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| ID | Type | Description | Link |
|---|---|---|---|
| 2010-024132-41 | EudraCT Number |
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| Name | Class |
|---|---|
| German Low Grade Lymphoma Study Group | OTHER |
| Institute of Cancer Research, United Kingdom | OTHER |
This open-label, randomized study will assess the efficacy and safety of obinutuzumab (RO5072759) in combination with chemotherapy compared to rituximab (MabThera/Rituxan) with chemotherapy followed by obinutuzumab or rituximab maintenance in participants with untreated advanced indolent non-Hodgkin's lymphoma. After the end of the induction period, participants achieving response (Complete response [CR] or partial response [PR]) will undergo a maintenance period continuing on the randomized antibody treatment alone every 2 months until disease progression for a total of 2 years. Anticipated time on study treatment is up to approximately 2.5 years. After maintenance or observation, participants will be followed for 5 years until progression. After progression, participants will be followed for new anti-lymphoma therapy and overall survival until the end of the study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Rituximab+Chemotherapy | Active Comparator | Participants will receive either 8 cycles of rituximab along with 6 cycles of cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) (21-day cycle) or 8 cycles of rituximab along with 8 cycles of cyclophosphamide, vincristine, and prednisone (CVP) (21-day cycles) or 6 cycles of rituximab along with 6 cycles of bendamustine (28-day cycle) during the induction period. The induction period will be followed by either a maintenance or observation period for responders or non-responders, respectively. Responders will receive rituximab monotherapy every 2 months for 2 years during the maintenance period. Non-responders will receive no protocol specified treatment during the 2-year observation period. Finally, participants will be followed during a 5-year follow-up period. The chemotherapy regimen (CHOP or CVP or bendamustine) for individual participant will be chosen by the site prior to initiation of the study. |
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| Obinutuzumab+Chemotherapy | Experimental | Participants will receive either 8 cycles of obinutuzumab along with 6 cycles of CHOP (21-day cycle) or 8 cycles of obinutuzumab along with 8 cycles of CVP (21-day cycles) or 6 cycles of obinutuzumab along with 6 cycles of bendamustine (28-day cycle) during induction period. The induction period will be followed by either a maintenance or observation period for responders or non-responders, respectively. Responders will receive obinutuzumab monotherapy every 2 months for 2 years during the maintenance period. Non-responders will receive no protocol specified treatment during the 2-year observation period. Finally, participants will be followed during a 5-year follow-up period. The chemotherapy regimen (CHOP or CVP or bendamustine) for individual participant will be chosen by the site prior to initiation of the study. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Obinutuzumab | Drug | Obinutuzumab 1000 milligrams (mg) intravenous (IV) infusion will be administered on Day 1, 8, and 15 of Cycle 1 and then on Day 1 of each subsequent cycle during induction period and obinutuzumab 1000 mg IV infusion every 2 months during maintenance period. |
| Measure | Description | Time Frame |
|---|---|---|
| Progression-Free Survival in the Follicular Lymphoma Population, Investigator-Assessed | Progression-free survival in participants with follicular lymphoma was defined as the time from randomization until the first documented day of disease progression or death from any cause, whichever occurred first, on the basis of investigator assessments according to the Revised Response Criteria for Malignant Lymphoma. Progression was defined as at least 50% increase in nodal lesions or >/=50% increase in any node > 1 centimeter (cm) or >/= 50% increase in other target measurable lesions (e.g., splenic or hepatic nodules) and/or appearance of any new bone marrow involvement and/or appearance of any new lesion > 1.5 cm or >/= 50% increase in any previously involved node with a diameter </= 1 cm such that it is now >1.5 cm. Tumor measurements were obtained by computed tomography (CT) or magnetic resonance imaging (MRI). | Baseline up to data cut-off (up to approximately 4 years and 7 months) |
| Measure | Description | Time Frame |
|---|---|---|
| Progression-Free Survival in the Follicular Lymphoma Population, Investigator-Assessed | Progression-free survival in participants with follicular lymphoma was defined as the time from randomization until the first documented day of disease progression or death from any cause, whichever occurred first, on the basis of investigator assessments according to the Revised Response Criteria for Malignant Lymphoma. Progression was defined as at least 50% increase in nodal lesions or >/=50% increase in any node > 1 centimeter (cm) or >/= 50% increase in other target measurable lesions (e.g., splenic or hepatic nodules) and/or appearance of any new bone marrow involvement and/or appearance of any new lesion > 1.5 cm or >/= 50% increase in any previously involved node with a diameter </= 1 cm such that it is now >1.5 cm. Tumor measurements were obtained by computed tomography (CT) or magnetic resonance imaging (MRI). |
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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 |
|---|---|---|---|---|---|---|
| Highlands Oncology Group | Springdale | Arkansas | 72762 | United States | ||
| The Regents of the University of California; Office of Research |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41879719 | Derived | Jorgensen JB, Hansen KV, Nielsen LK, Gade IL, Pedersen MA, Jensen P, Simonsen MR, Knapp A, Gormsen LC, El-Galaly TC. First-line immunochemotherapy for indolent lymphoma does not affect muscle volume: a post hoc analysis of 472 patients in long-term remissions from the GALLIUM study. Leuk Lymphoma. 2026 May;67(6):1352-1361. doi: 10.1080/10428194.2026.2642931. Epub 2026 Mar 25. | |
| 38096461 |
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Eleven participants withdrew from the study after randomization but prior to receiving study treatment.
The study was conducted at 177 centers in 18 countries.
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| ID | Title | Description |
|---|---|---|
| FG000 | Rituximab+Chemotherapy - Induction Period | Participants received either 8 cycles of rituximab along with 6 cycles of cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) (21-day cycle) or 8 cycles of rituximab along with 8 cycles of cyclophosphamide, vincristine, and prednisone (CVP) (21-day cycles) or 6 cycles of rituximab along with 6 cycles of bendamustine (28-day cycle) during induction period. The chemotherapy regimen (CHOP or CVP or bendamustine) for individual participant was chosen by the site prior to initiation of the study. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Induction Period |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Feb 15, 2020 | Jul 6, 2022 |
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| Cyclophosphamide | Drug | Cyclophosphamide 750 mg/m^2 IV will be administered on Day 1 of each cycle during induction period. |
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| Doxorubicin | Drug | Doxorubicin 50 mg/m^2 IV will be administered on Day 1 of each cycle during induction period. |
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| Vincristine | Drug | Vincristine 1.4 mg/m^2 (maximum 2 mg) IV will be administered on Day 1 of each cycle during induction period. |
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| Prednisone | Drug | Prednisone 100 mg (or equivalent prednisolone or methylprednisolone) will be administered orally on Days 1-5 of each cycle during induction period. |
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| Bendamustine | Drug | Bendamustine 90 mg/m^2 IV infusion will be administered on Days 1 and 2 of each cycle during induction period. |
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| Rituximab | Drug | Rituximab 375 milligrams per square meter (mg/m^2) IV infusion will be administered on Day 1 of each cycle during induction period and rituximab 375 mg/m^2 every 2 months during maintenance period. |
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| Baseline up to final analysis (up to 10 years) |
| Progression-Free Survival in the Overall Study Population, Investigator-Assessed | Progression-free survival in the overall study population was defined as the time from randomization until the first documented day of disease progression or death from any cause, whichever occurred first, on the basis of investigator assessments according to the Revised Response Criteria for Malignant Lymphoma. Progression was defined as at least 50% increase in nodal lesions or >/=50% increase in any node > 1 centimeter (cm) or >/= 50% increase in other target measurable lesions (e.g., splenic or hepatic nodules) and/or appearance of any new bone marrow involvement and/or appearance of any new lesion > 1.5 cm or >/= 50% increase in any previously involved node with a diameter </= 1 cm such that it is now >1.5 cm. Tumor measurements were obtained by CT/MRI. | Baseline up to data cut-off (up to approximately 5 years and 2 months) |
| Progression-Free Survival (Follicular Lymphoma Population), IRC-Assessed | Progression-free survival in the participants with follicular lymphoma was defined as the time from randomization until the first documented day of disease progression or death from any cause, whichever occurred first, on the basis of IRC assessments according to the Revised Response Criteria for Malignant Lymphoma. Progression was defined as at least 50% increase in nodal lesions or >/=50% increase in any node > 1 centimeter (cm) or >/= 50% increase in other target measurable lesions (e.g., splenic or hepatic nodules) and/or appearance of any new bone marrow involvement and/or appearance of any new lesion > 1.5 cm or >/= 50% increase in any previously involved node with a diameter </= 1 cm such that it is now >1.5 cm. Tumor measurements were obtained by CT/MRI. In the first 170 patients with follicular lymphoma, an FDG-PET was mandatory where a PET scanner was available. | Baseline up to data cut-off (up to approximately 5 years and 2 months) |
| Progression-Free Survival (Overall Study Population), Assessed by Independent Review Committee (IRC) | Progression-free survival in the overall study population was defined as the time from randomization until the first documented day of disease progression or death from any cause, whichever occurred first, on the basis of IRC assessments according to the Revised Response Criteria for Malignant Lymphoma. Progression was defined as at least 50% increase in nodal lesions or >/=50% increase in any node > 1 centimeter (cm) or >/= 50% increase in other target measurable lesions (e.g., splenic or hepatic nodules) and/or appearance of any new bone marrow involvement and/or appearance of any new lesion > 1.5 cm or >/= 50% increase in any previously involved node with a diameter </= 1 cm such that it is now >1.5 cm. Tumor measurements were obtained by CT/MRI. | Baseline up to data cut-off (up to approximately 5 years and 2 months) |
| Overall Response (Follicular Lymphoma Population), Investigator-Assessed | Overall response in the follicular lymphoma population was defined as percentage of participants with PR or complete response CR determined on the basis of investigator assessments with the use of Revised Response Criteria for Malignant Lymphoma. Tumor assessments were performed with CT/MRI with and without PET. CR was defined as disappearance of all target lesions; PR was defined as >=50% decrease target lesions in up to six dominant lesions identified at baseline, no new lesions and no increase in the size of the liver, spleen, or other nodes. Splenic and hepatic nodules must have regressed by >/= 50%. Overall Response (OR) = CR + PR. | Baseline up to end of induction period (up to approximately 7 months) |
| Overall Response (Overall Study Population), Investigator-Assessed | Overall response in the overall study population was defined as percentage of participants with partial response (PR) or complete response (CR) determined on the basis of investigator assessments with the use of Revised Response Criteria for Malignant Lymphoma. Tumor assessments were performed with CT/MRI with or without positron emission tomography (PET). CR was defined as disappearance of all target lesions; PR was defined as >=50% decrease target lesions in up to six dominant lesions identified at baseline, no new lesions and no increase in the size of the liver, spleen, or other nodes. Splenic and hepatic nodules must have regressed by >/= 50%; Overall Response (OR) = CR + PR. | Baseline up to end of induction period (up to approximately 7 months) |
| Complete Response (Follicular Lymphoma Population), Investigator-Assessed | Percentage of participants with complete response in the follicular lymphoma population was determined on the basis of investigator assessments with the use of Revised Response Criteria for Malignant Lymphoma. Tumor assessments were performed with CT/MRI with or without PET. CR was defined as disappearance of all target lesions. | Baseline up to end of induction period (up to approximately 7 months) |
| Complete Response (Overall Study Population), Investigator-Assessed | Percentage of participants with complete response in the overall study population was determined on the basis of investigator assessments with the use of Revised Response Criteria for Malignant Lymphoma. Tumor assessments were performed with CT/MRI with or without PET. CR was defined as disappearance of all target lesions. | Baseline up to end of induction period (up to approximately 7 months) |
| Overall Response (Follicular Lymphoma Population), IRC-Assessed | Overall response in the follicular lymphoma population was defined as percentage of participants with PR or complete response CR determined on the basis of IRC assessments with the use of Revised Response Criteria for Malignant Lymphoma. Tumor assessments were performed with CT/MRI with or without PET. CR was defined as disappearance of all target lesions; PR was defined as >=50% decrease target lesions in up to six dominant lesions identified at baseline, no new lesions and no increase in the size of the liver, spleen, or other nodes. Splenic and hepatic nodules must have regressed by >/= 50%. Overall Response (OR) = CR + PR. | Baseline up to end of induction period (up to approximately 7 months) |
| Overall Response (Overall Study Population), IRC-Assessed | Overall response in the overall study population was defined as percentage of participants with PR or CR determined on the basis of IRC assessments with the use of Revised Response Criteria for Malignant Lymphoma. Tumor assessments were performed with CT/MRI with or without PET. CR was defined as disappearance of all target lesions; PR was defined as >=50% decrease target lesions in up to six dominant lesions identified at baseline, no new lesions and no increase in the size of the liver, spleen, or other nodes. Splenic and hepatic nodules must have regressed by >/= 50%; Overall Response (OR) = CR + PR. | Baseline up to end of induction period (up to approximately 7 months) |
| Complete Response (Follicular Lymphoma Population), IRC-Assessed | Percentage of participants with complete response in the follicular lymphoma population was determined on the basis of IRC assessments with the use of Revised Response Criteria for Malignant Lymphoma. Tumor assessments were performed with CT/MRI with or without PET. CR was defined as disappearance of all target lesions. | Baseline up to end of induction period (up to approximately 7 months) |
| Complete Response (Overall Study Population), IRC-Assessed | Percentage of participants with complete response in the overall study population was determined on the basis of IRC assessments with the use of Revised Response Criteria for Malignant Lymphoma. Tumor assessments were performed with CT/MRI with or without PET. CR was defined as disappearance of all target lesions. | Baseline up to end of induction period (up to approximately 7 months)] |
| Overall Survival (Follicular Lymphoma Population) | Overall survival in the follicular lymphoma population was defined as the time from the date of randomization to the date of death from any cause. Reported is the percentage of participants with event. | Baseline up to 10 years |
| Overall Survival (Overall Study Population) | Overall survival in the overall study population was defined as the time from the date of randomization to the date of death from any cause. Reported is the percentage of participants with event. | Baseline up to data cut-off (up to approximately 5 years and 2 months) |
| Event-Free Survival (Follicular Lymphoma Population) | Event-free survival in the follicular lymphoma population was defined as the time from the date of randomization to the date to disease progression/relapse, death from any cause, or initiation of a new anti-lymphoma treatment (NALT) on the basis of investigator assessment assessments with the use of Revised Response Criteria for Malignant Lymphoma. Disease progression/relapse was defined as at least 50% increase in nodal lesions or >/=50% increase in any node > 1 centimeter (cm) or >/= 50% increase in other target measurable lesions (e.g., splenic or hepatic nodules) and/or appearance of any new bone marrow involvement and/or appearance of any new lesion > 1.5 cm or >/= 50% increase in any previously involved node with a diameter </= 1 cm such that it is now >1.5 cm. Tumor measurements were obtained by CT/MRI. Reported is the percentage of participants with an event. | Baseline up to 10 years |
| Event-Free Survival (Overall Study Population) | Event-free survival in the overall study population was defined as the time from the date of randomization to the date to disease progression/relapse, death from any cause, or initiation of a new anti-lymphoma treatment (NALT) on the basis of investigator assessment assessments with the use of Revised Response Criteria for Malignant Lymphoma. Disease progression/relapse was defined as at least 50% increase in nodal lesions or >/=50% increase in any node > 1 centimeter (cm) or >/= 50% increase in other target measurable lesions (e.g., splenic or hepatic nodules) and/or appearance of any new bone marrow involvement and/or appearance of any new lesion > 1.5 cm or >/= 50% increase in any previously involved node with a diameter </= 1 cm such that it is now >1.5 cm. Tumor measurements were obtained by CT/MRI. Reported is the percentage of participants with event. | Baseline up to data cut-off (up to approximately 5 years and 2 months) |
| Disease-Free Survival (Follicular Lymphoma Population) | Disease-free survival in the follicular lymphoma population was defined as the time from the date of the first occurrence of a documented CR to the date of disease progression/ relapse, or death from any cause for the subgroup of participants with a response of CR at any time prior to NALT on the basis of investigator assessments with the use of Revised Response Criteria for Malignant Lymphoma (RRCML). Tumor assessments were performed with CT/MRI. CR was defined as disappearance of all target lesions. Progression/relapse was defined as at least 50% increase in nodal lesions or >/=50% increase in any node > 1 centimeter (cm) or >/= 50% increase in other target measurable lesions (e.g., splenic or hepatic nodules) and/or appearance of any new bone marrow involvement and/or appearance of any new lesion > 1.5 cm or >/= 50% increase in any previously involved node with a diameter </= 1 cm such that it is now >1.5 cm. Reported is the percentage of participants with event. | From first occurrence of documented CR to data cut-off (up to approximately 5 years and 2 months) |
| Disease-Free Survival (Overall Study Population) | Disease-free survival in the overall study population was defined as the time from the date of the first occurrence of a documented CR to the date of disease progression/ relapse, or death from any cause for the subgroup of participants with a response of CR at any time prior to NALT on the basis of investigator assessments with the use of Revised Response Criteria for Malignant Lymphoma. Tumor assessments were performed with CT/MRI. CR was defined as disappearance of all target lesions. Progression/relapse was defined as at least 50% increase in nodal lesions or >/=50% increase in any node > 1 centimeter (cm) or >/= 50% increase in other target measurable lesions (e.g., splenic or hepatic nodules) and/or appearance of any new bone marrow involvement and/or appearance of any new lesion > 1.5 cm or >/= 50% increase in any previously involved node with a diameter </= 1 cm such that it is now >1.5 cm. Reported is the percentage of participants with event. | From first occurrence of documented CR to data cut-off (up to approximately 5 years and 2 months) |
| Duration of Response (DOR) (Follicular Lymphoma Population), Investigator-Assessed | DOR was defined as the time from first occurrence of a documented CR or PR to disease progression/relapse, or death from any cause for participants with a response of CR or PR any time prior to NALT based on RRCML. Tumor assessments were performed with CT/MRI. CR was defined as disappearance of all target lesions. PR was defined as >/=50% decrease target lesions in up to six dominant lesions identified at baseline, no new lesions and no increase in the size of the liver, spleen, or other nodes. Splenic and hepatic nodules must have regressed by >/= 50%. Progression/relapse was defined as at least 50% increase in nodal lesions or >/=50% increase in any node > 1 centimeter (cm) or >/= 50% increase in other target measurable lesions (e.g., splenic or hepatic nodules) and/or appearance of any new bone marrow involvement and/or appearance of any new lesion > 1.5 cm or >/= 50% increase in any previously involved node with a diameter </= 1 cm such that it is now >1.5 cm. | From first occurrence of documented CR or PR to data cut-off (up to approximately 5 years and 2 months) |
| Duration of Response (DOR) (Overall Study Population), Investigator-Assessed | DOR was defined as the time from first occurrence of a documented CR or PR to disease progression/relapse, or death from any cause for participants with a response of CR or PR any time prior to NALT based on RRCML. Tumor assessments were performed with CT/MRI. CR was defined as disappearance of all target lesions. PR was defined as >/=50% decrease target lesions in up to six dominant lesions identified at baseline, no new lesions and no increase in the size of the liver, spleen, or other nodes. Splenic and hepatic nodules must have regressed by >/= 50%. Progression/relapse was defined as at least 50% increase in nodal lesions or >/=50% increase in any node > 1 centimeter (cm) or >/= 50% increase in other target measurable lesions (e.g., splenic or hepatic nodules) and/or appearance of any new bone marrow involvement and/or appearance of any new lesion > 1.5 cm or >/= 50% increase in any previously involved node with a diameter </= 1 cm such that it is now >1.5 cm. | From first occurrence of documented CR or PR to data cut-off (up to approximately 4 years and 7 months) |
| Time to Next Anti-Lymphoma Treatment (Follicular Lymphoma Population) | Time to next anti-lymphoma treatment was defined as the time from the date of randomization to the start date of the next anti-lymphoma treatment or death from any cause. Reported is the percentage of participants with event. | Baseline up to 10 years |
| Time to Next Anti-Lymphoma Treatment (Overall Study Population) | Time to next anti-lymphoma treatment was defined as the time from the date of randomization to the start date of the next anti-lymphoma treatment or death from any cause. Reported is the percentage of participants with event. | Baseline up to data cut-off (up to approximately 5 years and 2 months) |
| Percentage of Participants With Adverse Events | An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as adverse events. | Baseline up to 10 years |
| Change From Baseline in All Domains of FACT-G (Follicular Lymphoma Population) | FACT-G consists of the following 4 FACT-Lym sub-questionnaires: Physical Well-being (range: 0-28), Social/Family Well-being (range: 0-28), Emotional Well-being (range: 0-24) and Functional Well-being (range: 0-28). Higher scores indicate better outcomes. A positive change from baseline indicates improvement. Maint = Maintenance period. | Baseline (Induction Cycle 1, Day 1), data cut-off (up to approximately 5 years and 2 months) |
| Change From Baseline in FACT-Lym Total Outcome Index (TOI) Score (Follicular Lymphoma Population) | The FACT-Lym TOI Score for the follicular lymphoma population was derived from the following 3 individual FACT-Lym questionnaire subscale scores: Physical Well-being (range: 0-28), Functional Well-being (range: 0-28) and Lymphoma (range: 0-60). The FACT-Lym TOI Score is the sum of the 3 individual subscales (range 0-116). Higher scores indicate better outcomes. A positive change from baseline indicates an improvement. | Baseline (Induction Cycle 1, Day 1), data cut-off (up to approximately 5 years and 2 months) |
| Change From Baseline in FACT-Lym Individual Subscale Lymphoma Score (Follicular Population) | The FACT-Lym Individual Subscale Lymphoma Score for the follicular lymphoma population was derived from the Lymphoma subscale questionnaire (range: 0-60). Higher scores indicate better outcomes. A positive change from baseline indicates an improvement. | Baseline (Induction Cycle 1, Day 1), data cut-off (up to approximately 5 years and 2 months) |
| Change From Baseline in Functional Assessment of Cancer Therapy-Lymphoma (FACT-Lym) Total Score (Follicular Population) | The FACT-Lym Total Score for the follicular lymphoma population was derived from the following 5 individual FACT-Lym questionnaire subscale scores: Physical Well-being (range: 0-28), Social/Family Well-being (range: 0-28), Emotional Well-being (range: 0-24),Functional Well-being (range: 0-28) and Lymphoma (range: 0-60). The FACT-Lym Total Score is the sum of all 5 individual subscales (range 0-168). Higher scores indicate better outcomes. A positive change from baseline indicates an improvement. | Baseline (Induction Cycle 1, Day 1), data cut-off (up to approximately 5 years and 2 months) |
| Change From Baseline in Euro-Quality of Life-5 Dimensions (EQ-5D) Questionnaire Summary Score (Follicular Lymphoma Population) During Induction Phase | The EQ-5D is a quality of life questionnaire with five questions, each with three categories (no problem, moderate problem, severe problems) and a visual analogue scale (VAS) from 0 (worst possible health state) to 100 (best possible health state. Summary score ranges from 0 to 1. Higher scores indicate better outcomes. A positive change from baseline indicates an improvement. Completion (Compl) includes completion visit and early termination visit. Maintenance/Observation is indicated as Maint/Obs. | Induction: Cycle 1 Day 1 (Baseline), Cycle 3 Day 1, End of Induction (up to 7 months); Maintenance: 2, 12 months after Day 1 of last induction cycle, Follow-up: every year up to data cut-off (up to 5 years and 2 months) |
| Change From Baseline in Euro-Quality of Life-5 Dimensions (EQ-5D) Questionnaire Summary Score (Follicular Lymphoma Population) During Maintenance/Observation Phase | The EQ-5D is a quality of life questionnaire with five questions, each with three categories (no problem, moderate problem, severe problems) and a visual analogue scale (VAS) from 0 (worst possible health state) to 100 (best possible health state. Summary score ranges from 0 to 1 Higher scores indicate better outcomes. A positive change from baseline indicates an improvement. Maintenance/Observation is indicated as Maint/Obs. Completion includes completion visit and early termination visit. | Induction: Cycle 1 Day 1 (Baseline), Cycle 3 Day 1, End of Induction (up to 7 months); Maintenance: 2, 12 months after Day 1 of last induction cycle, Follow-up: every year up to data cut-off (up to 5 years and 2 months) |
| Change From Baseline in Euro-Quality of Life-5 Dimensions (EQ-5D) Questionnaire Summary Score (Follicular Lymphoma Population) During Follow Up Phase | The EQ-5D is a quality of life questionnaire with five questions, each with three categories (no problem, moderate problem, severe problems) and a visual analogue scale (VAS) from 0 (worst possible health state) to 100 (best possible health state. Summary score ranges from 0 to 1. Higher scores indicate better outcomes. A positive change from baseline indicates an improvement. Maintenance/Observation is indicated as Maint/Obs in data categories. Completion includes completion visit and early termination visit. | Induction: Cycle 1 Day 1 (Baseline), Cycle 3 Day 1, End of Induction (up to 7 months); Maintenance: 2, 12 after Day 1 of last induction cycle, Follow-up: every year for up to data cut-off (up to 5 years and 2 months) |
| Irvine |
| California |
| 92697 |
| United States |
| Kootenai Cancer Center | Post Falls | Idaho | 83854 | United States |
| Illinois Cancer Care, P.C. - Galesburg | Galesburg | Illinois | 61401 | United States |
| Siouxland Hematology/Oncology | Sioux City | Iowa | 51101 | United States |
| University of Kansas; Medical Center & Medical pavilion | Westwood | Kansas | 66205 | United States |
| Cancer Center of Kansas | Wichita | Kansas | 67214-3728 | United States |
| Mercy Medical Research Institute | Springfield | Missouri | 65807 | United States |
| MT Cancer Inst Fndtn; MT Can Spec | Missoula | Montana | 59802 | United States |
| San Juan Oncology Associates | Farmington | New Mexico | 87401 | United States |
| Providence St. Vincent Medical Center | Portland | Oregon | 97225 | United States |
| Northwest Medical Specialties | Tacoma | Washington | 98405 | United States |
| Concord Repatriation General Hospital; Haematology | Sydney | New South Wales | 2139 | Australia |
| Westmead Hospital; Haematology | Sydney | New South Wales | 2145 | Australia |
| Princess Alexandra Hospital Woolloongabba; Clinical Hematology and Medical Oncology | Woolloongabba | Queensland | 4102 | Australia |
| St Vincent'S Hospital; Haematology | Fitzroy | Victoria | 3065 | Australia |
| Peter MacCallum Cancer Centre; Department of Haematology | Melbourne | Victoria | 3002 | Australia |
| Austin and Repatriation Medical Centre; Cancer Services | Melbourne | Victoria | 3084 | Australia |
| Monash Medical Centre; Haematology | Melbourne | Victoria | 3168 | Australia |
| Fiona Stanley Hospital | Murdoch | Western Australia | 6150 | Australia |
| UZ Gent | Ghent | 9000 | Belgium |
| AZ Groeninge | Kortrijk | 8500 | Belgium |
| UZ Leuven Gasthuisberg | Leuven | 3000 | Belgium |
| Tom Baker Cancer Centre-Calgary | Calgary | Alberta | T2N 4N2 | Canada |
| Cross Cancer Institute | Edmonton | Alberta | T6G 1Z2 | Canada |
| Dr. Georges L. Dumont University Hospital Centre | Moncton | New Brunswick | E1C 8X3 | Canada |
| Ottawa General Hospital | Ottawa | Ontario | K1H 8L6 | Canada |
| North York General Hospital | Toronto | Ontario | M2K 1E1 | Canada |
| Humber River Hospital | Toronto | Ontario | M3M 0B2 | Canada |
| Toronto East General Hospital; Haematology/Oncology | Toronto | Ontario | M4C 3E7 | Canada |
| Hopital Charles Lemoyne; Centre Integre de Lutte Contre Le Cancer de La Monteregie | Greenfield Park | Quebec | J4V 2H1 | Canada |
| Cancer Hospital Chinese Academy of Medical Sciences. | Beijing | 100021 | China |
| Peking University First Hospital | Beijing | 100034 | China |
| Beijing Cancer Hospital | Beijing | 100142 | China |
| General Hospital of Chinese PLA; Department of Hematology | Beijing | 100853 | China |
| the First Hospital of Jilin University | Changchun | 130021 | China |
| Fujian Medical University Union Hospital | Fuzhou | 350001 | China |
| Sun Yet-sen University Cancer Center | Guangzhou | 510060 | China |
| Harbin Medical University Cancer Hospital | Harbin | 150081 | China |
| Jiangsu Province Hospital | Nanjing | 210036 | China |
| Jiangsu Cancer Hospital | Nanjing | 211100 | China |
| Shanghai Jiao Tong University School of Medicine (SJTUSM) - Ruijin Hospital (GuangCi Hospital) | Shanghai | 200025 | China |
| Fudan University Shanghai Cancer Center | Shanghai | 200120 | China |
| Union Hospital of Tongji Medical College, Dept. of Cancer Center; Cancer Center | Wuhan | 430023 | China |
| Fakultni nemocnice Brno; Interni hematologicka a onkologicka klinika | Brno | 625 00 | Czechia |
| Fn Hr. Kralove; IV. Interni Hematologicka Klinika | Hradec Králové | 500 05 | Czechia |
| Vseobecna Fakultni Nemocnice v Praze, I. Interni Klinika - Klinika Hematoonkologie VFN a 1. LF UK | Prague | 128 08 | Czechia |
| Helsinki University Central Hospital; Dept of Oncology | Helsinki | 00250 | Finland |
| Hotel Dieu; Medecine D | Angers | 49933 | France |
| Hopital Augustin Morvan; Hematologie | Brest | 29609 | France |
| Chu Estaing; Hematologie Clinique Adultes | Clermont-Ferrand | 63003 | France |
| Clinique Victor Hugo | LeMans | 72000 | France |
| Hopital De La Conception; Hematologie Clinique | Marseille | 13005 | France |
| Hopital Saint Eloi; Hematologie Oncologie Medicale | Montpellier | 34295 | France |
| Hopital Saint Jean; Hematologie | Perpignan | 66046 | France |
| Onkologischer Schwerpunkt am Oskar-Helene-Heim; Dres. Herrenberger, Keitel-Wittig u. Kirsch | Berlin | 14195 | Germany |
| Klinikum Chemnitz gGmbH Krankenhaus Küchwald Klinik f.Innere Medizin III | Chemnitz | 09113 | Germany |
| Klinik der Uni zu Köln; Klinik für Innere Medizin | Cologne | 50924 | Germany |
| Städtisches Klinikum Dessau | Dessau | 06847 | Germany |
| BAG Freiberg-Richter, Jacobasch, Illmer, Wolf; Gemeinschaftspraxis Hämatologie-Onkologie | Dresden | 01307 | Germany |
| Gemeinschaftspraxis Dr. med. J. Mohm und Dr. med. G. Prange-Krex; Fachaerzte fuer Innere Medizin | Dresden | 01307 | Germany |
| HELIOS Klinikum Erfurt I.Medizinische Klinik | Erfurt | 99089 | Germany |
| St.-Antonius-Hospital gGmbH; Klinik für Hämatologie und Onkologie | Eschweiler | 52249 | Germany |
| Universitätsklinikum Essen; Innere Klinik und Poliklinik für Tumorforschung | Essen | 45122 | Germany |
| Klinik Johann Wolfgang von Goethe Uni; Medizinische Klinik II | Frankfurt | 60596 | Germany |
| Universitätsklinikum Freiburg; Klinik für Innere Medizin I; Hämatologie/Onkologie | Freiburg im Breisgau | 79106 | Germany |
| Uni Göttingen, Georg-August-Universität; Klinik für Hämatologie und Medizinische Onkologie | Göttingen | 37075 | Germany |
| Universitätsklinikum Greifswald Klinik für Innere Medizin C und Poliklinik | Greifswald | 17475 | Germany |
| Kath. Krankenhaus Hagen gem. GmbH, St.-Josefs-Hospital; Klinik für Hämatologie und Onkologie | Hagen | 58097 | Germany |
| Onkologische Schwerpunktpraxis Dres. Bernd Gaede, Hans-Ulrich Ehlers, Ulrike Rodewig u.w. | Hanover | 30171 | Germany |
| Dres.Andreas Karcher und Stefan Fuxius | Heidelberg | 69115 | Germany |
| Uniklinik Heidelberg, Medizinische Klinik & Poliklinik V | Heidelberg | 69120 | Germany |
| Universitaetsklinikum des Saarlandes; medizinische Klinik und Poliklinik; Innere Medizin I | Homburg/Saar | 64421 | Germany |
| Universitätsklinikum Jena; Klinik für Innere Medizin II | Jena | 07747 | Germany |
| UKSH, Campus Kiel; Klinik für Innere Medizin II, Hämatologie und Internistische Onkologie | Kiel | 24105 | Germany |
| Institut für Versorgungsforschung in der Onkologie GbR Koblenz | Koblenz | 56068 | Germany |
| Tagesklinik Landshut; Hämatologie/Onkologie | Landshut | 84028 | Germany |
| Gemeinschaftspraxis für Hämatologie und Onkologie | Lebach | 66822 | Germany |
| Klinikum St.Georg gGmbH Klinik für Internistische Onkologie und Hämotologie | Leipzig | 04129 | Germany |
| Klinikum der Stadt Ludwigshafen; Medizinische Klinik A | Ludwigshafen | 67063 | Germany |
| Onkologische Gemeinschaftspraxis | Magdeburg | 39104 | Germany |
| Otto von Guericke Uni Magdeburg Uniklinik; Hämatologie/Onkologie | Magdeburg | 39120 | Germany |
| Uni. der Johannes Gutenberg-Universitaet Mainz; III. Medizinische Klinik und Poliklinik | Mainz | 55131 | Germany |
| Mannheimer Onkologie Praxis Dres. Jürgen Brust Dieter Schuster | Mannheim | 68161 | Germany |
| Klinikum Mannheim III. Medizinische Klinik | Mannheim | 68167 | Germany |
| St. Frankziskus Krankenhaus, Med. Klinik I; Klinik für Hämatologie,Onkologie u. Gastroenterologie | Mönchengladbach | 41063 | Germany |
| Kliniken Ostalb, Stauferklinikum Schwäbisch-Gmünd; Zentrum für Innere Medizin | Mutlangen | 73557 | Germany |
| Klinikum der Universität München, Campus Großhadern; Medizinische Klinik und Poliklinik III | München | 81377 | Germany |
| Klinikum rechts der Isar der TU München; III. Medizinischen Klinik (Hämatologie/Onkologie) | München | 81675 | Germany |
| Gemeinschaftspraxis Dr. med. Holger Klaproth | Neunkirchen/Saar | 66538 | Germany |
| Pius-Hospital; Klinik fuer Haematologie und Onkologie | Oldenburg | 26121 | Germany |
| Brüderkrankenhaus St. Josef | Paderborn | 33098 | Germany |
| Prosper-Hospital, Medizinische Klinik I | Recklinghausen | 45659 | Germany |
| Krankenhaus Barmherziger Brüder; Klinik für Internistische Onkologie / Hämatologie | Regensburg | 93049 | Germany |
| Praxis für Hämatologie & Onkologie | Saarbrücken | 66113 | Germany |
| Krankenhaus der Barmherzigen Brüder Trier; Innere Medizin I, Hämatologie / Internistische Onkologie | Trier | 54292 | Germany |
| Universität Tübingen; Med. Klinik; Innere Medizin I | Tübingen | 72076 | Germany |
| Universtitätsklinikum Ulm; Klinik für Innere Medizin III | Ulm | 89081 | Germany |
| Helios Dr. Horst Schmidt Kliniken; Klinik Innere MED III: Hämatologie, Onkologie, Palliativmedizin | Wiesbaden | 65199 | Germany |
| Hämatologisch-Onkologische Schwerpunktpraxis Dres. Schlag & Schöttker | Würzburg | 97080 | Germany |
| Semmelweis University, First Dept of Medicine | Budapest | 1083 | Hungary |
| National Institute of Oncology, A Dept of Internal Medicine | Budapest | 1122 | Hungary |
| University of Debrecen Medical and Health Science Center, Institute of Internal Medicine, Hematology | Debrecen | 4032 | Hungary |
| Petz Aladar Megyei Korhaz; Hematologia | Győr | 9024 | Hungary |
| University of Szeged, II Dept of Internal Medicine | Szeged | 6720 | Hungary |
| Rambam Medical Center; Heamatology & Bone Marrow Transplantation | Haifa | 3109601 | Israel |
| Beilinson Medical Center; Haematology | Petah Tikva | 4910000 | Israel |
| Chaim Sheba Medical Center; Hematology BMT & CBB | Ramat Gan | 5262100 | Israel |
| Azienda Ospedaliera Universitaria di Modena | Modena | Emilia-Romagna | 41100 | Italy |
| Az. Osp. S. Camillo Forlanini; Uo Ematologia E Trapianti Di Midollo Osseo | Rome | Lazio | 00152 | Italy |
| ASST PAPA GIOVANNI XXIII; Ematologia | Bergamo | Lombardy | 24127 | Italy |
| Ospedale Maggiore Di Milano; U.O. Ematologia I - Padiglione Marcora | Milan | Lombardy | 20122 | Italy |
| Asst Grande Ospedale Metropolitano Niguarda; Dipartimento Di Ematologia Ed Oncologia | Milan | Lombardy | 20162 | Italy |
| Istituto Clinico Humanitas;U.O. Oncologia Medica Ed Ematologia | Rozzano | Lombardy | 20089 | Italy |
| Ospedale V. Cervello; U.O. Ematologia E Trapianti | Palermo | Sicily | 90146 | Italy |
| A.O. Univ.Ospedali Riuniti Umerto I -G.M.Lancisi G.Salesi; U.O. Clinica Di Ematologia | Torrette DI Ancona | The Marches | 60020 | Italy |
| Uni Degli Studi; Dip.Med.Clinica E Sperim. Ematologia | Padova | Veneto | 35128 | Italy |
| Aichi Cancer Center Hospital; Hematology and Cell Therapy | Aichi | 464-8681 | Japan |
| Japanese Red Cross Aichi Medical Center Nagoya Daini Hospital; Hematology & Oncology | Aichi | 466-8650 | Japan |
| Nagoya City University Hospital; Hematology and Oncology | Aichi | 467-8602 | Japan |
| Aomori Prefectural Central Hospital; Hematology | Aomori | 030-8553 | Japan |
| Chiba Cancer Center;Hematology and Oncology | Chiba | 260-8717 | Japan |
| National Cancer Center Hospital East;Hematology | Chiba | 277-8577 | Japan |
| Shikoku Cancer Center; Hematology and Oncology | Ehime | 791-0280 | Japan |
| National Hospital Organization Kyushu Cancer Center; Hematology | Fukuoka | 811-1395 | Japan |
| Gunma University Hospital;Hematology | Gunma | 371-8511 | Japan |
| Hiroshima University Hospital; Hematology | Hiroshima | 734-8551 | Japan |
| Kobe City Medical Center General Hospital; Hematology | Hyōgo | 650-0047 | Japan |
| Hyogo Cancer Center; Department of hematology | Hyōgo | 673-8558 | Japan |
| Tokai University Hospital; Hematology | Kanagawa | 259-1193 | Japan |
| Kumamoto University Hospital; Hematology Rheumatology and Clinical Immunology | Kumamoto | 860-8556 | Japan |
| University Hospital, Kyoto Prefectural University of Medicine; Hematology | Kyoto | 602-8566 | Japan |
| Tohoku University Hospital; Hematology and Immunology | Miyagi | 980-8574 | Japan |
| Shinshu University Hospital; Hematology | Nagano | 390-8621 | Japan |
| Niigata Cancer Center Hospital; Internal Medicine | Niigata | 951-8566 | Japan |
| Matsushita Memorial Hospital; hematology | Osaka | 570-8540 | Japan |
| Jichi Medical University Hospital; Hematology | Tochigi | 329-0498 | Japan |
| National Cancer Center Hospital; Hematology | Tokyo | 104-0045 | Japan |
| Toranomon Hospital; Hematology | Tokyo | 105-8470 | Japan |
| The Cancer Institute Hospital of JFCR; Hematology Oncology | Tokyo | 135-8550 | Japan |
| The Jikei University Daisan Hospital; Department of Clinical Oncology and Hematology | Tokyo | 201-8601 | Japan |
| FSBI Russian Oncology Research Center n.a. Blokhin of MOH RF | Moscow | 115478 | Russia |
| Regional Clinical Hospital N.A. Semashko; Hematology | Nizhny Novgorod | 603126 | Russia |
| Republican Clinical Hospital n.a. Baranov; Haematology | Petrozavodsk | 185019 | Russia |
| Hospital Universitari Germans Trias i Pujol; Servicio de Hematologia | Badalona | Barcelona | 08915 | Spain |
| Corporacio Sanitaria Parc Tauli; Servicio de Hematologia | Sabadell | Barcelona | 08208 | Spain |
| Fundacion Hospital de Alcorcon; Servicio de Hematologia | Alcorcón | Madrid | 28922 | Spain |
| Hospital de Basurto; Servicio de Hematologia | Bilbao | Vizcaya | 48013 | Spain |
| Hospital Univ. 12 de Octubre; Servicio de Hematologia | Madrid | 28041 | Spain |
| Hospital Universitario la Paz; Servicio de Hematologia | Madrid | 28046 | Spain |
| Sahlgrenska Universitetssjukhuset; Sektionen för hematologi och koagulation | Gothenburg | S-413 45 | Sweden |
| National Taiwan Universtiy Hospital; Division of Hematology | Taipei | 100 | Taiwan |
| Koo Foundation Sun Yat-Sen Cancer Center; Hemato-Oncology | Taipei | 11259 | Taiwan |
| Chang Gung Medical Foundation - Linkou; Division of Hematology- Oncology | Taoyuan | 333 | Taiwan |
| Aberdeen Royal Infirmary; Haematology - Ward 16 | Aberdeen | AB25 2ZN | United Kingdom |
| Queen Elizabeth Hospital; Centre for Clinical Haematology | Birmingham | B15 2TH | United Kingdom |
| Royal Bournemouth General Hospital; Haematology | Bournemouth | BH7 7DW | United Kingdom |
| Bristol Haematology and Oncology Centre | Bristol | BS2 8ED | United Kingdom |
| Addenbrookes Hospital; Haematology | Cambridge | CB2 0QQ | United Kingdom |
| Kent & Canterbury Hospital; Clinical Haematology | Canterbury | CT1 3NG | United Kingdom |
| Velindre NHS Trust; Haematology Department | Cardiff | CF14 2TL | United Kingdom |
| Castle Hill Hospital; The Queens Centre for Oncology and Haematology | Cottingham | HU16 5JG | United Kingdom |
| Western General Hospital; Department of Haematology | Edinburgh | EH4 2XU | United Kingdom |
| Beatson West of Scotland Cancer Centre | Glasgow | G12 0YN | United Kingdom |
| James Paget Hospital; Haematology Department | Great Yarmouth | NR31 6LA | United Kingdom |
| Princess Alexandra Hospital; Department of Haematology | Harlow | CM20 1QX | United Kingdom |
| St James Uni Hospital; Icrf Cancer Medicine Research Unit | Leeds | LS9 7TF | United Kingdom |
| Leicester Royal Infirmary; Dept of Haematology | Leicester | LE1 5WW | United Kingdom |
| St Bartholomew's Hospital | London | EC1M 6BQ | United Kingdom |
| King'S College Hospital; Haematology | London | SE5 9RS | United Kingdom |
| St. George'S Hospital; Haematology | London | SW17 0QT | United Kingdom |
| Hammersmith Hospital; Haematology | London | W12 OHS | United Kingdom |
| University College Hospital; Macmillan Cancer Centre | London | WC1E 6AG | United Kingdom |
| Christie Hospital; Breast Cancer Research Office | Manchester | M20 4QL | United Kingdom |
| Norfolk & Norwich Hospital; Dept of Haematology | Norwich | NR4 7UY | United Kingdom |
| Nottingham City Hospital; Dept of Haematology | Nottingham | NG5 1PB | United Kingdom |
| Churchill Hospital; Oxford Cancer and Haematology Centre | Oxford | OX3 7LJ | United Kingdom |
| Queen Alexandra Hospital; Haematology and Oncology Centre | Portsmouth | PO6 3LY | United Kingdom |
| Southampton General Hospital; Medical Oncology | Southampton | SO16 6YD | United Kingdom |
| Royal Marsden Hospital; Dept of Medical Oncology | Sutton | SM2 5PT | United Kingdom |
| Singleton Hospital; Pharmacy | Swansea | SA2 8QA | United Kingdom |
| Great Western;Department of Haematology | Swindon | SN3 6BB | United Kingdom |
| Royal Cornwall Hospital; Haematology Clinic | Truro | TR1 3LJ | United Kingdom |
| Derived |
| Pott C, Jurinovic V, Trotman J, Kehden B, Unterhalt M, Herold M, Jagt RV, Janssens A, Kneba M, Mayer J, Young M, Schmidt C, Knapp A, Nielsen T, Brown H, Spielewoy N, Harbron C, Bottos A, Mundt K, Marcus R, Hiddemann W, Hoster E. Minimal Residual Disease Status Predicts Outcome in Patients With Previously Untreated Follicular Lymphoma: A Prospective Analysis of the Phase III GALLIUM Study. J Clin Oncol. 2024 Feb 10;42(5):550-561. doi: 10.1200/JCO.23.00838. Epub 2023 Dec 14. |
| 36379880 | Derived | Casulo C, Herold M, Hiddemann W, Iyengar S, Marcus RE, Seymour JF, Launonen A, Knapp A, Nielsen TG, Mir F. Risk Factors for and Outcomes of Follicular Lymphoma Histological Transformation at First Progression in the GALLIUM Study. Clin Lymphoma Myeloma Leuk. 2023 Jan;23(1):40-48. doi: 10.1016/j.clml.2022.09.003. Epub 2022 Oct 4. |
| 35194005 | Derived | Hong X, Song Y, Shi Y, Zhang Q, Guo W, Wu G, Li J, Feng J, Kinkolykh A, Knapp A, Lin T. Efficacy and safety of obinutuzumab for the first-line treatment of follicular lymphoma: a subgroup analysis of Chinese patients enrolled in the phase III GALLIUM study. Chin Med J (Engl). 2021 Sep 16;135(4):433-440. doi: 10.1097/CM9.0000000000001737. |
| 34323957 | Derived | Strefford JC, Nowicka M, Hargreaves CE, Burton C, Davies A, Ganderton R, Hiddemann W, Iriyama C, Klapper W, Latham KV, Martelli M, Mir F, Parker H, Potter KN, Rose-Zerilli MJJ, Sehn LH, Trneny M, Vitolo U, Bolen CR, Klein C, Knapp A, Oestergaard MZ, Cragg MS. Single-nucleotide Fcgamma receptor polymorphisms do not impact obinutuzumab/rituximab outcome in patients with lymphoma. Blood Adv. 2021 Aug 10;5(15):2935-2944. doi: 10.1182/bloodadvances.2020003985. |
| 32314038 | Derived | Davies A, Trask P, Demeter J, Florschutz A, Hanel M, Kinoshita T, Pettengell R, Quach H, Robinson S, Sadullah S, Sancho JM, Udvardy M, Witzens-Harig M, Knapp A, Liu W. Health-related quality of life in the phase III GALLIUM study of obinutuzumab- or rituximab-based chemotherapy in patients with previously untreated advanced follicular lymphoma. Ann Hematol. 2020 Dec;99(12):2837-2846. doi: 10.1007/s00277-020-04021-6. Epub 2020 Apr 20. |
| 31053601 | Derived | Klanova M, Oestergaard MZ, Trneny M, Hiddemann W, Marcus R, Sehn LH, Vitolo U, Bazeos A, Goede V, Zeuner H, Knapp A, Sahin D, Spielewoy N, Bolen CR, Cardona A, Klein C, Venstrom JM, Nielsen T, Fingerle-Rowson G. Prognostic Impact of Natural Killer Cell Count in Follicular Lymphoma and Diffuse Large B-cell Lymphoma Patients Treated with Immunochemotherapy. Clin Cancer Res. 2019 Aug 1;25(15):4634-4643. doi: 10.1158/1078-0432.CCR-18-3270. Epub 2019 May 3. |
| 30341058 | Derived | Kusumoto S, Arcaini L, Hong X, Jin J, Kim WS, Kwong YL, Peters MG, Tanaka Y, Zelenetz AD, Kuriki H, Fingerle-Rowson G, Nielsen T, Ueda E, Piper-Lepoutre H, Sellam G, Tobinai K. Risk of HBV reactivation in patients with B-cell lymphomas receiving obinutuzumab or rituximab immunochemotherapy. Blood. 2019 Jan 10;133(2):137-146. doi: 10.1182/blood-2018-04-848044. Epub 2018 Oct 19. |
| 30309758 | Derived | Trotman J, Barrington SF, Belada D, Meignan M, MacEwan R, Owen C, Ptacnik V, Rosta A, Fingerle-Rowson GR, Zhu J, Nielsen T, Sahin D, Hiddemann W, Marcus RE, Davies A; PET investigators from the GALLIUM study. Prognostic value of end-of-induction PET response after first-line immunochemotherapy for follicular lymphoma (GALLIUM): secondary analysis of a randomised, phase 3 trial. Lancet Oncol. 2018 Nov;19(11):1530-1542. doi: 10.1016/S1470-2045(18)30618-1. Epub 2018 Oct 8. |
| 29856692 | Derived | Hiddemann W, Barbui AM, Canales MA, Cannell PK, Collins GP, Durig J, Forstpointner R, Herold M, Hertzberg M, Klanova M, Radford J, Seymour JF, Tobinai K, Trotman J, Burciu A, Fingerle-Rowson G, Wolbers M, Nielsen T, Marcus RE. Immunochemotherapy With Obinutuzumab or Rituximab for Previously Untreated Follicular Lymphoma in the GALLIUM Study: Influence of Chemotherapy on Efficacy and Safety. J Clin Oncol. 2018 Aug 10;36(23):2395-2404. doi: 10.1200/JCO.2017.76.8960. Epub 2018 Jun 1. |
| 28976863 | Derived | Marcus R, Davies A, Ando K, Klapper W, Opat S, Owen C, Phillips E, Sangha R, Schlag R, Seymour JF, Townsend W, Trneny M, Wenger M, Fingerle-Rowson G, Rufibach K, Moore T, Herold M, Hiddemann W. Obinutuzumab for the First-Line Treatment of Follicular Lymphoma. N Engl J Med. 2017 Oct 5;377(14):1331-1344. doi: 10.1056/NEJMoa1614598. |
| FG001 | Obinutuzumab+Chemotherapy - Induction Period | Participants received either 8 cycles of obinutuzumab along with 6 cycles of CHOP (21-day cycle) or 8 cycles of obinutuzumab along with 8 cycles of CVP (21-day cycles) or 6 cycles of obinutuzumab along with 6 cycles of bendamustine (28-day cycle) during induction period. The chemotherapy regimen (CHOP or CVP or bendamustine) for individual participant was chosen by the site prior to initiation of the study. |
| FG002 | Rituximab+Chemotherapy - Maintenance Period | The induction period was followed by either a maintenance or observation period for responders or non-responders, respectively. Responders received rituximab monotherapy every 2 months for 2 years during the maintenance period. |
| FG003 | Obinutuzumab+Chemotherapy - Maintenance Period | The induction period was followed by either a maintenance or observation period for responders or non-responders, respectively. Responders received obinutuzumab monotherapy every 2 months for 2 years during the maintenance period. |
| FG004 | Rituximab+Chemotherapy - Observation Period | Rituximab+Chemotherapy - Observation: The induction period was followed by either a maintenance or observation period for responders or non-responders, respectively. Non-responders received no protocol specified treatment during the 2-year observation period. |
| FG005 | Obinutuzumab+Chemotherapy - Observation Period | Obinutuzumab+Chemotherapy - Observation: The induction period was followed by either a maintenance or observation period for responders or non-responders, respectively. Non-responders received no protocol specified treatment during the 2-year observation period. |
| FG006 | Rituximab+Chemotherapy - Follow-Up Period | Finally, participants were followed during a 5-year follow-up period. |
| FG007 | Obinutuzumab+Chemotherapy - Follow-Up Period | Finally, participants were followed during a 5-year follow-up period. |
| COMPLETED |
|
| NOT COMPLETED |
|
|
| Maintenance/Observation Period |
|
|
| Follow-Up Period |
|
|
The intent-to treat (ITT) population was defined as all randomized participants grouped according to their randomized treatment arm regardless of what treatments were actually received.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Rituximab+Chemotherapy - Induction Period | Participants received either 8 cycles of rituximab along with 6 cycles of cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) (21-day cycle) or 8 cycles of rituximab along with 8 cycles of cyclophosphamide, vincristine, and prednisone (CVP) (21-day cycles) or 6 cycles of rituximab along with 6 cycles of bendamustine (28-day cycle) during induction period. The chemotherapy regimen (CHOP or CVP or bendamustine) for individual participant was chosen by the site prior to initiation of the study. |
| BG001 | Obinutuzumab+Chemotherapy - Induction Period | Participants received either 8 cycles of obinutuzumab along with 6 cycles of CHOP (21-day cycle) or 8 cycles of obinutuzumab along with 8 cycles of CVP (21-day cycles) or 6 cycles of obinutuzumab along with 6 cycles of bendamustine (28-day cycle) during induction period. The chemotherapy regimen (CHOP or CVP or bendamustine) for individual participant was chosen by the site prior to initiation of the study. |
| 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 |
| ||||||||||||||||
| Age Continuous in Follicular Lymphoma Sub-Population | Age continuous for participants with follicular lymphoma (FL) in each arm, who encompassed the population for the primary outcome measure. The FL ITT included participants in the ITT population with follicular histology (n=601 in each arm). | Mean | Standard Deviation | years |
| ||||||||||||||
| Gender in Follicular Lymphoma Sub-Population | Gender of participants with follicular lymphoma, who encompassed the population for the primary outcome measure. The FL ITT included participants in the ITT population with follicular histology (n=601 for each arm). | As this is a sub-population, the numbers analyzed differ from the overall population numbers as not all are included here. | 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 | Progression-Free Survival in the Follicular Lymphoma Population, Investigator-Assessed | Progression-free survival in participants with follicular lymphoma was defined as the time from randomization until the first documented day of disease progression or death from any cause, whichever occurred first, on the basis of investigator assessments according to the Revised Response Criteria for Malignant Lymphoma. Progression was defined as at least 50% increase in nodal lesions or >/=50% increase in any node > 1 centimeter (cm) or >/= 50% increase in other target measurable lesions (e.g., splenic or hepatic nodules) and/or appearance of any new bone marrow involvement and/or appearance of any new lesion > 1.5 cm or >/= 50% increase in any previously involved node with a diameter </= 1 cm such that it is now >1.5 cm. Tumor measurements were obtained by computed tomography (CT) or magnetic resonance imaging (MRI). | The intent-to-treat follicular lymphoma population (FL ITT), defined as all randomized participants with follicular histology, where participants were grouped according to their randomized treatment arm regardless of what treatments were actually received. | Posted | Number | percentage of participants with event | Baseline up to data cut-off (up to approximately 4 years and 7 months) |
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| Secondary | Progression-Free Survival in the Follicular Lymphoma Population, Investigator-Assessed | Progression-free survival in participants with follicular lymphoma was defined as the time from randomization until the first documented day of disease progression or death from any cause, whichever occurred first, on the basis of investigator assessments according to the Revised Response Criteria for Malignant Lymphoma. Progression was defined as at least 50% increase in nodal lesions or >/=50% increase in any node > 1 centimeter (cm) or >/= 50% increase in other target measurable lesions (e.g., splenic or hepatic nodules) and/or appearance of any new bone marrow involvement and/or appearance of any new lesion > 1.5 cm or >/= 50% increase in any previously involved node with a diameter </= 1 cm such that it is now >1.5 cm. Tumor measurements were obtained by computed tomography (CT) or magnetic resonance imaging (MRI). | The FL ITT population was defined as all randomized participants with follicular histology, where participants were grouped according to their randomized treatment arm regardless of what treatments were actually received. | Posted | Number | percentage of participants with event | Baseline up to final analysis (up to 10 years) |
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| Secondary | Progression-Free Survival in the Overall Study Population, Investigator-Assessed | Progression-free survival in the overall study population was defined as the time from randomization until the first documented day of disease progression or death from any cause, whichever occurred first, on the basis of investigator assessments according to the Revised Response Criteria for Malignant Lymphoma. Progression was defined as at least 50% increase in nodal lesions or >/=50% increase in any node > 1 centimeter (cm) or >/= 50% increase in other target measurable lesions (e.g., splenic or hepatic nodules) and/or appearance of any new bone marrow involvement and/or appearance of any new lesion > 1.5 cm or >/= 50% increase in any previously involved node with a diameter </= 1 cm such that it is now >1.5 cm. Tumor measurements were obtained by CT/MRI. | The ITT population defined as all randomized participants grouped according to their randomized treatment arm regardless of what treatments were actually received. | Posted | Number | percentage of participants with event | Baseline up to data cut-off (up to approximately 5 years and 2 months) |
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| Secondary | Progression-Free Survival (Follicular Lymphoma Population), IRC-Assessed | Progression-free survival in the participants with follicular lymphoma was defined as the time from randomization until the first documented day of disease progression or death from any cause, whichever occurred first, on the basis of IRC assessments according to the Revised Response Criteria for Malignant Lymphoma. Progression was defined as at least 50% increase in nodal lesions or >/=50% increase in any node > 1 centimeter (cm) or >/= 50% increase in other target measurable lesions (e.g., splenic or hepatic nodules) and/or appearance of any new bone marrow involvement and/or appearance of any new lesion > 1.5 cm or >/= 50% increase in any previously involved node with a diameter </= 1 cm such that it is now >1.5 cm. Tumor measurements were obtained by CT/MRI. In the first 170 patients with follicular lymphoma, an FDG-PET was mandatory where a PET scanner was available. | The FL ITT population, defined as all randomized participants with follicular histology, where participants were grouped according to their randomized treatment arm regardless of what treatments were actually received. | Posted | Number | percentage of participants with event | Baseline up to data cut-off (up to approximately 5 years and 2 months) |
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| Secondary | Progression-Free Survival (Overall Study Population), Assessed by Independent Review Committee (IRC) | Progression-free survival in the overall study population was defined as the time from randomization until the first documented day of disease progression or death from any cause, whichever occurred first, on the basis of IRC assessments according to the Revised Response Criteria for Malignant Lymphoma. Progression was defined as at least 50% increase in nodal lesions or >/=50% increase in any node > 1 centimeter (cm) or >/= 50% increase in other target measurable lesions (e.g., splenic or hepatic nodules) and/or appearance of any new bone marrow involvement and/or appearance of any new lesion > 1.5 cm or >/= 50% increase in any previously involved node with a diameter </= 1 cm such that it is now >1.5 cm. Tumor measurements were obtained by CT/MRI. | The ITT population defined as all randomized participants grouped according to their randomized treatment arm regardless of what treatments were actually received. | Posted | Number | percentage of participants with event | Baseline up to data cut-off (up to approximately 5 years and 2 months) |
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| Secondary | Overall Response (Follicular Lymphoma Population), Investigator-Assessed | Overall response in the follicular lymphoma population was defined as percentage of participants with PR or complete response CR determined on the basis of investigator assessments with the use of Revised Response Criteria for Malignant Lymphoma. Tumor assessments were performed with CT/MRI with and without PET. CR was defined as disappearance of all target lesions; PR was defined as >=50% decrease target lesions in up to six dominant lesions identified at baseline, no new lesions and no increase in the size of the liver, spleen, or other nodes. Splenic and hepatic nodules must have regressed by >/= 50%. Overall Response (OR) = CR + PR. | The FL ITT population, defined as all randomized participants with follicular histology, where participants were grouped according to their randomized treatment arm regardless of what treatments were actually received. | Posted | Number | percentage of participants with event | Baseline up to end of induction period (up to approximately 7 months) |
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| Secondary | Overall Response (Overall Study Population), Investigator-Assessed | Overall response in the overall study population was defined as percentage of participants with partial response (PR) or complete response (CR) determined on the basis of investigator assessments with the use of Revised Response Criteria for Malignant Lymphoma. Tumor assessments were performed with CT/MRI with or without positron emission tomography (PET). CR was defined as disappearance of all target lesions; PR was defined as >=50% decrease target lesions in up to six dominant lesions identified at baseline, no new lesions and no increase in the size of the liver, spleen, or other nodes. Splenic and hepatic nodules must have regressed by >/= 50%; Overall Response (OR) = CR + PR. | The ITT population defined as all randomized participants grouped according to their randomized treatment arm regardless of what treatments were actually received. | Posted | Number | percentage of participants with event | Baseline up to end of induction period (up to approximately 7 months) |
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| Secondary | Complete Response (Follicular Lymphoma Population), Investigator-Assessed | Percentage of participants with complete response in the follicular lymphoma population was determined on the basis of investigator assessments with the use of Revised Response Criteria for Malignant Lymphoma. Tumor assessments were performed with CT/MRI with or without PET. CR was defined as disappearance of all target lesions. | The FL ITT population, defined as all randomized participants with follicular histology, where participants were grouped according to their randomized treatment arm regardless of what treatments were actually received. | Posted | Number | percentage of participants with event | Baseline up to end of induction period (up to approximately 7 months) |
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| Secondary | Complete Response (Overall Study Population), Investigator-Assessed | Percentage of participants with complete response in the overall study population was determined on the basis of investigator assessments with the use of Revised Response Criteria for Malignant Lymphoma. Tumor assessments were performed with CT/MRI with or without PET. CR was defined as disappearance of all target lesions. | The ITT population defined as all randomized participants grouped according to their randomized treatment arm regardless of what treatments were actually received. | Posted | Number | percentage of participants with event | Baseline up to end of induction period (up to approximately 7 months) |
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| Secondary | Overall Response (Follicular Lymphoma Population), IRC-Assessed | Overall response in the follicular lymphoma population was defined as percentage of participants with PR or complete response CR determined on the basis of IRC assessments with the use of Revised Response Criteria for Malignant Lymphoma. Tumor assessments were performed with CT/MRI with or without PET. CR was defined as disappearance of all target lesions; PR was defined as >=50% decrease target lesions in up to six dominant lesions identified at baseline, no new lesions and no increase in the size of the liver, spleen, or other nodes. Splenic and hepatic nodules must have regressed by >/= 50%. Overall Response (OR) = CR + PR. | The FL ITT population, defined as all randomized participants with follicular histology, where participants were grouped according to their randomized treatment arm regardless of what treatments were actually received. | Posted | Number | percentage of participants with event | Baseline up to end of induction period (up to approximately 7 months) |
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| Secondary | Overall Response (Overall Study Population), IRC-Assessed | Overall response in the overall study population was defined as percentage of participants with PR or CR determined on the basis of IRC assessments with the use of Revised Response Criteria for Malignant Lymphoma. Tumor assessments were performed with CT/MRI with or without PET. CR was defined as disappearance of all target lesions; PR was defined as >=50% decrease target lesions in up to six dominant lesions identified at baseline, no new lesions and no increase in the size of the liver, spleen, or other nodes. Splenic and hepatic nodules must have regressed by >/= 50%; Overall Response (OR) = CR + PR. | The ITT population defined as all randomized participants grouped according to their randomized treatment arm regardless of what treatments were actually received. | Posted | Number | percentage of participants with event | Baseline up to end of induction period (up to approximately 7 months) |
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| Secondary | Complete Response (Follicular Lymphoma Population), IRC-Assessed | Percentage of participants with complete response in the follicular lymphoma population was determined on the basis of IRC assessments with the use of Revised Response Criteria for Malignant Lymphoma. Tumor assessments were performed with CT/MRI with or without PET. CR was defined as disappearance of all target lesions. | The FL ITT population, defined as all randomized participants with follicular histology, where participants were grouped according to their randomized treatment arm regardless of what treatments were actually received. | Posted | Number | percentage of participants with event | Baseline up to end of induction period (up to approximately 7 months) |
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| Secondary | Complete Response (Overall Study Population), IRC-Assessed | Percentage of participants with complete response in the overall study population was determined on the basis of IRC assessments with the use of Revised Response Criteria for Malignant Lymphoma. Tumor assessments were performed with CT/MRI with or without PET. CR was defined as disappearance of all target lesions. | The ITT population defined as all randomized participants grouped according to their randomized treatment arm regardless of what treatments were actually received. | Posted | Number | percentage of participants with event | Baseline up to end of induction period (up to approximately 7 months)] |
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| Secondary | Overall Survival (Follicular Lymphoma Population) | Overall survival in the follicular lymphoma population was defined as the time from the date of randomization to the date of death from any cause. Reported is the percentage of participants with event. | The FL ITT population, defined as all randomized participants with follicular histology, where participants were grouped according to their randomized treatment arm regardless of what treatments were actually received. | Posted | Number | percentage of participants with event | Baseline up to 10 years |
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| Secondary | Overall Survival (Overall Study Population) | Overall survival in the overall study population was defined as the time from the date of randomization to the date of death from any cause. Reported is the percentage of participants with event. | The ITT population defined as all randomized participants grouped according to their randomized treatment arm regardless of what treatments were actually received. | Posted | Number | percentage of participants with event | Baseline up to data cut-off (up to approximately 5 years and 2 months) |
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| Secondary | Event-Free Survival (Follicular Lymphoma Population) | Event-free survival in the follicular lymphoma population was defined as the time from the date of randomization to the date to disease progression/relapse, death from any cause, or initiation of a new anti-lymphoma treatment (NALT) on the basis of investigator assessment assessments with the use of Revised Response Criteria for Malignant Lymphoma. Disease progression/relapse was defined as at least 50% increase in nodal lesions or >/=50% increase in any node > 1 centimeter (cm) or >/= 50% increase in other target measurable lesions (e.g., splenic or hepatic nodules) and/or appearance of any new bone marrow involvement and/or appearance of any new lesion > 1.5 cm or >/= 50% increase in any previously involved node with a diameter </= 1 cm such that it is now >1.5 cm. Tumor measurements were obtained by CT/MRI. Reported is the percentage of participants with an event. | The FL ITT population, defined as all randomized participants with follicular histology, where participants were grouped according to their randomized treatment arm regardless of what treatments were actually received. | Posted | Number | percentage of participants with event | Baseline up to 10 years |
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| Secondary | Event-Free Survival (Overall Study Population) | Event-free survival in the overall study population was defined as the time from the date of randomization to the date to disease progression/relapse, death from any cause, or initiation of a new anti-lymphoma treatment (NALT) on the basis of investigator assessment assessments with the use of Revised Response Criteria for Malignant Lymphoma. Disease progression/relapse was defined as at least 50% increase in nodal lesions or >/=50% increase in any node > 1 centimeter (cm) or >/= 50% increase in other target measurable lesions (e.g., splenic or hepatic nodules) and/or appearance of any new bone marrow involvement and/or appearance of any new lesion > 1.5 cm or >/= 50% increase in any previously involved node with a diameter </= 1 cm such that it is now >1.5 cm. Tumor measurements were obtained by CT/MRI. Reported is the percentage of participants with event. | The ITT population defined as all randomized participants grouped according to their randomized treatment arm regardless of what treatments were actually received. | Posted | Number | percentage of participants with event | Baseline up to data cut-off (up to approximately 5 years and 2 months) |
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| Secondary | Disease-Free Survival (Follicular Lymphoma Population) | Disease-free survival in the follicular lymphoma population was defined as the time from the date of the first occurrence of a documented CR to the date of disease progression/ relapse, or death from any cause for the subgroup of participants with a response of CR at any time prior to NALT on the basis of investigator assessments with the use of Revised Response Criteria for Malignant Lymphoma (RRCML). Tumor assessments were performed with CT/MRI. CR was defined as disappearance of all target lesions. Progression/relapse was defined as at least 50% increase in nodal lesions or >/=50% increase in any node > 1 centimeter (cm) or >/= 50% increase in other target measurable lesions (e.g., splenic or hepatic nodules) and/or appearance of any new bone marrow involvement and/or appearance of any new lesion > 1.5 cm or >/= 50% increase in any previously involved node with a diameter </= 1 cm such that it is now >1.5 cm. Reported is the percentage of participants with event. | Participants with CR within the FL ITT population were included in the analysis.The FL ITT population, defined as all randomized participants with follicular histology, where participants were grouped according to their randomized treatment arm regardless of what treatments were actually received. | Posted | Number | percentage of participants with event | From first occurrence of documented CR to data cut-off (up to approximately 5 years and 2 months) |
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| Secondary | Disease-Free Survival (Overall Study Population) | Disease-free survival in the overall study population was defined as the time from the date of the first occurrence of a documented CR to the date of disease progression/ relapse, or death from any cause for the subgroup of participants with a response of CR at any time prior to NALT on the basis of investigator assessments with the use of Revised Response Criteria for Malignant Lymphoma. Tumor assessments were performed with CT/MRI. CR was defined as disappearance of all target lesions. Progression/relapse was defined as at least 50% increase in nodal lesions or >/=50% increase in any node > 1 centimeter (cm) or >/= 50% increase in other target measurable lesions (e.g., splenic or hepatic nodules) and/or appearance of any new bone marrow involvement and/or appearance of any new lesion > 1.5 cm or >/= 50% increase in any previously involved node with a diameter </= 1 cm such that it is now >1.5 cm. Reported is the percentage of participants with event. | Participants with CR within the ITT population were included in the analysis.The ITT population was defined as all randomized participants grouped according to their randomized treatment arm regardless of what treatments were actually received. | Posted | Number | percentage of participants with event | From first occurrence of documented CR to data cut-off (up to approximately 5 years and 2 months) |
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| Secondary | Duration of Response (DOR) (Follicular Lymphoma Population), Investigator-Assessed | DOR was defined as the time from first occurrence of a documented CR or PR to disease progression/relapse, or death from any cause for participants with a response of CR or PR any time prior to NALT based on RRCML. Tumor assessments were performed with CT/MRI. CR was defined as disappearance of all target lesions. PR was defined as >/=50% decrease target lesions in up to six dominant lesions identified at baseline, no new lesions and no increase in the size of the liver, spleen, or other nodes. Splenic and hepatic nodules must have regressed by >/= 50%. Progression/relapse was defined as at least 50% increase in nodal lesions or >/=50% increase in any node > 1 centimeter (cm) or >/= 50% increase in other target measurable lesions (e.g., splenic or hepatic nodules) and/or appearance of any new bone marrow involvement and/or appearance of any new lesion > 1.5 cm or >/= 50% increase in any previously involved node with a diameter </= 1 cm such that it is now >1.5 cm. | Participants with CR or PR within the FL ITT population were included in the analysis.The FL ITT population, defined as all randomized participants with follicular histology, where participants were grouped according to their randomized treatment arm regardless of what treatments were actually received. | Posted | Number | percentage of participants with event | From first occurrence of documented CR or PR to data cut-off (up to approximately 5 years and 2 months) |
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| Secondary | Duration of Response (DOR) (Overall Study Population), Investigator-Assessed | DOR was defined as the time from first occurrence of a documented CR or PR to disease progression/relapse, or death from any cause for participants with a response of CR or PR any time prior to NALT based on RRCML. Tumor assessments were performed with CT/MRI. CR was defined as disappearance of all target lesions. PR was defined as >/=50% decrease target lesions in up to six dominant lesions identified at baseline, no new lesions and no increase in the size of the liver, spleen, or other nodes. Splenic and hepatic nodules must have regressed by >/= 50%. Progression/relapse was defined as at least 50% increase in nodal lesions or >/=50% increase in any node > 1 centimeter (cm) or >/= 50% increase in other target measurable lesions (e.g., splenic or hepatic nodules) and/or appearance of any new bone marrow involvement and/or appearance of any new lesion > 1.5 cm or >/= 50% increase in any previously involved node with a diameter </= 1 cm such that it is now >1.5 cm. | Participants with CR or PR within the ITT population were included in the analysis. The ITT population defined as all randomized participants grouped according to their randomized treatment arm regardless of what treatments were actually received. | Posted | Number | percentage of participants with event | From first occurrence of documented CR or PR to data cut-off (up to approximately 4 years and 7 months) |
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| Secondary | Time to Next Anti-Lymphoma Treatment (Follicular Lymphoma Population) | Time to next anti-lymphoma treatment was defined as the time from the date of randomization to the start date of the next anti-lymphoma treatment or death from any cause. Reported is the percentage of participants with event. | The FL ITT population, defined as all randomized participants with follicular histology, where participants were grouped according to their randomized treatment arm regardless of what treatments were actually received. | Posted | Number | percentage of participants with event | Baseline up to 10 years |
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| Secondary | Time to Next Anti-Lymphoma Treatment (Overall Study Population) | Time to next anti-lymphoma treatment was defined as the time from the date of randomization to the start date of the next anti-lymphoma treatment or death from any cause. Reported is the percentage of participants with event. | The ITT population defined as all randomized participants grouped according to their randomized treatment arm regardless of what treatments were actually received. | Posted | Number | percentage of participants with event | Baseline up to data cut-off (up to approximately 5 years and 2 months) |
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| Secondary | Percentage of Participants With Adverse Events | An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as adverse events. | The safety analysis population included all participants who received any amount of any study drug and participants were analyzed according to the treatment received. | Posted | Number | percentage of participants | Baseline up to 10 years |
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| Secondary | Change From Baseline in All Domains of FACT-G (Follicular Lymphoma Population) | FACT-G consists of the following 4 FACT-Lym sub-questionnaires: Physical Well-being (range: 0-28), Social/Family Well-being (range: 0-28), Emotional Well-being (range: 0-24) and Functional Well-being (range: 0-28). Higher scores indicate better outcomes. A positive change from baseline indicates improvement. Maint = Maintenance period. | The FL ITT population was defined as all randomized participants with follicular histology grouped according to their randomized treatment arm regardless of what treatments were actually received. | Posted | Mean | Standard Deviation | units on a scale | Baseline (Induction Cycle 1, Day 1), data cut-off (up to approximately 5 years and 2 months) |
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| Secondary | Change From Baseline in FACT-Lym Total Outcome Index (TOI) Score (Follicular Lymphoma Population) | The FACT-Lym TOI Score for the follicular lymphoma population was derived from the following 3 individual FACT-Lym questionnaire subscale scores: Physical Well-being (range: 0-28), Functional Well-being (range: 0-28) and Lymphoma (range: 0-60). The FACT-Lym TOI Score is the sum of the 3 individual subscales (range 0-116). Higher scores indicate better outcomes. A positive change from baseline indicates an improvement. | The FL ITT population was defined as all randomized participants with follicular histology grouped according to their randomized treatment arm regardless of what treatments were actually received. | Posted | Mean | Standard Deviation | units on a scale | Baseline (Induction Cycle 1, Day 1), data cut-off (up to approximately 5 years and 2 months) |
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| Secondary | Change From Baseline in FACT-Lym Individual Subscale Lymphoma Score (Follicular Population) | The FACT-Lym Individual Subscale Lymphoma Score for the follicular lymphoma population was derived from the Lymphoma subscale questionnaire (range: 0-60). Higher scores indicate better outcomes. A positive change from baseline indicates an improvement. | The FL ITT population was defined as all randomized participants with follicular histology grouped according to their randomized treatment arm regardless of what treatments were actually received. | Posted | Mean | Standard Deviation | units on a scale | Baseline (Induction Cycle 1, Day 1), data cut-off (up to approximately 5 years and 2 months) |
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| Secondary | Change From Baseline in Functional Assessment of Cancer Therapy-Lymphoma (FACT-Lym) Total Score (Follicular Population) | The FACT-Lym Total Score for the follicular lymphoma population was derived from the following 5 individual FACT-Lym questionnaire subscale scores: Physical Well-being (range: 0-28), Social/Family Well-being (range: 0-28), Emotional Well-being (range: 0-24),Functional Well-being (range: 0-28) and Lymphoma (range: 0-60). The FACT-Lym Total Score is the sum of all 5 individual subscales (range 0-168). Higher scores indicate better outcomes. A positive change from baseline indicates an improvement. | The FL ITT population was defined as all randomized participants with follicular histology grouped according to their randomized treatment arm regardless of what treatments were actually received. | Posted | Mean | Standard Deviation | units on a scale | Baseline (Induction Cycle 1, Day 1), data cut-off (up to approximately 5 years and 2 months) |
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| Secondary | Change From Baseline in Euro-Quality of Life-5 Dimensions (EQ-5D) Questionnaire Summary Score (Follicular Lymphoma Population) During Induction Phase | The EQ-5D is a quality of life questionnaire with five questions, each with three categories (no problem, moderate problem, severe problems) and a visual analogue scale (VAS) from 0 (worst possible health state) to 100 (best possible health state. Summary score ranges from 0 to 1. Higher scores indicate better outcomes. A positive change from baseline indicates an improvement. Completion (Compl) includes completion visit and early termination visit. Maintenance/Observation is indicated as Maint/Obs. | The FL ITT population, defined as all randomized participants with follicular histology, where participants were grouped according to their randomized treatment arm regardless of what treatments were actually received. | Posted | Mean | Standard Deviation | units on a scale | Induction: Cycle 1 Day 1 (Baseline), Cycle 3 Day 1, End of Induction (up to 7 months); Maintenance: 2, 12 months after Day 1 of last induction cycle, Follow-up: every year up to data cut-off (up to 5 years and 2 months) |
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| Secondary | Change From Baseline in Euro-Quality of Life-5 Dimensions (EQ-5D) Questionnaire Summary Score (Follicular Lymphoma Population) During Maintenance/Observation Phase | The EQ-5D is a quality of life questionnaire with five questions, each with three categories (no problem, moderate problem, severe problems) and a visual analogue scale (VAS) from 0 (worst possible health state) to 100 (best possible health state. Summary score ranges from 0 to 1 Higher scores indicate better outcomes. A positive change from baseline indicates an improvement. Maintenance/Observation is indicated as Maint/Obs. Completion includes completion visit and early termination visit. | The FL ITT population, defined as all randomized participants with follicular histology, where participants were grouped according to their randomized treatment arm regardless of what treatments were actually received. | Posted | Mean | Standard Deviation | units on a scale | Induction: Cycle 1 Day 1 (Baseline), Cycle 3 Day 1, End of Induction (up to 7 months); Maintenance: 2, 12 months after Day 1 of last induction cycle, Follow-up: every year up to data cut-off (up to 5 years and 2 months) |
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| Secondary | Change From Baseline in Euro-Quality of Life-5 Dimensions (EQ-5D) Questionnaire Summary Score (Follicular Lymphoma Population) During Follow Up Phase | The EQ-5D is a quality of life questionnaire with five questions, each with three categories (no problem, moderate problem, severe problems) and a visual analogue scale (VAS) from 0 (worst possible health state) to 100 (best possible health state. Summary score ranges from 0 to 1. Higher scores indicate better outcomes. A positive change from baseline indicates an improvement. Maintenance/Observation is indicated as Maint/Obs in data categories. Completion includes completion visit and early termination visit. | The FL ITT population, defined as all randomized participants with follicular histology, where participants were grouped according to their randomized treatment arm regardless of what treatments were actually received. | Posted | Mean | Standard Deviation | units on a scale | Induction: Cycle 1 Day 1 (Baseline), Cycle 3 Day 1, End of Induction (up to 7 months); Maintenance: 2, 12 after Day 1 of last induction cycle, Follow-up: every year for up to data cut-off (up to 5 years and 2 months) |
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Baseline up to 10 years
The safety analysis population included all participants who received any amount of any study drug and participants were analyzed according to the treatment received.
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+Chemotherapy | Participants will receive either 8 cycles of rituximab along with 6 cycles of cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) (21-day cycle) or 8 cycles of rituximab along with 8 cycles of cyclophosphamide, vincristine, and prednisone (CVP) (21-day cycles) or 6 cycles of rituximab along with 6 cycles of bendamustine (28-day cycle) during the induction period. The induction period will be followed by either a maintenance or observation period for responders or non-responders, respectively. Responders will receive rituximab monotherapy every 2 months for 2 years during the maintenance period. Non-responders will receive no protocol specified treatment during the 2-year observation period. Finally, participants will be followed during a 5-year follow-up period. The chemotherapy regimen (CHOP or CVP or bendamustine) for individual participant will be chosen by the site prior to initiation of the study. | 111 | 692 | 309 | 692 | 675 | 692 |
| EG001 | Obinutuzumab+Chemotherapy | Participants will receive either 8 cycles of obinutuzumab along with 6 cycles of CHOP (21-day cycle) or 8 cycles of obinutuzumab along with 8 cycles of CVP (21-day cycles) or 6 cycles of obinutuzumab along with 6 cycles of bendamustine (28-day cycle) during induction period. The induction period will be followed by either a maintenance or observation period for responders or non-responders, respectively. Responders will receive obinutuzumab monotherapy every 2 months for 2 years during the maintenance period. Non-responders will receive no protocol specified treatment during the 2-year observation period. Finally, participants will be followed during a 5-year follow-up period. The chemotherapy regimen (CHOP or CVP or bendamustine) for individual participant will be chosen by the site prior to initiation of the study. | 104 | 698 | 361 | 698 | 690 | 698 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| ANAEMIA | Blood and lymphatic system disorders | MedDRA 24.0 | Systematic Assessment |
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| AUTOIMMUNE HAEMOLYTIC ANAEMIA | Blood and lymphatic system disorders | MedDRA 24.0 | Systematic Assessment |
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| DISSEMINATED INTRAVASCULAR COAGULATION | Blood and lymphatic system disorders | MedDRA 24.0 | Systematic Assessment |
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| FEBRILE NEUTROPENIA | Blood and lymphatic system disorders | MedDRA 24.0 | Systematic Assessment |
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| GRANULOCYTOPENIA | Blood and lymphatic system disorders | MedDRA 24.0 | Systematic Assessment |
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| HAEMOLYSIS | Blood and lymphatic system disorders | MedDRA 24.0 | Systematic Assessment |
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| HAEMOLYTIC ANAEMIA | Blood and lymphatic system disorders | MedDRA 24.0 | Systematic Assessment |
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| IMMUNE THROMBOCYTOPENIA | Blood and lymphatic system disorders | MedDRA 24.0 | Systematic Assessment |
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| LEUKOPENIA | Blood and lymphatic system disorders | MedDRA 24.0 | Systematic Assessment |
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| MYELOSUPPRESSION | Blood and lymphatic system disorders | MedDRA 24.0 | Systematic Assessment |
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| NEUTROPENIA | Blood and lymphatic system disorders | MedDRA 24.0 | Systematic Assessment |
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| SPLENOMEGALY | Blood and lymphatic system disorders | MedDRA 24.0 | Systematic Assessment |
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| THROMBOCYTOPENIA | Blood and lymphatic system disorders | MedDRA 24.0 | Systematic Assessment |
| |
| ACUTE MYOCARDIAL INFARCTION | Cardiac disorders | MedDRA 24.0 | Systematic Assessment |
| |
| ANGINA PECTORIS | Cardiac disorders | MedDRA 24.0 | Systematic Assessment |
| |
| AORTIC VALVE STENOSIS | Cardiac disorders | MedDRA 24.0 | Systematic Assessment |
| |
| ARRHYTHMIA | Cardiac disorders | MedDRA 24.0 | Systematic Assessment |
| |
| ATRIAL FIBRILLATION | Cardiac disorders | MedDRA 24.0 | Systematic Assessment |
| |
| ATRIAL FLUTTER | Cardiac disorders | MedDRA 24.0 | Systematic Assessment |
| |
| BRADYCARDIA | Cardiac disorders | MedDRA 24.0 | Systematic Assessment |
| |
| CARDIAC ARREST | Cardiac disorders | MedDRA 24.0 | Systematic Assessment |
| |
| CARDIAC FAILURE | Cardiac disorders | MedDRA 24.0 | Systematic Assessment |
| |
| CARDIAC FAILURE CONGESTIVE | Cardiac disorders | MedDRA 24.0 | Systematic Assessment |
| |
| CARDIO-RESPIRATORY ARREST | Cardiac disorders | MedDRA 24.0 | Systematic Assessment |
| |
| CARDIOGENIC SHOCK | Cardiac disorders | MedDRA 24.0 | Systematic Assessment |
| |
| CORONARY ARTERY DISEASE | Cardiac disorders | MedDRA 24.0 | Systematic Assessment |
| |
| CORONARY ARTERY STENOSIS | Cardiac disorders | MedDRA 24.0 | Systematic Assessment |
| |
| MYOCARDIAL INFARCTION | Cardiac disorders | MedDRA 24.0 | Systematic Assessment |
| |
| MYOCARDIAL ISCHAEMIA | Cardiac disorders | MedDRA 24.0 | Systematic Assessment |
| |
| PALPITATIONS | Cardiac disorders | MedDRA 24.0 | Systematic Assessment |
| |
| RIGHT VENTRICULAR FAILURE | Cardiac disorders | MedDRA 24.0 | Systematic Assessment |
| |
| SINUS BRADYCARDIA | Cardiac disorders | MedDRA 24.0 | Systematic Assessment |
| |
| SINUS TACHYCARDIA | Cardiac disorders | MedDRA 24.0 | Systematic Assessment |
| |
| SUPRAVENTRICULAR TACHYCARDIA | Cardiac disorders | MedDRA 24.0 | Systematic Assessment |
| |
| TACHYCARDIA | Cardiac disorders | MedDRA 24.0 | Systematic Assessment |
| |
| VENTRICULAR TACHYCARDIA | Cardiac disorders | MedDRA 24.0 | Systematic Assessment |
| |
| HEREDITARY MOTOR AND SENSORY NEUROPATHY | Congenital, familial and genetic disorders | MedDRA 24.0 | Systematic Assessment |
| |
| DEAFNESS | Ear and labyrinth disorders | MedDRA 24.0 | Systematic Assessment |
| |
| EAR PAIN | Ear and labyrinth disorders | MedDRA 24.0 | Systematic Assessment |
| |
| VERTIGO | Ear and labyrinth disorders | MedDRA 24.0 | Systematic Assessment |
| |
| CORNEAL OPACITY | Eye disorders | MedDRA 24.0 | Systematic Assessment |
| |
| ABDOMINAL PAIN | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| ABDOMINAL PAIN UPPER | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| ASCITES | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| COLITIS | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| CONSTIPATION | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| CROHN'S DISEASE | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| DIARRHOEA | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| DYSPEPSIA | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| ENTEROVESICAL FISTULA | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| FAECALOMA | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| GASTRIC HAEMORRHAGE | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| GASTRIC ULCER | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| GASTRITIS | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| GASTRITIS EROSIVE | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| GASTROENTERITIS EOSINOPHILIC | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| GASTROOESOPHAGEAL REFLUX DISEASE | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| HAEMATEMESIS | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| HAEMORRHOIDS | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| HIATUS HERNIA | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| ILEUS | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| INGUINAL HERNIA | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| INTESTINAL ISCHAEMIA | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| INTESTINAL OBSTRUCTION | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| INTESTINAL POLYP | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| INTESTINAL VILLI ATROPHY | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| LARGE INTESTINAL OBSTRUCTION | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| LARGE INTESTINE POLYP | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| MELAENA | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| MIKULICZ'S SYNDROME | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| MOUTH ULCERATION | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| NAUSEA | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| OBSTRUCTIVE PANCREATITIS | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| PANCREATITIS | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| PANCREATITIS ACUTE | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| RECTAL HAEMORRHAGE | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| SMALL INTESTINAL OBSTRUCTION | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| SUBACUTE PANCREATITIS | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| SWOLLEN TONGUE | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| UMBILICAL HERNIA | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| UPPER GASTROINTESTINAL HAEMORRHAGE | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| VOMITING | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| ADVERSE DRUG REACTION | General disorders | MedDRA 24.0 | Systematic Assessment |
| |
| CHEST DISCOMFORT | General disorders | MedDRA 24.0 | Systematic Assessment |
| |
| CHEST PAIN | General disorders | MedDRA 24.0 | Systematic Assessment |
| |
| CHILLS | General disorders | MedDRA 24.0 | Systematic Assessment |
| |
| CYST RUPTURE | General disorders | MedDRA 24.0 | Systematic Assessment |
| |
| DEATH | General disorders | MedDRA 24.0 | Systematic Assessment |
| |
| GENERAL PHYSICAL HEALTH DETERIORATION | General disorders | MedDRA 24.0 | Systematic Assessment |
| |
| HYPERPLASIA | General disorders | MedDRA 24.0 | Systematic Assessment |
| |
| HYPERTHERMIA | General disorders | MedDRA 24.0 | Systematic Assessment |
| |
| ILL-DEFINED DISORDER | General disorders | MedDRA 24.0 | Systematic Assessment |
| |
| INFLUENZA LIKE ILLNESS | General disorders | MedDRA 24.0 | Systematic Assessment |
| |
| INFUSION SITE EXTRAVASATION | General disorders | MedDRA 24.0 | Systematic Assessment |
| |
| MUCOSAL INFLAMMATION | General disorders | MedDRA 24.0 | Systematic Assessment |
| |
| MULTIPLE ORGAN DYSFUNCTION SYNDROME | General disorders | MedDRA 24.0 | Systematic Assessment |
| |
| NON-CARDIAC CHEST PAIN | General disorders | MedDRA 24.0 | Systematic Assessment |
| |
| OEDEMA PERIPHERAL | General disorders | MedDRA 24.0 | Systematic Assessment |
| |
| PAIN | General disorders | MedDRA 24.0 | Systematic Assessment |
| |
| PYREXIA | General disorders | MedDRA 24.0 | Systematic Assessment |
| |
| STENT-GRAFT ENDOLEAK | General disorders | MedDRA 24.0 | Systematic Assessment |
| |
| SWELLING FACE | General disorders | MedDRA 24.0 | Systematic Assessment |
| |
| BILE DUCT STENOSIS | Hepatobiliary disorders | MedDRA 24.0 | Systematic Assessment |
| |
| BILE DUCT STONE | Hepatobiliary disorders | MedDRA 24.0 | Systematic Assessment |
| |
| BILIARY COLIC | Hepatobiliary disorders | MedDRA 24.0 | Systematic Assessment |
| |
| CHOLANGITIS | Hepatobiliary disorders | MedDRA 24.0 | Systematic Assessment |
| |
| CHOLECYSTITIS | Hepatobiliary disorders | MedDRA 24.0 | Systematic Assessment |
| |
| CHOLECYSTITIS ACUTE | Hepatobiliary disorders | MedDRA 24.0 | Systematic Assessment |
| |
| CHOLELITHIASIS | Hepatobiliary disorders | MedDRA 24.0 | Systematic Assessment |
| |
| DRUG-INDUCED LIVER INJURY | Hepatobiliary disorders | MedDRA 24.0 | Systematic Assessment |
| |
| HEPATIC CIRRHOSIS | Hepatobiliary disorders | MedDRA 24.0 | Systematic Assessment |
| |
| HEPATIC FUNCTION ABNORMAL | Hepatobiliary disorders | MedDRA 24.0 | Systematic Assessment |
| |
| HEPATITIS | Hepatobiliary disorders | MedDRA 24.0 | Systematic Assessment |
| |
| HEPATITIS ACUTE | Hepatobiliary disorders | MedDRA 24.0 | Systematic Assessment |
| |
| ALLERGY TO ARTHROPOD BITE | Immune system disorders | MedDRA 24.0 | Systematic Assessment |
| |
| ANAPHYLACTIC REACTION | Immune system disorders | MedDRA 24.0 | Systematic Assessment |
| |
| ANAPHYLACTIC SHOCK | Immune system disorders | MedDRA 24.0 | Systematic Assessment |
| |
| CYTOKINE RELEASE SYNDROME | Immune system disorders | MedDRA 24.0 | Systematic Assessment |
| |
| DRUG HYPERSENSITIVITY | Immune system disorders | MedDRA 24.0 | Systematic Assessment |
| |
| HAEMOPHAGOCYTIC LYMPHOHISTIOCYTOSIS | Immune system disorders | MedDRA 24.0 | Systematic Assessment |
| |
| HYPERSENSITIVITY | Immune system disorders | MedDRA 24.0 | Systematic Assessment |
| |
| HYPOGAMMAGLOBULINAEMIA | Immune system disorders | MedDRA 24.0 | Systematic Assessment |
| |
| ABDOMINAL SEPSIS | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| ABSCESS | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| ABSCESS INTESTINAL | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| APPENDICITIS | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| ARTHRITIS BACTERIAL | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| ARTHRITIS INFECTIVE | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| ATYPICAL PNEUMONIA | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| BACTERAEMIA | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| BACTERIAL TRACHEITIS | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| BK VIRUS INFECTION | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| BREAST ABSCESS | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| BRONCHITIS | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| CAMPYLOBACTER INFECTION | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| CATHETER SITE CELLULITIS | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| CELLULITIS | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| CHRONIC SINUSITIS | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| CLOSTRIDIUM DIFFICILE COLITIS | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| COMPLICATED APPENDICITIS | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| CYSTITIS | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| CYTOMEGALOVIRUS INFECTION | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| DEVICE RELATED INFECTION | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| DEVICE RELATED SEPSIS | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| DISSEMINATED VARICELLA ZOSTER VIRUS INFECTION | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| DIVERTICULITIS | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| ENCEPHALITIS ENTEROVIRAL | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| ENDOCARDITIS | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| ENTEROCOCCAL INFECTION | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| EPIGLOTTITIS | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| ESCHERICHIA INFECTION | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| ESCHERICHIA URINARY TRACT INFECTION | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| FEBRILE INFECTION | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| GASTROENTERITIS | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| GASTROENTERITIS ESCHERICHIA COLI | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| GASTROENTERITIS VIRAL | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| HERPES ZOSTER | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| HERPES ZOSTER INFECTION NEUROLOGICAL | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| HERPES ZOSTER OTICUS | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| INFECTED CYST | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| INFECTION | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| INFECTIVE EXACERBATION OF CHRONIC OBSTRUCTIVE AIRWAYS DISEASE | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| INFLUENZA | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| INTERVERTEBRAL DISCITIS | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| LOWER RESPIRATORY TRACT INFECTION | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| MASTOIDITIS | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| MENINGITIS ENTEROVIRAL | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| MUCOSAL INFECTION | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| NEUROBORRELIOSIS | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| NEUTROPENIC INFECTION | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| NEUTROPENIC SEPSIS | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| OESOPHAGEAL CANDIDIASIS | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| OESOPHAGEAL INFECTION | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| OOPHORITIS | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| ORAL HERPES | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| OTITIS MEDIA CHRONIC | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| OVARIAN BACTERIAL INFECTION | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| PARAPHARYNGEAL SPACE INFECTION | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| PELVIC ABSCESS | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| PERIODONTITIS | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| PERITONSILLAR ABSCESS | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| PNEUMOCYSTIS JIROVECII INFECTION | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| PNEUMOCYSTIS JIROVECII PNEUMONIA | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| PNEUMONIA | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| PNEUMONIA BACTERIAL | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| PNEUMONIA FUNGAL | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| PNEUMONIA PNEUMOCOCCAL | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| POST PROCEDURAL INFECTION | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| PULMONARY SEPSIS | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| PYELONEPHRITIS | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| Q FEVER | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| RESPIRATORY TRACT INFECTION | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| RHINITIS | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| RHINOVIRUS INFECTION | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| SCROTAL ABSCESS | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| SEPSIS | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| SEPTIC SHOCK | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| SINUSITIS | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| SINUSITIS BACTERIAL | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| SINUSITIS FUNGAL | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| SOFT TISSUE INFECTION | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| STAPHYLOCOCCAL BACTERAEMIA | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| STAPHYLOCOCCAL INFECTION | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| SUBCUTANEOUS ABSCESS | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| TUBERCULOSIS | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| TUBO-OVARIAN ABSCESS | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| UPPER RESPIRATORY TRACT INFECTION | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| URINARY TRACT INFECTION | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| UROSEPSIS | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| VARICELLA ZOSTER SEPSIS | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| VASCULAR DEVICE INFECTION | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| VIRAL INFECTION | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| VIRAL MYOSITIS | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| ACCIDENT | Injury, poisoning and procedural complications | MedDRA 24.0 | Systematic Assessment |
| |
| ALCOHOL POISONING | Injury, poisoning and procedural complications | MedDRA 24.0 | Systematic Assessment |
| |
| ANASTOMOTIC STENOSIS | Injury, poisoning and procedural complications | MedDRA 24.0 | Systematic Assessment |
| |
| ANKLE FRACTURE | Injury, poisoning and procedural complications | MedDRA 24.0 | Systematic Assessment |
| |
| BRAIN CONTUSION | Injury, poisoning and procedural complications | MedDRA 24.0 | Systematic Assessment |
| |
| CARTILAGE INJURY | Injury, poisoning and procedural complications | MedDRA 24.0 | Systematic Assessment |
| |
| COMPRESSION FRACTURE | Injury, poisoning and procedural complications | MedDRA 24.0 | Systematic Assessment |
| |
| FACIAL BONES FRACTURE | Injury, poisoning and procedural complications | MedDRA 24.0 | Systematic Assessment |
| |
| FALL | Injury, poisoning and procedural complications | MedDRA 24.0 | Systematic Assessment |
| |
| FEMUR FRACTURE | Injury, poisoning and procedural complications | MedDRA 24.0 | Systematic Assessment |
| |
| FOOT FRACTURE | Injury, poisoning and procedural complications | MedDRA 24.0 | Systematic Assessment |
| |
| HAND FRACTURE | Injury, poisoning and procedural complications | MedDRA 24.0 | Systematic Assessment |
| |
| HUMERUS FRACTURE | Injury, poisoning and procedural complications | MedDRA 24.0 | Systematic Assessment |
| |
| INFUSION RELATED REACTION | Injury, poisoning and procedural complications | MedDRA 24.0 | Systematic Assessment |
| |
| LIGAMENT SPRAIN | Injury, poisoning and procedural complications | MedDRA 24.0 | Systematic Assessment |
| |
| LUMBAR VERTEBRAL FRACTURE | Injury, poisoning and procedural complications | MedDRA 24.0 | Systematic Assessment |
| |
| MEDICATION ERROR | Injury, poisoning and procedural complications | MedDRA 24.0 | Systematic Assessment |
| |
| MENISCUS INJURY | Injury, poisoning and procedural complications | MedDRA 24.0 | Systematic Assessment |
| |
| MULTIPLE FRACTURES | Injury, poisoning and procedural complications | MedDRA 24.0 | Systematic Assessment |
| |
| PNEUMOTHORAX TRAUMATIC | Injury, poisoning and procedural complications | MedDRA 24.0 | Systematic Assessment |
| |
| POST PROCEDURAL HAEMORRHAGE | Injury, poisoning and procedural complications | MedDRA 24.0 | Systematic Assessment |
| |
| SEROMA | Injury, poisoning and procedural complications | MedDRA 24.0 | Systematic Assessment |
| |
| SPINAL COMPRESSION FRACTURE | Injury, poisoning and procedural complications | MedDRA 24.0 | Systematic Assessment |
| |
| THORACIC VERTEBRAL FRACTURE | Injury, poisoning and procedural complications | MedDRA 24.0 | Systematic Assessment |
| |
| UPPER LIMB FRACTURE | Injury, poisoning and procedural complications | MedDRA 24.0 | Systematic Assessment |
| |
| ALANINE AMINOTRANSFERASE INCREASED | Investigations | MedDRA 24.0 | Systematic Assessment |
| |
| ASPARTATE AMINOTRANSFERASE INCREASED | Investigations | MedDRA 24.0 | Systematic Assessment |
| |
| BLOOD CREATININE INCREASED | Investigations | MedDRA 24.0 | Systematic Assessment |
| |
| EASTERN COOPERATIVE ONCOLOGY GROUP PERFORMANCE STATUS WORSENED | Investigations | MedDRA 24.0 | Systematic Assessment |
| |
| HEPATIC ENZYME INCREASED | Investigations | MedDRA 24.0 | Systematic Assessment |
| |
| INTERNATIONAL NORMALISED RATIO INCREASED | Investigations | MedDRA 24.0 | Systematic Assessment |
| |
| RESPIROVIRUS TEST POSITIVE | Investigations | MedDRA 24.0 | Systematic Assessment |
| |
| WHITE BLOOD CELLS URINE POSITIVE | Investigations | MedDRA 24.0 | Systematic Assessment |
| |
| DEHYDRATION | Metabolism and nutrition disorders | MedDRA 24.0 | Systematic Assessment |
| |
| DIABETES MELLITUS | Metabolism and nutrition disorders | MedDRA 24.0 | Systematic Assessment |
| |
| FLUID OVERLOAD | Metabolism and nutrition disorders | MedDRA 24.0 | Systematic Assessment |
| |
| HYPERCALCAEMIA | Metabolism and nutrition disorders | MedDRA 24.0 | Systematic Assessment |
| |
| HYPERGLYCAEMIA | Metabolism and nutrition disorders | MedDRA 24.0 | Systematic Assessment |
| |
| HYPOKALAEMIA | Metabolism and nutrition disorders | MedDRA 24.0 | Systematic Assessment |
| |
| HYPONATRAEMIA | Metabolism and nutrition disorders | MedDRA 24.0 | Systematic Assessment |
| |
| TUMOUR LYSIS SYNDROME | Metabolism and nutrition disorders | MedDRA 24.0 | Systematic Assessment |
| |
| ARTHROPATHY | Musculoskeletal and connective tissue disorders | MedDRA 24.0 | Systematic Assessment |
| |
| BACK PAIN | Musculoskeletal and connective tissue disorders | MedDRA 24.0 | Systematic Assessment |
| |
| FLANK PAIN | Musculoskeletal and connective tissue disorders | MedDRA 24.0 | Systematic Assessment |
| |
| HAEMARTHROSIS | Musculoskeletal and connective tissue disorders | MedDRA 24.0 | Systematic Assessment |
| |
| INTERVERTEBRAL DISC PROTRUSION | Musculoskeletal and connective tissue disorders | MedDRA 24.0 | Systematic Assessment |
| |
| MUSCULAR WEAKNESS | Musculoskeletal and connective tissue disorders | MedDRA 24.0 | Systematic Assessment |
| |
| MYOPATHY | Musculoskeletal and connective tissue disorders | MedDRA 24.0 | Systematic Assessment |
| |
| MYOSITIS | Musculoskeletal and connective tissue disorders | MedDRA 24.0 | Systematic Assessment |
| |
| NECK PAIN | Musculoskeletal and connective tissue disorders | MedDRA 24.0 | Systematic Assessment |
| |
| OSTEITIS DEFORMANS | Musculoskeletal and connective tissue disorders | MedDRA 24.0 | Systematic Assessment |
| |
| OSTEOARTHRITIS | Musculoskeletal and connective tissue disorders | MedDRA 24.0 | Systematic Assessment |
| |
| PAIN IN EXTREMITY | Musculoskeletal and connective tissue disorders | MedDRA 24.0 | Systematic Assessment |
| |
| PATHOLOGICAL FRACTURE | Musculoskeletal and connective tissue disorders | MedDRA 24.0 | Systematic Assessment |
| |
| ROTATOR CUFF SYNDROME | Musculoskeletal and connective tissue disorders | MedDRA 24.0 | Systematic Assessment |
| |
| SERONEGATIVE ARTHRITIS | Musculoskeletal and connective tissue disorders | MedDRA 24.0 | Systematic Assessment |
| |
| SPINAL PAIN | Musculoskeletal and connective tissue disorders | MedDRA 24.0 | Systematic Assessment |
| |
| SPINAL STENOSIS | Musculoskeletal and connective tissue disorders | MedDRA 24.0 | Systematic Assessment |
| |
| SYNOVITIS | Musculoskeletal and connective tissue disorders | MedDRA 24.0 | Systematic Assessment |
| |
| TEMPOROMANDIBULAR JOINT SYNDROME | Musculoskeletal and connective tissue disorders | MedDRA 24.0 | Systematic Assessment |
| |
| ACOUSTIC NEUROMA | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 24.0 | Systematic Assessment |
| |
| ACUTE LYMPHOCYTIC LEUKAEMIA | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 24.0 | Systematic Assessment |
| |
| ACUTE MYELOID LEUKAEMIA | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 24.0 | Systematic Assessment |
| |
| ADENOCARCINOMA | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 24.0 | Systematic Assessment |
| |
| ADENOCARCINOMA METASTATIC | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 24.0 | Systematic Assessment |
| |
| ADENOCARCINOMA OF COLON | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 24.0 | Systematic Assessment |
| |
| BASAL CELL CARCINOMA | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 24.0 | Systematic Assessment |
| |
| BENIGN LARYNGEAL NEOPLASM | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 24.0 | Systematic Assessment |
| |
| BLADDER TRANSITIONAL CELL CARCINOMA | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 24.0 | Systematic Assessment |
| |
| BLADDER TRANSITIONAL CELL CARCINOMA METASTATIC | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 24.0 | Systematic Assessment |
| |
| BOWEN'S DISEASE | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 24.0 | Systematic Assessment |
| |
| BREAST CANCER | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 24.0 | Systematic Assessment |
| |
| CANCER PAIN | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 24.0 | Systematic Assessment |
| |
| CHOLANGIOCARCINOMA | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 24.0 | Systematic Assessment |
| |
| COLON CANCER | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 24.0 | Systematic Assessment |
| |
| COLORECTAL CANCER | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 24.0 | Systematic Assessment |
| |
| DUCTAL ADENOCARCINOMA OF PANCREAS | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 24.0 | Systematic Assessment |
| |
| GASTRIC ADENOMA | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 24.0 | Systematic Assessment |
| |
| GASTRIC CANCER | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 24.0 | Systematic Assessment |
| |
| GASTROINTESTINAL NEOPLASM | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 24.0 | Systematic Assessment |
| |
| HEPATIC CANCER | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 24.0 | Systematic Assessment |
| |
| HODGKIN'S DISEASE | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 24.0 | Systematic Assessment |
| |
| HODGKIN'S DISEASE NODULAR SCLEROSIS | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 24.0 | Systematic Assessment |
| |
| HODGKIN'S DISEASE STAGE II | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 24.0 | Systematic Assessment |
| |
| HORMONE RECEPTOR POSITIVE BREAST CANCER | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 24.0 | Systematic Assessment |
| |
| INTRADUCTAL PROLIFERATIVE BREAST LESION | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 24.0 | Systematic Assessment |
| |
| INTRAOCULAR MELANOMA | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 24.0 | Systematic Assessment |
| |
| INVASIVE DUCTAL BREAST CARCINOMA | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 24.0 | Systematic Assessment |
| |
| KERATOACANTHOMA | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 24.0 | Systematic Assessment |
| |
| LARYNGEAL SQUAMOUS CELL CARCINOMA | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 24.0 | Systematic Assessment |
| |
| LENTIGO MALIGNA | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 24.0 | Systematic Assessment |
| |
| LUNG ADENOCARCINOMA | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 24.0 | Systematic Assessment |
| |
| LUNG NEOPLASM MALIGNANT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 24.0 | Systematic Assessment |
| |
| MALIGNANT MELANOMA | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 24.0 | Systematic Assessment |
| |
| MENINGIOMA | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 24.0 | Systematic Assessment |
| |
| MYELODYSPLASTIC SYNDROME | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 24.0 | Systematic Assessment |
| |
| NEUROENDOCRINE CARCINOMA OF THE SKIN | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 24.0 | Systematic Assessment |
| |
| NON-HODGKIN'S LYMPHOMA | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 24.0 | Systematic Assessment |
| |
| NON-SMALL CELL LUNG CANCER | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 24.0 | Systematic Assessment |
| |
| NON-SMALL CELL LUNG CANCER STAGE IV | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 24.0 | Systematic Assessment |
| |
| OESOPHAGEAL CARCINOMA | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 24.0 | Systematic Assessment |
| |
| PANCREATIC CARCINOMA | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 24.0 | Systematic Assessment |
| |
| PAPILLARY THYROID CANCER | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 24.0 | Systematic Assessment |
| |
| PITUITARY TUMOUR BENIGN | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 24.0 | Systematic Assessment |
| |
| PROSTATE CANCER | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 24.0 | Systematic Assessment |
| |
| RECTAL ADENOCARCINOMA | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 24.0 | Systematic Assessment |
| |
| RENAL CANCER | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 24.0 | Systematic Assessment |
| |
| RENAL CELL CARCINOMA | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 24.0 | Systematic Assessment |
| |
| SCHWANNOMA | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 24.0 | Systematic Assessment |
| |
| SQUAMOUS CELL BREAST CARCINOMA | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 24.0 | Systematic Assessment |
| |
| SQUAMOUS CELL CARCINOMA | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 24.0 | Systematic Assessment |
| |
| SQUAMOUS CELL CARCINOMA OF SKIN | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 24.0 | Systematic Assessment |
| |
| THYROID ADENOMA | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 24.0 | Systematic Assessment |
| |
| TONGUE NEOPLASM MALIGNANT STAGE UNSPECIFIED | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 24.0 | Systematic Assessment |
| |
| TRANSITIONAL CELL CARCINOMA | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 24.0 | Systematic Assessment |
| |
| TUMOUR FLARE | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 24.0 | Systematic Assessment |
| |
| UTERINE CANCER | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 24.0 | Systematic Assessment |
| |
| VULVOVAGINAL WARTS | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 24.0 | Systematic Assessment |
| |
| AMYOTROPHIC LATERAL SCLEROSIS | Nervous system disorders | MedDRA 24.0 | Systematic Assessment |
| |
| ATAXIA | Nervous system disorders | MedDRA 24.0 | Systematic Assessment |
| |
| BRACHIAL PLEXOPATHY | Nervous system disorders | MedDRA 24.0 | Systematic Assessment |
| |
| CAROTID ARTERY STENOSIS | Nervous system disorders | MedDRA 24.0 | Systematic Assessment |
| |
| CEREBRAL DISORDER | Nervous system disorders | MedDRA 24.0 | Systematic Assessment |
| |
| CEREBRAL HAEMATOMA | Nervous system disorders | MedDRA 24.0 | Systematic Assessment |
| |
| CEREBRAL INFARCTION | Nervous system disorders | MedDRA 24.0 | Systematic Assessment |
| |
| CEREBRAL ISCHAEMIA | Nervous system disorders | MedDRA 24.0 | Systematic Assessment |
| |
| CEREBROVASCULAR ACCIDENT | Nervous system disorders | MedDRA 24.0 | Systematic Assessment |
| |
| DEMENTIA | Nervous system disorders | MedDRA 24.0 | Systematic Assessment |
| |
| DIZZINESS | Nervous system disorders | MedDRA 24.0 | Systematic Assessment |
| |
| DIZZINESS POSTURAL | Nervous system disorders | MedDRA 24.0 | Systematic Assessment |
| |
| DYSDIADOCHOKINESIS | Nervous system disorders | MedDRA 24.0 | Systematic Assessment |
| |
| ENCEPHALOPATHY | Nervous system disorders | MedDRA 24.0 | Systematic Assessment |
| |
| EPILEPSY | Nervous system disorders | MedDRA 24.0 | Systematic Assessment |
| |
| FACIAL PARALYSIS | Nervous system disorders | MedDRA 24.0 | Systematic Assessment |
| |
| HAEMORRHAGE INTRACRANIAL | Nervous system disorders | MedDRA 24.0 | Systematic Assessment |
| |
| HAEMORRHAGIC STROKE | Nervous system disorders | MedDRA 24.0 | Systematic Assessment |
| |
| HYPERAMMONAEMIC ENCEPHALOPATHY | Nervous system disorders | MedDRA 24.0 | Systematic Assessment |
| |
| HYPOTONIA | Nervous system disorders | MedDRA 24.0 | Systematic Assessment |
| |
| ISCHAEMIC STROKE | Nervous system disorders | MedDRA 24.0 | Systematic Assessment |
| |
| LETHARGY | Nervous system disorders | MedDRA 24.0 | Systematic Assessment |
| |
| LOSS OF CONSCIOUSNESS | Nervous system disorders | MedDRA 24.0 | Systematic Assessment |
| |
| MONOPARESIS | Nervous system disorders | MedDRA 24.0 | Systematic Assessment |
| |
| NERVOUS SYSTEM DISORDER | Nervous system disorders | MedDRA 24.0 | Systematic Assessment |
| |
| NEURALGIA | Nervous system disorders | MedDRA 24.0 | Systematic Assessment |
| |
| NEUROPATHY PERIPHERAL | Nervous system disorders | MedDRA 24.0 | Systematic Assessment |
| |
| ORTHOSTATIC INTOLERANCE | Nervous system disorders | MedDRA 24.0 | Systematic Assessment |
| |
| ORTHOSTATIC TREMOR | Nervous system disorders | MedDRA 24.0 | Systematic Assessment |
| |
| PARKINSON'S DISEASE | Nervous system disorders | MedDRA 24.0 | Systematic Assessment |
| |
| POLYNEUROPATHY | Nervous system disorders | MedDRA 24.0 | Systematic Assessment |
| |
| PRESYNCOPE | Nervous system disorders | MedDRA 24.0 | Systematic Assessment |
| |
| SEIZURE | Nervous system disorders | MedDRA 24.0 | Systematic Assessment |
| |
| SPINAL CORD COMPRESSION | Nervous system disorders | MedDRA 24.0 | Systematic Assessment |
| |
| SUBARACHNOID HAEMORRHAGE | Nervous system disorders | MedDRA 24.0 | Systematic Assessment |
| |
| SYNCOPE | Nervous system disorders | MedDRA 24.0 | Systematic Assessment |
| |
| TRANSIENT ISCHAEMIC ATTACK | Nervous system disorders | MedDRA 24.0 | Systematic Assessment |
| |
| TREMOR | Nervous system disorders | MedDRA 24.0 | Systematic Assessment |
| |
| ABORTION | Pregnancy, puerperium and perinatal conditions | MedDRA 24.0 | Systematic Assessment |
| |
| DEVICE BREAKAGE | Product Issues | MedDRA 24.0 | Systematic Assessment |
| |
| ALCOHOL PROBLEM | Psychiatric disorders | MedDRA 24.0 | Systematic Assessment |
| |
| ANXIETY | Psychiatric disorders | MedDRA 24.0 | Systematic Assessment |
| |
| CONFUSIONAL STATE | Psychiatric disorders | MedDRA 24.0 | Systematic Assessment |
| |
| DELIRIUM | Psychiatric disorders | MedDRA 24.0 | Systematic Assessment |
| |
| DEPRESSION | Psychiatric disorders | MedDRA 24.0 | Systematic Assessment |
| |
| EMOTIONAL DISORDER | Psychiatric disorders | MedDRA 24.0 | Systematic Assessment |
| |
| MENTAL STATUS CHANGES | Psychiatric disorders | MedDRA 24.0 | Systematic Assessment |
| |
| PSYCHOTIC DISORDER | Psychiatric disorders | MedDRA 24.0 | Systematic Assessment |
| |
| SUBSTANCE-INDUCED PSYCHOTIC DISORDER | Psychiatric disorders | MedDRA 24.0 | Systematic Assessment |
| |
| SUICIDE ATTEMPT | Psychiatric disorders | MedDRA 24.0 | Systematic Assessment |
| |
| ACUTE KIDNEY INJURY | Renal and urinary disorders | MedDRA 24.0 | Systematic Assessment |
| |
| NEPHROLITHIASIS | Renal and urinary disorders | MedDRA 24.0 | Systematic Assessment |
| |
| RENAL COLIC | Renal and urinary disorders | MedDRA 24.0 | Systematic Assessment |
| |
| RENAL FAILURE | Renal and urinary disorders | MedDRA 24.0 | Systematic Assessment |
| |
| RENAL INFARCT | Renal and urinary disorders | MedDRA 24.0 | Systematic Assessment |
| |
| RENAL PAIN | Renal and urinary disorders | MedDRA 24.0 | Systematic Assessment |
| |
| RENAL PELVIS FISTULA | Renal and urinary disorders | MedDRA 24.0 | Systematic Assessment |
| |
| URETERIC OBSTRUCTION | Renal and urinary disorders | MedDRA 24.0 | Systematic Assessment |
| |
| OVARIAN CYST | Reproductive system and breast disorders | MedDRA 24.0 | Systematic Assessment |
| |
| OVARIAN MASS | Reproductive system and breast disorders | MedDRA 24.0 | Systematic Assessment |
| |
| PROSTATITIS | Reproductive system and breast disorders | MedDRA 24.0 | Systematic Assessment |
| |
| VAGINAL ULCERATION | Reproductive system and breast disorders | MedDRA 24.0 | Systematic Assessment |
| |
| VULVOVAGINAL PAIN | Reproductive system and breast disorders | MedDRA 24.0 | Systematic Assessment |
| |
| ACUTE LUNG INJURY | Respiratory, thoracic and mediastinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| ACUTE RESPIRATORY DISTRESS SYNDROME | Respiratory, thoracic and mediastinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| ACUTE RESPIRATORY FAILURE | Respiratory, thoracic and mediastinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| ASTHMA | Respiratory, thoracic and mediastinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| BRONCHOSPASM | Respiratory, thoracic and mediastinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| CHRONIC OBSTRUCTIVE PULMONARY DISEASE | Respiratory, thoracic and mediastinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| COUGH | Respiratory, thoracic and mediastinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| DYSPNOEA | Respiratory, thoracic and mediastinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| DYSPNOEA EXERTIONAL | Respiratory, thoracic and mediastinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| EMPHYSEMA | Respiratory, thoracic and mediastinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| EPISTAXIS | Respiratory, thoracic and mediastinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| HAEMOPTYSIS | Respiratory, thoracic and mediastinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| HYPOXIA | Respiratory, thoracic and mediastinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| INTERSTITIAL LUNG DISEASE | Respiratory, thoracic and mediastinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| LUNG CONSOLIDATION | Respiratory, thoracic and mediastinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| LUNG DISORDER | Respiratory, thoracic and mediastinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| PARANASAL CYST | Respiratory, thoracic and mediastinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| PHARYNGEAL INFLAMMATION | Respiratory, thoracic and mediastinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| PHARYNGEAL PARAESTHESIA | Respiratory, thoracic and mediastinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| PLEURAL EFFUSION | Respiratory, thoracic and mediastinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| PLEURISY | Respiratory, thoracic and mediastinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| PLEURITIC PAIN | Respiratory, thoracic and mediastinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| PNEUMONIA ASPIRATION | Respiratory, thoracic and mediastinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| PNEUMONITIS | Respiratory, thoracic and mediastinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| PNEUMOTHORAX | Respiratory, thoracic and mediastinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| PULMONARY ARTERIAL HYPERTENSION | Respiratory, thoracic and mediastinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| PULMONARY CONGESTION | Respiratory, thoracic and mediastinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| PULMONARY EMBOLISM | Respiratory, thoracic and mediastinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| PULMONARY OEDEMA | Respiratory, thoracic and mediastinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| RESPIRATORY ARREST | Respiratory, thoracic and mediastinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| RESPIRATORY DISORDER | Respiratory, thoracic and mediastinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| RESPIRATORY FAILURE | Respiratory, thoracic and mediastinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| ACTINIC KERATOSIS | Skin and subcutaneous tissue disorders | MedDRA 24.0 | Systematic Assessment |
| |
| DERMATITIS CONTACT | Skin and subcutaneous tissue disorders | MedDRA 24.0 | Systematic Assessment |
| |
| DERMATITIS EXFOLIATIVE GENERALISED | Skin and subcutaneous tissue disorders | MedDRA 24.0 | Systematic Assessment |
| |
| DRUG ERUPTION | Skin and subcutaneous tissue disorders | MedDRA 24.0 | Systematic Assessment |
| |
| RASH | Skin and subcutaneous tissue disorders | MedDRA 24.0 | Systematic Assessment |
| |
| RASH MACULO-PAPULAR | Skin and subcutaneous tissue disorders | MedDRA 24.0 | Systematic Assessment |
| |
| URTICARIA | Skin and subcutaneous tissue disorders | MedDRA 24.0 | Systematic Assessment |
| |
| AXILLARY VEIN THROMBOSIS | Vascular disorders | MedDRA 24.0 | Systematic Assessment |
| |
| CIRCULATORY COLLAPSE | Vascular disorders | MedDRA 24.0 | Systematic Assessment |
| |
| DEEP VEIN THROMBOSIS | Vascular disorders | MedDRA 24.0 | Systematic Assessment |
| |
| EMBOLISM | Vascular disorders | MedDRA 24.0 | Systematic Assessment |
| |
| HYPERTENSIVE CRISIS | Vascular disorders | MedDRA 24.0 | Systematic Assessment |
| |
| HYPERTENSIVE URGENCY | Vascular disorders | MedDRA 24.0 | Systematic Assessment |
| |
| HYPOTENSION | Vascular disorders | MedDRA 24.0 | Systematic Assessment |
| |
| PELVIC VENOUS THROMBOSIS | Vascular disorders | MedDRA 24.0 | Systematic Assessment |
| |
| PERIPHERAL ARTERY ANEURYSM | Vascular disorders | MedDRA 24.0 | Systematic Assessment |
| |
| PERIPHERAL ISCHAEMIA | Vascular disorders | MedDRA 24.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| ANAEMIA | Blood and lymphatic system disorders | MedDRA 24.0 | Systematic Assessment |
| |
| LEUKOPENIA | Blood and lymphatic system disorders | MedDRA 24.0 | Systematic Assessment |
| |
| NEUTROPENIA | Blood and lymphatic system disorders | MedDRA 24.0 | Systematic Assessment |
| |
| THROMBOCYTOPENIA | Blood and lymphatic system disorders | MedDRA 24.0 | Systematic Assessment |
| |
| ABDOMINAL PAIN | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| ABDOMINAL PAIN UPPER | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| CONSTIPATION | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| DIARRHOEA | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| DRY MOUTH | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| DYSPEPSIA | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| NAUSEA | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| STOMATITIS | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| VOMITING | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| ASTHENIA | General disorders | MedDRA 24.0 | Systematic Assessment |
| |
| CHEST DISCOMFORT | General disorders | MedDRA 24.0 | Systematic Assessment |
| |
| CHILLS | General disorders | MedDRA 24.0 | Systematic Assessment |
| |
| FATIGUE | General disorders | MedDRA 24.0 | Systematic Assessment |
| |
| INFLUENZA LIKE ILLNESS | General disorders | MedDRA 24.0 | Systematic Assessment |
| |
| MUCOSAL INFLAMMATION | General disorders | MedDRA 24.0 | Systematic Assessment |
| |
| OEDEMA PERIPHERAL | General disorders | MedDRA 24.0 | Systematic Assessment |
| |
| PAIN | General disorders | MedDRA 24.0 | Systematic Assessment |
| |
| PYREXIA | General disorders | MedDRA 24.0 | Systematic Assessment |
| |
| BRONCHITIS | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| CONJUNCTIVITIS | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| HERPES ZOSTER | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| LOWER RESPIRATORY TRACT INFECTION | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| NASOPHARYNGITIS | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| ORAL HERPES | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| PNEUMONIA | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| RESPIRATORY TRACT INFECTION | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| RHINITIS | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| SINUSITIS | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| UPPER RESPIRATORY TRACT INFECTION | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| URINARY TRACT INFECTION | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| INFUSION RELATED REACTION | Injury, poisoning and procedural complications | MedDRA 24.0 | Systematic Assessment |
| |
| WEIGHT DECREASED | Investigations | MedDRA 24.0 | Systematic Assessment |
| |
| DECREASED APPETITE | Metabolism and nutrition disorders | MedDRA 24.0 | Systematic Assessment |
| |
| HYPOKALAEMIA | Metabolism and nutrition disorders | MedDRA 24.0 | Systematic Assessment |
| |
| ARTHRALGIA | Musculoskeletal and connective tissue disorders | MedDRA 24.0 | Systematic Assessment |
| |
| BACK PAIN | Musculoskeletal and connective tissue disorders | MedDRA 24.0 | Systematic Assessment |
| |
| BONE PAIN | Musculoskeletal and connective tissue disorders | MedDRA 24.0 | Systematic Assessment |
| |
| MUSCLE SPASMS | Musculoskeletal and connective tissue disorders | MedDRA 24.0 | Systematic Assessment |
| |
| MYALGIA | Musculoskeletal and connective tissue disorders | MedDRA 24.0 | Systematic Assessment |
| |
| PAIN IN EXTREMITY | Musculoskeletal and connective tissue disorders | MedDRA 24.0 | Systematic Assessment |
| |
| DIZZINESS | Nervous system disorders | MedDRA 24.0 | Systematic Assessment |
| |
| DYSGEUSIA | Nervous system disorders | MedDRA 24.0 | Systematic Assessment |
| |
| HEADACHE | Nervous system disorders | MedDRA 24.0 | Systematic Assessment |
| |
| NEUROPATHY PERIPHERAL | Nervous system disorders | MedDRA 24.0 | Systematic Assessment |
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| PARAESTHESIA | Nervous system disorders | MedDRA 24.0 | Systematic Assessment |
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| PERIPHERAL SENSORY NEUROPATHY | Nervous system disorders | MedDRA 24.0 | Systematic Assessment |
| |
| ANXIETY | Psychiatric disorders | MedDRA 24.0 | Systematic Assessment |
| |
| INSOMNIA | Psychiatric disorders | MedDRA 24.0 | Systematic Assessment |
| |
| COUGH | Respiratory, thoracic and mediastinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| DYSPNOEA | Respiratory, thoracic and mediastinal disorders | MedDRA 24.0 | Systematic Assessment |
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| OROPHARYNGEAL PAIN | Respiratory, thoracic and mediastinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| PRODUCTIVE COUGH | Respiratory, thoracic and mediastinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| THROAT IRRITATION | Respiratory, thoracic and mediastinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| ALOPECIA | Skin and subcutaneous tissue disorders | MedDRA 24.0 | Systematic Assessment |
| |
| DRY SKIN | Skin and subcutaneous tissue disorders | MedDRA 24.0 | Systematic Assessment |
| |
| ERYTHEMA | Skin and subcutaneous tissue disorders | MedDRA 24.0 | Systematic Assessment |
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| NIGHT SWEATS | Skin and subcutaneous tissue disorders | MedDRA 24.0 | Systematic Assessment |
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| PRURITUS | Skin and subcutaneous tissue disorders | MedDRA 24.0 | Systematic Assessment |
| |
| RASH | Skin and subcutaneous tissue disorders | MedDRA 24.0 | Systematic Assessment |
| |
| FLUSHING | Vascular disorders | MedDRA 24.0 | Systematic Assessment |
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| HOT FLUSH | Vascular disorders | MedDRA 24.0 | Systematic Assessment |
| |
| HYPERTENSION | Vascular disorders | MedDRA 24.0 | Systematic Assessment |
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| HYPOTENSION | Vascular disorders | MedDRA 24.0 | 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 | Hoffmann-La Roche | 800 821-8590 | genentech@druginfo.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Apr 12, 2016 | Jul 6, 2022 | SAP_001.pdf |
| 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 |
|---|---|
| C543332 | obinutuzumab |
| D003520 | Cyclophosphamide |
| D004317 | Doxorubicin |
| D014750 | Vincristine |
| D011241 | Prednisone |
| D000069461 | Bendamustine Hydrochloride |
| D000069283 | Rituximab |
| ID | Term |
|---|---|
| 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 |
| D002087 | Butyrates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D001562 | Benzimidazoles |
| 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
| Death |
|
| Lost to Follow-up |
|
| Non-compliance |
|
| Other |
|
| Physician Decision |
|
| Progressive Disease |
|
| Protocol Violation |
|
| Withdrawal by Subject |
|
| Death |
|
| Lost to Follow-up |
|
| Non-compliance |
|
| Other |
|
| Physician Decision |
|
| Progressive Disease |
|
| Protocol Violation |
|
| Withdrawal by Subject |
|
| No reason provided |
|
|
|
|
| OG001 | Obinutuzumab+Chemotherapy | Participants will receive either 8 cycles of obinutuzumab along with 6 cycles of CHOP (21-day cycle) or 8 cycles of obinutuzumab along with 8 cycles of CVP (21-day cycles) or 6 cycles of obinutuzumab along with 6 cycles of bendamustine (28-day cycle) during induction period. The induction period will be followed by either a maintenance or observation period for responders or non-responders, respectively. Responders will receive obinutuzumab monotherapy every 2 months for 2 years during the maintenance period. Non-responders will receive no protocol specified treatment during the 2-year observation period. Finally, participants will be followed during a 5-year follow-up period. The chemotherapy regimen (CHOP or CVP or bendamustine) for individual participant will be chosen by the site prior to initiation of the study. |
|
|
|
| OG001 | Obinutuzumab+Chemotherapy | Participants will receive either 8 cycles of obinutuzumab along with 6 cycles of CHOP (21-day cycle) or 8 cycles of obinutuzumab along with 8 cycles of CVP (21-day cycles) or 6 cycles of obinutuzumab along with 6 cycles of bendamustine (28-day cycle) during induction period. The induction period will be followed by either a maintenance or observation period for responders or non-responders, respectively. Responders will receive obinutuzumab monotherapy every 2 months for 2 years during the maintenance period. Non-responders will receive no protocol specified treatment during the 2-year observation period. Finally, participants will be followed during a 5-year follow-up period. The chemotherapy regimen (CHOP or CVP or bendamustine) for individual participant will be chosen by the site prior to initiation of the study. |
|
|
|
| OG001 | Obinutuzumab+Chemotherapy | Participants will receive either 8 cycles of obinutuzumab along with 6 cycles of CHOP (21-day cycle) or 8 cycles of obinutuzumab along with 8 cycles of CVP (21-day cycles) or 6 cycles of obinutuzumab along with 6 cycles of bendamustine (28-day cycle) during induction period. The induction period will be followed by either a maintenance or observation period for responders or non-responders, respectively. Responders will receive obinutuzumab monotherapy every 2 months for 2 years during the maintenance period. Non-responders will receive no protocol specified treatment during the 2-year observation period. Finally, participants will be followed during a 5-year follow-up period. The chemotherapy regimen (CHOP or CVP or bendamustine) for individual participant will be chosen by the site prior to initiation of the study. |
|
|
|
| OG001 | Obinutuzumab+Chemotherapy | Participants will receive either 8 cycles of obinutuzumab along with 6 cycles of CHOP (21-day cycle) or 8 cycles of obinutuzumab along with 8 cycles of CVP (21-day cycles) or 6 cycles of obinutuzumab along with 6 cycles of bendamustine (28-day cycle) during induction period. The induction period will be followed by either a maintenance or observation period for responders or non-responders, respectively. Responders will receive obinutuzumab monotherapy every 2 months for 2 years during the maintenance period. Non-responders will receive no protocol specified treatment during the 2-year observation period. Finally, participants will be followed during a 5-year follow-up period. The chemotherapy regimen (CHOP or CVP or bendamustine) for individual participant will be chosen by the site prior to initiation of the study. |
|
|
|
| OG001 | Obinutuzumab+Chemotherapy | Participants will receive either 8 cycles of obinutuzumab along with 6 cycles of CHOP (21-day cycle) or 8 cycles of obinutuzumab along with 8 cycles of CVP (21-day cycles) or 6 cycles of obinutuzumab along with 6 cycles of bendamustine (28-day cycle) during induction period. The induction period will be followed by either a maintenance or observation period for responders or non-responders, respectively. Responders will receive obinutuzumab monotherapy every 2 months for 2 years during the maintenance period. Non-responders will receive no protocol specified treatment during the 2-year observation period. Finally, participants will be followed during a 5-year follow-up period. The chemotherapy regimen (CHOP or CVP or bendamustine) for individual participant will be chosen by the site prior to initiation of the study. |
|
|
|
| OG001 | Obinutuzumab+Chemotherapy | Participants will receive either 8 cycles of obinutuzumab along with 6 cycles of CHOP (21-day cycle) or 8 cycles of obinutuzumab along with 8 cycles of CVP (21-day cycles) or 6 cycles of obinutuzumab along with 6 cycles of bendamustine (28-day cycle) during induction period. The induction period will be followed by either a maintenance or observation period for responders or non-responders, respectively. Responders will receive obinutuzumab monotherapy every 2 months for 2 years during the maintenance period. Non-responders will receive no protocol specified treatment during the 2-year observation period. Finally, participants will be followed during a 5-year follow-up period. The chemotherapy regimen (CHOP or CVP or bendamustine) for individual participant will be chosen by the site prior to initiation of the study. |
|
|
|
| OG001 | Obinutuzumab+Chemotherapy | Participants will receive either 8 cycles of obinutuzumab along with 6 cycles of CHOP (21-day cycle) or 8 cycles of obinutuzumab along with 8 cycles of CVP (21-day cycles) or 6 cycles of obinutuzumab along with 6 cycles of bendamustine (28-day cycle) during induction period. The induction period will be followed by either a maintenance or observation period for responders or non-responders, respectively. Responders will receive obinutuzumab monotherapy every 2 months for 2 years during the maintenance period. Non-responders will receive no protocol specified treatment during the 2-year observation period. Finally, participants will be followed during a 5-year follow-up period. The chemotherapy regimen (CHOP or CVP or bendamustine) for individual participant will be chosen by the site prior to initiation of the study. |
|
|
|
| OG001 | Obinutuzumab+Chemotherapy | Participants will receive either 8 cycles of obinutuzumab along with 6 cycles of CHOP (21-day cycle) or 8 cycles of obinutuzumab along with 8 cycles of CVP (21-day cycles) or 6 cycles of obinutuzumab along with 6 cycles of bendamustine (28-day cycle) during induction period. The induction period will be followed by either a maintenance or observation period for responders or non-responders, respectively. Responders will receive obinutuzumab monotherapy every 2 months for 2 years during the maintenance period. Non-responders will receive no protocol specified treatment during the 2-year observation period. Finally, participants will be followed during a 5-year follow-up period. The chemotherapy regimen (CHOP or CVP or bendamustine) for individual participant will be chosen by the site prior to initiation of the study. |
|
|
|
| OG001 | Obinutuzumab+Chemotherapy | Participants will receive either 8 cycles of obinutuzumab along with 6 cycles of CHOP (21-day cycle) or 8 cycles of obinutuzumab along with 8 cycles of CVP (21-day cycles) or 6 cycles of obinutuzumab along with 6 cycles of bendamustine (28-day cycle) during induction period. The induction period will be followed by either a maintenance or observation period for responders or non-responders, respectively. Responders will receive obinutuzumab monotherapy every 2 months for 2 years during the maintenance period. Non-responders will receive no protocol specified treatment during the 2-year observation period. Finally, participants will be followed during a 5-year follow-up period. The chemotherapy regimen (CHOP or CVP or bendamustine) for individual participant will be chosen by the site prior to initiation of the study. |
|
|
|
| OG001 | Obinutuzumab+Chemotherapy | Participants will receive either 8 cycles of obinutuzumab along with 6 cycles of CHOP (21-day cycle) or 8 cycles of obinutuzumab along with 8 cycles of CVP (21-day cycles) or 6 cycles of obinutuzumab along with 6 cycles of bendamustine (28-day cycle) during induction period. The induction period will be followed by either a maintenance or observation period for responders or non-responders, respectively. Responders will receive obinutuzumab monotherapy every 2 months for 2 years during the maintenance period. Non-responders will receive no protocol specified treatment during the 2-year observation period. Finally, participants will be followed during a 5-year follow-up period. The chemotherapy regimen (CHOP or CVP or bendamustine) for individual participant will be chosen by the site prior to initiation of the study. |
|
|
|
| OG001 | Obinutuzumab+Chemotherapy | Participants will receive either 8 cycles of obinutuzumab along with 6 cycles of CHOP (21-day cycle) or 8 cycles of obinutuzumab along with 8 cycles of CVP (21-day cycles) or 6 cycles of obinutuzumab along with 6 cycles of bendamustine (28-day cycle) during induction period. The induction period will be followed by either a maintenance or observation period for responders or non-responders, respectively. Responders will receive obinutuzumab monotherapy every 2 months for 2 years during the maintenance period. Non-responders will receive no protocol specified treatment during the 2-year observation period. Finally, participants will be followed during a 5-year follow-up period. The chemotherapy regimen (CHOP or CVP or bendamustine) for individual participant will be chosen by the site prior to initiation of the study. |
|
|
|
| OG001 |
| Obinutuzumab+Chemotherapy |
Participants will receive either 8 cycles of obinutuzumab along with 6 cycles of CHOP (21-day cycle) or 8 cycles of obinutuzumab along with 8 cycles of CVP (21-day cycles) or 6 cycles of obinutuzumab along with 6 cycles of bendamustine (28-day cycle) during induction period. The induction period will be followed by either a maintenance or observation period for responders or non-responders, respectively. Responders will receive obinutuzumab monotherapy every 2 months for 2 years during the maintenance period. Non-responders will receive no protocol specified treatment during the 2-year observation period. Finally, participants will be followed during a 5-year follow-up period. The chemotherapy regimen (CHOP or CVP or bendamustine) for individual participant will be chosen by the site prior to initiation of the study. |
|
|
|
Participants will receive either 8 cycles of obinutuzumab along with 6 cycles of CHOP (21-day cycle) or 8 cycles of obinutuzumab along with 8 cycles of CVP (21-day cycles) or 6 cycles of obinutuzumab along with 6 cycles of bendamustine (28-day cycle) during induction period. The induction period will be followed by either a maintenance or observation period for responders or non-responders, respectively. Responders will receive obinutuzumab monotherapy every 2 months for 2 years during the maintenance period. Non-responders will receive no protocol specified treatment during the 2-year observation period. Finally, participants will be followed during a 5-year follow-up period. The chemotherapy regimen (CHOP or CVP or bendamustine) for individual participant will be chosen by the site prior to initiation of the study. |
|
|
|
Participants will receive either 8 cycles of obinutuzumab along with 6 cycles of CHOP (21-day cycle) or 8 cycles of obinutuzumab along with 8 cycles of CVP (21-day cycles) or 6 cycles of obinutuzumab along with 6 cycles of bendamustine (28-day cycle) during induction period. The induction period will be followed by either a maintenance or observation period for responders or non-responders, respectively. Responders will receive obinutuzumab monotherapy every 2 months for 2 years during the maintenance period. Non-responders will receive no protocol specified treatment during the 2-year observation period. Finally, participants will be followed during a 5-year follow-up period. The chemotherapy regimen (CHOP or CVP or bendamustine) for individual participant will be chosen by the site prior to initiation of the study. |
|
|
|
| OG001 | Obinutuzumab+Chemotherapy | Participants will receive either 8 cycles of obinutuzumab along with 6 cycles of CHOP (21-day cycle) or 8 cycles of obinutuzumab along with 8 cycles of CVP (21-day cycles) or 6 cycles of obinutuzumab along with 6 cycles of bendamustine (28-day cycle) during induction period. The induction period will be followed by either a maintenance or observation period for responders or non-responders, respectively. Responders will receive obinutuzumab monotherapy every 2 months for 2 years during the maintenance period. Non-responders will receive no protocol specified treatment during the 2-year observation period. Finally, participants will be followed during a 5-year follow-up period. The chemotherapy regimen (CHOP or CVP or bendamustine) for individual participant will be chosen by the site prior to initiation of the study. |
|
|
|
| OG001 | Obinutuzumab+Chemotherapy | Participants will receive either 8 cycles of obinutuzumab along with 6 cycles of CHOP (21-day cycle) or 8 cycles of obinutuzumab along with 8 cycles of CVP (21-day cycles) or 6 cycles of obinutuzumab along with 6 cycles of bendamustine (28-day cycle) during induction period. The induction period will be followed by either a maintenance or observation period for responders or non-responders, respectively. Responders will receive obinutuzumab monotherapy every 2 months for 2 years during the maintenance period. Non-responders will receive no protocol specified treatment during the 2-year observation period. Finally, participants will be followed during a 5-year follow-up period. The chemotherapy regimen (CHOP or CVP or bendamustine) for individual participant will be chosen by the site prior to initiation of the study. |
|
|
|
| OG001 | Obinutuzumab+Chemotherapy | Participants will receive either 8 cycles of obinutuzumab along with 6 cycles of CHOP (21-day cycle) or 8 cycles of obinutuzumab along with 8 cycles of CVP (21-day cycles) or 6 cycles of obinutuzumab along with 6 cycles of bendamustine (28-day cycle) during induction period. The induction period will be followed by either a maintenance or observation period for responders or non-responders, respectively. Responders will receive obinutuzumab monotherapy every 2 months for 2 years during the maintenance period. Non-responders will receive no protocol specified treatment during the 2-year observation period. Finally, participants will be followed during a 5-year follow-up period. The chemotherapy regimen (CHOP or CVP or bendamustine) for individual participant will be chosen by the site prior to initiation of the study. |
|
|
|
| OG001 | Obinutuzumab+Chemotherapy | Participants will receive either 8 cycles of obinutuzumab along with 6 cycles of CHOP (21-day cycle) or 8 cycles of obinutuzumab along with 8 cycles of CVP (21-day cycles) or 6 cycles of obinutuzumab along with 6 cycles of bendamustine (28-day cycle) during induction period. The induction period will be followed by either a maintenance or observation period for responders or non-responders, respectively. Responders will receive obinutuzumab monotherapy every 2 months for 2 years during the maintenance period. Non-responders will receive no protocol specified treatment during the 2-year observation period. Finally, participants will be followed during a 5-year follow-up period. The chemotherapy regimen (CHOP or CVP or bendamustine) for individual participant will be chosen by the site prior to initiation of the study. |
|
|
|
| OG001 | Obinutuzumab+Chemotherapy | Participants will receive either 8 cycles of obinutuzumab along with 6 cycles of CHOP (21-day cycle) or 8 cycles of obinutuzumab along with 8 cycles of CVP (21-day cycles) or 6 cycles of obinutuzumab along with 6 cycles of bendamustine (28-day cycle) during induction period. The induction period will be followed by either a maintenance or observation period for responders or non-responders, respectively. Responders will receive obinutuzumab monotherapy every 2 months for 2 years during the maintenance period. Non-responders will receive no protocol specified treatment during the 2-year observation period. Finally, participants will be followed during a 5-year follow-up period. The chemotherapy regimen (CHOP or CVP or bendamustine) for individual participant will be chosen by the site prior to initiation of the study. |
|
|
|
| OG001 | Obinutuzumab+Chemotherapy | Participants will receive either 8 cycles of obinutuzumab along with 6 cycles of CHOP (21-day cycle) or 8 cycles of obinutuzumab along with 8 cycles of CVP (21-day cycles) or 6 cycles of obinutuzumab along with 6 cycles of bendamustine (28-day cycle) during induction period. The induction period will be followed by either a maintenance or observation period for responders or non-responders, respectively. Responders will receive obinutuzumab monotherapy every 2 months for 2 years during the maintenance period. Non-responders will receive no protocol specified treatment during the 2-year observation period. Finally, participants will be followed during a 5-year follow-up period. The chemotherapy regimen (CHOP or CVP or bendamustine) for individual participant will be chosen by the site prior to initiation of the study. |
|
|
|
| Obinutuzumab+Chemotherapy |
Participants will receive either 8 cycles of obinutuzumab along with 6 cycles of CHOP (21-day cycle) or 8 cycles of obinutuzumab along with 8 cycles of CVP (21-day cycles) or 6 cycles of obinutuzumab along with 6 cycles of bendamustine (28-day cycle) during induction period. The induction period will be followed by either a maintenance or observation period for responders or non-responders, respectively. Responders will receive obinutuzumab monotherapy every 2 months for 2 years during the maintenance period. Non-responders will receive no protocol specified treatment during the 2-year observation period. Finally, participants will be followed during a 5-year follow-up period. The chemotherapy regimen (CHOP or CVP or bendamustine) for individual participant will be chosen by the site prior to initiation of the study. |
|
|
|
| Obinutuzumab+Chemotherapy |
Participants will receive either 8 cycles of obinutuzumab along with 6 cycles of CHOP (21-day cycle) or 8 cycles of obinutuzumab along with 8 cycles of CVP (21-day cycles) or 6 cycles of obinutuzumab along with 6 cycles of bendamustine (28-day cycle) during induction period. The induction period will be followed by either a maintenance or observation period for responders or non-responders, respectively. Responders will receive obinutuzumab monotherapy every 2 months for 2 years during the maintenance period. Non-responders will receive no protocol specified treatment during the 2-year observation period. Finally, participants will be followed during a 5-year follow-up period. The chemotherapy regimen (CHOP or CVP or bendamustine) for individual participant will be chosen by the site prior to initiation of the study. |
|
|
|
| OG001 | Obinutuzumab+Chemotherapy | Participants will receive either 8 cycles of obinutuzumab along with 6 cycles of CHOP (21-day cycle) or 8 cycles of obinutuzumab along with 8 cycles of CVP (21-day cycles) or 6 cycles of obinutuzumab along with 6 cycles of bendamustine (28-day cycle) during induction period. The induction period will be followed by either a maintenance or observation period for responders or non-responders, respectively. Responders will receive obinutuzumab monotherapy every 2 months for 2 years during the maintenance period. Non-responders will receive no protocol specified treatment during the 2-year observation period. Finally, participants will be followed during a 5-year follow-up period. The chemotherapy regimen (CHOP or CVP or bendamustine) for individual participant will be chosen by the site prior to initiation of the study. |
|
|
| OG001 | Obinutuzumab+Chemotherapy | Participants received either 8 cycles of obinutuzumab along with 6 cycles of CHOP (21-day cycle) or 8 cycles of obinutuzumab along with 8 cycles of CVP (21-day cycles) or 6 cycles of obinutuzumab along with 6 cycles of bendamustine (28-day cycle) during induction period. The induction period was followed by either a maintenance or observation period for responders or non-responders, respectively. Responders received obinutuzumab monotherapy every 2 months for 2 years during the maintenance period. Non-responders received no protocol specified treatment during the 2-year observation period. Finally, participants were followed during a 5-year follow-up period. The chemotherapy regimen (CHOP or CVP or bendamustine) for individual participant was chosen by the site prior to initiation of the study. |
|
|
| OG001 | Obinutuzumab+Chemotherapy | Participants received either 8 cycles of obinutuzumab along with 6 cycles of CHOP (21-day cycle) or 8 cycles of obinutuzumab along with 8 cycles of CVP (21-day cycles) or 6 cycles of obinutuzumab along with 6 cycles of bendamustine (28-day cycle) during induction period. The induction period was followed by either a maintenance or observation period for responders or non-responders, respectively. Responders received obinutuzumab monotherapy every 2 months for 2 years during the maintenance period. Non-responders received no protocol specified treatment during the 2-year observation period. Finally, participants were followed during a 5-year follow-up period. The chemotherapy regimen (CHOP or CVP or bendamustine) for individual participant was chosen by the site prior to initiation of the study. |
|
|
| OG001 |
| Obinutuzumab+Chemotherapy |
Participants received either 8 cycles of obinutuzumab along with 6 cycles of CHOP (21-day cycle) or 8 cycles of obinutuzumab along with 8 cycles of CVP (21-day cycles) or 6 cycles of obinutuzumab along with 6 cycles of bendamustine (28-day cycle) during induction period. The induction period was followed by either a maintenance or observation period for responders or non-responders, respectively. Responders received obinutuzumab monotherapy every 2 months for 2 years during the maintenance period. Non-responders received no protocol specified treatment during the 2-year observation period. Finally, participants were followed during a 5-year follow-up period. The chemotherapy regimen (CHOP or CVP or bendamustine) for individual participant was chosen by the site prior to initiation of the study. |
|
|
| OG001 | Obinutuzumab+Chemotherapy | Participants received either 8 cycles of obinutuzumab along with 6 cycles of CHOP (21-day cycle) or 8 cycles of obinutuzumab along with 8 cycles of CVP (21-day cycles) or 6 cycles of obinutuzumab along with 6 cycles of bendamustine (28-day cycle) during induction period. The induction period was followed by either a maintenance or observation period for responders or non-responders, respectively. Responders received obinutuzumab monotherapy every 2 months for 2 years during the maintenance period. Non-responders received no protocol specified treatment during the 2-year observation period. Finally, participants were followed during a 5-year follow-up period. The chemotherapy regimen (CHOP or CVP or bendamustine) for individual participant was chosen by the site prior to initiation of the study. |
|
|
| OG001 | Obinutuzumab+Chemotherapy | Participants will receive either 8 cycles of obinutuzumab along with 6 cycles of CHOP (21-day cycle) or 8 cycles of obinutuzumab along with 8 cycles of CVP (21-day cycles) or 6 cycles of obinutuzumab along with 6 cycles of bendamustine (28-day cycle) during induction period. The induction period will be followed by either a maintenance or observation period for responders or non-responders, respectively. Responders will receive obinutuzumab monotherapy every 2 months for 2 years during the maintenance period. Non-responders will receive no protocol specified treatment during the 2-year observation period. Finally, participants will be followed during a 5-year follow-up period. The chemotherapy regimen (CHOP or CVP or bendamustine) for individual participant will be chosen by the site prior to initiation of the study. |
|
|
| OG001 | Obinutuzumab+Chemotherapy | Participants will receive either 8 cycles of obinutuzumab along with 6 cycles of CHOP (21-day cycle) or 8 cycles of obinutuzumab along with 8 cycles of CVP (21-day cycles) or 6 cycles of obinutuzumab along with 6 cycles of bendamustine (28-day cycle) during induction period. The induction period will be followed by either a maintenance or observation period for responders or non-responders, respectively. Responders will receive obinutuzumab monotherapy every 2 months for 2 years during the maintenance period. Non-responders will receive no protocol specified treatment during the 2-year observation period. Finally, participants will be followed during a 5-year follow-up period. The chemotherapy regimen (CHOP or CVP or bendamustine) for individual participant will be chosen by the site prior to initiation of the study. |
|
|
| OG001 | Obinutuzumab+Chemotherapy | Participants will receive either 8 cycles of obinutuzumab along with 6 cycles of CHOP (21-day cycle) or 8 cycles of obinutuzumab along with 8 cycles of CVP (21-day cycles) or 6 cycles of obinutuzumab along with 6 cycles of bendamustine (28-day cycle) during induction period. The induction period will be followed by either a maintenance or observation period for responders or non-responders, respectively. Responders will receive obinutuzumab monotherapy every 2 months for 2 years during the maintenance period. Non-responders will receive no protocol specified treatment during the 2-year observation period. Finally, participants will be followed during a 5-year follow-up period. The chemotherapy regimen (CHOP or CVP or bendamustine) for individual participant will be chosen by the site prior to initiation of the study. |
|
|