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Multi-center, randomized, multiple-dose study to evaluate the safety, tolerability and efficacy of ACE-011 in patients with osteolytic lesions of multiple myeloma.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | Subcutaneous injection on days 1, 29, 57 and 85. |
|
| ACE-011 0.1 mg/kg | Experimental | Subcutaneous injection of ACE-011 0.1 mg/kg every 28 days totaling four doses (days 1, 29, 57 and 85). |
|
| ACE-011 0.3 mg/kg | Experimental | Subcutaneous injection of ACE-011 0.3 mg/kg every 28 days totaling four doses (days 1, 29, 57 and 85). |
|
| ACE-011 0.5 mg/kg | Experimental | Subcutaneous injection of ACE-011 0.5 mg/kg every 28 days totaling four doses (days 1, 29, 57 and 85). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ACE-011 | Biological | ACE-011 given by the subcutaneous route of administration monthly for 4 doses. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Treatment Emergent Adverse Events (TEAEs) | A treatment emergent adverse event (TEAE) was defined as any untoward medical occurrence in a participant administered a pharmaceutical product, regardless of causality assessment. A TEAE could therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not considered related to the medicinal (investigational) product. Any worsening (i.e., any clinical significant adverse change in frequency and/or intensity) of a preexisting condition, which was temporally associated with the use of the sponsor's medicinal (investigational) product, was also a TEAE. The number of participants with at least one TEAE are reported. | From first dose to termination visit on Day 169 |
| Number of Participants With Treatment Emergent Adverse Events (TEAEs) Related to Study Drug | A treatment emergent adverse event (TEAE) related to study drug was defined as any untoward medical occurrence in a participant administered a pharmaceutical product, that was determined to be related to the study drug. A TEAE could therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product. Any worsening (i.e., any clinical significant adverse change in frequency and/or intensity) of a preexisting condition, which was temporally associated with the use of the sponsor's medicinal (investigational) product, was also a TEAE. The number of participants with at least one TEAE are reported. Treatment emergent adverse events were assessed by the investigator as possibly, probably, or definitely related to the study drug. | From first dose to termination visit on Day 169 |
| Number of Participants With Serious Adverse Events (SAEs) | A Serious Adverse Event (SAE) was defined as any untoward medical occurrence that at any dose (including overdose) that was fatal, was life threatening, required or prolonged inpatient hospitalization, resulted in permanent or significant disability/incapacity, or was a congenital anomaly/birth defect. The number of participants with at least one serious adverse event are reported. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Skeletal-related Events (SRE) | Skeletal-related events are defined as pathologic fracture, radiation therapy to bone, surgery to bone, or spinal cord compression, within 2 weeks of study enrollment. They are determined by skeletal surveys, including x-rays of the skull, entire spine, pelvis, ribs, humeri, and femora. | From first dose up to 2 weeks post first dose |
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Key Inclusion Criteria:
Key Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Abderrahmane Laadem, MD | Celgene Corporation | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Investigative Site | Moscow | Russia | ||||
| Investigative Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24650009 | Background | Abdulkadyrov KM, Salogub GN, Khuazheva NK, Sherman ML, Laadem A, Barger R, Knight R, Srinivasan S, Terpos E. Sotatercept in patients with osteolytic lesions of multiple myeloma. Br J Haematol. 2014 Jun;165(6):814-23. doi: 10.1111/bjh.12835. Epub 2014 Mar 21. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | Placebo was administered within 28 days of screening. Subsequent doses were administered every 28 days for a total of four doses. |
| FG001 | 0.1 mg/kg ACE 011 | 0.1 mg/kg administered via subcutaneous injection every 28 days for a total of four doses (i.e., Days 1, 29, 57, and 85), with safety follow-up visits 1 week after each dose (i.e., Days 8, 36, 64, and 92). After completion of the treatment period, participants returned to the study site monthly for follow-up assessments for an additional 3 months (i.e., Days 113, 141, and 169). |
| FG002 | 0.3 mg/kg ACE 011 | 0.3 mg/kg administered via subcutaneous injection every 28 days for a total of four doses (i.e., Days 1, 29, 57, and 85), with safety follow-up visits 1 week after each dose (i.e., Days 8, 36, 64, and 92). After completion of the treatment period, participants returned to the study site monthly for follow-up assessments for an additional 3 months (i.e., Days 113, 141, and 169) |
| FG003 | 0.5 mg/kg ACE 011 | 0.5 mg/kg administered via subcutaneous injection every 28 days for a total of four doses (i.e., Days 1, 29, 57, and 85), with safety follow-up visits 1 week after each dose (i.e., Days 8, 36, 64, and 92). After completion of the treatment period, participants returned to the study site monthly for follow-up assessments for an additional 3 months (i.e., Days 113, 141, and 169). |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | Placebo was administered within 28 days of screening. Subsequent doses were administered every 28 days for a total of four doses. |
| BG001 | 0.1 mg/kg ACE 011 | 0.1 mg/kg administered via subcutaneous injection every 28 days for a total of four doses (i.e., Days 1, 29, 57, and 85), with safety follow-up visits 1 week after each dose (i.e., Days 8, 36, 64, and 92). After completion of the treatment period, participants returned to the study site monthly for follow-up assessments for an additional 3 months (i.e., Days 113, 141, and 169). |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants With Treatment Emergent Adverse Events (TEAEs) | A treatment emergent adverse event (TEAE) was defined as any untoward medical occurrence in a participant administered a pharmaceutical product, regardless of causality assessment. A TEAE could therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not considered related to the medicinal (investigational) product. Any worsening (i.e., any clinical significant adverse change in frequency and/or intensity) of a preexisting condition, which was temporally associated with the use of the sponsor's medicinal (investigational) product, was also a TEAE. The number of participants with at least one TEAE are reported. | All randomized participants | Posted | Count of Participants | Participants | From first dose to termination visit on Day 169 |
|
Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 10 months). SAEs and Other AEs were assessed from first dose to Day 169.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | ACE 011 0.1 mg/kg | 0.1 mg/kg administered via subcutaneous injection every 28 days for a total of four doses (i.e., Days 1, 29, 57, and 85), with safety follow-up visits 1 week after each dose (i.e., Days 8, 36, 64, and 92). After completion of the treatment period, participants returned to the study site monthly for follow-up assessments for an additional 3 months (i.e., Days 113, 141, and 169). |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Atrial fibrillation | Cardiac disorders | 11.1 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | 11.1 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Bristol-Myers Squibb Study Director | Bristol-Myers Squibb | Please Email | Clinical.Trials@bms.com |
Not provided
| ID | Term |
|---|---|
| D009101 | Multiple Myeloma |
| ID | Term |
|---|---|
| D054219 | Neoplasms, Plasma Cell |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D020141 | Hemostatic Disorders |
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| ID | Term |
|---|---|
| C542017 | ACE-011 |
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|
| Placebo | Biological | Placebo given by the subcutaneous route of administration monthly for 4 doses. |
|
| From first dose up to termination visit on Day 169 |
| Change From Baseline in Hemoglobin | Summary of the change from baseline in hemoglobin (g/dL) by the pre-specified timepoints. Baseline was defined as the last measurement prior to dosing. Data were summarized for all treated participants who had at least 1 postdosing measurement. | Day 1 (baseline), Day 8, Day 29, Day 36, Day 57, Day 85, Day 113, Day 169 |
| Number of Participants With Electrocardiogram Abnormalities | The number of participants with at least one clinically significant postbaseline electrocardiogram abnormality. The abnormalities included left ventricular hypertrophy, atrial fibrillation, sinus bradycardia, sinus tachycardia, and myocardial ischemia. Data is reported as the cumulative number of participants with abnormalities over the scheduled collection timepoints. | Pre-dose, Day 1, Day 92, and Day 169 |
| Number of Participants With Hypertension or Increased Blood Pressure | The number of participants who experienced hypertension or an increase in blood pressure from baseline up to Day 92. Abnormal blood pressure was defined as:
| From baseline up to Day 92 |
| Percent Change From Baseline in Bone Pain Visual Analog Scale (VAS) | The visual analog scale (VAS) is a pain rating scale. Scores are based on the percent change from baseline (Day 1) in self-reported measures of symptoms that are recorded with a single handwritten mark placed at one point along the length of a 10-cm line that represents a continuum between the two ends of the scale-"no pain" on the left end (0 cm) of the scale and the "worst pain" on the right end of the scale (10 cm). Measurements from the starting point (left end) of the scale to the patients' marks are recorded in centimeters and are interpreted as their pain. The values can be used to track pain progression for a patient or to compare pain between patients with similar conditions. In addition to pain, the scale has also been used to evaluate mood, appetite, asthma, dyspepsia, and ambulation. | From baseline (Day 1) to Day 29, Day 57, Day 85, Day 113, Day 141, Day 169 |
| Saint Petersburg |
| Russia |
| Withdrew consent |
|
| Adverse Event |
|
| BG002 | 0.3 mg/kg ACE 011 | 0.3 mg/kg administered via subcutaneous injection every 28 days for a total of four doses (i.e., Days 1, 29, 57, and 85), with safety follow-up visits 1 week after each dose (i.e., Days 8, 36, 64, and 92). After completion of the treatment period, participants returned to the study site monthly for follow-up assessments for an additional 3 months (i.e., Days 113, 141, and 169) |
| BG003 | 0.5 mg/kg ACE 011 | 0.5 mg/kg administered via subcutaneous injection every 28 days for a total of four doses (i.e., Days 1, 29, 57, and 85), with safety follow-up visits 1 week after each dose (i.e., Days 8, 36, 64, and 92). After completion of the treatment period, participants returned to the study site monthly for follow-up assessments for an additional 3 months (i.e., Days 113, 141, and 169). |
| BG004 | Total | Total of all reporting groups |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
Placebo was administered within 28 days of screening. Subsequent doses were administered every 28 days for a total of four doses. |
| OG001 | 0.1 mg/kg ACE 011 | 0.1 mg/kg administered via subcutaneous injection every 28 days for a total of four doses (i.e., Days 1, 29, 57, and 85), with safety follow-up visits 1 week after each dose (i.e., Days 8, 36, 64, and 92). After completion of the treatment period, participants returned to the study site monthly for follow-up assessments for an additional 3 months (i.e., Days 113, 141, and 169). |
| OG002 | 0.3 mg/kg ACE 011 | 0.3 mg/kg administered via subcutaneous injection every 28 days for a total of four doses (i.e., Days 1, 29, 57, and 85), with safety follow-up visits 1 week after each dose (i.e., Days 8, 36, 64, and 92). After completion of the treatment period, participants returned to the study site monthly for follow-up assessments for an additional 3 months (i.e., Days 113, 141, and 169) |
| OG003 | 0.5 mg/kg ACE 011 | 0.5 mg/kg administered via subcutaneous injection every 28 days for a total of four doses (i.e., Days 1, 29, 57, and 85), with safety follow-up visits 1 week after each dose (i.e., Days 8, 36, 64, and 92). After completion of the treatment period, participants returned to the study site monthly for follow-up assessments for an additional 3 months (i.e., Days 113, 141, and 169). |
|
|
| Primary | Number of Participants With Treatment Emergent Adverse Events (TEAEs) Related to Study Drug | A treatment emergent adverse event (TEAE) related to study drug was defined as any untoward medical occurrence in a participant administered a pharmaceutical product, that was determined to be related to the study drug. A TEAE could therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product. Any worsening (i.e., any clinical significant adverse change in frequency and/or intensity) of a preexisting condition, which was temporally associated with the use of the sponsor's medicinal (investigational) product, was also a TEAE. The number of participants with at least one TEAE are reported. Treatment emergent adverse events were assessed by the investigator as possibly, probably, or definitely related to the study drug. | All randomized participants | Posted | Count of Participants | Participants | From first dose to termination visit on Day 169 |
|
|
|
| Primary | Number of Participants With Serious Adverse Events (SAEs) | A Serious Adverse Event (SAE) was defined as any untoward medical occurrence that at any dose (including overdose) that was fatal, was life threatening, required or prolonged inpatient hospitalization, resulted in permanent or significant disability/incapacity, or was a congenital anomaly/birth defect. The number of participants with at least one serious adverse event are reported. | All randomized participants | Posted | Count of Participants | Participants | From first dose up to termination visit on Day 169 |
|
|
|
| Primary | Change From Baseline in Hemoglobin | Summary of the change from baseline in hemoglobin (g/dL) by the pre-specified timepoints. Baseline was defined as the last measurement prior to dosing. Data were summarized for all treated participants who had at least 1 postdosing measurement. | All randomized participants | Posted | Mean | Standard Deviation | g/dL | Day 1 (baseline), Day 8, Day 29, Day 36, Day 57, Day 85, Day 113, Day 169 |
|
|
|
| Primary | Number of Participants With Electrocardiogram Abnormalities | The number of participants with at least one clinically significant postbaseline electrocardiogram abnormality. The abnormalities included left ventricular hypertrophy, atrial fibrillation, sinus bradycardia, sinus tachycardia, and myocardial ischemia. Data is reported as the cumulative number of participants with abnormalities over the scheduled collection timepoints. | All randomized participants | Posted | Count of Participants | Participants | Pre-dose, Day 1, Day 92, and Day 169 |
|
|
|
| Primary | Number of Participants With Hypertension or Increased Blood Pressure | The number of participants who experienced hypertension or an increase in blood pressure from baseline up to Day 92. Abnormal blood pressure was defined as:
| All randomized participants | Posted | Count of Participants | Participants | From baseline up to Day 92 |
|
|
|
| Secondary | Number of Participants With Skeletal-related Events (SRE) | Skeletal-related events are defined as pathologic fracture, radiation therapy to bone, surgery to bone, or spinal cord compression, within 2 weeks of study enrollment. They are determined by skeletal surveys, including x-rays of the skull, entire spine, pelvis, ribs, humeri, and femora. | All randomized participants | Posted | Count of Participants | Participants | From first dose up to 2 weeks post first dose |
|
|
|
| Secondary | Percent Change From Baseline in Bone Pain Visual Analog Scale (VAS) | The visual analog scale (VAS) is a pain rating scale. Scores are based on the percent change from baseline (Day 1) in self-reported measures of symptoms that are recorded with a single handwritten mark placed at one point along the length of a 10-cm line that represents a continuum between the two ends of the scale-"no pain" on the left end (0 cm) of the scale and the "worst pain" on the right end of the scale (10 cm). Measurements from the starting point (left end) of the scale to the patients' marks are recorded in centimeters and are interpreted as their pain. The values can be used to track pain progression for a patient or to compare pain between patients with similar conditions. In addition to pain, the scale has also been used to evaluate mood, appetite, asthma, dyspepsia, and ambulation. | All treated participants who had at least 1 postdosing measurement | Posted | Mean | Standard Deviation | Percent change | From baseline (Day 1) to Day 29, Day 57, Day 85, Day 113, Day 141, Day 169 |
|
|
|
| 1 |
| 8 |
| 1 |
| 8 |
| 7 |
| 8 |
| EG001 | ACE 011 0.3 mg/kg | 0.3 mg/kg administered via subcutaneous injection every 28 days for a total of four doses (i.e., Days 1, 29, 57, and 85), with safety follow-up visits 1 week after each dose (i.e., Days 8, 36, 64, and 92). After completion of the treatment period, participants returned to the study site monthly for follow-up assessments for an additional 3 months (i.e., Days 113, 141, and 169) | 0 | 8 | 0 | 8 | 7 | 8 |
| EG002 | ACE 011 0.5 mg/kg | 0.5 mg/kg administered via subcutaneous injection every 28 days for a total of four doses (i.e., Days 1, 29, 57, and 85), with safety follow-up visits 1 week after each dose (i.e., Days 8, 36, 64, and 92). After completion of the treatment period, participants returned to the study site monthly for follow-up assessments for an additional 3 months (i.e., Days 113, 141, and 169). | 0 | 8 | 3 | 8 | 8 | 8 |
| EG003 | Placebo | Placebo was administered within 28 days of screening. Subsequent doses were administered every 28 days for a total of four doses. | 0 | 6 | 0 | 6 | 4 | 6 |
| Sudden death | General disorders | 11.1 | Systematic Assessment |
|
| Pneumonia | Infections and infestations | 11.1 | Systematic Assessment |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | 11.1 | Systematic Assessment |
|
| Pathological fracture | Musculoskeletal and connective tissue disorders | 11.1 | Systematic Assessment |
|
| Eosinophilia | Blood and lymphatic system disorders | 11.1 | Systematic Assessment |
|
| Granulocytopenia | Blood and lymphatic system disorders | 11.1 | Systematic Assessment |
|
| Leukopenia | Blood and lymphatic system disorders | 11.1 | Systematic Assessment |
|
| Neutropenia | Blood and lymphatic system disorders | 11.1 | Systematic Assessment |
|
| Thrombocytopenia | Blood and lymphatic system disorders | 11.1 | Systematic Assessment |
|
| Angina pectoris | Cardiac disorders | 11.1 | Systematic Assessment |
|
| Atrial conduction time prolongation | Cardiac disorders | 11.1 | Systematic Assessment |
|
| Atrial fibrillation | Cardiac disorders | 11.1 | Systematic Assessment |
|
| Myocardial ischaemia | Cardiac disorders | 11.1 | Systematic Assessment |
|
| Sinus bradycardia | Cardiac disorders | 11.1 | Systematic Assessment |
|
| Hypothyroidism | Endocrine disorders | 11.1 | Systematic Assessment |
|
| Blepharitis | Eye disorders | 11.1 | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | 11.1 | Systematic Assessment |
|
| Asthenia | General disorders | 11.1 | Systematic Assessment |
|
| Fatigue | General disorders | 11.1 | Systematic Assessment |
|
| Oedema peripheral | General disorders | 11.1 | Systematic Assessment |
|
| Pyrexia | General disorders | 11.1 | Systematic Assessment |
|
| Bronchitis | Infections and infestations | 11.1 | Systematic Assessment |
|
| Herpes zoster | Infections and infestations | 11.1 | Systematic Assessment |
|
| Pneumonia | Infections and infestations | 11.1 | Systematic Assessment |
|
| Respiratory tract infection | Infections and infestations | 11.1 | Systematic Assessment |
|
| Rhinitis | Infections and infestations | 11.1 | Systematic Assessment |
|
| Compression fracture | Injury, poisoning and procedural complications | 11.1 | Systematic Assessment |
|
| Concussion | Injury, poisoning and procedural complications | 11.1 | Systematic Assessment |
|
| Rib fracture | Injury, poisoning and procedural complications | 11.1 | Systematic Assessment |
|
| Blood pressure increased | Investigations | 11.1 | Systematic Assessment |
|
| Platelet count decreased | Investigations | 11.1 | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | 11.1 | Systematic Assessment |
|
| Intervertebral disc degeneration | Musculoskeletal and connective tissue disorders | 11.1 | Systematic Assessment |
|
| Intervertebral disc protrusion | Musculoskeletal and connective tissue disorders | 11.1 | Systematic Assessment |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | 11.1 | Systematic Assessment |
|
| Pathological fracture | Musculoskeletal and connective tissue disorders | 11.1 | Systematic Assessment |
|
| Somnolence | Nervous system disorders | 11.1 | Systematic Assessment |
|
| Dermatitis allergic | Skin and subcutaneous tissue disorders | 11.1 | Systematic Assessment |
|
| Hair texture abnormal | Skin and subcutaneous tissue disorders | 11.1 | Systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | 11.1 | Systematic Assessment |
|
| Hypertension | Vascular disorders | 11.1 | Systematic Assessment |
|
| Phlebitis | Vascular disorders | 11.1 | Systematic Assessment |
|
| Post thrombotic syndrome | Vascular disorders | 11.1 | Systematic Assessment |
|
Bristol-Myers Squibb Co. agreements with investigators vary; constant is our right to embargo communications regarding trial results prior to public release for a period ≤60 days from submittal for review. We will not prohibit investigators from publishing but will prohibit the disclosure of previously undisclosed confidential information other than study results, and request postponement of single-center publications until after disclosure of the clinical trial's primary publication.
| D014652 |
| Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D010265 | Paraproteinemias |
| D001796 | Blood Protein Disorders |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D006474 | Hemorrhagic Disorders |
| D008232 | Lymphoproliferative Disorders |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
|
| Day 29 |
|
|
| Day 36 |
|
|
| Day 57 |
|
|
| Day 85 |
|
|
| Day 113 |
|
|
| Day 169/Early Termination |
|
|
|
| Day 57 |
|
|
| Day 85 |
|
|
| Day 113 |
|
|
| Day 141 |
|
|
| Day 169 |
|
|