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The purpose of this study is to determine the efficacy of SyB L-0501 in combination with rituximab in patients with relapsed/refractory diffuse large B-cell lymphoma.
Primary Objective is to determine the efficacy, as measured by overall response rate on the basis of Revised Response Criteria for Malignant Lymphoma, of SyB L-0501 at 120 mg/m^2/day on day2 and 3 in combination with rituximab at 375 mg/m^2 on day 1 of each 21-day cycle in patients with relapsed/refractory diffuse large B-cell lymphoma.
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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 120 mg/m^2/day by intravenous infusion on day 2 and 3 of each 21-day cycle with up to 6 cycles. Dose modifications are permitted from 2nd cycle according to dose reduction schedule. SyB L-0501 60 mg/m^2, 90 mg/m^2 or 120 mg/m^2/day on Day 2 and Day 3 will be followed by 18 days of observation. |
| Measure | Description | Time Frame |
|---|---|---|
| The Overall Response Rate [Complete Response (CR) + Partial Response (PR)] Determined on the Basis of Revised Response Criteria for Malignant Lymphoma | CR: Disappearance of all evidence of disease. PR: Regression of measurable disease and no new sites. For the criteria for CR, See Outcome measure 2 description. The criteria for PR is as below. Nodal Masses: more than 50% decrease in sum of the product of the perpendicular diameters (SPD) of up to 6 largest dominant masses; no increase in size of other nodes
Spleen, Liver: more than 50% decrease in SPD of nodules (for single nodule in greatest transverse diameter); no increase in size of liver or spleen Bone Marrow: Irrelevant if positive prior to therapy; cell type should be specified | up to 30 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| The Complete Response (CR) Rate Determined on the Basis of Revised Response Criteria for Malignant Lymphoma | The criteria for CR is as below Nodal Masses:
Spleen, Liver: Not palpable, nodules disappeared Bone Marrow: Infiltrate cleared on repeat biopsy; if indeterminate by morphology, immunohistochemistry should be negative |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kensei Tobinai, MD, Ph D | National Cancer Center Hospital | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nagoya | Aichi-ken | Japan | ||||
Among the 63 subjects enrolled in the study, 59 subjects received study drug and four subjects were excluded before the first study drug administration. The reasons for exclusion were adverse events and major protocol deviation/violation for two subjects each.
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| ID | Title | Description |
|---|---|---|
| FG000 | SyB L-0501 | SyB L-0501 was administered in combination with rituximab. SyB L-0501 was administered at 120 mg/m^2/day by intravenous infusion on day 2 and 3 of each 21-day cycle with up to 6 cycles. Dose modifications are permitted from 2nd cycle according to dose reduction schedule. Rituximab was administered at 375 mg/m^2/day by intravenous infusion on day 1 of each 21-day cycle with up to 6 cycles. Dose modifications are not permitted. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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|
|
| Rituximab | Drug | The administration of rituximab at 375 mg/m^2/day by intravenous infusion on day 1 of each 21-day cycle with up to 6 cycles. Dose modifications are not permitted. |
|
| up to 30 weeks |
| Progression Free Survival (PFS) | PFS = day of the first PFS event - day of start of study treatment + 1 The definitions of PFS event are as below.
| up to 30 weeks |
| Number of Subjects With Adverse Event | up to 30 weeks |
| Number of Adverse Events | up to 30 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 grade 4 : life threatening or disabling grade 5 : death related to adverse event | up to 30 weeks |
| Number of Subjects With Grade ≥3 Physical Examination Finding | up to 30 weeks |
| Concomitant Medication Usage | up to 30 weeks |
| The Maximum Concentration (Cmax) of Unchanged SyB L-0501 in Japan | Prior to and 30 min after start of administration, and 0, 30, 60, 120 min after completion of administration on Day 2 of the 1st cycle |
| The Maximum Drug Concentration Time (Tmax) of Unchanged SyB L-0501 in Japan | Prior to and 30 min after start of administration, and 0, 30, 60, 120 min after completion of administration on Day 2 of the 1st cycle |
| The Area Under the Curve (AUC) for Unchanged SyB L-0501 in Japan | Prior to and 30 min after start of administration, and 0, 30, 60, 120 min after completion of administration on Day 2 of the 1st cycle |
| The Half-life Period (t1/2) of Unchanged SyB L-0501 in Japan | Prior to and 30 min after start of administration, and 0, 30, 60, 120 min after completion of administration on Day 2 of the 1st cycle |
| The Maximum Concentration (Cmax) of Unchanged SyB L-0501 in Korea | Prior to and 30 min after start of administration, and 0, 30, 60, 120 min after completion of administration on Day 2 of the 1st cycle |
| The Maximum Drug Concentration Time (Tmax) of Unchanged SyB L-0501 in Korea | Prior to and 30 min after start of administration, and 0, 30, 60, 120 min after completion of administration on Day 2 of the 1st cycle |
| The Area Under the Curve (AUC) for Unchanged SyB L-0501 in Korea | Prior to and 30 min after start of administration, and 0, 30, 60, 120 min after completion of administration on Day 2 of the 1st cycle |
| The Half-life Period (t1/2) of Unchanged SyB L-0501 in Korea | Prior to and 30 min after start of administration, and 0, 30, 60, 120 min after completion of administration on Day 2 of the 1st cycle |
| Akita |
| Akita |
| Japan |
| Matsuyama | Ehime | Japan |
| Fukuoka | Fukuoka | Japan |
| Kurume | Fukuoka | Japan |
| Maebashi | Gunma | Japan |
| Sapporo | Hokkaido | Japan |
| Kanazawa | Ishikawa-ken | Japan |
| Kagoshima | Kagoshima-ken | Japan |
| Isehara | Kanagawa | Japan |
| Ninomaru | Kumamoto | Japan |
| Kyoto | Kyoto | Japan |
| Sendai | Miyagi | Japan |
| Kita-ku | Okayama-ken | Japan |
| Kurashiki | Okayama-ken | Japan |
| Hidaka | Saitama | Japan |
| Izumo | Shimane | Japan |
| Chuo-ku | Tokyo | Japan |
| Seo-gu | Busan | South Korea |
| Jung-gu | Daegu | South Korea |
| Goyang-si | Gyeonggi-do | South Korea |
| Hwasun-gun | Jeollanam-do | South Korea |
| Gangnam-gu | Seoul | South Korea |
| Seodaemun-gu | Seoul | South Korea |
| Songpa-gu | Seoul | South Korea |
| COMPLETED |
|
| NOT COMPLETED |
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | SyB L-0501 | SyB L-0501 was administered in combination with rituximab. SyB L-0501 was administered at 120 mg/m^2/day by intravenous infusion on day 2 and 3 of each 21-day cycle with up to 6 cycles. Dose modifications are permitted from 2nd cycle according to dose reduction schedule. Rituximab was administered at 375 mg/m^2/day by intravenous infusion on day 1 of each 21-day cycle with up to 6 cycles. Dose modifications are not permitted. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age Continuous | Mean | Standard Deviation | Year |
| ||||||||||||||||||||||
| Age, Customized | Number | Percentage of participants |
| |||||||||||||||||||||||
| Age, Customized | Number | Percentage of participants |
| |||||||||||||||||||||||
| Sex/Gender, Customized | Number | percentage of participants |
| |||||||||||||||||||||||
| Diagnosis of Relapsed/Refractory Diffuse Large B-Cell Lymphoma | Number | percentage of participants |
| |||||||||||||||||||||||
| Clinical Stage (Ann Arbor staging) | The criteria for Clinical Stage (Ann Arbor staging) are as below: I: involvement of a single nodal region. II: involvement of 2 or more lymph node regions on the same side of the diaphragm. III: involvement of lymph node regions on both sides of the diaphragm. IV: disseminated involvement of 1 or more extra-lymphatic sites with or without associated lymph node involvement E: if accompanied by localized involvement of a extra-lymphatic organ or site. S: if accompanied by involvement of the spleen. SE: if both S and E | Number | Percentage of participants |
| ||||||||||||||||||||||
| Systemic symptoms (B symptoms) (Ann Arbor staging) | Number | Percentage of participants |
| |||||||||||||||||||||||
| Medical history of diffuse large B-cell lymphoma (DLBCL) | Number | Percentage of participants |
| |||||||||||||||||||||||
| Complications of DLBCL | Number | Percentage of participants |
| |||||||||||||||||||||||
| Prior medication/therapy for DLBCL | Number | Percentage of participants |
| |||||||||||||||||||||||
| Prior medication/therapy for DLBCL (Transplant) | Number | Percentage of participants |
| |||||||||||||||||||||||
| Prior treatment for DLBCL | Number | Percentage of participants |
| |||||||||||||||||||||||
| Number of regimens | Number | Percentage of participants |
| |||||||||||||||||||||||
| P.S.(performance status)[the Eastern Cooperative Oncology Group (ECOG) criteria] | P.S.(ECOG) criteria are as 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. 3: Capable of only limited selfcare, confined to bed or chair more than 50% of waking hours. 4: Completely disabled. Cannot carry on any self-care. Totally confined to bed or chair | Number | Percentage of Participants |
| ||||||||||||||||||||||
| Tumor diameter | Number | Percentage of Participants |
| |||||||||||||||||||||||
| Tumor diameter | Number | Percentage of Participants |
| |||||||||||||||||||||||
| lactate dehydrogenase (LDH) | The normal ranges vary among institutions. | Number | Percentage of Participants |
| ||||||||||||||||||||||
| LDH | Number | Percentage of Participants |
| |||||||||||||||||||||||
| Site of disease | Number | Percentage of Participants |
| |||||||||||||||||||||||
| Site of disease | Number | Percentage of Participants |
| |||||||||||||||||||||||
| Bone marrow involvement | Number | Percentage of Participants |
| |||||||||||||||||||||||
| Response to prior treatment | Number | Percentage of Participants |
| |||||||||||||||||||||||
| Time from prior treatment | Time from the initiation of prior treatment to the initiation of the study drug in subjects with 1 regimen of prior treatment (64.4% of all the subjects). | Number | Percentage of Participants |
| ||||||||||||||||||||||
| International Prognostic Index risk category | The criteria for International Prognostic Index risk category are as below: Low (score=0-1): 5-year survival of 73%. Low (score=2): 5-year survival of 51%. High-intermediate (score=3): 5-year survival of 43%. High (score=4-5): 5-year survival of 26% | Number | Percentage of Participants |
| ||||||||||||||||||||||
| International Prognostic Index risk category | Number | Percentage of Participants |
| |||||||||||||||||||||||
| Height | Mean | Standard Deviation | cm |
| ||||||||||||||||||||||
| Weight | Mean | Standard Deviation | kg |
| ||||||||||||||||||||||
| Body Surface Area（BSA） | Mean | Standard Deviation | m^2 |
|
| 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 | The Overall Response Rate [Complete Response (CR) + Partial Response (PR)] Determined on the Basis of Revised Response Criteria for Malignant Lymphoma | CR: Disappearance of all evidence of disease. PR: Regression of measurable disease and no new sites. For the criteria for CR, See Outcome measure 2 description. The criteria for PR is as below. Nodal Masses: more than 50% decrease in sum of the product of the perpendicular diameters (SPD) of up to 6 largest dominant masses; no increase in size of other nodes
Spleen, Liver: more than 50% decrease in SPD of nodules (for single nodule in greatest transverse diameter); no increase in size of liver or spleen Bone Marrow: Irrelevant if positive prior to therapy; cell type should be specified | Posted | Number | 95% Confidence Interval | Percentage of Participants | up to 30 weeks |
|
|
| ||||||||||||||||||||||||||
| Secondary | The Complete Response (CR) Rate Determined on the Basis of Revised Response Criteria for Malignant Lymphoma | The criteria for CR is as below Nodal Masses:
Spleen, Liver: Not palpable, nodules disappeared Bone Marrow: Infiltrate cleared on repeat biopsy; if indeterminate by morphology, immunohistochemistry should be negative | Posted | Number | 95% Confidence Interval | Percentage of participants | up to 30 weeks |
|
| |||||||||||||||||||||||||||
| Secondary | Progression Free Survival (PFS) | PFS = day of the first PFS event - day of start of study treatment + 1 The definitions of PFS event are as below.
| Posted | Median | 95% Confidence Interval | Days | up to 30 weeks |
|
| |||||||||||||||||||||||||||
| Secondary | Number of Subjects With Adverse Event | Posted | Number | Participants | up to 30 weeks |
|
| |||||||||||||||||||||||||||||
| Secondary | Number of Adverse Events | Posted | Number | Events | up to 30 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 grade 4 : life threatening or disabling grade 5 : death related to adverse event | Posted | Number | Participants | up to 30 weeks |
|
| ||||||||||||||||||||||||||||
| Secondary | Number of Subjects With Grade ≥3 Physical Examination Finding | Posted | Number | Participants | up to 30 weeks |
|
| |||||||||||||||||||||||||||||
| Secondary | Concomitant Medication Usage | Posted | Number | Participants | up to 30 weeks |
|
| |||||||||||||||||||||||||||||
| Secondary | The Maximum Concentration (Cmax) of Unchanged SyB L-0501 in Japan | Posted | Mean | Standard Deviation | ng/mL | Prior to and 30 min after start of administration, and 0, 30, 60, 120 min after completion of administration on Day 2 of the 1st cycle |
|
| ||||||||||||||||||||||||||||
| Secondary | The Maximum Drug Concentration Time (Tmax) of Unchanged SyB L-0501 in Japan | Posted | Median | Standard Deviation | hour | Prior to and 30 min after start of administration, and 0, 30, 60, 120 min after completion of administration on Day 2 of the 1st cycle |
|
| ||||||||||||||||||||||||||||
| Secondary | The Area Under the Curve (AUC) for Unchanged SyB L-0501 in Japan | Posted | Mean | Standard Deviation | ng・h/mL | Prior to and 30 min after start of administration, and 0, 30, 60, 120 min after completion of administration on Day 2 of the 1st cycle |
|
| ||||||||||||||||||||||||||||
| Secondary | The Half-life Period (t1/2) of Unchanged SyB L-0501 in Japan | Posted | Median | Standard Deviation | hour | Prior to and 30 min after start of administration, and 0, 30, 60, 120 min after completion of administration on Day 2 of the 1st cycle |
|
| ||||||||||||||||||||||||||||
| Secondary | The Maximum Concentration (Cmax) of Unchanged SyB L-0501 in Korea | Posted | Mean | Standard Deviation | ng/mL | Prior to and 30 min after start of administration, and 0, 30, 60, 120 min after completion of administration on Day 2 of the 1st cycle |
|
| ||||||||||||||||||||||||||||
| Secondary | The Maximum Drug Concentration Time (Tmax) of Unchanged SyB L-0501 in Korea | Posted | Median | Standard Deviation | hour | Prior to and 30 min after start of administration, and 0, 30, 60, 120 min after completion of administration on Day 2 of the 1st cycle |
|
| ||||||||||||||||||||||||||||
| Secondary | The Area Under the Curve (AUC) for Unchanged SyB L-0501 in Korea | Posted | Mean | Standard Deviation | ng・h/mL | Prior to and 30 min after start of administration, and 0, 30, 60, 120 min after completion of administration on Day 2 of the 1st cycle |
|
| ||||||||||||||||||||||||||||
| Secondary | The Half-life Period (t1/2) of Unchanged SyB L-0501 in Korea | Posted | Median | Standard Deviation | hour | Prior to and 30 min after start of administration, and 0, 30, 60, 120 min after completion of administration on Day 2 of the 1st cycle |
|
|
up to 30 weeks
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 | SyB L-0501 | SyB L-0501 was administered in combination with rituximab. SyB L-0501 was administered at 120 mg/m^2/day by intravenous infusion on day 2 and 3 of each 21-day cycle with up to 6 cycles. Dose modifications are permitted from 2nd cycle according to dose reduction schedule. Rituximab was administered at 375 mg/m^2/day by intravenous infusion on day 1 of each 21-day cycle with up to 6 cycles. Dose modifications are not permitted. | 14 | 59 | 59 | 59 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Neutropenia | Blood and lymphatic system disorders | MedDRA 14.1 |
| ||
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 14.1 |
| ||
| Constipation | Gastrointestinal disorders | MedDRA 14.1 |
| ||
| Diarrhoea | Gastrointestinal disorders | MedDRA 14.1 |
| ||
| Asthenia | General disorders | MedDRA 14.1 |
| ||
| Death | General disorders | MedDRA 14.1 |
| ||
| Mucosal inflammation | General disorders | MedDRA 14.1 |
| ||
| Cytomegalovirus infection | Infections and infestations | MedDRA 14.1 |
| ||
| Infection | Infections and infestations | MedDRA 14.1 |
| ||
| Pneumonia | Infections and infestations | MedDRA 14.1 |
| ||
| Pneumonia cytomegaloviral | Infections and infestations | MedDRA 14.1 |
| ||
| Gastric cancer | Infections and infestations | MedDRA 14.1 |
| ||
| Urinary retention | Renal and urinary disorders | MedDRA 14.1 |
| ||
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 14.1 |
| ||
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 14.1 |
| ||
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 14.1 |
| ||
| Shock haemorrhagic | Vascular disorders | MedDRA 14.1 |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 14.1 |
| ||
| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA 14.1 |
| ||
| Leukocytosis | Blood and lymphatic system disorders | MedDRA 14.1 |
| ||
| Leukopenia | Blood and lymphatic system disorders | MedDRA 14.1 |
| ||
| Lymphopenia | Blood and lymphatic system disorders | MedDRA 14.1 |
| ||
| Neutropenia | Blood and lymphatic system disorders | MedDRA 14.1 |
| ||
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 14.1 |
| ||
| Arrhythmia supraventricular | Cardiac disorders | MedDRA 14.1 |
| ||
| Palpitations | Cardiac disorders | MedDRA 14.1 |
| ||
| Sinus tachycardia | Cardiac disorders | MedDRA 14.1 |
| ||
| Supraventricular extrasystoles | Cardiac disorders | MedDRA 14.1 |
| ||
| Conjunctival haemorrhage | Eye disorders | MedDRA 14.1 |
| ||
| Lacrimation increased | Eye disorders | MedDRA 14.1 |
| ||
| Vision blurred | Eye disorders | MedDRA 14.1 |
| ||
| Vitreous floaters | Eye disorders | MedDRA 14.1 |
| ||
| Abdominal discomfort | Gastrointestinal disorders | MedDRA 14.1 |
| ||
| Abdominal pain | Gastrointestinal disorders | MedDRA 14.1 |
| ||
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 14.1 |
| ||
| Anal ulcer | Gastrointestinal disorders | MedDRA 14.1 |
| ||
| Cheilitis | Gastrointestinal disorders | MedDRA 14.1 |
| ||
| Constipation | Gastrointestinal disorders | MedDRA 14.1 |
| ||
| Diarrhoea | Gastrointestinal disorders | MedDRA 14.1 |
| ||
| Dysphagia | Gastrointestinal disorders | MedDRA 14.1 |
| ||
| Enterocolitis | Gastrointestinal disorders | MedDRA 14.1 |
| ||
| Glossitis | Gastrointestinal disorders | MedDRA 14.1 |
| ||
| Nausea | Gastrointestinal disorders | MedDRA 14.1 |
| ||
| Oral discomfort | Gastrointestinal disorders | MedDRA 14.1 |
| ||
| Oral pain | Gastrointestinal disorders | MedDRA 14.1 |
| ||
| Periodontitis | Gastrointestinal disorders | MedDRA 14.1 |
| ||
| Stomatitis | Gastrointestinal disorders | MedDRA 14.1 |
| ||
| Vomiting | Gastrointestinal disorders | MedDRA 14.1 |
| ||
| Epigastric discomfort | Gastrointestinal disorders | MedDRA 14.1 |
| ||
| Oral mucosa erosion | Gastrointestinal disorders | MedDRA 14.1 |
| ||
| Application site reaction | General disorders | MedDRA 14.1 |
| ||
| Asthenia | General disorders | MedDRA 14.1 |
| ||
| Chest discomfort | General disorders | MedDRA 14.1 |
| ||
| Chills | General disorders | MedDRA 14.1 |
| ||
| Face oedema | General disorders | MedDRA 14.1 |
| ||
| Fatigue | General disorders | MedDRA 14.1 |
| ||
| Feeling hot | General disorders | MedDRA 14.1 |
| ||
| Generalised oedema | General disorders | MedDRA 14.1 |
| ||
| Influenza like illness | General disorders | MedDRA 14.1 |
| ||
| Injection site erythema | General disorders | MedDRA 14.1 |
| ||
| Injection site pain | General disorders | MedDRA 14.1 |
| ||
| Injection site phlebitis | General disorders | MedDRA 14.1 |
| ||
| Injection site reaction | General disorders | MedDRA 14.1 |
| ||
| Malaise | General disorders | MedDRA 14.1 |
| ||
| Mucosal inflammation | General disorders | MedDRA 14.1 |
| ||
| Multi-organ failure | General disorders | MedDRA 14.1 |
| ||
| Oedema | General disorders | MedDRA 14.1 |
| ||
| Oedema peripheral | General disorders | MedDRA 14.1 |
| ||
| Pyrexia | General disorders | MedDRA 14.1 |
| ||
| Infusion site reaction | General disorders | MedDRA 14.1 |
| ||
| Inflammation | General disorders | MedDRA 14.1 |
| ||
| Jaundice | Hepatobiliary disorders | MedDRA 14.1 |
| ||
| Liver disorder | Hepatobiliary disorders | MedDRA 14.1 |
| ||
| Liver injury | Hepatobiliary disorders | MedDRA 14.1 |
| ||
| Hypersensitivity | Immune system disorders | MedDRA 14.1 |
| ||
| Bronchitis | Infections and infestations | MedDRA 14.1 |
| ||
| Cystitis | Infections and infestations | MedDRA 14.1 |
| ||
| Cytomegalovirus infection | Infections and infestations | MedDRA 14.1 |
| ||
| Gastrointestinal infection | Infections and infestations | MedDRA 14.1 |
| ||
| Herpes zoster | Infections and infestations | MedDRA 14.1 |
| ||
| Infection | Infections and infestations | MedDRA 14.1 |
| ||
| Nasopharyngitis | Infections and infestations | MedDRA 14.1 |
| ||
| Oral candidiasis | Infections and infestations | MedDRA 14.1 |
| ||
| Sinusitis | Infections and infestations | MedDRA 14.1 |
| ||
| Upper respiratory tract infection | Infections and infestations | MedDRA 14.1 |
| ||
| Urinary tract infection | Infections and infestations | MedDRA 14.1 |
| ||
| Enterocolitis infectious | Infections and infestations | MedDRA 14.1 |
| ||
| Oral herpes | Infections and infestations | MedDRA 14.1 |
| ||
| Fall | Injury, poisoning and procedural complications | MedDRA 14.1 |
| ||
| Tooth injury | Injury, poisoning and procedural complications | MedDRA 14.1 |
| ||
| Open wound | Injury, poisoning and procedural complications | MedDRA 14.1 |
| ||
| Alanine aminotransferase increased | Investigations | MedDRA 14.1 |
| ||
| Aspartate aminotransferase increased | Investigations | MedDRA 14.1 |
| ||
| Blood albumin decreased | Investigations | MedDRA 14.1 |
| ||
| Blood bilirubin increased | Investigations | MedDRA 14.1 |
| ||
| Blood chloride increased | Investigations | MedDRA 14.1 |
| ||
| Blood creatinine increased | Investigations | MedDRA 14.1 |
| ||
| Blood immunoglobulin A decreased | Investigations | MedDRA 14.1 |
| ||
| Blood immunoglobulin G decreased | Investigations | MedDRA 14.1 |
| ||
| Blood lactate dehydrogenase increased | Investigations | MedDRA 14.1 |
| ||
| Blood potassium increased | Investigations | MedDRA 14.1 |
| ||
| Blood urea decreased | Investigations | MedDRA 14.1 |
| ||
| Blood urea increased | Investigations | MedDRA 14.1 |
| ||
| Blood uric acid decreased | Investigations | MedDRA 14.1 |
| ||
| Blood uric acid increased | Investigations | MedDRA 14.1 |
| ||
| C-reactive protein increased | Investigations | MedDRA 14.1 |
| ||
| CD4 lymphocytes decreased | Investigations | MedDRA 14.1 |
| ||
| Eosinophil count increased | Investigations | MedDRA 14.1 |
| ||
| Gamma-glutamyltransferase increased | Investigations | MedDRA 14.1 |
| ||
| Glucose urine present | Investigations | MedDRA 14.1 |
| ||
| Glycosylated haemoglobin increased | Investigations | MedDRA 14.1 |
| ||
| Blood urine present | Investigations | MedDRA 14.1 |
| ||
| Haemoglobin decreased | Investigations | MedDRA 14.1 |
| ||
| Liver function test abnormal | Investigations | MedDRA 14.1 |
| ||
| Lymphocyte count decreased | Investigations | MedDRA 14.1 |
| ||
| Neutrophil count decreased | Investigations | MedDRA 14.1 |
| ||
| Platelet count decreased | Investigations | MedDRA 14.1 |
| ||
| Protein total decreased | Investigations | MedDRA 14.1 |
| ||
| Red blood cell count decreased | Investigations | MedDRA 14.1 |
| ||
| Weight decreased | Investigations | MedDRA 14.1 |
| ||
| Weight increased | Investigations | MedDRA 14.1 |
| ||
| White blood cell count decreased | Investigations | MedDRA 14.1 |
| ||
| White blood cell count increased | Investigations | MedDRA 14.1 |
| ||
| Blood bilirubin decreased | Investigations | MedDRA 14.1 |
| ||
| Platelet count increased | Investigations | MedDRA 14.1 |
| ||
| Basophil percentage increased | Investigations | MedDRA 14.1 |
| ||
| Eosinophil percentage decreased | Investigations | MedDRA 14.1 |
| ||
| Eosinophil percentage increased | Investigations | MedDRA 14.1 |
| ||
| Monocyte percentage decreased | Investigations | MedDRA 14.1 |
| ||
| Monocyte percentage increased | Investigations | MedDRA 14.1 |
| ||
| Blood alkaline phosphatase increased | Investigations | MedDRA 14.1 |
| ||
| Hepatitis B virus test positive | Investigations | MedDRA 14.1 |
| ||
| Dehydration | Metabolism and nutrition disorders | MedDRA 14.1 |
| ||
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA 14.1 |
| ||
| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA 14.1 |
| ||
| Hyperuricaemia | Metabolism and nutrition disorders | MedDRA 14.1 |
| ||
| Hypoalbuminaemia | Metabolism and nutrition disorders | MedDRA 14.1 |
| ||
| Hypocalcaemia | Metabolism and nutrition disorders | MedDRA 14.1 |
| ||
| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA 14.1 |
| ||
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 14.1 |
| ||
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA 14.1 |
| ||
| Hypoproteinaemia | Metabolism and nutrition disorders | MedDRA 14.1 |
| ||
| Hypouricaemia | Metabolism and nutrition disorders | MedDRA 14.1 |
| ||
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 14.1 |
| ||
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 14.1 |
| ||
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 14.1 |
| ||
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA 14.1 |
| ||
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 14.1 |
| ||
| Musculoskeletal stiffness | Musculoskeletal and connective tissue disorders | MedDRA 14.1 |
| ||
| Tumour pain | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 14.1 |
| ||
| Tumour haemorrhage | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 14.1 |
| ||
| Burning sensation | Nervous system disorders | MedDRA 14.1 |
| ||
| Dizziness | Nervous system disorders | MedDRA 14.1 |
| ||
| Dysgeusia | Nervous system disorders | MedDRA 14.1 |
| ||
| Headache | Nervous system disorders | MedDRA 14.1 |
| ||
| Hypoaesthesia | Nervous system disorders | MedDRA 14.1 |
| ||
| Peripheral sensory neuropathy | Nervous system disorders | MedDRA 14.1 |
| ||
| Tremor | Nervous system disorders | MedDRA 14.1 |
| ||
| Delirium | Psychiatric disorders | MedDRA 14.1 |
| ||
| Insomnia | Psychiatric disorders | MedDRA 14.1 |
| ||
| Major depression | Psychiatric disorders | MedDRA 14.1 |
| ||
| Haematuria | Renal and urinary disorders | MedDRA 14.1 |
| ||
| Pollakiuria | Renal and urinary disorders | MedDRA 14.1 |
| ||
| Proteinuria | Renal and urinary disorders | MedDRA 14.1 |
| ||
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA 14.1 |
| ||
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 14.1 |
| ||
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 14.1 |
| ||
| Haemoptysis | Respiratory, thoracic and mediastinal disorders | MedDRA 14.1 |
| ||
| Hiccups | Respiratory, thoracic and mediastinal disorders | MedDRA 14.1 |
| ||
| Interstitial lung disease | Respiratory, thoracic and mediastinal disorders | MedDRA 14.1 |
| ||
| Productive cough | Respiratory, thoracic and mediastinal disorders | MedDRA 14.1 |
| ||
| Respiratory disorder | Respiratory, thoracic and mediastinal disorders | MedDRA 14.1 |
| ||
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA 14.1 |
| ||
| Oropharyngeal discomfort | Respiratory, thoracic and mediastinal disorders | MedDRA 14.1 |
| ||
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 14.1 |
| ||
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA 14.1 |
| ||
| Dermatitis exfoliative | Skin and subcutaneous tissue disorders | MedDRA 14.1 |
| ||
| Drug eruption | Skin and subcutaneous tissue disorders | MedDRA 14.1 |
| ||
| Dry skin | Skin and subcutaneous tissue disorders | MedDRA 14.1 |
| ||
| Erythema | Skin and subcutaneous tissue disorders | MedDRA 14.1 |
| ||
| Hyperhidrosis | Skin and subcutaneous tissue disorders | MedDRA 14.1 |
| ||
| Nail discolouration | Skin and subcutaneous tissue disorders | MedDRA 14.1 |
| ||
| Pain of skin | Skin and subcutaneous tissue disorders | MedDRA 14.1 |
| ||
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 14.1 |
| ||
| Rash | Skin and subcutaneous tissue disorders | MedDRA 14.1 |
| ||
| Rash maculo-papular | Skin and subcutaneous tissue disorders | MedDRA 14.1 |
| ||
| Skin depigmentation | Skin and subcutaneous tissue disorders | MedDRA 14.1 |
| ||
| Skin erosion | Skin and subcutaneous tissue disorders | MedDRA 14.1 |
| ||
| Urticaria | Skin and subcutaneous tissue disorders | MedDRA 14.1 |
| ||
| Photodermatosis | Skin and subcutaneous tissue disorders | MedDRA 14.1 |
| ||
| Flushing | Vascular disorders | MedDRA 14.1 |
| ||
| Hypertension | Vascular disorders | MedDRA 14.1 |
| ||
| Hypotension | Vascular disorders | MedDRA 14.1 |
| ||
| Phlebitis | Vascular disorders | MedDRA 14.1 |
| ||
| Vasculitis | Vascular disorders | MedDRA 14.1 |
| ||
| Haemorrhage | Vascular disorders | MedDRA 14.1 |
| ||
| Angiopathy | Vascular disorders | MedDRA 14.1 |
| ||
| Hot flush | Vascular disorders | MedDRA 14.1 |
| ||
| Thirst | Gastrointestinal disorders | MedDRA 14.1 |
| ||
| Blood immunoglobulin M decreased | Investigations | MedDRA 14.1 |
| ||
| Neutrophil count increased | Investigations | MedDRA 14.1 |
| ||
| Bone pain | Musculoskeletal and connective tissue disorders | MedDRA 14.1 |
|
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Toshihiko Nagase | Symbio Pharmaceuticals | 81-3-5472-1127 | tnagase.331@symbiopharma.com |
| ID | Term |
|---|---|
| D008228 | Lymphoma, Non-Hodgkin |
| D054739 | Dendritic Cell Sarcoma, Interdigitating |
| D020522 | Lymphoma, Mantle-Cell |
| D008223 | Lymphoma |
| D008224 | Lymphoma, Follicular |
| ID | Term |
|---|---|
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D015620 | Histiocytic Disorders, Malignant |
| D015614 | Histiocytosis |
Not provided
Not provided
| ID | Term |
|---|---|
| D000069461 | Bendamustine Hydrochloride |
| D000069283 | Rituximab |
| ID | Term |
|---|---|
| D002087 | Butyrates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
| D009588 | Nitrogen Mustard Compounds |
| D009150 | Mustard Compounds |
| D006846 | Hydrocarbons, Halogenated |
| D006838 | Hydrocarbons |
| D001562 | Benzimidazoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D058846 | Antibodies, Monoclonal, Murine-Derived |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
Not provided
Not provided
| 40-49 years |
|
| 50-59 years |
|
| 60-69 years |
|
| 70-75 years |
|
| Title |
|---|
| Measurements |
|---|
|
| Stage II |
|
| Stage II-E |
|
| Stage III |
|
| Stage III-S |
|
| Stage III-E |
|
| Stage III-SE |
|
| Stage IV |
|
| Unknown |
|
| Unknown |
|
| 3 |
|
| Title | Measurements |
|---|---|
|
| Indeterminate |
|
| Unknown |
|
| Unknown |
|
| Unknown |
|
| High-Intermediate (score=3) |
|
| High(score=4-5) |
|
| Unknown |
|
| Unknown |
|
|
| Participants |
|
|
| Title | Denominators | Categories | ||||
|---|---|---|---|---|---|---|
| Subjects with adverse event |
| |||||
| Subjects with serious adverse event |
|
| Title | Denominators | Categories | ||||
|---|---|---|---|---|---|---|
| Adverse events |
| |||||
| Serious adverse events |
|
|
| Title | Denominators | Categories | ||||
|---|---|---|---|---|---|---|
| Subjects with grade 3 Physical Findings |
| |||||
| Subjects with grade 4 Physical Findings |
|
| Title | Denominators | Categories | ||||
|---|---|---|---|---|---|---|
| concomitant medications for adverse events |
| |||||
| concomitant medications for complications |
| |||||
| concomitant medications for supportive therapy |
| |||||
| concomitant medications for other reasons |
|
|
|
|
|
|
|
|
|