Classical Hodgkin Lymphoma, Relapsed or Refractory Classical Hodgkin Lymphoma
Conditions
Keywords
Drug therapy
Brief summary
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.
Detailed description
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).
Interventions
None listed
Sponsors
Takeda
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Participants newly diagnosed with high-risk stage IIb-IV cHL (for Group 1) or RRHL (for Group 2) between 01 January 2010 and 31 December 2013. 2. Age greater than or equal to (\>=) 18 years at diagnosis of cHL (Group 1) or RRHL (Group 2). 3. Alive or deceased. 4. Written informed consent is obtained for study data collection, where necessary, according to local regulations.
Exclusion criteria
1. Participants for whom the minimum study dataset is not available from their hospital medical records. 2. Participants who have participated in an interventional clinical trial at any stage of their cHL (Group 1) or RRHL (Group 2) management.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Group 2, RRHL: Progression Free Survival (PFS) | 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]) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Group 2, RRHL: Number of Participants Based on Clinical Staging According to Ann Arbor Staging at Diagnosis | Day 1 at RRHL 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). |
| Group 2, RRHL: Number of Participants Based on Clinical Staging According to Ann Arbor Staging at Relapse After First Relapse or Refractory Diagnosis | At second, third, fourth, and fifth relapse (up to 9 years 10 months) | 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). |
| Group 1, cHL: Number of Participants Based on Each International Prognostic Score (IPS) Category | Day 1 at cHL diagnosis | 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. |
| Group 1, cHL: Number of Participants With B Symptoms at Diagnosis | Day 1 at cHL 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. |
| Group 2, RRHL: Number of Participants With B Symptoms at Diagnosis | Day 1 at RRHL 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. |
| Group 2, RRHL: Number of Participants Categorized Based on Prior Therapies for Hodgkin Lymphoma (HL) at Each Line of Treatment | Day 1 at RRHL diagnosis | Number of participants were categorized based on prior therapies for HL at each line of treatment. |
| 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 | 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]) | 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. |
| Group 1, cHL: Median Number of Treatment Cycles Associated With Each Frontline Treatment Regimen | 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]) | 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. |
| Group 1, cHL: Number of Participants Who Received Treatments for HL After Completion of Frontline Therapy (Before Relapse) | 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]) | 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. |
| 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 | 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]) | Assessment was done for RT's whether used for pre-planned frontline treatment or for residual Fluorodeoxyglucose (FDG)-avid disease. |
| 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 | 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]) | Therapy regimens were numbered as 1: ABVD; 6: C-MOPP; 8: ESHAP; 11: IGEV; 12: Mini-BEAM; 18: Brentuximab vedotin; 22: Nivolumab; 24: Other. |
| Group 2, RRHL: Number of Non-ASCT Participants Categorized Based on Reasons for Not Undergoing ASCT Despite Being ASCT Eligible | 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]) | 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. |
| Group 2, RRHL: Number of Non-ASCT Participants Based on Reasons for ASCT Ineligibility | 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]) | Reasons for ASCT ineligibility included advanced age, comorbid conditions, chemoresistant disease, cumulative toxicities, and others. |
| Group 2, RRHL: Number of Non-ASCT Participants Categorized Based on Treatment Regimens Received at Each Line of 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]) | 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. |
| 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 | 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]) | 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. |
| 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 | 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]) | 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 |
| 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 | 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]) | 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. |
| Group 2, RRHL: Number of Participants Categorized Based on With Known Risk Factors for Relapse 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]) | 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). |
| Group 2, RRHL: Median Number of Cycles Associated With Each Salvage Regimen 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]) | 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. |
| 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 | 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]) | 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. |
| Group 2, RRHL: Percentage of Participants Who Relapse After ASCT Categorized Based on Palliative Therapy Regimens | 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]) | Therapy regimens were numbered as 9: GVD; 10: ICE; 11: IGEV; 12: Mini-BEAM; 18: Brentuximab vedotin; 19: Bendamustine; 22: Nivolumab. |
| Group 2, RRHL: Number of Cycles Received at Each Line of Treatment for Each Treatment Regimen 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]) | 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. |
| 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 | 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]) | 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. |
| Group 2, RRHL: Mean Frequency of PET or PET-CT Scan Assessments 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]) | Data for PET-CT scan and CT scans were assessed for baseline, frontline and relapse or refractory, as planned. |
| 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 | 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]) | 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. |
| Group 1, cHL: Number of Participants Based on Best Clinical Response Post Completion of Frontline Treatment | 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]) | 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. |
| Group 2, RRHL: Number of Participants With Best Clinical Response Post Completion of Each Line of Treatment | 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]) | 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. |
| Mean Duration of Best Response | 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]) | 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. |
| Median Overall Survival (OS) | 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]) | 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. |
| Group 1, cHL: Overall Survival Rate After Diagnosis at 1 and 5 Years | At 1 year and 5 years after diagnosis (observed retrospectively from 2010 until date of data collection [up to 9 years 10 months]) | 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. |
| Group 2, RRHL: Overall Survival Rate at 1 and 5 Years | At 1 year and 5 years after relapse (observed retrospectively from 2010 until date of data collection [up to 9 years 10 months]) | 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. |
| 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 Based on Clinical Staging According to Ann Arbor Staging at Diagnosis | Day 1 at cHL 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). |
| Group 1, cHL: Mean Overall Length of Stay and Length of Stay by Unit/Ward 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]) | Length of stay by unit or ward included general, high dependency/intermediate, intensive care unit, bone marrow transplant unit, and emergency visits. |
| 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 | 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]) | Each participant had more than one category presented for salvage therapy and ASCT. |
| Group 2, RRHL: Number of Participants Categorized Based on Reasons for Inpatient Hospital Admissions Related to HL 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]) | Each participant had more than one category presented for salvage therapy and ASCT. |
| 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 | 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]) | 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. |
| 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 | 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]) | 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. |
| 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]) | — |
| 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]) | — |
Countries
South Korea
Participant flow
Recruitment details
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.
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 1,598 |
| 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. | 105 |
| Total | 1,703 |
Baseline characteristics
| Characteristic | Group 1: cHL | Group 2: RRHL | Total |
|---|---|---|---|
| Age, Customized Greater than or equal to (>=) 60 years | 216 Participants | 11 Participants | 227 Participants |
| Age, Customized Less than (<) 60 years | 1382 Participants | 94 Participants | 1476 Participants |
| Race/Ethnicity, Customized American Indian or Alaska Native | 22 Participants | 0 Participants | 22 Participants |
| Race/Ethnicity, Customized Asian | 560 Participants | 29 Participants | 589 Participants |
| Race/Ethnicity, Customized Black or African American | 62 Participants | 2 Participants | 64 Participants |
| Race/Ethnicity, Customized Not Reported | 197 Participants | 12 Participants | 209 Participants |
| Race/Ethnicity, Customized Other | 232 Participants | 5 Participants | 237 Participants |
| Race/Ethnicity, Customized White or Caucasian | 525 Participants | 57 Participants | 582 Participants |
| Sex: Female, Male Female | 719 Participants | 41 Participants | 760 Participants |
| Sex: Female, Male Male | 879 Participants | 64 Participants | 943 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 243 / 1,598 | 136 / 426 |
| other Total, other adverse events | 642 / 1,598 | 187 / 426 |
| serious Total, serious adverse events | 303 / 1,598 | 103 / 426 |
Outcome results
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.
Time frame: 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])
Population: The FAS included all participants who were eligible for RRHL group including the common participants in both the groups.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Group 2: RRHL | Group 2, RRHL: Progression Free Survival (PFS) | 13.17 months |
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
Time frame: 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])
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Group 2: RRHL | Group 1, cHL: Mean Number of Courses of Treatment With G-CSF/Pegylated G-CSF or Other High-cost Medicines Related to HL Treatment | Courses: G-CSF treatment/other high cost medicines | 5.6 days | Standard Deviation 6.99 |
| Group 2: RRHL | Group 1, cHL: Mean Number of Courses of Treatment With G-CSF/Pegylated G-CSF or Other High-cost Medicines Related to HL Treatment | Courses: Pegylated G-CSF | 2.5 days | Standard Deviation 2.99 |
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.
Time frame: 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])
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Group 2: RRHL | Group 1, cHL: Mean Overall Length of Stay and Length of Stay by Unit/Ward for Inpatient Hospital Admissions Related to HL | Overall length of stay | 15.1 days | Standard Deviation 41.02 |
| Group 2: RRHL | 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/ward: General | 13.2 days | Standard Deviation 41.86 |
| Group 2: RRHL | 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/ward: High dependency/intermediate | 20.2 days | Standard Deviation 17.29 |
| Group 2: RRHL | 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/ward: Intensive Care Unit | 28.0 days | Standard Deviation 26.14 |
| Group 2: RRHL | 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/ward: Bone marrow transplant unit | 32.7 days | Standard Deviation 39.7 |
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.
Time frame: 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])
Population: 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.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Group 2: RRHL | Group 1, cHL: Median Number of Treatment Cycles Associated With Each Frontline Treatment Regimen | Therapy regimen 1 | 6.0 cycles |
| Group 2: RRHL | Group 1, cHL: Median Number of Treatment Cycles Associated With Each Frontline Treatment Regimen | Therapy regimen 3 | 5.0 cycles |
| Group 2: RRHL | Group 1, cHL: Median Number of Treatment Cycles Associated With Each Frontline Treatment Regimen | Therapy regimen 6 | 6.0 cycles |
| Group 2: RRHL | Group 1, cHL: Median Number of Treatment Cycles Associated With Each Frontline Treatment Regimen | Therapy regimen 7 | 2.0 cycles |
| Group 2: RRHL | Group 1, cHL: Median Number of Treatment Cycles Associated With Each Frontline Treatment Regimen | Therapy regimen 8 | 2.0 cycles |
| Group 2: RRHL | Group 1, cHL: Median Number of Treatment Cycles Associated With Each Frontline Treatment Regimen | Therapy regimen 10 | 2.0 cycles |
| Group 2: RRHL | Group 1, cHL: Median Number of Treatment Cycles Associated With Each Frontline Treatment Regimen | Therapy regimen 11 | 4.0 cycles |
| Group 2: RRHL | Group 1, cHL: Median Number of Treatment Cycles Associated With Each Frontline Treatment Regimen | Therapy regimen 17 | 7.0 cycles |
| Group 2: RRHL | Group 1, cHL: Median Number of Treatment Cycles Associated With Each Frontline Treatment Regimen | Therapy regimen 18 | 3.0 cycles |
| Group 2: RRHL | Group 1, cHL: Median Number of Treatment Cycles Associated With Each Frontline Treatment Regimen | Therapy regimen 4 | 6.0 cycles |
| Group 2: RRHL | Group 1, cHL: Median Number of Treatment Cycles Associated With Each Frontline Treatment Regimen | Therapy regimen 14 | 6.0 cycles |
| Group 2: RRHL | Group 1, cHL: Median Number of Treatment Cycles Associated With Each Frontline Treatment Regimen | Therapy regimen 15 | 3.5 cycles |
| Group 2: RRHL | Group 1, cHL: Median Number of Treatment Cycles Associated With Each Frontline Treatment Regimen | Therapy regimen 2 | 6.0 cycles |
| Group 2: RRHL | Group 1, cHL: Median Number of Treatment Cycles Associated With Each Frontline Treatment Regimen | Therapy regimen 24 | 6.0 cycles |
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.
Time frame: 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])
Population: The FAS included all participants who were eligible for cHL group including the common participants in both the groups.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Group 2: RRHL | Group 1, cHL: Median PFS | NA months |
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.
Time frame: 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])
Population: The FAS included all participants who were eligible for cHL group including the common participants in both the groups.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Group 2: RRHL | Group 1, cHL: Number of Participants Based on Best Clinical Response Post Completion of Frontline Treatment | CR | 968 participants |
| Group 2: RRHL | Group 1, cHL: Number of Participants Based on Best Clinical Response Post Completion of Frontline Treatment | PR | 356 participants |
| Group 2: RRHL | Group 1, cHL: Number of Participants Based on Best Clinical Response Post Completion of Frontline Treatment | SD | 80 participants |
| Group 2: RRHL | Group 1, cHL: Number of Participants Based on Best Clinical Response Post Completion of Frontline Treatment | PD | 109 participants |
| Group 2: RRHL | Group 1, cHL: Number of Participants Based on Best Clinical Response Post Completion of Frontline Treatment | Other | 85 participants |
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).
Time frame: Day 1 at cHL diagnosis
Population: The FAS included all participants who were eligible for cHL group including the common participants in both the groups.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Group 2: RRHL | Group 1, cHL: Number of Participants Based on Clinical Staging According to Ann Arbor Staging at Diagnosis | Stage I-A | 0 Participants |
| Group 2: RRHL | Group 1, cHL: Number of Participants Based on Clinical Staging According to Ann Arbor Staging at Diagnosis | Stage I-B | 0 Participants |
| Group 2: RRHL | Group 1, cHL: Number of Participants Based on Clinical Staging According to Ann Arbor Staging at Diagnosis | Stage II-A | 0 Participants |
| Group 2: RRHL | Group 1, cHL: Number of Participants Based on Clinical Staging According to Ann Arbor Staging at Diagnosis | Stage II-B | 441 Participants |
| Group 2: RRHL | Group 1, cHL: Number of Participants Based on Clinical Staging According to Ann Arbor Staging at Diagnosis | Stage III-A | 207 Participants |
| Group 2: RRHL | Group 1, cHL: Number of Participants Based on Clinical Staging According to Ann Arbor Staging at Diagnosis | Stage III-B | 356 Participants |
| Group 2: RRHL | Group 1, cHL: Number of Participants Based on Clinical Staging According to Ann Arbor Staging at Diagnosis | Stage IV-A | 161 Participants |
| Group 2: RRHL | Group 1, cHL: Number of Participants Based on Clinical Staging According to Ann Arbor Staging at Diagnosis | Stage IV-B | 433 Participants |
| Group 2: RRHL | Group 1, cHL: Number of Participants Based on Clinical Staging According to Ann Arbor Staging at Diagnosis | Stage unknown | 0 Participants |
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.
Time frame: Day 1 at cHL diagnosis
Population: 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.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Group 2: RRHL | Group 1, cHL: Number of Participants Based on Each International Prognostic Score (IPS) Category | Good risk (IPS 0-1) | 289 Participants |
| Group 2: RRHL | Group 1, cHL: Number of Participants Based on Each International Prognostic Score (IPS) Category | Fair risk (IPS 2-3) | 504 Participants |
| Group 2: RRHL | Group 1, cHL: Number of Participants Based on Each International Prognostic Score (IPS) Category | Poor risk (IPS 4-7) | 294 Participants |
Secondary
Group 1, cHL: Number of Participants Based on Radiotherapy (RT) Type and Site When Received at Frontline
Time frame: 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])
Population: 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.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Group 2: RRHL | Group 1, cHL: Number of Participants Based on Radiotherapy (RT) Type and Site When Received at Frontline | RT Type: Whole body | 10 Participants |
| Group 2: RRHL | Group 1, cHL: Number of Participants Based on Radiotherapy (RT) Type and Site When Received at Frontline | RT Site: Pancreas | 1 Participants |
| Group 2: RRHL | Group 1, cHL: Number of Participants Based on Radiotherapy (RT) Type and Site When Received at Frontline | RT Site: Para-aortic nodes | 6 Participants |
| Group 2: RRHL | Group 1, cHL: Number of Participants Based on Radiotherapy (RT) Type and Site When Received at Frontline | RT Site: Para-iliac nodes | 3 Participants |
| Group 2: RRHL | Group 1, cHL: Number of Participants Based on Radiotherapy (RT) Type and Site When Received at Frontline | RT Site: Pelvic nodes | 7 Participants |
| Group 2: RRHL | Group 1, cHL: Number of Participants Based on Radiotherapy (RT) Type and Site When Received at Frontline | RT Site: Skin | 3 Participants |
| Group 2: RRHL | Group 1, cHL: Number of Participants Based on Radiotherapy (RT) Type and Site When Received at Frontline | RT Site: Soft tissue | 2 Participants |
| Group 2: RRHL | Group 1, cHL: Number of Participants Based on Radiotherapy (RT) Type and Site When Received at Frontline | RT Site: Spleen | 7 Participants |
| Group 2: RRHL | Group 1, cHL: Number of Participants Based on Radiotherapy (RT) Type and Site When Received at Frontline | RT Site: Supraclavicular nodes | 14 Participants |
| Group 2: RRHL | Group 1, cHL: Number of Participants Based on Radiotherapy (RT) Type and Site When Received at Frontline | RT Site: Thyroid | 1 Participants |
| Group 2: RRHL | Group 1, cHL: Number of Participants Based on Radiotherapy (RT) Type and Site When Received at Frontline | RT Site: Other | 42 Participants |
| Group 2: RRHL | Group 1, cHL: Number of Participants Based on Radiotherapy (RT) Type and Site When Received at Frontline | RT Type: Involved-field | 244 Participants |
| Group 2: RRHL | Group 1, cHL: Number of Participants Based on Radiotherapy (RT) Type and Site When Received at Frontline | RT Type: Involved-site | 94 Participants |
| Group 2: RRHL | Group 1, cHL: Number of Participants Based on Radiotherapy (RT) Type and Site When Received at Frontline | RT Type: Involved-node | 60 Participants |
| Group 2: RRHL | Group 1, cHL: Number of Participants Based on Radiotherapy (RT) Type and Site When Received at Frontline | RT Type: Other | 1 Participants |
| Group 2: RRHL | Group 1, cHL: Number of Participants Based on Radiotherapy (RT) Type and Site When Received at Frontline | RT Site: Abdominal nodes | 8 Participants |
| Group 2: RRHL | Group 1, cHL: Number of Participants Based on Radiotherapy (RT) Type and Site When Received at Frontline | RT Site: Axillary nodes | 21 Participants |
| Group 2: RRHL | Group 1, cHL: Number of Participants Based on Radiotherapy (RT) Type and Site When Received at Frontline | RT Site: Bone lesions | 9 Participants |
| Group 2: RRHL | Group 1, cHL: Number of Participants Based on Radiotherapy (RT) Type and Site When Received at Frontline | RT Site: Breast | 3 Participants |
| Group 2: RRHL | Group 1, cHL: Number of Participants Based on Radiotherapy (RT) Type and Site When Received at Frontline | RT Site: Cervix | 3 Participants |
| Group 2: RRHL | Group 1, cHL: Number of Participants Based on Radiotherapy (RT) Type and Site When Received at Frontline | RT Site: Inguinal nodes | 7 Participants |
| Group 2: RRHL | Group 1, cHL: Number of Participants Based on Radiotherapy (RT) Type and Site When Received at Frontline | RT Site: Larynx | 1 Participants |
| Group 2: RRHL | Group 1, cHL: Number of Participants Based on Radiotherapy (RT) Type and Site When Received at Frontline | RT Site: Lung | 5 Participants |
| Group 2: RRHL | Group 1, cHL: Number of Participants Based on Radiotherapy (RT) Type and Site When Received at Frontline | RT Site: Mediastinal nodes | 197 Participants |
| Group 2: RRHL | Group 1, cHL: Number of Participants Based on Radiotherapy (RT) Type and Site When Received at Frontline | RT Site: Neck nodes | 69 Participants |
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
Time frame: 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])
Population: 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.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Group 2: RRHL | 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 | RT received | 357 Participants |
| Group 2: RRHL | 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 | Scan/procedure: Chest x-Ray | 427 Participants |
| Group 2: RRHL | 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 | Scan/procedure: Magnetic resonance imaging (MRI) | 92 Participants |
| Group 2: RRHL | 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 | Scan/procedure: Needle biopsy | 273 Participants |
| Group 2: RRHL | 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 | Scan/procedure: Bone scan | 19 Participants |
| Group 2: RRHL | 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 | Scan/procedure: Bone marrow aspiration | 997 Participants |
| Group 2: RRHL | 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 | Scan/procedure: Flow cytometry | 61 Participants |
| Group 2: RRHL | 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 | Scan/procedure: Other scan procedures | 315 Participants |
| Group 2: RRHL | 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 | Received G-CSF/ other high cost medications | 794 Participants |
| Group 2: RRHL | 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 | Received Pegylated G-CSF | 143 Participants |
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.
Time frame: 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])
Population: The FAS included all participants who were eligible for cHL group including the common participants in both the groups.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Group 2: RRHL | Group 1, cHL: Number of Participants Categorized Based on Frontline Treatment Regimens | Therapy regimen 1 | 1363 Participants |
| Group 2: RRHL | Group 1, cHL: Number of Participants Categorized Based on Frontline Treatment Regimens | Therapy regimen 3 | 1 Participants |
| Group 2: RRHL | Group 1, cHL: Number of Participants Categorized Based on Frontline Treatment Regimens | Therapy regimen 6 | 2 Participants |
| Group 2: RRHL | Group 1, cHL: Number of Participants Categorized Based on Frontline Treatment Regimens | Therapy regimen 7 | 9 Participants |
| Group 2: RRHL | Group 1, cHL: Number of Participants Categorized Based on Frontline Treatment Regimens | Therapy regimen 8 | 11 Participants |
| Group 2: RRHL | Group 1, cHL: Number of Participants Categorized Based on Frontline Treatment Regimens | Therapy regimen 10 | 3 Participants |
| Group 2: RRHL | Group 1, cHL: Number of Participants Categorized Based on Frontline Treatment Regimens | Therapy regimen 11 | 1 Participants |
| Group 2: RRHL | Group 1, cHL: Number of Participants Categorized Based on Frontline Treatment Regimens | Therapy regimen 17 | 2 Participants |
| Group 2: RRHL | Group 1, cHL: Number of Participants Categorized Based on Frontline Treatment Regimens | Therapy regimen 18 | 1 Participants |
| Group 2: RRHL | Group 1, cHL: Number of Participants Categorized Based on Frontline Treatment Regimens | Therapy regimen 4 | 104 Participants |
| Group 2: RRHL | Group 1, cHL: Number of Participants Categorized Based on Frontline Treatment Regimens | Therapy regimen 14 | 15 Participants |
| Group 2: RRHL | Group 1, cHL: Number of Participants Categorized Based on Frontline Treatment Regimens | Therapy regimen 15 | 4 Participants |
| Group 2: RRHL | Group 1, cHL: Number of Participants Categorized Based on Frontline Treatment Regimens | Therapy regimen 2 | 33 Participants |
| Group 2: RRHL | Group 1, cHL: Number of Participants Categorized Based on Frontline Treatment Regimens | Therapy regimen 24 | 114 Participants |
Secondary
Group 1, cHL: Number of Participants Categorized Based on Reasons for Inpatient Hospital Admissions Related to HL
Time frame: 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])
Population: The FAS included all participants who were eligible for cHL group including common participants in both the groups, and who had HL inpatient hospitalizations.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Group 2: RRHL | Group 1, cHL: Number of Participants Categorized Based on Reasons for Inpatient Hospital Admissions Related to HL | Chemotherapy | 563 Participants |
| Group 2: RRHL | Group 1, cHL: Number of Participants Categorized Based on Reasons for Inpatient Hospital Admissions Related to HL | Radiotherapy | 39 Participants |
| Group 2: RRHL | Group 1, cHL: Number of Participants Categorized Based on Reasons for Inpatient Hospital Admissions Related to HL | Stem cell transplant | 146 Participants |
| Group 2: RRHL | Group 1, cHL: Number of Participants Categorized Based on Reasons for Inpatient Hospital Admissions Related to HL | Adverse event | 287 Participants |
| Group 2: RRHL | Group 1, cHL: Number of Participants Categorized Based on Reasons for Inpatient Hospital Admissions Related to HL | Unknown | 37 Participants |
| Group 2: RRHL | Group 1, cHL: Number of Participants Categorized Based on Reasons for Inpatient Hospital Admissions Related to HL | Other | 384 Participants |
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.
Time frame: 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])
Population: 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.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Group 2: RRHL | 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 | RT for pre-planned frontline treatment | 225 Participants |
| Group 2: RRHL | 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 | RT for residual FDG-avid disease | 115 Participants |
Secondary
Group 1, cHL: Number of Participants Who Had Inpatient Hospital Admissions, Emergency Room Visits, and Outpatient Visits by Healthcare Professionals Related to HL
Time frame: 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])
Population: The FAS included all participants who were eligible for cHL group including common participants in both the groups.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Group 2: RRHL | Group 1, cHL: Number of Participants Who Had Inpatient Hospital Admissions, Emergency Room Visits, and Outpatient Visits by Healthcare Professionals Related to HL | Inpatient Hospital Admissions | 864 Participants |
| Group 2: RRHL | Group 1, cHL: Number of Participants Who Had Inpatient Hospital Admissions, Emergency Room Visits, and Outpatient Visits by Healthcare Professionals Related to HL | Emergency Room Visits | 357 Participants |
| Group 2: RRHL | Group 1, cHL: Number of Participants Who Had Inpatient Hospital Admissions, Emergency Room Visits, and Outpatient Visits by Healthcare Professionals Related to HL | Outpatient Visits | 1135 Participants |
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.
Time frame: 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])
Population: 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.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Group 2: RRHL | Group 1, cHL: Number of Participants Who Received Treatments for HL After Completion of Frontline Therapy (Before Relapse) | Therapy regimen 14 | 2 Participants |
| Group 2: RRHL | Group 1, cHL: Number of Participants Who Received Treatments for HL After Completion of Frontline Therapy (Before Relapse) | Therapy regimen 1 | 2 Participants |
| Group 2: RRHL | Group 1, cHL: Number of Participants Who Received Treatments for HL After Completion of Frontline Therapy (Before Relapse) | Therapy regimen 6 | 1 Participants |
| Group 2: RRHL | Group 1, cHL: Number of Participants Who Received Treatments for HL After Completion of Frontline Therapy (Before Relapse) | Therapy regimen 7 | 8 Participants |
| Group 2: RRHL | Group 1, cHL: Number of Participants Who Received Treatments for HL After Completion of Frontline Therapy (Before Relapse) | Therapy regimen 8 | 15 Participants |
| Group 2: RRHL | Group 1, cHL: Number of Participants Who Received Treatments for HL After Completion of Frontline Therapy (Before Relapse) | Therapy regimen 10 | 8 Participants |
| Group 2: RRHL | Group 1, cHL: Number of Participants Who Received Treatments for HL After Completion of Frontline Therapy (Before Relapse) | Therapy regimen 11 | 6 Participants |
| Group 2: RRHL | Group 1, cHL: Number of Participants Who Received Treatments for HL After Completion of Frontline Therapy (Before Relapse) | Therapy regimen 12 | 2 Participants |
| Group 2: RRHL | Group 1, cHL: Number of Participants Who Received Treatments for HL After Completion of Frontline Therapy (Before Relapse) | Therapy regimen 13 | 1 Participants |
| Group 2: RRHL | Group 1, cHL: Number of Participants Who Received Treatments for HL After Completion of Frontline Therapy (Before Relapse) | Therapy regimen 18 | 2 Participants |
| Group 2: RRHL | Group 1, cHL: Number of Participants Who Received Treatments for HL After Completion of Frontline Therapy (Before Relapse) | Therapy regimen 16 | 6 Participants |
| Group 2: RRHL | Group 1, cHL: Number of Participants Who Received Treatments for HL After Completion of Frontline Therapy (Before Relapse) | Therapy regimen 4 | 6 Participants |
| Group 2: RRHL | Group 1, cHL: Number of Participants Who Received Treatments for HL After Completion of Frontline Therapy (Before Relapse) | Therapy regimen 24 | 10 Participants |
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.
Time frame: Day 1 at cHL diagnosis
Population: The FAS included all participants who were eligible for cHL group including the common participants in both the groups.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Group 2: RRHL | Group 1, cHL: Number of Participants With B Symptoms at Diagnosis | Presence of B-symptoms | 1230 Participants |
| Group 2: RRHL | Group 1, cHL: Number of Participants With B Symptoms at Diagnosis | Absence of B-symptoms | 368 Participants |
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.
Time frame: At 1 year and 5 years after diagnosis (observed retrospectively from 2010 until date of data collection [up to 9 years 10 months])
Population: The FAS included all participants who were eligible for cHL group including the common participants in both the groups.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Group 2: RRHL | Group 1, cHL: Overall Survival Rate After Diagnosis at 1 and 5 Years | At 1 year | 95.65 percentage of participants |
| Group 2: RRHL | Group 1, cHL: Overall Survival Rate After Diagnosis at 1 and 5 Years | At 5 years | 84.74 percentage of participants |
Secondary
Group 2, RRHL: CD34+ Count Administered in Participants Undergoing ASCT
Time frame: 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])
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Group 2: RRHL | Group 2, RRHL: CD34+ Count Administered in Participants Undergoing ASCT | 211.2 cells per kilogram | Standard Deviation 248.65 |
Secondary
Group 2, RRHL: Duration of Each Line of Treatment for Participants Who Relapse After ASCT
Time frame: 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])
Population: 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.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Group 2: RRHL | Group 2, RRHL: Duration of Each Line of Treatment for Participants Who Relapse After ASCT | Frontline Treatment | 5.9 months |
| Group 2: RRHL | Group 2, RRHL: Duration of Each Line of Treatment for Participants Who Relapse After ASCT | Second line Treatment | 2.0 months |
| Group 2: RRHL | Group 2, RRHL: Duration of Each Line of Treatment for Participants Who Relapse After ASCT | Third line Treatment | 2.0 months |
| Group 2: RRHL | Group 2, RRHL: Duration of Each Line of Treatment for Participants Who Relapse After ASCT | Pre-SCT Treatment | 0.2 months |
| Group 2: RRHL | Group 2, RRHL: Duration of Each Line of Treatment for Participants Who Relapse After ASCT | Post-SCT Treatment | 7.2 months |
| Group 2: RRHL | Group 2, RRHL: Duration of Each Line of Treatment for Participants Who Relapse After ASCT | Other Treatment | 4.0 months |
Secondary
Group 2, RRHL: Duration of Each Line of Treatment in Non-ASCT Participants
Time frame: 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])
Population: 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.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Group 2: RRHL | Group 2, RRHL: Duration of Each Line of Treatment in Non-ASCT Participants | Frontline Treatment | 5.4 months |
| Group 2: RRHL | Group 2, RRHL: Duration of Each Line of Treatment in Non-ASCT Participants | Second line Treatment | 2.2 months |
| Group 2: RRHL | Group 2, RRHL: Duration of Each Line of Treatment in Non-ASCT Participants | Third line Treatment | 2.1 months |
| Group 2: RRHL | Group 2, RRHL: Duration of Each Line of Treatment in Non-ASCT Participants | Other Treatment | 9.7 months |
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
Time frame: 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])
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Group 2: RRHL | 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 | ASCT: Pegylated G-CSF | 6.0 days | — |
| Group 2: RRHL | 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 | Salvage Therapy: G-CSF treatment/other high cost medicines | 2.8 days | Standard Deviation 2.78 |
| Group 2: RRHL | 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 | Salvage Therapy: Pegylated G-CSF | 2.6 days | Standard Deviation 2.9 |
| Group 2: RRHL | 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 | ASCT: G-CSF treatment/other high cost medicines | 4.2 days | Standard Deviation 2.64 |
Secondary
Group 2, RRHL: Group 2, RRHL: Median Number of ASCTs for Each Participant Who Relapse After ASCT
Time frame: 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])
Population: The FAS included all participants who were eligible for RRHL group including common participants, and who relapsed after ASCT.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Group 2: RRHL | Group 2, RRHL: Group 2, RRHL: Median Number of ASCTs for Each Participant Who Relapse After ASCT | 1.0 ASCTs |
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.
Time frame: 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])
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Group 2: RRHL | Group 2, RRHL: Mean Frequency of PET or PET-CT Scan Assessments for Participants Who Relapse After ASCT | PET or PET-CT scan: Baseline | 1.0 scans | Standard Deviation 0 |
| Group 2: RRHL | Group 2, RRHL: Mean Frequency of PET or PET-CT Scan Assessments for Participants Who Relapse After ASCT | PET or PET-CT scan: Frontline | 2.0 scans | Standard Deviation 1.26 |
| Group 2: RRHL | Group 2, RRHL: Mean Frequency of PET or PET-CT Scan Assessments for Participants Who Relapse After ASCT | PET or PET-CT scan: Relapse /refractory | 5.6 scans | Standard Deviation 3.62 |
| Group 2: RRHL | Group 2, RRHL: Mean Frequency of PET or PET-CT Scan Assessments for Participants Who Relapse After ASCT | CT Scan: Baseline | 1.0 scans | Standard Deviation 0.21 |
| Group 2: RRHL | Group 2, RRHL: Mean Frequency of PET or PET-CT Scan Assessments for Participants Who Relapse After ASCT | CT Scan: Frontline | 2.6 scans | Standard Deviation 2.26 |
| Group 2: RRHL | Group 2, RRHL: Mean Frequency of PET or PET-CT Scan Assessments for Participants Who Relapse After ASCT | CT Scan: Relapse/refractory | 4.3 scans | Standard Deviation 4.37 |
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.
Time frame: 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])
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Group 2: RRHL | 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 | Salvage Therapy: Overall length of stay | 13.6 days | Standard Deviation 16.3 |
| Group 2: RRHL | 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 | Salvage Therapy: General | 11.4 days | Standard Deviation 15.79 |
| Group 2: RRHL | 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 | Salvage Therapy: High dependency/intermediate | 25.8 days | Standard Deviation 18.24 |
| Group 2: RRHL | 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 | Salvage Therapy: Intensive Care Unit | 13.0 days | Standard Deviation 7.07 |
| Group 2: RRHL | 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 | Salvage Therapy: Bone marrow transplant unit | 25.8 days | Standard Deviation 10.08 |
| Group 2: RRHL | 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 | ASCT: Overall length of stay | 7.8 days | Standard Deviation 4.54 |
| Group 2: RRHL | 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 | ASCT: General | 4.9 days | Standard Deviation 1.23 |
| Group 2: RRHL | 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 | ASCT: High dependency/intermediate | 10.5 days | Standard Deviation 6.36 |
| Group 2: RRHL | 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 | ASCT: Intensive Care Unit | 18.0 days | — |
Secondary
Group 2, RRHL: Median Duration of Treatment for Consolidation Therapies Used in Participants Undergoing ASCT
Time frame: 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])
Population: 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.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Group 2: RRHL | Group 2, RRHL: Median Duration of Treatment for Consolidation Therapies Used in Participants Undergoing ASCT | 11.1 months |
Secondary
Group 2, RRHL: Median Frequency of PET or PET-CT Scan Assessment for Non-ASCT Participants
Time frame: 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])
Population: 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.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Group 2: RRHL | Group 2, RRHL: Median Frequency of PET or PET-CT Scan Assessment for Non-ASCT Participants | Frequency of PET or PET-CT Scan at Baseline | 1.0 scans |
| Group 2: RRHL | Group 2, RRHL: Median Frequency of PET or PET-CT Scan Assessment for Non-ASCT Participants | Frequency of PET or PET-CT Scan at Frontline | 1.0 scans |
| Group 2: RRHL | Group 2, RRHL: Median Frequency of PET or PET-CT Scan Assessment for Non-ASCT Participants | Frequency of PET or PET-CT Scan at Relapse | 1.0 scans |
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.
Time frame: 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])
Population: 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.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Group 2: RRHL | Group 2, RRHL: Median Number of Cycles Associated With Each Salvage Regimen in Participants Undergoing ASCT | Therapy regimen 1 | 3.0 cycles |
| Group 2: RRHL | Group 2, RRHL: Median Number of Cycles Associated With Each Salvage Regimen in Participants Undergoing ASCT | Therapy regimen 6 | 5.5 cycles |
| Group 2: RRHL | Group 2, RRHL: Median Number of Cycles Associated With Each Salvage Regimen in Participants Undergoing ASCT | Therapy regimen 7 | 3.0 cycles |
| Group 2: RRHL | Group 2, RRHL: Median Number of Cycles Associated With Each Salvage Regimen in Participants Undergoing ASCT | Therapy regimen 8 | 3.0 cycles |
| Group 2: RRHL | Group 2, RRHL: Median Number of Cycles Associated With Each Salvage Regimen in Participants Undergoing ASCT | Therapy regimen 9 | 2.0 cycles |
| Group 2: RRHL | Group 2, RRHL: Median Number of Cycles Associated With Each Salvage Regimen in Participants Undergoing ASCT | Therapy regimen 10 | 3.0 cycles |
| Group 2: RRHL | Group 2, RRHL: Median Number of Cycles Associated With Each Salvage Regimen in Participants Undergoing ASCT | Therapy regimen 11 | 3.0 cycles |
| Group 2: RRHL | Group 2, RRHL: Median Number of Cycles Associated With Each Salvage Regimen in Participants Undergoing ASCT | Therapy regimen 12 | 1.0 cycles |
| Group 2: RRHL | Group 2, RRHL: Median Number of Cycles Associated With Each Salvage Regimen in Participants Undergoing ASCT | Therapy regimen 13 | 5.0 cycles |
| Group 2: RRHL | Group 2, RRHL: Median Number of Cycles Associated With Each Salvage Regimen in Participants Undergoing ASCT | Therapy regimen 17 | 8.0 cycles |
| Group 2: RRHL | Group 2, RRHL: Median Number of Cycles Associated With Each Salvage Regimen in Participants Undergoing ASCT | Therapy regimen 18 | 6.0 cycles |
| Group 2: RRHL | Group 2, RRHL: Median Number of Cycles Associated With Each Salvage Regimen in Participants Undergoing ASCT | Therapy regimen 19 | 4.0 cycles |
| Group 2: RRHL | Group 2, RRHL: Median Number of Cycles Associated With Each Salvage Regimen in Participants Undergoing ASCT | Therapy regimen 22 | 6.5 cycles |
| Group 2: RRHL | Group 2, RRHL: Median Number of Cycles Associated With Each Salvage Regimen in Participants Undergoing ASCT | Therapy regimen 23 | 21.0 cycles |
| Group 2: RRHL | Group 2, RRHL: Median Number of Cycles Associated With Each Salvage Regimen in Participants Undergoing ASCT | Therapy regimen 16 | 3.0 cycles |
| Group 2: RRHL | Group 2, RRHL: Median Number of Cycles Associated With Each Salvage Regimen in Participants Undergoing ASCT | Therapy regimen 4 | 4.0 cycles |
| Group 2: RRHL | Group 2, RRHL: Median Number of Cycles Associated With Each Salvage Regimen in Participants Undergoing ASCT | Therapy regimen 14 | 1.0 cycles |
| Group 2: RRHL | Group 2, RRHL: Median Number of Cycles Associated With Each Salvage Regimen in Participants Undergoing ASCT | Therapy regimen 2 | 2.0 cycles |
| Group 2: RRHL | Group 2, RRHL: Median Number of Cycles Associated With Each Salvage Regimen in Participants Undergoing ASCT | Therapy regimen 24 | 2.3 cycles |
Secondary
Group 2, RRHL: Median Number of Previous Treatment Regimens (Chemotherapies) Received
Time frame: Day 1 at RRHL diagnosis
Population: 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.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Group 2: RRHL | Group 2, RRHL: Median Number of Previous Treatment Regimens (Chemotherapies) Received | 1.0 previous treatment regimen |
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.
Time frame: 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])
Population: 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.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Group 2: RRHL | Group 2, RRHL: Median Number of Treatment Cycles Associated With Relapse/ Refractory Treatment Regimen for ASCT | Therapy regimen 1 | 6.0 cycles |
| Group 2: RRHL | Group 2, RRHL: Median Number of Treatment Cycles Associated With Relapse/ Refractory Treatment Regimen for ASCT | Therapy regimen 6 | 8.0 cycles |
| Group 2: RRHL | Group 2, RRHL: Median Number of Treatment Cycles Associated With Relapse/ Refractory Treatment Regimen for ASCT | Therapy regimen 8 | 2.0 cycles |
| Group 2: RRHL | Group 2, RRHL: Median Number of Treatment Cycles Associated With Relapse/ Refractory Treatment Regimen for ASCT | Therapy regimen 11 | 3.0 cycles |
| Group 2: RRHL | Group 2, RRHL: Median Number of Treatment Cycles Associated With Relapse/ Refractory Treatment Regimen for ASCT | Therapy regimen 12 | 5.0 cycles |
| Group 2: RRHL | Group 2, RRHL: Median Number of Treatment Cycles Associated With Relapse/ Refractory Treatment Regimen for ASCT | Therapy regimen 18 | 4.0 cycles |
| Group 2: RRHL | Group 2, RRHL: Median Number of Treatment Cycles Associated With Relapse/ Refractory Treatment Regimen for ASCT | Therapy regimen 22 | 6.0 cycles |
| Group 2: RRHL | Group 2, RRHL: Median Number of Treatment Cycles Associated With Relapse/ Refractory Treatment Regimen for ASCT | Therapy regimen 24 | 2.0 cycles |
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.
Time frame: 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])
Population: 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.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Group 2: RRHL | Group 2, RRHL: Median Number of Treatment Cycles Received in Each Treatment Regimen at Each Line of Treatment in Non-ASCT Participants | Other treatments: Therapy regimen 6 | 1.0 cycles |
| Group 2: RRHL | Group 2, RRHL: Median Number of Treatment Cycles Received in Each Treatment Regimen at Each Line of Treatment in Non-ASCT Participants | Other treatments: Therapy regimen 8 | 2.0 cycles |
| Group 2: RRHL | Group 2, RRHL: Median Number of Treatment Cycles Received in Each Treatment Regimen at Each Line of Treatment in Non-ASCT Participants | Other treatments: Therapy regimen 13 | 6.0 cycles |
| Group 2: RRHL | Group 2, RRHL: Median Number of Treatment Cycles Received in Each Treatment Regimen at Each Line of Treatment in Non-ASCT Participants | Other treatments: Therapy regimen 18 | 6.0 cycles |
| Group 2: RRHL | Group 2, RRHL: Median Number of Treatment Cycles Received in Each Treatment Regimen at Each Line of Treatment in Non-ASCT Participants | Other treatments: Therapy regimen 16 | 4.0 cycles |
| Group 2: RRHL | Group 2, RRHL: Median Number of Treatment Cycles Received in Each Treatment Regimen at Each Line of Treatment in Non-ASCT Participants | Other treatments: Therapy regimen 24 | 6.0 cycles |
| Group 2: RRHL | Group 2, RRHL: Median Number of Treatment Cycles Received in Each Treatment Regimen at Each Line of Treatment in Non-ASCT Participants | Frontline: Therapy regimen 1 | 6.0 cycles |
| Group 2: RRHL | Group 2, RRHL: Median Number of Treatment Cycles Received in Each Treatment Regimen at Each Line of Treatment in Non-ASCT Participants | Frontline: Therapy regimen 3 | 6.0 cycles |
| Group 2: RRHL | Group 2, RRHL: Median Number of Treatment Cycles Received in Each Treatment Regimen at Each Line of Treatment in Non-ASCT Participants | Frontline: Therapy regimen 6 | 6.0 cycles |
| Group 2: RRHL | Group 2, RRHL: Median Number of Treatment Cycles Received in Each Treatment Regimen at Each Line of Treatment in Non-ASCT Participants | Frontline: Therapy regimen 7 | 3.0 cycles |
| Group 2: RRHL | Group 2, RRHL: Median Number of Treatment Cycles Received in Each Treatment Regimen at Each Line of Treatment in Non-ASCT Participants | Frontline: Therapy regimen 11 | 4.0 cycles |
| Group 2: RRHL | Group 2, RRHL: Median Number of Treatment Cycles Received in Each Treatment Regimen at Each Line of Treatment in Non-ASCT Participants | Frontline: Therapy regimen 18 | 3.0 cycles |
| Group 2: RRHL | Group 2, RRHL: Median Number of Treatment Cycles Received in Each Treatment Regimen at Each Line of Treatment in Non-ASCT Participants | Frontline: Therapy regimen 4 | 6.5 cycles |
| Group 2: RRHL | Group 2, RRHL: Median Number of Treatment Cycles Received in Each Treatment Regimen at Each Line of Treatment in Non-ASCT Participants | Frontline: Therapy regimen 14 | 6.0 cycles |
| Group 2: RRHL | Group 2, RRHL: Median Number of Treatment Cycles Received in Each Treatment Regimen at Each Line of Treatment in Non-ASCT Participants | Frontline: Therapy regimen 15 | 7.0 cycles |
| Group 2: RRHL | Group 2, RRHL: Median Number of Treatment Cycles Received in Each Treatment Regimen at Each Line of Treatment in Non-ASCT Participants | Frontline: Therapy regimen 2 | 7.0 cycles |
| Group 2: RRHL | Group 2, RRHL: Median Number of Treatment Cycles Received in Each Treatment Regimen at Each Line of Treatment in Non-ASCT Participants | Frontline: Therapy regimen 24 | 3.0 cycles |
| Group 2: RRHL | Group 2, RRHL: Median Number of Treatment Cycles Received in Each Treatment Regimen at Each Line of Treatment in Non-ASCT Participants | Second line: Therapy regimen 1 | 4.0 cycles |
| Group 2: RRHL | Group 2, RRHL: Median Number of Treatment Cycles Received in Each Treatment Regimen at Each Line of Treatment in Non-ASCT Participants | Second line: Therapy regimen 6 | 5.0 cycles |
| Group 2: RRHL | Group 2, RRHL: Median Number of Treatment Cycles Received in Each Treatment Regimen at Each Line of Treatment in Non-ASCT Participants | Second line: Therapy regimen 7 | 2.0 cycles |
| Group 2: RRHL | Group 2, RRHL: Median Number of Treatment Cycles Received in Each Treatment Regimen at Each Line of Treatment in Non-ASCT Participants | Second line: Therapy regimen 8 | 2.0 cycles |
| Group 2: RRHL | Group 2, RRHL: Median Number of Treatment Cycles Received in Each Treatment Regimen at Each Line of Treatment in Non-ASCT Participants | Second line: Therapy regimen 9 | 2.0 cycles |
| Group 2: RRHL | Group 2, RRHL: Median Number of Treatment Cycles Received in Each Treatment Regimen at Each Line of Treatment in Non-ASCT Participants | Second line: Therapy regimen 10 | 3.0 cycles |
| Group 2: RRHL | Group 2, RRHL: Median Number of Treatment Cycles Received in Each Treatment Regimen at Each Line of Treatment in Non-ASCT Participants | Second line: Therapy regimen 11 | 4.0 cycles |
| Group 2: RRHL | Group 2, RRHL: Median Number of Treatment Cycles Received in Each Treatment Regimen at Each Line of Treatment in Non-ASCT Participants | Second line: Therapy regimen 13 | 4.0 cycles |
| Group 2: RRHL | Group 2, RRHL: Median Number of Treatment Cycles Received in Each Treatment Regimen at Each Line of Treatment in Non-ASCT Participants | Second line: Therapy regimen 24 | 3.0 cycles |
| Group 2: RRHL | Group 2, RRHL: Median Number of Treatment Cycles Received in Each Treatment Regimen at Each Line of Treatment in Non-ASCT Participants | Second line: Therapy regimen 17 | 3.0 cycles |
| Group 2: RRHL | Group 2, RRHL: Median Number of Treatment Cycles Received in Each Treatment Regimen at Each Line of Treatment in Non-ASCT Participants | Second line: Therapy regimen 18 | 6.0 cycles |
| Group 2: RRHL | Group 2, RRHL: Median Number of Treatment Cycles Received in Each Treatment Regimen at Each Line of Treatment in Non-ASCT Participants | Second line: Therapy regimen 19 | 2.0 cycles |
| Group 2: RRHL | Group 2, RRHL: Median Number of Treatment Cycles Received in Each Treatment Regimen at Each Line of Treatment in Non-ASCT Participants | Second line: Therapy regimen 4 | 4.0 cycles |
| Group 2: RRHL | Group 2, RRHL: Median Number of Treatment Cycles Received in Each Treatment Regimen at Each Line of Treatment in Non-ASCT Participants | Second line: Therapy regimen 14 | 3.0 cycles |
| Group 2: RRHL | Group 2, RRHL: Median Number of Treatment Cycles Received in Each Treatment Regimen at Each Line of Treatment in Non-ASCT Participants | Second line: Therapy regimen 15 | 5.0 cycles |
| Group 2: RRHL | Group 2, RRHL: Median Number of Treatment Cycles Received in Each Treatment Regimen at Each Line of Treatment in Non-ASCT Participants | Second line: Therapy regimen 2 | 6.0 cycles |
| Group 2: RRHL | Group 2, RRHL: Median Number of Treatment Cycles Received in Each Treatment Regimen at Each Line of Treatment in Non-ASCT Participants | Third line: Therapy regimen 1 | 3.0 cycles |
| Group 2: RRHL | Group 2, RRHL: Median Number of Treatment Cycles Received in Each Treatment Regimen at Each Line of Treatment in Non-ASCT Participants | Third line: Therapy regimen 7 | 4.0 cycles |
| Group 2: RRHL | Group 2, RRHL: Median Number of Treatment Cycles Received in Each Treatment Regimen at Each Line of Treatment in Non-ASCT Participants | Third line: Therapy regimen 8 | 2.0 cycles |
| Group 2: RRHL | Group 2, RRHL: Median Number of Treatment Cycles Received in Each Treatment Regimen at Each Line of Treatment in Non-ASCT Participants | Third line: Therapy regimen 9 | 4.5 cycles |
| Group 2: RRHL | Group 2, RRHL: Median Number of Treatment Cycles Received in Each Treatment Regimen at Each Line of Treatment in Non-ASCT Participants | Third line: Therapy regimen 10 | 3.5 cycles |
| Group 2: RRHL | Group 2, RRHL: Median Number of Treatment Cycles Received in Each Treatment Regimen at Each Line of Treatment in Non-ASCT Participants | Third line: Therapy regimen 11 | 2.0 cycles |
| Group 2: RRHL | Group 2, RRHL: Median Number of Treatment Cycles Received in Each Treatment Regimen at Each Line of Treatment in Non-ASCT Participants | Third line: Therapy regimen 13 | 6.0 cycles |
| Group 2: RRHL | Group 2, RRHL: Median Number of Treatment Cycles Received in Each Treatment Regimen at Each Line of Treatment in Non-ASCT Participants | Third line: Therapy regimen 18 | 2.0 cycles |
| Group 2: RRHL | Group 2, RRHL: Median Number of Treatment Cycles Received in Each Treatment Regimen at Each Line of Treatment in Non-ASCT Participants | Third line: Therapy regimen 17 | 12.0 cycles |
| Group 2: RRHL | Group 2, RRHL: Median Number of Treatment Cycles Received in Each Treatment Regimen at Each Line of Treatment in Non-ASCT Participants | Third line: Therapy regimen 22 | 43.0 cycles |
| Group 2: RRHL | Group 2, RRHL: Median Number of Treatment Cycles Received in Each Treatment Regimen at Each Line of Treatment in Non-ASCT Participants | Third line: Therapy regimen 4 | 3.5 cycles |
| Group 2: RRHL | Group 2, RRHL: Median Number of Treatment Cycles Received in Each Treatment Regimen at Each Line of Treatment in Non-ASCT Participants | Third line: Therapy regimen 24 | 3.0 cycles |
| Group 2: RRHL | Group 2, RRHL: Median Number of Treatment Cycles Received in Each Treatment Regimen at Each Line of Treatment in Non-ASCT Participants | Other treatments: Therapy regimen 10 | 4.0 cycles |
| Group 2: RRHL | Group 2, RRHL: Median Number of Treatment Cycles Received in Each Treatment Regimen at Each Line of Treatment in Non-ASCT Participants | Other treatments: Therapy regimen 22 | 12.0 cycles |
| Group 2: RRHL | Group 2, RRHL: Median Number of Treatment Cycles Received in Each Treatment Regimen at Each Line of Treatment in Non-ASCT Participants | Other treatments: Therapy regimen 4 | 5.0 cycles |
Secondary
Group 2, RRHL: Median Time From Relapse (After End of Frontline Treatment) to ASCT in Participants Undergoing ASCT
Time frame: 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])
Population: 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.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Group 2: RRHL | Group 2, RRHL: Median Time From Relapse (After End of Frontline Treatment) to ASCT in Participants Undergoing ASCT | 182.5 days |
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.
Time frame: 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])
Population: 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.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Group 2: RRHL | Group 2, RRHL: Number of Cycles Received at Each Line of Treatment for Each Treatment Regimen in Participants Who Relapse After ASCT | Frontline: Therapy regimen 1 | 6.0 cycles |
| Group 2: RRHL | Group 2, RRHL: Number of Cycles Received at Each Line of Treatment for Each Treatment Regimen in Participants Who Relapse After ASCT | Frontline: Therapy regimen 7 | 2.0 cycles |
| Group 2: RRHL | Group 2, RRHL: Number of Cycles Received at Each Line of Treatment for Each Treatment Regimen in Participants Who Relapse After ASCT | Frontline: Therapy regimen 10 | 2.0 cycles |
| Group 2: RRHL | Group 2, RRHL: Number of Cycles Received at Each Line of Treatment for Each Treatment Regimen in Participants Who Relapse After ASCT | Frontline: Therapy regimen 11 | 2.0 cycles |
| Group 2: RRHL | Group 2, RRHL: Number of Cycles Received at Each Line of Treatment for Each Treatment Regimen in Participants Who Relapse After ASCT | Frontline: Therapy regimen 4 | 6.0 cycles |
| Group 2: RRHL | Group 2, RRHL: Number of Cycles Received at Each Line of Treatment for Each Treatment Regimen in Participants Who Relapse After ASCT | Frontline: Therapy regimen 2 | 7.0 cycles |
| Group 2: RRHL | Group 2, RRHL: Number of Cycles Received at Each Line of Treatment for Each Treatment Regimen in Participants Who Relapse After ASCT | Frontline: Therapy regimen 24 | 2.0 cycles |
| Group 2: RRHL | Group 2, RRHL: Number of Cycles Received at Each Line of Treatment for Each Treatment Regimen in Participants Who Relapse After ASCT | Second line: Therapy regimen 7 | 2.0 cycles |
| Group 2: RRHL | Group 2, RRHL: Number of Cycles Received at Each Line of Treatment for Each Treatment Regimen in Participants Who Relapse After ASCT | Second line: Therapy regimen 8 | 3.0 cycles |
| Group 2: RRHL | Group 2, RRHL: Number of Cycles Received at Each Line of Treatment for Each Treatment Regimen in Participants Who Relapse After ASCT | Second line: Therapy regimen 10 | 3.0 cycles |
| Group 2: RRHL | Group 2, RRHL: Number of Cycles Received at Each Line of Treatment for Each Treatment Regimen in Participants Who Relapse After ASCT | Second line: Therapy regimen 11 | 3.0 cycles |
| Group 2: RRHL | Group 2, RRHL: Number of Cycles Received at Each Line of Treatment for Each Treatment Regimen in Participants Who Relapse After ASCT | Second line: Therapy regimen 12 | 1.0 cycles |
| Group 2: RRHL | Group 2, RRHL: Number of Cycles Received at Each Line of Treatment for Each Treatment Regimen in Participants Who Relapse After ASCT | Second line: Therapy regimen 13 | 3.5 cycles |
| Group 2: RRHL | Group 2, RRHL: Number of Cycles Received at Each Line of Treatment for Each Treatment Regimen in Participants Who Relapse After ASCT | Second line: Therapy regimen 18 | 3.0 cycles |
| Group 2: RRHL | Group 2, RRHL: Number of Cycles Received at Each Line of Treatment for Each Treatment Regimen in Participants Who Relapse After ASCT | Second line: Therapy regimen 4 | 4.0 cycles |
| Group 2: RRHL | Group 2, RRHL: Number of Cycles Received at Each Line of Treatment for Each Treatment Regimen in Participants Who Relapse After ASCT | Second line: Therapy regimen 24 | 4.0 cycles |
| Group 2: RRHL | Group 2, RRHL: Number of Cycles Received at Each Line of Treatment for Each Treatment Regimen in Participants Who Relapse After ASCT | Third line: Therapy regimen 7 | 1.5 cycles |
| Group 2: RRHL | Group 2, RRHL: Number of Cycles Received at Each Line of Treatment for Each Treatment Regimen in Participants Who Relapse After ASCT | Third line: Therapy regimen 8 | 2.0 cycles |
| Group 2: RRHL | Group 2, RRHL: Number of Cycles Received at Each Line of Treatment for Each Treatment Regimen in Participants Who Relapse After ASCT | Third line: Therapy regimen 9 | 6.0 cycles |
| Group 2: RRHL | Group 2, RRHL: Number of Cycles Received at Each Line of Treatment for Each Treatment Regimen in Participants Who Relapse After ASCT | Third line: Therapy regimen 10 | 3.0 cycles |
| Group 2: RRHL | Group 2, RRHL: Number of Cycles Received at Each Line of Treatment for Each Treatment Regimen in Participants Who Relapse After ASCT | Third line: Therapy regimen 11 | 3.0 cycles |
| Group 2: RRHL | Group 2, RRHL: Number of Cycles Received at Each Line of Treatment for Each Treatment Regimen in Participants Who Relapse After ASCT | Third line: Therapy regimen 12 | 2.0 cycles |
| Group 2: RRHL | Group 2, RRHL: Number of Cycles Received at Each Line of Treatment for Each Treatment Regimen in Participants Who Relapse After ASCT | Third line: Therapy regimen 13 | 6.0 cycles |
| Group 2: RRHL | Group 2, RRHL: Number of Cycles Received at Each Line of Treatment for Each Treatment Regimen in Participants Who Relapse After ASCT | Third line: Therapy regimen 18 | 5.0 cycles |
| Group 2: RRHL | Group 2, RRHL: Number of Cycles Received at Each Line of Treatment for Each Treatment Regimen in Participants Who Relapse After ASCT | Third line: Therapy regimen 22 | 8.0 cycles |
| Group 2: RRHL | Group 2, RRHL: Number of Cycles Received at Each Line of Treatment for Each Treatment Regimen in Participants Who Relapse After ASCT | Third line: Therapy regimen 23 | 1.0 cycles |
| Group 2: RRHL | Group 2, RRHL: Number of Cycles Received at Each Line of Treatment for Each Treatment Regimen in Participants Who Relapse After ASCT | Third line: Therapy regimen 16 | 3.0 cycles |
| Group 2: RRHL | Group 2, RRHL: Number of Cycles Received at Each Line of Treatment for Each Treatment Regimen in Participants Who Relapse After ASCT | Third line: Therapy regimen 4 | 3.0 cycles |
| Group 2: RRHL | Group 2, RRHL: Number of Cycles Received at Each Line of Treatment for Each Treatment Regimen in Participants Who Relapse After ASCT | Pre-SCT: Therapy regimen 10 | 2.0 cycles |
| Group 2: RRHL | Group 2, RRHL: Number of Cycles Received at Each Line of Treatment for Each Treatment Regimen in Participants Who Relapse After ASCT | Pre-SCT: Therapy regimen 12 | 1.0 cycles |
| Group 2: RRHL | Group 2, RRHL: Number of Cycles Received at Each Line of Treatment for Each Treatment Regimen in Participants Who Relapse After ASCT | Pre-SCT: Therapy regimen 18 | 7.5 cycles |
| Group 2: RRHL | Group 2, RRHL: Number of Cycles Received at Each Line of Treatment for Each Treatment Regimen in Participants Who Relapse After ASCT | Pre-SCT: Therapy regimen 19 | 6.0 cycles |
| Group 2: RRHL | Group 2, RRHL: Number of Cycles Received at Each Line of Treatment for Each Treatment Regimen in Participants Who Relapse After ASCT | Pre-SCT: Therapy regimen 14 | 1.0 cycles |
| Group 2: RRHL | Group 2, RRHL: Number of Cycles Received at Each Line of Treatment for Each Treatment Regimen in Participants Who Relapse After ASCT | Pre-SCT: Therapy regimen 24 | 1.0 cycles |
| Group 2: RRHL | Group 2, RRHL: Number of Cycles Received at Each Line of Treatment for Each Treatment Regimen in Participants Who Relapse After ASCT | Post-SCT: Therapy regimen 18 | 9.0 cycles |
| Group 2: RRHL | Group 2, RRHL: Number of Cycles Received at Each Line of Treatment for Each Treatment Regimen in Participants Who Relapse After ASCT | Other treatment: Therapy regimen 7 | 3.0 cycles |
| Group 2: RRHL | Group 2, RRHL: Number of Cycles Received at Each Line of Treatment for Each Treatment Regimen in Participants Who Relapse After ASCT | Other treatment: Therapy regimen 9 | 4.0 cycles |
| Group 2: RRHL | Group 2, RRHL: Number of Cycles Received at Each Line of Treatment for Each Treatment Regimen in Participants Who Relapse After ASCT | Other treatment: Therapy regimen 10 | 2.5 cycles |
| Group 2: RRHL | Group 2, RRHL: Number of Cycles Received at Each Line of Treatment for Each Treatment Regimen in Participants Who Relapse After ASCT | Other treatment: Therapy regimen 11 | 4.0 cycles |
| Group 2: RRHL | Group 2, RRHL: Number of Cycles Received at Each Line of Treatment for Each Treatment Regimen in Participants Who Relapse After ASCT | Other treatment: Therapy regimen 17 | 8.0 cycles |
| Group 2: RRHL | Group 2, RRHL: Number of Cycles Received at Each Line of Treatment for Each Treatment Regimen in Participants Who Relapse After ASCT | Other treatment: Therapy regimen 18 | 12.0 cycles |
| Group 2: RRHL | Group 2, RRHL: Number of Cycles Received at Each Line of Treatment for Each Treatment Regimen in Participants Who Relapse After ASCT | Other treatment: Therapy regimen 19 | 4.0 cycles |
| Group 2: RRHL | Group 2, RRHL: Number of Cycles Received at Each Line of Treatment for Each Treatment Regimen in Participants Who Relapse After ASCT | Other treatment: Therapy regimen 22 | 7.0 cycles |
| Group 2: RRHL | Group 2, RRHL: Number of Cycles Received at Each Line of Treatment for Each Treatment Regimen in Participants Who Relapse After ASCT | Other treatment: Therapy regimen 23 | 23.0 cycles |
| Group 2: RRHL | Group 2, RRHL: Number of Cycles Received at Each Line of Treatment for Each Treatment Regimen in Participants Who Relapse After ASCT | Other treatment: Therapy regimen 16 | 2.0 cycles |
| Group 2: RRHL | Group 2, RRHL: Number of Cycles Received at Each Line of Treatment for Each Treatment Regimen in Participants Who Relapse After ASCT | Other treatment: Therapy regimen 4 | 2.0 cycles |
| Group 2: RRHL | Group 2, RRHL: Number of Cycles Received at Each Line of Treatment for Each Treatment Regimen in Participants Who Relapse After ASCT | Other treatment: Therapy regimen 24 | 4.0 cycles |
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.
Time frame: 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])
Population: 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.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Group 2: RRHL | Group 2, RRHL: Number of Non-ASCT Participants Based on Reasons for ASCT Ineligibility | Chemo-resistant disease | 19 Participants |
| Group 2: RRHL | Group 2, RRHL: Number of Non-ASCT Participants Based on Reasons for ASCT Ineligibility | Cumulative toxicities | 1 Participants |
| Group 2: RRHL | Group 2, RRHL: Number of Non-ASCT Participants Based on Reasons for ASCT Ineligibility | Unknown | 55 Participants |
| Group 2: RRHL | Group 2, RRHL: Number of Non-ASCT Participants Based on Reasons for ASCT Ineligibility | Advanced age | 12 Participants |
| Group 2: RRHL | Group 2, RRHL: Number of Non-ASCT Participants Based on Reasons for ASCT Ineligibility | Comorbid conditions | 13 Participants |
| Group 2: RRHL | Group 2, RRHL: Number of Non-ASCT Participants Based on Reasons for ASCT Ineligibility | Other | 11 Participants |
| Group 2: RRHL | Group 2, RRHL: Number of Non-ASCT Participants Based on Reasons for ASCT Ineligibility | Participant refusal | 5 Participants |
| Group 2: RRHL | Group 2, RRHL: Number of Non-ASCT Participants Based on Reasons for ASCT Ineligibility | Inability to mobilize stem cells | 1 Participants |
| Group 2: RRHL | Group 2, RRHL: Number of Non-ASCT Participants Based on Reasons for ASCT Ineligibility | Loss of response to chemotherapy | 4 Participants |
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.
Time frame: 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])
Population: 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.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Group 2: RRHL | Group 2, RRHL: Number of Non-ASCT Participants Categorized Based on Reasons for Not Undergoing ASCT Despite Being ASCT Eligible | Participant refusal | 21 Participants |
| Group 2: RRHL | Group 2, RRHL: Number of Non-ASCT Participants Categorized Based on Reasons for Not Undergoing ASCT Despite Being ASCT Eligible | Inability to mobilize stem cells | 3 Participants |
| Group 2: RRHL | Group 2, RRHL: Number of Non-ASCT Participants Categorized Based on Reasons for Not Undergoing ASCT Despite Being ASCT Eligible | Loss of response to chemotherapy | 13 Participants |
| Group 2: RRHL | Group 2, RRHL: Number of Non-ASCT Participants Categorized Based on Reasons for Not Undergoing ASCT Despite Being ASCT Eligible | Cumulative Toxicities | 1 Participants |
| Group 2: RRHL | Group 2, RRHL: Number of Non-ASCT Participants Categorized Based on Reasons for Not Undergoing ASCT Despite Being ASCT Eligible | Other | 11 Participants |
| Group 2: RRHL | Group 2, RRHL: Number of Non-ASCT Participants Categorized Based on Reasons for Not Undergoing ASCT Despite Being ASCT Eligible | Comorbid conditions | 2 Participants |
| Group 2: RRHL | Group 2, RRHL: Number of Non-ASCT Participants Categorized Based on Reasons for Not Undergoing ASCT Despite Being ASCT Eligible | Unknown | 29 Participants |
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.
Time frame: 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])
Population: 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.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Group 2: RRHL | Group 2, RRHL: Number of Non-ASCT Participants Categorized Based on Treatment Regimens Received at Each Line of Treatment | Second line: Therapy regimen 18 | 1 Participants |
| Group 2: RRHL | Group 2, RRHL: Number of Non-ASCT Participants Categorized Based on Treatment Regimens Received at Each Line of Treatment | Second line: Therapy regimen 19 | 1 Participants |
| Group 2: RRHL | Group 2, RRHL: Number of Non-ASCT Participants Categorized Based on Treatment Regimens Received at Each Line of Treatment | Third line: Therapy regimen 13 | 3 Participants |
| Group 2: RRHL | Group 2, RRHL: Number of Non-ASCT Participants Categorized Based on Treatment Regimens Received at Each Line of Treatment | Third line: Therapy regimen 24 | 23 Participants |
| Group 2: RRHL | Group 2, RRHL: Number of Non-ASCT Participants Categorized Based on Treatment Regimens Received at Each Line of Treatment | Other treatment: Therapy regimen 6 | 1 Participants |
| Group 2: RRHL | Group 2, RRHL: Number of Non-ASCT Participants Categorized Based on Treatment Regimens Received at Each Line of Treatment | Other treatment: Therapy regimen 7 | 1 Participants |
| Group 2: RRHL | Group 2, RRHL: Number of Non-ASCT Participants Categorized Based on Treatment Regimens Received at Each Line of Treatment | Frontline: Therapy regimen 1 | 161 Participants |
| Group 2: RRHL | Group 2, RRHL: Number of Non-ASCT Participants Categorized Based on Treatment Regimens Received at Each Line of Treatment | Frontline: Therapy regimen 3 | 1 Participants |
| Group 2: RRHL | Group 2, RRHL: Number of Non-ASCT Participants Categorized Based on Treatment Regimens Received at Each Line of Treatment | Frontline: Therapy regimen 6 | 1 Participants |
| Group 2: RRHL | Group 2, RRHL: Number of Non-ASCT Participants Categorized Based on Treatment Regimens Received at Each Line of Treatment | Frontline: Therapy regimen 7 | 4 Participants |
| Group 2: RRHL | Group 2, RRHL: Number of Non-ASCT Participants Categorized Based on Treatment Regimens Received at Each Line of Treatment | Frontline: Therapy regimen 11 | 1 Participants |
| Group 2: RRHL | Group 2, RRHL: Number of Non-ASCT Participants Categorized Based on Treatment Regimens Received at Each Line of Treatment | Frontline: Therapy regimen 18 | 1 Participants |
| Group 2: RRHL | Group 2, RRHL: Number of Non-ASCT Participants Categorized Based on Treatment Regimens Received at Each Line of Treatment | Front line: Therapy regimen 4 | 16 Participants |
| Group 2: RRHL | Group 2, RRHL: Number of Non-ASCT Participants Categorized Based on Treatment Regimens Received at Each Line of Treatment | Frontline: Therapy regimen 14 | 3 Participants |
| Group 2: RRHL | Group 2, RRHL: Number of Non-ASCT Participants Categorized Based on Treatment Regimens Received at Each Line of Treatment | Frontline: Therapy regimen 15 | 1 Participants |
| Group 2: RRHL | Group 2, RRHL: Number of Non-ASCT Participants Categorized Based on Treatment Regimens Received at Each Line of Treatment | Frontline: Therapy regimen 2 | 6 Participants |
| Group 2: RRHL | Group 2, RRHL: Number of Non-ASCT Participants Categorized Based on Treatment Regimens Received at Each Line of Treatment | Frontline: Therapy regimen 24 | 16 Participants |
| Group 2: RRHL | Group 2, RRHL: Number of Non-ASCT Participants Categorized Based on Treatment Regimens Received at Each Line of Treatment | Second line: Therapy regimen 1 | 13 Participants |
| Group 2: RRHL | Group 2, RRHL: Number of Non-ASCT Participants Categorized Based on Treatment Regimens Received at Each Line of Treatment | Second line: Therapy regimen 6 | 3 Participants |
| Group 2: RRHL | Group 2, RRHL: Number of Non-ASCT Participants Categorized Based on Treatment Regimens Received at Each Line of Treatment | Second line: Therapy regimen 7 | 23 Participants |
| Group 2: RRHL | Group 2, RRHL: Number of Non-ASCT Participants Categorized Based on Treatment Regimens Received at Each Line of Treatment | Second line: Therapy regimen 8 | 21 Participants |
| Group 2: RRHL | Group 2, RRHL: Number of Non-ASCT Participants Categorized Based on Treatment Regimens Received at Each Line of Treatment | Second line: Therapy regimen 9 | 1 Participants |
| Group 2: RRHL | Group 2, RRHL: Number of Non-ASCT Participants Categorized Based on Treatment Regimens Received at Each Line of Treatment | Second line: Therapy regimen 10 | 18 Participants |
| Group 2: RRHL | Group 2, RRHL: Number of Non-ASCT Participants Categorized Based on Treatment Regimens Received at Each Line of Treatment | Second line: Therapy regimen 11 | 7 Participants |
| Group 2: RRHL | Group 2, RRHL: Number of Non-ASCT Participants Categorized Based on Treatment Regimens Received at Each Line of Treatment | Second line: Therapy regimen 13 | 7 Participants |
| Group 2: RRHL | Group 2, RRHL: Number of Non-ASCT Participants Categorized Based on Treatment Regimens Received at Each Line of Treatment | Second line: Therapy regimen 17 | 2 Participants |
| Group 2: RRHL | Group 2, RRHL: Number of Non-ASCT Participants Categorized Based on Treatment Regimens Received at Each Line of Treatment | Second line: Therapy regimen 4 | 13 Participants |
| Group 2: RRHL | Group 2, RRHL: Number of Non-ASCT Participants Categorized Based on Treatment Regimens Received at Each Line of Treatment | Second line: Therapy regimen 14 | 5 Participants |
| Group 2: RRHL | Group 2, RRHL: Number of Non-ASCT Participants Categorized Based on Treatment Regimens Received at Each Line of Treatment | Second line: Therapy regimen 15 | 1 Participants |
| Group 2: RRHL | Group 2, RRHL: Number of Non-ASCT Participants Categorized Based on Treatment Regimens Received at Each Line of Treatment | Second line: Therapy regimen 2 | 5 Participants |
| Group 2: RRHL | Group 2, RRHL: Number of Non-ASCT Participants Categorized Based on Treatment Regimens Received at Each Line of Treatment | Second line: Therapy regimen 24 | 39 Participants |
| Group 2: RRHL | Group 2, RRHL: Number of Non-ASCT Participants Categorized Based on Treatment Regimens Received at Each Line of Treatment | Third line: Therapy regimen 1 | 3 Participants |
| Group 2: RRHL | Group 2, RRHL: Number of Non-ASCT Participants Categorized Based on Treatment Regimens Received at Each Line of Treatment | Third line: Therapy regimen 7 | 4 Participants |
| Group 2: RRHL | Group 2, RRHL: Number of Non-ASCT Participants Categorized Based on Treatment Regimens Received at Each Line of Treatment | Third line: Therapy regimen 8 | 3 Participants |
| Group 2: RRHL | Group 2, RRHL: Number of Non-ASCT Participants Categorized Based on Treatment Regimens Received at Each Line of Treatment | Third line: Therapy regimen 9 | 2 Participants |
| Group 2: RRHL | Group 2, RRHL: Number of Non-ASCT Participants Categorized Based on Treatment Regimens Received at Each Line of Treatment | Third line: Therapy regimen 10 | 8 Participants |
| Group 2: RRHL | Group 2, RRHL: Number of Non-ASCT Participants Categorized Based on Treatment Regimens Received at Each Line of Treatment | Third line: Therapy regimen 11 | 11 Participants |
| Group 2: RRHL | Group 2, RRHL: Number of Non-ASCT Participants Categorized Based on Treatment Regimens Received at Each Line of Treatment | Third line: Therapy regimen 17 | 1 Participants |
| Group 2: RRHL | Group 2, RRHL: Number of Non-ASCT Participants Categorized Based on Treatment Regimens Received at Each Line of Treatment | Third line: Therapy regimen 18 | 3 Participants |
| Group 2: RRHL | Group 2, RRHL: Number of Non-ASCT Participants Categorized Based on Treatment Regimens Received at Each Line of Treatment | Third line: Therapy regimen 22 | 1 Participants |
| Group 2: RRHL | Group 2, RRHL: Number of Non-ASCT Participants Categorized Based on Treatment Regimens Received at Each Line of Treatment | Third line: Therapy regimen 4 | 2 Participants |
| Group 2: RRHL | Group 2, RRHL: Number of Non-ASCT Participants Categorized Based on Treatment Regimens Received at Each Line of Treatment | Other treatment: Therapy regimen 10 | 1 Participants |
| Group 2: RRHL | Group 2, RRHL: Number of Non-ASCT Participants Categorized Based on Treatment Regimens Received at Each Line of Treatment | Other treatment: Therapy regimen 13 | 1 Participants |
| Group 2: RRHL | Group 2, RRHL: Number of Non-ASCT Participants Categorized Based on Treatment Regimens Received at Each Line of Treatment | Other treatment: Therapy regimen 18 | 5 Participants |
| Group 2: RRHL | Group 2, RRHL: Number of Non-ASCT Participants Categorized Based on Treatment Regimens Received at Each Line of Treatment | Other treatment: Therapy regimen 22 | 2 Participants |
| Group 2: RRHL | Group 2, RRHL: Number of Non-ASCT Participants Categorized Based on Treatment Regimens Received at Each Line of Treatment | Other treatment: Therapy regimen 16 | 1 Participants |
| Group 2: RRHL | Group 2, RRHL: Number of Non-ASCT Participants Categorized Based on Treatment Regimens Received at Each Line of Treatment | Other treatment: Therapy regimen 4 | 1 Participants |
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).
Time frame: Day 1 at RRHL diagnosis
Population: The FAS included all participants who were eligible for RRHL group including the common participants in both the groups.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Group 2: RRHL | Group 2, RRHL: Number of Participants Based on Clinical Staging According to Ann Arbor Staging at Diagnosis | Stage I-A | 7 Participants |
| Group 2: RRHL | Group 2, RRHL: Number of Participants Based on Clinical Staging According to Ann Arbor Staging at Diagnosis | Stage I-B | 2 Participants |
| Group 2: RRHL | Group 2, RRHL: Number of Participants Based on Clinical Staging According to Ann Arbor Staging at Diagnosis | Stage II-A | 24 Participants |
| Group 2: RRHL | Group 2, RRHL: Number of Participants Based on Clinical Staging According to Ann Arbor Staging at Diagnosis | Stage II-B | 61 Participants |
| Group 2: RRHL | Group 2, RRHL: Number of Participants Based on Clinical Staging According to Ann Arbor Staging at Diagnosis | Stage III-A | 52 Participants |
| Group 2: RRHL | Group 2, RRHL: Number of Participants Based on Clinical Staging According to Ann Arbor Staging at Diagnosis | Stage III-B | 78 Participants |
| Group 2: RRHL | Group 2, RRHL: Number of Participants Based on Clinical Staging According to Ann Arbor Staging at Diagnosis | Stage IV-A | 53 Participants |
| Group 2: RRHL | Group 2, RRHL: Number of Participants Based on Clinical Staging According to Ann Arbor Staging at Diagnosis | Stage IV-B | 107 Participants |
| Group 2: RRHL | Group 2, RRHL: Number of Participants Based on Clinical Staging According to Ann Arbor Staging at Diagnosis | Stage unknown | 42 Participants |
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).
Time frame: At second, third, fourth, and fifth relapse (up to 9 years 10 months)
Population: 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.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Group 2: RRHL | Group 2, RRHL: Number of Participants Based on Clinical Staging According to Ann Arbor Staging at Relapse After First Relapse or Refractory Diagnosis | Clinical stage at 2nd relapse | Stage I-A | 1 Participants |
| Group 2: RRHL | Group 2, RRHL: Number of Participants Based on Clinical Staging According to Ann Arbor Staging at Relapse After First Relapse or Refractory Diagnosis | Clinical stage at 2nd relapse | Stage I-B | 0 Participants |
| Group 2: RRHL | Group 2, RRHL: Number of Participants Based on Clinical Staging According to Ann Arbor Staging at Relapse After First Relapse or Refractory Diagnosis | Clinical stage at 2nd relapse | Stage II-A | 6 Participants |
| Group 2: RRHL | Group 2, RRHL: Number of Participants Based on Clinical Staging According to Ann Arbor Staging at Relapse After First Relapse or Refractory Diagnosis | Clinical stage at 2nd relapse | Stage II-B | 9 Participants |
| Group 2: RRHL | Group 2, RRHL: Number of Participants Based on Clinical Staging According to Ann Arbor Staging at Relapse After First Relapse or Refractory Diagnosis | Clinical stage at 2nd relapse | Stage III-A | 9 Participants |
| Group 2: RRHL | Group 2, RRHL: Number of Participants Based on Clinical Staging According to Ann Arbor Staging at Relapse After First Relapse or Refractory Diagnosis | Clinical stage at 2nd relapse | Stage III-B | 15 Participants |
| Group 2: RRHL | Group 2, RRHL: Number of Participants Based on Clinical Staging According to Ann Arbor Staging at Relapse After First Relapse or Refractory Diagnosis | Clinical stage at 2nd relapse | Stage IV-A | 9 Participants |
| Group 2: RRHL | Group 2, RRHL: Number of Participants Based on Clinical Staging According to Ann Arbor Staging at Relapse After First Relapse or Refractory Diagnosis | Clinical stage at 2nd relapse | Stage IV-B | 14 Participants |
| Group 2: RRHL | Group 2, RRHL: Number of Participants Based on Clinical Staging According to Ann Arbor Staging at Relapse After First Relapse or Refractory Diagnosis | Clinical stage at 2nd relapse | Stage unknown | 16 Participants |
| Group 2: RRHL | Group 2, RRHL: Number of Participants Based on Clinical Staging According to Ann Arbor Staging at Relapse After First Relapse or Refractory Diagnosis | Clinical stage at 3rd relapse | Stage I-A | 0 Participants |
| Group 2: RRHL | Group 2, RRHL: Number of Participants Based on Clinical Staging According to Ann Arbor Staging at Relapse After First Relapse or Refractory Diagnosis | Clinical stage at 3rd relapse | Stage I-B | 0 Participants |
| Group 2: RRHL | Group 2, RRHL: Number of Participants Based on Clinical Staging According to Ann Arbor Staging at Relapse After First Relapse or Refractory Diagnosis | Clinical stage at 3rd relapse | Stage II-A | 2 Participants |
| Group 2: RRHL | Group 2, RRHL: Number of Participants Based on Clinical Staging According to Ann Arbor Staging at Relapse After First Relapse or Refractory Diagnosis | Clinical stage at 3rd relapse | Stage II-B | 4 Participants |
| Group 2: RRHL | Group 2, RRHL: Number of Participants Based on Clinical Staging According to Ann Arbor Staging at Relapse After First Relapse or Refractory Diagnosis | Clinical stage at 3rd relapse | Stage III-A | 2 Participants |
| Group 2: RRHL | Group 2, RRHL: Number of Participants Based on Clinical Staging According to Ann Arbor Staging at Relapse After First Relapse or Refractory Diagnosis | Clinical stage at 3rd relapse | Stage III-B | 4 Participants |
| Group 2: RRHL | Group 2, RRHL: Number of Participants Based on Clinical Staging According to Ann Arbor Staging at Relapse After First Relapse or Refractory Diagnosis | Clinical stage at 3rd relapse | Stage IV-A | 1 Participants |
| Group 2: RRHL | Group 2, RRHL: Number of Participants Based on Clinical Staging According to Ann Arbor Staging at Relapse After First Relapse or Refractory Diagnosis | Clinical stage at 3rd relapse | Stage IV-B | 3 Participants |
| Group 2: RRHL | Group 2, RRHL: Number of Participants Based on Clinical Staging According to Ann Arbor Staging at Relapse After First Relapse or Refractory Diagnosis | Clinical stage at 3rd relapse | Stage unknown | 6 Participants |
| Group 2: RRHL | Group 2, RRHL: Number of Participants Based on Clinical Staging According to Ann Arbor Staging at Relapse After First Relapse or Refractory Diagnosis | Clinical stage at 4th relapse | Stage I-A | 1 Participants |
| Group 2: RRHL | Group 2, RRHL: Number of Participants Based on Clinical Staging According to Ann Arbor Staging at Relapse After First Relapse or Refractory Diagnosis | Clinical stage at 4th relapse | Stage I-B | 0 Participants |
| Group 2: RRHL | Group 2, RRHL: Number of Participants Based on Clinical Staging According to Ann Arbor Staging at Relapse After First Relapse or Refractory Diagnosis | Clinical stage at 4th relapse | Stage II-A | 1 Participants |
| Group 2: RRHL | Group 2, RRHL: Number of Participants Based on Clinical Staging According to Ann Arbor Staging at Relapse After First Relapse or Refractory Diagnosis | Clinical stage at 4th relapse | Stage II-B | 0 Participants |
| Group 2: RRHL | Group 2, RRHL: Number of Participants Based on Clinical Staging According to Ann Arbor Staging at Relapse After First Relapse or Refractory Diagnosis | Clinical stage at 4th relapse | Stage III-A | 0 Participants |
| Group 2: RRHL | Group 2, RRHL: Number of Participants Based on Clinical Staging According to Ann Arbor Staging at Relapse After First Relapse or Refractory Diagnosis | Clinical stage at 4th relapse | Stage III-B | 1 Participants |
| Group 2: RRHL | Group 2, RRHL: Number of Participants Based on Clinical Staging According to Ann Arbor Staging at Relapse After First Relapse or Refractory Diagnosis | Clinical stage at 4th relapse | Stage IV-A | 1 Participants |
| Group 2: RRHL | Group 2, RRHL: Number of Participants Based on Clinical Staging According to Ann Arbor Staging at Relapse After First Relapse or Refractory Diagnosis | Clinical stage at 4th relapse | Stage IV-B | 2 Participants |
| Group 2: RRHL | Group 2, RRHL: Number of Participants Based on Clinical Staging According to Ann Arbor Staging at Relapse After First Relapse or Refractory Diagnosis | Clinical stage at 4th relapse | Stage unknown | 2 Participants |
| Group 2: RRHL | Group 2, RRHL: Number of Participants Based on Clinical Staging According to Ann Arbor Staging at Relapse After First Relapse or Refractory Diagnosis | Clinical stage at 5th relapse | Stage I-A | 0 Participants |
| Group 2: RRHL | Group 2, RRHL: Number of Participants Based on Clinical Staging According to Ann Arbor Staging at Relapse After First Relapse or Refractory Diagnosis | Clinical stage at 5th relapse | Stage I-B | 0 Participants |
| Group 2: RRHL | Group 2, RRHL: Number of Participants Based on Clinical Staging According to Ann Arbor Staging at Relapse After First Relapse or Refractory Diagnosis | Clinical stage at 5th relapse | Stage II-A | 1 Participants |
| Group 2: RRHL | Group 2, RRHL: Number of Participants Based on Clinical Staging According to Ann Arbor Staging at Relapse After First Relapse or Refractory Diagnosis | Clinical stage at 5th relapse | Stage II-B | 0 Participants |
| Group 2: RRHL | Group 2, RRHL: Number of Participants Based on Clinical Staging According to Ann Arbor Staging at Relapse After First Relapse or Refractory Diagnosis | Clinical stage at 5th relapse | Stage III-A | 0 Participants |
| Group 2: RRHL | Group 2, RRHL: Number of Participants Based on Clinical Staging According to Ann Arbor Staging at Relapse After First Relapse or Refractory Diagnosis | Clinical stage at 5th relapse | Stage III-B | 0 Participants |
| Group 2: RRHL | Group 2, RRHL: Number of Participants Based on Clinical Staging According to Ann Arbor Staging at Relapse After First Relapse or Refractory Diagnosis | Clinical stage at 5th relapse | Stage IV-A | 0 Participants |
| Group 2: RRHL | Group 2, RRHL: Number of Participants Based on Clinical Staging According to Ann Arbor Staging at Relapse After First Relapse or Refractory Diagnosis | Clinical stage at 5th relapse | Stage IV-B | 0 Participants |
| Group 2: RRHL | Group 2, RRHL: Number of Participants Based on Clinical Staging According to Ann Arbor Staging at Relapse After First Relapse or Refractory Diagnosis | Clinical stage at 5th relapse | Stage unknown | 1 Participants |
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
Time frame: 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])
Population: 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.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Group 2: RRHL | 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 | Relapse/refractory: Mediastinal nodes | 12 Participants |
| Group 2: RRHL | 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 | Frontline: Axillary nodes | 1 Participants |
| Group 2: RRHL | 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 | Frontline: Bone lesions | 1 Participants |
| Group 2: RRHL | 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 | Frontline: Mediastinal nodes | 4 Participants |
| Group 2: RRHL | 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 | Frontline: Neck nodes | 2 Participants |
| Group 2: RRHL | 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 | Frontline: Other | 7 Participants |
| Group 2: RRHL | 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 | Relapse/refractory: Abdominal nodes | 4 Participants |
| Group 2: RRHL | 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 | Relapse/refractory: Axillary nodes | 4 Participants |
| Group 2: RRHL | 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 | Relapse/refractory: Bone lesions | 3 Participants |
| Group 2: RRHL | 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 | Relapse/refractory: Neck nodes | 5 Participants |
| Group 2: RRHL | 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 | Relapse/refractory: Other | 2 Participants |
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.
Time frame: 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])
Population: 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.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Group 2: RRHL | 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 | Salvage Therapy: Chest x-Ray | 63 Participants |
| Group 2: RRHL | 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 | Salvage Therapy: Magnetic resonance imaging | 8 Participants |
| Group 2: RRHL | 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 | Salvage Therapy: Needle biopsy | 19 Participants |
| Group 2: RRHL | 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 | Salvage Therapy: Bone scan | 3 Participants |
| Group 2: RRHL | 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 | Salvage Therapy: Bone marrow aspiration | 43 Participants |
| Group 2: RRHL | 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 | Salvage Therapy: Flow cytometry | 4 Participants |
| Group 2: RRHL | 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 | Salvage Therapy: Other scan procedures | 40 Participants |
| Group 2: RRHL | 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 | Salvage Therapy: G-CSF/ other high cost medications | 150 Participants |
| Group 2: RRHL | 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 | Salvage Therapy: Pegylated G-CSF | 17 Participants |
| Group 2: RRHL | 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 | ASCT: G-CSF/ other high cost medications | 6 Participants |
| Group 2: RRHL | 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 | ASCT: Pegylated G-CSF | 1 Participants |
Secondary
Group 2, RRHL: Number of Participants Categorized Based on Intent of Treatment of Radiotherapies in Participants Who Relapse After ASCT
Time frame: 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])
Population: The FAS included all participants who were eligible for RRHL group including common participants, and who relapsed after ASCT.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Group 2: RRHL | Group 2, RRHL: Number of Participants Categorized Based on Intent of Treatment of Radiotherapies in Participants Who Relapse After ASCT | Frontline: Radical/Cure Intent | 14 Participants |
| Group 2: RRHL | Group 2, RRHL: Number of Participants Categorized Based on Intent of Treatment of Radiotherapies in Participants Who Relapse After ASCT | Frontline: Other | 1 Participants |
| Group 2: RRHL | Group 2, RRHL: Number of Participants Categorized Based on Intent of Treatment of Radiotherapies in Participants Who Relapse After ASCT | Relapse/refractory: Radical/Cure Intent | 23 Participants |
| Group 2: RRHL | Group 2, RRHL: Number of Participants Categorized Based on Intent of Treatment of Radiotherapies in Participants Who Relapse After ASCT | Relapse/refractory: Palliative Intent | 5 Participants |
| Group 2: RRHL | Group 2, RRHL: Number of Participants Categorized Based on Intent of Treatment of Radiotherapies in Participants Who Relapse After ASCT | Relapse/refractory: Other | 2 Participants |
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.
Time frame: 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])
Population: 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.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Group 2: RRHL | Group 2, RRHL: Number of Participants Categorized Based on Post-ASCT Regimens Received at Each Line of Treatment in Participants Who Relapse After ASCT | Frontline: Therapy regimen 1 | 57 Participants |
| Group 2: RRHL | Group 2, RRHL: Number of Participants Categorized Based on Post-ASCT Regimens Received at Each Line of Treatment in Participants Who Relapse After ASCT | Frontline: Therapy regimen 7 | 1 Participants |
| Group 2: RRHL | Group 2, RRHL: Number of Participants Categorized Based on Post-ASCT Regimens Received at Each Line of Treatment in Participants Who Relapse After ASCT | Frontline: Therapy regimen 10 | 1 Participants |
| Group 2: RRHL | Group 2, RRHL: Number of Participants Categorized Based on Post-ASCT Regimens Received at Each Line of Treatment in Participants Who Relapse After ASCT | Frontline: Therapy regimen 11 | 1 Participants |
| Group 2: RRHL | Group 2, RRHL: Number of Participants Categorized Based on Post-ASCT Regimens Received at Each Line of Treatment in Participants Who Relapse After ASCT | Frontline: Therapy regimen 4 | 4 Participants |
| Group 2: RRHL | Group 2, RRHL: Number of Participants Categorized Based on Post-ASCT Regimens Received at Each Line of Treatment in Participants Who Relapse After ASCT | Frontline: Therapy regimen 2 | 2 Participants |
| Group 2: RRHL | Group 2, RRHL: Number of Participants Categorized Based on Post-ASCT Regimens Received at Each Line of Treatment in Participants Who Relapse After ASCT | Frontline: Therapy regimen 24 | 3 Participants |
| Group 2: RRHL | Group 2, RRHL: Number of Participants Categorized Based on Post-ASCT Regimens Received at Each Line of Treatment in Participants Who Relapse After ASCT | Second line: Therapy regimen 7 | 9 Participants |
| Group 2: RRHL | Group 2, RRHL: Number of Participants Categorized Based on Post-ASCT Regimens Received at Each Line of Treatment in Participants Who Relapse After ASCT | Second line: Therapy regimen 8 | 28 Participants |
| Group 2: RRHL | Group 2, RRHL: Number of Participants Categorized Based on Post-ASCT Regimens Received at Each Line of Treatment in Participants Who Relapse After ASCT | Second line: Therapy regimen 10 | 10 Participants |
| Group 2: RRHL | Group 2, RRHL: Number of Participants Categorized Based on Post-ASCT Regimens Received at Each Line of Treatment in Participants Who Relapse After ASCT | Second line: Therapy regimen 11 | 4 Participants |
| Group 2: RRHL | Group 2, RRHL: Number of Participants Categorized Based on Post-ASCT Regimens Received at Each Line of Treatment in Participants Who Relapse After ASCT | Second line: Therapy regimen 12 | 1 Participants |
| Group 2: RRHL | Group 2, RRHL: Number of Participants Categorized Based on Post-ASCT Regimens Received at Each Line of Treatment in Participants Who Relapse After ASCT | Second line: Therapy regimen 13 | 2 Participants |
| Group 2: RRHL | Group 2, RRHL: Number of Participants Categorized Based on Post-ASCT Regimens Received at Each Line of Treatment in Participants Who Relapse After ASCT | Second line: Therapy regimen 18 | 1 Participants |
| Group 2: RRHL | Group 2, RRHL: Number of Participants Categorized Based on Post-ASCT Regimens Received at Each Line of Treatment in Participants Who Relapse After ASCT | Second line: Therapy regimen 4 | 4 Participants |
| Group 2: RRHL | Group 2, RRHL: Number of Participants Categorized Based on Post-ASCT Regimens Received at Each Line of Treatment in Participants Who Relapse After ASCT | Second line: Therapy regimen 24 | 5 Participants |
| Group 2: RRHL | Group 2, RRHL: Number of Participants Categorized Based on Post-ASCT Regimens Received at Each Line of Treatment in Participants Who Relapse After ASCT | Third line: Therapy regimen 7 | 2 Participants |
| Group 2: RRHL | Group 2, RRHL: Number of Participants Categorized Based on Post-ASCT Regimens Received at Each Line of Treatment in Participants Who Relapse After ASCT | Third line: Therapy regimen 8 | 3 Participants |
| Group 2: RRHL | Group 2, RRHL: Number of Participants Categorized Based on Post-ASCT Regimens Received at Each Line of Treatment in Participants Who Relapse After ASCT | Third line: Therapy regimen 9 | 3 Participants |
| Group 2: RRHL | Group 2, RRHL: Number of Participants Categorized Based on Post-ASCT Regimens Received at Each Line of Treatment in Participants Who Relapse After ASCT | Third line: Therapy regimen 10 | 6 Participants |
| Group 2: RRHL | Group 2, RRHL: Number of Participants Categorized Based on Post-ASCT Regimens Received at Each Line of Treatment in Participants Who Relapse After ASCT | Third line: Therapy regimen 11 | 9 Participants |
| Group 2: RRHL | Group 2, RRHL: Number of Participants Categorized Based on Post-ASCT Regimens Received at Each Line of Treatment in Participants Who Relapse After ASCT | Third line: Therapy regimen 12 | 3 Participants |
| Group 2: RRHL | Group 2, RRHL: Number of Participants Categorized Based on Post-ASCT Regimens Received at Each Line of Treatment in Participants Who Relapse After ASCT | Third line: Therapy regimen 13 | 1 Participants |
| Group 2: RRHL | Group 2, RRHL: Number of Participants Categorized Based on Post-ASCT Regimens Received at Each Line of Treatment in Participants Who Relapse After ASCT | Third line: Therapy regimen 18 | 9 Participants |
| Group 2: RRHL | Group 2, RRHL: Number of Participants Categorized Based on Post-ASCT Regimens Received at Each Line of Treatment in Participants Who Relapse After ASCT | Third line: Therapy regimen 22 | 1 Participants |
| Group 2: RRHL | Group 2, RRHL: Number of Participants Categorized Based on Post-ASCT Regimens Received at Each Line of Treatment in Participants Who Relapse After ASCT | Third line: Therapy regimen 23 | 1 Participants |
| Group 2: RRHL | Group 2, RRHL: Number of Participants Categorized Based on Post-ASCT Regimens Received at Each Line of Treatment in Participants Who Relapse After ASCT | Third line: Therapy regimen 16 | 4 Participants |
| Group 2: RRHL | Group 2, RRHL: Number of Participants Categorized Based on Post-ASCT Regimens Received at Each Line of Treatment in Participants Who Relapse After ASCT | Third line: Therapy regimen 4 | 1 Participants |
| Group 2: RRHL | Group 2, RRHL: Number of Participants Categorized Based on Post-ASCT Regimens Received at Each Line of Treatment in Participants Who Relapse After ASCT | Third line: Therapy regimen 24 | 13 Participants |
| Group 2: RRHL | Group 2, RRHL: Number of Participants Categorized Based on Post-ASCT Regimens Received at Each Line of Treatment in Participants Who Relapse After ASCT | Pre-SCT: Therapy regimen 10 | 2 Participants |
| Group 2: RRHL | Group 2, RRHL: Number of Participants Categorized Based on Post-ASCT Regimens Received at Each Line of Treatment in Participants Who Relapse After ASCT | Pre-SCT: Therapy regimen 12 | 3 Participants |
| Group 2: RRHL | Group 2, RRHL: Number of Participants Categorized Based on Post-ASCT Regimens Received at Each Line of Treatment in Participants Who Relapse After ASCT | Pre-SCT: Therapy regimen 18 | 2 Participants |
| Group 2: RRHL | Group 2, RRHL: Number of Participants Categorized Based on Post-ASCT Regimens Received at Each Line of Treatment in Participants Who Relapse After ASCT | Pre-SCT: Therapy regimen 19 | 1 Participants |
| Group 2: RRHL | Group 2, RRHL: Number of Participants Categorized Based on Post-ASCT Regimens Received at Each Line of Treatment in Participants Who Relapse After ASCT | Pre-SCT: Therapy regimen 14 | 1 Participants |
| Group 2: RRHL | Group 2, RRHL: Number of Participants Categorized Based on Post-ASCT Regimens Received at Each Line of Treatment in Participants Who Relapse After ASCT | Pre-SCT: Therapy regimen 24 | 9 Participants |
| Group 2: RRHL | Group 2, RRHL: Number of Participants Categorized Based on Post-ASCT Regimens Received at Each Line of Treatment in Participants Who Relapse After ASCT | Post-SCT: Therapy regimen 18 | 2 Participants |
| Group 2: RRHL | Group 2, RRHL: Number of Participants Categorized Based on Post-ASCT Regimens Received at Each Line of Treatment in Participants Who Relapse After ASCT | Other treatment: Therapy regimen 7 | 1 Participants |
| Group 2: RRHL | Group 2, RRHL: Number of Participants Categorized Based on Post-ASCT Regimens Received at Each Line of Treatment in Participants Who Relapse After ASCT | Other treatment: Therapy regimen 9 | 1 Participants |
| Group 2: RRHL | Group 2, RRHL: Number of Participants Categorized Based on Post-ASCT Regimens Received at Each Line of Treatment in Participants Who Relapse After ASCT | Other treatment: Therapy regimen 10 | 2 Participants |
| Group 2: RRHL | Group 2, RRHL: Number of Participants Categorized Based on Post-ASCT Regimens Received at Each Line of Treatment in Participants Who Relapse After ASCT | Other treatment: Therapy regimen 11 | 1 Participants |
| Group 2: RRHL | Group 2, RRHL: Number of Participants Categorized Based on Post-ASCT Regimens Received at Each Line of Treatment in Participants Who Relapse After ASCT | Other treatment: Therapy regimen 17 | 1 Participants |
| Group 2: RRHL | Group 2, RRHL: Number of Participants Categorized Based on Post-ASCT Regimens Received at Each Line of Treatment in Participants Who Relapse After ASCT | Other treatment: Therapy regimen 18 | 7 Participants |
| Group 2: RRHL | Group 2, RRHL: Number of Participants Categorized Based on Post-ASCT Regimens Received at Each Line of Treatment in Participants Who Relapse After ASCT | Other treatment: Therapy regimen 19 | 7 Participants |
| Group 2: RRHL | Group 2, RRHL: Number of Participants Categorized Based on Post-ASCT Regimens Received at Each Line of Treatment in Participants Who Relapse After ASCT | Other treatment: Therapy regimen 22 | 5 Participants |
| Group 2: RRHL | Group 2, RRHL: Number of Participants Categorized Based on Post-ASCT Regimens Received at Each Line of Treatment in Participants Who Relapse After ASCT | Other treatment: Therapy regimen 23 | 2 Participants |
| Group 2: RRHL | Group 2, RRHL: Number of Participants Categorized Based on Post-ASCT Regimens Received at Each Line of Treatment in Participants Who Relapse After ASCT | Other treatment: Therapy regimen 16 | 1 Participants |
| Group 2: RRHL | Group 2, RRHL: Number of Participants Categorized Based on Post-ASCT Regimens Received at Each Line of Treatment in Participants Who Relapse After ASCT | Other treatment: Therapy regimen 4 | 1 Participants |
| Group 2: RRHL | Group 2, RRHL: Number of Participants Categorized Based on Post-ASCT Regimens Received at Each Line of Treatment in Participants Who Relapse After ASCT | Other treatment: Therapy regimen 24 | 15 Participants |
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.
Time frame: Day 1 at RRHL diagnosis
Population: 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.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Group 2: RRHL | Group 2, RRHL: Number of Participants Categorized Based on Prior Therapies for Hodgkin Lymphoma (HL) at Each Line of Treatment | Frontline treatment | 425 Participants |
| Group 2: RRHL | Group 2, RRHL: Number of Participants Categorized Based on Prior Therapies for Hodgkin Lymphoma (HL) at Each Line of Treatment | Second line treatment | 17 Participants |
| Group 2: RRHL | Group 2, RRHL: Number of Participants Categorized Based on Prior Therapies for Hodgkin Lymphoma (HL) at Each Line of Treatment | Third line treatment | 1 Participants |
| Group 2: RRHL | Group 2, RRHL: Number of Participants Categorized Based on Prior Therapies for Hodgkin Lymphoma (HL) at Each Line of Treatment | Pre-SCT line treatment | 1 Participants |
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.
Time frame: 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])
Population: 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.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Group 2: RRHL | Group 2, RRHL: Number of Participants Categorized Based on Reasons for Inpatient Hospital Admissions Related to HL for Salvage Therapy and ASCT | Salvage Therapy: Stem cell transplant | 50 Participants |
| Group 2: RRHL | Group 2, RRHL: Number of Participants Categorized Based on Reasons for Inpatient Hospital Admissions Related to HL for Salvage Therapy and ASCT | Salvage Therapy: Chemotherapy | 144 Participants |
| Group 2: RRHL | Group 2, RRHL: Number of Participants Categorized Based on Reasons for Inpatient Hospital Admissions Related to HL for Salvage Therapy and ASCT | Salvage Therapy: Radiotherapy | 6 Participants |
| Group 2: RRHL | Group 2, RRHL: Number of Participants Categorized Based on Reasons for Inpatient Hospital Admissions Related to HL for Salvage Therapy and ASCT | Salvage Therapy: Adverse event | 36 Participants |
| Group 2: RRHL | Group 2, RRHL: Number of Participants Categorized Based on Reasons for Inpatient Hospital Admissions Related to HL for Salvage Therapy and ASCT | Salvage Therapy: Unknown | 6 Participants |
| Group 2: RRHL | Group 2, RRHL: Number of Participants Categorized Based on Reasons for Inpatient Hospital Admissions Related to HL for Salvage Therapy and ASCT | Salvage Therapy: Other | 51 Participants |
| Group 2: RRHL | Group 2, RRHL: Number of Participants Categorized Based on Reasons for Inpatient Hospital Admissions Related to HL for Salvage Therapy and ASCT | ASCT: Chemotherapy | 2 Participants |
| Group 2: RRHL | Group 2, RRHL: Number of Participants Categorized Based on Reasons for Inpatient Hospital Admissions Related to HL for Salvage Therapy and ASCT | ASCT: Adverse event | 3 Participants |
Secondary
Group 2, RRHL: Number of Participants Categorized Based on Source of ASCT Procedures in Participants Undergoing ASCT
Time frame: 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])
Population: 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.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Group 2: RRHL | Group 2, RRHL: Number of Participants Categorized Based on Source of ASCT Procedures in Participants Undergoing ASCT | Bone marrow | 36 Participants |
| Group 2: RRHL | Group 2, RRHL: Number of Participants Categorized Based on Source of ASCT Procedures in Participants Undergoing ASCT | Peripheral | 182 Participants |
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.
Time frame: 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])
Population: 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.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Group 2: RRHL | Group 2, RRHL: Number of Participants Categorized Based on Various Chemotherapeutic Regimen and Therapies Used in Participants Undergoing ASCT | Salvage Regimens: Pre-SCT, Therapy regimen 16 | 1 Participants |
| Group 2: RRHL | Group 2, RRHL: Number of Participants Categorized Based on Various Chemotherapeutic Regimen and Therapies Used in Participants Undergoing ASCT | Salvage Regimens: Pre-SCT, Therapy regimen 8 | 1 Participants |
| Group 2: RRHL | Group 2, RRHL: Number of Participants Categorized Based on Various Chemotherapeutic Regimen and Therapies Used in Participants Undergoing ASCT | Salvage Regimens: Pre-SCT, Therapy regimen 10 | 2 Participants |
| Group 2: RRHL | Group 2, RRHL: Number of Participants Categorized Based on Various Chemotherapeutic Regimen and Therapies Used in Participants Undergoing ASCT | Salvage Regimens: Pre-SCT, Therapy regimen 11 | 1 Participants |
| Group 2: RRHL | Group 2, RRHL: Number of Participants Categorized Based on Various Chemotherapeutic Regimen and Therapies Used in Participants Undergoing ASCT | Salvage Regimens: Pre-SCT, Therapy regimen 12 | 5 Participants |
| Group 2: RRHL | Group 2, RRHL: Number of Participants Categorized Based on Various Chemotherapeutic Regimen and Therapies Used in Participants Undergoing ASCT | Salvage Regimens: Pre-SCT, Therapy regimen 18 | 3 Participants |
| Group 2: RRHL | Group 2, RRHL: Number of Participants Categorized Based on Various Chemotherapeutic Regimen and Therapies Used in Participants Undergoing ASCT | Salvage Regimens: Pre-SCT, Therapy regimen 19 | 1 Participants |
| Group 2: RRHL | Group 2, RRHL: Number of Participants Categorized Based on Various Chemotherapeutic Regimen and Therapies Used in Participants Undergoing ASCT | Salvage Regimens: Pre-SCT, Therapy regimen 24 | 23 Participants |
| Group 2: RRHL | Group 2, RRHL: Number of Participants Categorized Based on Various Chemotherapeutic Regimen and Therapies Used in Participants Undergoing ASCT | Salvage Regimens: Post-SCT, Therapy regimen 10 | 1 Participants |
| Group 2: RRHL | Group 2, RRHL: Number of Participants Categorized Based on Various Chemotherapeutic Regimen and Therapies Used in Participants Undergoing ASCT | Salvage Regimens: Post-SCT, Therapy regimen 11 | 1 Participants |
| Group 2: RRHL | Group 2, RRHL: Number of Participants Categorized Based on Various Chemotherapeutic Regimen and Therapies Used in Participants Undergoing ASCT | Salvage Regimens: Post-SCT, Therapy regimen 18 | 3 Participants |
| Group 2: RRHL | Group 2, RRHL: Number of Participants Categorized Based on Various Chemotherapeutic Regimen and Therapies Used in Participants Undergoing ASCT | Salvage Regimens: Post-SCT, Therapy regimen 19 | 1 Participants |
| Group 2: RRHL | Group 2, RRHL: Number of Participants Categorized Based on Various Chemotherapeutic Regimen and Therapies Used in Participants Undergoing ASCT | Salvage Regimens: Post-SCT, Therapy regimen 24 | 2 Participants |
| Group 2: RRHL | Group 2, RRHL: Number of Participants Categorized Based on Various Chemotherapeutic Regimen and Therapies Used in Participants Undergoing ASCT | Conditioning Regimens: BEAM | 132 Participants |
| Group 2: RRHL | Group 2, RRHL: Number of Participants Categorized Based on Various Chemotherapeutic Regimen and Therapies Used in Participants Undergoing ASCT | Conditioning Regimens: CBV | 22 Participants |
| Group 2: RRHL | Group 2, RRHL: Number of Participants Categorized Based on Various Chemotherapeutic Regimen and Therapies Used in Participants Undergoing ASCT | Conditioning Regimens: BeEAM | 6 Participants |
| Group 2: RRHL | Group 2, RRHL: Number of Participants Categorized Based on Various Chemotherapeutic Regimen and Therapies Used in Participants Undergoing ASCT | Conditioning Regimens: Gemcitabine/Bu/Mel | 1 Participants |
| Group 2: RRHL | Group 2, RRHL: Number of Participants Categorized Based on Various Chemotherapeutic Regimen and Therapies Used in Participants Undergoing ASCT | Conditioning Regimens: Other | 55 Participants |
| Group 2: RRHL | Group 2, RRHL: Number of Participants Categorized Based on Various Chemotherapeutic Regimen and Therapies Used in Participants Undergoing ASCT | Conditioning Regimens: Unknown | 3 Participants |
| Group 2: RRHL | Group 2, RRHL: Number of Participants Categorized Based on Various Chemotherapeutic Regimen and Therapies Used in Participants Undergoing ASCT | Consolidation Therapy : Post -SCT | 4 Participants |
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).
Time frame: 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])
Population: 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.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Group 2: RRHL | Group 2, RRHL: Number of Participants Categorized Based on With Known Risk Factors for Relapse Post ASCT in Participants Undergoing ASCT | Time to first relapse <=3 months | 19 Participants |
| Group 2: RRHL | Group 2, RRHL: Number of Participants Categorized Based on With Known Risk Factors for Relapse Post ASCT in Participants Undergoing ASCT | Stage IV disease at relapse | 81 Participants |
| Group 2: RRHL | Group 2, RRHL: Number of Participants Categorized Based on With Known Risk Factors for Relapse Post ASCT in Participants Undergoing ASCT | Bulky disease >=5 cm at relapse | 47 Participants |
| Group 2: RRHL | Group 2, RRHL: Number of Participants Categorized Based on With Known Risk Factors for Relapse Post ASCT in Participants Undergoing ASCT | Extranodal disease | 83 Participants |
| Group 2: RRHL | Group 2, RRHL: Number of Participants Categorized Based on With Known Risk Factors for Relapse Post ASCT in Participants Undergoing ASCT | Inadequate response to salvage chemotherapy | 63 Participants |
| Group 2: RRHL | Group 2, RRHL: Number of Participants Categorized Based on With Known Risk Factors for Relapse Post ASCT in Participants Undergoing ASCT | Performance status (ECOG) >=1 | 73 Participants |
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.
Time frame: 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])
Population: 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.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Group 2: RRHL | 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 | Salvage Therapy: Inpatient Hospital Admissions | 175 Participants |
| Group 2: RRHL | 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 | Salvage Therapy: Emergency Room Visits | 44 Participants |
| Group 2: RRHL | 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 | Salvage Therapy: Outpatient Visits | 185 Participants |
| Group 2: RRHL | 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 | ASCT: Inpatient Hospital Admissions | 5 Participants |
| Group 2: RRHL | 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 | ASCT: Emergency Room Visits | 2 Participants |
| Group 2: RRHL | 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 | ASCT: Outpatient Visits | 4 Participants |
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.
Time frame: 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])
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Group 2: RRHL | Group 2, RRHL: Number of Participants With Best Clinical Response Post Completion of Each Line of Treatment | Frontline: CR | 131 participants |
| Group 2: RRHL | Group 2, RRHL: Number of Participants With Best Clinical Response Post Completion of Each Line of Treatment | Frontline: PR | 133 participants |
| Group 2: RRHL | Group 2, RRHL: Number of Participants With Best Clinical Response Post Completion of Each Line of Treatment | Frontline: SD | 40 participants |
| Group 2: RRHL | Group 2, RRHL: Number of Participants With Best Clinical Response Post Completion of Each Line of Treatment | Frontline: PD | 98 participants |
| Group 2: RRHL | Group 2, RRHL: Number of Participants With Best Clinical Response Post Completion of Each Line of Treatment | Frontline: Other | 24 participants |
| Group 2: RRHL | Group 2, RRHL: Number of Participants With Best Clinical Response Post Completion of Each Line of Treatment | Second line: CR | 107 participants |
| Group 2: RRHL | Group 2, RRHL: Number of Participants With Best Clinical Response Post Completion of Each Line of Treatment | Second line: PR | 113 participants |
| Group 2: RRHL | Group 2, RRHL: Number of Participants With Best Clinical Response Post Completion of Each Line of Treatment | Second line: SD | 32 participants |
| Group 2: RRHL | Group 2, RRHL: Number of Participants With Best Clinical Response Post Completion of Each Line of Treatment | Second line: PD | 80 participants |
| Group 2: RRHL | Group 2, RRHL: Number of Participants With Best Clinical Response Post Completion of Each Line of Treatment | Second line: Other | 42 participants |
| Group 2: RRHL | Group 2, RRHL: Number of Participants With Best Clinical Response Post Completion of Each Line of Treatment | Third line: CR | 46 participants |
| Group 2: RRHL | Group 2, RRHL: Number of Participants With Best Clinical Response Post Completion of Each Line of Treatment | Third line: PR | 38 participants |
| Group 2: RRHL | Group 2, RRHL: Number of Participants With Best Clinical Response Post Completion of Each Line of Treatment | Third line: SD | 22 participants |
| Group 2: RRHL | Group 2, RRHL: Number of Participants With Best Clinical Response Post Completion of Each Line of Treatment | Third line: PD | 48 participants |
| Group 2: RRHL | Group 2, RRHL: Number of Participants With Best Clinical Response Post Completion of Each Line of Treatment | Third line: Other | 24 participants |
| Group 2: RRHL | Group 2, RRHL: Number of Participants With Best Clinical Response Post Completion of Each Line of Treatment | Pre-SCT: CR | 14 participants |
| Group 2: RRHL | Group 2, RRHL: Number of Participants With Best Clinical Response Post Completion of Each Line of Treatment | Pre-SCT: PR | 12 participants |
| Group 2: RRHL | Group 2, RRHL: Number of Participants With Best Clinical Response Post Completion of Each Line of Treatment | Pre-SCT: SD | 2 participants |
| Group 2: RRHL | Group 2, RRHL: Number of Participants With Best Clinical Response Post Completion of Each Line of Treatment | Pre-SCT: PD | 4 participants |
| Group 2: RRHL | Group 2, RRHL: Number of Participants With Best Clinical Response Post Completion of Each Line of Treatment | Post-SCT: CR | 5 participants |
| Group 2: RRHL | Group 2, RRHL: Number of Participants With Best Clinical Response Post Completion of Each Line of Treatment | Pre-SCT: Other | 18 participants |
| Group 2: RRHL | Group 2, RRHL: Number of Participants With Best Clinical Response Post Completion of Each Line of Treatment | Post-SCT: PR | 1 participants |
| Group 2: RRHL | Group 2, RRHL: Number of Participants With Best Clinical Response Post Completion of Each Line of Treatment | Post-SCT: SD | 1 participants |
| Group 2: RRHL | Group 2, RRHL: Number of Participants With Best Clinical Response Post Completion of Each Line of Treatment | Post-SCT: PD | 2 participants |
| Group 2: RRHL | Group 2, RRHL: Number of Participants With Best Clinical Response Post Completion of Each Line of Treatment | Post-SCT: Other | 1 participants |
| Group 2: RRHL | Group 2, RRHL: Number of Participants With Best Clinical Response Post Completion of Each Line of Treatment | Other line: CR | 17 participants |
| Group 2: RRHL | Group 2, RRHL: Number of Participants With Best Clinical Response Post Completion of Each Line of Treatment | Other line: PR | 17 participants |
| Group 2: RRHL | Group 2, RRHL: Number of Participants With Best Clinical Response Post Completion of Each Line of Treatment | Other line: SD | 10 participants |
| Group 2: RRHL | Group 2, RRHL: Number of Participants With Best Clinical Response Post Completion of Each Line of Treatment | Other line: PD | 15 participants |
| Group 2: RRHL | Group 2, RRHL: Number of Participants With Best Clinical Response Post Completion of Each Line of Treatment | Other line: Other | 10 participants |
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.
Time frame: Day 1 at RRHL diagnosis
Population: The FAS included all participants who were eligible for RRHL group including the common participants in both the groups.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Group 2: RRHL | Group 2, RRHL: Number of Participants With B Symptoms at Diagnosis | Presence of B-symptoms | 248 Participants |
| Group 2: RRHL | Group 2, RRHL: Number of Participants With B Symptoms at Diagnosis | Absence of B-symptoms | 178 Participants |
Secondary
Group 2, RRHL: Number of Participants With Non-ASCT Assessed for RT Type, Site at Relapse/ Refractory
Time frame: 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])
Population: 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.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Group 2: RRHL | Group 2, RRHL: Number of Participants With Non-ASCT Assessed for RT Type, Site at Relapse/ Refractory | RT Type: Whole body | 0 Participants |
| Group 2: RRHL | Group 2, RRHL: Number of Participants With Non-ASCT Assessed for RT Type, Site at Relapse/ Refractory | RT Type: Involved-field | 24 Participants |
| Group 2: RRHL | Group 2, RRHL: Number of Participants With Non-ASCT Assessed for RT Type, Site at Relapse/ Refractory | RT Type: Involved-site | 20 Participants |
| Group 2: RRHL | Group 2, RRHL: Number of Participants With Non-ASCT Assessed for RT Type, Site at Relapse/ Refractory | RT Type: Involved-node | 10 Participants |
| Group 2: RRHL | Group 2, RRHL: Number of Participants With Non-ASCT Assessed for RT Type, Site at Relapse/ Refractory | RT Type: Other | 1 Participants |
| Group 2: RRHL | Group 2, RRHL: Number of Participants With Non-ASCT Assessed for RT Type, Site at Relapse/ Refractory | RT Site: Abdominal nodes | 2 Participants |
| Group 2: RRHL | Group 2, RRHL: Number of Participants With Non-ASCT Assessed for RT Type, Site at Relapse/ Refractory | RT Site: Axillary nodes | 4 Participants |
| Group 2: RRHL | Group 2, RRHL: Number of Participants With Non-ASCT Assessed for RT Type, Site at Relapse/ Refractory | RT Site: Bone lesions | 8 Participants |
| Group 2: RRHL | Group 2, RRHL: Number of Participants With Non-ASCT Assessed for RT Type, Site at Relapse/ Refractory | RT Site: Brain | 1 Participants |
| Group 2: RRHL | Group 2, RRHL: Number of Participants With Non-ASCT Assessed for RT Type, Site at Relapse/ Refractory | RT Site: Cervix | 1 Participants |
| Group 2: RRHL | Group 2, RRHL: Number of Participants With Non-ASCT Assessed for RT Type, Site at Relapse/ Refractory | RT Site: Inguinal nodes | 2 Participants |
| Group 2: RRHL | Group 2, RRHL: Number of Participants With Non-ASCT Assessed for RT Type, Site at Relapse/ Refractory | RT Site: Mediastinal nodes | 17 Participants |
| Group 2: RRHL | Group 2, RRHL: Number of Participants With Non-ASCT Assessed for RT Type, Site at Relapse/ Refractory | RT Site: Neck nodes | 9 Participants |
| Group 2: RRHL | Group 2, RRHL: Number of Participants With Non-ASCT Assessed for RT Type, Site at Relapse/ Refractory | RT Site: Para-iliac nodes | 1 Participants |
| Group 2: RRHL | Group 2, RRHL: Number of Participants With Non-ASCT Assessed for RT Type, Site at Relapse/ Refractory | RT Site: Pelvic nodes | 3 Participants |
| Group 2: RRHL | Group 2, RRHL: Number of Participants With Non-ASCT Assessed for RT Type, Site at Relapse/ Refractory | RT Site: Supraclavicular nodes | 2 Participants |
| Group 2: RRHL | Group 2, RRHL: Number of Participants With Non-ASCT Assessed for RT Type, Site at Relapse/ Refractory | RT Site: Other | 5 Participants |
Secondary
Group 2, RRHL: Number of Participants With Non-ASCT Assessed for RT Type, Site Received at Frontline
Time frame: 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])
Population: 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.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Group 2: RRHL | Group 2, RRHL: Number of Participants With Non-ASCT Assessed for RT Type, Site Received at Frontline | RT Type: Whole body | 1 Participants |
| Group 2: RRHL | Group 2, RRHL: Number of Participants With Non-ASCT Assessed for RT Type, Site Received at Frontline | RT Type: Involved-field | 19 Participants |
| Group 2: RRHL | Group 2, RRHL: Number of Participants With Non-ASCT Assessed for RT Type, Site Received at Frontline | RT Type: Involved-site | 9 Participants |
| Group 2: RRHL | Group 2, RRHL: Number of Participants With Non-ASCT Assessed for RT Type, Site Received at Frontline | RT Type: Involved-node | 10 Participants |
| Group 2: RRHL | Group 2, RRHL: Number of Participants With Non-ASCT Assessed for RT Type, Site Received at Frontline | RT Site: Abdominal nodes | 2 Participants |
| Group 2: RRHL | Group 2, RRHL: Number of Participants With Non-ASCT Assessed for RT Type, Site Received at Frontline | RT Site: Axillary nodes | 3 Participants |
| Group 2: RRHL | Group 2, RRHL: Number of Participants With Non-ASCT Assessed for RT Type, Site Received at Frontline | RT Site: Breast | 2 Participants |
| Group 2: RRHL | Group 2, RRHL: Number of Participants With Non-ASCT Assessed for RT Type, Site Received at Frontline | RT Site: Inguinal nodes | 3 Participants |
| Group 2: RRHL | Group 2, RRHL: Number of Participants With Non-ASCT Assessed for RT Type, Site Received at Frontline | RT Site: Liver | 1 Participants |
| Group 2: RRHL | Group 2, RRHL: Number of Participants With Non-ASCT Assessed for RT Type, Site Received at Frontline | RT Site: Mediastinal nodes | 13 Participants |
| Group 2: RRHL | Group 2, RRHL: Number of Participants With Non-ASCT Assessed for RT Type, Site Received at Frontline | RT Site: Neck nodes | 7 Participants |
| Group 2: RRHL | Group 2, RRHL: Number of Participants With Non-ASCT Assessed for RT Type, Site Received at Frontline | RT Site: Para-iliac nodes | 1 Participants |
| Group 2: RRHL | Group 2, RRHL: Number of Participants With Non-ASCT Assessed for RT Type, Site Received at Frontline | RT Site: Pelvic nodes | 1 Participants |
| Group 2: RRHL | Group 2, RRHL: Number of Participants With Non-ASCT Assessed for RT Type, Site Received at Frontline | RT Site: Soft tissue | 1 Participants |
| Group 2: RRHL | Group 2, RRHL: Number of Participants With Non-ASCT Assessed for RT Type, Site Received at Frontline | RT Site: Other | 5 Participants |
Secondary
Group 2, RRHL: Number of Participants With Types of Radiotherapies Received at Frontline and at Relapse/Refractory in Participants Who Relapse After ASCT
Time frame: 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])
Population: 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.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Group 2: RRHL | Group 2, RRHL: Number of Participants With Types of Radiotherapies Received at Frontline and at Relapse/Refractory in Participants Who Relapse After ASCT | Frontline: Whole body | 1 Participants |
| Group 2: RRHL | Group 2, RRHL: Number of Participants With Types of Radiotherapies Received at Frontline and at Relapse/Refractory in Participants Who Relapse After ASCT | Frontline: Involved-field radiotherapy | 8 Participants |
| Group 2: RRHL | Group 2, RRHL: Number of Participants With Types of Radiotherapies Received at Frontline and at Relapse/Refractory in Participants Who Relapse After ASCT | Frontline: Involved-site radiotherapy | 4 Participants |
| Group 2: RRHL | Group 2, RRHL: Number of Participants With Types of Radiotherapies Received at Frontline and at Relapse/Refractory in Participants Who Relapse After ASCT | Frontline: Involved-node radiotherapy | 2 Participants |
| Group 2: RRHL | Group 2, RRHL: Number of Participants With Types of Radiotherapies Received at Frontline and at Relapse/Refractory in Participants Who Relapse After ASCT | Relapse/refractory: Whole body | 1 Participants |
| Group 2: RRHL | Group 2, RRHL: Number of Participants With Types of Radiotherapies Received at Frontline and at Relapse/Refractory in Participants Who Relapse After ASCT | Relapse/refractory: Involved-field radiotherapy | 21 Participants |
| Group 2: RRHL | Group 2, RRHL: Number of Participants With Types of Radiotherapies Received at Frontline and at Relapse/Refractory in Participants Who Relapse After ASCT | Relapse/refractory: Involved-site radiotherapy | 4 Participants |
| Group 2: RRHL | Group 2, RRHL: Number of Participants With Types of Radiotherapies Received at Frontline and at Relapse/Refractory in Participants Who Relapse After ASCT | Relapse/refractory: Involved-node radiotherapy | 3 Participants |
| Group 2: RRHL | Group 2, RRHL: Number of Participants With Types of Radiotherapies Received at Frontline and at Relapse/Refractory in Participants Who Relapse After ASCT | Relapse/refractory: Other | 1 Participants |
Secondary
Group 2, RRHL: Number of PET or CT Scan Assessments
Time frame: 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])
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Group 2: RRHL | Group 2, RRHL: Number of PET or CT Scan Assessments | Baseline | 1.1 scans | Standard Deviation 0.23 |
| Group 2: RRHL | Group 2, RRHL: Number of PET or CT Scan Assessments | Frontline | 1.4 scans | Standard Deviation 0.57 |
| Group 2: RRHL | Group 2, RRHL: Number of PET or CT Scan Assessments | Relapse | 2.0 scans | Standard Deviation 1.58 |
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.
Time frame: At 1 year and 5 years after relapse (observed retrospectively from 2010 until date of data collection [up to 9 years 10 months])
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Group 2: RRHL | Group 2, RRHL: Overall Survival Rate at 1 and 5 Years | At 1 year | 89.15 percentage of participants |
| Group 2: RRHL | Group 2, RRHL: Overall Survival Rate at 1 and 5 Years | At 5 years | 70.68 percentage of participants |
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
Time frame: 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])
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Group 2: RRHL | Group 2, RRHL: Percentage of Non-ASCT Participants Categorized Based on Dose Delays in Each Treatment Regimen at Each Line of Treatment | Second line: Therapy regimen 6 | 0.0 percentage of participants |
| Group 2: RRHL | Group 2, RRHL: Percentage of Non-ASCT Participants Categorized Based on Dose Delays in Each Treatment Regimen at Each Line of Treatment | Second line: Therapy regimen 11 | 14.3 percentage of participants |
| Group 2: RRHL | Group 2, RRHL: Percentage of Non-ASCT Participants Categorized Based on Dose Delays in Each Treatment Regimen at Each Line of Treatment | Second line: Therapy regimen 13 | 42.9 percentage of participants |
| Group 2: RRHL | Group 2, RRHL: Percentage of Non-ASCT Participants Categorized Based on Dose Delays in Each Treatment Regimen at Each Line of Treatment | Third line: Therapy regimen 11 | 0.0 percentage of participants |
| Group 2: RRHL | Group 2, RRHL: Percentage of Non-ASCT Participants Categorized Based on Dose Delays in Each Treatment Regimen at Each Line of Treatment | Third line: Therapy regimen 24 | 12.5 percentage of participants |
| Group 2: RRHL | Group 2, RRHL: Percentage of Non-ASCT Participants Categorized Based on Dose Delays in Each Treatment Regimen at Each Line of Treatment | Other treatment: Therapy regimen 6 | 0.0 percentage of participants |
| Group 2: RRHL | Group 2, RRHL: Percentage of Non-ASCT Participants Categorized Based on Dose Delays in Each Treatment Regimen at Each Line of Treatment | Frontline: Therapy regimen 1 | 14.3 percentage of participants |
| Group 2: RRHL | Group 2, RRHL: Percentage of Non-ASCT Participants Categorized Based on Dose Delays in Each Treatment Regimen at Each Line of Treatment | Frontline: Therapy regimen 3 | 0.0 percentage of participants |
| Group 2: RRHL | Group 2, RRHL: Percentage of Non-ASCT Participants Categorized Based on Dose Delays in Each Treatment Regimen at Each Line of Treatment | Frontline: Therapy regimen 6 | 0.0 percentage of participants |
| Group 2: RRHL | Group 2, RRHL: Percentage of Non-ASCT Participants Categorized Based on Dose Delays in Each Treatment Regimen at Each Line of Treatment | Frontline: Therapy regimen 7 | 0.0 percentage of participants |
| Group 2: RRHL | Group 2, RRHL: Percentage of Non-ASCT Participants Categorized Based on Dose Delays in Each Treatment Regimen at Each Line of Treatment | Frontline: Therapy regimen 11 | 0.0 percentage of participants |
| Group 2: RRHL | Group 2, RRHL: Percentage of Non-ASCT Participants Categorized Based on Dose Delays in Each Treatment Regimen at Each Line of Treatment | Frontline: Therapy regimen 18 | 0.0 percentage of participants |
| Group 2: RRHL | Group 2, RRHL: Percentage of Non-ASCT Participants Categorized Based on Dose Delays in Each Treatment Regimen at Each Line of Treatment | Frontline: Therapy regimen 4 | 6.3 percentage of participants |
| Group 2: RRHL | Group 2, RRHL: Percentage of Non-ASCT Participants Categorized Based on Dose Delays in Each Treatment Regimen at Each Line of Treatment | Frontline: Therapy regimen 15 | 0.0 percentage of participants |
| Group 2: RRHL | Group 2, RRHL: Percentage of Non-ASCT Participants Categorized Based on Dose Delays in Each Treatment Regimen at Each Line of Treatment | Frontline: Therapy regimen 14 | 0.0 percentage of participants |
| Group 2: RRHL | Group 2, RRHL: Percentage of Non-ASCT Participants Categorized Based on Dose Delays in Each Treatment Regimen at Each Line of Treatment | Frontline: Therapy regimen 2 | 0.0 percentage of participants |
| Group 2: RRHL | Group 2, RRHL: Percentage of Non-ASCT Participants Categorized Based on Dose Delays in Each Treatment Regimen at Each Line of Treatment | Frontline: Therapy regimen 24 | 12.5 percentage of participants |
| Group 2: RRHL | Group 2, RRHL: Percentage of Non-ASCT Participants Categorized Based on Dose Delays in Each Treatment Regimen at Each Line of Treatment | Second line: Therapy regimen 1 | 2.06 percentage of participants |
| Group 2: RRHL | Group 2, RRHL: Percentage of Non-ASCT Participants Categorized Based on Dose Delays in Each Treatment Regimen at Each Line of Treatment | Second line: Therapy regimen 19 | 0.0 percentage of participants |
| Group 2: RRHL | Group 2, RRHL: Percentage of Non-ASCT Participants Categorized Based on Dose Delays in Each Treatment Regimen at Each Line of Treatment | Second line: Therapy regimen 7 | 4.3 percentage of participants |
| Group 2: RRHL | Group 2, RRHL: Percentage of Non-ASCT Participants Categorized Based on Dose Delays in Each Treatment Regimen at Each Line of Treatment | Second line: Therapy regimen 8 | 0.0 percentage of participants |
| Group 2: RRHL | Group 2, RRHL: Percentage of Non-ASCT Participants Categorized Based on Dose Delays in Each Treatment Regimen at Each Line of Treatment | Second line: Therapy regimen 9 | 0.0 percentage of participants |
| Group 2: RRHL | Group 2, RRHL: Percentage of Non-ASCT Participants Categorized Based on Dose Delays in Each Treatment Regimen at Each Line of Treatment | Second line: Therapy regimen 10 | 5.6 percentage of participants |
| Group 2: RRHL | Group 2, RRHL: Percentage of Non-ASCT Participants Categorized Based on Dose Delays in Each Treatment Regimen at Each Line of Treatment | Second line: Therapy regimen 17 | 0.0 percentage of participants |
| Group 2: RRHL | Group 2, RRHL: Percentage of Non-ASCT Participants Categorized Based on Dose Delays in Each Treatment Regimen at Each Line of Treatment | Second line: Therapy regimen 18 | 0.0 percentage of participants |
| Group 2: RRHL | Group 2, RRHL: Percentage of Non-ASCT Participants Categorized Based on Dose Delays in Each Treatment Regimen at Each Line of Treatment | Second line: Therapy regimen 14 | 0.0 percentage of participants |
| Group 2: RRHL | Group 2, RRHL: Percentage of Non-ASCT Participants Categorized Based on Dose Delays in Each Treatment Regimen at Each Line of Treatment | Second line: Therapy regimen 15 | 0.0 percentage of participants |
| Group 2: RRHL | Group 2, RRHL: Percentage of Non-ASCT Participants Categorized Based on Dose Delays in Each Treatment Regimen at Each Line of Treatment | Second line: Therapy regimen 2 | 0.0 percentage of participants |
| Group 2: RRHL | Group 2, RRHL: Percentage of Non-ASCT Participants Categorized Based on Dose Delays in Each Treatment Regimen at Each Line of Treatment | Second line: Therapy regimen 24 | 5.3 percentage of participants |
| Group 2: RRHL | Group 2, RRHL: Percentage of Non-ASCT Participants Categorized Based on Dose Delays in Each Treatment Regimen at Each Line of Treatment | Third line: Therapy regimen 1 | 33.3 percentage of participants |
| Group 2: RRHL | Group 2, RRHL: Percentage of Non-ASCT Participants Categorized Based on Dose Delays in Each Treatment Regimen at Each Line of Treatment | Third line: Therapy regimen 7 | 0.0 percentage of participants |
| Group 2: RRHL | Group 2, RRHL: Percentage of Non-ASCT Participants Categorized Based on Dose Delays in Each Treatment Regimen at Each Line of Treatment | Third line: Therapy regimen 8 | 0.0 percentage of participants |
| Group 2: RRHL | Group 2, RRHL: Percentage of Non-ASCT Participants Categorized Based on Dose Delays in Each Treatment Regimen at Each Line of Treatment | Third line: Therapy regimen 9 | 50.0 percentage of participants |
| Group 2: RRHL | Group 2, RRHL: Percentage of Non-ASCT Participants Categorized Based on Dose Delays in Each Treatment Regimen at Each Line of Treatment | Third line: Therapy regimen 10 | 0.0 percentage of participants |
| Group 2: RRHL | Group 2, RRHL: Percentage of Non-ASCT Participants Categorized Based on Dose Delays in Each Treatment Regimen at Each Line of Treatment | Third line: Therapy regimen 13 | 33.3 percentage of participants |
| Group 2: RRHL | Group 2, RRHL: Percentage of Non-ASCT Participants Categorized Based on Dose Delays in Each Treatment Regimen at Each Line of Treatment | Third line: Therapy regimen 17 | 0.0 percentage of participants |
| Group 2: RRHL | Group 2, RRHL: Percentage of Non-ASCT Participants Categorized Based on Dose Delays in Each Treatment Regimen at Each Line of Treatment | Third line: Therapy regimen 18 | 0.0 percentage of participants |
| Group 2: RRHL | Group 2, RRHL: Percentage of Non-ASCT Participants Categorized Based on Dose Delays in Each Treatment Regimen at Each Line of Treatment | Third line: Therapy regimen 22 | 0.0 percentage of participants |
| Group 2: RRHL | Group 2, RRHL: Percentage of Non-ASCT Participants Categorized Based on Dose Delays in Each Treatment Regimen at Each Line of Treatment | Third line: Therapy regimen 4 | 0.0 percentage of participants |
| Group 2: RRHL | Group 2, RRHL: Percentage of Non-ASCT Participants Categorized Based on Dose Delays in Each Treatment Regimen at Each Line of Treatment | Other treatment: Therapy regimen 8 | 0.0 percentage of participants |
| Group 2: RRHL | Group 2, RRHL: Percentage of Non-ASCT Participants Categorized Based on Dose Delays in Each Treatment Regimen at Each Line of Treatment | Other treatment: Therapy regimen 10 | 0.0 percentage of participants |
| Group 2: RRHL | Group 2, RRHL: Percentage of Non-ASCT Participants Categorized Based on Dose Delays in Each Treatment Regimen at Each Line of Treatment | Other treatment: Therapy regimen 13 | 0.0 percentage of participants |
| Group 2: RRHL | Group 2, RRHL: Percentage of Non-ASCT Participants Categorized Based on Dose Delays in Each Treatment Regimen at Each Line of Treatment | Other treatment: Therapy regimen 18 | 0.0 percentage of participants |
| Group 2: RRHL | Group 2, RRHL: Percentage of Non-ASCT Participants Categorized Based on Dose Delays in Each Treatment Regimen at Each Line of Treatment | Other treatment: Therapy regimen 22 | 0.0 percentage of participants |
| Group 2: RRHL | Group 2, RRHL: Percentage of Non-ASCT Participants Categorized Based on Dose Delays in Each Treatment Regimen at Each Line of Treatment | Other treatment: Therapy regimen 16 | 0.0 percentage of participants |
| Group 2: RRHL | Group 2, RRHL: Percentage of Non-ASCT Participants Categorized Based on Dose Delays in Each Treatment Regimen at Each Line of Treatment | Other treatment: Therapy regimen 4 | 100.0 percentage of participants |
| Group 2: RRHL | Group 2, RRHL: Percentage of Non-ASCT Participants Categorized Based on Dose Delays in Each Treatment Regimen at Each Line of Treatment | Other treatment: Therapy regimen 24 | 11.1 percentage of participants |
Secondary
Group 2, RRHL: Percentage of Non-ASCT Participants for Whom Treatment is Palliative
Time frame: 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])
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Group 2: RRHL | Group 2, RRHL: Percentage of Non-ASCT Participants for Whom Treatment is Palliative | Palliative at Frontline | 2.6 percentage of participants |
| Group 2: RRHL | Group 2, RRHL: Percentage of Non-ASCT Participants for Whom Treatment is Palliative | Palliative at Relapse | 43.6 percentage of participants |
Secondary
Group 2, RRHL: Percentage of Non-ASCT Participants Receiving Positron Emission Tomography (PET) or Computed Tomography (CT) at Each Line of Treatment Pathway
Time frame: 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])
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Group 2: RRHL | Group 2, RRHL: Percentage of Non-ASCT Participants Receiving Positron Emission Tomography (PET) or Computed Tomography (CT) at Each Line of Treatment Pathway | PET or PET-CT scan at Baseline | 31.4 percentage of participants |
| Group 2: RRHL | Group 2, RRHL: Percentage of Non-ASCT Participants Receiving Positron Emission Tomography (PET) or Computed Tomography (CT) at Each Line of Treatment Pathway | PET or PET-CT scan at Frontline | 59.3 percentage of participants |
| Group 2: RRHL | Group 2, RRHL: Percentage of Non-ASCT Participants Receiving Positron Emission Tomography (PET) or Computed Tomography (CT) at Each Line of Treatment Pathway | PET or PET-CT scan at Relapse | 50 percentage of participants |
Secondary
Group 2, RRHL: Percentage of Non-ASCT Participants Receiving RT at Each Line of Treatment Pathway
Time frame: 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])
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Group 2: RRHL | Group 2, RRHL: Percentage of Non-ASCT Participants Receiving RT at Each Line of Treatment Pathway | RT at Frontline | 17.4 percentage of participants |
| Group 2: RRHL | Group 2, RRHL: Percentage of Non-ASCT Participants Receiving RT at Each Line of Treatment Pathway | RT at Relapse | 22.9 percentage of participants |
Secondary
Group 2, RRHL: Percentage of Participants Categorized Based on ASCT Eligibility Assessment
Time frame: 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])
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Group 2: RRHL | Group 2, RRHL: Percentage of Participants Categorized Based on ASCT Eligibility Assessment | Eligible and did not receive ASCT | 26.5 percentage of participants |
| Group 2: RRHL | Group 2, RRHL: Percentage of Participants Categorized Based on ASCT Eligibility Assessment | Eligible for ASCT | 68.7 percentage of participants |
| Group 2: RRHL | Group 2, RRHL: Percentage of Participants Categorized Based on ASCT Eligibility Assessment | Ineligible for ASCT | 31.3 percentage of participants |
| Group 2: RRHL | Group 2, RRHL: Percentage of Participants Categorized Based on ASCT Eligibility Assessment | Initially ineligible and became eligible for ASCT | 7.6 percentage of participants |
| Group 2: RRHL | Group 2, RRHL: Percentage of Participants Categorized Based on ASCT Eligibility Assessment | Became eligible and received ASCT | 60.0 percentage of participants |
| Group 2: RRHL | Group 2, RRHL: Percentage of Participants Categorized Based on ASCT Eligibility Assessment | Eligible and received ASCT | 73.5 percentage of participants |
Secondary
Group 2, RRHL: Percentage of Participants Receiving Consolidation Therapy Post-ASCT in Participants Undergoing ASCT
Time frame: 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])
Population: The FAS included all participants who were eligible for RRHL group including the common participants in both the groups, and who were undergoing ASCT.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Group 2: RRHL | Group 2, RRHL: Percentage of Participants Receiving Consolidation Therapy Post-ASCT in Participants Undergoing ASCT | 1.4 percentage of participants |
Secondary
Group 2, RRHL: Percentage of Participants Undergoing Subsequent ASCTs and Allogeneic Stem Cell Transplantation (Allo-SCT)
Time frame: 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])
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Group 2: RRHL | Group 2, RRHL: Percentage of Participants Undergoing Subsequent ASCTs and Allogeneic Stem Cell Transplantation (Allo-SCT) | Undergoing subsequent ASCTs | 38.1 percentage of participants |
| Group 2: RRHL | Group 2, RRHL: Percentage of Participants Undergoing Subsequent ASCTs and Allogeneic Stem Cell Transplantation (Allo-SCT) | Undergoing allo-SCT | 4.8 percentage of participants |
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.
Time frame: 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])
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Group 2: RRHL | 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 | PET-CT scan: Baseline | 23.6 percentage of participants |
| Group 2: RRHL | 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 | PET-CT scan: Frontline | 54.5 percentage of participants |
| Group 2: RRHL | 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 | PET-CT scan: Relapse and /or refractory | 60.0 percentage of participants |
| Group 2: RRHL | 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 | CT scan: Baseline | 47.9 percentage of participants |
| Group 2: RRHL | 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 | CT scan: Frontline | 60.4 percentage of participants |
| Group 2: RRHL | 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 | CT scan: Relapse and /or refractory | 70.8 percentage of participants |
| Group 2: RRHL | 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 | Radiotherapy: Frontline | 22.2 percentage of participants |
| Group 2: RRHL | 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 | Radiotherapy: Relapse/refractory | 36.5 percentage of participants |
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.
Time frame: 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])
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Group 2: RRHL | Group 2, RRHL: Percentage of Participants Who Relapse After ASCT Categorized Based on Palliative Therapy Regimens | Therapy regimen 22 | 12.5 percentage of participants |
| Group 2: RRHL | Group 2, RRHL: Percentage of Participants Who Relapse After ASCT Categorized Based on Palliative Therapy Regimens | Therapy regimen 9 | 12.5 percentage of participants |
| Group 2: RRHL | Group 2, RRHL: Percentage of Participants Who Relapse After ASCT Categorized Based on Palliative Therapy Regimens | Therapy regimen 10 | 12.5 percentage of participants |
| Group 2: RRHL | Group 2, RRHL: Percentage of Participants Who Relapse After ASCT Categorized Based on Palliative Therapy Regimens | Therapy regimen 11 | 12.5 percentage of participants |
| Group 2: RRHL | Group 2, RRHL: Percentage of Participants Who Relapse After ASCT Categorized Based on Palliative Therapy Regimens | Therapy regimen 12 | 12.5 percentage of participants |
| Group 2: RRHL | Group 2, RRHL: Percentage of Participants Who Relapse After ASCT Categorized Based on Palliative Therapy Regimens | Therapy regimen 18 | 12.5 percentage of participants |
| Group 2: RRHL | Group 2, RRHL: Percentage of Participants Who Relapse After ASCT Categorized Based on Palliative Therapy Regimens | Therapy regimen 19 | 12.5 percentage of participants |
| Group 2: RRHL | Group 2, RRHL: Percentage of Participants Who Relapse After ASCT Categorized Based on Palliative Therapy Regimens | Other | 75.0 percentage of participants |
Secondary
Group 2, RRHL: Time From ASCT to First Relapse in Participants Who Relapse After ASCT
Time frame: 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])
Population: The FAS included all participants who were eligible for RRHL group including common participants, and who relapsed after ASCT.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Group 2: RRHL | Group 2, RRHL: Time From ASCT to First Relapse in Participants Who Relapse After ASCT | 9.9 months |
Secondary
Group 2, RRHL: Time From ASCT to First Treatment After Relapse in Participants Who Relapse After ASCT
Time frame: 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])
Population: 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.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Group 2: RRHL | Group 2, RRHL: Time From ASCT to First Treatment After Relapse in Participants Who Relapse After ASCT | 16.0 months |
Secondary
Group 2, RRHL: Time From Relapse (After Frontline Treatment) to First Treatment Post-relapse in Non-ASCT Participants
Time frame: 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])
Population: 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.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Group 2: RRHL | Group 2, RRHL: Time From Relapse (After Frontline Treatment) to First Treatment Post-relapse in Non-ASCT Participants | 24.0 days |
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
Time frame: 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])
Population: 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.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Group 2: RRHL | 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 ASCT to 1st treatment | 16.0 months |
| Group 2: RRHL | 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 ASCT to 2nd treatment | 19.1 months |
| Group 2: RRHL | 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 ASCT to 3rd treatment | 28.1 months |
| Group 2: RRHL | 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 completion of 1st treatment to next treatment | 63.0 months |
| Group 2: RRHL | 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 completion of 2nd treatment to next treatment | 87.0 months |
Secondary
Group 2, RRHL: Time to Initiation of Each Subsequent Treatment, From Relapse and Completion of Previous Treatment in Non-ASCT Participants
Time frame: 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])
Population: 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.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Group 2: RRHL | Group 2, RRHL: Time to Initiation of Each Subsequent Treatment, From Relapse and Completion of Previous Treatment in Non-ASCT Participants | From end of 1st treatment post 1st relapse to subsequent treatment | 33.0 days |
| Group 2: RRHL | Group 2, RRHL: Time to Initiation of Each Subsequent Treatment, From Relapse and Completion of Previous Treatment in Non-ASCT Participants | From end of 2nd treatment post 1st relapse to subsequent treatment | 36.5 days |
Secondary
Group 2, RRHL: Total Dose of Radiotherapies in Non-ASCT Participants
Time frame: 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])
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Group 2: RRHL | Group 2, RRHL: Total Dose of Radiotherapies in Non-ASCT Participants | Frontline | 36.0 Gray | Standard Deviation 9.77 |
| Group 2: RRHL | Group 2, RRHL: Total Dose of Radiotherapies in Non-ASCT Participants | Relapse/refractory | 30.5 Gray | Standard Deviation 10.37 |
Secondary
Group 2, RRHL: Total Dose of Radiotherapies Received at Frontline and Relapse/Refractory in Participants Who Relapse After ASCT
Time frame: 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])
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Group 2: RRHL | Group 2, RRHL: Total Dose of Radiotherapies Received at Frontline and Relapse/Refractory in Participants Who Relapse After ASCT | Total Dose of RT at Frontline | 32.0 Gray | Standard Deviation 7.28 |
| Group 2: RRHL | Group 2, RRHL: Total Dose of Radiotherapies Received at Frontline and Relapse/Refractory in Participants Who Relapse After ASCT | Total Dose of RT at Relapse/refractory | 33.0 Gray | Standard Deviation 6.96 |
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.
Time frame: 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])
Population: 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.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Group 2: RRHL | Mean Duration of Best Response | NA months |
| Group 2: RRHL | Mean Duration of Best Response | 51.08 months |
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.
Time frame: 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])
Population: 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.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Group 2: RRHL | Median Overall Survival (OS) | NA months |
| Group 2: RRHL | Median Overall Survival (OS) | NA months |