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This observational study will assess the therapeutic efficiency, treatment schedules, handling procedures, and the safety profile of rituximab in routine care in participants with CLL.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Participants With CLL | Participants with CLL who are being treated with intravenous (IV) rituximab in combination with chemotherapy, will be observed for 24 months including 6-month treatment period. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rituximab | Drug | Rituximab IV |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Progression-Free Survival (PFS) as Assessed Using Kaplan-Meier Estimate | PFS was defined as the time from initiation of treatment with rituximab in combination with chemotherapy to disease progression or death due to any cause, whichever occurred first. Disease progression was defined as the occurrence of at least one of the following: greater than or equal to (>/=) 50 percent (%) increase in the longest diameter of at least two enlarged lymph nodes, increase in spleen and/or liver size by at least 2 centimeters (cm) from Baseline as determined by measurement below the costal margin, or >/=50% increase in the number of circulating lymphocytes. Participants without disease progression or death at the time of analysis were censored at the last date of tumor evaluation in terms of PFS. | From initiation of treatment up to disease progression or death due to any cause, whichever occurred first (assessed up to 24 months) |
| Percentage of Participants Without Progression or Death | Disease progression was defined as the occurrence of at least one of the following: >/=50% increase in the longest diameter of at least two enlarged lymph nodes, increase in spleen and/or liver size by at least 2 cm from Baseline as determined by measurement below the costal margin, or >/=50% increase in the number of circulating lymphocytes. | From initiation of treatment up to disease progression or death due to any cause, whichever occurred first (assessed up to 24 months) |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Progression and Death | Percentage of participants with an event (progression or death) was reported. Disease progression was defined as the occurrence of at least one of the following: >/=50% increase in the longest diameter of at least two enlarged lymph nodes, increase in spleen and/or liver size by at least 2 cm from Baseline as determined by measurement below the costal margin, or >/=50% increase in the number of circulating lymphocytes. |
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Inclusion Criteria:
Exclusion Criteria:
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Participants with CLL on chemotherapy receiving rituximab
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Hoffmann-La Roche | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| PIOH PD Dr. R. Schnell - Dr. H. Schulz - Dr. M. Hellmann | Frechen | 50226 | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29393986 | Derived | Reiser M, Dorfel S, Hensel M, Hoesl M, Jordan WO, Koenigsmann M, Meyer D, Reichert D, Schwarzer A, Marquardt M, Kellershohn K, Jentsch-Ullrich K. Rituximab in combination with chemotherapy for the treatment of chronic lymphocytic leukaemia in clinical practice. Eur J Haematol. 2018 May;100(5):455-464. doi: 10.1111/ejh.13040. Epub 2018 Mar 22. |
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This single arm study had baseline and analysis reported per 2 arms (Unselected Population and "Slow Go" Subpopulation).
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| ID | Title | Description |
|---|---|---|
| FG000 | Participants With Chonic Lymphatic Leukemia (CLL) | Participants with CLL who were treated with intravenous (IV) rituximab in combination with chemotherapy, were observed for 24 months including 6-month treatment period. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Baseline characteristics of EAS has been reported.
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| ID | Title | Description |
|---|---|---|
| BG000 | Unselected Population (Participants With Any Comorbidity) | Unselected population (participants with any comorbidity) who were treated with IV rituximab in combination with chemotherapy, were observed for 24 months including 6-month treatment period. |
| BG001 | "Slow Go" Subpopulation |
| 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 | Progression-Free Survival (PFS) as Assessed Using Kaplan-Meier Estimate | PFS was defined as the time from initiation of treatment with rituximab in combination with chemotherapy to disease progression or death due to any cause, whichever occurred first. Disease progression was defined as the occurrence of at least one of the following: greater than or equal to (>/=) 50 percent (%) increase in the longest diameter of at least two enlarged lymph nodes, increase in spleen and/or liver size by at least 2 centimeters (cm) from Baseline as determined by measurement below the costal margin, or >/=50% increase in the number of circulating lymphocytes. Participants without disease progression or death at the time of analysis were censored at the last date of tumor evaluation in terms of PFS. | Analysis was performed on EAS. | Posted | Median | 95% Confidence Interval | months | From initiation of treatment up to disease progression or death due to any cause, whichever occurred first (assessed up to 24 months) |
|
Baseline up to 24 months
Analysis was performed on safety analysis set.
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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 | Unselected Population (Participants With Any Comorbidity) | Unselected population (participants with any comorbidity) who were treated with IV rituximab in combination with chemotherapy, were observed for 24 months including 6-month treatment period. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anemia | Blood and lymphatic system disorders | MedDRA 18.1 | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anemia | Blood and lymphatic system disorders | MedDRA 18.1 | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Medical Communications | Hoffmann-La Roche | 800-821-8590 | global-roche-genentech-trials@gene.com |
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| ID | Term |
|---|---|
| D015451 | Leukemia, Lymphocytic, Chronic, B-Cell |
| ID | Term |
|---|---|
| D015448 | Leukemia, B-Cell |
| D007945 | Leukemia, Lymphoid |
| D007938 | Leukemia |
| D009370 | Neoplasms by Histologic Type |
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| ID | Term |
|---|---|
| D000069283 | Rituximab |
| ID | Term |
|---|---|
| D058846 | Antibodies, Monoclonal, Murine-Derived |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
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| From initiation of treatment up to disease progression or death due to any cause, whichever occurred first (assessed up to 24 months) |
| Percentage of Participants Who Received Each Treatment During the Course of Study | The chemotherapeutic regimen administereted during the course of study were: Rituximab-Bendamustine (R-Benda), Rituximab-Fludarabine-Cyclophosphamide (R-FC), Rituximab-Clorambucil (R-Clb), R-Other and Rituximab mono. | Baseline, Cycle 1, 2, 3, 4, 5, 6, 7, 8, last Cycle (Cycle 18) (each cycle=1 month) |
| Mean Body Weight | Baseline, last cycle (Cycle 18) (each cycle=1 month), last visit (follow-up) (24 months) |
| Percentage of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status | ECOG performance status was measured on a 4 point scale to assess participant's performance status. 0=Fully active, able to carry on all pre-disease activities without restriction; 1=Restricted in physically strenuous activity, ambulatory and able to carry out light or sedentary work; 2=Ambulatory (>50% of waking hours), capable of all self-care, unable to carry out any work activities; 3=Capable of only limited self-care, confined to bed/chair >50% of waking hours. | Baseline, last cycle (Cycle 18) (each cycle=1 month), last visit (follow-up) (24 months) |
| Percentage of Participants With Karnofsky Performance Status Index | Performance status was reflected by the Karnofsky index. Karnofsky performance status index ranges from 0-100% with higher scores indicating better functional status. An index between 90% and 100% corresponds to ECOG grade 0, index between 70% and 80% corresponds to ECOG grade 1, index between 50% and 60% corresponds to ECOG grade 2, index 40% corresponds to ECOG grade 3. ECOG grade 0=Fully active, able to carry on all pre-disease activities without restriction; grade 1=Restricted in physically strenuous activity, ambulatory and able to carry out light or sedentary work; grade 2=Ambulatory (>50% of waking hours), capable of all self-care, unable to carry out any work activities; grade 3=Capable of only limited self-care, confined to bed/chair >50% of waking hours. | Baseline, last cycle (Cycle 18) (each cycle=1 month), last visit (follow-up) (24 months) |
| Percentage of Participants With General Symptoms | General symptoms included fatigue, reduced performance, frequent infections, abdominal pain and exhaustion. | Baseline, last cycle (Cycle 18) (each cycle=1 month), last visit (follow-up) (24 months) |
| Percentage of Participants With B-Symptoms | B-symptoms included fever, night sweats, weight loss. | Baseline, last cycle (Cycle 18) (each cycle=1 month), last visit (follow-up) (24 months) |
| Percentage of Participants With Best Overall Response (BOR) | Response to treatment was assessed as per clinical routine. BOR included complete response(CR or CR with incomplete hematopoietic regeneration),partial response(PR or nodular PR),stable disease(SD),progressive disease(PD). CR:hemoglobin>/=11 grams/deciliter(g/dL), lymphocytes<4000 cells/cubic millimeter(cells/mm^3), neutrophils>5000 cells/mm^3,platelets>100,000 cells/mm^3,bone marrow biopsy with <30% lymphocytes with no lymphocytic infiltrates, no evidence of lymphoid nodules on physical exam, performance status of 0. PR:>50% decrease in size of enlarged lymph nodes, hepatomegaly, splenomegaly, with peripheral counts meeting same criteria as CR or >/=50% improvement from pre-treatment values.PD:occurrence of at least one of following: >/=50% increase in longest diameter of at least 2 enlarged lymph nodes, increase in spleen and liver size by at least 2 cm from Baseline, or >/=50% increase in number of circulating lymphocytes. Participants without CR/PR or PD were considered having SD. | From initiation of treatment up to disease progression or death due to any cause, whichever occurred first (assessed up to 24 months) |
| Death |
|
| Other unspecified |
|
| Excluded from EAS |
|
"Slow go" subpopulation (participants with cumulative illness rating scale for geriatrics [CIRS-G] score greater than [>] 6 and/or creatinine clearance less than [<] 70 milliliters per minute [mL/min]) who were treated with IV rituximab in combination with chemotherapy, were observed for 24 months including 6-month treatment period. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Unselected Population (Participants With Any Comorbidity) |
Unselected population (participants with any comorbidity) who were treated with IV rituximab in combination with chemotherapy, were observed for 24 months including 6-month treatment period. |
| OG001 | "Slow Go" Subpopulation | "Slow go" subpopulation (participants with CIRS-G score >6 and/or creatinine clearance <70 mL/min) who were treated with IV rituximab in combination with chemotherapy, were observed for 24 months including 6-month treatment period. |
|
|
| Primary | Percentage of Participants Without Progression or Death | Disease progression was defined as the occurrence of at least one of the following: >/=50% increase in the longest diameter of at least two enlarged lymph nodes, increase in spleen and/or liver size by at least 2 cm from Baseline as determined by measurement below the costal margin, or >/=50% increase in the number of circulating lymphocytes. | Analysis was performed on EAS. | Posted | Number | 95% Confidence Interval | percentage of participants | From initiation of treatment up to disease progression or death due to any cause, whichever occurred first (assessed up to 24 months) |
|
|
|
| Secondary | Percentage of Participants With Progression and Death | Percentage of participants with an event (progression or death) was reported. Disease progression was defined as the occurrence of at least one of the following: >/=50% increase in the longest diameter of at least two enlarged lymph nodes, increase in spleen and/or liver size by at least 2 cm from Baseline as determined by measurement below the costal margin, or >/=50% increase in the number of circulating lymphocytes. | Analysis was performed on EAS with events. | Posted | Number | percentage of participants | From initiation of treatment up to disease progression or death due to any cause, whichever occurred first (assessed up to 24 months) |
|
|
|
| Secondary | Percentage of Participants Who Received Each Treatment During the Course of Study | The chemotherapeutic regimen administereted during the course of study were: Rituximab-Bendamustine (R-Benda), Rituximab-Fludarabine-Cyclophosphamide (R-FC), Rituximab-Clorambucil (R-Clb), R-Other and Rituximab mono. | Analysis was performed on EAS. | Posted | Number | percentage of participants | Baseline, Cycle 1, 2, 3, 4, 5, 6, 7, 8, last Cycle (Cycle 18) (each cycle=1 month) |
|
|
|
| Secondary | Mean Body Weight | Analysis was performed on EAS. Overall number of participants analyzed=participants analyzed for this outcome. Here, number analyzed=participants evaluable at specified time-point. | Posted | Mean | Standard Deviation | kilograms (kg) | Baseline, last cycle (Cycle 18) (each cycle=1 month), last visit (follow-up) (24 months) |
|
|
|
| Secondary | Percentage of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status | ECOG performance status was measured on a 4 point scale to assess participant's performance status. 0=Fully active, able to carry on all pre-disease activities without restriction; 1=Restricted in physically strenuous activity, ambulatory and able to carry out light or sedentary work; 2=Ambulatory (>50% of waking hours), capable of all self-care, unable to carry out any work activities; 3=Capable of only limited self-care, confined to bed/chair >50% of waking hours. | Analysis was performed on EAS. Here, number analyzed=participants evaluable at specified time-point. | Posted | Number | percentage of participants | Baseline, last cycle (Cycle 18) (each cycle=1 month), last visit (follow-up) (24 months) |
|
|
|
| Secondary | Percentage of Participants With Karnofsky Performance Status Index | Performance status was reflected by the Karnofsky index. Karnofsky performance status index ranges from 0-100% with higher scores indicating better functional status. An index between 90% and 100% corresponds to ECOG grade 0, index between 70% and 80% corresponds to ECOG grade 1, index between 50% and 60% corresponds to ECOG grade 2, index 40% corresponds to ECOG grade 3. ECOG grade 0=Fully active, able to carry on all pre-disease activities without restriction; grade 1=Restricted in physically strenuous activity, ambulatory and able to carry out light or sedentary work; grade 2=Ambulatory (>50% of waking hours), capable of all self-care, unable to carry out any work activities; grade 3=Capable of only limited self-care, confined to bed/chair >50% of waking hours. | Analysis was performed on EAS. Here, number analyzed=participants evaluable at specified time-point. | Posted | Number | percentage of participants | Baseline, last cycle (Cycle 18) (each cycle=1 month), last visit (follow-up) (24 months) |
|
|
|
| Secondary | Percentage of Participants With General Symptoms | General symptoms included fatigue, reduced performance, frequent infections, abdominal pain and exhaustion. | Analysis was performed on EAS. Here, number analyzed=participants evaluable at specified time-point. | Posted | Number | percentage of participants | Baseline, last cycle (Cycle 18) (each cycle=1 month), last visit (follow-up) (24 months) |
|
|
|
| Secondary | Percentage of Participants With B-Symptoms | B-symptoms included fever, night sweats, weight loss. | Analysis was performed on EAS. Here, number analyzed=participants evaluable at specified time-point. | Posted | Number | percentage of participants | Baseline, last cycle (Cycle 18) (each cycle=1 month), last visit (follow-up) (24 months) |
|
|
|
| Secondary | Percentage of Participants With Best Overall Response (BOR) | Response to treatment was assessed as per clinical routine. BOR included complete response(CR or CR with incomplete hematopoietic regeneration),partial response(PR or nodular PR),stable disease(SD),progressive disease(PD). CR:hemoglobin>/=11 grams/deciliter(g/dL), lymphocytes<4000 cells/cubic millimeter(cells/mm^3), neutrophils>5000 cells/mm^3,platelets>100,000 cells/mm^3,bone marrow biopsy with <30% lymphocytes with no lymphocytic infiltrates, no evidence of lymphoid nodules on physical exam, performance status of 0. PR:>50% decrease in size of enlarged lymph nodes, hepatomegaly, splenomegaly, with peripheral counts meeting same criteria as CR or >/=50% improvement from pre-treatment values.PD:occurrence of at least one of following: >/=50% increase in longest diameter of at least 2 enlarged lymph nodes, increase in spleen and liver size by at least 2 cm from Baseline, or >/=50% increase in number of circulating lymphocytes. Participants without CR/PR or PD were considered having SD. | Analysis was performed on EAS. | Posted | Number | percentage of participants | From initiation of treatment up to disease progression or death due to any cause, whichever occurred first (assessed up to 24 months) |
|
|
|
| 85 |
| 485 |
| 259 |
| 485 |
| EG001 | "Slow Go" Subpopulation | "Slow go" subpopulation (participants with CIRS-G score >6 and/or creatinine clearance <70 mL/min) who were treated with IV rituximab in combination with chemotherapy, were observed for 24 months including 6-month treatment period. | 44 | 196 | 98 | 196 |
| Autoimmune hemolytic anemia | Blood and lymphatic system disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| Bone marrow toxicity | Blood and lymphatic system disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| Cytopenia | Blood and lymphatic system disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| Leukopenia | Blood and lymphatic system disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| Neutropenia | Blood and lymphatic system disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| Pancytopenia | Blood and lymphatic system disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| Acute myocardial infarction | Cardiac disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| Arrhythmia | Cardiac disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| Cardiac disorder | Cardiac disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| Cardiac failure | Cardiac disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| Adrenal mass | Endocrine disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| Gastrointestinal hemorrhage | Gastrointestinal disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| Ileus | Gastrointestinal disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| Melena | Gastrointestinal disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| Mouth hemorrhage | Gastrointestinal disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| Asthenia | General disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| Chills | General disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| Death | General disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| Disease progression | General disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| Effusion | General disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| General physical health deterioration | General disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| Pyrexia | General disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| Hypersensitivity | Immune system disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| Secondary immunodeficiency | Immune system disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| Atypical Pneumonia | Infections and infestations | MedDRA 18.1 | Non-systematic Assessment |
|
| Bacterial infection | Infections and infestations | MedDRA 18.1 | Non-systematic Assessment |
|
| Bronchitis | Infections and infestations | MedDRA 18.1 | Non-systematic Assessment |
|
| Device related infection | Infections and infestations | MedDRA 18.1 | Non-systematic Assessment |
|
| Fungal infection | Infections and infestations | MedDRA 18.1 | Non-systematic Assessment |
|
| Herpes zoster | Infections and infestations | MedDRA 18.1 | Non-systematic Assessment |
|
| Klebsiella bacteraemia | Infections and infestations | MedDRA 18.1 | Non-systematic Assessment |
|
| Meningitis | Infections and infestations | MedDRA 18.1 | Non-systematic Assessment |
|
| Necrotizing fasciitis | Infections and infestations | MedDRA 18.1 | Non-systematic Assessment |
|
| Pneumonia viral | Infections and infestations | MedDRA 18.1 | Non-systematic Assessment |
|
| Sepsis | Infections and infestations | MedDRA 18.1 | Non-systematic Assessment |
|
| Staphylococcal sepsis | Infections and infestations | MedDRA 18.1 | Non-systematic Assessment |
|
| Viral infection | Infections and infestations | MedDRA 18.1 | Non-systematic Assessment |
|
| Injury | Injury, poisoning and procedural complications | MedDRA 18.1 | Non-systematic Assessment |
|
| Splenic rupture | Injury, poisoning and procedural complications | MedDRA 18.1 | Non-systematic Assessment |
|
| Blood pressure increased | Investigations | MedDRA 18.1 | Non-systematic Assessment |
|
| Body temperature increased | Investigations | MedDRA 18.1 | Non-systematic Assessment |
|
| White blood cell count increased | Investigations | MedDRA 18.1 | Non-systematic Assessment |
|
| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| Tumour lysis syndrome | Metabolism and nutrition disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| Colon cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 18.1 | Non-systematic Assessment |
|
| Malignant melanoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 18.1 | Non-systematic Assessment |
|
| Malignant neoplasm progression | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 18.1 | Non-systematic Assessment |
|
| Metastases to bone | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 18.1 | Non-systematic Assessment |
|
| Metastases to liver | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 18.1 | Non-systematic Assessment |
|
| Metastases to lung | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 18.1 | Non-systematic Assessment |
|
| Metastatic neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 18.1 | Non-systematic Assessment |
|
| Rectal cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 18.1 | Non-systematic Assessment |
|
| Small cell lung cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 18.1 | Non-systematic Assessment |
|
| Cerebrovascular accident | Nervous system disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| Depressed level of consciousness | Nervous system disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| Syncope | Nervous system disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| Chronic kidney disease | Renal and urinary disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| Hematuria | Renal and urinary disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| Lung infiltration | Respiratory, thoracic and mediastinal disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| Drug eruption | Skin and subcutaneous tissue disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| Swelling face | Skin and subcutaneous tissue disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| Dental operation | Surgical and medical procedures | MedDRA 18.1 | Non-systematic Assessment |
|
| Circulatory collapse | Vascular disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| Embolism | Vascular disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| Haematoma | Vascular disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| Hot flush | Vascular disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| Thrombosis | Vascular disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| Hematotoxicity | Blood and lymphatic system disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| Atrial fibrillation | Cardiac disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| Pancreatitis acute | Gastrointestinal disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| Endocarditis | Infections and infestations | MedDRA 18.1 | Non-systematic Assessment |
|
| Enterococcal infection | Infections and infestations | MedDRA 18.1 | Non-systematic Assessment |
|
| Febrile infection | Infections and infestations | MedDRA 18.1 | Non-systematic Assessment |
|
| Infection | Infections and infestations | MedDRA 18.1 | Non-systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA 18.1 | Non-systematic Assessment |
|
| Septic shock | Infections and infestations | MedDRA 18.1 | Non-systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | MedDRA 18.1 | Non-systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDRA 18.1 | Non-systematic Assessment |
|
| Hemoglobin decreased | Investigations | MedDRA 18.1 | Non-systematic Assessment |
|
| Ankle fracture | Injury, poisoning and procedural complications | MedDRA 18.1 | Non-systematic Assessment |
|
| Fall | Injury, poisoning and procedural complications | MedDRA 18.1 | Non-systematic Assessment |
|
| Femur fracture | Injury, poisoning and procedural complications | MedDRA 18.1 | Non-systematic Assessment |
|
| Toxicity to various agents | Injury, poisoning and procedural complications | MedDRA 18.1 | Non-systematic Assessment |
|
| Dehydration | Metabolism and nutrition disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| Lymphatic system neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 18.1 | Non-systematic Assessment |
|
| Epilepsy | Nervous system disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| Paraesthesia | Nervous system disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| Peroneal nerve palsy | Nervous system disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| Presyncope | Nervous system disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| Seizure | Nervous system disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| Acute kidney injury | Renal and urinary disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| Renal failure | Renal and urinary disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| Rash pruritic | Skin and subcutaneous tissue disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| Hospitalization | Surgical and medical procedures | MedDRA 18.1 | Non-systematic Assessment |
|
| Deep vein thrombosis | Vascular disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| Hypertensive crisis | Vascular disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| Leukopenia | Blood and lymphatic system disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| Neutropenia | Blood and lymphatic system disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| Chills | General disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| Pyrexia | General disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| Hypersensitivity | Immune system disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| Bacterial infection | Infections and infestations | MedDRA 18.1 | Non-systematic Assessment |
|
| Fatigue | General disorders | MedDRA 18.1 | Non-systematic Assessment |
|
The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.
| D009369 |
| Neoplasms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| R-Benda at Cycle 2 |
|
| R-Benda at Cycle 3 |
|
| R-Benda at Cycle 4 |
|
| R-Benda at Cycle 5 |
|
| R-Benda at Cycle 6 |
|
| R-Benda at Cycle 7 |
|
| R-Benda at Cycle 8 |
|
| R-Benda at Last Cycle |
|
| R-FC at Baseline |
|
| R-FC at Cycle 1 |
|
| R-FC at Cycle 2 |
|
| R-FC at Cycle 3 |
|
| R-FC at Cycle 4 |
|
| R-FC at Cycle 5 |
|
| R-FC at Cycle 6 |
|
| R-FC at Cycle 7 |
|
| R-FC at Cycle 8 |
|
| R-FC at Last Cycle |
|
| R-Clb at Baseline |
|
| R-Clb at Cycle 1 |
|
| R-Clb at Cycle 2 |
|
| R-Clb at Cycle 3 |
|
| R-Clb at Cycle 4 |
|
| R-Clb at Cycle 5 |
|
| R-Clb at Cycle 6 |
|
| R-Clb at Cycle 7 |
|
| R-Clb at Cycle 8 |
|
| R-Clb at Last Cycle |
|
| R-Other at Baseline |
|
| R-Other at Cycle 1 |
|
| R-Other at Cycle 2 |
|
| R-Other at Cycle 3 |
|
| R-Other at Cycle 4 |
|
| R-Other at Cycle 5 |
|
| R-Other at Cycle 6 |
|
| R-Other at Cycle 7 |
|
| R-Other at Cycle 8 |
|
| R-Other at Last Cycle |
|
| Rituximab Mono at Baseline |
|
| Rituximab Mono at Cycle 1 |
|
| Rituximab Mono at Cycle 2 |
|
| Rituximab Mono at Cycle 3 |
|
| Rituximab Mono at Cycle 4 |
|
| Rituximab Mono at Cycle 5 |
|
| Rituximab Mono at Cycle 6 |
|
| Rituximab Mono at Cycle 7 |
|
| Rituximab Mono at Cycle 8 |
|
| Rituximab Mono at Last Cycle |
|
| Last Cycle |
|
|
| Last Visit |
|
|
| Grade 0 at Last Cycle |
|
|
| Grade 0 at Last Visit |
|
|
| Grade 1 at Baseline |
|
|
| Grade 1 at Last Cycle |
|
|
| Grade 1 at Last Visit |
|
|
| Grade 2 at Baseline |
|
|
| Grade 2 at Last Cycle |
|
|
| Grade 2 at Last Visit |
|
|
| Grade 3 at Baseline |
|
|
| Grade 3 at Last Cycle |
|
|
| Grade 3 at Last Visit |
|
|
| Missing at Baseline |
|
|
| Missing at Last Cycle |
|
|
| Missing at Last Visit |
|
|
| Karnofsky index 100% at Last Cycle |
|
|
| Karnofsky index 100% at Last Visit |
|
|
| Karnofsky index 90% at Baseline |
|
|
| Karnofsky index 90% at Last Cycle |
|
|
| Karnofsky index 90% at Last Visit |
|
|
| Karnofsky index 80% at Baseline |
|
|
| Karnofsky index 80% at Last Cycle |
|
|
| Karnofsky index 80% at Last Visit |
|
|
| Karnofsky index 70% at Baseline |
|
|
| Karnofsky index 70% at Last Cycle |
|
|
| Karnofsky index 70% at Last Visit |
|
|
| Karnofsky index 60% at Baseline |
|
|
| Karnofsky index 60% at Last Cycle |
|
|
| Karnofsky index 60% at Last Visit |
|
|
| Karnofsky index 50% at Baseline |
|
|
| Karnofsky index 50% at Last Cycle |
|
|
| Karnofsky index 50% at Last Visit |
|
|
| Karnofsky index 40% at Baseline |
|
|
| Karnofsky index 40% at Last Cycle |
|
|
| Karnofsky index 40% at Last Visit |
|
|
| Missing at Baseline |
|
|
| Missing at Last Cycle |
|
|
| Missing at Last Visit |
|
|
| Fatigue at Last Cycle |
|
|
| Fatigue at Last Visit |
|
|
| Reduced Performance at Baseline |
|
|
| Reduced Performance at Last Cycle |
|
|
| Reduced Performance at Last Visit |
|
|
| Frequent Infections at Baseline |
|
|
| Frequent Infections at Last Cycle |
|
|
| Frequent Infections at Last Visit |
|
|
| Abdominal Pain at Baseline |
|
|
| Abdominal Pain at Last Cycle |
|
|
| Abdominal Pain at Last Visit |
|
|
| Exhaustion at Baseline |
|
|
| Exhaustion at Last Cycle |
|
|
| Exhaustion at Last Visit |
|
|
| Fever at Last Cycle |
|
|
| Fever at Last Visit |
|
|
| Night Sweats at Baseline |
|
|
| Night Sweats at Last Cycle |
|
|
| Night Sweats at Last Visit |
|
|
| Weight Loss at Baseline |
|
|
| Weight Loss at Last Cycle |
|
|
| Weight Loss at Last Visit |
|
|
| SD |
|
| PD |
|
| Not assessable |
|
| Not assessed / Missing |
|