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A Brentuximab Vedotin Trial for Patients Who Have Previously Participated in a Brentuximab Vedotin Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00947856
Recruitment Status : Completed
First Posted : July 28, 2009
Results First Posted : May 26, 2014
Last Update Posted : February 2, 2017
Sponsor:
Collaborator:
Millennium Pharmaceuticals, Inc.
Information provided by (Responsible Party):
Seagen Inc.

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Disease, Hodgkin
Lymphoma, Large-Cell, Anaplastic
Lymphoma, Non-Hodgkin
Intervention Drug: brentuximab vedotin
Enrollment 110
Recruitment Details Jul 2009 - Mar 2013
Pre-assignment Details  
Arm/Group Title BV Extension BV Retreatment
Hide Arm/Group Description Brentuximab vedotin 1.2 or 1.8 mg/kg every 3 weeks by IV infusion (continued treatment) Brentuximab vedotin 1.2 or 1.8 mg/kg every 3 weeks by IV infusion (retreatment after relapse)
Period Title: Treatment Period
Started 78 32 [1]
Completed 0 0 [2]
Not Completed 78 32
Reason Not Completed
Progressive Disease             33             12
Adverse Event             15             9
Physician Decision             14             6
Study Stopped by Sponsor             4             4
Withdrawal by Subject             12             1
[1]
Two patients in extension arm re-enrolled in retreatment arm and are represented in both arms
[2]
Patients treated until disease progression, unacceptable toxicity or study closure
Period Title: Follow-up Period
Started 78 32 [1]
Completed 27 9 [2]
Not Completed 51 23
Reason Not Completed
Study Stopped by Sponsor             40             20
Re-enrolled for Retreatment             2             3
Lost to Follow-up             7             0
Patient unavailable for site visits             1             0
Withdrawal by Subject             1             0
[1]
All participants were followed after treatment; thus, number started will not match number completed
[2]
Completed survival follow-up due to death
Arm/Group Title BV Extension BV Retreatment Total
Hide Arm/Group Description Brentuximab vedotin 1.2 or 1.8 mg/kg every 3 weeks by IV infusion (continued treatment) Brentuximab vedotin 1.2 or 1.8 mg/kg every 3 weeks by IV infusion (retreatment after relapse) Total of all reporting groups
Overall Number of Baseline Participants 78 32 110
Hide Baseline Analysis Population Description
All participants who received treatment
Age, Customized  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 78 participants 32 participants 110 participants
32
(15 to 78)
37
(16 to 72)
33.5
(15 to 78)
Gender  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 78 participants 32 participants 110 participants
Female
35
  44.9%
17
  53.1%
52
  47.3%
Male
43
  55.1%
15
  46.9%
58
  52.7%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 78 participants 32 participants 110 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
3
   3.8%
0
   0.0%
3
   2.7%
Native Hawaiian or Other Pacific Islander
1
   1.3%
0
   0.0%
1
   0.9%
Black or African American
7
   9.0%
4
  12.5%
11
  10.0%
White
66
  84.6%
27
  84.4%
93
  84.5%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
1
   1.3%
1
   3.1%
2
   1.8%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 78 participants 32 participants 110 participants
France 0 3 3
United States 78 29 107
Eastern Cooperative Oncology Group Performance Status   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 78 participants 32 participants 110 participants
0 47 12 59
1 30 18 48
2 0 2 2
3-5 0 0 0
Missing 1 0 1
[1]
Measure Description:

0 = Normal activity

  1. = Symptoms but ambulatory
  2. = In bed <50% of the time
  3. = In bed >50% of the time
  4. = 100% bedridden
  5. = Dead
Disease diagnosis  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 78 participants 32 participants 110 participants
Hodgkin lymphoma (HL) 68 21 89
Systemic anaplastic large cell lymphoma (ALCL) 8 8 16
Other 2 3 5
1.Primary Outcome
Title Objective Response Rate by Investigator
Hide Description Percentage of participants in the retreatment arm 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.
Time Frame Up to approximately 38 months
Hide Outcome Measure Data
Hide Analysis Population Description
Any patient who received retreatment and had postbaseline response results; 1 HL patient did not have postbaseline response results and 3 ALCL patients were retreated more than once.
Arm/Group Title BV Retreatment - HL BV Retreatment - ALCL BV Retreatment - Other BV Retreatment Total
Hide Arm/Group Description:
Patients with Hodgkin lymphoma (HL) enrolled and treated on the retreatment arm
Patients with anaplastic large cell lymphoma (ALCL) enrolled and treated on the retreatment arm
Patients with other disease diagnoses enrolled and treated on the retreatment arm
All patients enrolled and treated on the retreatment arm, including 3 patients retreated more than once
Overall Number of Participants Analyzed 21 8 3 32
Overall Number of Units Analyzed
Type of Units Analyzed: Retreatment Experiences
20 11 3 34
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of retreatment experiences
60
(36.1 to 80.9)
91
(58.7 to 99.8)
33
(0.8 to 90.6)
68
(49.5 to 82.6)
2.Primary Outcome
Title Adverse Events by Severity, Seriousness, and Relationship to Treatment
Hide Description Counts of participants who had adverse events or treatment-emergent adverse events (TEAE, defined as newly occurring or worsening after first dose on SGN35-006). 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.
Time Frame up to 39 months
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who received treatment
Arm/Group Title BV Extension BV Retreatment
Hide Arm/Group Description:
Brentuximab vedotin 1.2 or 1.8 mg/kg every 3 weeks by IV infusion (continued treatment)
Brentuximab vedotin 1.2 or 1.8 mg/kg every 3 weeks by IV infusion (retreatment after relapse)
Overall Number of Participants Analyzed 78 32
Measure Type: Number
Unit of Measure: participants
Any TEAE 75 31
TEAE related to study drug 65 27
TEAE with severity grade >/=3 37 16
Discontinued treatment due to adverse event 13 9
Serious adverse event 16 9
Serious adverse event related to study drug 10 4
3.Primary Outcome
Title Laboratory Abnormalities >/= Grade 3
Hide Description Counts of study participants with post-baseline 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.
Time Frame Up to 39 months
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who received treatment
Arm/Group Title BV Extension BV Retreatment
Hide Arm/Group Description:
Brentuximab vedotin 1.2 or 1.8 mg/kg every 3 weeks by IV infusion (continued treatment)
Brentuximab vedotin 1.2 or 1.8 mg/kg every 3 weeks by IV infusion (retreatment after relapse)
Overall Number of Participants Analyzed 78 32
Measure Type: Number
Unit of Measure: participants
Any >/= Grade 3 laboratory abnormality 29 12
Lymphocytes (low) 16 8
Leukocytes (low) 3 3
Neutrophils (low) 7 3
Phosphate (low) 7 3
Platelets (low) 4 3
Aspartate aminotransferase (high) 1 2
Glucose (high) 3 2
Alanine aminotransferase (high) 1 1
Bilirubin (high) 0 1
Calcium (low) 0 1
Hemoglobin (low) 1 1
Potassium (low) 0 1
Sodium (low) 2 0
4.Secondary Outcome
Title Duration of Objective Response by Kaplan-Meier Analysis
Hide Description Duration of objective response (CR + PR) on retreatment, defined as time of initial response until disease progression or death
Time Frame Up to 38 months
Hide Outcome Measure Data
Hide Analysis Population Description
Participants with objective response among those who received retreatment
Arm/Group Title BV Retreatment - HL BV Retreatment - ALCL BV Retreatment - Other BV Retreatment Total
Hide Arm/Group Description:
Patients with Hodgkin lymphoma (HL) enrolled and treated on the retreatment arm
Patients with anaplastic large cell lymphoma (ALCL) enrolled and treated on the retreatment arm
Patients with other disease diagnoses enrolled and treated on the retreatment arm
All patients enrolled and treated on the retreatment arm, including 3 patients retreated more than once
Overall Number of Participants Analyzed 21 8 3 32
Overall Number of Units Analyzed
Type of Units Analyzed: Retreatment Experiences
12 10 1 23
Median (95% Confidence Interval)
Unit of Measure: months
9.2 [1] 
(2.1 to NA)
8.8
(1.4 to 12.9)
NA [2] 
(NA to NA)
9.2
(6.6 to 12.9)
[1]
Insufficient number of events to estimate upper bound
[2]
Insufficient number of events to estimate median and upper and lower bounds
5.Secondary Outcome
Title Progression-free Survival by Kaplan-Meier Analysis
Hide Description Progression-free survival, defined as time from start of study treatment in the retreatment arm to disease progression per investigator or death due to any cause
Time Frame Up to approximately 29 months
Hide Outcome Measure Data
Hide Analysis Population Description
Any patient who received retreatment and had postbaseline response results; 1 HL patient did not have postbaseline response results and 3 ALCL patients were retreated more than once.
Arm/Group Title BV Retreatment - HL BV Retreatment - ALCL BV Retreatment - Other BV Retreatment Total
Hide Arm/Group Description:
Patients with Hodgkin lymphoma (HL) enrolled and treated on the retreatment arm
Patients with anaplastic large cell lymphoma (ALCL) enrolled and treated on the retreatment arm
Patients with other disease diagnoses enrolled and treated on the retreatment arm
All patients enrolled and treated on the retreatment arm, including 3 patients retreated more than once
Overall Number of Participants Analyzed 21 8 3 32
Overall Number of Units Analyzed
Type of Units Analyzed: Retreatment Experiences
20 11 3 34
Median (95% Confidence Interval)
Unit of Measure: months
9.9
(3.4 to 13.4)
12.9
(3.4 to 18.5)
4.4 [1] 
(1.2 to NA)
9.9
(4.4 to 13.4)
[1]
Insufficient number of events to estimate upper bound
6.Secondary Outcome
Title Overall Survival
Hide Description Overall survival for both extension and retreatment arms, defined as time from start of study treatment to date of death due to any cause
Time Frame Up to approximately 41 months
Hide Outcome Measure Data
Hide Analysis Population Description
Patients who received treatment on the extension arm, and patients who received retreatment and had postbaseline response results; 1 HL patient on the retreatment arm did not have postbaseline response results and 3 ALCL patients on the retreatment arm were retreated more than once.
Arm/Group Title BV Extension Total BV Retreatment - HL BV Retreatment - ALCL BV Retreatment - Other BV Retreatment Total
Hide Arm/Group Description:
All patients enrolled and treated on the extension arm
Patients with Hodgkin lymphoma (HL) enrolled and treated on the retreatment arm
Patients with anaplastic large cell lymphoma (ALCL) enrolled and treated on the retreatment arm
Patients with other disease diagnoses enrolled and treated on the retreatment arm
All patients enrolled and treated on the retreatment arm, including 3 patients retreated more than once
Overall Number of Participants Analyzed 78 21 8 3 32
Overall Number of Units Analyzed
Type of Units Analyzed: Retreatment or Extension Trt Experiences
78 20 11 3 34
Median (95% Confidence Interval)
Unit of Measure: months
NA [1] 
(32.1 to NA)
NA [1] 
(11.4 to NA)
NA [2] 
(NA to NA)
NA [1] 
(5.1 to NA)
NA [1] 
(19.5 to NA)
[1]
Insufficient number of events to estimate median and upper bound
[2]
Insufficient number of events to estimate median and upper and lower bounds
7.Secondary Outcome
Title Incidence of Antitherapeutic Antibodies
Hide Description Counts of participants with anti-brentuximab vedotin antibodies at any time during extension treatment on Study SGN35-006 or number of retreatment experiences with anti-brentuximab vedotin antibodies at any time during retreatment
Time Frame Up to 39 months
Hide Outcome Measure Data
Hide Analysis Population Description
Any patient who received extension treatment or retreatment and had baseline and postbaseline sample results; 1 HL patient on the retreatment arm did not have postbaseline sample results and 3 ALCL patients on the retreatment arm were retreated more than once and had samples.
Arm/Group Title BV Extension BV Retreatment
Hide Arm/Group Description:
Brentuximab vedotin 1.2 or 1.8 mg/kg every 3 weeks by IV infusion (continued treatment)
Brentuximab vedotin 1.2 or 1.8 mg/kg every 3 weeks by IV infusion (retreatment after relapse)
Overall Number of Participants Analyzed 78 31
Overall Number of Units Analyzed
Type of Units Analyzed: Retreatment or Extension Txt Experiences
78 34
Measure Type: Number
Unit of Measure: participants or experiences
15 12
Time Frame [Not Specified]
Adverse Event Reporting Description Treatment-emergent adverse events (TEAEs) defined as newly occurring (not present at baseline) or worsening after first dose of investigational product on Study SGN35-006
 
Arm/Group Title BV Extension BV Retreatment
Hide Arm/Group Description Brentuximab vedotin 1.2 or 1.8 mg/kg every 3 weeks by IV infusion Brentuximab vedotin 1.2 or 1.8 mg/kg every 3 weeks by IV infusion
All-Cause Mortality
BV Extension BV Retreatment
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Hide Serious Adverse Events
BV Extension BV Retreatment
Affected / at Risk (%) Affected / at Risk (%)
Total   16/78 (20.51%)   9/32 (28.13%) 
Blood and lymphatic system disorders     
Febrile neutropenia  1  0/78 (0.00%)  1/32 (3.13%) 
Leukocytosis  1  0/78 (0.00%)  1/32 (3.13%) 
Methaemoglobinaemia  1  0/78 (0.00%)  1/32 (3.13%) 
Thrombotic thrombocytopenic purpura  1  0/78 (0.00%)  1/32 (3.13%) 
Neutropenia  1  1/78 (1.28%)  0/32 (0.00%) 
Thrombocytopenia  1  1/78 (1.28%)  0/32 (0.00%) 
Eye disorders     
Glaucoma  1  0/78 (0.00%)  1/32 (3.13%) 
Necrotising retinitis  1  0/78 (0.00%)  1/32 (3.13%) 
Gastrointestinal disorders     
Gastrointestinal obstruction  1  0/78 (0.00%)  1/32 (3.13%) 
Nausea  1  1/78 (1.28%)  1/32 (3.13%) 
Pancreatitis  1  0/78 (0.00%)  1/32 (3.13%) 
Peptic ulcer  1  0/78 (0.00%)  1/32 (3.13%) 
Vomiting  1  1/78 (1.28%)  1/32 (3.13%) 
Small intestine obstruction  1  1/78 (1.28%)  0/32 (0.00%) 
General disorders     
Fatigue  1  1/78 (1.28%)  1/32 (3.13%) 
Mucosal inflammation  1  1/78 (1.28%)  0/32 (0.00%) 
Immune system disorders     
Graft versus host disease  1  0/78 (0.00%)  1/32 (3.13%) 
Anaphylactic reaction  1  1/78 (1.28%)  0/32 (0.00%) 
Infections and infestations     
Bacteraemia  1  0/78 (0.00%)  1/32 (3.13%) 
Bronchitis viral  1  0/78 (0.00%)  1/32 (3.13%) 
Bronchopulmonary aspergillosis  1  0/78 (0.00%)  1/32 (3.13%) 
Herpes zoster disseminated  1  0/78 (0.00%)  1/32 (3.13%) 
Pneumonia  1  3/78 (3.85%)  2/32 (6.25%) 
Atypical pneumonia  1  1/78 (1.28%)  0/32 (0.00%) 
Gangrene  1  1/78 (1.28%)  0/32 (0.00%) 
Gastrointestinal candidiasis  1  1/78 (1.28%)  0/32 (0.00%) 
Influenza  1  1/78 (1.28%)  0/32 (0.00%) 
Pneumocystis jiroveci pneumonia  1  1/78 (1.28%)  0/32 (0.00%) 
Pneumonia influenzal  1  1/78 (1.28%)  0/32 (0.00%) 
Pneumonia pseudomonas aeruginosa  1  1/78 (1.28%)  0/32 (0.00%) 
Pseudomonal sepsis  1  1/78 (1.28%)  0/32 (0.00%) 
Respiratory syncytial virus bronchiolitis  1  1/78 (1.28%)  0/32 (0.00%) 
Injury, poisoning and procedural complications     
Hip fracture  1  1/78 (1.28%)  0/32 (0.00%) 
Metabolism and nutrition disorders     
Dehydration  1  0/78 (0.00%)  2/32 (6.25%) 
Failure to thrive  1  0/78 (0.00%)  1/32 (3.13%) 
Hypercalcaemia  1  0/78 (0.00%)  1/32 (3.13%) 
Hyperglycaemia  1  0/78 (0.00%)  2/32 (6.25%) 
Hyponatraemia  1  1/78 (1.28%)  0/32 (0.00%) 
Metabolic acidosis  1  1/78 (1.28%)  0/32 (0.00%) 
Musculoskeletal and connective tissue disorders     
Arthralgia  1  0/78 (0.00%)  1/32 (3.13%) 
Back pain  1  0/78 (0.00%)  1/32 (3.13%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Acute myeloid leukemia  1  1/78 (1.28%)  0/32 (0.00%) 
Hodgkin's disease  1  1/78 (1.28%)  0/32 (0.00%) 
Oesophageal carcinoma  1  1/78 (1.28%)  0/32 (0.00%) 
Nervous system disorders     
Peripheral motor neuropathy  1  2/78 (2.56%)  1/32 (3.13%) 
Peripheral sensory neuropathy  1  0/78 (0.00%)  2/32 (6.25%) 
Extrapyramidal disorder  1  1/78 (1.28%)  0/32 (0.00%) 
Psychiatric disorders     
Mental status changes  1  1/78 (1.28%)  2/32 (6.25%) 
Renal and urinary disorders     
Renal failure acute  1  1/78 (1.28%)  0/32 (0.00%) 
Respiratory, thoracic and mediastinal disorders     
Pleural effusion  1  0/78 (0.00%)  1/32 (3.13%) 
Respiratory failure  1  0/78 (0.00%)  1/32 (3.13%) 
Dyspnoea  1  1/78 (1.28%)  0/32 (0.00%) 
Pneumonitis  1  2/78 (2.56%)  0/32 (0.00%) 
Pulmonary haemorrhage  1  1/78 (1.28%)  0/32 (0.00%) 
Respiratory acidosis  1  1/78 (1.28%)  0/32 (0.00%) 
Skin and subcutaneous tissue disorders     
Rash erythematous  1  1/78 (1.28%)  0/32 (0.00%) 
Vascular disorders     
Hypotension  1  1/78 (1.28%)  0/32 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (16.0)
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
BV Extension BV Retreatment
Affected / at Risk (%) Affected / at Risk (%)
Total   75/78 (96.15%)   31/32 (96.88%) 
Blood and lymphatic system disorders     
Anaemia  1  7/78 (8.97%)  7/32 (21.88%) 
Neutropenia  1  10/78 (12.82%)  3/32 (9.38%) 
Thrombocytopenia  1  4/78 (5.13%)  4/32 (12.50%) 
Cardiac disorders     
Tachycardia  1  4/78 (5.13%)  2/32 (6.25%) 
Endocrine disorders     
Adrenal insufficiency  1  0/78 (0.00%)  2/32 (6.25%) 
Eye disorders     
Vision blurred  1  0/78 (0.00%)  2/32 (6.25%) 
Gastrointestinal disorders     
Abdominal pain  1  8/78 (10.26%)  3/32 (9.38%) 
Abdominal pain upper  1  0/78 (0.00%)  2/32 (6.25%) 
Constipation  1  10/78 (12.82%)  5/32 (15.63%) 
Diarrhoea  1  15/78 (19.23%)  12/32 (37.50%) 
Dyspepsia  1  3/78 (3.85%)  3/32 (9.38%) 
Gastrooesophageal reflux disease  1  1/78 (1.28%)  3/32 (9.38%) 
Nausea  1  19/78 (24.36%)  12/32 (37.50%) 
Vomiting  1  12/78 (15.38%)  0/32 (0.00%) 
General disorders     
Chills  1  5/78 (6.41%)  2/32 (6.25%) 
Fatigue  1  23/78 (29.49%)  11/32 (34.38%) 
Infusion site extravasation  1  0/78 (0.00%)  2/32 (6.25%) 
Non-cardiac chest pain  1  6/78 (7.69%)  4/32 (12.50%) 
Oedema peripheral  1  7/78 (8.97%)  5/32 (15.63%) 
Pyrexia  1  20/78 (25.64%)  8/32 (25.00%) 
Chest discomfort  1  4/78 (5.13%)  0/32 (0.00%) 
Pain  1  6/78 (7.69%)  0/32 (0.00%) 
Immune system disorders     
Hypogammaglobulinaemia  1  0/78 (0.00%)  2/32 (6.25%) 
Infections and infestations     
Oral candidiasis  1  0/78 (0.00%)  3/32 (9.38%) 
Sinusitis  1  5/78 (6.41%)  4/32 (12.50%) 
Upper respiratory tract infection  1  25/78 (32.05%)  6/32 (18.75%) 
Urinary tract infection  1  0/78 (0.00%)  3/32 (9.38%) 
Herpes zoster  1  7/78 (8.97%)  0/32 (0.00%) 
Pneumonia  1  5/78 (6.41%)  0/32 (0.00%) 
Injury, poisoning and procedural complications     
Skin injury  1  0/78 (0.00%)  3/32 (9.38%) 
Investigations     
Weight decreased  1  5/78 (6.41%)  3/32 (9.38%) 
Metabolism and nutrition disorders     
Decreased appetite  1  11/78 (14.10%)  3/32 (9.38%) 
Dehydration  1  0/78 (0.00%)  2/32 (6.25%) 
Hyperglycaemia  1  0/78 (0.00%)  2/32 (6.25%) 
Hypocalcaemia  1  0/78 (0.00%)  2/32 (6.25%) 
Hypokalaemia  1  6/78 (7.69%)  5/32 (15.63%) 
Hypophosphataemia  1  5/78 (6.41%)  4/32 (12.50%) 
Hypomagnesaemia  1  4/78 (5.13%)  0/32 (0.00%) 
Musculoskeletal and connective tissue disorders     
Arthralgia  1  12/78 (15.38%)  7/32 (21.88%) 
Back pain  1  8/78 (10.26%)  5/32 (15.63%) 
Muscle spasms  1  12/78 (15.38%)  4/32 (12.50%) 
Myalgia  1  11/78 (14.10%)  3/32 (9.38%) 
Muscular weakness  1  5/78 (6.41%)  0/32 (0.00%) 
Pain in extremity  1  4/78 (5.13%)  0/32 (0.00%) 
Nervous system disorders     
Dizziness  1  6/78 (7.69%)  5/32 (15.63%) 
Headache  1  10/78 (12.82%)  9/32 (28.13%) 
Paraesthesia  1  4/78 (5.13%)  2/32 (6.25%) 
Peripheral motor neuropathy  1  4/78 (5.13%)  8/32 (25.00%) 
Peripheral sensory neuropathy  1  36/78 (46.15%)  17/32 (53.13%) 
Syncope  1  0/78 (0.00%)  2/32 (6.25%) 
Psychiatric disorders     
Anxiety  1  4/78 (5.13%)  3/32 (9.38%) 
Confusional state  1  0/78 (0.00%)  2/32 (6.25%) 
Depression  1  1/78 (1.28%)  2/32 (6.25%) 
Insomnia  1  6/78 (7.69%)  4/32 (12.50%) 
Respiratory, thoracic and mediastinal disorders     
Cough  1  16/78 (20.51%)  6/32 (18.75%) 
Dyspnoea  1  7/78 (8.97%)  8/32 (25.00%) 
Nasal congestion  1  4/78 (5.13%)  2/32 (6.25%) 
Wheezing  1  3/78 (3.85%)  3/32 (9.38%) 
Skin and subcutaneous tissue disorders     
Alopecia  1  12/78 (15.38%)  4/32 (12.50%) 
Erythema  1  0/78 (0.00%)  2/32 (6.25%) 
Night sweats  1  6/78 (7.69%)  3/32 (9.38%) 
Pruritus  1  10/78 (12.82%)  4/32 (12.50%) 
Rash erythematous  1  0/78 (0.00%)  2/32 (6.25%) 
Rash generalised  1  0/78 (0.00%)  2/32 (6.25%) 
Skin lesion  1  0/78 (0.00%)  2/32 (6.25%) 
Vascular disorders     
Flushing  1  0/78 (0.00%)  3/32 (9.38%) 
Hypertension  1  3/78 (3.85%)  2/32 (6.25%) 
Hypotension  1  4/78 (5.13%)  2/32 (6.25%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (16.0)
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 90 days from the time submitted to the sponsor for review. The sponsor cannot require changes to the communication and cannot extend the embargo.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Chief Medical Officer
Organization: Seattle Genetics, Inc.
Phone: 855-473-2436
EMail: medinfo@seagen.com
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Responsible Party: Seagen Inc.
ClinicalTrials.gov Identifier: NCT00947856    
Other Study ID Numbers: SGN35-006
2010-019932-11 ( EudraCT Number )
First Submitted: July 24, 2009
First Posted: July 28, 2009
Results First Submitted: March 21, 2014
Results First Posted: May 26, 2014
Last Update Posted: February 2, 2017