Outcome
| Type |
Measure |
Description |
Time frame |
Safety issue |
| Primary |
Number of Participants Who Received First Line Chemotherapy According to National Trial or Treatment Guideline |
In this outcome measure, number of participants who were treated with the first-line chemotherapy during anytime between initial diagnosis of ALL and InO initiation, were reported. |
Anytime between initial diagnosis of ALL and InO initiation, during data identification period from June 2016 to January 2021 (approximately 4.7 years); retrieved data was analyzed during 12 months of this observational study |
|
| Primary |
Number of Participants According to Number of Lines of Salvage Therapy |
In this outcome measure, number of participants according to number of lines of salvage therapy anytime between initial diagnosis of ALL and InO initiation, were reported. |
Anytime between initial diagnosis of ALL and InO initiation, during data identification period from June 2016 to January 2021 (approximately 4.7 years); retrieved data was analyzed during 12 months of this observational study |
|
| Primary |
Number of Participants According to Prior Hematopoietic Stem Cell Transplant (HSCT) |
In this outcome measure, number of participants, who were treated with hematopoietic stem cell transplant (HSCT) before initiation of InO, were reported. |
Anytime between initial diagnosis of ALL and InO initiation, during data identification period from June 2016 to January 2021 (approximately 4.5 years); retrieved data was analyzed during 12 months of this observational study |
|
| Primary |
Number of Participants According to Type of Conditioning Regimen for Each HSCT |
In this outcome measure, number of participants were classified according to different type of conditioning regimen for each HSCT (high-dose intensity myeloablative, reduced-intensity/non-myeloablative), were reported. |
Anytime between initial diagnosis of ALL and InO initiation, during data identification period from June 2016 to January 2021 (approximately 4.7 years); retrieved data was analyzed during 12 months of this observational study |
|
| Primary |
Number of Participants Who Were Treated Previously With Blinatumomab |
In this outcome measure, number of participants who were previously treated with blinatumomab, were reported. |
Anytime between initial diagnosis of ALL and InO initiation, during data identification period from June 2016 to January 2021 (approximately 4.7 years); retrieved data was analyzed during 12 months of this observational study |
|
| Primary |
Number of Participants Treated With Chimeric Antigen Receptor (CAR) T-Cell Therapies |
In this outcome measure, number of participants treated with chimeric antigen receptor (CAR) T-cell therapies before initiation of InO, were reported. |
Anytime between initial diagnosis of ALL and InO initiation, during data identification period from June 2016 to January 2021 (approximately 4.7 years); retrieved data was analyzed during 12 months of this observational study |
|
| Secondary |
Total Duration of Treatment With Inotuzumab Ozogamicin |
In this outcome measure, total duration of InO treatment was reported. |
From InO initiation date to date of end of treatment, during data identification period from June 2016 to January 2021 (approximately 4.7 years); retrieved data was analyzed during 12 months of this observational study |
|
| Secondary |
Number of Participants According to Number of Inotuzumab Ozogamicin Treatment Cycles |
In this outcome measure, number of participants were classified according to total number of InO treatment cycles received. |
From InO initiation date to date of end of treatment, during data identification period from June 2016 to January 2021 (approximately 4.7 years); retrieved data was analyzed during 12 months of this observational study |
|
| Secondary |
Number of Participants According to Interrupted Inotuzumab Ozogamicin Treatment Cycles |
In this outcome measure, number of participants were classified according to number of interrupted cycles of InO treatment. |
From InO initiation date to date of end of treatment, during data identification period from June 2016 to January 2021 (approximately 4.7 years); retrieved data was analyzed during 12 months of this observational study |
|
| Secondary |
Number of Participants According to Reasons for Inotuzumab Ozogamicin Treatment Interruption |
In this outcome measure, number of participants, were reported according to reasons of interruption in respective Cycles. |
From InO initiation date to date of end of treatment, during data identification period from June 2016 to January 2021 (approximately 4.7 years); retrieved data was analyzed during 12 months of this observational study |
|
| Secondary |
Number of Participants According to Prescribed Inotuzumab Ozogamicin Doses |
In this outcome measure, number of participants according to prescribed starting InO dose, were reported. |
From InO initiation date to date of end of treatment, during data identification period from June 2016 to January 2021 (approximately 4.7 years); retrieved data was analyzed during 12 months of this observational study |
|
| Secondary |
Number of Participants Classified on the Basis of Any Modifications in Inotuzumab Ozogamicin Dose |
In this outcome measure, number of participants were classified as following: 1) with no dose modification and 2) no data recorded. |
From InO initiation date to date of end of treatment, during data identification period from June 2016 to January 2021 (approximately 4.7 years); retrieved data was analyzed during 12 months of this observational study |
|
| Secondary |
Number of Participants Who Were Treated With Concomitant Azole Antifungal Therapy |
In this outcome measure, number of participants who were treated with concomitant azole antifungal therapy along with InO treatment were reported. |
From InO initiation date to date of end of treatment, during data identification period from June 2016 to January 2021 (approximately 4.7 years); retrieved data was analyzed during 12 months of this observational study |
|
| Secondary |
Duration of Concomitant Azole Antifungal Therapy |
In this outcome measure, time/duration between start date and end date of concomitant azole antifungal, was reported. |
From InO initiation date to date of end of treatment, during data identification period from June 2016 to January 2021 (approximately 4.7 years); retrieved data was analyzed during 12 months of this observational study |
|
| Secondary |
Number of Participants Who Achieved Complete Remission (CR) by the End of InO Treatment |
CR was defined as documented in medical records or (if unavailable in the records) as less than (<) 5% blasts in the bone marrow and the absence of peripheral blood leukemic blasts, full recovery of peripheral blood counts (platelets greater than or equal to [>=] 100*10^9 cells per liter [/L] and absolute neutrophil counts [ANC] >=1*10^9 cells/L) and resolution of any extramedullary disease. |
From InO initiation date to date of end of treatment, during data identification period from June 2016 to January 2021 (approximately 4.7 years); retrieved data was analyzed during 12 months of this observational study |
|
| Secondary |
Number of Participants Who Achieved CR With Incomplete Hematological Recovery (CRi) by the End of InO Treatment |
CRi was defined as documented in medical records or (if unavailable in the records) <5% blasts in the bone marrow and the absence of peripheral blood leukemic blasts, incomplete recovery of peripheral blood counts (platelets <100* 10^9 cells/L and ANC <1*10^9 cells/L) and resolution of any extramedullary disease. |
From InO initiation date to date of end of treatment, during data identification period from June 2016 to January 2021 (approximately 4.7 years); retrieved data was analyzed during 12 months of this observational study |
|
| Secondary |
Number of Participants With CR/CRi by the End of InO Treatment |
In this outcome, number of participants who achieved CR/CRi at the end of InO treatment are reported. CR was defined as documented in medical records or as <5% blasts in the bone marrow and the absence of peripheral blood leukemic blasts, full recovery of peripheral blood counts (platelets >=100*10^9 cells/L and ANC >=1*10^9 cells/L) and resolution of any extramedullary disease. CRi was defined as documented in medical records or <5% blasts in the bone marrow and the absence of peripheral blood leukemic blasts, incomplete recovery of peripheral blood counts (platelets <100*10^9 cells/L and ANC <1*10^9 cells/L) and resolution of any extramedullary disease. |
From InO initiation date to date of end of treatment, during data identification period from June 2016 to January 2021 (approximately 4.7 years); retrieved data was analyzed during 12 months of this observational study |
|
| Secondary |
Median Time to CR/CRi |
CR was defined as documented in medical records or as <5% blasts in the bone marrow and the absence of peripheral blood leukemic blasts, full recovery of peripheral blood counts (platelets >=100*10^9 cells/L and ANC >=1*10^9 cells/L) and resolution of any extramedullary disease. CRi was defined as documented in medical records or <5% blasts in the bone marrow and the absence of peripheral blood leukemic blasts, incomplete recovery of peripheral blood counts (platelets <100*10^9 cells/L and ANC <1*10^9 cells/L) and resolution of any extramedullary disease. |
From InO initiation date to date of end of treatment, during data identification period from June 2016 to January 2021 (approximately 4.7 years); retrieved data was analyzed during 12 months of this observational study |
|
| Secondary |
Number of Participants Who Achieved Negative Minimal Residual Disease (MRD) 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. This outcome measure was analyzed in participants with CR/CRi. CR was defined as documented in medical records or as <5% blasts in the bone marrow and the absence of peripheral blood leukemic blasts, full recovery of peripheral blood counts (platelets >=100*10^9 cells/L and ANC >=1*10^9 cells/L) and resolution of any extramedullary disease. CRi was defined as documented in medical records or <5% blasts in the bone marrow and the absence of peripheral blood leukemic blasts, incomplete recovery of peripheral blood counts (platelets <100*10^9 cells/L and ANC <1*10^9 cells/L) and resolution of any extramedullary disease. |
From InO initiation date to date of end of treatment, during data identification period from June 2016 to January 2021 (approximately 4.7 years); retrieved data was analyzed during 12 months of this observational study |
|
| Secondary |
Number of Participants Who Achieved Negative MRD Classified Per InO Cycles |
Negative MRD (among those who had CR/CRi) 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. CR was defined as documented in medical records or as <5% blasts in the bone marrow and the absence of peripheral blood leukemic blasts, full recovery of peripheral blood counts (platelets >=100*10^9 cells/L and ANC >=1*10^9 cells/L) and resolution of any extramedullary disease. CRi was defined as documented in medical records or <5% blasts in the bone marrow and the absence of peripheral blood leukemic blasts, incomplete recovery of peripheral blood counts (platelets <100*10^9 cells/L and ANC <1*10^9 cells/L) and resolution of any extramedullary disease. |
From InO initiation date to date of end of treatment, during data identification period from June 2016 to January 2021 (approximately 4.7 years); retrieved data was analyzed during 12 months of this observational study |
|
| Secondary |
Number of Participants Who Survived at 3, 6 and 12 Months Post InO Treatment Initiation |
In this outcome measure, number of participants who survived 3, 6, and 12 post InO treatment, were reported. |
At 3, 6, and 12 months post InO initiation date, during data identification period from June 2016 to January 2021 (approximately 4.7 years); retrieved data was analyzed during 12 months of this observational study |
|
| Secondary |
Number of Participants Classified According to Their Cause of Death |
In this outcome measure, number of participants according to their cause of death were reported. |
From InO initiation date to date of end of treatment, during data identification period from June 2016 to January 2021 (approximately 4.7 years); retrieved data was analyzed during 12 months of this observational study |
|
| Secondary |
Overall Survival (OS) |
OS was defined as the time from the index date to the date of death. Participants were censored at date of latest visit at the time of data collection. Kaplan-Meier method was used for OS analysis. |
InO initiation date to death due to any cause or last visit at time of data collection, during data identification period from June 2016 to January 2021 (approximately 4.7 years); retrieved data was analyzed during 12 months of this observational study |
|
| Secondary |
Percentage of Participants Who Were Relapse-free at 3, 6 and 12 Months Post InO Treatment Initiation |
Relapse free survival: the time from the start of treatment to 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), and start of new induction therapy or post-therapy HSCT without achieving CR/CRi; as documented in medical records. CR: documented in medical records or as <5% blasts in the bone marrow and the absence of peripheral blood leukemic blasts, full recovery of peripheral blood counts (platelets >=100*10^9/L and ANC >=1*10^9/L) and resolution of any extramedullary disease. CRi: documented in medical records or <5% blasts in the bone marrow and the absence of peripheral blood leukemic blasts, incomplete recovery of peripheral blood counts (platelets <100*10^9/L and ANC <1*10^9/L) and resolution of any extramedullary disease. Progressive disease (PD): a doubling of peripheral blasts with an absolute increase of >5*10^9 cells/L. |
At 3, 6, and 12 months from InO initiation date, during data identification period from June 2016 to January 2021 (approximately 4.7 years); retrieved data was analyzed during 12 months of this observational study |
|
| Secondary |
Relapse-free Survival (RFS) |
RFS was defined as the time from the start of treatment to earliest date of the following events: death, PD (including objective progression, relapse from CR/CRi, treatment discontinuation due to global deterioration of health status), and start of new induction therapy or post-therapy HSCT without achieving CR/CRi; as documented in medical records. CR was defined as documented in medical records or as <5% blasts in the bone marrow and the absence of peripheral blood leukemic blasts, full recovery of peripheral blood counts (platelets >=100*10^9 cells /L and ANC >=1*10^9 cells/L) and resolution of any extramedullary disease. CRi was defined as documented in medical records or <5% blasts in the bone marrow and the absence of peripheral blood leukemic blasts, incomplete recovery of peripheral blood counts (platelets <100*10^9 cells/L and ANC <1*10^9 cells/L) and resolution of any extramedullary disease. PD: a doubling of peripheral blasts with an absolute increase of >5*10^9 cells/L. |
From InO initiation date to death or progressive disease, during data identification period from June 2016 to January 2021 (approximately 4.7 years); retrieved data was analyzed during 12 months of this observational study |
|
| Secondary |
Time to Non-relapse Mortality (NRM) |
NRM was defined as the time from the date of follow-up HSCT until death due to any cause without disease progression or relapse. |
Post InO treatment from date of follow up HSCT to death, during data identification period from June 2016 to January 2021 (approximately 4.7 years); retrieved data was analyzed during 12 months of this observational study |
|
| Secondary |
Number of Participants According to Types of Therapies Post Inotuzumab Ozogamicin Treatment |
In this outcome measure, number of participants according to therapies they initiated post InO treatment were reported. One participant could have more than 1 type of therapies. |
Post InO treatment, during data identification period from June 2016 to January 2021 (approximately 4.7 years); retrieved data was analyzed during 12 months of this observational study |
|
| Secondary |
Number of Participants Who Achieved CR, CRi, Progressive Disease and Stable Disease With Different Types of Post Inotuzumab Ozogamicin Treatments |
CR was defined as documented in medical records or as <5% blasts in the bone marrow and the absence of peripheral blood leukemic blasts, full recovery of peripheral blood counts (platelets >=100*10^9 cells/L and ANC >=1*10^9 cells/L) and resolution of any extramedullary disease. CRi was defined as documented in medical records or <5% blasts in the bone marrow and the absence of peripheral blood leukemic blasts, incomplete recovery of peripheral blood counts (platelets <100*10^9 cells/L and ANC <1*10^9 cells/L) and resolution of any extramedullary disease. PD was defined as a doubling of peripheral blasts with an absolute increase of >5*10^9 cells/L. Stable disease was defined as increase of peripheral blasts with an absolute increase not >50%. |
Post InO treatment, during data identification period from June 2016 to January 2021 (approximately 4.7 years); retrieved data was analyzed during 12 months of this observational study |
|
| Secondary |
Number of Participants Who Survived Post InO Blinatumomab Treatment |
In this outcome measure, number of participants who survived at completion of InO treatment were reported. |
Post InO treatment, during data identification period from June 2016 to January 2021 (approximately 4.7 years); retrieved data was analyzed during 12 months of this observational study |
|
| Secondary |
Number of Participants Who Experienced a Documented Diagnosis of Veno-occlusive Disease (VOD)/Sinusoidal Obstruction Syndrome (SOS) Post InO Treatment |
VOD, also called SOS, happens when the small blood vessels that lead into the liver and are inside the liver become blocked. |
Post InO treatment, during data identification period from June 2016 to January 2021 (approximately 4.7 years); retrieved data was analyzed during 12 months of this observational study |
|
| Secondary |
Number of Participants According to Type of Treatments Received for Documented Diagnoses of Veno-occlusive Disease (VOD)/Sinusoidal Obstruction Syndrome (SOS) |
VOD, also called SOS, happens when the small blood vessels that lead into the liver and are inside the liver become blocked. |
Post InO treatment, during data identification period from June 2016 to January 2021 (approximately 4.7 years); retrieved data was analyzed during 12 months of this observational study |
|
| Secondary |
Number of Participants Who Survived Following Treatment For Documented Diagnoses of Veno-occlusive Disease (VOD)/Sinusoidal Obstruction Syndrome (SOS) |
VOD, also called SOS, happens when the small blood vessels that lead into the liver and are inside the liver become blocked. |
Post InO treatment, during data identification period from June 2016 to January 2021 (approximately 4.7 years); retrieved data was analyzed during 12 months of this observational study |
|
| Secondary |
Number of Participants With Interrupted InO Treatment Due to VOD/SOS |
VOD, also called SOS, happens when the small blood vessels that lead into the liver and are inside the liver become blocked. |
Post InO treatment, during data identification period from June 2016 to January 2021 (approximately 4.7 years); retrieved data was analyzed during 12 months of this observational study |
|
| Secondary |
Number of Participants With Moderate Severity VOD/SOS |
VOD, also called SOS, happens when the small blood vessels that lead into the liver and are inside the liver become blocked. |
Post InO Treatment, during data identification period from June 2016 to January 2021 (approximately 4.5 years); from the data collected and observed retrospectively over approximately 12 months of this study |
|
| Secondary |
Number of Participants Who Experienced Grade 3 and Grade 4 (Lung/Cardiac/Kidney/Liver) Treatment Related Adverse Event (TRAE) Following Inotuzumab Ozogamicin Initiation |
Adverse event (AE) was defined as any untoward medical occurrence in participant who received study drug without regard to possibility of causal relationship. Grade 3 were severe events. Grade 4 were life-threatening events. Information for grades was recorded as per participants' medical records. |
From InO initiation date to date of end of treatment, during data identification period from June 2016 to January 2021 (approximately 4.7 years); retrieved data was analyzed during 12 months of this observational study |
|
| Secondary |
Number of Participants According to Types of Treatments Received for Grade3/4 TRAE Following Inotuzumab Ozogamicin Initiation |
AE was defined as any untoward medical occurrence in participant who received study drug without regard to possibility of causal relationship. Grade 3 were severe events. Grade 4 were life-threatening events. Information for grades was recorded as per participants' medical records. |
From InO initiation date to date of end of treatment, during data identification period from June 2016 to January 2021 (approximately 4.7 years); retrieved data was analyzed during 12 months of this observational study |
|
| Secondary |
Number of Participants With Liver Dysfunction Following Inotuzumab Ozogamicin Initiation |
|
From InO initiation date to date of end of treatment, during data identification period from June 2016 to January 2021 (approximately 4.7 years); retrieved data was analyzed during 12 months of this observational study |
|
| Secondary |
Number of Participants With Peripheral Blood Blast Counts Measurement Prior to Post InO HSCT |
|
Prior to post InO HSCT, during data identification period from June 2016 to January 2021 (approximately 4.7 years); retrieved data was analyzed during 12 months of this observational study |
|
| Secondary |
Number of Participants With Significant Risk Factors for VOD/SOS |
In this outcome measure, participants with significant risk factor for VOD/ SOS occurrence were reported. VOD, also called SOS, happens when the small blood vessels that lead into the liver and are inside the liver become blocked |
From InO initiation date to date of end of treatment, during data identification period from June 2016 to January 2021 (approximately 4.7 years); retrieved data was analyzed during 12 months of this observational study |
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