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This was a prospective, open-label, Phase III, multicenter, single-arm trial designed to assess the safety, pharmacokinetics, and pharmacodynamics of an alternative dosing rate of rituximab in previously untreated patients with diffuse large B-cell lymphoma (DLBCL) and follicular non-Hodgkin lymphoma (NHL).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Rituximab 375 mg/m^2 | Experimental | Patients received 6 or 8 21-day cycles of CHOP (cyclophosphamide, hydroxydaunorubicin [doxorubicin], Oncovin [vincristine], prednisone) or CVP (cyclophosphamide, vincristine, prednisone) in combination with rituximab 375 mg/m^2 administered by intravenous (IV) infusion on Day 1 of each cycle. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rituximab | Drug | During Cycle 1 rituximab was administered at an initial rate of 50 mg/hour. In the absence of infusion toxicity during Cycle 1, the infusion rate was escalated by 50 mg/h increments every 30 minutes to a maximum rate of 400 mg/hour. In case of infusion-related reactions, the infusion was interrupted or the infusion rate reduced. In case of Grade 3/4 infusion reactions, the rituximab infusion was discontinued and medical treatment provided. If the rituximab infusion in Cycle 1 was tolerated without a serious adverse event (AE) or Grade 3/4 infusion-related AE, as judged by the investigator, infusions in Cycle 2 onwards were administered as follows: 20% of the total dose was given over 30 minutes and the remaining 80% of the dose was given over the next 60 minutes, for a total infusion time of 90 minutes. Commercial preparations of rituximab were used. |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Patients Who Developed Grade 3 or 4 Infusion-related Reactions (IRR) Resulting From Faster Infusion of Rituximab During Days 1 and 2 of Cycle 2 | The percentage of patients who developed Grade 3 or 4 IRRs resulting from faster infusion of rituximab at Cycle 2 was assessed in patients who had previously received rituximab at the standard infusion rate without experiencing a Grade 3 or 4 IRR at Cycle 1. IRRs were a predefined list of Medical Dictionary for Regulatory Activities (MedDRA) terms for infusion-related adverse events occurring on the day of and/or the day after rituximab infusion. The list of IRR terms was compiled based on IRRs observed in the present and previous studies in which rituximab was infused at the standard rate. | Days 1 and 2 of Cycle 2 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Patients Who Had an Adverse Event of Any Grade or Seriousness During Cycle 1 | Cycle 1 | |
| Percentage of Patients Who Had an Adverse Event of Any Grade or Seriousness During Cycle 2 Through Cycle 6 or 8 (End of Study) | Cycle 2 through Cycle 6 or 8 (end of study) |
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Inclusion Criteria:
Exclusion Criteria:
* Clinically significant cardiovascular disease (eg, uncontrolled hypertension, myocardial infarction, unstable angina), New York Heart Association (NYHA) Classification Grade II or greater congestive heart failure, a ventricular arrhythmia requiring medication within 1 year prior to Day 1, or NYHA Grade II or greater peripheral vascular disease on Day 1 (first day of treatment)
Patients who meet any of the following criteria will be excluded from further study participation after Cycle 1:
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| Name | Affiliation | Role |
|---|---|---|
| Deborah Hurst, M.D. | Genentech, Inc. | Study Director |
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Of 451 enrolled patients, 26 withdrew before receiving treatment and are not included in the Baseline Characteristics nor any of the Outcome Measures.
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| ID | Title | Description |
|---|---|---|
| FG000 | Rituximab 375 mg/m^2 | Patients received 6 or 8 21-day cycles of CHOP (cyclophosphamide, hydroxydaunorubicin [doxorubicin], Oncovin [vincristine], prednisone) or CVP (cyclophosphamide, vincristine, prednisone) in combination with rituximab 375 mg/m^2 administered by intravenous (IV) infusion on Day 1 of each cycle. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Enrolled in Study |
|
Not provided
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Not provided
|
| CHOP (cyclophosphamide, hydroxydaunorubicin [doxorubicin], Oncovin [vincristine], prednisone) | Drug | Commercial preparations of CHOP were used. Prednisone was administered prior to rituximab infusion. |
|
| CVP (cyclophosphamide, vincristine, prednisone) | Drug | Commercial preparations of CVP were used. Prednisone was administered prior to rituximab infusion. |
|
| Analgesic/antipyretic and antihistamine drugs | Drug | An analgesic/antipyretic (eg, acetaminophen) and an antihistamine (eg, diphenhydramine) were administered 30 minutes before each infusion of rituximab. |
|
| Duration of Rituximab Infusion Including Dose Interruption Times | The median duration of the rituximab infusion on Day 1 of each cycle, including the duration of dose interruptions, is reported. | Day 1 of each of Cycles 1 to 6 or 8 |
| Maximum Serum Concentration (Cmax) of Rituximab Post-dose at the First Alternative Dosing Rate (Cycle 2) and the Last Cycle (Either Cycle 6 or 8) | Serum samples for rituximab pharmacokinetic analysis were taken pre-dose (within 15 minutes before rituximab infusion) and post-dose (within 15 minutes after the end of the rituximab infusion) after the first faster infusion (Cycle 2) and after the last infusion (either Cycle 6 or 8). An enzyme-linked immunosorbent assay (ELISA) was used to measure rituximab levels in the serum samples. | Day 1 of Cycles 2 and either 6 or 8 (last cycle) |
| Percentage of Patients Who Had Undetectable Levels of CD19+ Lymphocytes at Cycle 2 and Either Cycle 6 or 8 (Last Cycle) | Serum samples for measurement of CD19+ lymphocytes were taken pre-dose (within 15 minutes before rituximab infusion). CD19+ lymphocyte counts were measured by flow cytometry using a fluorescent-activated cell sorter (FACS). | Day 1 of Cycle 2 and either Cycle 6 or 8 (last cycle) |
| COMPLETED |
|
| NOT COMPLETED |
|
|
| Received Cycle 1 Treatment |
|
|
| Received Cycle 2 Treatment |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Rituximab 375 mg/m^2 | Patients received 6 or 8 21-day cycles of CHOP (cyclophosphamide, hydroxydaunorubicin [doxorubicin], Oncovin [vincristine], prednisone) or CVP (cyclophosphamide, vincristine, prednisone) in combination with rituximab 375 mg/m^2 administered by intravenous (IV) infusion on Day 1 of each cycle. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Demographic data are reported for the intent-to-treat (ITT) population which included all patients who received at least 1 dose of rituximab regardless of infusion rate. Of the 451 enrolled patients, 26 withdrew before receiving treatment and were not included in the ITT population. | Mean | Standard Deviation | years |
| ||||||||||||||||
| Sex: Female, Male | Demographic data are reported for the intent-to-treat (ITT) population which included all patients who received at least 1 dose of rituximab regardless of infusion rate. Of the 451 enrolled patients, 26 withdrew before receiving treatment and were not included in the ITT population. | Count of Participants | 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 | Percentage of Patients Who Developed Grade 3 or 4 Infusion-related Reactions (IRR) Resulting From Faster Infusion of Rituximab During Days 1 and 2 of Cycle 2 | The percentage of patients who developed Grade 3 or 4 IRRs resulting from faster infusion of rituximab at Cycle 2 was assessed in patients who had previously received rituximab at the standard infusion rate without experiencing a Grade 3 or 4 IRR at Cycle 1. IRRs were a predefined list of Medical Dictionary for Regulatory Activities (MedDRA) terms for infusion-related adverse events occurring on the day of and/or the day after rituximab infusion. The list of IRR terms was compiled based on IRRs observed in the present and previous studies in which rituximab was infused at the standard rate. | Per-protocol evaluable population: All patients who received rituximab by faster infusion in Cycle 2 and who did not experience a Grade 3 or 4 infusion-related reaction during the rituximab infusion given at the standard rate during Cycle 1. | Posted | Number | 95% Confidence Interval | Percentage of participants | Days 1 and 2 of Cycle 2 |
|
|
| |||||||||||||||||||||||||
| Secondary | Percentage of Patients Who Had an Adverse Event of Any Grade or Seriousness During Cycle 1 | Intent-to-treat (ITT) population: All patients who received at least 1 dose of rituximab regardless of infusion rate. | Posted | Number | Percentage of participants | Cycle 1 |
|
| ||||||||||||||||||||||||||||
| Secondary | Percentage of Patients Who Had an Adverse Event of Any Grade or Seriousness During Cycle 2 Through Cycle 6 or 8 (End of Study) | Per-protocol evaluable population: All patients who received rituximab by faster infusion in Cycle 2 and who did not experience a Grade 3 or 4 infusion-related reaction during the rituximab infusion given at the standard rate during Cycle 1. | Posted | Number | Percentage of participants | Cycle 2 through Cycle 6 or 8 (end of study) |
|
| ||||||||||||||||||||||||||||
| Secondary | Duration of Rituximab Infusion Including Dose Interruption Times | The median duration of the rituximab infusion on Day 1 of each cycle, including the duration of dose interruptions, is reported. | Per-protocol evaluable population: All patients who received rituximab by faster infusion in Cycle 2 and who did not experience a Grade 3 or 4 infusion-related reaction during the rituximab infusion given at the standard rate during Cycle 1. | Posted | Median | Inter-Quartile Range | Minutes | Day 1 of each of Cycles 1 to 6 or 8 |
|
| ||||||||||||||||||||||||||
| Secondary | Maximum Serum Concentration (Cmax) of Rituximab Post-dose at the First Alternative Dosing Rate (Cycle 2) and the Last Cycle (Either Cycle 6 or 8) | Serum samples for rituximab pharmacokinetic analysis were taken pre-dose (within 15 minutes before rituximab infusion) and post-dose (within 15 minutes after the end of the rituximab infusion) after the first faster infusion (Cycle 2) and after the last infusion (either Cycle 6 or 8). An enzyme-linked immunosorbent assay (ELISA) was used to measure rituximab levels in the serum samples. | Pharmacokinetic evaluable population: All patients who received at least 1 infusion of rituximab and had rituximab concentration data. | Posted | Mean | Standard Deviation | µg/mL | Day 1 of Cycles 2 and either 6 or 8 (last cycle) |
|
| ||||||||||||||||||||||||||
| Secondary | Percentage of Patients Who Had Undetectable Levels of CD19+ Lymphocytes at Cycle 2 and Either Cycle 6 or 8 (Last Cycle) | Serum samples for measurement of CD19+ lymphocytes were taken pre-dose (within 15 minutes before rituximab infusion). CD19+ lymphocyte counts were measured by flow cytometry using a fluorescent-activated cell sorter (FACS). | Per-protocol evaluable population: All patients who received rituximab by faster infusion in Cycle 2 and who did not experience a Grade 3 or 4 infusion-related reaction during the rituximab infusion given at the standard rate during Cycle 1. Only patients with pre-dose CD19+ lymphocyte counts at each time point were included in the analyses. | Posted | Number | Percentage of participants | Day 1 of Cycle 2 and either Cycle 6 or 8 (last cycle) |
|
|
Adverse events and serious adverse events were recorded from the start of study treatment until 30 days following the last administration of study treatment or at study discontinuation/early termination, whichever occurred earlier.
Adverse events are reported for the intent-to-treat (ITT) population which included all patients who received at least 1 dose of rituximab, regardless of infusion rate.
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 | Rituximab 375 mg/m^2 | Patients received 6 or 8 21-day cycles of CHOP (cyclophosphamide, hydroxydaunorubicin [doxorubicin], Oncovin [vincristine], prednisone) or CVP (cyclophosphamide, vincristine, prednisone) in combination with rituximab 375 mg/m^2 administered by intravenous (IV) infusion on Day 1 of each cycle. | 107 | 425 | 421 | 425 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA (14.0) | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA (14.0) | Systematic Assessment |
| |
| Pancytopenia | Blood and lymphatic system disorders | MedDRA (14.0) | Systematic Assessment |
| |
| Anaemia | Blood and lymphatic system disorders | MedDRA (14.0) | Systematic Assessment |
| |
| Leukopenia | Blood and lymphatic system disorders | MedDRA (14.0) | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA (14.0) | Systematic Assessment |
| |
| Cardiac arrest | Cardiac disorders | MedDRA (14.0) | Systematic Assessment |
| |
| Ventricular tachycardia | Cardiac disorders | MedDRA (14.0) | Systematic Assessment |
| |
| Cardiac failure congestive | Cardiac disorders | MedDRA (14.0) | Systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MedDRA (14.0) | Systematic Assessment |
| |
| Cardiomyopathy | Cardiac disorders | MedDRA (14.0) | Systematic Assessment |
| |
| Acute myocardial infarction | Cardiac disorders | MedDRA (14.0) | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA (14.0) | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA (14.0) | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA (14.0) | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA (14.0) | Systematic Assessment |
| |
| Small intestinal obstruction | Gastrointestinal disorders | MedDRA (14.0) | Systematic Assessment |
| |
| Pancreatitis | Gastrointestinal disorders | MedDRA (14.0) | Systematic Assessment |
| |
| Colitis | Gastrointestinal disorders | MedDRA (14.0) | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA (14.0) | Systematic Assessment |
| |
| Faecaloma | Gastrointestinal disorders | MedDRA (14.0) | Systematic Assessment |
| |
| Gastric perforation | Gastrointestinal disorders | MedDRA (14.0) | Systematic Assessment |
| |
| Gastritis | Gastrointestinal disorders | MedDRA (14.0) | Systematic Assessment |
| |
| Intestinal mass | Gastrointestinal disorders | MedDRA (14.0) | Systematic Assessment |
| |
| Dysphagia | Gastrointestinal disorders | MedDRA (14.0) | Systematic Assessment |
| |
| Haemorrhoids | Gastrointestinal disorders | MedDRA (14.0) | Systematic Assessment |
| |
| Small intestinal perforation | Gastrointestinal disorders | MedDRA (14.0) | Systematic Assessment |
| |
| Colonic obstruction | Gastrointestinal disorders | MedDRA (14.0) | Systematic Assessment |
| |
| Megacolon | Gastrointestinal disorders | MedDRA (14.0) | Systematic Assessment |
| |
| Gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA (14.0) | Systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | MedDRA (14.0) | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA (14.0) | Systematic Assessment |
| |
| Chest pain | General disorders | MedDRA (14.0) | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA (14.0) | Systematic Assessment |
| |
| Hepatic failure | Hepatobiliary disorders | MedDRA (14.0) | Systematic Assessment |
| |
| Ischaemic hepatitis | Hepatobiliary disorders | MedDRA (14.0) | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA (14.0) | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA (14.0) | Systematic Assessment |
| |
| Lung infection | Infections and infestations | MedDRA (14.0) | Systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA (14.0) | Systematic Assessment |
| |
| Device related sepsis | Infections and infestations | MedDRA (14.0) | Systematic Assessment |
| |
| Fungal sepsis | Infections and infestations | MedDRA (14.0) | Systematic Assessment |
| |
| Neutropenic sepsis | Infections and infestations | MedDRA (14.0) | Systematic Assessment |
| |
| Septic shock | Infections and infestations | MedDRA (14.0) | Systematic Assessment |
| |
| Staphylococcal infection | Infections and infestations | MedDRA (14.0) | Systematic Assessment |
| |
| Staphylococcal sepsis | Infections and infestations | MedDRA (14.0) | Systematic Assessment |
| |
| Pseudomonal sepsis | Infections and infestations | MedDRA (14.0) | Systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA (14.0) | Systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA (14.0) | Systematic Assessment |
| |
| Mastitis | Infections and infestations | MedDRA (14.0) | Systematic Assessment |
| |
| Meningitis aseptic | Infections and infestations | MedDRA (14.0) | Systematic Assessment |
| |
| Hepatitis B | Infections and infestations | MedDRA (14.0) | Systematic Assessment |
| |
| Herpes zoster | Infections and infestations | MedDRA (14.0) | Systematic Assessment |
| |
| Streptococcal bacteraemia | Infections and infestations | MedDRA (14.0) | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA (14.0) | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA (14.0) | Systematic Assessment |
| |
| Wound dehiscence | Injury, poisoning and procedural complications | MedDRA (14.0) | Systematic Assessment |
| |
| Accidental overdose | Injury, poisoning and procedural complications | MedDRA (14.0) | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA (14.0) | Systematic Assessment |
| |
| Failure to thrive | Metabolism and nutrition disorders | MedDRA (14.0) | Systematic Assessment |
| |
| Malnutrition | Metabolism and nutrition disorders | MedDRA (14.0) | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA (14.0) | Systematic Assessment |
| |
| Hypercalcaemia | Metabolism and nutrition disorders | MedDRA (14.0) | Systematic Assessment |
| |
| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA (14.0) | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA (14.0) | Systematic Assessment |
| |
| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA (14.0) | Systematic Assessment |
| |
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA (14.0) | Systematic Assessment |
| |
| Breast cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (14.0) | Systematic Assessment |
| |
| Lymphoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (14.0) | Systematic Assessment |
| |
| Cerebrovascular accident | Nervous system disorders | MedDRA (14.0) | Systematic Assessment |
| |
| Cerebral ischaemia | Nervous system disorders | MedDRA (14.0) | Systematic Assessment |
| |
| Convulsion | Nervous system disorders | MedDRA (14.0) | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA (14.0) | Systematic Assessment |
| |
| Renal failure | Renal and urinary disorders | MedDRA (14.0) | Systematic Assessment |
| |
| Renal failure acute | Renal and urinary disorders | MedDRA (14.0) | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (14.0) | Systematic Assessment |
| |
| Respiratory distress | Respiratory, thoracic and mediastinal disorders | MedDRA (14.0) | Systematic Assessment |
| |
| Acute respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA (14.0) | Systematic Assessment |
| |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA (14.0) | Systematic Assessment |
| |
| Pneumonia aspiration | Respiratory, thoracic and mediastinal disorders | MedDRA (14.0) | Systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA (14.0) | Systematic Assessment |
| |
| Deep vein thrombosis | Vascular disorders | MedDRA (14.0) | Systematic Assessment |
| |
| Jugular vein thrombosis | Vascular disorders | MedDRA (14.0) | Systematic Assessment |
| |
| Venous thrombosis limb | Vascular disorders | MedDRA (14.0) | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA (14.0) | Systematic Assessment |
| |
| Orthostatic hypotension | Vascular disorders | MedDRA (14.0) | Systematic Assessment |
| |
| Thrombosis | Vascular disorders | MedDRA (14.0) | Systematic Assessment |
| |
| Superior vena cava syndrome | Vascular disorders | MedDRA (14.0) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Neutropenia | Blood and lymphatic system disorders | MedDRA (14.0) | Systematic Assessment |
| |
| Anaemia | Blood and lymphatic system disorders | MedDRA (14.0) | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA (14.0) | Systematic Assessment |
| |
| Leukopenia | Blood and lymphatic system disorders | MedDRA (14.0) | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA (14.0) | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA (14.0) | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA (14.0) | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA (14.0) | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA (14.0) | Systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA (14.0) | Systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | MedDRA (14.0) | Systematic Assessment |
| |
| Dry mouth | Gastrointestinal disorders | MedDRA (14.0) | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA (14.0) | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA (14.0) | Systematic Assessment |
| |
| Pain | General disorders | MedDRA (14.0) | Systematic Assessment |
| |
| Chest pain | General disorders | MedDRA (14.0) | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA (14.0) | Systematic Assessment |
| |
| Chills | General disorders | MedDRA (14.0) | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA (14.0) | Systematic Assessment |
| |
| Mucosal inflammation | General disorders | MedDRA (14.0) | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA (14.0) | Systematic Assessment |
| |
| Candidiasis | Infections and infestations | MedDRA (14.0) | Systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA (14.0) | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA (14.0) | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA (14.0) | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA (14.0) | Systematic Assessment |
| |
| Hypomagnesaemia | Metabolism and nutrition disorders | MedDRA (14.0) | Systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA (14.0) | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (14.0) | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA (14.0) | Systematic Assessment |
| |
| Bone pain | Musculoskeletal and connective tissue disorders | MedDRA (14.0) | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (14.0) | Systematic Assessment |
| |
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA (14.0) | Systematic Assessment |
| |
| Neuropathy peripheral | Nervous system disorders | MedDRA (14.0) | Systematic Assessment |
| |
| Peripheral sensory neuropathy | Nervous system disorders | MedDRA (14.0) | Systematic Assessment |
| |
| Dysgeusia | Nervous system disorders | MedDRA (14.0) | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA (14.0) | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA (14.0) | Systematic Assessment |
| |
| Paraesthesia | Nervous system disorders | MedDRA (14.0) | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA (14.0) | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA (14.0) | Systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA (14.0) | Systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA (14.0) | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (14.0) | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (14.0) | Systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA (14.0) | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA (14.0) | Systematic Assessment |
| |
| Hyperhidrosis | Skin and subcutaneous tissue disorders | MedDRA (14.0) | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA (14.0) | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA (14.0) | 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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Medical Communications | Genentech, Inc. | 800-821-8590 |
| ID | Term |
|---|---|
| D008228 | Lymphoma, Non-Hodgkin |
| ID | Term |
|---|---|
| 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 |
|---|---|
| D000069283 | Rituximab |
| D003520 | Cyclophosphamide |
| D004317 | Doxorubicin |
| D014750 | Vincristine |
| D011241 | Prednisone |
| C034588 | COP protocol 2 |
| D000700 | Analgesics |
| D058633 | Antipyretics |
| D006633 | Histamine Antagonists |
| ID | Term |
|---|---|
| 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 |
| D009930 | Organic Chemicals |
| 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 |
| D014748 | Vinca Alkaloids |
| D046948 | Secologanin Tryptamine Alkaloids |
| D026121 | Indole Alkaloids |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D054836 | Indolizidines |
| D007212 | Indolizines |
| D011244 | Pregnadienediols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D018689 | Sensory System Agents |
| D018373 | Peripheral Nervous System Agents |
| D045505 | Physiological Effects of Drugs |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
| D002491 | Central Nervous System Agents |
| D045506 | Therapeutic Uses |
| D018494 | Histamine Agents |
| D018377 | Neurotransmitter Agents |
| D045504 | Molecular Mechanisms of Pharmacological Action |
Not provided
Not provided
| Physician decision to withdraw patient |
|
| Subject decision to withdraw |
|
| Various Reasons |
|
| Lost to Follow-up |
|
| Physician decision to withdraw patient |
|
| Subject decision to withdraw |
|
| Various Reasons |
|
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