Trial Outcomes & Findings for A Phase 2 Open Label Trial of Brentuximab Vedotin (SGN-35) for Systemic Anaplastic Large Cell Lymphoma (NCT NCT00866047)

NCT ID: NCT00866047

Last Updated: 2017-03-22

Results Overview

Percentage of participants who achieved a best response of complete remission (CR, disappearance of all evidence of disease) or partial remission (PR, regression of greater than or equal to 50% of measurable disease and no new sites) per Cheson 2007 Revised Response Criteria for Malignant Lymphoma.

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 58 participants
• Primary outcome timeframe: up to 12 months
• Results posted on: 2017-03-22

Participant Flow

Enrollment period: Jun 2009 - May 2010

Participant milestones

Measure	Brentuximab Vedotin Brentuximab vedotin 1.8 mg/kg every 3 weeks by intravenous (IV) infusion
Treatment Period STARTED	58
Treatment Period COMPLETED	10
Treatment Period NOT COMPLETED	48
Follow-up Period STARTED	58
Follow-up Period COMPLETED	53
Follow-up Period NOT COMPLETED	5

Reasons for withdrawal

Measure	Brentuximab Vedotin Brentuximab vedotin 1.8 mg/kg every 3 weeks by intravenous (IV) infusion
Treatment Period Progressive disease	13
Treatment Period Adverse Event	16
Treatment Period Physician Decision	14
Treatment Period Withdrawal by Subject	5
Follow-up Period Lost to Follow-up	5

Baseline Characteristics

A Phase 2 Open Label Trial of Brentuximab Vedotin (SGN-35) for Systemic Anaplastic Large Cell Lymphoma

Baseline characteristics by cohort

Measure	Brentuximab Vedotin n=58 Participants Brentuximab vedotin 1.8 mg/kg every 3 weeks by IV infusion
Age, Customized	52.0 years n=5 Participants
Sex: Female, Male Female	25 Participants n=5 Participants
Sex: Female, Male Male	33 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	7 Participants n=5 Participants
Race (NIH/OMB) White	48 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	2 Participants n=5 Participants
Eastern Cooperative Oncology Group Performance Status 0	19 participants n=5 Participants
Eastern Cooperative Oncology Group Performance Status 1	38 participants n=5 Participants
Eastern Cooperative Oncology Group Performance Status 2	1 participants n=5 Participants
Eastern Cooperative Oncology Group Performance Status 3-5	0 participants n=5 Participants
ALK Status Positive	16 participants n=5 Participants
ALK Status Negative	42 participants n=5 Participants

PRIMARY outcome

Timeframe: up to 12 months

Population: Intention to treat

Percentage of participants who achieved a best response of complete remission (CR, disappearance of all evidence of disease) or partial remission (PR, regression of greater than or equal to 50% of measurable disease and no new sites) per Cheson 2007 Revised Response Criteria for Malignant Lymphoma.

Outcome measures

Measure	Brentuximab Vedotin n=58 Participants Brentuximab vedotin 1.8 mg/kg every 3 weeks by IV infusion
Objective Response Rate by Independent Review Group	86 percent of participants Interval 74.6 to 93.9

SECONDARY outcome

Timeframe: up to 12 months

Population: Intention to treat

Percentage of participants who achieved a best response of CR (disappearance of all evidence of disease) per Cheson 2007 Revised Response Criteria for Malignant Lymphoma.

Outcome measures

Measure	Brentuximab Vedotin n=58 Participants Brentuximab vedotin 1.8 mg/kg every 3 weeks by IV infusion
Complete Remission Rate by Independent Review Group	59 percent of participants Interval 44.9 to 71.4

SECONDARY outcome

Timeframe: up to approximately 3 years

Population: Participants with objective response among the intention to treat population

Duration of objective response (CR + PR) by independent review group, defined as time of initial response until disease progression or death.

Outcome measures

Measure	Brentuximab Vedotin n=50 Participants Brentuximab vedotin 1.8 mg/kg every 3 weeks by IV infusion
Duration of Objective Response by Kaplan-Meier Analysis	13.2 months Interval 5.7 to 26.3

SECONDARY outcome

Timeframe: up to approximately 3 years

Population: Participants with complete remission among the intention to treat population

Duration of response from start of first objective tumor response (CR or PR) by independent review group to disease progression or death due to any cause in participants with CR.

Outcome measures

Measure	Brentuximab Vedotin n=34 Participants Brentuximab vedotin 1.8 mg/kg every 3 weeks by IV infusion
Duration of Objective Response in Participants With Complete Remission by Kaplan-Meier Analysis	26.3 months Interval 13.2 to Insufficient number of events to estimate upper bound

SECONDARY outcome

Timeframe: up to approximately 3 years

Population: Intention to treat

Time from start of study treatment to disease progression per independent review group or death due to any cause.

Outcome measures

Measure	Brentuximab Vedotin n=58 Participants Brentuximab vedotin 1.8 mg/kg every 3 weeks by IV infusion
Progression-free Survival by Kaplan-Meier Analysis	14.6 months Interval 6.9 to 20.6

SECONDARY outcome

Timeframe: up to approximately 7 years

Population: Intention to treat

Time from start of study treatment to date of death due to any cause.

Outcome measures

Measure	Brentuximab Vedotin n=58 Participants Brentuximab vedotin 1.8 mg/kg every 3 weeks by IV infusion
Overall Survival	NA months Interval 21.3 to Insufficient number of events to estimate median and upper bound

SECONDARY outcome

Timeframe: up to 12 months

Population: All participants who received treatment

Counts of participants who had adverse events or treatment-emergent adverse events (TEAE, defined as newly occurring or worsening after first dose). Serious adverse events are reported from the time of informed consent. National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE version 3.0) were used to assess severity (1=mild, 2=moderate, 3=severe, 4=life threatening/disabling, 5=death). Relatedness to study drug was assessed by the investigator (Yes/No). Participants with multiple occurrences of an adverse event within a category are counted once within the category.

Outcome measures

Measure	Brentuximab Vedotin n=58 Participants Brentuximab vedotin 1.8 mg/kg every 3 weeks by IV infusion
Adverse Events by Severity, Seriousness, and Relationship to Treatment Any TEAE	58 participants
Adverse Events by Severity, Seriousness, and Relationship to Treatment TEAE related to study drug	53 participants
Adverse Events by Severity, Seriousness, and Relationship to Treatment TEAE with CTCAE severity grade >/=3	36 participants
Adverse Events by Severity, Seriousness, and Relationship to Treatment Serious adverse event	25 participants
Adverse Events by Severity, Seriousness, and Relationship to Treatment Serious adverse event related to study drug	11 participants
Adverse Events by Severity, Seriousness, and Relationship to Treatment Discontinued treatment due to adverse event	16 participants

SECONDARY outcome

Timeframe: up to 12 months

Population: All participants who received treatment

Counts of study participants with post-baseline hematology laboratory abnormalities of Grade 3 or greater per NCI CTCAE version 3.0. Participants with multiple occurrences of a laboratory abnormality within a category are counted once in that category.

Outcome measures

Measure	Brentuximab Vedotin n=58 Participants Brentuximab vedotin 1.8 mg/kg every 3 weeks by IV infusion
Hematology Laboratory Abnormalities >/= Grade 3 Platelets (low)	3 participants
Hematology Laboratory Abnormalities >/= Grade 3 Any >/= Grade 3 hematology laboratory abnormality	17 participants
Hematology Laboratory Abnormalities >/= Grade 3 Leukocytes (low)	3 participants
Hematology Laboratory Abnormalities >/= Grade 3 Lymphocytes (low)	10 participants
Hematology Laboratory Abnormalities >/= Grade 3 Neutrophils (low)	7 participants

SECONDARY outcome

Timeframe: up to 12 months

Population: All participants who received treatment

Counts of study participants with post-baseline chemistry laboratory abnormalities of Grade 3 or greater per NCI CTCAE version 3.0. Participants with multiple occurrences of a laboratory abnormality within a category are counted once in that category.

Outcome measures

Measure	Brentuximab Vedotin n=58 Participants Brentuximab vedotin 1.8 mg/kg every 3 weeks by IV infusion
Chemistry Laboratory Abnormalities >/= Grade 3 Any >/= Grade 3 chemistry laboratory abnormality	13 participants
Chemistry Laboratory Abnormalities >/= Grade 3 Glucose (high)	4 participants
Chemistry Laboratory Abnormalities >/= Grade 3 Calcium (low)	3 participants
Chemistry Laboratory Abnormalities >/= Grade 3 Potassium (low)	1 participants
Chemistry Laboratory Abnormalities >/= Grade 3 Aspartate aminotransferase (high)	1 participants
Chemistry Laboratory Abnormalities >/= Grade 3 Sodium (low)	1 participants
Chemistry Laboratory Abnormalities >/= Grade 3 Urate (high)	3 participants

SECONDARY outcome

Timeframe: 3 weeks

Population: All participants who received treatment

Area under the serum concentration-time curve from time 0 to 21 days following the first dose of brentuximab vedotin

Outcome measures

Measure	Brentuximab Vedotin n=58 Participants Brentuximab vedotin 1.8 mg/kg every 3 weeks by IV infusion
Area Under the Curve	98 day * microgram/mL Geometric Coefficient of Variation 69

SECONDARY outcome

Timeframe: 3 weeks

Population: All participants who received treatment

Maximum serum concentration from 0 to 21 days following the first dose of brentuximab vedotin

Outcome measures

Measure	Brentuximab Vedotin n=58 Participants Brentuximab vedotin 1.8 mg/kg every 3 weeks by IV infusion
Maximum Serum Concentration	37 microgram/mL Geometric Coefficient of Variation 20

SECONDARY outcome

Timeframe: 3 weeks

Population: All participants who received treatment

Time of maximum serum concentration from 0 to 21 days following the first dose of brentuximab vedotin

Outcome measures

Measure	Brentuximab Vedotin n=58 Participants Brentuximab vedotin 1.8 mg/kg every 3 weeks by IV infusion
Time of Maximum Serum Concentration	0.02 days Interval 0.02 to 0.02

OTHER_PRE_SPECIFIED outcome

Timeframe: up to 12 months

Population: Participants with B symptoms at baseline

Percentage of participants with lymphoma-related symptoms (B symptoms: fever, night sweats, or weight loss >10%) at baseline who achieved resolution of all B symptoms at any time during the treatment period.

Outcome measures

Measure	Brentuximab Vedotin n=17 Participants Brentuximab vedotin 1.8 mg/kg every 3 weeks by IV infusion
B Symptom Resolution	82 percent of participants Interval 56.6 to 96.2

Adverse Events

Brentuximab Vedotin

Serious events: 25 serious events

Other events: 58 other events

Deaths: 0 deaths

Serious adverse events

Measure	Brentuximab Vedotin n=58 participants at risk Brentuximab vedotin 1.8 mg/kg every 3 weeks by IV infusion
Blood and lymphatic system disorders Anaemia	1.7% 1/58 • Adverse events through 30 days after last dose (up to 12 months)
Blood and lymphatic system disorders Neutropenia	1.7% 1/58 • Adverse events through 30 days after last dose (up to 12 months)
Cardiac disorders Acute myocardial infarction	1.7% 1/58 • Adverse events through 30 days after last dose (up to 12 months)
Cardiac disorders Arrhythmia supraventricular	3.4% 2/58 • Adverse events through 30 days after last dose (up to 12 months)
Cardiac disorders Atrial fibrillation	1.7% 1/58 • Adverse events through 30 days after last dose (up to 12 months)
Cardiac disorders Atrioventricular block complete	1.7% 1/58 • Adverse events through 30 days after last dose (up to 12 months)
Cardiac disorders Bradycardia	1.7% 1/58 • Adverse events through 30 days after last dose (up to 12 months)
Eye disorders Retinal vein occlusion	1.7% 1/58 • Adverse events through 30 days after last dose (up to 12 months)
Gastrointestinal disorders Abdominal pain	1.7% 1/58 • Adverse events through 30 days after last dose (up to 12 months)
Gastrointestinal disorders Constipation	1.7% 1/58 • Adverse events through 30 days after last dose (up to 12 months)
Gastrointestinal disorders Diarrhoea	1.7% 1/58 • Adverse events through 30 days after last dose (up to 12 months)
Gastrointestinal disorders Gastrointestinal haemorrhage	1.7% 1/58 • Adverse events through 30 days after last dose (up to 12 months)
Gastrointestinal disorders Vomiting	1.7% 1/58 • Adverse events through 30 days after last dose (up to 12 months)
General disorders Asthenia	1.7% 1/58 • Adverse events through 30 days after last dose (up to 12 months)
General disorders Generalised oedema	1.7% 1/58 • Adverse events through 30 days after last dose (up to 12 months)
General disorders Sudden death	1.7% 1/58 • Adverse events through 30 days after last dose (up to 12 months)
Infections and infestations Cellulitis	1.7% 1/58 • Adverse events through 30 days after last dose (up to 12 months)
Infections and infestations Endocarditis staphylococcal	1.7% 1/58 • Adverse events through 30 days after last dose (up to 12 months)
Infections and infestations Gastroenteritis viral	1.7% 1/58 • Adverse events through 30 days after last dose (up to 12 months)
Infections and infestations Klebsiella bacteraemia	1.7% 1/58 • Adverse events through 30 days after last dose (up to 12 months)
Infections and infestations Pneumonia	1.7% 1/58 • Adverse events through 30 days after last dose (up to 12 months)
Infections and infestations Septic shock	3.4% 2/58 • Adverse events through 30 days after last dose (up to 12 months)
Infections and infestations Superinfection bacterial	1.7% 1/58 • Adverse events through 30 days after last dose (up to 12 months)
Infections and infestations Urinary tract infection	3.4% 2/58 • Adverse events through 30 days after last dose (up to 12 months)
Injury, poisoning and procedural complications Lower limb fracture	1.7% 1/58 • Adverse events through 30 days after last dose (up to 12 months)
Metabolism and nutrition disorders Decreased appetite	1.7% 1/58 • Adverse events through 30 days after last dose (up to 12 months)
Metabolism and nutrition disorders Fluid overload	1.7% 1/58 • Adverse events through 30 days after last dose (up to 12 months)
Metabolism and nutrition disorders Hypercalcaemia	1.7% 1/58 • Adverse events through 30 days after last dose (up to 12 months)
Metabolism and nutrition disorders Tumour lysis syndrome	1.7% 1/58 • Adverse events through 30 days after last dose (up to 12 months)
Musculoskeletal and connective tissue disorders Myositis	1.7% 1/58 • Adverse events through 30 days after last dose (up to 12 months)
Musculoskeletal and connective tissue disorders Pain in extremity	3.4% 2/58 • Adverse events through 30 days after last dose (up to 12 months)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Anaplastic large cell lymphoma t- and null-cell types recurrent	5.2% 3/58 • Adverse events through 30 days after last dose (up to 12 months)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Mycosis fungoides	1.7% 1/58 • Adverse events through 30 days after last dose (up to 12 months)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tumour flare	1.7% 1/58 • Adverse events through 30 days after last dose (up to 12 months)
Nervous system disorders Encephalopathy	1.7% 1/58 • Adverse events through 30 days after last dose (up to 12 months)
Nervous system disorders Haemorrhage intracranial	1.7% 1/58 • Adverse events through 30 days after last dose (up to 12 months)
Nervous system disorders Neuralgia	1.7% 1/58 • Adverse events through 30 days after last dose (up to 12 months)
Nervous system disorders Peripheral motor neuropathy	1.7% 1/58 • Adverse events through 30 days after last dose (up to 12 months)
Nervous system disorders Peripheral sensory neuropathy	1.7% 1/58 • Adverse events through 30 days after last dose (up to 12 months)
Nervous system disorders Spinal cord compression	1.7% 1/58 • Adverse events through 30 days after last dose (up to 12 months)
Nervous system disorders Syncope	1.7% 1/58 • Adverse events through 30 days after last dose (up to 12 months)
Psychiatric disorders Mental status changes	1.7% 1/58 • Adverse events through 30 days after last dose (up to 12 months)
Renal and urinary disorders Hydronephrosis	1.7% 1/58 • Adverse events through 30 days after last dose (up to 12 months)
Renal and urinary disorders Renal failure	1.7% 1/58 • Adverse events through 30 days after last dose (up to 12 months)
Renal and urinary disorders Renal failure acute	1.7% 1/58 • Adverse events through 30 days after last dose (up to 12 months)
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	1.7% 1/58 • Adverse events through 30 days after last dose (up to 12 months)
Respiratory, thoracic and mediastinal disorders Pulmonary oedema	1.7% 1/58 • Adverse events through 30 days after last dose (up to 12 months)
Respiratory, thoracic and mediastinal disorders Respiratory failure	1.7% 1/58 • Adverse events through 30 days after last dose (up to 12 months)
Respiratory, thoracic and mediastinal disorders Tracheal disorder	1.7% 1/58 • Adverse events through 30 days after last dose (up to 12 months)
Skin and subcutaneous tissue disorders Rash papular	1.7% 1/58 • Adverse events through 30 days after last dose (up to 12 months)
Vascular disorders Deep vein thrombosis	1.7% 1/58 • Adverse events through 30 days after last dose (up to 12 months)
Nervous system disorders Demyelinating polyneuropathy	1.7% 1/58 • Adverse events through 30 days after last dose (up to 12 months)

Other adverse events

Measure	Brentuximab Vedotin n=58 participants at risk Brentuximab vedotin 1.8 mg/kg every 3 weeks by IV infusion
Blood and lymphatic system disorders Anaemia	8.6% 5/58 • Adverse events through 30 days after last dose (up to 12 months)
Blood and lymphatic system disorders Lymphadenopathy	10.3% 6/58 • Adverse events through 30 days after last dose (up to 12 months)
Blood and lymphatic system disorders Neutropenia	19.0% 11/58 • Adverse events through 30 days after last dose (up to 12 months)
Blood and lymphatic system disorders Thrombocytopenia	13.8% 8/58 • Adverse events through 30 days after last dose (up to 12 months)
Gastrointestinal disorders Abdominal distension	5.2% 3/58 • Adverse events through 30 days after last dose (up to 12 months)
Gastrointestinal disorders Abdominal pain	8.6% 5/58 • Adverse events through 30 days after last dose (up to 12 months)
Gastrointestinal disorders Constipation	20.7% 12/58 • Adverse events through 30 days after last dose (up to 12 months)
Gastrointestinal disorders Diarrhoea	27.6% 16/58 • Adverse events through 30 days after last dose (up to 12 months)
Gastrointestinal disorders Dyspepsia	8.6% 5/58 • Adverse events through 30 days after last dose (up to 12 months)
Gastrointestinal disorders Nausea	39.7% 23/58 • Adverse events through 30 days after last dose (up to 12 months)
Gastrointestinal disorders Oral pain	8.6% 5/58 • Adverse events through 30 days after last dose (up to 12 months)
Gastrointestinal disorders Vomiting	15.5% 9/58 • Adverse events through 30 days after last dose (up to 12 months)
General disorders Asthenia	8.6% 5/58 • Adverse events through 30 days after last dose (up to 12 months)
General disorders Chills	13.8% 8/58 • Adverse events through 30 days after last dose (up to 12 months)
General disorders Fatigue	37.9% 22/58 • Adverse events through 30 days after last dose (up to 12 months)
General disorders Oedema peripheral	13.8% 8/58 • Adverse events through 30 days after last dose (up to 12 months)
General disorders Pain	10.3% 6/58 • Adverse events through 30 days after last dose (up to 12 months)
General disorders Pyrexia	34.5% 20/58 • Adverse events through 30 days after last dose (up to 12 months)
Infections and infestations Bronchitis	5.2% 3/58 • Adverse events through 30 days after last dose (up to 12 months)
Infections and infestations Folliculitis	8.6% 5/58 • Adverse events through 30 days after last dose (up to 12 months)
Infections and infestations Upper respiratory tract infection	19.0% 11/58 • Adverse events through 30 days after last dose (up to 12 months)
Injury, poisoning and procedural complications Excoriation	5.2% 3/58 • Adverse events through 30 days after last dose (up to 12 months)
Investigations Weight decreased	13.8% 8/58 • Adverse events through 30 days after last dose (up to 12 months)
Metabolism and nutrition disorders Decreased appetite	13.8% 8/58 • Adverse events through 30 days after last dose (up to 12 months)
Metabolism and nutrition disorders Dehydration	5.2% 3/58 • Adverse events through 30 days after last dose (up to 12 months)
Metabolism and nutrition disorders Hyperglycaemia	5.2% 3/58 • Adverse events through 30 days after last dose (up to 12 months)
Metabolism and nutrition disorders Hypokalaemia	8.6% 5/58 • Adverse events through 30 days after last dose (up to 12 months)
Musculoskeletal and connective tissue disorders Arthralgia	8.6% 5/58 • Adverse events through 30 days after last dose (up to 12 months)
Musculoskeletal and connective tissue disorders Back pain	8.6% 5/58 • Adverse events through 30 days after last dose (up to 12 months)
Musculoskeletal and connective tissue disorders Groin pain	8.6% 5/58 • Adverse events through 30 days after last dose (up to 12 months)
Musculoskeletal and connective tissue disorders Muscle spasms	13.8% 8/58 • Adverse events through 30 days after last dose (up to 12 months)
Musculoskeletal and connective tissue disorders Musculoskeletal pain	6.9% 4/58 • Adverse events through 30 days after last dose (up to 12 months)
Musculoskeletal and connective tissue disorders Myalgia	15.5% 9/58 • Adverse events through 30 days after last dose (up to 12 months)
Musculoskeletal and connective tissue disorders Neck pain	8.6% 5/58 • Adverse events through 30 days after last dose (up to 12 months)
Musculoskeletal and connective tissue disorders Pain in extremity	10.3% 6/58 • Adverse events through 30 days after last dose (up to 12 months)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tumour flare	6.9% 4/58 • Adverse events through 30 days after last dose (up to 12 months)
Nervous system disorders Dizziness	15.5% 9/58 • Adverse events through 30 days after last dose (up to 12 months)
Nervous system disorders Headache	19.0% 11/58 • Adverse events through 30 days after last dose (up to 12 months)
Nervous system disorders Paraesthesia	8.6% 5/58 • Adverse events through 30 days after last dose (up to 12 months)
Nervous system disorders Peripheral motor neuropathy	5.2% 3/58 • Adverse events through 30 days after last dose (up to 12 months)
Nervous system disorders Peripheral sensory neuropathy	41.4% 24/58 • Adverse events through 30 days after last dose (up to 12 months)
Psychiatric disorders Anxiety	6.9% 4/58 • Adverse events through 30 days after last dose (up to 12 months)
Psychiatric disorders Confusional state	5.2% 3/58 • Adverse events through 30 days after last dose (up to 12 months)
Psychiatric disorders Depression	6.9% 4/58 • Adverse events through 30 days after last dose (up to 12 months)
Psychiatric disorders Insomnia	15.5% 9/58 • Adverse events through 30 days after last dose (up to 12 months)
Respiratory, thoracic and mediastinal disorders Cough	17.2% 10/58 • Adverse events through 30 days after last dose (up to 12 months)
Respiratory, thoracic and mediastinal disorders Dyspnoea	19.0% 11/58 • Adverse events through 30 days after last dose (up to 12 months)
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	6.9% 4/58 • Adverse events through 30 days after last dose (up to 12 months)
Respiratory, thoracic and mediastinal disorders Productive cough	5.2% 3/58 • Adverse events through 30 days after last dose (up to 12 months)
Skin and subcutaneous tissue disorders Alopecia	13.8% 8/58 • Adverse events through 30 days after last dose (up to 12 months)
Skin and subcutaneous tissue disorders Dermatitis	6.9% 4/58 • Adverse events through 30 days after last dose (up to 12 months)
Skin and subcutaneous tissue disorders Dry skin	10.3% 6/58 • Adverse events through 30 days after last dose (up to 12 months)
Skin and subcutaneous tissue disorders Night sweats	6.9% 4/58 • Adverse events through 30 days after last dose (up to 12 months)
Skin and subcutaneous tissue disorders Pruritus	19.0% 11/58 • Adverse events through 30 days after last dose (up to 12 months)
Skin and subcutaneous tissue disorders Rash	24.1% 14/58 • Adverse events through 30 days after last dose (up to 12 months)
Skin and subcutaneous tissue disorders Rash pruritic	6.9% 4/58 • Adverse events through 30 days after last dose (up to 12 months)
Vascular disorders Hot flush	5.2% 3/58 • Adverse events through 30 days after last dose (up to 12 months)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Anaplastic large cell lymphoma t- and null-cell types recurrent	5.2% 3/58 • Adverse events through 30 days after last dose (up to 12 months)
Metabolism and nutrition disorders Hypomagnesaemia	5.2% 3/58 • Adverse events through 30 days after last dose (up to 12 months)
Infections and infestations Nasopharyngitis	5.2% 3/58 • Adverse events through 30 days after last dose (up to 12 months)
Infections and infestations Sinusitis	6.9% 4/58 • Adverse events through 30 days after last dose (up to 12 months)
Cardiac disorders Tachycardia	5.2% 3/58 • Adverse events through 30 days after last dose (up to 12 months)
Gastrointestinal disorders Gastrooesophageal reflux disease	5.2% 3/58 • Adverse events through 30 days after last dose (up to 12 months)
Gastrointestinal disorders Haemorrhoids	5.2% 3/58 • Adverse events through 30 days after last dose (up to 12 months)
Nervous system disorders Memory impairment	5.2% 3/58 • Adverse events through 30 days after last dose (up to 12 months)
Nervous system disorders Neuralgia	5.2% 3/58 • Adverse events through 30 days after last dose (up to 12 months)

Additional Information

Chief Medical Officer

Seattle Genetics, Inc.

Phone: 855-473-2436

Email: medinfo@seagen.com

Results disclosure agreements

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

Restriction type: LTE60