Trial Outcomes & Findings for Brentuximab Vedotin (Recombinant) for IV Infusion - Special Drug Use Surveillance (All-case Surveillance) "Relapsed or Refractory CD30+ Hodgkin's Lymphoma or Anaplastic Large Cell Lymphoma" (NCT NCT02139592)

NCT ID: NCT02139592

Last Updated: 2020-07-13

Results Overview

• Recruitment status: COMPLETED
• Target enrollment: 292 participants
• Primary outcome timeframe: Up to Week 48 or until discontinuation of treatment
• Results posted on: 2020-07-13

Participant Flow

Participants took part in the study at 198 investigative sites in Japan, from 17 April 2014 to 30 June 2017. Registration period for patients was from 17 April 2014 to 30 September 2014.

Participants with a historical diagnosis of relapsed/refractory CD30+ Hodgkin's lymphoma (HL) or anaplastic large cell lymphoma (ALCL) were enrolled. Participants received interventions as part of routine medical care.

Participant milestones

Measure	Brentuximab Vedotin Infusion Intravenous infusion of 1.8 mg/kg (body weight) of brentuximab vedotin (recombinant) administered once every three weeks. Participants received interventions as part of routine medical care.
Overall Study STARTED	292
Overall Study COMPLETED	284
Overall Study NOT COMPLETED	8

Reasons for withdrawal

Measure	Brentuximab Vedotin Infusion Intravenous infusion of 1.8 mg/kg (body weight) of brentuximab vedotin (recombinant) administered once every three weeks. Participants received interventions as part of routine medical care.
Overall Study Case Report Forms Uncollected	8

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	Brentuximab Vedotin Infusion n=284 Participants Intravenous infusion of 1.8 mg/kg (body weight) of brentuximab vedotin (recombinant) administered once every three weeks. Participants received interventions as part of routine medical care.
Age, Continuous	56.7 Years STANDARD_DEVIATION 19.80 • n=284 Participants
Sex: Female, Male Female	100 Participants n=284 Participants
Sex: Female, Male Male	184 Participants n=284 Participants
Region of Enrollment Japan	284 Participants n=284 Participants
Duration of Diagnosis of Hodgkin's Lymphoma (HL) or Anaplastic Large Cell Lymphoma (ALCL) < 1 Year	75 Participants n=284 Participants
Duration of Diagnosis of Hodgkin's Lymphoma (HL) or Anaplastic Large Cell Lymphoma (ALCL) >= 1 Year and < 3 Years	105 Participants n=284 Participants
Duration of Diagnosis of Hodgkin's Lymphoma (HL) or Anaplastic Large Cell Lymphoma (ALCL) >= 3 Years and < 5 Years	47 Participants n=284 Participants
Duration of Diagnosis of Hodgkin's Lymphoma (HL) or Anaplastic Large Cell Lymphoma (ALCL) >= 5 Years	55 Participants n=284 Participants
Duration of Diagnosis of Hodgkin's Lymphoma (HL) or Anaplastic Large Cell Lymphoma (ALCL) Unknown	2 Participants n=284 Participants
Diagnosis HL	182 Participants n=284 Participants
Diagnosis ALCL	101 Participants n=284 Participants
Diagnosis Others	1 Participants n=284 Participants
Recurrent and Refractory or Primary Recurrent and Refractory	281 Participants n=284 Participants
Recurrent and Refractory or Primary Primary	3 Participants n=284 Participants
Number of participants with CD30 Positive	284 Participants n=284 Participants
ALK Positive or Negative ALK-Positive	15 Participants n=101 Participants • This baseline characteristic was analyzed only in participants who had been diagnosed with ALCL.
ALK Positive or Negative ALK-Negative	77 Participants n=101 Participants • This baseline characteristic was analyzed only in participants who had been diagnosed with ALCL.
ALK Positive or Negative Unknown	9 Participants n=101 Participants • This baseline characteristic was analyzed only in participants who had been diagnosed with ALCL.
Staging of Lymphoma Stage 1	10 Participants n=284 Participants
Staging of Lymphoma Stage 2	63 Participants n=284 Participants
Staging of Lymphoma Stage 3	70 Participants n=284 Participants
Staging of Lymphoma Stage 4	140 Participants n=284 Participants
Staging of Lymphoma Unknown	1 Participants n=284 Participants
B Symptom Had B symptom	124 Participants n=284 Participants
B Symptom Had No B symptom	160 Participants n=284 Participants
Eastern Cooperative Oncology Group (ECOG) Performance Status 0	114 Participants n=284 Participants
Eastern Cooperative Oncology Group (ECOG) Performance Status 1	104 Participants n=284 Participants
Eastern Cooperative Oncology Group (ECOG) Performance Status 2	32 Participants n=284 Participants
Eastern Cooperative Oncology Group (ECOG) Performance Status 3	19 Participants n=284 Participants
Eastern Cooperative Oncology Group (ECOG) Performance Status 4	15 Participants n=284 Participants
Healthcare Category Outpatient	45 Participants n=284 Participants
Healthcare Category Inpatient	238 Participants n=284 Participants
Healthcare Category Unknown	1 Participants n=284 Participants
Predisposition to Hypersensitivity Had Predisposition to Hypersensitivity	51 Participants n=284 Participants
Predisposition to Hypersensitivity Had No Predisposition to Hypersensitivity	231 Participants n=284 Participants
Predisposition to Hypersensitivity Unknown	2 Participants n=284 Participants
Hepatitis C Virus (HCV) Antibody Positive or Negative HCV Antibody-Positive	6 Participants n=284 Participants
Hepatitis C Virus (HCV) Antibody Positive or Negative HCV Antibody- Negative	274 Participants n=284 Participants
Hepatitis C Virus (HCV) Antibody Positive or Negative Unknown	4 Participants n=284 Participants
Hepatitis B Surface (HBs) Antigen Positive or Negative HBs Antigen-Positive	6 Participants n=284 Participants
Hepatitis B Surface (HBs) Antigen Positive or Negative HBs Antigen-Negative	271 Participants n=284 Participants
Hepatitis B Surface (HBs) Antigen Positive or Negative Unknown	7 Participants n=284 Participants
HBs Antibody Positive or Negative HBs Antibody-Positive	41 Participants n=284 Participants
HBs Antibody Positive or Negative HBs Antibody- Negative	208 Participants n=284 Participants
HBs Antibody Positive or Negative Unknown	35 Participants n=284 Participants
Hepatitis B Virus Deoxyribonucleic Acid (HBV DNA) Positive or Negative HBV DNA-Positive	4 Participants n=284 Participants
Hepatitis B Virus Deoxyribonucleic Acid (HBV DNA) Positive or Negative HBV DNA-Negative	106 Participants n=284 Participants
Hepatitis B Virus Deoxyribonucleic Acid (HBV DNA) Positive or Negative Unknown	174 Participants n=284 Participants
Medical History of Lung Disorder Had Medical History	9 Participants n=284 Participants
Medical History of Lung Disorder Had No Medical History	275 Participants n=284 Participants
Medical Complications of Lung Disorder Had Presence of Medical Complications	20 Participants n=284 Participants
Medical Complications of Lung Disorder Had No Presence of Medical Complications	264 Participants n=284 Participants
Medical History of Malignant Tumor Had Presence of Medical History	33 Participants n=284 Participants
Medical History of Malignant Tumor Had No Presence of Medical History	251 Participants n=284 Participants
Medical Complications of Malignant Tumor Had Presence of Medical Complications	5 Participants n=284 Participants
Medical Complications of Malignant Tumor Had No Presence of Medical Complications	279 Participants n=284 Participants
Medical History (Other Than Lung Disorder or Malignant Tumor) Had Presence of Medical History	68 Participants n=284 Participants
Medical History (Other Than Lung Disorder or Malignant Tumor) Had No Presence of Medical History	216 Participants n=284 Participants
Medical Complications (Other Than Lung Disorder or Malignant Tumor) Had Presence of Medical Complications	182 Participants n=284 Participants
Medical Complications (Other Than Lung Disorder or Malignant Tumor) Had No Presence of Medical Complications	102 Participants n=284 Participants
Concomitant Hepatic Disorder Had Concomitant Hepatic Disorder	25 Participants n=284 Participants
Concomitant Hepatic Disorder Had No Concomitant Hepatic Disorder	259 Participants n=284 Participants
Concomitant Renal Disorder Had Concomitant Renal Disorder	20 Participants n=284 Participants
Concomitant Renal Disorder Had No Concomitant Renal Disorder	264 Participants n=284 Participants
Weight	58.158 Kilograms (kg) STANDARD_DEVIATION 13.0751 • n=284 Participants
BMI	22.00 kg/meter (m)^2 STANDARD_DEVIATION 3.991 • n=284 Participants
Smoking Classification Never Smoked	130 Participants n=284 Participants
Smoking Classification Current Smoker	16 Participants n=284 Participants
Smoking Classification Ex-Smoker	84 Participants n=284 Participants
Smoking Classification Unknown	54 Participants n=284 Participants
Drug Therapy before Start of Brentuximab Vedotin Administration Had Drug Therapy	279 Participants n=284 Participants
Drug Therapy before Start of Brentuximab Vedotin Administration Had No Drug Therapy	5 Participants n=284 Participants
Number of Regimens before Start of Brentuximab Vedotin Administration	2.7 Number of Regimens STANDARD_DEVIATION 1.57 • n=279 Participants • Population Analysis Description: This baseline characteristic was analyzed only in participants who had drug therapy before start of Brentuximab Vedotin administration.
Time in Days from Last Month of Previous Drug Therapy Regimen to First Cycle of Brentuximab Vendotin	299.1 Days STANDARD_DEVIATION 564.04 • n=284 Participants
Radiotherapy before Start of Brentuximab Vedotin Administration Had Radiotherapy	105 Participants n=284 Participants
Radiotherapy before Start of Brentuximab Vedotin Administration Had No Radiotherapy	179 Participants n=284 Participants
Time in Days from Last Month of Most Recent Radiotherapy to First Cycle of Brentuximab Vendotin	703.4 Days STANDARD_DEVIATION 954.27 • n=94 Participants • Population Analysis Description: This baseline characteristic was analyzed only in participants who had radiotherapy before start of Brentuximab Vedotin administration. The number analyzed is the number of participants with data available for analysis.
Hematopoietic Stem Cell Transplantation before Start of Brentuximab Vedotin Administration Had No Hematopoietic Stem Cell Transplantation	219 Participants n=284 Participants
Hematopoietic Stem Cell Transplantation before Start of Brentuximab Vedotin Administration Had Autologous Transplantation	43 Participants n=284 Participants
Hematopoietic Stem Cell Transplantation before Start of Brentuximab Vedotin Administration Had Allogeneic Transplantation	9 Participants n=284 Participants
Hematopoietic Stem Cell Transplantation before Start of Brentuximab Vedotin Administration Had Autologous and Allogeneic Transplantation	12 Participants n=284 Participants
Hematopoietic Stem Cell Transplantation before Start of Brentuximab Vedotin Administration Unknown	1 Participants n=284 Participants
Number of Participants Who Were Not Pregnant	100 Participants n=100 Participants • This baseline characteristic was analyzed only in female participants.

PRIMARY outcome

Timeframe: Up to Week 48 or until discontinuation of treatment

Population: Safety Analysis Set; The safety analysis set was defined as all participants who had the safety data defined on the protocol.

Outcome measures

Measure	Brentuximab Vedotin Infusion n=284 Participants Intravenous infusion of 1.8 mg/kg (body weight) of brentuximab vedotin (recombinant) administered once every three weeks. Participants received interventions as part of routine medical care.
Number of Participants Who Had One or More Adverse Events (AE) and Serious Adverse Events (SAE) AE	238 Participants
Number of Participants Who Had One or More Adverse Events (AE) and Serious Adverse Events (SAE) SAE	97 Participants

SECONDARY outcome

Timeframe: Up to Week 48 or until discontinuation of treatment

Population: Efficacy assessment population; The efficacy assessment population was defined as participants who met the requirement of this study and had efficacy data available for analysis. The number analyzed is the number of participants with data available for analysis in the given timeframe.

Best response is defined as the cumulative numbers of participants who achieve each level of best response including partial response (PR), complete response uncertain (CRu) (when no positron emission tomography [PET] data are available), and complete response (CR) after each cycle of treatment. Reported data are divided into 4 populations; Hodgkin's lymphoma (HL) participants with PET data, HL participants without PET data, anaplastic large cell lymphoma (ALCL) participants with PET data, and ALCL participants without PET data. PET is used in cancer diagnosis and treatment.

Outcome measures

Measure	Brentuximab Vedotin Infusion n=241 Participants Intravenous infusion of 1.8 mg/kg (body weight) of brentuximab vedotin (recombinant) administered once every three weeks. Participants received interventions as part of routine medical care.
Percentage of Participants Who Achieve or Maintain Any Best Response HL Participants with PET Data	64.9 Percentage of participants Interval 53.22 to 75.47
Percentage of Participants Who Achieve or Maintain Any Best Response HL Participants without PET Data	36.5 Percentage of participants Interval 26.29 to 47.62
Percentage of Participants Who Achieve or Maintain Any Best Response ALCL Participants with PET Data	67.6 Percentage of participants Interval 50.21 to 81.99
Percentage of Participants Who Achieve or Maintain Any Best Response ALCL Participants without PET Data	57.1 Percentage of participants Interval 40.96 to 72.28

SECONDARY outcome

Timeframe: Up to Week 48 or until discontinuation of treatment

Population: Efficacy assessment population; The efficacy assessment population was defined as participants who met the requirement of this study and had efficacy data available for analysis.

OS is defined as the period from the start of therapy in standard medical care to the time when death (regardless of the cause of death) is confirmed. Reported data as OS was point estimates of 1 year survival rate for HL and ALCL participants.

Outcome measures

Measure	Brentuximab Vedotin Infusion n=280 Participants Intravenous infusion of 1.8 mg/kg (body weight) of brentuximab vedotin (recombinant) administered once every three weeks. Participants received interventions as part of routine medical care.
Overall Survival (OS) HL Participants	82.7 Percentage of participants Interval 75.4 to 88.0
Overall Survival (OS) ALCL Participants	79.3 Percentage of participants Interval 68.4 to 86.7

Adverse Events

Brentuximab Vedotin Infusion

Serious events: 97 serious events

Other events: 238 other events

Deaths: 51 deaths

Serious adverse events

Measure	Brentuximab Vedotin Infusion n=284 participants at risk Intravenous infusion of 1.8 mg/kg (body weight) of brentuximab vedotin (recombinant) administered once every three weeks. Participants received interventions as part of routine medical care.
Infections and infestations Bacteraemia	0.35% 1/284 • Up to Week 48 or until discontinuation of treatment At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. For data of "Other Adverse Events", participants may be represented in more than 1 category.
Infections and infestations Epstein-Barr virus infection	0.35% 1/284 • Up to Week 48 or until discontinuation of treatment At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. For data of "Other Adverse Events", participants may be represented in more than 1 category.
Infections and infestations Cytomegalovirus infection	0.70% 2/284 • Up to Week 48 or until discontinuation of treatment At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. For data of "Other Adverse Events", participants may be represented in more than 1 category.
Infections and infestations Herpes zoster	0.70% 2/284 • Up to Week 48 or until discontinuation of treatment At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. For data of "Other Adverse Events", participants may be represented in more than 1 category.
Infections and infestations Meningitis aseptic	0.35% 1/284 • Up to Week 48 or until discontinuation of treatment At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. For data of "Other Adverse Events", participants may be represented in more than 1 category.
Infections and infestations Fungal infection	0.35% 1/284 • Up to Week 48 or until discontinuation of treatment At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. For data of "Other Adverse Events", participants may be represented in more than 1 category.
Infections and infestations Pneumonia	3.2% 9/284 • Up to Week 48 or until discontinuation of treatment At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. For data of "Other Adverse Events", participants may be represented in more than 1 category.
Infections and infestations Pyelonephritis	0.35% 1/284 • Up to Week 48 or until discontinuation of treatment At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. For data of "Other Adverse Events", participants may be represented in more than 1 category.
Infections and infestations Sepsis	1.8% 5/284 • Up to Week 48 or until discontinuation of treatment At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. For data of "Other Adverse Events", participants may be represented in more than 1 category.
Infections and infestations Systemic candida	0.35% 1/284 • Up to Week 48 or until discontinuation of treatment At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. For data of "Other Adverse Events", participants may be represented in more than 1 category.
Infections and infestations Anal abscess	0.35% 1/284 • Up to Week 48 or until discontinuation of treatment At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. For data of "Other Adverse Events", participants may be represented in more than 1 category.
Infections and infestations Pneumonia fungal	0.35% 1/284 • Up to Week 48 or until discontinuation of treatment At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. For data of "Other Adverse Events", participants may be represented in more than 1 category.
Infections and infestations Device related infection	0.35% 1/284 • Up to Week 48 or until discontinuation of treatment At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. For data of "Other Adverse Events", participants may be represented in more than 1 category.
Infections and infestations Herpes zoster disseminated	0.35% 1/284 • Up to Week 48 or until discontinuation of treatment At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. For data of "Other Adverse Events", participants may be represented in more than 1 category.
Infections and infestations Pneumocystis jirovecii pneumonia	1.1% 3/284 • Up to Week 48 or until discontinuation of treatment At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. For data of "Other Adverse Events", participants may be represented in more than 1 category.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Hodgkin's disease	7.4% 21/284 • Up to Week 48 or until discontinuation of treatment At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. For data of "Other Adverse Events", participants may be represented in more than 1 category.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Peripheral T-cell lymphoma unspecified	0.35% 1/284 • Up to Week 48 or until discontinuation of treatment At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. For data of "Other Adverse Events", participants may be represented in more than 1 category.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Gingival cancer	0.35% 1/284 • Up to Week 48 or until discontinuation of treatment At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. For data of "Other Adverse Events", participants may be represented in more than 1 category.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Anaplastic large-cell lymphoma	4.6% 13/284 • Up to Week 48 or until discontinuation of treatment At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. For data of "Other Adverse Events", participants may be represented in more than 1 category.
Blood and lymphatic system disorders Anaemia	1.1% 3/284 • Up to Week 48 or until discontinuation of treatment At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. For data of "Other Adverse Events", participants may be represented in more than 1 category.
Blood and lymphatic system disorders Disseminated intravascular coagulation	0.70% 2/284 • Up to Week 48 or until discontinuation of treatment At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. For data of "Other Adverse Events", participants may be represented in more than 1 category.
Blood and lymphatic system disorders Febrile neutropenia	1.4% 4/284 • Up to Week 48 or until discontinuation of treatment At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. For data of "Other Adverse Events", participants may be represented in more than 1 category.
Blood and lymphatic system disorders Leukopenia	0.35% 1/284 • Up to Week 48 or until discontinuation of treatment At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. For data of "Other Adverse Events", participants may be represented in more than 1 category.
Blood and lymphatic system disorders Lymphopenia	0.35% 1/284 • Up to Week 48 or until discontinuation of treatment At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. For data of "Other Adverse Events", participants may be represented in more than 1 category.
Blood and lymphatic system disorders Neutropenia	5.3% 15/284 • Up to Week 48 or until discontinuation of treatment At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. For data of "Other Adverse Events", participants may be represented in more than 1 category.
Blood and lymphatic system disorders Thrombocytopenia	1.1% 3/284 • Up to Week 48 or until discontinuation of treatment At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. For data of "Other Adverse Events", participants may be represented in more than 1 category.
Blood and lymphatic system disorders Bone marrow failure	0.35% 1/284 • Up to Week 48 or until discontinuation of treatment At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. For data of "Other Adverse Events", participants may be represented in more than 1 category.
Immune system disorders Graft versus host disease	0.35% 1/284 • Up to Week 48 or until discontinuation of treatment At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. For data of "Other Adverse Events", participants may be represented in more than 1 category.
Immune system disorders Acute graft versus host disease	0.35% 1/284 • Up to Week 48 or until discontinuation of treatment At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. For data of "Other Adverse Events", participants may be represented in more than 1 category.
Metabolism and nutrition disorders Diabetes mellitus	0.35% 1/284 • Up to Week 48 or until discontinuation of treatment At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. For data of "Other Adverse Events", participants may be represented in more than 1 category.
Metabolism and nutrition disorders Hyperglycaemia	0.35% 1/284 • Up to Week 48 or until discontinuation of treatment At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. For data of "Other Adverse Events", participants may be represented in more than 1 category.
Metabolism and nutrition disorders Decreased appetite	0.35% 1/284 • Up to Week 48 or until discontinuation of treatment At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. For data of "Other Adverse Events", participants may be represented in more than 1 category.
Nervous system disorders Altered state of consciousness	0.70% 2/284 • Up to Week 48 or until discontinuation of treatment At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. For data of "Other Adverse Events", participants may be represented in more than 1 category.
Nervous system disorders Cerebral haemorrhage	0.35% 1/284 • Up to Week 48 or until discontinuation of treatment At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. For data of "Other Adverse Events", participants may be represented in more than 1 category.
Nervous system disorders Peripheral motor neuropathy	1.8% 5/284 • Up to Week 48 or until discontinuation of treatment At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. For data of "Other Adverse Events", participants may be represented in more than 1 category.
Nervous system disorders Peripheral sensory neuropathy	2.1% 6/284 • Up to Week 48 or until discontinuation of treatment At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. For data of "Other Adverse Events", participants may be represented in more than 1 category.
Nervous system disorders Clonic convulsion	0.35% 1/284 • Up to Week 48 or until discontinuation of treatment At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. For data of "Other Adverse Events", participants may be represented in more than 1 category.
Cardiac disorders Cardiac failure	0.70% 2/284 • Up to Week 48 or until discontinuation of treatment At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. For data of "Other Adverse Events", participants may be represented in more than 1 category.
Cardiac disorders Cardiomegaly	0.35% 1/284 • Up to Week 48 or until discontinuation of treatment At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. For data of "Other Adverse Events", participants may be represented in more than 1 category.
Cardiac disorders Left ventricular dysfunction	0.35% 1/284 • Up to Week 48 or until discontinuation of treatment At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. For data of "Other Adverse Events", participants may be represented in more than 1 category.
Respiratory, thoracic and mediastinal disorders Acute respiratory distress syndrome	0.35% 1/284 • Up to Week 48 or until discontinuation of treatment At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. For data of "Other Adverse Events", participants may be represented in more than 1 category.
Respiratory, thoracic and mediastinal disorders Interstitial lung disease	4.6% 13/284 • Up to Week 48 or until discontinuation of treatment At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. For data of "Other Adverse Events", participants may be represented in more than 1 category.
Respiratory, thoracic and mediastinal disorders Pneumonia aspiration	0.35% 1/284 • Up to Week 48 or until discontinuation of treatment At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. For data of "Other Adverse Events", participants may be represented in more than 1 category.
Respiratory, thoracic and mediastinal disorders Pneumonitis	0.35% 1/284 • Up to Week 48 or until discontinuation of treatment At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. For data of "Other Adverse Events", participants may be represented in more than 1 category.
Respiratory, thoracic and mediastinal disorders Respiratory disorder	0.35% 1/284 • Up to Week 48 or until discontinuation of treatment At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. For data of "Other Adverse Events", participants may be represented in more than 1 category.
Respiratory, thoracic and mediastinal disorders Respiratory failure	0.70% 2/284 • Up to Week 48 or until discontinuation of treatment At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. For data of "Other Adverse Events", participants may be represented in more than 1 category.
Gastrointestinal disorders Diarrhoea	0.35% 1/284 • Up to Week 48 or until discontinuation of treatment At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. For data of "Other Adverse Events", participants may be represented in more than 1 category.
Gastrointestinal disorders Gastrointestinal haemorrhage	0.35% 1/284 • Up to Week 48 or until discontinuation of treatment At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. For data of "Other Adverse Events", participants may be represented in more than 1 category.
Gastrointestinal disorders Ileus	0.35% 1/284 • Up to Week 48 or until discontinuation of treatment At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. For data of "Other Adverse Events", participants may be represented in more than 1 category.
Gastrointestinal disorders Ileus paralytic	0.35% 1/284 • Up to Week 48 or until discontinuation of treatment At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. For data of "Other Adverse Events", participants may be represented in more than 1 category.
Gastrointestinal disorders Melaena	0.35% 1/284 • Up to Week 48 or until discontinuation of treatment At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. For data of "Other Adverse Events", participants may be represented in more than 1 category.
Gastrointestinal disorders Pancreatitis acute	0.35% 1/284 • Up to Week 48 or until discontinuation of treatment At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. For data of "Other Adverse Events", participants may be represented in more than 1 category.
Gastrointestinal disorders Small intestinal perforation	0.35% 1/284 • Up to Week 48 or until discontinuation of treatment At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. For data of "Other Adverse Events", participants may be represented in more than 1 category.
Gastrointestinal disorders Lower gastrointestinal haemorrhage	0.35% 1/284 • Up to Week 48 or until discontinuation of treatment At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. For data of "Other Adverse Events", participants may be represented in more than 1 category.
Hepatobiliary disorders Cholecystitis	0.35% 1/284 • Up to Week 48 or until discontinuation of treatment At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. For data of "Other Adverse Events", participants may be represented in more than 1 category.
Hepatobiliary disorders Liver disorder	0.35% 1/284 • Up to Week 48 or until discontinuation of treatment At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. For data of "Other Adverse Events", participants may be represented in more than 1 category.
Skin and subcutaneous tissue disorders Drug eruption	0.35% 1/284 • Up to Week 48 or until discontinuation of treatment At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. For data of "Other Adverse Events", participants may be represented in more than 1 category.
Skin and subcutaneous tissue disorders Erythema multiforme	0.35% 1/284 • Up to Week 48 or until discontinuation of treatment At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. For data of "Other Adverse Events", participants may be represented in more than 1 category.
Skin and subcutaneous tissue disorders Rash	0.35% 1/284 • Up to Week 48 or until discontinuation of treatment At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. For data of "Other Adverse Events", participants may be represented in more than 1 category.
Skin and subcutaneous tissue disorders Generalised erythema	0.35% 1/284 • Up to Week 48 or until discontinuation of treatment At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. For data of "Other Adverse Events", participants may be represented in more than 1 category.
Renal and urinary disorders Renal disorder	0.35% 1/284 • Up to Week 48 or until discontinuation of treatment At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. For data of "Other Adverse Events", participants may be represented in more than 1 category.
Renal and urinary disorders Chronic kidney disease	0.35% 1/284 • Up to Week 48 or until discontinuation of treatment At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. For data of "Other Adverse Events", participants may be represented in more than 1 category.
General disorders Oedema peripheral	0.35% 1/284 • Up to Week 48 or until discontinuation of treatment At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. For data of "Other Adverse Events", participants may be represented in more than 1 category.
General disorders Pyrexia	0.35% 1/284 • Up to Week 48 or until discontinuation of treatment At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. For data of "Other Adverse Events", participants may be represented in more than 1 category.
General disorders Multiple organ dysfunction syndrome	0.70% 2/284 • Up to Week 48 or until discontinuation of treatment At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. For data of "Other Adverse Events", participants may be represented in more than 1 category.
Investigations Blood creatine phosphokinase increased	0.35% 1/284 • Up to Week 48 or until discontinuation of treatment At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. For data of "Other Adverse Events", participants may be represented in more than 1 category.
Investigations Blood lactate dehydrogenase increased	0.70% 2/284 • Up to Week 48 or until discontinuation of treatment At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. For data of "Other Adverse Events", participants may be represented in more than 1 category.
Investigations Alanine aminotransferase increased	0.35% 1/284 • Up to Week 48 or until discontinuation of treatment At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. For data of "Other Adverse Events", participants may be represented in more than 1 category.
Investigations Aspartate aminotransferase increased	0.35% 1/284 • Up to Week 48 or until discontinuation of treatment At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. For data of "Other Adverse Events", participants may be represented in more than 1 category.
Investigations Blood bilirubin increased	0.70% 2/284 • Up to Week 48 or until discontinuation of treatment At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. For data of "Other Adverse Events", participants may be represented in more than 1 category.
Investigations Transaminases increased	0.35% 1/284 • Up to Week 48 or until discontinuation of treatment At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. For data of "Other Adverse Events", participants may be represented in more than 1 category.
Investigations C-reactive protein increased	0.35% 1/284 • Up to Week 48 or until discontinuation of treatment At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. For data of "Other Adverse Events", participants may be represented in more than 1 category.
Investigations Blood urea increased	0.35% 1/284 • Up to Week 48 or until discontinuation of treatment At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. For data of "Other Adverse Events", participants may be represented in more than 1 category.
Investigations Weight increased	0.35% 1/284 • Up to Week 48 or until discontinuation of treatment At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. For data of "Other Adverse Events", participants may be represented in more than 1 category.
Injury, poisoning and procedural complications Brain herniation	0.35% 1/284 • Up to Week 48 or until discontinuation of treatment At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. For data of "Other Adverse Events", participants may be represented in more than 1 category.
Injury, poisoning and procedural complications Fall	0.35% 1/284 • Up to Week 48 or until discontinuation of treatment At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. For data of "Other Adverse Events", participants may be represented in more than 1 category.
Injury, poisoning and procedural complications Femoral neck fracture	0.35% 1/284 • Up to Week 48 or until discontinuation of treatment At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. For data of "Other Adverse Events", participants may be represented in more than 1 category.
Injury, poisoning and procedural complications Patella fracture	0.35% 1/284 • Up to Week 48 or until discontinuation of treatment At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. For data of "Other Adverse Events", participants may be represented in more than 1 category.

Other adverse events

Measure	Brentuximab Vedotin Infusion n=284 participants at risk Intravenous infusion of 1.8 mg/kg (body weight) of brentuximab vedotin (recombinant) administered once every three weeks. Participants received interventions as part of routine medical care.
Blood and lymphatic system disorders Lymphopenia	7.7% 22/284 • Up to Week 48 or until discontinuation of treatment At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. For data of "Other Adverse Events", participants may be represented in more than 1 category.
Blood and lymphatic system disorders Neutropenia	53.9% 153/284 • Up to Week 48 or until discontinuation of treatment At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. For data of "Other Adverse Events", participants may be represented in more than 1 category.
Blood and lymphatic system disorders Thrombocytopenia	6.0% 17/284 • Up to Week 48 or until discontinuation of treatment At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. For data of "Other Adverse Events", participants may be represented in more than 1 category.
Nervous system disorders Peripheral sensory neuropathy	45.4% 129/284 • Up to Week 48 or until discontinuation of treatment At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. For data of "Other Adverse Events", participants may be represented in more than 1 category.
Skin and subcutaneous tissue disorders Rash	5.3% 15/284 • Up to Week 48 or until discontinuation of treatment At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. For data of "Other Adverse Events", participants may be represented in more than 1 category.
General disorders Pyrexia	5.3% 15/284 • Up to Week 48 or until discontinuation of treatment At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. For data of "Other Adverse Events", participants may be represented in more than 1 category.
Injury, poisoning and procedural complications Infusion related reaction	10.9% 31/284 • Up to Week 48 or until discontinuation of treatment At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. For data of "Other Adverse Events", participants may be represented in more than 1 category.

Additional Information

Medical Director

Takeda

Phone: +1-877-825-3327

Email: trialdisclosures@takeda.com

Results disclosure agreements

• Principal investigator is a sponsor employee 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.
• Publication restrictions are in place

Restriction type: OTHER