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The purpose of this study is to determine the antitumor efficacy and safety of bendamustine (SyB L-0501: 90 mg/m^2/day) for a maximum of 6 cycles (1 cycle: intravenous administration for 2 consecutive days and 26-day observation period) in patients with relapsed/refractory multiple myeloma.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SyB L-0501 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SyB L-0501 | Drug | The administration of SyB L-0501 at 90 mg/m^2/day by 60-minute intravenous infusion for 2 consecutive days followed by 26 days of monitoring. This is considered to be one cycle and may be repeated up to 6 times. Dose reduction or discontinuation is permitted from the second cycle as necessary according to adverse events and the results of monitoring during the previous cycle. |
| Measure | Description | Time Frame |
|---|---|---|
| Response Rate [Stringent CR (sCR)+Complete Response (CR)+Very Good PR (VGPR)+Partial Response (PR)]Based on International Myeloma Working Group (IMWG) Criteria | The criteria for sCR, CR, VGPR, and PR based on IMWG are shown below. sCR: Fulfills CR criteria as well as all of the following conditions
CR: Fulfills all of the following criteria
VGPR: Fulfills at least one of the following criteria
PR: Fulfills the following criteria
| up to around 44 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Response Rate (sCR+CR) Based on IMWG Criteria | up to around 44 weeks | |
| Complete Response (CR) Based on the Blade Criteria | The criteria for CR based on the Blade are shown below. CR requires all of the followings:
|
Not provided
Inclusion Criteria:
Patients who are diagnosed with multiple myeloma on the basis of the response criteria of the International Myeloma Working Group (IMWG) and confirmed to meet one or more of the following criteria:
(definition of progression according to the IMWG response criteria)
25% or more increase compared to baseline for the following values
Clear appearance of new bone lesions or soft tissue plasmacytoma or apparent growth in size of current bone lesions or soft tissue plasmacytoma
Appearance of hypercalcemia (corrected calcium level ≥ 11.5 mg/dL and if determined to be caused solely by myelomas)
Patients with measurable lesions (meets at least one of the following two criteria
Patients who meet either one of the following items for all prior chemotherapy using proteasome inhibitors, Immunomodulatory Drugs (IMiDs) (thalidomide or lenalidomide) or alkylating agents.
Patients who have undergone a washout period of more than 3 weeks after the end of the previous therapy and determined not to be under the effect of previous treatment (antitumor effectiveness).
Patients who are expected to survive for at least 3 months
Patients aged from 20 to 79 years at the time of interim registration
Performance Status (P.S.) of 0 to 125. However, P.S. 2 due to pain from lytic bone lesions is acceptable
Patients with adequately maintained organ functions (e.g., bone marrow, heart, lung, liver, and kidney functions)
Patients who have provided written consent for participation in this study
Exclusion Criteria:
Patients with apparent infections (including viral infections)
Patients with serious complications (hepatic or renal dysfunction, etc.)
Patients with complications or medical history of serious cardiac disease (e.g., myocardial infarction, ischemic heart disease) within 2 years of the date of interim registration or patients with arrhythmias that require treatment
Patients with serious gastrointestinal symptoms (e.g., severe nausea, vomiting, or diarrhea)
Patients positive for Hepatitis B surface (HBs) antigen, Hepatitis C virus (HCV) antibody, or HIV antibody
Patients with serious bleeding tendencies (e.g., disseminated intravascular coagulation: DIC)
Patients with, or confirmed in the past to have had, interstitial pneumonia, pulmonary fibrosis, or pulmonary emphysema which requires treatment.
Patients with a complication of apparent cardiac amyloidosis
Patients with infiltration to the central nervous system (CNS) or patients with clinical symptoms of suspected infiltration to the CNS,
Patients with active multiple primary cancer
Patients with, or confirmed in the past to have had, autoimmune hemolytic anemia
Patients who have received this investigational product in the past
Patients who have received allogeneic stem cell transplants in the past. (patients who have received autologous stem cell transplantation are acceptable)
Patients who received cytokine preparations such as erythropoietin or granulocyte colony stimulating factor (G-CSF) or blood transfusions within 1 week prior to the examination conducted before interim registration for this study
Patients who received other investigational products or unapproved medications within 3 months before interim registration for this study
Patients with prior allergies to medications that are similar to this investigational product (e.g., alkylating agents, or purine-nucleoside derivatives) or mannitol
Patients with drug addiction, narcotics addiction, and/or alcohol dependency
Patients who are pregnant, who may possibly be pregnant, or lactating
Patients who do not agree to practice contraception for the following periods:
Male: During investigational product administration and until 6 months after final administration Female: During investigational product administration and until 4 months after final administration
Patients otherwise judged by the investigator or sub-investigator to be unsuitable for inclusion in this study](streamdown:incomplete-link)
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chūōku | Japan | |||||
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| ID | Title | Description |
|---|---|---|
| FG000 | SyB L-0501 | SyB L-0501: The administration of SyB L-0501 at 90 mg/m^2/day by 60-minute intravenous infusion for 2 consecutive days followed by 26 days of monitoring. This is considered to be one cycle and may be repeated up to 6 times. Dose reduction or discontinuation is permitted from the second cycle as necessary according to adverse events and the results of monitoring during the previous cycle. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | SyB L-0501 | SyB L-0501: The administration of SyB L-0501 at 90 mg/m^2/day by 60-minute intravenous infusion for 2 consecutive days followed by 26 days of monitoring. This is considered to be one cycle and may be repeated up to 6 times. Dose reduction or discontinuation is permitted from the second cycle as necessary according to adverse events and the results of monitoring during the previous cycle. |
| 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 | Response Rate [Stringent CR (sCR)+Complete Response (CR)+Very Good PR (VGPR)+Partial Response (PR)]Based on International Myeloma Working Group (IMWG) Criteria | The criteria for sCR, CR, VGPR, and PR based on IMWG are shown below. sCR: Fulfills CR criteria as well as all of the following conditions
CR: Fulfills all of the following criteria
VGPR: Fulfills at least one of the following criteria
PR: Fulfills the following criteria
| Posted | Number | 95% Confidence Interval | percentage of paticipants | up to around 44 weeks |
|
up to around 44 weeks
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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 | SyB L-0501 | SyB L-0501: The administration of SyB L-0501 at 90 mg/m^2/day by 60-minute intravenous infusion for 2 consecutive days followed by 26 days of monitoring. This is considered to be one cycle and may be repeated up to 6 times. Dose reduction or discontinuation is permitted from the second cycle as necessary according to adverse events and the results of monitoring during the previous cycle. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Plasma cell myeloma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Ver 16.0 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA Ver 16.0 |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Toshihiko Nagase | SymBio Pharmaceuticals | +81-3-5472-1127 |
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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|
| up to around 44 weeks |
| Response Rate (CR+PR) Based on the Blade Criteria | The criteria for PR based on the Blade are shown below. PR requires 1. or all of the others:
| up to around 44 weeks |
| Progression-Free Survival (PFS) | Using the registration date as the start date, PFS with relapse/recurrence or progression, and death regardless of the cause as events are to be summarized using the Kaplan-Meier estimator and the 50% point according to the Greenwood's formula and the 95% confidence interval are to be calculated. | up to around 44 weeks |
| Time to Treatment Failure (TTF) | Using the registration date as the start date, TTF with relapse/recurrence or progression, death regardless of the cause, and early discontinuation of treatment as events are to be summarized using the Kaplan-Meier estimator and the 50% point according to the Greenwood's formula and 95% confidence interval are to be calculated. | up to around 44 weeks |
| Duration of Response (DOR) | From initial response (PR or higher), DOR with relapse/recurrence or progression, and death, regardless of cause, as events, are to be summarized using the Kaplan-Meier estimator and the 50% point according to the Greenwood's formula and 95% confidence interval are to be calculated. | up to around 44 weeks |
| Overall Survival (OS) | Using the registration date as the start date, OS with death, regardless of the cause, as events, are to be summarized using the Kaplan-Meier estimator and the 50% point according to the Greenwood's formula and 95% confidence interval are to be calculated. | up to around 44 weeks |
| Adverse Events | All adverse events occurring during the administration of the investigational product are to be examined for safety by cross tabulation lists and tables of incidence from the viewpoint of relationship with the drug, disease severity and medicine treated group. | up to around 44 weeks |
| Number of Subjects With Abnormality (Grade ≥3) in Laboratory Test Values | Abnormalities in laboratory test values in overall study period were analyzed. Severity of abnormalities were evaluated using Common Terminology Criteria for Adverse Events (CTCAE). grade 1 : mild, grade 2 : moderate, grade 3 : severe or medically significant but not immediately life-threatening grade, 4 : life threatening or disabling grade, 5 : death related to adverse event | up to around 44 weeks |
| Number of Abnormalities (Grade ≥3) in Laboratory Test Values | Abnormalities in laboratory test values in overall study period were analyzed. Severity of abnormalities were evaluated using Common Terminology Criteria for Adverse Events (CTCAE). grade 1 : mild, grade 2 : moderate, grade 3 : severe or medically significant but not immediately life-threatening grade, 4 : life threatening or disabling grade, 5 : death related to adverse event | up to around 44 weeks |
| Fukuoka |
| Japan |
| Isehara | Japan |
| Kōtoku | Japan |
| Kyoto | Japan |
| Nagoya | Japan |
| Niigata | Japan |
| Okayama | Japan |
| Sapporo | Japan |
| Sendai | Japan |
| Shibukawa | Japan |
| Shibuya-ku | Japan |
| Tokushima | Japan |
| Utsunomiya | Japan |
| Years |
|
| Age, Customized | Number | participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Subtype of myeloma | One participant could carry multiple subtypes of myeloma. | Number | participants |
|
| Prior therapy | Number | participants |
|
| Performance status | The criteria of Eastern Cooperative Oncology Group (ECOG) performance status are shown below. 0: Fully active, able to carry on all pre-disease performance without restriction , 1: Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, e.g., light house work, office work , 2: Ambulatory and capable of all selfcare but unable to carry out any work activities. Up and about more than 50% of waking hours | Number | participants |
|
| Clinical disease stage (International Staging System) | The criteria of clinical disease stage (International Staging System) are shown below. stage I: Serum β2-microglobulin < 3.5 mg/L plus serum albumin ≥ 3.5 g/dL, stage II: neither stage I nor III , stage III: Serum β2-microglobulin ≥ 5.5 mg/L | Number | participants |
|
| Medical history | Number | participants |
|
| Accompanying symptoms of the primary disease | Number | participants |
|
| Complication | A complication is a disease or condition that arises as a result of multiple myeloma. | Number | participants |
|
| Serum β2 microglobulin | Mean | Standard Deviation | mg/L |
|
| Height | Mean | Standard Deviation | cm |
|
| Body weight | Mean | Standard Deviation | kg |
|
| Body surface area | Mean | Standard Deviation | m^2 |
|
| OG000 |
| SyB L-0501 |
SyB L-0501: The administration of SyB L-0501 at 90 mg/m^2/day by 60-minute intravenous infusion for 2 consecutive days followed by 26 days of monitoring. This is considered to be one cycle and may be repeated up to 6 times. Dose reduction or discontinuation is permitted from the second cycle as necessary according to adverse events and the results of monitoring during the previous cycle. |
|
|
| Secondary | Response Rate (sCR+CR) Based on IMWG Criteria | Posted | Number | 95% Confidence Interval | percentage of paticipants | up to around 44 weeks |
|
|
|
| Secondary | Complete Response (CR) Based on the Blade Criteria | The criteria for CR based on the Blade are shown below. CR requires all of the followings:
| Posted | Number | 95% Confidence Interval | percentage of paticipants | up to around 44 weeks |
|
|
|
| Secondary | Response Rate (CR+PR) Based on the Blade Criteria | The criteria for PR based on the Blade are shown below. PR requires 1. or all of the others:
| Posted | Number | 95% Confidence Interval | percentage of paticipants | up to around 44 weeks |
|
|
|
| Secondary | Progression-Free Survival (PFS) | Using the registration date as the start date, PFS with relapse/recurrence or progression, and death regardless of the cause as events are to be summarized using the Kaplan-Meier estimator and the 50% point according to the Greenwood's formula and the 95% confidence interval are to be calculated. | Posted | Median | 95% Confidence Interval | Days | up to around 44 weeks |
|
|
|
| Secondary | Time to Treatment Failure (TTF) | Using the registration date as the start date, TTF with relapse/recurrence or progression, death regardless of the cause, and early discontinuation of treatment as events are to be summarized using the Kaplan-Meier estimator and the 50% point according to the Greenwood's formula and 95% confidence interval are to be calculated. | Posted | Median | 95% Confidence Interval | Days | up to around 44 weeks |
|
|
|
| Secondary | Duration of Response (DOR) | From initial response (PR or higher), DOR with relapse/recurrence or progression, and death, regardless of cause, as events, are to be summarized using the Kaplan-Meier estimator and the 50% point according to the Greenwood's formula and 95% confidence interval are to be calculated. | Posted | Median | 95% Confidence Interval | Days | up to around 44 weeks |
|
|
|
| Secondary | Overall Survival (OS) | Using the registration date as the start date, OS with death, regardless of the cause, as events, are to be summarized using the Kaplan-Meier estimator and the 50% point according to the Greenwood's formula and 95% confidence interval are to be calculated. | Posted | Median | 95% Confidence Interval | Days | up to around 44 weeks |
|
|
|
| Secondary | Adverse Events | All adverse events occurring during the administration of the investigational product are to be examined for safety by cross tabulation lists and tables of incidence from the viewpoint of relationship with the drug, disease severity and medicine treated group. | Posted | Number | participants | up to around 44 weeks |
|
|
|
| Secondary | Number of Subjects With Abnormality (Grade ≥3) in Laboratory Test Values | Abnormalities in laboratory test values in overall study period were analyzed. Severity of abnormalities were evaluated using Common Terminology Criteria for Adverse Events (CTCAE). grade 1 : mild, grade 2 : moderate, grade 3 : severe or medically significant but not immediately life-threatening grade, 4 : life threatening or disabling grade, 5 : death related to adverse event | Posted | Number | participants | up to around 44 weeks |
|
|
|
| Secondary | Number of Abnormalities (Grade ≥3) in Laboratory Test Values | Abnormalities in laboratory test values in overall study period were analyzed. Severity of abnormalities were evaluated using Common Terminology Criteria for Adverse Events (CTCAE). grade 1 : mild, grade 2 : moderate, grade 3 : severe or medically significant but not immediately life-threatening grade, 4 : life threatening or disabling grade, 5 : death related to adverse event | Posted | Number | Events | up to around 44 weeks |
|
|
|
| 4 |
| 17 |
| 17 |
| 17 |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA Ver 16.0 |
|
| Pneumonia | Infections and infestations | MedDRA Ver 16.0 |
|
| Constipation | Gastrointestinal disorders | MedDRA Ver 16.0 |
|
| Conjunctivitis | Eye disorders | MedDRA Ver 16.0 |
|
| Dry eye | Eye disorders | MedDRA Ver 16.0 |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA Ver 16.0 |
|
| Constipation | Gastrointestinal disorders | MedDRA Ver 16.0 |
|
| Dental caries | Gastrointestinal disorders | MedDRA Ver 16.0 |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA Ver 16.0 |
|
| Haemorrhoids | Gastrointestinal disorders | MedDRA Ver 16.0 |
|
| Nausea | Gastrointestinal disorders | MedDRA Ver 16.0 |
|
| Proctalgia | Gastrointestinal disorders | MedDRA Ver 16.0 |
|
| Stomatitis | Gastrointestinal disorders | MedDRA Ver 16.0 |
|
| Vomiting | Gastrointestinal disorders | MedDRA Ver 16.0 |
|
| Dyschezia | Gastrointestinal disorders | MedDRA Ver 16.0 |
|
| Asthenia | General disorders | MedDRA Ver 16.0 |
|
| Chest pain | General disorders | MedDRA Ver 16.0 |
|
| Gait disturbance | General disorders | MedDRA Ver 16.0 |
|
| Generalised oedema | General disorders | MedDRA Ver 16.0 |
|
| Injection site reaction | General disorders | MedDRA Ver 16.0 |
|
| Malaise | General disorders | MedDRA Ver 16.0 |
|
| Oedema peripheral | General disorders | MedDRA Ver 16.0 |
|
| Pyrexia | General disorders | MedDRA Ver 16.0 |
|
| Injection site vasculitis | General disorders | MedDRA Ver 16.0 |
|
| Hepatic function abnormal | Hepatobiliary disorders | MedDRA Ver 16.0 |
|
| Bronchopneumonia | Infections and infestations | MedDRA Ver 16.0 |
|
| Nasopharyngitis | Infections and infestations | MedDRA Ver 16.0 |
|
| Periodontitis | Infections and infestations | MedDRA Ver 16.0 |
|
| Pharyngitis | Infections and infestations | MedDRA Ver 16.0 |
|
| Pneumonia | Infections and infestations | MedDRA Ver 16.0 |
|
| Fall | Injury, poisoning and procedural complications | MedDRA Ver 16.0 |
|
| Fracture | Injury, poisoning and procedural complications | MedDRA Ver 16.0 |
|
| Spinal compression fracture | Injury, poisoning and procedural complications | MedDRA Ver 16.0 |
|
| Alanine aminotransferase increased | Investigations | MedDRA Ver 16.0 |
|
| Aspartate aminotransferase increased | Investigations | MedDRA Ver 16.0 |
|
| Blood albumin decreased | Investigations | MedDRA Ver 16.0 |
|
| Blood calcium increased | Investigations | MedDRA Ver 16.0 |
|
| Blood chloride decreased | Investigations | MedDRA Ver 16.0 |
|
| Blood creatinine increased | Investigations | MedDRA Ver 16.0 |
|
| Blood lactate dehydrogenase increased | Investigations | MedDRA Ver 16.0 |
|
| Blood potassium decreased | Investigations | MedDRA Ver 16.0 |
|
| Blood pressure decreased | Investigations | MedDRA Ver 16.0 |
|
| Blood sodium decreased | Investigations | MedDRA Ver 16.0 |
|
| Blood urea increased | Investigations | MedDRA Ver 16.0 |
|
| Blood uric acid decreased | Investigations | MedDRA Ver 16.0 |
|
| Blood uric acid increased | Investigations | MedDRA Ver 16.0 |
|
| C-reactive protein increased | Investigations | MedDRA Ver 16.0 |
|
| CD4 lymphocytes decreased | Investigations | MedDRA Ver 16.0 |
|
| Electrocardiogram QT prolonged | Investigations | MedDRA Ver 16.0 |
|
| Gamma-glutamyltransferase increased | Investigations | MedDRA Ver 16.0 |
|
| Blood urine present | Investigations | MedDRA Ver 16.0 |
|
| Haemoglobin decreased | Investigations | MedDRA Ver 16.0 |
|
| Lymphocyte count decreased | Investigations | MedDRA Ver 16.0 |
|
| Neutrophil count decreased | Investigations | MedDRA Ver 16.0 |
|
| Neutrophil count increased | Investigations | MedDRA Ver 16.0 |
|
| Platelet count decreased | Investigations | MedDRA Ver 16.0 |
|
| Protein total decreased | Investigations | MedDRA Ver 16.0 |
|
| Protein total increased | Investigations | MedDRA Ver 16.0 |
|
| Red blood cell count decreased | Investigations | MedDRA Ver 16.0 |
|
| Weight decreased | Investigations | MedDRA Ver 16.0 |
|
| Weight increased | Investigations | MedDRA Ver 16.0 |
|
| White blood cell count decreased | Investigations | MedDRA Ver 16.0 |
|
| White blood cell count increased | Investigations | MedDRA Ver 16.0 |
|
| Protein urine present | Investigations | MedDRA Ver 16.0 |
|
| Blood alkaline phosphatase increased | Investigations | MedDRA Ver 16.0 |
|
| Urine output decreased | Investigations | MedDRA Ver 16.0 |
|
| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA Ver 16.0 |
|
| Hyperuricaemia | Metabolism and nutrition disorders | MedDRA Ver 16.0 |
|
| Hypoalbuminaemia | Metabolism and nutrition disorders | MedDRA Ver 16.0 |
|
| Hypochloraemia | Metabolism and nutrition disorders | MedDRA Ver 16.0 |
|
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA Ver 16.0 |
|
| Hypophosphataemia | Metabolism and nutrition disorders | MedDRA Ver 16.0 |
|
| Decreased appetite | Metabolism and nutrition disorders | MedDRA Ver 16.0 |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA Ver 16.0 |
|
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA Ver 16.0 |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA Ver 16.0 |
|
| Bone pain | Musculoskeletal and connective tissue disorders | MedDRA Ver 16.0 |
|
| Muscle haemorrhage | Musculoskeletal and connective tissue disorders | MedDRA Ver 16.0 |
|
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA Ver 16.0 |
|
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA Ver 16.0 |
|
| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA Ver 16.0 |
|
| Dysgeusia | Nervous system disorders | MedDRA Ver 16.0 |
|
| Headache | Nervous system disorders | MedDRA Ver 16.0 |
|
| Neuropathy peripheral | Nervous system disorders | MedDRA Ver 16.0 |
|
| Somnolence | Nervous system disorders | MedDRA Ver 16.0 |
|
| Delirium | Psychiatric disorders | MedDRA Ver 16.0 |
|
| Insomnia | Psychiatric disorders | MedDRA Ver 16.0 |
|
| Renal failure | Renal and urinary disorders | MedDRA Ver 16.0 |
|
| Renal impairment | Renal and urinary disorders | MedDRA Ver 16.0 |
|
| Hiccups | Respiratory, thoracic and mediastinal disorders | MedDRA Ver 16.0 |
|
| Hypoxia | Respiratory, thoracic and mediastinal disorders | MedDRA Ver 16.0 |
|
| Upper respiratory tract inflammation | Respiratory, thoracic and mediastinal disorders | MedDRA Ver 16.0 |
|
| Pharyngeal erythema | Respiratory, thoracic and mediastinal disorders | MedDRA Ver 16.0 |
|
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA Ver 16.0 |
|
| Decubitus ulcer | Skin and subcutaneous tissue disorders | MedDRA Ver 16.0 |
|
| Dermatitis contact | Skin and subcutaneous tissue disorders | MedDRA Ver 16.0 |
|
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA Ver 16.0 |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA Ver 16.0 |
|
| Tooth extraction | Surgical and medical procedures | MedDRA Ver 16.0 |
|
| Hypertension | Vascular disorders | MedDRA Ver 16.0 |
|
| Dysuria | Renal and urinary disorders | MedDRA Ver 16.0 |
|
Not provided
Not provided
| 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 |
| Title | Measurements |
|---|---|
|
| Death |
|
| Discontinuation due to adverse events |
|
| Title | Measurements |
|---|---|
|
| Investigations - Other, potassium decreased |
|
| Investigations - Other, calcium increased |
|
| Investigations - Other, Haemoglobin decreased |
|
| Lymphocyte count decreased |
|
| Neutrophil count decreased |
|
| Platelet count decreased |
|
| Weight increased |
|
| White blood cell decreased |
|
| Title | Measurements |
|---|---|
|
| Investigations - Other, potassium decreased |
|
| Investigations - Other, calcium increased |
|
| Investigations - Other, Haemoglobin decreased |
|
| Lymphocyte count decreased |
|
| Neutrophil count decreased |
|
| Platelet count decreased |
|
| Weight increased |
|
| White blood cell decreased |
|