Trial Outcomes & Findings for Study of Brentuximab Vedotin Combined With Bendamustine in Patients With Hodgkin Lymphoma (NCT NCT01874054)

Last Updated: 2019-02-12

Results Overview

Complete remission rate among all subjects (Phase 1 and 2 combined) treated at the dose level selected for Phase 2. Complete remission (CR) per Cheson 2007 Revised Response Criteria for Malignant Lymphoma is a disappearance of all evidence of disease.

Recruitment status

COMPLETED

Study phase

PHASE1/PHASE2

Target enrollment

55 participants

Primary outcome timeframe

Up to 4.6 months

Results posted on

2019-02-12

Participant Flow

June 2013 - July 2016

Participant milestones

Participant milestones
Measure	Brentuximab Vedotin + Bendamustine brentuximab vedotin (BV): 1.8 mg/kg on Day 1 of 3-week cycles by intravenous (IV) infusion bendamustine: 90 mg/m\^2 on Days 1 and 2 of 3-week cycles by intravenous (IV) infusion
Overall Study STARTED	55
Overall Study Completed ≥2 Cycles of Combo Treatment	53
Overall Study Completed 16 Cycles of BV Treatment	17
Overall Study COMPLETED	0
Overall Study NOT COMPLETED	55

Reasons for withdrawal

Reasons for withdrawal
Measure	Brentuximab Vedotin + Bendamustine brentuximab vedotin (BV): 1.8 mg/kg on Day 1 of 3-week cycles by intravenous (IV) infusion bendamustine: 90 mg/m\^2 on Days 1 and 2 of 3-week cycles by intravenous (IV) infusion
Overall Study Withdrawal by Subject	3
Overall Study Study Termination by Sponsor	42
Overall Study Lost to Follow-up	5
Overall Study Death	5

Baseline Characteristics

Study of Brentuximab Vedotin Combined With Bendamustine in Patients With Hodgkin Lymphoma

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Brentuximab Vedotin + Bendamustine n=55 Participants brentuximab vedotin: 1.8 mg/kg on Day 1 of 3-week cycles by intravenous (IV) infusion bendamustine: 90 mg/m\^2 on Days 1 and 2 of 3-week cycles by intravenous (IV) infusion
Race (NIH/OMB) Black or African American	6 Participants n=5 Participants
Race (NIH/OMB) White	46 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	3 Participants n=5 Participants
Region of Enrollment United States	55 participants n=5 Participants
Eastern Cooperative Group Oncology Performance Status 0	31 Participants n=5 Participants
Eastern Cooperative Group Oncology Performance Status 1	23 Participants n=5 Participants
Eastern Cooperative Group Oncology Performance Status 2	1 Participants n=5 Participants
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	50 Participants n=5 Participants
Age, Categorical >=65 years	5 Participants n=5 Participants
Age, Continuous	36 years n=5 Participants
Sex: Female, Male Female	31 Participants n=5 Participants
Sex: Female, Male Male	24 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	3 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	51 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: Up to 4.6 months

Population: All patients who received at least 2 cycles of combination treatment at the recommended dose level and had a baseline tumor assessment and at least 1 postbaseline tumor assessment, or who had documented disease progression (including clinical disease progression) at any time after the first dose of combination therapy at the recommended dose level.

Outcome measures

Outcome measures
Measure	Brentuximab Vedotin + Bendamustine n=53 Participants brentuximab vedotin: 1.8 mg/kg on Day 1 of 3-week cycles by intravenous (IV) infusion bendamustine: 90 mg/m\^2 on Days 1 and 2 of 3-week cycles by intravenous (IV) infusion
Complete Remission Rate	73.6 percentage of participants Interval 59.67 to 84.74

PRIMARY outcome

Timeframe: Up to 13.8 months

Population: All subjects who were enrolled and received at least 1 dose of brentuximab vedotin.

All AEs reported after initiation of treatment and pre-existing conditions that worsen after initiation of treatment will be considered treatment-emergent AEs (TEAEs). All AEs will be coded by system organ class, MedDRA preferred term, and severity grade using NCI CTCAE V4.03. All recorded AEs will be included in the data listings.

Outcome measures

Outcome measures
Measure	Brentuximab Vedotin + Bendamustine n=55 Participants brentuximab vedotin: 1.8 mg/kg on Day 1 of 3-week cycles by intravenous (IV) infusion bendamustine: 90 mg/m\^2 on Days 1 and 2 of 3-week cycles by intravenous (IV) infusion
Incidence of Adverse Events (AEs) Any Treatment-Related Serious Adverse Event	15 Participants
Incidence of Adverse Events (AEs) Any Treatment-Emergent Adverse Event (TEAE)	55 Participants
Incidence of Adverse Events (AEs) Any TEAE with Severity >= Grade 3	31 Participants
Incidence of Adverse Events (AEs) Any Treatment-Related Adverse Event	54 Participants
Incidence of Adverse Events (AEs) Any Serious Adverse Event	18 Participants
Incidence of Adverse Events (AEs) Treatment Discontinuation Due to Adverse Event	20 Participants

SECONDARY outcome

Timeframe: Up to 3 weeks; first cycle of therapy through the first day of Cycle 2

Population: An initial safety cohort of 10 patients who enrolled and received at least 1 dose of brentuximab vedotin were evaluated for this outcome.

Incidence of dose-limiting toxicity (DLT) was evaluated in an initial safety cohort of 10 patients who were followed for protocol-defined DLT events until Cycle 2 Day 1.

Outcome measures

Outcome measures
Measure	Brentuximab Vedotin + Bendamustine n=10 Participants brentuximab vedotin: 1.8 mg/kg on Day 1 of 3-week cycles by intravenous (IV) infusion bendamustine: 90 mg/m\^2 on Days 1 and 2 of 3-week cycles by intravenous (IV) infusion
Incidence of Dose-limiting Toxicities	0 Participants

SECONDARY outcome

Timeframe: Up to 4.6 months

Population: All patients who received at least 2 cycles of combination treatment, had a baseline tumor assessment, and at least 1 post-baseline tumor assessment, or who had documented disease progression (including clinical disease progression) any time after the first dose of combination therapy.

Percentage of participants who achieved a best response of complete remission (CR, disappearance of all evidence of disease), partial remission (PR, regression of greater than or equal to 50% of measurable disease and no new sites), stable disease (SD, failure to obtain a complete or partial response or progressive disease), or progressive disease (PD, any new lesion or increase by 50% or more of previously involved sites from nadir) per Cheson 2007 Revised Response Criteria for Malignant Lymphoma

Outcome measures

Outcome measures
Measure	Brentuximab Vedotin + Bendamustine n=53 Participants brentuximab vedotin: 1.8 mg/kg on Day 1 of 3-week cycles by intravenous (IV) infusion bendamustine: 90 mg/m\^2 on Days 1 and 2 of 3-week cycles by intravenous (IV) infusion
Overall Best Response Rate Complete Remission	39 Participants
Overall Best Response Rate Partial Remission	10 Participants
Overall Best Response Rate Stable Disease	3 Participants
Overall Best Response Rate Progressive Disease	1 Participants

SECONDARY outcome

Timeframe: Up to 47.8 months

Population: Patients with a complete or partial response who received at least 2 cycles of combination treatment and had a baseline tumor assessment and at least 2 post-baseline tumor assessment, or who had documented disease progression (including clinical disease progression) at any time after the first dose of combination therapy.

The time from first observation of remission to disease progression/relapse or death from any cause, whichever occurs first.

Outcome measures

Outcome measures
Measure	Brentuximab Vedotin + Bendamustine n=49 Participants brentuximab vedotin: 1.8 mg/kg on Day 1 of 3-week cycles by intravenous (IV) infusion bendamustine: 90 mg/m\^2 on Days 1 and 2 of 3-week cycles by intravenous (IV) infusion
Duration of Response	43.0 months Interval 18.7 to 47.8

SECONDARY outcome

Timeframe: Up to 49 months

Population: All patients who received at least 2 cycles of combination treatment and had a baseline tumor assessment and at least 1 post-baseline tumor assessment, or who had documented disease progression (including clinical disease progression) at any time after the first dose of combination therapy.

The time from first dose of study medication to first documentation of disease progression/relapse, or to death due to any cause, whichever occurs first.

Outcome measures

Outcome measures
Measure	Brentuximab Vedotin + Bendamustine n=53 Participants brentuximab vedotin: 1.8 mg/kg on Day 1 of 3-week cycles by intravenous (IV) infusion bendamustine: 90 mg/m\^2 on Days 1 and 2 of 3-week cycles by intravenous (IV) infusion
Progression-free Survival	44.2 months Interval 20.9 to 49.0

Adverse Events

Brentuximab Vedotin + Bendamustine

Serious events: 18 serious events

Other events: 55 other events

Deaths: 5 deaths

Serious adverse events

Serious adverse events
Measure	Brentuximab Vedotin + Bendamustine n=55 participants at risk brentuximab vedotin: 1.8 mg/kg on Day 1 of 3-week cycles by intravenous (IV) infusion bendamustine: 90 mg/m\^2 on Days 1 and 2 of 3-week cycles by intravenous (IV) infusion
General disorders Pyrexia	14.5% 8/55 • Up to 13.8 months Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug.
General disorders Chills	5.5% 3/55 • Up to 13.8 months Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug.
General disorders Malaise	3.6% 2/55 • Up to 13.8 months Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug.
General disorders Pain	1.8% 1/55 • Up to 13.8 months Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug.
Vascular disorders Hypotension	9.1% 5/55 • Up to 13.8 months Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug.
Vascular disorders Deep vein thrombosis	1.8% 1/55 • Up to 13.8 months Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug.
Gastrointestinal disorders Diarrhoea	3.6% 2/55 • Up to 13.8 months Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug.
Gastrointestinal disorders Nausea	3.6% 2/55 • Up to 13.8 months Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug.
Gastrointestinal disorders Vomiting	3.6% 2/55 • Up to 13.8 months Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug.
Gastrointestinal disorders Colitis	1.8% 1/55 • Up to 13.8 months Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug.
Respiratory, thoracic and mediastinal disorders Chronic obstructive pulmonary disease	1.8% 1/55 • Up to 13.8 months Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug.
Respiratory, thoracic and mediastinal disorders Hypoxia	1.8% 1/55 • Up to 13.8 months Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug.
Respiratory, thoracic and mediastinal disorders Pneumonitis	1.8% 1/55 • Up to 13.8 months Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug.
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	1.8% 1/55 • Up to 13.8 months Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug.
Respiratory, thoracic and mediastinal disorders Throat tightness	1.8% 1/55 • Up to 13.8 months Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug.
Respiratory, thoracic and mediastinal disorders Wheezing	1.8% 1/55 • Up to 13.8 months Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug.
Skin and subcutaneous tissue disorders Rash maculo-papular	3.6% 2/55 • Up to 13.8 months Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug.
Skin and subcutaneous tissue disorders Urticaria	3.6% 2/55 • Up to 13.8 months Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug.
Skin and subcutaneous tissue disorders Erythema	1.8% 1/55 • Up to 13.8 months Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug.
Skin and subcutaneous tissue disorders Rash papular	1.8% 1/55 • Up to 13.8 months Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug.
Blood and lymphatic system disorders Febrile neutropenia	3.6% 2/55 • Up to 13.8 months Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug.
Infections and infestations Phlebitis infective	1.8% 1/55 • Up to 13.8 months Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug.
Infections and infestations Pneumonia	1.8% 1/55 • Up to 13.8 months Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug.
Metabolism and nutrition disorders Decreased appetite	3.6% 2/55 • Up to 13.8 months Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug.
Metabolism and nutrition disorders Dehydration	3.6% 2/55 • Up to 13.8 months Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug.
Musculoskeletal and connective tissue disorders Arthralgia	1.8% 1/55 • Up to 13.8 months Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug.
Musculoskeletal and connective tissue disorders Myalgia	1.8% 1/55 • Up to 13.8 months Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Myelodysplastic syndrome	1.8% 1/55 • Up to 13.8 months Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug.
Nervous system disorders Syncope	1.8% 1/55 • Up to 13.8 months Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug.

Other adverse events

Other adverse events
Measure	Brentuximab Vedotin + Bendamustine n=55 participants at risk brentuximab vedotin: 1.8 mg/kg on Day 1 of 3-week cycles by intravenous (IV) infusion bendamustine: 90 mg/m\^2 on Days 1 and 2 of 3-week cycles by intravenous (IV) infusion
Gastrointestinal disorders Nausea	72.7% 40/55 • Up to 13.8 months Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug.
Gastrointestinal disorders Diarrhoea	36.4% 20/55 • Up to 13.8 months Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug.
Gastrointestinal disorders Vomiting	36.4% 20/55 • Up to 13.8 months Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug.
Gastrointestinal disorders Constipation	30.9% 17/55 • Up to 13.8 months Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug.
Gastrointestinal disorders Abdominal pain	9.1% 5/55 • Up to 13.8 months Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug.
Gastrointestinal disorders Dry mouth	7.3% 4/55 • Up to 13.8 months Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug.
Gastrointestinal disorders Dyspepsia	7.3% 4/55 • Up to 13.8 months Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug.
Gastrointestinal disorders Dysphagia	7.3% 4/55 • Up to 13.8 months Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug.
Gastrointestinal disorders Gastrooesophageal reflux disease	5.5% 3/55 • Up to 13.8 months Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug.
General disorders Fatigue	54.5% 30/55 • Up to 13.8 months Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug.
General disorders Chills	27.3% 15/55 • Up to 13.8 months Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug.
General disorders Pyrexia	27.3% 15/55 • Up to 13.8 months Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug.
General disorders Oedemia peripheral	12.7% 7/55 • Up to 13.8 months Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug.
General disorders Pain	12.7% 7/55 • Up to 13.8 months Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug.
General disorders Malaise	7.3% 4/55 • Up to 13.8 months Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug.
General disorders Non-cardiac chest pain	7.3% 4/55 • Up to 13.8 months Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug.
General disorders Asthenia	5.5% 3/55 • Up to 13.8 months Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug.
General disorders Chest discomfort	5.5% 3/55 • Up to 13.8 months Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug.
Skin and subcutaneous tissue disorders Alopecia	25.5% 14/55 • Up to 13.8 months Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug.
Skin and subcutaneous tissue disorders Rash	25.5% 14/55 • Up to 13.8 months Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug.
Skin and subcutaneous tissue disorders Pruritus	23.6% 13/55 • Up to 13.8 months Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug.
Skin and subcutaneous tissue disorders Rash generalised	12.7% 7/55 • Up to 13.8 months Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug.
Skin and subcutaneous tissue disorders Rash maculo-papular	12.7% 7/55 • Up to 13.8 months Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug.
Skin and subcutaneous tissue disorders Rash pruritic	10.9% 6/55 • Up to 13.8 months Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug.
Skin and subcutaneous tissue disorders Night sweats	9.1% 5/55 • Up to 13.8 months Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug.
Skin and subcutaneous tissue disorders Erythema	5.5% 3/55 • Up to 13.8 months Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug.
Skin and subcutaneous tissue disorders Pruritus generalised	5.5% 3/55 • Up to 13.8 months Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug.
Skin and subcutaneous tissue disorders Rash erythematous	5.5% 3/55 • Up to 13.8 months Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug.
Skin and subcutaneous tissue disorders Swelling face	5.5% 3/55 • Up to 13.8 months Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug.
Nervous system disorders Peripheral sensory neuropathy	25.5% 14/55 • Up to 13.8 months Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug.
Nervous system disorders Headache	20.0% 11/55 • Up to 13.8 months Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug.
Nervous system disorders Neuropathy peripheral	18.2% 10/55 • Up to 13.8 months Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug.
Nervous system disorders Dizziness	14.5% 8/55 • Up to 13.8 months Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug.
Nervous system disorders Paraesthesia	14.5% 8/55 • Up to 13.8 months Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug.
Nervous system disorders Hypoaesthesia	7.3% 4/55 • Up to 13.8 months Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug.
Nervous system disorders Dysgeusia	5.5% 3/55 • Up to 13.8 months Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug.
Respiratory, thoracic and mediastinal disorders Dyspnoea	25.5% 14/55 • Up to 13.8 months Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug.
Respiratory, thoracic and mediastinal disorders Cough	23.6% 13/55 • Up to 13.8 months Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug.
Respiratory, thoracic and mediastinal disorders Nasal congestion	12.7% 7/55 • Up to 13.8 months Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug.
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	10.9% 6/55 • Up to 13.8 months Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug.
Respiratory, thoracic and mediastinal disorders Dyspnoea exertional	9.1% 5/55 • Up to 13.8 months Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug.
Respiratory, thoracic and mediastinal disorders Productive cough	7.3% 4/55 • Up to 13.8 months Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug.
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	5.5% 3/55 • Up to 13.8 months Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug.
Respiratory, thoracic and mediastinal disorders Throat tightness	5.5% 3/55 • Up to 13.8 months Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug.
Respiratory, thoracic and mediastinal disorders Wheezing	5.5% 3/55 • Up to 13.8 months Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug.
Musculoskeletal and connective tissue disorders Back pain	18.2% 10/55 • Up to 13.8 months Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug.
Musculoskeletal and connective tissue disorders Bone pain	16.4% 9/55 • Up to 13.8 months Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug.
Musculoskeletal and connective tissue disorders Arthralgia	14.5% 8/55 • Up to 13.8 months Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug.
Musculoskeletal and connective tissue disorders Muscular weakness	12.7% 7/55 • Up to 13.8 months Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug.
Musculoskeletal and connective tissue disorders Pain in extremity	7.3% 4/55 • Up to 13.8 months Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug.
Musculoskeletal and connective tissue disorders Musculoskeletal pain	5.5% 3/55 • Up to 13.8 months Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug.
Musculoskeletal and connective tissue disorders Neck pain	5.5% 3/55 • Up to 13.8 months Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug.
Metabolism and nutrition disorders Decreased appetite	18.2% 10/55 • Up to 13.8 months Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug.
Metabolism and nutrition disorders Dehydration	9.1% 5/55 • Up to 13.8 months Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug.
Metabolism and nutrition disorders Hypokalaemia	9.1% 5/55 • Up to 13.8 months Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug.
Metabolism and nutrition disorders Hyperglycaemia	7.3% 4/55 • Up to 13.8 months Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug.
Metabolism and nutrition disorders Hyperuricaemia	5.5% 3/55 • Up to 13.8 months Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug.
Vascular disorders Flushing	18.2% 10/55 • Up to 13.8 months Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug.
Vascular disorders Hot flush	10.9% 6/55 • Up to 13.8 months Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug.
Vascular disorders Hypotension	5.5% 3/55 • Up to 13.8 months Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug.
Infections and infestations Upper respiratory tract infection	14.5% 8/55 • Up to 13.8 months Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug.
Infections and infestations Urinary tract infection	9.1% 5/55 • Up to 13.8 months Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug.
Infections and infestations Herpes zoster	5.5% 3/55 • Up to 13.8 months Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug.
Investigations Weight decreased	9.1% 5/55 • Up to 13.8 months Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug.
Blood and lymphatic system disorders Lymphopenia	12.7% 7/55 • Up to 13.8 months Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug.
Blood and lymphatic system disorders Neutropenia	7.3% 4/55 • Up to 13.8 months Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug.
Psychiatric disorders Insomnia	20.0% 11/55 • Up to 13.8 months Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug.
Psychiatric disorders Anxiety	9.1% 5/55 • Up to 13.8 months Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug.
Cardiac disorders Tachycardia	5.5% 3/55 • Up to 13.8 months Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug.
Ear and labyrinth disorders Ear pain	5.5% 3/55 • Up to 13.8 months Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug.

Additional Information

Chief Medical Officer

Seattle Genetics, Inc.

Phone: 855-473-2436

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee The first study related publication will be a multi-center publication submitted within 18 months after conclusion or termination of a study at all sites. After such multi-site publication, all proposed site publications and presentations will be submitted to the Sponsor for review 60 days in advance of publication. Site will remove Sponsor confidential information unrelated to study results. Sponsor can delay a proposed publication for another 60 days to preserve intellectual property.
Publication restrictions are in place

Restriction type: OTHER