B-HOLISTIC: B-CD30 + Hodgkin Lymphoma International Multi-center Retrospective Study of Treatment Practices and Outcomes

Sponsor

Takeda (Industry)

Overall Status

Completed

CT.gov ID

NCT03327571

Collaborator

(none)

1,770

Enrollment

Location

23.3

Actual Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Classical Hodgkin Lymphoma Relapsed or Refractory Classical Hodgkin Lymphoma

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).

Study Design

Study Type:

Observational

Actual Enrollment :

1770 participants

Observational Model:

Cohort

Time Perspective:

Retrospective

Official Title:

An International, Multi-centre, Non-interventional Retrospective Study to Describe Treatment Pathways, Outcomes, and Resource Use in Patients With Classical Hodgkin Lymphoma (B-HOLISTIC)

Actual Study Start Date :

Nov 21, 2017

Actual Primary Completion Date :

Oct 31, 2019

Actual Study Completion Date :

Oct 31, 2019

Arms and Interventions

Arm	Intervention/Treatment
Group 1: cHL Participants diagnosed with high-risk stage IIb-IV cHL, received frontline treatment with chemotherapy with or without radiotherapy between 01 January 2010 and 31 December 2013 from the 13 participating countries will be observed for various treatments received for cHL, associated adverse events and resources used from the date of cHL diagnosis until the date of first documented relapse or disease progression after frontline therapy. Participants will be continue to be observed for overall survival until the date of death or data collection, whichever occurs first.
Group 2: RRHL Participants diagnosed with RRHL, between 01 January 2010 and 31 December 2013 from the 13 participating countries will be observed for various treatments received for RRHL, detailed data on treatment pathways, clinical outcomes, associated adverse events and resources used from the date of RRHL diagnosis until the date death or data collection, whichever occurs first. Participants will be continue to be observed for overall survival until the date of death or data collection, whichever occurs first.

Arm

Intervention/Treatment

Group 1: cHL

Participants diagnosed with high-risk stage IIb-IV cHL, received frontline treatment with chemotherapy with or without radiotherapy between 01 January 2010 and 31 December 2013 from the 13 participating countries will be observed for various treatments received for cHL, associated adverse events and resources used from the date of cHL diagnosis until the date of first documented relapse or disease progression after frontline therapy. Participants will be continue to be observed for overall survival until the date of death or data collection, whichever occurs first.

Group 2: RRHL

Participants diagnosed with RRHL, between 01 January 2010 and 31 December 2013 from the 13 participating countries will be observed for various treatments received for RRHL, detailed data on treatment pathways, clinical outcomes, associated adverse events and resources used from the date of RRHL diagnosis until the date death or data collection, whichever occurs first. Participants will be continue to be observed for overall survival until the date of death or data collection, whichever occurs first.

Outcome Measures

Primary Outcome Measures

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 Outcome Measures

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 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 Categorized Based on Reasons for Inpatient Hospital Admissions Related to HL [From initial diagnosis until the date of death (or the date when the participant was last known to be alive) (observed retrospectively from 2010 until date of data collection [up to 9 years 10 months])]
Group 1, cHL: Mean Overall Length of Stay and Length of Stay by Unit/Ward for Inpatient Hospital Admissions Related to HL [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])]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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.
Age greater than or equal to (>=) 18 years at diagnosis of cHL (Group 1) or RRHL (Group 2).
Alive or deceased.
Written informed consent is obtained for study data collection, where necessary, according to local regulations.

Exclusion Criteria:

Participants for whom the minimum study dataset is not available from their hospital medical records.
Participants who have participated in an interventional clinical trial at any stage of their cHL (Group 1) or RRHL (Group 2) management.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Pusan National University Hospital	Busan		Korea, Republic of	49241

Sponsors and Collaborators

Takeda

Investigators

Study Director: Medical Director, Takeda

Study Documents (Full-Text)

More Information

Publications

None provided.

Responsible Party:

Takeda

ClinicalTrials.gov Identifier:

NCT03327571

Other Study ID Numbers:

CHL-5001

First Posted:

Oct 31, 2017

Last Update Posted:

Jun 25, 2021

Last Verified:

Jun 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Yes

Plan to Share IPD:

Yes

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Takeda

Drug therapy

Additional relevant MeSH terms:

Lymphoma

Hodgkin Disease

Study Results

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 Detail

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.

Arm/Group Title	Group 1: cHL	Group 2: RRHL
Arm/Group Description	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.	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.
Period Title: Group 1: cHL
STARTED	1598	0
COMPLETED	1598	0
NOT COMPLETED	0	0
Period Title: Group 1: cHL
STARTED	0	426
Participants Were Counted in Both Groups	0	321
COMPLETED	0	426
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	Group 1: cHL	Group 2: RRHL	Total
Arm/Group Description	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.	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.	Total of all reporting groups
Overall Participants	1598	105	1703
Age, Customized (Count of Participants)
Less than (<) 60 years	1382 86.5%	94 89.5%	1476 86.7%
Greater than or equal to (>=) 60 years	216 13.5%	11 10.5%	227 13.3%
Sex: Female, Male (Count of Participants)
Female	719 45%	41 39%	760 44.6%
Male	879 55%	64 61%	943 55.4%
Race/Ethnicity, Customized (Count of Participants)
Black or African American	62 3.9%	2 1.9%	64 3.8%
American Indian or Alaska Native	22 1.4%	0 0%	22 1.3%
Asian	560 35%	29 27.6%	589 34.6%
White or Caucasian	525 32.9%	57 54.3%	582 34.2%
Not Reported	197 12.3%	12 11.4%	209 12.3%
Other	232 14.5%	5 4.8%	237 13.9%

Outcome Measures

1. Primary Outcome

Title	Group 2, RRHL: Progression Free Survival (PFS)
Description	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])

Outcome Measure Data

Analysis Population Description
The FAS included all participants who were eligible for RRHL group including the common participants in both the groups.

Arm/Group Title	Group 2: RRHL
Arm/Group Description	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.
Measure Participants	426
Median (95% Confidence Interval) [months]	13.17

2. Secondary Outcome

Title	Group 1, cHL: Number of Participants Based on Clinical Staging According to Ann Arbor Staging at Diagnosis
Description	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

Outcome Measure Data

Analysis Population Description
The FAS included all participants who were eligible for cHL group including the common participants in both the groups.

Arm/Group Title	Group 1: cHL
Arm/Group Description	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.
Measure Participants	1598
Stage I-A	0 0%
Stage I-B	0 0%
Stage II-A	0 0%
Stage II-B	441 27.6%
Stage III-A	207 13%
Stage III-B	356 22.3%
Stage IV-A	161 10.1%
Stage IV-B	433 27.1%
Stage unknown	0 0%

3. Secondary Outcome

Title	Group 2, RRHL: Number of Participants Based on Clinical Staging According to Ann Arbor Staging at Diagnosis
Description	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

Outcome Measure Data

Analysis Population Description
The FAS included all participants who were eligible for RRHL group including the common participants in both the groups.

Arm/Group Title	Group 2: RRHL
Arm/Group Description	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.
Measure Participants	426
Stage I-A	7 0.4%
Stage I-B	2 0.1%
Stage II-A	24 1.5%
Stage II-B	61 3.8%
Stage III-A	52 3.3%
Stage III-B	78 4.9%
Stage IV-A	53 3.3%
Stage IV-B	107 6.7%
Stage unknown	42 2.6%

4. Secondary Outcome

Title	Group 2, RRHL: Number of Participants Based on Clinical Staging According to Ann Arbor Staging at Relapse After First Relapse or Refractory Diagnosis
Description	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)

Outcome Measure Data

Analysis Population Description
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/Group Title	Group 2: RRHL
Arm/Group Description	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.
Measure Participants	79
Stage I-A	1 0.1%
Stage I-B	0 0%
Stage II-A	6 0.4%
Stage II-B	9 0.6%
Stage III-A	9 0.6%
Stage III-B	15 0.9%
Stage IV-A	9 0.6%
Stage IV-B	14 0.9%
Stage unknown	16 1%
Stage I-A	0 0%
Stage I-B	0 0%
Stage II-A	2 0.1%
Stage II-B	4 0.3%
Stage III-A	2 0.1%
Stage III-B	4 0.3%
Stage IV-A	1 0.1%
Stage IV-B	3 0.2%
Stage unknown	6 0.4%
Stage I-A	1 0.1%
Stage I-B	0 0%
Stage II-A	1 0.1%
Stage II-B	0 0%
Stage III-A	0 0%
Stage III-B	1 0.1%
Stage IV-A	1 0.1%
Stage IV-B	2 0.1%
Stage unknown	2 0.1%
Stage I-A	0 0%
Stage I-B	0 0%
Stage II-A	1 0.1%
Stage II-B	0 0%
Stage III-A	0 0%
Stage III-B	0 0%
Stage IV-A	0 0%
Stage IV-B	0 0%
Stage unknown	1 0.1%

5. Secondary Outcome

Title	Group 1, cHL: Number of Participants Based on Each International Prognostic Score (IPS) Category
Description	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)>=1510^9 per liter (/L), haemoglobin <10.5 g/L, and lymphocyte count<0.610^6/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

Outcome Measure Data

Analysis Population Description
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/Group Title	Group 1: cHL
Arm/Group Description	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.
Measure Participants	1087
Good risk (IPS 0-1)	289 18.1%
Fair risk (IPS 2-3)	504 31.5%
Poor risk (IPS 4-7)	294 18.4%

6. Secondary Outcome

Title	Group 1, cHL: Number of Participants With B Symptoms at Diagnosis
Description	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

Outcome Measure Data

Analysis Population Description
The FAS included all participants who were eligible for cHL group including the common participants in both the groups.

Arm/Group Title	Group 1: cHL
Arm/Group Description	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.
Measure Participants	1598
Presence of B-symptoms	1230 77%
Absence of B-symptoms	368 23%

7. Secondary Outcome

Title	Group 2, RRHL: Number of Participants With B Symptoms at Diagnosis
Description	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

Outcome Measure Data

Analysis Population Description
The FAS included all participants who were eligible for RRHL group including the common participants in both the groups.

Arm/Group Title	Group 2: RRHL
Arm/Group Description	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.
Measure Participants	426
Presence of B-symptoms	248 15.5%
Absence of B-symptoms	178 11.1%

8. Secondary Outcome

Title	Group 2, RRHL: Number of Participants Categorized Based on Prior Therapies for Hodgkin Lymphoma (HL) at Each Line of Treatment
Description	Number of participants were categorized based on prior therapies for HL at each line of treatment.
Time Frame	Day 1 at RRHL diagnosis

Outcome Measure Data

Analysis Population Description
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/Group Title	Group 2: RRHL
Arm/Group Description	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.
Measure Participants	425
Frontline treatment	425 26.6%
Second line treatment	17 1.1%
Third line treatment	1 0.1%
Pre-SCT line treatment	1 0.1%

9. Secondary Outcome

Title	Group 2, RRHL: Median Number of Previous Treatment Regimens (Chemotherapies) Received
Description
Time Frame	Day 1 at RRHL diagnosis

Outcome Measure Data

Analysis Population Description
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/Group Title	Group 2: RRHL
Arm/Group Description	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.
Measure Participants	425
Median (Full Range) [previous treatment regimen]	1.0

10. Secondary Outcome

Title	Group 1, cHL: Number of Participants Categorized Based on Frontline Treatment Regimens
Description	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])

Outcome Measure Data

Analysis Population Description
The FAS included all participants who were eligible for cHL group including the common participants in both the groups.

Arm/Group Title	Group 1: cHL
Arm/Group Description	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.
Measure Participants	1598
Therapy regimen 1	1363 85.3%
Therapy regimen 3	1 0.1%
Therapy regimen 6	2 0.1%
Therapy regimen 7	9 0.6%
Therapy regimen 8	11 0.7%
Therapy regimen 10	3 0.2%
Therapy regimen 11	1 0.1%
Therapy regimen 17	2 0.1%
Therapy regimen 18	1 0.1%
Therapy regimen 4	104 6.5%
Therapy regimen 14	15 0.9%
Therapy regimen 15	4 0.3%
Therapy regimen 2	33 2.1%
Therapy regimen 24	114 7.1%

11. Secondary Outcome

Title	Group 1, cHL: Median Number of Treatment Cycles Associated With Each Frontline Treatment Regimen
Description	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])

Outcome Measure Data

Analysis Population Description
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/Group Title	Group 1: cHL
Arm/Group Description	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.
Measure Participants	1362
Therapy regimen 1	6.0
Therapy regimen 3	5.0
Therapy regimen 6	6.0
Therapy regimen 7	2.0
Therapy regimen 8	2.0
Therapy regimen 10	2.0
Therapy regimen 11	4.0
Therapy regimen 17	7.0
Therapy regimen 18	3.0
Therapy regimen 4	6.0
Therapy regimen 14	6.0
Therapy regimen 15	3.5
Therapy regimen 2	6.0
Therapy regimen 24	6.0

12. Secondary Outcome

Title	Group 1, cHL: Number of Participants Who Received Treatments for HL After Completion of Frontline Therapy (Before Relapse)
Description	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])

Outcome Measure Data

Analysis Population Description
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/Group Title	Group 1: cHL
Arm/Group Description	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.
Measure Participants	63
Therapy regimen 1	2 0.1%
Therapy regimen 6	1 0.1%
Therapy regimen 7	8 0.5%
Therapy regimen 8	15 0.9%
Therapy regimen 10	8 0.5%
Therapy regimen 11	6 0.4%
Therapy regimen 12	2 0.1%
Therapy regimen 13	1 0.1%
Therapy regimen 18	2 0.1%
Therapy regimen 16	6 0.4%
Therapy regimen 4	6 0.4%
Therapy regimen 14	2 0.1%
Therapy regimen 24	10 0.6%

13. Secondary Outcome

Title	Group 1, cHL: Number of Participants Based on Radiotherapy (RT) Type and Site When Received at Frontline
Description
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])

Outcome Measure Data

Analysis Population Description
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/Group Title	Group 1: cHL
Arm/Group Description	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.
Measure Participants	409
RT Type: Whole body	10 0.6%
RT Type: Involved-field	244 15.3%
RT Type: Involved-site	94 5.9%
RT Type: Involved-node	60 3.8%
RT Type: Other	1 0.1%
RT Site: Abdominal nodes	8 0.5%
RT Site: Axillary nodes	21 1.3%
RT Site: Bone lesions	9 0.6%
RT Site: Breast	3 0.2%
RT Site: Cervix	3 0.2%
RT Site: Inguinal nodes	7 0.4%
RT Site: Larynx	1 0.1%
RT Site: Lung	5 0.3%
RT Site: Mediastinal nodes	197 12.3%
RT Site: Neck nodes	69 4.3%
RT Site: Pancreas	1 0.1%
RT Site: Para-aortic nodes	6 0.4%
RT Site: Para-iliac nodes	3 0.2%
RT Site: Pelvic nodes	7 0.4%
RT Site: Skin	3 0.2%
RT Site: Soft tissue	2 0.1%
RT Site: Spleen	7 0.4%
RT Site: Supraclavicular nodes	14 0.9%
RT Site: Thyroid	1 0.1%
RT Site: Other	42 2.6%

14. Secondary Outcome

Title	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
Description	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])

Outcome Measure Data

Analysis Population Description
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/Group Title	Group 1: cHL
Arm/Group Description	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.
Measure Participants	409
RT for pre-planned frontline treatment	225 14.1%
RT for residual FDG-avid disease	115 7.2%

15. Secondary Outcome

Title	Group 2, RRHL: Percentage of Participants Categorized Based on ASCT Eligibility Assessment
Description
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])

Outcome Measure Data

Analysis Population Description
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/Group Title	Group 2: RRHL
Arm/Group Description	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.
Measure Participants	425
Eligible for ASCT	68.7 4.3%
Ineligible for ASCT	31.3 2%
Initially ineligible and became eligible for ASCT	7.6 0.5%
Became eligible and received ASCT	60.0 3.8%
Eligible and received ASCT	73.5 4.6%
Eligible and did not receive ASCT	26.5 1.7%

16. Secondary Outcome

Title	Group 2, RRHL: Median Number of Treatment Cycles Associated With Relapse/ Refractory Treatment Regimen for ASCT
Description	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])

Outcome Measure Data

Analysis Population Description
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/Group Title	Group 2: RRHL
Arm/Group Description	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.
Measure Participants	6
Therapy regimen 1	6.0
Therapy regimen 6	8.0
Therapy regimen 8	2.0
Therapy regimen 11	3.0
Therapy regimen 12	5.0
Therapy regimen 18	4.0
Therapy regimen 22	6.0
Therapy regimen 24	2.0

17. Secondary Outcome

Title	Group 2, RRHL: Number of Non-ASCT Participants Categorized Based on Reasons for Not Undergoing ASCT Despite Being ASCT Eligible
Description	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])

Outcome Measure Data

Analysis Population Description
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/Group Title	Group 2: RRHL
Arm/Group Description	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.
Measure Participants	80
Participant refusal	21 1.3%
Inability to mobilize stem cells	3 0.2%
Loss of response to chemotherapy	13 0.8%
Cumulative Toxicities	1 0.1%
Other	11 0.7%
Comorbid conditions	2 0.1%
Unknown	29 1.8%

18. Secondary Outcome

Title	Group 2, RRHL: Number of Non-ASCT Participants Based on Reasons for ASCT Ineligibility
Description	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])

Outcome Measure Data

Analysis Population Description
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/Group Title	Group 2: RRHL
Arm/Group Description	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.
Measure Participants	201
Advanced age	12 0.8%
Comorbid conditions	13 0.8%
Chemo-resistant disease	19 1.2%
Cumulative toxicities	1 0.1%
Other	11 0.7%
Participant refusal	5 0.3%
Inability to mobilize stem cells	1 0.1%
Loss of response to chemotherapy	4 0.3%
Unknown	55 3.4%

19. Secondary Outcome

Title	Group 2, RRHL: Number of Non-ASCT Participants Categorized Based on Treatment Regimens Received at Each Line of Treatment
Description	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])

Outcome Measure Data

Analysis Population Description
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/Group Title	Group 2: RRHL
Arm/Group Description	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.
Measure Participants	201
Frontline: Therapy regimen 1	161 10.1%
Frontline: Therapy regimen 3	1 0.1%
Frontline: Therapy regimen 6	1 0.1%
Frontline: Therapy regimen 7	4 0.3%
Frontline: Therapy regimen 11	1 0.1%
Frontline: Therapy regimen 18	1 0.1%
Front line: Therapy regimen 4	16 1%
Frontline: Therapy regimen 14	3 0.2%
Frontline: Therapy regimen 15	1 0.1%
Frontline: Therapy regimen 2	6 0.4%
Frontline: Therapy regimen 24	16 1%
Second line: Therapy regimen 1	13 0.8%
Second line: Therapy regimen 6	3 0.2%
Second line: Therapy regimen 7	23 1.4%
Second line: Therapy regimen 8	21 1.3%
Second line: Therapy regimen 9	1 0.1%
Second line: Therapy regimen 10	18 1.1%
Second line: Therapy regimen 11	7 0.4%
Second line: Therapy regimen 13	7 0.4%
Second line: Therapy regimen 17	2 0.1%
Second line: Therapy regimen 18	1 0.1%
Second line: Therapy regimen 19	1 0.1%
Second line: Therapy regimen 4	13 0.8%
Second line: Therapy regimen 14	5 0.3%
Second line: Therapy regimen 15	1 0.1%
Second line: Therapy regimen 2	5 0.3%
Second line: Therapy regimen 24	39 2.4%
Third line: Therapy regimen 1	3 0.2%
Third line: Therapy regimen 7	4 0.3%
Third line: Therapy regimen 8	3 0.2%
Third line: Therapy regimen 9	2 0.1%
Third line: Therapy regimen 10	8 0.5%
Third line: Therapy regimen 11	11 0.7%
Third line: Therapy regimen 13	3 0.2%
Third line: Therapy regimen 17	1 0.1%
Third line: Therapy regimen 18	3 0.2%
Third line: Therapy regimen 22	1 0.1%
Third line: Therapy regimen 4	2 0.1%
Third line: Therapy regimen 24	23 1.4%
Other treatment: Therapy regimen 6	1 0.1%
Other treatment: Therapy regimen 7	1 0.1%
Other treatment: Therapy regimen 10	1 0.1%
Other treatment: Therapy regimen 13	1 0.1%
Other treatment: Therapy regimen 18	5 0.3%
Other treatment: Therapy regimen 22	2 0.1%
Other treatment: Therapy regimen 16	1 0.1%
Other treatment: Therapy regimen 4	1 0.1%

20. Secondary Outcome

Title	Group 2, RRHL: Percentage of Non-ASCT Participants for Whom Treatment is Palliative
Description
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])

Outcome Measure Data

Analysis Population Description
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/Group Title	Group 2: RRHL
Arm/Group Description	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.
Measure Participants	55
Palliative at Frontline	2.6 0.2%
Palliative at Relapse	43.6 2.7%

21. Secondary Outcome

Title	Group 2, RRHL: Percentage of Non-ASCT Participants Receiving Positron Emission Tomography (PET) or Computed Tomography (CT) at Each Line of Treatment Pathway
Description
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])

Outcome Measure Data

Analysis Population Description
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/Group Title	Group 2: RRHL
Arm/Group Description	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.
Measure Participants	118
PET or PET-CT scan at Baseline	31.4 2%
PET or PET-CT scan at Frontline	59.3 3.7%
PET or PET-CT scan at Relapse	50 3.1%

22. Secondary Outcome

Title	Group 2, RRHL: Percentage of Non-ASCT Participants Receiving RT at Each Line of Treatment Pathway
Description
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])

Outcome Measure Data

Analysis Population Description
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/Group Title	Group 2: RRHL
Arm/Group Description	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.
Measure Participants	201
RT at Frontline	17.4 1.1%
RT at Relapse	22.9 1.4%

23. Secondary Outcome

Title	Group 2, RRHL: Median Frequency of PET or PET-CT Scan Assessment for Non-ASCT Participants
Description
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])

Outcome Measure Data

Analysis Population Description
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/Group Title	Group 2: RRHL
Arm/Group Description	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.
Measure Participants	70
Frequency of PET or PET-CT Scan at Baseline	1.0
Frequency of PET or PET-CT Scan at Frontline	1.0
Frequency of PET or PET-CT Scan at Relapse	1.0

24. Secondary Outcome

Title	Group 2, RRHL: Median Number of Treatment Cycles Received in Each Treatment Regimen at Each Line of Treatment in Non-ASCT Participants
Description	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])

Outcome Measure Data

Analysis Population Description
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/Group Title	Group 2: RRHL
Arm/Group Description	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.
Measure Participants	161
Frontline: Therapy regimen 1	6.0
Frontline: Therapy regimen 3	6.0
Frontline: Therapy regimen 6	6.0
Frontline: Therapy regimen 7	3.0
Frontline: Therapy regimen 11	4.0
Frontline: Therapy regimen 18	3.0
Frontline: Therapy regimen 4	6.5
Frontline: Therapy regimen 14	6.0
Frontline: Therapy regimen 15	7.0
Frontline: Therapy regimen 2	7.0
Frontline: Therapy regimen 24	3.0
Second line: Therapy regimen 1	4.0
Second line: Therapy regimen 6	5.0
Second line: Therapy regimen 7	2.0
Second line: Therapy regimen 8	2.0
Second line: Therapy regimen 9	2.0
Second line: Therapy regimen 10	3.0
Second line: Therapy regimen 11	4.0
Second line: Therapy regimen 13	4.0
Second line: Therapy regimen 24	3.0
Second line: Therapy regimen 17	3.0
Second line: Therapy regimen 18	6.0
Second line: Therapy regimen 19	2.0
Second line: Therapy regimen 4	4.0
Second line: Therapy regimen 14	3.0
Second line: Therapy regimen 15	5.0
Second line: Therapy regimen 2	6.0
Third line: Therapy regimen 1	3.0
Third line: Therapy regimen 7	4.0
Third line: Therapy regimen 8	2.0
Third line: Therapy regimen 9	4.5
Third line: Therapy regimen 10	3.5
Third line: Therapy regimen 11	2.0
Third line: Therapy regimen 13	6.0
Third line: Therapy regimen 18	2.0
Third line: Therapy regimen 17	12.0
Third line: Therapy regimen 22	43.0
Third line: Therapy regimen 4	3.5
Third line: Therapy regimen 24	3.0
Other treatments: Therapy regimen 6	1.0
Other treatments: Therapy regimen 8	2.0
Other treatments: Therapy regimen 10	4.0
Other treatments: Therapy regimen 13	6.0
Other treatments: Therapy regimen 18	6.0
Other treatments: Therapy regimen 22	12.0
Other treatments: Therapy regimen 16	4.0
Other treatments: Therapy regimen 4	5.0
Other treatments: Therapy regimen 24	6.0

25. Secondary Outcome

Title	Group 2, RRHL: Duration of Each Line of Treatment in Non-ASCT Participants
Description
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])

Outcome Measure Data

Analysis Population Description
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/Group Title	Group 2: RRHL
Arm/Group Description	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.
Measure Participants	201
Frontline Treatment	5.4
Second line Treatment	2.2
Third line Treatment	2.1
Other Treatment	9.7

26. Secondary Outcome

Title	Group 2, RRHL: Percentage of Non-ASCT Participants Categorized Based on Dose Delays in Each Treatment Regimen at Each Line of Treatment
Description	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])

Outcome Measure Data

Analysis Population Description
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/Group Title	Group 2: RRHL
Arm/Group Description	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.
Measure Participants	161
Frontline: Therapy regimen 1	14.3 0.9%
Frontline: Therapy regimen 3	0.0 0%
Frontline: Therapy regimen 6	0.0 0%
Frontline: Therapy regimen 7	0.0 0%
Frontline: Therapy regimen 11	0.0 0%
Frontline: Therapy regimen 18	0.0 0%
Frontline: Therapy regimen 4	6.3 0.4%
Frontline: Therapy regimen 15	0.0 0%
Frontline: Therapy regimen 14	0.0 0%
Frontline: Therapy regimen 2	0.0 0%
Frontline: Therapy regimen 24	12.5 0.8%
Second line: Therapy regimen 1	2.06 0.1%
Second line: Therapy regimen 6	0.0 0%
Second line: Therapy regimen 7	4.3 0.3%
Second line: Therapy regimen 8	0.0 0%
Second line: Therapy regimen 9	0.0 0%
Second line: Therapy regimen 10	5.6 0.4%
Second line: Therapy regimen 11	14.3 0.9%
Second line: Therapy regimen 13	42.9 2.7%
Second line: Therapy regimen 17	0.0 0%
Second line: Therapy regimen 18	0.0 0%
Second line: Therapy regimen 19	0.0 0%
Second line: Therapy regimen 14	0.0 0%
Second line: Therapy regimen 15	0.0 0%
Second line: Therapy regimen 2	0.0 0%
Second line: Therapy regimen 24	5.3 0.3%
Third line: Therapy regimen 1	33.3 2.1%
Third line: Therapy regimen 7	0.0 0%
Third line: Therapy regimen 8	0.0 0%
Third line: Therapy regimen 9	50.0 3.1%
Third line: Therapy regimen 10	0.0 0%
Third line: Therapy regimen 11	0.0 0%
Third line: Therapy regimen 13	33.3 2.1%
Third line: Therapy regimen 17	0.0 0%
Third line: Therapy regimen 18	0.0 0%
Third line: Therapy regimen 22	0.0 0%
Third line: Therapy regimen 4	0.0 0%
Third line: Therapy regimen 24	12.5 0.8%
Other treatment: Therapy regimen 6	0.0 0%
Other treatment: Therapy regimen 8	0.0 0%
Other treatment: Therapy regimen 10	0.0 0%
Other treatment: Therapy regimen 13	0.0 0%
Other treatment: Therapy regimen 18	0.0 0%
Other treatment: Therapy regimen 22	0.0 0%
Other treatment: Therapy regimen 16	0.0 0%
Other treatment: Therapy regimen 4	100.0 6.3%
Other treatment: Therapy regimen 24	11.1 0.7%

27. Secondary Outcome

Title	Group 2, RRHL: Time From Relapse (After Frontline Treatment) to First Treatment Post-relapse in Non-ASCT Participants
Description
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])

Outcome Measure Data

Analysis Population Description
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/Group Title	Group 2: RRHL
Arm/Group Description	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.
Measure Participants	61
Median (Full Range) [days]	24.0

28. Secondary Outcome

Title	Group 2, RRHL: Time to Initiation of Each Subsequent Treatment, From Relapse and Completion of Previous Treatment in Non-ASCT Participants
Description
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])

Outcome Measure Data

Analysis Population Description
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/Group Title	Group 2: RRHL
Arm/Group Description	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.
Measure Participants	17
From end of 1st treatment post 1st relapse to subsequent treatment	33.0
From end of 2nd treatment post 1st relapse to subsequent treatment	36.5

29. Secondary Outcome

Title	Group 2, RRHL: Number of Participants With Non-ASCT Assessed for RT Type, Site Received at Frontline
Description
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])

Outcome Measure Data

Analysis Population Description
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/Group Title	Group 2: RRHL
Arm/Group Description	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.
Measure Participants	39
RT Type: Whole body	1 0.1%
RT Type: Involved-field	19 1.2%
RT Type: Involved-site	9 0.6%
RT Type: Involved-node	10 0.6%
RT Site: Abdominal nodes	2 0.1%
RT Site: Axillary nodes	3 0.2%
RT Site: Breast	2 0.1%
RT Site: Inguinal nodes	3 0.2%
RT Site: Liver	1 0.1%
RT Site: Mediastinal nodes	13 0.8%
RT Site: Neck nodes	7 0.4%
RT Site: Para-iliac nodes	1 0.1%
RT Site: Pelvic nodes	1 0.1%
RT Site: Soft tissue	1 0.1%
RT Site: Other	5 0.3%

30. Secondary Outcome

Title	Group 2, RRHL: Number of Participants With Non-ASCT Assessed for RT Type, Site at Relapse/ Refractory
Description
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])

Outcome Measure Data

Analysis Population Description
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/Group Title	Group 2: RRHL
Arm/Group Description	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.
Measure Participants	55
RT Type: Whole body	0 0%
RT Type: Involved-field	24 1.5%
RT Type: Involved-site	20 1.3%
RT Type: Involved-node	10 0.6%
RT Type: Other	1 0.1%
RT Site: Abdominal nodes	2 0.1%
RT Site: Axillary nodes	4 0.3%
RT Site: Bone lesions	8 0.5%
RT Site: Brain	1 0.1%
RT Site: Cervix	1 0.1%
RT Site: Inguinal nodes	2 0.1%
RT Site: Mediastinal nodes	17 1.1%
RT Site: Neck nodes	9 0.6%
RT Site: Para-iliac nodes	1 0.1%
RT Site: Pelvic nodes	3 0.2%
RT Site: Supraclavicular nodes	2 0.1%
RT Site: Other	5 0.3%

31. Secondary Outcome

Title	Group 2, RRHL: Total Dose of Radiotherapies in Non-ASCT Participants
Description
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])

Outcome Measure Data

Analysis Population Description
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/Group Title	Group 2: RRHL
Arm/Group Description	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.
Measure Participants	31
Frontline	36.0 (9.77)
Relapse/refractory	30.5 (10.37)

32. Secondary Outcome

Title	Group 2, RRHL: Number of PET or CT Scan Assessments
Description
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])

Outcome Measure Data

Analysis Population Description
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/Group Title	Group 2: RRHL
Arm/Group Description	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.
Measure Participants	70
Baseline	1.1 (0.23)
Frontline	1.4 (0.57)
Relapse	2.0 (1.58)

33. Secondary Outcome

Title	Group 2, RRHL: Number of Participants Categorized Based on Various Chemotherapeutic Regimen and Therapies Used in Participants Undergoing ASCT
Description	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])

Outcome Measure Data

Analysis Population Description
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/Group Title	Group 2: RRHL
Arm/Group Description	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.
Measure Participants	222
Salvage Regimens: Pre-SCT, Therapy regimen 8	1 0.1%
Salvage Regimens: Pre-SCT, Therapy regimen 10	2 0.1%
Salvage Regimens: Pre-SCT, Therapy regimen 11	1 0.1%
Salvage Regimens: Pre-SCT, Therapy regimen 12	5 0.3%
Salvage Regimens: Pre-SCT, Therapy regimen 18	3 0.2%
Salvage Regimens: Pre-SCT, Therapy regimen 19	1 0.1%
Salvage Regimens: Pre-SCT, Therapy regimen 16	1 0.1%
Salvage Regimens: Pre-SCT, Therapy regimen 24	23 1.4%
Salvage Regimens: Post-SCT, Therapy regimen 10	1 0.1%
Salvage Regimens: Post-SCT, Therapy regimen 11	1 0.1%
Salvage Regimens: Post-SCT, Therapy regimen 18	3 0.2%
Salvage Regimens: Post-SCT, Therapy regimen 19	1 0.1%
Salvage Regimens: Post-SCT, Therapy regimen 24	2 0.1%
Conditioning Regimens: BEAM	132 8.3%
Conditioning Regimens: CBV	22 1.4%
Conditioning Regimens: BeEAM	6 0.4%
Conditioning Regimens: Gemcitabine/Bu/Mel	1 0.1%
Conditioning Regimens: Other	55 3.4%
Conditioning Regimens: Unknown	3 0.2%
Consolidation Therapy : Post -SCT	4 0.3%

34. Secondary Outcome

Title	Group 2, RRHL: Number of Participants Categorized Based on With Known Risk Factors for Relapse Post ASCT in Participants Undergoing ASCT
Description	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])

Outcome Measure Data

Analysis Population Description
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/Group Title	Group 2: RRHL
Arm/Group Description	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.
Measure Participants	222
Time to first relapse <=3 months	19 1.2%
Stage IV disease at relapse	81 5.1%
Bulky disease >=5 cm at relapse	47 2.9%
Extranodal disease	83 5.2%
Inadequate response to salvage chemotherapy	63 3.9%
Performance status (ECOG) >=1	73 4.6%

35. Secondary Outcome

Title	Group 2, RRHL: Median Number of Cycles Associated With Each Salvage Regimen in Participants Undergoing ASCT
Description	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])

Outcome Measure Data

Analysis Population Description
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/Group Title	Group 2: RRHL
Arm/Group Description	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.
Measure Participants	80
Therapy regimen 1	3.0
Therapy regimen 6	5.5
Therapy regimen 7	3.0
Therapy regimen 8	3.0
Therapy regimen 9	2.0
Therapy regimen 10	3.0
Therapy regimen 11	3.0
Therapy regimen 12	1.0
Therapy regimen 13	5.0
Therapy regimen 17	8.0
Therapy regimen 18	6.0
Therapy regimen 19	4.0
Therapy regimen 22	6.5
Therapy regimen 23	21.0
Therapy regimen 16	3.0
Therapy regimen 4	4.0
Therapy regimen 14	1.0
Therapy regimen 2	2.0
Therapy regimen 24	2.3

36. Secondary Outcome

Title	Group 2, RRHL: Percentage of Participants Receiving Consolidation Therapy Post-ASCT in Participants Undergoing ASCT
Description
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])

Outcome Measure Data

Analysis Population Description
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/Group Title	Group 2: RRHL
Arm/Group Description	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.
Measure Participants	222
Number [percentage of participants]	1.4 0.1%

37. Secondary Outcome

Title	Group 2, RRHL: Median Duration of Treatment for Consolidation Therapies Used in Participants Undergoing ASCT
Description
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])

Outcome Measure Data

Analysis Population Description
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/Group Title	Group 2: RRHL
Arm/Group Description	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.
Measure Participants	4
Median (Full Range) [months]	11.1

38. Secondary Outcome

Title	Group 2, RRHL: Number of Participants Categorized Based on Source of ASCT Procedures in Participants Undergoing ASCT
Description
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])

Outcome Measure Data

Analysis Population Description
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/Group Title	Group 2: RRHL
Arm/Group Description	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.
Measure Participants	219
Bone marrow	36 2.3%
Peripheral	182 11.4%

39. Secondary Outcome

Title	Group 2, RRHL: Median Time From Relapse (After End of Frontline Treatment) to ASCT in Participants Undergoing ASCT
Description
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])

Outcome Measure Data

Analysis Population Description
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/Group Title	Group 2: RRHL
Arm/Group Description	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.
Measure Participants	82
Median (Full Range) [days]	182.5

40. Secondary Outcome

Title	Group 2, RRHL: CD34+ Count Administered in Participants Undergoing ASCT
Description
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])

Outcome Measure Data

Analysis Population Description
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/Group Title	Group 2: RRHL
Arm/Group Description	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.
Measure Participants	93
Mean (Standard Deviation) [cells per kilogram]	211.2 (248.65)

41. Secondary Outcome

Title	Group 2, RRHL: Time From ASCT to First Relapse in Participants Who Relapse After ASCT
Description
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])

Outcome Measure Data

Analysis Population Description
The FAS included all participants who were eligible for RRHL group including common participants, and who relapsed after ASCT.

Arm/Group Title	Group 2: RRHL
Arm/Group Description	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.
Measure Participants	63
Median (Full Range) [months]	9.9

42. Secondary Outcome

Title	Group 2, RRHL: Number of Participants Categorized Based on Post-ASCT Regimens Received at Each Line of Treatment in Participants Who Relapse After ASCT
Description	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])

Outcome Measure Data

Analysis Population Description
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/Group Title	Group 2: RRHL
Arm/Group Description	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.
Measure Participants	63
Frontline: Therapy regimen 1	57 3.6%
Frontline: Therapy regimen 7	1 0.1%
Frontline: Therapy regimen 10	1 0.1%
Frontline: Therapy regimen 11	1 0.1%
Frontline: Therapy regimen 4	4 0.3%
Frontline: Therapy regimen 2	2 0.1%
Frontline: Therapy regimen 24	3 0.2%
Second line: Therapy regimen 7	9 0.6%
Second line: Therapy regimen 8	28 1.8%
Second line: Therapy regimen 10	10 0.6%
Second line: Therapy regimen 11	4 0.3%
Second line: Therapy regimen 12	1 0.1%
Second line: Therapy regimen 13	2 0.1%
Second line: Therapy regimen 18	1 0.1%
Second line: Therapy regimen 4	4 0.3%
Second line: Therapy regimen 24	5 0.3%
Third line: Therapy regimen 7	2 0.1%
Third line: Therapy regimen 8	3 0.2%
Third line: Therapy regimen 9	3 0.2%
Third line: Therapy regimen 10	6 0.4%
Third line: Therapy regimen 11	9 0.6%
Third line: Therapy regimen 12	3 0.2%
Third line: Therapy regimen 13	1 0.1%
Third line: Therapy regimen 18	9 0.6%
Third line: Therapy regimen 22	1 0.1%
Third line: Therapy regimen 23	1 0.1%
Third line: Therapy regimen 16	4 0.3%
Third line: Therapy regimen 4	1 0.1%
Third line: Therapy regimen 24	13 0.8%
Pre-SCT: Therapy regimen 10	2 0.1%
Pre-SCT: Therapy regimen 12	3 0.2%
Pre-SCT: Therapy regimen 18	2 0.1%
Pre-SCT: Therapy regimen 19	1 0.1%
Pre-SCT: Therapy regimen 14	1 0.1%
Pre-SCT: Therapy regimen 24	9 0.6%
Post-SCT: Therapy regimen 18	2 0.1%
Other treatment: Therapy regimen 7	1 0.1%
Other treatment: Therapy regimen 9	1 0.1%
Other treatment: Therapy regimen 10	2 0.1%
Other treatment: Therapy regimen 11	1 0.1%
Other treatment: Therapy regimen 17	1 0.1%
Other treatment: Therapy regimen 18	7 0.4%
Other treatment: Therapy regimen 19	7 0.4%
Other treatment: Therapy regimen 22	5 0.3%
Other treatment: Therapy regimen 23	2 0.1%
Other treatment: Therapy regimen 16	1 0.1%
Other treatment: Therapy regimen 4	1 0.1%
Other treatment: Therapy regimen 24	15 0.9%

43. Secondary Outcome

Title	Group 2, RRHL: Percentage of Participants Who Relapse After ASCT Categorized Based on Palliative Therapy Regimens
Description	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])

Outcome Measure Data

Analysis Population Description
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/Group Title	Group 2: RRHL
Arm/Group Description	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.
Measure Participants	8
Therapy regimen 9	12.5 0.8%
Therapy regimen 10	12.5 0.8%
Therapy regimen 11	12.5 0.8%
Therapy regimen 12	12.5 0.8%
Therapy regimen 18	12.5 0.8%
Therapy regimen 19	12.5 0.8%
Therapy regimen 22	12.5 0.8%
Other	75.0 4.7%

44. Secondary Outcome

Title	Group 2, RRHL: Number of Cycles Received at Each Line of Treatment for Each Treatment Regimen in Participants Who Relapse After ASCT
Description	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])

Outcome Measure Data

Analysis Population Description
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/Group Title	Group 2: RRHL
Arm/Group Description	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.
Measure Participants	63
Frontline: Therapy regimen 1	6.0
Frontline: Therapy regimen 7	2.0
Frontline: Therapy regimen 10	2.0
Frontline: Therapy regimen 11	2.0
Frontline: Therapy regimen 4	6.0
Frontline: Therapy regimen 2	7.0
Frontline: Therapy regimen 24	2.0
Second line: Therapy regimen 7	2.0
Second line: Therapy regimen 8	3.0
Second line: Therapy regimen 10	3.0
Second line: Therapy regimen 11	3.0
Second line: Therapy regimen 12	1.0
Second line: Therapy regimen 13	3.5
Second line: Therapy regimen 18	3.0
Second line: Therapy regimen 4	4.0
Second line: Therapy regimen 24	4.0
Third line: Therapy regimen 7	1.5
Third line: Therapy regimen 8	2.0
Third line: Therapy regimen 9	6.0
Third line: Therapy regimen 10	3.0
Third line: Therapy regimen 11	3.0
Third line: Therapy regimen 12	2.0
Third line: Therapy regimen 13	6.0
Third line: Therapy regimen 18	5.0
Third line: Therapy regimen 22	8.0
Third line: Therapy regimen 23	1.0
Third line: Therapy regimen 16	3.0
Third line: Therapy regimen 4	3.0
Pre-SCT: Therapy regimen 10	2.0
Pre-SCT: Therapy regimen 12	1.0
Pre-SCT: Therapy regimen 18	7.5
Pre-SCT: Therapy regimen 19	6.0
Pre-SCT: Therapy regimen 14	1.0
Pre-SCT: Therapy regimen 24	1.0
Post-SCT: Therapy regimen 18	9.0
Other treatment: Therapy regimen 7	3.0
Other treatment: Therapy regimen 9	4.0
Other treatment: Therapy regimen 10	2.5
Other treatment: Therapy regimen 11	4.0
Other treatment: Therapy regimen 17	8.0
Other treatment: Therapy regimen 18	12.0
Other treatment: Therapy regimen 19	4.0
Other treatment: Therapy regimen 22	7.0
Other treatment: Therapy regimen 23	23.0
Other treatment: Therapy regimen 16	2.0
Other treatment: Therapy regimen 4	2.0
Other treatment: Therapy regimen 24	4.0

45. Secondary Outcome

Title	Group 2, RRHL: Duration of Each Line of Treatment for Participants Who Relapse After ASCT
Description
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])

Outcome Measure Data

Analysis Population Description
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/Group Title	Group 2: RRHL
Arm/Group Description	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.
Measure Participants	63
Frontline Treatment	5.9
Second line Treatment	2.0
Third line Treatment	2.0
Pre-SCT Treatment	0.2
Post-SCT Treatment	7.2
Other Treatment	4.0

46. Secondary Outcome

Title	Group 2, RRHL: Time From ASCT to First Treatment After Relapse in Participants Who Relapse After ASCT
Description
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])

Outcome Measure Data

Analysis Population Description
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/Group Title	Group 2: RRHL
Arm/Group Description	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.
Measure Participants	52
Median (Full Range) [months]	16.0

47. Secondary Outcome

Title	Group 2, RRHL: Time to Initiation of Each Subsequent Treatment, From ASCT and From Completion of Previous Treatment in Participants Who Relapse From ASCT
Description
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])

Outcome Measure Data

Analysis Population Description
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/Group Title	Group 2: RRHL
Arm/Group Description	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.
Measure Participants	52
From ASCT to 1st treatment	16.0
From ASCT to 2nd treatment	19.1
From ASCT to 3rd treatment	28.1
From completion of 1st treatment to next treatment	63.0
From completion of 2nd treatment to next treatment	87.0

48. Secondary Outcome

Title	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
Description	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])

Outcome Measure Data

Analysis Population Description
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/Group Title	Group 2: RRHL
Arm/Group Description	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.
Measure Participants	63
PET-CT scan: Baseline	23.6 1.5%
PET-CT scan: Frontline	54.5 3.4%
PET-CT scan: Relapse and /or refractory	60.0 3.8%
CT scan: Baseline	47.9 3%
CT scan: Frontline	60.4 3.8%
CT scan: Relapse and /or refractory	70.8 4.4%
Radiotherapy: Frontline	22.2 1.4%
Radiotherapy: Relapse/refractory	36.5 2.3%

49. Secondary Outcome

Title	Group 2, RRHL: Mean Frequency of PET or PET-CT Scan Assessments for Participants Who Relapse After ASCT
Description	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])

Outcome Measure Data

Analysis Population Description
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/Group Title	Group 2: RRHL
Arm/Group Description	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.
Measure Participants	34
PET or PET-CT scan: Baseline	1.0 (0.00)
PET or PET-CT scan: Frontline	2.0 (1.26)
PET or PET-CT scan: Relapse /refractory	5.6 (3.62)
CT Scan: Baseline	1.0 (0.21)
CT Scan: Frontline	2.6 (2.26)
CT Scan: Relapse/refractory	4.3 (4.37)

50. Secondary Outcome

Title	Group 2, RRHL: Number of Participants With Types of Radiotherapies Received at Frontline and at Relapse/Refractory in Participants Who Relapse After ASCT
Description
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])

Outcome Measure Data

Analysis Population Description
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/Group Title	Group 2: RRHL
Arm/Group Description	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.
Measure Participants	23
Frontline: Whole body	1 0.1%
Frontline: Involved-field radiotherapy	8 0.5%
Frontline: Involved-site radiotherapy	4 0.3%
Frontline: Involved-node radiotherapy	2 0.1%
Relapse/refractory: Whole body	1 0.1%
Relapse/refractory: Involved-field radiotherapy	21 1.3%
Relapse/refractory: Involved-site radiotherapy	4 0.3%
Relapse/refractory: Involved-node radiotherapy	3 0.2%
Relapse/refractory: Other	1 0.1%

51. Secondary Outcome

Title	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
Description
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])

Outcome Measure Data

Analysis Population Description
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/Group Title	Group 2: RRHL
Arm/Group Description	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.
Measure Participants	23
Frontline: Axillary nodes	1 0.1%
Frontline: Bone lesions	1 0.1%
Frontline: Mediastinal nodes	4 0.3%
Frontline: Neck nodes	2 0.1%
Frontline: Other	7 0.4%
Relapse/refractory: Abdominal nodes	4 0.3%
Relapse/refractory: Axillary nodes	4 0.3%
Relapse/refractory: Bone lesions	3 0.2%
Relapse/refractory: Mediastinal nodes	12 0.8%
Relapse/refractory: Neck nodes	5 0.3%
Relapse/refractory: Other	2 0.1%

52. Secondary Outcome

Title	Group 2, RRHL: Number of Participants Categorized Based on Intent of Treatment of Radiotherapies in Participants Who Relapse After ASCT
Description
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])

Outcome Measure Data

Analysis Population Description
The FAS included all participants who were eligible for RRHL group including common participants, and who relapsed after ASCT.

Arm/Group Title	Group 2: RRHL
Arm/Group Description	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.
Measure Participants	63
Frontline: Radical/Cure Intent	14 0.9%
Frontline: Other	1 0.1%
Relapse/refractory: Radical/Cure Intent	23 1.4%
Relapse/refractory: Palliative Intent	5 0.3%
Relapse/refractory: Other	2 0.1%

53. Secondary Outcome

Title	Group 2, RRHL: Total Dose of Radiotherapies Received at Frontline and Relapse/Refractory in Participants Who Relapse After ASCT
Description
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])

Outcome Measure Data

Analysis Population Description
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/Group Title	Group 2: RRHL
Arm/Group Description	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.
Measure Participants	20
Total Dose of RT at Frontline	32.0 (7.28)
Total Dose of RT at Relapse/refractory	33.0 (6.96)

54. Secondary Outcome

Title	Group 2, RRHL: Percentage of Participants Undergoing Subsequent ASCTs and Allogeneic Stem Cell Transplantation (Allo-SCT)
Description
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])

Outcome Measure Data

Analysis Population Description
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/Group Title	Group 2: RRHL
Arm/Group Description	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.
Measure Participants	20
Undergoing subsequent ASCTs	38.1 2.4%
Undergoing allo-SCT	4.8 0.3%

55. Secondary Outcome

Title	Group 2, RRHL: Group 2, RRHL: Median Number of ASCTs for Each Participant Who Relapse After ASCT
Description
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])

Outcome Measure Data

Analysis Population Description
The FAS included all participants who were eligible for RRHL group including common participants, and who relapsed after ASCT.

Arm/Group Title	Group 2: RRHL
Arm/Group Description	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.
Measure Participants	63
Median (Full Range) [ASCTs]	1.0

56. Secondary Outcome

Title	Group 1, cHL: Median PFS
Description	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])

Outcome Measure Data

Analysis Population Description
The FAS included all participants who were eligible for cHL group including the common participants in both the groups.

Arm/Group Title	Group 1: cHL
Arm/Group Description	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.
Measure Participants	1598
Median (95% Confidence Interval) [months]	NA

57. Secondary Outcome

Title	Group 1, cHL: Number of Participants Based on Best Clinical Response Post Completion of Frontline Treatment
Description	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])

Outcome Measure Data

Analysis Population Description
The FAS included all participants who were eligible for cHL group including the common participants in both the groups.

Arm/Group Title	Group 1: cHL
Arm/Group Description	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.
Measure Participants	1598
CR	968 60.6%
PR	356 22.3%
SD	80 5%
PD	109 6.8%
Other	85 5.3%

58. Secondary Outcome

Title	Group 2, RRHL: Number of Participants With Best Clinical Response Post Completion of Each Line of Treatment
Description	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])

Outcome Measure Data

Analysis Population Description
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/Group Title	Group 2: RRHL
Arm/Group Description	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.
Measure Participants	426
Frontline: CR	131 8.2%
Frontline: PR	133 8.3%
Frontline: SD	40 2.5%
Frontline: PD	98 6.1%
Frontline: Other	24 1.5%
Second line: CR	107 6.7%
Second line: PR	113 7.1%
Second line: SD	32 2%
Second line: PD	80 5%
Second line: Other	42 2.6%
Third line: CR	46 2.9%
Third line: PR	38 2.4%
Third line: SD	22 1.4%
Third line: PD	48 3%
Third line: Other	24 1.5%
Pre-SCT: CR	14 0.9%
Pre-SCT: PR	12 0.8%
Pre-SCT: SD	2 0.1%
Pre-SCT: PD	4 0.3%
Post-SCT: CR	5 0.3%
Pre-SCT: Other	18 1.1%
Post-SCT: PR	1 0.1%
Post-SCT: SD	1 0.1%
Post-SCT: PD	2 0.1%
Post-SCT: Other	1 0.1%
Other line: CR	17 1.1%
Other line: PR	17 1.1%
Other line: SD	10 0.6%
Other line: PD	15 0.9%
Other line: Other	10 0.6%

59. Secondary Outcome

Title	Mean Duration of Best Response
Description	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])

Outcome Measure Data

Analysis Population Description
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/Group Title	Group 1: cHL	Group 2: RRHL
Arm/Group Description	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.	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.
Measure Participants	1452	298
Median (95% Confidence Interval) [months]	NA	51.08

60. Secondary Outcome

Title	Median Overall Survival (OS)
Description	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])

Outcome Measure Data

Analysis Population Description
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/Group Title	Group 1: cHL	Group 2: RRHL
Arm/Group Description	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.	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.
Measure Participants	1598	249
Median (95% Confidence Interval) [months]	NA	NA

61. Secondary Outcome

Title	Group 1, cHL: Overall Survival Rate After Diagnosis at 1 and 5 Years
Description	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])

Outcome Measure Data

Analysis Population Description
The FAS included all participants who were eligible for cHL group including the common participants in both the groups.

Arm/Group Title	Group 1: cHL
Arm/Group Description	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.
Measure Participants	1598
At 1 year	95.65 6%
At 5 years	84.74 5.3%

62. Secondary Outcome

Title	Group 2, RRHL: Overall Survival Rate at 1 and 5 Years
Description	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])

Outcome Measure Data

Analysis Population Description
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/Group Title	Group 2: RRHL
Arm/Group Description	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.
Measure Participants	249
At 1 year	89.15 5.6%
At 5 years	70.68 4.4%

63. Secondary Outcome

Title	Group 1, cHL: Number of Participants Who Had Inpatient Hospital Admissions, Emergency Room Visits, and Outpatient Visits by Healthcare Professionals Related to HL
Description
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])

Outcome Measure Data

Analysis Population Description
The FAS included all participants who were eligible for cHL group including common participants in both the groups.

Arm/Group Title	Group 1: cHL
Arm/Group Description	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.
Measure Participants	1598
Inpatient Hospital Admissions	864 54.1%
Emergency Room Visits	357 22.3%
Outpatient Visits	1135 71%

64. Secondary Outcome

Title	Group 1, cHL: Number of Participants Categorized Based on Reasons for Inpatient Hospital Admissions Related to HL
Description
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])

Outcome Measure Data

Analysis Population Description
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/Group Title	Group 1: cHL
Arm/Group Description	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.
Measure Participants	864
Chemotherapy	563 35.2%
Radiotherapy	39 2.4%
Stem cell transplant	146 9.1%
Adverse event	287 18%
Unknown	37 2.3%
Other	384 24%

65. Secondary Outcome

Title	Group 1, cHL: Mean Overall Length of Stay and Length of Stay by Unit/Ward for Inpatient Hospital Admissions Related to HL
Description	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])

Outcome Measure Data

Analysis Population Description
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/Group Title	Group 1: cHL
Arm/Group Description	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.
Measure Participants	864
Overall length of stay	15.1 (41.02)
Length of stay by unit/ward: General	13.2 (41.86)
Length of stay by unit/ward: High dependency/intermediate	20.2 (17.29)
Length of stay by unit/ward: Intensive Care Unit	28.0 (26.14)
Length of stay by unit/ward: Bone marrow transplant unit	32.7 (39.70)

66. Secondary Outcome

Title	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
Description
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])

Outcome Measure Data

Analysis Population Description
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/Group Title	Group 1: cHL
Arm/Group Description	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.
Measure Participants	1598
RT received	357 22.3%
Scan/procedure: Chest x-Ray	427 26.7%
Scan/procedure: Magnetic resonance imaging (MRI)	92 5.8%
Scan/procedure: Needle biopsy	273 17.1%
Scan/procedure: Bone scan	19 1.2%
Scan/procedure: Bone marrow aspiration	997 62.4%
Scan/procedure: Flow cytometry	61 3.8%
Scan/procedure: Other scan procedures	315 19.7%
Received G-CSF/ other high cost medications	794 49.7%
Received Pegylated G-CSF	143 8.9%

67. Secondary Outcome

Title	Group 1, cHL: Mean Number of Courses of Treatment With G-CSF/Pegylated G-CSF or Other High-cost Medicines Related to HL Treatment
Description
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])

Outcome Measure Data

Analysis Population Description
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/Group Title	Group 1: cHL
Arm/Group Description	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.
Measure Participants	792
Courses: G-CSF treatment/other high cost medicines	5.6 (6.99)
Courses: Pegylated G-CSF	2.5 (2.99)

68. Secondary Outcome

Title	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
Description	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])

Outcome Measure Data

Analysis Population Description
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/Group Title	Group 2: RRHL
Arm/Group Description	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.
Measure Participants	333
Salvage Therapy: Inpatient Hospital Admissions	175 11%
Salvage Therapy: Emergency Room Visits	44 2.8%
Salvage Therapy: Outpatient Visits	185 11.6%
ASCT: Inpatient Hospital Admissions	5 0.3%
ASCT: Emergency Room Visits	2 0.1%
ASCT: Outpatient Visits	4 0.3%

69. Secondary Outcome

Title	Group 2, RRHL: Number of Participants Categorized Based on Reasons for Inpatient Hospital Admissions Related to HL for Salvage Therapy and ASCT
Description	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])

Outcome Measure Data

Analysis Population Description
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/Group Title	Group 2: RRHL
Arm/Group Description	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.
Measure Participants	175
Salvage Therapy: Chemotherapy	144 9%
Salvage Therapy: Radiotherapy	6 0.4%
Salvage Therapy: Stem cell transplant	50 3.1%
Salvage Therapy: Adverse event	36 2.3%
Salvage Therapy: Unknown	6 0.4%
Salvage Therapy: Other	51 3.2%
ASCT: Chemotherapy	2 0.1%
ASCT: Adverse event	3 0.2%

70. Secondary Outcome

Title	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
Description	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])

Outcome Measure Data

Analysis Population Description
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/Group Title	Group 2: RRHL
Arm/Group Description	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.
Measure Participants	426
Salvage Therapy: Overall length of stay	13.6 (16.30)
Salvage Therapy: General	11.4 (15.79)
Salvage Therapy: High dependency/intermediate	25.8 (18.24)
Salvage Therapy: Intensive Care Unit	13.0 (7.07)
Salvage Therapy: Bone marrow transplant unit	25.8 (10.08)
ASCT: Overall length of stay	7.8 (4.54)
ASCT: General	4.9 (1.23)
ASCT: High dependency/intermediate	10.5 (6.36)
ASCT: Intensive Care Unit	18.0 (NA)

71. Secondary Outcome

Title	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
Description	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])

Outcome Measure Data

Analysis Population Description
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/Group Title	Group 2: RRHL
Arm/Group Description	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.
Measure Participants	188
Salvage Therapy: Chest x-Ray	63 3.9%
Salvage Therapy: Magnetic resonance imaging	8 0.5%
Salvage Therapy: Needle biopsy	19 1.2%
Salvage Therapy: Bone scan	3 0.2%
Salvage Therapy: Bone marrow aspiration	43 2.7%
Salvage Therapy: Flow cytometry	4 0.3%
Salvage Therapy: Other scan procedures	40 2.5%
Salvage Therapy: G-CSF/ other high cost medications	150 9.4%
Salvage Therapy: Pegylated G-CSF	17 1.1%
ASCT: G-CSF/ other high cost medications	6 0.4%
ASCT: Pegylated G-CSF	1 0.1%

72. Secondary Outcome

Title	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
Description
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])

Outcome Measure Data

Analysis Population Description
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/Group Title	Group 2: RRHL
Arm/Group Description	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.
Measure Participants	150
Salvage Therapy: G-CSF treatment/other high cost medicines	2.8 (2.78)
Salvage Therapy: Pegylated G-CSF	2.6 (2.90)
ASCT: G-CSF treatment/other high cost medicines	4.2 (2.64)
ASCT: Pegylated G-CSF	6.0 (NA)

Adverse Events

	Group 1: cHL		Group 2: RRHL
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])
Adverse Event Reporting Description	At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.

Arm/Group Title	Group 1: cHL		Group 2: RRHL
Arm/Group Description	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.		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.
All Cause Mortality
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	243/1598 (15.2%)		136/426 (31.9%)
Serious Adverse Events
	Group 1: cHL		Group 2: RRHL
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	303/1598 (19%)		103/426 (24.2%)
Blood and lymphatic system disorders
Febrile neutropenia	69/1598 (4.3%)		25/426 (5.9%)
Neutropenia	30/1598 (1.9%)		8/426 (1.9%)
Anaemia	15/1598 (0.9%)		3/426 (0.7%)
Thrombocytopenia	7/1598 (0.4%)		1/426 (0.2%)
Pancytopenia	5/1598 (0.3%)		3/426 (0.7%)
Disseminated intravascular coagulation	1/1598 (0.1%)		1/426 (0.2%)
Iron deficiency anaemia	1/1598 (0.1%)		0/426 (0%)
Leukocytosis	1/1598 (0.1%)		0/426 (0%)
Platelet disorder	1/1598 (0.1%)		0/426 (0%)
Bone marrow failure	0/1598 (0%)		1/426 (0.2%)
Cardiac disorders
Cardiac arrest	5/1598 (0.3%)		3/426 (0.7%)
Bradycardia	2/1598 (0.1%)		0/426 (0%)
Cardiac tamponade	2/1598 (0.1%)		2/426 (0.5%)
Myocardial infarction	2/1598 (0.1%)		0/426 (0%)
Acute coronary syndrome	1/1598 (0.1%)		0/426 (0%)
Angina pectoris	1/1598 (0.1%)		0/426 (0%)
Cardiac failure	1/1598 (0.1%)		0/426 (0%)
Cardiomyopathy	1/1598 (0.1%)		0/426 (0%)
Cardiotoxicity	1/1598 (0.1%)		1/426 (0.2%)
Myocardial ischaemia	1/1598 (0.1%)		0/426 (0%)
Palpitations	1/1598 (0.1%)		1/426 (0.2%)
Sinus tachycardia	1/1598 (0.1%)		0/426 (0%)
Supraventricular tachycardia	1/1598 (0.1%)		0/426 (0%)
Tachycardia	1/1598 (0.1%)		0/426 (0%)
Cardiac failure congestive	0/1598 (0%)		1/426 (0.2%)
Endocrine disorders
Hypercalcaemia of malignancy	1/1598 (0.1%)		1/426 (0.2%)
Eye disorders
Diplopia	1/1598 (0.1%)		1/426 (0.2%)
Photophobia	1/1598 (0.1%)		0/426 (0%)
Gastrointestinal disorders
Diarrhoea	6/1598 (0.4%)		1/426 (0.2%)
Nausea	3/1598 (0.2%)		1/426 (0.2%)
Stomatitis	3/1598 (0.2%)		1/426 (0.2%)
Vomiting	3/1598 (0.2%)		1/426 (0.2%)
Abdominal pain	2/1598 (0.1%)		1/426 (0.2%)
Abdominal pain upper	2/1598 (0.1%)		1/426 (0.2%)
Constipation	2/1598 (0.1%)		2/426 (0.5%)
Abdominal distension	1/1598 (0.1%)		0/426 (0%)
Duodenal perforation	1/1598 (0.1%)		0/426 (0%)
Duodenitis	1/1598 (0.1%)		0/426 (0%)
Enteritis	1/1598 (0.1%)		0/426 (0%)
Ileus paralytic	1/1598 (0.1%)		0/426 (0%)
Intestinal obstruction	1/1598 (0.1%)		0/426 (0%)
Mouth ulceration	1/1598 (0.1%)		0/426 (0%)
Oesophagitis	1/1598 (0.1%)		1/426 (0.2%)
Rectal prolapse	1/1598 (0.1%)		1/426 (0.2%)
Ascites	2/1598 (0.1%)		0/426 (0%)
Neutropenic colitis	2/1598 (0.1%)		1/426 (0.2%)
Abdominal discomfort	1/1598 (0.1%)		0/426 (0%)
Enterocolitis	1/1598 (0.1%)		0/426 (0%)
Haematemesis	1/1598 (0.1%)		0/426 (0%)
General disorders
Pyrexia	46/1598 (2.9%)		16/426 (3.8%)
Asthenia	3/1598 (0.2%)		1/426 (0.2%)
Chest pain	2/1598 (0.1%)		0/426 (0%)
Mucosal inflammation	2/1598 (0.1%)		2/426 (0.5%)
Adverse drug reaction	1/1598 (0.1%)		1/426 (0.2%)
Catheter site necrosis	1/1598 (0.1%)		0/426 (0%)
Death	1/1598 (0.1%)		1/426 (0.2%)
Fatigue	1/1598 (0.1%)		1/426 (0.2%)
Gait disturbance	1/1598 (0.1%)		0/426 (0%)
Non-cardiac chest pain	1/1598 (0.1%)		0/426 (0%)
Systemic inflammatory response syndrome	1/1598 (0.1%)		0/426 (0%)
Multiple organ dysfunction syndrome	0/1598 (0%)		1/426 (0.2%)
Hepatobiliary disorders
Hepatic failure	2/1598 (0.1%)		0/426 (0%)
Cholangitis	1/1598 (0.1%)		0/426 (0%)
Hepatitis	1/1598 (0.1%)		0/426 (0%)
Immune system disorders
Drug hypersensitivity	3/1598 (0.2%)		0/426 (0%)
Graft versus host disease in gastrointestinal tract	2/1598 (0.1%)		2/426 (0.5%)
Acute graft versus host disease	1/1598 (0.1%)		1/426 (0.2%)
Graft versus host disease	1/1598 (0.1%)		0/426 (0%)
Haemophagocytic lymphohistiocytosis	1/1598 (0.1%)		1/426 (0.2%)
Acute graft versus host disease in skin	1/1598 (0.1%)		1/426 (0.2%)
Anaphylactic reaction	1/1598 (0.1%)		0/426 (0%)
Engraftment syndrome	0/1598 (0%)		1/426 (0.2%)
Infections and infestations
Pneumonia	33/1598 (2.1%)		6/426 (1.4%)
Neutropenic sepsis	8/1598 (0.5%)		6/426 (1.4%)
Herpes zoster	7/1598 (0.4%)		4/426 (0.9%)
Sepsis	6/1598 (0.4%)		3/426 (0.7%)
Urinary tract infection	5/1598 (0.3%)		2/426 (0.5%)
Septic shock	4/1598 (0.3%)		0/426 (0%)
Bacteraemia	3/1598 (0.2%)		1/426 (0.2%)
Device related infection	3/1598 (0.2%)		2/426 (0.5%)
Cellulitis	2/1598 (0.1%)		0/426 (0%)
Lower respiratory tract infection	2/1598 (0.1%)		0/426 (0%)
Lung infection	2/1598 (0.1%)		2/426 (0.5%)
Upper respiratory tract infection	2/1598 (0.1%)		0/426 (0%)
Abscess limb	1/1598 (0.1%)		0/426 (0%)
Acute sinusitis	1/1598 (0.1%)		0/426 (0%)
Anal abscess	1/1598 (0.1%)		1/426 (0.2%)
Anal infection	1/1598 (0.1%)		0/426 (0%)
Appendicitis	1/1598 (0.1%)		0/426 (0%)
Aspergillus infection	1/1598 (0.1%)		0/426 (0%)
Bacterial sepsis	1/1598 (0.1%)		0/426 (0%)
Bronchitis	1/1598 (0.1%)		0/426 (0%)
Carbuncle	1/1598 (0.1%)		0/426 (0%)
Catheter site infection	1/1598 (0.1%)		1/426 (0.2%)
Clostridial sepsis	1/1598 (0.1%)		0/426 (0%)
Clostridium difficile colitis	1/1598 (0.1%)		0/426 (0%)
Cryptococcosis	1/1598 (0.1%)		1/426 (0.2%)
Cystitis	1/1598 (0.1%)		0/426 (0%)
Device related sepsis	1/1598 (0.1%)		1/426 (0.2%)
Endocarditis	1/1598 (0.1%)		1/426 (0.2%)
Fungal sepsis	1/1598 (0.1%)		0/426 (0%)
Gastroenteritis	1/1598 (0.1%)		0/426 (0%)
Gastroenteritis viral	1/1598 (0.1%)		0/426 (0%)
Herpes simplex	1/1598 (0.1%)		0/426 (0%)
Herpes virus infection	1/1598 (0.1%)		1/426 (0.2%)
Herpes zoster disseminated	1/1598 (0.1%)		1/426 (0.2%)
Infection	1/1598 (0.1%)		1/426 (0.2%)
Influenza	1/1598 (0.1%)		1/426 (0.2%)
Klebsiella sepsis	1/1598 (0.1%)		1/426 (0.2%)
Large intestine infection	1/1598 (0.1%)		1/426 (0.2%)
Mastoiditis	1/1598 (0.1%)		0/426 (0%)
Mucormycosis	1/1598 (0.1%)		1/426 (0.2%)
Osteomyelitis	1/1598 (0.1%)		0/426 (0%)
Periorbital cellulitis	1/1598 (0.1%)		0/426 (0%)
Peritonitis bacterial	1/1598 (0.1%)		0/426 (0%)
Pneumocystis jirovecii pneumonia	1/1598 (0.1%)		0/426 (0%)
Pneumonia chlamydial	1/1598 (0.1%)		0/426 (0%)
Pyelonephritis acute	1/1598 (0.1%)		1/426 (0.2%)
Renal abscess	1/1598 (0.1%)		1/426 (0.2%)
Systemic candida	1/1598 (0.1%)		0/426 (0%)
Urosepsis	1/1598 (0.1%)		0/426 (0%)
Viral infection	1/1598 (0.1%)		1/426 (0.2%)
Klebsiella bacteraemia	2/1598 (0.1%)		0/426 (0%)
Conjunctivitis	0/1598 (0%)		1/426 (0.2%)
Otitis media	0/1598 (0%)		1/426 (0.2%)
Injury, poisoning and procedural complications
Toxicity to various agents	6/1598 (0.4%)		1/426 (0.2%)
Traumatic lung injury	4/1598 (0.3%)		1/426 (0.2%)
Lumbar vertebral fracture	1/1598 (0.1%)		0/426 (0%)
Pneumonitis chemical	1/1598 (0.1%)		0/426 (0%)
Radiation mucositis	1/1598 (0.1%)		1/426 (0.2%)
Radiation pneumonitis	1/1598 (0.1%)		0/426 (0%)
Investigations
Blood bilirubin increased	1/1598 (0.1%)		0/426 (0%)
Ejection fraction decreased	1/1598 (0.1%)		1/426 (0.2%)
General physical condition abnormal	1/1598 (0.1%)		1/426 (0.2%)
Neutrophil count decreased	1/1598 (0.1%)		0/426 (0%)
Platelet count decreased	1/1598 (0.1%)		1/426 (0.2%)
Metabolism and nutrition disorders
Diabetes mellitus	2/1598 (0.1%)		0/426 (0%)
Tumour lysis syndrome	2/1598 (0.1%)		0/426 (0%)
Cachexia	1/1598 (0.1%)		0/426 (0%)
Fluid overload	1/1598 (0.1%)		0/426 (0%)
Hypercalcaemia	1/1598 (0.1%)		0/426 (0%)
Hyperglycaemia	1/1598 (0.1%)		1/426 (0.2%)
Hypocalcaemia	1/1598 (0.1%)		0/426 (0%)
Hypokalaemia	1/1598 (0.1%)		2/426 (0.5%)
Musculoskeletal and connective tissue disorders
Back pain	2/1598 (0.1%)		0/426 (0%)
Pain in extremity	2/1598 (0.1%)		0/426 (0%)
Bone pain	1/1598 (0.1%)		0/426 (0%)
Musculoskeletal chest pain	1/1598 (0.1%)		0/426 (0%)
Myofascial pain syndrome	1/1598 (0.1%)		0/426 (0%)
Synovitis	1/1598 (0.1%)		0/426 (0%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Diffuse large B-cell lymphoma stage II	1/1598 (0.1%)		1/426 (0.2%)
Post transplant lymphoproliferative disorder	1/1598 (0.1%)		1/426 (0.2%)
Tumour associated fever	1/1598 (0.1%)		1/426 (0.2%)
Nervous system disorders
Headache	5/1598 (0.3%)		1/426 (0.2%)
Neuropathy peripheral	3/1598 (0.2%)		1/426 (0.2%)
Dizziness	2/1598 (0.1%)		0/426 (0%)
Hemiplegia	1/1598 (0.1%)		0/426 (0%)
Monoparesis	1/1598 (0.1%)		0/426 (0%)
Myxoedema coma	1/1598 (0.1%)		0/426 (0%)
Speech disorder	1/1598 (0.1%)		0/426 (0%)
Spinal cord compression	1/1598 (0.1%)		1/426 (0.2%)
Subdural hygroma	1/1598 (0.1%)		0/426 (0%)
Syncope	1/1598 (0.1%)		0/426 (0%)
Tension headache	1/1598 (0.1%)		0/426 (0%)
Psychiatric disorders
Delirium	1/1598 (0.1%)		1/426 (0.2%)
Renal and urinary disorders
Acute kidney injury	3/1598 (0.2%)		2/426 (0.5%)
Cystitis haemorrhagic	1/1598 (0.1%)		0/426 (0%)
Reproductive system and breast disorders
Vaginal ulceration	1/1598 (0.1%)		0/426 (0%)
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism	9/1598 (0.6%)		2/426 (0.5%)
Pneumonitis	6/1598 (0.4%)		0/426 (0%)
Pulmonary toxicity	6/1598 (0.4%)		1/426 (0.2%)
Dyspnoea	5/1598 (0.3%)		1/426 (0.2%)
Respiratory distress	4/1598 (0.3%)		1/426 (0.2%)
Respiratory failure	3/1598 (0.2%)		3/426 (0.7%)
Epistaxis	2/1598 (0.1%)		1/426 (0.2%)
Interstitial lung disease	2/1598 (0.1%)		0/426 (0%)
Pleural effusion	2/1598 (0.1%)		1/426 (0.2%)
Acute lung injury	1/1598 (0.1%)		0/426 (0%)
Acute respiratory distress syndrome	1/1598 (0.1%)		0/426 (0%)
Acute respiratory failure	1/1598 (0.1%)		0/426 (0%)
Asthma	1/1598 (0.1%)		1/426 (0.2%)
Bronchiectasis	1/1598 (0.1%)		0/426 (0%)
Mediastinal disorder	1/1598 (0.1%)		1/426 (0.2%)
Obstructive airways disorder	1/1598 (0.1%)		0/426 (0%)
Pharyngeal inflammation	1/1598 (0.1%)		0/426 (0%)
Pneumonia aspiration	1/1598 (0.1%)		1/426 (0.2%)
Pulmonary fibrosis	1/1598 (0.1%)		1/426 (0.2%)
Skin and subcutaneous tissue disorders
Rash pruritic	1/1598 (0.1%)		0/426 (0%)
Skin ulcer	1/1598 (0.1%)		0/426 (0%)
Vascular disorders
Hypotension	3/1598 (0.2%)		0/426 (0%)
Arterial haemorrhage	1/1598 (0.1%)		0/426 (0%)
Hypovolaemic shock	1/1598 (0.1%)		1/426 (0.2%)
Phlebitis	1/1598 (0.1%)		0/426 (0%)
Thrombophlebitis superficial	1/1598 (0.1%)		0/426 (0%)
Other (Not Including Serious) Adverse Events
	Group 1: cHL		Group 2: RRHL
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	642/1598 (40.2%)		187/426 (43.9%)
Blood and lymphatic system disorders
Neutropenia	256/1598 (16%)		80/426 (18.8%)
Leukopenia	68/1598 (4.3%)		24/426 (5.6%)
Febrile neutropenia	56/1598 (3.5%)		29/426 (6.8%)
Anaemia	46/1598 (2.9%)		20/426 (4.7%)
Thrombocytopenia	27/1598 (1.7%)		20/426 (4.7%)
Bone marrow failure	22/1598 (1.4%)		12/426 (2.8%)
Erythropenia	5/1598 (0.3%)		1/426 (0.2%)
Pancytopenia	3/1598 (0.2%)		1/426 (0.2%)
Agranulocytosis	1/1598 (0.1%)		1/426 (0.2%)
Autoimmune haemolytic anaemia	1/1598 (0.1%)		1/426 (0.2%)
Bicytopenia	1/1598 (0.1%)		0/426 (0%)
Cytopenia	1/1598 (0.1%)		1/426 (0.2%)
Eosinophilia	1/1598 (0.1%)		0/426 (0%)
Haematotoxicity	1/1598 (0.1%)		0/426 (0%)
Lymphadenitis	1/1598 (0.1%)		0/426 (0%)
Lymphadenopathy	1/1598 (0.1%)		1/426 (0.2%)
Lymphopenia	1/1598 (0.1%)		0/426 (0%)
Splenomegaly	1/1598 (0.1%)		0/426 (0%)
Cardiac disorders
Palpitations	5/1598 (0.3%)		3/426 (0.7%)
Angina pectoris	2/1598 (0.1%)		0/426 (0%)
Arrhythmia	1/1598 (0.1%)		0/426 (0%)
Atrial fibrillation	1/1598 (0.1%)		1/426 (0.2%)
Tachycardia	1/1598 (0.1%)		0/426 (0%)
Cardiomyopathy	0/1598 (0%)		1/426 (0.2%)
Congenital, familial and genetic disorders
Hydrocele	1/1598 (0.1%)		0/426 (0%)
Ear and labyrinth disorders
Tinnitus	3/1598 (0.2%)		3/426 (0.7%)
Hypoacusis	2/1598 (0.1%)		1/426 (0.2%)
Vertigo	2/1598 (0.1%)		1/426 (0.2%)
Endocrine disorders
Hypothyroidism	2/1598 (0.1%)		0/426 (0%)
Autoimmune hypothyroidism	1/1598 (0.1%)		0/426 (0%)
Eye disorders
Vision blurred	3/1598 (0.2%)		2/426 (0.5%)
Macular pigmentation	1/1598 (0.1%)		0/426 (0%)
Swelling of eyelid	1/1598 (0.1%)		0/426 (0%)
Visual acuity reduced	1/1598 (0.1%)		0/426 (0%)
Gastrointestinal disorders
Nausea	70/1598 (4.4%)		24/426 (5.6%)
Vomiting	60/1598 (3.8%)		20/426 (4.7%)
Constipation	31/1598 (1.9%)		8/426 (1.9%)
Stomatitis	30/1598 (1.9%)		13/426 (3.1%)
Diarrhoea	28/1598 (1.8%)		14/426 (3.3%)
Gastrointestinal disorder	24/1598 (1.5%)		11/426 (2.6%)
Abdominal pain	14/1598 (0.9%)		7/426 (1.6%)
Mouth ulceration	12/1598 (0.8%)		2/426 (0.5%)
Abdominal pain upper	9/1598 (0.6%)		3/426 (0.7%)
Dyspepsia	6/1598 (0.4%)		5/426 (1.2%)
Gastrooesophageal reflux disease	5/1598 (0.3%)		2/426 (0.5%)
Abdominal discomfort	4/1598 (0.3%)		1/426 (0.2%)
Abdominal distension	4/1598 (0.3%)		1/426 (0.2%)
Haemorrhoids	4/1598 (0.3%)		0/426 (0%)
Odynophagia	4/1598 (0.3%)		1/426 (0.2%)
Dysphagia	3/1598 (0.2%)		2/426 (0.5%)
Epigastric discomfort	2/1598 (0.1%)		1/426 (0.2%)
Gastritis	2/1598 (0.1%)		0/426 (0%)
Proctalgia	2/1598 (0.1%)		1/426 (0.2%)
Proctitis	2/1598 (0.1%)		1/426 (0.2%)
Anal fissure	1/1598 (0.1%)		0/426 (0%)
Aphthous ulcer	1/1598 (0.1%)		0/426 (0%)
Chronic gastritis	1/1598 (0.1%)		0/426 (0%)
Colitis	1/1598 (0.1%)		0/426 (0%)
Dry mouth	1/1598 (0.1%)		1/426 (0.2%)
Enterocolitis	1/1598 (0.1%)		0/426 (0%)
Gastric ulcer	1/1598 (0.1%)		1/426 (0.2%)
Gastritis erosive	1/1598 (0.1%)		1/426 (0.2%)
Gastrointestinal haemorrhage	1/1598 (0.1%)		0/426 (0%)
Gastrointestinal inflammation	1/1598 (0.1%)		0/426 (0%)
Gastrointestinal toxicity	1/1598 (0.1%)		0/426 (0%)
Gingival bleeding	1/1598 (0.1%)		0/426 (0%)
Gingival pain	1/1598 (0.1%)		1/426 (0.2%)
Glossodynia	1/1598 (0.1%)		0/426 (0%)
Intestinal cyst	1/1598 (0.1%)		0/426 (0%)
Large intestinal stenosis	1/1598 (0.1%)		0/426 (0%)
Lip ulceration	1/1598 (0.1%)		2/426 (0.5%)
Oesophagitis	1/1598 (0.1%)		1/426 (0.2%)
Oral mucosal eruption	1/1598 (0.1%)		1/426 (0.2%)
Rectal haemorrhage	1/1598 (0.1%)		1/426 (0.2%)
Salivary gland pain	1/1598 (0.1%)		1/426 (0.2%)
Toothache	1/1598 (0.1%)		1/426 (0.2%)
Hypoaesthesia oral	0/1598 (0%)		1/426 (0.2%)
Ileus	0/1598 (0%)		1/426 (0.2%)
Tongue ulceration	0/1598 (0%)		1/426 (0.2%)
General disorders
Pyrexia	68/1598 (4.3%)		45/426 (10.6%)
Fatigue	31/1598 (1.9%)		12/426 (2.8%)
Pain	8/1598 (0.5%)		4/426 (0.9%)
Malaise	7/1598 (0.4%)		2/426 (0.5%)
Oedema peripheral	7/1598 (0.4%)		5/426 (1.2%)
Non-cardiac chest pain	6/1598 (0.4%)		5/426 (1.2%)
Asthenia	5/1598 (0.3%)		1/426 (0.2%)
Chills	5/1598 (0.3%)		2/426 (0.5%)
Mucosal inflammation	5/1598 (0.3%)		4/426 (0.9%)
Swelling	3/1598 (0.2%)		0/426 (0%)
Adverse drug reaction	2/1598 (0.1%)		0/426 (0%)
Chest discomfort	2/1598 (0.1%)		0/426 (0%)
Peripheral swelling	2/1598 (0.1%)		1/426 (0.2%)
Axillary pain	1/1598 (0.1%)		1/426 (0.2%)
Catheter site pain	1/1598 (0.1%)		0/426 (0%)
Chest pain	1/1598 (0.1%)		0/426 (0%)
Extravasation	1/1598 (0.1%)		0/426 (0%)
Gait disturbance	1/1598 (0.1%)		1/426 (0.2%)
Hyperthermia	1/1598 (0.1%)		0/426 (0%)
Inflammation	1/1598 (0.1%)		1/426 (0.2%)
Influenza like illness	1/1598 (0.1%)		0/426 (0%)
Injection site hypoaesthesia	1/1598 (0.1%)		0/426 (0%)
Injection site pain	1/1598 (0.1%)		0/426 (0%)
Sensation of foreign body	1/1598 (0.1%)		0/426 (0%)
Vessel puncture site pain	1/1598 (0.1%)		0/426 (0%)
Catheter site rash	0/1598 (0%)		1/426 (0.2%)
Hepatobiliary disorders
Hepatic steatosis	1/1598 (0.1%)		1/426 (0.2%)
Hepatitis toxic	1/1598 (0.1%)		0/426 (0%)
Hepatotoxicity	1/1598 (0.1%)		0/426 (0%)
Jaundice	1/1598 (0.1%)		1/426 (0.2%)
Hepatic function abnormal	0/1598 (0%)		1/426 (0.2%)
Liver injury	0/1598 (0%)		1/426 (0.2%)
Immune system disorders
Drug hypersensitivity	2/1598 (0.1%)		2/426 (0.5%)
Graft versus host disease in skin	2/1598 (0.1%)		2/426 (0.5%)
Hypersensitivity	2/1598 (0.1%)		0/426 (0%)
Anaphylactic reaction	1/1598 (0.1%)		0/426 (0%)
Chronic graft versus host disease	1/1598 (0.1%)		1/426 (0.2%)
Chronic graft versus host disease in skin	1/1598 (0.1%)		1/426 (0.2%)
Engraftment syndrome	1/1598 (0.1%)		0/426 (0%)
Graft versus host disease	1/1598 (0.1%)		1/426 (0.2%)
Infections and infestations
Pneumonia	18/1598 (1.1%)		5/426 (1.2%)
Upper respiratory tract infection	17/1598 (1.1%)		5/426 (1.2%)
Herpes zoster	9/1598 (0.6%)		4/426 (0.9%)
Urinary tract infection	8/1598 (0.5%)		3/426 (0.7%)
Influenza	6/1598 (0.4%)		1/426 (0.2%)
Sepsis	6/1598 (0.4%)		1/426 (0.2%)
Lung infection	5/1598 (0.3%)		0/426 (0%)
Oral candidiasis	5/1598 (0.3%)		1/426 (0.2%)
Pharyngitis	5/1598 (0.3%)		1/426 (0.2%)
Sinusitis	5/1598 (0.3%)		2/426 (0.5%)
Device related sepsis	4/1598 (0.3%)		3/426 (0.7%)
Anal abscess	3/1598 (0.2%)		2/426 (0.5%)
Cellulitis	3/1598 (0.2%)		1/426 (0.2%)
Folliculitis	3/1598 (0.2%)		2/426 (0.5%)
Furuncle	3/1598 (0.2%)		0/426 (0%)
Nasopharyngitis	3/1598 (0.2%)		1/426 (0.2%)
Oesophageal candidiasis	3/1598 (0.2%)		0/426 (0%)
Clostridium difficile colitis	2/1598 (0.1%)		0/426 (0%)
Cytomegalovirus infection	2/1598 (0.1%)		2/426 (0.5%)
Gastroenteritis	2/1598 (0.1%)		4/426 (0.9%)
Genital herpes	2/1598 (0.1%)		0/426 (0%)
Gingivitis	2/1598 (0.1%)		1/426 (0.2%)
Herpes virus infection	2/1598 (0.1%)		0/426 (0%)
Infection	2/1598 (0.1%)		0/426 (0%)
Neutropenic sepsis	2/1598 (0.1%)		1/426 (0.2%)
Oropharyngeal candidiasis	2/1598 (0.1%)		1/426 (0.2%)
Pneumocystis jirovecii pneumonia	2/1598 (0.1%)		0/426 (0%)
Pulmonary tuberculosis	2/1598 (0.1%)		0/426 (0%)
Respiratory tract infection	2/1598 (0.1%)		0/426 (0%)
Varicella	2/1598 (0.1%)		0/426 (0%)
Vascular device infection	2/1598 (0.1%)		2/426 (0.5%)
Acute sinusitis	1/1598 (0.1%)		0/426 (0%)
Bronchitis	1/1598 (0.1%)		0/426 (0%)
Bronchitis bacterial	1/1598 (0.1%)		0/426 (0%)
Bronchopulmonary aspergillosis	1/1598 (0.1%)		1/426 (0.2%)
Conjunctivitis	1/1598 (0.1%)		0/426 (0%)
Conjunctivitis viral	1/1598 (0.1%)		1/426 (0.2%)
Device related infection	1/1598 (0.1%)		0/426 (0%)
Endocarditis	1/1598 (0.1%)		1/426 (0.2%)
Epstein-Barr virus infection	1/1598 (0.1%)		0/426 (0%)
Fungal infection	1/1598 (0.1%)		0/426 (0%)
Gastroenteritis viral	1/1598 (0.1%)		0/426 (0%)
Genital infection fungal	1/1598 (0.1%)		0/426 (0%)
Lip infection	1/1598 (0.1%)		1/426 (0.2%)
Nail bed infection	1/1598 (0.1%)		0/426 (0%)
Onychomycosis	1/1598 (0.1%)		0/426 (0%)
Oral herpes	1/1598 (0.1%)		0/426 (0%)
Orchitis	1/1598 (0.1%)		0/426 (0%)
Otitis media	1/1598 (0.1%)		0/426 (0%)
Paronychia	1/1598 (0.1%)		0/426 (0%)
Pathogen resistance	1/1598 (0.1%)		0/426 (0%)
Peritonitis	1/1598 (0.1%)		0/426 (0%)
Pneumonia cytomegaloviral	1/1598 (0.1%)		0/426 (0%)
Pneumonia fungal	1/1598 (0.1%)		0/426 (0%)
Postpartum sepsis	1/1598 (0.1%)		1/426 (0.2%)
Rash pustular	1/1598 (0.1%)		0/426 (0%)
Rhinitis	1/1598 (0.1%)		1/426 (0.2%)
Skin candida	1/1598 (0.1%)		0/426 (0%)
Soft tissue infection	1/1598 (0.1%)		0/426 (0%)
Staphylococcal bacteraemia	1/1598 (0.1%)		0/426 (0%)
Subcutaneous abscess	1/1598 (0.1%)		1/426 (0.2%)
Tinea infection	1/1598 (0.1%)		0/426 (0%)
Tinea pedis	1/1598 (0.1%)		0/426 (0%)
Tonsillitis	1/1598 (0.1%)		0/426 (0%)
Tracheobronchitis	1/1598 (0.1%)		0/426 (0%)
Tuberculosis	1/1598 (0.1%)		0/426 (0%)
Vulvovaginal candidiasis	1/1598 (0.1%)		0/426 (0%)
Bronchiolitis	0/1598 (0%)		1/426 (0.2%)
Febrile infection	0/1598 (0%)		1/426 (0.2%)
Postoperative wound infection	0/1598 (0%)		1/426 (0.2%)
Tooth abscess	0/1598 (0%)		1/426 (0.2%)
Injury, poisoning and procedural complications
Toxicity to various agents	9/1598 (0.6%)		2/426 (0.5%)
Traumatic lung injury	3/1598 (0.2%)		1/426 (0.2%)
Fall	1/1598 (0.1%)		0/426 (0%)
Gastrointestinal injury	1/1598 (0.1%)		1/426 (0.2%)
Infusion related reaction	1/1598 (0.1%)		2/426 (0.5%)
Joint dislocation	1/1598 (0.1%)		1/426 (0.2%)
Joint injury	1/1598 (0.1%)		0/426 (0%)
Radiation pneumonitis	1/1598 (0.1%)		0/426 (0%)
Transfusion reaction	1/1598 (0.1%)		1/426 (0.2%)
Investigations
Neutrophil count decreased	35/1598 (2.2%)		15/426 (3.5%)
Haemoglobin decreased	28/1598 (1.8%)		14/426 (3.3%)
Platelet count decreased	6/1598 (0.4%)		5/426 (1.2%)
Weight decreased	6/1598 (0.4%)		2/426 (0.5%)
White blood cell count decreased	4/1598 (0.3%)		2/426 (0.5%)
Alanine aminotransferase increased	2/1598 (0.1%)		0/426 (0%)
International normalised ratio increased	2/1598 (0.1%)		1/426 (0.2%)
Transaminases increased	2/1598 (0.1%)		1/426 (0.2%)
Aspartate aminotransferase increased	1/1598 (0.1%)		0/426 (0%)
Blood creatinine increased	1/1598 (0.1%)		0/426 (0%)
Blood glucose increased	1/1598 (0.1%)		1/426 (0.2%)
Blood uric acid increased	1/1598 (0.1%)		0/426 (0%)
Campylobacter test positive	1/1598 (0.1%)		0/426 (0%)
Cytomegalovirus test	1/1598 (0.1%)		1/426 (0.2%)
Ejection fraction decreased	1/1598 (0.1%)		0/426 (0%)
HIV test positive	1/1598 (0.1%)		0/426 (0%)
Oxygen saturation decreased	1/1598 (0.1%)		0/426 (0%)
Serum ferritin increased	1/1598 (0.1%)		1/426 (0.2%)
Transaminases abnormal	1/1598 (0.1%)		0/426 (0%)
Urine analysis normal	1/1598 (0.1%)		1/426 (0.2%)
Venous pressure	1/1598 (0.1%)		0/426 (0%)
Metabolism and nutrition disorders
Decreased appetite	16/1598 (1%)		10/426 (2.3%)
Hypokalaemia	3/1598 (0.2%)		1/426 (0.2%)
Hyperglycaemia	2/1598 (0.1%)		2/426 (0.5%)
Hyperkalaemia	2/1598 (0.1%)		0/426 (0%)
Hyponatraemia	2/1598 (0.1%)		0/426 (0%)
Fluid overload	1/1598 (0.1%)		1/426 (0.2%)
Hyperlipidaemia	1/1598 (0.1%)		0/426 (0%)
Hypoalbuminaemia	1/1598 (0.1%)		0/426 (0%)
Hypocalcaemia	1/1598 (0.1%)		1/426 (0.2%)
Hypophagia	1/1598 (0.1%)		2/426 (0.5%)
Increased appetite	1/1598 (0.1%)		0/426 (0%)
Iron overload	1/1598 (0.1%)		0/426 (0%)
Steroid diabetes	1/1598 (0.1%)		1/426 (0.2%)
Dehydration	0/1598 (0%)		1/426 (0.2%)
Diabetic metabolic decompensation	0/1598 (0%)		1/426 (0.2%)
Musculoskeletal and connective tissue disorders
Bone pain	12/1598 (0.8%)		6/426 (1.4%)
Pain in extremity	10/1598 (0.6%)		2/426 (0.5%)
Back pain	9/1598 (0.6%)		5/426 (1.2%)
Musculoskeletal chest pain	7/1598 (0.4%)		5/426 (1.2%)
Musculoskeletal pain	7/1598 (0.4%)		6/426 (1.4%)
Arthralgia	6/1598 (0.4%)		3/426 (0.7%)
Myalgia	4/1598 (0.3%)		1/426 (0.2%)
Flank pain	3/1598 (0.2%)		2/426 (0.5%)
Muscle spasms	2/1598 (0.1%)		0/426 (0%)
Muscular weakness	2/1598 (0.1%)		2/426 (0.5%)
Pain in jaw	2/1598 (0.1%)		1/426 (0.2%)
Clubbing	1/1598 (0.1%)		0/426 (0%)
Enthesopathy	1/1598 (0.1%)		1/426 (0.2%)
Musculoskeletal discomfort	1/1598 (0.1%)		0/426 (0%)
Musculoskeletal stiffness	1/1598 (0.1%)		1/426 (0.2%)
Neck pain	1/1598 (0.1%)		2/426 (0.5%)
Osteoarthritis	1/1598 (0.1%)		0/426 (0%)
Periostitis	1/1598 (0.1%)		0/426 (0%)
Spinal pain	1/1598 (0.1%)		0/426 (0%)
Arthritis	0/1598 (0%)		1/426 (0.2%)
Joint swelling	0/1598 (0%)		1/426 (0.2%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Diffuse large B-cell lymphoma	2/1598 (0.1%)		0/426 (0%)
Gastrooesophageal cancer	1/1598 (0.1%)		0/426 (0%)
Marginal zone lymphoma	1/1598 (0.1%)		0/426 (0%)
Ovarian germ cell teratoma	1/1598 (0.1%)		0/426 (0%)
Nervous system disorders
Neuropathy peripheral	42/1598 (2.6%)		7/426 (1.6%)
Headache	18/1598 (1.1%)		6/426 (1.4%)
Dizziness	16/1598 (1%)		7/426 (1.6%)
Hypoaesthesia	10/1598 (0.6%)		4/426 (0.9%)
Facial paralysis	2/1598 (0.1%)		0/426 (0%)
Neurotoxicity	2/1598 (0.1%)		0/426 (0%)
Paraesthesia	2/1598 (0.1%)		0/426 (0%)
Peripheral sensory neuropathy	2/1598 (0.1%)		0/426 (0%)
Cerebellar infarction	1/1598 (0.1%)		1/426 (0.2%)
Lethargy	1/1598 (0.1%)		1/426 (0.2%)
Neuritis	1/1598 (0.1%)		1/426 (0.2%)
Polyneuropathy	1/1598 (0.1%)		1/426 (0.2%)
Somnolence	1/1598 (0.1%)		0/426 (0%)
Taste disorder	1/1598 (0.1%)		0/426 (0%)
Toxic neuropathy	1/1598 (0.1%)		0/426 (0%)
Presyncope	0/1598 (0%)		1/426 (0.2%)
Syncope	0/1598 (0%)		1/426 (0.2%)
Psychiatric disorders
Insomnia	7/1598 (0.4%)		5/426 (1.2%)
Anxiety	3/1598 (0.2%)		1/426 (0.2%)
Depression	2/1598 (0.1%)		0/426 (0%)
Bipolar I disorder	1/1598 (0.1%)		0/426 (0%)
Confusional state	1/1598 (0.1%)		1/426 (0.2%)
Delirium	1/1598 (0.1%)		0/426 (0%)
Depressed mood	1/1598 (0.1%)		0/426 (0%)
Renal and urinary disorders
Cystitis haemorrhagic	2/1598 (0.1%)		0/426 (0%)
Dysuria	2/1598 (0.1%)		1/426 (0.2%)
Acute kidney injury	1/1598 (0.1%)		1/426 (0.2%)
Nephrolithiasis	1/1598 (0.1%)		1/426 (0.2%)
Renal impairment	1/1598 (0.1%)		0/426 (0%)
Renal vascular thrombosis	1/1598 (0.1%)		1/426 (0.2%)
Renal vein thrombosis	1/1598 (0.1%)		1/426 (0.2%)
Urinary tract disorder	1/1598 (0.1%)		0/426 (0%)
Reproductive system and breast disorders
Gynaecomastia	2/1598 (0.1%)		0/426 (0%)
Vaginal discharge	1/1598 (0.1%)		0/426 (0%)
Vaginal haemorrhage	1/1598 (0.1%)		0/426 (0%)
Vulvovaginal pruritus	1/1598 (0.1%)		0/426 (0%)
Ovarian cyst	0/1598 (0%)		1/426 (0.2%)
Respiratory, thoracic and mediastinal disorders
Cough	28/1598 (1.8%)		9/426 (2.1%)
Dyspnoea	21/1598 (1.3%)		7/426 (1.6%)
Pulmonary toxicity	14/1598 (0.9%)		2/426 (0.5%)
Oropharyngeal pain	9/1598 (0.6%)		6/426 (1.4%)
Productive cough	6/1598 (0.4%)		2/426 (0.5%)
Dyspnoea exertional	5/1598 (0.3%)		1/426 (0.2%)
Epistaxis	4/1598 (0.3%)		1/426 (0.2%)
Asthma	3/1598 (0.2%)		1/426 (0.2%)
Pleural effusion	3/1598 (0.2%)		3/426 (0.7%)
Pneumonitis	3/1598 (0.2%)		0/426 (0%)
Wheezing	3/1598 (0.2%)		2/426 (0.5%)
Dysphonia	2/1598 (0.1%)		2/426 (0.5%)
Hiccups	2/1598 (0.1%)		2/426 (0.5%)
Acute pulmonary oedema	1/1598 (0.1%)		1/426 (0.2%)
Chronic obstructive pulmonary disease	1/1598 (0.1%)		0/426 (0%)
Hydrothorax	1/1598 (0.1%)		0/426 (0%)
Lung disorder	1/1598 (0.1%)		0/426 (0%)
Lung infiltration	1/1598 (0.1%)		1/426 (0.2%)
Nasal congestion	1/1598 (0.1%)		1/426 (0.2%)
Organising pneumonia	1/1598 (0.1%)		0/426 (0%)
Oropharyngeal spasm	1/1598 (0.1%)		0/426 (0%)
Pharyngeal disorder	1/1598 (0.1%)		0/426 (0%)
Pulmonary artery thrombosis	1/1598 (0.1%)		1/426 (0.2%)
Pulmonary fibrosis	1/1598 (0.1%)		0/426 (0%)
Pulmonary hypertension	1/1598 (0.1%)		0/426 (0%)
Pulmonary mass	1/1598 (0.1%)		0/426 (0%)
Rhinitis allergic	1/1598 (0.1%)		0/426 (0%)
Rhinorrhoea	1/1598 (0.1%)		0/426 (0%)
Sputum increased	1/1598 (0.1%)		1/426 (0.2%)
Tachypnoea	1/1598 (0.1%)		0/426 (0%)
Upper-airway cough syndrome	1/1598 (0.1%)		1/426 (0.2%)
Pleuritic pain	0/1598 (0%)		1/426 (0.2%)
Skin and subcutaneous tissue disorders
Pruritus	13/1598 (0.8%)		8/426 (1.9%)
Alopecia	12/1598 (0.8%)		3/426 (0.7%)
Night sweats	9/1598 (0.6%)		3/426 (0.7%)
Rash	7/1598 (0.4%)		7/426 (1.6%)
Rash pruritic	6/1598 (0.4%)		2/426 (0.5%)
Skin hyperpigmentation	6/1598 (0.4%)		0/426 (0%)
Dermatitis	5/1598 (0.3%)		1/426 (0.2%)
Erythema	5/1598 (0.3%)		2/426 (0.5%)
Rash maculo-papular	5/1598 (0.3%)		1/426 (0.2%)
Drug eruption	4/1598 (0.3%)		1/426 (0.2%)
Hyperhidrosis	4/1598 (0.3%)		1/426 (0.2%)
Dermatitis allergic	3/1598 (0.2%)		1/426 (0.2%)
Eczema	3/1598 (0.2%)		1/426 (0.2%)
Rash generalised	3/1598 (0.2%)		0/426 (0%)
Pruritus generalised	2/1598 (0.1%)		0/426 (0%)
Rash papular	2/1598 (0.1%)		0/426 (0%)
Skin exfoliation	2/1598 (0.1%)		1/426 (0.2%)
Skin reaction	2/1598 (0.1%)		0/426 (0%)
Swelling face	2/1598 (0.1%)		1/426 (0.2%)
Blister	1/1598 (0.1%)		1/426 (0.2%)
Dermatitis acneiform	1/1598 (0.1%)		1/426 (0.2%)
Dermatosis	1/1598 (0.1%)		0/426 (0%)
Generalised erythema	1/1598 (0.1%)		0/426 (0%)
Hidradenitis	1/1598 (0.1%)		0/426 (0%)
Nail discolouration	1/1598 (0.1%)		0/426 (0%)
Nail disorder	1/1598 (0.1%)		0/426 (0%)
Onychomadesis	1/1598 (0.1%)		0/426 (0%)
Papule	1/1598 (0.1%)		1/426 (0.2%)
Pigmentation disorder	1/1598 (0.1%)		1/426 (0.2%)
Post inflammatory pigmentation change	1/1598 (0.1%)		0/426 (0%)
Psoriasis	1/1598 (0.1%)		0/426 (0%)
Rash macular	1/1598 (0.1%)		1/426 (0.2%)
Skin discolouration	1/1598 (0.1%)		0/426 (0%)
Skin toxicity	1/1598 (0.1%)		0/426 (0%)
Dyshidrotic eczema	0/1598 (0%)		1/426 (0.2%)
Vascular disorders
Deep vein thrombosis	4/1598 (0.3%)		1/426 (0.2%)
Hot flush	4/1598 (0.3%)		1/426 (0.2%)
Orthostatic hypotension	3/1598 (0.2%)		1/426 (0.2%)
Thrombophlebitis superficial	3/1598 (0.2%)		0/426 (0%)
Hypotension	2/1598 (0.1%)		0/426 (0%)
Jugular vein thrombosis	2/1598 (0.1%)		2/426 (0.5%)
Pallor	2/1598 (0.1%)		1/426 (0.2%)
Phlebitis	2/1598 (0.1%)		1/426 (0.2%)
Thrombophlebitis	2/1598 (0.1%)		0/426 (0%)
Thrombosis	2/1598 (0.1%)		1/426 (0.2%)
Embolism venous	1/1598 (0.1%)		0/426 (0%)
Superior vena cava syndrome	1/1598 (0.1%)		1/426 (0.2%)
Varicose vein	1/1598 (0.1%)		0/426 (0%)
Vasculitis	1/1598 (0.1%)		0/426 (0%)
Venous thrombosis	1/1598 (0.1%)		0/426 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

The first study related publication will be a multi-center publication submitted within 24 months after conclusion or termination of a study at all sites. After such multi site publication, all proposed site publications and presentations will be submitted to sponsor for review 60 days in advance of publication. Site will remove Sponsor confidential information unrelated to study results. Sponsor can delay a proposed publication for another 60 days to preserve intellectual property.

Results Point of Contact

Name/Title	Medical Director
Organization	Takeda
Phone	+1-877-825-3327
Email	trialdisclosures@takeda.com

Responsible Party:

Takeda

ClinicalTrials.gov Identifier:

NCT03327571

Other Study ID Numbers:

CHL-5001

First Posted:

Oct 31, 2017

Last Update Posted:

Jun 25, 2021

Last Verified:

Jun 1, 2021