Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Biotest | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This Phase I/IIa clinical study is to test safety and anti-tumor activity of BT062 to define the best dose in treating patients with relapsed or refractory multiple myeloma with multiple doses of BT062.
Phase I/IIa, open-label, 3 + 3 multi-dose escalation study. The Phase I part of the study was to include the dose escalation cohort; a conventional dose escalation design, following 3 + 3 rules was chosen to define the MTD.
The Phase IIa part was to include the MTD/recommended phase II dose (RPTD) expansion cohort in which descriptive statistical methods for evaluation of response, time to event endpoints, and safety were to be performed.
35 subjects in the Safety population, 34 subjects in the ITT and PP populations.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BT062 | Experimental | BT062 was to be administered as single-dose IV infusions via a 0.22 μm in-line filter preferably in a forearm vein, according to medically accepted procedures on Days 1, 8, and 15 of each 28-day cycle. Alternatively BT062 may have been administered through a central venous line or a peripherally inserted central catheter (PICC). Other administration routes were only to be allowed after approval from Biotest. Each subject was to be monitored carefully for the effects of exposure to BT062. No subject was to have received more than 3 doses of BT062 per 28-day treatment cycle. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BT062 | Drug | intravenous administration |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Dose Limiting Toxicities (DLT) - Number of Participants With at Least 1 DLT | The primary safety variable was to determine the incidence of DLTs in subjects with relapsed or relapsed/refractory multiple myeloma treated with BT062. | Starting with first study drug administration until 30-day follow-up visit (average 4.99 months) |
| Maximum Tolerated Dose (MTD) | The Phase I part of the study was to include the dose escalation cohort; a conventional dose escalation design, following 3 + 3 rules was chosen to define the MTD. Only DLTs occurring in cycle 1 for each subject were counted in the dose escalation decisions. Three subjects were treated at the first or newest dose level as available. If none of the 3 subjects experienced a DLT during Cycle 1, three subjects could be treated at the next dose level as available. In case of a DLT the cohort was expanded to up to 6 subjects. If not more than 1 of these 6 subjects experienced a DLT during Cycle 1, a first subject could be treated at the next dose level. If 2 or more of the 6 subjects experienced a DLT during Cycle 1 the dose escalation was stopped. The highest dose level at which < 2 of 6 subjects experienced a DLT is defined as the MTD. | First 28-day cycle |
| Measure | Description | Time Frame |
|---|---|---|
| Qualitative and Quantitative Toxicities of BT062 | Qualitative and quantitative toxicities assessed by incidence of adverse events and by clinically significant changes in the patient's physical examination, vital signs, and clinical laboratory results. The incidence of treatment emergent adverse events (TEAEs), including serious adverse events (SAEs). | Starting with first study drug administration until 30-day follow-up visit (average 4.99 months) |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Kenneth C. Anderson, MD | Dana-Farber Cancer Institute | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Emory University Winship Cancer Institute | Atlanta | Georgia | 30322 | United States | ||
| The University of Chicago |
The Intention-to-treat (ITT) population included all subjects who were enrolled in the study and received at least 1 dose of BT062 and who had any post-Baseline evaluations or data. One subject did not have at least one post-injection assessment of the treatment response and was excluded from both the ITT and PP populations (n = 34).
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | BT062 40 mg/m² | 40 mg/m² BT062 was administered by IV infusion on Days 1, 8, and 15 of every 28-day cycle. |
| FG001 | BT062 50 mg/m² | 50 mg/m² BT062 was administered by IV infusion on Days 1, 8, and 15 of every 28-day cycle. |
| FG002 | BT062 65 mg/m² | 65 mg/m² BT062 was administered by IV infusion on Days 1, 8, and 15 of every 28-day cycle. |
| FG003 | BT062 80 mg/m² | 80 mg/m² BT062 was administered by IV infusion on Days 1, 8, and 15 of every 28-day cycle. |
| FG004 | BT062 100 mg/m² | 100 mg/m² BT062 was administered by IV infusion on Days 1, 8, and 15 of every 28-day cycle. |
| FG005 | BT062 120 mg/m² | 120 mg/m² BT062 was administered by IV infusion on Days 1, 8, and 15 of every 28-day cycle. |
| FG006 | BT062 140 mg/m² | 140 mg/m² BT062 was administered by IV infusion on Days 1, 8, and 15 of every 28-day cycle. |
| FG007 | BT062 160 mg/m² | 160 mg/m² BT062 was administered by IV infusion on Days 1, 8, and 15 of every 28-day cycle. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
ITT: The Intention-to-treat (ITT) population included all subjects who were enrolled in the study and received at least 1 dose of BT062 and who had any post-Baseline evaluations or data. One subject did not have at least one post-injection assessment of the treatment response and was excluded from both the ITT and PP populations (n = 34).
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | BT062 40 mg/m² | 40 mg/m² BT062 was administered by IV infusion on Days 1, 8, and 15 of every 28-day cycle. |
| BG001 | BT062 50 mg/m² | 50 mg/m² BT062 was administered by IV infusion on Days 1, 8, and 15 of every 28-day cycle. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | Dose Limiting Toxicities (DLT) - Number of Participants With at Least 1 DLT | The primary safety variable was to determine the incidence of DLTs in subjects with relapsed or relapsed/refractory multiple myeloma treated with BT062. | The Safety population included all subjects who were enrolled and received at least 1 dose of BT062 (n = 35). | Posted | Count of Participants | Participants | Starting with first study drug administration until 30-day follow-up visit (average 4.99 months) |
|
Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | BT062 40 mg/m² | 40 mg/m² BT062 was administered by IV infusion on Days 1, 8, and 15 of every 28-day cycle. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| NEUTROPENIA | Blood and lymphatic system disorders | MedDRA (17.1) | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| ANAEMIA | Blood and lymphatic system disorders | MedDRA (17.1) | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Iris Bobenhausen | Biotest AG | +49 6103 801 | 4832 | iris.bobenhausen@biotest.com |
Not provided
| ID | Term |
|---|---|
| D009101 | Multiple Myeloma |
| D012008 | Recurrence |
| ID | Term |
|---|---|
| D054219 | Neoplasms, Plasma Cell |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D020141 | Hemostatic Disorders |
Not provided
Not provided
| ID | Term |
|---|---|
| C000625392 | indatuximab ravtansine |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Multi-dose Pharmacokinetics Properties of BT062 - Cmax | Multi-dose Pharmacokinetics properties of BT062 after intravenous (IV) Administration of escalating doses of BT062 as assessed by measuring intact BT062 conjugate. Please note that not all subjects reached Cycle 4 due to early termination . A lower number of samples could be analyzed for Cycle 4. | Starting with first study drug administration until 30-day follow-up visit (average 4.99 months). |
| Anti-tumor Activity of BT062 in Subjects With Relapsed or Relapsed/Refractory Multiple Myeloma by Number of Participants With Objective Response(ORR) and/or Clinial Benefit(CBR) Based on the International Myeloma Working Group Uniform Response Criteria | sCR:CR+normal FLC+absence of clonal cells in BM; CR:Negative immunofixation,disappearance of soft tissue plasmacytomas +≤5% plasma cells in BM+normal FLC; VGPR:M-protein detectable by immunofixation,not on electrophoresis or 90% or greater reduction in serum M-protein+urine M-protein level <100mg per 24h,>90% decrease in the difference between involved/uninvolved FLC; PR:≥50% reduction of serum M-protein and reduction in 24-h urinary M-protein by ≥90% or to <200 mg per 24 h or ≥50% decrease in the difference between involved/uninvolved FLC or ≥50% reduction in plasma cells, provided baseline bone marrow plasma cell percentage was ≥30%, ≥50% size reduction of soft tissue plasmacytomas; MR:25%-49% reduction of serum M-protein+reduction in 24h urinary M-protein by 50-89%(still >200 mg/24h),25-49% soft tissue plasmacytomas size reduction,no increase in size or number of lytic bone lesions; SD:no response or PD ORR: %of subjects with MR+PR+VGPR+CR+sCR CBR:ORR + %of subjects with SD. | On day 1 of each treatment cycle (on a monthly basis) starting with first study drug administration until Close Out visit (average 3.84 months). |
| Time to Progression (TTP), Progression Free Survival (PFS) and Overall Survival (OS) | Progressive disease Requires any one or more of the following: Increase of ≥ 25% from baseline in
Only in patients without measurable serum and urine M-protein levels: the difference between involved and uninvolved FLC levels. The absolute increase must be > 10 mg/dL. Bone marrow plasma cell percentage: the absolute % must be ≥ 10% (relapse form CR as a 5% cutoff instead of 10%). Definite development of new bone lesions or soft tissue plasmacytomas or definite increase in the size of existing bone lesions or soft tissue plasmacytomas. Development of hypercalcemia (corrected serum calcium > 11.5 mg/dL or 2.65 mmol/l) that can be attributed solely to the plasma cell proliferative disorder. | Starting with first study drug administration until death or 3 years from first study treatment. |
| Chicago |
| Illinois |
| 60637 |
| United States |
| Dana-Farber Cancer Institute | Boston | Massachusetts | 02115 | United States |
| Roswell Park Cancer Institute | Buffalo | New York | 14263 | United States |
| The Mount Sinai School of Medicine | New York | New York | 10029 | United States |
| BG002 | BT062 65 mg/m² | 65 mg/m² BT062 was administered by IV infusion on Days 1, 8, and 15 of every 28-day cycle. |
| BG003 | BT062 80 mg/m² | 80 mg/m² BT062 was administered by IV infusion on Days 1, 8, and 15 of every 28-day cycle. |
| BG004 | BT062 100 mg/m² | 100 mg/m² BT062 was administered by IV infusion on Days 1, 8, and 15 of every 28-day cycle. |
| BG005 | BT062 120 mg/m² | 120 mg/m² BT062 was administered by IV infusion on Days 1, 8, and 15 of every 28-day cycle. |
| BG006 | BT062 140 mg/m² | 140 mg/m² BT062 was administered by IV infusion on Days 1, 8, and 15 of every 28-day cycle. |
| BG007 | BT062 160 mg/m² | 160 mg/m² BT062 was administered by IV infusion on Days 1, 8, and 15 of every 28-day cycle. |
| BG008 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
50 mg/m² BT062 was administered by IV infusion on Days 1, 8, and 15 of every 28-day cycle.
| OG002 | BT062 65 mg/m² | 65 mg/m² BT062 was administered by IV infusion on Days 1, 8, and 15 of every 28-day cycle. |
| OG003 | BT062 80 mg/m² | 80 mg/m² BT062 was administered by IV infusion on Days 1, 8, and 15 of every 28-day cycle. |
| OG004 | BT062 100 mg/m² | 100 mg/m² BT062 was administered by IV infusion on Days 1, 8, and 15 of every 28-day cycle. |
| OG005 | BT062 120 mg/m² | 120 mg/m² BT062 was administered by IV infusion on Days 1, 8, and 15 of every 28-day cycle. |
| OG006 | BT062 140 mg/m² | 140 mg/m² BT062 was administered by IV infusion on Days 1, 8, and 15 of every 28-day cycle. |
| OG007 | BT062 160 mg/m² | 160 mg/m² BT062 was administered by IV infusion on Days 1, 8, and 15 of every 28-day cycle. |
| OG008 | Total | BT062 administration (all dose levels) |
|
|
| Primary | Maximum Tolerated Dose (MTD) | The Phase I part of the study was to include the dose escalation cohort; a conventional dose escalation design, following 3 + 3 rules was chosen to define the MTD. Only DLTs occurring in cycle 1 for each subject were counted in the dose escalation decisions. Three subjects were treated at the first or newest dose level as available. If none of the 3 subjects experienced a DLT during Cycle 1, three subjects could be treated at the next dose level as available. In case of a DLT the cohort was expanded to up to 6 subjects. If not more than 1 of these 6 subjects experienced a DLT during Cycle 1, a first subject could be treated at the next dose level. If 2 or more of the 6 subjects experienced a DLT during Cycle 1 the dose escalation was stopped. The highest dose level at which < 2 of 6 subjects experienced a DLT is defined as the MTD. | Posted | Number | mg/m² | First 28-day cycle |
|
|
|
| Secondary | Qualitative and Quantitative Toxicities of BT062 | Qualitative and quantitative toxicities assessed by incidence of adverse events and by clinically significant changes in the patient's physical examination, vital signs, and clinical laboratory results. The incidence of treatment emergent adverse events (TEAEs), including serious adverse events (SAEs). | Safety Population: The Safety population included all subjects who were enrolled and received at least 1 dose of BT062 (n = 35). | Posted | Count of Participants | Participants | Starting with first study drug administration until 30-day follow-up visit (average 4.99 months) |
|
|
|
| Secondary | Multi-dose Pharmacokinetics Properties of BT062 - Cmax | Multi-dose Pharmacokinetics properties of BT062 after intravenous (IV) Administration of escalating doses of BT062 as assessed by measuring intact BT062 conjugate. Please note that not all subjects reached Cycle 4 due to early termination . A lower number of samples could be analyzed for Cycle 4. | Safety Population: The Safety population included all subjects who were enrolled and received at least 1 dose of BT062 (n = 35). | Posted | Median | Full Range | ng/ml | Starting with first study drug administration until 30-day follow-up visit (average 4.99 months). |
|
|
|
| Secondary | Anti-tumor Activity of BT062 in Subjects With Relapsed or Relapsed/Refractory Multiple Myeloma by Number of Participants With Objective Response(ORR) and/or Clinial Benefit(CBR) Based on the International Myeloma Working Group Uniform Response Criteria | sCR:CR+normal FLC+absence of clonal cells in BM; CR:Negative immunofixation,disappearance of soft tissue plasmacytomas +≤5% plasma cells in BM+normal FLC; VGPR:M-protein detectable by immunofixation,not on electrophoresis or 90% or greater reduction in serum M-protein+urine M-protein level <100mg per 24h,>90% decrease in the difference between involved/uninvolved FLC; PR:≥50% reduction of serum M-protein and reduction in 24-h urinary M-protein by ≥90% or to <200 mg per 24 h or ≥50% decrease in the difference between involved/uninvolved FLC or ≥50% reduction in plasma cells, provided baseline bone marrow plasma cell percentage was ≥30%, ≥50% size reduction of soft tissue plasmacytomas; MR:25%-49% reduction of serum M-protein+reduction in 24h urinary M-protein by 50-89%(still >200 mg/24h),25-49% soft tissue plasmacytomas size reduction,no increase in size or number of lytic bone lesions; SD:no response or PD ORR: %of subjects with MR+PR+VGPR+CR+sCR CBR:ORR + %of subjects with SD. | ITT: The Intention-to-treat (ITT) population included all subjects who were enrolled in the study and received at least 1 dose of BT062 and who had any post-Baseline evaluations or data. One subject did not have at least one post-injection assessment of the treatment response and was excluded from both the ITT and PP populations (n = 34). | Posted | Count of Participants | Participants | On day 1 of each treatment cycle (on a monthly basis) starting with first study drug administration until Close Out visit (average 3.84 months). |
|
|
|
| Secondary | Time to Progression (TTP), Progression Free Survival (PFS) and Overall Survival (OS) | Progressive disease Requires any one or more of the following: Increase of ≥ 25% from baseline in
Only in patients without measurable serum and urine M-protein levels: the difference between involved and uninvolved FLC levels. The absolute increase must be > 10 mg/dL. Bone marrow plasma cell percentage: the absolute % must be ≥ 10% (relapse form CR as a 5% cutoff instead of 10%). Definite development of new bone lesions or soft tissue plasmacytomas or definite increase in the size of existing bone lesions or soft tissue plasmacytomas. Development of hypercalcemia (corrected serum calcium > 11.5 mg/dL or 2.65 mmol/l) that can be attributed solely to the plasma cell proliferative disorder. | The Intention-to-treat (ITT) population included all subjects who were enrolled in the study and received at least 1 dose of BT062 and who had any post-Baseline evaluations or data (n = 34). | Posted | Median | 95% Confidence Interval | months | Starting with first study drug administration until death or 3 years from first study treatment. |
|
|
|
| 0 |
| 4 |
| 2 |
| 4 |
| 3 |
| 4 |
| EG001 | BT062 50 mg/m² | 50 mg/m² BT062 was administered by IV infusion on Days 1, 8, and 15 of every 28-day cycle. | 0 | 3 | 0 | 3 | 3 | 3 |
| EG002 | BT062 65 mg/m² | 65 mg/m² BT062 was administered by IV infusion on Days 1, 8, and 15 of every 28-day cycle. | 0 | 4 | 0 | 4 | 3 | 4 |
| EG003 | BT062 80 mg/m² | 80 mg/m² BT062 was administered by IV infusion on Days 1, 8, and 15 of every 28-day cycle. | 0 | 3 | 2 | 3 | 2 | 3 |
| EG004 | BT062 100 mg/m² | 100 mg/m² BT062 was administered by IV infusion on Days 1, 8, and 15 of every 28-day cycle. | 1 | 4 | 2 | 4 | 3 | 4 |
| EG005 | BT062 120 mg/m² | 120 mg/m² BT062 was administered by IV infusion on Days 1, 8, and 15 of every 28-day cycle. | 1 | 3 | 1 | 3 | 3 | 3 |
| EG006 | BT062 140 mg/m² | 140 mg/m² BT062 was administered by IV infusion on Days 1, 8, and 15 of every 28-day cycle. | 1 | 10 | 5 | 10 | 8 | 10 |
| EG007 | BT062 160 mg/m² | 160 mg/m² BT062 was administered by IV infusion on Days 1, 8, and 15 of every 28-day cycle. | 1 | 4 | 2 | 4 | 3 | 4 |
| EG008 | Total | BT062 administration (all dose levels) | 4 | 35 | 14 | 35 | 28 | 35 |
| ATRIAL FIBRILLATION | Cardiac disorders | MedDRA (17.1) | Systematic Assessment |
|
| EXTRAOCULAR MUSCLE PARESIS | Eye disorders | MedDRA (17.1) | Systematic Assessment |
|
| PYREXIA | General disorders | MedDRA (17.1) | Systematic Assessment |
|
| PNEUMONIA | Infections and infestations | MedDRA (17.1) | Systematic Assessment |
|
| HEAD INJURY | Injury, poisoning and procedural complications | MedDRA (17.1) | Systematic Assessment |
|
| HIP FRACTURE | Injury, poisoning and procedural complications | MedDRA (17.1) | Systematic Assessment |
|
| PELVIC FRACTURE | Injury, poisoning and procedural complications | MedDRA (17.1) | Systematic Assessment |
|
| TRANSAMINASES INCREASED | Investigations | MedDRA (17.1) | Systematic Assessment |
|
| BONE PAIN | Musculoskeletal and connective tissue disorders | MedDRA (17.1) | Systematic Assessment |
|
| BRAIN MASS | Nervous system disorders | MedDRA (17.1) | Systematic Assessment |
|
| HAEMORRHAGE INTRACRANIAL | Nervous system disorders | MedDRA (17.1) | Systematic Assessment |
|
| RENAL FAILURE ACUTE | Renal and urinary disorders | MedDRA (17.1) | Systematic Assessment |
|
| ALVEOLITIS ALLERGIC | Respiratory, thoracic and mediastinal disorders | MedDRA (17.1) | Systematic Assessment |
|
| PULMONARY EMBOLISM | Respiratory, thoracic and mediastinal disorders | MedDRA (17.1) | Systematic Assessment |
|
| PALMAR-PLANTAR / ERYTHRODYSAESTHESIA SYNDROME | Skin and subcutaneous tissue disorders | MedDRA (17.1) | Systematic Assessment |
|
| STEVENS-JOHNSON SYNDROME | Skin and subcutaneous tissue disorders | MedDRA (17.1) | Systematic Assessment |
|
| DEEP VEIN THROMBOSIS | Vascular disorders | MedDRA (17.1) | Systematic Assessment |
|
| LEUKOPENIA | Blood and lymphatic system disorders | MedDRA (17.1) | Systematic Assessment |
|
| LYMPHOPENIA | Blood and lymphatic system disorders | MedDRA (17.1) | Systematic Assessment |
|
| NEUTROPENIA | Blood and lymphatic system disorders | MedDRA (17.1) | Systematic Assessment |
|
| THROMBOCYTOPENIA | Blood and lymphatic system disorders | MedDRA (17.1) | Systematic Assessment |
|
| ABDOMINAL DISTENSION | Gastrointestinal disorders | MedDRA (17.1) | Systematic Assessment |
|
| ABDOMINAL PAIN | Gastrointestinal disorders | MedDRA (17.1) | Systematic Assessment |
|
| CONSTIPATION | Gastrointestinal disorders | MedDRA (17.1) | Systematic Assessment |
|
| DIARRHOEA | Gastrointestinal disorders | MedDRA (17.1) | Systematic Assessment |
|
| DYSPEPSIA | Gastrointestinal disorders | MedDRA (17.1) | Systematic Assessment |
|
| HAEMATOCHEZIA | Gastrointestinal disorders | MedDRA (17.1) | Systematic Assessment |
|
| NAUSEA | Gastrointestinal disorders | MedDRA (17.1) | Systematic Assessment |
|
| FATIGUE | General disorders | MedDRA (17.1) | Systematic Assessment |
|
| INFLUENZA LIKE ILLNESS | General disorders | MedDRA (17.1) | Systematic Assessment |
|
| INFUSION SITE ERYTHEMA | General disorders | MedDRA (17.1) | Systematic Assessment |
|
| NON-CARDIAC CHEST PAIN | General disorders | MedDRA (17.1) | Systematic Assessment |
|
| OEDEMA PERIPHERAL | General disorders | MedDRA (17.1) | Systematic Assessment |
|
| PYREXIA | General disorders | MedDRA (17.1) | Systematic Assessment |
|
| PNEUMONIA | Infections and infestations | MedDRA (17.1) | Systematic Assessment |
|
| UPPER RESPIRATORY TRACT INFECTION | Infections and infestations | MedDRA (17.1) | Systematic Assessment |
|
| FALL | Injury, poisoning and procedural complications | MedDRA (17.1) | Systematic Assessment |
|
| INFUSION RELATED | Injury, poisoning and procedural complications | MedDRA (17.1) | Systematic Assessment |
|
| SKIN ABRASION | Injury, poisoning and procedural complications | MedDRA (17.1) | Systematic Assessment |
|
| ALANINE AMINOTRANSFERASE INCREASED | Investigations | MedDRA (17.1) | Systematic Assessment |
|
| AMYLASE INCREASED | Investigations | MedDRA (17.1) | Systematic Assessment |
|
| ASPARTATE AMINOTRANSFERASE INCREASED | Investigations | MedDRA (17.1) | Systematic Assessment |
|
| BLOOD CREATINE PHOSPHOKINASE INCREASED | Investigations | MedDRA (17.1) | Systematic Assessment |
|
| BLOOD CREATININE INCREASED | Investigations | MedDRA (17.1) | Systematic Assessment |
|
| BLOOD LACTATE DEHYDROGENASE INCREASED | Investigations | MedDRA (17.1) | Systematic Assessment |
|
| BLOOD URIC ACID INCREASED | Investigations | MedDRA (17.1) | Systematic Assessment |
|
| GAMMA-GLUTAMYLTRANSFERASE INCREASED | Investigations | MedDRA (17.1) | Systematic Assessment |
|
| LIPASE INCREASED | Investigations | MedDRA (17.1) | Systematic Assessment |
|
| LYMPHOCYTE COUNT DECREASED | Investigations | MedDRA (17.1) | Systematic Assessment |
|
| NEUTROPHIL COUNT DECREASED | Investigations | MedDRA (17.1) | Systematic Assessment |
|
| OCCULT BLOOD POSITIVE | Investigations | MedDRA (17.1) | Systematic Assessment |
|
| DECREASED APPETITE | Metabolism and nutrition disorders | MedDRA (17.1) | Systematic Assessment |
|
| HYPERCALCAEMIA | Metabolism and nutrition disorders | MedDRA (17.1) | Systematic Assessment |
|
| HYPERGLYCAEMIA | Metabolism and nutrition disorders | MedDRA (17.1) | Systematic Assessment |
|
| HYPERKALAEMIA | Metabolism and nutrition disorders | MedDRA (17.1) | Systematic Assessment |
|
| HYPOKALAEMIA | Metabolism and nutrition disorders | MedDRA (17.1) | Systematic Assessment |
|
| HYPONATRAEMIA | Metabolism and nutrition disorders | MedDRA (17.1) | Systematic Assessment |
|
| ARTHRALGIA | Musculoskeletal and connective tissue disorders | MedDRA (17.1) | Systematic Assessment |
|
| BACK PAIN | Musculoskeletal and connective tissue disorders | MedDRA (17.1) | Systematic Assessment |
|
| BONE PAIN | Musculoskeletal and connective tissue disorders | MedDRA (17.1) | Systematic Assessment |
|
| FLANK PAIN | Musculoskeletal and connective tissue disorders | MedDRA (17.1) | Systematic Assessment |
|
| MUSCULOSKELETAL CHEST PAIN | Musculoskeletal and connective tissue disorders | MedDRA (17.1) | Systematic Assessment |
|
| MUSCULOSKELETAL PAIN | Musculoskeletal and connective tissue disorders | MedDRA (17.1) | Systematic Assessment |
|
| MYALGIA | Musculoskeletal and connective tissue disorders | MedDRA (17.1) | Systematic Assessment |
|
| PAIN IN EXTREMITY | Musculoskeletal and connective tissue disorders | MedDRA (17.1) | Systematic Assessment |
|
| HYPOAESTHESIA | Nervous system disorders | MedDRA (17.1) | Systematic Assessment |
|
| NEURALGIA | Nervous system disorders | MedDRA (17.1) | Systematic Assessment |
|
| NEUROPATHY PERIPHERAL | Nervous system disorders | MedDRA (17.1) | Systematic Assessment |
|
| ANXIETY | Psychiatric disorders | MedDRA (17.1) | Systematic Assessment |
|
| INSOMNIA | Psychiatric disorders | MedDRA (17.1) | Systematic Assessment |
|
| DYSURIA | Renal and urinary disorders | MedDRA (17.1) | Systematic Assessment |
|
| COUGH | Respiratory, thoracic and mediastinal disorders | MedDRA (17.1) | Systematic Assessment |
|
| DYSPNOEA | Respiratory, thoracic and mediastinal disorders | MedDRA (17.1) | Systematic Assessment |
|
| DYSPNOEA EXERTIONAL | Respiratory, thoracic and mediastinal disorders | MedDRA (17.1) | Systematic Assessment |
|
| PRODUCTIVE COUGH | Respiratory, thoracic and mediastinal disorders | MedDRA (17.1) | Systematic Assessment |
|
| UPPER-AIRWAY COUGH SYNDROME | Respiratory, thoracic and mediastinal disorders | MedDRA (17.1) | Systematic Assessment |
|
| BLISTER | Skin and subcutaneous tissue disorders | MedDRA (17.1) | Systematic Assessment |
|
| DRY SKIN | Skin and subcutaneous tissue disorders | MedDRA (17.1) | Systematic Assessment |
|
| ERYTHEMA | Skin and subcutaneous tissue disorders | MedDRA (17.1) | Systematic Assessment |
|
| PRURITUS | Skin and subcutaneous tissue disorders | MedDRA (17.1) | Systematic Assessment |
|
| RASH | Skin and subcutaneous tissue disorders | MedDRA (17.1) | Systematic Assessment |
|
| RASH ERYTHEMATOUS | Skin and subcutaneous tissue disorders | MedDRA (17.1) | Systematic Assessment |
|
| HOT FLUSH | Vascular disorders | MedDRA (17.1) | Systematic Assessment |
|
Part of CTA:The Investigator or any Site employee, consultant or admitting physician to the Site or Study Team member is not allowed to make any publication of any Study Data, information, results, or similar information without the review and comment of SPONSOR. As the Study is part of a multi-center trial, and the Investigator/site agree that no publication by Site/Investigator of the results of the Study conducted at the Site shall be made before the first multi-centre 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 |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| At least one treatment related SAE |
|
|
| BT062 plasma concentration Cycle 4 - Cmax |
|
|
| no |
|
| Clinical Benefit rate |
|
| Title | Measurements |
|---|---|
|