| Primary | Number of Participants Who Achieved Complete Remission (CR) or Complete Remission With Incomplete Hematological Recovery (CRi) Following Treatment With InO | CR was defined as 5 percent (%) bone marrow blasts, no evidence of disease in the bone marrow, and recovery of peripheral blood count (platelet count of [more than] >100*10^9 cells/liter [L] and absolute neutrophil count of >1*10^9 cells/L). CRi was defined as 5% bone marrow blasts and no evidence of disease in the bone marrow, but with incomplete recovery of peripheral blood count. | Analysis population included all eligible participants whose data were retrieved and observed in this study. | Posted | | Count of Participants | | Participants | | From InO treatment initiation (Apr 2018) till end of follow-up (Apr 2023) [Maximum up to 61 Months]; data retrospectively collected from 08-Mar-2023 to 10-Jul-2023 (approximately 4 months of this study) | | | | ID | Title | Description |
|---|
| OG000 | Inotuzumab Ozogamicin (InO) | Participants who were treated with InO as a monotherapy and completed at least one cycle of InO and were CD22 positive, in real world setting under routine clinical practice outside of clinical trials were observed retrospectively. |
| | | Title | Denominators | Categories |
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| Primary | Number of Participants Who Achieved Complete Remission (CR) or Complete Remission With Incomplete Hematological Recovery (CRi) Following Treatment With InO, Classified Per Number of Lines of Salvage Therapies Prior to InO Initiation | CR was defined as 5 percent (%) bone marrow blasts, no evidence of disease in the bone marrow, and recovery of peripheral blood count (platelet count of [more than] >100*10^9 cells/liter [L] and absolute neutrophil count of >1*10^9 cells/L). CRi was defined as 5% bone marrow blasts and no evidence of disease in the bone marrow, but with incomplete recovery of peripheral blood count. Salvage therapy is use of drugs after standard conventional chemotherapeutic regimens have failed to achieve remission. | Analysis population included all eligible participants whose data were retrieved and observed in this study. All participants reported under "Number of Participants Analyzed" contributed data to the table; however, may not have evaluable data for every row. Here, "Number Analyzed" signifies number of participants evaluable for specified rows. | Posted | | Count of Participants | | Participants | | From InO treatment initiation (Apr 2018) till end of follow-up (Apr 2023) [Maximum up to 61 Months]; data retrospectively collected from 08-Mar-2023 to 10-Jul-2023 (approximately 4 months of this study) | | | | ID | Title | Description |
|---|
| OG000 | Inotuzumab Ozogamicin (InO) | Participants who were treated with InO as a monotherapy and completed at least one cycle of InO and were CD22 positive, in real world setting under routine clinical practice outside of clinical trials were observed retrospectively. |
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| Primary | Number of Participants Who Achieved CR or CRi Following Treatment With InO, Classified Per High Burden and Low Burden Disease | CR was defined as 5% bone marrow blasts, no evidence of disease in the bone marrow, and recovery of peripheral blood count (platelet count of >100*10^9 cells/L and absolute neutrophil count of >1*10^9 cells/L). CRi was defined as 5% bone marrow blasts and no evidence of disease in the bone marrow, but with incomplete recovery of peripheral blood count. Disease burden was defined using percentage of bone marrow blasts (BMB). In this outcome measure low disease burden indicated BMB <50% and high disease burden indicated BMB >=50%. | Analysis population included all eligible participants whose data were retrieved and observed in this study. All participants reported under "Number of Participants Analyzed" contributed data to the table; however, may not have evaluable data for every row. Here, "Number Analyzed" signifies number of participants evaluable for specified rows. | Posted | | Count of Participants | | Participants | | From InO treatment initiation (Apr 2018) till end of follow-up (Apr 2023) [Maximum up to 61 Months]; data retrospectively collected from 08-Mar-2023 to 10-Jul-2023 (approximately 4 months of this study) | | | | ID | Title | Description |
|---|
| OG000 | Inotuzumab Ozogamicin (InO) | Participants who were treated with InO as a monotherapy and completed at least one cycle of InO and were CD22 positive, in real world setting under routine clinical practice outside of clinical trials were observed retrospectively. |
| |
| Secondary | Number of Participants Who Achieved Minimal Residual Disease (MRD) Negativity Following Initiation of Ino Among Those Who Had CR/CRi | Negative MRD was defined as documented in medical records or (if unavailable in the records) as leukemic cells comprising <1*10^-4 (<0.01%) of bone marrow nucleated cells. MRD was assessed by multicolor flow cytometry. CR was defined as 5% bone marrow blasts, no evidence of disease in the bone marrow, and recovery of peripheral blood count (platelet count of >100*10^9/L and absolute neutrophil count of >1*10^9/L). CRi was defined as 5% bone marrow blasts and no evidence of disease in the bone marrow, but with incomplete recovery of peripheral blood count. | Analysis population included all eligible participants whose data were retrieved and observed in this study. All participants reported under "Number of Participants Analyzed" contributed data to the table; however, may not have evaluable data for every row. Here, "Number of Participants Analyzed" signifies participants evaluable for this outcome measure and "Number Analyzed" signifies number of participants evaluable for specified rows. | Posted | | Count of Participants | | Participants | | From InO treatment initiation (Apr 2018) till end of follow-up (Apr 2023) [Maximum up to 61 Months]; data retrospectively collected from 08-Mar-2023 to 10-Jul-2023 (approximately 4 months of this study) | | | | ID | Title | Description |
|---|
| OG000 | Inotuzumab Ozogamicin (InO) | Participants who were treated with InO as a monotherapy and completed at least one cycle of InO and were CD22 positive, in real world setting under routine clinical practice outside of clinical trials were observed retrospectively. |
|
| Secondary | Number of Participants Who Achieved MRD Negativity Classified Per Number of Lines of Salvage Therapies Following Initiation of InO Among Those Who Had CR/CRi | Negative MRD was defined as documented in medical records or (if unavailable in the records) as leukemic cells comprising <1*10^-4 (<0.01%) of bone marrow nucleated cells. MRD was assessed by multicolour flow cytometry. CR was defined as 5% bone marrow blasts, no evidence of disease in the bone marrow, and recovery of peripheral blood count (platelet count of >100*10^9/L and absolute neutrophil count of >1*10^9/L). CRi was defined as 5% bone marrow blasts and no evidence of disease in the bone marrow, but with incomplete recovery of peripheral blood count. Salvage therapy is use of drugs after standard conventional chemotherapeutic regimens have failed to achieve remission. Participants with either CR or CRi who achieved MRD negativity classified per number of lines of salvage therapies are reported in this outcome measure. | Analysis population included all eligible participants whose data were retrieved and observed in this study. All participants reported under "Number of Participants Analyzed" contributed data to the table; however, may not have evaluable data for every row. Here, "Number of Participants Analyzed" signifies participants evaluable for this outcome measure and "Number Analyzed" signifies number of participants evaluable for specified rows. | Posted | | Count of Participants | | Participants | | From InO treatment initiation (Apr 2018) till end of follow-up (Apr 2023) [Maximum up to 61 Months]; data retrospectively collected from 08-Mar-2023 to 10-Jul-2023 (approximately 4 months of this study) | | | | ID | Title | Description |
|---|
| OG000 | Inotuzumab Ozogamicin (InO) | |
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| Secondary | Number of Participants Who Achieved MRD Negativity Classified Per High Burden and Low Burden Disease Following Initiation of InO Among Those Who Had CR/CRi | Negative MRD was defined as documented in medical records or (if unavailable in the records) as leukemic cells comprising <1*10^-4 (<0.01%) of bone marrow nucleated cells. MRD was assessed by multicolour flow cytometry. CR was defined as 5% bone marrow blasts, no evidence of disease in the bone marrow, and recovery of peripheral blood count (platelet count of >100*10^9/L and absolute neutrophil count of >1*10^9/L). CRi was defined as 5% bone marrow blasts and no evidence of disease in the bone marrow, but with incomplete recovery of peripheral blood count. Disease burden was defined using percentage of BMB. In this outcome measure low disease burden indicated BMB <50% and high disease burden indicated BMB >=50%. Participants with either CR or CRi who achieved MRD negativity classified per high burden and low burden disease are reported in this outcome measure. | Analysis population included all eligible participants whose data were retrieved and observed in this study. All participants reported under "Number of Participants Analyzed" contributed data to the table; however, may not have evaluable data for every row. Here, "Number of Participants Analyzed" signifies participants evaluable for this outcome measure and "Number Analyzed" signifies number of participants evaluable for specified rows. | Posted | | Count of Participants | | Participants | | From InO treatment initiation (Apr 2018) till end of follow-up (Apr 2023) [Maximum up to 61 Months]; data retrospectively collected from 08-Mar-2023 to 10-Jul-2023 (approximately 4 months of this study) | | | | ID | Title | Description |
|---|
| OG000 | Inotuzumab Ozogamicin (InO) |
|
| Secondary | Number of Participants Achieving MRD Negativity Following Initiation of InO Among Those Who Had CR/CRi in Elderly Participants (>65 Years) | Negative MRD was defined as documented in medical records or (if unavailable in the records) as leukemic cells comprising <1*10^-4 (<0.01%) of bone marrow nucleated cells. MRD was assessed by multicolour flow cytometry. CR was defined as 5% bone marrow blasts, no evidence of disease in the bone marrow, and recovery of peripheral blood count (platelet count of >100*10^9/L and absolute neutrophil count of >1*10^9/L). CRi was defined as 5% bone marrow blasts and no evidence of disease in the bone marrow, but with incomplete recovery of peripheral blood count. | Analysis population included all eligible participants whose data were retrieved and observed in this study. Here, "Number of Participants Analyzed" signifies number of participants evaluable for this outcome measure. | Posted | | Count of Participants | | Participants | | From InO treatment initiation (Apr 2018) till end of follow-up (Apr 2023) [Maximum up to 61 Months]; data retrospectively collected from 08-Mar-2023 to 10-Jul-2023 (approximately 4 months of this study) | | | | ID | Title | Description |
|---|
| OG000 | Inotuzumab Ozogamicin (InO) | Participants who were treated with InO as a monotherapy and completed at least one cycle of InO and were CD22 positive, in real world setting under routine clinical practice outside of clinical trials were observed retrospectively. |
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| Secondary | Median Number of Cycles of InO Treatment | The median number of cycles of InO a participant received during treatment were included. Standard dose of InO: 1.8 mg/m^2 per 21 days cycle. | Analysis population included all eligible participants whose data were retrieved and observed in this study. | Posted | | Median | Full Range | Cycles of InO Treatment | | From InO treatment initiation (Apr 2018) till end of follow-up (Apr 2023) [Maximum up to 61 Months]; data retrospectively collected from 08-Mar-2023 to 10-Jul-2023 (approximately 4 months of this study) | | | | ID | Title | Description |
|---|
| OG000 | Inotuzumab Ozogamicin (InO) | Participants who were treated with InO as a monotherapy and completed at least one cycle of InO and were CD22 positive, in real world setting under routine clinical practice outside of clinical trials were observed retrospectively. |
| |
| Secondary | Median Number of Cycles of InO Needed to Attain CR/CRi | CR was defined as 5% bone marrow blasts, no evidence of disease in the bone marrow, and recovery of peripheral blood count (platelet count of >100*10^9/L and absolute neutrophil count of >1*10^9/L). CRi was defined as 5% bone marrow blasts and no evidence of disease in the bone marrow, but with incomplete recovery of peripheral blood count. | Analysis population included all eligible participants whose data were retrieved and observed in this study. 'Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure. | Posted | | Median | Full Range | Cycles of InO treatment | | From InO treatment initiation (Apr 2018) till end of follow-up (Apr 2023) [Maximum up to 61 Months]; data retrospectively collected from 08-Mar-2023 to 10-Jul-2023 (approximately 4 months of this study) | | | | ID | Title | Description |
|---|
| OG000 | Inotuzumab Ozogamicin (InO) | Participants who were treated with InO as a monotherapy and completed at least one cycle of InO and were CD22 positive, in real world setting under routine clinical practice outside of clinical trials were observed retrospectively. |
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| Secondary | Mean Number of Cycles of InO Needed to Attain CR or CRi Classified Per Number of Lines of Salvage Therapies | CR was defined as 5% bone marrow blasts, no evidence of disease in the bone marrow, and recovery of peripheral blood count (platelet count of >100*10^9/L and absolute neutrophil count of >1*10^9/L). CRi was defined as 5% bone marrow blasts and no evidence of disease in the bone marrow, but with incomplete recovery of peripheral blood count. Salvage therapy is use of drugs after standard conventional chemotherapeutic regimens have failed to achieve remission. | Analysis population included all eligible participants whose data were retrieved and observed in this study. All participants reported under "Number of Participants Analyzed" contributed data to the table; however, may not have evaluable data for every row. Here, "Number of Participants Analyzed" signifies participants evaluable for this outcome measure and "Number Analyzed" signifies number of participants evaluable for specified rows. | Posted | | Mean | Standard Deviation | Cycles of InO treatment | | From InO treatment initiation (Apr 2018) till end of follow-up (Apr 2023) [Maximum up to 61 Months]; data retrospectively collected from 08-Mar-2023 to 10-Jul-2023 (approximately 4 months of this study) | | | | ID | Title | Description |
|---|
| OG000 | Inotuzumab Ozogamicin (InO) | Participants who were treated with InO as a monotherapy and completed at least one cycle of InO and were CD22 positive, in real world setting under routine clinical practice outside of clinical trials were observed retrospectively. |
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| Secondary | Duration of Remission (DOR) | Remission was defined as either the reduction or disappearance of the signs and symptoms of leukemia for this study. | Analysis population included all eligible participants whose data were retrieved and observed in this study. "Number of Participants Analyzed" signifies number of participants evaluable for this outcome measure. | Posted | | Median | Full Range | Months | | From InO treatment initiation (Apr 2018) till end of follow-up (Apr 2023) [Maximum up to 61 Months]; data retrospectively collected from 08-Mar-2023 to 10-Jul-2023 (approximately 4 months of this study) | | | | ID | Title | Description |
|---|
| OG000 | Inotuzumab Ozogamicin (InO) | Participants who were treated with InO as a monotherapy and completed at least one cycle of InO and were CD22 positive, in real world setting under routine clinical practice outside of clinical trials were observed retrospectively. |
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| Secondary | Number of Participants Categorized as Per InO Doses | Standard dose of InO was 1.8 milligrams (mg) per meter square (m^2) per cycle. Under dose of InO was less than 1.8 mg/m^2 per cycle. Overdose of InO was more than 1.8 mg/m^2 per cycle. | Analysis population included all eligible participants whose data were retrieved and observed in this study. | Posted | | Count of Participants | | Participants | | From InO treatment initiation (Apr 2018) till end of follow-up (Apr 2023) [Maximum up to 61 Months]; data retrospectively collected from 08-Mar-2023 to 10-Jul-2023 (approximately 4 months of this study) | | | | ID | Title | Description |
|---|
| OG000 | Inotuzumab Ozogamicin (InO) | Participants who were treated with InO as a monotherapy and completed at least one cycle of InO and were CD22 positive, in real world setting under routine clinical practice outside of clinical trials were observed retrospectively. |
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| Secondary | Number of Participants With InO Dose Modifications | Number of participants for whom there was deviation in InO dose from the standard dose (1.8 mg/ m^2 per cycle) were included. | Analysis population included all eligible participants whose data were retrieved and observed in this study. | Posted | | Count of Participants | | Participants | | From InO treatment initiation (Apr 2018) till end of follow-up (Apr 2023) [Maximum up to 61 Months]; data retrospectively collected from 08-Mar-2023 to 10-Jul-2023 (approximately 4 months of this study) | | | | ID | Title | Description |
|---|
| OG000 | Inotuzumab Ozogamicin (InO) | Participants who were treated with InO as a monotherapy and completed at least one cycle of InO and were CD22 positive, in real world setting under routine clinical practice outside of clinical trials were observed retrospectively. |
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| Secondary | Number of Participants Who Received Concomitant Medications | Concomitant medication was defined as any medication other than, and in addition to, the study medication taken for any period of time during the treatment. | Analysis population included all eligible participants whose data were retrieved and observed in this study. | Posted | | Count of Participants | | Participants | | From InO treatment initiation (Apr 2018) till end of follow-up (Apr 2023) [Maximum up to 61 Months]; data retrospectively collected from 08-Mar-2023 to 10-Jul-2023 (approximately 4 months of this study) | | | | ID | Title | Description |
|---|
| OG000 | Inotuzumab Ozogamicin (InO) | Participants who were treated with InO as a monotherapy and completed at least one cycle of InO and were CD22 positive, in real world setting under routine clinical practice outside of clinical trials were observed retrospectively. |
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| Secondary | Number of Participants Who Proceeded to Hematopoietic Stem Cell Transplantation (HSCT) | HSCT is the transplantation of multipotent hematopoietic stem cells to treat some type of cancers and other diseases. | Analysis population included all eligible participants whose data were retrieved and observed in this study. | Posted | | Count of Participants | | Participants | | From InO treatment initiation (Apr 2018) till end of follow-up (Apr 2023) [Maximum up to 61 Months]; data retrospectively collected from 08-Mar-2023 to 10-Jul-2023 (approximately 4 months of this study) | | | | ID | Title | Description |
|---|
| OG000 | Inotuzumab Ozogamicin (InO) | Participants who were treated with InO as a monotherapy and completed at least one cycle of InO and were CD22 positive, in real world setting under routine clinical practice outside of clinical trials were observed retrospectively. |
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| Secondary | Survival Rate at 6 and 12 Months in Transplanted and Non-Transplanted Participants Who Achieved CR/CRi and MRD Negativity | Survival rate: percentage of participants in a study or treatment group who were still alive for a certain period of time after they were diagnosed with or started treatment for a disease. Negative MRD was defined as documented in medical records or (if unavailable in the records) as leukemic cells comprising <1*10^-4 (<0.01%) of bone marrow nucleated cells. MRD was assessed by multicolour flow cytometry. CR was defined as 5% bone marrow blasts, no evidence of disease in the bone marrow, and recovery of peripheral blood count (platelet count of >100*10^9 cells/L and absolute neutrophil count of >1*10^9 cells/L). CRi was defined as 5% bone marrow blasts and no evidence of disease in the bone marrow, but with incomplete recovery of peripheral blood count. In this outcome measure percentage of participants who had either CR or CRi with MRD negativity and survived at the end of 6 months and 12 months post initiation of InO treatment are reported on the basis of transplantation status. | Analysis population included all eligible participants whose data were retrieved and observed in this study. All participants reported under "Number of Participants Analyzed" contributed data to the table; however, may not have evaluable data for every row. Here, "Number of Participants Analyzed" signifies participants evaluable for this outcome measure and "Number Analyzed" signifies number of participants evaluable for specified rows. | Posted | | Number | | Percentage of participants | | 6 and 12 months post initiation of InO treatment; data retrospectively collected from 08-Mar-2023 to 10-Jul-2023 (approximately 4 months of this study) | | | | ID | Title | Description |
|---|
| OG000 | Inotuzumab Ozogamicin (InO) |
|
| Secondary | Survival Rate at 6 and 12 Months in Transplanted and Non-Transplanted Participants Classified Per Number of Lines of Salvage Therapies | Survival rate was defined as the percentage of participants in a study or treatment group who were still alive for a certain period of time after they were diagnosed with or started treatment for a disease. Salvage therapy is use of drugs after standard conventional chemotherapeutic regimens have failed to achieve remission. In this outcome measure percentage of transplanted and non-transplanted participants who survived at the end of 6 months and 12 months post initiation of InO treatment are classified based on number of lines of salvage therapies. | Analysis population included all eligible participants whose data were retrieved and observed in this study. All participants reported under "Number of Participants Analyzed" contributed data to the table; however, may not have evaluable data for every row. Here, "Number of Participants Analyzed" signifies participants evaluable for this outcome measure and "Number Analyzed" signifies number of participants evaluable for specified rows. | Posted | | Number | | Percentage of participants | | 6 and 12 months post initiation of InO treatment; data retrospectively collected from 08-Mar-2023 to 10-Jul-2023 (approximately 4 months of this study) | | | | ID | Title | Description |
|---|
| OG000 | Inotuzumab Ozogamicin (InO) | Participants who were treated with InO as a monotherapy and completed at least one cycle of InO and were CD22 positive, in real world setting under routine clinical practice outside of clinical trials were observed retrospectively. |
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| Secondary | Survival Rate at 6 and 12 Months in Transplanted and Non-Transplanted Participants Classified Per High Burden and Low Burden Disease | Survival rate was defined as the percentage of participants in a study or treatment group who were still alive for a certain period of time after they were diagnosed with or started treatment for a disease. Disease burden was defined using percentage of BMB. In this outcome measure low disease burden indicated BMB <50% and high disease burden indicated BMB >=50%. In this outcome measure percentage of transplanted and non-transplanted participants who survived at the end of 6 months and 12 months post initiation of InO treatment are classified based on high burden and low burden disease. | Analysis population included all eligible participants whose data were retrieved and observed in this study. All participants reported under "Number of Participants Analyzed" contributed data to the table; however, may not have evaluable data for every row. Here, "Number of Participants Analyzed" signifies participants evaluable for this outcome measure and "Number Analyzed" signifies number of participants evaluable for specified rows. | Posted | | Number | | Percentage of participants | | 6 and 12 months post initiation of InO treatment; data retrospectively collected from 08-Mar-2023 to 10-Jul-2023 (approximately 4 months of this study) | | | | ID | Title | Description |
|---|
| OG000 | Inotuzumab Ozogamicin (InO) | Participants who were treated with InO as a monotherapy and completed at least one cycle of InO and were CD22 positive, in real world setting under routine clinical practice outside of clinical trials were observed retrospectively. |
|
| Secondary | Survival Rate at 6 and 12 Months in Transplanted and Non-Transplanted Elderly Participants (>65 Years) | Survival rate was defined as the percentage of participants in a study or treatment group who were still alive for a certain period of time after they were diagnosed with or started treatment for a disease. In this outcome measure percentage of transplanted and non-transplanted participants greater than 65 years of age, who survived at the end of 6 months and 12 months post initiation of InO treatment are reported. | Analysis population included all eligible participants whose data were retrieved and observed in this study. All participants reported under "Number of Participants Analyzed" contributed data to the table; however, may not have evaluable data for every row. Here, "Number of Participants Analyzed" signifies participants evaluable for this outcome measure and "Number Analyzed" signifies number of participants evaluable for specified rows. | Posted | | Number | | Percentage of participants | | 6 and 12 months post initiation of InO treatment; data retrospectively collected from 08-Mar-2023 to 10-Jul-2023 (approximately 4 months of this study) | | | | ID | Title | Description |
|---|
| OG000 | Inotuzumab Ozogamicin (InO) | Participants who were treated with InO as a monotherapy and completed at least one cycle of InO and were CD22 positive, in real world setting under routine clinical practice outside of clinical trials were observed retrospectively. |
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| Secondary | Number of Participants Categorized According to Cause of Death | | Analysis population included all eligible participants whose data were retrieved and observed in this study. Here "Number of Participants Analyzed" signifies number of participants evaluable for this outcome measure. | Posted | | Count of Participants | | Participants | | From InO treatment initiation (Apr 2018) till end of follow-up (Apr 2023) [Maximum up to 61 Months]; data retrospectively collected from 08-Mar-2023 to 10-Jul-2023 (approximately 4 months of this study) | | | | ID | Title | Description |
|---|
| OG000 | Inotuzumab Ozogamicin (InO) | Participants who were treated with InO as a monotherapy and completed at least one cycle of InO and were CD22 positive, in real world setting under routine clinical practice outside of clinical trials were observed retrospectively. |
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| Secondary | Relapse Free Survival (RFS) in All Participants and Participants With or Without Follow-up HSCT | RFS was defined as time from index date to the earliest date of the following events: death, progressive disease (including objective progression, relapse from CR/CRi, treatment discontinuation due to global deterioration of health status), or the start of new induction therapy or posttherapy HSCT without achieving CR/CRi. Index date was defined as the date of initiation of the first cycle of InO. CR was defined as 5% bone marrow blasts, no evidence of disease in the bone marrow, and recovery of peripheral blood count (platelet count of >100*10^9/L and absolute neutrophil count of >1*10^9/L). CRi was defined as 5% bone marrow blasts and no evidence of disease in the bone marrow, but with incomplete recovery of peripheral blood count. Median duration of relapse free survival in all participants included those participants who had achieved CR/CRi is reported in this outcome measure. | Analysis population included all eligible participants whose data were retrieved and observed in this study. All participants reported under "Number of Participants Analyzed" contributed data to the table; however, may not have evaluable data for every row. Here, "Number of Participants Analyzed" signifies participants evaluable for this outcome measure and "Number Analyzed" signifies number of participants evaluable for specified rows. | Posted | | Median | Full Range | Months | | From InO treatment initiation (Apr 2018) till end of follow-up (Apr 2023) [Maximum up to 61 Months]; data retrospectively collected from 08-Mar-2023 to 10-Jul-2023 (approximately 4 months of this study) | | | | ID | Title | Description |
|---|
| OG000 | Inotuzumab Ozogamicin (InO) | |
|
| Secondary | Percentage of HSCT Transplanted Participants With VOD and Percentage of HSCT Non-transplanted Participants With VOD | VOD occurs when the small blood vessels in the liver are blocked. | Analysis population included all eligible participants whose data were retrieved and observed in this study. All participants reported under "Number of Participants Analyzed" contributed data to the table; however, may not have evaluable data for every row. Here, "Number Analyzed" signifies number of participants evaluable for specified rows. | Posted | | Number | | Percentage of participants | | From InO treatment initiation (Apr 2018) till end of follow-up (Apr 2023) [Maximum up to 61 Months]; data retrospectively collected from 08-Mar-2023 to 10-Jul-2023 (approximately 4 months of this study) | | | | ID | Title | Description |
|---|
| OG000 | Inotuzumab Ozogamicin (InO) | Participants who were treated with InO as a monotherapy and completed at least one cycle of InO and were CD22 positive, in real world setting under routine clinical practice outside of clinical trials were observed retrospectively. |
| |
| Secondary | Percentage of Participants With VOD in Participants Classified Per Number of Lines of Salvage Therapies | VOD occurs when the small blood vessels in the liver are blocked. Salvage therapy is use of drugs after standard conventional chemotherapeutic regimens have failed to achieve remission. | Analysis population included all eligible participants whose data were retrieved and observed in this study. All participants reported under "Number of Participants Analyzed' contributed data to the table; however, may not have evaluable data for every row. Here, "Number Analyzed" signifies number of participants evaluable for specified rows. | Posted | | Number | | Percentage of participants | | From InO treatment initiation (Apr 2018) till end of follow-up (Apr 2023) [Maximum up to 61 Months]; data retrospectively collected from 08-Mar-2023 to 10-Jul-2023 (approximately 4 months of this study) | | | | ID | Title | Description |
|---|
| OG000 | Inotuzumab Ozogamicin (InO) | Participants who were treated with InO as a monotherapy and completed at least one cycle of InO and were CD22 positive, in real world setting under routine clinical practice outside of clinical trials were observed retrospectively. |
| |
| Secondary | Percentage of Participants With VOD Classified Per High Burden and Low Burden Disease | VOD occurs when the small blood vessels in the liver are blocked. Disease burden was defined using percentage of BMB. In this outcome measure low disease burden indicated BMB <50% and high disease burden indicated BMB >=50%. | Analysis population included all eligible participants whose data were retrieved and observed in this study. All participants reported under "Number of Participants Analyzed' contributed data to the table; however, may not have evaluable data for every row. Here, "Number Analyzed" signifies number of participants evaluable for specified rows. | Posted | | Number | | Percentage of participants | | From InO treatment initiation (Apr 2018) till end of follow-up (Apr 2023) [Maximum up to 61 Months]; data retrospectively collected from 08-Mar-2023 to 10-Jul-2023 (approximately 4 months of this study) | | | | ID | Title | Description |
|---|
| OG000 | Inotuzumab Ozogamicin (InO) | Participants who were treated with InO as a monotherapy and completed at least one cycle of InO and were CD22 positive, in real world setting under routine clinical practice outside of clinical trials were observed retrospectively. |
| |
| Secondary | Percentage of Participants With VOD in Elderly Participants (>65 Years) | VOD occurs when the small blood vessels in the liver are blocked. | Analysis population included all eligible participants whose data were retrieved and observed in this study. Here, "Number of Participants Analyzed" signifies participants evaluable for this outcome measure. | Posted | | Number | | Percentage of participants | | From InO treatment initiation (Apr 2018) till end of follow-up (Apr 2023) [Maximum up to 61 Months]; data retrospectively collected from 08-Mar-2023 to 10-Jul-2023 (approximately 4 months of this study) | | | | ID | Title | Description |
|---|
| OG000 | Inotuzumab Ozogamicin (InO) | Participants who were treated with InO as a monotherapy and completed at least one cycle of InO and were CD22 positive, in real world setting under routine clinical practice outside of clinical trials were observed retrospectively. |
| |
| Secondary | Number of Participants With Grade 3/4 Treatment Related Liver Toxicity (Hepatobiliary Disorder) Adverse Events (TEAEs) Following InO Initiation | Treatment-related AE was any untoward medical occurrence in a participant who has received the study drug. Liver toxicity parameters included: Aspartate aminotransferase (level) >=2.5*upper limit of normal (ULN); alanine transaminase (level) >=2.5*ULN and total serum bilirubin >=1.5*ULN. Here, Grade 3 indicates severe events and Grade 4 indicates Life-threatening events where urgent intervention was required. | Analysis population included all eligible participants whose data were retrieved and observed in this study. | Posted | | Count of Participants | | Participants | | From InO treatment initiation (Apr 2018) till end of follow-up (Apr 2023) [Maximum up to 61 Months]; data retrospectively collected from 08-Mar-2023 to 10-Jul-2023 (approximately 4 months of this study) | | | | ID | Title | Description |
|---|
| OG000 | Inotuzumab Ozogamicin (InO) | Participants who were treated with InO as a monotherapy and completed at least one cycle of InO and were CD22 positive, in real world setting under routine clinical practice outside of clinical trials were observed retrospectively. |
| |
| Secondary | Number of Participants With Hematological Toxicities Following InO Initiation | Hematological toxicities included: Febrile neutropenia= absolute neutrophil count (ANC) < 1.0*10^9 cells/L, fever >=38.5 degree C); Neutropenia= absolute granulocyte count < 1.0*10^9 cells/L; Thrombocytopenia= platelet count < 150,000 platelets per microliter. | Analysis population included all eligible participants whose data were retrieved and observed in this study. | Posted | | Count of Participants | | Participants | | From InO treatment initiation (Apr 2018) till end of follow-up (Apr 2023) [Maximum up to 61 Months]; data retrospectively collected from 08-Mar-2023 to 10-Jul-2023 (approximately 4 months of this study) | | | | ID | Title | Description |
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| OG000 | Inotuzumab Ozogamicin (InO) | Participants who were treated with InO as a monotherapy and completed at least one cycle of InO and were CD22 positive, in real world setting under routine clinical practice outside of clinical trials were observed retrospectively. |
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| Secondary | Number of Participants With Extramedullary Disease (EMD) or Lymphoblastic Lymphoma (LBL) Who Achieved CR or CRi | Extramedullary disease was the presence of leukemic cell aggregates in the form of solid tumor outside that of bone marrow. Lymphoblastic lymphoma, was a clonal hematopoietic stem cell disorder of B or T cell origin. CR was defined as 5% bone marrow blasts, no evidence of disease in the bone marrow, and recovery of peripheral blood count (platelet count of >100*10^9/L and absolute neutrophil count of >1*10^9/L). CRi was defined as 5% bone marrow blasts and no evidence of disease in the bone marrow, but with incomplete recovery of peripheral blood count. | Analysis population included all eligible participants whose data were retrieved and observed in this study. "Number of Participants Analyzed" signifies participants evaluable for this outcome measure. | Posted | | Count of Participants | | Participants | | From InO treatment initiation (Apr 2018) till end of follow-up (Apr 2023) [Maximum up to 61 Months]; data retrospectively collected from 08-Mar-2023 to 10-Jul-2023 (approximately 4 months of this study) | | | | ID | Title | Description |
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| OG000 | Inotuzumab Ozogamicin (InO) | Participants who were treated with InO as a monotherapy and completed at least one cycle of InO and were CD22 positive, in real world setting under routine clinical practice outside of clinical trials were observed retrospectively. |
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