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| Name | Class |
|---|---|
| Johnson & Johnson Pharmaceutical Research & Development, L.L.C. | INDUSTRY |
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This is a randomized, open-label, active-control, parallel-group, multicenter, multinational Phase 2 Study of the efficacy and safety of VELCADE, Rituximab, Cyclophosphamide, Doxorubicin, and Prednisone (VR-CAP) or Rituximab, Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone (R-CHOP) in Patients With Newly Diagnosed Non-Germinal Center B-Cell (non-GCB) Subtype of Diffuse Large B-Cell Lymphoma (DLBCL)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| VR-CAP | Experimental | VR-CAP arm received rituximab 375 mg/m2 IV on Day 1, cyclophosphamide 750 mg/m2 IV on Day 1, doxorubicin 50 mg/m2 IV on Day 1, VELCADE 1.3 mg/m2 IV on Days 1, 4, 8, and 11, and prednisone 100 mg/m2 orally on Days 1 through 5 of each 21-day (3-week) cycle for up to 6 cycles. |
|
| R-CHOP | Active Comparator | R-CHOP received rituximab 375 mg/m2IV on Day 1, cyclophosphamide 750 mg/m2 IV on Day 1, doxorubicin 50 mg/m2 IV on Day 1, vincristine 1.4 mg/m2 (maximum total of 2 mg) IV on Day 1, and prednisone 100 mg/m2 orally on Days 1 through 5 of each 21-day (3-week) cycle for up to 6 cycles.Prednisone |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| VELCADE | Drug | VELCADE intravenous on Days 1, 4, 8, and 11 of a 21 day (3 week) cycle for 6 cycles. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Complete Response (CR) Rate | Complete response was evaluated by an Independent Radiology Review Committee using available computed tomography (CT) and positron emission tomography (PET) scans collected at Baseline, end of cycle 3, and end of cycle 6 (or end of treatment) based on the Revised Response Criteria for Malignant Lymphoma.
| 6 cycles |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Response Rate | Overall response = Complete Response (CR) + Partial Response (PR) Response was evaluated by an Independent Radiology Review Committee using available computed tomography (CT) and positron emission tomography (PET) scans collected at Baseline, end of cycle 3, and end of cycle 6 (or end of treatment) based on the Revised Response Criteria for Malignant Lymphoma. Complete Response: see primary endpoint Partial Response: At least a 50% decrease in the sum of the product of the diameters (SPD) of up to 6 of the largest dominant nodes or nodal masses. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Monitor | Millennium Pharmaceuticals, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Universitair Ziekenhuis Gent - UZ GENT, Hematologie, 9K12IE 9de verdiep- polikliniek Hematologie | Ghent | Belgium |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26232170 | Derived | Offner F, Samoilova O, Osmanov E, Eom HS, Topp MS, Raposo J, Pavlov V, Ricci D, Chaturvedi S, Zhu E, van de Velde H, Enny C, Rizo A, Ferhanoglu B. Frontline rituximab, cyclophosphamide, doxorubicin, and prednisone with bortezomib (VR-CAP) or vincristine (R-CHOP) for non-GCB DLBCL. Blood. 2015 Oct 15;126(16):1893-901. doi: 10.1182/blood-2015-03-632430. Epub 2015 Jul 31. |
Not provided
Not provided
164 participants were randomized, three participants did not receive study treatment (2 in the VR-CAP and 1 in the R-CHOP arm) for a total of 161 treated.
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| ID | Title | Description |
|---|---|---|
| FG000 | VR-CAP | VR-CAP arm received rituximab 375 mg/m2 IV on Day 1, cyclophosphamide 750 mg/m2 IV on Day 1, doxorubicin 50 mg/m2 IV on Day 1, VELCADE 1.3 mg/m2 IV on Days 1, 4, 8, and 11, and prednisone 100 mg/m2 orally on Days 1 through 5 of each 21-day (3-week) cycle for up to 6 cycles. |
| FG001 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Rituximab | Drug | Rituximab intravenous on Day 1 of a 21 day (3 week) cycle for 6 cycles |
|
| Cyclophosphamide | Drug | Intravenous on Day 1 of a 21 day (3 week) cycle for 6 cycles |
|
| Doxorubicin | Drug | Intravenous on Day 1 of a 21 day (3 week) cycle for 6 cycles |
|
| Prednisone | Drug | Orally on Day 1 to Day 5 of a 21 day (3 week) cycle for 6 cycles |
|
| Vincristine | Drug | Intravenous on Day 1 of a 21 day (3 week) cycle for 6 cycles |
|
| 6 cycles |
| Rate of Durable Response | Proportion of subjects who achieved a CR or PR with duration of at least 6 months. Duration of response (CR or PR) was calculated from the date of initial documentation of a response to the date of first documented evidence of disease progression or death due to disease progression. Response was evaluated by an Independent Radiology Review Committee using available computed tomography (CT) and positron emission tomography (PET) scans collected at Baseline, end of cycle 3, end of cycle 6 (or end of treatment) based on the Revised Response Criteria for Malignant Lymphoma. | Median follow up approx. 12 months |
| Rate of Durable Complete Response | Proportion of subjects who achieved a CR with duration of at least 6 months | Median follow up approx 12 months |
| Subsequent Anti-lymphoma Therapy Rate at 1-year | Kaplan-meier estimate of subsequent anti-lymphoma therapy at 1-year. Time to subsequent anti-lymphoma therapy was measured from the date of randomization to the start date of new treatment. Death due to disease progression prior to subsequent therapy was considered as an event. Otherwise, time to next anti-lymphoma treatment was censored at the date of death or the last date known to be alive. | 1 year |
| Progression-free Survival (PFS)Rate at 1-year | Kaplan-meier estimate of progression-free survival at 1-year. Progression-free survival was defined as the interval between the date of randomization and the date of first documented evidence of disease progression or death. | 1 year |
| Overall Survival Rate at 1-year | Kaplan-meier estimate of overall survival at 1-year measured from date of randomization. | 1 year |
| Change in Fatigue and Patient Utility Scores | 18-24 months |
| R-CHOP |
R-CHOP received rituximab 375 mg/m2IV on Day 1, cyclophosphamide 750 mg/m2 IV on Day 1, doxorubicin 50 mg/m2 IV on Day 1, vincristine 1.4 mg/m2 (maximum total of 2 mg) IV on Day 1, and prednisone 100 mg/m2 orally on Days 1 through 5 of each 21-day (3-week) cycle for up to 6 cycles.Prednisone |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Intent to Treat, Randomized
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| ID | Title | Description |
|---|---|---|
| BG000 | VR-CAP | VELCADE, Rituximab, Cyclophosphamide, Doxorubicin and Prednisone |
| BG001 | R-CHOP | Rituximab, Cyclophosphamide, Doxorubicin, Vincristine and Prednisone |
| BG002 | Total | Total of all reporting groups |
| 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 | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | Number | participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Complete Response (CR) Rate | Complete response was evaluated by an Independent Radiology Review Committee using available computed tomography (CT) and positron emission tomography (PET) scans collected at Baseline, end of cycle 3, and end of cycle 6 (or end of treatment) based on the Revised Response Criteria for Malignant Lymphoma.
| All randomized subjects with non-GCB DLBCL who received at least 1 dose of any study drug, had at least 1 measurable lesion at baseline, and had at least 1 post-baseline response assessment | Posted | Number | 90% Confidence Interval | percentage of participants | 6 cycles |
|
|
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Overall Response Rate | Overall response = Complete Response (CR) + Partial Response (PR) Response was evaluated by an Independent Radiology Review Committee using available computed tomography (CT) and positron emission tomography (PET) scans collected at Baseline, end of cycle 3, and end of cycle 6 (or end of treatment) based on the Revised Response Criteria for Malignant Lymphoma. Complete Response: see primary endpoint Partial Response: At least a 50% decrease in the sum of the product of the diameters (SPD) of up to 6 of the largest dominant nodes or nodal masses. | All randomized subjects with non-GCB DLBCL who received at least 1 dose of any study drug, had at least 1 measurable lesion at baseline, and had at least 1 post-baseline response assessment | Posted | Number | 90% Confidence Interval | percentage of participants | 6 cycles |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Rate of Durable Response | Proportion of subjects who achieved a CR or PR with duration of at least 6 months. Duration of response (CR or PR) was calculated from the date of initial documentation of a response to the date of first documented evidence of disease progression or death due to disease progression. Response was evaluated by an Independent Radiology Review Committee using available computed tomography (CT) and positron emission tomography (PET) scans collected at Baseline, end of cycle 3, end of cycle 6 (or end of treatment) based on the Revised Response Criteria for Malignant Lymphoma. | Posted | Number | 95% Confidence Interval | percentage of participants | Median follow up approx. 12 months |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Rate of Durable Complete Response | Proportion of subjects who achieved a CR with duration of at least 6 months | Posted | Number | 95% Confidence Interval | percentage of participants | Median follow up approx 12 months |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Subsequent Anti-lymphoma Therapy Rate at 1-year | Kaplan-meier estimate of subsequent anti-lymphoma therapy at 1-year. Time to subsequent anti-lymphoma therapy was measured from the date of randomization to the start date of new treatment. Death due to disease progression prior to subsequent therapy was considered as an event. Otherwise, time to next anti-lymphoma treatment was censored at the date of death or the last date known to be alive. | Intent to Treat Population | Posted | Number | 95% Confidence Interval | percentage of participants | 1 year |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Progression-free Survival (PFS)Rate at 1-year | Kaplan-meier estimate of progression-free survival at 1-year. Progression-free survival was defined as the interval between the date of randomization and the date of first documented evidence of disease progression or death. | Intent to Treat Population | Posted | Number | 95% Confidence Interval | percentage of partipants | 1 year |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Overall Survival Rate at 1-year | Kaplan-meier estimate of overall survival at 1-year measured from date of randomization. | Intent to Treat Population | Posted | Number | 95% Confidence Interval | percentage of partipants | 1 year |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change in Fatigue and Patient Utility Scores | Not Posted | 18-24 months |
Not provided
Number at risk is based on the safety population defined as patients who were randomized and received at least one dose of study drug. A total of 164 participants were randomized and 3 participants did not receive study treatment (2 in the VR-CAP arm, 1 in the R-CHOP arm) for a total of 161 treated (82 in the VR-CAP arm, 79 in the R-CHOP arm).
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 | VR-CAP | VELCADE, Rituximab, Cyclophosphamide, Doxorubicin and Prednisone | 31 | 82 | 73 | 82 | ||
| EG001 | R-CHOP | Rituximab, Cyclophosphamide, Doxorubicin, Vincristine and Prednisone | 27 | 79 | 72 | 79 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Febrile neutropenia | Blood and lymphatic system disorders | MeDRA Version 15.0 | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MeDRA Version 15.0 | Systematic Assessment |
| |
| Febrile bone marrow aplasia | Blood and lymphatic system disorders | MeDRA Version 15.0 | Systematic Assessment |
| |
| Leukopenia | Blood and lymphatic system disorders | MeDRA Version 15.0 | Systematic Assessment |
| |
| Lymphadenopathy | Blood and lymphatic system disorders | MeDRA Version 15.0 | Systematic Assessment |
| |
| Splenomegaly | Blood and lymphatic system disorders | MeDRA Version 15.0 | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MeDRA Version 15.0 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MeDRA Version 15.0 | Systematic Assessment |
| |
| Device related infection | Infections and infestations | MeDRA Version 15.0 | Systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MeDRA Version 15.0 | Systematic Assessment |
| |
| Lung infection | Infections and infestations | MeDRA Version 15.0 | Systematic Assessment |
| |
| Septic shock | Infections and infestations | MeDRA Version 15.0 | Systematic Assessment |
| |
| Abscess neck | Infections and infestations | MeDRA Version 15.0 | Systematic Assessment |
| |
| Hepatitis viral | Infections and infestations | MeDRA Version 15.0 | Systematic Assessment |
| |
| Herpes zoster | Infections and infestations | MeDRA Version 15.0 | Systematic Assessment |
| |
| Oral candidiasis | Infections and infestations | MeDRA Version 15.0 | Systematic Assessment |
| |
| Pneumocystis jiroveci pneumonia | Infections and infestations | MeDRA Version 15.0 | Systematic Assessment |
| |
| Respiratory tract infection | Infections and infestations | MeDRA Version 15.0 | Systematic Assessment |
| |
| Sepsis | Infections and infestations | MeDRA Version 15.0 | Systematic Assessment |
| |
| Skin infection | Infections and infestations | MeDRA Version 15.0 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MeDRA Version 15.0 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MeDRA Version 15.0 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MeDRA Version 15.0 | Systematic Assessment |
| |
| Gastrointestinal haemorrhage | Gastrointestinal disorders | MeDRA Version 15.0 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MeDRA Version 15.0 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MeDRA Version 15.0 | Systematic Assessment |
| |
| Dyphagia | Gastrointestinal disorders | MeDRA Version 15.0 | Systematic Assessment |
| |
| Gastritis | Gastrointestinal disorders | MeDRA Version 15.0 | Systematic Assessment |
| |
| Ileus paralytic | Gastrointestinal disorders | MeDRA Version 15.0 | Systematic Assessment |
| |
| Small intestinal obstruction | Gastrointestinal disorders | MeDRA Version 15.0 | Systematic Assessment |
| |
| Upper gastrointestinal haemorrhage | Gastrointestinal disorders | MeDRA Version 15.0 | Systematic Assessment |
| |
| Pyrexia | General disorders | MeDRA Version 15.0 | Systematic Assessment |
| |
| Asthenia | General disorders | MeDRA Version 15.0 | Systematic Assessment |
| |
| Chest pain | General disorders | MeDRA Version 15.0 | Systematic Assessment |
| |
| General physical health deterioration | General disorders | MeDRA Version 15.0 | Systematic Assessment |
| |
| Malaise | General disorders | MeDRA Version 15.0 | Systematic Assessment |
| |
| Performance status decreased | General disorders | MeDRA Version 15.0 | Systematic Assessment |
| |
| Cardiac arrest | Cardiac disorders | MeDRA Version 15.0 | Systematic Assessment |
| |
| Arrhythmia | Cardiac disorders | MeDRA Version 15.0 | Systematic Assessment |
| |
| Atrial flutter | Cardiac disorders | MeDRA Version 15.0 | Systematic Assessment |
| |
| Cardiac failure acute | Cardiac disorders | MeDRA Version 15.0 | Systematic Assessment |
| |
| Extrasystoles | Cardiac disorders | MeDRA Version 15.0 | Systematic Assessment |
| |
| Pericarditis | Cardiac disorders | MeDRA Version 15.0 | Systematic Assessment |
| |
| Cerebrovascular accident | Nervous system disorders | MeDRA Version 15.0 | Systematic Assessment |
| |
| Diabetic neuropathy | Nervous system disorders | MeDRA Version 15.0 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MeDRA Version 15.0 | Systematic Assessment |
| |
| Paraesthesia | Nervous system disorders | MeDRA Version 15.0 | Systematic Assessment |
| |
| Syncope | Nervous system disorders | MeDRA Version 15.0 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MeDRA Version 15.0 | Systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MeDRA Version 15.0 | Systematic Assessment |
| |
| Acute pulmonary oedema | Respiratory, thoracic and mediastinal disorders | MeDRA Version 15.0 | Systematic Assessment |
| |
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | MeDRA Version 15.0 | Systematic Assessment |
| |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MeDRA Version 15.0 | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MeDRA Version 15.0 | Systematic Assessment |
| |
| Deep vein thrombosis | Vascular disorders | MeDRA Version 15.0 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MeDRA Version 15.0 | Systematic Assessment |
| |
| Orthostatic hypotension | Vascular disorders | MeDRA Version 15.0 | Systematic Assessment |
| |
| Venous thrombosis | Vascular disorders | MeDRA Version 15.0 | Systematic Assessment |
| |
| Arthritis | Musculoskeletal and connective tissue disorders | MeDRA Version 15.0 | Systematic Assessment |
| |
| Lumbar spinal stenosis | Musculoskeletal and connective tissue disorders | MeDRA Version 15.0 | Systematic Assessment |
| |
| Muscle fatigue | Musculoskeletal and connective tissue disorders | MeDRA Version 15.0 | Systematic Assessment |
| |
| Muscular weakness | Musculoskeletal and connective tissue disorders | MeDRA Version 15.0 | Systematic Assessment |
| |
| Vertigo | Ear and labyrinth disorders | MeDRA Version 15.0 | Systematic Assessment |
| |
| Hyperphosphatasaemia | Metabolism and nutrition disorders | MeDRA Version 15.0 | Systematic Assessment |
| |
| Hypokalemia | Metabolism and nutrition disorders | MeDRA Version 15.0 | Systematic Assessment |
| |
| Hypomagnesaemia | Metabolism and nutrition disorders | MeDRA Version 15.0 | Systematic Assessment |
| |
| Retinal detachment | Eye disorders | MeDRA Version 15.0 | Systematic Assessment |
| |
| Contusion | Injury, poisoning and procedural complications | MeDRA Version 15.0 | Systematic Assessment |
| |
| International normalised ratio increased | Investigations | MeDRA Version 15.0 | Systematic Assessment |
| |
| Skin discoloration | Skin and subcutaneous tissue disorders | MeDRA Version 15.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Constipation | Gastrointestinal disorders | MeDRA Version 15.0 | Systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MeDRA Version 15.0 | Systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | MeDRA Version 15.0 | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MeDRA Version 15.0 | Systematic Assessment |
| |
| Peripheral sensory neuropathy | Nervous system disorders | MeDRA Version 15.0 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MeDRA Version 15.0 | Systematic Assessment |
| |
| Hypoaesthesia | Nervous system disorders | MeDRA Version 15.0 | Systematic Assessment |
| |
| Neuralgia | Nervous system disorders | MeDRA Version 15.0 | Systematic Assessment |
| |
| Dysgeusia | Nervous system disorders | MeDRA Version 15.0 | Systematic Assessment |
| |
| Fatigue | General disorders | MeDRA Version 15.0 | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MeDRA Version 15.0 | Systematic Assessment |
| |
| Chills | General disorders | MeDRA Version 15.0 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MeDRA Version 15.0 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MeDRA Version 15.0 | Systematic Assessment |
| |
| Bone pain | Musculoskeletal and connective tissue disorders | MeDRA Version 15.0 | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MeDRA Version 15.0 | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MeDRA Version 15.0 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MeDRA Version 15.0 | Systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MeDRA Version 15.0 | Systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | MeDRA Version 15.0 | Systematic Assessment |
| |
| Pruritis | Skin and subcutaneous tissue disorders | MeDRA Version 15.0 | Systematic Assessment |
| |
| Anaemia | Blood and lymphatic system disorders | MeDRA Version 15.0 | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MeDRA Version 15.0 | Systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MeDRA Version 15.0 | Systematic Assessment |
| |
| Hypophosphataemia | Metabolism and nutrition disorders | MeDRA Version 15.0 | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MeDRA Version 15.0 | Systematic Assessment |
| |
| Hepatic function abnormal | Hepatobiliary disorders | MeDRA Version 15.0 | Systematic Assessment |
| |
| Conjunctivitis | Eye disorders | MeDRA Version 15.0 | Systematic Assessment |
| |
| Weight decreased | Investigations | MeDRA Version 15.0 | Systematic Assessment |
|
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Helgi van de Velde | Johnson & Johnson Pharmaceutical Research & Development | HVDVELDE@ITS.JNJ.COM |
| ID | Term |
|---|---|
| D016403 | Lymphoma, Large B-Cell, Diffuse |
| ID | Term |
|---|---|
| D016393 | Lymphoma, B-Cell |
| D008228 | Lymphoma, Non-Hodgkin |
| D008223 | Lymphoma |
| 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 |
Not provided
Not provided
| ID | Term |
|---|---|
| D000069286 | Bortezomib |
| D000069283 | Rituximab |
| D003520 | Cyclophosphamide |
| D004317 | Doxorubicin |
| D011241 | Prednisone |
| D014750 | Vincristine |
| ID | Term |
|---|---|
| D001897 | Boronic Acids |
| D000148 | Acids, Noncarboxylic |
| D000143 | Acids |
| D007287 | Inorganic Chemicals |
| D001896 | Boron Compounds |
| D009930 | Organic Chemicals |
| D011719 | Pyrazines |
| D006573 | Heterocyclic Compounds, 1-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 |
| D010752 | Phosphoramide Mustards |
| D009588 | Nitrogen Mustard Compounds |
| D009150 | Mustard Compounds |
| D006846 | Hydrocarbons, Halogenated |
| D006838 | Hydrocarbons |
| D063088 | Phosphoramides |
| D009943 | Organophosphorus Compounds |
| D003630 | Daunorubicin |
| D018943 | Anthracyclines |
| D009279 | Naphthacenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D011083 | Polycyclic Compounds |
| D000617 | Aminoglycosides |
| D006027 | Glycosides |
| D002241 | Carbohydrates |
| D011244 | Pregnadienediols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D014748 | Vinca Alkaloids |
| D046948 | Secologanin Tryptamine Alkaloids |
| D026121 | Indole Alkaloids |
| D000470 | Alkaloids |
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D054836 | Indolizidines |
| D007212 | Indolizines |
Not provided
Not provided
| Male |
|
| Turkey |
|
| Korea, Republic of |
|
| Malaysia |
|
| Canada |
|
| India |
|
| Brazil |
|
| Argentina |
|
| Singapore |
|
| Mexico |
|
| Germany |
|
| Portugal |
|
| Italy |
|
| Czech Republic |
|
| Spain |
|
| France |
|
| Belgium |
|
| Ireland |
|
|
|
|
|
|
|