptomatic Anemia at Week 26 | Light headedness | 5.3 percentage of participants |
| BIVV009 | Part A: Percentage of Participants With Solicited Symptomatic Anemia at Week 26 | Chest pain | 0 percentage of participants |
| Placebo | Part A: Percentage of Participants With Solicited Symptomatic Anemia at Week 26 | Light headedness | 15.8 percentage of participants |
| Placebo | Part A: Percentage of Participants With Solicited Symptomatic Anemia at Week 26 | Fatigue | 68.4 percentage of participants |
| Placebo | Part A: Percentage of Participants With Solicited Symptomatic Anemia at Week 26 | Palpitations | 15.8 percentage of participants |
| Placebo | Part A: Percentage of Participants With Solicited Symptomatic Anemia at Week 26 | Weakness | 31.6 percentage of participants |
| Placebo | Part A: Percentage of Participants With Solicited Symptomatic Anemia at Week 26 | Chest pain | 5.3 percentage of participants |
| Placebo | Part A: Percentage of Participants With Solicited Symptomatic Anemia at Week 26 | Shortness of breath | 36.8 percentage of participants |
Secondary
Part B: Change From Baseline in 12-Item Short-Form Survey (SF-12) Physical Component Summary (PCS) and Mental Component Summary (MCS) Scores at Each Specified Time Points
SF-12: 12 item-questionnaire assessed health-related quality of life (HRQOL), contained 12 items, categorized into 8 domains (subscales) of functioning and well-being: physical functioning, role-physical, role emotional, mental health, bodily pain, general health, vitality and social functioning, with each domain score ranged from 0 (poor health) to 100 (better health). Higher scores = good health condition. These 8 domains were further summarized into 2 summary scores, PCS and MCS that ranged from 0 (poor health) to 100 (better health). Higher scores = better HRQOL. Baseline (Week 0): last non-missing value prior to first administration of study drug in Part A. ET visit/SFU visit: 9 weeks after administration of last dose (i.e., up to Week 184).
Time frame: Baseline (Week 0), Weeks 39, 51, 63, 75, 87, 99, 111, 123, 135, 147, 159, 171 and ET Visit/SFU visit (i.e., up to Week 184)
Population: Analysis was performed on Part B-FAS. Here, 'number analyzed'=participants with available data for each specified category and 0 in the number analyzed field signifies that none of participants were available for assessment at the specified timepoints. Data for this outcome measure was planned to be collected and analyzed for combined population of BIVV009 (i.e., all participants who received BIVV009 \[either 6.5 g or 7.5 g\]).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| BIVV009 | Part B: Change From Baseline in 12-Item Short-Form Survey (SF-12) Physical Component Summary (PCS) and Mental Component Summary (MCS) Scores at Each Specified Time Points | Week 111-MCS | 8.705 score on a scale | Standard Deviation 7.777 |
| BIVV009 | Part B: Change From Baseline in 12-Item Short-Form Survey (SF-12) Physical Component Summary (PCS) and Mental Component Summary (MCS) Scores at Each Specified Time Points | Week 39-PCS | 4.814 score on a scale | Standard Deviation 8.83 |
| BIVV009 | Part B: Change From Baseline in 12-Item Short-Form Survey (SF-12) Physical Component Summary (PCS) and Mental Component Summary (MCS) Scores at Each Specified Time Points | Week 123-PCS | 4.147 score on a scale | Standard Deviation 7.11 |
| BIVV009 | Part B: Change From Baseline in 12-Item Short-Form Survey (SF-12) Physical Component Summary (PCS) and Mental Component Summary (MCS) Scores at Each Specified Time Points | Week 63-MCS | 8.117 score on a scale | Standard Deviation 9.955 |
| BIVV009 | Part B: Change From Baseline in 12-Item Short-Form Survey (SF-12) Physical Component Summary (PCS) and Mental Component Summary (MCS) Scores at Each Specified Time Points | Week 123-MCS | 8.650 score on a scale | Standard Deviation 8.323 |
| BIVV009 | Part B: Change From Baseline in 12-Item Short-Form Survey (SF-12) Physical Component Summary (PCS) and Mental Component Summary (MCS) Scores at Each Specified Time Points | Week 39-MCS | 8.543 score on a scale | Standard Deviation 9.155 |
| BIVV009 | Part B: Change From Baseline in 12-Item Short-Form Survey (SF-12) Physical Component Summary (PCS) and Mental Component Summary (MCS) Scores at Each Specified Time Points | Week 135-PCS | 6.660 score on a scale | Standard Deviation 9.096 |
| BIVV009 | Part B: Change From Baseline in 12-Item Short-Form Survey (SF-12) Physical Component Summary (PCS) and Mental Component Summary (MCS) Scores at Each Specified Time Points | Week 87-PCS | 5.226 score on a scale | Standard Deviation 8.196 |
| BIVV009 | Part B: Change From Baseline in 12-Item Short-Form Survey (SF-12) Physical Component Summary (PCS) and Mental Component Summary (MCS) Scores at Each Specified Time Points | Week 135-MCS | 8.860 score on a scale | Standard Deviation 9.817 |
| BIVV009 | Part B: Change From Baseline in 12-Item Short-Form Survey (SF-12) Physical Component Summary (PCS) and Mental Component Summary (MCS) Scores at Each Specified Time Points | Week 75-PCS | 5.723 score on a scale | Standard Deviation 7.563 |
| BIVV009 | Part B: Change From Baseline in 12-Item Short-Form Survey (SF-12) Physical Component Summary (PCS) and Mental Component Summary (MCS) Scores at Each Specified Time Points | Week 147-PCS | -1.655 score on a scale | Standard Deviation 3.769 |
| BIVV009 | Part B: Change From Baseline in 12-Item Short-Form Survey (SF-12) Physical Component Summary (PCS) and Mental Component Summary (MCS) Scores at Each Specified Time Points | Week 87-MCS | 6.058 score on a scale | Standard Deviation 10.981 |
| BIVV009 | Part B: Change From Baseline in 12-Item Short-Form Survey (SF-12) Physical Component Summary (PCS) and Mental Component Summary (MCS) Scores at Each Specified Time Points | Week 147-MCS | 11.220 score on a scale | Standard Deviation 6.095 |
| BIVV009 | Part B: Change From Baseline in 12-Item Short-Form Survey (SF-12) Physical Component Summary (PCS) and Mental Component Summary (MCS) Scores at Each Specified Time Points | Week 75-MCS | 7.932 score on a scale | Standard Deviation 9.279 |
| BIVV009 | Part B: Change From Baseline in 12-Item Short-Form Survey (SF-12) Physical Component Summary (PCS) and Mental Component Summary (MCS) Scores at Each Specified Time Points | Week 159-PCS | 5.620 score on a scale | — |
| BIVV009 | Part B: Change From Baseline in 12-Item Short-Form Survey (SF-12) Physical Component Summary (PCS) and Mental Component Summary (MCS) Scores at Each Specified Time Points | Week 99-PCS | 3.945 score on a scale | Standard Deviation 7.463 |
| BIVV009 | Part B: Change From Baseline in 12-Item Short-Form Survey (SF-12) Physical Component Summary (PCS) and Mental Component Summary (MCS) Scores at Each Specified Time Points | Week 159-MCS | 16.400 score on a scale | — |
| BIVV009 | Part B: Change From Baseline in 12-Item Short-Form Survey (SF-12) Physical Component Summary (PCS) and Mental Component Summary (MCS) Scores at Each Specified Time Points | Week 51-MCS | 8.461 score on a scale | Standard Deviation 6.754 |
| BIVV009 | Part B: Change From Baseline in 12-Item Short-Form Survey (SF-12) Physical Component Summary (PCS) and Mental Component Summary (MCS) Scores at Each Specified Time Points | Week 171-PCS | 11.980 score on a scale | — |
| BIVV009 | Part B: Change From Baseline in 12-Item Short-Form Survey (SF-12) Physical Component Summary (PCS) and Mental Component Summary (MCS) Scores at Each Specified Time Points | Week 171-MCS | 0.250 score on a scale | — |
| BIVV009 | Part B: Change From Baseline in 12-Item Short-Form Survey (SF-12) Physical Component Summary (PCS) and Mental Component Summary (MCS) Scores at Each Specified Time Points | ET/SFU Visit-PCS | -3.478 score on a scale | Standard Deviation 10.875 |
| BIVV009 | Part B: Change From Baseline in 12-Item Short-Form Survey (SF-12) Physical Component Summary (PCS) and Mental Component Summary (MCS) Scores at Each Specified Time Points | Week 99-MCS | 7.136 score on a scale | Standard Deviation 11.85 |
| BIVV009 | Part B: Change From Baseline in 12-Item Short-Form Survey (SF-12) Physical Component Summary (PCS) and Mental Component Summary (MCS) Scores at Each Specified Time Points | ET/SFU Visit-MCS | 1.835 score on a scale | Standard Deviation 11.882 |
| BIVV009 | Part B: Change From Baseline in 12-Item Short-Form Survey (SF-12) Physical Component Summary (PCS) and Mental Component Summary (MCS) Scores at Each Specified Time Points | Week 51-PCS | 5.320 score on a scale | Standard Deviation 6.913 |
| BIVV009 | Part B: Change From Baseline in 12-Item Short-Form Survey (SF-12) Physical Component Summary (PCS) and Mental Component Summary (MCS) Scores at Each Specified Time Points | Week 111-PCS | 4.800 score on a scale | Standard Deviation 7.985 |
| BIVV009 | Part B: Change From Baseline in 12-Item Short-Form Survey (SF-12) Physical Component Summary (PCS) and Mental Component Summary (MCS) Scores at Each Specified Time Points | Week 63-PCS | 5.840 score on a scale | Standard Deviation 6.916 |
| Placebo | Part B: Change From Baseline in 12-Item Short-Form Survey (SF-12) Physical Component Summary (PCS) and Mental Component Summary (MCS) Scores at Each Specified Time Points | ET/SFU Visit-MCS | -2.137 score on a scale | Standard Deviation 10.148 |
| Placebo | Part B: Change From Baseline in 12-Item Short-Form Survey (SF-12) Physical Component Summary (PCS) and Mental Component Summary (MCS) Scores at Each Specified Time Points | Week 63-MCS | 1.722 score on a scale | Standard Deviation 10.175 |
| Placebo | Part B: Change From Baseline in 12-Item Short-Form Survey (SF-12) Physical Component Summary (PCS) and Mental Component Summary (MCS) Scores at Each Specified Time Points | Week 39-PCS | 6.745 score on a scale | Standard Deviation 11.255 |
| Placebo | Part B: Change From Baseline in 12-Item Short-Form Survey (SF-12) Physical Component Summary (PCS) and Mental Component Summary (MCS) Scores at Each Specified Time Points | Week 39-MCS | 1.151 score on a scale | Standard Deviation 11.591 |
| Placebo | Part B: Change From Baseline in 12-Item Short-Form Survey (SF-12) Physical Component Summary (PCS) and Mental Component Summary (MCS) Scores at Each Specified Time Points | Week 51-PCS | 5.654 score on a scale | Standard Deviation 8.527 |
| Placebo | Part B: Change From Baseline in 12-Item Short-Form Survey (SF-12) Physical Component Summary (PCS) and Mental Component Summary (MCS) Scores at Each Specified Time Points | Week 51-MCS | 1.704 score on a scale | Standard Deviation 8.813 |
| Placebo | Part B: Change From Baseline in 12-Item Short-Form Survey (SF-12) Physical Component Summary (PCS) and Mental Component Summary (MCS) Scores at Each Specified Time Points | Week 63-PCS | 6.216 score on a scale | Standard Deviation 9.514 |
| Placebo | Part B: Change From Baseline in 12-Item Short-Form Survey (SF-12) Physical Component Summary (PCS) and Mental Component Summary (MCS) Scores at Each Specified Time Points | Week 75-PCS | 7.661 score on a scale | Standard Deviation 10.418 |
| Placebo | Part B: Change From Baseline in 12-Item Short-Form Survey (SF-12) Physical Component Summary (PCS) and Mental Component Summary (MCS) Scores at Each Specified Time Points | Week 75-MCS | 3.519 score on a scale | Standard Deviation 7.891 |
| Placebo | Part B: Change From Baseline in 12-Item Short-Form Survey (SF-12) Physical Component Summary (PCS) and Mental Component Summary (MCS) Scores at Each Specified Time Points | Week 87-PCS | 8.778 score on a scale | Standard Deviation 12.405 |
| Placebo | Part B: Change From Baseline in 12-Item Short-Form Survey (SF-12) Physical Component Summary (PCS) and Mental Component Summary (MCS) Scores at Each Specified Time Points | Week 87-MCS | 2.219 score on a scale | Standard Deviation 9.111 |
| Placebo | Part B: Change From Baseline in 12-Item Short-Form Survey (SF-12) Physical Component Summary (PCS) and Mental Component Summary (MCS) Scores at Each Specified Time Points | Week 99-PCS | 8.262 score on a scale | Standard Deviation 12.534 |
| Placebo | Part B: Change From Baseline in 12-Item Short-Form Survey (SF-12) Physical Component Summary (PCS) and Mental Component Summary (MCS) Scores at Each Specified Time Points | Week 99-MCS | 4.682 score on a scale | Standard Deviation 7.698 |
| Placebo | Part B: Change From Baseline in 12-Item Short-Form Survey (SF-12) Physical Component Summary (PCS) and Mental Component Summary (MCS) Scores at Each Specified Time Points | Week 111-PCS | 8.080 score on a scale | Standard Deviation 12.302 |
| Placebo | Part B: Change From Baseline in 12-Item Short-Form Survey (SF-12) Physical Component Summary (PCS) and Mental Component Summary (MCS) Scores at Each Specified Time Points | Week 111-MCS | 4.411 score on a scale | Standard Deviation 10.249 |
| Placebo | Part B: Change From Baseline in 12-Item Short-Form Survey (SF-12) Physical Component Summary (PCS) and Mental Component Summary (MCS) Scores at Each Specified Time Points | Week 123-PCS | 7.973 score on a scale | Standard Deviation 13.2 |
| Placebo | Part B: Change From Baseline in 12-Item Short-Form Survey (SF-12) Physical Component Summary (PCS) and Mental Component Summary (MCS) Scores at Each Specified Time Points | Week 123-MCS | -2.538 score on a scale | Standard Deviation 13.136 |
| Placebo | Part B: Change From Baseline in 12-Item Short-Form Survey (SF-12) Physical Component Summary (PCS) and Mental Component Summary (MCS) Scores at Each Specified Time Points | Week 135-PCS | 6.070 score on a scale | Standard Deviation 13.819 |
| Placebo | Part B: Change From Baseline in 12-Item Short-Form Survey (SF-12) Physical Component Summary (PCS) and Mental Component Summary (MCS) Scores at Each Specified Time Points | Week 135-MCS | 2.790 score on a scale | Standard Deviation 6.17 |
| Placebo | Part B: Change From Baseline in 12-Item Short-Form Survey (SF-12) Physical Component Summary (PCS) and Mental Component Summary (MCS) Scores at Each Specified Time Points | Week 147-PCS | -3.740 score on a scale | Standard Deviation 1.824 |
| Placebo | Part B: Change From Baseline in 12-Item Short-Form Survey (SF-12) Physical Component Summary (PCS) and Mental Component Summary (MCS) Scores at Each Specified Time Points | Week 147-MCS | -1.110 score on a scale | Standard Deviation 0.679 |
| Placebo | Part B: Change From Baseline in 12-Item Short-Form Survey (SF-12) Physical Component Summary (PCS) and Mental Component Summary (MCS) Scores at Each Specified Time Points | Week 159-PCS | -10.410 score on a scale | — |
| Placebo | Part B: Change From Baseline in 12-Item Short-Form Survey (SF-12) Physical Component Summary (PCS) and Mental Component Summary (MCS) Scores at Each Specified Time Points | Week 159-MCS | 9.590 score on a scale | — |
| Placebo | Part B: Change From Baseline in 12-Item Short-Form Survey (SF-12) Physical Component Summary (PCS) and Mental Component Summary (MCS) Scores at Each Specified Time Points | ET/SFU Visit-PCS | -0.429 score on a scale | Standard Deviation 10.922 |
Secondary
Part B: Change From Baseline in 5-level European Quality of Life 5- Dimensions 5-Level Questionnaire (EQ-5D-5L) Health State Utility Index and VAS Scores at Each Specified Time Points
EQ-5D-5L included 2 components: health state utility index (descriptive system) and Visual Analog Scale (VAS). EQ-5D descriptive system comprises 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 response option: no problem, slight problem, moderate problem, severe problem and extreme problems measured with Likert scale. EQ-5D-5L responses converted into single index utility score between 0 to 1. Higher score=better health. EQ-5D-5L VAS rated participant's current health state on scale from 0 (worst imaginable health) to 100 (best imaginable health). Baseline (Week 0): last non-missing value prior to first administration of study drug in Part A. ET visit/SFU visit: 9 weeks after administration of last dose (i.e., up to Week 184).
Time frame: Baseline (Week 0), Weeks 39, 51, 63, 75, 87, 99, 111, 123, 135, 147, 159, 171 and ET Visit/SFU visit (i.e., up to Week 184)
Population: Analysis was performed on Part B-FAS. Here, 'number analyzed'=participants with available data for each specified category and 0 in the number analyzed field signifies that none of participants were available for assessment at the specified timepoints. Data for this outcome measure was planned to be collected and analyzed for combined population of BIVV009 (i.e., all participants who received BIVV009 \[either 6.5 g or 7.5 g\]).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| BIVV009 | Part B: Change From Baseline in 5-level European Quality of Life 5- Dimensions 5-Level Questionnaire (EQ-5D-5L) Health State Utility Index and VAS Scores at Each Specified Time Points | ET/SFU Visit-Index score | -0.108 score on a scale | Standard Deviation 0.238 |
| BIVV009 | Part B: Change From Baseline in 5-level European Quality of Life 5- Dimensions 5-Level Questionnaire (EQ-5D-5L) Health State Utility Index and VAS Scores at Each Specified Time Points | Week 75-Index score | -0.004 score on a scale | Standard Deviation 0.144 |
| BIVV009 | Part B: Change From Baseline in 5-level European Quality of Life 5- Dimensions 5-Level Questionnaire (EQ-5D-5L) Health State Utility Index and VAS Scores at Each Specified Time Points | Week 39-VAS | 20.647 score on a scale | Standard Deviation 16.871 |
| BIVV009 | Part B: Change From Baseline in 5-level European Quality of Life 5- Dimensions 5-Level Questionnaire (EQ-5D-5L) Health State Utility Index and VAS Scores at Each Specified Time Points | Week 135-VAS | 26.000 score on a scale | Standard Deviation 20.433 |
| BIVV009 | Part B: Change From Baseline in 5-level European Quality of Life 5- Dimensions 5-Level Questionnaire (EQ-5D-5L) Health State Utility Index and VAS Scores at Each Specified Time Points | Week 51-VAS | 14.800 score on a scale | Standard Deviation 27.589 |
| BIVV009 | Part B: Change From Baseline in 5-level European Quality of Life 5- Dimensions 5-Level Questionnaire (EQ-5D-5L) Health State Utility Index and VAS Scores at Each Specified Time Points | Week 99-Index score | -0.058 score on a scale | Standard Deviation 0.216 |
| BIVV009 | Part B: Change From Baseline in 5-level European Quality of Life 5- Dimensions 5-Level Questionnaire (EQ-5D-5L) Health State Utility Index and VAS Scores at Each Specified Time Points | Week 63-VAS | 19.867 score on a scale | Standard Deviation 21.603 |
| BIVV009 | Part B: Change From Baseline in 5-level European Quality of Life 5- Dimensions 5-Level Questionnaire (EQ-5D-5L) Health State Utility Index and VAS Scores at Each Specified Time Points | Week 87-Index score | -0.034 score on a scale | Standard Deviation 0.24 |
| BIVV009 | Part B: Change From Baseline in 5-level European Quality of Life 5- Dimensions 5-Level Questionnaire (EQ-5D-5L) Health State Utility Index and VAS Scores at Each Specified Time Points | Week 75-VAS | 16.846 score on a scale | Standard Deviation 22.12 |
| BIVV009 | Part B: Change From Baseline in 5-level European Quality of Life 5- Dimensions 5-Level Questionnaire (EQ-5D-5L) Health State Utility Index and VAS Scores at Each Specified Time Points | Week 39-Index score | 0.020 score on a scale | Standard Deviation 0.165 |
| BIVV009 | Part B: Change From Baseline in 5-level European Quality of Life 5- Dimensions 5-Level Questionnaire (EQ-5D-5L) Health State Utility Index and VAS Scores at Each Specified Time Points | Week 87-VAS | 14.077 score on a scale | Standard Deviation 25.221 |
| BIVV009 | Part B: Change From Baseline in 5-level European Quality of Life 5- Dimensions 5-Level Questionnaire (EQ-5D-5L) Health State Utility Index and VAS Scores at Each Specified Time Points | Week 123-Index score | -0.020 score on a scale | Standard Deviation 0.235 |
| BIVV009 | Part B: Change From Baseline in 5-level European Quality of Life 5- Dimensions 5-Level Questionnaire (EQ-5D-5L) Health State Utility Index and VAS Scores at Each Specified Time Points | Week 99-VAS | 19.364 score on a scale | Standard Deviation 20.796 |
| BIVV009 | Part B: Change From Baseline in 5-level European Quality of Life 5- Dimensions 5-Level Questionnaire (EQ-5D-5L) Health State Utility Index and VAS Scores at Each Specified Time Points | Week 51-Index score | 0.075 score on a scale | Standard Deviation 0.173 |
| BIVV009 | Part B: Change From Baseline in 5-level European Quality of Life 5- Dimensions 5-Level Questionnaire (EQ-5D-5L) Health State Utility Index and VAS Scores at Each Specified Time Points | Week 135-Index score | 0.008 score on a scale | Standard Deviation 0.351 |
| BIVV009 | Part B: Change From Baseline in 5-level European Quality of Life 5- Dimensions 5-Level Questionnaire (EQ-5D-5L) Health State Utility Index and VAS Scores at Each Specified Time Points | Week 123-VAS | 21.667 score on a scale | Standard Deviation 18.371 |
| BIVV009 | Part B: Change From Baseline in 5-level European Quality of Life 5- Dimensions 5-Level Questionnaire (EQ-5D-5L) Health State Utility Index and VAS Scores at Each Specified Time Points | Week 111-Index score | -0.033 score on a scale | Standard Deviation 0.205 |
| BIVV009 | Part B: Change From Baseline in 5-level European Quality of Life 5- Dimensions 5-Level Questionnaire (EQ-5D-5L) Health State Utility Index and VAS Scores at Each Specified Time Points | Week 147-Index score | 0.054 score on a scale | Standard Deviation 0.037 |
| BIVV009 | Part B: Change From Baseline in 5-level European Quality of Life 5- Dimensions 5-Level Questionnaire (EQ-5D-5L) Health State Utility Index and VAS Scores at Each Specified Time Points | Week 147-VAS | 17.500 score on a scale | Standard Deviation 17.678 |
| BIVV009 | Part B: Change From Baseline in 5-level European Quality of Life 5- Dimensions 5-Level Questionnaire (EQ-5D-5L) Health State Utility Index and VAS Scores at Each Specified Time Points | Week 159-VAS | 40.000 score on a scale | — |
| BIVV009 | Part B: Change From Baseline in 5-level European Quality of Life 5- Dimensions 5-Level Questionnaire (EQ-5D-5L) Health State Utility Index and VAS Scores at Each Specified Time Points | Week 63-Index score | 0.060 score on a scale | Standard Deviation 0.214 |
| BIVV009 | Part B: Change From Baseline in 5-level European Quality of Life 5- Dimensions 5-Level Questionnaire (EQ-5D-5L) Health State Utility Index and VAS Scores at Each Specified Time Points | Week 171-VAS | 35.000 score on a scale | — |
| BIVV009 | Part B: Change From Baseline in 5-level European Quality of Life 5- Dimensions 5-Level Questionnaire (EQ-5D-5L) Health State Utility Index and VAS Scores at Each Specified Time Points | ET/SFU Visit-VAS | 1.526 score on a scale | Standard Deviation 17.976 |
| BIVV009 | Part B: Change From Baseline in 5-level European Quality of Life 5- Dimensions 5-Level Questionnaire (EQ-5D-5L) Health State Utility Index and VAS Scores at Each Specified Time Points | Week 159-Index score | 0.174 score on a scale | — |
| BIVV009 | Part B: Change From Baseline in 5-level European Quality of Life 5- Dimensions 5-Level Questionnaire (EQ-5D-5L) Health State Utility Index and VAS Scores at Each Specified Time Points | Week 111-VAS | 18.273 score on a scale | Standard Deviation 19.463 |
| BIVV009 | Part B: Change From Baseline in 5-level European Quality of Life 5- Dimensions 5-Level Questionnaire (EQ-5D-5L) Health State Utility Index and VAS Scores at Each Specified Time Points | Week 171-Index score | 0.053 score on a scale | — |
| Placebo | Part B: Change From Baseline in 5-level European Quality of Life 5- Dimensions 5-Level Questionnaire (EQ-5D-5L) Health State Utility Index and VAS Scores at Each Specified Time Points | ET/SFU Visit-VAS | -2.056 score on a scale | Standard Deviation 14.957 |
| Placebo | Part B: Change From Baseline in 5-level European Quality of Life 5- Dimensions 5-Level Questionnaire (EQ-5D-5L) Health State Utility Index and VAS Scores at Each Specified Time Points | Week 87-Index score | 0.059 score on a scale | Standard Deviation 0.158 |
| Placebo | Part B: Change From Baseline in 5-level European Quality of Life 5- Dimensions 5-Level Questionnaire (EQ-5D-5L) Health State Utility Index and VAS Scores at Each Specified Time Points | Week 147-VAS | 3.500 score on a scale | Standard Deviation 26.163 |
| Placebo | Part B: Change From Baseline in 5-level European Quality of Life 5- Dimensions 5-Level Questionnaire (EQ-5D-5L) Health State Utility Index and VAS Scores at Each Specified Time Points | Week 51-Index score | -0.008 score on a scale | Standard Deviation 0.197 |
| Placebo | Part B: Change From Baseline in 5-level European Quality of Life 5- Dimensions 5-Level Questionnaire (EQ-5D-5L) Health State Utility Index and VAS Scores at Each Specified Time Points | Week 63-Index score | 0.015 score on a scale | Standard Deviation 0.157 |
| Placebo | Part B: Change From Baseline in 5-level European Quality of Life 5- Dimensions 5-Level Questionnaire (EQ-5D-5L) Health State Utility Index and VAS Scores at Each Specified Time Points | Week 75-Index score | 0.063 score on a scale | Standard Deviation 0.152 |
| Placebo | Part B: Change From Baseline in 5-level European Quality of Life 5- Dimensions 5-Level Questionnaire (EQ-5D-5L) Health State Utility Index and VAS Scores at Each Specified Time Points | Week 99-Index score | 0.058 score on a scale | Standard Deviation 0.146 |
| Placebo | Part B: Change From Baseline in 5-level European Quality of Life 5- Dimensions 5-Level Questionnaire (EQ-5D-5L) Health State Utility Index and VAS Scores at Each Specified Time Points | Week 111-Index score | 0.050 score on a scale | Standard Deviation 0.194 |
| Placebo | Part B: Change From Baseline in 5-level European Quality of Life 5- Dimensions 5-Level Questionnaire (EQ-5D-5L) Health State Utility Index and VAS Scores at Each Specified Time Points | Week 123-Index score | 0.031 score on a scale | Standard Deviation 0.221 |
| Placebo | Part B: Change From Baseline in 5-level European Quality of Life 5- Dimensions 5-Level Questionnaire (EQ-5D-5L) Health State Utility Index and VAS Scores at Each Specified Time Points | Week 135-Index score | 0.094 score on a scale | Standard Deviation 0.245 |
| Placebo | Part B: Change From Baseline in 5-level European Quality of Life 5- Dimensions 5-Level Questionnaire (EQ-5D-5L) Health State Utility Index and VAS Scores at Each Specified Time Points | Week 147-Index score | -0.087 score on a scale | Standard Deviation 0.222 |
| Placebo | Part B: Change From Baseline in 5-level European Quality of Life 5- Dimensions 5-Level Questionnaire (EQ-5D-5L) Health State Utility Index and VAS Scores at Each Specified Time Points | Week 159-Index score | 0.087 score on a scale | — |
| Placebo | Part B: Change From Baseline in 5-level European Quality of Life 5- Dimensions 5-Level Questionnaire (EQ-5D-5L) Health State Utility Index and VAS Scores at Each Specified Time Points | ET/SFU Visit-Index score | -0.077 score on a scale | Standard Deviation 0.169 |
| Placebo | Part B: Change From Baseline in 5-level European Quality of Life 5- Dimensions 5-Level Questionnaire (EQ-5D-5L) Health State Utility Index and VAS Scores at Each Specified Time Points | Week 39-VAS | 12.000 score on a scale | Standard Deviation 17.146 |
| Placebo | Part B: Change From Baseline in 5-level European Quality of Life 5- Dimensions 5-Level Questionnaire (EQ-5D-5L) Health State Utility Index and VAS Scores at Each Specified Time Points | Week 51-VAS | 9.125 score on a scale | Standard Deviation 21.112 |
| Placebo | Part B: Change From Baseline in 5-level European Quality of Life 5- Dimensions 5-Level Questionnaire (EQ-5D-5L) Health State Utility Index and VAS Scores at Each Specified Time Points | Week 63-VAS | 14.375 score on a scale | Standard Deviation 15.573 |
| Placebo | Part B: Change From Baseline in 5-level European Quality of Life 5- Dimensions 5-Level Questionnaire (EQ-5D-5L) Health State Utility Index and VAS Scores at Each Specified Time Points | Week 75-VAS | 18.933 score on a scale | Standard Deviation 20.243 |
| Placebo | Part B: Change From Baseline in 5-level European Quality of Life 5- Dimensions 5-Level Questionnaire (EQ-5D-5L) Health State Utility Index and VAS Scores at Each Specified Time Points | Week 87-VAS | 16.867 score on a scale | Standard Deviation 17.912 |
| Placebo | Part B: Change From Baseline in 5-level European Quality of Life 5- Dimensions 5-Level Questionnaire (EQ-5D-5L) Health State Utility Index and VAS Scores at Each Specified Time Points | Week 99-VAS | 18.385 score on a scale | Standard Deviation 20.706 |
| Placebo | Part B: Change From Baseline in 5-level European Quality of Life 5- Dimensions 5-Level Questionnaire (EQ-5D-5L) Health State Utility Index and VAS Scores at Each Specified Time Points | Week 111-VAS | 22.833 score on a scale | Standard Deviation 20.621 |
| Placebo | Part B: Change From Baseline in 5-level European Quality of Life 5- Dimensions 5-Level Questionnaire (EQ-5D-5L) Health State Utility Index and VAS Scores at Each Specified Time Points | Week 123-VAS | 18.000 score on a scale | Standard Deviation 30.389 |
| Placebo | Part B: Change From Baseline in 5-level European Quality of Life 5- Dimensions 5-Level Questionnaire (EQ-5D-5L) Health State Utility Index and VAS Scores at Each Specified Time Points | Week 135-VAS | 23.400 score on a scale | Standard Deviation 27.574 |
| Placebo | Part B: Change From Baseline in 5-level European Quality of Life 5- Dimensions 5-Level Questionnaire (EQ-5D-5L) Health State Utility Index and VAS Scores at Each Specified Time Points | Week 159-VAS | 27.000 score on a scale | — |
| Placebo | Part B: Change From Baseline in 5-level European Quality of Life 5- Dimensions 5-Level Questionnaire (EQ-5D-5L) Health State Utility Index and VAS Scores at Each Specified Time Points | Week 39-Index score | 0.054 score on a scale | Standard Deviation 0.135 |
Secondary
Part B: Change From Baseline in Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Scale Score (Quality of Life) at Each Specified Time Points
FACIT-Fatigue scale consists of 13 questions assessed using a 5-point scale (0=not at all; 1 = a little bit, 2 = somewhat, 3 = quite a bit and 4 = very much). Responses to each question were added to obtain a total score. The Total score ranged from 0 to 52, with higher score indicating more fatigue. Baseline (Week 0) was defined as the last non-missing value prior to the first administration of study drug in Part A. ET visit/SFU visit was 9 weeks after administration of last dose (i.e., up to Week 184).
Time frame: Baseline (Week 0), Weeks 39, 51, 63, 75, 87, 99, 111, 123, 135, 147, 159, 171 and ET Visit/SFU visit (i.e., up to Week 184)
Population: Analysis was performed on Part B-FAS. Here, 'number analyzed'=participants with available data for each specified category and 0 in the number analyzed field signifies that none of participants were available for assessment at the specified timepoints. Data for this outcome measure was planned to be collected and analyzed for combined population of BIVV009 (i.e., all participants who received BIVV009 \[either 6.5 g or 7.5 g\]).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| BIVV009 | Part B: Change From Baseline in Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Scale Score (Quality of Life) at Each Specified Time Points | Week 63 | 10.672 score on a scale | Standard Deviation 13.225 |
| BIVV009 | Part B: Change From Baseline in Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Scale Score (Quality of Life) at Each Specified Time Points | Week 99 | 12.109 score on a scale | Standard Deviation 14.786 |
| BIVV009 | Part B: Change From Baseline in Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Scale Score (Quality of Life) at Each Specified Time Points | Week 111 | 11.563 score on a scale | Standard Deviation 13.411 |
| BIVV009 | Part B: Change From Baseline in Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Scale Score (Quality of Life) at Each Specified Time Points | Week 123 | 10.806 score on a scale | Standard Deviation 13.736 |
| BIVV009 | Part B: Change From Baseline in Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Scale Score (Quality of Life) at Each Specified Time Points | Week 135 | 16.683 score on a scale | Standard Deviation 18.953 |
| BIVV009 | Part B: Change From Baseline in Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Scale Score (Quality of Life) at Each Specified Time Points | Week 147 | 9.208 score on a scale | Standard Deviation 1.12 |
| BIVV009 | Part B: Change From Baseline in Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Scale Score (Quality of Life) at Each Specified Time Points | Week 159 | 20.000 score on a scale | — |
| BIVV009 | Part B: Change From Baseline in Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Scale Score (Quality of Life) at Each Specified Time Points | Week 171 | 15.000 score on a scale | — |
| BIVV009 | Part B: Change From Baseline in Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Scale Score (Quality of Life) at Each Specified Time Points | ET/SFU Visit | -1.257 score on a scale | Standard Deviation 10.399 |
| BIVV009 | Part B: Change From Baseline in Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Scale Score (Quality of Life) at Each Specified Time Points | Week 39 | 11.048 score on a scale | Standard Deviation 12.333 |
| BIVV009 | Part B: Change From Baseline in Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Scale Score (Quality of Life) at Each Specified Time Points | Week 51 | 10.080 score on a scale | Standard Deviation 11.506 |
| BIVV009 | Part B: Change From Baseline in Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Scale Score (Quality of Life) at Each Specified Time Points | Week 75 | 9.861 score on a scale | Standard Deviation 12.953 |
| BIVV009 | Part B: Change From Baseline in Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Scale Score (Quality of Life) at Each Specified Time Points | Week 87 | 11.015 score on a scale | Standard Deviation 13.972 |
| Placebo | Part B: Change From Baseline in Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Scale Score (Quality of Life) at Each Specified Time Points | Week 63 | 8.499 score on a scale | Standard Deviation 11.146 |
| Placebo | Part B: Change From Baseline in Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Scale Score (Quality of Life) at Each Specified Time Points | Week 87 | 8.483 score on a scale | Standard Deviation 11.323 |
| Placebo | Part B: Change From Baseline in Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Scale Score (Quality of Life) at Each Specified Time Points | Week 51 | 6.354 score on a scale | Standard Deviation 9.68 |
| Placebo | Part B: Change From Baseline in Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Scale Score (Quality of Life) at Each Specified Time Points | Week 99 | 8.788 score on a scale | Standard Deviation 10.985 |
| Placebo | Part B: Change From Baseline in Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Scale Score (Quality of Life) at Each Specified Time Points | Week 159 | 10.000 score on a scale | — |
| Placebo | Part B: Change From Baseline in Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Scale Score (Quality of Life) at Each Specified Time Points | Week 111 | 10.688 score on a scale | Standard Deviation 11.768 |
| Placebo | Part B: Change From Baseline in Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Scale Score (Quality of Life) at Each Specified Time Points | Week 39 | 7.958 score on a scale | Standard Deviation 12.003 |
| Placebo | Part B: Change From Baseline in Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Scale Score (Quality of Life) at Each Specified Time Points | Week 123 | 6.583 score on a scale | Standard Deviation 16.613 |
| Placebo | Part B: Change From Baseline in Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Scale Score (Quality of Life) at Each Specified Time Points | Week 75 | 10.304 score on a scale | Standard Deviation 9.722 |
| Placebo | Part B: Change From Baseline in Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Scale Score (Quality of Life) at Each Specified Time Points | Week 135 | 12.650 score on a scale | Standard Deviation 15.243 |
| Placebo | Part B: Change From Baseline in Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Scale Score (Quality of Life) at Each Specified Time Points | ET/SFU Visit | -1.551 score on a scale | Standard Deviation 12.84 |
| Placebo | Part B: Change From Baseline in Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Scale Score (Quality of Life) at Each Specified Time Points | Week 147 | 0.500 score on a scale | Standard Deviation 2.121 |
Secondary
Part B: Change From Baseline in Hemoglobin (Hgb) Level at Each Specified Time Points
Change from baseline (Week 0) in Hgb levels at each specified time points (i.e., Week 27, 29, 31, 33, 35, 37, 39, 41, 43,45, 47, 49, 51, 53, 55, 57, 59, 61, 63, 65, 67, 69, 71, 73, 75, 77, 79, 81, 83,85,87, 89,91, 93, 95, 97, 99,101,103, 105, 107,109, 111,113,115,117,119, 121,123, 125, 127,129,131,133,135,137,139,141,143,145,147,149,151,153, 155,157,159,161,163,165,167,169,171,173,175 and ET/SFU Visit) is reported in this outcome measure. Baseline was defined as the last non-missing value prior to the first administration of study drug in Part A. Early Termination (ET) visit/safety follow up (SFU) visit was 9 weeks after administration of last dose (i.e., up to Week 184). Here, 0 in the number analyzed field signifies that none of participants were available for assessment at the specified timepoints.
Time frame: Baseline (Week 0), every 2 weeks starting from Week 27 till Week 175 and at ET/SFU visit (i.e., up to Week 184)
Population: Analyzed on Part B-FAS which included all participants who enrolled in Part B and received at least 1 dose (including partial dose) of study drug (BIVV009). Here, 'number analyzed' = participants with available data for each specified category. Data for this outcome measure was planned to be collected and analyzed for combined population of BIVV009 (i.e., all participants who received BIVV009 \[either 6.5 g or 7.5 g\]).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| BIVV009 | Part B: Change From Baseline in Hemoglobin (Hgb) Level at Each Specified Time Points | Week 27 | 2.647 grams per deciliter | Standard Deviation 1.348 |
| BIVV009 | Part B: Change From Baseline in Hemoglobin (Hgb) Level at Each Specified Time Points | Week 169 | 4.300 grams per deciliter | — |
| BIVV009 | Part B: Change From Baseline in Hemoglobin (Hgb) Level at Each Specified Time Points | Week 29 | 2.507 grams per deciliter | Standard Deviation 1.669 |
| BIVV009 | Part B: Change From Baseline in Hemoglobin (Hgb) Level at Each Specified Time Points | Week 45 | 2.644 grams per deciliter | Standard Deviation 1.688 |
| BIVV009 | Part B: Change From Baseline in Hemoglobin (Hgb) Level at Each Specified Time Points | Week 31 | 2.490 grams per deciliter | Standard Deviation 1.55 |
| BIVV009 | Part B: Change From Baseline in Hemoglobin (Hgb) Level at Each Specified Time Points | Week 97 | 2.413 grams per deciliter | Standard Deviation 2.262 |
| BIVV009 | Part B: Change From Baseline in Hemoglobin (Hgb) Level at Each Specified Time Points | Week 33 | 2.519 grams per deciliter | Standard Deviation 1.52 |
| BIVV009 | Part B: Change From Baseline in Hemoglobin (Hgb) Level at Each Specified Time Points | Week 171 | 4.200 grams per deciliter | — |
| BIVV009 | Part B: Change From Baseline in Hemoglobin (Hgb) Level at Each Specified Time Points | Week 35 | 2.611 grams per deciliter | Standard Deviation 1.522 |
| BIVV009 | Part B: Change From Baseline in Hemoglobin (Hgb) Level at Each Specified Time Points | Week 99 | 2.019 grams per deciliter | Standard Deviation 1.799 |
| BIVV009 | Part B: Change From Baseline in Hemoglobin (Hgb) Level at Each Specified Time Points | Week 37 | 2.197 grams per deciliter | Standard Deviation 1.461 |
| BIVV009 | Part B: Change From Baseline in Hemoglobin (Hgb) Level at Each Specified Time Points | Week 173 | 4.000 grams per deciliter | — |
| BIVV009 | Part B: Change From Baseline in Hemoglobin (Hgb) Level at Each Specified Time Points | Week 47 | 2.335 grams per deciliter | Standard Deviation 1.108 |
| BIVV009 | Part B: Change From Baseline in Hemoglobin (Hgb) Level at Each Specified Time Points | Week 107 | 2.319 grams per deciliter | Standard Deviation 1.511 |
| BIVV009 | Part B: Change From Baseline in Hemoglobin (Hgb) Level at Each Specified Time Points | Week 49 | 2.531 grams per deciliter | Standard Deviation 1.28 |
| BIVV009 | Part B: Change From Baseline in Hemoglobin (Hgb) Level at Each Specified Time Points | Week 53 | 2.346 grams per deciliter | Standard Deviation 1.182 |
| BIVV009 | Part B: Change From Baseline in Hemoglobin (Hgb) Level at Each Specified Time Points | Week 51 | 2.349 grams per deciliter | Standard Deviation 1.26 |
| BIVV009 | Part B: Change From Baseline in Hemoglobin (Hgb) Level at Each Specified Time Points | Week 55 | 2.438 grams per deciliter | Standard Deviation 1.396 |
| BIVV009 | Part B: Change From Baseline in Hemoglobin (Hgb) Level at Each Specified Time Points | Week 127 | 3.371 grams per deciliter | Standard Deviation 1.551 |
| BIVV009 | Part B: Change From Baseline in Hemoglobin (Hgb) Level at Each Specified Time Points | Week 57 | 2.531 grams per deciliter | Standard Deviation 1.446 |
| BIVV009 | Part B: Change From Baseline in Hemoglobin (Hgb) Level at Each Specified Time Points | Week 175 | 2.500 grams per deciliter | — |
| BIVV009 | Part B: Change From Baseline in Hemoglobin (Hgb) Level at Each Specified Time Points | Week 129 | 3.171 grams per deciliter | Standard Deviation 1.566 |
| BIVV009 | Part B: Change From Baseline in Hemoglobin (Hgb) Level at Each Specified Time Points | Week 61 | 4.073 grams per deciliter | Standard Deviation 6.761 |
| BIVV009 | Part B: Change From Baseline in Hemoglobin (Hgb) Level at Each Specified Time Points | Week 59 | 2.590 grams per deciliter | Standard Deviation 1.397 |
| BIVV009 | Part B: Change From Baseline in Hemoglobin (Hgb) Level at Each Specified Time Points | Week 63 | 2.382 grams per deciliter | Standard Deviation 1.546 |
| BIVV009 | Part B: Change From Baseline in Hemoglobin (Hgb) Level at Each Specified Time Points | Week 67 | 4.170 grams per deciliter | Standard Deviation 6.509 |
| BIVV009 | Part B: Change From Baseline in Hemoglobin (Hgb) Level at Each Specified Time Points | Week 135 | 3.611 grams per deciliter | Standard Deviation 1.458 |
| BIVV009 | Part B: Change From Baseline in Hemoglobin (Hgb) Level at Each Specified Time Points | Week 69 | 2.777 grams per deciliter | Standard Deviation 1.411 |
| BIVV009 | Part B: Change From Baseline in Hemoglobin (Hgb) Level at Each Specified Time Points | ET/SFU Visit | 0.149 grams per deciliter | Standard Deviation 2.073 |
| BIVV009 | Part B: Change From Baseline in Hemoglobin (Hgb) Level at Each Specified Time Points | Week 71 | 2.654 grams per deciliter | Standard Deviation 1.495 |
| BIVV009 | Part B: Change From Baseline in Hemoglobin (Hgb) Level at Each Specified Time Points | Week 137 | 4.074 grams per deciliter | Standard Deviation 2.392 |
| BIVV009 | Part B: Change From Baseline in Hemoglobin (Hgb) Level at Each Specified Time Points | Week 79 | 2.614 grams per deciliter | Standard Deviation 1.874 |
| BIVV009 | Part B: Change From Baseline in Hemoglobin (Hgb) Level at Each Specified Time Points | Week 83 | 2.469 grams per deciliter | Standard Deviation 1.777 |
| BIVV009 | Part B: Change From Baseline in Hemoglobin (Hgb) Level at Each Specified Time Points | Week 65 | 2.925 grams per deciliter | Standard Deviation 1.447 |
| BIVV009 | Part B: Change From Baseline in Hemoglobin (Hgb) Level at Each Specified Time Points | Week 85 | 2.755 grams per deciliter | Standard Deviation 1.942 |
| BIVV009 | Part B: Change From Baseline in Hemoglobin (Hgb) Level at Each Specified Time Points | Week 139 | 3.929 grams per deciliter | Standard Deviation 1.889 |
| BIVV009 | Part B: Change From Baseline in Hemoglobin (Hgb) Level at Each Specified Time Points | Week 89 | 2.551 grams per deciliter | Standard Deviation 1.835 |
| BIVV009 | Part B: Change From Baseline in Hemoglobin (Hgb) Level at Each Specified Time Points | Week 163 | 4.100 grams per deciliter | — |
| BIVV009 | Part B: Change From Baseline in Hemoglobin (Hgb) Level at Each Specified Time Points | Week 91 | 2.380 grams per deciliter | Standard Deviation 2.084 |
| BIVV009 | Part B: Change From Baseline in Hemoglobin (Hgb) Level at Each Specified Time Points | Week 141 | 3.500 grams per deciliter | Standard Deviation 0.656 |
| BIVV009 | Part B: Change From Baseline in Hemoglobin (Hgb) Level at Each Specified Time Points | Week 93 | 2.931 grams per deciliter | Standard Deviation 2.386 |
| BIVV009 | Part B: Change From Baseline in Hemoglobin (Hgb) Level at Each Specified Time Points | Week 75 | 2.391 grams per deciliter | Standard Deviation 1.7 |
| BIVV009 | Part B: Change From Baseline in Hemoglobin (Hgb) Level at Each Specified Time Points | Week 143 | 3.220 grams per deciliter | Standard Deviation 1.064 |
| BIVV009 | Part B: Change From Baseline in Hemoglobin (Hgb) Level at Each Specified Time Points | Week 101 | 2.276 grams per deciliter | Standard Deviation 1.986 |
| BIVV009 | Part B: Change From Baseline in Hemoglobin (Hgb) Level at Each Specified Time Points | Week 73 | 2.800 grams per deciliter | Standard Deviation 2.132 |
| BIVV009 | Part B: Change From Baseline in Hemoglobin (Hgb) Level at Each Specified Time Points | Week 103 | 2.378 grams per deciliter | Standard Deviation 2.342 |
| BIVV009 | Part B: Change From Baseline in Hemoglobin (Hgb) Level at Each Specified Time Points | Week 145 | 3.350 grams per deciliter | Standard Deviation 0.636 |
| BIVV009 | Part B: Change From Baseline in Hemoglobin (Hgb) Level at Each Specified Time Points | Week 105 | 2.291 grams per deciliter | Standard Deviation 1.719 |
| BIVV009 | Part B: Change From Baseline in Hemoglobin (Hgb) Level at Each Specified Time Points | Week 39 | 2.528 grams per deciliter | Standard Deviation 1.607 |
| BIVV009 | Part B: Change From Baseline in Hemoglobin (Hgb) Level at Each Specified Time Points | Week 109 | 2.509 grams per deciliter | Standard Deviation 1.772 |
| BIVV009 | Part B: Change From Baseline in Hemoglobin (Hgb) Level at Each Specified Time Points | Week 147 | 3.202 grams per deciliter | Standard Deviation 0.591 |
| BIVV009 | Part B: Change From Baseline in Hemoglobin (Hgb) Level at Each Specified Time Points | Week 111 | 2.416 grams per deciliter | Standard Deviation 1.908 |
| BIVV009 | Part B: Change From Baseline in Hemoglobin (Hgb) Level at Each Specified Time Points | Week 165 | 3.800 grams per deciliter | — |
| BIVV009 | Part B: Change From Baseline in Hemoglobin (Hgb) Level at Each Specified Time Points | Week 113 | 2.860 grams per deciliter | Standard Deviation 1.832 |
| BIVV009 | Part B: Change From Baseline in Hemoglobin (Hgb) Level at Each Specified Time Points | Week 149 | 2.900 grams per deciliter | — |
| BIVV009 | Part B: Change From Baseline in Hemoglobin (Hgb) Level at Each Specified Time Points | Week 115 | 2.622 grams per deciliter | Standard Deviation 1.986 |
| BIVV009 | Part B: Change From Baseline in Hemoglobin (Hgb) Level at Each Specified Time Points | Week 77 | 3.074 grams per deciliter | Standard Deviation 2.088 |
| BIVV009 | Part B: Change From Baseline in Hemoglobin (Hgb) Level at Each Specified Time Points | Week 117 | 3.135 grams per deciliter | Standard Deviation 1.598 |
| BIVV009 | Part B: Change From Baseline in Hemoglobin (Hgb) Level at Each Specified Time Points | Week 151 | 2.961 grams per deciliter | Standard Deviation 0.37 |
| BIVV009 | Part B: Change From Baseline in Hemoglobin (Hgb) Level at Each Specified Time Points | Week 119 | 3.106 grams per deciliter | Standard Deviation 1.493 |
| BIVV009 | Part B: Change From Baseline in Hemoglobin (Hgb) Level at Each Specified Time Points | Week 41 | 2.162 grams per deciliter | Standard Deviation 1.636 |
| BIVV009 | Part B: Change From Baseline in Hemoglobin (Hgb) Level at Each Specified Time Points | Week 121 | 3.388 grams per deciliter | Standard Deviation 1.616 |
| BIVV009 | Part B: Change From Baseline in Hemoglobin (Hgb) Level at Each Specified Time Points | Week 153 | 2.800 grams per deciliter | — |
| BIVV009 | Part B: Change From Baseline in Hemoglobin (Hgb) Level at Each Specified Time Points | Week 123 | 3.255 grams per deciliter | Standard Deviation 1.346 |
| BIVV009 | Part B: Change From Baseline in Hemoglobin (Hgb) Level at Each Specified Time Points | Week 155 | 2.700 grams per deciliter | — |
| BIVV009 | Part B: Change From Baseline in Hemoglobin (Hgb) Level at Each Specified Time Points | Week 125 | 3.197 grams per deciliter | Standard Deviation 1.366 |
| BIVV009 | Part B: Change From Baseline in Hemoglobin (Hgb) Level at Each Specified Time Points | Week 167 | 4.700 grams per deciliter | — |
| BIVV009 | Part B: Change From Baseline in Hemoglobin (Hgb) Level at Each Specified Time Points | Week 131 | 3.453 grams per deciliter | Standard Deviation 1.823 |
| BIVV009 | Part B: Change From Baseline in Hemoglobin (Hgb) Level at Each Specified Time Points | Week 157 | 2.700 grams per deciliter | — |
| BIVV009 | Part B: Change From Baseline in Hemoglobin (Hgb) Level at Each Specified Time Points | Week 133 | 3.520 grams per deciliter | Standard Deviation 1.707 |
| BIVV009 | Part B: Change From Baseline in Hemoglobin (Hgb) Level at Each Specified Time Points | Week 81 | 2.598 grams per deciliter | Standard Deviation 1.801 |
| BIVV009 | Part B: Change From Baseline in Hemoglobin (Hgb) Level at Each Specified Time Points | Week 159 | 3.300 grams per deciliter | — |
| BIVV009 | Part B: Change From Baseline in Hemoglobin (Hgb) Level at Each Specified Time Points | Week 43 | 2.436 grams per deciliter | Standard Deviation 1.103 |
| BIVV009 | Part B: Change From Baseline in Hemoglobin (Hgb) Level at Each Specified Time Points | Week 161 | 4.100 grams per deciliter | — |
| BIVV009 | Part B: Change From Baseline in Hemoglobin (Hgb) Level at Each Specified Time Points | Week 95 | 2.262 grams per deciliter | Standard Deviation 2.014 |
| BIVV009 | Part B: Change From Baseline in Hemoglobin (Hgb) Level at Each Specified Time Points | Week 87 | 2.477 grams per deciliter | Standard Deviation 1.779 |
| Placebo | Part B: Change From Baseline in Hemoglobin (Hgb) Level at Each Specified Time Points | Week 49 | 2.121 grams per deciliter | Standard Deviation 1.883 |
| Placebo | Part B: Change From Baseline in Hemoglobin (Hgb) Level at Each Specified Time Points | ET/SFU Visit | 0.359 grams per deciliter | Standard Deviation 1.872 |
| Placebo | Part B: Change From Baseline in Hemoglobin (Hgb) Level at Each Specified Time Points | Week 39 | 2.368 grams per deciliter | Standard Deviation 1.835 |
| Placebo | Part B: Change From Baseline in Hemoglobin (Hgb) Level at Each Specified Time Points | Week 41 | 2.074 grams per deciliter | Standard Deviation 1.825 |
| Placebo | Part B: Change From Baseline in Hemoglobin (Hgb) Level at Each Specified Time Points | Week 43 | 2.182 grams per deciliter | Standard Deviation 1.643 |
| Placebo | Part B: Change From Baseline in Hemoglobin (Hgb) Level at Each Specified Time Points | Week 45 | 2.249 grams per deciliter | Standard Deviation 1.858 |
| Placebo | Part B: Change From Baseline in Hemoglobin (Hgb) Level at Each Specified Time Points | Week 51 | 2.394 grams per deciliter | Standard Deviation 1.87 |
| Placebo | Part B: Change From Baseline in Hemoglobin (Hgb) Level at Each Specified Time Points | Week 53 | 2.411 grams per deciliter | Standard Deviation 1.786 |
| Placebo | Part B: Change From Baseline in Hemoglobin (Hgb) Level at Each Specified Time Points | Week 63 | 2.102 grams per deciliter | Standard Deviation 1.78 |
| Placebo | Part B: Change From Baseline in Hemoglobin (Hgb) Level at Each Specified Time Points | Week 65 | 2.311 grams per deciliter | Standard Deviation 1.986 |
| Placebo | Part B: Change From Baseline in Hemoglobin (Hgb) Level at Each Specified Time Points | Week 73 | 2.197 grams per deciliter | Standard Deviation 1.989 |
| Placebo | Part B: Change From Baseline in Hemoglobin (Hgb) Level at Each Specified Time Points | Week 75 | 2.175 grams per deciliter | Standard Deviation 2.151 |
| Placebo | Part B: Change From Baseline in Hemoglobin (Hgb) Level at Each Specified Time Points | Week 77 | 2.451 grams per deciliter | Standard Deviation 1.878 |
| Placebo | Part B: Change From Baseline in Hemoglobin (Hgb) Level at Each Specified Time Points | Week 79 | 2.419 grams per deciliter | Standard Deviation 2.247 |
| Placebo | Part B: Change From Baseline in Hemoglobin (Hgb) Level at Each Specified Time Points | Week 81 | 2.458 grams per deciliter | Standard Deviation 1.579 |
| Placebo | Part B: Change From Baseline in Hemoglobin (Hgb) Level at Each Specified Time Points | Week 87 | 2.765 grams per deciliter | Standard Deviation 1.605 |
| Placebo | Part B: Change From Baseline in Hemoglobin (Hgb) Level at Each Specified Time Points | Week 95 | 2.578 grams per deciliter | Standard Deviation 1.97 |
| Placebo | Part B: Change From Baseline in Hemoglobin (Hgb) Level at Each Specified Time Points | Week 97 | 2.551 grams per deciliter | Standard Deviation 1.544 |
| Placebo | Part B: Change From Baseline in Hemoglobin (Hgb) Level at Each Specified Time Points | Week 105 | 2.321 grams per deciliter | Standard Deviation 1.805 |
| Placebo | Part B: Change From Baseline in Hemoglobin (Hgb) Level at Each Specified Time Points | Week 125 | 1.700 grams per deciliter | Standard Deviation 2.684 |
| Placebo | Part B: Change From Baseline in Hemoglobin (Hgb) Level at Each Specified Time Points | Week 127 | 2.102 grams per deciliter | Standard Deviation 3.211 |
| Placebo | Part B: Change From Baseline in Hemoglobin (Hgb) Level at Each Specified Time Points | Week 133 | 2.025 grams per deciliter | Standard Deviation 1.167 |
| Placebo | Part B: Change From Baseline in Hemoglobin (Hgb) Level at Each Specified Time Points | Week 135 | 3.048 grams per deciliter | Standard Deviation 1.62 |
| Placebo | Part B: Change From Baseline in Hemoglobin (Hgb) Level at Each Specified Time Points | Week 137 | 2.400 grams per deciliter | Standard Deviation 1.808 |
| Placebo | Part B: Change From Baseline in Hemoglobin (Hgb) Level at Each Specified Time Points | Week 139 | 3.334 grams per deciliter | Standard Deviation 2.669 |
| Placebo | Part B: Change From Baseline in Hemoglobin (Hgb) Level at Each Specified Time Points | Week 141 | 2.733 grams per deciliter | Standard Deviation 1.674 |
| Placebo | Part B: Change From Baseline in Hemoglobin (Hgb) Level at Each Specified Time Points | Week 143 | 2.985 grams per deciliter | Standard Deviation 1.904 |
| Placebo | Part B: Change From Baseline in Hemoglobin (Hgb) Level at Each Specified Time Points | Week 145 | 3.467 grams per deciliter | Standard Deviation 2.108 |
| Placebo | Part B: Change From Baseline in Hemoglobin (Hgb) Level at Each Specified Time Points | Week 147 | 2.300 grams per deciliter | Standard Deviation 0.566 |
| Placebo | Part B: Change From Baseline in Hemoglobin (Hgb) Level at Each Specified Time Points | Week 149 | 2.550 grams per deciliter | Standard Deviation 0.778 |
| Placebo | Part B: Change From Baseline in Hemoglobin (Hgb) Level at Each Specified Time Points | Week 151 | 3.000 grams per deciliter | — |
| Placebo | Part B: Change From Baseline in Hemoglobin (Hgb) Level at Each Specified Time Points | Week 155 | 3.600 grams per deciliter | — |
| Placebo | Part B: Change From Baseline in Hemoglobin (Hgb) Level at Each Specified Time Points | Week 157 | 3.000 grams per deciliter | — |
| Placebo | Part B: Change From Baseline in Hemoglobin (Hgb) Level at Each Specified Time Points | Week 159 | 2.300 grams per deciliter | — |
| Placebo | Part B: Change From Baseline in Hemoglobin (Hgb) Level at Each Specified Time Points | Week 161 | 2.400 grams per deciliter | — |
| Placebo | Part B: Change From Baseline in Hemoglobin (Hgb) Level at Each Specified Time Points | Week 163 | 2.600 grams per deciliter | — |
| Placebo | Part B: Change From Baseline in Hemoglobin (Hgb) Level at Each Specified Time Points | Week 27 | 1.125 grams per deciliter | Standard Deviation 1.545 |
| Placebo | Part B: Change From Baseline in Hemoglobin (Hgb) Level at Each Specified Time Points | Week 29 | 1.947 grams per deciliter | Standard Deviation 1.467 |
| Placebo | Part B: Change From Baseline in Hemoglobin (Hgb) Level at Each Specified Time Points | Week 31 | 2.358 grams per deciliter | Standard Deviation 1.471 |
| Placebo | Part B: Change From Baseline in Hemoglobin (Hgb) Level at Each Specified Time Points | Week 33 | 1.987 grams per deciliter | Standard Deviation 2.054 |
| Placebo | Part B: Change From Baseline in Hemoglobin (Hgb) Level at Each Specified Time Points | Week 35 | 1.977 grams per deciliter | Standard Deviation 2.01 |
| Placebo | Part B: Change From Baseline in Hemoglobin (Hgb) Level at Each Specified Time Points | Week 37 | 2.469 grams per deciliter | Standard Deviation 1.55 |
| Placebo | Part B: Change From Baseline in Hemoglobin (Hgb) Level at Each Specified Time Points | Week 47 | 2.315 grams per deciliter | Standard Deviation 2.129 |
| Placebo | Part B: Change From Baseline in Hemoglobin (Hgb) Level at Each Specified Time Points | Week 153 | 2.800 grams per deciliter | — |
| Placebo | Part B: Change From Baseline in Hemoglobin (Hgb) Level at Each Specified Time Points | Week 55 | 2.539 grams per deciliter | Standard Deviation 1.403 |
| Placebo | Part B: Change From Baseline in Hemoglobin (Hgb) Level at Each Specified Time Points | Week 57 | 2.250 grams per deciliter | Standard Deviation 1.774 |
| Placebo | Part B: Change From Baseline in Hemoglobin (Hgb) Level at Each Specified Time Points | Week 59 | 2.008 grams per deciliter | Standard Deviation 2.615 |
| Placebo | Part B: Change From Baseline in Hemoglobin (Hgb) Level at Each Specified Time Points | Week 61 | 2.059 grams per deciliter | Standard Deviation 1.911 |
| Placebo | Part B: Change From Baseline in Hemoglobin (Hgb) Level at Each Specified Time Points | Week 67 | 2.534 grams per deciliter | Standard Deviation 2.036 |
| Placebo | Part B: Change From Baseline in Hemoglobin (Hgb) Level at Each Specified Time Points | Week 69 | 2.505 grams per deciliter | Standard Deviation 2.093 |
| Placebo | Part B: Change From Baseline in Hemoglobin (Hgb) Level at Each Specified Time Points | Week 71 | 2.357 grams per deciliter | Standard Deviation 1.758 |
| Placebo | Part B: Change From Baseline in Hemoglobin (Hgb) Level at Each Specified Time Points | Week 83 | 2.762 grams per deciliter | Standard Deviation 1.539 |
| Placebo | Part B: Change From Baseline in Hemoglobin (Hgb) Level at Each Specified Time Points | Week 85 | 2.489 grams per deciliter | Standard Deviation 1.375 |
| Placebo | Part B: Change From Baseline in Hemoglobin (Hgb) Level at Each Specified Time Points | Week 89 | 2.482 grams per deciliter | Standard Deviation 2.004 |
| Placebo | Part B: Change From Baseline in Hemoglobin (Hgb) Level at Each Specified Time Points | Week 91 | 2.556 grams per deciliter | Standard Deviation 1.538 |
| Placebo | Part B: Change From Baseline in Hemoglobin (Hgb) Level at Each Specified Time Points | Week 93 | 2.655 grams per deciliter | Standard Deviation 2.033 |
| Placebo | Part B: Change From Baseline in Hemoglobin (Hgb) Level at Each Specified Time Points | Week 99 | 2.412 grams per deciliter | Standard Deviation 1.822 |
| Placebo | Part B: Change From Baseline in Hemoglobin (Hgb) Level at Each Specified Time Points | Week 101 | 2.171 grams per deciliter | Standard Deviation 1.852 |
| Placebo | Part B: Change From Baseline in Hemoglobin (Hgb) Level at Each Specified Time Points | Week 103 | 2.527 grams per deciliter | Standard Deviation 1.807 |
| Placebo | Part B: Change From Baseline in Hemoglobin (Hgb) Level at Each Specified Time Points | Week 107 | 2.560 grams per deciliter | Standard Deviation 1.858 |
| Placebo | Part B: Change From Baseline in Hemoglobin (Hgb) Level at Each Specified Time Points | Week 109 | 2.645 grams per deciliter | Standard Deviation 1.608 |
| Placebo | Part B: Change From Baseline in Hemoglobin (Hgb) Level at Each Specified Time Points | Week 111 | 2.750 grams per deciliter | Standard Deviation 1.707 |
| Placebo | Part B: Change From Baseline in Hemoglobin (Hgb) Level at Each Specified Time Points | Week 113 | 2.268 grams per deciliter | Standard Deviation 1.497 |
| Placebo | Part B: Change From Baseline in Hemoglobin (Hgb) Level at Each Specified Time Points | Week 115 | 2.326 grams per deciliter | Standard Deviation 1.809 |
| Placebo | Part B: Change From Baseline in Hemoglobin (Hgb) Level at Each Specified Time Points | Week 117 | 2.474 grams per deciliter | Standard Deviation 1.808 |
| Placebo | Part B: Change From Baseline in Hemoglobin (Hgb) Level at Each Specified Time Points | Week 119 | 2.608 grams per deciliter | Standard Deviation 2.045 |
| Placebo | Part B: Change From Baseline in Hemoglobin (Hgb) Level at Each Specified Time Points | Week 121 | 2.325 grams per deciliter | Standard Deviation 2.223 |
| Placebo | Part B: Change From Baseline in Hemoglobin (Hgb) Level at Each Specified Time Points | Week 123 | 2.878 grams per deciliter | Standard Deviation 2.667 |
| Placebo | Part B: Change From Baseline in Hemoglobin (Hgb) Level at Each Specified Time Points | Week 129 | 2.129 grams per deciliter | Standard Deviation 2.739 |
| Placebo | Part B: Change From Baseline in Hemoglobin (Hgb) Level at Each Specified Time Points | Week 131 | 1.423 grams per deciliter | Standard Deviation 3.184 |
Secondary
Part B: Change From Baseline in Total Bilirubin Levels at Each Specified Time Points
Change from baseline (Week 0) in total bilirubin levels at each specified time points (i.e., Week 27, 29, 31, 33, 35, 37, 39, 41, 43, 45, 47, 49, 51, 53, 55, 57, 59, 61, 63, 65,67,69,71,73,75, 77, 79, 81,83, 85, 87, 89, 91, 93, 95, 97, 99,101,103, 105, 107,109, 111,113,115,117,119, 121, 123, 125, 127,129,131,133,135,137,139,141,143, 145,147,149,151,153,155,157,159, 161,163,165,167,169,171,173,175 and ET/SFU Visit) is reported in this outcome measure. Baseline was defined as the last non-missing value prior to the first administration of study drug in Part A. ET visit/SFU visit was 9 weeks after administration of last dose (i.e., up to Week 184). Here, 0 in the number analyzed field signifies that none of participants were available for assessment at the specified timepoints.
Time frame: Baseline (Week 0), every 2 weeks starting from Week 27 till Week 175 and at ET/SFU visit (i.e., up to Week 184)
Population: Analysis was performed on Part B-FAS. Here, 'overall number of participants analyzed'=participants with available data for this outcome measure and 'number analyzed' = participants with available data for each specified category. Data for this outcome measure was planned to be collected and analyzed for combined population of BIVV009 (i.e., all participants who received BIVV009 \[either 6.5 g or 7.5 g\]).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| BIVV009 | Part B: Change From Baseline in Total Bilirubin Levels at Each Specified Time Points | Week 131 | -19.420 micromoles per liter | Standard Deviation 12.936 |
| BIVV009 | Part B: Change From Baseline in Total Bilirubin Levels at Each Specified Time Points | Week 41 | -18.694 micromoles per liter | Standard Deviation 12.189 |
| BIVV009 | Part B: Change From Baseline in Total Bilirubin Levels at Each Specified Time Points | Week 43 | -20.593 micromoles per liter | Standard Deviation 11.449 |
| BIVV009 | Part B: Change From Baseline in Total Bilirubin Levels at Each Specified Time Points | Week 45 | -18.556 micromoles per liter | Standard Deviation 11.213 |
| BIVV009 | Part B: Change From Baseline in Total Bilirubin Levels at Each Specified Time Points | Week 47 | -20.400 micromoles per liter | Standard Deviation 9.803 |
| BIVV009 | Part B: Change From Baseline in Total Bilirubin Levels at Each Specified Time Points | Week 49 | -21.450 micromoles per liter | Standard Deviation 10.271 |
| BIVV009 | Part B: Change From Baseline in Total Bilirubin Levels at Each Specified Time Points | Week 51 | -19.686 micromoles per liter | Standard Deviation 11.072 |
| BIVV009 | Part B: Change From Baseline in Total Bilirubin Levels at Each Specified Time Points | Week 57 | -21.708 micromoles per liter | Standard Deviation 10.467 |
| BIVV009 | Part B: Change From Baseline in Total Bilirubin Levels at Each Specified Time Points | Week 59 | -19.979 micromoles per liter | Standard Deviation 9.706 |
| BIVV009 | Part B: Change From Baseline in Total Bilirubin Levels at Each Specified Time Points | Week 63 | -21.587 micromoles per liter | Standard Deviation 9.68 |
| BIVV009 | Part B: Change From Baseline in Total Bilirubin Levels at Each Specified Time Points | Week 67 | -22.680 micromoles per liter | Standard Deviation 10.317 |
| BIVV009 | Part B: Change From Baseline in Total Bilirubin Levels at Each Specified Time Points | Week 77 | -23.267 micromoles per liter | Standard Deviation 8.972 |
| BIVV009 | Part B: Change From Baseline in Total Bilirubin Levels at Each Specified Time Points | Week 79 | -21.125 micromoles per liter | Standard Deviation 12.701 |
| BIVV009 | Part B: Change From Baseline in Total Bilirubin Levels at Each Specified Time Points | Week 89 | -17.790 micromoles per liter | Standard Deviation 11.036 |
| BIVV009 | Part B: Change From Baseline in Total Bilirubin Levels at Each Specified Time Points | Week 91 | -16.944 micromoles per liter | Standard Deviation 13.476 |
| BIVV009 | Part B: Change From Baseline in Total Bilirubin Levels at Each Specified Time Points | Week 93 | -18.300 micromoles per liter | Standard Deviation 11.132 |
| BIVV009 | Part B: Change From Baseline in Total Bilirubin Levels at Each Specified Time Points | Week 95 | -18.613 micromoles per liter | Standard Deviation 12.265 |
| BIVV009 | Part B: Change From Baseline in Total Bilirubin Levels at Each Specified Time Points | Week 97 | -18.656 micromoles per liter | Standard Deviation 11.462 |
| BIVV009 | Part B: Change From Baseline in Total Bilirubin Levels at Each Specified Time Points | Week 103 | -18.178 micromoles per liter | Standard Deviation 11.156 |
| BIVV009 | Part B: Change From Baseline in Total Bilirubin Levels at Each Specified Time Points | Week 105 | -19.422 micromoles per liter | Standard Deviation 8.444 |
| BIVV009 | Part B: Change From Baseline in Total Bilirubin Levels at Each Specified Time Points | Week 109 | -18.456 micromoles per liter | Standard Deviation 10.606 |
| BIVV009 | Part B: Change From Baseline in Total Bilirubin Levels at Each Specified Time Points | Week 113 | -19.389 micromoles per liter | Standard Deviation 9.192 |
| BIVV009 | Part B: Change From Baseline in Total Bilirubin Levels at Each Specified Time Points | Week 133 | -27.600 micromoles per liter | Standard Deviation 7.477 |
| BIVV009 | Part B: Change From Baseline in Total Bilirubin Levels at Each Specified Time Points | Week 137 | -28.833 micromoles per liter | Standard Deviation 8.615 |
| BIVV009 | Part B: Change From Baseline in Total Bilirubin Levels at Each Specified Time Points | Week 157 | -32.400 micromoles per liter | — |
| BIVV009 | Part B: Change From Baseline in Total Bilirubin Levels at Each Specified Time Points | ET/SFU Visit | 1.976 micromoles per liter | Standard Deviation 9.444 |
| BIVV009 | Part B: Change From Baseline in Total Bilirubin Levels at Each Specified Time Points | Week 35 | -20.540 micromoles per liter | Standard Deviation 10.557 |
| BIVV009 | Part B: Change From Baseline in Total Bilirubin Levels at Each Specified Time Points | Week 53 | -19.107 micromoles per liter | Standard Deviation 11.267 |
| BIVV009 | Part B: Change From Baseline in Total Bilirubin Levels at Each Specified Time Points | Week 55 | -19.354 micromoles per liter | Standard Deviation 12.209 |
| BIVV009 | Part B: Change From Baseline in Total Bilirubin Levels at Each Specified Time Points | Week 61 | -18.254 micromoles per liter | Standard Deviation 10.541 |
| BIVV009 | Part B: Change From Baseline in Total Bilirubin Levels at Each Specified Time Points | Week 65 | -20.400 micromoles per liter | Standard Deviation 9.866 |
| BIVV009 | Part B: Change From Baseline in Total Bilirubin Levels at Each Specified Time Points | Week 69 | -21.279 micromoles per liter | Standard Deviation 9.423 |
| BIVV009 | Part B: Change From Baseline in Total Bilirubin Levels at Each Specified Time Points | Week 71 | -19.008 micromoles per liter | Standard Deviation 8.255 |
| BIVV009 | Part B: Change From Baseline in Total Bilirubin Levels at Each Specified Time Points | Week 73 | -23.058 micromoles per liter | Standard Deviation 7.766 |
| BIVV009 | Part B: Change From Baseline in Total Bilirubin Levels at Each Specified Time Points | Week 75 | -21.492 micromoles per liter | Standard Deviation 7.453 |
| BIVV009 | Part B: Change From Baseline in Total Bilirubin Levels at Each Specified Time Points | Week 81 | -19.255 micromoles per liter | Standard Deviation 9.478 |
| BIVV009 | Part B: Change From Baseline in Total Bilirubin Levels at Each Specified Time Points | Week 83 | -16.567 micromoles per liter | Standard Deviation 12.565 |
| BIVV009 | Part B: Change From Baseline in Total Bilirubin Levels at Each Specified Time Points | Week 85 | -18.045 micromoles per liter | Standard Deviation 12.183 |
| BIVV009 | Part B: Change From Baseline in Total Bilirubin Levels at Each Specified Time Points | Week 87 | -19.990 micromoles per liter | Standard Deviation 12.043 |
| BIVV009 | Part B: Change From Baseline in Total Bilirubin Levels at Each Specified Time Points | Week 99 | -17.389 micromoles per liter | Standard Deviation 10.932 |
| BIVV009 | Part B: Change From Baseline in Total Bilirubin Levels at Each Specified Time Points | Week 101 | -18.411 micromoles per liter | Standard Deviation 10.175 |
| BIVV009 | Part B: Change From Baseline in Total Bilirubin Levels at Each Specified Time Points | Week 107 | -18.100 micromoles per liter | Standard Deviation 9.955 |
| BIVV009 | Part B: Change From Baseline in Total Bilirubin Levels at Each Specified Time Points | Week 111 | -19.767 micromoles per liter | Standard Deviation 9.992 |
| BIVV009 | Part B: Change From Baseline in Total Bilirubin Levels at Each Specified Time Points | Week 115 | -19.622 micromoles per liter | Standard Deviation 8.194 |
| BIVV009 | Part B: Change From Baseline in Total Bilirubin Levels at Each Specified Time Points | Week 117 | -22.088 micromoles per liter | Standard Deviation 10.247 |
| BIVV009 | Part B: Change From Baseline in Total Bilirubin Levels at Each Specified Time Points | Week 119 | -20.038 micromoles per liter | Standard Deviation 8.529 |
| BIVV009 | Part B: Change From Baseline in Total Bilirubin Levels at Each Specified Time Points | Week 121 | -22.063 micromoles per liter | Standard Deviation 7.215 |
| BIVV009 | Part B: Change From Baseline in Total Bilirubin Levels at Each Specified Time Points | Week 123 | -21.438 micromoles per liter | Standard Deviation 8.058 |
| BIVV009 | Part B: Change From Baseline in Total Bilirubin Levels at Each Specified Time Points | Week 125 | -20.657 micromoles per liter | Standard Deviation 8.889 |
| BIVV009 | Part B: Change From Baseline in Total Bilirubin Levels at Each Specified Time Points | Week 127 | -20.550 micromoles per liter | Standard Deviation 9.782 |
| BIVV009 | Part B: Change From Baseline in Total Bilirubin Levels at Each Specified Time Points | Week 129 | -22.883 micromoles per liter | Standard Deviation 11.291 |
| BIVV009 | Part B: Change From Baseline in Total Bilirubin Levels at Each Specified Time Points | Week 27 | -22.965 micromoles per liter | Standard Deviation 9.899 |
| BIVV009 | Part B: Change From Baseline in Total Bilirubin Levels at Each Specified Time Points | Week 135 | -29.500 micromoles per liter | Standard Deviation 7.816 |
| BIVV009 | Part B: Change From Baseline in Total Bilirubin Levels at Each Specified Time Points | Week 139 | -25.800 micromoles per liter | Standard Deviation 9.081 |
| BIVV009 | Part B: Change From Baseline in Total Bilirubin Levels at Each Specified Time Points | Week 141 | -34.400 micromoles per liter | Standard Deviation 2.404 |
| BIVV009 | Part B: Change From Baseline in Total Bilirubin Levels at Each Specified Time Points | Week 143 | -26.967 micromoles per liter | Standard Deviation 9.235 |
| BIVV009 | Part B: Change From Baseline in Total Bilirubin Levels at Each Specified Time Points | Week 145 | -32.900 micromoles per liter | Standard Deviation 3.677 |
| BIVV009 | Part B: Change From Baseline in Total Bilirubin Levels at Each Specified Time Points | Week 147 | -29.300 micromoles per liter | Standard Deviation 7.418 |
| BIVV009 | Part B: Change From Baseline in Total Bilirubin Levels at Each Specified Time Points | Week 149 | -31.700 micromoles per liter | — |
| BIVV009 | Part B: Change From Baseline in Total Bilirubin Levels at Each Specified Time Points | Week 151 | -21.500 micromoles per liter | Standard Deviation 0.566 |
| BIVV009 | Part B: Change From Baseline in Total Bilirubin Levels at Each Specified Time Points | Week 153 | -30.800 micromoles per liter | — |
| BIVV009 | Part B: Change From Baseline in Total Bilirubin Levels at Each Specified Time Points | Week 155 | -35.300 micromoles per liter | — |
| BIVV009 | Part B: Change From Baseline in Total Bilirubin Levels at Each Specified Time Points | Week 159 | -32.500 micromoles per liter | — |
| BIVV009 | Part B: Change From Baseline in Total Bilirubin Levels at Each Specified Time Points | Week 161 | -36.800 micromoles per liter | — |
| BIVV009 | Part B: Change From Baseline in Total Bilirubin Levels at Each Specified Time Points | Week 163 | -37.100 micromoles per liter | — |
| BIVV009 | Part B: Change From Baseline in Total Bilirubin Levels at Each Specified Time Points | Week 165 | -36.300 micromoles per liter | — |
| BIVV009 | Part B: Change From Baseline in Total Bilirubin Levels at Each Specified Time Points | Week 167 | -34.300 micromoles per liter | — |
| BIVV009 | Part B: Change From Baseline in Total Bilirubin Levels at Each Specified Time Points | Week 169 | -32.700 micromoles per liter | — |
| BIVV009 | Part B: Change From Baseline in Total Bilirubin Levels at Each Specified Time Points | Week 171 | -33.100 micromoles per liter | — |
| BIVV009 | Part B: Change From Baseline in Total Bilirubin Levels at Each Specified Time Points | Week 173 | -32.100 micromoles per liter | — |
| BIVV009 | Part B: Change From Baseline in Total Bilirubin Levels at Each Specified Time Points | Week 175 | -28.400 micromoles per liter | — |
| BIVV009 | Part B: Change From Baseline in Total Bilirubin Levels at Each Specified Time Points | Week 29 | -20.119 micromoles per liter | Standard Deviation 12.17 |
| BIVV009 | Part B: Change From Baseline in Total Bilirubin Levels at Each Specified Time Points | Week 31 | -21.675 micromoles per liter | Standard Deviation 11.025 |
| BIVV009 | Part B: Change From Baseline in Total Bilirubin Levels at Each Specified Time Points | Week 33 | -19.860 micromoles per liter | Standard Deviation 11.527 |
| BIVV009 | Part B: Change From Baseline in Total Bilirubin Levels at Each Specified Time Points | Week 37 | -21.350 micromoles per liter | Standard Deviation 13.234 |
| BIVV009 | Part B: Change From Baseline in Total Bilirubin Levels at Each Specified Time Points | Week 39 | -23.493 micromoles per liter | Standard Deviation 11.425 |
| Placebo | Part B: Change From Baseline in Total Bilirubin Levels at Each Specified Time Points | Week 27 | -18.761 micromoles per liter | Standard Deviation 13.353 |
| Placebo | Part B: Change From Baseline in Total Bilirubin Levels at Each Specified Time Points | Week 145 | -18.100 micromoles per liter | Standard Deviation 27.217 |
| Placebo | Part B: Change From Baseline in Total Bilirubin Levels at Each Specified Time Points | Week 29 | -19.889 micromoles per liter | Standard Deviation 14.5 |
| Placebo | Part B: Change From Baseline in Total Bilirubin Levels at Each Specified Time Points | Week 53 | -20.335 micromoles per liter | Standard Deviation 17.126 |
| Placebo | Part B: Change From Baseline in Total Bilirubin Levels at Each Specified Time Points | Week 31 | -22.153 micromoles per liter | Standard Deviation 14.962 |
| Placebo | Part B: Change From Baseline in Total Bilirubin Levels at Each Specified Time Points | Week 157 | -0.100 micromoles per liter | — |
| Placebo | Part B: Change From Baseline in Total Bilirubin Levels at Each Specified Time Points | Week 33 | -24.263 micromoles per liter | Standard Deviation 15.169 |
| Placebo | Part B: Change From Baseline in Total Bilirubin Levels at Each Specified Time Points | Week 35 | -21.888 micromoles per liter | Standard Deviation 13.93 |
| Placebo | Part B: Change From Baseline in Total Bilirubin Levels at Each Specified Time Points | Week 125 | -19.560 micromoles per liter | Standard Deviation 12.997 |
| Placebo | Part B: Change From Baseline in Total Bilirubin Levels at Each Specified Time Points | Week 37 | -22.527 micromoles per liter | Standard Deviation 16.315 |
| Placebo | Part B: Change From Baseline in Total Bilirubin Levels at Each Specified Time Points | Week 147 | -3.300 micromoles per liter | Standard Deviation 34.083 |
| Placebo | Part B: Change From Baseline in Total Bilirubin Levels at Each Specified Time Points | Week 39 | -21.173 micromoles per liter | Standard Deviation 15.901 |
| Placebo | Part B: Change From Baseline in Total Bilirubin Levels at Each Specified Time Points | Week 127 | -21.433 micromoles per liter | Standard Deviation 15.85 |
| Placebo | Part B: Change From Baseline in Total Bilirubin Levels at Each Specified Time Points | Week 41 | -21.138 micromoles per liter | Standard Deviation 16.15 |
| Placebo | Part B: Change From Baseline in Total Bilirubin Levels at Each Specified Time Points | Week 69 | -17.827 micromoles per liter | Standard Deviation 22.194 |
| Placebo | Part B: Change From Baseline in Total Bilirubin Levels at Each Specified Time Points | Week 43 | -21.544 micromoles per liter | Standard Deviation 16.603 |
| Placebo | Part B: Change From Baseline in Total Bilirubin Levels at Each Specified Time Points | ET/SFU Visit | 1.165 micromoles per liter | Standard Deviation 18.773 |
| Placebo | Part B: Change From Baseline in Total Bilirubin Levels at Each Specified Time Points | Week 45 | -20.156 micromoles per liter | Standard Deviation 16.757 |
| Placebo | Part B: Change From Baseline in Total Bilirubin Levels at Each Specified Time Points | Week 129 | -19.020 micromoles per liter | Standard Deviation 11.749 |
| Placebo | Part B: Change From Baseline in Total Bilirubin Levels at Each Specified Time Points | Week 47 | -20.250 micromoles per liter | Standard Deviation 15.536 |
| Placebo | Part B: Change From Baseline in Total Bilirubin Levels at Each Specified Time Points | Week 149 | -7.300 micromoles per liter | Standard Deviation 28.284 |
| Placebo | Part B: Change From Baseline in Total Bilirubin Levels at Each Specified Time Points | Week 49 | -21.024 micromoles per liter | Standard Deviation 13.63 |
| Placebo | Part B: Change From Baseline in Total Bilirubin Levels at Each Specified Time Points | Week 131 | -23.100 micromoles per liter | Standard Deviation 15.797 |
| Placebo | Part B: Change From Baseline in Total Bilirubin Levels at Each Specified Time Points | Week 51 | -19.444 micromoles per liter | Standard Deviation 15.942 |
| Placebo | Part B: Change From Baseline in Total Bilirubin Levels at Each Specified Time Points | Week 55 | -23.481 micromoles per liter | Standard Deviation 12.3 |
| Placebo | Part B: Change From Baseline in Total Bilirubin Levels at Each Specified Time Points | Week 133 | -17.450 micromoles per liter | Standard Deviation 16.917 |
| Placebo | Part B: Change From Baseline in Total Bilirubin Levels at Each Specified Time Points | Week 57 | -18.953 micromoles per liter | Standard Deviation 15.825 |
| Placebo | Part B: Change From Baseline in Total Bilirubin Levels at Each Specified Time Points | Week 159 | 4.700 micromoles per liter | — |
| Placebo | Part B: Change From Baseline in Total Bilirubin Levels at Each Specified Time Points | Week 59 | -19.820 micromoles per liter | Standard Deviation 16.209 |
| Placebo | Part B: Change From Baseline in Total Bilirubin Levels at Each Specified Time Points | Week 61 | -21.073 micromoles per liter | Standard Deviation 17.457 |
| Placebo | Part B: Change From Baseline in Total Bilirubin Levels at Each Specified Time Points | Week 135 | -21.900 micromoles per liter | Standard Deviation 19.552 |
| Placebo | Part B: Change From Baseline in Total Bilirubin Levels at Each Specified Time Points | Week 63 | -21.753 micromoles per liter | Standard Deviation 16.663 |
| Placebo | Part B: Change From Baseline in Total Bilirubin Levels at Each Specified Time Points | Week 65 | -20.950 micromoles per liter | Standard Deviation 19.833 |
| Placebo | Part B: Change From Baseline in Total Bilirubin Levels at Each Specified Time Points | Week 97 | -26.122 micromoles per liter | Standard Deviation 11.87 |
| Placebo | Part B: Change From Baseline in Total Bilirubin Levels at Each Specified Time Points | Week 67 | -20.150 micromoles per liter | Standard Deviation 20.25 |
| Placebo | Part B: Change From Baseline in Total Bilirubin Levels at Each Specified Time Points | Week 71 | -20.585 micromoles per liter | Standard Deviation 21.125 |
| Placebo | Part B: Change From Baseline in Total Bilirubin Levels at Each Specified Time Points | Week 73 | -20.080 micromoles per liter | Standard Deviation 17.803 |
| Placebo | Part B: Change From Baseline in Total Bilirubin Levels at Each Specified Time Points | Week 75 | -20.771 micromoles per liter | Standard Deviation 20.261 |
| Placebo | Part B: Change From Baseline in Total Bilirubin Levels at Each Specified Time Points | Week 137 | -11.650 micromoles per liter | Standard Deviation 18.173 |
| Placebo | Part B: Change From Baseline in Total Bilirubin Levels at Each Specified Time Points | Week 77 | -19.814 micromoles per liter | Standard Deviation 19.337 |
| Placebo | Part B: Change From Baseline in Total Bilirubin Levels at Each Specified Time Points | Week 151 | 0.300 micromoles per liter | — |
| Placebo | Part B: Change From Baseline in Total Bilirubin Levels at Each Specified Time Points | Week 79 | -21.027 micromoles per liter | Standard Deviation 19.83 |
| Placebo | Part B: Change From Baseline in Total Bilirubin Levels at Each Specified Time Points | Week 81 | -22.331 micromoles per liter | Standard Deviation 20.117 |
| Placebo | Part B: Change From Baseline in Total Bilirubin Levels at Each Specified Time Points | Week 83 | -25.091 micromoles per liter | Standard Deviation 13.838 |
| Placebo | Part B: Change From Baseline in Total Bilirubin Levels at Each Specified Time Points | Week 85 | -23.292 micromoles per liter | Standard Deviation 12.976 |
| Placebo | Part B: Change From Baseline in Total Bilirubin Levels at Each Specified Time Points | Week 87 | -21.473 micromoles per liter | Standard Deviation 14.444 |
| Placebo | Part B: Change From Baseline in Total Bilirubin Levels at Each Specified Time Points | Week 105 | -26.920 micromoles per liter | Standard Deviation 10.996 |
| Placebo | Part B: Change From Baseline in Total Bilirubin Levels at Each Specified Time Points | Week 89 | -24.782 micromoles per liter | Standard Deviation 13.39 |
| Placebo | Part B: Change From Baseline in Total Bilirubin Levels at Each Specified Time Points | Week 139 | -24.733 micromoles per liter | Standard Deviation 17.47 |
| Placebo | Part B: Change From Baseline in Total Bilirubin Levels at Each Specified Time Points | Week 91 | -23.091 micromoles per liter | Standard Deviation 14.949 |
| Placebo | Part B: Change From Baseline in Total Bilirubin Levels at Each Specified Time Points | Week 109 | -25.422 micromoles per liter | Standard Deviation 14.1 |
| Placebo | Part B: Change From Baseline in Total Bilirubin Levels at Each Specified Time Points | Week 93 | -24.970 micromoles per liter | Standard Deviation 13.852 |
| Placebo | Part B: Change From Baseline in Total Bilirubin Levels at Each Specified Time Points | Week 163 | 13.000 micromoles per liter | — |
| Placebo | Part B: Change From Baseline in Total Bilirubin Levels at Each Specified Time Points | Week 95 | -23.564 micromoles per liter | Standard Deviation 11.122 |
| Placebo | Part B: Change From Baseline in Total Bilirubin Levels at Each Specified Time Points | Week 111 | -24.380 micromoles per liter | Standard Deviation 12.298 |
| Placebo | Part B: Change From Baseline in Total Bilirubin Levels at Each Specified Time Points | Week 99 | -23.700 micromoles per liter | Standard Deviation 12.919 |
| Placebo | Part B: Change From Baseline in Total Bilirubin Levels at Each Specified Time Points | Week 101 | -25.940 micromoles per liter | Standard Deviation 12.309 |
| Placebo | Part B: Change From Baseline in Total Bilirubin Levels at Each Specified Time Points | Week 113 | -23.940 micromoles per liter | Standard Deviation 15.514 |
| Placebo | Part B: Change From Baseline in Total Bilirubin Levels at Each Specified Time Points | Week 103 | -22.655 micromoles per liter | Standard Deviation 11.308 |
| Placebo | Part B: Change From Baseline in Total Bilirubin Levels at Each Specified Time Points | Week 141 | -13.833 micromoles per liter | Standard Deviation 16.669 |
| Placebo | Part B: Change From Baseline in Total Bilirubin Levels at Each Specified Time Points | Week 107 | -23.018 micromoles per liter | Standard Deviation 12.755 |
| Placebo | Part B: Change From Baseline in Total Bilirubin Levels at Each Specified Time Points | Week 115 | -21.533 micromoles per liter | Standard Deviation 14.215 |
| Placebo | Part B: Change From Baseline in Total Bilirubin Levels at Each Specified Time Points | Week 153 | -11.400 micromoles per liter | — |
| Placebo | Part B: Change From Baseline in Total Bilirubin Levels at Each Specified Time Points | Week 123 | -22.029 micromoles per liter | Standard Deviation 12.421 |
| Placebo | Part B: Change From Baseline in Total Bilirubin Levels at Each Specified Time Points | Week 117 | -22.225 micromoles per liter | Standard Deviation 15.256 |
| Placebo | Part B: Change From Baseline in Total Bilirubin Levels at Each Specified Time Points | Week 143 | -20.033 micromoles per liter | Standard Deviation 22.861 |
| Placebo | Part B: Change From Baseline in Total Bilirubin Levels at Each Specified Time Points | Week 155 | 0.700 micromoles per liter | — |
| Placebo | Part B: Change From Baseline in Total Bilirubin Levels at Each Specified Time Points | Week 119 | -22.713 micromoles per liter | Standard Deviation 14.859 |
| Placebo | Part B: Change From Baseline in Total Bilirubin Levels at Each Specified Time Points | Week 161 | 5.500 micromoles per liter | — |
| Placebo | Part B: Change From Baseline in Total Bilirubin Levels at Each Specified Time Points | Week 121 | -21.183 micromoles per liter | Standard Deviation 10.75 |
Secondary
Part B: Mean Change From Baseline in Haptoglobin Values at Each Specified Time Points
Change from baseline (Week 0) in haptoglobin values at each specified time points (i.e., Week 27, 29, 31, 33, 35, 37, 39, 41, 43, 45, 47, 49, 51, 53, 55, 57, 59, 61, 63, 65, 67, 69, 71, 73, 75, 77, 79, 81, 83, 85, 87, 89, 91, 93, 95, 97,99,101,103, 105, 107,109, 111,113,115,117,119, 121,123, 125, 127, 129,131,133,135,137,139,141,143, 145,147,149,151,153,155,157,159, 161,163,165,167,169,171,173,175 and ET/SFU Visit) is reported in this outcome measure. Baseline was defined as the last non-missing value prior to the first administration of study drug in Part A. ET/SFU visit was 9 weeks after administration of last dose (i.e., up to Week 184). Haptoglobin values \<0.2 were imputed as 0.2.
Time frame: Baseline (Week 0), every 2 weeks starting from Week 27 till Week 175 and at ET/SFU visit (i.e., up to Week 184)
Population: Analysis was performed on Part B-FAS. Here, 'number analyzed' = participants with available data for each specified category and 0 in the number analyzed field signifies that none of participants were available for assessment at the specified timepoints. Data for this outcome measure was planned to be collected and analyzed for combined population of BIVV009 (i.e., all participants who received BIVV009 \[either 6.5 g or 7.5 g\]).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| BIVV009 | Part B: Mean Change From Baseline in Haptoglobin Values at Each Specified Time Points | Week 125 | 0.303 grams per liter | Standard Deviation 0.425 |
| BIVV009 | Part B: Mean Change From Baseline in Haptoglobin Values at Each Specified Time Points | Week 95 | 0.263 grams per liter | Standard Deviation 0.495 |
| BIVV009 | Part B: Mean Change From Baseline in Haptoglobin Values at Each Specified Time Points | Week 139 | 0.494 grams per liter | Standard Deviation 0.676 |
| BIVV009 | Part B: Mean Change From Baseline in Haptoglobin Values at Each Specified Time Points | Week 137 | 0.545 grams per liter | Standard Deviation 0.631 |
| BIVV009 | Part B: Mean Change From Baseline in Haptoglobin Values at Each Specified Time Points | Week 69 | 0.168 grams per liter | Standard Deviation 0.255 |
| BIVV009 | Part B: Mean Change From Baseline in Haptoglobin Values at Each Specified Time Points | Week 103 | 0.219 grams per liter | Standard Deviation 0.291 |
| BIVV009 | Part B: Mean Change From Baseline in Haptoglobin Values at Each Specified Time Points | Week 27 | 0.219 grams per liter | Standard Deviation 0.38 |
| BIVV009 | Part B: Mean Change From Baseline in Haptoglobin Values at Each Specified Time Points | Week 141 | 0.667 grams per liter | Standard Deviation 0.583 |
| BIVV009 | Part B: Mean Change From Baseline in Haptoglobin Values at Each Specified Time Points | Week 105 | 0.216 grams per liter | Standard Deviation 0.291 |
| BIVV009 | Part B: Mean Change From Baseline in Haptoglobin Values at Each Specified Time Points | Week 143 | 0.513 grams per liter | Standard Deviation 0.604 |
| BIVV009 | Part B: Mean Change From Baseline in Haptoglobin Values at Each Specified Time Points | Week 71 | 0.220 grams per liter | Standard Deviation 0.288 |
| BIVV009 | Part B: Mean Change From Baseline in Haptoglobin Values at Each Specified Time Points | Week 29 | 0.240 grams per liter | Standard Deviation 0.317 |
| BIVV009 | Part B: Mean Change From Baseline in Haptoglobin Values at Each Specified Time Points | Week 31 | 0.183 grams per liter | Standard Deviation 0.311 |
| BIVV009 | Part B: Mean Change From Baseline in Haptoglobin Values at Each Specified Time Points | Week 107 | 0.182 grams per liter | Standard Deviation 0.273 |
| BIVV009 | Part B: Mean Change From Baseline in Haptoglobin Values at Each Specified Time Points | Week 33 | 0.212 grams per liter | Standard Deviation 0.423 |
| BIVV009 | Part B: Mean Change From Baseline in Haptoglobin Values at Each Specified Time Points | Week 129 | 0.393 grams per liter | Standard Deviation 0.506 |
| BIVV009 | Part B: Mean Change From Baseline in Haptoglobin Values at Each Specified Time Points | Week 35 | 0.207 grams per liter | Standard Deviation 0.355 |
| BIVV009 | Part B: Mean Change From Baseline in Haptoglobin Values at Each Specified Time Points | Week 73 | 0.261 grams per liter | Standard Deviation 0.335 |
| BIVV009 | Part B: Mean Change From Baseline in Haptoglobin Values at Each Specified Time Points | Week 37 | 0.232 grams per liter | Standard Deviation 0.419 |
| BIVV009 | Part B: Mean Change From Baseline in Haptoglobin Values at Each Specified Time Points | Week 111 | 0.282 grams per liter | Standard Deviation 0.556 |
| BIVV009 | Part B: Mean Change From Baseline in Haptoglobin Values at Each Specified Time Points | Week 39 | 0.213 grams per liter | Standard Deviation 0.33 |
| BIVV009 | Part B: Mean Change From Baseline in Haptoglobin Values at Each Specified Time Points | Week 47 | 0.135 grams per liter | Standard Deviation 0.243 |
| BIVV009 | Part B: Mean Change From Baseline in Haptoglobin Values at Each Specified Time Points | Week 41 | 0.119 grams per liter | Standard Deviation 0.238 |
| BIVV009 | Part B: Mean Change From Baseline in Haptoglobin Values at Each Specified Time Points | Week 155 | 0.000 grams per liter | — |
| BIVV009 | Part B: Mean Change From Baseline in Haptoglobin Values at Each Specified Time Points | Week 43 | 0.100 grams per liter | Standard Deviation 0.224 |
| BIVV009 | Part B: Mean Change From Baseline in Haptoglobin Values at Each Specified Time Points | Week 127 | 0.309 grams per liter | Standard Deviation 0.401 |
| BIVV009 | Part B: Mean Change From Baseline in Haptoglobin Values at Each Specified Time Points | Week 45 | 0.114 grams per liter | Standard Deviation 0.205 |
| BIVV009 | Part B: Mean Change From Baseline in Haptoglobin Values at Each Specified Time Points | Week 157 | 0.000 grams per liter | — |
| BIVV009 | Part B: Mean Change From Baseline in Haptoglobin Values at Each Specified Time Points | Week 49 | 0.139 grams per liter | Standard Deviation 0.205 |
| BIVV009 | Part B: Mean Change From Baseline in Haptoglobin Values at Each Specified Time Points | Week 79 | 0.299 grams per liter | Standard Deviation 0.419 |
| BIVV009 | Part B: Mean Change From Baseline in Haptoglobin Values at Each Specified Time Points | Week 51 | 0.083 grams per liter | Standard Deviation 0.197 |
| BIVV009 | Part B: Mean Change From Baseline in Haptoglobin Values at Each Specified Time Points | Week 53 | 0.045 grams per liter | Standard Deviation 0.137 |
| BIVV009 | Part B: Mean Change From Baseline in Haptoglobin Values at Each Specified Time Points | Week 55 | 0.149 grams per liter | Standard Deviation 0.251 |
| BIVV009 | Part B: Mean Change From Baseline in Haptoglobin Values at Each Specified Time Points | Week 159 | 0.000 grams per liter | — |
| BIVV009 | Part B: Mean Change From Baseline in Haptoglobin Values at Each Specified Time Points | Week 57 | 0.158 grams per liter | Standard Deviation 0.234 |
| BIVV009 | Part B: Mean Change From Baseline in Haptoglobin Values at Each Specified Time Points | Week 131 | 0.480 grams per liter | Standard Deviation 0.529 |
| BIVV009 | Part B: Mean Change From Baseline in Haptoglobin Values at Each Specified Time Points | Week 59 | 0.132 grams per liter | Standard Deviation 0.229 |
| BIVV009 | Part B: Mean Change From Baseline in Haptoglobin Values at Each Specified Time Points | Week 61 | 0.153 grams per liter | Standard Deviation 0.286 |
| BIVV009 | Part B: Mean Change From Baseline in Haptoglobin Values at Each Specified Time Points | Week 161 | 0.180 grams per liter | — |
| BIVV009 | Part B: Mean Change From Baseline in Haptoglobin Values at Each Specified Time Points | Week 63 | 0.202 grams per liter | Standard Deviation 0.265 |
| BIVV009 | Part B: Mean Change From Baseline in Haptoglobin Values at Each Specified Time Points | Week 81 | 0.438 grams per liter | Standard Deviation 0.463 |
| BIVV009 | Part B: Mean Change From Baseline in Haptoglobin Values at Each Specified Time Points | Week 65 | 0.101 grams per liter | Standard Deviation 0.232 |
| BIVV009 | Part B: Mean Change From Baseline in Haptoglobin Values at Each Specified Time Points | Week 77 | 0.249 grams per liter | Standard Deviation 0.374 |
| BIVV009 | Part B: Mean Change From Baseline in Haptoglobin Values at Each Specified Time Points | Week 163 | 0.000 grams per liter | — |
| BIVV009 | Part B: Mean Change From Baseline in Haptoglobin Values at Each Specified Time Points | Week 75 | 0.275 grams per liter | Standard Deviation 0.321 |
| BIVV009 | Part B: Mean Change From Baseline in Haptoglobin Values at Each Specified Time Points | Week 83 | 0.297 grams per liter | Standard Deviation 0.379 |
| BIVV009 | Part B: Mean Change From Baseline in Haptoglobin Values at Each Specified Time Points | Week 133 | 0.342 grams per liter | Standard Deviation 0.469 |
| BIVV009 | Part B: Mean Change From Baseline in Haptoglobin Values at Each Specified Time Points | Week 89 | 0.348 grams per liter | Standard Deviation 0.482 |
| BIVV009 | Part B: Mean Change From Baseline in Haptoglobin Values at Each Specified Time Points | Week 101 | 0.289 grams per liter | Standard Deviation 0.289 |
| BIVV009 | Part B: Mean Change From Baseline in Haptoglobin Values at Each Specified Time Points | Week 165 | 0.000 grams per liter | — |
| BIVV009 | Part B: Mean Change From Baseline in Haptoglobin Values at Each Specified Time Points | Week 167 | 0.000 grams per liter | — |
| BIVV009 | Part B: Mean Change From Baseline in Haptoglobin Values at Each Specified Time Points | Week 169 | 0.000 grams per liter | — |
| BIVV009 | Part B: Mean Change From Baseline in Haptoglobin Values at Each Specified Time Points | Week 93 | 0.262 grams per liter | Standard Deviation 0.383 |
| BIVV009 | Part B: Mean Change From Baseline in Haptoglobin Values at Each Specified Time Points | Week 85 | 0.374 grams per liter | Standard Deviation 0.374 |
| BIVV009 | Part B: Mean Change From Baseline in Haptoglobin Values at Each Specified Time Points | Week 109 | 0.207 grams per liter | Standard Deviation 0.311 |
| BIVV009 | Part B: Mean Change From Baseline in Haptoglobin Values at Each Specified Time Points | Week 113 | 0.248 grams per liter | Standard Deviation 0.366 |
| BIVV009 | Part B: Mean Change From Baseline in Haptoglobin Values at Each Specified Time Points | Week 171 | 0.000 grams per liter | — |
| BIVV009 | Part B: Mean Change From Baseline in Haptoglobin Values at Each Specified Time Points | Week 145 | 0.580 grams per liter | Standard Deviation 0.82 |
| BIVV009 | Part B: Mean Change From Baseline in Haptoglobin Values at Each Specified Time Points | Week 173 | 0.000 grams per liter | — |
| BIVV009 | Part B: Mean Change From Baseline in Haptoglobin Values at Each Specified Time Points | Week 147 | 0.400 grams per liter | Standard Deviation 0.592 |
| BIVV009 | Part B: Mean Change From Baseline in Haptoglobin Values at Each Specified Time Points | Week 175 | 0.000 grams per liter | — |
| BIVV009 | Part B: Mean Change From Baseline in Haptoglobin Values at Each Specified Time Points | Week 149 | 0.000 grams per liter | — |
| BIVV009 | Part B: Mean Change From Baseline in Haptoglobin Values at Each Specified Time Points | ET/SFU Visit | 0.055 grams per liter | Standard Deviation 0.2 |
| BIVV009 | Part B: Mean Change From Baseline in Haptoglobin Values at Each Specified Time Points | Week 151 | 0.000 grams per liter | Standard Deviation 0 |
| BIVV009 | Part B: Mean Change From Baseline in Haptoglobin Values at Each Specified Time Points | Week 97 | 0.245 grams per liter | Standard Deviation 0.306 |
| BIVV009 | Part B: Mean Change From Baseline in Haptoglobin Values at Each Specified Time Points | Week 135 | 0.454 grams per liter | Standard Deviation 0.643 |
| BIVV009 | Part B: Mean Change From Baseline in Haptoglobin Values at Each Specified Time Points | Week 99 | 0.266 grams per liter | Standard Deviation 0.351 |
| BIVV009 | Part B: Mean Change From Baseline in Haptoglobin Values at Each Specified Time Points | Week 119 | 0.348 grams per liter | Standard Deviation 0.4 |
| BIVV009 | Part B: Mean Change From Baseline in Haptoglobin Values at Each Specified Time Points | Week 153 | 0.000 grams per liter | — |
| BIVV009 | Part B: Mean Change From Baseline in Haptoglobin Values at Each Specified Time Points | Week 115 | 0.324 grams per liter | Standard Deviation 0.413 |
| BIVV009 | Part B: Mean Change From Baseline in Haptoglobin Values at Each Specified Time Points | Week 87 | 0.334 grams per liter | Standard Deviation 0.409 |
| BIVV009 | Part B: Mean Change From Baseline in Haptoglobin Values at Each Specified Time Points | Week 117 | 0.450 grams per liter | Standard Deviation 0.492 |
| BIVV009 | Part B: Mean Change From Baseline in Haptoglobin Values at Each Specified Time Points | Week 91 | 0.313 grams per liter | Standard Deviation 0.449 |
| BIVV009 | Part B: Mean Change From Baseline in Haptoglobin Values at Each Specified Time Points | Week 121 | 0.459 grams per liter | Standard Deviation 0.414 |
| BIVV009 | Part B: Mean Change From Baseline in Haptoglobin Values at Each Specified Time Points | Week 123 | 0.350 grams per liter | Standard Deviation 0.375 |
| BIVV009 | Part B: Mean Change From Baseline in Haptoglobin Values at Each Specified Time Points | Week 67 | 0.178 grams per liter | Standard Deviation 0.241 |
| Placebo | Part B: Mean Change From Baseline in Haptoglobin Values at Each Specified Time Points | Week 153 | 0.000 grams per liter | — |
| Placebo | Part B: Mean Change From Baseline in Haptoglobin Values at Each Specified Time Points | Week 121 | 0.174 grams per liter | Standard Deviation 0.479 |
| Placebo | Part B: Mean Change From Baseline in Haptoglobin Values at Each Specified Time Points | Week 127 | 0.220 grams per liter | Standard Deviation 0.42 |
| Placebo | Part B: Mean Change From Baseline in Haptoglobin Values at Each Specified Time Points | Week 129 | 0.191 grams per liter | Standard Deviation 0.506 |
| Placebo | Part B: Mean Change From Baseline in Haptoglobin Values at Each Specified Time Points | Week 137 | 0.070 grams per liter | Standard Deviation 0.121 |
| Placebo | Part B: Mean Change From Baseline in Haptoglobin Values at Each Specified Time Points | Week 29 | 0.182 grams per liter | Standard Deviation 0.482 |
| Placebo | Part B: Mean Change From Baseline in Haptoglobin Values at Each Specified Time Points | Week 47 | 0.255 grams per liter | Standard Deviation 0.416 |
| Placebo | Part B: Mean Change From Baseline in Haptoglobin Values at Each Specified Time Points | Week 51 | 0.207 grams per liter | Standard Deviation 0.369 |
| Placebo | Part B: Mean Change From Baseline in Haptoglobin Values at Each Specified Time Points | Week 53 | 0.122 grams per liter | Standard Deviation 0.296 |
| Placebo | Part B: Mean Change From Baseline in Haptoglobin Values at Each Specified Time Points | Week 59 | 0.131 grams per liter | Standard Deviation 0.306 |
| Placebo | Part B: Mean Change From Baseline in Haptoglobin Values at Each Specified Time Points | Week 65 | 0.198 grams per liter | Standard Deviation 0.384 |
| Placebo | Part B: Mean Change From Baseline in Haptoglobin Values at Each Specified Time Points | Week 67 | 0.162 grams per liter | Standard Deviation 0.363 |
| Placebo | Part B: Mean Change From Baseline in Haptoglobin Values at Each Specified Time Points | Week 69 | 0.169 grams per liter | Standard Deviation 0.348 |
| Placebo | Part B: Mean Change From Baseline in Haptoglobin Values at Each Specified Time Points | Week 71 | 0.236 grams per liter | Standard Deviation 0.388 |
| Placebo | Part B: Mean Change From Baseline in Haptoglobin Values at Each Specified Time Points | Week 73 | 0.174 grams per liter | Standard Deviation 0.348 |
| Placebo | Part B: Mean Change From Baseline in Haptoglobin Values at Each Specified Time Points | Week 75 | 0.197 grams per liter | Standard Deviation 0.362 |
| Placebo | Part B: Mean Change From Baseline in Haptoglobin Values at Each Specified Time Points | Week 79 | 0.290 grams per liter | Standard Deviation 0.464 |
| Placebo | Part B: Mean Change From Baseline in Haptoglobin Values at Each Specified Time Points | Week 81 | 0.207 grams per liter | Standard Deviation 0.421 |
| Placebo | Part B: Mean Change From Baseline in Haptoglobin Values at Each Specified Time Points | Week 83 | 0.233 grams per liter | Standard Deviation 0.394 |
| Placebo | Part B: Mean Change From Baseline in Haptoglobin Values at Each Specified Time Points | Week 85 | 0.266 grams per liter | Standard Deviation 0.426 |
| Placebo | Part B: Mean Change From Baseline in Haptoglobin Values at Each Specified Time Points | Week 93 | 0.178 grams per liter | Standard Deviation 0.373 |
| Placebo | Part B: Mean Change From Baseline in Haptoglobin Values at Each Specified Time Points | Week 95 | 0.198 grams per liter | Standard Deviation 0.414 |
| Placebo | Part B: Mean Change From Baseline in Haptoglobin Values at Each Specified Time Points | Week 99 | 0.213 grams per liter | Standard Deviation 0.37 |
| Placebo | Part B: Mean Change From Baseline in Haptoglobin Values at Each Specified Time Points | Week 103 | 0.212 grams per liter | Standard Deviation 0.389 |
| Placebo | Part B: Mean Change From Baseline in Haptoglobin Values at Each Specified Time Points | Week 105 | 0.174 grams per liter | Standard Deviation 0.399 |
| Placebo | Part B: Mean Change From Baseline in Haptoglobin Values at Each Specified Time Points | Week 107 | 0.245 grams per liter | Standard Deviation 0.459 |
| Placebo | Part B: Mean Change From Baseline in Haptoglobin Values at Each Specified Time Points | Week 109 | 0.254 grams per liter | Standard Deviation 0.507 |
| Placebo | Part B: Mean Change From Baseline in Haptoglobin Values at Each Specified Time Points | Week 111 | 0.263 grams per liter | Standard Deviation 0.459 |
| Placebo | Part B: Mean Change From Baseline in Haptoglobin Values at Each Specified Time Points | Week 155 | 0.000 grams per liter | — |
| Placebo | Part B: Mean Change From Baseline in Haptoglobin Values at Each Specified Time Points | Week 157 | 0.000 grams per liter | — |
| Placebo | Part B: Mean Change From Baseline in Haptoglobin Values at Each Specified Time Points | Week 159 | 0.000 grams per liter | — |
| Placebo | Part B: Mean Change From Baseline in Haptoglobin Values at Each Specified Time Points | Week 161 | 0.000 grams per liter | — |
| Placebo | Part B: Mean Change From Baseline in Haptoglobin Values at Each Specified Time Points | Week 163 | 0.000 grams per liter | — |
| Placebo | Part B: Mean Change From Baseline in Haptoglobin Values at Each Specified Time Points | ET/SFU Visit | 0.181 grams per liter | Standard Deviation 0.426 |
| Placebo | Part B: Mean Change From Baseline in Haptoglobin Values at Each Specified Time Points | Week 113 | 0.335 grams per liter | Standard Deviation 0.614 |
| Placebo | Part B: Mean Change From Baseline in Haptoglobin Values at Each Specified Time Points | Week 115 | 0.165 grams per liter | Standard Deviation 0.432 |
| Placebo | Part B: Mean Change From Baseline in Haptoglobin Values at Each Specified Time Points | Week 119 | 0.187 grams per liter | Standard Deviation 0.404 |
| Placebo | Part B: Mean Change From Baseline in Haptoglobin Values at Each Specified Time Points | Week 123 | 0.192 grams per liter | Standard Deviation 0.512 |
| Placebo | Part B: Mean Change From Baseline in Haptoglobin Values at Each Specified Time Points | Week 125 | 0.114 grams per liter | Standard Deviation 0.298 |
| Placebo | Part B: Mean Change From Baseline in Haptoglobin Values at Each Specified Time Points | Week 131 | 0.222 grams per liter | Standard Deviation 0.43 |
| Placebo | Part B: Mean Change From Baseline in Haptoglobin Values at Each Specified Time Points | Week 133 | 0.125 grams per liter | Standard Deviation 0.155 |
| Placebo | Part B: Mean Change From Baseline in Haptoglobin Values at Each Specified Time Points | Week 135 | 0.280 grams per liter | Standard Deviation 0.425 |
| Placebo | Part B: Mean Change From Baseline in Haptoglobin Values at Each Specified Time Points | Week 139 | 0.293 grams per liter | Standard Deviation 0.508 |
| Placebo | Part B: Mean Change From Baseline in Haptoglobin Values at Each Specified Time Points | Week 141 | 0.025 grams per liter | Standard Deviation 0.035 |
| Placebo | Part B: Mean Change From Baseline in Haptoglobin Values at Each Specified Time Points | Week 27 | 0.082 grams per liter | Standard Deviation 0.197 |
| Placebo | Part B: Mean Change From Baseline in Haptoglobin Values at Each Specified Time Points | Week 31 | 0.256 grams per liter | Standard Deviation 0.516 |
| Placebo | Part B: Mean Change From Baseline in Haptoglobin Values at Each Specified Time Points | Week 33 | 0.229 grams per liter | Standard Deviation 0.379 |
| Placebo | Part B: Mean Change From Baseline in Haptoglobin Values at Each Specified Time Points | Week 35 | 0.151 grams per liter | Standard Deviation 0.28 |
| Placebo | Part B: Mean Change From Baseline in Haptoglobin Values at Each Specified Time Points | Week 37 | 0.187 grams per liter | Standard Deviation 0.291 |
| Placebo | Part B: Mean Change From Baseline in Haptoglobin Values at Each Specified Time Points | Week 39 | 0.165 grams per liter | Standard Deviation 0.295 |
| Placebo | Part B: Mean Change From Baseline in Haptoglobin Values at Each Specified Time Points | Week 41 | 0.082 grams per liter | Standard Deviation 0.168 |
| Placebo | Part B: Mean Change From Baseline in Haptoglobin Values at Each Specified Time Points | Week 43 | 0.161 grams per liter | Standard Deviation 0.234 |
| Placebo | Part B: Mean Change From Baseline in Haptoglobin Values at Each Specified Time Points | Week 45 | 0.189 grams per liter | Standard Deviation 0.275 |
| Placebo | Part B: Mean Change From Baseline in Haptoglobin Values at Each Specified Time Points | Week 49 | 0.172 grams per liter | Standard Deviation 0.345 |
| Placebo | Part B: Mean Change From Baseline in Haptoglobin Values at Each Specified Time Points | Week 55 | 0.179 grams per liter | Standard Deviation 0.343 |
| Placebo | Part B: Mean Change From Baseline in Haptoglobin Values at Each Specified Time Points | Week 57 | 0.158 grams per liter | Standard Deviation 0.362 |
| Placebo | Part B: Mean Change From Baseline in Haptoglobin Values at Each Specified Time Points | Week 61 | 0.184 grams per liter | Standard Deviation 0.35 |
| Placebo | Part B: Mean Change From Baseline in Haptoglobin Values at Each Specified Time Points | Week 63 | 0.177 grams per liter | Standard Deviation 0.357 |
| Placebo | Part B: Mean Change From Baseline in Haptoglobin Values at Each Specified Time Points | Week 77 | 0.232 grams per liter | Standard Deviation 0.398 |
| Placebo | Part B: Mean Change From Baseline in Haptoglobin Values at Each Specified Time Points | Week 87 | 0.344 grams per liter | Standard Deviation 0.471 |
| Placebo | Part B: Mean Change From Baseline in Haptoglobin Values at Each Specified Time Points | Week 101 | 0.207 grams per liter | Standard Deviation 0.417 |
| Placebo | Part B: Mean Change From Baseline in Haptoglobin Values at Each Specified Time Points | Week 89 | 0.198 grams per liter | Standard Deviation 0.351 |
| Placebo | Part B: Mean Change From Baseline in Haptoglobin Values at Each Specified Time Points | Week 91 | 0.279 grams per liter | Standard Deviation 0.449 |
| Placebo | Part B: Mean Change From Baseline in Haptoglobin Values at Each Specified Time Points | Week 143 | 0.270 grams per liter | Standard Deviation 0.292 |
| Placebo | Part B: Mean Change From Baseline in Haptoglobin Values at Each Specified Time Points | Week 145 | 0.130 grams per liter | Standard Deviation 0.141 |
| Placebo | Part B: Mean Change From Baseline in Haptoglobin Values at Each Specified Time Points | Week 147 | 0.195 grams per liter | Standard Deviation 0.276 |
| Placebo | Part B: Mean Change From Baseline in Haptoglobin Values at Each Specified Time Points | Week 149 | 0.000 grams per liter | Standard Deviation 0 |
| Placebo | Part B: Mean Change From Baseline in Haptoglobin Values at Each Specified Time Points | Week 97 | 0.210 grams per liter | Standard Deviation 0.407 |
| Placebo | Part B: Mean Change From Baseline in Haptoglobin Values at Each Specified Time Points | Week 151 | 0.000 grams per liter | — |
| Placebo | Part B: Mean Change From Baseline in Haptoglobin Values at Each Specified Time Points | Week 117 | 0.181 grams per liter | Standard Deviation 0.489 |
Secondary
Part B: Mean Change From Baseline in Lactate Dehydrogenase (LDH) Level at Each Specified Time Points
Change from baseline (Week 0) in LDH levels at each specified time points (i.e., Week 27, 29, 31, 33, 35, 37, 39, 41, 43, 45, 47, 49, 51, 53, 55, 57, 59, 61, 63, 65, 67, 69, 71, 73, 75, 77, 79, 81, 83, 85, 87, 89, 91, 93, 95, 97, 99, 101, 103, 105, 107,109, 111, 113, 115, 117, 119, 121,123, 125, 127,129,131,133,135,137,139,141,143,145,147, 149, 151,153,155,157,159,161,163,165,167,169, 171, 173, 175 and ET/SFU Visit) is reported in this outcome measure. Baseline was defined as the last non-missing value prior to the first administration of study drug in Part A. ET/SFU visit was 9 weeks after administration of last dose (i.e., up to Week 184).
Time frame: Baseline (Week 0), every 2 weeks starting from Week 27 till Week 175 and at ET/SFU visit (i.e., up to Week 184)
Population: Analysis was performed on Part B-FAS. Here, 'number analyzed' = participants with available data for each specified category and 0 in the number analyzed field signifies that none of participants were available for assessment at the specified timepoints. Data for this outcome measure was planned to be collected and analyzed for combined population of BIVV009 (i.e., all participants who received BIVV009 \[either 6.5 g or 7.5 g\]).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| BIVV009 | Part B: Mean Change From Baseline in Lactate Dehydrogenase (LDH) Level at Each Specified Time Points | Week 129 | -136.429 units per liter | Standard Deviation 234.954 |
| BIVV009 | Part B: Mean Change From Baseline in Lactate Dehydrogenase (LDH) Level at Each Specified Time Points | Week 47 | -22.600 units per liter | Standard Deviation 302.511 |
| BIVV009 | Part B: Mean Change From Baseline in Lactate Dehydrogenase (LDH) Level at Each Specified Time Points | Week 99 | -80.909 units per liter | Standard Deviation 312.405 |
| BIVV009 | Part B: Mean Change From Baseline in Lactate Dehydrogenase (LDH) Level at Each Specified Time Points | Week 49 | -29.250 units per liter | Standard Deviation 289.392 |
| BIVV009 | Part B: Mean Change From Baseline in Lactate Dehydrogenase (LDH) Level at Each Specified Time Points | Week 131 | -120.833 units per liter | Standard Deviation 300.454 |
| BIVV009 | Part B: Mean Change From Baseline in Lactate Dehydrogenase (LDH) Level at Each Specified Time Points | Week 51 | -12.563 units per liter | Standard Deviation 290.489 |
| BIVV009 | Part B: Mean Change From Baseline in Lactate Dehydrogenase (LDH) Level at Each Specified Time Points | Week 133 | -179.000 units per liter | Standard Deviation 298.811 |
| BIVV009 | Part B: Mean Change From Baseline in Lactate Dehydrogenase (LDH) Level at Each Specified Time Points | Week 53 | -16.938 units per liter | Standard Deviation 299.788 |
| BIVV009 | Part B: Mean Change From Baseline in Lactate Dehydrogenase (LDH) Level at Each Specified Time Points | Week 109 | -50.727 units per liter | Standard Deviation 335.078 |
| BIVV009 | Part B: Mean Change From Baseline in Lactate Dehydrogenase (LDH) Level at Each Specified Time Points | Week 55 | -89.500 units per liter | Standard Deviation 219.634 |
| BIVV009 | Part B: Mean Change From Baseline in Lactate Dehydrogenase (LDH) Level at Each Specified Time Points | Week 135 | -211.800 units per liter | Standard Deviation 265.438 |
| BIVV009 | Part B: Mean Change From Baseline in Lactate Dehydrogenase (LDH) Level at Each Specified Time Points | Week 57 | -78.200 units per liter | Standard Deviation 285.14 |
| BIVV009 | Part B: Mean Change From Baseline in Lactate Dehydrogenase (LDH) Level at Each Specified Time Points | Week 85 | -72.000 units per liter | Standard Deviation 350.021 |
| BIVV009 | Part B: Mean Change From Baseline in Lactate Dehydrogenase (LDH) Level at Each Specified Time Points | Week 59 | -84.438 units per liter | Standard Deviation 220.376 |
| BIVV009 | Part B: Mean Change From Baseline in Lactate Dehydrogenase (LDH) Level at Each Specified Time Points | Week 137 | -252.500 units per liter | Standard Deviation 264.591 |
| BIVV009 | Part B: Mean Change From Baseline in Lactate Dehydrogenase (LDH) Level at Each Specified Time Points | Week 61 | -74.353 units per liter | Standard Deviation 215.414 |
| BIVV009 | Part B: Mean Change From Baseline in Lactate Dehydrogenase (LDH) Level at Each Specified Time Points | Week 111 | -83.000 units per liter | Standard Deviation 303.258 |
| BIVV009 | Part B: Mean Change From Baseline in Lactate Dehydrogenase (LDH) Level at Each Specified Time Points | Week 63 | -98.235 units per liter | Standard Deviation 185.259 |
| BIVV009 | Part B: Mean Change From Baseline in Lactate Dehydrogenase (LDH) Level at Each Specified Time Points | Week 139 | -181.800 units per liter | Standard Deviation 284.966 |
| BIVV009 | Part B: Mean Change From Baseline in Lactate Dehydrogenase (LDH) Level at Each Specified Time Points | Week 65 | -97.438 units per liter | Standard Deviation 212.335 |
| BIVV009 | Part B: Mean Change From Baseline in Lactate Dehydrogenase (LDH) Level at Each Specified Time Points | Week 101 | -90.273 units per liter | Standard Deviation 293.68 |
| BIVV009 | Part B: Mean Change From Baseline in Lactate Dehydrogenase (LDH) Level at Each Specified Time Points | Week 67 | -127.824 units per liter | Standard Deviation 192.148 |
| BIVV009 | Part B: Mean Change From Baseline in Lactate Dehydrogenase (LDH) Level at Each Specified Time Points | Week 113 | -80.700 units per liter | Standard Deviation 319.283 |
| BIVV009 | Part B: Mean Change From Baseline in Lactate Dehydrogenase (LDH) Level at Each Specified Time Points | Week 69 | -113.625 units per liter | Standard Deviation 197.27 |
| BIVV009 | Part B: Mean Change From Baseline in Lactate Dehydrogenase (LDH) Level at Each Specified Time Points | Week 143 | -160.250 units per liter | Standard Deviation 357.021 |
| BIVV009 | Part B: Mean Change From Baseline in Lactate Dehydrogenase (LDH) Level at Each Specified Time Points | Week 71 | -101.692 units per liter | Standard Deviation 320.348 |
| BIVV009 | Part B: Mean Change From Baseline in Lactate Dehydrogenase (LDH) Level at Each Specified Time Points | Week 155 | -50.000 units per liter | — |
| BIVV009 | Part B: Mean Change From Baseline in Lactate Dehydrogenase (LDH) Level at Each Specified Time Points | Week 73 | -174.500 units per liter | Standard Deviation 177.153 |
| BIVV009 | Part B: Mean Change From Baseline in Lactate Dehydrogenase (LDH) Level at Each Specified Time Points | Week 157 | -50.000 units per liter | — |
| BIVV009 | Part B: Mean Change From Baseline in Lactate Dehydrogenase (LDH) Level at Each Specified Time Points | Week 75 | -157.429 units per liter | Standard Deviation 184.525 |
| BIVV009 | Part B: Mean Change From Baseline in Lactate Dehydrogenase (LDH) Level at Each Specified Time Points | Week 159 | -155.000 units per liter | — |
| BIVV009 | Part B: Mean Change From Baseline in Lactate Dehydrogenase (LDH) Level at Each Specified Time Points | Week 79 | -98.077 units per liter | Standard Deviation 271.632 |
| BIVV009 | Part B: Mean Change From Baseline in Lactate Dehydrogenase (LDH) Level at Each Specified Time Points | Week 91 | -143.000 units per liter | Standard Deviation 273.54 |
| BIVV009 | Part B: Mean Change From Baseline in Lactate Dehydrogenase (LDH) Level at Each Specified Time Points | Week 81 | -127.846 units per liter | Standard Deviation 233.663 |
| BIVV009 | Part B: Mean Change From Baseline in Lactate Dehydrogenase (LDH) Level at Each Specified Time Points | Week 165 | -155.000 units per liter | — |
| BIVV009 | Part B: Mean Change From Baseline in Lactate Dehydrogenase (LDH) Level at Each Specified Time Points | Week 169 | -180.000 units per liter | — |
| BIVV009 | Part B: Mean Change From Baseline in Lactate Dehydrogenase (LDH) Level at Each Specified Time Points | Week 87 | -101.385 units per liter | Standard Deviation 285.59 |
| BIVV009 | Part B: Mean Change From Baseline in Lactate Dehydrogenase (LDH) Level at Each Specified Time Points | Week 173 | -171.000 units per liter | — |
| BIVV009 | Part B: Mean Change From Baseline in Lactate Dehydrogenase (LDH) Level at Each Specified Time Points | Week 89 | -78.667 units per liter | Standard Deviation 351.059 |
| BIVV009 | Part B: Mean Change From Baseline in Lactate Dehydrogenase (LDH) Level at Each Specified Time Points | Week 117 | -140.444 units per liter | Standard Deviation 280.944 |
| BIVV009 | Part B: Mean Change From Baseline in Lactate Dehydrogenase (LDH) Level at Each Specified Time Points | Week 93 | -133.500 units per liter | Standard Deviation 254.332 |
| BIVV009 | Part B: Mean Change From Baseline in Lactate Dehydrogenase (LDH) Level at Each Specified Time Points | Week 103 | -50.273 units per liter | Standard Deviation 331.072 |
| BIVV009 | Part B: Mean Change From Baseline in Lactate Dehydrogenase (LDH) Level at Each Specified Time Points | Week 95 | -59.364 units per liter | Standard Deviation 368.708 |
| BIVV009 | Part B: Mean Change From Baseline in Lactate Dehydrogenase (LDH) Level at Each Specified Time Points | Week 27 | -151.000 units per liter | Standard Deviation 184.64 |
| BIVV009 | Part B: Mean Change From Baseline in Lactate Dehydrogenase (LDH) Level at Each Specified Time Points | Week 97 | -53.364 units per liter | Standard Deviation 343.82 |
| BIVV009 | Part B: Mean Change From Baseline in Lactate Dehydrogenase (LDH) Level at Each Specified Time Points | Week 115 | -109.500 units per liter | Standard Deviation 256.395 |
| BIVV009 | Part B: Mean Change From Baseline in Lactate Dehydrogenase (LDH) Level at Each Specified Time Points | Week 119 | -149.556 units per liter | Standard Deviation 237.771 |
| BIVV009 | Part B: Mean Change From Baseline in Lactate Dehydrogenase (LDH) Level at Each Specified Time Points | Week 29 | -115.944 units per liter | Standard Deviation 226.913 |
| BIVV009 | Part B: Mean Change From Baseline in Lactate Dehydrogenase (LDH) Level at Each Specified Time Points | Week 83 | -59.000 units per liter | Standard Deviation 346.917 |
| BIVV009 | Part B: Mean Change From Baseline in Lactate Dehydrogenase (LDH) Level at Each Specified Time Points | Week 141 | -259.667 units per liter | Standard Deviation 362.136 |
| BIVV009 | Part B: Mean Change From Baseline in Lactate Dehydrogenase (LDH) Level at Each Specified Time Points | Week 31 | -85.111 units per liter | Standard Deviation 247.506 |
| BIVV009 | Part B: Mean Change From Baseline in Lactate Dehydrogenase (LDH) Level at Each Specified Time Points | Week 145 | -340.500 units per liter | Standard Deviation 458.912 |
| BIVV009 | Part B: Mean Change From Baseline in Lactate Dehydrogenase (LDH) Level at Each Specified Time Points | Week 121 | -195.778 units per liter | Standard Deviation 225.978 |
| BIVV009 | Part B: Mean Change From Baseline in Lactate Dehydrogenase (LDH) Level at Each Specified Time Points | Week 147 | -248.667 units per liter | Standard Deviation 355.136 |
| BIVV009 | Part B: Mean Change From Baseline in Lactate Dehydrogenase (LDH) Level at Each Specified Time Points | Week 149 | -78.000 units per liter | — |
| BIVV009 | Part B: Mean Change From Baseline in Lactate Dehydrogenase (LDH) Level at Each Specified Time Points | Week 33 | -66.176 units per liter | Standard Deviation 324.145 |
| BIVV009 | Part B: Mean Change From Baseline in Lactate Dehydrogenase (LDH) Level at Each Specified Time Points | Week 123 | -185.000 units per liter | Standard Deviation 231.489 |
| BIVV009 | Part B: Mean Change From Baseline in Lactate Dehydrogenase (LDH) Level at Each Specified Time Points | Week 161 | -175.000 units per liter | — |
| BIVV009 | Part B: Mean Change From Baseline in Lactate Dehydrogenase (LDH) Level at Each Specified Time Points | Week 163 | -149.000 units per liter | — |
| BIVV009 | Part B: Mean Change From Baseline in Lactate Dehydrogenase (LDH) Level at Each Specified Time Points | Week 35 | -64.667 units per liter | Standard Deviation 261.431 |
| BIVV009 | Part B: Mean Change From Baseline in Lactate Dehydrogenase (LDH) Level at Each Specified Time Points | Week 167 | -162.000 units per liter | — |
| BIVV009 | Part B: Mean Change From Baseline in Lactate Dehydrogenase (LDH) Level at Each Specified Time Points | Week 171 | -167.000 units per liter | — |
| BIVV009 | Part B: Mean Change From Baseline in Lactate Dehydrogenase (LDH) Level at Each Specified Time Points | Week 175 | -121.000 units per liter | — |
| BIVV009 | Part B: Mean Change From Baseline in Lactate Dehydrogenase (LDH) Level at Each Specified Time Points | ET/SFU Visit | -2.500 units per liter | Standard Deviation 195.967 |
| BIVV009 | Part B: Mean Change From Baseline in Lactate Dehydrogenase (LDH) Level at Each Specified Time Points | Week 151 | 58.000 units per liter | Standard Deviation 32.527 |
| BIVV009 | Part B: Mean Change From Baseline in Lactate Dehydrogenase (LDH) Level at Each Specified Time Points | Week 105 | -96.455 units per liter | Standard Deviation 276.907 |
| BIVV009 | Part B: Mean Change From Baseline in Lactate Dehydrogenase (LDH) Level at Each Specified Time Points | Week 153 | 7.000 units per liter | — |
| BIVV009 | Part B: Mean Change From Baseline in Lactate Dehydrogenase (LDH) Level at Each Specified Time Points | Week 37 | 4.438 units per liter | Standard Deviation 398.843 |
| BIVV009 | Part B: Mean Change From Baseline in Lactate Dehydrogenase (LDH) Level at Each Specified Time Points | Week 125 | -99.429 units per liter | Standard Deviation 285.513 |
| BIVV009 | Part B: Mean Change From Baseline in Lactate Dehydrogenase (LDH) Level at Each Specified Time Points | Week 39 | -88.500 units per liter | Standard Deviation 271.941 |
| BIVV009 | Part B: Mean Change From Baseline in Lactate Dehydrogenase (LDH) Level at Each Specified Time Points | Week 77 | -142.857 units per liter | Standard Deviation 199.169 |
| BIVV009 | Part B: Mean Change From Baseline in Lactate Dehydrogenase (LDH) Level at Each Specified Time Points | Week 41 | 23.778 units per liter | Standard Deviation 342.195 |
| BIVV009 | Part B: Mean Change From Baseline in Lactate Dehydrogenase (LDH) Level at Each Specified Time Points | Week 127 | -154.714 units per liter | Standard Deviation 231.922 |
| BIVV009 | Part B: Mean Change From Baseline in Lactate Dehydrogenase (LDH) Level at Each Specified Time Points | Week 43 | -22.118 units per liter | Standard Deviation 310.381 |
| BIVV009 | Part B: Mean Change From Baseline in Lactate Dehydrogenase (LDH) Level at Each Specified Time Points | Week 107 | -28.091 units per liter | Standard Deviation 354.244 |
| BIVV009 | Part B: Mean Change From Baseline in Lactate Dehydrogenase (LDH) Level at Each Specified Time Points | Week 45 | 26.529 units per liter | Standard Deviation 329.717 |
| Placebo | Part B: Mean Change From Baseline in Lactate Dehydrogenase (LDH) Level at Each Specified Time Points | Week 59 | 31.647 units per liter | Standard Deviation 226.128 |
| Placebo | Part B: Mean Change From Baseline in Lactate Dehydrogenase (LDH) Level at Each Specified Time Points | Week 83 | 8.818 units per liter | Standard Deviation 250.068 |
| Placebo | Part B: Mean Change From Baseline in Lactate Dehydrogenase (LDH) Level at Each Specified Time Points | Week 91 | 0.846 units per liter | Standard Deviation 288.451 |
| Placebo | Part B: Mean Change From Baseline in Lactate Dehydrogenase (LDH) Level at Each Specified Time Points | Week 97 | -38.500 units per liter | Standard Deviation 188.403 |
| Placebo | Part B: Mean Change From Baseline in Lactate Dehydrogenase (LDH) Level at Each Specified Time Points | Week 99 | -12.917 units per liter | Standard Deviation 183.844 |
| Placebo | Part B: Mean Change From Baseline in Lactate Dehydrogenase (LDH) Level at Each Specified Time Points | Week 101 | -17.182 units per liter | Standard Deviation 249.134 |
| Placebo | Part B: Mean Change From Baseline in Lactate Dehydrogenase (LDH) Level at Each Specified Time Points | Week 103 | 5.692 units per liter | Standard Deviation 211.233 |
| Placebo | Part B: Mean Change From Baseline in Lactate Dehydrogenase (LDH) Level at Each Specified Time Points | Week 105 | -34.250 units per liter | Standard Deviation 147.738 |
| Placebo | Part B: Mean Change From Baseline in Lactate Dehydrogenase (LDH) Level at Each Specified Time Points | Week 107 | 20.769 units per liter | Standard Deviation 222.772 |
| Placebo | Part B: Mean Change From Baseline in Lactate Dehydrogenase (LDH) Level at Each Specified Time Points | Week 109 | -2.000 units per liter | Standard Deviation 243.243 |
| Placebo | Part B: Mean Change From Baseline in Lactate Dehydrogenase (LDH) Level at Each Specified Time Points | Week 111 | -5.583 units per liter | Standard Deviation 219.85 |
| Placebo | Part B: Mean Change From Baseline in Lactate Dehydrogenase (LDH) Level at Each Specified Time Points | Week 113 | 0.667 units per liter | Standard Deviation 294.904 |
| Placebo | Part B: Mean Change From Baseline in Lactate Dehydrogenase (LDH) Level at Each Specified Time Points | Week 117 | 12.700 units per liter | Standard Deviation 254.786 |
| Placebo | Part B: Mean Change From Baseline in Lactate Dehydrogenase (LDH) Level at Each Specified Time Points | Week 119 | -26.500 units per liter | Standard Deviation 274.168 |
| Placebo | Part B: Mean Change From Baseline in Lactate Dehydrogenase (LDH) Level at Each Specified Time Points | Week 123 | 22.222 units per liter | Standard Deviation 278.037 |
| Placebo | Part B: Mean Change From Baseline in Lactate Dehydrogenase (LDH) Level at Each Specified Time Points | Week 125 | -85.143 units per liter | Standard Deviation 265.374 |
| Placebo | Part B: Mean Change From Baseline in Lactate Dehydrogenase (LDH) Level at Each Specified Time Points | Week 127 | -28.875 units per liter | Standard Deviation 312.483 |
| Placebo | Part B: Mean Change From Baseline in Lactate Dehydrogenase (LDH) Level at Each Specified Time Points | Week 129 | -18.571 units per liter | Standard Deviation 354.584 |
| Placebo | Part B: Mean Change From Baseline in Lactate Dehydrogenase (LDH) Level at Each Specified Time Points | Week 133 | -47.500 units per liter | Standard Deviation 367.639 |
| Placebo | Part B: Mean Change From Baseline in Lactate Dehydrogenase (LDH) Level at Each Specified Time Points | Week 135 | 58.000 units per liter | Standard Deviation 449.233 |
| Placebo | Part B: Mean Change From Baseline in Lactate Dehydrogenase (LDH) Level at Each Specified Time Points | Week 137 | 46.500 units per liter | Standard Deviation 768.625 |
| Placebo | Part B: Mean Change From Baseline in Lactate Dehydrogenase (LDH) Level at Each Specified Time Points | Week 139 | -48.667 units per liter | Standard Deviation 373.339 |
| Placebo | Part B: Mean Change From Baseline in Lactate Dehydrogenase (LDH) Level at Each Specified Time Points | Week 141 | 30.667 units per liter | Standard Deviation 372.889 |
| Placebo | Part B: Mean Change From Baseline in Lactate Dehydrogenase (LDH) Level at Each Specified Time Points | Week 159 | 365.000 units per liter | — |
| Placebo | Part B: Mean Change From Baseline in Lactate Dehydrogenase (LDH) Level at Each Specified Time Points | ET/SFU Visit | -11.706 units per liter | Standard Deviation 206.321 |
| Placebo | Part B: Mean Change From Baseline in Lactate Dehydrogenase (LDH) Level at Each Specified Time Points | Week 147 | 311.000 units per liter | Standard Deviation 547.301 |
| Placebo | Part B: Mean Change From Baseline in Lactate Dehydrogenase (LDH) Level at Each Specified Time Points | Week 27 | 0.650 units per liter | Standard Deviation 208.051 |
| Placebo | Part B: Mean Change From Baseline in Lactate Dehydrogenase (LDH) Level at Each Specified Time Points | Week 29 | 11.000 units per liter | Standard Deviation 222.383 |
| Placebo | Part B: Mean Change From Baseline in Lactate Dehydrogenase (LDH) Level at Each Specified Time Points | Week 31 | 38.882 units per liter | Standard Deviation 211.386 |
| Placebo | Part B: Mean Change From Baseline in Lactate Dehydrogenase (LDH) Level at Each Specified Time Points | Week 33 | 4.813 units per liter | Standard Deviation 203.939 |
| Placebo | Part B: Mean Change From Baseline in Lactate Dehydrogenase (LDH) Level at Each Specified Time Points | Week 35 | -19.313 units per liter | Standard Deviation 142.989 |
| Placebo | Part B: Mean Change From Baseline in Lactate Dehydrogenase (LDH) Level at Each Specified Time Points | Week 37 | 25.765 units per liter | Standard Deviation 219.679 |
| Placebo | Part B: Mean Change From Baseline in Lactate Dehydrogenase (LDH) Level at Each Specified Time Points | Week 39 | 27.313 units per liter | Standard Deviation 210.705 |
| Placebo | Part B: Mean Change From Baseline in Lactate Dehydrogenase (LDH) Level at Each Specified Time Points | Week 41 | -6.000 units per liter | Standard Deviation 173.81 |
| Placebo | Part B: Mean Change From Baseline in Lactate Dehydrogenase (LDH) Level at Each Specified Time Points | Week 43 | -21.706 units per liter | Standard Deviation 181.668 |
| Placebo | Part B: Mean Change From Baseline in Lactate Dehydrogenase (LDH) Level at Each Specified Time Points | Week 45 | -13.500 units per liter | Standard Deviation 190.46 |
| Placebo | Part B: Mean Change From Baseline in Lactate Dehydrogenase (LDH) Level at Each Specified Time Points | Week 47 | -24.944 units per liter | Standard Deviation 153.58 |
| Placebo | Part B: Mean Change From Baseline in Lactate Dehydrogenase (LDH) Level at Each Specified Time Points | Week 49 | 15.722 units per liter | Standard Deviation 193.63 |
| Placebo | Part B: Mean Change From Baseline in Lactate Dehydrogenase (LDH) Level at Each Specified Time Points | Week 51 | -9.556 units per liter | Standard Deviation 155.646 |
| Placebo | Part B: Mean Change From Baseline in Lactate Dehydrogenase (LDH) Level at Each Specified Time Points | Week 53 | 12.529 units per liter | Standard Deviation 206.642 |
| Placebo | Part B: Mean Change From Baseline in Lactate Dehydrogenase (LDH) Level at Each Specified Time Points | Week 55 | -11.250 units per liter | Standard Deviation 177.647 |
| Placebo | Part B: Mean Change From Baseline in Lactate Dehydrogenase (LDH) Level at Each Specified Time Points | Week 57 | 64.188 units per liter | Standard Deviation 266.395 |
| Placebo | Part B: Mean Change From Baseline in Lactate Dehydrogenase (LDH) Level at Each Specified Time Points | Week 75 | 7.067 units per liter | Standard Deviation 285.183 |
| Placebo | Part B: Mean Change From Baseline in Lactate Dehydrogenase (LDH) Level at Each Specified Time Points | Week 61 | 20.588 units per liter | Standard Deviation 263.984 |
| Placebo | Part B: Mean Change From Baseline in Lactate Dehydrogenase (LDH) Level at Each Specified Time Points | Week 63 | 38.059 units per liter | Standard Deviation 325.329 |
| Placebo | Part B: Mean Change From Baseline in Lactate Dehydrogenase (LDH) Level at Each Specified Time Points | Week 65 | -16.467 units per liter | Standard Deviation 246.765 |
| Placebo | Part B: Mean Change From Baseline in Lactate Dehydrogenase (LDH) Level at Each Specified Time Points | Week 67 | 29.667 units per liter | Standard Deviation 269.918 |
| Placebo | Part B: Mean Change From Baseline in Lactate Dehydrogenase (LDH) Level at Each Specified Time Points | Week 69 | 36.563 units per liter | Standard Deviation 303.55 |
| Placebo | Part B: Mean Change From Baseline in Lactate Dehydrogenase (LDH) Level at Each Specified Time Points | Week 71 | 4.067 units per liter | Standard Deviation 307.924 |
| Placebo | Part B: Mean Change From Baseline in Lactate Dehydrogenase (LDH) Level at Each Specified Time Points | Week 73 | 7.063 units per liter | Standard Deviation 245.723 |
| Placebo | Part B: Mean Change From Baseline in Lactate Dehydrogenase (LDH) Level at Each Specified Time Points | Week 77 | -24.867 units per liter | Standard Deviation 291.754 |
| Placebo | Part B: Mean Change From Baseline in Lactate Dehydrogenase (LDH) Level at Each Specified Time Points | Week 79 | -20.063 units per liter | Standard Deviation 265.761 |
| Placebo | Part B: Mean Change From Baseline in Lactate Dehydrogenase (LDH) Level at Each Specified Time Points | Week 81 | 7.200 units per liter | Standard Deviation 219.952 |
| Placebo | Part B: Mean Change From Baseline in Lactate Dehydrogenase (LDH) Level at Each Specified Time Points | Week 85 | 28.400 units per liter | Standard Deviation 282.626 |
| Placebo | Part B: Mean Change From Baseline in Lactate Dehydrogenase (LDH) Level at Each Specified Time Points | Week 87 | 83.385 units per liter | Standard Deviation 288.731 |
| Placebo | Part B: Mean Change From Baseline in Lactate Dehydrogenase (LDH) Level at Each Specified Time Points | Week 89 | 10.833 units per liter | Standard Deviation 323.647 |
| Placebo | Part B: Mean Change From Baseline in Lactate Dehydrogenase (LDH) Level at Each Specified Time Points | Week 93 | 10.818 units per liter | Standard Deviation 268.308 |
| Placebo | Part B: Mean Change From Baseline in Lactate Dehydrogenase (LDH) Level at Each Specified Time Points | Week 95 | 18.231 units per liter | Standard Deviation 241.354 |
| Placebo | Part B: Mean Change From Baseline in Lactate Dehydrogenase (LDH) Level at Each Specified Time Points | Week 115 | 44.700 units per liter | Standard Deviation 295.946 |
| Placebo | Part B: Mean Change From Baseline in Lactate Dehydrogenase (LDH) Level at Each Specified Time Points | Week 121 | -42.375 units per liter | Standard Deviation 211.84 |
| Placebo | Part B: Mean Change From Baseline in Lactate Dehydrogenase (LDH) Level at Each Specified Time Points | Week 131 | -2.000 units per liter | Standard Deviation 270.245 |
| Placebo | Part B: Mean Change From Baseline in Lactate Dehydrogenase (LDH) Level at Each Specified Time Points | Week 143 | -7.500 units per liter | Standard Deviation 21.92 |
| Placebo | Part B: Mean Change From Baseline in Lactate Dehydrogenase (LDH) Level at Each Specified Time Points | Week 145 | 290.000 units per liter | Standard Deviation 562.857 |
| Placebo | Part B: Mean Change From Baseline in Lactate Dehydrogenase (LDH) Level at Each Specified Time Points | Week 149 | 116.000 units per liter | Standard Deviation 175.362 |
| Placebo | Part B: Mean Change From Baseline in Lactate Dehydrogenase (LDH) Level at Each Specified Time Points | Week 157 | 369.000 units per liter | — |
| Placebo | Part B: Mean Change From Baseline in Lactate Dehydrogenase (LDH) Level at Each Specified Time Points | Week 163 | 782.000 units per liter | — |
| Placebo | Part B: Mean Change From Baseline in Lactate Dehydrogenase (LDH) Level at Each Specified Time Points | Week 151 | 295.000 units per liter | — |
| Placebo | Part B: Mean Change From Baseline in Lactate Dehydrogenase (LDH) Level at Each Specified Time Points | Week 153 | 75.000 units per liter | — |
Secondary
Part B: Number of Blood Transfusions Per Participant
A participant was to receive a transfusion if his or her Hgb level met either of the following criteria: Hgb was \<9 g/dL and the participant had symptoms of anemia or Hgb was \<7 g/dL and the participant was asymptomatic.
Time frame: From Week 27 up to 149 weeks of treatment (i.e., up to Week 176)
Population: Analysis was performed on Part B-FAS. Data for this outcome measure was planned to be collected and analyzed for combined population of BIVV009 (i.e., all participants who received BIVV009 \[either 6.5 g or 7.5 g\]).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| BIVV009 | Part B: Number of Blood Transfusions Per Participant | 0.4 blood transfusions per participant | Standard Deviation 0.8 |
| Placebo | Part B: Number of Blood Transfusions Per Participant | 0.3 blood transfusions per participant | Standard Deviation 0.4 |
Secondary
Part B: Number of Healthcare Visits by Type
In this outcome measure, number of healthcare visits which included non-study healthcare resource utilization visit (consisted mainly of extra visits to the office of the study doctor, visit to a generalist doctor or visit to a specialist doctor), hospitalization visit and visit to hospital emergency is reported.
Time frame: From Week 27 up to 149 weeks of treatment (i.e., up to Week 176)
Population: Analysis was performed on Part B-FAS. Data for this outcome measure was planned to be collected and analyzed for combined population of BIVV009 (i.e., all participants who received BIVV009 \[either 6.5 g or 7.5 g\]).
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| BIVV009 | Part B: Number of Healthcare Visits by Type | Non-study healthcare resource utilization visits | 13 visits |
| BIVV009 | Part B: Number of Healthcare Visits by Type | Hospitalization | 3 visits |
| BIVV009 | Part B: Number of Healthcare Visits by Type | Visit to a hospital emergency room | 1 visits |
| Placebo | Part B: Number of Healthcare Visits by Type | Non-study healthcare resource utilization visits | 12 visits |
| Placebo | Part B: Number of Healthcare Visits by Type | Hospitalization | 1 visits |
| Placebo | Part B: Number of Healthcare Visits by Type | Visit to a hospital emergency room | 3 visits |
Secondary
Part B: Number of Participants With Response to Participant's Global Impression of Change (PGIC) Questionnaire at Each Specified Time Points
PGIC is a self-administered questionnaire to evaluate the improvement or worsening compared to the start of the study. PGIC was assessed on a 7-point Likert scale ranged from 1 (greatly improved) to 7 (greatly worsened). Categories were defined based on the PGIC scores as follows: 1=very much improved, 2=much improved, 3=minimally improved, 4=no change, 5=minimally worse, 6=much worse and 7=very much worsen. Higher scores indicated greater severity. ET visit/SFU visit was 9 weeks after administration of last dose (i.e., up to Week 184).
Time frame: Baseline (Week 0), Weeks 39, 51, 63, 75, 87, 99, 111, 123, 135, 147, 159, 171 and ET Visit/SFU visit (i.e., up to Week 184)
Population: Analysis was performed on Part B-FAS. Here, 'number analyzed' = participants with available data for each specified category and 0 in the number analyzed field signifies that none of participants were available for assessment at the specified timepoints. Data for this outcome measure was planned to be collected and analyzed for combined population of BIVV009 (i.e., all participants who received BIVV009 \[either 6.5 g or 7.5 g\]).
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| BIVV009 | Part B: Number of Participants With Response to Participant's Global Impression of Change (PGIC) Questionnaire at Each Specified Time Points | Week 63 - Very much improved | 5 Participants |
| BIVV009 | Part B: Number of Participants With Response to Participant's Global Impression of Change (PGIC) Questionnaire at Each Specified Time Points | Week 99 - No change | 3 Participants |
| BIVV009 | Part B: Number of Participants With Response to Participant's Global Impression of Change (PGIC) Questionnaire at Each Specified Time Points | Week 39 - Minimally improved | 2 Participants |
| BIVV009 | Part B: Number of Participants With Response to Participant's Global Impression of Change (PGIC) Questionnaire at Each Specified Time Points | Week 99 - Minimally worse | 1 Participants |
| BIVV009 | Part B: Number of Participants With Response to Participant's Global Impression of Change (PGIC) Questionnaire at Each Specified Time Points | Week 63 - Much improved | 8 Participants |
| BIVV009 | Part B: Number of Participants With Response to Participant's Global Impression of Change (PGIC) Questionnaire at Each Specified Time Points | Week 99 - Much worse | 0 Participants |
| BIVV009 | Part B: Number of Participants With Response to Participant's Global Impression of Change (PGIC) Questionnaire at Each Specified Time Points | Week 171- Much worse | 0 Participants |
| BIVV009 | Part B: Number of Participants With Response to Participant's Global Impression of Change (PGIC) Questionnaire at Each Specified Time Points | Week 99 - Very much worse | 0 Participants |
| BIVV009 | Part B: Number of Participants With Response to Participant's Global Impression of Change (PGIC) Questionnaire at Each Specified Time Points | Week 63 - Minimally improved | 0 Participants |
| BIVV009 | Part B: Number of Participants With Response to Participant's Global Impression of Change (PGIC) Questionnaire at Each Specified Time Points | Week 111 - Very much improved | 3 Participants |
| BIVV009 | Part B: Number of Participants With Response to Participant's Global Impression of Change (PGIC) Questionnaire at Each Specified Time Points | Week 39 - No Change | 2 Participants |
| BIVV009 | Part B: Number of Participants With Response to Participant's Global Impression of Change (PGIC) Questionnaire at Each Specified Time Points | Week 111 - Much improved | 5 Participants |
| BIVV009 | Part B: Number of Participants With Response to Participant's Global Impression of Change (PGIC) Questionnaire at Each Specified Time Points | Week 63 - No change | 4 Participants |
| BIVV009 | Part B: Number of Participants With Response to Participant's Global Impression of Change (PGIC) Questionnaire at Each Specified Time Points | Week 111 - Minimally improved | 1 Participants |
| BIVV009 | Part B: Number of Participants With Response to Participant's Global Impression of Change (PGIC) Questionnaire at Each Specified Time Points | Week 147 - Very much worse | 0 Participants |
| BIVV009 | Part B: Number of Participants With Response to Participant's Global Impression of Change (PGIC) Questionnaire at Each Specified Time Points | Week 111 - No Change | 2 Participants |
| BIVV009 | Part B: Number of Participants With Response to Participant's Global Impression of Change (PGIC) Questionnaire at Each Specified Time Points | Week 63 - Minimally worse | 0 Participants |
| BIVV009 | Part B: Number of Participants With Response to Participant's Global Impression of Change (PGIC) Questionnaire at Each Specified Time Points | Week 111 - Minimally worse | 0 Participants |
| BIVV009 | Part B: Number of Participants With Response to Participant's Global Impression of Change (PGIC) Questionnaire at Each Specified Time Points | Week 39 - Minimally worse | 1 Participants |
| BIVV009 | Part B: Number of Participants With Response to Participant's Global Impression of Change (PGIC) Questionnaire at Each Specified Time Points | Week 111 - Much worse | 0 Participants |
| BIVV009 | Part B: Number of Participants With Response to Participant's Global Impression of Change (PGIC) Questionnaire at Each Specified Time Points | Week 63 - Much worse | 0 Participants |
| BIVV009 | Part B: Number of Participants With Response to Participant's Global Impression of Change (PGIC) Questionnaire at Each Specified Time Points | Week 111 - Very much worse | 0 Participants |
| BIVV009 | Part B: Number of Participants With Response to Participant's Global Impression of Change (PGIC) Questionnaire at Each Specified Time Points | Week 159 - Much worse | 0 Participants |
| BIVV009 | Part B: Number of Participants With Response to Participant's Global Impression of Change (PGIC) Questionnaire at Each Specified Time Points | Week 123 - Very much improved | 3 Participants |
| BIVV009 | Part B: Number of Participants With Response to Participant's Global Impression of Change (PGIC) Questionnaire at Each Specified Time Points | Week 63 - Very much worse | 0 Participants |
| BIVV009 | Part B: Number of Participants With Response to Participant's Global Impression of Change (PGIC) Questionnaire at Each Specified Time Points | Week 123 - Much improved | 3 Participants |
| BIVV009 | Part B: Number of Participants With Response to Participant's Global Impression of Change (PGIC) Questionnaire at Each Specified Time Points | Week 39 - Much worse | 0 Participants |
| BIVV009 | Part B: Number of Participants With Response to Participant's Global Impression of Change (PGIC) Questionnaire at Each Specified Time Points | Week 123 - Minimally improved | 2 Participants |
| BIVV009 | Part B: Number of Participants With Response to Participant's Global Impression of Change (PGIC) Questionnaire at Each Specified Time Points | Week 75 - Very much improved | 6 Participants |
| BIVV009 | Part B: Number of Participants With Response to Participant's Global Impression of Change (PGIC) Questionnaire at Each Specified Time Points | Week 123 - No Change | 1 Participants |
| BIVV009 | Part B: Number of Participants With Response to Participant's Global Impression of Change (PGIC) Questionnaire at Each Specified Time Points | ET/SFU Visit- Much improved | 5 Participants |
| BIVV009 | Part B: Number of Participants With Response to Participant's Global Impression of Change (PGIC) Questionnaire at Each Specified Time Points | Week 123 - Much worse | 0 Participants |
| BIVV009 | Part B: Number of Participants With Response to Participant's Global Impression of Change (PGIC) Questionnaire at Each Specified Time Points | Week 75 - Much improved | 2 Participants |
| BIVV009 | Part B: Number of Participants With Response to Participant's Global Impression of Change (PGIC) Questionnaire at Each Specified Time Points | Week 123 - Very much worse | 0 Participants |
| BIVV009 | Part B: Number of Participants With Response to Participant's Global Impression of Change (PGIC) Questionnaire at Each Specified Time Points | Week 51 - Very much improved | 5 Participants |
| BIVV009 | Part B: Number of Participants With Response to Participant's Global Impression of Change (PGIC) Questionnaire at Each Specified Time Points | Week 135 - Very much improved | 2 Participants |
| BIVV009 | Part B: Number of Participants With Response to Participant's Global Impression of Change (PGIC) Questionnaire at Each Specified Time Points | Week 75 - Minimally improved | 1 Participants |
| BIVV009 | Part B: Number of Participants With Response to Participant's Global Impression of Change (PGIC) Questionnaire at Each Specified Time Points | Week 135 - Much improved | 2 Participants |
| BIVV009 | Part B: Number of Participants With Response to Participant's Global Impression of Change (PGIC) Questionnaire at Each Specified Time Points | Week 75 - No Change | 4 Participants |
| BIVV009 | Part B: Number of Participants With Response to Participant's Global Impression of Change (PGIC) Questionnaire at Each Specified Time Points | Week 135 - Minimally improved | 0 Participants |
| BIVV009 | Part B: Number of Participants With Response to Participant's Global Impression of Change (PGIC) Questionnaire at Each Specified Time Points | Week 75 - Minimally worse | 0 Participants |
| BIVV009 | Part B: Number of Participants With Response to Participant's Global Impression of Change (PGIC) Questionnaire at Each Specified Time Points | Week 135 - No Change | 0 Participants |
| BIVV009 | Part B: Number of Participants With Response to Participant's Global Impression of Change (PGIC) Questionnaire at Each Specified Time Points | Week 51 - Much improved | 3 Participants |
| BIVV009 | Part B: Number of Participants With Response to Participant's Global Impression of Change (PGIC) Questionnaire at Each Specified Time Points | Week 135 - Minimally worse | 1 Participants |
| BIVV009 | Part B: Number of Participants With Response to Participant's Global Impression of Change (PGIC) Questionnaire at Each Specified Time Points | Week 75 - Much worse | 0 Participants |
| BIVV009 | Part B: Number of Participants With Response to Participant's Global Impression of Change (PGIC) Questionnaire at Each Specified Time Points | Week 135 - Much worse | 0 Participants |
| BIVV009 | Part B: Number of Participants With Response to Participant's Global Impression of Change (PGIC) Questionnaire at Each Specified Time Points | ET/SFU Visit- Minimally improved | 4 Participants |
| BIVV009 | Part B: Number of Participants With Response to Participant's Global Impression of Change (PGIC) Questionnaire at Each Specified Time Points | Week 135 - Very much worse | 0 Participants |
| BIVV009 | Part B: Number of Participants With Response to Participant's Global Impression of Change (PGIC) Questionnaire at Each Specified Time Points | Week 75 - Very much worse | 0 Participants |
| BIVV009 | Part B: Number of Participants With Response to Participant's Global Impression of Change (PGIC) Questionnaire at Each Specified Time Points | Week 147 - Very much improved | 1 Participants |
| BIVV009 | Part B: Number of Participants With Response to Participant's Global Impression of Change (PGIC) Questionnaire at Each Specified Time Points | Week 51 - Minimally improved | 2 Participants |
| BIVV009 | Part B: Number of Participants With Response to Participant's Global Impression of Change (PGIC) Questionnaire at Each Specified Time Points | Week 147 - Much improved | 0 Participants |
| BIVV009 | Part B: Number of Participants With Response to Participant's Global Impression of Change (PGIC) Questionnaire at Each Specified Time Points | Week 87 - Very much improved | 7 Participants |
| BIVV009 | Part B: Number of Participants With Response to Participant's Global Impression of Change (PGIC) Questionnaire at Each Specified Time Points | Week 147 - Minimally improved | 0 Participants |
| BIVV009 | Part B: Number of Participants With Response to Participant's Global Impression of Change (PGIC) Questionnaire at Each Specified Time Points | Week 39 - Very much worse | 0 Participants |
| BIVV009 | Part B: Number of Participants With Response to Participant's Global Impression of Change (PGIC) Questionnaire at Each Specified Time Points | Week 147 - No Change | 1 Participants |
| BIVV009 | Part B: Number of Participants With Response to Participant's Global Impression of Change (PGIC) Questionnaire at Each Specified Time Points | Week 87 - Much improved | 0 Participants |
| BIVV009 | Part B: Number of Participants With Response to Participant's Global Impression of Change (PGIC) Questionnaire at Each Specified Time Points | Week 147 - Minimally worse | 0 Participants |
| BIVV009 | Part B: Number of Participants With Response to Participant's Global Impression of Change (PGIC) Questionnaire at Each Specified Time Points | Week 51 - No Change | 5 Participants |
| BIVV009 | Part B: Number of Participants With Response to Participant's Global Impression of Change (PGIC) Questionnaire at Each Specified Time Points | Week 147 - Much worse | 0 Participants |
| BIVV009 | Part B: Number of Participants With Response to Participant's Global Impression of Change (PGIC) Questionnaire at Each Specified Time Points | Week 87 - Minimally improved | 2 Participants |
| BIVV009 | Part B: Number of Participants With Response to Participant's Global Impression of Change (PGIC) Questionnaire at Each Specified Time Points | Week 159 - Very much improved | 1 Participants |
| BIVV009 | Part B: Number of Participants With Response to Participant's Global Impression of Change (PGIC) Questionnaire at Each Specified Time Points | Week 39 - Very much improved | 4 Participants |
| BIVV009 | Part B: Number of Participants With Response to Participant's Global Impression of Change (PGIC) Questionnaire at Each Specified Time Points | Week 159 - Much improved | 0 Participants |
| BIVV009 | Part B: Number of Participants With Response to Participant's Global Impression of Change (PGIC) Questionnaire at Each Specified Time Points | Week 87 - No Change | 2 Participants |
| BIVV009 | Part B: Number of Participants With Response to Participant's Global Impression of Change (PGIC) Questionnaire at Each Specified Time Points | Week 159 - Minimally improved | 0 Participants |
| BIVV009 | Part B: Number of Participants With Response to Participant's Global Impression of Change (PGIC) Questionnaire at Each Specified Time Points | Week 51 - Minimally worse | 0 Participants |
| BIVV009 | Part B: Number of Participants With Response to Participant's Global Impression of Change (PGIC) Questionnaire at Each Specified Time Points | Week 159 - No Change | 0 Participants |
| BIVV009 | Part B: Number of Participants With Response to Participant's Global Impression of Change (PGIC) Questionnaire at Each Specified Time Points | Week 87 - Minimally worse | 1 Participants |
| BIVV009 | Part B: Number of Participants With Response to Participant's Global Impression of Change (PGIC) Questionnaire at Each Specified Time Points | Week 159 - Minimally worse | 0 Participants |
| BIVV009 | Part B: Number of Participants With Response to Participant's Global Impression of Change (PGIC) Questionnaire at Each Specified Time Points | Week 171- Much improved | 0 Participants |
| BIVV009 | Part B: Number of Participants With Response to Participant's Global Impression of Change (PGIC) Questionnaire at Each Specified Time Points | Week 87 - Much worse | 1 Participants |
| BIVV009 | Part B: Number of Participants With Response to Participant's Global Impression of Change (PGIC) Questionnaire at Each Specified Time Points | Week 159 - Very much worse | 0 Participants |
| BIVV009 | Part B: Number of Participants With Response to Participant's Global Impression of Change (PGIC) Questionnaire at Each Specified Time Points | Week 171- Very much improved | 1 Participants |
| BIVV009 | Part B: Number of Participants With Response to Participant's Global Impression of Change (PGIC) Questionnaire at Each Specified Time Points | Week 171- Minimally improved | 0 Participants |
| BIVV009 | Part B: Number of Participants With Response to Participant's Global Impression of Change (PGIC) Questionnaire at Each Specified Time Points | Week 51 - Much worse | 0 Participants |
| BIVV009 | Part B: Number of Participants With Response to Participant's Global Impression of Change (PGIC) Questionnaire at Each Specified Time Points | Week 171- No Change | 0 Participants |
| BIVV009 | Part B: Number of Participants With Response to Participant's Global Impression of Change (PGIC) Questionnaire at Each Specified Time Points | Week 87 - Very much worse | 0 Participants |
| BIVV009 | Part B: Number of Participants With Response to Participant's Global Impression of Change (PGIC) Questionnaire at Each Specified Time Points | Week 171- Minimally worse | 0 Participants |
| BIVV009 | Part B: Number of Participants With Response to Participant's Global Impression of Change (PGIC) Questionnaire at Each Specified Time Points | Week 39 - Much improved | 8 Participants |
| BIVV009 | Part B: Number of Participants With Response to Participant's Global Impression of Change (PGIC) Questionnaire at Each Specified Time Points | Week 171- Very much worse | 0 Participants |
| BIVV009 | Part B: Number of Participants With Response to Participant's Global Impression of Change (PGIC) Questionnaire at Each Specified Time Points | Week 99 - Very much improved | 3 Participants |
| BIVV009 | Part B: Number of Participants With Response to Participant's Global Impression of Change (PGIC) Questionnaire at Each Specified Time Points | ET/SFU Visit- Very much improved | 3 Participants |
| BIVV009 | Part B: Number of Participants With Response to Participant's Global Impression of Change (PGIC) Questionnaire at Each Specified Time Points | ET/SFU Visit- No Change | 3 Participants |
| BIVV009 | Part B: Number of Participants With Response to Participant's Global Impression of Change (PGIC) Questionnaire at Each Specified Time Points | Week 51 - Very much worse | 0 Participants |
| BIVV009 | Part B: Number of Participants With Response to Participant's Global Impression of Change (PGIC) Questionnaire at Each Specified Time Points | ET/SFU Visit- Minimally worse | 1 Participants |
| BIVV009 | Part B: Number of Participants With Response to Participant's Global Impression of Change (PGIC) Questionnaire at Each Specified Time Points | Week 99 - Much improved | 3 Participants |
| BIVV009 | Part B: Number of Participants With Response to Participant's Global Impression of Change (PGIC) Questionnaire at Each Specified Time Points | ET/SFU Visit- Much worse | 3 Participants |
| BIVV009 | Part B: Number of Participants With Response to Participant's Global Impression of Change (PGIC) Questionnaire at Each Specified Time Points | Week 123 - Minimally worse | 0 Participants |
| BIVV009 | Part B: Number of Participants With Response to Participant's Global Impression of Change (PGIC) Questionnaire at Each Specified Time Points | ET/SFU Visit- Very much worse | 0 Participants |
| BIVV009 | Part B: Number of Participants With Response to Participant's Global Impression of Change (PGIC) Questionnaire at Each Specified Time Points | Week 99 - Minimally improved | 1 Participants |
| Placebo | Part B: Number of Participants With Response to Participant's Global Impression of Change (PGIC) Questionnaire at Each Specified Time Points | ET/SFU Visit- Very much worse | 0 Participants |
| Placebo | Part B: Number of Participants With Response to Participant's Global Impression of Change (PGIC) Questionnaire at Each Specified Time Points | Week 75 - No Change | 1 Participants |
| Placebo | Part B: Number of Participants With Response to Participant's Global Impression of Change (PGIC) Questionnaire at Each Specified Time Points | Week 147 - Very much worse | 0 Participants |
| Placebo | Part B: Number of Participants With Response to Participant's Global Impression of Change (PGIC) Questionnaire at Each Specified Time Points | Week 123 - No Change | 1 Participants |
| Placebo | Part B: Number of Participants With Response to Participant's Global Impression of Change (PGIC) Questionnaire at Each Specified Time Points | Week 159 - Very much worse | 0 Participants |
| Placebo | Part B: Number of Participants With Response to Participant's Global Impression of Change (PGIC) Questionnaire at Each Specified Time Points | Week 171- Very much improved | 0 Participants |
| Placebo | Part B: Number of Participants With Response to Participant's Global Impression of Change (PGIC) Questionnaire at Each Specified Time Points | Week 171- Much improved | 0 Participants |
| Placebo | Part B: Number of Participants With Response to Participant's Global Impression of Change (PGIC) Questionnaire at Each Specified Time Points | Week 171- Much worse | 0 Participants |
| Placebo | Part B: Number of Participants With Response to Participant's Global Impression of Change (PGIC) Questionnaire at Each Specified Time Points | ET/SFU Visit- Very much improved | 3 Participants |
| Placebo | Part B: Number of Participants With Response to Participant's Global Impression of Change (PGIC) Questionnaire at Each Specified Time Points | ET/SFU Visit- Much improved | 6 Participants |
| Placebo | Part B: Number of Participants With Response to Participant's Global Impression of Change (PGIC) Questionnaire at Each Specified Time Points | ET/SFU Visit- Minimally improved | 1 Participants |
| Placebo | Part B: Number of Participants With Response to Participant's Global Impression of Change (PGIC) Questionnaire at Each Specified Time Points | Week 39 - Very much improved | 3 Participants |
| Placebo | Part B: Number of Participants With Response to Participant's Global Impression of Change (PGIC) Questionnaire at Each Specified Time Points | Week 39 - Much improved | 6 Participants |
| Placebo | Part B: Number of Participants With Response to Participant's Global Impression of Change (PGIC) Questionnaire at Each Specified Time Points | Week 39 - Minimally improved | 6 Participants |
| Placebo | Part B: Number of Participants With Response to Participant's Global Impression of Change (PGIC) Questionnaire at Each Specified Time Points | Week 39 - No Change | 1 Participants |
| Placebo | Part B: Number of Participants With Response to Participant's Global Impression of Change (PGIC) Questionnaire at Each Specified Time Points | Week 39 - Minimally worse | 0 Participants |
| Placebo | Part B: Number of Participants With Response to Participant's Global Impression of Change (PGIC) Questionnaire at Each Specified Time Points | Week 39 - Very much worse | 0 Participants |
| Placebo | Part B: Number of Participants With Response to Participant's Global Impression of Change (PGIC) Questionnaire at Each Specified Time Points | Week 51 - Very much improved | 3 Participants |
| Placebo | Part B: Number of Participants With Response to Participant's Global Impression of Change (PGIC) Questionnaire at Each Specified Time Points | Week 51 - Much improved | 6 Participants |
| Placebo | Part B: Number of Participants With Response to Participant's Global Impression of Change (PGIC) Questionnaire at Each Specified Time Points | Week 51 - Minimally improved | 4 Participants |
| Placebo | Part B: Number of Participants With Response to Participant's Global Impression of Change (PGIC) Questionnaire at Each Specified Time Points | Week 51 - No Change | 2 Participants |
| Placebo | Part B: Number of Participants With Response to Participant's Global Impression of Change (PGIC) Questionnaire at Each Specified Time Points | Week 51 - Minimally worse | 0 Participants |
| Placebo | Part B: Number of Participants With Response to Participant's Global Impression of Change (PGIC) Questionnaire at Each Specified Time Points | Week 51 - Much worse | 1 Participants |
| Placebo | Part B: Number of Participants With Response to Participant's Global Impression of Change (PGIC) Questionnaire at Each Specified Time Points | Week 51 - Very much worse | 0 Participants |
| Placebo | Part B: Number of Participants With Response to Participant's Global Impression of Change (PGIC) Questionnaire at Each Specified Time Points | Week 63 - Very much improved | 3 Participants |
| Placebo | Part B: Number of Participants With Response to Participant's Global Impression of Change (PGIC) Questionnaire at Each Specified Time Points | Week 63 - Much improved | 4 Participants |
| Placebo | Part B: Number of Participants With Response to Participant's Global Impression of Change (PGIC) Questionnaire at Each Specified Time Points | Week 63 - Minimally improved | 5 Participants |
| Placebo | Part B: Number of Participants With Response to Participant's Global Impression of Change (PGIC) Questionnaire at Each Specified Time Points | Week 63 - No change | 3 Participants |
| Placebo | Part B: Number of Participants With Response to Participant's Global Impression of Change (PGIC) Questionnaire at Each Specified Time Points | Week 63 - Minimally worse | 0 Participants |
| Placebo | Part B: Number of Participants With Response to Participant's Global Impression of Change (PGIC) Questionnaire at Each Specified Time Points | Week 63 - Much worse | 1 Participants |
| Placebo | Part B: Number of Participants With Response to Participant's Global Impression of Change (PGIC) Questionnaire at Each Specified Time Points | Week 63 - Very much worse | 0 Participants |
| Placebo | Part B: Number of Participants With Response to Participant's Global Impression of Change (PGIC) Questionnaire at Each Specified Time Points | Week 75 - Very much improved | 6 Participants |
| Placebo | Part B: Number of Participants With Response to Participant's Global Impression of Change (PGIC) Questionnaire at Each Specified Time Points | Week 75 - Much improved | 3 Participants |
| Placebo | Part B: Number of Participants With Response to Participant's Global Impression of Change (PGIC) Questionnaire at Each Specified Time Points | Week 75 - Minimally improved | 5 Participants |
| Placebo | Part B: Number of Participants With Response to Participant's Global Impression of Change (PGIC) Questionnaire at Each Specified Time Points | Week 75 - Minimally worse | 0 Participants |
| Placebo | Part B: Number of Participants With Response to Participant's Global Impression of Change (PGIC) Questionnaire at Each Specified Time Points | Week 75 - Much worse | 0 Participants |
| Placebo | Part B: Number of Participants With Response to Participant's Global Impression of Change (PGIC) Questionnaire at Each Specified Time Points | Week 75 - Very much worse | 0 Participants |
| Placebo | Part B: Number of Participants With Response to Participant's Global Impression of Change (PGIC) Questionnaire at Each Specified Time Points | Week 87 - Very much improved | 7 Participants |
| Placebo | Part B: Number of Participants With Response to Participant's Global Impression of Change (PGIC) Questionnaire at Each Specified Time Points | Week 87 - Much improved | 3 Participants |
| Placebo | Part B: Number of Participants With Response to Participant's Global Impression of Change (PGIC) Questionnaire at Each Specified Time Points | Week 87 - Minimally improved | 1 Participants |
| Placebo | Part B: Number of Participants With Response to Participant's Global Impression of Change (PGIC) Questionnaire at Each Specified Time Points | Week 87 - No Change | 3 Participants |
| Placebo | Part B: Number of Participants With Response to Participant's Global Impression of Change (PGIC) Questionnaire at Each Specified Time Points | Week 87 - Minimally worse | 1 Participants |
| Placebo | Part B: Number of Participants With Response to Participant's Global Impression of Change (PGIC) Questionnaire at Each Specified Time Points | Week 87 - Much worse | 0 Participants |
| Placebo | Part B: Number of Participants With Response to Participant's Global Impression of Change (PGIC) Questionnaire at Each Specified Time Points | Week 87 - Very much worse | 0 Participants |
| Placebo | Part B: Number of Participants With Response to Participant's Global Impression of Change (PGIC) Questionnaire at Each Specified Time Points | Week 99 - Very much improved | 8 Participants |
| Placebo | Part B: Number of Participants With Response to Participant's Global Impression of Change (PGIC) Questionnaire at Each Specified Time Points | Week 99 - Much improved | 2 Participants |
| Placebo | Part B: Number of Participants With Response to Participant's Global Impression of Change (PGIC) Questionnaire at Each Specified Time Points | Week 99 - Minimally improved | 3 Participants |
| Placebo | Part B: Number of Participants With Response to Participant's Global Impression of Change (PGIC) Questionnaire at Each Specified Time Points | Week 99 - No change | 0 Participants |
| Placebo | Part B: Number of Participants With Response to Participant's Global Impression of Change (PGIC) Questionnaire at Each Specified Time Points | Week 99 - Minimally worse | 0 Participants |
| Placebo | Part B: Number of Participants With Response to Participant's Global Impression of Change (PGIC) Questionnaire at Each Specified Time Points | Week 99 - Much worse | 0 Participants |
| Placebo | Part B: Number of Participants With Response to Participant's Global Impression of Change (PGIC) Questionnaire at Each Specified Time Points | Week 99 - Very much worse | 0 Participants |
| Placebo | Part B: Number of Participants With Response to Participant's Global Impression of Change (PGIC) Questionnaire at Each Specified Time Points | Week 111 - Very much improved | 6 Participants |
| Placebo | Part B: Number of Participants With Response to Participant's Global Impression of Change (PGIC) Questionnaire at Each Specified Time Points | Week 111 - Much improved | 4 Participants |
| Placebo | Part B: Number of Participants With Response to Participant's Global Impression of Change (PGIC) Questionnaire at Each Specified Time Points | Week 111 - Minimally improved | 1 Participants |
| Placebo | Part B: Number of Participants With Response to Participant's Global Impression of Change (PGIC) Questionnaire at Each Specified Time Points | Week 111 - No Change | 1 Participants |
| Placebo | Part B: Number of Participants With Response to Participant's Global Impression of Change (PGIC) Questionnaire at Each Specified Time Points | Week 111 - Minimally worse | 0 Participants |
| Placebo | Part B: Number of Participants With Response to Participant's Global Impression of Change (PGIC) Questionnaire at Each Specified Time Points | Week 111 - Much worse | 0 Participants |
| Placebo | Part B: Number of Participants With Response to Participant's Global Impression of Change (PGIC) Questionnaire at Each Specified Time Points | Week 111 - Very much worse | 0 Participants |
| Placebo | Part B: Number of Participants With Response to Participant's Global Impression of Change (PGIC) Questionnaire at Each Specified Time Points | Week 123 - Very much improved | 4 Participants |
| Placebo | Part B: Number of Participants With Response to Participant's Global Impression of Change (PGIC) Questionnaire at Each Specified Time Points | Week 123 - Much improved | 3 Participants |
| Placebo | Part B: Number of Participants With Response to Participant's Global Impression of Change (PGIC) Questionnaire at Each Specified Time Points | Week 123 - Minimally improved | 1 Participants |
| Placebo | Part B: Number of Participants With Response to Participant's Global Impression of Change (PGIC) Questionnaire at Each Specified Time Points | Week 123 - Minimally worse | 0 Participants |
| Placebo | Part B: Number of Participants With Response to Participant's Global Impression of Change (PGIC) Questionnaire at Each Specified Time Points | Week 123 - Much worse | 0 Participants |
| Placebo | Part B: Number of Participants With Response to Participant's Global Impression of Change (PGIC) Questionnaire at Each Specified Time Points | Week 123 - Very much worse | 0 Participants |
| Placebo | Part B: Number of Participants With Response to Participant's Global Impression of Change (PGIC) Questionnaire at Each Specified Time Points | Week 135 - Very much improved | 2 Participants |
| Placebo | Part B: Number of Participants With Response to Participant's Global Impression of Change (PGIC) Questionnaire at Each Specified Time Points | Week 135 - Much improved | 1 Participants |
| Placebo | Part B: Number of Participants With Response to Participant's Global Impression of Change (PGIC) Questionnaire at Each Specified Time Points | Week 135 - Minimally improved | 1 Participants |
| Placebo | Part B: Number of Participants With Response to Participant's Global Impression of Change (PGIC) Questionnaire at Each Specified Time Points | Week 135 - No Change | 1 Participants |
| Placebo | Part B: Number of Participants With Response to Participant's Global Impression of Change (PGIC) Questionnaire at Each Specified Time Points | Week 135 - Minimally worse | 0 Participants |
| Placebo | Part B: Number of Participants With Response to Participant's Global Impression of Change (PGIC) Questionnaire at Each Specified Time Points | Week 135 - Much worse | 0 Participants |
| Placebo | Part B: Number of Participants With Response to Participant's Global Impression of Change (PGIC) Questionnaire at Each Specified Time Points | Week 135 - Very much worse | 0 Participants |
| Placebo | Part B: Number of Participants With Response to Participant's Global Impression of Change (PGIC) Questionnaire at Each Specified Time Points | Week 147 - Very much improved | 0 Participants |
| Placebo | Part B: Number of Participants With Response to Participant's Global Impression of Change (PGIC) Questionnaire at Each Specified Time Points | Week 147 - Much improved | 1 Participants |
| Placebo | Part B: Number of Participants With Response to Participant's Global Impression of Change (PGIC) Questionnaire at Each Specified Time Points | Week 147 - Minimally improved | 1 Participants |
| Placebo | Part B: Number of Participants With Response to Participant's Global Impression of Change (PGIC) Questionnaire at Each Specified Time Points | Week 147 - No Change | 0 Participants |
| Placebo | Part B: Number of Participants With Response to Participant's Global Impression of Change (PGIC) Questionnaire at Each Specified Time Points | Week 147 - Minimally worse | 0 Participants |
| Placebo | Part B: Number of Participants With Response to Participant's Global Impression of Change (PGIC) Questionnaire at Each Specified Time Points | Week 147 - Much worse | 0 Participants |
| Placebo | Part B: Number of Participants With Response to Participant's Global Impression of Change (PGIC) Questionnaire at Each Specified Time Points | Week 159 - Very much improved | 0 Participants |
| Placebo | Part B: Number of Participants With Response to Participant's Global Impression of Change (PGIC) Questionnaire at Each Specified Time Points | Week 159 - Much improved | 0 Participants |
| Placebo | Part B: Number of Participants With Response to Participant's Global Impression of Change (PGIC) Questionnaire at Each Specified Time Points | Week 159 - Minimally improved | 1 Participants |
| Placebo | Part B: Number of Participants With Response to Participant's Global Impression of Change (PGIC) Questionnaire at Each Specified Time Points | Week 159 - No Change | 0 Participants |
| Placebo | Part B: Number of Participants With Response to Participant's Global Impression of Change (PGIC) Questionnaire at Each Specified Time Points | Week 159 - Minimally worse | 0 Participants |
| Placebo | Part B: Number of Participants With Response to Participant's Global Impression of Change (PGIC) Questionnaire at Each Specified Time Points | Week 159 - Much worse | 0 Participants |
| Placebo | Part B: Number of Participants With Response to Participant's Global Impression of Change (PGIC) Questionnaire at Each Specified Time Points | Week 171- Minimally improved | 0 Participants |
| Placebo | Part B: Number of Participants With Response to Participant's Global Impression of Change (PGIC) Questionnaire at Each Specified Time Points | Week 171- No Change | 0 Participants |
| Placebo | Part B: Number of Participants With Response to Participant's Global Impression of Change (PGIC) Questionnaire at Each Specified Time Points | Week 171- Minimally worse | 0 Participants |
| Placebo | Part B: Number of Participants With Response to Participant's Global Impression of Change (PGIC) Questionnaire at Each Specified Time Points | Week 171- Very much worse | 0 Participants |
| Placebo | Part B: Number of Participants With Response to Participant's Global Impression of Change (PGIC) Questionnaire at Each Specified Time Points | ET/SFU Visit- No Change | 3 Participants |
| Placebo | Part B: Number of Participants With Response to Participant's Global Impression of Change (PGIC) Questionnaire at Each Specified Time Points | ET/SFU Visit- Minimally worse | 2 Participants |
| Placebo | Part B: Number of Participants With Response to Participant's Global Impression of Change (PGIC) Questionnaire at Each Specified Time Points | ET/SFU Visit- Much worse | 3 Participants |
| Placebo | Part B: Number of Participants With Response to Participant's Global Impression of Change (PGIC) Questionnaire at Each Specified Time Points | Week 39 - Much worse | 0 Participants |
Secondary
Part B: Number of Participants With Response to Participant's Global Impression of (Fatigue) Severity (PGIS) Questionnaire at Each Specified Time Points
The PGIS is a self-reported scale. The PGIS is a 1-item questionnaire designed to assess participant's impression of disease severity using a 5-point scale ranging from 1 to 5, where 1=none, 2=mild, 3=moderate, 4=severe, 5=very severe. Higher scores indicated greater severity. ET visit/SFU visit was 9 weeks after administration of last dose (i.e., up to Week 184).
Time frame: Baseline (Week 0), Weeks 39, 51, 63, 75, 87, 99, 111, 123, 135, 147, 159, 171 and ET Visit/SFU visit (i.e., up to Week 184)
Population: Analysis was performed on Part B-FAS. Here, 'number analyzed' = participants with available data for each specified category and 0 in the number analyzed field signifies that none of participants were available for assessment at the specified timepoints. Data for this outcome measure was planned to be collected and analyzed for combined population of BIVV009 (i.e., all participants who received BIVV009 \[either 6.5 g or 7.5 g\]).
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| BIVV009 | Part B: Number of Participants With Response to Participant's Global Impression of (Fatigue) Severity (PGIS) Questionnaire at Each Specified Time Points | Week 123 - None | 2 Participants |
| BIVV009 | Part B: Number of Participants With Response to Participant's Global Impression of (Fatigue) Severity (PGIS) Questionnaire at Each Specified Time Points | Week 99 - Severe | 0 Participants |
| BIVV009 | Part B: Number of Participants With Response to Participant's Global Impression of (Fatigue) Severity (PGIS) Questionnaire at Each Specified Time Points | Week 63 - Moderate | 3 Participants |
| BIVV009 | Part B: Number of Participants With Response to Participant's Global Impression of (Fatigue) Severity (PGIS) Questionnaire at Each Specified Time Points | Week 99 - Very Severe | 0 Participants |
| BIVV009 | Part B: Number of Participants With Response to Participant's Global Impression of (Fatigue) Severity (PGIS) Questionnaire at Each Specified Time Points | Week 39 - Severe | 1 Participants |
| BIVV009 | Part B: Number of Participants With Response to Participant's Global Impression of (Fatigue) Severity (PGIS) Questionnaire at Each Specified Time Points | Week 111 - None | 5 Participants |
| BIVV009 | Part B: Number of Participants With Response to Participant's Global Impression of (Fatigue) Severity (PGIS) Questionnaire at Each Specified Time Points | Week 63 - Severe | 0 Participants |
| BIVV009 | Part B: Number of Participants With Response to Participant's Global Impression of (Fatigue) Severity (PGIS) Questionnaire at Each Specified Time Points | Week 111 - Mild | 4 Participants |
| BIVV009 | Part B: Number of Participants With Response to Participant's Global Impression of (Fatigue) Severity (PGIS) Questionnaire at Each Specified Time Points | ET/SFU - Severe | 3 Participants |
| BIVV009 | Part B: Number of Participants With Response to Participant's Global Impression of (Fatigue) Severity (PGIS) Questionnaire at Each Specified Time Points | Week 111 - Moderate | 2 Participants |
| BIVV009 | Part B: Number of Participants With Response to Participant's Global Impression of (Fatigue) Severity (PGIS) Questionnaire at Each Specified Time Points | Week 63 - Very Severe | 0 Participants |
| BIVV009 | Part B: Number of Participants With Response to Participant's Global Impression of (Fatigue) Severity (PGIS) Questionnaire at Each Specified Time Points | Week 111 - Severe | 0 Participants |
| BIVV009 | Part B: Number of Participants With Response to Participant's Global Impression of (Fatigue) Severity (PGIS) Questionnaire at Each Specified Time Points | Week 39 - Very Severe | 0 Participants |
| BIVV009 | Part B: Number of Participants With Response to Participant's Global Impression of (Fatigue) Severity (PGIS) Questionnaire at Each Specified Time Points | Week 111 - Very Severe | 0 Participants |
| BIVV009 | Part B: Number of Participants With Response to Participant's Global Impression of (Fatigue) Severity (PGIS) Questionnaire at Each Specified Time Points | Week 75 - None | 5 Participants |
| BIVV009 | Part B: Number of Participants With Response to Participant's Global Impression of (Fatigue) Severity (PGIS) Questionnaire at Each Specified Time Points | Week 123 - Mild | 6 Participants |
| BIVV009 | Part B: Number of Participants With Response to Participant's Global Impression of (Fatigue) Severity (PGIS) Questionnaire at Each Specified Time Points | Week 171 - Very Severe | 0 Participants |
| BIVV009 | Part B: Number of Participants With Response to Participant's Global Impression of (Fatigue) Severity (PGIS) Questionnaire at Each Specified Time Points | Week 123 - Moderate | 1 Participants |
| BIVV009 | Part B: Number of Participants With Response to Participant's Global Impression of (Fatigue) Severity (PGIS) Questionnaire at Each Specified Time Points | Week 75 - Mild | 6 Participants |
| BIVV009 | Part B: Number of Participants With Response to Participant's Global Impression of (Fatigue) Severity (PGIS) Questionnaire at Each Specified Time Points | Week 123 - Severe | 0 Participants |
| BIVV009 | Part B: Number of Participants With Response to Participant's Global Impression of (Fatigue) Severity (PGIS) Questionnaire at Each Specified Time Points | Week 51 - None | 5 Participants |
| BIVV009 | Part B: Number of Participants With Response to Participant's Global Impression of (Fatigue) Severity (PGIS) Questionnaire at Each Specified Time Points | Week 123 - Very Severe | 0 Participants |
| BIVV009 | Part B: Number of Participants With Response to Participant's Global Impression of (Fatigue) Severity (PGIS) Questionnaire at Each Specified Time Points | Week 75 - Moderate | 2 Participants |
| BIVV009 | Part B: Number of Participants With Response to Participant's Global Impression of (Fatigue) Severity (PGIS) Questionnaire at Each Specified Time Points | Week 135 - None | 0 Participants |
| BIVV009 | Part B: Number of Participants With Response to Participant's Global Impression of (Fatigue) Severity (PGIS) Questionnaire at Each Specified Time Points | Week 39 - None | 7 Participants |
| BIVV009 | Part B: Number of Participants With Response to Participant's Global Impression of (Fatigue) Severity (PGIS) Questionnaire at Each Specified Time Points | Week 135 - Mild | 3 Participants |
| BIVV009 | Part B: Number of Participants With Response to Participant's Global Impression of (Fatigue) Severity (PGIS) Questionnaire at Each Specified Time Points | Week 75 - Severe | 0 Participants |
| BIVV009 | Part B: Number of Participants With Response to Participant's Global Impression of (Fatigue) Severity (PGIS) Questionnaire at Each Specified Time Points | Week 135 - Moderate | 2 Participants |
| BIVV009 | Part B: Number of Participants With Response to Participant's Global Impression of (Fatigue) Severity (PGIS) Questionnaire at Each Specified Time Points | Week 51 - Mild | 8 Participants |
| BIVV009 | Part B: Number of Participants With Response to Participant's Global Impression of (Fatigue) Severity (PGIS) Questionnaire at Each Specified Time Points | Week 135 - Severe | 0 Participants |
| BIVV009 | Part B: Number of Participants With Response to Participant's Global Impression of (Fatigue) Severity (PGIS) Questionnaire at Each Specified Time Points | Week 75 - Very Severe | 0 Participants |
| BIVV009 | Part B: Number of Participants With Response to Participant's Global Impression of (Fatigue) Severity (PGIS) Questionnaire at Each Specified Time Points | Week 135 - Very Severe | 0 Participants |
| BIVV009 | Part B: Number of Participants With Response to Participant's Global Impression of (Fatigue) Severity (PGIS) Questionnaire at Each Specified Time Points | Week 147 - Severe | 0 Participants |
| BIVV009 | Part B: Number of Participants With Response to Participant's Global Impression of (Fatigue) Severity (PGIS) Questionnaire at Each Specified Time Points | Week 147 - None | 0 Participants |
| BIVV009 | Part B: Number of Participants With Response to Participant's Global Impression of (Fatigue) Severity (PGIS) Questionnaire at Each Specified Time Points | Week 87 - None | 6 Participants |
| BIVV009 | Part B: Number of Participants With Response to Participant's Global Impression of (Fatigue) Severity (PGIS) Questionnaire at Each Specified Time Points | Week 147 - Mild | 1 Participants |
| BIVV009 | Part B: Number of Participants With Response to Participant's Global Impression of (Fatigue) Severity (PGIS) Questionnaire at Each Specified Time Points | Week 51 - Moderate | 2 Participants |
| BIVV009 | Part B: Number of Participants With Response to Participant's Global Impression of (Fatigue) Severity (PGIS) Questionnaire at Each Specified Time Points | Week 147 - Moderate | 1 Participants |
| BIVV009 | Part B: Number of Participants With Response to Participant's Global Impression of (Fatigue) Severity (PGIS) Questionnaire at Each Specified Time Points | Week 87 - Mild | 5 Participants |
| BIVV009 | Part B: Number of Participants With Response to Participant's Global Impression of (Fatigue) Severity (PGIS) Questionnaire at Each Specified Time Points | Week 147 - Very Severe | 0 Participants |
| BIVV009 | Part B: Number of Participants With Response to Participant's Global Impression of (Fatigue) Severity (PGIS) Questionnaire at Each Specified Time Points | Week 39 - Mild | 8 Participants |
| BIVV009 | Part B: Number of Participants With Response to Participant's Global Impression of (Fatigue) Severity (PGIS) Questionnaire at Each Specified Time Points | Week 159 - None | 0 Participants |
| BIVV009 | Part B: Number of Participants With Response to Participant's Global Impression of (Fatigue) Severity (PGIS) Questionnaire at Each Specified Time Points | Week 87 - Moderate | 1 Participants |
| BIVV009 | Part B: Number of Participants With Response to Participant's Global Impression of (Fatigue) Severity (PGIS) Questionnaire at Each Specified Time Points | Week 159 - Mild | 0 Participants |
| BIVV009 | Part B: Number of Participants With Response to Participant's Global Impression of (Fatigue) Severity (PGIS) Questionnaire at Each Specified Time Points | Week 51 - Very Severe | 0 Participants |
| BIVV009 | Part B: Number of Participants With Response to Participant's Global Impression of (Fatigue) Severity (PGIS) Questionnaire at Each Specified Time Points | Week 159 - Moderate | 1 Participants |
| BIVV009 | Part B: Number of Participants With Response to Participant's Global Impression of (Fatigue) Severity (PGIS) Questionnaire at Each Specified Time Points | Week 87 - Severe | 1 Participants |
| BIVV009 | Part B: Number of Participants With Response to Participant's Global Impression of (Fatigue) Severity (PGIS) Questionnaire at Each Specified Time Points | Week 159 - Severe | 0 Participants |
| BIVV009 | Part B: Number of Participants With Response to Participant's Global Impression of (Fatigue) Severity (PGIS) Questionnaire at Each Specified Time Points | ET/SFU - None | 2 Participants |
| BIVV009 | Part B: Number of Participants With Response to Participant's Global Impression of (Fatigue) Severity (PGIS) Questionnaire at Each Specified Time Points | Week 159 - Very Severe | 0 Participants |
| BIVV009 | Part B: Number of Participants With Response to Participant's Global Impression of (Fatigue) Severity (PGIS) Questionnaire at Each Specified Time Points | Week 87 - Very Severe | 0 Participants |
| BIVV009 | Part B: Number of Participants With Response to Participant's Global Impression of (Fatigue) Severity (PGIS) Questionnaire at Each Specified Time Points | Week 171 - None | 0 Participants |
| BIVV009 | Part B: Number of Participants With Response to Participant's Global Impression of (Fatigue) Severity (PGIS) Questionnaire at Each Specified Time Points | Week 63 - None | 6 Participants |
| BIVV009 | Part B: Number of Participants With Response to Participant's Global Impression of (Fatigue) Severity (PGIS) Questionnaire at Each Specified Time Points | Week 171 - Mild | 1 Participants |
| BIVV009 | Part B: Number of Participants With Response to Participant's Global Impression of (Fatigue) Severity (PGIS) Questionnaire at Each Specified Time Points | Week 99 - None | 5 Participants |
| BIVV009 | Part B: Number of Participants With Response to Participant's Global Impression of (Fatigue) Severity (PGIS) Questionnaire at Each Specified Time Points | Week 171 - Moderate | 0 Participants |
| BIVV009 | Part B: Number of Participants With Response to Participant's Global Impression of (Fatigue) Severity (PGIS) Questionnaire at Each Specified Time Points | Week 39 - Moderate | 1 Participants |
| BIVV009 | Part B: Number of Participants With Response to Participant's Global Impression of (Fatigue) Severity (PGIS) Questionnaire at Each Specified Time Points | Week 171 - Severe | 0 Participants |
| BIVV009 | Part B: Number of Participants With Response to Participant's Global Impression of (Fatigue) Severity (PGIS) Questionnaire at Each Specified Time Points | Week 99 - Mild | 5 Participants |
| BIVV009 | Part B: Number of Participants With Response to Participant's Global Impression of (Fatigue) Severity (PGIS) Questionnaire at Each Specified Time Points | ET/SFU - Mild | 5 Participants |
| BIVV009 | Part B: Number of Participants With Response to Participant's Global Impression of (Fatigue) Severity (PGIS) Questionnaire at Each Specified Time Points | Week 63 - Mild | 8 Participants |
| BIVV009 | Part B: Number of Participants With Response to Participant's Global Impression of (Fatigue) Severity (PGIS) Questionnaire at Each Specified Time Points | ET/SFU - Moderate | 7 Participants |
| BIVV009 | Part B: Number of Participants With Response to Participant's Global Impression of (Fatigue) Severity (PGIS) Questionnaire at Each Specified Time Points | Week 99 - Moderate | 1 Participants |
| BIVV009 | Part B: Number of Participants With Response to Participant's Global Impression of (Fatigue) Severity (PGIS) Questionnaire at Each Specified Time Points | ET/SFU - Very Severe | 2 Participants |
| BIVV009 | Part B: Number of Participants With Response to Participant's Global Impression of (Fatigue) Severity (PGIS) Questionnaire at Each Specified Time Points | Week 51 - Severe | 0 Participants |
| Placebo | Part B: Number of Participants With Response to Participant's Global Impression of (Fatigue) Severity (PGIS) Questionnaire at Each Specified Time Points | ET/SFU - Very Severe | 1 Participants |
| Placebo | Part B: Number of Participants With Response to Participant's Global Impression of (Fatigue) Severity (PGIS) Questionnaire at Each Specified Time Points | Week 51 - Severe | 0 Participants |
| Placebo | Part B: Number of Participants With Response to Participant's Global Impression of (Fatigue) Severity (PGIS) Questionnaire at Each Specified Time Points | Week 123 - None | 5 Participants |
| Placebo | Part B: Number of Participants With Response to Participant's Global Impression of (Fatigue) Severity (PGIS) Questionnaire at Each Specified Time Points | Week 147 - Severe | 0 Participants |
| Placebo | Part B: Number of Participants With Response to Participant's Global Impression of (Fatigue) Severity (PGIS) Questionnaire at Each Specified Time Points | Week 171 - Very Severe | 0 Participants |
| Placebo | Part B: Number of Participants With Response to Participant's Global Impression of (Fatigue) Severity (PGIS) Questionnaire at Each Specified Time Points | ET/SFU - None | 4 Participants |
| Placebo | Part B: Number of Participants With Response to Participant's Global Impression of (Fatigue) Severity (PGIS) Questionnaire at Each Specified Time Points | ET/SFU - Severe | 5 Participants |
| Placebo | Part B: Number of Participants With Response to Participant's Global Impression of (Fatigue) Severity (PGIS) Questionnaire at Each Specified Time Points | Week 39 - None | 5 Participants |
| Placebo | Part B: Number of Participants With Response to Participant's Global Impression of (Fatigue) Severity (PGIS) Questionnaire at Each Specified Time Points | Week 39 - Mild | 7 Participants |
| Placebo | Part B: Number of Participants With Response to Participant's Global Impression of (Fatigue) Severity (PGIS) Questionnaire at Each Specified Time Points | Week 39 - Moderate | 5 Participants |
| Placebo | Part B: Number of Participants With Response to Participant's Global Impression of (Fatigue) Severity (PGIS) Questionnaire at Each Specified Time Points | Week 39 - Severe | 0 Participants |
| Placebo | Part B: Number of Participants With Response to Participant's Global Impression of (Fatigue) Severity (PGIS) Questionnaire at Each Specified Time Points | Week 39 - Very Severe | 0 Participants |
| Placebo | Part B: Number of Participants With Response to Participant's Global Impression of (Fatigue) Severity (PGIS) Questionnaire at Each Specified Time Points | Week 51 - None | 4 Participants |
| Placebo | Part B: Number of Participants With Response to Participant's Global Impression of (Fatigue) Severity (PGIS) Questionnaire at Each Specified Time Points | Week 51 - Mild | 7 Participants |
| Placebo | Part B: Number of Participants With Response to Participant's Global Impression of (Fatigue) Severity (PGIS) Questionnaire at Each Specified Time Points | Week 51 - Moderate | 5 Participants |
| Placebo | Part B: Number of Participants With Response to Participant's Global Impression of (Fatigue) Severity (PGIS) Questionnaire at Each Specified Time Points | Week 51 - Very Severe | 0 Participants |
| Placebo | Part B: Number of Participants With Response to Participant's Global Impression of (Fatigue) Severity (PGIS) Questionnaire at Each Specified Time Points | Week 63 - None | 4 Participants |
| Placebo | Part B: Number of Participants With Response to Participant's Global Impression of (Fatigue) Severity (PGIS) Questionnaire at Each Specified Time Points | Week 63 - Mild | 7 Participants |
| Placebo | Part B: Number of Participants With Response to Participant's Global Impression of (Fatigue) Severity (PGIS) Questionnaire at Each Specified Time Points | Week 63 - Moderate | 5 Participants |
| Placebo | Part B: Number of Participants With Response to Participant's Global Impression of (Fatigue) Severity (PGIS) Questionnaire at Each Specified Time Points | Week 63 - Severe | 0 Participants |
| Placebo | Part B: Number of Participants With Response to Participant's Global Impression of (Fatigue) Severity (PGIS) Questionnaire at Each Specified Time Points | Week 63 - Very Severe | 0 Participants |
| Placebo | Part B: Number of Participants With Response to Participant's Global Impression of (Fatigue) Severity (PGIS) Questionnaire at Each Specified Time Points | Week 75 - None | 6 Participants |
| Placebo | Part B: Number of Participants With Response to Participant's Global Impression of (Fatigue) Severity (PGIS) Questionnaire at Each Specified Time Points | Week 75 - Mild | 6 Participants |
| Placebo | Part B: Number of Participants With Response to Participant's Global Impression of (Fatigue) Severity (PGIS) Questionnaire at Each Specified Time Points | Week 75 - Moderate | 3 Participants |
| Placebo | Part B: Number of Participants With Response to Participant's Global Impression of (Fatigue) Severity (PGIS) Questionnaire at Each Specified Time Points | Week 75 - Severe | 0 Participants |
| Placebo | Part B: Number of Participants With Response to Participant's Global Impression of (Fatigue) Severity (PGIS) Questionnaire at Each Specified Time Points | Week 75 - Very Severe | 0 Participants |
| Placebo | Part B: Number of Participants With Response to Participant's Global Impression of (Fatigue) Severity (PGIS) Questionnaire at Each Specified Time Points | Week 87 - None | 7 Participants |
| Placebo | Part B: Number of Participants With Response to Participant's Global Impression of (Fatigue) Severity (PGIS) Questionnaire at Each Specified Time Points | Week 87 - Mild | 4 Participants |
| Placebo | Part B: Number of Participants With Response to Participant's Global Impression of (Fatigue) Severity (PGIS) Questionnaire at Each Specified Time Points | Week 87 - Moderate | 3 Participants |
| Placebo | Part B: Number of Participants With Response to Participant's Global Impression of (Fatigue) Severity (PGIS) Questionnaire at Each Specified Time Points | Week 87 - Severe | 1 Participants |
| Placebo | Part B: Number of Participants With Response to Participant's Global Impression of (Fatigue) Severity (PGIS) Questionnaire at Each Specified Time Points | Week 87 - Very Severe | 0 Participants |
| Placebo | Part B: Number of Participants With Response to Participant's Global Impression of (Fatigue) Severity (PGIS) Questionnaire at Each Specified Time Points | Week 99 - None | 8 Participants |
| Placebo | Part B: Number of Participants With Response to Participant's Global Impression of (Fatigue) Severity (PGIS) Questionnaire at Each Specified Time Points | Week 99 - Mild | 3 Participants |
| Placebo | Part B: Number of Participants With Response to Participant's Global Impression of (Fatigue) Severity (PGIS) Questionnaire at Each Specified Time Points | Week 99 - Moderate | 2 Participants |
| Placebo | Part B: Number of Participants With Response to Participant's Global Impression of (Fatigue) Severity (PGIS) Questionnaire at Each Specified Time Points | Week 99 - Severe | 0 Participants |
| Placebo | Part B: Number of Participants With Response to Participant's Global Impression of (Fatigue) Severity (PGIS) Questionnaire at Each Specified Time Points | Week 99 - Very Severe | 0 Participants |
| Placebo | Part B: Number of Participants With Response to Participant's Global Impression of (Fatigue) Severity (PGIS) Questionnaire at Each Specified Time Points | Week 111 - None | 7 Participants |
| Placebo | Part B: Number of Participants With Response to Participant's Global Impression of (Fatigue) Severity (PGIS) Questionnaire at Each Specified Time Points | Week 111 - Mild | 3 Participants |
| Placebo | Part B: Number of Participants With Response to Participant's Global Impression of (Fatigue) Severity (PGIS) Questionnaire at Each Specified Time Points | Week 111 - Moderate | 2 Participants |
| Placebo | Part B: Number of Participants With Response to Participant's Global Impression of (Fatigue) Severity (PGIS) Questionnaire at Each Specified Time Points | Week 111 - Severe | 0 Participants |
| Placebo | Part B: Number of Participants With Response to Participant's Global Impression of (Fatigue) Severity (PGIS) Questionnaire at Each Specified Time Points | Week 111 - Very Severe | 0 Participants |
| Placebo | Part B: Number of Participants With Response to Participant's Global Impression of (Fatigue) Severity (PGIS) Questionnaire at Each Specified Time Points | Week 123 - Mild | 2 Participants |
| Placebo | Part B: Number of Participants With Response to Participant's Global Impression of (Fatigue) Severity (PGIS) Questionnaire at Each Specified Time Points | Week 123 - Moderate | 2 Participants |
| Placebo | Part B: Number of Participants With Response to Participant's Global Impression of (Fatigue) Severity (PGIS) Questionnaire at Each Specified Time Points | Week 123 - Severe | 0 Participants |
| Placebo | Part B: Number of Participants With Response to Participant's Global Impression of (Fatigue) Severity (PGIS) Questionnaire at Each Specified Time Points | Week 123 - Very Severe | 0 Participants |
| Placebo | Part B: Number of Participants With Response to Participant's Global Impression of (Fatigue) Severity (PGIS) Questionnaire at Each Specified Time Points | Week 135 - None | 2 Participants |
| Placebo | Part B: Number of Participants With Response to Participant's Global Impression of (Fatigue) Severity (PGIS) Questionnaire at Each Specified Time Points | Week 135 - Mild | 1 Participants |
| Placebo | Part B: Number of Participants With Response to Participant's Global Impression of (Fatigue) Severity (PGIS) Questionnaire at Each Specified Time Points | Week 135 - Moderate | 2 Participants |
| Placebo | Part B: Number of Participants With Response to Participant's Global Impression of (Fatigue) Severity (PGIS) Questionnaire at Each Specified Time Points | Week 135 - Severe | 0 Participants |
| Placebo | Part B: Number of Participants With Response to Participant's Global Impression of (Fatigue) Severity (PGIS) Questionnaire at Each Specified Time Points | Week 135 - Very Severe | 0 Participants |
| Placebo | Part B: Number of Participants With Response to Participant's Global Impression of (Fatigue) Severity (PGIS) Questionnaire at Each Specified Time Points | Week 147 - None | 1 Participants |
| Placebo | Part B: Number of Participants With Response to Participant's Global Impression of (Fatigue) Severity (PGIS) Questionnaire at Each Specified Time Points | Week 147 - Mild | 0 Participants |
| Placebo | Part B: Number of Participants With Response to Participant's Global Impression of (Fatigue) Severity (PGIS) Questionnaire at Each Specified Time Points | Week 147 - Moderate | 1 Participants |
| Placebo | Part B: Number of Participants With Response to Participant's Global Impression of (Fatigue) Severity (PGIS) Questionnaire at Each Specified Time Points | Week 147 - Very Severe | 0 Participants |
| Placebo | Part B: Number of Participants With Response to Participant's Global Impression of (Fatigue) Severity (PGIS) Questionnaire at Each Specified Time Points | Week 159 - None | 0 Participants |
| Placebo | Part B: Number of Participants With Response to Participant's Global Impression of (Fatigue) Severity (PGIS) Questionnaire at Each Specified Time Points | Week 159 - Mild | 0 Participants |
| Placebo | Part B: Number of Participants With Response to Participant's Global Impression of (Fatigue) Severity (PGIS) Questionnaire at Each Specified Time Points | Week 159 - Moderate | 1 Participants |
| Placebo | Part B: Number of Participants With Response to Participant's Global Impression of (Fatigue) Severity (PGIS) Questionnaire at Each Specified Time Points | Week 159 - Severe | 0 Participants |
| Placebo | Part B: Number of Participants With Response to Participant's Global Impression of (Fatigue) Severity (PGIS) Questionnaire at Each Specified Time Points | Week 159 - Very Severe | 0 Participants |
| Placebo | Part B: Number of Participants With Response to Participant's Global Impression of (Fatigue) Severity (PGIS) Questionnaire at Each Specified Time Points | Week 171 - None | 0 Participants |
| Placebo | Part B: Number of Participants With Response to Participant's Global Impression of (Fatigue) Severity (PGIS) Questionnaire at Each Specified Time Points | Week 171 - Mild | 0 Participants |
| Placebo | Part B: Number of Participants With Response to Participant's Global Impression of (Fatigue) Severity (PGIS) Questionnaire at Each Specified Time Points | Week 171 - Moderate | 0 Participants |
| Placebo | Part B: Number of Participants With Response to Participant's Global Impression of (Fatigue) Severity (PGIS) Questionnaire at Each Specified Time Points | Week 171 - Severe | 0 Participants |
| Placebo | Part B: Number of Participants With Response to Participant's Global Impression of (Fatigue) Severity (PGIS) Questionnaire at Each Specified Time Points | ET/SFU - Mild | 3 Participants |
| Placebo | Part B: Number of Participants With Response to Participant's Global Impression of (Fatigue) Severity (PGIS) Questionnaire at Each Specified Time Points | ET/SFU - Moderate | 5 Participants |