Trial Outcomes & Findings for Brentuximab Vedotin + Rituximab as Frontline Therapy for Pts w/ CD30+ and/or EBV+ Lymphomas (NCT NCT01805037)

Last Updated: 2021-09-01

Results Overview

To identify the recommended phase 2 dose (RP2D)/maximum tolerated dose (MTD) of brentuximab vedotin in combination with rituximab. The dose limiting toxicity monitoring period for brentuximab vedotin and rituximab is first 21 days (during induction).The RP2D/MTD will be defined as the highest dose of brentuximab vedotin that causes dose limiting toxicities (DLTs) in \<2 of 6 patients. The Phase I portion of the study follows a 3+3 design. Brentuximab has two dose levels: Level 1 (starting dose) 1.2 mg/kg IV, and Level -1 (de-escalation dose): 0.8 mg/kg IV. Toxicity will be assessed using the National Cancer Institute (NCI) Common Toxicity Criteria for Adverse Events (CTCAE), version 4.03.

Recruitment status

TERMINATED

Study phase

PHASE1/PHASE2

Target enrollment

20 participants

Primary outcome timeframe

The first 21 days of Induction

Results posted on

2021-09-01

Participant Flow

The study opened for accrual on March 4th, 2013 with goal of up to 33 patients. The 1st patient started treatment in Phase 1 on March 5th, 2013. 6 patients were accrued in Phase 1. March 26th, 2014 the study opened to Phase II, 14 patients were accrued. October 29th, 2018 the study closed due to lack of funding.

Participant milestones

Participant milestones
Measure	Brentuximab Vedotin Dose Level -1 (0.8 mg/kg) Treatment: Induction: * Brentuximab vedotin 0.8 mg/kg IV infusion over 30 minutes, weekly x 3 (1 cycle = 4 weeks ) * Rituximab 375 mg/m2 IV infusion per standard protocol, once weekly for 4 weeks (1 cycle = 4 weeks) Consolidation (optional): Identical to Induction. Maintenance: Brentuximab vedotin 1.8 mg/kg IV infusion over 30 minutes once every 3 weeks (1 cycle = 3 weeks), for a total of one year from the first induction dose or until progression of disease. Rituximab 375 mg/m2 IV infusion per standard protocol, once every 6 weeks for a total of one year from the first induction dose or until progression of disease.	Brentuximb Vedotin Dose Level 1 (1.2 mg/kg) Induction: * Brentuximab vedotin 1.2 mg/kg IV infusion over 30 minutes, weekly x 3 (1 cycle = 4 weeks * Rituximab 375 mg/m2 IV infusion per standard protocol, once weekly for 4 weeks (1 cycle = 4 weeks) Consolidation (optional): Identical to Induction. Maintenance: * Brentuximab vedotin 1.8 mg/kg IV infusion over 30 minutes once every 3 weeks (1 cycle = 3 weeks), for a total of one year from the first induction dose or until progression of disease. * Rituximab 375 mg/m2 IV infusion per standard protocol, once every 6 weeks for a total of one year from the first induction dose or until progression of disease.
Induction (4 Weeks) STARTED	0	20
Induction (4 Weeks) Received Dose of Study Drug	0	20
Induction (4 Weeks) COMPLETED	0	20
Induction (4 Weeks) NOT COMPLETED	0	0
Consolidation (Optional, 4 Weeks) STARTED	0	6
Consolidation (Optional, 4 Weeks) Received Dose of Study Drug	0	6
Consolidation (Optional, 4 Weeks) COMPLETED	0	6
Consolidation (Optional, 4 Weeks) NOT COMPLETED	0	0
1st Cycle of Maintenance (3 Weeks) STARTED	0	20
1st Cycle of Maintenance (3 Weeks) Received Dose of Study Drug	0	14
1st Cycle of Maintenance (3 Weeks) COMPLETED	0	14
1st Cycle of Maintenance (3 Weeks) NOT COMPLETED	0	6
2nd Cycle of Maintenance and Beyond STARTED	0	14
2nd Cycle of Maintenance and Beyond Received Dose of Study Drug	0	14
2nd Cycle of Maintenance and Beyond COMPLETED	0	2
2nd Cycle of Maintenance and Beyond NOT COMPLETED	0	12
Follow Up (up to 3 Years) STARTED	0	20
Follow Up (up to 3 Years) COMPLETED	0	14
Follow Up (up to 3 Years) NOT COMPLETED	0	6

Reasons for withdrawal

Reasons for withdrawal
Measure	Brentuximab Vedotin Dose Level -1 (0.8 mg/kg) Treatment: Induction: * Brentuximab vedotin 0.8 mg/kg IV infusion over 30 minutes, weekly x 3 (1 cycle = 4 weeks ) * Rituximab 375 mg/m2 IV infusion per standard protocol, once weekly for 4 weeks (1 cycle = 4 weeks) Consolidation (optional): Identical to Induction. Maintenance: Brentuximab vedotin 1.8 mg/kg IV infusion over 30 minutes once every 3 weeks (1 cycle = 3 weeks), for a total of one year from the first induction dose or until progression of disease. Rituximab 375 mg/m2 IV infusion per standard protocol, once every 6 weeks for a total of one year from the first induction dose or until progression of disease.	Brentuximb Vedotin Dose Level 1 (1.2 mg/kg) Induction: * Brentuximab vedotin 1.2 mg/kg IV infusion over 30 minutes, weekly x 3 (1 cycle = 4 weeks * Rituximab 375 mg/m2 IV infusion per standard protocol, once weekly for 4 weeks (1 cycle = 4 weeks) Consolidation (optional): Identical to Induction. Maintenance: * Brentuximab vedotin 1.8 mg/kg IV infusion over 30 minutes once every 3 weeks (1 cycle = 3 weeks), for a total of one year from the first induction dose or until progression of disease. * Rituximab 375 mg/m2 IV infusion per standard protocol, once every 6 weeks for a total of one year from the first induction dose or until progression of disease.
1st Cycle of Maintenance (3 Weeks) Lack of Efficacy	0	2
1st Cycle of Maintenance (3 Weeks) Withdrawal by Subject	0	2
1st Cycle of Maintenance (3 Weeks) Adverse Event	0	1
1st Cycle of Maintenance (3 Weeks) Death	0	1
2nd Cycle of Maintenance and Beyond Adverse Event	0	10
2nd Cycle of Maintenance and Beyond Progressive Disease	0	1
2nd Cycle of Maintenance and Beyond Withdrawal by Subject	0	1
Follow Up (up to 3 Years) Death	0	2
Follow Up (up to 3 Years) Withdrawal by Subject	0	3
Follow Up (up to 3 Years) Lost to Follow-up	0	1

Baseline Characteristics

Brentuximab Vedotin + Rituximab as Frontline Therapy for Pts w/ CD30+ and/or EBV+ Lymphomas

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Brentuximb Vedotin Dose Level 1 (1.2 mg/kg) n=20 Participants Induction: * Brentuximab vedotin 1.2 mg/kg IV infusion over 30 minutes, weekly x 3 (1 cycle = 4 weeks * Rituximab 375 mg/m2 IV infusion per standard protocol, once weekly for 4 weeks (1 cycle = 4 weeks) Consolidation (optional): Identical to Induction. Maintenance: * Brentuximab vedotin 1.8 mg/kg IV infusion over 30 minutes once every 3 weeks (1 cycle = 3 weeks), for a total of one year from the first induction dose or until progression of disease. * Rituximab 375 mg/m2 IV infusion per standard protocol, once every 6 weeks for a total of one year from the first induction dose or until progression of disease.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	9 Participants n=5 Participants
Age, Categorical >=65 years	11 Participants n=5 Participants
Sex: Female, Male Female	8 Participants n=5 Participants
Sex: Female, Male Male	12 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	3 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	17 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	2 Participants n=5 Participants
Race (NIH/OMB) White	16 Participants n=5 Participants
Race (NIH/OMB) More than one race	1 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	20 participants n=5 Participants

PRIMARY outcome

Timeframe: The first 21 days of Induction

Outcome measures

Outcome measures
Measure	Brentuximb Vedotin Dose Level 1 (1.2 mg/kg) n=6 Participants Induction: * Brentuximab vedotin 1.2 mg/kg IV infusion over 30 minutes, weekly x 3 (1 cycle = 4 weeks * Rituximab 375 mg/m2 IV infusion per standard protocol, once weekly for 4 weeks (1 cycle = 4 weeks) Consolidation (optional): Identical to Induction. Maintenance: * Brentuximab vedotin 1.8 mg/kg IV infusion over 30 minutes once every 3 weeks (1 cycle = 3 weeks), for a total of one year from the first induction dose or until progression of disease. * Rituximab 375 mg/m2 IV infusion per standard protocol, once every 6 weeks for a total of one year from the first induction dose or until progression of disease.
For Phase I: The Recommended Phase 2 Dose of Brentuximab Vedotin in Combination With Rituximab.	1.2 mg/kg

PRIMARY outcome

Timeframe: The first 21 days of induction

Population: Six patients in Phase 1 received dose level 1 of brentuximab vedotin (1.2 mg/kg IV).

Dose limiting toxicities (DLT) will be monitored for Phase 1 patients for the first 21 days of Induction (the DLT monitoring period) to evaluate safety. In general, a non-hematologic DLT is defined as any Grade ≥ 3 toxicity, and a hematologic DLT is defined as any Grade ≥ 4 toxicity, both by CTCAE v4.03 criteria.

Outcome measures

Outcome measures
Measure	Brentuximb Vedotin Dose Level 1 (1.2 mg/kg) n=6 Participants Induction: * Brentuximab vedotin 1.2 mg/kg IV infusion over 30 minutes, weekly x 3 (1 cycle = 4 weeks * Rituximab 375 mg/m2 IV infusion per standard protocol, once weekly for 4 weeks (1 cycle = 4 weeks) Consolidation (optional): Identical to Induction. Maintenance: * Brentuximab vedotin 1.8 mg/kg IV infusion over 30 minutes once every 3 weeks (1 cycle = 3 weeks), for a total of one year from the first induction dose or until progression of disease. * Rituximab 375 mg/m2 IV infusion per standard protocol, once every 6 weeks for a total of one year from the first induction dose or until progression of disease.
Phase 1: Number of Dose Limiting Toxicities of Brentuximab Vedotin and Rituximab in Patients With Immunosuppressed Lymphoid Malignancies.	1 Grade 3 hyponatremia

PRIMARY outcome

Timeframe: Every 12 weeks for up to 1 year on treatment (Range of cycles attempted from induction, +/- consolidation, + maintenance = 1-17 cycles) Induction = 4 weeks, consolidation = 4 weeks, 1 maintenance cycle = 3 weeks

Overall response will be defined as the detection of Partial Response (PR) or Complete Response (CR) by CT or PET/CT, and/or resolution of marrow-only involvement. Response will be assessed according to the Revised Response Criteria for Malignant Lymphoma (Cheson, et al). CR is defined as a complete disappearance of all detectable clinical evidence of disease and disease-related symptoms, if present before therapy. A post-treatment residual mass of any size is permitted as long as it is PET negative. If a pretreatment PET scan was negative, all lymph nodes and nodal masses must have regressed on CT to normal size. A PR is defined as At least a 50% decrease in sum of the product of the diameters of up to six of the largest dominant nodes or nodal masses. No increase should be observed in the size of other nodes, liver, or spleen.

Outcome measures

Outcome measures
Measure	Brentuximb Vedotin Dose Level 1 (1.2 mg/kg) n=20 Participants Induction: * Brentuximab vedotin 1.2 mg/kg IV infusion over 30 minutes, weekly x 3 (1 cycle = 4 weeks * Rituximab 375 mg/m2 IV infusion per standard protocol, once weekly for 4 weeks (1 cycle = 4 weeks) Consolidation (optional): Identical to Induction. Maintenance: * Brentuximab vedotin 1.8 mg/kg IV infusion over 30 minutes once every 3 weeks (1 cycle = 3 weeks), for a total of one year from the first induction dose or until progression of disease. * Rituximab 375 mg/m2 IV infusion per standard protocol, once every 6 weeks for a total of one year from the first induction dose or until progression of disease.
Phase II: Percent of Participants With an Overall Response	75 percent of participants Interval 51.0 to 91.0

SECONDARY outcome

Timeframe: From time of treatment to 30 days post discontinuation (range of cycles attempted from induction +/- consolidation, & maintenance = 1-17 cycles) About 1 year Induction = 4 weeks, consolidation = 4 weeks, 1 maintenance cycle = 3 weeks

Toxicity, both frequency and severity, will continue to be measured by monitoring the occurrence of adverse events. Adverse events will be defined as those included in CTCAE v 4.03. AEs that were determined to be at least possibly related to study drug and graded 3, 4, 5 are included here. Grade 1 (mild): the event causes discomfort without disruption of normal daily activities. Grade 2 (moderate): the event causes discomfort that affects normal daily activities. Grade 3 (severe): the event makes the patient unable to perform normal daily activities or significantly affects his/her clinical status. Grade 4 (Life-threatening): the patient was at risk of death at the time of the event. Grade 5 (fatal): the event caused death.

Outcome measures

Outcome measures
Measure	Brentuximb Vedotin Dose Level 1 (1.2 mg/kg) n=20 Participants Induction: * Brentuximab vedotin 1.2 mg/kg IV infusion over 30 minutes, weekly x 3 (1 cycle = 4 weeks * Rituximab 375 mg/m2 IV infusion per standard protocol, once weekly for 4 weeks (1 cycle = 4 weeks) Consolidation (optional): Identical to Induction. Maintenance: * Brentuximab vedotin 1.8 mg/kg IV infusion over 30 minutes once every 3 weeks (1 cycle = 3 weeks), for a total of one year from the first induction dose or until progression of disease. * Rituximab 375 mg/m2 IV infusion per standard protocol, once every 6 weeks for a total of one year from the first induction dose or until progression of disease.
Number of Participants With Adverse Events Possibly Related to Study Drug Graded 3, 4, and 5 Grade 3 Diarrhea	1 Participants
Number of Participants With Adverse Events Possibly Related to Study Drug Graded 3, 4, and 5 Grade 4 Hyperbilirubinemia	1 Participants
Number of Participants With Adverse Events Possibly Related to Study Drug Graded 3, 4, and 5 Grade 3 AST elevation	2 Participants
Number of Participants With Adverse Events Possibly Related to Study Drug Graded 3, 4, and 5 Grade 4 Lipase elevation	2 Participants
Number of Participants With Adverse Events Possibly Related to Study Drug Graded 3, 4, and 5 Grade 3 Amylase elevation	1 Participants
Number of Participants With Adverse Events Possibly Related to Study Drug Graded 3, 4, and 5 Grade 4 Amylase elevation	1 Participants
Number of Participants With Adverse Events Possibly Related to Study Drug Graded 3, 4, and 5 Grade 4 Typhlitis	1 Participants
Number of Participants With Adverse Events Possibly Related to Study Drug Graded 3, 4, and 5 Grade 3 Anemia	2 Participants
Number of Participants With Adverse Events Possibly Related to Study Drug Graded 3, 4, and 5 Grade 3 Febrile Neutropenia	1 Participants
Number of Participants With Adverse Events Possibly Related to Study Drug Graded 3, 4, and 5 Grade 3 Lymphopenia	7 Participants
Number of Participants With Adverse Events Possibly Related to Study Drug Graded 3, 4, and 5 Grade 4 Lymphopenia	2 Participants
Number of Participants With Adverse Events Possibly Related to Study Drug Graded 3, 4, and 5 Grade 4 Neutropenia	1 Participants
Number of Participants With Adverse Events Possibly Related to Study Drug Graded 3, 4, and 5 Grade 3 Neutropenia	7 Participants
Number of Participants With Adverse Events Possibly Related to Study Drug Graded 3, 4, and 5 Grade 3 Elevated creatinine	1 Participants
Number of Participants With Adverse Events Possibly Related to Study Drug Graded 3, 4, and 5 Grade 3 Acute kidney injury	2 Participants
Number of Participants With Adverse Events Possibly Related to Study Drug Graded 3, 4, and 5 Grade 3 Hypophosphatemia	1 Participants
Number of Participants With Adverse Events Possibly Related to Study Drug Graded 3, 4, and 5 Grade 3 Peripheral neuropathy	2 Participants

SECONDARY outcome

Timeframe: start of treatment to time of progression (up to 2 years after treatment discontinuation)

Population: One patient was excluded from the analysis because they were lost to follow-up.

Study treatment efficacy will be evaluated using PET or CT scan images to determine Progression Free Survival (PFS). PFS is defined as the duration of time from start of treatment to time of progression. Response criteria will be those specified by Cheson, et al as the Revised Response Criteria for Malignant Lymphoma. Progressive Disease (PD) is defined as the appearance of any new lesion more than 1.5 cm in any axis during or at the end of therapy, even if other lesions are decreasing in size, or at least a 50% increase from nadir in the diameter of any previously involved nodes, or in a single involved node, or the size of other lesions. All patients who have had at least one dose of study treatment will be evaluable for PFS with censoring of patients who are lost to follow-up. PFS will be reported as percentage of participants without progression.

Outcome measures

Outcome measures
Measure	Brentuximb Vedotin Dose Level 1 (1.2 mg/kg) n=19 Participants Induction: * Brentuximab vedotin 1.2 mg/kg IV infusion over 30 minutes, weekly x 3 (1 cycle = 4 weeks * Rituximab 375 mg/m2 IV infusion per standard protocol, once weekly for 4 weeks (1 cycle = 4 weeks) Consolidation (optional): Identical to Induction. Maintenance: * Brentuximab vedotin 1.8 mg/kg IV infusion over 30 minutes once every 3 weeks (1 cycle = 3 weeks), for a total of one year from the first induction dose or until progression of disease. * Rituximab 375 mg/m2 IV infusion per standard protocol, once every 6 weeks for a total of one year from the first induction dose or until progression of disease.
Percentage of Participants Without Progression (Progression Free Survival (PFS))	75 percentage of participants Interval 52.0 to 96.0

SECONDARY outcome

Timeframe: From start of treatment to 2 years post treatment discontinuation

Population: One patient was censored from overall survival because they were lost to follow-up.

Overall survival (OS) will be measured from treatment initiation until death from any cause for up to 1 year post-treatment discontinuation. Overall survival is defined as the duration of time from start of treatment to time of death. All patients who have had at least one dose of study treatment will be evaluable for OS. OS will be reported as percentage of participants alive at 2 years post treatment discontinuation, with censoring of patients who are lost to follow-up.

Outcome measures

Outcome measures
Measure	Brentuximb Vedotin Dose Level 1 (1.2 mg/kg) n=19 Participants Induction: * Brentuximab vedotin 1.2 mg/kg IV infusion over 30 minutes, weekly x 3 (1 cycle = 4 weeks * Rituximab 375 mg/m2 IV infusion per standard protocol, once weekly for 4 weeks (1 cycle = 4 weeks) Consolidation (optional): Identical to Induction. Maintenance: * Brentuximab vedotin 1.8 mg/kg IV infusion over 30 minutes once every 3 weeks (1 cycle = 3 weeks), for a total of one year from the first induction dose or until progression of disease. * Rituximab 375 mg/m2 IV infusion per standard protocol, once every 6 weeks for a total of one year from the first induction dose or until progression of disease.
Percentage of Participants Alive at 2 Years (Overall Survival)	90 percent of participants Interval 77.0 to 100.0

SECONDARY outcome

The best overall response (BOR) is the best response recorded from the start of the treatment until disease progression/recurrence. Best response assessed by CT or PET/CT according to the Revised Response Criteria for Malignant Lymphoma (Cheson et. al). Responses include Complete Response (CR), Partial Response (PR), and Stable Disease (SD). CR: Complete disappearance of all detectable clinical evidence of disease and disease-related symptoms, if present before therapy. If a pretreatment PET scan was negative, all lymph nodes and nodal masses must have regressed on CT to normal size. PR: At least a 50% decrease in sum of the product of the diameters of up to six of the largest dominant nodes or nodal masses. No increase should be observed in the size of other nodes, liver, or spleen. SD: neither CR or PR, or progressive disease (PD). PD: Appearance of new lesion \> 1.5 cm in any axis, or at least a 50% increase from nadir in the diameter of any previously involved nodes.

Outcome measures

Outcome measures
Measure	Brentuximb Vedotin Dose Level 1 (1.2 mg/kg) n=20 Participants Induction: * Brentuximab vedotin 1.2 mg/kg IV infusion over 30 minutes, weekly x 3 (1 cycle = 4 weeks * Rituximab 375 mg/m2 IV infusion per standard protocol, once weekly for 4 weeks (1 cycle = 4 weeks) Consolidation (optional): Identical to Induction. Maintenance: * Brentuximab vedotin 1.8 mg/kg IV infusion over 30 minutes once every 3 weeks (1 cycle = 3 weeks), for a total of one year from the first induction dose or until progression of disease. * Rituximab 375 mg/m2 IV infusion per standard protocol, once every 6 weeks for a total of one year from the first induction dose or until progression of disease.
Number of Participants With Best Overall Response (BOR) Complete Response	12 participants
Number of Participants With Best Overall Response (BOR) Partial Response	3 participants
Number of Participants With Best Overall Response (BOR) Stable Disease	3 participants

SECONDARY outcome

Timeframe: Time from start of study treatment to last dose of study drug (Range of cycles attempted from induction, +/- consolidation, + maintenance = 1-17 cycles, up to 1 year) Induction = 4 weeks, consolidation = 4 weeks, 1 maintenance cycle = 3 weeks

Population: 1 patient was not evaluable. They withdrew consent before data could be collected.

EBV activation will be evaluated in all patients who receive at least one dose of study treatment and have an evaluable tissue microarray (TMA) collected at baseline. EBV activation and proliferation will be measured by viral loads from blood collections as measured at time of enrollment and monthly thereafter in all enrolled patients, until completion of study therapy. Epstein Barr Virus (EBV) quantitative PCR is used to an aid in monitoring EBV-related disease. Lab thresholds vary at sites however, labs results are considered either "negative" or "abnormal". Number of participants who experienced EBV activation, i.e an abnormal lab result (YES) and patients who did not experience EBV activation, i.e. a negative lab result (NO) will be reported.

Outcome measures

Outcome measures
Measure	Brentuximb Vedotin Dose Level 1 (1.2 mg/kg) n=19 Participants Induction: * Brentuximab vedotin 1.2 mg/kg IV infusion over 30 minutes, weekly x 3 (1 cycle = 4 weeks * Rituximab 375 mg/m2 IV infusion per standard protocol, once weekly for 4 weeks (1 cycle = 4 weeks) Consolidation (optional): Identical to Induction. Maintenance: * Brentuximab vedotin 1.8 mg/kg IV infusion over 30 minutes once every 3 weeks (1 cycle = 3 weeks), for a total of one year from the first induction dose or until progression of disease. * Rituximab 375 mg/m2 IV infusion per standard protocol, once every 6 weeks for a total of one year from the first induction dose or until progression of disease.
Number of Participants With Epstein Barr Virus (EBV) Activation and Number of Participants Without EBV Activation EBV Activation: YES	1 participants
Number of Participants With Epstein Barr Virus (EBV) Activation and Number of Participants Without EBV Activation EBV Activation: NO	18 participants

SECONDARY outcome

Timeframe: Up to 3 years from treatment discontinuation

Population: Follow-up data for time to initiation of cytotoxic chemotherapy was collected for only 5 patients. That data is reported below.

Time to initiation of cytotoxic chemotherapy will be defined as the time elapsed between study treatment initiation, and time of first non-targeted cytotoxic chemotherapy (off study treatment). Time to cytotoxic chemotherapy will be evaluated in all patients who receive at least one dose of study treatment.

Outcome measures

Outcome measures
Measure	Brentuximb Vedotin Dose Level 1 (1.2 mg/kg) n=5 Participants Induction: * Brentuximab vedotin 1.2 mg/kg IV infusion over 30 minutes, weekly x 3 (1 cycle = 4 weeks * Rituximab 375 mg/m2 IV infusion per standard protocol, once weekly for 4 weeks (1 cycle = 4 weeks) Consolidation (optional): Identical to Induction. Maintenance: * Brentuximab vedotin 1.8 mg/kg IV infusion over 30 minutes once every 3 weeks (1 cycle = 3 weeks), for a total of one year from the first induction dose or until progression of disease. * Rituximab 375 mg/m2 IV infusion per standard protocol, once every 6 weeks for a total of one year from the first induction dose or until progression of disease.
Time to Initiation of Cytotoxic Chemotherapy Patient 5	66 number of days
Time to Initiation of Cytotoxic Chemotherapy Patient 1	35 number of days
Time to Initiation of Cytotoxic Chemotherapy Patient 2	147 number of days
Time to Initiation of Cytotoxic Chemotherapy Patient 3	38 number of days
Time to Initiation of Cytotoxic Chemotherapy Patient 4	184 number of days

SECONDARY outcome

Timeframe: From start of treatment to 3 years post treatment discontinuation

Population: 1 patient was not evaluable. They withdrew consent before data could be collected.

Graft rejection will be defined as any of the following: documentation of new or progressive rejection by tissue biopsy of the graft; re-transplantation due to graft rejection; clinical diagnosis of new or progressive graft rejection, since start of treatment on protocol, as given by the patient's transplant physician. Escalation of intensity of immunosuppression will not, by itself, be considered evidence of graft rejection. Note: patients with clinically active graft rejection will not be excluded from trial enrollment, but will not be considered to have treatment emergent graft rejection unless progression of rejection is documented. Rates of graft rejection will be evaluated in all patients who receive at least one dose of study treatment.

Outcome measures

Outcome measures
Measure	Brentuximb Vedotin Dose Level 1 (1.2 mg/kg) n=19 Participants Induction: * Brentuximab vedotin 1.2 mg/kg IV infusion over 30 minutes, weekly x 3 (1 cycle = 4 weeks * Rituximab 375 mg/m2 IV infusion per standard protocol, once weekly for 4 weeks (1 cycle = 4 weeks) Consolidation (optional): Identical to Induction. Maintenance: * Brentuximab vedotin 1.8 mg/kg IV infusion over 30 minutes once every 3 weeks (1 cycle = 3 weeks), for a total of one year from the first induction dose or until progression of disease. * Rituximab 375 mg/m2 IV infusion per standard protocol, once every 6 weeks for a total of one year from the first induction dose or until progression of disease.
Number of Participants With Graft Rejection vs Without Graft Rejection Graft Rejection: YES	1 participants
Number of Participants With Graft Rejection vs Without Graft Rejection Graft Rejection: NO	18 participants

POST_HOC outcome

Timeframe: From start of treatment, every 12 weeks for up to 1 year on treatment (Range of cycles attempted from induction, +/- consolidation, + maintenance = 1-17 cycles) Induction = 4 weeks, consolidation = 4 weeks, 1 maintenance cycle = 3 weeks

Time to best response = the number of days from treatment initiation to best response (complete response/CR or partial response/PR). Best response assessed by CT or PET/CT according to the Revised Response Criteria for Malignant Lymphoma (Cheson et. al). Responses include Complete Response (CR), Partial Response (PR), and Stable Disease (SD). CR: Complete disappearance of all detectable clinical evidence of disease and disease-related symptoms, if present before therapy. If a pretreatment PET scan was negative, all lymph nodes and nodal masses must have regressed on CT to normal size. PR: At least a 50% decrease in sum of the product of the diameters of up to six of the largest dominant nodes or nodal masses. No increase should be observed in the size of other nodes, liver, or spleen. SD: neither CR or PR, or progressive disease (PD). PD: Appearance of new lesion \> 1.5 cm in any axis, or at least a 50% increase from nadir in the diameter of any previously involved nodes.

Outcome measures

Outcome measures
Measure	Brentuximb Vedotin Dose Level 1 (1.2 mg/kg) n=20 Participants Induction: * Brentuximab vedotin 1.2 mg/kg IV infusion over 30 minutes, weekly x 3 (1 cycle = 4 weeks * Rituximab 375 mg/m2 IV infusion per standard protocol, once weekly for 4 weeks (1 cycle = 4 weeks) Consolidation (optional): Identical to Induction. Maintenance: * Brentuximab vedotin 1.8 mg/kg IV infusion over 30 minutes once every 3 weeks (1 cycle = 3 weeks), for a total of one year from the first induction dose or until progression of disease. * Rituximab 375 mg/m2 IV infusion per standard protocol, once every 6 weeks for a total of one year from the first induction dose or until progression of disease.
Median Time to Best Response	28 number of days Interval 23.0 to 151.0

Adverse Events

Brentuximb Vedotin Dose Level 1 (1.2 mg/kg)

Serious events: 14 serious events

Other events: 20 other events

Deaths: 2 deaths

Serious adverse events

Serious adverse events
Measure	Brentuximb Vedotin Dose Level 1 (1.2 mg/kg) n=20 participants at risk Induction: * Brentuximab vedotin 1.2 mg/kg IV infusion over 30 minutes, weekly x 3 (1 cycle = 4 weeks * Rituximab 375 mg/m2 IV infusion per standard protocol, once weekly for 4 weeks (1 cycle = 4 weeks) Consolidation (optional): Identical to Induction. Maintenance: * Brentuximab vedotin 1.8 mg/kg IV infusion over 30 minutes once every 3 weeks (1 cycle = 3 weeks), for a total of one year from the first induction dose or until progression of disease. * Rituximab 375 mg/m2 IV infusion per standard protocol, once every 6 weeks for a total of one year from the first induction dose or until progression of disease.
Blood and lymphatic system disorders Febrile neutropenia	5.0% 1/20 • Adverse Events (AEs) were collected over a 5 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment. Induction = 28 days, consolidation (optional) = 28 days, 1 maintenance cycle = 21 days, with treatment lasting up to 1 year from induction. The range of cycles attempted was 1-17 (including induction +/- consolidation, and maintenance). Brentuximab vedotin dose level -1 (dose de-escalation level) never opened. All 20 patients received dose level 1 (1.2 mg/kg) of brentuximab vedotin.
Infections and infestations Lung Infection	10.0% 2/20 • Adverse Events (AEs) were collected over a 5 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment. Induction = 28 days, consolidation (optional) = 28 days, 1 maintenance cycle = 21 days, with treatment lasting up to 1 year from induction. The range of cycles attempted was 1-17 (including induction +/- consolidation, and maintenance). Brentuximab vedotin dose level -1 (dose de-escalation level) never opened. All 20 patients received dose level 1 (1.2 mg/kg) of brentuximab vedotin.
Investigations Neutrophil count decreased	5.0% 1/20 • Adverse Events (AEs) were collected over a 5 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment. Induction = 28 days, consolidation (optional) = 28 days, 1 maintenance cycle = 21 days, with treatment lasting up to 1 year from induction. The range of cycles attempted was 1-17 (including induction +/- consolidation, and maintenance). Brentuximab vedotin dose level -1 (dose de-escalation level) never opened. All 20 patients received dose level 1 (1.2 mg/kg) of brentuximab vedotin.
Renal and urinary disorders Acute kidney injury	10.0% 2/20 • Adverse Events (AEs) were collected over a 5 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment. Induction = 28 days, consolidation (optional) = 28 days, 1 maintenance cycle = 21 days, with treatment lasting up to 1 year from induction. The range of cycles attempted was 1-17 (including induction +/- consolidation, and maintenance). Brentuximab vedotin dose level -1 (dose de-escalation level) never opened. All 20 patients received dose level 1 (1.2 mg/kg) of brentuximab vedotin.
Gastrointestinal disorders Abdominal pain	5.0% 1/20 • Adverse Events (AEs) were collected over a 5 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment. Induction = 28 days, consolidation (optional) = 28 days, 1 maintenance cycle = 21 days, with treatment lasting up to 1 year from induction. The range of cycles attempted was 1-17 (including induction +/- consolidation, and maintenance). Brentuximab vedotin dose level -1 (dose de-escalation level) never opened. All 20 patients received dose level 1 (1.2 mg/kg) of brentuximab vedotin.
Psychiatric disorders Confusion	5.0% 1/20 • Adverse Events (AEs) were collected over a 5 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment. Induction = 28 days, consolidation (optional) = 28 days, 1 maintenance cycle = 21 days, with treatment lasting up to 1 year from induction. The range of cycles attempted was 1-17 (including induction +/- consolidation, and maintenance). Brentuximab vedotin dose level -1 (dose de-escalation level) never opened. All 20 patients received dose level 1 (1.2 mg/kg) of brentuximab vedotin.
Infections and infestations Sepsis	10.0% 2/20 • Adverse Events (AEs) were collected over a 5 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment. Induction = 28 days, consolidation (optional) = 28 days, 1 maintenance cycle = 21 days, with treatment lasting up to 1 year from induction. The range of cycles attempted was 1-17 (including induction +/- consolidation, and maintenance). Brentuximab vedotin dose level -1 (dose de-escalation level) never opened. All 20 patients received dose level 1 (1.2 mg/kg) of brentuximab vedotin.
Metabolism and nutrition disorders Dehydration	5.0% 1/20 • Adverse Events (AEs) were collected over a 5 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment. Induction = 28 days, consolidation (optional) = 28 days, 1 maintenance cycle = 21 days, with treatment lasting up to 1 year from induction. The range of cycles attempted was 1-17 (including induction +/- consolidation, and maintenance). Brentuximab vedotin dose level -1 (dose de-escalation level) never opened. All 20 patients received dose level 1 (1.2 mg/kg) of brentuximab vedotin.
Infections and infestations Urinary tract infection	5.0% 1/20 • Adverse Events (AEs) were collected over a 5 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment. Induction = 28 days, consolidation (optional) = 28 days, 1 maintenance cycle = 21 days, with treatment lasting up to 1 year from induction. The range of cycles attempted was 1-17 (including induction +/- consolidation, and maintenance). Brentuximab vedotin dose level -1 (dose de-escalation level) never opened. All 20 patients received dose level 1 (1.2 mg/kg) of brentuximab vedotin.
General disorders Fatigue	5.0% 1/20 • Adverse Events (AEs) were collected over a 5 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment. Induction = 28 days, consolidation (optional) = 28 days, 1 maintenance cycle = 21 days, with treatment lasting up to 1 year from induction. The range of cycles attempted was 1-17 (including induction +/- consolidation, and maintenance). Brentuximab vedotin dose level -1 (dose de-escalation level) never opened. All 20 patients received dose level 1 (1.2 mg/kg) of brentuximab vedotin.
Respiratory, thoracic and mediastinal disorders Pneumonitis	5.0% 1/20 • Adverse Events (AEs) were collected over a 5 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment. Induction = 28 days, consolidation (optional) = 28 days, 1 maintenance cycle = 21 days, with treatment lasting up to 1 year from induction. The range of cycles attempted was 1-17 (including induction +/- consolidation, and maintenance). Brentuximab vedotin dose level -1 (dose de-escalation level) never opened. All 20 patients received dose level 1 (1.2 mg/kg) of brentuximab vedotin.
Gastrointestinal disorders Vomiting	5.0% 1/20 • Adverse Events (AEs) were collected over a 5 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment. Induction = 28 days, consolidation (optional) = 28 days, 1 maintenance cycle = 21 days, with treatment lasting up to 1 year from induction. The range of cycles attempted was 1-17 (including induction +/- consolidation, and maintenance). Brentuximab vedotin dose level -1 (dose de-escalation level) never opened. All 20 patients received dose level 1 (1.2 mg/kg) of brentuximab vedotin.
Gastrointestinal disorders Diarrhea	5.0% 1/20 • Adverse Events (AEs) were collected over a 5 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment. Induction = 28 days, consolidation (optional) = 28 days, 1 maintenance cycle = 21 days, with treatment lasting up to 1 year from induction. The range of cycles attempted was 1-17 (including induction +/- consolidation, and maintenance). Brentuximab vedotin dose level -1 (dose de-escalation level) never opened. All 20 patients received dose level 1 (1.2 mg/kg) of brentuximab vedotin.
Gastrointestinal disorders Typhlitis	5.0% 1/20 • Adverse Events (AEs) were collected over a 5 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment. Induction = 28 days, consolidation (optional) = 28 days, 1 maintenance cycle = 21 days, with treatment lasting up to 1 year from induction. The range of cycles attempted was 1-17 (including induction +/- consolidation, and maintenance). Brentuximab vedotin dose level -1 (dose de-escalation level) never opened. All 20 patients received dose level 1 (1.2 mg/kg) of brentuximab vedotin.

Other adverse events

Other adverse events
Measure	Brentuximb Vedotin Dose Level 1 (1.2 mg/kg) n=20 participants at risk Induction: * Brentuximab vedotin 1.2 mg/kg IV infusion over 30 minutes, weekly x 3 (1 cycle = 4 weeks * Rituximab 375 mg/m2 IV infusion per standard protocol, once weekly for 4 weeks (1 cycle = 4 weeks) Consolidation (optional): Identical to Induction. Maintenance: * Brentuximab vedotin 1.8 mg/kg IV infusion over 30 minutes once every 3 weeks (1 cycle = 3 weeks), for a total of one year from the first induction dose or until progression of disease. * Rituximab 375 mg/m2 IV infusion per standard protocol, once every 6 weeks for a total of one year from the first induction dose or until progression of disease.
Blood and lymphatic system disorders Anemia	85.0% 17/20 • Adverse Events (AEs) were collected over a 5 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment. Induction = 28 days, consolidation (optional) = 28 days, 1 maintenance cycle = 21 days, with treatment lasting up to 1 year from induction. The range of cycles attempted was 1-17 (including induction +/- consolidation, and maintenance). Brentuximab vedotin dose level -1 (dose de-escalation level) never opened. All 20 patients received dose level 1 (1.2 mg/kg) of brentuximab vedotin.
Blood and lymphatic system disorders Febrile neutropenia	5.0% 1/20 • Adverse Events (AEs) were collected over a 5 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment. Induction = 28 days, consolidation (optional) = 28 days, 1 maintenance cycle = 21 days, with treatment lasting up to 1 year from induction. The range of cycles attempted was 1-17 (including induction +/- consolidation, and maintenance). Brentuximab vedotin dose level -1 (dose de-escalation level) never opened. All 20 patients received dose level 1 (1.2 mg/kg) of brentuximab vedotin.
Cardiac disorders Atrial flutter	5.0% 1/20 • Adverse Events (AEs) were collected over a 5 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment. Induction = 28 days, consolidation (optional) = 28 days, 1 maintenance cycle = 21 days, with treatment lasting up to 1 year from induction. The range of cycles attempted was 1-17 (including induction +/- consolidation, and maintenance). Brentuximab vedotin dose level -1 (dose de-escalation level) never opened. All 20 patients received dose level 1 (1.2 mg/kg) of brentuximab vedotin.
Cardiac disorders Heart murmur	5.0% 1/20 • Adverse Events (AEs) were collected over a 5 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment. Induction = 28 days, consolidation (optional) = 28 days, 1 maintenance cycle = 21 days, with treatment lasting up to 1 year from induction. The range of cycles attempted was 1-17 (including induction +/- consolidation, and maintenance). Brentuximab vedotin dose level -1 (dose de-escalation level) never opened. All 20 patients received dose level 1 (1.2 mg/kg) of brentuximab vedotin.
Cardiac disorders Chest pain - cardiac	5.0% 1/20 • Adverse Events (AEs) were collected over a 5 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment. Induction = 28 days, consolidation (optional) = 28 days, 1 maintenance cycle = 21 days, with treatment lasting up to 1 year from induction. The range of cycles attempted was 1-17 (including induction +/- consolidation, and maintenance). Brentuximab vedotin dose level -1 (dose de-escalation level) never opened. All 20 patients received dose level 1 (1.2 mg/kg) of brentuximab vedotin.
Cardiac disorders Palpitations	5.0% 1/20 • Adverse Events (AEs) were collected over a 5 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment. Induction = 28 days, consolidation (optional) = 28 days, 1 maintenance cycle = 21 days, with treatment lasting up to 1 year from induction. The range of cycles attempted was 1-17 (including induction +/- consolidation, and maintenance). Brentuximab vedotin dose level -1 (dose de-escalation level) never opened. All 20 patients received dose level 1 (1.2 mg/kg) of brentuximab vedotin.
Cardiac disorders Pericarditis	5.0% 1/20 • Adverse Events (AEs) were collected over a 5 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment. Induction = 28 days, consolidation (optional) = 28 days, 1 maintenance cycle = 21 days, with treatment lasting up to 1 year from induction. The range of cycles attempted was 1-17 (including induction +/- consolidation, and maintenance). Brentuximab vedotin dose level -1 (dose de-escalation level) never opened. All 20 patients received dose level 1 (1.2 mg/kg) of brentuximab vedotin.
Cardiac disorders Sinus tachycardia	20.0% 4/20 • Adverse Events (AEs) were collected over a 5 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment. Induction = 28 days, consolidation (optional) = 28 days, 1 maintenance cycle = 21 days, with treatment lasting up to 1 year from induction. The range of cycles attempted was 1-17 (including induction +/- consolidation, and maintenance). Brentuximab vedotin dose level -1 (dose de-escalation level) never opened. All 20 patients received dose level 1 (1.2 mg/kg) of brentuximab vedotin.
Cardiac disorders Ventricular arrhythmia	5.0% 1/20 • Adverse Events (AEs) were collected over a 5 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment. Induction = 28 days, consolidation (optional) = 28 days, 1 maintenance cycle = 21 days, with treatment lasting up to 1 year from induction. The range of cycles attempted was 1-17 (including induction +/- consolidation, and maintenance). Brentuximab vedotin dose level -1 (dose de-escalation level) never opened. All 20 patients received dose level 1 (1.2 mg/kg) of brentuximab vedotin.
Eye disorders Blurred vision	5.0% 1/20 • Adverse Events (AEs) were collected over a 5 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment. Induction = 28 days, consolidation (optional) = 28 days, 1 maintenance cycle = 21 days, with treatment lasting up to 1 year from induction. The range of cycles attempted was 1-17 (including induction +/- consolidation, and maintenance). Brentuximab vedotin dose level -1 (dose de-escalation level) never opened. All 20 patients received dose level 1 (1.2 mg/kg) of brentuximab vedotin.
Eye disorders Cataract	5.0% 1/20 • Adverse Events (AEs) were collected over a 5 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment. Induction = 28 days, consolidation (optional) = 28 days, 1 maintenance cycle = 21 days, with treatment lasting up to 1 year from induction. The range of cycles attempted was 1-17 (including induction +/- consolidation, and maintenance). Brentuximab vedotin dose level -1 (dose de-escalation level) never opened. All 20 patients received dose level 1 (1.2 mg/kg) of brentuximab vedotin.
Eye disorders Eye pain	5.0% 1/20 • Adverse Events (AEs) were collected over a 5 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment. Induction = 28 days, consolidation (optional) = 28 days, 1 maintenance cycle = 21 days, with treatment lasting up to 1 year from induction. The range of cycles attempted was 1-17 (including induction +/- consolidation, and maintenance). Brentuximab vedotin dose level -1 (dose de-escalation level) never opened. All 20 patients received dose level 1 (1.2 mg/kg) of brentuximab vedotin.
Eye disorders Floaters	5.0% 1/20 • Adverse Events (AEs) were collected over a 5 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment. Induction = 28 days, consolidation (optional) = 28 days, 1 maintenance cycle = 21 days, with treatment lasting up to 1 year from induction. The range of cycles attempted was 1-17 (including induction +/- consolidation, and maintenance). Brentuximab vedotin dose level -1 (dose de-escalation level) never opened. All 20 patients received dose level 1 (1.2 mg/kg) of brentuximab vedotin.
Gastrointestinal disorders Abdominal distension	5.0% 1/20 • Adverse Events (AEs) were collected over a 5 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment. Induction = 28 days, consolidation (optional) = 28 days, 1 maintenance cycle = 21 days, with treatment lasting up to 1 year from induction. The range of cycles attempted was 1-17 (including induction +/- consolidation, and maintenance). Brentuximab vedotin dose level -1 (dose de-escalation level) never opened. All 20 patients received dose level 1 (1.2 mg/kg) of brentuximab vedotin.
Gastrointestinal disorders Abdominal pain	45.0% 9/20 • Adverse Events (AEs) were collected over a 5 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment. Induction = 28 days, consolidation (optional) = 28 days, 1 maintenance cycle = 21 days, with treatment lasting up to 1 year from induction. The range of cycles attempted was 1-17 (including induction +/- consolidation, and maintenance). Brentuximab vedotin dose level -1 (dose de-escalation level) never opened. All 20 patients received dose level 1 (1.2 mg/kg) of brentuximab vedotin.
Gastrointestinal disorders Ascites	5.0% 1/20 • Adverse Events (AEs) were collected over a 5 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment. Induction = 28 days, consolidation (optional) = 28 days, 1 maintenance cycle = 21 days, with treatment lasting up to 1 year from induction. The range of cycles attempted was 1-17 (including induction +/- consolidation, and maintenance). Brentuximab vedotin dose level -1 (dose de-escalation level) never opened. All 20 patients received dose level 1 (1.2 mg/kg) of brentuximab vedotin.
Gastrointestinal disorders Bloating	10.0% 2/20 • Adverse Events (AEs) were collected over a 5 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment. Induction = 28 days, consolidation (optional) = 28 days, 1 maintenance cycle = 21 days, with treatment lasting up to 1 year from induction. The range of cycles attempted was 1-17 (including induction +/- consolidation, and maintenance). Brentuximab vedotin dose level -1 (dose de-escalation level) never opened. All 20 patients received dose level 1 (1.2 mg/kg) of brentuximab vedotin.
Gastrointestinal disorders Colitis	5.0% 1/20 • Adverse Events (AEs) were collected over a 5 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment. Induction = 28 days, consolidation (optional) = 28 days, 1 maintenance cycle = 21 days, with treatment lasting up to 1 year from induction. The range of cycles attempted was 1-17 (including induction +/- consolidation, and maintenance). Brentuximab vedotin dose level -1 (dose de-escalation level) never opened. All 20 patients received dose level 1 (1.2 mg/kg) of brentuximab vedotin.
Gastrointestinal disorders Constipation	40.0% 8/20 • Adverse Events (AEs) were collected over a 5 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment. Induction = 28 days, consolidation (optional) = 28 days, 1 maintenance cycle = 21 days, with treatment lasting up to 1 year from induction. The range of cycles attempted was 1-17 (including induction +/- consolidation, and maintenance). Brentuximab vedotin dose level -1 (dose de-escalation level) never opened. All 20 patients received dose level 1 (1.2 mg/kg) of brentuximab vedotin.
Gastrointestinal disorders Diarrhea	50.0% 10/20 • Adverse Events (AEs) were collected over a 5 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment. Induction = 28 days, consolidation (optional) = 28 days, 1 maintenance cycle = 21 days, with treatment lasting up to 1 year from induction. The range of cycles attempted was 1-17 (including induction +/- consolidation, and maintenance). Brentuximab vedotin dose level -1 (dose de-escalation level) never opened. All 20 patients received dose level 1 (1.2 mg/kg) of brentuximab vedotin.
Gastrointestinal disorders Dyspepsia	5.0% 1/20 • Adverse Events (AEs) were collected over a 5 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment. Induction = 28 days, consolidation (optional) = 28 days, 1 maintenance cycle = 21 days, with treatment lasting up to 1 year from induction. The range of cycles attempted was 1-17 (including induction +/- consolidation, and maintenance). Brentuximab vedotin dose level -1 (dose de-escalation level) never opened. All 20 patients received dose level 1 (1.2 mg/kg) of brentuximab vedotin.
Gastrointestinal disorders Dysphagia	15.0% 3/20 • Adverse Events (AEs) were collected over a 5 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment. Induction = 28 days, consolidation (optional) = 28 days, 1 maintenance cycle = 21 days, with treatment lasting up to 1 year from induction. The range of cycles attempted was 1-17 (including induction +/- consolidation, and maintenance). Brentuximab vedotin dose level -1 (dose de-escalation level) never opened. All 20 patients received dose level 1 (1.2 mg/kg) of brentuximab vedotin.
Gastrointestinal disorders Enterocolitis	5.0% 1/20 • Adverse Events (AEs) were collected over a 5 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment. Induction = 28 days, consolidation (optional) = 28 days, 1 maintenance cycle = 21 days, with treatment lasting up to 1 year from induction. The range of cycles attempted was 1-17 (including induction +/- consolidation, and maintenance). Brentuximab vedotin dose level -1 (dose de-escalation level) never opened. All 20 patients received dose level 1 (1.2 mg/kg) of brentuximab vedotin.
Gastrointestinal disorders Flatulence	15.0% 3/20 • Adverse Events (AEs) were collected over a 5 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment. Induction = 28 days, consolidation (optional) = 28 days, 1 maintenance cycle = 21 days, with treatment lasting up to 1 year from induction. The range of cycles attempted was 1-17 (including induction +/- consolidation, and maintenance). Brentuximab vedotin dose level -1 (dose de-escalation level) never opened. All 20 patients received dose level 1 (1.2 mg/kg) of brentuximab vedotin.
Gastrointestinal disorders Gastroesophageal reflux disease	10.0% 2/20 • Adverse Events (AEs) were collected over a 5 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment. Induction = 28 days, consolidation (optional) = 28 days, 1 maintenance cycle = 21 days, with treatment lasting up to 1 year from induction. The range of cycles attempted was 1-17 (including induction +/- consolidation, and maintenance). Brentuximab vedotin dose level -1 (dose de-escalation level) never opened. All 20 patients received dose level 1 (1.2 mg/kg) of brentuximab vedotin.
Gastrointestinal disorders Abnormal satiety	5.0% 1/20 • Adverse Events (AEs) were collected over a 5 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment. Induction = 28 days, consolidation (optional) = 28 days, 1 maintenance cycle = 21 days, with treatment lasting up to 1 year from induction. The range of cycles attempted was 1-17 (including induction +/- consolidation, and maintenance). Brentuximab vedotin dose level -1 (dose de-escalation level) never opened. All 20 patients received dose level 1 (1.2 mg/kg) of brentuximab vedotin.
Gastrointestinal disorders Hemorrhoids	5.0% 1/20 • Adverse Events (AEs) were collected over a 5 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment. Induction = 28 days, consolidation (optional) = 28 days, 1 maintenance cycle = 21 days, with treatment lasting up to 1 year from induction. The range of cycles attempted was 1-17 (including induction +/- consolidation, and maintenance). Brentuximab vedotin dose level -1 (dose de-escalation level) never opened. All 20 patients received dose level 1 (1.2 mg/kg) of brentuximab vedotin.
Gastrointestinal disorders Mucositis oral	10.0% 2/20 • Adverse Events (AEs) were collected over a 5 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment. Induction = 28 days, consolidation (optional) = 28 days, 1 maintenance cycle = 21 days, with treatment lasting up to 1 year from induction. The range of cycles attempted was 1-17 (including induction +/- consolidation, and maintenance). Brentuximab vedotin dose level -1 (dose de-escalation level) never opened. All 20 patients received dose level 1 (1.2 mg/kg) of brentuximab vedotin.
Gastrointestinal disorders Nausea	45.0% 9/20 • Adverse Events (AEs) were collected over a 5 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment. Induction = 28 days, consolidation (optional) = 28 days, 1 maintenance cycle = 21 days, with treatment lasting up to 1 year from induction. The range of cycles attempted was 1-17 (including induction +/- consolidation, and maintenance). Brentuximab vedotin dose level -1 (dose de-escalation level) never opened. All 20 patients received dose level 1 (1.2 mg/kg) of brentuximab vedotin.
Gastrointestinal disorders Oral pain	5.0% 1/20 • Adverse Events (AEs) were collected over a 5 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment. Induction = 28 days, consolidation (optional) = 28 days, 1 maintenance cycle = 21 days, with treatment lasting up to 1 year from induction. The range of cycles attempted was 1-17 (including induction +/- consolidation, and maintenance). Brentuximab vedotin dose level -1 (dose de-escalation level) never opened. All 20 patients received dose level 1 (1.2 mg/kg) of brentuximab vedotin.
Gastrointestinal disorders Typhlitis	5.0% 1/20 • Adverse Events (AEs) were collected over a 5 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment. Induction = 28 days, consolidation (optional) = 28 days, 1 maintenance cycle = 21 days, with treatment lasting up to 1 year from induction. The range of cycles attempted was 1-17 (including induction +/- consolidation, and maintenance). Brentuximab vedotin dose level -1 (dose de-escalation level) never opened. All 20 patients received dose level 1 (1.2 mg/kg) of brentuximab vedotin.
Gastrointestinal disorders Vomiting	40.0% 8/20 • Adverse Events (AEs) were collected over a 5 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment. Induction = 28 days, consolidation (optional) = 28 days, 1 maintenance cycle = 21 days, with treatment lasting up to 1 year from induction. The range of cycles attempted was 1-17 (including induction +/- consolidation, and maintenance). Brentuximab vedotin dose level -1 (dose de-escalation level) never opened. All 20 patients received dose level 1 (1.2 mg/kg) of brentuximab vedotin.
General disorders Chills	10.0% 2/20 • Adverse Events (AEs) were collected over a 5 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment. Induction = 28 days, consolidation (optional) = 28 days, 1 maintenance cycle = 21 days, with treatment lasting up to 1 year from induction. The range of cycles attempted was 1-17 (including induction +/- consolidation, and maintenance). Brentuximab vedotin dose level -1 (dose de-escalation level) never opened. All 20 patients received dose level 1 (1.2 mg/kg) of brentuximab vedotin.
General disorders Edema face	5.0% 1/20 • Adverse Events (AEs) were collected over a 5 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment. Induction = 28 days, consolidation (optional) = 28 days, 1 maintenance cycle = 21 days, with treatment lasting up to 1 year from induction. The range of cycles attempted was 1-17 (including induction +/- consolidation, and maintenance). Brentuximab vedotin dose level -1 (dose de-escalation level) never opened. All 20 patients received dose level 1 (1.2 mg/kg) of brentuximab vedotin.
General disorders Edema limbs	35.0% 7/20 • Adverse Events (AEs) were collected over a 5 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment. Induction = 28 days, consolidation (optional) = 28 days, 1 maintenance cycle = 21 days, with treatment lasting up to 1 year from induction. The range of cycles attempted was 1-17 (including induction +/- consolidation, and maintenance). Brentuximab vedotin dose level -1 (dose de-escalation level) never opened. All 20 patients received dose level 1 (1.2 mg/kg) of brentuximab vedotin.
General disorders Fatigue	50.0% 10/20 • Adverse Events (AEs) were collected over a 5 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment. Induction = 28 days, consolidation (optional) = 28 days, 1 maintenance cycle = 21 days, with treatment lasting up to 1 year from induction. The range of cycles attempted was 1-17 (including induction +/- consolidation, and maintenance). Brentuximab vedotin dose level -1 (dose de-escalation level) never opened. All 20 patients received dose level 1 (1.2 mg/kg) of brentuximab vedotin.
General disorders Fever	30.0% 6/20 • Adverse Events (AEs) were collected over a 5 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment. Induction = 28 days, consolidation (optional) = 28 days, 1 maintenance cycle = 21 days, with treatment lasting up to 1 year from induction. The range of cycles attempted was 1-17 (including induction +/- consolidation, and maintenance). Brentuximab vedotin dose level -1 (dose de-escalation level) never opened. All 20 patients received dose level 1 (1.2 mg/kg) of brentuximab vedotin.
General disorders Night sweats	10.0% 2/20 • Adverse Events (AEs) were collected over a 5 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment. Induction = 28 days, consolidation (optional) = 28 days, 1 maintenance cycle = 21 days, with treatment lasting up to 1 year from induction. The range of cycles attempted was 1-17 (including induction +/- consolidation, and maintenance). Brentuximab vedotin dose level -1 (dose de-escalation level) never opened. All 20 patients received dose level 1 (1.2 mg/kg) of brentuximab vedotin.
General disorders Infusion related reaction	10.0% 2/20 • Adverse Events (AEs) were collected over a 5 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment. Induction = 28 days, consolidation (optional) = 28 days, 1 maintenance cycle = 21 days, with treatment lasting up to 1 year from induction. The range of cycles attempted was 1-17 (including induction +/- consolidation, and maintenance). Brentuximab vedotin dose level -1 (dose de-escalation level) never opened. All 20 patients received dose level 1 (1.2 mg/kg) of brentuximab vedotin.
General disorders Injection site reaction	5.0% 1/20 • Adverse Events (AEs) were collected over a 5 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment. Induction = 28 days, consolidation (optional) = 28 days, 1 maintenance cycle = 21 days, with treatment lasting up to 1 year from induction. The range of cycles attempted was 1-17 (including induction +/- consolidation, and maintenance). Brentuximab vedotin dose level -1 (dose de-escalation level) never opened. All 20 patients received dose level 1 (1.2 mg/kg) of brentuximab vedotin.
General disorders Irritability	5.0% 1/20 • Adverse Events (AEs) were collected over a 5 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment. Induction = 28 days, consolidation (optional) = 28 days, 1 maintenance cycle = 21 days, with treatment lasting up to 1 year from induction. The range of cycles attempted was 1-17 (including induction +/- consolidation, and maintenance). Brentuximab vedotin dose level -1 (dose de-escalation level) never opened. All 20 patients received dose level 1 (1.2 mg/kg) of brentuximab vedotin.
General disorders Malaise	15.0% 3/20 • Adverse Events (AEs) were collected over a 5 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment. Induction = 28 days, consolidation (optional) = 28 days, 1 maintenance cycle = 21 days, with treatment lasting up to 1 year from induction. The range of cycles attempted was 1-17 (including induction +/- consolidation, and maintenance). Brentuximab vedotin dose level -1 (dose de-escalation level) never opened. All 20 patients received dose level 1 (1.2 mg/kg) of brentuximab vedotin.
General disorders Non-cardiac chest pain	15.0% 3/20 • Adverse Events (AEs) were collected over a 5 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment. Induction = 28 days, consolidation (optional) = 28 days, 1 maintenance cycle = 21 days, with treatment lasting up to 1 year from induction. The range of cycles attempted was 1-17 (including induction +/- consolidation, and maintenance). Brentuximab vedotin dose level -1 (dose de-escalation level) never opened. All 20 patients received dose level 1 (1.2 mg/kg) of brentuximab vedotin.
General disorders Pain	35.0% 7/20 • Adverse Events (AEs) were collected over a 5 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment. Induction = 28 days, consolidation (optional) = 28 days, 1 maintenance cycle = 21 days, with treatment lasting up to 1 year from induction. The range of cycles attempted was 1-17 (including induction +/- consolidation, and maintenance). Brentuximab vedotin dose level -1 (dose de-escalation level) never opened. All 20 patients received dose level 1 (1.2 mg/kg) of brentuximab vedotin.
Hepatobiliary disorders Cholecystitis	5.0% 1/20 • Adverse Events (AEs) were collected over a 5 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment. Induction = 28 days, consolidation (optional) = 28 days, 1 maintenance cycle = 21 days, with treatment lasting up to 1 year from induction. The range of cycles attempted was 1-17 (including induction +/- consolidation, and maintenance). Brentuximab vedotin dose level -1 (dose de-escalation level) never opened. All 20 patients received dose level 1 (1.2 mg/kg) of brentuximab vedotin.
Immune system disorders Allergic reaction	5.0% 1/20 • Adverse Events (AEs) were collected over a 5 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment. Induction = 28 days, consolidation (optional) = 28 days, 1 maintenance cycle = 21 days, with treatment lasting up to 1 year from induction. The range of cycles attempted was 1-17 (including induction +/- consolidation, and maintenance). Brentuximab vedotin dose level -1 (dose de-escalation level) never opened. All 20 patients received dose level 1 (1.2 mg/kg) of brentuximab vedotin.
Immune system disorders Systemic inflammatory response syndrome	5.0% 1/20 • Adverse Events (AEs) were collected over a 5 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment. Induction = 28 days, consolidation (optional) = 28 days, 1 maintenance cycle = 21 days, with treatment lasting up to 1 year from induction. The range of cycles attempted was 1-17 (including induction +/- consolidation, and maintenance). Brentuximab vedotin dose level -1 (dose de-escalation level) never opened. All 20 patients received dose level 1 (1.2 mg/kg) of brentuximab vedotin.
Infections and infestations Bronchial infection	5.0% 1/20 • Adverse Events (AEs) were collected over a 5 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment. Induction = 28 days, consolidation (optional) = 28 days, 1 maintenance cycle = 21 days, with treatment lasting up to 1 year from induction. The range of cycles attempted was 1-17 (including induction +/- consolidation, and maintenance). Brentuximab vedotin dose level -1 (dose de-escalation level) never opened. All 20 patients received dose level 1 (1.2 mg/kg) of brentuximab vedotin.
Infections and infestations Lung Infection	5.0% 1/20 • Adverse Events (AEs) were collected over a 5 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment. Induction = 28 days, consolidation (optional) = 28 days, 1 maintenance cycle = 21 days, with treatment lasting up to 1 year from induction. The range of cycles attempted was 1-17 (including induction +/- consolidation, and maintenance). Brentuximab vedotin dose level -1 (dose de-escalation level) never opened. All 20 patients received dose level 1 (1.2 mg/kg) of brentuximab vedotin.
Infections and infestations Sepsis	20.0% 4/20 • Adverse Events (AEs) were collected over a 5 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment. Induction = 28 days, consolidation (optional) = 28 days, 1 maintenance cycle = 21 days, with treatment lasting up to 1 year from induction. The range of cycles attempted was 1-17 (including induction +/- consolidation, and maintenance). Brentuximab vedotin dose level -1 (dose de-escalation level) never opened. All 20 patients received dose level 1 (1.2 mg/kg) of brentuximab vedotin.
Infections and infestations Sinusitis	10.0% 2/20 • Adverse Events (AEs) were collected over a 5 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment. Induction = 28 days, consolidation (optional) = 28 days, 1 maintenance cycle = 21 days, with treatment lasting up to 1 year from induction. The range of cycles attempted was 1-17 (including induction +/- consolidation, and maintenance). Brentuximab vedotin dose level -1 (dose de-escalation level) never opened. All 20 patients received dose level 1 (1.2 mg/kg) of brentuximab vedotin.
Infections and infestations Upper respiratory infection	15.0% 3/20 • Adverse Events (AEs) were collected over a 5 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment. Induction = 28 days, consolidation (optional) = 28 days, 1 maintenance cycle = 21 days, with treatment lasting up to 1 year from induction. The range of cycles attempted was 1-17 (including induction +/- consolidation, and maintenance). Brentuximab vedotin dose level -1 (dose de-escalation level) never opened. All 20 patients received dose level 1 (1.2 mg/kg) of brentuximab vedotin.
Infections and infestations Urinary tract infection	15.0% 3/20 • Adverse Events (AEs) were collected over a 5 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment. Induction = 28 days, consolidation (optional) = 28 days, 1 maintenance cycle = 21 days, with treatment lasting up to 1 year from induction. The range of cycles attempted was 1-17 (including induction +/- consolidation, and maintenance). Brentuximab vedotin dose level -1 (dose de-escalation level) never opened. All 20 patients received dose level 1 (1.2 mg/kg) of brentuximab vedotin.
Injury, poisoning and procedural complications Swollen ankle	5.0% 1/20 • Adverse Events (AEs) were collected over a 5 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment. Induction = 28 days, consolidation (optional) = 28 days, 1 maintenance cycle = 21 days, with treatment lasting up to 1 year from induction. The range of cycles attempted was 1-17 (including induction +/- consolidation, and maintenance). Brentuximab vedotin dose level -1 (dose de-escalation level) never opened. All 20 patients received dose level 1 (1.2 mg/kg) of brentuximab vedotin.
Investigations Alanine aminotransferase increased	40.0% 8/20 • Adverse Events (AEs) were collected over a 5 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment. Induction = 28 days, consolidation (optional) = 28 days, 1 maintenance cycle = 21 days, with treatment lasting up to 1 year from induction. The range of cycles attempted was 1-17 (including induction +/- consolidation, and maintenance). Brentuximab vedotin dose level -1 (dose de-escalation level) never opened. All 20 patients received dose level 1 (1.2 mg/kg) of brentuximab vedotin.
Investigations Alkaline phosphatase increased	45.0% 9/20 • Adverse Events (AEs) were collected over a 5 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment. Induction = 28 days, consolidation (optional) = 28 days, 1 maintenance cycle = 21 days, with treatment lasting up to 1 year from induction. The range of cycles attempted was 1-17 (including induction +/- consolidation, and maintenance). Brentuximab vedotin dose level -1 (dose de-escalation level) never opened. All 20 patients received dose level 1 (1.2 mg/kg) of brentuximab vedotin.
Investigations Aspartate aminotransferase increased	55.0% 11/20 • Adverse Events (AEs) were collected over a 5 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment. Induction = 28 days, consolidation (optional) = 28 days, 1 maintenance cycle = 21 days, with treatment lasting up to 1 year from induction. The range of cycles attempted was 1-17 (including induction +/- consolidation, and maintenance). Brentuximab vedotin dose level -1 (dose de-escalation level) never opened. All 20 patients received dose level 1 (1.2 mg/kg) of brentuximab vedotin.
Investigations Blood bilirubin increased	25.0% 5/20 • Adverse Events (AEs) were collected over a 5 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment. Induction = 28 days, consolidation (optional) = 28 days, 1 maintenance cycle = 21 days, with treatment lasting up to 1 year from induction. The range of cycles attempted was 1-17 (including induction +/- consolidation, and maintenance). Brentuximab vedotin dose level -1 (dose de-escalation level) never opened. All 20 patients received dose level 1 (1.2 mg/kg) of brentuximab vedotin.
Investigations Creatinine increased	55.0% 11/20 • Adverse Events (AEs) were collected over a 5 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment. Induction = 28 days, consolidation (optional) = 28 days, 1 maintenance cycle = 21 days, with treatment lasting up to 1 year from induction. The range of cycles attempted was 1-17 (including induction +/- consolidation, and maintenance). Brentuximab vedotin dose level -1 (dose de-escalation level) never opened. All 20 patients received dose level 1 (1.2 mg/kg) of brentuximab vedotin.
Investigations INR increased	15.0% 3/20 • Adverse Events (AEs) were collected over a 5 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment. Induction = 28 days, consolidation (optional) = 28 days, 1 maintenance cycle = 21 days, with treatment lasting up to 1 year from induction. The range of cycles attempted was 1-17 (including induction +/- consolidation, and maintenance). Brentuximab vedotin dose level -1 (dose de-escalation level) never opened. All 20 patients received dose level 1 (1.2 mg/kg) of brentuximab vedotin.
Investigations Lipase increased	10.0% 2/20 • Adverse Events (AEs) were collected over a 5 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment. Induction = 28 days, consolidation (optional) = 28 days, 1 maintenance cycle = 21 days, with treatment lasting up to 1 year from induction. The range of cycles attempted was 1-17 (including induction +/- consolidation, and maintenance). Brentuximab vedotin dose level -1 (dose de-escalation level) never opened. All 20 patients received dose level 1 (1.2 mg/kg) of brentuximab vedotin.
Investigations Lymphocyte count decreased	90.0% 18/20 • Adverse Events (AEs) were collected over a 5 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment. Induction = 28 days, consolidation (optional) = 28 days, 1 maintenance cycle = 21 days, with treatment lasting up to 1 year from induction. The range of cycles attempted was 1-17 (including induction +/- consolidation, and maintenance). Brentuximab vedotin dose level -1 (dose de-escalation level) never opened. All 20 patients received dose level 1 (1.2 mg/kg) of brentuximab vedotin.
Investigations Neutrophil count decreased	50.0% 10/20 • Adverse Events (AEs) were collected over a 5 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment. Induction = 28 days, consolidation (optional) = 28 days, 1 maintenance cycle = 21 days, with treatment lasting up to 1 year from induction. The range of cycles attempted was 1-17 (including induction +/- consolidation, and maintenance). Brentuximab vedotin dose level -1 (dose de-escalation level) never opened. All 20 patients received dose level 1 (1.2 mg/kg) of brentuximab vedotin.
Investigations Platelet count decreased	40.0% 8/20 • Adverse Events (AEs) were collected over a 5 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment. Induction = 28 days, consolidation (optional) = 28 days, 1 maintenance cycle = 21 days, with treatment lasting up to 1 year from induction. The range of cycles attempted was 1-17 (including induction +/- consolidation, and maintenance). Brentuximab vedotin dose level -1 (dose de-escalation level) never opened. All 20 patients received dose level 1 (1.2 mg/kg) of brentuximab vedotin.
Investigations Serum amylase increased	20.0% 4/20 • Adverse Events (AEs) were collected over a 5 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment. Induction = 28 days, consolidation (optional) = 28 days, 1 maintenance cycle = 21 days, with treatment lasting up to 1 year from induction. The range of cycles attempted was 1-17 (including induction +/- consolidation, and maintenance). Brentuximab vedotin dose level -1 (dose de-escalation level) never opened. All 20 patients received dose level 1 (1.2 mg/kg) of brentuximab vedotin.
Investigations Weight loss	10.0% 2/20 • Adverse Events (AEs) were collected over a 5 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment. Induction = 28 days, consolidation (optional) = 28 days, 1 maintenance cycle = 21 days, with treatment lasting up to 1 year from induction. The range of cycles attempted was 1-17 (including induction +/- consolidation, and maintenance). Brentuximab vedotin dose level -1 (dose de-escalation level) never opened. All 20 patients received dose level 1 (1.2 mg/kg) of brentuximab vedotin.
Investigations White blood cell decreased	50.0% 10/20 • Adverse Events (AEs) were collected over a 5 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment. Induction = 28 days, consolidation (optional) = 28 days, 1 maintenance cycle = 21 days, with treatment lasting up to 1 year from induction. The range of cycles attempted was 1-17 (including induction +/- consolidation, and maintenance). Brentuximab vedotin dose level -1 (dose de-escalation level) never opened. All 20 patients received dose level 1 (1.2 mg/kg) of brentuximab vedotin.
Metabolism and nutrition disorders Acidosis	5.0% 1/20 • Adverse Events (AEs) were collected over a 5 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment. Induction = 28 days, consolidation (optional) = 28 days, 1 maintenance cycle = 21 days, with treatment lasting up to 1 year from induction. The range of cycles attempted was 1-17 (including induction +/- consolidation, and maintenance). Brentuximab vedotin dose level -1 (dose de-escalation level) never opened. All 20 patients received dose level 1 (1.2 mg/kg) of brentuximab vedotin.
Metabolism and nutrition disorders Alkalosis	5.0% 1/20 • Adverse Events (AEs) were collected over a 5 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment. Induction = 28 days, consolidation (optional) = 28 days, 1 maintenance cycle = 21 days, with treatment lasting up to 1 year from induction. The range of cycles attempted was 1-17 (including induction +/- consolidation, and maintenance). Brentuximab vedotin dose level -1 (dose de-escalation level) never opened. All 20 patients received dose level 1 (1.2 mg/kg) of brentuximab vedotin.
Metabolism and nutrition disorders Anorexia	35.0% 7/20 • Adverse Events (AEs) were collected over a 5 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment. Induction = 28 days, consolidation (optional) = 28 days, 1 maintenance cycle = 21 days, with treatment lasting up to 1 year from induction. The range of cycles attempted was 1-17 (including induction +/- consolidation, and maintenance). Brentuximab vedotin dose level -1 (dose de-escalation level) never opened. All 20 patients received dose level 1 (1.2 mg/kg) of brentuximab vedotin.
Metabolism and nutrition disorders Dehydration	15.0% 3/20 • Adverse Events (AEs) were collected over a 5 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment. Induction = 28 days, consolidation (optional) = 28 days, 1 maintenance cycle = 21 days, with treatment lasting up to 1 year from induction. The range of cycles attempted was 1-17 (including induction +/- consolidation, and maintenance). Brentuximab vedotin dose level -1 (dose de-escalation level) never opened. All 20 patients received dose level 1 (1.2 mg/kg) of brentuximab vedotin.
Metabolism and nutrition disorders Hypercalcemia	5.0% 1/20 • Adverse Events (AEs) were collected over a 5 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment. Induction = 28 days, consolidation (optional) = 28 days, 1 maintenance cycle = 21 days, with treatment lasting up to 1 year from induction. The range of cycles attempted was 1-17 (including induction +/- consolidation, and maintenance). Brentuximab vedotin dose level -1 (dose de-escalation level) never opened. All 20 patients received dose level 1 (1.2 mg/kg) of brentuximab vedotin.
Metabolism and nutrition disorders Hyperglycemia	60.0% 12/20 • Adverse Events (AEs) were collected over a 5 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment. Induction = 28 days, consolidation (optional) = 28 days, 1 maintenance cycle = 21 days, with treatment lasting up to 1 year from induction. The range of cycles attempted was 1-17 (including induction +/- consolidation, and maintenance). Brentuximab vedotin dose level -1 (dose de-escalation level) never opened. All 20 patients received dose level 1 (1.2 mg/kg) of brentuximab vedotin.
Metabolism and nutrition disorders Hyperkalemia	40.0% 8/20 • Adverse Events (AEs) were collected over a 5 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment. Induction = 28 days, consolidation (optional) = 28 days, 1 maintenance cycle = 21 days, with treatment lasting up to 1 year from induction. The range of cycles attempted was 1-17 (including induction +/- consolidation, and maintenance). Brentuximab vedotin dose level -1 (dose de-escalation level) never opened. All 20 patients received dose level 1 (1.2 mg/kg) of brentuximab vedotin.
Metabolism and nutrition disorders Hypermagnesemia	10.0% 2/20 • Adverse Events (AEs) were collected over a 5 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment. Induction = 28 days, consolidation (optional) = 28 days, 1 maintenance cycle = 21 days, with treatment lasting up to 1 year from induction. The range of cycles attempted was 1-17 (including induction +/- consolidation, and maintenance). Brentuximab vedotin dose level -1 (dose de-escalation level) never opened. All 20 patients received dose level 1 (1.2 mg/kg) of brentuximab vedotin.
Metabolism and nutrition disorders Hypernatremia	5.0% 1/20 • Adverse Events (AEs) were collected over a 5 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment. Induction = 28 days, consolidation (optional) = 28 days, 1 maintenance cycle = 21 days, with treatment lasting up to 1 year from induction. The range of cycles attempted was 1-17 (including induction +/- consolidation, and maintenance). Brentuximab vedotin dose level -1 (dose de-escalation level) never opened. All 20 patients received dose level 1 (1.2 mg/kg) of brentuximab vedotin.
Metabolism and nutrition disorders Hypoalbuminemia	55.0% 11/20 • Adverse Events (AEs) were collected over a 5 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment. Induction = 28 days, consolidation (optional) = 28 days, 1 maintenance cycle = 21 days, with treatment lasting up to 1 year from induction. The range of cycles attempted was 1-17 (including induction +/- consolidation, and maintenance). Brentuximab vedotin dose level -1 (dose de-escalation level) never opened. All 20 patients received dose level 1 (1.2 mg/kg) of brentuximab vedotin.
Metabolism and nutrition disorders Hypocalcemia	55.0% 11/20 • Adverse Events (AEs) were collected over a 5 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment. Induction = 28 days, consolidation (optional) = 28 days, 1 maintenance cycle = 21 days, with treatment lasting up to 1 year from induction. The range of cycles attempted was 1-17 (including induction +/- consolidation, and maintenance). Brentuximab vedotin dose level -1 (dose de-escalation level) never opened. All 20 patients received dose level 1 (1.2 mg/kg) of brentuximab vedotin.
Metabolism and nutrition disorders Hypokalemia	50.0% 10/20 • Adverse Events (AEs) were collected over a 5 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment. Induction = 28 days, consolidation (optional) = 28 days, 1 maintenance cycle = 21 days, with treatment lasting up to 1 year from induction. The range of cycles attempted was 1-17 (including induction +/- consolidation, and maintenance). Brentuximab vedotin dose level -1 (dose de-escalation level) never opened. All 20 patients received dose level 1 (1.2 mg/kg) of brentuximab vedotin.
Metabolism and nutrition disorders Hypomagnesemia	25.0% 5/20 • Adverse Events (AEs) were collected over a 5 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment. Induction = 28 days, consolidation (optional) = 28 days, 1 maintenance cycle = 21 days, with treatment lasting up to 1 year from induction. The range of cycles attempted was 1-17 (including induction +/- consolidation, and maintenance). Brentuximab vedotin dose level -1 (dose de-escalation level) never opened. All 20 patients received dose level 1 (1.2 mg/kg) of brentuximab vedotin.
Metabolism and nutrition disorders Hyponatremia	40.0% 8/20 • Adverse Events (AEs) were collected over a 5 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment. Induction = 28 days, consolidation (optional) = 28 days, 1 maintenance cycle = 21 days, with treatment lasting up to 1 year from induction. The range of cycles attempted was 1-17 (including induction +/- consolidation, and maintenance). Brentuximab vedotin dose level -1 (dose de-escalation level) never opened. All 20 patients received dose level 1 (1.2 mg/kg) of brentuximab vedotin.
Metabolism and nutrition disorders Hypophosphatemia	15.0% 3/20 • Adverse Events (AEs) were collected over a 5 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment. Induction = 28 days, consolidation (optional) = 28 days, 1 maintenance cycle = 21 days, with treatment lasting up to 1 year from induction. The range of cycles attempted was 1-17 (including induction +/- consolidation, and maintenance). Brentuximab vedotin dose level -1 (dose de-escalation level) never opened. All 20 patients received dose level 1 (1.2 mg/kg) of brentuximab vedotin.
Musculoskeletal and connective tissue disorders Arthralgia	15.0% 3/20 • Adverse Events (AEs) were collected over a 5 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment. Induction = 28 days, consolidation (optional) = 28 days, 1 maintenance cycle = 21 days, with treatment lasting up to 1 year from induction. The range of cycles attempted was 1-17 (including induction +/- consolidation, and maintenance). Brentuximab vedotin dose level -1 (dose de-escalation level) never opened. All 20 patients received dose level 1 (1.2 mg/kg) of brentuximab vedotin.
Musculoskeletal and connective tissue disorders Back pain	20.0% 4/20 • Adverse Events (AEs) were collected over a 5 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment. Induction = 28 days, consolidation (optional) = 28 days, 1 maintenance cycle = 21 days, with treatment lasting up to 1 year from induction. The range of cycles attempted was 1-17 (including induction +/- consolidation, and maintenance). Brentuximab vedotin dose level -1 (dose de-escalation level) never opened. All 20 patients received dose level 1 (1.2 mg/kg) of brentuximab vedotin.
Musculoskeletal and connective tissue disorders Fibrosis deep connective tissue	5.0% 1/20 • Adverse Events (AEs) were collected over a 5 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment. Induction = 28 days, consolidation (optional) = 28 days, 1 maintenance cycle = 21 days, with treatment lasting up to 1 year from induction. The range of cycles attempted was 1-17 (including induction +/- consolidation, and maintenance). Brentuximab vedotin dose level -1 (dose de-escalation level) never opened. All 20 patients received dose level 1 (1.2 mg/kg) of brentuximab vedotin.
Musculoskeletal and connective tissue disorders Muscle weakness left-sided	5.0% 1/20 • Adverse Events (AEs) were collected over a 5 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment. Induction = 28 days, consolidation (optional) = 28 days, 1 maintenance cycle = 21 days, with treatment lasting up to 1 year from induction. The range of cycles attempted was 1-17 (including induction +/- consolidation, and maintenance). Brentuximab vedotin dose level -1 (dose de-escalation level) never opened. All 20 patients received dose level 1 (1.2 mg/kg) of brentuximab vedotin.
Musculoskeletal and connective tissue disorders Neck pain	5.0% 1/20 • Adverse Events (AEs) were collected over a 5 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment. Induction = 28 days, consolidation (optional) = 28 days, 1 maintenance cycle = 21 days, with treatment lasting up to 1 year from induction. The range of cycles attempted was 1-17 (including induction +/- consolidation, and maintenance). Brentuximab vedotin dose level -1 (dose de-escalation level) never opened. All 20 patients received dose level 1 (1.2 mg/kg) of brentuximab vedotin.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Sessile polyp in descending colon	5.0% 1/20 • Adverse Events (AEs) were collected over a 5 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment. Induction = 28 days, consolidation (optional) = 28 days, 1 maintenance cycle = 21 days, with treatment lasting up to 1 year from induction. The range of cycles attempted was 1-17 (including induction +/- consolidation, and maintenance). Brentuximab vedotin dose level -1 (dose de-escalation level) never opened. All 20 patients received dose level 1 (1.2 mg/kg) of brentuximab vedotin.
Nervous system disorders Dizziness	25.0% 5/20 • Adverse Events (AEs) were collected over a 5 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment. Induction = 28 days, consolidation (optional) = 28 days, 1 maintenance cycle = 21 days, with treatment lasting up to 1 year from induction. The range of cycles attempted was 1-17 (including induction +/- consolidation, and maintenance). Brentuximab vedotin dose level -1 (dose de-escalation level) never opened. All 20 patients received dose level 1 (1.2 mg/kg) of brentuximab vedotin.
Nervous system disorders Encephalopathy	5.0% 1/20 • Adverse Events (AEs) were collected over a 5 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment. Induction = 28 days, consolidation (optional) = 28 days, 1 maintenance cycle = 21 days, with treatment lasting up to 1 year from induction. The range of cycles attempted was 1-17 (including induction +/- consolidation, and maintenance). Brentuximab vedotin dose level -1 (dose de-escalation level) never opened. All 20 patients received dose level 1 (1.2 mg/kg) of brentuximab vedotin.
Nervous system disorders Headache	25.0% 5/20 • Adverse Events (AEs) were collected over a 5 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment. Induction = 28 days, consolidation (optional) = 28 days, 1 maintenance cycle = 21 days, with treatment lasting up to 1 year from induction. The range of cycles attempted was 1-17 (including induction +/- consolidation, and maintenance). Brentuximab vedotin dose level -1 (dose de-escalation level) never opened. All 20 patients received dose level 1 (1.2 mg/kg) of brentuximab vedotin.
Nervous system disorders Memory impairment	5.0% 1/20 • Adverse Events (AEs) were collected over a 5 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment. Induction = 28 days, consolidation (optional) = 28 days, 1 maintenance cycle = 21 days, with treatment lasting up to 1 year from induction. The range of cycles attempted was 1-17 (including induction +/- consolidation, and maintenance). Brentuximab vedotin dose level -1 (dose de-escalation level) never opened. All 20 patients received dose level 1 (1.2 mg/kg) of brentuximab vedotin.
Nervous system disorders Peripheral motor neuropathy	5.0% 1/20 • Adverse Events (AEs) were collected over a 5 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment. Induction = 28 days, consolidation (optional) = 28 days, 1 maintenance cycle = 21 days, with treatment lasting up to 1 year from induction. The range of cycles attempted was 1-17 (including induction +/- consolidation, and maintenance). Brentuximab vedotin dose level -1 (dose de-escalation level) never opened. All 20 patients received dose level 1 (1.2 mg/kg) of brentuximab vedotin.
Nervous system disorders Peripheral sensory neuropathy	35.0% 7/20 • Adverse Events (AEs) were collected over a 5 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment. Induction = 28 days, consolidation (optional) = 28 days, 1 maintenance cycle = 21 days, with treatment lasting up to 1 year from induction. The range of cycles attempted was 1-17 (including induction +/- consolidation, and maintenance). Brentuximab vedotin dose level -1 (dose de-escalation level) never opened. All 20 patients received dose level 1 (1.2 mg/kg) of brentuximab vedotin.
Psychiatric disorders Anxiety	25.0% 5/20 • Adverse Events (AEs) were collected over a 5 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment. Induction = 28 days, consolidation (optional) = 28 days, 1 maintenance cycle = 21 days, with treatment lasting up to 1 year from induction. The range of cycles attempted was 1-17 (including induction +/- consolidation, and maintenance). Brentuximab vedotin dose level -1 (dose de-escalation level) never opened. All 20 patients received dose level 1 (1.2 mg/kg) of brentuximab vedotin.
Psychiatric disorders Confusion	20.0% 4/20 • Adverse Events (AEs) were collected over a 5 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment. Induction = 28 days, consolidation (optional) = 28 days, 1 maintenance cycle = 21 days, with treatment lasting up to 1 year from induction. The range of cycles attempted was 1-17 (including induction +/- consolidation, and maintenance). Brentuximab vedotin dose level -1 (dose de-escalation level) never opened. All 20 patients received dose level 1 (1.2 mg/kg) of brentuximab vedotin.
Psychiatric disorders Depression	5.0% 1/20 • Adverse Events (AEs) were collected over a 5 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment. Induction = 28 days, consolidation (optional) = 28 days, 1 maintenance cycle = 21 days, with treatment lasting up to 1 year from induction. The range of cycles attempted was 1-17 (including induction +/- consolidation, and maintenance). Brentuximab vedotin dose level -1 (dose de-escalation level) never opened. All 20 patients received dose level 1 (1.2 mg/kg) of brentuximab vedotin.
Psychiatric disorders Insomnia	15.0% 3/20 • Adverse Events (AEs) were collected over a 5 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment. Induction = 28 days, consolidation (optional) = 28 days, 1 maintenance cycle = 21 days, with treatment lasting up to 1 year from induction. The range of cycles attempted was 1-17 (including induction +/- consolidation, and maintenance). Brentuximab vedotin dose level -1 (dose de-escalation level) never opened. All 20 patients received dose level 1 (1.2 mg/kg) of brentuximab vedotin.
Psychiatric disorders Altered mental state	5.0% 1/20 • Adverse Events (AEs) were collected over a 5 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment. Induction = 28 days, consolidation (optional) = 28 days, 1 maintenance cycle = 21 days, with treatment lasting up to 1 year from induction. The range of cycles attempted was 1-17 (including induction +/- consolidation, and maintenance). Brentuximab vedotin dose level -1 (dose de-escalation level) never opened. All 20 patients received dose level 1 (1.2 mg/kg) of brentuximab vedotin.
Renal and urinary disorders Acute kidney injury	35.0% 7/20 • Adverse Events (AEs) were collected over a 5 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment. Induction = 28 days, consolidation (optional) = 28 days, 1 maintenance cycle = 21 days, with treatment lasting up to 1 year from induction. The range of cycles attempted was 1-17 (including induction +/- consolidation, and maintenance). Brentuximab vedotin dose level -1 (dose de-escalation level) never opened. All 20 patients received dose level 1 (1.2 mg/kg) of brentuximab vedotin.
Renal and urinary disorders Hematuria	5.0% 1/20 • Adverse Events (AEs) were collected over a 5 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment. Induction = 28 days, consolidation (optional) = 28 days, 1 maintenance cycle = 21 days, with treatment lasting up to 1 year from induction. The range of cycles attempted was 1-17 (including induction +/- consolidation, and maintenance). Brentuximab vedotin dose level -1 (dose de-escalation level) never opened. All 20 patients received dose level 1 (1.2 mg/kg) of brentuximab vedotin.
Renal and urinary disorders Urinary frequency	5.0% 1/20 • Adverse Events (AEs) were collected over a 5 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment. Induction = 28 days, consolidation (optional) = 28 days, 1 maintenance cycle = 21 days, with treatment lasting up to 1 year from induction. The range of cycles attempted was 1-17 (including induction +/- consolidation, and maintenance). Brentuximab vedotin dose level -1 (dose de-escalation level) never opened. All 20 patients received dose level 1 (1.2 mg/kg) of brentuximab vedotin.
Renal and urinary disorders Urinary incontinence	5.0% 1/20 • Adverse Events (AEs) were collected over a 5 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment. Induction = 28 days, consolidation (optional) = 28 days, 1 maintenance cycle = 21 days, with treatment lasting up to 1 year from induction. The range of cycles attempted was 1-17 (including induction +/- consolidation, and maintenance). Brentuximab vedotin dose level -1 (dose de-escalation level) never opened. All 20 patients received dose level 1 (1.2 mg/kg) of brentuximab vedotin.
Renal and urinary disorders Urinary retention	5.0% 1/20 • Adverse Events (AEs) were collected over a 5 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment. Induction = 28 days, consolidation (optional) = 28 days, 1 maintenance cycle = 21 days, with treatment lasting up to 1 year from induction. The range of cycles attempted was 1-17 (including induction +/- consolidation, and maintenance). Brentuximab vedotin dose level -1 (dose de-escalation level) never opened. All 20 patients received dose level 1 (1.2 mg/kg) of brentuximab vedotin.
Respiratory, thoracic and mediastinal disorders Aspiration	10.0% 2/20 • Adverse Events (AEs) were collected over a 5 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment. Induction = 28 days, consolidation (optional) = 28 days, 1 maintenance cycle = 21 days, with treatment lasting up to 1 year from induction. The range of cycles attempted was 1-17 (including induction +/- consolidation, and maintenance). Brentuximab vedotin dose level -1 (dose de-escalation level) never opened. All 20 patients received dose level 1 (1.2 mg/kg) of brentuximab vedotin.
Respiratory, thoracic and mediastinal disorders Cough	30.0% 6/20 • Adverse Events (AEs) were collected over a 5 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment. Induction = 28 days, consolidation (optional) = 28 days, 1 maintenance cycle = 21 days, with treatment lasting up to 1 year from induction. The range of cycles attempted was 1-17 (including induction +/- consolidation, and maintenance). Brentuximab vedotin dose level -1 (dose de-escalation level) never opened. All 20 patients received dose level 1 (1.2 mg/kg) of brentuximab vedotin.
Respiratory, thoracic and mediastinal disorders Dyspnea	30.0% 6/20 • Adverse Events (AEs) were collected over a 5 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment. Induction = 28 days, consolidation (optional) = 28 days, 1 maintenance cycle = 21 days, with treatment lasting up to 1 year from induction. The range of cycles attempted was 1-17 (including induction +/- consolidation, and maintenance). Brentuximab vedotin dose level -1 (dose de-escalation level) never opened. All 20 patients received dose level 1 (1.2 mg/kg) of brentuximab vedotin.
Respiratory, thoracic and mediastinal disorders Hiccups	10.0% 2/20 • Adverse Events (AEs) were collected over a 5 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment. Induction = 28 days, consolidation (optional) = 28 days, 1 maintenance cycle = 21 days, with treatment lasting up to 1 year from induction. The range of cycles attempted was 1-17 (including induction +/- consolidation, and maintenance). Brentuximab vedotin dose level -1 (dose de-escalation level) never opened. All 20 patients received dose level 1 (1.2 mg/kg) of brentuximab vedotin.
Respiratory, thoracic and mediastinal disorders Nasal congestion	10.0% 2/20 • Adverse Events (AEs) were collected over a 5 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment. Induction = 28 days, consolidation (optional) = 28 days, 1 maintenance cycle = 21 days, with treatment lasting up to 1 year from induction. The range of cycles attempted was 1-17 (including induction +/- consolidation, and maintenance). Brentuximab vedotin dose level -1 (dose de-escalation level) never opened. All 20 patients received dose level 1 (1.2 mg/kg) of brentuximab vedotin.
Respiratory, thoracic and mediastinal disorders Pleural effusion	5.0% 1/20 • Adverse Events (AEs) were collected over a 5 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment. Induction = 28 days, consolidation (optional) = 28 days, 1 maintenance cycle = 21 days, with treatment lasting up to 1 year from induction. The range of cycles attempted was 1-17 (including induction +/- consolidation, and maintenance). Brentuximab vedotin dose level -1 (dose de-escalation level) never opened. All 20 patients received dose level 1 (1.2 mg/kg) of brentuximab vedotin.
Respiratory, thoracic and mediastinal disorders Postnasal drip	15.0% 3/20 • Adverse Events (AEs) were collected over a 5 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment. Induction = 28 days, consolidation (optional) = 28 days, 1 maintenance cycle = 21 days, with treatment lasting up to 1 year from induction. The range of cycles attempted was 1-17 (including induction +/- consolidation, and maintenance). Brentuximab vedotin dose level -1 (dose de-escalation level) never opened. All 20 patients received dose level 1 (1.2 mg/kg) of brentuximab vedotin.
Respiratory, thoracic and mediastinal disorders Pulmonary edema	10.0% 2/20 • Adverse Events (AEs) were collected over a 5 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment. Induction = 28 days, consolidation (optional) = 28 days, 1 maintenance cycle = 21 days, with treatment lasting up to 1 year from induction. The range of cycles attempted was 1-17 (including induction +/- consolidation, and maintenance). Brentuximab vedotin dose level -1 (dose de-escalation level) never opened. All 20 patients received dose level 1 (1.2 mg/kg) of brentuximab vedotin.
Respiratory, thoracic and mediastinal disorders Sore throat	5.0% 1/20 • Adverse Events (AEs) were collected over a 5 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment. Induction = 28 days, consolidation (optional) = 28 days, 1 maintenance cycle = 21 days, with treatment lasting up to 1 year from induction. The range of cycles attempted was 1-17 (including induction +/- consolidation, and maintenance). Brentuximab vedotin dose level -1 (dose de-escalation level) never opened. All 20 patients received dose level 1 (1.2 mg/kg) of brentuximab vedotin.
Skin and subcutaneous tissue disorders Alopecia	10.0% 2/20 • Adverse Events (AEs) were collected over a 5 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment. Induction = 28 days, consolidation (optional) = 28 days, 1 maintenance cycle = 21 days, with treatment lasting up to 1 year from induction. The range of cycles attempted was 1-17 (including induction +/- consolidation, and maintenance). Brentuximab vedotin dose level -1 (dose de-escalation level) never opened. All 20 patients received dose level 1 (1.2 mg/kg) of brentuximab vedotin.
Skin and subcutaneous tissue disorders Dry skin	5.0% 1/20 • Adverse Events (AEs) were collected over a 5 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment. Induction = 28 days, consolidation (optional) = 28 days, 1 maintenance cycle = 21 days, with treatment lasting up to 1 year from induction. The range of cycles attempted was 1-17 (including induction +/- consolidation, and maintenance). Brentuximab vedotin dose level -1 (dose de-escalation level) never opened. All 20 patients received dose level 1 (1.2 mg/kg) of brentuximab vedotin.
Skin and subcutaneous tissue disorders Pruritus	10.0% 2/20 • Adverse Events (AEs) were collected over a 5 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment. Induction = 28 days, consolidation (optional) = 28 days, 1 maintenance cycle = 21 days, with treatment lasting up to 1 year from induction. The range of cycles attempted was 1-17 (including induction +/- consolidation, and maintenance). Brentuximab vedotin dose level -1 (dose de-escalation level) never opened. All 20 patients received dose level 1 (1.2 mg/kg) of brentuximab vedotin.
Skin and subcutaneous tissue disorders Rash maculo-papular	5.0% 1/20 • Adverse Events (AEs) were collected over a 5 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment. Induction = 28 days, consolidation (optional) = 28 days, 1 maintenance cycle = 21 days, with treatment lasting up to 1 year from induction. The range of cycles attempted was 1-17 (including induction +/- consolidation, and maintenance). Brentuximab vedotin dose level -1 (dose de-escalation level) never opened. All 20 patients received dose level 1 (1.2 mg/kg) of brentuximab vedotin.
Skin and subcutaneous tissue disorders Urticaria	5.0% 1/20 • Adverse Events (AEs) were collected over a 5 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment. Induction = 28 days, consolidation (optional) = 28 days, 1 maintenance cycle = 21 days, with treatment lasting up to 1 year from induction. The range of cycles attempted was 1-17 (including induction +/- consolidation, and maintenance). Brentuximab vedotin dose level -1 (dose de-escalation level) never opened. All 20 patients received dose level 1 (1.2 mg/kg) of brentuximab vedotin.
Vascular disorders Hypertension	55.0% 11/20 • Adverse Events (AEs) were collected over a 5 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment. Induction = 28 days, consolidation (optional) = 28 days, 1 maintenance cycle = 21 days, with treatment lasting up to 1 year from induction. The range of cycles attempted was 1-17 (including induction +/- consolidation, and maintenance). Brentuximab vedotin dose level -1 (dose de-escalation level) never opened. All 20 patients received dose level 1 (1.2 mg/kg) of brentuximab vedotin.
Vascular disorders Hypotension	15.0% 3/20 • Adverse Events (AEs) were collected over a 5 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment. Induction = 28 days, consolidation (optional) = 28 days, 1 maintenance cycle = 21 days, with treatment lasting up to 1 year from induction. The range of cycles attempted was 1-17 (including induction +/- consolidation, and maintenance). Brentuximab vedotin dose level -1 (dose de-escalation level) never opened. All 20 patients received dose level 1 (1.2 mg/kg) of brentuximab vedotin.
Vascular disorders Thromboembolic event	5.0% 1/20 • Adverse Events (AEs) were collected over a 5 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment. Induction = 28 days, consolidation (optional) = 28 days, 1 maintenance cycle = 21 days, with treatment lasting up to 1 year from induction. The range of cycles attempted was 1-17 (including induction +/- consolidation, and maintenance). Brentuximab vedotin dose level -1 (dose de-escalation level) never opened. All 20 patients received dose level 1 (1.2 mg/kg) of brentuximab vedotin.
Vascular disorders Orthostatic hypotension	5.0% 1/20 • Adverse Events (AEs) were collected over a 5 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment. Induction = 28 days, consolidation (optional) = 28 days, 1 maintenance cycle = 21 days, with treatment lasting up to 1 year from induction. The range of cycles attempted was 1-17 (including induction +/- consolidation, and maintenance). Brentuximab vedotin dose level -1 (dose de-escalation level) never opened. All 20 patients received dose level 1 (1.2 mg/kg) of brentuximab vedotin.
Hepatobiliary disorders Elevated liver enzymes	5.0% 1/20 • Adverse Events (AEs) were collected over a 5 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment. Induction = 28 days, consolidation (optional) = 28 days, 1 maintenance cycle = 21 days, with treatment lasting up to 1 year from induction. The range of cycles attempted was 1-17 (including induction +/- consolidation, and maintenance). Brentuximab vedotin dose level -1 (dose de-escalation level) never opened. All 20 patients received dose level 1 (1.2 mg/kg) of brentuximab vedotin.
Hepatobiliary disorders Drug-induced liver injury	5.0% 1/20 • Adverse Events (AEs) were collected over a 5 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment. Induction = 28 days, consolidation (optional) = 28 days, 1 maintenance cycle = 21 days, with treatment lasting up to 1 year from induction. The range of cycles attempted was 1-17 (including induction +/- consolidation, and maintenance). Brentuximab vedotin dose level -1 (dose de-escalation level) never opened. All 20 patients received dose level 1 (1.2 mg/kg) of brentuximab vedotin.
Hepatobiliary disorders Hepatic steatosis	5.0% 1/20 • Adverse Events (AEs) were collected over a 5 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment. Induction = 28 days, consolidation (optional) = 28 days, 1 maintenance cycle = 21 days, with treatment lasting up to 1 year from induction. The range of cycles attempted was 1-17 (including induction +/- consolidation, and maintenance). Brentuximab vedotin dose level -1 (dose de-escalation level) never opened. All 20 patients received dose level 1 (1.2 mg/kg) of brentuximab vedotin.
Nervous system disorders Benign paroxysmal positional vertigo	5.0% 1/20 • Adverse Events (AEs) were collected over a 5 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment. Induction = 28 days, consolidation (optional) = 28 days, 1 maintenance cycle = 21 days, with treatment lasting up to 1 year from induction. The range of cycles attempted was 1-17 (including induction +/- consolidation, and maintenance). Brentuximab vedotin dose level -1 (dose de-escalation level) never opened. All 20 patients received dose level 1 (1.2 mg/kg) of brentuximab vedotin.
Nervous system disorders Difficulty with fine motor skills	5.0% 1/20 • Adverse Events (AEs) were collected over a 5 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment. Induction = 28 days, consolidation (optional) = 28 days, 1 maintenance cycle = 21 days, with treatment lasting up to 1 year from induction. The range of cycles attempted was 1-17 (including induction +/- consolidation, and maintenance). Brentuximab vedotin dose level -1 (dose de-escalation level) never opened. All 20 patients received dose level 1 (1.2 mg/kg) of brentuximab vedotin.
Nervous system disorders Restless leg syndrome	5.0% 1/20 • Adverse Events (AEs) were collected over a 5 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment. Induction = 28 days, consolidation (optional) = 28 days, 1 maintenance cycle = 21 days, with treatment lasting up to 1 year from induction. The range of cycles attempted was 1-17 (including induction +/- consolidation, and maintenance). Brentuximab vedotin dose level -1 (dose de-escalation level) never opened. All 20 patients received dose level 1 (1.2 mg/kg) of brentuximab vedotin.
Renal and urinary disorders Increase urinary frequency	10.0% 2/20 • Adverse Events (AEs) were collected over a 5 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment. Induction = 28 days, consolidation (optional) = 28 days, 1 maintenance cycle = 21 days, with treatment lasting up to 1 year from induction. The range of cycles attempted was 1-17 (including induction +/- consolidation, and maintenance). Brentuximab vedotin dose level -1 (dose de-escalation level) never opened. All 20 patients received dose level 1 (1.2 mg/kg) of brentuximab vedotin.
Renal and urinary disorders Malodorous urine	5.0% 1/20 • Adverse Events (AEs) were collected over a 5 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment. Induction = 28 days, consolidation (optional) = 28 days, 1 maintenance cycle = 21 days, with treatment lasting up to 1 year from induction. The range of cycles attempted was 1-17 (including induction +/- consolidation, and maintenance). Brentuximab vedotin dose level -1 (dose de-escalation level) never opened. All 20 patients received dose level 1 (1.2 mg/kg) of brentuximab vedotin.
Renal and urinary disorders Low glomerular filtration rate	5.0% 1/20 • Adverse Events (AEs) were collected over a 5 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment. Induction = 28 days, consolidation (optional) = 28 days, 1 maintenance cycle = 21 days, with treatment lasting up to 1 year from induction. The range of cycles attempted was 1-17 (including induction +/- consolidation, and maintenance). Brentuximab vedotin dose level -1 (dose de-escalation level) never opened. All 20 patients received dose level 1 (1.2 mg/kg) of brentuximab vedotin.
Renal and urinary disorders Renal tubulitis	5.0% 1/20 • Adverse Events (AEs) were collected over a 5 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment. Induction = 28 days, consolidation (optional) = 28 days, 1 maintenance cycle = 21 days, with treatment lasting up to 1 year from induction. The range of cycles attempted was 1-17 (including induction +/- consolidation, and maintenance). Brentuximab vedotin dose level -1 (dose de-escalation level) never opened. All 20 patients received dose level 1 (1.2 mg/kg) of brentuximab vedotin.
Renal and urinary disorders Catheter associated urinary tract infection	5.0% 1/20 • Adverse Events (AEs) were collected over a 5 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment. Induction = 28 days, consolidation (optional) = 28 days, 1 maintenance cycle = 21 days, with treatment lasting up to 1 year from induction. The range of cycles attempted was 1-17 (including induction +/- consolidation, and maintenance). Brentuximab vedotin dose level -1 (dose de-escalation level) never opened. All 20 patients received dose level 1 (1.2 mg/kg) of brentuximab vedotin.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Polyp underneath eye	5.0% 1/20 • Adverse Events (AEs) were collected over a 5 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment. Induction = 28 days, consolidation (optional) = 28 days, 1 maintenance cycle = 21 days, with treatment lasting up to 1 year from induction. The range of cycles attempted was 1-17 (including induction +/- consolidation, and maintenance). Brentuximab vedotin dose level -1 (dose de-escalation level) never opened. All 20 patients received dose level 1 (1.2 mg/kg) of brentuximab vedotin.
Investigations Platelet count increased	5.0% 1/20 • Adverse Events (AEs) were collected over a 5 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment. Induction = 28 days, consolidation (optional) = 28 days, 1 maintenance cycle = 21 days, with treatment lasting up to 1 year from induction. The range of cycles attempted was 1-17 (including induction +/- consolidation, and maintenance). Brentuximab vedotin dose level -1 (dose de-escalation level) never opened. All 20 patients received dose level 1 (1.2 mg/kg) of brentuximab vedotin.
Investigations Abnormal Blood Urea Nitrogen	10.0% 2/20 • Adverse Events (AEs) were collected over a 5 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment. Induction = 28 days, consolidation (optional) = 28 days, 1 maintenance cycle = 21 days, with treatment lasting up to 1 year from induction. The range of cycles attempted was 1-17 (including induction +/- consolidation, and maintenance). Brentuximab vedotin dose level -1 (dose de-escalation level) never opened. All 20 patients received dose level 1 (1.2 mg/kg) of brentuximab vedotin.
Investigations Increased Lactate Dehydrogenase	5.0% 1/20 • Adverse Events (AEs) were collected over a 5 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment. Induction = 28 days, consolidation (optional) = 28 days, 1 maintenance cycle = 21 days, with treatment lasting up to 1 year from induction. The range of cycles attempted was 1-17 (including induction +/- consolidation, and maintenance). Brentuximab vedotin dose level -1 (dose de-escalation level) never opened. All 20 patients received dose level 1 (1.2 mg/kg) of brentuximab vedotin.
Investigations Decreased monocytes	5.0% 1/20 • Adverse Events (AEs) were collected over a 5 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment. Induction = 28 days, consolidation (optional) = 28 days, 1 maintenance cycle = 21 days, with treatment lasting up to 1 year from induction. The range of cycles attempted was 1-17 (including induction +/- consolidation, and maintenance). Brentuximab vedotin dose level -1 (dose de-escalation level) never opened. All 20 patients received dose level 1 (1.2 mg/kg) of brentuximab vedotin.
Musculoskeletal and connective tissue disorders Generalized body soreness	5.0% 1/20 • Adverse Events (AEs) were collected over a 5 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment. Induction = 28 days, consolidation (optional) = 28 days, 1 maintenance cycle = 21 days, with treatment lasting up to 1 year from induction. The range of cycles attempted was 1-17 (including induction +/- consolidation, and maintenance). Brentuximab vedotin dose level -1 (dose de-escalation level) never opened. All 20 patients received dose level 1 (1.2 mg/kg) of brentuximab vedotin.
Musculoskeletal and connective tissue disorders Tendonitis	5.0% 1/20 • Adverse Events (AEs) were collected over a 5 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment. Induction = 28 days, consolidation (optional) = 28 days, 1 maintenance cycle = 21 days, with treatment lasting up to 1 year from induction. The range of cycles attempted was 1-17 (including induction +/- consolidation, and maintenance). Brentuximab vedotin dose level -1 (dose de-escalation level) never opened. All 20 patients received dose level 1 (1.2 mg/kg) of brentuximab vedotin.
Musculoskeletal and connective tissue disorders Muscle twinges in legs, abdomen, and chest	5.0% 1/20 • Adverse Events (AEs) were collected over a 5 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment. Induction = 28 days, consolidation (optional) = 28 days, 1 maintenance cycle = 21 days, with treatment lasting up to 1 year from induction. The range of cycles attempted was 1-17 (including induction +/- consolidation, and maintenance). Brentuximab vedotin dose level -1 (dose de-escalation level) never opened. All 20 patients received dose level 1 (1.2 mg/kg) of brentuximab vedotin.
Musculoskeletal and connective tissue disorders Left shoulder pain	5.0% 1/20 • Adverse Events (AEs) were collected over a 5 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment. Induction = 28 days, consolidation (optional) = 28 days, 1 maintenance cycle = 21 days, with treatment lasting up to 1 year from induction. The range of cycles attempted was 1-17 (including induction +/- consolidation, and maintenance). Brentuximab vedotin dose level -1 (dose de-escalation level) never opened. All 20 patients received dose level 1 (1.2 mg/kg) of brentuximab vedotin.
Metabolism and nutrition disorders Hypovolemia	5.0% 1/20 • Adverse Events (AEs) were collected over a 5 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment. Induction = 28 days, consolidation (optional) = 28 days, 1 maintenance cycle = 21 days, with treatment lasting up to 1 year from induction. The range of cycles attempted was 1-17 (including induction +/- consolidation, and maintenance). Brentuximab vedotin dose level -1 (dose de-escalation level) never opened. All 20 patients received dose level 1 (1.2 mg/kg) of brentuximab vedotin.
Metabolism and nutrition disorders Low iron	5.0% 1/20 • Adverse Events (AEs) were collected over a 5 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment. Induction = 28 days, consolidation (optional) = 28 days, 1 maintenance cycle = 21 days, with treatment lasting up to 1 year from induction. The range of cycles attempted was 1-17 (including induction +/- consolidation, and maintenance). Brentuximab vedotin dose level -1 (dose de-escalation level) never opened. All 20 patients received dose level 1 (1.2 mg/kg) of brentuximab vedotin.
Metabolism and nutrition disorders Lactic Acidosis	5.0% 1/20 • Adverse Events (AEs) were collected over a 5 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment. Induction = 28 days, consolidation (optional) = 28 days, 1 maintenance cycle = 21 days, with treatment lasting up to 1 year from induction. The range of cycles attempted was 1-17 (including induction +/- consolidation, and maintenance). Brentuximab vedotin dose level -1 (dose de-escalation level) never opened. All 20 patients received dose level 1 (1.2 mg/kg) of brentuximab vedotin.
Respiratory, thoracic and mediastinal disorders Mouth sores	5.0% 1/20 • Adverse Events (AEs) were collected over a 5 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment. Induction = 28 days, consolidation (optional) = 28 days, 1 maintenance cycle = 21 days, with treatment lasting up to 1 year from induction. The range of cycles attempted was 1-17 (including induction +/- consolidation, and maintenance). Brentuximab vedotin dose level -1 (dose de-escalation level) never opened. All 20 patients received dose level 1 (1.2 mg/kg) of brentuximab vedotin.
Respiratory, thoracic and mediastinal disorders Rhinorrhea	5.0% 1/20 • Adverse Events (AEs) were collected over a 5 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment. Induction = 28 days, consolidation (optional) = 28 days, 1 maintenance cycle = 21 days, with treatment lasting up to 1 year from induction. The range of cycles attempted was 1-17 (including induction +/- consolidation, and maintenance). Brentuximab vedotin dose level -1 (dose de-escalation level) never opened. All 20 patients received dose level 1 (1.2 mg/kg) of brentuximab vedotin.
Respiratory, thoracic and mediastinal disorders Worsening of right lung opacity in CT scan	5.0% 1/20 • Adverse Events (AEs) were collected over a 5 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment. Induction = 28 days, consolidation (optional) = 28 days, 1 maintenance cycle = 21 days, with treatment lasting up to 1 year from induction. The range of cycles attempted was 1-17 (including induction +/- consolidation, and maintenance). Brentuximab vedotin dose level -1 (dose de-escalation level) never opened. All 20 patients received dose level 1 (1.2 mg/kg) of brentuximab vedotin.
Respiratory, thoracic and mediastinal disorders Pneumonia	5.0% 1/20 • Adverse Events (AEs) were collected over a 5 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment. Induction = 28 days, consolidation (optional) = 28 days, 1 maintenance cycle = 21 days, with treatment lasting up to 1 year from induction. The range of cycles attempted was 1-17 (including induction +/- consolidation, and maintenance). Brentuximab vedotin dose level -1 (dose de-escalation level) never opened. All 20 patients received dose level 1 (1.2 mg/kg) of brentuximab vedotin.
Respiratory, thoracic and mediastinal disorders Shortness of breath with exertion	5.0% 1/20 • Adverse Events (AEs) were collected over a 5 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment. Induction = 28 days, consolidation (optional) = 28 days, 1 maintenance cycle = 21 days, with treatment lasting up to 1 year from induction. The range of cycles attempted was 1-17 (including induction +/- consolidation, and maintenance). Brentuximab vedotin dose level -1 (dose de-escalation level) never opened. All 20 patients received dose level 1 (1.2 mg/kg) of brentuximab vedotin.
Skin and subcutaneous tissue disorders Rash	10.0% 2/20 • Adverse Events (AEs) were collected over a 5 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment. Induction = 28 days, consolidation (optional) = 28 days, 1 maintenance cycle = 21 days, with treatment lasting up to 1 year from induction. The range of cycles attempted was 1-17 (including induction +/- consolidation, and maintenance). Brentuximab vedotin dose level -1 (dose de-escalation level) never opened. All 20 patients received dose level 1 (1.2 mg/kg) of brentuximab vedotin.
Skin and subcutaneous tissue disorders Erythema	5.0% 1/20 • Adverse Events (AEs) were collected over a 5 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment. Induction = 28 days, consolidation (optional) = 28 days, 1 maintenance cycle = 21 days, with treatment lasting up to 1 year from induction. The range of cycles attempted was 1-17 (including induction +/- consolidation, and maintenance). Brentuximab vedotin dose level -1 (dose de-escalation level) never opened. All 20 patients received dose level 1 (1.2 mg/kg) of brentuximab vedotin.
Skin and subcutaneous tissue disorders Itching of medial portion of the knees	5.0% 1/20 • Adverse Events (AEs) were collected over a 5 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment. Induction = 28 days, consolidation (optional) = 28 days, 1 maintenance cycle = 21 days, with treatment lasting up to 1 year from induction. The range of cycles attempted was 1-17 (including induction +/- consolidation, and maintenance). Brentuximab vedotin dose level -1 (dose de-escalation level) never opened. All 20 patients received dose level 1 (1.2 mg/kg) of brentuximab vedotin.
Skin and subcutaneous tissue disorders tender back	5.0% 1/20 • Adverse Events (AEs) were collected over a 5 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment. Induction = 28 days, consolidation (optional) = 28 days, 1 maintenance cycle = 21 days, with treatment lasting up to 1 year from induction. The range of cycles attempted was 1-17 (including induction +/- consolidation, and maintenance). Brentuximab vedotin dose level -1 (dose de-escalation level) never opened. All 20 patients received dose level 1 (1.2 mg/kg) of brentuximab vedotin.
Skin and subcutaneous tissue disorders redness of left leg	5.0% 1/20 • Adverse Events (AEs) were collected over a 5 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment. Induction = 28 days, consolidation (optional) = 28 days, 1 maintenance cycle = 21 days, with treatment lasting up to 1 year from induction. The range of cycles attempted was 1-17 (including induction +/- consolidation, and maintenance). Brentuximab vedotin dose level -1 (dose de-escalation level) never opened. All 20 patients received dose level 1 (1.2 mg/kg) of brentuximab vedotin.
Skin and subcutaneous tissue disorders Cellulitis behind ear	5.0% 1/20 • Adverse Events (AEs) were collected over a 5 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment. Induction = 28 days, consolidation (optional) = 28 days, 1 maintenance cycle = 21 days, with treatment lasting up to 1 year from induction. The range of cycles attempted was 1-17 (including induction +/- consolidation, and maintenance). Brentuximab vedotin dose level -1 (dose de-escalation level) never opened. All 20 patients received dose level 1 (1.2 mg/kg) of brentuximab vedotin.

Additional Information

Barbara Pro, MD

Northwestern University, Feinberg School of Medicine

Phone: 312-695-6180

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place