Study of Brentuximab Vedotin (SGN-35) in Pediatric Partic... | NCT01492088

ID	Type	Description
2011-001240-29	EudraCT Number
U1111-1158-2613	Registry Identifier	WHO
133300410A0384	Registry Identifier	RNEC
NL38209.078.11	Registry Identifier	CCMO

Label	Type	Description	Intervention Names
Brentuximab vedotin: Phase 1	Experimental	Brentuximab vedotin 1.4 mg/kg, 30-minute IV infusion, Day 1 of every 21-day cycle, until there was evidence of disease progression or unacceptable toxicity. Dose was escalated up to 1.8 mg/kg using a 3 + 3 dose escalation design to determine a maximum tolerated dose (MTD) and/or recommended Phase 2 dose (RP2D) depending upon the dose limiting toxicity (DLT).	Drug: Brentuximab vedotin
Brentuximab vedotin: Phase 2	Experimental	Brentuximab vedotin 1.8 mg/kg, 30-minute IV infusion, Day 1 of every 21-day cycle, until there is evidence of disease progression or unacceptable toxicity (Up to 16 cycles). Treatment with brentuximab vedotin beyond 16 cycles was permitted at the joint discretion of the sponsor and the investigator for those participants experiencing continued clinical benefit.	Drug: Brentuximab vedotin

Name	Type	Description	Arm Group Labels	Other Names
Brentuximab vedotin	Drug	Brentuximab vedotin IV infusion	Brentuximab vedotin: Phase 1 Brentuximab vedotin: Phase 2

Measure	Description	Time Frame
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) (Phase 1)	An Adverse Event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. A Serious Adverse Event (SAE) is any experience that suggests a significant hazard, contraindication, side effect or precaution that: results in death, is life-threatening, required in-patient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or is medically significant. A treatment-emergent adverse event (TEAE) is defined as an adverse event with an onset that occurs after receiving study drug. AE severity was graded according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.03.	From the first dose through 30 days after the last dose of study medication (Up to 15 months)
Number of Participants With Abnormal Clinical Laboratory Values Reported as AEs (Phase 1)	Abnormal clinical laboratory values (serum chemistry and hematology) were reported as AEs if they were considered by the investigator to be a clinically significant change from Baseline or led to premature discontinuation of study treatment, dose modification, or other therapeutic intervention.	From the first dose through 30 days after the last dose of study medication (Up to 15 months)
Number of Participants With Clinically Significant Vital Signs Values Reported as AEs (Phase 1)	Vital signs measurements included supine (after 3-5 minutes in this position) and standing (after 3-5 minutes in this position) measurements of diastolic and systolic blood pressure, heart rate, and oral temperature.	From the first dose through 30 days after the last dose of study medication (Up to 15 months)
Antibody-drug Conjugate (ADC) Serum Concentrations (Phase 1)	Blood samples were collected and tested for serum concentrations of brentuximab vedotin antibody-drug conjugate.

Measure	Description	Time Frame
Number of Participants With Antitherapeutic Antibodies (ATA) and Neutralizing ATA (nATA) (Phase 1 and 2)	Blood samples were collected to assess the immunogenicity of brentuximab vedotin (ATA and nATA development) using a laboratory test. ATA-positive samples were further characterized as transiently ATA positive (defined as 1 or 2 post-Baseline ATA-positive responses), persistently ATA positive (defined as more than 2 post-Baseline ATA positive responses), and nATA positive or negative.

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Male or female participants aged 2 to <18 years (5 to <18 years for Hodgkin lymphoma [HL])
Diagnosis of systemic anaplastic large-cell lymphoma (sALCL), or HL for which standard, curative, life-prolonging, or palliative treatment does not exist or is no longer effective
Participants with sALCL must have documented anaplastic lymphoma kinase (ALK) status and must be beyond first remission or refractory to front-line chemotherapy
Participants diagnosed with any relapsed or refractory CD30+ hematologic malignancy (e.g., primary mediastinal B-cell lymphoma) may be included in phase 1 of the study
Participants with HL must be in their second of later relapse, have failed systemic chemotherapy either as induction therapy for advanced stage disease or salvage therapy, and were ineligible for, refused, or previously received a stem cell transplant
Performance score ≥ 60 from Lansky Play Performance Scale if ≤16 years
Negative pregnancy test
Fertile Participants must use 2 effective methods of contraception prior to and through 6 months after the last dose of the study drug

Exclusion Criteria:

Current diagnosis of primary cutaneous ALCL (those with systemic ALCL are eligible)
Received an allogeneic stem cell transplant <3 months prior to the first dose of study medication, or presence of polymerase chain reaction (PCR)-detectable cytomegalovirus (CMV) in any post-allogeneic transplant participant
Receiving immunosuppressive therapy
Receiving systemic therapy for chronic graft-versus-host disease (topical therapy is allowed)
Previous treatment with any anti-CD30 antibody
Therapeutic monoclonal antibody use within the longer of 6 weeks or 5 plasma half-lives
Systemic cardiac disease that would, in the opinion of the investigator or medical monitor, interfere with assessment of efficacy or safety of the drug
History of another primary malignancy not in remission for at least 3 years (the following are exempt from the 3-year limit: nonmelanoma skin cancer and cervical carcinoma in situ on biopsy or a squamous intraepithelial lesion on Pap smear)
Known active cerebral/meningeal disease, including signs or symptoms of progressive multifocal leukoencephalopathy (PML) or any history of PML
History of cirrhosis
Active systemic viral, bacterial, or fungal infection requiring antimicrobial, antiviral therapy or antifungal therapy within 2 weeks prior to the first dose of study drug (routine antimicrobial prophylaxis is acceptable)
Concurrent therapy with other anti-neoplastic or experimental agents
Systemic corticosteroid therapy <7 days prior to first dose of the study medication
Any serious underlying medical condition that, in the opinion of the investigator or medical monitor, would impair their ability to receive or tolerate the planned treatment
Known hypersensitivity to recombinant proteins, murine proteins, or any excipient contained in the drug formulation
Received nitrogen mustard agents, melphalan, or BCNU therapy within 6 weeks prior to the first study dose
Prior autologous hematopoietic stem cell infusion <4 weeks prior to first study dose
Grade 2 or greater unresolved toxicity from prior antineoplastic therapy
Grade 2 or greater peripheral neuropathy
Female participants who are both lactating and breastfeeding, or have a positive serum pregnancy test during the screening period or a positive urine pregnancy test on Day 1 before the first dose of study drug
Received local palliative radiation therapy <14 days prior to the first dose of study medication
Received radiation therapy to more than 25% of the bone marrow-containing spaces < 84 days prior to first dose of study medication
Received a strong or listed moderate inhibitor of CYP3A4 <2 weeks prior to first study dose
Participants must have fully recovered from the acute toxic effects of all prior chemotherapy, immunotherapy, or radiotherapy prior to entering this study

Name	Affiliation	Role
Medical Monitor	Millennium Pharmaceuticals, Inc.	Study Director

PubMed Identifier	Type	Citation	Retractions
17242396	Result	Cheson BD, Pfistner B, Juweid ME, Gascoyne RD, Specht L, Horning SJ, Coiffier B, Fisher RI, Hagenbeek A, Zucca E, Rosen ST, Stroobants S, Lister TA, Hoppe RT, Dreyling M, Tobinai K, Vose JM, Connors JM, Federico M, Diehl V; International Harmonization Project on Lymphoma. Revised response criteria for malignant lymphoma. J Clin Oncol. 2007 Feb 10;25(5):579-86. doi: 10.1200/JCO.2006.09.2403. Epub 2007 Jan 22.
32596842

ID	Title	Description
FG000	Brentuximab Vedotin 1.4 mg/kg: Phase 1	Brentuximab vedotin 1.4 mg/kg, 30-minute IV infusion, Day 1 of every 21-day cycle, until there was evidence of disease progression or unacceptable toxicity.
FG001	Brentuximab Vedotin 1.8 mg/kg: Phase 1 and 2 r/r HL Only

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	Jun 12, 2014	Oct 10, 2018

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) (Phase 1)

An Adverse Event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. A Serious Adverse Event (SAE) is any experience that suggests a significant hazard, contraindication, side effect or precaution that: results in death, is life-threatening, required in-patient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or is medically significant. A treatment-emergent adverse event (TEAE) is defined as an adverse event with an onset that occurs after receiving study drug. AE severity was graded according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.03.

Safety population is defined as all participants who received at least 1 dose of study drug. Participants enrolled in Phase 1 of study were evaluated for this outcome measure.

Posted

Count of Participants

Participants

From the first dose through 30 days after the last dose of study medication (Up to 15 months)

ID	Title	Description
OG000	Brentuximab Vedotin 1.4 mg/kg: Phase 1	Brentuximab vedotin 1.4 mg/kg, 30-minute IV infusion, Day 1 of every 21-day cycle, until there was evidence of disease progression or unacceptable toxicity.
OG001	Brentuximab Vedotin 1.8 mg/kg: Phase 1	Brentuximab vedotin 1.8 mg/kg, 30-minute IV infusion, Day 1 of every 21-day cycle until there was evidence of disease progression or unacceptable toxicity (Up to 16 cycles). Treatment with brentuximab vedotin beyond 16 cycles was permitted at the joint discretion of the sponsor and the investigator for those participants experiencing continued clinical benefit.

Units	Counts
Participants	OG0003 OG0019

Title

Denominators

Categories

TEAE

Title	Measurements
	OG0003 OG0019

SAE

Title	Measurements
	OG000

Primary

Number of Participants With Abnormal Clinical Laboratory Values Reported as AEs (Phase 1)

Abnormal clinical laboratory values (serum chemistry and hematology) were reported as AEs if they were considered by the investigator to be a clinically significant change from Baseline or led to premature discontinuation of study treatment, dose modification, or other therapeutic intervention.

Safety population is defined as all participants who received at least 1 dose of study drug. Participants enrolled in Phase 1 of study were evaluated for this outcome measure.

Posted

Count of Participants

Participants

From the first dose through 30 days after the last dose of study medication (Up to 15 months)

ID	Title	Description
OG000	Brentuximab Vedotin 1.4 mg/kg: Phase 1	Brentuximab vedotin 1.4 mg/kg, 30-minute IV infusion, Day 1 of every 21-day cycle, until there was evidence of disease progression or unacceptable toxicity.
OG001	Brentuximab Vedotin 1.8 mg/kg: Phase 1	Brentuximab vedotin 1.8 mg/kg, 30-minute IV infusion, Day 1 of every 21-day cycle until there was evidence of disease progression or unacceptable toxicity (Up to 16 cycles). Treatment with brentuximab vedotin beyond 16 cycles was permitted at the joint discretion of the sponsor and the investigator for those participants experiencing continued clinical benefit.

Primary

Number of Participants With Clinically Significant Vital Signs Values Reported as AEs (Phase 1)

Vital signs measurements included supine (after 3-5 minutes in this position) and standing (after 3-5 minutes in this position) measurements of diastolic and systolic blood pressure, heart rate, and oral temperature.

Safety population is defined as all participants who received at least 1 dose of study drug. Participants enrolled in Phase 1 of study were evaluated for this outcome measure.

Posted

Count of Participants

Participants

From the first dose through 30 days after the last dose of study medication (Up to 15 months)

ID	Title	Description
OG000	Brentuximab Vedotin 1.4 mg/kg: Phase 1	Brentuximab vedotin 1.4 mg/kg, 30-minute IV infusion, Day 1 of every 21-day cycle, until there was evidence of disease progression or unacceptable toxicity.
OG001	Brentuximab Vedotin 1.8 mg/kg: Phase 1	Brentuximab vedotin 1.8 mg/kg, 30-minute IV infusion, Day 1 of every 21-day cycle starting from Cycle 2 until there was evidence of disease progression or unacceptable toxicity (Up to 16 cycles). Treatment with brentuximab vedotin beyond 16 cycles was permitted at the joint discretion of the sponsor and the investigator for those participants experiencing continued clinical benefit.

Primary

Antibody-drug Conjugate (ADC) Serum Concentrations (Phase 1)

Blood samples were collected and tested for serum concentrations of brentuximab vedotin antibody-drug conjugate.

Data for this outcome measure was not summarized for Phase 1 participants only, data was summarized together for Phase 1 and 2 participants in brentuximab 1.4 mg/kg and 1.8 mg/kg arms groups. Data has been presented in OM 19.

Posted

Cycle 1 and 8 pre-dose and 5 minutes, 24, 48, 96 and 312 hours post-dose; Cycle 2 pre-dose, 5 minutes and 24, 48 and 96 hours post-dose; Cycle 3 to 16 pre-dose and 5 minutes post-dose

ID	Title	Description
OG000	Brentuximab Vedotin 1.4 mg/kg: Phase 1	Brentuximab vedotin 1.4 mg/kg, 30-minute IV infusion, Day 1 of every 21-day cycle, until there was evidence of disease progression or unacceptable toxicity.
OG001	Brentuximab Vedotin 1.8 mg/kg: Phase 1	Brentuximab vedotin 1.8 mg/kg, 30-minute IV infusion, Day 1 of every 21-day cycle starting from Cycle 2 until there was evidence of disease progression or unacceptable toxicity (Up to 16 cycles). Treatment with brentuximab vedotin beyond 16 cycles was permitted at the joint discretion of the sponsor and the investigator for those participants experiencing continued clinical benefit.

Primary

Serum Concentration of Total Antibodies (Conjugated and Unconjugated) (Phase 1)

Blood samples were collected and tested for conjugated and unconjugated antibodies.

Posted

Cycle 1 and 8 pre-dose and 5 minutes, 24, 48, 96 and 312 hours post-dose; Cycle 2 pre-dose, 5 minutes and 24, 48 and 96 hours post-dose; Cycle 3 to 16 pre-dose and 5 minutes post-dose

ID	Title	Description
OG000	Brentuximab Vedotin 1.4 mg/kg: Phase 1	Brentuximab vedotin 1.4 mg/kg, 30-minute IV infusion, Day 1 of every 21-day cycle, until there was evidence of disease progression or unacceptable toxicity.
OG001	Brentuximab Vedotin 1.8 mg/kg: Phase 1	Brentuximab vedotin 1.8 mg/kg, 30-minute IV infusion, Day 1 of every 21-day cycle starting from Cycle 2 until there was evidence of disease progression or unacceptable toxicity (Up to 16 cycles). Treatment with brentuximab vedotin beyond 16 cycles was permitted at the joint discretion of the sponsor and the investigator for those participants experiencing continued clinical benefit.

Primary

Monomethyl Auristatin E (MMAE) Plasma Concentrations (Phase 1)

Blood samples were collected and tested for MMAE plasma concentrations.

Posted

Cycle 1 and 8 pre-dose and 5 minutes, 24, 48, 96 and 312 hours post-dose; Cycle 2 pre-dose, 5 minutes and 24, 48 and 96 hours post-dose; Cycle 3 to 16 pre-dose and 5 minutes post-dose

ID	Title	Description
OG000	Brentuximab Vedotin 1.4 mg/kg: Phase 1	Brentuximab vedotin 1.4 mg/kg, 30-minute IV infusion, Day 1 of every 21-day cycle, until there was evidence of disease progression or unacceptable toxicity.
OG001	Brentuximab Vedotin 1.8 mg/kg: Phase 1	Brentuximab vedotin 1.8 mg/kg, 30-minute IV infusion, Day 1 of every 21-day cycle starting from Cycle 2 until there was evidence of disease progression or unacceptable toxicity (Up to 16 cycles). Treatment with brentuximab vedotin beyond 16 cycles was permitted at the joint discretion of the sponsor and the investigator for those participants experiencing continued clinical benefit.

Units

Primary

Overall Response Rate (ORR) (Phase 1 and 2)

Overall response rate is defined as the percentage of participants with complete remission (CR) or partial remission (PR) as assessed by an independent review facility (IRF) using International Working Group (IWG) Revised Response Criteria for Malignant Lymphoma. CR is defined as the disappearance of all evidence of disease and PR is defined as regression of measurable disease and no new sites.

Response-evaluable population included participants who received at least 1 dose of study drug, have measurable disease at baseline, and 1 postbaseline disease assessment. Data was summarized together for Phase 1 and 2 participants in brentuximab 1.8 mg/kg arm group.

Posted

Number

95% Confidence Interval

percentage of participants

Cycles 2, 4, 7, 10, 13 and 16 (21-day cycles) until disease progression, death or end of treatment (EOT) (Up to 15 months)

ID	Title	Description
OG000	Brentuximab Vedotin 1.4 mg/kg: Phase 1	Brentuximab vedotin 1.4 mg/kg, 30-minute IV infusion, Day 1 of every 21-day cycle, until there was evidence of disease progression or unacceptable toxicity.
OG001	Brentuximab Vedotin 1.8 mg/kg: Phase 1 and 2 r/r HL Only	Participants with r/r Hodgkin Lymphoma (HL) received brentuximab vedotin 1.8 mg/kg, 30-minute IV infusion, Day 1 of every 21-day cycle until there was evidence of disease progression or unacceptable toxicity (Up to 16 cycles). Treatment with brentuximab vedotin beyond 16 cycles was permitted at the joint discretion of the sponsor and the investigator for those participants experiencing continued clinical benefit.

Secondary

Number of Participants With Antitherapeutic Antibodies (ATA) and Neutralizing ATA (nATA) (Phase 1 and 2)

Blood samples were collected to assess the immunogenicity of brentuximab vedotin (ATA and nATA development) using a laboratory test. ATA-positive samples were further characterized as transiently ATA positive (defined as 1 or 2 post-Baseline ATA-positive responses), persistently ATA positive (defined as more than 2 post-Baseline ATA positive responses), and nATA positive or negative.

Participants from the Safety Population, all enrolled participants who received at least one dose of brentuximab vedotin, with data available for analysis.

Posted

Count of Participants

Participants

Baseline up to EOT (Up to 15 months)

ID	Title	Description
OG000	Brentuximab Vedotin 1.4 mg/kg: Phase 1	Brentuximab vedotin 1.4 mg/kg, 30-minute IV infusion, Day 1 of every 21-day cycle, until there was evidence of disease progression or unacceptable toxicity.
OG001	Brentuximab Vedotin 1.8 mg/kg: Phase 1 and 2 r/r HL Only	Participants with r/r HL received brentuximab vedotin 1.8 mg/kg, 30-minute IV infusion, Day 1 of every 21-day cycle until there was evidence of disease progression or unacceptable toxicity (Up to 16 cycles). Treatment with brentuximab vedotin beyond 16 cycles was permitted at the joint discretion of the sponsor and the investigator for those participants experiencing continued clinical benefit.

Secondary

Overall Response Rate (ORR) (Phase 1)

Overall response rate is defined as the percentage of participants with CR or PR as assessed by an IRF using IWG Revised Response Criteria for Malignant Lymphoma. CR is defined as the disappearance of all evidence of disease and PR is defined as regression of measurable disease and no new sites.

Response-evaluable population included participants who received at least 1 dose of study drug, have measurable disease at baseline, and 1 postbaseline disease assessment. Participants enrolled in Phase 1 of the study were evaluated for this outcome measure.

Posted

Number

95% Confidence Interval

percentage of participants

Cycles 2, 4, 7, 10, 13 and 16 (21-day cycles) until disease progression, death or EOT (Up to 15 months)

ID	Title	Description
OG000	Brentuximab Vedotin 1.4 mg/kg: Phase 1	Brentuximab vedotin 1.4 mg/kg, 30-minute IV infusion, Day 1 of every 21-day cycle, until there was evidence of disease progression or unacceptable toxicity.
OG001	Brentuximab Vedotin 1.8 mg/kg: Phase 1	Brentuximab vedotin 1.8 mg/kg, 30-minute IV infusion, Day 1 of every 21-day cycle starting from Cycle 2 until there was evidence of disease progression or unacceptable toxicity (Up to 16 cycles). Treatment with brentuximab vedotin beyond 16 cycles was permitted at the joint discretion of the sponsor and the investigator for those participants experiencing continued clinical benefit.

Secondary

Time to Progression (TTP) (Phase 1 and 2)

TTP is defined as the time in months from first dose until the first subsequent documentation of objective tumor progression. Progressive disease (PD) is defined as any new lesion or increase by ≥50% of previously involved sites from nadir.

Safety population is defined as all participants who received at least 1 dose of study drug. TTP was censored on last radiological assessment of measured lesions documenting absence of PD for participants who did not have tumor progression.

Posted

Median

95% Confidence Interval

months

Cycles 2, 4, 7, 10, 13 and 16 (21-day cycles) until disease progression, death or EOT and then every 12 weeks for 12 months after EOT, until disease progression, or death (Up to 27 months)

ID	Title	Description
OG000	Brentuximab Vedotin 1.4 mg/kg: Phase 1	Brentuximab vedotin 1.4 mg/kg, 30-minute IV infusion, Day 1 of every 21-day cycle, until there was evidence of disease progression or unacceptable toxicity.
OG001	Brentuximab Vedotin 1.8 mg/kg: Phase 1 and 2 r/r HL Only	Participants with r/r HL received brentuximab vedotin 1.8 mg/kg, 30-minute IV infusion, Day 1 of every 21-day cycle until there was evidence of disease progression or unacceptable toxicity (Up to 16 cycles). Treatment with brentuximab vedotin beyond 16 cycles was permitted at the joint discretion of the sponsor and the investigator for those participants experiencing continued clinical benefit.

Secondary

Time to Response (Phase 1 and 2)

Time to response is defined as the time in months from the first dose of study treatment until the date of the first assessment of confirmed CR or PR. as assessed by an IRF using IWG revised response criteria for malignant lymphoma. CR is defined as the disappearance of all evidence of disease and PR is defined as regression of measurable disease and no new sites.

Response-evaluable population included participants who received at least 1 dose of study drug, have measurable disease at baseline, and 1 postbaseline disease assessment. Time to response was censored on the last radiological assessment of measured lesions documenting absence of CR or PR for participants who did not have CR or PR.

Posted

Median

95% Confidence Interval

months

Cycles 2, 4, 7, 10, 13 and 16 (21-day cycles) until disease progression, death or EOT (Up to 15 months)

ID	Title	Description
OG000	Brentuximab Vedotin 1.4 mg/kg: Phase 1	Brentuximab vedotin 1.4 mg/kg, 30-minute IV infusion, Day 1 of every 21-day cycle, until there was evidence of disease progression or unacceptable toxicity.
OG001	Brentuximab Vedotin 1.8 mg/kg: Phase 1 and 2 r/r HL Only	Participants with r/r HL received brentuximab vedotin 1.8 mg/kg, 30-minute IV infusion, Day 1 of every 21-day cycle until there was evidence of disease progression or unacceptable toxicity (Up to 16 cycles). Treatment with brentuximab vedotin beyond 16 cycles was permitted at the joint discretion of the sponsor and the investigator for those participants experiencing continued clinical benefit.

Secondary

Duration of Response (DOR) (Phase 1 and 2)

DOR is defined as the time in months from the date of first documentation of a CR or PR to the date of first documentation of tumor progression or PD per IRF assessment according to IWG criteria or to death due to any cause, whichever comes first. CR is defined as the disappearance of all evidence of disease and PD is defined as any new lesion or increase by >50% of previously involved sites from nadir.

Participants with response from the Safety Population, all enrolled participants who received at least one dose of brentuximab vedotin, with data available for analysis. Duration of response was censored at last observation documenting absence of PD for participants who did not have tumor progression.

Posted

Median

95% Confidence Interval

months

Cycles 2, 4, 7, 10, 13 and 16 (21-day cycles) until disease progression, death or EOT and then every 12 weeks for 12 months after EOT, until disease progression, or death or end of study (Up to 72 months)

ID	Title	Description
OG000	Brentuximab Vedotin 1.4 mg/kg: Phase 1	Brentuximab vedotin 1.4 mg/kg, 30-minute IV infusion, Day 1 of every 21-day cycle, until there was evidence of disease progression or unacceptable toxicity.
OG001	Brentuximab Vedotin 1.8 mg/kg: Phase 1 and 2 r/r HL Only	Participants with r/r HL received brentuximab vedotin 1.8 mg/kg, 30-minute IV infusion, Day 1 of every 21-day cycle until there was evidence of disease progression or unacceptable toxicity (Up to 16 cycles). Treatment with brentuximab vedotin beyond 16 cycles was permitted at the joint discretion of the sponsor and the investigator for those participants experiencing continued clinical benefit.

Secondary

Event Free Survival (EFS) (Phase 1 and 2)

EFS is defined as the time in months from first dose until any cause of treatment failure: disease progression, premature discontinuation of treatment for any reason, or death due to any cause, whichever occurs first. PD is defined as any new lesion or increase by >50% of previously involved sites from nadir.

Safety population is defined as all participants who received at least 1 dose of study drug. EFS was censored on the last follow-up date if none of the above events occur during the study.

Posted

Median

95% Confidence Interval

months

Cycles 2, 4, 7, 10, 13 and 16 (21-day cycles) until disease progression, death or EOT and then every 12 weeks for 12 months after EOT, until disease progression, or death (Up to 27 months)

ID	Title	Description
OG000	Brentuximab Vedotin 1.4 mg/kg: Phase 1	Brentuximab vedotin 1.4 mg/kg, 30-minute IV infusion, Day 1 of every 21-day cycle, until there was evidence of disease progression or unacceptable toxicity.
OG001	Brentuximab Vedotin 1.8 mg/kg: Phase 1 and 2 r/r HL Only	Participants with r/r HL received brentuximab vedotin 1.8 mg/kg, 30-minute IV infusion, Day 1 of every 21-day cycle until there was evidence of disease progression or unacceptable toxicity (Up to 16 cycles). Treatment with brentuximab vedotin beyond 16 cycles was permitted at the joint discretion of the sponsor and the investigator for those participants experiencing continued clinical benefit.

Secondary

Progression Free Survival (PFS) (Phase 1 and 2)

PFS is defined as time in months from start of study treatment to first documentation of objective tumor progression per IRF assessment or up to death due to any cause, whichever occurs first. PD is defined as any new lesion or increase by >50% of previously involved sites from nadir.

Safety population is defined as all participants who received at least 1 dose of study drug. PFS was censored on the day following the date of last radiological assessment of measured lesions documenting absence of PD for participants who did not have tumor progression.

Posted

Median

95% Confidence Interval

months

ID	Title	Description
OG000	Brentuximab Vedotin 1.4 mg/kg: Phase 1	Brentuximab vedotin 1.4 mg/kg, 30-minute IV infusion, Day 1 of every 21-day cycle, until there was evidence of disease progression or unacceptable toxicity.
OG001	Brentuximab Vedotin 1.8 mg/kg: Phase 1 and 2 r/r HL Only	Participants with r/r HL received brentuximab vedotin 1.8 mg/kg, 30-minute IV infusion, Day 1 of every 21-day cycle until there was evidence of disease progression or unacceptable toxicity (Up to 16 cycles). Treatment with brentuximab vedotin beyond 16 cycles was permitted at the joint discretion of the sponsor and the investigator for those participants experiencing continued clinical benefit.

Secondary

Overall Survival (OS) (Phase 1 and 2)

OS is the time in months from start of study treatment to date of death due to any cause.

Safety population is defined as all participants who received at least 1 dose of study drug.

Posted

Median

95% Confidence Interval

months

Every 6 months after EOT, until the sooner of death, study closure, or 2 years after enrolment of the last participant (Up to 72 months)

ID	Title	Description
OG000	Brentuximab Vedotin 1.4 mg/kg: Phase 1	Brentuximab vedotin 1.4 mg/kg, 30-minute IV infusion, Day 1 of every 21-day cycle, until there was evidence of disease progression or unacceptable toxicity.
OG001	Brentuximab Vedotin 1.8 mg/kg: Phase 1 and 2 r/r HL Only	Participants with r/r HL received brentuximab vedotin 1.8 mg/kg, 30-minute IV infusion, Day 1 of every 21-day cycle until there was evidence of disease progression or unacceptable toxicity (Up to 16 cycles). Treatment with brentuximab vedotin beyond 16 cycles was permitted at the joint discretion of the sponsor and the investigator for those participants experiencing continued clinical benefit.
OG002	Brentuximab Vedotin 1.8 mg/kg: Phase 1 and 2 r/r sALCL Only	Participants with r/r systemic anaplastic large-cell lymphoma (sALCL) received brentuximab vedotin 1.8 mg/kg, 30-minute IV infusion, Day 1 of every 21-day cycle until there was evidence of disease progression or unacceptable toxicity (Up to 16 cycles). Treatment with brentuximab vedotin beyond 16 cycles was permitted at the joint discretion of the sponsor and the investigator for those participants experiencing continued clinical benefit.

Secondary

Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) (Phase 1 and 2)

An AE is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. A SAE is any experience that suggests a significant hazard, contraindication, side effect or precaution that: results in death, is life-threatening, required in-patient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or is medically significant. A treatment-emergent adverse event (TEAE) is defined as an adverse event with an onset that occurs after receiving study drug. AE severity was graded according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.03.

Safety population is defined as all participants who received at least 1 dose of study drug. Data was summarized together for Phase 1 and 2 participants in brentuximab 1.8 mg/kg arm group.

Posted

Count of Participants

Participants

From the first dose through 30 days after the last dose of study medication (up to 15 months)

ID	Title	Description
OG000	Brentuximab Vedotin 1.4 mg/kg: Phase 1	Brentuximab vedotin 1.4 mg/kg, 30-minute IV infusion, Day 1 of every 21-day cycle, until there was evidence of disease progression or unacceptable toxicity.
OG001	Brentuximab Vedotin 1.8 mg/kg: Phase 1 and 2 r/r HL Only

Secondary

Number of Participants With Abnormal Clinical Laboratory Values Reported as AEs (Phase 1 and 2)

Safety population is defined as all participants who received at least 1 dose of study drug. Data was summarized together for Phase 1 and 2 participants in brentuximab 1.8 mg/kg arm group.

Posted

Count of Participants

Participants

From the first dose through 30 days after the last dose of study medication (Up to 15 months)

ID	Title	Description
OG000	Brentuximab Vedotin 1.4 mg/kg: Phase 1	Brentuximab vedotin 1.4 mg/kg, 30-minute IV infusion, Day 1 of every 21-day cycle, until there was evidence of disease progression or unacceptable toxicity.
OG001	Brentuximab Vedotin 1.8 mg/kg: Phase 1 and 2 r/r HL Only	Participants with r/r HL received brentuximab vedotin 1.8 mg/kg, 30-minute IV infusion, Day 1 of every 21-day cycle until there was evidence of disease progression or unacceptable toxicity (Up to 16 cycles). Treatment with brentuximab vedotin beyond 16 cycles was permitted at the joint discretion of the sponsor and the investigator for those participants experiencing continued clinical benefit.

Secondary

Number of Participants With Clinically Significant Vital Signs Reported as AEs (Phase 1 and 2)

Safety population is defined as all participants who received at least 1 dose of study drug. Data was summarized together for Phase 1 and 2 participants in brentuximab 1.8 mg/kg arm group.

Posted

Count of Participants

Participants

From the first dose through 30 days after the last dose of study medication (Up to 15 months)

ID	Title	Description
OG000	Brentuximab Vedotin 1.4 mg/kg: Phase 1	Brentuximab vedotin 1.4 mg/kg, 30-minute IV infusion, Day 1 of every 21-day cycle, until there was evidence of disease progression or unacceptable toxicity.
OG001	Brentuximab Vedotin 1.8 mg/kg: Phase 1 and 2 r/r HL Only	Participants with r/r HL received brentuximab vedotin 1.8 mg/kg, 30-minute IV infusion, Day 1 of every 21-day cycle until there was evidence of disease progression or unacceptable toxicity (Up to 16 cycles). Treatment with brentuximab vedotin beyond 16 cycles was permitted at the joint discretion of the sponsor and the investigator for those participants experiencing continued clinical benefit.
OG002

Secondary

Antibody-drug Conjugate (ADC) Serum Concentrations (Phase 1 and 2)

Blood samples were collected and tested for serum concentrations of brentuximab vedotin antibody-drug conjugate.

PK-evaluable population was defined as participants with sufficient dosing and PK data to reliably estimate PK parameters. Cycle 2 Day 2 values are collected in phase 1 participants only. Here, number analyzed is number of participants assessed at given time-point. Data summarized together for all participants in brentuximab vedotin 1.8 mg/kg arm.

Posted

Mean

Standard Deviation

ug/mL

Cycle 1 and 8 pre-dose and 5 minutes, 24, 48, 96 and 312 hours post-dose; Cycle 2 pre-dose, 5 minutes and 24, 48 and 96 hours post-dose; Cycle 3 to 16 pre-dose and 5 minutes post-dose

ID	Title	Description
OG000	Brentuximab Vedotin 1.4 mg/kg: Phase 1	Brentuximab vedotin 1.4 mg/kg, 30-minute IV infusion, Day 1 of every 21-day cycle, until there was evidence of disease progression or unacceptable toxicity.
OG001	Brentuximab Vedotin 1.8 mg/kg: Phase 1	Brentuximab vedotin 1.8 mg/kg, 30-minute IV infusion, Day 1 of every 21-day cycle until there was evidence of disease progression or unacceptable toxicity (Up to 16 cycles). Treatment with brentuximab vedotin beyond 16 cycles was permitted at the joint discretion of the sponsor and the investigator for those participants experiencing continued clinical benefit.

Secondary

Serum Concentration of Total Antibodies (Conjugated and Unconjugated)

Blood samples were collected and tested for conjugated and unconjugated antibodies.

Posted

Mean

Standard Deviation

ug/mL

Cycle 1 and 8 pre-dose and 5 minutes, 24, 48, 96 and 312 hours post-dose; Cycle 2 pre-dose, 5 minutes and 24, 48 and 96 hours post-dose; Cycle 3 to 16 pre-dose and 5 minutes post-dose

ID	Title	Description
OG000	Brentuximab Vedotin 1.4 mg/kg: Phase 1	Brentuximab vedotin 1.4 mg/kg, 30-minute IV infusion, Day 1 of every 21-day cycle, until there was evidence of disease progression or unacceptable toxicity.
OG001	Brentuximab Vedotin 1.8 mg/kg: Phase 1	Brentuximab vedotin 1.8 mg/kg, 30-minute IV infusion, Day 1 of every 21-day cycle until there was evidence of disease progression or unacceptable toxicity (Up to 16 cycles). Treatment with brentuximab vedotin beyond 16 cycles was permitted at the joint discretion of the sponsor and the investigator for those participants experiencing continued clinical benefit.

Secondary

Monomethyl Auristatin E (MMAE) Plasma Concentrations (Phase 1 and 2)

Blood samples were collected and tested for MMAE plasma concentrations.

Posted

Mean

Standard Deviation

ng/mL

Cycle 1 and 8 pre-dose and 5 minutes, 24, 48, 96 and 312 hours post-dose; Cycle 2 pre-dose, 5 minutes and 24, 48 and 96 hours post-dose; Cycle 3 to 16 pre-dose and 5 minutes post-dose

ID	Title	Description
OG000	Brentuximab Vedotin 1.4 mg/kg: Phase 1	Brentuximab vedotin 1.4 mg/kg, 30-minute IV infusion, Day 1 of every 21-day cycle, until there was evidence of disease progression or unacceptable toxicity.
OG001	Brentuximab Vedotin 1.8 mg/kg: Phase 1	Brentuximab vedotin 1.8 mg/kg, 30-minute IV infusion, Day 1 of every 21-day cycle until there was evidence of disease progression or unacceptable toxicity (Up to 16 cycles). Treatment with brentuximab vedotin beyond 16 cycles was permitted at the joint discretion of the sponsor and the investigator for those participants experiencing continued clinical benefit.

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Nausea	Gastrointestinal disorders	MedDRA v 19.0	Systematic Assessment	EG0002 affected3 at risk EG0017 affected16 at risk EG0024 affected17 at risk
Vomiting	Gastrointestinal disorders	MedDRA v 19.0	Systematic Assessment	EG0000 affected3 at risk EG0012 affected16 at risk EG0023 affected17 at risk
Abdominal pain upper	Gastrointestinal disorders	MedDRA v 19.0	Systematic Assessment	EG0001 affected3 at risk EG0012 affected16 at risk EG0021 affected17 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA v 19.0	Systematic Assessment	EG0001 affected3 at risk EG0012 affected16 at risk EG0020 affected17 at risk
Gastrointestinal pain	Gastrointestinal disorders	MedDRA v 19.0	Systematic Assessment	EG0000 affected3 at risk EG0011 affected16 at risk EG0020 affected17 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA v 19.0	Systematic Assessment	EG0000 affected3 at risk EG0012 affected16 at risk EG0023 affected17 at risk
Constipation	Gastrointestinal disorders	MedDRA v 19.0	Systematic Assessment	EG0000 affected3 at risk EG0012 affected16 at risk EG0020 affected17 at risk
Gastrooesophageal reflux disease	Gastrointestinal disorders	MedDRA v 19.0	Systematic Assessment	EG0000 affected3 at risk EG0011 affected16 at risk EG0020 affected17 at risk
Gastritis	Gastrointestinal disorders	MedDRA v 19.0	Systematic Assessment	EG0000 affected3 at risk EG0011 affected16 at risk EG0021 affected17 at risk
Toothache	Gastrointestinal disorders	MedDRA v 19.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected16 at risk EG0021 affected17 at risk
Dyspepsia	Gastrointestinal disorders	MedDRA v 19.0	Systematic Assessment	EG0000 affected3 at risk EG0011 affected16 at risk EG0020 affected17 at risk
Gastrointestinal motility disorder	Gastrointestinal disorders	MedDRA v 19.0	Systematic Assessment	EG0000 affected3 at risk EG0011 affected16 at risk EG0020 affected17 at risk
Dysphagia	Gastrointestinal disorders	MedDRA v 19.0	Systematic Assessment	EG0000 affected3 at risk EG0011 affected16 at risk EG0020 affected17 at risk
Odynophagia	Gastrointestinal disorders	MedDRA v 19.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected16 at risk EG0021 affected17 at risk
Pyrexia	General disorders	MedDRA v 19.0	Systematic Assessment	EG0001 affected3 at risk EG0018 affected16 at risk EG0027 affected17 at risk
Fatigue	General disorders	MedDRA v 19.0	Systematic Assessment	EG0000 affected3 at risk EG0012 affected16 at risk EG0021 affected17 at risk
Asthenia	General disorders	MedDRA v 19.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected16 at risk EG0021 affected17 at risk
Feeling hot	General disorders	MedDRA v 19.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected16 at risk EG0021 affected17 at risk
Oedema peripheral	General disorders	MedDRA v 19.0	Systematic Assessment	EG0000 affected3 at risk EG0011 affected16 at risk EG0020 affected17 at risk
Rhinitis	Infections and infestations	MedDRA v 19.0	Systematic Assessment	EG0000 affected3 at risk EG0013 affected16 at risk EG0024 affected17 at risk
Pharyngitis	Infections and infestations	MedDRA v 19.0	Systematic Assessment	EG0000 affected3 at risk EG0013 affected16 at risk EG0023 affected17 at risk
Nasopharyngitis	Infections and infestations	MedDRA v 19.0	Systematic Assessment	EG0000 affected3 at risk EG0011 affected16 at risk EG0021 affected17 at risk
Sinusitis	Infections and infestations	MedDRA v 19.0	Systematic Assessment	EG0000 affected3 at risk EG0011 affected16 at risk EG0020 affected17 at risk
Upper respiratory tract infection	Infections and infestations	MedDRA v 19.0	Systematic Assessment	EG0001 affected3 at risk EG0010 affected16 at risk EG0020 affected17 at risk
Gingivitis	Infections and infestations	MedDRA v 19.0	Systematic Assessment	EG0000 affected3 at risk EG0011 affected16 at risk EG0020 affected17 at risk
Tooth abscess	Infections and infestations	MedDRA v 19.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected16 at risk EG0021 affected17 at risk
Clostridium difficile colitis	Infections and infestations	MedDRA v 19.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected16 at risk EG0021 affected17 at risk
Conjunctivitis	Infections and infestations	MedDRA v 19.0	Systematic Assessment	EG0000 affected3 at risk EG0011 affected16 at risk EG0020 affected17 at risk
Vulvovaginal mycotic infection	Infections and infestations	MedDRA v 19.0	Systematic Assessment	EG0000 affected3 at risk EG0011 affected16 at risk EG0020 affected17 at risk
Herpes zoster	Infections and infestations	MedDRA v 19.0	Systematic Assessment	EG0000 affected3 at risk EG0011 affected16 at risk EG0020 affected17 at risk
Influenza	Infections and infestations	MedDRA v 19.0	Systematic Assessment	EG0000 affected3 at risk EG0011 affected16 at risk EG0020 affected17 at risk
Respiratory syncytial virus infection	Infections and infestations	MedDRA v 19.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected16 at risk EG0021 affected17 at risk
Paronychia	Infections and infestations	MedDRA v 19.0	Systematic Assessment	EG0000 affected3 at risk EG0011 affected16 at risk EG0020 affected17 at risk
Paraesthesia	Nervous system disorders	MedDRA v 19.0	Systematic Assessment	EG0001 affected3 at risk EG0015 affected16 at risk EG0021 affected17 at risk
Peripheral sensory neuropathy	Nervous system disorders	MedDRA v 19.0	Systematic Assessment	EG0000 affected3 at risk EG0012 affected16 at risk EG0022 affected17 at risk
Neuropathy peripheral	Nervous system disorders	MedDRA v 19.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected16 at risk EG0021 affected17 at risk
Peripheral motor neuropathy	Nervous system disorders	MedDRA v 19.0	Systematic Assessment	EG0000 affected3 at risk EG0011 affected16 at risk EG0020 affected17 at risk
Headache	Nervous system disorders	MedDRA v 19.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected16 at risk EG0023 affected17 at risk
Migraine	Nervous system disorders	MedDRA v 19.0	Systematic Assessment	EG0000 affected3 at risk EG0011 affected16 at risk EG0020 affected17 at risk
Dysgeusia	Nervous system disorders	MedDRA v 19.0	Systematic Assessment	EG0001 affected3 at risk EG0010 affected16 at risk EG0020 affected17 at risk
Tremor	Nervous system disorders	MedDRA v 19.0	Systematic Assessment	EG0000 affected3 at risk EG0011 affected16 at risk EG0020 affected17 at risk
Vocal cord paralysis	Nervous system disorders	MedDRA v 19.0	Systematic Assessment	EG0000 affected3 at risk EG0011 affected16 at risk EG0020 affected17 at risk
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA v 19.0	Systematic Assessment	EG0000 affected3 at risk EG0012 affected16 at risk EG0021 affected17 at risk
Musculoskeletal pain	Musculoskeletal and connective tissue disorders	MedDRA v 19.0	Systematic Assessment	EG0000 affected3 at risk EG0012 affected16 at risk EG0020 affected17 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA v 19.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected16 at risk EG0021 affected17 at risk
Neck pain	Musculoskeletal and connective tissue disorders	MedDRA v 19.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected16 at risk EG0021 affected17 at risk
Myalgia	Musculoskeletal and connective tissue disorders	MedDRA v 19.0	Systematic Assessment	EG0000 affected3 at risk EG0014 affected16 at risk EG0020 affected17 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA v 19.0	Systematic Assessment	EG0001 affected3 at risk EG0011 affected16 at risk EG0020 affected17 at risk
Muscle spasms	Musculoskeletal and connective tissue disorders	MedDRA v 19.0	Systematic Assessment	EG0000 affected3 at risk EG0011 affected16 at risk EG0021 affected17 at risk
Groin pain	Musculoskeletal and connective tissue disorders	MedDRA v 19.0	Systematic Assessment	EG0000 affected3 at risk EG0011 affected16 at risk EG0021 affected17 at risk
Rash	Skin and subcutaneous tissue disorders	MedDRA v 19.0	Systematic Assessment	EG0000 affected3 at risk EG0011 affected16 at risk EG0021 affected17 at risk
Rash maculo-papular	Skin and subcutaneous tissue disorders	MedDRA v 19.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected16 at risk EG0022 affected17 at risk
Blister	Skin and subcutaneous tissue disorders	MedDRA v 19.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected16 at risk EG0021 affected17 at risk
Dermatosis	Skin and subcutaneous tissue disorders	MedDRA v 19.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected16 at risk EG0021 affected17 at risk
Dry skin	Skin and subcutaneous tissue disorders	MedDRA v 19.0	Systematic Assessment	EG0000 affected3 at risk EG0011 affected16 at risk EG0020 affected17 at risk
Pruritus	Skin and subcutaneous tissue disorders	MedDRA v 19.0	Systematic Assessment	EG0000 affected3 at risk EG0012 affected16 at risk EG0020 affected17 at risk
Urticaria	Skin and subcutaneous tissue disorders	MedDRA v 19.0	Systematic Assessment	EG0000 affected3 at risk EG0011 affected16 at risk EG0021 affected17 at risk
Alopecia	Skin and subcutaneous tissue disorders	MedDRA v 19.0	Systematic Assessment	EG0000 affected3 at risk EG0011 affected16 at risk EG0020 affected17 at risk
Night sweats	Skin and subcutaneous tissue disorders	MedDRA v 19.0	Systematic Assessment	EG0000 affected3 at risk EG0011 affected16 at risk EG0020 affected17 at risk
Seborrhoeic dermatitis	Skin and subcutaneous tissue disorders	MedDRA v 19.0	Systematic Assessment	EG0000 affected3 at risk EG0011 affected16 at risk EG0020 affected17 at risk
Drug eruption	Skin and subcutaneous tissue disorders	MedDRA v 19.0	Systematic Assessment	EG0001 affected3 at risk EG0010 affected16 at risk EG0020 affected17 at risk
Erythema	Skin and subcutaneous tissue disorders	MedDRA v 19.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected16 at risk EG0021 affected17 at risk
Neutropenia	Blood and lymphatic system disorders	MedDRA v 19.0	Systematic Assessment	EG0000 affected3 at risk EG0014 affected16 at risk EG0021 affected17 at risk
Lymph node pain	Blood and lymphatic system disorders	MedDRA v 19.0	Systematic Assessment	EG0000 affected3 at risk EG0012 affected16 at risk EG0021 affected17 at risk
Lymphadenopathy	Blood and lymphatic system disorders	MedDRA v 19.0	Systematic Assessment	EG0000 affected3 at risk EG0011 affected16 at risk EG0020 affected17 at risk
Anaemia	Blood and lymphatic system disorders	MedDRA v 19.0	Systematic Assessment	EG0000 affected3 at risk EG0012 affected16 at risk EG0020 affected17 at risk
Leukopenia	Blood and lymphatic system disorders	MedDRA v 19.0	Systematic Assessment	EG0000 affected3 at risk EG0012 affected16 at risk EG0020 affected17 at risk
Thrombocytopenia	Blood and lymphatic system disorders	MedDRA v 19.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected16 at risk EG0021 affected17 at risk
Gamma-glutamyltransferase increased	Investigations	MedDRA v 19.0	Systematic Assessment	EG0000 affected3 at risk EG0012 affected16 at risk EG0020 affected17 at risk
Alanine aminotransferase increased	Investigations	MedDRA v 19.0	Systematic Assessment	EG0000 affected3 at risk EG0011 affected16 at risk EG0020 affected17 at risk
Aspartate aminotransferase increased	Investigations	MedDRA v 19.0	Systematic Assessment	EG0000 affected3 at risk EG0011 affected16 at risk EG0020 affected17 at risk
Transaminases increased	Investigations	MedDRA v 19.0	Systematic Assessment	EG0000 affected3 at risk EG0011 affected16 at risk EG0020 affected17 at risk
Lymphocyte count decreased	Investigations	MedDRA v 19.0	Systematic Assessment	EG0001 affected3 at risk EG0010 affected16 at risk EG0022 affected17 at risk
Neutrophil count decreased	Investigations	MedDRA v 19.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected16 at risk EG0022 affected17 at risk
White blood cell count decreased	Investigations	MedDRA v 19.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected16 at risk EG0021 affected17 at risk
Blood bicarbonate decreased	Investigations	MedDRA v 19.0	Systematic Assessment	EG0000 affected3 at risk EG0011 affected16 at risk EG0020 affected17 at risk
Weight decreased	Investigations	MedDRA v 19.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected16 at risk EG0021 affected17 at risk
C-reactive protein increased	Investigations	MedDRA v 19.0	Systematic Assessment	EG0000 affected3 at risk EG0011 affected16 at risk EG0020 affected17 at risk
Blood alkaline phosphatase increased	Investigations	MedDRA v 19.0	Systematic Assessment	EG0000 affected3 at risk EG0011 affected16 at risk EG0020 affected17 at risk
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA v 19.0	Systematic Assessment	EG0000 affected3 at risk EG0013 affected16 at risk EG0021 affected17 at risk
Oropharyngeal pain	Respiratory, thoracic and mediastinal disorders	MedDRA v 19.0	Systematic Assessment	EG0000 affected3 at risk EG0012 affected16 at risk EG0020 affected17 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA v 19.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected16 at risk EG0021 affected17 at risk
Decreased appetite	Metabolism and nutrition disorders	MedDRA v 19.0	Systematic Assessment	EG0000 affected3 at risk EG0013 affected16 at risk EG0020 affected17 at risk
Hypokalaemia	Metabolism and nutrition disorders	MedDRA v 19.0	Systematic Assessment	EG0000 affected3 at risk EG0012 affected16 at risk EG0021 affected17 at risk
Hyperuricaemia	Metabolism and nutrition disorders	MedDRA v 19.0	Systematic Assessment	EG0000 affected3 at risk EG0011 affected16 at risk EG0020 affected17 at risk
Hypophosphataemia	Metabolism and nutrition disorders	MedDRA v 19.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected16 at risk EG0021 affected17 at risk
Hypoalbuminaemia	Metabolism and nutrition disorders	MedDRA v 19.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected16 at risk EG0021 affected17 at risk
Hepatotoxicity	Hepatobiliary disorders	MedDRA v 19.0	Systematic Assessment	EG0000 affected3 at risk EG0012 affected16 at risk EG0020 affected17 at risk
Hypertransaminasaemia	Hepatobiliary disorders	MedDRA v 19.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected16 at risk EG0021 affected17 at risk
Hepatic pain	Hepatobiliary disorders	MedDRA v 19.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected16 at risk EG0021 affected17 at risk
Joint dislocation	Injury, poisoning and procedural complications	MedDRA v 19.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected16 at risk EG0021 affected17 at risk
Muscle strain	Injury, poisoning and procedural complications	MedDRA v 19.0	Systematic Assessment	EG0001 affected3 at risk EG0010 affected16 at risk EG0020 affected17 at risk
Head injury	Injury, poisoning and procedural complications	MedDRA v 19.0	Systematic Assessment	EG0000 affected3 at risk EG0011 affected16 at risk EG0020 affected17 at risk
Facial bones fracture	Injury, poisoning and procedural complications	MedDRA v 19.0	Systematic Assessment	EG0000 affected3 at risk EG0011 affected16 at risk EG0020 affected17 at risk
Angina pectoris	Cardiac disorders	MedDRA v 19.0	Systematic Assessment	EG0000 affected3 at risk EG0011 affected16 at risk EG0020 affected17 at risk
Sinus tachycardia	Cardiac disorders	MedDRA v 19.0	Systematic Assessment	EG0000 affected3 at risk EG0011 affected16 at risk EG0020 affected17 at risk
Insomnia	Psychiatric disorders	MedDRA v 19.0	Systematic Assessment	EG0000 affected3 at risk EG0011 affected16 at risk EG0021 affected17 at risk
Anxiety	Psychiatric disorders	MedDRA v 19.0	Systematic Assessment	EG0000 affected3 at risk EG0011 affected16 at risk EG0020 affected17 at risk
Haematoma	Vascular disorders	MedDRA v 19.0	Systematic Assessment	EG0000 affected3 at risk EG0011 affected16 at risk EG0020 affected17 at risk
Flushing	Vascular disorders	MedDRA v 19.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected16 at risk EG0021 affected17 at risk
Tinnitus	Ear and labyrinth disorders	MedDRA v 19.0	Systematic Assessment	EG0000 affected3 at risk EG0011 affected16 at risk EG0020 affected17 at risk
Eye discharge	Eye disorders	MedDRA v 19.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected16 at risk EG0021 affected17 at risk
Cancer pain	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA v 19.0	Systematic Assessment	EG0001 affected3 at risk EG0010 affected16 at risk EG0020 affected17 at risk
Pollakiuria	Renal and urinary disorders	MedDRA v 19.0	Systematic Assessment	EG0000 affected3 at risk EG0011 affected16 at risk EG0020 affected17 at risk
Urinary tract pain	Renal and urinary disorders	MedDRA v 19.0	Systematic Assessment	EG0000 affected3 at risk EG0011 affected16 at risk EG0020 affected17 at risk
Menstruation irregular	Reproductive system and breast disorders	MedDRA v 19.0	Systematic Assessment	EG0000 affected3 at risk EG0011 affected16 at risk EG0020 affected17 at risk
Erythema multiforme	Skin and subcutaneous tissue disorders	MedDRA v 19.0	Systematic Assessment	EG0000 affected3 at risk EG0011 affected16 at risk EG0020 affected17 at risk

Facility	Status	City	State	ZIP	Country	Contacts
		Aurora	Colorado		United States

ID	Term
D012008	Recurrence
D006689	Hodgkin Disease
D017728	Lymphoma, Large-Cell, Anaplastic
D008223	Lymphoma

ID	Term
D020969	Disease Attributes
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms
D009370	Neoplasms by Histologic Type
D009369	Neoplasms
D008232	Lymphoproliferative Disorders
D008206	Lymphatic Diseases
D006425	Hemic and Lymphatic Diseases
D007160	Immunoproliferative Disorders
D007154	Immune System Diseases
D016399	Lymphoma, T-Cell
D008228	Lymphoma, Non-Hodgkin

ID	Term
D009842	Oligopeptides
D010455	Peptides
D000602	Amino Acids, Peptides, and Proteins
D061067	Antibodies, Monoclonal, Humanized
D000911	Antibodies, Monoclonal
D000906	Antibodies
D007136	Immunoglobulins
D007162	Immunoproteins
D001798	Blood Proteins
D011506	Proteins
D012712	Serum Globulins
D005916	Globulins

ID	Title	Description
BG000	Brentuximab Vedotin 1.4 mg/kg: Phase 1	Brentuximab vedotin 1.4 mg/kg, 30-minute IV infusion, Day 1 of every 21-day cycle, until there was evidence of disease progression or unacceptable toxicity.
BG001	Brentuximab Vedotin 1.8 mg/kg: Phase 1 and 2 r/r HL Only	Participants with r/r HL received brentuximab vedotin 1.8 mg/kg, 30-minute IV infusion, Day 1 of every 21-day cycle until there was evidence of disease progression or unacceptable toxicity (Up to 16 cycles). Treatment with brentuximab vedotin beyond 16 cycles was permitted at the joint discretion of the sponsor and the investigator for those participants experiencing continued clinical benefit.
BG002	Brentuximab Vedotin 1.8 mg/kg: Phase 1 and 2 r/r sALCL Only	Participants with r/r systemic anaplastic large-cell lymphoma (sALCL) received brentuximab vedotin 1.8 mg/kg, 30-minute IV infusion, Day 1 of every 21-day cycle until there was evidence of disease progression or unacceptable toxicity (Up to 16 cycles). Treatment with brentuximab vedotin beyond 16 cycles was permitted at the joint discretion of the sponsor and the investigator for those participants experiencing continued clinical benefit.
BG003	Total	Total of all reporting groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Brentuximab Vedotin 1.4 mg/kg: Phase 1	Brentuximab vedotin 1.4 mg/kg, 30-minute IV infusion, Day 1 of every 21-day cycle, until there was evidence of disease progression or unacceptable toxicity.	1	3	0	3	3	3
EG001	Brentuximab Vedotin 1.8 mg/kg: Phase 1 and 2 r/r HL Only	Participants with r/r HL received brentuximab vedotin 1.8 mg/kg, 30-minute IV infusion, Day 1 of every 21-day cycle until there was evidence of disease progression or unacceptable toxicity (Up to 16 cycles). Treatment with brentuximab vedotin beyond 16 cycles was permitted at the joint discretion of the sponsor and the investigator for those participants experiencing continued clinical benefit.	6	16	7	16	16	16
EG002	Brentuximab Vedotin 1.8 mg/kg: Phase 1 and 2 r/r sALCL Only	Participants with r/r systemic anaplastic large-cell lymphoma (sALCL) received brentuximab vedotin 1.8 mg/kg, 30-minute IV infusion, Day 1 of every 21-day cycle until there was evidence of disease progression or unacceptable toxicity (Up to 16 cycles). Treatment with brentuximab vedotin beyond 16 cycles was permitted at the joint discretion of the sponsor and the investigator for those participants experiencing continued clinical benefit.	2	17	1	17	17	17