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This single arm study will evaluate the efficacy and safety of MabThera monotherapy in patients with refractory, relapsing or chronic idiopathic thrombocytopenic purpura (ITP). Patients will receive infusions of MabThera 1000mg i.v. on days 1 and 15. The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| rituximab [MabThera/Rituxan] | Drug | 1000mg iv on days 1 and 15 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Achieving a Complete Hematological Response (CR) or Confirmed Partial Hematological Response (PR) | Percentage of participants with an overall response at Week 8 achieving a CR or PR as evaluated by platelets, new or increased Idiopathic Thrombocytopenic Purpura (ITP)-related treatments and corticosteroids given for Adverse Events (AEs). CR was defined as a platelet count of greater than (>) 150x10^9/ liters (L) over at least 2 consecutive measurements at least 2 weeks apart, but no more than 60 days apart, with no increase in concomitant ITP therapy or initiation of new ITP therapy. PR was defined as platelet count of >50x10^9/L over at least 2 consecutive measurements at least <2 weeks apart, but no more than 60 days apart, with no increase in concomitant ITP therapy or initiation of new ITP therapy. Overall response rate (participants who achieved CR or confirmed PR) was evaluated using platelets, new or increased ITP related treatments, and corticosteroids given for AEs. | Week 8 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Hematological CR, PR, or Minor Response (MR) | Percentage of participants with CR, PR, and MR at Week 8 as evaluated by platelet count where CR is greater than or equal to (≥)150x10^9/L, PR ≥ 50x10^9/L, MR equals (=) 30x10^9/L over 2 consecutive measurements at least 2 weeks apart but no more than 60 days apart with no increase in concomitant therapy or initiation of new ITP therapy. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Hoffmann-La Roche | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Adelaide | New South Wales | 5011 | Australia | |||
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| ID | Title | Description |
|---|---|---|
| FG000 | Rituximab | Participants received rituximab 1000 milligrams (mg) intravenously (IV) on Days 1 and 15. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Week 8 |
| Percentage of Participants Who Achieved CR | CR was defined as platelet counts >150x10^9/L over ≥2 consecutive measurements ≥2 weeks apart, but no more than 60 days apart, and with no increase in concomitant ITP therapy or initiation of new ITP therapy. | Week 52 |
| Time to CR | Time to CR was defined as the time from the first infusion to the first date on which CR was achieved. CR was defined as platelet counts >150x10^9/L over ≥2 consecutive measurements ≥2 weeks apart, but no more than 60 days apart, and with no increase in concomitant ITP therapy or initiation of new ITP therapy. Participants without an event were censored at the date of last assessment. | Baseline to Week 52 |
| Percentage of Participants Who Achieved PR | PR was defined as platelet counts >50x10^9/L over ≥2 consecutive measurements ≥2 weeks apart, but no more than 60 days apart, with no increase in concomitant ITP therapy or initiation of new ITP therapy. | Week 52 |
| Time to PR | Time to response was defined as the time from the first infusion to the first date on which PR was achieved. PR was defined as platelet counts > 50x10^9/L over ≥ 2 consecutive measurements ≥ 2 weeks apart, but no more than 60 days apart, with no increase in concomitant ITP therapy or initiation of new ITP therapy. | Baseline to Week 52 |
| Percentage of Participants Who Achieved MR | MR was defined as participants registered with chronic ITP with a platelet count of >30x10^9/L over ≥2 consecutive measurements ≥2 weeks apart, but no more than 60 days apart, with a 50 to 100% reduction in the dose intensity of concomitant ITP therapy compared with that at screening, and with no increase in concomitant ITP therapy or initiation of new ITP therapy. | Week 52 |
| Time to MR | Time to response was defined as the time from the first infusion to the first date on which MR was achieved. MR was defined as participants registered with chronic ITP with a platelet count of >30x10^9/L over ≥2 consecutive measurements ≥2 weeks apart, but no more than 60 days apart, with a 50 percent (%) to 100% reduction in the dose intensity of concomitant ITP therapy compared with that at screening, and with no increase in concomitant ITP therapy or initiation of new ITP therapy. | Baseline to Week 52 |
| Percentage of Participants With Continued CR From Week 8 to Week 52 | The number of participants with a durable CR assessed in CR responders whose responses were sustained from Week 8 through to the end of the study or withdrawal, irrespective of change of treatment. CR was defined as platelet counts >150x10^9/L over ≥2 consecutive measurements ≥ 2 weeks apart, but no more than 60 days apart, and with no increase in concomitant ITP therapy or initiation of new ITP therapy. | Week 8 to Week 52 |
| Duration of CR in Participants With Continued CR From Week 8 Until Week 52 | Duration of response was assessed in all responders who reached Week 8 and was defined as the time from Week 8 to the end of CR, irrespective of change of treatment. CR was defined as platelet counts >150x10^9/L over ≥2 consecutive measurements ≥2 weeks apart, but no more than 60 days apart, and with no increase in concomitant ITP therapy or initiation of new ITP therapy. | Week 8 to Week 52 |
| Duration of PR in Participants With Continued PR From Week 8 Until Week 52 | Duration of PR was assessed in all responders who reached Week 8 and was defined as the time from Week 8 to the end of PR, irrespective of change of treatment. PR was defined as platelet counts >50x10^9/L over ≥2 consecutive measurements ≥2 weeks apart, but no more than 60 days apart, with no increase in concomitant ITP therapy or initiation of new ITP therapy. | Week 8 to Week 52 |
| Duration of MR in Participants With Continued MR From Week 8 Until Week 52 | Duration of response was assessed in all responders who reached Week 8 and was defined as the time from Week 8 to the end of MR, irrespective of change of treatment. MR was defined as participants registered with ITP in relapse with a platelet count of > 30x10^9/L over ≥2 consecutive measurements ≥2 weeks apart, but no more than 60 days apart, with no increase in concomitant ITP therapy or initiation of new ITP therapy. Participants registered with chronic ITP with a platelet count of >30x10^9/L over ≥2 consecutive measurements ≥2 weeks apart, but no more than 60 days apart, with a 50% to 100% reduction in the dose intensity of concomitant ITP therapy compared with that at screening, and with no increase in concomitant ITP therapy or initiation of new ITP therapy. | Week 8 to Week 52 |
| Time to Inititiation of New ITP Therapy - Percentage of Participants With an Event | Percentage of participants with an event of initiation of new ITP therapy and/or increase in dose of existing ITP therapy, including date on which decision made in relation to splenectomy, from time of first treatment to Week 52. | Week 52 |
| Time to Initiation of New ITP Therapy | Median time in days to initiation of new ITP therapy and/or increase in dose of existing ITP therapy, including date on which decision made in relation to splenectomy, from time of first treatment to Week 52. | Baseline to Week 52 |
| Percentage of Therapeutic Responders | Percentage of participants with a therapeutic response, defined as achieving CR, PR, or MR assessed at Week 26 and Week 52 or hematological response, defined as achieving CR, PR, or MR at Week 8. CR was defined as no platelet response or no reduction in the dose intensity of concomitant ITP therapy compared with that at screening. PR response was defined as at least a minor platelet response that enabled a 50% to 99% reduction in the dose intensity of concomitant ITP therapy compared with that at screening. MR was defined as at least a minor platelet response that enabled a 1% to 49% reduction in the dose intensity of concomitant ITP therapy compared with that at screening. | Week 26 and Week 52 |
| Percentage of Participants With a Therapeutic Response | Number of therapeutic responder participants by CR, PR, MR, or no response (NR) measured at Week 26 and Week 52. CR was defined as no platelet response or no reduction in the dose intensity of concomitant ITP therapy compared with that at screening. PR was defined as at least minor platelet response that enabled a 50% to 99% reduction in the dose intensity of concomitant ITP therapy compared with that at screening. MR was defined as at least minor platelet response that enabled a 1% to 49% reduction in the dose intensity of concomitant ITP therapy compared with that at screening. | Week 26 and Week 52 |
| Cluster of Differentiation 19 (CD19) B Cell Count | Value of mean CD19+ B cell count at baseline. The standard reference range for CD19 is 0.05 to 0.35 x10^9/L. | Baseline, Weeks 1, 3, and 8, Follow-up Months 4, 6, 8, 10, and 12, and Last Day |
| Change From Baseline in CD19 B Cell Count | Actual values of CD19+ mean B cell count assessed at Weeks 3 and 8, and Months 4, 6, 8, 10 and 12, and last day. The standard reference range for CD19 is 0.05 to 0.35 x10^9/L. | Weeks 3, 8 and Months 4, 6, 8, 10 and 12, and last day |
| Gosford |
| New South Wales |
| 2250 |
| Australia |
| Randwick | New South Wales | NSW 2031 | Australia |
| Sydney | New South Wales | 2139 | Australia |
| Sydney | New South Wales | 2747 | Australia |
| Westmead | New South Wales | 2145 | Australia |
| Woolloongabba | Queensland | 4102 | Australia |
| Adelaide | South Australia | 5042 | Australia |
| Frankston | Victoria | 3199 | Australia |
| Malvern | Victoria | 3144 | Australia |
| Melbourne | Victoria | 3168 | Australia |
| Parkville | Victoria | 3052 | Australia |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Safety population: all participants who received at least one dose of study medication and for whom follow-up safety information was available.
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| ID | Title | Description |
|---|---|---|
| BG000 | Rituximab | Participants received rituximab 1000 mg IV on Days 1 and 15. |
| 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 |
|
| 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 Participants Achieving a Complete Hematological Response (CR) or Confirmed Partial Hematological Response (PR) | Percentage of participants with an overall response at Week 8 achieving a CR or PR as evaluated by platelets, new or increased Idiopathic Thrombocytopenic Purpura (ITP)-related treatments and corticosteroids given for Adverse Events (AEs). CR was defined as a platelet count of greater than (>) 150x10^9/ liters (L) over at least 2 consecutive measurements at least 2 weeks apart, but no more than 60 days apart, with no increase in concomitant ITP therapy or initiation of new ITP therapy. PR was defined as platelet count of >50x10^9/L over at least 2 consecutive measurements at least <2 weeks apart, but no more than 60 days apart, with no increase in concomitant ITP therapy or initiation of new ITP therapy. Overall response rate (participants who achieved CR or confirmed PR) was evaluated using platelets, new or increased ITP related treatments, and corticosteroids given for AEs. | Intent-to-Treat Replaced (ITTR) Population: participants who received at least 1 dose of study medication, excluded those lost to follow-up before completing treatment (reasons other than disease progression/toxicity) and/or those without documented platelet count of less than or equal to (≤)50x10^9/L within 7 days prior to 1st rituximab infusion. | Posted | Number | 95% Confidence Interval | percentage of participants | Week 8 |
|
|
| |||||||||||||||||||||||||
| Secondary | Percentage of Participants With Hematological CR, PR, or Minor Response (MR) | Percentage of participants with CR, PR, and MR at Week 8 as evaluated by platelet count where CR is greater than or equal to (≥)150x10^9/L, PR ≥ 50x10^9/L, MR equals (=) 30x10^9/L over 2 consecutive measurements at least 2 weeks apart but no more than 60 days apart with no increase in concomitant therapy or initiation of new ITP therapy. | ITTR Population | Posted | Number | 95% Confidence Interval | percentage of participants | Week 8 |
|
| ||||||||||||||||||||||||||
| Secondary | Percentage of Participants Who Achieved CR | CR was defined as platelet counts >150x10^9/L over ≥2 consecutive measurements ≥2 weeks apart, but no more than 60 days apart, and with no increase in concomitant ITP therapy or initiation of new ITP therapy. | ITTR Population | Posted | Number | percentage of participants | Week 52 |
|
| |||||||||||||||||||||||||||
| Secondary | Time to CR | Time to CR was defined as the time from the first infusion to the first date on which CR was achieved. CR was defined as platelet counts >150x10^9/L over ≥2 consecutive measurements ≥2 weeks apart, but no more than 60 days apart, and with no increase in concomitant ITP therapy or initiation of new ITP therapy. Participants without an event were censored at the date of last assessment. | ITTR Population | Posted | Median | 95% Confidence Interval | days | Baseline to Week 52 |
|
| ||||||||||||||||||||||||||
| Secondary | Percentage of Participants Who Achieved PR | PR was defined as platelet counts >50x10^9/L over ≥2 consecutive measurements ≥2 weeks apart, but no more than 60 days apart, with no increase in concomitant ITP therapy or initiation of new ITP therapy. | ITTR Population | Posted | Number | percentage of participants | Week 52 |
|
| |||||||||||||||||||||||||||
| Secondary | Time to PR | Time to response was defined as the time from the first infusion to the first date on which PR was achieved. PR was defined as platelet counts > 50x10^9/L over ≥ 2 consecutive measurements ≥ 2 weeks apart, but no more than 60 days apart, with no increase in concomitant ITP therapy or initiation of new ITP therapy. | ITTR Population | Posted | Median | 95% Confidence Interval | days | Baseline to Week 52 |
|
| ||||||||||||||||||||||||||
| Secondary | Percentage of Participants Who Achieved MR | MR was defined as participants registered with chronic ITP with a platelet count of >30x10^9/L over ≥2 consecutive measurements ≥2 weeks apart, but no more than 60 days apart, with a 50 to 100% reduction in the dose intensity of concomitant ITP therapy compared with that at screening, and with no increase in concomitant ITP therapy or initiation of new ITP therapy. | ITTR Population | Posted | Number | percentage of participants | Week 52 |
|
| |||||||||||||||||||||||||||
| Secondary | Time to MR | Time to response was defined as the time from the first infusion to the first date on which MR was achieved. MR was defined as participants registered with chronic ITP with a platelet count of >30x10^9/L over ≥2 consecutive measurements ≥2 weeks apart, but no more than 60 days apart, with a 50 percent (%) to 100% reduction in the dose intensity of concomitant ITP therapy compared with that at screening, and with no increase in concomitant ITP therapy or initiation of new ITP therapy. | ITTR Population | Posted | Median | 95% Confidence Interval | days | Baseline to Week 52 |
|
| ||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Continued CR From Week 8 to Week 52 | The number of participants with a durable CR assessed in CR responders whose responses were sustained from Week 8 through to the end of the study or withdrawal, irrespective of change of treatment. CR was defined as platelet counts >150x10^9/L over ≥2 consecutive measurements ≥ 2 weeks apart, but no more than 60 days apart, and with no increase in concomitant ITP therapy or initiation of new ITP therapy. | ITTR Population; only participants with a CR at Week 8 were included in the analysis. | Posted | Number | percentage of participants | Week 8 to Week 52 |
|
| |||||||||||||||||||||||||||
| Secondary | Duration of CR in Participants With Continued CR From Week 8 Until Week 52 | Duration of response was assessed in all responders who reached Week 8 and was defined as the time from Week 8 to the end of CR, irrespective of change of treatment. CR was defined as platelet counts >150x10^9/L over ≥2 consecutive measurements ≥2 weeks apart, but no more than 60 days apart, and with no increase in concomitant ITP therapy or initiation of new ITP therapy. | ITTR Population; only participants with a CR at Week 8 were included in the analysis. | Posted | Median | 95% Confidence Interval | days | Week 8 to Week 52 |
|
| ||||||||||||||||||||||||||
| Secondary | Duration of PR in Participants With Continued PR From Week 8 Until Week 52 | Duration of PR was assessed in all responders who reached Week 8 and was defined as the time from Week 8 to the end of PR, irrespective of change of treatment. PR was defined as platelet counts >50x10^9/L over ≥2 consecutive measurements ≥2 weeks apart, but no more than 60 days apart, with no increase in concomitant ITP therapy or initiation of new ITP therapy. | ITTR Population | Posted | Median | 95% Confidence Interval | days | Week 8 to Week 52 |
|
| ||||||||||||||||||||||||||
| Secondary | Duration of MR in Participants With Continued MR From Week 8 Until Week 52 | Duration of response was assessed in all responders who reached Week 8 and was defined as the time from Week 8 to the end of MR, irrespective of change of treatment. MR was defined as participants registered with ITP in relapse with a platelet count of > 30x10^9/L over ≥2 consecutive measurements ≥2 weeks apart, but no more than 60 days apart, with no increase in concomitant ITP therapy or initiation of new ITP therapy. Participants registered with chronic ITP with a platelet count of >30x10^9/L over ≥2 consecutive measurements ≥2 weeks apart, but no more than 60 days apart, with a 50% to 100% reduction in the dose intensity of concomitant ITP therapy compared with that at screening, and with no increase in concomitant ITP therapy or initiation of new ITP therapy. | ITTR Population | Posted | Median | 95% Confidence Interval | days | Week 8 to Week 52 |
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| Secondary | Time to Inititiation of New ITP Therapy - Percentage of Participants With an Event | Percentage of participants with an event of initiation of new ITP therapy and/or increase in dose of existing ITP therapy, including date on which decision made in relation to splenectomy, from time of first treatment to Week 52. | ITTR Population | Posted | Number | percentage of participants | Week 52 |
|
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| Secondary | Time to Initiation of New ITP Therapy | Median time in days to initiation of new ITP therapy and/or increase in dose of existing ITP therapy, including date on which decision made in relation to splenectomy, from time of first treatment to Week 52. | ITTR Population | Posted | Median | 95% Confidence Interval | days | Baseline to Week 52 |
|
| ||||||||||||||||||||||||||
| Secondary | Percentage of Therapeutic Responders | Percentage of participants with a therapeutic response, defined as achieving CR, PR, or MR assessed at Week 26 and Week 52 or hematological response, defined as achieving CR, PR, or MR at Week 8. CR was defined as no platelet response or no reduction in the dose intensity of concomitant ITP therapy compared with that at screening. PR response was defined as at least a minor platelet response that enabled a 50% to 99% reduction in the dose intensity of concomitant ITP therapy compared with that at screening. MR was defined as at least a minor platelet response that enabled a 1% to 49% reduction in the dose intensity of concomitant ITP therapy compared with that at screening. | ITTR Population | Posted | Number | percentage of participants | Week 26 and Week 52 |
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| Secondary | Percentage of Participants With a Therapeutic Response | Number of therapeutic responder participants by CR, PR, MR, or no response (NR) measured at Week 26 and Week 52. CR was defined as no platelet response or no reduction in the dose intensity of concomitant ITP therapy compared with that at screening. PR was defined as at least minor platelet response that enabled a 50% to 99% reduction in the dose intensity of concomitant ITP therapy compared with that at screening. MR was defined as at least minor platelet response that enabled a 1% to 49% reduction in the dose intensity of concomitant ITP therapy compared with that at screening. | ITTR Population | Posted | Number | 95% Confidence Interval | percentage participants | Week 26 and Week 52 |
|
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| Secondary | Cluster of Differentiation 19 (CD19) B Cell Count | Value of mean CD19+ B cell count at baseline. The standard reference range for CD19 is 0.05 to 0.35 x10^9/L. | Safety Analysis Population; n (number) = number of participants assessed for the specified parameter at a given visit. | Posted | Mean | Standard Deviation | 10^9 cells/L | Baseline, Weeks 1, 3, and 8, Follow-up Months 4, 6, 8, 10, and 12, and Last Day |
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| Secondary | Change From Baseline in CD19 B Cell Count | Actual values of CD19+ mean B cell count assessed at Weeks 3 and 8, and Months 4, 6, 8, 10 and 12, and last day. The standard reference range for CD19 is 0.05 to 0.35 x10^9/L. | Safety Analysis Population; n=number of participants assessed for the specified parameter at a given visit. | Posted | Mean | Standard Deviation | 10^9 cells/L | Weeks 3, 8 and Months 4, 6, 8, 10 and 12, and last day |
|
|
Up to Week 52
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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 | Rituximab 1000 mg | Participants received rituximab 1000 mg IV on Days 1 and 15. | 12 | 122 | 62 | 122 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Asbestosis | Injury, poisoning and procedural complications | MedDRA (14.1) | Non-systematic Assessment |
| |
| Spinal Compression Fracture | Injury, poisoning and procedural complications | MedDRA (14.1) | Non-systematic Assessment |
| |
| Spinal Fracture | Injury, poisoning and procedural complications | MedDRA (14.1) | Non-systematic Assessment |
| |
| Subdural Haematoma | Injury, poisoning and procedural complications | MedDRA (14.1) | Non-systematic Assessment |
| |
| Subdural Haemorrhage | Injury, poisoning and procedural complications | MedDRA (14.1) | Non-systematic Assessment |
| |
| Back Pain | Musculoskeletal and connective tissue disorders | MedDRA (14.1) | Non-systematic Assessment |
| |
| Osteoporosis | Musculoskeletal and connective tissue disorders | MedDRA (14.1) | Non-systematic Assessment |
| |
| Pain in Extremity | Musculoskeletal and connective tissue disorders | MedDRA (14.1) | Non-systematic Assessment |
| |
| Lower Respiratory Tract Infection | Infections and infestations | MedDRA (14.1) | Non-systematic Assessment |
| |
| Streptococcal Bacteraemia | Infections and infestations | MedDRA (14.1) | Non-systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA (14.1) | Non-systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA (14.1) | Non-systematic Assessment |
| |
| Platelet Count Decreased | Investigations | MedDRA (14.1) | Non-systematic Assessment |
| |
| Respiratory Failure | Respiratory, thoracic and mediastinal disorders | MedDRA (14.1) | Non-systematic Assessment |
| |
| Haemorrhage | Vascular disorders | MedDRA (14.1) | Non-systematic Assessment |
| |
| Pneumocystis jiroveci pneumonia | Infections and infestations | MedDRA (14.1) | Non-systematic Assessment |
| |
| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA (14.1) | Non-systematic Assessment |
| |
| Stress | Psychiatric disorders | MedDRA (14.1) | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nasopharyngitis | Infections and infestations | MedDRA (14.1) | Non-systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA (14.1) | Non-systematic Assessment |
| |
| Respiratory tract infection | Infections and infestations | MedDRA (14.1) | Non-systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA (14.1) | Non-systematic Assessment |
| |
| Ear infection | Infections and infestations | MedDRA (14.1) | Non-systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA (14.1) | Non-systematic Assessment |
| |
| Gastroenteritis viral | Infections and infestations | MedDRA (14.1) | Non-systematic Assessment |
| |
| Pharyngitis | Infections and infestations | MedDRA (14.1) | Non-systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA (14.1) | Non-systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA (14.1) | Non-systematic Assessment |
| |
| Viral infection | Infections and infestations | MedDRA (14.1) | Non-systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA (14.1) | Non-systematic Assessment |
| |
| Gingival bleeding | Gastrointestinal disorders | MedDRA (14.1) | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA (14.1) | Non-systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA (14.1) | Non-systematic Assessment |
| |
| Gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA (14.1) | Non-systematic Assessment |
| |
| Gastrointestinal pain | Gastrointestinal disorders | MedDRA (14.1) | Non-systematic Assessment |
| |
| Abdominal distension | Gastrointestinal disorders | MedDRA (14.1) | Non-systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA (14.1) | Non-systematic Assessment |
| |
| Gingival pain | Gastrointestinal disorders | MedDRA (14.1) | Non-systematic Assessment |
| |
| Haematochezia | Gastrointestinal disorders | MedDRA (14.1) | Non-systematic Assessment |
| |
| Melaena | Gastrointestinal disorders | MedDRA (14.1) | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA (14.1) | Non-systematic Assessment |
| |
| Fatigue | General disorders | MedDRA (14.1) | Non-systematic Assessment |
| |
| Influenza like illness | General disorders | MedDRA (14.1) | Non-systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA (14.1) | Non-systematic Assessment |
| |
| Chest pain | General disorders | MedDRA (14.1) | Non-systematic Assessment |
| |
| Chills | General disorders | MedDRA (14.1) | Non-systematic Assessment |
| |
| Ill-defined disorder | General disorders | MedDRA (14.1) | Non-systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA (14.1) | Non-systematic Assessment |
| |
| Pain | General disorders | MedDRA (14.1) | Non-systematic Assessment |
| |
| Contusion | Injury, poisoning and procedural complications | MedDRA (14.1) | Non-systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA (14.1) | Non-systematic Assessment |
| |
| Incision site pain | Injury, poisoning and procedural complications | MedDRA (14.1) | Non-systematic Assessment |
| |
| Transfusion reaction | Injury, poisoning and procedural complications | MedDRA (14.1) | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA (14.1) | Non-systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA (14.1) | Non-systematic Assessment |
| |
| Lethargy | Nervous system disorders | MedDRA (14.1) | Non-systematic Assessment |
| |
| Cognitive disorder | Nervous system disorders | MedDRA (14.1) | Non-systematic Assessment |
| |
| Dysgeusia | Nervous system disorders | MedDRA (14.1) | Non-systematic Assessment |
| |
| Paraesthesia | Nervous system disorders | MedDRA (14.1) | Non-systematic Assessment |
| |
| Presyncope | Nervous system disorders | MedDRA (14.1) | Non-systematic Assessment |
| |
| Restless legs syndrome | Nervous system disorders | MedDRA (14.1) | Non-systematic Assessment |
| |
| Somnolence | Nervous system disorders | MedDRA (14.1) | Non-systematic Assessment |
| |
| Tremor | Nervous system disorders | MedDRA (14.1) | Non-systematic Assessment |
| |
| Petechiae | Skin and subcutaneous tissue disorders | MedDRA (14.1) | Non-systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA (14.1) | Non-systematic Assessment |
| |
| Urticaria | Skin and subcutaneous tissue disorders | MedDRA (14.1) | Non-systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA (14.1) | Non-systematic Assessment |
| |
| Skin pruritic | Skin and subcutaneous tissue disorders | MedDRA (14.1) | Non-systematic Assessment |
| |
| Skin exfoliation | Skin and subcutaneous tissue disorders | MedDRA (14.1) | Non-systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (14.1) | Non-systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA (14.1) | Non-systematic Assessment |
| |
| Arthritis | Musculoskeletal and connective tissue disorders | MedDRA (14.1) | Non-systematic Assessment |
| |
| Flank pain | Musculoskeletal and connective tissue disorders | MedDRA (14.1) | Non-systematic Assessment |
| |
| Joint stiffness | Musculoskeletal and connective tissue disorders | MedDRA (14.1) | Non-systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA (14.1) | Non-systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA (14.1) | Non-systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (14.1) | Non-systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (14.1) | Non-systematic Assessment |
| |
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA (14.1) | Non-systematic Assessment |
| |
| Haemorrhage | Vascular disorders | MedDRA (14.1) | Non-systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA (14.1) | Non-systematic Assessment |
| |
| Hot flush | Vascular disorders | MedDRA (14.1) | Non-systematic Assessment |
| |
| Vertigo | Ear and labyrinth disorders | MedDRA (14.1) | Non-systematic Assessment |
| |
| Ear haemorrhage | Ear and labyrinth disorders | MedDRA (14.1) | Non-systematic Assessment |
| |
| Ear pain | Ear and labyrinth disorders | MedDRA (14.1) | Non-systematic Assessment |
| |
| Platelet count decreased | Investigations | MedDRA (14.1) | Non-systematic Assessment |
| |
| Intraocular pressure increased | Investigations | MedDRA (14.1) | Non-systematic Assessment |
| |
| Hypersensitivity | Immune system disorders | MedDRA (14.1) | Non-systematic Assessment |
| |
| Seasonal allergy | Immune system disorders | MedDRA (14.1) | Non-systematic Assessment |
| |
| Serum sickness | Immune system disorders | MedDRA (14.1) | Non-systematic Assessment |
| |
| Vaginal haemorrhage | Reproductive system and breast disorders | MedDRA (14.1) | Non-systematic Assessment |
| |
| Breast haematoma | Reproductive system and breast disorders | MedDRA (14.1) | Non-systematic Assessment |
| |
| Eye pain | Eye disorders | MedDRA (14.1) | Non-systematic Assessment |
| |
| Eye swelling | Eye disorders | MedDRA (14.1) | Non-systematic Assessment |
| |
| Photophobia | Eye disorders | MedDRA (14.1) | Non-systematic Assessment |
| |
| Vision blurred | Eye disorders | MedDRA (14.1) | Non-systematic Assessment |
| |
| Lymphadenopathy | Blood and lymphatic system disorders | MedDRA (14.1) | Non-systematic Assessment |
| |
| Angina pectoris | Cardiac disorders | MedDRA (14.1) | Non-systematic Assessment |
| |
| Palpitation | Cardiac disorders | MedDRA (14.1) | Non-systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA (14.1) | Non-systematic Assessment |
| |
| Iron deficiency | Metabolism and nutrition disorders | MedDRA (14.1) | Non-systematic Assessment |
| |
| Jaundice cholestatic | Hepatobiliary disorders | MedDRA (14.1) | Non-systematic Assessment |
| |
| Myelodysplastic syndrome | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (14.1) | Non-systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA (14.1) | 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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Medical Communications | Hoffmann-LaRoche | 800-821-8590 | genentech@druginfo.com |
| ID | Term |
|---|---|
| D016553 | Purpura, Thrombocytopenic, Idiopathic |
| ID | Term |
|---|---|
| D011696 | Purpura, Thrombocytopenic |
| D011693 | Purpura |
| D001778 | Blood Coagulation Disorders |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D057049 | Thrombotic Microangiopathies |
| D013921 | Thrombocytopenia |
| D001791 | Blood Platelet Disorders |
| D000095542 | Cytopenia |
| D006474 | Hemorrhagic Disorders |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D006470 | Hemorrhage |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012877 | Skin Manifestations |
| D012816 | Signs and Symptoms |
Not provided
Not provided
| ID | Term |
|---|---|
| D000069283 | Rituximab |
| 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 |
Not provided
Not provided
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