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The purpose of this study is to describe progression-free survival (PFS) in participants with relapsed or refractory classical Hodgkin lymphoma (RRHL), defined as the time from initiation of first treatment for RRHL to first documentation of relapse or disease progression, or death.
This is a retrospective, non-interventional study of participants with newly-diagnosed cHL, or with RRHL. The study will review the medical records of participants to describe participant's demographics, disease characteristics, treatments received, outcomes, health resources used by the participants, and adverse events that are associated with treatments, and resources used for treatment.
The study will enroll approximately 50 to 100 participants in each group at each of the 13 participating countries. Based on the diagnosis of the disease, participants will be assigned to one of the following groups:
Group 1: cHL Group 2: RRHL
This multi-center trial will be conducted in Argentina, Australia, China, Colombia, Hong Kong, Mexico, Republic of Korea, Russia, Saudi Arabia, Singapore, South Africa, Taiwan, and Turkey. The data for Group 1 and Group 2 will be collected from date of cHL or RRHL diagnosis until the date of death (or the date when the participant was last known to be alive, whichever occurs first).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1: cHL | Participants diagnosed with high-risk stage IIb-IV cHL, received frontline treatment with chemotherapy with or without radiotherapy between 01 January 2010 and 31 December 2013 from the 13 participating countries will be observed for various treatments received for cHL, associated adverse events and resources used from the date of cHL diagnosis until the date of first documented relapse or disease progression after frontline therapy. Participants will be continue to be observed for overall survival until the date of death or data collection, whichever occurs first. | ||
| Group 2: RRHL | Participants diagnosed with RRHL, between 01 January 2010 and 31 December 2013 from the 13 participating countries will be observed for various treatments received for RRHL, detailed data on treatment pathways, clinical outcomes, associated adverse events and resources used from the date of RRHL diagnosis until the date death or data collection, whichever occurs first. Participants will be continue to be observed for overall survival until the date of death or data collection, whichever occurs first. |
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| Measure | Description | Time Frame |
|---|---|---|
| Group 2, RRHL: Progression Free Survival (PFS) | PFS was defined as time from initiation of frontline regimen to first documentation of relapse or disease progression or death, censored at date of most recent follow-up/contact. Progressive disease (PD) was defined as any new lesion or increase by >=50% of previously involved site from nadir, and was evaluated based on International Working Group (IWG) criteria (Cheson et al 2007). Median PFS was estimated using the Kaplan-Meier method. | From initiation of first treatment until first documentation of relapse/PD/until date of death (or date when participant was last alive), whichever occurred first (observed retrospectively from 2010 until date of data collection [up to 9 years 10 months]) |
| Measure | Description | Time Frame |
|---|---|---|
| Group 1, cHL: Number of Participants Based on Clinical Staging According to Ann Arbor Staging at Diagnosis | The Ann Arbor staging system of lymphomas is used to summarize the extent of the cancer's spread. Stages are classified by Roman numerals I (lessspread) to IV (more spread). Additional sub staging variables include: A, asymptomatic; and B, presence of B symptoms (including fever, night sweats and weight loss of >=10 percent [%] of body weight over 6 months). |
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Inclusion Criteria:
Exclusion Criteria:
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Participants diagnosed with high-risk stage IIb-IV cHL and/or with RRHL between 01 January 2010 and 31st December 2013 from the 13 participating countries.
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Takeda | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pusan National University Hospital | Busan | 49241 | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40624058 | Derived | Hernandez-Caballero A, Salazar R, Zerga M, Rivas-Vera S, Huang Z, Karduss A. Subgroup analysis of treatment pathways and clinical outcomes in Hodgkin lymphoma in Latin America from the retrospective B-HOLISTIC study. Sci Rep. 2025 Jul 7;15(1):24197. doi: 10.1038/s41598-025-07704-0. | |
| 36200380 | Derived | Ferhanoglu B, Kim TM, Karduss A, Brittain D, Tumyan G, Al-Mansour M, Zerga M, Song Y, Rivas-Vera S, Kwong YL, Lim ST, Yeh SP, Abdillah A, Huang Z, Dalal M, Wan H, Hertzberg M. Treatment pathways and clinical outcomes in Hodgkin lymphoma outside Europe and North America: results from the international, multicenter, retrospective, B-HOLISTIC study. Leuk Lymphoma. 2022 Dec;63(14):3317-3330. doi: 10.1080/10428194.2022.2126281. Epub 2022 Oct 6. |
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Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.
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IPD from eligible studies will be shared with qualified researchers according to the criteria and process described on https://vivli.org/ourmember/takeda/. For approved requests, the researchers will be provided access to anonymized data (to respect patient privacy in line with applicable laws and regulations) and with information necessary to address the research objectives under the terms of a data sharing agreement.
1770 participants were enrolled in this study, of which, 1703 were eligible for analysis set of the study. Out of 1703 participants, 1598 participants were eligible and enrolled in Group 1 (cHL) and further, 426 participants were eligible and enrolled in Group 2 (RRHL). Out of 426 participants in Group 2, 321 participants who were diagnosed with CHL, and subsequently RRHL between 2010 and 2013 were common in Group 1 and 2.
Data abstraction took place in Argentina, Australia, China, Colombia, Hong Kong, Mexico, Russia, Saudi Arabia, South Africa, Province Of China, Turkey, Singapore and Republic of Korea from 21 November 2017 to 31 October 2019. Participants diagnosed with high-risk stage IIb-IV classical Hodgkin lymphoma (cHL) (Group 1) or with relapsed/refractory classical Hodgkin lymphoma (RRHL) (Group 2) between 2010 and 2013 were observed in this study.
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| ID | Title | Description |
|---|---|---|
| FG000 | Group 1: cHL | Participants diagnosed with high-risk stage IIb-IV cHL between 01 January 2010 and 31 December 2013, who received frontline treatment with chemotherapy with or without radiotherapy, and participants who were diagnosed with high-risk stage IIb-IV cHL and then were subsequently diagnosed with RRHL between 2010 and 2013 were observed retrospectively until the date of death or data collection, whichever occurred first. |
| FG001 | Group 2: RRHL | Participants diagnosed with RRHL between 01 January 2010 and 31 December 2013, and participants who were diagnosed with high-risk stage IIb-IV cHL and then were subsequently diagnosed with RRHL between 2010 and 2013 were observed retrospectively until the date of death or data collection, whichever occurred first. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Group 1: cHL |
| |||||||||||||
| Group 2: RRHL |
|
The full analysis set (FAS) included all participants who were eligible for cHL or RRHL group including the common participants in both the groups.
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| ID | Title | Description |
|---|---|---|
| BG000 | Group 1: cHL | Participants diagnosed with high-risk stage IIb-IV cHL between 01 January 2010 and 31 December 2013, who received frontline treatment with chemotherapy with or without radiotherapy, and participants who were diagnosed with high-risk stage IIb-IV cHL and then were subsequently diagnosed with RRHL between 2010 and 2013 were observed retrospectively until the date of death or data collection, whichever occurred first. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Count of 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 | Group 2, RRHL: Progression Free Survival (PFS) | PFS was defined as time from initiation of frontline regimen to first documentation of relapse or disease progression or death, censored at date of most recent follow-up/contact. Progressive disease (PD) was defined as any new lesion or increase by >=50% of previously involved site from nadir, and was evaluated based on International Working Group (IWG) criteria (Cheson et al 2007). Median PFS was estimated using the Kaplan-Meier method. | The FAS included all participants who were eligible for RRHL group including the common participants in both the groups. | Posted | Median | 95% Confidence Interval | months | From initiation of first treatment until first documentation of relapse/PD/until date of death (or date when participant was last alive), whichever occurred first (observed retrospectively from 2010 until date of data collection [up to 9 years 10 months]) |
|
From initial diagnosis until the date of death (or the date when the participant was last known to be alive) (observed retrospectively from 2010 until date of data collection [up to 9 years 10 months])
At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Group 1: cHL | Participants diagnosed with high-risk stage IIb-IV cHL between 01 January 2010 and 31 December 2013, who received frontline treatment with chemotherapy with or without radiotherapy, and participants who were diagnosed with high-risk stage IIb-IV cHL and then were subsequently diagnosed with RRHL between 2010 and 2013 were observed retrospectively until the date of death or data collection, whichever occurred first. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA (22.0) | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Neutropenia | Blood and lymphatic system disorders | MedDRA (22.0) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Medical Director | Takeda | +1-877-825-3327 | trialdisclosures@takeda.com |
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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 | May 4, 2017 | Oct 29, 2020 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Feb 24, 2020 | Oct 29, 2020 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D012008 | Recurrence |
| ID | Term |
|---|---|
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| Day 1 at cHL diagnosis |
| Group 2, RRHL: Number of Participants Based on Clinical Staging According to Ann Arbor Staging at Diagnosis | The Ann Arbor staging system of lymphomas is used to summarize the extent of the cancer's spread. Stages are classified by Roman numerals I (lessspread) to IV (more spread). Additional sub staging variables include: A, asymptomatic; and B, presence of B symptoms (including fever, night sweats and weight loss of >=10 % of body weight over 6 months). | Day 1 at RRHL diagnosis |
| Group 2, RRHL: Number of Participants Based on Clinical Staging According to Ann Arbor Staging at Relapse After First Relapse or Refractory Diagnosis | The Ann Arbor staging system of lymphomas is used to summarize the extent of the cancer's spread. Stages are classified by Roman numerals I (less spread) to IV (more spread). Additional sub staging variables include: A, asymptomatic; and B, presence of B symptoms (including fever, night sweats and weight loss of >=10% of body weight over 6 months). | At second, third, fourth, and fifth relapse (up to 9 years 10 months) |
| Group 1, cHL: Number of Participants Based on Each International Prognostic Score (IPS) Category | IPS score was calculated based on following factors: age >=45 years, male sex, stage IV disease, albumin<4 gram per liter (g/L), white blood cell (WBC)>=15*10^9 per liter (/L), haemoglobin <10.5 g/L, and lymphocyte count<0.6*10^6/L or <8% of differential. One point was assigned for each of above factors. The sum of points allotted correlates with following risk groups: good risk (0-1 points)-5 year survival of 89-90%; fair risk (2 to 3 points)-5 year survival of 78-81%; poor risk (4-7 points)-5 year survival of 56-61%. Total score range is 0 to 7, lower scores indicate higher survival rate. | Day 1 at cHL diagnosis |
| Group 1, cHL: Number of Participants With B Symptoms at Diagnosis | The Ann Arbor staging system of lymphomas is used to summarize the extent of the cancer's spread. Stages are classified by Roman numerals I (less spread) to IV (more spread). If the following symptoms (B-symptoms) are present, a "B" classification is added to the stage: fever, night sweats and weight loss of >=10% of body weight over 6 months. B-symptoms indicate the presence of systemic symptoms. The presence or absence of B-symptoms has prognostic significance and is reflected in the staging of these lymphomas. | Day 1 at cHL diagnosis |
| Group 2, RRHL: Number of Participants With B Symptoms at Diagnosis | The Ann Arbor staging system of lymphomas is used to summarize the extent of the cancer's spread. Stages are classified by Roman numerals I (less spread) to IV (more spread). If the following symptoms (B-symptoms) are present, a "B" classification is added to the stage: fever, night sweats and weight loss of >=10% of body weight over 6 months. B-symptoms indicate the presence of systemic symptoms. The presence or absence of B-symptoms has prognostic significance and is reflected in the staging of these lymphomas. | Day 1 at RRHL diagnosis |
| Group 2, RRHL: Number of Participants Categorized Based on Prior Therapies for Hodgkin Lymphoma (HL) at Each Line of Treatment | Number of participants were categorized based on prior therapies for HL at each line of treatment. | Day 1 at RRHL diagnosis |
| Group 2, RRHL: Median Number of Previous Treatment Regimens (Chemotherapies) Received | Day 1 at RRHL diagnosis |
| Group 1, cHL: Number of Participants Categorized Based on Frontline Treatment Regimens | Therapy regimens were numbered as 1: Doxorubicin (Doxo) + Bleomycin (bleo) + Vinblastine (Vinbl) + Decarbazine (Dacar) (ABVD); 3: Doxo + Vinbl + Mechlorethamine + Etoposide (Eto) + Vincristilne (Vinc) + Bleo + Prednisone (Pred) (Stanford V); 6: Cyclophophamide (Cyclo) + Vinc + Procarbazine (Procarb) + Pred (C-MOPP); 7: Dexamethasone + Cytarabine + Cisplatin (DHAP); 8: Eto + Methylprednisolone + Cytarabine + Cisplatin (ESHAP); 10: Ifosfamide+ Carboplatin + Eto (ICE); 11: Ifosfamide + Gemcitabine +Vinorelbine + Pred (IGEV); 17: Rituximab; 18: Brentuximab vedotin; 4: Bleo + Eto + Doxo + Cyclo + Vinc + Procarb + Pred (BEACOPP); 14: Cycl + Doxo + Vinc + Pred (CHOP); 15: Cycl + Vinc + Pred (CVP); 2: ABVD + Doxo + Bleo + Vinbl + Dacar then Bleo + Eto + Doxo + Cycl + Vinc + Procarb+ Pred ( Escalated BEACOPP); 24: Other. | From initial diagnosis until the date of death (or the date when the participant was last known to be alive) (observed retrospectively from 2010 until date of data collection [up to 9 years 10 months]) |
| Group 1, cHL: Median Number of Treatment Cycles Associated With Each Frontline Treatment Regimen | Therapy regimens were numbered as 1: ABVD; 3: Stanford V; 6: C-MOPP; 7: DHAP; 8: ESHAP; 10: ICE; 11: IGEV; 17: Rituximab; 18: Brentuximab vedotin; 4: BEACOPP; 14: CHOP; 15: CVP; 2: ABVD + Escalated BEACOPP; 24: Other. | From initial diagnosis until the date of death (or the date when the participant was last known to be alive) (observed retrospectively from 2010 until date of data collection [up to 9 years 10 months]) |
| Group 1, cHL: Number of Participants Who Received Treatments for HL After Completion of Frontline Therapy (Before Relapse) | Therapy regimens were numbered as 1: ABVD; 6: C-MOPP; 7: DHAP; 8: ESHAP; 10: ICE; 11: IGEV; 12: Carmustine + Cytarabine + Etoposide + Melphalan (Mini-BEAM); 13: Etoposide + Ifosfamide + Mesna + Mitoxantrone (MINE); 18: Brentuximab vedotin; 16: Gemcitabine + Vinoreilbine + Pegylated liposomal doxorubicin (GVD); 4: BEACOPP; 14: CHOP; 24: Other. | From initial diagnosis until the date of death (or the date when the participant was last known to be alive) (observed retrospectively from 2010 until date of data collection [up to 9 years 10 months]) |
| Group 1, cHL: Number of Participants Based on Radiotherapy (RT) Type and Site When Received at Frontline | From initial diagnosis until the date of death (or the date when the participant was last known to be alive) (observed retrospectively from 2010 until date of data collection [up to 9 years 10 months]) |
| Group 1, cHL: Number of Participants Categorized Based on RT Treatment Given as Pre-planned Frontline Treatment and RT Treatment Given for Residual Fluorodeoxyglucose (FDG)-Avid Disease | Assessment was done for RT's whether used for pre-planned frontline treatment or for residual Fluorodeoxyglucose (FDG)-avid disease. | From initial diagnosis until the date of death (or the date when the participant was last known to be alive) (observed retrospectively from 2010 until date of data collection [up to 9 years 10 months]) |
| Group 2, RRHL: Percentage of Participants Categorized Based on ASCT Eligibility Assessment | From initial diagnosis until the date of death (or the date when the participant was last known to be alive) (observed retrospectively from 2010 until date of data collection [up to 9 years 10 months]) |
| Group 2, RRHL: Median Number of Treatment Cycles Associated With Relapse/ Refractory Treatment Regimen for ASCT | Therapy regimens were numbered as 1: ABVD; 6: C-MOPP; 8: ESHAP; 11: IGEV; 12: Mini-BEAM; 18: Brentuximab vedotin; 22: Nivolumab; 24: Other. | From initial diagnosis until the date of death (or the date when the participant was last known to be alive) (observed retrospectively from 2010 until date of data collection [up to 9 years 10 months]) |
| Group 2, RRHL: Number of Non-ASCT Participants Categorized Based on Reasons for Not Undergoing ASCT Despite Being ASCT Eligible | Reasons for ASCT-eligible participants for not undergoing ASCT included participant refusal, inability to mobilize stem cells, loss of response to chemotherapy, cumulative toxicities, comorbid conditions, others, and unknown. | From initial diagnosis until the date of death (or the date when the participant was last known to be alive) (observed retrospectively from 2010 until date of data collection [up to 9 years 10 months]) |
| Group 2, RRHL: Number of Non-ASCT Participants Based on Reasons for ASCT Ineligibility | Reasons for ASCT ineligibility included advanced age, comorbid conditions, chemoresistant disease, cumulative toxicities, and others. | From initial diagnosis until the date of death (or the date when the participant was last known to be alive) (observed retrospectively from 2010 until date of data collection [up to 9 years 10 months]) |
| Group 2, RRHL: Number of Non-ASCT Participants Categorized Based on Treatment Regimens Received at Each Line of Treatment | Therapy regimens were numbered as 1: ABVD; 2: ABVD followed by Escalated BEACOPP; 3: Stanford V; 4: BEACOPP; 6: Cyclophosphamide C-MOPP; 7: DHAP; 8: ESHAP; 9: GCD; 10: ICE; 11: IGEV; 12: Mini-BEAM; 13: MINE; 14: CHOP; 15: CVP; 16: GVD; 17: Rituximab; 18: Brentuximab vedotin; 19: Bendamustine; 22: Nivolumab; 23: Pembrolizumab; 24: Other. More than one line of treatment or therapy was selected for each participant. | From initial diagnosis until the date of death (or the date when the participant was last known to be alive) (observed retrospectively from 2010 until date of data collection [up to 9 years 10 months]) |
| Group 2, RRHL: Percentage of Non-ASCT Participants for Whom Treatment is Palliative | From initial diagnosis until the date of death (or the date when the participant was last known to be alive) (observed retrospectively from 2010 until date of data collection [up to 9 years 10 months]) |
| Group 2, RRHL: Percentage of Non-ASCT Participants Receiving Positron Emission Tomography (PET) or Computed Tomography (CT) at Each Line of Treatment Pathway | From initial diagnosis until the date of death (or the date when the participant was last known to be alive) (observed retrospectively from 2010 until date of data collection [up to 9 years 10 months]) |
| Group 2, RRHL: Percentage of Non-ASCT Participants Receiving RT at Each Line of Treatment Pathway | From initial diagnosis until the date of death (or the date when the participant was last known to be alive) (observed retrospectively from 2010 until date of data collection [up to 9 years 10 months]) |
| Group 2, RRHL: Median Frequency of PET or PET-CT Scan Assessment for Non-ASCT Participants | From initial diagnosis until the date of death (or the date when the participant was last known to be alive) (observed retrospectively from 2010 until date of data collection [up to 9 years 10 months]) |
| Group 2, RRHL: Median Number of Treatment Cycles Received in Each Treatment Regimen at Each Line of Treatment in Non-ASCT Participants | Therapy regimens were numbered as 1: ABVD; 3: Stanford V; 6: C-MOPP; 7: DHAP; 11: IGEV; 19: Bendamustine; 4: BEACOPP; 13: MINE; 14: CHOP; 24: Other; 8: ESHAP; 9: Gemcitabine + Carboplatin + Dexamethasone (GCD); 10: ICE; 17: Rituximab; 18: Brentuximab vedotin; 15: CVP; 2: ABVD followed by Escalated BEACOPP; 22: Nivolumab; 16: GVD; 21: Lenalidomide; 24: Other. | From initiation of first treatment until first documentation of relapse/PD/until date of death( or date when participant was last alive), whichever occurred first (observed retrospectively from 2010 until date of data collection [up to 9 years 10 months]) |
| Group 2, RRHL: Duration of Each Line of Treatment in Non-ASCT Participants | From initiation of first treatment until first documentation of relapse/PD/until date of death( or date when participant was last alive), whichever occurred first (observed retrospectively from 2010 until date of data collection [up to 9 years 10 months]) |
| Group 2, RRHL: Percentage of Non-ASCT Participants Categorized Based on Dose Delays in Each Treatment Regimen at Each Line of Treatment | Therapy regimens were numbered as 1: ABVD; 3: Stanford V; 6: C-MOPP; 7: DHAP; 11: IGEV; 4: BEACOPP; 14: CHOP; 15: CVP; 2: ABVD followed by Escalated BEACOPP; 24: Other; 8: ESHAP; 9: GCD; 10: ICE; 13: MINE; 17: Rituximab; 18: Brentuximab vedotin; 19: Bendamustine; 22: Nivolumab. More than one line of treatment or therapy was selected for each participant | From initial diagnosis until the date of death (or the date when the participant was last known to be alive) (observed retrospectively from 2010 until date of data collection [up to 9 years 10 months]) |
| Group 2, RRHL: Time From Relapse (After Frontline Treatment) to First Treatment Post-relapse in Non-ASCT Participants | From relapse after frontline treatment to first treatment post-relapse or until the date of death (or the date when the participant was last known to be alive) (observed retrospectively from 2010 until date of data collection [up to 9 years 10 months]) |
| Group 2, RRHL: Time to Initiation of Each Subsequent Treatment, From Relapse and Completion of Previous Treatment in Non-ASCT Participants | From both relapse and from completion of previous treatment to initiation of each subsequent treatment (observed retrospectively from 2010 until date of data collection [up to 9 years 10 months]) |
| Group 2, RRHL: Number of Participants With Non-ASCT Assessed for RT Type, Site Received at Frontline | From initial diagnosis until the date of death (or the date when the participant was last known to be alive) (observed retrospectively from 2010 until date of data collection [up to 9 years 10 months]) |
| Group 2, RRHL: Number of Participants With Non-ASCT Assessed for RT Type, Site at Relapse/ Refractory | From initial diagnosis until the date of death (or the date when the participant was last known to be alive) (observed retrospectively from 2010 until date of data collection [up to 9 years 10 months]) |
| Group 2, RRHL: Total Dose of Radiotherapies in Non-ASCT Participants | From initial diagnosis until the date of death (or the date when the participant was last known to be alive) (observed retrospectively from 2010 until date of data collection [up to 9 years 10 months]) |
| Group 2, RRHL: Number of PET or CT Scan Assessments | From initial diagnosis until the date of death (or the date when the participant was last known to be alive) (observed retrospectively from 2010 until date of data collection [up to 9 years 10 months]) |
| Group 2, RRHL: Number of Participants Categorized Based on Various Chemotherapeutic Regimen and Therapies Used in Participants Undergoing ASCT | Therapy regimens were numbered as 8: ESHAP; 10: ICE; 11: IGEV; 12: Mini-BEAM; 18: Brentuximab vedotin; 19: Bendamustine; 16: GVD; 24: Other. Conditioning regimens are BEAM (Carmustine + Etoposide + Cytarabine + Melphalan), CBV (cyclophosphamide + Carmustine + vp16) BeEAM (bendamustine) and Gemcitabine/Busulfan/Melphalan. | From initial diagnosis until the date of death (or the date when the participant was last known to be alive) (observed retrospectively from 2010 until date of data collection [up to 9 years 10 months]) |
| Group 2, RRHL: Number of Participants Categorized Based on With Known Risk Factors for Relapse Post ASCT in Participants Undergoing ASCT | Known risk factors for relapse after ASCT included time to first relapse less than or equal to (<=) 3 months, stage IV disease at relapse, bulky disease >=5 centimeter (cm) at relapse, extranodal disease, inadequate response to salvage chemotherapy (partial remission [PR] or PET positivity), performance status (eastern Cooperative oncology group [ECOG]) >=1. The ECOG assessment used a 3-point scale, including scores of 0 (fully active/able to carry on all pre-disease activities without restriction), 1 (restricted in physically strenuous activity but ambulatory/able to carry out light or sedentary work), or 2 (ambulatory for more than 50% of waking hours and capable of all self care but unable to carry out any work activities). | From initial diagnosis until the date of death (or the date when the participant was last known to be alive) (observed retrospectively from 2010 until date of data collection [up to 9 years 10 months]) |
| Group 2, RRHL: Median Number of Cycles Associated With Each Salvage Regimen in Participants Undergoing ASCT | Therapy regimens were numbered as 1: ABVD; 6: C-MOPP; 7: DHAP; 8: ESHAP; 9: GCD; 10: ICE; 11: IGEV; 12: Mini-BEAM; 13: Eto + Ifosfamide + Mesna + Mitoxantrone (MINE); 18: Brentuximab vedotin; 19: Bendamustine; 22: Nivolumab; 16: GVD; 4: BEACOPP; 14: CHOP; 2: ABVD + Escalated BEACOPP; 24: Other. | From initial diagnosis until the date of death (or the date when the participant was last known to be alive) (observed retrospectively from 2010 until date of data collection [up to 9 years 10 months]) |
| Group 2, RRHL: Percentage of Participants Receiving Consolidation Therapy Post-ASCT in Participants Undergoing ASCT | From initial diagnosis until the date of death (or the date when the participant was last known to be alive) (observed retrospectively from 2010 until date of data collection [up to 9 years 10 months]) |
| Group 2, RRHL: Median Duration of Treatment for Consolidation Therapies Used in Participants Undergoing ASCT | From initial diagnosis until the date of death (or the date when the participant was last known to be alive) (observed retrospectively from 2010 until date of data collection [up to 9 years 10 months]) |
| Group 2, RRHL: Number of Participants Categorized Based on Source of ASCT Procedures in Participants Undergoing ASCT | From initial diagnosis until the date of death (or the date when the participant was last known to be alive) (observed retrospectively from 2010 until date of data collection [up to 9 years 10 months]) |
| Group 2, RRHL: Median Time From Relapse (After End of Frontline Treatment) to ASCT in Participants Undergoing ASCT | From initial diagnosis until the date of death (or the date when the participant was last known to be alive) (observed retrospectively from 2010 until date of data collection [up to 9 years 10 months]) |
| Group 2, RRHL: CD34+ Count Administered in Participants Undergoing ASCT | From initial diagnosis until the date of death (or the date when the participant was last known to be alive) (observed retrospectively from 2010 until date of data collection [up to 9 years 10 months]) |
| Group 2, RRHL: Time From ASCT to First Relapse in Participants Who Relapse After ASCT | From initial diagnosis until the date of death (or the date when the participant was last known to be alive) (observed retrospectively from 2010 until date of data collection [up to 9 years 10 months]) |
| Group 2, RRHL: Number of Participants Categorized Based on Post-ASCT Regimens Received at Each Line of Treatment in Participants Who Relapse After ASCT | Therapy regimens were numbered as 1: ABVD; 7: DHAP; 10: ICE; 11: IGEV; 4: BEACOPP; 2: ABVD followed by Escalated BEACOPP; 8: ESHAP; 12: Mini-BEAM; 13: MINE; 18: Brentuximab vedotin; 22: Nivolumab; 23: Pembrolizumab; 16: GVD, 9: GCD; 24: other; 19: Bendamustine; 14: CHOP; 17: Rituximab. | From initial diagnosis until the date of death (or the date when the participant was last known to be alive) (observed retrospectively from 2010 until date of data collection [up to 9 years 10 months]) |
| Group 2, RRHL: Percentage of Participants Who Relapse After ASCT Categorized Based on Palliative Therapy Regimens | Therapy regimens were numbered as 9: GVD; 10: ICE; 11: IGEV; 12: Mini-BEAM; 18: Brentuximab vedotin; 19: Bendamustine; 22: Nivolumab. | From initial diagnosis until the date of death (or the date when the participant was last known to be alive) (observed retrospectively from 2010 until date of data collection [up to 9 years 10 months]) |
| Group 2, RRHL: Number of Cycles Received at Each Line of Treatment for Each Treatment Regimen in Participants Who Relapse After ASCT | Therapy regimens were numbered as 1: ABVD; 7: DHAP; 10: ICE; 11: IGEV; 4: BEACOPP; 2: ABVD followed by Escalated BEACOPP; 8: ESHAP; 12: Mini-BEAM; 13: MINE; 18: Brentuximab vedotin; 9: GCD; 22: Nivolumab; 23: Pembrolizumab; 16: GVD. | From initial diagnosis until the date of death (or the date when the participant was last known to be alive) (observed retrospectively from 2010 until date of data collection [up to 9 years 10 months]) |
| Group 2, RRHL: Duration of Each Line of Treatment for Participants Who Relapse After ASCT | From initial diagnosis until the date of death (or the date when the participant was last known to be alive) (observed retrospectively from 2010 until date of data collection [up to 9 years 10 months]) |
| Group 2, RRHL: Time From ASCT to First Treatment After Relapse in Participants Who Relapse After ASCT | From initial diagnosis until the date of death (or the date when the participant was last known to be alive) (observed retrospectively from 2010 until date of data collection [up to 9 years 10 months]) |
| Group 2, RRHL: Time to Initiation of Each Subsequent Treatment, From ASCT and From Completion of Previous Treatment in Participants Who Relapse From ASCT | From initial diagnosis until the date of death (or the date when the participant was last known to be alive) (observed retrospectively from 2010 until date of data collection [up to 9 years 10 months]) |
| Group 2, RRHL: Percentage of Participants Who Received PET-CT Scan, CT Scan and Radiotherapy at Each Stage of the Treatment Pathway in Participants Who Relapse After ASCT | Data for PET-CT scan and CT scans were assessed for baseline, frontline and relapse/or refractory, and radiotherapy was assessed for frontline and relapse/refractory, as planned. | From initial diagnosis until the date of death (or the date when the participant was last known to be alive) (observed retrospectively from 2010 until date of data collection [up to 9 years 10 months]) |
| Group 2, RRHL: Mean Frequency of PET or PET-CT Scan Assessments for Participants Who Relapse After ASCT | Data for PET-CT scan and CT scans were assessed for baseline, frontline and relapse or refractory, as planned. | From initial diagnosis until the date of death (or the date when the participant was last known to be alive) (observed retrospectively from 2010 until date of data collection [up to 9 years 10 months]) |
| Group 2, RRHL: Number of Participants With Types of Radiotherapies Received at Frontline and at Relapse/Refractory in Participants Who Relapse After ASCT | From initial diagnosis and until death or date of data collected, whichever occurred first (observed retrospectively from 2010 until date of data collection [up to 9 years 10 months]) |
| Group 2, RRHL: Number of Participants Categorized Based on Anatomical Site of Radiotherapies in Participants Who Relapse After ASCT at Frontline and at Relapse/Refractory | From initial diagnosis until the date of death (or the date when the participant was last known to be alive) (observed retrospectively from 2010 until date of data collection [up to 9 years 10 months]) |
| Group 2, RRHL: Number of Participants Categorized Based on Intent of Treatment of Radiotherapies in Participants Who Relapse After ASCT | From initial diagnosis until the date of death (or the date when the participant was last known to be alive) (observed retrospectively from 2010 until date of data collection [up to 9 years 10 months]) |
| Group 2, RRHL: Total Dose of Radiotherapies Received at Frontline and Relapse/Refractory in Participants Who Relapse After ASCT | From initial diagnosis until the date of death (or the date when the participant was last known to be alive) (observed retrospectively from 2010 until date of data collection [up to 9 years 10 months]) |
| Group 2, RRHL: Percentage of Participants Undergoing Subsequent ASCTs and Allogeneic Stem Cell Transplantation (Allo-SCT) | From initial diagnosis until the date of death (or the date when the participant was last known to be alive) (observed retrospectively from 2010 until date of data collection [up to 9 years 10 months]) |
| Group 2, RRHL: Group 2, RRHL: Median Number of ASCTs for Each Participant Who Relapse After ASCT | From initial diagnosis until the date of death (or the date when the participant was last known to be alive) (observed retrospectively from 2010 until date of data collection [up to 9 years 10 months]) |
| Group 1, cHL: Median PFS | PFS was defined as time from initiation of frontline regimen to first documentation of relapse or disease progression or death, censored at date of most recent follow-up/contact. PD was defined as any new lesion or increase by >= 50% of previously involved site from nadir, and was evaluated based on IWG criteria (Cheson et al 2007). Median PFS was estimated using the Kaplan-Meier method. | From initiation of frontline regimen to first documentation of relapse/PD/until date of death (or date when participant was last alive), whichever occurred first (observed retrospectively from 2010 until date of data collection [up to 9 years 10 months]) |
| Group 1, cHL: Number of Participants Based on Best Clinical Response Post Completion of Frontline Treatment | Best clinical response as complete remission (CR), partial remission (PR), stable disease (SD), or PD was evaluated based on IWG criteria (Cheson et al 2007). CR was the disappearance of all evidence of disease. PR was the regression of measurable disease and no new sites. SD was defined by failure to achieve CR, PR, or PD. PD was defined as any new lesion or increase by >=50% of previously involved sites from nadir. | From post completion of frontline treatment until the date of death (or the date when the participant was last known to be alive) (observed retrospectively from 2010 until date of data collection [up to 9 years 10 months]) |
| Group 2, RRHL: Number of Participants With Best Clinical Response Post Completion of Each Line of Treatment | Best clinical response as CR, PR, SD, or PD was evaluated based on IWG criteria (Cheson et al 2007). CR was the disappearance of all evidence of disease. PR was the regression of measurable disease and no new sites. SD was defined by failure to achieve CR, PR, or PD. PD was defined as any new lesion or increase by >=50% of previously involved sites from nadir. | From post completion of frontline treatment until the date of death (or the date when the participant was last known to be alive) (observed retrospectively from 2010 until date of data collection [up to 9 years 10 months]) |
| Mean Duration of Best Response | Duration of best response was defined as the time from when the criteria for response (CR or PR) were met to first documentation of relapse or disease progression, and was evaluated based on IWG criteria (Cheson et al 2007). CR was the disappearance of all evidence of disease. PR was the regression of measurable disease and no new sites. PD was defined as any new lesion or increase by >=50% of previously involved sites from nadir. | From CR or PR until first documentation of relapse or disease progression or until the date of death (or the date when the participant was last known to be alive) (observed retrospectively from 2010 until date of data collection [up to 9 years 10 months]) |
| Median Overall Survival (OS) | Median OS was defined as the time from diagnosis of cHL to death(Group 1)/ time from first relapse after frontline therapy to death (Group 2), censored at date of most recent follow-up/contact. | From initial diagnosis until the date of death (or date when the participant was alive) (Group 1); From first relapse after frontline therapy to death (Group 2) (observed retrospectively from 2010 until date of data collection [up to 9 years 10 months]) |
| Group 1, cHL: Overall Survival Rate After Diagnosis at 1 and 5 Years | Percentage of participants who were alive at 1 and 5 years after diagnosis in cHL participants are reported. 5 year overall survival data were reported only for participants who had >5 year observation periods. | At 1 year and 5 years after diagnosis (observed retrospectively from 2010 until date of data collection [up to 9 years 10 months]) |
| Group 2, RRHL: Overall Survival Rate at 1 and 5 Years | Percentage of participants who were alive at 1 and 5 years after diagnosis in RRHL participants are reported. 5 year overall survival data were reported only for participants who had >5 year observation periods. | At 1 year and 5 years after relapse (observed retrospectively from 2010 until date of data collection [up to 9 years 10 months]) |
| Group 1, cHL: Number of Participants Who Had Inpatient Hospital Admissions, Emergency Room Visits, and Outpatient Visits by Healthcare Professionals Related to HL | From initial diagnosis until the date of death (or the date when the participant was last known to be alive) (observed retrospectively from 2010 until date of data collection [up to 9 years 10 months]) |
| Group 1, cHL: Number of Participants Categorized Based on Reasons for Inpatient Hospital Admissions Related to HL | From initial diagnosis until the date of death (or the date when the participant was last known to be alive) (observed retrospectively from 2010 until date of data collection [up to 9 years 10 months]) |
| Group 1, cHL: Mean Overall Length of Stay and Length of Stay by Unit/Ward for Inpatient Hospital Admissions Related to HL | Length of stay by unit or ward included general, high dependency/intermediate, intensive care unit, bone marrow transplant unit, and emergency visits. | From initial diagnosis until the date of death (or the date when the participant was last known to be alive) (observed retrospectively from 2010 until date of data collection [up to 9 years 10 months]) |
| Group 1, cHL: Number of Participants Categorized Based on Episodes of RT Received, Type of Scan or Procedure, and Who Received Granulocyte-colony Stimulating Factor (G-CSF) or High-cost Medicines and Pegylated G-CSF Related to HL | From initial diagnosis until the date of death (or the date when the participant was last known to be alive) (observed retrospectively from 2010 until date of data collection [up to 9 years 10 months]) |
| Group 1, cHL: Mean Number of Courses of Treatment With G-CSF/Pegylated G-CSF or Other High-cost Medicines Related to HL Treatment | From initial diagnosis until the date of death (or the date when the participant was last known to be alive) (observed retrospectively from 2010 until date of data collection [up to 9 years 10 months]) |
| Group 2, RRHL: Number of Participants Who Had Inpatient Hospital Admissions, Emergency Room Visits, and Outpatient Visits by Healthcare Professional Related to HL for Salvage Therapy and ASCT | Each participant had more than one category presented for salvage therapy and ASCT. | From initial diagnosis until the date of death (or the date when the participant was last known to be alive) (observed retrospectively from 2010 until date of data collection [up to 9 years 10 months]) |
| Group 2, RRHL: Number of Participants Categorized Based on Reasons for Inpatient Hospital Admissions Related to HL for Salvage Therapy and ASCT | Each participant had more than one category presented for salvage therapy and ASCT. | From initial diagnosis until the date of death (or the date when the participant was last known to be alive) (observed retrospectively from 2010 until date of data collection [up to 9 years 10 months]) |
| Group 2, RRHL: Mean Overall Length of Stay and Length of Stay by Unit/Ward for Inpatient Hospital Admissions Related to HL for Salvage Therapy and ASCT | Length of stay by unit or ward included general, high dependency/intermediate, intensive care unit, bone marrow transplant unit, and emergency visits. Each participant had more than one category presented for salvage therapy and ASCT. | From initial diagnosis until the date of death (or the date when the participant was last known to be alive) (observed retrospectively from 2010 until date of data collection [up to 9 years 10 months]) |
| Group 2, RRHL: Number of Participants Categorized Based on Episodes of RT, Type of Scan or Procedure, and Who Received G-CSF or High-cost Medicines Related to HL for Salvage Therapy and ASCT | Each participant had more than one category presented for salvage therapy and ASCT. Scan procedures included chest x-ray, magnetic resonance imaging, needle biopsy, bone scan, bone marrow aspiration, flow cytometry, and other scan procedures. | From initial diagnosis until the date of death (or the date when the participant was last known to be alive) (observed retrospectively from 2010 until date of data collection [up to 9 years 10 months]) |
| Group 2, RRHL: Group 2, RRHL: Mean Number of Courses of Treatment With G-CSF/Pegylated G-CSF or Other High-cost Medicines Related to HL Treatment for Salvage Therapy and ASCT | From initial diagnosis until the date of death (or the date when the participant was last known to be alive) (observed retrospectively from 2010 until date of data collection [up to 9 years 10 months]) |
| COMPLETED |
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| NOT COMPLETED |
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| BG001 | Group 2: RRHL | Participants diagnosed with RRHL between 01 January 2010 and 31 December 2013, and participants who were diagnosed with high-risk stage IIb-IV cHL and then were subsequently diagnosed with RRHL between 2010 and 2013 were observed retrospectively until the date of death or data collection, whichever occurred first. |
| BG002 | Total | Total of all reporting groups |
| Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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Participants diagnosed with RRHL between 01 January 2010 and 31 December 2013, and participants who were diagnosed with high-risk stage IIb-IV cHL and then were subsequently diagnosed with RRHL between 2010 and 2013 were observed retrospectively until the date of death or data collection, whichever occurred first. |
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| Secondary | Group 1, cHL: Number of Participants Based on Clinical Staging According to Ann Arbor Staging at Diagnosis | The Ann Arbor staging system of lymphomas is used to summarize the extent of the cancer's spread. Stages are classified by Roman numerals I (lessspread) to IV (more spread). Additional sub staging variables include: A, asymptomatic; and B, presence of B symptoms (including fever, night sweats and weight loss of >=10 percent [%] of body weight over 6 months). | The FAS included all participants who were eligible for cHL group including the common participants in both the groups. | Posted | Count of Participants | Participants | Day 1 at cHL diagnosis |
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| Secondary | Group 2, RRHL: Number of Participants Based on Clinical Staging According to Ann Arbor Staging at Diagnosis | The Ann Arbor staging system of lymphomas is used to summarize the extent of the cancer's spread. Stages are classified by Roman numerals I (lessspread) to IV (more spread). Additional sub staging variables include: A, asymptomatic; and B, presence of B symptoms (including fever, night sweats and weight loss of >=10 % of body weight over 6 months). | The FAS included all participants who were eligible for RRHL group including the common participants in both the groups. | Posted | Count of Participants | Participants | Day 1 at RRHL diagnosis |
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| Secondary | Group 2, RRHL: Number of Participants Based on Clinical Staging According to Ann Arbor Staging at Relapse After First Relapse or Refractory Diagnosis | The Ann Arbor staging system of lymphomas is used to summarize the extent of the cancer's spread. Stages are classified by Roman numerals I (less spread) to IV (more spread). Additional sub staging variables include: A, asymptomatic; and B, presence of B symptoms (including fever, night sweats and weight loss of >=10% of body weight over 6 months). | The FAS included all participants who were eligible for RRHL group including the common participants in both the groups. Here "overall number of participants" analyzed are those who were evaluable for this outcome measure. | Posted | Count of Participants | Participants | At second, third, fourth, and fifth relapse (up to 9 years 10 months) |
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| Secondary | Group 1, cHL: Number of Participants Based on Each International Prognostic Score (IPS) Category | IPS score was calculated based on following factors: age >=45 years, male sex, stage IV disease, albumin<4 gram per liter (g/L), white blood cell (WBC)>=15*10^9 per liter (/L), haemoglobin <10.5 g/L, and lymphocyte count<0.6*10^6/L or <8% of differential. One point was assigned for each of above factors. The sum of points allotted correlates with following risk groups: good risk (0-1 points)-5 year survival of 89-90%; fair risk (2 to 3 points)-5 year survival of 78-81%; poor risk (4-7 points)-5 year survival of 56-61%. Total score range is 0 to 7, lower scores indicate higher survival rate. | The FAS included all participants who were eligible for cHL group including the common participants in both the groups. Here "overall number of participants" analyzed are those who were evaluable for this outcome measure. | Posted | Count of Participants | Participants | Day 1 at cHL diagnosis |
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| Secondary | Group 1, cHL: Number of Participants With B Symptoms at Diagnosis | The Ann Arbor staging system of lymphomas is used to summarize the extent of the cancer's spread. Stages are classified by Roman numerals I (less spread) to IV (more spread). If the following symptoms (B-symptoms) are present, a "B" classification is added to the stage: fever, night sweats and weight loss of >=10% of body weight over 6 months. B-symptoms indicate the presence of systemic symptoms. The presence or absence of B-symptoms has prognostic significance and is reflected in the staging of these lymphomas. | The FAS included all participants who were eligible for cHL group including the common participants in both the groups. | Posted | Count of Participants | Participants | Day 1 at cHL diagnosis |
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| Secondary | Group 2, RRHL: Number of Participants With B Symptoms at Diagnosis | The Ann Arbor staging system of lymphomas is used to summarize the extent of the cancer's spread. Stages are classified by Roman numerals I (less spread) to IV (more spread). If the following symptoms (B-symptoms) are present, a "B" classification is added to the stage: fever, night sweats and weight loss of >=10% of body weight over 6 months. B-symptoms indicate the presence of systemic symptoms. The presence or absence of B-symptoms has prognostic significance and is reflected in the staging of these lymphomas. | The FAS included all participants who were eligible for RRHL group including the common participants in both the groups. | Posted | Count of Participants | Participants | Day 1 at RRHL diagnosis |
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| Secondary | Group 2, RRHL: Number of Participants Categorized Based on Prior Therapies for Hodgkin Lymphoma (HL) at Each Line of Treatment | Number of participants were categorized based on prior therapies for HL at each line of treatment. | The FAS included all participants who were eligible for RRHL group including the common participants in both the groups. Here "overall number of participants" analyzed are those who were evaluable for this outcome measure. | Posted | Count of Participants | Participants | Day 1 at RRHL diagnosis |
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| Secondary | Group 2, RRHL: Median Number of Previous Treatment Regimens (Chemotherapies) Received | The FAS included all participants who were eligible for RRHL group including the common participants in both the groups. Here "overall number of participants" analyzed are those who were evaluable for this outcome measure. | Posted | Median | Full Range | previous treatment regimen | Day 1 at RRHL diagnosis |
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| Secondary | Group 1, cHL: Number of Participants Categorized Based on Frontline Treatment Regimens | Therapy regimens were numbered as 1: Doxorubicin (Doxo) + Bleomycin (bleo) + Vinblastine (Vinbl) + Decarbazine (Dacar) (ABVD); 3: Doxo + Vinbl + Mechlorethamine + Etoposide (Eto) + Vincristilne (Vinc) + Bleo + Prednisone (Pred) (Stanford V); 6: Cyclophophamide (Cyclo) + Vinc + Procarbazine (Procarb) + Pred (C-MOPP); 7: Dexamethasone + Cytarabine + Cisplatin (DHAP); 8: Eto + Methylprednisolone + Cytarabine + Cisplatin (ESHAP); 10: Ifosfamide+ Carboplatin + Eto (ICE); 11: Ifosfamide + Gemcitabine +Vinorelbine + Pred (IGEV); 17: Rituximab; 18: Brentuximab vedotin; 4: Bleo + Eto + Doxo + Cyclo + Vinc + Procarb + Pred (BEACOPP); 14: Cycl + Doxo + Vinc + Pred (CHOP); 15: Cycl + Vinc + Pred (CVP); 2: ABVD + Doxo + Bleo + Vinbl + Dacar then Bleo + Eto + Doxo + Cycl + Vinc + Procarb+ Pred ( Escalated BEACOPP); 24: Other. | The FAS included all participants who were eligible for cHL group including the common participants in both the groups. | Posted | Count of Participants | Participants | From initial diagnosis until the date of death (or the date when the participant was last known to be alive) (observed retrospectively from 2010 until date of data collection [up to 9 years 10 months]) |
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| Secondary | Group 1, cHL: Median Number of Treatment Cycles Associated With Each Frontline Treatment Regimen | Therapy regimens were numbered as 1: ABVD; 3: Stanford V; 6: C-MOPP; 7: DHAP; 8: ESHAP; 10: ICE; 11: IGEV; 17: Rituximab; 18: Brentuximab vedotin; 4: BEACOPP; 14: CHOP; 15: CVP; 2: ABVD + Escalated BEACOPP; 24: Other. | The FAS included all participants who were eligible for cHL group including the common participants in both the groups. Here "overall number of participants" analyzed are those who were evaluable for this outcome measure. Here number analyzed "n" are the participants who were evaluable for the outcome measure at given categories. | Posted | Median | Full Range | cycles | From initial diagnosis until the date of death (or the date when the participant was last known to be alive) (observed retrospectively from 2010 until date of data collection [up to 9 years 10 months]) |
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| Secondary | Group 1, cHL: Number of Participants Who Received Treatments for HL After Completion of Frontline Therapy (Before Relapse) | Therapy regimens were numbered as 1: ABVD; 6: C-MOPP; 7: DHAP; 8: ESHAP; 10: ICE; 11: IGEV; 12: Carmustine + Cytarabine + Etoposide + Melphalan (Mini-BEAM); 13: Etoposide + Ifosfamide + Mesna + Mitoxantrone (MINE); 18: Brentuximab vedotin; 16: Gemcitabine + Vinoreilbine + Pegylated liposomal doxorubicin (GVD); 4: BEACOPP; 14: CHOP; 24: Other. | The FAS included all participants who were eligible for cHL group including the common participants in both the groups. Here "overall number of participants" analyzed are those who were evaluable for this outcome measure. | Posted | Count of Participants | Participants | From initial diagnosis until the date of death (or the date when the participant was last known to be alive) (observed retrospectively from 2010 until date of data collection [up to 9 years 10 months]) |
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| Secondary | Group 1, cHL: Number of Participants Based on Radiotherapy (RT) Type and Site When Received at Frontline | The FAS included all participants who were eligible for cHL group including the common participants in both the groups. Here "overall number of participants" analyzed are those who were evaluable for this outcome measure. | Posted | Count of Participants | Participants | From initial diagnosis until the date of death (or the date when the participant was last known to be alive) (observed retrospectively from 2010 until date of data collection [up to 9 years 10 months]) |
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| Secondary | Group 1, cHL: Number of Participants Categorized Based on RT Treatment Given as Pre-planned Frontline Treatment and RT Treatment Given for Residual Fluorodeoxyglucose (FDG)-Avid Disease | Assessment was done for RT's whether used for pre-planned frontline treatment or for residual Fluorodeoxyglucose (FDG)-avid disease. | The FAS included all participants who were eligible for cHL group including the common participants in both the groups. Here "overall number of participants" analyzed are those who were evaluable for this outcome measure. | Posted | Count of Participants | Participants | From initial diagnosis until the date of death (or the date when the participant was last known to be alive) (observed retrospectively from 2010 until date of data collection [up to 9 years 10 months]) |
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| Secondary | Group 2, RRHL: Percentage of Participants Categorized Based on ASCT Eligibility Assessment | The FAS included all participants who were eligible for RRHL group including the common participants in both the groups. Here "overall number of participants" analyzed are those who were evaluable for this outcome measure. Here number analyzed "n" are the participants who were evaluable for the outcome measure at given categories. | Posted | Number | percentage of participants | From initial diagnosis until the date of death (or the date when the participant was last known to be alive) (observed retrospectively from 2010 until date of data collection [up to 9 years 10 months]) |
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| Secondary | Group 2, RRHL: Median Number of Treatment Cycles Associated With Relapse/ Refractory Treatment Regimen for ASCT | Therapy regimens were numbered as 1: ABVD; 6: C-MOPP; 8: ESHAP; 11: IGEV; 12: Mini-BEAM; 18: Brentuximab vedotin; 22: Nivolumab; 24: Other. | The FAS included all participants who were eligible for RRHL group including the common participants in both the groups. . Here "overall number of participants" analyzed are those who were evaluable for this outcome measure. Here number analyzed "n" are the participants who were evaluable for the outcome measure at given categories. | Posted | Median | Full Range | cycles | From initial diagnosis until the date of death (or the date when the participant was last known to be alive) (observed retrospectively from 2010 until date of data collection [up to 9 years 10 months]) |
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| Secondary | Group 2, RRHL: Number of Non-ASCT Participants Categorized Based on Reasons for Not Undergoing ASCT Despite Being ASCT Eligible | Reasons for ASCT-eligible participants for not undergoing ASCT included participant refusal, inability to mobilize stem cells, loss of response to chemotherapy, cumulative toxicities, comorbid conditions, others, and unknown. | The FAS included all participants who were eligible for RRHL group including common participants. Here "overall number of participants" analyzed are those who were evaluable for this outcome measure. | Posted | Count of Participants | Participants | From initial diagnosis until the date of death (or the date when the participant was last known to be alive) (observed retrospectively from 2010 until date of data collection [up to 9 years 10 months]) |
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| Secondary | Group 2, RRHL: Number of Non-ASCT Participants Based on Reasons for ASCT Ineligibility | Reasons for ASCT ineligibility included advanced age, comorbid conditions, chemoresistant disease, cumulative toxicities, and others. | The FAS included all participants who were eligible for RRHL group including the common participants in both the groups. Here "overall number of participants" analyzed are those who were evaluable for this outcome measure. Here number analyzed "n" are the participants who were evaluable for the outcome measure at given categories. | Posted | Count of Participants | Participants | From initial diagnosis until the date of death (or the date when the participant was last known to be alive) (observed retrospectively from 2010 until date of data collection [up to 9 years 10 months]) |
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| Secondary | Group 2, RRHL: Number of Non-ASCT Participants Categorized Based on Treatment Regimens Received at Each Line of Treatment | Therapy regimens were numbered as 1: ABVD; 2: ABVD followed by Escalated BEACOPP; 3: Stanford V; 4: BEACOPP; 6: Cyclophosphamide C-MOPP; 7: DHAP; 8: ESHAP; 9: GCD; 10: ICE; 11: IGEV; 12: Mini-BEAM; 13: MINE; 14: CHOP; 15: CVP; 16: GVD; 17: Rituximab; 18: Brentuximab vedotin; 19: Bendamustine; 22: Nivolumab; 23: Pembrolizumab; 24: Other. More than one line of treatment or therapy was selected for each participant. | The FAS included all participants who were eligible for RRHL group including the common participants in both the groups. Here "overall number of participants" analyzed are those who were evaluable for this outcome measure. Here number analyzed "n" are the participants who were evaluable for the outcome measure at given categories. | Posted | Count of Participants | Participants | From initial diagnosis until the date of death (or the date when the participant was last known to be alive) (observed retrospectively from 2010 until date of data collection [up to 9 years 10 months]) |
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| Secondary | Group 2, RRHL: Percentage of Non-ASCT Participants for Whom Treatment is Palliative | The FAS included all participants who were eligible for RRHL group including the common participants in both the groups. Here "overall number of participants" analyzed are those who were evaluable for this outcome measure. Here number analyzed "n" are the participants who were evaluable for the outcome measure at given categories. | Posted | Number | percentage of participants | From initial diagnosis until the date of death (or the date when the participant was last known to be alive) (observed retrospectively from 2010 until date of data collection [up to 9 years 10 months]) |
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| Secondary | Group 2, RRHL: Percentage of Non-ASCT Participants Receiving Positron Emission Tomography (PET) or Computed Tomography (CT) at Each Line of Treatment Pathway | The FAS included all participants who were eligible for RRHL group including the common participants in both the groups. Here "overall number of participants" analyzed are those who were evaluable for this outcome measure. | Posted | Number | percentage of participants | From initial diagnosis until the date of death (or the date when the participant was last known to be alive) (observed retrospectively from 2010 until date of data collection [up to 9 years 10 months]) |
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| Secondary | Group 2, RRHL: Percentage of Non-ASCT Participants Receiving RT at Each Line of Treatment Pathway | The FAS included all participants who were eligible for RRHL group including the common participants in both the groups. Here "overall number of participants" analyzed are those who were evaluable for this outcome measure. | Posted | Number | percentage of participants | From initial diagnosis until the date of death (or the date when the participant was last known to be alive) (observed retrospectively from 2010 until date of data collection [up to 9 years 10 months]) |
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| Secondary | Group 2, RRHL: Median Frequency of PET or PET-CT Scan Assessment for Non-ASCT Participants | The FAS included all participants who were eligible for RRHL group including the common participants in both the groups. Here "overall number of participants" analyzed are those who were evaluable for this outcome measure. Here number analyzed "n" are the participants who were evaluable for the outcome measure at given categories. | Posted | Median | Full Range | scans | From initial diagnosis until the date of death (or the date when the participant was last known to be alive) (observed retrospectively from 2010 until date of data collection [up to 9 years 10 months]) |
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| Secondary | Group 2, RRHL: Median Number of Treatment Cycles Received in Each Treatment Regimen at Each Line of Treatment in Non-ASCT Participants | Therapy regimens were numbered as 1: ABVD; 3: Stanford V; 6: C-MOPP; 7: DHAP; 11: IGEV; 19: Bendamustine; 4: BEACOPP; 13: MINE; 14: CHOP; 24: Other; 8: ESHAP; 9: Gemcitabine + Carboplatin + Dexamethasone (GCD); 10: ICE; 17: Rituximab; 18: Brentuximab vedotin; 15: CVP; 2: ABVD followed by Escalated BEACOPP; 22: Nivolumab; 16: GVD; 21: Lenalidomide; 24: Other. | The FAS included all participants who were eligible for RRHL group including the common participants in both the groups. Here "overall number of participants" analyzed are those who were evaluable for this outcome measure. Here number analyzed "n" are the participants who were evaluable for the outcome measure at given categories. | Posted | Median | Full Range | cycles | From initiation of first treatment until first documentation of relapse/PD/until date of death( or date when participant was last alive), whichever occurred first (observed retrospectively from 2010 until date of data collection [up to 9 years 10 months]) |
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| Secondary | Group 2, RRHL: Duration of Each Line of Treatment in Non-ASCT Participants | The FAS included all participants who were eligible for RRHL group including the common participants in both the groups. Here "overall number of participants" analyzed are those who were evaluable for this outcome measure. Here number analyzed "n" are the participants who were evaluable for the outcome measure at given categories. | Posted | Median | Full Range | months | From initiation of first treatment until first documentation of relapse/PD/until date of death( or date when participant was last alive), whichever occurred first (observed retrospectively from 2010 until date of data collection [up to 9 years 10 months]) |
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| Secondary | Group 2, RRHL: Percentage of Non-ASCT Participants Categorized Based on Dose Delays in Each Treatment Regimen at Each Line of Treatment | Therapy regimens were numbered as 1: ABVD; 3: Stanford V; 6: C-MOPP; 7: DHAP; 11: IGEV; 4: BEACOPP; 14: CHOP; 15: CVP; 2: ABVD followed by Escalated BEACOPP; 24: Other; 8: ESHAP; 9: GCD; 10: ICE; 13: MINE; 17: Rituximab; 18: Brentuximab vedotin; 19: Bendamustine; 22: Nivolumab. More than one line of treatment or therapy was selected for each participant | The FAS included all participants who were eligible for RRHL group including the common participants in both the groups. Here "overall number of participants" analyzed are those who were evaluable for this outcome measure. Here number analyzed "n" are the participants who were evaluable for the outcome measure at given categories. | Posted | Number | percentage of participants | From initial diagnosis until the date of death (or the date when the participant was last known to be alive) (observed retrospectively from 2010 until date of data collection [up to 9 years 10 months]) |
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| Secondary | Group 2, RRHL: Time From Relapse (After Frontline Treatment) to First Treatment Post-relapse in Non-ASCT Participants | The FAS included all participants who were eligible for RRHL group including the common participants in both the groups. Here "overall number of participants" analyzed are those who were evaluable for this outcome measure. | Posted | Median | Full Range | days | From relapse after frontline treatment to first treatment post-relapse or until the date of death (or the date when the participant was last known to be alive) (observed retrospectively from 2010 until date of data collection [up to 9 years 10 months]) |
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| Secondary | Group 2, RRHL: Time to Initiation of Each Subsequent Treatment, From Relapse and Completion of Previous Treatment in Non-ASCT Participants | The FAS included all participants who were eligible for RRHL group including the common participants in both the groups. Here "overall number of participants" analyzed are those who were evaluable for this outcome measure. Here number analyzed "n" are the participants who were evaluable for the outcome measure at given categories. | Posted | Median | Full Range | days | From both relapse and from completion of previous treatment to initiation of each subsequent treatment (observed retrospectively from 2010 until date of data collection [up to 9 years 10 months]) |
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| Secondary | Group 2, RRHL: Number of Participants With Non-ASCT Assessed for RT Type, Site Received at Frontline | The FAS included all participants who were eligible for RRHL group including the common participants in both the groups. Here "overall number of participants" analyzed are those who were evaluable for this outcome measure. | Posted | Count of Participants | Participants | From initial diagnosis until the date of death (or the date when the participant was last known to be alive) (observed retrospectively from 2010 until date of data collection [up to 9 years 10 months]) |
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| Secondary | Group 2, RRHL: Number of Participants With Non-ASCT Assessed for RT Type, Site at Relapse/ Refractory | The FAS included all participants who were eligible for RRHL group including the common participants in both the groups. Here "overall number of participants" analyzed are those who were evaluable for this outcome measure. | Posted | Count of Participants | Participants | From initial diagnosis until the date of death (or the date when the participant was last known to be alive) (observed retrospectively from 2010 until date of data collection [up to 9 years 10 months]) |
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| Secondary | Group 2, RRHL: Total Dose of Radiotherapies in Non-ASCT Participants | The FAS included all participants who were eligible for RRHL group including the common participants in both the groups. Here "overall number of participants" analyzed are those who were evaluable for this outcome measure. Here number analyzed "n" are the participants who were evaluable for the outcome measure at given categories. | Posted | Mean | Standard Deviation | Gray | From initial diagnosis until the date of death (or the date when the participant was last known to be alive) (observed retrospectively from 2010 until date of data collection [up to 9 years 10 months]) |
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| Secondary | Group 2, RRHL: Number of PET or CT Scan Assessments | The FAS included all participants who were eligible for RRHL group including the common participants in both the groups. Here "overall number of participants" analyzed are those who were evaluable for this outcome measure. Here number analyzed "n" are the participants who were evaluable for the outcome measure at given categories. | Posted | Mean | Standard Deviation | scans | From initial diagnosis until the date of death (or the date when the participant was last known to be alive) (observed retrospectively from 2010 until date of data collection [up to 9 years 10 months]) |
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| Secondary | Group 2, RRHL: Number of Participants Categorized Based on Various Chemotherapeutic Regimen and Therapies Used in Participants Undergoing ASCT | Therapy regimens were numbered as 8: ESHAP; 10: ICE; 11: IGEV; 12: Mini-BEAM; 18: Brentuximab vedotin; 19: Bendamustine; 16: GVD; 24: Other. Conditioning regimens are BEAM (Carmustine + Etoposide + Cytarabine + Melphalan), CBV (cyclophosphamide + Carmustine + vp16) BeEAM (bendamustine) and Gemcitabine/Busulfan/Melphalan. | The FAS included all participants who were eligible for RRHL group including the common participants in both the groups, and who were undergoing ASCT. Here number analyzed "n" are the participants who were evaluable for the outcome measure at given categories. | Posted | Count of Participants | Participants | From initial diagnosis until the date of death (or the date when the participant was last known to be alive) (observed retrospectively from 2010 until date of data collection [up to 9 years 10 months]) |
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| Secondary | Group 2, RRHL: Number of Participants Categorized Based on With Known Risk Factors for Relapse Post ASCT in Participants Undergoing ASCT | Known risk factors for relapse after ASCT included time to first relapse less than or equal to (<=) 3 months, stage IV disease at relapse, bulky disease >=5 centimeter (cm) at relapse, extranodal disease, inadequate response to salvage chemotherapy (partial remission [PR] or PET positivity), performance status (eastern Cooperative oncology group [ECOG]) >=1. The ECOG assessment used a 3-point scale, including scores of 0 (fully active/able to carry on all pre-disease activities without restriction), 1 (restricted in physically strenuous activity but ambulatory/able to carry out light or sedentary work), or 2 (ambulatory for more than 50% of waking hours and capable of all self care but unable to carry out any work activities). | The FAS included all participants who were eligible for RRHL group including the common participants in both the groups, and who were undergoing ASCT. Here number analyzed "n" are the participants who were evaluable for the outcome measure at given categories. | Posted | Count of Participants | Participants | From initial diagnosis until the date of death (or the date when the participant was last known to be alive) (observed retrospectively from 2010 until date of data collection [up to 9 years 10 months]) |
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| Secondary | Group 2, RRHL: Median Number of Cycles Associated With Each Salvage Regimen in Participants Undergoing ASCT | Therapy regimens were numbered as 1: ABVD; 6: C-MOPP; 7: DHAP; 8: ESHAP; 9: GCD; 10: ICE; 11: IGEV; 12: Mini-BEAM; 13: Eto + Ifosfamide + Mesna + Mitoxantrone (MINE); 18: Brentuximab vedotin; 19: Bendamustine; 22: Nivolumab; 16: GVD; 4: BEACOPP; 14: CHOP; 2: ABVD + Escalated BEACOPP; 24: Other. | The FAS included all participants who were eligible for RRHL group including the common participants in both the groups, and who were undergoing ASCT. Here "overall number of participants" analyzed are those who were evaluable for this outcome measure. Here number analyzed "n" are the participants who were evaluable for the outcome measure at given categories. | Posted | Median | Full Range | cycles | From initial diagnosis until the date of death (or the date when the participant was last known to be alive) (observed retrospectively from 2010 until date of data collection [up to 9 years 10 months]) |
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| Secondary | Group 2, RRHL: Percentage of Participants Receiving Consolidation Therapy Post-ASCT in Participants Undergoing ASCT | The FAS included all participants who were eligible for RRHL group including the common participants in both the groups, and who were undergoing ASCT. | Posted | Number | percentage of participants | From initial diagnosis until the date of death (or the date when the participant was last known to be alive) (observed retrospectively from 2010 until date of data collection [up to 9 years 10 months]) |
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| Secondary | Group 2, RRHL: Median Duration of Treatment for Consolidation Therapies Used in Participants Undergoing ASCT | The FAS included all participants who were eligible for RRHL group including the common participants in both the groups, and who were undergoing ASCT. Here "overall number of participants" analyzed are those who received consolidation therapy post-SCT. | Posted | Median | Full Range | months | From initial diagnosis until the date of death (or the date when the participant was last known to be alive) (observed retrospectively from 2010 until date of data collection [up to 9 years 10 months]) |
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| Secondary | Group 2, RRHL: Number of Participants Categorized Based on Source of ASCT Procedures in Participants Undergoing ASCT | The FAS included all participants who were eligible for RRHL group including the common participants in both the groups, and who were undergoing ASCT. Here "overall number of participants" analyzed are those who were evaluable for this outcome measure. | Posted | Count of Participants | Participants | From initial diagnosis until the date of death (or the date when the participant was last known to be alive) (observed retrospectively from 2010 until date of data collection [up to 9 years 10 months]) |
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| Secondary | Group 2, RRHL: Median Time From Relapse (After End of Frontline Treatment) to ASCT in Participants Undergoing ASCT | The FAS included all participants who were eligible for RRHL group including the common participants in both the groups, and who were undergoing ASCT. Here "overall number of participants" analyzed are those who were evaluable for this outcome measure. | Posted | Median | Full Range | days | From initial diagnosis until the date of death (or the date when the participant was last known to be alive) (observed retrospectively from 2010 until date of data collection [up to 9 years 10 months]) |
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| Secondary | Group 2, RRHL: CD34+ Count Administered in Participants Undergoing ASCT | The FAS included all participants who were eligible for RRHL group including the common participants in both the groups, and who were undergoing ASCT. Here "overall number of participants" analyzed are those who were evaluable for this outcome measure. | Posted | Mean | Standard Deviation | cells per kilogram | From initial diagnosis until the date of death (or the date when the participant was last known to be alive) (observed retrospectively from 2010 until date of data collection [up to 9 years 10 months]) |
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| Secondary | Group 2, RRHL: Time From ASCT to First Relapse in Participants Who Relapse After ASCT | The FAS included all participants who were eligible for RRHL group including common participants, and who relapsed after ASCT. | Posted | Median | Full Range | months | From initial diagnosis until the date of death (or the date when the participant was last known to be alive) (observed retrospectively from 2010 until date of data collection [up to 9 years 10 months]) |
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| Secondary | Group 2, RRHL: Number of Participants Categorized Based on Post-ASCT Regimens Received at Each Line of Treatment in Participants Who Relapse After ASCT | Therapy regimens were numbered as 1: ABVD; 7: DHAP; 10: ICE; 11: IGEV; 4: BEACOPP; 2: ABVD followed by Escalated BEACOPP; 8: ESHAP; 12: Mini-BEAM; 13: MINE; 18: Brentuximab vedotin; 22: Nivolumab; 23: Pembrolizumab; 16: GVD, 9: GCD; 24: other; 19: Bendamustine; 14: CHOP; 17: Rituximab. | The FAS included all participants who were eligible for RRHL group including common participants, and who relapsed after ASCT. Here number analyzed "n" are the participants who were evaluable for the outcome measure at given categories. | Posted | Count of Participants | Participants | From initial diagnosis until the date of death (or the date when the participant was last known to be alive) (observed retrospectively from 2010 until date of data collection [up to 9 years 10 months]) |
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| Secondary | Group 2, RRHL: Percentage of Participants Who Relapse After ASCT Categorized Based on Palliative Therapy Regimens | Therapy regimens were numbered as 9: GVD; 10: ICE; 11: IGEV; 12: Mini-BEAM; 18: Brentuximab vedotin; 19: Bendamustine; 22: Nivolumab. | The FAS included all participants who were eligible for RRHL group including common participants, and who relapsed after ASCT. Here "overall number of participants" analyzed are those who were evaluable for this outcome measure. | Posted | Number | percentage of participants | From initial diagnosis until the date of death (or the date when the participant was last known to be alive) (observed retrospectively from 2010 until date of data collection [up to 9 years 10 months]) |
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| Secondary | Group 2, RRHL: Number of Cycles Received at Each Line of Treatment for Each Treatment Regimen in Participants Who Relapse After ASCT | Therapy regimens were numbered as 1: ABVD; 7: DHAP; 10: ICE; 11: IGEV; 4: BEACOPP; 2: ABVD followed by Escalated BEACOPP; 8: ESHAP; 12: Mini-BEAM; 13: MINE; 18: Brentuximab vedotin; 9: GCD; 22: Nivolumab; 23: Pembrolizumab; 16: GVD. | The FAS included all participants who were eligible for RRHL group including common participants, and who relapsed after ASCT. Here number analyzed "n" are the participants who were evaluable for the outcome measure at given categories. | Posted | Median | Full Range | cycles | From initial diagnosis until the date of death (or the date when the participant was last known to be alive) (observed retrospectively from 2010 until date of data collection [up to 9 years 10 months]) |
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| Secondary | Group 2, RRHL: Duration of Each Line of Treatment for Participants Who Relapse After ASCT | The FAS included all participants who were eligible for RRHL group including common participants, and who relapsed after ASCT. Here number analyzed "n" are the participants who were evaluable for the outcome measure at given categories. | Posted | Median | Full Range | months | From initial diagnosis until the date of death (or the date when the participant was last known to be alive) (observed retrospectively from 2010 until date of data collection [up to 9 years 10 months]) |
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| Secondary | Group 2, RRHL: Time From ASCT to First Treatment After Relapse in Participants Who Relapse After ASCT | The FAS included all participants who were eligible for RRHL group including common participants, and who relapsed after ASCT. Here "overall number of participants" analyzed are those who were evaluable for this outcome measure. | Posted | Median | Full Range | months | From initial diagnosis until the date of death (or the date when the participant was last known to be alive) (observed retrospectively from 2010 until date of data collection [up to 9 years 10 months]) |
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| Secondary | Group 2, RRHL: Time to Initiation of Each Subsequent Treatment, From ASCT and From Completion of Previous Treatment in Participants Who Relapse From ASCT | The FAS included all participants who were eligible for RRHL group including common participants, and who relapsed after ASCT. Here "overall number of participants" analyzed are those who were evaluable for this outcome measure. Here number analyzed "n" are the participants who were evaluable for the outcome measure at given categories. | Posted | Median | Full Range | months | From initial diagnosis until the date of death (or the date when the participant was last known to be alive) (observed retrospectively from 2010 until date of data collection [up to 9 years 10 months]) |
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| Secondary | Group 2, RRHL: Percentage of Participants Who Received PET-CT Scan, CT Scan and Radiotherapy at Each Stage of the Treatment Pathway in Participants Who Relapse After ASCT | Data for PET-CT scan and CT scans were assessed for baseline, frontline and relapse/or refractory, and radiotherapy was assessed for frontline and relapse/refractory, as planned. | The FAS included all participants who were eligible for RRHL group including common participants, and who relapsed after ASCT. Here number analyzed "n" are the participants who were evaluable for the outcome measure at given categories. | Posted | Number | percentage of participants | From initial diagnosis until the date of death (or the date when the participant was last known to be alive) (observed retrospectively from 2010 until date of data collection [up to 9 years 10 months]) |
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| Secondary | Group 2, RRHL: Mean Frequency of PET or PET-CT Scan Assessments for Participants Who Relapse After ASCT | Data for PET-CT scan and CT scans were assessed for baseline, frontline and relapse or refractory, as planned. | The FAS included all participants who were eligible for RRHL group including common participants, and who relapsed after ASCT. Here "overall number of participants" analyzed are those who were evaluable for this outcome measure. Here number analyzed "n" are the participants who were evaluable for the outcome measure at given categories. | Posted | Mean | Standard Deviation | scans | From initial diagnosis until the date of death (or the date when the participant was last known to be alive) (observed retrospectively from 2010 until date of data collection [up to 9 years 10 months]) |
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| Secondary | Group 2, RRHL: Number of Participants With Types of Radiotherapies Received at Frontline and at Relapse/Refractory in Participants Who Relapse After ASCT | The FAS included all participants who were eligible for RRHL group including common participants, and who relapsed after ASCT. Here "overall number of participants" analyzed are those who were evaluable for this outcome measure. Here number analyzed "n" are the participants who were evaluable for the outcome measure at given categories. | Posted | Count of Participants | Participants | From initial diagnosis and until death or date of data collected, whichever occurred first (observed retrospectively from 2010 until date of data collection [up to 9 years 10 months]) |
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| Secondary | Group 2, RRHL: Number of Participants Categorized Based on Anatomical Site of Radiotherapies in Participants Who Relapse After ASCT at Frontline and at Relapse/Refractory | The FAS included all participants who were eligible for RRHL group including common participants, and who relapsed after ASCT. Here "overall number of participants" analyzed are those who were evaluable for this outcome measure. Here number analyzed "n" are the participants who were evaluable for the outcome measure at given categories. | Posted | Count of Participants | Participants | From initial diagnosis until the date of death (or the date when the participant was last known to be alive) (observed retrospectively from 2010 until date of data collection [up to 9 years 10 months]) |
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| Secondary | Group 2, RRHL: Number of Participants Categorized Based on Intent of Treatment of Radiotherapies in Participants Who Relapse After ASCT | The FAS included all participants who were eligible for RRHL group including common participants, and who relapsed after ASCT. | Posted | Count of Participants | Participants | From initial diagnosis until the date of death (or the date when the participant was last known to be alive) (observed retrospectively from 2010 until date of data collection [up to 9 years 10 months]) |
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| Secondary | Group 2, RRHL: Total Dose of Radiotherapies Received at Frontline and Relapse/Refractory in Participants Who Relapse After ASCT | The FAS included all participants who were eligible for RRHL group including common participants, and who relapsed after ASCT. Here "overall number of participants" analyzed are those who were evaluable for this outcome measure. Here number analyzed "n" are the participants who were evaluable for the outcome measure at given categories. | Posted | Mean | Standard Deviation | Gray | From initial diagnosis until the date of death (or the date when the participant was last known to be alive) (observed retrospectively from 2010 until date of data collection [up to 9 years 10 months]) |
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| Secondary | Group 2, RRHL: Percentage of Participants Undergoing Subsequent ASCTs and Allogeneic Stem Cell Transplantation (Allo-SCT) | The FAS included all participants who were eligible for RRHL group including common participants, and who relapsed after ASCT. Here "overall number of participants" analyzed are those who were evaluable for this outcome measure. | Posted | Number | percentage of participants | From initial diagnosis until the date of death (or the date when the participant was last known to be alive) (observed retrospectively from 2010 until date of data collection [up to 9 years 10 months]) |
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| Secondary | Group 2, RRHL: Group 2, RRHL: Median Number of ASCTs for Each Participant Who Relapse After ASCT | The FAS included all participants who were eligible for RRHL group including common participants, and who relapsed after ASCT. | Posted | Median | Full Range | ASCTs | From initial diagnosis until the date of death (or the date when the participant was last known to be alive) (observed retrospectively from 2010 until date of data collection [up to 9 years 10 months]) |
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| Secondary | Group 1, cHL: Median PFS | PFS was defined as time from initiation of frontline regimen to first documentation of relapse or disease progression or death, censored at date of most recent follow-up/contact. PD was defined as any new lesion or increase by >= 50% of previously involved site from nadir, and was evaluated based on IWG criteria (Cheson et al 2007). Median PFS was estimated using the Kaplan-Meier method. | The FAS included all participants who were eligible for cHL group including the common participants in both the groups. | Posted | Median | 95% Confidence Interval | months | From initiation of frontline regimen to first documentation of relapse/PD/until date of death (or date when participant was last alive), whichever occurred first (observed retrospectively from 2010 until date of data collection [up to 9 years 10 months]) |
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| Secondary | Group 1, cHL: Number of Participants Based on Best Clinical Response Post Completion of Frontline Treatment | Best clinical response as complete remission (CR), partial remission (PR), stable disease (SD), or PD was evaluated based on IWG criteria (Cheson et al 2007). CR was the disappearance of all evidence of disease. PR was the regression of measurable disease and no new sites. SD was defined by failure to achieve CR, PR, or PD. PD was defined as any new lesion or increase by >=50% of previously involved sites from nadir. | The FAS included all participants who were eligible for cHL group including the common participants in both the groups. | Posted | Number | participants | From post completion of frontline treatment until the date of death (or the date when the participant was last known to be alive) (observed retrospectively from 2010 until date of data collection [up to 9 years 10 months]) |
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| Secondary | Group 2, RRHL: Number of Participants With Best Clinical Response Post Completion of Each Line of Treatment | Best clinical response as CR, PR, SD, or PD was evaluated based on IWG criteria (Cheson et al 2007). CR was the disappearance of all evidence of disease. PR was the regression of measurable disease and no new sites. SD was defined by failure to achieve CR, PR, or PD. PD was defined as any new lesion or increase by >=50% of previously involved sites from nadir. | The FAS included all participants who were eligible for RRHL group including the common participants in both the groups. Here number analyzed "n" are the participants who were evaluable for the outcome measure at given categories. | Posted | Number | participants | From post completion of frontline treatment until the date of death (or the date when the participant was last known to be alive) (observed retrospectively from 2010 until date of data collection [up to 9 years 10 months]) |
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| Secondary | Mean Duration of Best Response | Duration of best response was defined as the time from when the criteria for response (CR or PR) were met to first documentation of relapse or disease progression, and was evaluated based on IWG criteria (Cheson et al 2007). CR was the disappearance of all evidence of disease. PR was the regression of measurable disease and no new sites. PD was defined as any new lesion or increase by >=50% of previously involved sites from nadir. | The FAS included all participants who were eligible for cHL or RRHL group including the common participants in both the groups. Here "overall number of participants" analyzed are those who were evaluable for this outcome measure. | Posted | Median | 95% Confidence Interval | months | From CR or PR until first documentation of relapse or disease progression or until the date of death (or the date when the participant was last known to be alive) (observed retrospectively from 2010 until date of data collection [up to 9 years 10 months]) |
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| Secondary | Median Overall Survival (OS) | Median OS was defined as the time from diagnosis of cHL to death(Group 1)/ time from first relapse after frontline therapy to death (Group 2), censored at date of most recent follow-up/contact. | The FAS included all participants who were eligible for cHL or RRHL group including the common participants in both the groups. Here "overall number of participants" analyzed are those who were evaluable for this outcome measure. | Posted | Median | 95% Confidence Interval | months | From initial diagnosis until the date of death (or date when the participant was alive) (Group 1); From first relapse after frontline therapy to death (Group 2) (observed retrospectively from 2010 until date of data collection [up to 9 years 10 months]) |
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| Secondary | Group 1, cHL: Overall Survival Rate After Diagnosis at 1 and 5 Years | Percentage of participants who were alive at 1 and 5 years after diagnosis in cHL participants are reported. 5 year overall survival data were reported only for participants who had >5 year observation periods. | The FAS included all participants who were eligible for cHL group including the common participants in both the groups. | Posted | Number | 95% Confidence Interval | percentage of participants | At 1 year and 5 years after diagnosis (observed retrospectively from 2010 until date of data collection [up to 9 years 10 months]) |
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| Secondary | Group 2, RRHL: Overall Survival Rate at 1 and 5 Years | Percentage of participants who were alive at 1 and 5 years after diagnosis in RRHL participants are reported. 5 year overall survival data were reported only for participants who had >5 year observation periods. | The FAS included all participants who were eligible for RRHL group including the common participants in both the groups. Here "overall number of participants" analyzed are those who were evaluable for this outcome measure. | Posted | Number | 95% Confidence Interval | percentage of participants | At 1 year and 5 years after relapse (observed retrospectively from 2010 until date of data collection [up to 9 years 10 months]) |
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| Secondary | Group 1, cHL: Number of Participants Who Had Inpatient Hospital Admissions, Emergency Room Visits, and Outpatient Visits by Healthcare Professionals Related to HL | The FAS included all participants who were eligible for cHL group including common participants in both the groups. | Posted | Count of Participants | Participants | From initial diagnosis until the date of death (or the date when the participant was last known to be alive) (observed retrospectively from 2010 until date of data collection [up to 9 years 10 months]) |
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| Secondary | Group 1, cHL: Number of Participants Categorized Based on Reasons for Inpatient Hospital Admissions Related to HL | The FAS included all participants who were eligible for cHL group including common participants in both the groups, and who had HL inpatient hospitalizations. | Posted | Count of Participants | Participants | From initial diagnosis until the date of death (or the date when the participant was last known to be alive) (observed retrospectively from 2010 until date of data collection [up to 9 years 10 months]) |
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| Secondary | Group 1, cHL: Mean Overall Length of Stay and Length of Stay by Unit/Ward for Inpatient Hospital Admissions Related to HL | Length of stay by unit or ward included general, high dependency/intermediate, intensive care unit, bone marrow transplant unit, and emergency visits. | The FAS included all participants who were eligible for cHL group including common participants in both the groups, and who had HL inpatient hospitalizations. Here number analyzed "n" are the participants who were evaluable for the outcome measure at given categories. | Posted | Mean | Standard Deviation | days | From initial diagnosis until the date of death (or the date when the participant was last known to be alive) (observed retrospectively from 2010 until date of data collection [up to 9 years 10 months]) |
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| Secondary | Group 1, cHL: Number of Participants Categorized Based on Episodes of RT Received, Type of Scan or Procedure, and Who Received Granulocyte-colony Stimulating Factor (G-CSF) or High-cost Medicines and Pegylated G-CSF Related to HL | The FAS included all participants who were eligible for cHL group including common participants in both the groups. Here number analyzed "n" are the participants who were evaluable for the outcome measure at given categories. | Posted | Count of Participants | Participants | From initial diagnosis until the date of death (or the date when the participant was last known to be alive) (observed retrospectively from 2010 until date of data collection [up to 9 years 10 months]) |
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| Secondary | Group 1, cHL: Mean Number of Courses of Treatment With G-CSF/Pegylated G-CSF or Other High-cost Medicines Related to HL Treatment | The FAS included all participants who were eligible for cHL group including common participants in both the groups. Here "overall number of participants" analyzed are those who were evaluable for this outcome measure. Here number analyzed "n" are the participants who were evaluable for the outcome measure at given categories. | Posted | Mean | Standard Deviation | days | From initial diagnosis until the date of death (or the date when the participant was last known to be alive) (observed retrospectively from 2010 until date of data collection [up to 9 years 10 months]) |
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| Secondary | Group 2, RRHL: Number of Participants Who Had Inpatient Hospital Admissions, Emergency Room Visits, and Outpatient Visits by Healthcare Professional Related to HL for Salvage Therapy and ASCT | Each participant had more than one category presented for salvage therapy and ASCT. | The FAS included all participants who were eligible for RRHL group including common participants in both the groups. Here "overall number of participants" analyzed are those who were evaluable for this outcome measure. Here number analyzed "n" are the participants who were evaluable for the outcome measure at given categories. | Posted | Count of Participants | Participants | From initial diagnosis until the date of death (or the date when the participant was last known to be alive) (observed retrospectively from 2010 until date of data collection [up to 9 years 10 months]) |
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| Secondary | Group 2, RRHL: Number of Participants Categorized Based on Reasons for Inpatient Hospital Admissions Related to HL for Salvage Therapy and ASCT | Each participant had more than one category presented for salvage therapy and ASCT. | The FAS included all participants who were eligible for RRHL group including common participants in both the groups. Here "overall number of participants" analyzed are those who were evaluable for this outcome measure. Here number analyzed "n" are the participants who were evaluable for the outcome measure at given categories. | Posted | Count of Participants | Participants | From initial diagnosis until the date of death (or the date when the participant was last known to be alive) (observed retrospectively from 2010 until date of data collection [up to 9 years 10 months]) |
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| Secondary | Group 2, RRHL: Mean Overall Length of Stay and Length of Stay by Unit/Ward for Inpatient Hospital Admissions Related to HL for Salvage Therapy and ASCT | Length of stay by unit or ward included general, high dependency/intermediate, intensive care unit, bone marrow transplant unit, and emergency visits. Each participant had more than one category presented for salvage therapy and ASCT. | The FAS included all participants who were eligible for RRHL group including common participants in both the groups. Here number analyzed "n" are the participants who were evaluable for the outcome measure at given categories. | Posted | Mean | Standard Deviation | days | From initial diagnosis until the date of death (or the date when the participant was last known to be alive) (observed retrospectively from 2010 until date of data collection [up to 9 years 10 months]) |
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| Secondary | Group 2, RRHL: Number of Participants Categorized Based on Episodes of RT, Type of Scan or Procedure, and Who Received G-CSF or High-cost Medicines Related to HL for Salvage Therapy and ASCT | Each participant had more than one category presented for salvage therapy and ASCT. Scan procedures included chest x-ray, magnetic resonance imaging, needle biopsy, bone scan, bone marrow aspiration, flow cytometry, and other scan procedures. | The FAS included all participants who were eligible for RRHL group including common participants in both the groups. Here "overall number of participants" analyzed are those who were evaluable for this outcome measure. Here number analyzed "n" are the participants who were evaluable for the outcome measure at given categories. | Posted | Count of Participants | Participants | From initial diagnosis until the date of death (or the date when the participant was last known to be alive) (observed retrospectively from 2010 until date of data collection [up to 9 years 10 months]) |
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| Secondary | Group 2, RRHL: Group 2, RRHL: Mean Number of Courses of Treatment With G-CSF/Pegylated G-CSF or Other High-cost Medicines Related to HL Treatment for Salvage Therapy and ASCT | The FAS included all participants who were eligible for RRHL group including common participants in both the groups. Here "overall number of participants" analyzed are those who were evaluable for this outcome measure. Here number analyzed "n" are the participants who were evaluable for the outcome measure at given categories. | Posted | Mean | Standard Deviation | days | From initial diagnosis until the date of death (or the date when the participant was last known to be alive) (observed retrospectively from 2010 until date of data collection [up to 9 years 10 months]) |
|
|
|
| 243 |
| 1,598 |
| 303 |
| 1,598 |
| 642 |
| 1,598 |
| EG001 | Group 2: RRHL | Participants diagnosed with RRHL between 01 January 2010 and 31 December 2013, and participants who were diagnosed with high-risk stage IIb-IV cHL and then were subsequently diagnosed with RRHL between 2010 and 2013 were observed retrospectively until the date of death or data collection, whichever occurred first. | 136 | 426 | 103 | 426 | 187 | 426 |
| Neutropenia | Blood and lymphatic system disorders | MedDRA (22.0) | Systematic Assessment |
|
| Anaemia | Blood and lymphatic system disorders | MedDRA (22.0) | Systematic Assessment |
|
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA (22.0) | Systematic Assessment |
|
| Pancytopenia | Blood and lymphatic system disorders | MedDRA (22.0) | Systematic Assessment |
|
| Disseminated intravascular coagulation | Blood and lymphatic system disorders | MedDRA (22.0) | Systematic Assessment |
|
| Iron deficiency anaemia | Blood and lymphatic system disorders | MedDRA (22.0) | Systematic Assessment |
|
| Leukocytosis | Blood and lymphatic system disorders | MedDRA (22.0) | Systematic Assessment |
|
| Platelet disorder | Blood and lymphatic system disorders | MedDRA (22.0) | Systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA (22.0) | Systematic Assessment |
|
| Neutropenic sepsis | Infections and infestations | MedDRA (22.0) | Systematic Assessment |
|
| Herpes zoster | Infections and infestations | MedDRA (22.0) | Systematic Assessment |
|
| Sepsis | Infections and infestations | MedDRA (22.0) | Systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDRA (22.0) | Systematic Assessment |
|
| Septic shock | Infections and infestations | MedDRA (22.0) | Systematic Assessment |
|
| Bacteraemia | Infections and infestations | MedDRA (22.0) | Systematic Assessment |
|
| Device related infection | Infections and infestations | MedDRA (22.0) | Systematic Assessment |
|
| Cellulitis | Infections and infestations | MedDRA (22.0) | Systematic Assessment |
|
| Lower respiratory tract infection | Infections and infestations | MedDRA (22.0) | Systematic Assessment |
|
| Lung infection | Infections and infestations | MedDRA (22.0) | Systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | MedDRA (22.0) | Systematic Assessment |
|
| Abscess limb | Infections and infestations | MedDRA (22.0) | Systematic Assessment |
|
| Acute sinusitis | Infections and infestations | MedDRA (22.0) | Systematic Assessment |
|
| Anal abscess | Infections and infestations | MedDRA (22.0) | Systematic Assessment |
|
| Anal infection | Infections and infestations | MedDRA (22.0) | Systematic Assessment |
|
| Appendicitis | Infections and infestations | MedDRA (22.0) | Systematic Assessment |
|
| Aspergillus infection | Infections and infestations | MedDRA (22.0) | Systematic Assessment |
|
| Bacterial sepsis | Infections and infestations | MedDRA (22.0) | Systematic Assessment |
|
| Bronchitis | Infections and infestations | MedDRA (22.0) | Systematic Assessment |
|
| Carbuncle | Infections and infestations | MedDRA (22.0) | Systematic Assessment |
|
| Catheter site infection | Infections and infestations | MedDRA (22.0) | Systematic Assessment |
|
| Clostridial sepsis | Infections and infestations | MedDRA (22.0) | Systematic Assessment |
|
| Clostridium difficile colitis | Infections and infestations | MedDRA (22.0) | Systematic Assessment |
|
| Cryptococcosis | Infections and infestations | MedDRA (22.0) | Systematic Assessment |
|
| Cystitis | Infections and infestations | MedDRA (22.0) | Systematic Assessment |
|
| Device related sepsis | Infections and infestations | MedDRA (22.0) | Systematic Assessment |
|
| Endocarditis | Infections and infestations | MedDRA (22.0) | Systematic Assessment |
|
| Fungal sepsis | Infections and infestations | MedDRA (22.0) | Systematic Assessment |
|
| Gastroenteritis | Infections and infestations | MedDRA (22.0) | Systematic Assessment |
|
| Gastroenteritis viral | Infections and infestations | MedDRA (22.0) | Systematic Assessment |
|
| Herpes simplex | Infections and infestations | MedDRA (22.0) | Systematic Assessment |
|
| Herpes virus infection | Infections and infestations | MedDRA (22.0) | Systematic Assessment |
|
| Herpes zoster disseminated | Infections and infestations | MedDRA (22.0) | Systematic Assessment |
|
| Infection | Infections and infestations | MedDRA (22.0) | Systematic Assessment |
|
| Influenza | Infections and infestations | MedDRA (22.0) | Systematic Assessment |
|
| Klebsiella sepsis | Infections and infestations | MedDRA (22.0) | Systematic Assessment |
|
| Large intestine infection | Infections and infestations | MedDRA (22.0) | Systematic Assessment |
|
| Mastoiditis | Infections and infestations | MedDRA (22.0) | Systematic Assessment |
|
| Mucormycosis | Infections and infestations | MedDRA (22.0) | Systematic Assessment |
|
| Osteomyelitis | Infections and infestations | MedDRA (22.0) | Systematic Assessment |
|
| Periorbital cellulitis | Infections and infestations | MedDRA (22.0) | Systematic Assessment |
|
| Peritonitis bacterial | Infections and infestations | MedDRA (22.0) | Systematic Assessment |
|
| Pneumocystis jirovecii pneumonia | Infections and infestations | MedDRA (22.0) | Systematic Assessment |
|
| Pneumonia chlamydial | Infections and infestations | MedDRA (22.0) | Systematic Assessment |
|
| Pyelonephritis acute | Infections and infestations | MedDRA (22.0) | Systematic Assessment |
|
| Renal abscess | Infections and infestations | MedDRA (22.0) | Systematic Assessment |
|
| Systemic candida | Infections and infestations | MedDRA (22.0) | Systematic Assessment |
|
| Urosepsis | Infections and infestations | MedDRA (22.0) | Systematic Assessment |
|
| Viral infection | Infections and infestations | MedDRA (22.0) | Systematic Assessment |
|
| Klebsiella bacteraemia | Infections and infestations | MedDRA (22.0) | Systematic Assessment |
|
| Pyrexia | General disorders | MedDRA (22.0) | Systematic Assessment |
|
| Asthenia | General disorders | MedDRA (22.0) | Systematic Assessment |
|
| Chest pain | General disorders | MedDRA (22.0) | Systematic Assessment |
|
| Mucosal inflammation | General disorders | MedDRA (22.0) | Systematic Assessment |
|
| Adverse drug reaction | General disorders | MedDRA (22.0) | Systematic Assessment |
|
| Catheter site necrosis | General disorders | MedDRA (22.0) | Systematic Assessment |
|
| Death | General disorders | MedDRA (22.0) | Non-systematic Assessment |
|
| Fatigue | General disorders | MedDRA (22.0) | Systematic Assessment |
|
| Gait disturbance | General disorders | MedDRA (22.0) | Systematic Assessment |
|
| Non-cardiac chest pain | General disorders | MedDRA (22.0) | Systematic Assessment |
|
| Systemic inflammatory response syndrome | General disorders | MedDRA (22.0) | Systematic Assessment |
|
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA (22.0) | Systematic Assessment |
|
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | MedDRA (22.0) | Systematic Assessment |
|
| Pulmonary toxicity | Respiratory, thoracic and mediastinal disorders | MedDRA (22.0) | Systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (22.0) | Systematic Assessment |
|
| Respiratory distress | Respiratory, thoracic and mediastinal disorders | MedDRA (22.0) | Systematic Assessment |
|
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA (22.0) | Systematic Assessment |
|
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA (22.0) | Systematic Assessment |
|
| Interstitial lung disease | Respiratory, thoracic and mediastinal disorders | MedDRA (22.0) | Systematic Assessment |
|
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA (22.0) | Systematic Assessment |
|
| Acute lung injury | Respiratory, thoracic and mediastinal disorders | MedDRA (22.0) | Systematic Assessment |
|
| Acute respiratory distress syndrome | Respiratory, thoracic and mediastinal disorders | MedDRA (22.0) | Systematic Assessment |
|
| Acute respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA (22.0) | Systematic Assessment |
|
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA (22.0) | Systematic Assessment |
|
| Bronchiectasis | Respiratory, thoracic and mediastinal disorders | MedDRA (22.0) | Systematic Assessment |
|
| Mediastinal disorder | Respiratory, thoracic and mediastinal disorders | MedDRA (22.0) | Systematic Assessment |
|
| Obstructive airways disorder | Respiratory, thoracic and mediastinal disorders | MedDRA (22.0) | Systematic Assessment |
|
| Pharyngeal inflammation | Respiratory, thoracic and mediastinal disorders | MedDRA (22.0) | Systematic Assessment |
|
| Pneumonia aspiration | Respiratory, thoracic and mediastinal disorders | MedDRA (22.0) | Systematic Assessment |
|
| Pulmonary fibrosis | Respiratory, thoracic and mediastinal disorders | MedDRA (22.0) | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA (22.0) | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA (22.0) | Systematic Assessment |
|
| Stomatitis | Gastrointestinal disorders | MedDRA (22.0) | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA (22.0) | Systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA (22.0) | Systematic Assessment |
|
| Abdominal pain upper | Gastrointestinal disorders | MedDRA (22.0) | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA (22.0) | Systematic Assessment |
|
| Abdominal distension | Gastrointestinal disorders | MedDRA (22.0) | Systematic Assessment |
|
| Duodenal perforation | Gastrointestinal disorders | MedDRA (22.0) | Systematic Assessment |
|
| Duodenitis | Gastrointestinal disorders | MedDRA (22.0) | Systematic Assessment |
|
| Enteritis | Gastrointestinal disorders | MedDRA (22.0) | Systematic Assessment |
|
| Ileus paralytic | Gastrointestinal disorders | MedDRA (22.0) | Systematic Assessment |
|
| Intestinal obstruction | Gastrointestinal disorders | MedDRA (22.0) | Systematic Assessment |
|
| Mouth ulceration | Gastrointestinal disorders | MedDRA (22.0) | Systematic Assessment |
|
| Oesophagitis | Gastrointestinal disorders | MedDRA (22.0) | Systematic Assessment |
|
| Rectal prolapse | Gastrointestinal disorders | MedDRA (22.0) | Systematic Assessment |
|
| Ascites | Gastrointestinal disorders | MedDRA (22.0) | Systematic Assessment |
|
| Neutropenic colitis | Gastrointestinal disorders | MedDRA (22.0) | Systematic Assessment |
|
| Abdominal discomfort | Gastrointestinal disorders | MedDRA (22.0) | Systematic Assessment |
|
| Enterocolitis | Gastrointestinal disorders | MedDRA (22.0) | Systematic Assessment |
|
| Haematemesis | Gastrointestinal disorders | MedDRA (22.0) | Systematic Assessment |
|
| Cardiac arrest | Cardiac disorders | MedDRA (22.0) | Systematic Assessment |
|
| Bradycardia | Cardiac disorders | MedDRA (22.0) | Systematic Assessment |
|
| Cardiac tamponade | Cardiac disorders | MedDRA (22.0) | Systematic Assessment |
|
| Myocardial infarction | Cardiac disorders | MedDRA (22.0) | Systematic Assessment |
|
| Acute coronary syndrome | Cardiac disorders | MedDRA (22.0) | Systematic Assessment |
|
| Angina pectoris | Cardiac disorders | MedDRA (22.0) | Systematic Assessment |
|
| Cardiac failure | Cardiac disorders | MedDRA (22.0) | Systematic Assessment |
|
| Cardiomyopathy | Cardiac disorders | MedDRA (22.0) | Systematic Assessment |
|
| Cardiotoxicity | Cardiac disorders | MedDRA (22.0) | Systematic Assessment |
|
| Myocardial ischaemia | Cardiac disorders | MedDRA (22.0) | Systematic Assessment |
|
| Palpitations | Cardiac disorders | MedDRA (22.0) | Systematic Assessment |
|
| Sinus tachycardia | Cardiac disorders | MedDRA (22.0) | Systematic Assessment |
|
| Supraventricular tachycardia | Cardiac disorders | MedDRA (22.0) | Systematic Assessment |
|
| Tachycardia | Cardiac disorders | MedDRA (22.0) | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA (22.0) | Systematic Assessment |
|
| Neuropathy peripheral | Nervous system disorders | MedDRA (22.0) | Systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA (22.0) | Systematic Assessment |
|
| Hemiplegia | Nervous system disorders | MedDRA (22.0) | Systematic Assessment |
|
| Monoparesis | Nervous system disorders | MedDRA (22.0) | Systematic Assessment |
|
| Myxoedema coma | Nervous system disorders | MedDRA (22.0) | Systematic Assessment |
|
| Speech disorder | Nervous system disorders | MedDRA (22.0) | Systematic Assessment |
|
| Spinal cord compression | Nervous system disorders | MedDRA (22.0) | Systematic Assessment |
|
| Subdural hygroma | Nervous system disorders | MedDRA (22.0) | Systematic Assessment |
|
| Syncope | Nervous system disorders | MedDRA (22.0) | Systematic Assessment |
|
| Tension headache | Nervous system disorders | MedDRA (22.0) | Systematic Assessment |
|
| Toxicity to various agents | Injury, poisoning and procedural complications | MedDRA (22.0) | Systematic Assessment |
|
| Traumatic lung injury | Injury, poisoning and procedural complications | MedDRA (22.0) | Systematic Assessment |
|
| Lumbar vertebral fracture | Injury, poisoning and procedural complications | MedDRA (22.0) | Systematic Assessment |
|
| Pneumonitis chemical | Injury, poisoning and procedural complications | MedDRA (22.0) | Systematic Assessment |
|
| Radiation mucositis | Injury, poisoning and procedural complications | MedDRA (22.0) | Systematic Assessment |
|
| Radiation pneumonitis | Injury, poisoning and procedural complications | MedDRA (22.0) | Systematic Assessment |
|
| Diabetes mellitus | Metabolism and nutrition disorders | MedDRA (22.0) | Systematic Assessment |
|
| Tumour lysis syndrome | Metabolism and nutrition disorders | MedDRA (22.0) | Systematic Assessment |
|
| Cachexia | Metabolism and nutrition disorders | MedDRA (22.0) | Systematic Assessment |
|
| Fluid overload | Metabolism and nutrition disorders | MedDRA (22.0) | Systematic Assessment |
|
| Hypercalcaemia | Metabolism and nutrition disorders | MedDRA (22.0) | Systematic Assessment |
|
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA (22.0) | Systematic Assessment |
|
| Hypocalcaemia | Metabolism and nutrition disorders | MedDRA (22.0) | Systematic Assessment |
|
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA (22.0) | Systematic Assessment |
|
| Drug hypersensitivity | Immune system disorders | MedDRA (22.0) | Systematic Assessment |
|
| Graft versus host disease in gastrointestinal tract | Immune system disorders | MedDRA (22.0) | Systematic Assessment |
|
| Acute graft versus host disease | Immune system disorders | MedDRA (22.0) | Systematic Assessment |
|
| Graft versus host disease | Immune system disorders | MedDRA (22.0) | Systematic Assessment |
|
| Haemophagocytic lymphohistiocytosis | Immune system disorders | MedDRA (22.0) | Systematic Assessment |
|
| Acute graft versus host disease in skin | Immune system disorders | MedDRA (22.0) | Systematic Assessment |
|
| Anaphylactic reaction | Immune system disorders | MedDRA (22.0) | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (22.0) | Systematic Assessment |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA (22.0) | Systematic Assessment |
|
| Bone pain | Musculoskeletal and connective tissue disorders | MedDRA (22.0) | Systematic Assessment |
|
| Musculoskeletal chest pain | Musculoskeletal and connective tissue disorders | MedDRA (22.0) | Systematic Assessment |
|
| Myofascial pain syndrome | Musculoskeletal and connective tissue disorders | MedDRA (22.0) | Systematic Assessment |
|
| Synovitis | Musculoskeletal and connective tissue disorders | MedDRA (22.0) | Systematic Assessment |
|
| Hypotension | Vascular disorders | MedDRA (22.0) | Systematic Assessment |
|
| Arterial haemorrhage | Vascular disorders | MedDRA (22.0) | Systematic Assessment |
|
| Hypovolaemic shock | Vascular disorders | MedDRA (22.0) | Systematic Assessment |
|
| Phlebitis | Vascular disorders | MedDRA (22.0) | Systematic Assessment |
|
| Thrombophlebitis superficial | Vascular disorders | MedDRA (22.0) | Systematic Assessment |
|
| Blood bilirubin increased | Investigations | MedDRA (22.0) | Systematic Assessment |
|
| Ejection fraction decreased | Investigations | MedDRA (22.0) | Systematic Assessment |
|
| General physical condition abnormal | Investigations | MedDRA (22.0) | Systematic Assessment |
|
| Neutrophil count decreased | Investigations | MedDRA (22.0) | Systematic Assessment |
|
| Platelet count decreased | Investigations | MedDRA (22.0) | Systematic Assessment |
|
| Acute kidney injury | Renal and urinary disorders | MedDRA (22.0) | Systematic Assessment |
|
| Cystitis haemorrhagic | Renal and urinary disorders | MedDRA (22.0) | Systematic Assessment |
|
| Hepatic failure | Hepatobiliary disorders | MedDRA (22.0) | Systematic Assessment |
|
| Cholangitis | Hepatobiliary disorders | MedDRA (22.0) | Systematic Assessment |
|
| Hepatitis | Hepatobiliary disorders | MedDRA (22.0) | Systematic Assessment |
|
| Diffuse large B-cell lymphoma stage II | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (22.0) | Systematic Assessment |
|
| Post transplant lymphoproliferative disorder | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (22.0) | Systematic Assessment |
|
| Tumour associated fever | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (22.0) | Systematic Assessment |
|
| Diplopia | Eye disorders | MedDRA (22.0) | Systematic Assessment |
|
| Photophobia | Eye disorders | MedDRA (22.0) | Systematic Assessment |
|
| Rash pruritic | Skin and subcutaneous tissue disorders | MedDRA (22.0) | Systematic Assessment |
|
| Skin ulcer | Skin and subcutaneous tissue disorders | MedDRA (22.0) | Systematic Assessment |
|
| Hypercalcaemia of malignancy | Endocrine disorders | MedDRA (22.0) | Systematic Assessment |
|
| Delirium | Psychiatric disorders | MedDRA (22.0) | Systematic Assessment |
|
| Vaginal ulceration | Reproductive system and breast disorders | MedDRA (22.0) | Systematic Assessment |
|
| Bone marrow failure | Blood and lymphatic system disorders | MedDRA (22.0) | Systematic Assessment |
|
| Conjunctivitis | Infections and infestations | MedDRA (22.0) | Systematic Assessment |
|
| Otitis media | Infections and infestations | MedDRA (22.0) | Systematic Assessment |
|
| Multiple organ dysfunction syndrome | General disorders | MedDRA (22.0) | Systematic Assessment |
|
| Cardiac failure congestive | Cardiac disorders | MedDRA (22.0) | Systematic Assessment |
|
| Engraftment syndrome | Immune system disorders | MedDRA (22.0) | Systematic Assessment |
|
| Leukopenia | Blood and lymphatic system disorders | MedDRA (22.0) | Systematic Assessment |
|
| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA (22.0) | Systematic Assessment |
|
| Anaemia | Blood and lymphatic system disorders | MedDRA (22.0) | Non-systematic Assessment |
|
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA (22.0) | Systematic Assessment |
|
| Bone marrow failure | Blood and lymphatic system disorders | MedDRA (22.0) | Non-systematic Assessment |
|
| Erythropenia | Blood and lymphatic system disorders | MedDRA (22.0) | Systematic Assessment |
|
| Pancytopenia | Blood and lymphatic system disorders | MedDRA (22.0) | Systematic Assessment |
|
| Agranulocytosis | Blood and lymphatic system disorders | MedDRA (22.0) | Systematic Assessment |
|
| Autoimmune haemolytic anaemia | Blood and lymphatic system disorders | MedDRA (22.0) | Systematic Assessment |
|
| Bicytopenia | Blood and lymphatic system disorders | MedDRA (22.0) | Systematic Assessment |
|
| Cytopenia | Blood and lymphatic system disorders | MedDRA (22.0) | Systematic Assessment |
|
| Eosinophilia | Blood and lymphatic system disorders | MedDRA (22.0) | Systematic Assessment |
|
| Haematotoxicity | Blood and lymphatic system disorders | MedDRA (22.0) | Systematic Assessment |
|
| Lymphadenitis | Blood and lymphatic system disorders | MedDRA (22.0) | Systematic Assessment |
|
| Lymphadenopathy | Blood and lymphatic system disorders | MedDRA (22.0) | Systematic Assessment |
|
| Lymphopenia | Blood and lymphatic system disorders | MedDRA (22.0) | Systematic Assessment |
|
| Splenomegaly | Blood and lymphatic system disorders | MedDRA (22.0) | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA (22.0) | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA (22.0) | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA (22.0) | Systematic Assessment |
|
| Stomatitis | Gastrointestinal disorders | MedDRA (22.0) | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA (22.0) | Systematic Assessment |
|
| Gastrointestinal disorder | Gastrointestinal disorders | MedDRA (22.0) | Systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA (22.0) | Systematic Assessment |
|
| Mouth ulceration | Gastrointestinal disorders | MedDRA (22.0) | Systematic Assessment |
|
| Abdominal pain upper | Gastrointestinal disorders | MedDRA (22.0) | Systematic Assessment |
|
| Dyspepsia | Gastrointestinal disorders | MedDRA (22.0) | Systematic Assessment |
|
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA (22.0) | Systematic Assessment |
|
| Abdominal discomfort | Gastrointestinal disorders | MedDRA (22.0) | Systematic Assessment |
|
| Abdominal distension | Gastrointestinal disorders | MedDRA (22.0) | Systematic Assessment |
|
| Haemorrhoids | Gastrointestinal disorders | MedDRA (22.0) | Systematic Assessment |
|
| Odynophagia | Gastrointestinal disorders | MedDRA (22.0) | Systematic Assessment |
|
| Dysphagia | Gastrointestinal disorders | MedDRA (22.0) | Systematic Assessment |
|
| Epigastric discomfort | Gastrointestinal disorders | MedDRA (22.0) | Systematic Assessment |
|
| Gastritis | Gastrointestinal disorders | MedDRA (22.0) | Systematic Assessment |
|
| Proctalgia | Gastrointestinal disorders | MedDRA (22.0) | Systematic Assessment |
|
| Proctitis | Gastrointestinal disorders | MedDRA (22.0) | Systematic Assessment |
|
| Anal fissure | Gastrointestinal disorders | MedDRA (22.0) | Non-systematic Assessment |
|
| Aphthous ulcer | Gastrointestinal disorders | MedDRA (22.0) | Systematic Assessment |
|
| Chronic gastritis | Gastrointestinal disorders | MedDRA (22.0) | Systematic Assessment |
|
| Colitis | Gastrointestinal disorders | MedDRA (22.0) | Systematic Assessment |
|
| Dry mouth | Gastrointestinal disorders | MedDRA (22.0) | Systematic Assessment |
|
| Enterocolitis | Gastrointestinal disorders | MedDRA (22.0) | Systematic Assessment |
|
| Gastric ulcer | Gastrointestinal disorders | MedDRA (22.0) | Systematic Assessment |
|
| Gastritis erosive | Gastrointestinal disorders | MedDRA (22.0) | Systematic Assessment |
|
| Gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA (22.0) | Systematic Assessment |
|
| Gastrointestinal inflammation | Gastrointestinal disorders | MedDRA (22.0) | Systematic Assessment |
|
| Gastrointestinal toxicity | Gastrointestinal disorders | MedDRA (22.0) | Systematic Assessment |
|
| Gingival bleeding | Gastrointestinal disorders | MedDRA (22.0) | Systematic Assessment |
|
| Gingival pain | Gastrointestinal disorders | MedDRA (22.0) | Systematic Assessment |
|
| Glossodynia | Gastrointestinal disorders | MedDRA (22.0) | Systematic Assessment |
|
| Intestinal cyst | Gastrointestinal disorders | MedDRA (22.0) | Systematic Assessment |
|
| Large intestinal stenosis | Gastrointestinal disorders | MedDRA (22.0) | Systematic Assessment |
|
| Lip ulceration | Gastrointestinal disorders | MedDRA (22.0) | Systematic Assessment |
|
| Oesophagitis | Gastrointestinal disorders | MedDRA (22.0) | Systematic Assessment |
|
| Oral mucosal eruption | Gastrointestinal disorders | MedDRA (22.0) | Systematic Assessment |
|
| Rectal haemorrhage | Gastrointestinal disorders | MedDRA (22.0) | Systematic Assessment |
|
| Salivary gland pain | Gastrointestinal disorders | MedDRA (22.0) | Systematic Assessment |
|
| Toothache | Gastrointestinal disorders | MedDRA (22.0) | Systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA (22.0) | Systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | MedDRA (22.0) | Systematic Assessment |
|
| Herpes zoster | Infections and infestations | MedDRA (22.0) | Systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDRA (22.0) | Systematic Assessment |
|
| Influenza | Infections and infestations | MedDRA (22.0) | Systematic Assessment |
|
| Sepsis | Infections and infestations | MedDRA (22.0) | Systematic Assessment |
|
| Lung infection | Infections and infestations | MedDRA (22.0) | Systematic Assessment |
|
| Oral candidiasis | Infections and infestations | MedDRA (22.0) | Systematic Assessment |
|
| Pharyngitis | Infections and infestations | MedDRA (22.0) | Systematic Assessment |
|
| Sinusitis | Infections and infestations | MedDRA (22.0) | Systematic Assessment |
|
| Device related sepsis | Infections and infestations | MedDRA (22.0) | Systematic Assessment |
|
| Anal abscess | Infections and infestations | MedDRA (22.0) | Systematic Assessment |
|
| Cellulitis | Infections and infestations | MedDRA (22.0) | Systematic Assessment |
|
| Folliculitis | Infections and infestations | MedDRA (22.0) | Systematic Assessment |
|
| Furuncle | Infections and infestations | MedDRA (22.0) | Systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA (22.0) | Systematic Assessment |
|
| Oesophageal candidiasis | Infections and infestations | MedDRA (22.0) | Systematic Assessment |
|
| Clostridium difficile colitis | Infections and infestations | MedDRA (22.0) | Systematic Assessment |
|
| Cytomegalovirus infection | Infections and infestations | MedDRA (22.0) | Systematic Assessment |
|
| Gastroenteritis | Infections and infestations | MedDRA (22.0) | Systematic Assessment |
|
| Genital herpes | Infections and infestations | MedDRA (22.0) | Systematic Assessment |
|
| Gingivitis | Infections and infestations | MedDRA (22.0) | Systematic Assessment |
|
| Herpes virus infection | Infections and infestations | MedDRA (22.0) | Systematic Assessment |
|
| Infection | Infections and infestations | MedDRA (22.0) | Systematic Assessment |
|
| Neutropenic sepsis | Infections and infestations | MedDRA (22.0) | Systematic Assessment |
|
| Oropharyngeal candidiasis | Infections and infestations | MedDRA (22.0) | Systematic Assessment |
|
| Pneumocystis jirovecii pneumonia | Infections and infestations | MedDRA (22.0) | Systematic Assessment |
|
| Pulmonary tuberculosis | Infections and infestations | MedDRA (22.0) | Systematic Assessment |
|
| Respiratory tract infection | Infections and infestations | MedDRA (22.0) | Systematic Assessment |
|
| Varicella | Infections and infestations | MedDRA (22.0) | Systematic Assessment |
|
| Vascular device infection | Infections and infestations | MedDRA (22.0) | Systematic Assessment |
|
| Acute sinusitis | Infections and infestations | MedDRA (22.0) | Systematic Assessment |
|
| Bronchitis | Infections and infestations | MedDRA (22.0) | Systematic Assessment |
|
| Bronchitis bacterial | Infections and infestations | MedDRA (22.0) | Systematic Assessment |
|
| Bronchopulmonary aspergillosis | Infections and infestations | MedDRA (22.0) | Systematic Assessment |
|
| Conjunctivitis | Infections and infestations | MedDRA (22.0) | Systematic Assessment |
|
| Conjunctivitis viral | Infections and infestations | MedDRA (22.0) | Systematic Assessment |
|
| Device related infection | Infections and infestations | MedDRA (22.0) | Systematic Assessment |
|
| Endocarditis | Infections and infestations | MedDRA (22.0) | Systematic Assessment |
|
| Epstein-Barr virus infection | Infections and infestations | MedDRA (22.0) | Systematic Assessment |
|
| Fungal infection | Infections and infestations | MedDRA (22.0) | Systematic Assessment |
|
| Gastroenteritis viral | Infections and infestations | MedDRA (22.0) | Systematic Assessment |
|
| Genital infection fungal | Infections and infestations | MedDRA (22.0) | Systematic Assessment |
|
| Lip infection | Infections and infestations | MedDRA (22.0) | Systematic Assessment |
|
| Nail bed infection | Infections and infestations | MedDRA (22.0) | Systematic Assessment |
|
| Onychomycosis | Infections and infestations | MedDRA (22.0) | Systematic Assessment |
|
| Oral herpes | Infections and infestations | MedDRA (22.0) | Systematic Assessment |
|
| Orchitis | Infections and infestations | MedDRA (22.0) | Systematic Assessment |
|
| Otitis media | Infections and infestations | MedDRA (22.0) | Systematic Assessment |
|
| Paronychia | Infections and infestations | MedDRA (22.0) | Systematic Assessment |
|
| Pathogen resistance | Infections and infestations | MedDRA (22.0) | Systematic Assessment |
|
| Peritonitis | Infections and infestations | MedDRA (22.0) | Systematic Assessment |
|
| Pneumonia cytomegaloviral | Infections and infestations | MedDRA (22.0) | Systematic Assessment |
|
| Pneumonia fungal | Infections and infestations | MedDRA (22.0) | Systematic Assessment |
|
| Postpartum sepsis | Infections and infestations | MedDRA (22.0) | Systematic Assessment |
|
| Rash pustular | Infections and infestations | MedDRA (22.0) | Systematic Assessment |
|
| Rhinitis | Infections and infestations | MedDRA (22.0) | Systematic Assessment |
|
| Skin candida | Infections and infestations | MedDRA (22.0) | Systematic Assessment |
|
| Soft tissue infection | Infections and infestations | MedDRA (22.0) | Systematic Assessment |
|
| Staphylococcal bacteraemia | Infections and infestations | MedDRA (22.0) | Systematic Assessment |
|
| Subcutaneous abscess | Infections and infestations | MedDRA (22.0) | Systematic Assessment |
|
| Tinea infection | Infections and infestations | MedDRA (22.0) | Systematic Assessment |
|
| Tinea pedis | Infections and infestations | MedDRA (22.0) | Systematic Assessment |
|
| Tonsillitis | Infections and infestations | MedDRA (22.0) | Systematic Assessment |
|
| Tracheobronchitis | Infections and infestations | MedDRA (22.0) | Systematic Assessment |
|
| Tuberculosis | Infections and infestations | MedDRA (22.0) | Systematic Assessment |
|
| Vulvovaginal candidiasis | Infections and infestations | MedDRA (22.0) | Systematic Assessment |
|
| Pyrexia | General disorders | MedDRA (22.0) | Systematic Assessment |
|
| Fatigue | General disorders | MedDRA (22.0) | Systematic Assessment |
|
| Pain | General disorders | MedDRA (22.0) | Systematic Assessment |
|
| Malaise | General disorders | MedDRA (22.0) | Systematic Assessment |
|
| Oedema peripheral | General disorders | MedDRA (22.0) | Systematic Assessment |
|
| Non-cardiac chest pain | General disorders | MedDRA (22.0) | Systematic Assessment |
|
| Asthenia | General disorders | MedDRA (22.0) | Systematic Assessment |
|
| Chills | General disorders | MedDRA (22.0) | Systematic Assessment |
|
| Mucosal inflammation | General disorders | MedDRA (22.0) | Systematic Assessment |
|
| Swelling | General disorders | MedDRA (22.0) | Systematic Assessment |
|
| Adverse drug reaction | General disorders | MedDRA (22.0) | Systematic Assessment |
|
| Chest discomfort | General disorders | MedDRA (22.0) | Systematic Assessment |
|
| Peripheral swelling | General disorders | MedDRA (22.0) | Systematic Assessment |
|
| Axillary pain | General disorders | MedDRA (22.0) | Systematic Assessment |
|
| Catheter site pain | General disorders | MedDRA (22.0) | Systematic Assessment |
|
| Chest pain | General disorders | MedDRA (22.0) | Systematic Assessment |
|
| Extravasation | General disorders | MedDRA (22.0) | Systematic Assessment |
|
| Gait disturbance | General disorders | MedDRA (22.0) | Systematic Assessment |
|
| Hyperthermia | General disorders | MedDRA (22.0) | Systematic Assessment |
|
| Inflammation | General disorders | MedDRA (22.0) | Systematic Assessment |
|
| Influenza like illness | General disorders | MedDRA (22.0) | Systematic Assessment |
|
| Injection site hypoaesthesia | General disorders | MedDRA (22.0) | Systematic Assessment |
|
| Injection site pain | General disorders | MedDRA (22.0) | Systematic Assessment |
|
| Sensation of foreign body | General disorders | MedDRA (22.0) | Systematic Assessment |
|
| Vessel puncture site pain | General disorders | MedDRA (22.0) | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (22.0) | Systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (22.0) | Systematic Assessment |
|
| Pulmonary toxicity | Respiratory, thoracic and mediastinal disorders | MedDRA (22.0) | Systematic Assessment |
|
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA (22.0) | Systematic Assessment |
|
| Productive cough | Respiratory, thoracic and mediastinal disorders | MedDRA (22.0) | Systematic Assessment |
|
| Dyspnoea exertional | Respiratory, thoracic and mediastinal disorders | MedDRA (22.0) | Systematic Assessment |
|
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA (22.0) | Systematic Assessment |
|
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA (22.0) | Systematic Assessment |
|
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA (22.0) | Systematic Assessment |
|
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | MedDRA (22.0) | Systematic Assessment |
|
| Wheezing | Respiratory, thoracic and mediastinal disorders | MedDRA (22.0) | Systematic Assessment |
|
| Dysphonia | Respiratory, thoracic and mediastinal disorders | MedDRA (22.0) | Systematic Assessment |
|
| Hiccups | Respiratory, thoracic and mediastinal disorders | MedDRA (22.0) | Systematic Assessment |
|
| Acute pulmonary oedema | Respiratory, thoracic and mediastinal disorders | MedDRA (22.0) | Systematic Assessment |
|
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA (22.0) | Systematic Assessment |
|
| Hydrothorax | Respiratory, thoracic and mediastinal disorders | MedDRA (22.0) | Systematic Assessment |
|
| Lung disorder | Respiratory, thoracic and mediastinal disorders | MedDRA (22.0) | Systematic Assessment |
|
| Lung infiltration | Respiratory, thoracic and mediastinal disorders | MedDRA (22.0) | Systematic Assessment |
|
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA (22.0) | Systematic Assessment |
|
| Organising pneumonia | Respiratory, thoracic and mediastinal disorders | MedDRA (22.0) | Systematic Assessment |
|
| Oropharyngeal spasm | Respiratory, thoracic and mediastinal disorders | MedDRA (22.0) | Systematic Assessment |
|
| Pharyngeal disorder | Respiratory, thoracic and mediastinal disorders | MedDRA (22.0) | Systematic Assessment |
|
| Pulmonary artery thrombosis | Respiratory, thoracic and mediastinal disorders | MedDRA (22.0) | Systematic Assessment |
|
| Pulmonary fibrosis | Respiratory, thoracic and mediastinal disorders | MedDRA (22.0) | Systematic Assessment |
|
| Pulmonary hypertension | Respiratory, thoracic and mediastinal disorders | MedDRA (22.0) | Systematic Assessment |
|
| Pulmonary mass | Respiratory, thoracic and mediastinal disorders | MedDRA (22.0) | Systematic Assessment |
|
| Rhinitis allergic | Respiratory, thoracic and mediastinal disorders | MedDRA (22.0) | Systematic Assessment |
|
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA (22.0) | Systematic Assessment |
|
| Sputum increased | Respiratory, thoracic and mediastinal disorders | MedDRA (22.0) | Systematic Assessment |
|
| Tachypnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (22.0) | Systematic Assessment |
|
| Upper-airway cough syndrome | Respiratory, thoracic and mediastinal disorders | MedDRA (22.0) | Systematic Assessment |
|
| Neuropathy peripheral | Nervous system disorders | MedDRA (22.0) | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA (22.0) | Systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA (22.0) | Systematic Assessment |
|
| Hypoaesthesia | Nervous system disorders | MedDRA (22.0) | Systematic Assessment |
|
| Facial paralysis | Nervous system disorders | MedDRA (22.0) | Systematic Assessment |
|
| Neurotoxicity | Nervous system disorders | MedDRA (22.0) | Systematic Assessment |
|
| Paraesthesia | Nervous system disorders | MedDRA (22.0) | Systematic Assessment |
|
| Peripheral sensory neuropathy | Nervous system disorders | MedDRA (22.0) | Systematic Assessment |
|
| Cerebellar infarction | Nervous system disorders | MedDRA (22.0) | Systematic Assessment |
|
| Lethargy | Nervous system disorders | MedDRA (22.0) | Systematic Assessment |
|
| Neuritis | Nervous system disorders | MedDRA (22.0) | Systematic Assessment |
|
| Polyneuropathy | Nervous system disorders | MedDRA (22.0) | Systematic Assessment |
|
| Somnolence | Nervous system disorders | MedDRA (22.0) | Systematic Assessment |
|
| Taste disorder | Nervous system disorders | MedDRA (22.0) | Systematic Assessment |
|
| Toxic neuropathy | Nervous system disorders | MedDRA (22.0) | Systematic Assessment |
|
| Neutrophil count decreased | Investigations | MedDRA (22.0) | Systematic Assessment |
|
| Haemoglobin decreased | Investigations | MedDRA (22.0) | Systematic Assessment |
|
| Platelet count decreased | Investigations | MedDRA (22.0) | Systematic Assessment |
|
| Weight decreased | Investigations | MedDRA (22.0) | Systematic Assessment |
|
| White blood cell count decreased | Investigations | MedDRA (22.0) | Systematic Assessment |
|
| Alanine aminotransferase increased | Investigations | MedDRA (22.0) | Systematic Assessment |
|
| International normalised ratio increased | Investigations | MedDRA (22.0) | Systematic Assessment |
|
| Transaminases increased | Investigations | MedDRA (22.0) | Systematic Assessment |
|
| Aspartate aminotransferase increased | Investigations | MedDRA (22.0) | Systematic Assessment |
|
| Blood creatinine increased | Investigations | MedDRA (22.0) | Systematic Assessment |
|
| Blood glucose increased | Investigations | MedDRA (22.0) | Systematic Assessment |
|
| Blood uric acid increased | Investigations | MedDRA (22.0) | Systematic Assessment |
|
| Campylobacter test positive | Investigations | MedDRA (22.0) | Systematic Assessment |
|
| Cytomegalovirus test | Investigations | MedDRA (22.0) | Systematic Assessment |
|
| Ejection fraction decreased | Investigations | MedDRA (22.0) | Systematic Assessment |
|
| HIV test positive | Investigations | MedDRA (22.0) | Systematic Assessment |
|
| Oxygen saturation decreased | Investigations | MedDRA (22.0) | Systematic Assessment |
|
| Serum ferritin increased | Investigations | MedDRA (22.0) | Systematic Assessment |
|
| Total lung capacity decreased | Investigations | MedDRA (22.0) | Systematic Assessment |
|
| Transaminases abnormal | Investigations | MedDRA (22.0) | Systematic Assessment |
|
| Urine analysis normal | Investigations | MedDRA (22.0) | Systematic Assessment |
|
| Venous pressure | Investigations | MedDRA (22.0) | Systematic Assessment |
|
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA (22.0) | Systematic Assessment |
|
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA (22.0) | Systematic Assessment |
|
| Night sweats | Skin and subcutaneous tissue disorders | MedDRA (22.0) | Systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA (22.0) | Systematic Assessment |
|
| Rash pruritic | Skin and subcutaneous tissue disorders | MedDRA (22.0) | Systematic Assessment |
|
| Skin hyperpigmentation | Skin and subcutaneous tissue disorders | MedDRA (22.0) | Systematic Assessment |
|
| Dermatitis | Skin and subcutaneous tissue disorders | MedDRA (22.0) | Systematic Assessment |
|
| Erythema | Skin and subcutaneous tissue disorders | MedDRA (22.0) | Systematic Assessment |
|
| Rash maculo-papular | Skin and subcutaneous tissue disorders | MedDRA (22.0) | Systematic Assessment |
|
| Drug eruption | Skin and subcutaneous tissue disorders | MedDRA (22.0) | Systematic Assessment |
|
| Hyperhidrosis | Skin and subcutaneous tissue disorders | MedDRA (22.0) | Systematic Assessment |
|
| Dermatitis allergic | Skin and subcutaneous tissue disorders | MedDRA (22.0) | Systematic Assessment |
|
| Eczema | Skin and subcutaneous tissue disorders | MedDRA (22.0) | Systematic Assessment |
|
| Rash generalised | Skin and subcutaneous tissue disorders | MedDRA (22.0) | Systematic Assessment |
|
| Pruritus generalised | Skin and subcutaneous tissue disorders | MedDRA (22.0) | Systematic Assessment |
|
| Rash papular | Skin and subcutaneous tissue disorders | MedDRA (22.0) | Systematic Assessment |
|
| Skin exfoliation | Skin and subcutaneous tissue disorders | MedDRA (22.0) | Systematic Assessment |
|
| Skin reaction | Skin and subcutaneous tissue disorders | MedDRA (22.0) | Systematic Assessment |
|
| Swelling face | Skin and subcutaneous tissue disorders | MedDRA (22.0) | Systematic Assessment |
|
| Blister | Skin and subcutaneous tissue disorders | MedDRA (22.0) | Systematic Assessment |
|
| Dermatitis acneiform | Skin and subcutaneous tissue disorders | MedDRA (22.0) | Systematic Assessment |
|
| Dermatosis | Skin and subcutaneous tissue disorders | MedDRA (22.0) | Systematic Assessment |
|
| Generalised erythema | Skin and subcutaneous tissue disorders | MedDRA (22.0) | Systematic Assessment |
|
| Hidradenitis | Skin and subcutaneous tissue disorders | MedDRA (22.0) | Systematic Assessment |
|
| Nail discolouration | Skin and subcutaneous tissue disorders | MedDRA (22.0) | Systematic Assessment |
|
| Nail disorder | Skin and subcutaneous tissue disorders | MedDRA (22.0) | Systematic Assessment |
|
| Onychomadesis | Skin and subcutaneous tissue disorders | MedDRA (22.0) | Systematic Assessment |
|
| Papule | Skin and subcutaneous tissue disorders | MedDRA (22.0) | Systematic Assessment |
|
| Pigmentation disorder | Skin and subcutaneous tissue disorders | MedDRA (22.0) | Systematic Assessment |
|
| Post inflammatory pigmentation change | Skin and subcutaneous tissue disorders | MedDRA (22.0) | Systematic Assessment |
|
| Psoriasis | Skin and subcutaneous tissue disorders | MedDRA (22.0) | Systematic Assessment |
|
| Rash macular | Skin and subcutaneous tissue disorders | MedDRA (22.0) | Systematic Assessment |
|
| Skin discolouration | Skin and subcutaneous tissue disorders | MedDRA (22.0) | Systematic Assessment |
|
| Skin toxicity | Skin and subcutaneous tissue disorders | MedDRA (22.0) | Systematic Assessment |
|
| Bone pain | Musculoskeletal and connective tissue disorders | MedDRA (22.0) | Systematic Assessment |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA (22.0) | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (22.0) | Systematic Assessment |
|
| Musculoskeletal chest pain | Musculoskeletal and connective tissue disorders | MedDRA (22.0) | Systematic Assessment |
|
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA (22.0) | Systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (22.0) | Systematic Assessment |
|
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA (22.0) | Systematic Assessment |
|
| Flank pain | Musculoskeletal and connective tissue disorders | MedDRA (22.0) | Systematic Assessment |
|
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA (22.0) | Systematic Assessment |
|
| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA (22.0) | Systematic Assessment |
|
| Pain in jaw | Musculoskeletal and connective tissue disorders | MedDRA (22.0) | Systematic Assessment |
|
| Clubbing | Musculoskeletal and connective tissue disorders | MedDRA (22.0) | Systematic Assessment |
|
| Enthesopathy | Musculoskeletal and connective tissue disorders | MedDRA (22.0) | Systematic Assessment |
|
| Musculoskeletal discomfort | Musculoskeletal and connective tissue disorders | MedDRA (22.0) | Systematic Assessment |
|
| Musculoskeletal stiffness | Musculoskeletal and connective tissue disorders | MedDRA (22.0) | Systematic Assessment |
|
| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA (22.0) | Systematic Assessment |
|
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA (22.0) | Systematic Assessment |
|
| Periostitis | Musculoskeletal and connective tissue disorders | MedDRA (22.0) | Systematic Assessment |
|
| Spinal pain | Musculoskeletal and connective tissue disorders | MedDRA (22.0) | Systematic Assessment |
|
| Decreased appetite | Metabolism and nutrition disorders | MedDRA (22.0) | Systematic Assessment |
|
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA (22.0) | Systematic Assessment |
|
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA (22.0) | Systematic Assessment |
|
| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA (22.0) | Systematic Assessment |
|
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA (22.0) | Systematic Assessment |
|
| Fluid overload | Metabolism and nutrition disorders | MedDRA (22.0) | Systematic Assessment |
|
| Hyperlipidaemia | Metabolism and nutrition disorders | MedDRA (22.0) | Systematic Assessment |
|
| Hypoalbuminaemia | Metabolism and nutrition disorders | MedDRA (22.0) | Systematic Assessment |
|
| Hypocalcaemia | Metabolism and nutrition disorders | MedDRA (22.0) | Systematic Assessment |
|
| Hypophagia | Metabolism and nutrition disorders | MedDRA (22.0) | Systematic Assessment |
|
| Increased appetite | Metabolism and nutrition disorders | MedDRA (22.0) | Systematic Assessment |
|
| Iron overload | Metabolism and nutrition disorders | MedDRA (22.0) | Systematic Assessment |
|
| Steroid diabetes | Metabolism and nutrition disorders | MedDRA (22.0) | Systematic Assessment |
|
| Deep vein thrombosis | Vascular disorders | MedDRA (22.0) | Systematic Assessment |
|
| Hot flush | Vascular disorders | MedDRA (22.0) | Systematic Assessment |
|
| Orthostatic hypotension | Vascular disorders | MedDRA (22.0) | Systematic Assessment |
|
| Thrombophlebitis superficial | Vascular disorders | MedDRA (22.0) | Systematic Assessment |
|
| Hypotension | Vascular disorders | MedDRA (22.0) | Systematic Assessment |
|
| Jugular vein thrombosis | Vascular disorders | MedDRA (22.0) | Systematic Assessment |
|
| Pallor | Vascular disorders | MedDRA (22.0) | Systematic Assessment |
|
| Phlebitis | Vascular disorders | MedDRA (22.0) | Systematic Assessment |
|
| Thrombophlebitis | Vascular disorders | MedDRA (22.0) | Systematic Assessment |
|
| Thrombosis | Vascular disorders | MedDRA (22.0) | Systematic Assessment |
|
| Embolism venous | Vascular disorders | MedDRA (22.0) | Systematic Assessment |
|
| Superior vena cava syndrome | Vascular disorders | MedDRA (22.0) | Systematic Assessment |
|
| Varicose vein | Vascular disorders | MedDRA (22.0) | Systematic Assessment |
|
| Vasculitis | Vascular disorders | MedDRA (22.0) | Systematic Assessment |
|
| Venous thrombosis | Vascular disorders | MedDRA (22.0) | Systematic Assessment |
|
| Toxicity to various agents | Injury, poisoning and procedural complications | MedDRA (22.0) | Systematic Assessment |
|
| Traumatic lung injury | Injury, poisoning and procedural complications | MedDRA (22.0) | Systematic Assessment |
|
| Fall | Injury, poisoning and procedural complications | MedDRA (22.0) | Systematic Assessment |
|
| Gastrointestinal injury | Injury, poisoning and procedural complications | MedDRA (22.0) | Systematic Assessment |
|
| Infusion related reaction | Injury, poisoning and procedural complications | MedDRA (22.0) | Systematic Assessment |
|
| Joint dislocation | Injury, poisoning and procedural complications | MedDRA (22.0) | Systematic Assessment |
|
| Joint injury | Injury, poisoning and procedural complications | MedDRA (22.0) | Systematic Assessment |
|
| Radiation pneumonitis | Injury, poisoning and procedural complications | MedDRA (22.0) | Systematic Assessment |
|
| Transfusion reaction | Injury, poisoning and procedural complications | MedDRA (22.0) | Systematic Assessment |
|
| Insomnia | Psychiatric disorders | MedDRA (22.0) | Systematic Assessment |
|
| Anxiety | Psychiatric disorders | MedDRA (22.0) | Systematic Assessment |
|
| Depression | Psychiatric disorders | MedDRA (22.0) | Systematic Assessment |
|
| Bipolar I disorder | Psychiatric disorders | MedDRA (22.0) | Systematic Assessment |
|
| Confusional state | Psychiatric disorders | MedDRA (22.0) | Systematic Assessment |
|
| Delirium | Psychiatric disorders | MedDRA (22.0) | Systematic Assessment |
|
| Depressed mood | Psychiatric disorders | MedDRA (22.0) | Systematic Assessment |
|
| Drug hypersensitivity | Immune system disorders | MedDRA (22.0) | Systematic Assessment |
|
| Graft versus host disease in skin | Immune system disorders | MedDRA (22.0) | Systematic Assessment |
|
| Hypersensitivity | Immune system disorders | MedDRA (22.0) | Systematic Assessment |
|
| Anaphylactic reaction | Immune system disorders | MedDRA (22.0) | Systematic Assessment |
|
| Chronic graft versus host disease | Immune system disorders | MedDRA (22.0) | Systematic Assessment |
|
| Chronic graft versus host disease in skin | Immune system disorders | MedDRA (22.0) | Systematic Assessment |
|
| Engraftment syndrome | Immune system disorders | MedDRA (22.0) | Systematic Assessment |
|
| Graft versus host disease | Immune system disorders | MedDRA (22.0) | Systematic Assessment |
|
| Palpitations | Cardiac disorders | MedDRA (22.0) | Systematic Assessment |
|
| Angina pectoris | Cardiac disorders | MedDRA (22.0) | Systematic Assessment |
|
| Arrhythmia | Cardiac disorders | MedDRA (22.0) | Systematic Assessment |
|
| Atrial fibrillation | Cardiac disorders | MedDRA (22.0) | Systematic Assessment |
|
| Tachycardia | Cardiac disorders | MedDRA (22.0) | Systematic Assessment |
|
| Cystitis haemorrhagic | Renal and urinary disorders | MedDRA (22.0) | Systematic Assessment |
|
| Dysuria | Renal and urinary disorders | MedDRA (22.0) | Systematic Assessment |
|
| Acute kidney injury | Renal and urinary disorders | MedDRA (22.0) | Systematic Assessment |
|
| Nephrolithiasis | Renal and urinary disorders | MedDRA (22.0) | Systematic Assessment |
|
| Renal impairment | Renal and urinary disorders | MedDRA (22.0) | Systematic Assessment |
|
| Renal vascular thrombosis | Renal and urinary disorders | MedDRA (22.0) | Systematic Assessment |
|
| Renal vein thrombosis | Renal and urinary disorders | MedDRA (22.0) | Systematic Assessment |
|
| Urinary tract disorder | Renal and urinary disorders | MedDRA (22.0) | Systematic Assessment |
|
| Tinnitus | Ear and labyrinth disorders | MedDRA (22.0) | Systematic Assessment |
|
| Hypoacusis | Ear and labyrinth disorders | MedDRA (22.0) | Systematic Assessment |
|
| Vertigo | Ear and labyrinth disorders | MedDRA (22.0) | Systematic Assessment |
|
| Vision blurred | Eye disorders | MedDRA (22.0) | Systematic Assessment |
|
| Macular pigmentation | Eye disorders | MedDRA (22.0) | Systematic Assessment |
|
| Swelling of eyelid | Eye disorders | MedDRA (22.0) | Systematic Assessment |
|
| Visual acuity reduced | Eye disorders | MedDRA (22.0) | Systematic Assessment |
|
| Diffuse large B-cell lymphoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (22.0) | Systematic Assessment |
|
| Gastrooesophageal cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (22.0) | Systematic Assessment |
|
| Marginal zone lymphoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (22.0) | Systematic Assessment |
|
| Ovarian germ cell teratoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (22.0) | Systematic Assessment |
|
| Gynaecomastia | Reproductive system and breast disorders | MedDRA (22.0) | Systematic Assessment |
|
| Vaginal discharge | Reproductive system and breast disorders | MedDRA (22.0) | Systematic Assessment |
|
| Vaginal haemorrhage | Reproductive system and breast disorders | MedDRA (22.0) | Systematic Assessment |
|
| Vulvovaginal pruritus | Reproductive system and breast disorders | MedDRA (22.0) | Systematic Assessment |
|
| Hepatic steatosis | Hepatobiliary disorders | MedDRA (22.0) | Systematic Assessment |
|
| Hepatitis toxic | Hepatobiliary disorders | MedDRA (22.0) | Systematic Assessment |
|
| Hepatotoxicity | Hepatobiliary disorders | MedDRA (22.0) | Systematic Assessment |
|
| Jaundice | Hepatobiliary disorders | MedDRA (22.0) | Systematic Assessment |
|
| Hypothyroidism | Endocrine disorders | MedDRA (22.0) | Systematic Assessment |
|
| Autoimmune hypothyroidism | Endocrine disorders | MedDRA (22.0) | Systematic Assessment |
|
| Hydrocele | Congenital, familial and genetic disorders | MedDRA (22.0) | Systematic Assessment |
|
| Catheter site rash | General disorders | MedDRA (22.0) | Systematic Assessment |
|
| Hypoaesthesia oral | Gastrointestinal disorders | MedDRA (22.0) | Systematic Assessment |
|
| Ileus | Gastrointestinal disorders | MedDRA (22.0) | Systematic Assessment |
|
| Tongue ulceration | Gastrointestinal disorders | MedDRA (22.0) | Systematic Assessment |
|
| Bronchiolitis | Infections and infestations | MedDRA (22.0) | Systematic Assessment |
|
| Febrile infection | Infections and infestations | MedDRA (22.0) | Systematic Assessment |
|
| Postoperative wound infection | Infections and infestations | MedDRA (22.0) | Systematic Assessment |
|
| Tooth abscess | Infections and infestations | MedDRA (22.0) | Systematic Assessment |
|
| Pleuritic pain | Respiratory, thoracic and mediastinal disorders | MedDRA (22.0) | Systematic Assessment |
|
| Presyncope | Nervous system disorders | MedDRA (22.0) | Systematic Assessment |
|
| Syncope | Nervous system disorders | MedDRA (22.0) | Systematic Assessment |
|
| Dyshidrotic eczema | Skin and subcutaneous tissue disorders | MedDRA (22.0) | Systematic Assessment |
|
| Arthritis | Musculoskeletal and connective tissue disorders | MedDRA (22.0) | Systematic Assessment |
|
| Joint swelling | Musculoskeletal and connective tissue disorders | MedDRA (22.0) | Systematic Assessment |
|
| Dehydration | Metabolism and nutrition disorders | MedDRA (22.0) | Systematic Assessment |
|
| Diabetic metabolic decompensation | Metabolism and nutrition disorders | MedDRA (22.0) | Systematic Assessment |
|
| Cardiomyopathy | Cardiac disorders | MedDRA (22.0) | Systematic Assessment |
|
| Hepatic function abnormal | Hepatobiliary disorders | MedDRA (22.0) | Systematic Assessment |
|
| Liver injury | Hepatobiliary disorders | MedDRA (22.0) | Systematic Assessment |
|
| Ovarian cyst | Reproductive system and breast disorders | MedDRA (22.0) | Systematic Assessment |
|
The first study related publication will be a multi-center publication submitted within 24 months after conclusion or termination of a study at all sites. After such multi site publication, all proposed site publications and presentations will be submitted to sponsor for review 60 days in advance of publication. Site will remove Sponsor confidential information unrelated to study results. Sponsor can delay a proposed publication for another 60 days to preserve intellectual property.
| Stage II-B |
|
| Stage III-A |
|
| Stage III-B |
|
| Stage IV-A |
|
| Stage IV-B |
|
| Stage unknown |
|
| Stage II-B |
|
| Stage III-A |
|
| Stage III-B |
|
| Stage IV-A |
|
| Stage IV-B |
|
| Stage unknown |
|
| Stage II-A |
|
| Stage II-B |
|
| Stage III-A |
|
| Stage III-B |
|
| Stage IV-A |
|
| Stage IV-B |
|
| Stage unknown |
|
| Clinical stage at 3rd relapse |
|
|
| Clinical stage at 4th relapse |
|
|
| Clinical stage at 5th relapse |
|
|
| Title | Measurements |
|---|---|
|
| Pre-SCT line treatment |
|
| Title | Measurements |
|---|---|
|
| Therapy regimen 7 |
|
| Therapy regimen 8 |
|
| Therapy regimen 10 |
|
| Therapy regimen 11 |
|
| Therapy regimen 17 |
|
| Therapy regimen 18 |
|
| Therapy regimen 4 |
|
| Therapy regimen 14 |
|
| Therapy regimen 15 |
|
| Therapy regimen 2 |
|
| Therapy regimen 24 |
|
|
| Therapy regimen 6 |
|
|
| Therapy regimen 7 |
|
|
| Therapy regimen 8 |
|
|
| Therapy regimen 10 |
|
|
| Therapy regimen 11 |
|
|
| Therapy regimen 17 |
|
|
| Therapy regimen 18 |
|
|
| Therapy regimen 4 |
|
|
| Therapy regimen 14 |
|
|
| Therapy regimen 15 |
|
|
| Therapy regimen 2 |
|
|
| Therapy regimen 24 |
|
|
| Title | Measurements |
|---|---|
|
| Therapy regimen 8 |
|
| Therapy regimen 10 |
|
| Therapy regimen 11 |
|
| Therapy regimen 12 |
|
| Therapy regimen 13 |
|
| Therapy regimen 18 |
|
| Therapy regimen 16 |
|
| Therapy regimen 4 |
|
| Therapy regimen 14 |
|
| Therapy regimen 24 |
|
| Title | Measurements |
|---|---|
|
| RT Type: Involved-node |
|
| RT Type: Other |
|
| RT Site: Abdominal nodes |
|
| RT Site: Axillary nodes |
|
| RT Site: Bone lesions |
|
| RT Site: Breast |
|
| RT Site: Cervix |
|
| RT Site: Inguinal nodes |
|
| RT Site: Larynx |
|
| RT Site: Lung |
|
| RT Site: Mediastinal nodes |
|
| RT Site: Neck nodes |
|
| RT Site: Pancreas |
|
| RT Site: Para-aortic nodes |
|
| RT Site: Para-iliac nodes |
|
| RT Site: Pelvic nodes |
|
| RT Site: Skin |
|
| RT Site: Soft tissue |
|
| RT Site: Spleen |
|
| RT Site: Supraclavicular nodes |
|
| RT Site: Thyroid |
|
| RT Site: Other |
|
|
| Initially ineligible and became eligible for ASCT |
|
|
| Became eligible and received ASCT |
|
|
| Eligible and received ASCT |
|
|
| Eligible and did not receive ASCT |
|
|
|
| Therapy regimen 8 |
|
|
| Therapy regimen 11 |
|
|
| Therapy regimen 12 |
|
|
| Therapy regimen 18 |
|
|
| Therapy regimen 22 |
|
|
| Therapy regimen 24 |
|
|
| Title | Measurements |
|---|---|
|
| Cumulative Toxicities |
|
| Other |
|
| Comorbid conditions |
|
| Unknown |
|
|
| Chemo-resistant disease |
|
|
| Cumulative toxicities |
|
|
| Other |
|
|
| Participant refusal |
|
|
| Inability to mobilize stem cells |
|
|
| Loss of response to chemotherapy |
|
|
| Unknown |
|
|
|
| Frontline: Therapy regimen 6 |
|
|
| Frontline: Therapy regimen 7 |
|
|
| Frontline: Therapy regimen 11 |
|
|
| Frontline: Therapy regimen 18 |
|
|
| Front line: Therapy regimen 4 |
|
|
| Frontline: Therapy regimen 14 |
|
|
| Frontline: Therapy regimen 15 |
|
|
| Frontline: Therapy regimen 2 |
|
|
| Frontline: Therapy regimen 24 |
|
|
| Second line: Therapy regimen 1 |
|
|
| Second line: Therapy regimen 6 |
|
|
| Second line: Therapy regimen 7 |
|
|
| Second line: Therapy regimen 8 |
|
|
| Second line: Therapy regimen 9 |
|
|
| Second line: Therapy regimen 10 |
|
|
| Second line: Therapy regimen 11 |
|
|
| Second line: Therapy regimen 13 |
|
|
| Second line: Therapy regimen 17 |
|
|
| Second line: Therapy regimen 18 |
|
|
| Second line: Therapy regimen 19 |
|
|
| Second line: Therapy regimen 4 |
|
|
| Second line: Therapy regimen 14 |
|
|
| Second line: Therapy regimen 15 |
|
|
| Second line: Therapy regimen 2 |
|
|
| Second line: Therapy regimen 24 |
|
|
| Third line: Therapy regimen 1 |
|
|
| Third line: Therapy regimen 7 |
|
|
| Third line: Therapy regimen 8 |
|
|
| Third line: Therapy regimen 9 |
|
|
| Third line: Therapy regimen 10 |
|
|
| Third line: Therapy regimen 11 |
|
|
| Third line: Therapy regimen 13 |
|
|
| Third line: Therapy regimen 17 |
|
|
| Third line: Therapy regimen 18 |
|
|
| Third line: Therapy regimen 22 |
|
|
| Third line: Therapy regimen 4 |
|
|
| Third line: Therapy regimen 24 |
|
|
| Other treatment: Therapy regimen 6 |
|
|
| Other treatment: Therapy regimen 7 |
|
|
| Other treatment: Therapy regimen 10 |
|
|
| Other treatment: Therapy regimen 13 |
|
|
| Other treatment: Therapy regimen 18 |
|
|
| Other treatment: Therapy regimen 22 |
|
|
| Other treatment: Therapy regimen 16 |
|
|
| Other treatment: Therapy regimen 4 |
|
|
|
| Title | Measurements |
|---|---|
|
|
| Frequency of PET or PET-CT Scan at Relapse |
|
|
|
| Frontline: Therapy regimen 6 |
|
|
| Frontline: Therapy regimen 7 |
|
|
| Frontline: Therapy regimen 11 |
|
|
| Frontline: Therapy regimen 18 |
|
|
| Frontline: Therapy regimen 4 |
|
|
| Frontline: Therapy regimen 14 |
|
|
| Frontline: Therapy regimen 15 |
|
|
| Frontline: Therapy regimen 2 |
|
|
| Frontline: Therapy regimen 24 |
|
|
| Second line: Therapy regimen 1 |
|
|
| Second line: Therapy regimen 6 |
|
|
| Second line: Therapy regimen 7 |
|
|
| Second line: Therapy regimen 8 |
|
|
| Second line: Therapy regimen 9 |
|
|
| Second line: Therapy regimen 10 |
|
|
| Second line: Therapy regimen 11 |
|
|
| Second line: Therapy regimen 13 |
|
|
| Second line: Therapy regimen 24 |
|
|
| Second line: Therapy regimen 17 |
|
|
| Second line: Therapy regimen 18 |
|
|
| Second line: Therapy regimen 19 |
|
|
| Second line: Therapy regimen 4 |
|
|
| Second line: Therapy regimen 14 |
|
|
| Second line: Therapy regimen 15 |
|
|
| Second line: Therapy regimen 2 |
|
|
| Third line: Therapy regimen 1 |
|
|
| Third line: Therapy regimen 7 |
|
|
| Third line: Therapy regimen 8 |
|
|
| Third line: Therapy regimen 9 |
|
|
| Third line: Therapy regimen 10 |
|
|
| Third line: Therapy regimen 11 |
|
|
| Third line: Therapy regimen 13 |
|
|
| Third line: Therapy regimen 18 |
|
|
| Third line: Therapy regimen 17 |
|
|
| Third line: Therapy regimen 22 |
|
|
| Third line: Therapy regimen 4 |
|
|
| Third line: Therapy regimen 24 |
|
|
| Other treatments: Therapy regimen 6 |
|
|
| Other treatments: Therapy regimen 8 |
|
|
| Other treatments: Therapy regimen 10 |
|
|
| Other treatments: Therapy regimen 13 |
|
|
| Other treatments: Therapy regimen 18 |
|
|
| Other treatments: Therapy regimen 22 |
|
|
| Other treatments: Therapy regimen 16 |
|
|
| Other treatments: Therapy regimen 4 |
|
|
| Other treatments: Therapy regimen 24 |
|
|
|
| Third line Treatment |
|
|
| Other Treatment |
|
|
|
| Frontline: Therapy regimen 6 |
|
|
| Frontline: Therapy regimen 7 |
|
|
| Frontline: Therapy regimen 11 |
|
|
| Frontline: Therapy regimen 18 |
|
|
| Frontline: Therapy regimen 4 |
|
|
| Frontline: Therapy regimen 15 |
|
|
| Frontline: Therapy regimen 14 |
|
|
| Frontline: Therapy regimen 2 |
|
|
| Frontline: Therapy regimen 24 |
|
|
| Second line: Therapy regimen 1 |
|
|
| Second line: Therapy regimen 6 |
|
|
| Second line: Therapy regimen 7 |
|
|
| Second line: Therapy regimen 8 |
|
|
| Second line: Therapy regimen 9 |
|
|
| Second line: Therapy regimen 10 |
|
|
| Second line: Therapy regimen 11 |
|
|
| Second line: Therapy regimen 13 |
|
|
| Second line: Therapy regimen 17 |
|
|
| Second line: Therapy regimen 18 |
|
|
| Second line: Therapy regimen 19 |
|
|
| Second line: Therapy regimen 14 |
|
|
| Second line: Therapy regimen 15 |
|
|
| Second line: Therapy regimen 2 |
|
|
| Second line: Therapy regimen 24 |
|
|
| Third line: Therapy regimen 1 |
|
|
| Third line: Therapy regimen 7 |
|
|
| Third line: Therapy regimen 8 |
|
|
| Third line: Therapy regimen 9 |
|
|
| Third line: Therapy regimen 10 |
|
|
| Third line: Therapy regimen 11 |
|
|
| Third line: Therapy regimen 13 |
|
|
| Third line: Therapy regimen 17 |
|
|
| Third line: Therapy regimen 18 |
|
|
| Third line: Therapy regimen 22 |
|
|
| Third line: Therapy regimen 4 |
|
|
| Third line: Therapy regimen 24 |
|
|
| Other treatment: Therapy regimen 6 |
|
|
| Other treatment: Therapy regimen 8 |
|
|
| Other treatment: Therapy regimen 10 |
|
|
| Other treatment: Therapy regimen 13 |
|
|
| Other treatment: Therapy regimen 18 |
|
|
| Other treatment: Therapy regimen 22 |
|
|
| Other treatment: Therapy regimen 16 |
|
|
| Other treatment: Therapy regimen 4 |
|
|
| Other treatment: Therapy regimen 24 |
|
|
|
| Title | Measurements |
|---|---|
|
| RT Type: Involved-node |
|
| RT Site: Abdominal nodes |
|
| RT Site: Axillary nodes |
|
| RT Site: Breast |
|
| RT Site: Inguinal nodes |
|
| RT Site: Liver |
|
| RT Site: Mediastinal nodes |
|
| RT Site: Neck nodes |
|
| RT Site: Para-iliac nodes |
|
| RT Site: Pelvic nodes |
|
| RT Site: Soft tissue |
|
| RT Site: Other |
|
| Title | Measurements |
|---|---|
|
| RT Type: Involved-node |
|
| RT Type: Other |
|
| RT Site: Abdominal nodes |
|
| RT Site: Axillary nodes |
|
| RT Site: Bone lesions |
|
| RT Site: Brain |
|
| RT Site: Cervix |
|
| RT Site: Inguinal nodes |
|
| RT Site: Mediastinal nodes |
|
| RT Site: Neck nodes |
|
| RT Site: Para-iliac nodes |
|
| RT Site: Pelvic nodes |
|
| RT Site: Supraclavicular nodes |
|
| RT Site: Other |
|
|
|
| Relapse |
|
|
|
| Salvage Regimens: Pre-SCT, Therapy regimen 11 |
|
|
| Salvage Regimens: Pre-SCT, Therapy regimen 12 |
|
|
| Salvage Regimens: Pre-SCT, Therapy regimen 18 |
|
|
| Salvage Regimens: Pre-SCT, Therapy regimen 19 |
|
|
| Salvage Regimens: Pre-SCT, Therapy regimen 16 |
|
|
| Salvage Regimens: Pre-SCT, Therapy regimen 24 |
|
|
| Salvage Regimens: Post-SCT, Therapy regimen 10 |
|
|
| Salvage Regimens: Post-SCT, Therapy regimen 11 |
|
|
| Salvage Regimens: Post-SCT, Therapy regimen 18 |
|
|
| Salvage Regimens: Post-SCT, Therapy regimen 19 |
|
|
| Salvage Regimens: Post-SCT, Therapy regimen 24 |
|
|
| Conditioning Regimens: BEAM |
|
|
| Conditioning Regimens: CBV |
|
|
| Conditioning Regimens: BeEAM |
|
|
| Conditioning Regimens: Gemcitabine/Bu/Mel |
|
|
| Conditioning Regimens: Other |
|
|
| Conditioning Regimens: Unknown |
|
|
| Consolidation Therapy : Post -SCT |
|
|
|
| Bulky disease >=5 cm at relapse |
|
|
| Extranodal disease |
|
|
| Inadequate response to salvage chemotherapy |
|
|
| Performance status (ECOG) >=1 |
|
|
|
| Therapy regimen 7 |
|
|
| Therapy regimen 8 |
|
|
| Therapy regimen 9 |
|
|
| Therapy regimen 10 |
|
|
| Therapy regimen 11 |
|
|
| Therapy regimen 12 |
|
|
| Therapy regimen 13 |
|
|
| Therapy regimen 17 |
|
|
| Therapy regimen 18 |
|
|
| Therapy regimen 19 |
|
|
| Therapy regimen 22 |
|
|
| Therapy regimen 23 |
|
|
| Therapy regimen 16 |
|
|
| Therapy regimen 4 |
|
|
| Therapy regimen 14 |
|
|
| Therapy regimen 2 |
|
|
| Therapy regimen 24 |
|
|
|
| Frontline: Therapy regimen 10 |
|
|
| Frontline: Therapy regimen 11 |
|
|
| Frontline: Therapy regimen 4 |
|
|
| Frontline: Therapy regimen 2 |
|
|
| Frontline: Therapy regimen 24 |
|
|
| Second line: Therapy regimen 7 |
|
|
| Second line: Therapy regimen 8 |
|
|
| Second line: Therapy regimen 10 |
|
|
| Second line: Therapy regimen 11 |
|
|
| Second line: Therapy regimen 12 |
|
|
| Second line: Therapy regimen 13 |
|
|
| Second line: Therapy regimen 18 |
|
|
| Second line: Therapy regimen 4 |
|
|
| Second line: Therapy regimen 24 |
|
|
| Third line: Therapy regimen 7 |
|
|
| Third line: Therapy regimen 8 |
|
|
| Third line: Therapy regimen 9 |
|
|
| Third line: Therapy regimen 10 |
|
|
| Third line: Therapy regimen 11 |
|
|
| Third line: Therapy regimen 12 |
|
|
| Third line: Therapy regimen 13 |
|
|
| Third line: Therapy regimen 18 |
|
|
| Third line: Therapy regimen 22 |
|
|
| Third line: Therapy regimen 23 |
|
|
| Third line: Therapy regimen 16 |
|
|
| Third line: Therapy regimen 4 |
|
|
| Third line: Therapy regimen 24 |
|
|
| Pre-SCT: Therapy regimen 10 |
|
|
| Pre-SCT: Therapy regimen 12 |
|
|
| Pre-SCT: Therapy regimen 18 |
|
|
| Pre-SCT: Therapy regimen 19 |
|
|
| Pre-SCT: Therapy regimen 14 |
|
|
| Pre-SCT: Therapy regimen 24 |
|
|
| Post-SCT: Therapy regimen 18 |
|
|
| Other treatment: Therapy regimen 7 |
|
|
| Other treatment: Therapy regimen 9 |
|
|
| Other treatment: Therapy regimen 10 |
|
|
| Other treatment: Therapy regimen 11 |
|
|
| Other treatment: Therapy regimen 17 |
|
|
| Other treatment: Therapy regimen 18 |
|
|
| Other treatment: Therapy regimen 19 |
|
|
| Other treatment: Therapy regimen 22 |
|
|
| Other treatment: Therapy regimen 23 |
|
|
| Other treatment: Therapy regimen 16 |
|
|
| Other treatment: Therapy regimen 4 |
|
|
| Other treatment: Therapy regimen 24 |
|
|
| Title | Measurements |
|---|---|
|
| Therapy regimen 12 |
|
| Therapy regimen 18 |
|
| Therapy regimen 19 |
|
| Therapy regimen 22 |
|
| Other |
|
|
| Frontline: Therapy regimen 10 |
|
|
| Frontline: Therapy regimen 11 |
|
|
| Frontline: Therapy regimen 4 |
|
|
| Frontline: Therapy regimen 2 |
|
|
| Frontline: Therapy regimen 24 |
|
|
| Second line: Therapy regimen 7 |
|
|
| Second line: Therapy regimen 8 |
|
|
| Second line: Therapy regimen 10 |
|
|
| Second line: Therapy regimen 11 |
|
|
| Second line: Therapy regimen 12 |
|
|
| Second line: Therapy regimen 13 |
|
|
| Second line: Therapy regimen 18 |
|
|
| Second line: Therapy regimen 4 |
|
|
| Second line: Therapy regimen 24 |
|
|
| Third line: Therapy regimen 7 |
|
|
| Third line: Therapy regimen 8 |
|
|
| Third line: Therapy regimen 9 |
|
|
| Third line: Therapy regimen 10 |
|
|
| Third line: Therapy regimen 11 |
|
|
| Third line: Therapy regimen 12 |
|
|
| Third line: Therapy regimen 13 |
|
|
| Third line: Therapy regimen 18 |
|
|
| Third line: Therapy regimen 22 |
|
|
| Third line: Therapy regimen 23 |
|
|
| Third line: Therapy regimen 16 |
|
|
| Third line: Therapy regimen 4 |
|
|
| Pre-SCT: Therapy regimen 10 |
|
|
| Pre-SCT: Therapy regimen 12 |
|
|
| Pre-SCT: Therapy regimen 18 |
|
|
| Pre-SCT: Therapy regimen 19 |
|
|
| Pre-SCT: Therapy regimen 14 |
|
|
| Pre-SCT: Therapy regimen 24 |
|
|
| Post-SCT: Therapy regimen 18 |
|
|
| Other treatment: Therapy regimen 7 |
|
|
| Other treatment: Therapy regimen 9 |
|
|
| Other treatment: Therapy regimen 10 |
|
|
| Other treatment: Therapy regimen 11 |
|
|
| Other treatment: Therapy regimen 17 |
|
|
| Other treatment: Therapy regimen 18 |
|
|
| Other treatment: Therapy regimen 19 |
|
|
| Other treatment: Therapy regimen 22 |
|
|
| Other treatment: Therapy regimen 23 |
|
|
| Other treatment: Therapy regimen 16 |
|
|
| Other treatment: Therapy regimen 4 |
|
|
| Other treatment: Therapy regimen 24 |
|
|
|
| Third line Treatment |
|
|
| Pre-SCT Treatment |
|
|
| Post-SCT Treatment |
|
|
| Other Treatment |
|
|
|
| From ASCT to 3rd treatment |
|
|
| From completion of 1st treatment to next treatment |
|
|
| From completion of 2nd treatment to next treatment |
|
|
|
| PET-CT scan: Relapse and /or refractory |
|
|
| CT scan: Baseline |
|
|
| CT scan: Frontline |
|
|
| CT scan: Relapse and /or refractory |
|
|
| Radiotherapy: Frontline |
|
|
| Radiotherapy: Relapse/refractory |
|
|
|
| PET or PET-CT scan: Relapse /refractory |
|
|
| CT Scan: Baseline |
|
|
| CT Scan: Frontline |
|
|
| CT Scan: Relapse/refractory |
|
|
|
| Frontline: Involved-site radiotherapy |
|
|
| Frontline: Involved-node radiotherapy |
|
|
| Relapse/refractory: Whole body |
|
|
| Relapse/refractory: Involved-field radiotherapy |
|
|
| Relapse/refractory: Involved-site radiotherapy |
|
|
| Relapse/refractory: Involved-node radiotherapy |
|
|
| Relapse/refractory: Other |
|
|
|
| Frontline: Mediastinal nodes |
|
|
| Frontline: Neck nodes |
|
|
| Frontline: Other |
|
|
| Relapse/refractory: Abdominal nodes |
|
|
| Relapse/refractory: Axillary nodes |
|
|
| Relapse/refractory: Bone lesions |
|
|
| Relapse/refractory: Mediastinal nodes |
|
|
| Relapse/refractory: Neck nodes |
|
|
| Relapse/refractory: Other |
|
|
| Title | Measurements |
|---|---|
|
| Relapse/refractory: Palliative Intent |
|
| Relapse/refractory: Other |
|
|
| Title | Measurements |
|---|
|
| PD |
|
| Other |
|
|
| Frontline: SD |
|
|
| Frontline: PD |
|
|
| Frontline: Other |
|
|
| Second line: CR |
|
|
| Second line: PR |
|
|
| Second line: SD |
|
|
| Second line: PD |
|
|
| Second line: Other |
|
|
| Third line: CR |
|
|
| Third line: PR |
|
|
| Third line: SD |
|
|
| Third line: PD |
|
|
| Third line: Other |
|
|
| Pre-SCT: CR |
|
|
| Pre-SCT: PR |
|
|
| Pre-SCT: SD |
|
|
| Pre-SCT: PD |
|
|
| Post-SCT: CR |
|
|
| Pre-SCT: Other |
|
|
| Post-SCT: PR |
|
|
| Post-SCT: SD |
|
|
| Post-SCT: PD |
|
|
| Post-SCT: Other |
|
|
| Other line: CR |
|
|
| Other line: PR |
|
|
| Other line: SD |
|
|
| Other line: PD |
|
|
| Other line: Other |
|
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| Adverse event |
|
| Unknown |
|
| Other |
|
|
| Length of stay by unit/ward: High dependency/intermediate |
|
|
| Length of stay by unit/ward: Intensive Care Unit |
|
|
| Length of stay by unit/ward: Bone marrow transplant unit |
|
|
|
| Scan/procedure: Magnetic resonance imaging (MRI) |
|
|
| Scan/procedure: Needle biopsy |
|
|
| Scan/procedure: Bone scan |
|
|
| Scan/procedure: Bone marrow aspiration |
|
|
| Scan/procedure: Flow cytometry |
|
|
| Scan/procedure: Other scan procedures |
|
|
| Received G-CSF/ other high cost medications |
|
|
| Received Pegylated G-CSF |
|
|
|
|
| Salvage Therapy: Outpatient Visits |
|
|
| ASCT: Inpatient Hospital Admissions |
|
|
| ASCT: Emergency Room Visits |
|
|
| ASCT: Outpatient Visits |
|
|
|
| Salvage Therapy: Stem cell transplant |
|
|
| Salvage Therapy: Adverse event |
|
|
| Salvage Therapy: Unknown |
|
|
| Salvage Therapy: Other |
|
|
| ASCT: Chemotherapy |
|
|
| ASCT: Adverse event |
|
|
|
| Salvage Therapy: High dependency/intermediate |
|
|
| Salvage Therapy: Intensive Care Unit |
|
|
| Salvage Therapy: Bone marrow transplant unit |
|
|
| ASCT: Overall length of stay |
|
|
| ASCT: General |
|
|
| ASCT: High dependency/intermediate |
|
|
| ASCT: Intensive Care Unit |
|
|
| ASCT: Bone marrow transplant unit |
|
|
| Salvage Therapy: Needle biopsy |
|
|
| Salvage Therapy: Bone scan |
|
|
| Salvage Therapy: Bone marrow aspiration |
|
|
| Salvage Therapy: Flow cytometry |
|
|
| Salvage Therapy: Other scan procedures |
|
|
| Salvage Therapy: G-CSF/ other high cost medications |
|
|
| Salvage Therapy: Pegylated G-CSF |
|
|
| ASCT: Chest x-ray |
|
| ASCT: Magnetic resonance imaging |
|
| ASCT: Needle biopsy |
|
| ASCT: Bone scan |
|
| ASCT: Bone marrow aspiration |
|
| ASCT: Flow cytometry |
|
| ASCT: Other scan procedures |
|
| ASCT: G-CSF/ other high cost medications |
|
|
| ASCT: Pegylated G-CSF |
|
|
|
| ASCT: G-CSF treatment/other high cost medicines |
|
|
| ASCT: Pegylated G-CSF |
|
|