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Trial record 10 of 877 for:    "Reticulum Cell Sarcoma"

Brentuximab Vedotin (Recombinant) for IV Infusion - Special Drug Use Surveillance (All-case Surveillance) "Relapsed or Refractory CD30+ Hodgkin's Lymphoma or Anaplastic Large Cell Lymphoma"

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ClinicalTrials.gov Identifier: NCT02139592
Recruitment Status : Completed
First Posted : May 15, 2014
Results First Posted : May 6, 2019
Last Update Posted : May 21, 2019
Sponsor:
Information provided by (Responsible Party):
Takeda

Study Type Observational
Study Design Observational Model: Cohort;   Time Perspective: Prospective
Condition Relapsed or Refractory CD30+ Hodgkin's Lymphoma or Anaplastic Large Cell Lymphoma
Intervention Drug: Brentuximab vedotin (recombinant)
Enrollment 292
Recruitment Details Participants took part in the study at 198 investigative sites in Japan, from 17 April 2014 to 30 June 2017.
Pre-assignment Details Participants with a historical diagnosis of relapsed/refractory CD30+ Hodgkin’s lymphoma (HL) or anaplastic large cell lymphoma (ALCL) were enrolled. Participants received interventions as part of routine medical care.
Arm/Group Title Brentuximab Vedotin Infusion
Hide Arm/Group Description Intravenous infusion of 1.8 mg/kg (body weight) of brentuximab vedotin (recombinant) administered once every three weeks. Participants received interventions as part of routine medical care.
Period Title: Overall Study
Started 292
Completed 284
Not Completed 8
Reason Not Completed
Case Report Forms Uncollected             8
Arm/Group Title Brentuximab Vedotin Infusion
Hide Arm/Group Description Intravenous infusion of 1.8 mg/kg (body weight) of brentuximab vedotin (recombinant) administered once every three weeks. Participants received interventions as part of routine medical care.
Overall Number of Baseline Participants 284
Hide Baseline Analysis Population Description
Safety Analysis Set; The safety analysis set was defined as all participants who had all of the required safety data defined on the protocol.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 284 participants
56.7  (19.80)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 284 participants
Female
100
  35.2%
Male
184
  64.8%
Race and Ethnicity Not Collected   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 0 participants
[1]
Measure Analysis Population Description: Race and Ethnicity were not collected from any participant.
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Japan Number Analyzed 284 participants
284
Duration of Diagnosis of Hodgkin’s Lymphoma (HL) or Anaplastic Large Cell Lymphoma (ALCL)   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 284 participants
< 1 Year
75
  26.4%
>= 1 Year and < 3 Years
105
  37.0%
>= 3 Years and < 5 Years
47
  16.5%
>= 5 Years
55
  19.4%
Unknown
2
   0.7%
[1]
Measure Description: Mean duration between start of study and first time of diagnosis of HL or ALCL was reported.
Diagnosis  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 284 participants
HL
182
  64.1%
ALCL
101
  35.6%
Others
1
   0.4%
Recurrent and Refractory or Primary  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 284 participants
Recurrent and Refractory
281
  98.9%
Primary
3
   1.1%
Number of participants with CD30 Positive  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 284 participants
284
 100.0%
ALK Positive or Negative   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 101 participants
ALK-Positive
15
  14.9%
ALK-Negative
77
  76.2%
Unknown
9
   8.9%
[1]
Measure Analysis Population Description: This baseline characteristic was analyzed only in participants who had been diagnosed with ALCL.
Staging of Lymphoma   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 284 participants
Stage 1
10
   3.5%
Stage 2
63
  22.2%
Stage 3
70
  24.6%
Stage 4
140
  49.3%
Unknown
1
   0.4%
[1]
Measure Description: Lymphoma is classified with following stages. Stage 1; Lymphoma in only 1 group of lymph nodes. Stage 2; Lymphoma in 2 or more groups of lymph nodes. Stage 3; There are lymph nodes that contain lymphoma on both sides of the diaphragm. Stage 4; The most advanced stage of lymphoma and lymphoma cells have spread to at least 1 body organ outside the lymphatic system.
B Symptom   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 284 participants
Had B symptom
124
  43.7%
Had No B symptom
160
  56.3%
[1]
Measure Description: B symptom means participants have 1 or more these symptoms as following; Unintentional weight loss (more than 10% in the 6 months before you were diagnosed), Night sweats, Fevers (temperatures above 38 Celsius degrees).
Eastern Cooperative Oncology Group (ECOG) Performance Status   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 284 participants
0
114
  40.1%
1
104
  36.6%
2
32
  11.3%
3
19
   6.7%
4
15
   5.3%
[1]
Measure Description: Following are ECOG grades. 0: Fully active, perform all pre-disease activities without restriction. 1: Restricted in physically strenuous activity but ambulatory, carry out work of a light or sedentary nature. 2: Ambulatory, capable of selfcare, unable to carry out any work activities, up and about more than (>) 50% of waking hours. 3: Capable of limited selfcare, confined to bed or chair >50% of waking hours. 4: Completely disabled, not capable of any selfcare, totally confined to bed or chair.
Healthcare Category   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 284 participants
Outpatient
45
  15.8%
Inpatient
238
  83.8%
Unknown
1
   0.4%
[1]
Measure Description: Participants were categorized as outpatient and inpatient.
Predisposition to Hypersensitivity   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 284 participants
Had Predisposition to Hypersensitivity
51
  18.0%
Had No Predisposition to Hypersensitivity
231
  81.3%
Unknown
2
   0.7%
[1]
Measure Description: The baseline characteristic was analyzed in participants who had a liability or tendency to suffer from hypersensitivity.
Hepatitis C Virus (HCV) Antibody Positive or Negative  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 284 participants
HCV Antibody-Positive
6
   2.1%
HCV Antibody- Negative
274
  96.5%
Unknown
4
   1.4%
Hepatitis B Surface (HBs) Antigen Positive or Negative  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 284 participants
HBs Antigen-Positive
6
   2.1%
HBs Antigen-Negative
271
  95.4%
Unknown
7
   2.5%
HBs Antibody Positive or Negative  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 284 participants
HBs Antibody-Positive
41
  14.4%
HBs Antibody- Negative
208
  73.2%
Unknown
35
  12.3%
Hepatitis B Virus Deoxyribonucleic Acid (HBV DNA) Positive or Negative  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 284 participants
HBV DNA-Positive
4
   1.4%
HBV DNA-Negative
106
  37.3%
Unknown
174
  61.3%
Medical History of Lung Disorder   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 284 participants
Had Medical History
9
   3.2%
Had No Medical History
275
  96.8%
[1]
Measure Description: Medical history defined as a disease or a health condition for each participant before start of the study. Medical history was classified as congenital anomalies, hematologic disorders, psychiatric and nervous system disorders, cardiovascular disorders, respiratory disorders, GI disorders, hepatic and biliary disorders, renal disease and other medical history. Other medical history included all medical history except for those mentioned above.
Medical Complications of Lung Disorder   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 284 participants
Had Presence of Medical Complications
20
   7.0%
Had No Presence of Medical Complications
264
  93.0%
[1]
Measure Description: Complications defined as a disease or a health condition for each participant at the start of study. Complications were classified as congenital anomalies, endocrine disorders, hematologic disorders, psychiatric and nervous system disorders, cardiovascular disorders, respiratory disorders, gastrointestinal (GI) disorders, renal disease and other complications. Other complications included all complications except for those mentioned above.
Medical History of Malignant Tumor   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 284 participants
Had Presence of Medical History
33
  11.6%
Had No Presence of Medical History
251
  88.4%
[1]
Measure Description: Medical history defined as a disease or a health condition for each participant before start of the study. Medical history was classified as congenital anomalies, hematologic disorders, psychiatric and nervous system disorders, cardiovascular disorders, respiratory disorders, GI disorders, hepatic and biliary disorders, renal disease and other medical history. Other medical history included all medical history except for those mentioned above.
Medical Complications of Malignant Tumor   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 284 participants
Had Presence of Medical Complications
5
   1.8%
Had No Presence of Medical Complications
279
  98.2%
[1]
Measure Description: Complications defined as a disease or a health condition for each participant at the start of study. Complications were classified as congenital anomalies, endocrine disorders, hematologic disorders, psychiatric and nervous system disorders, cardiovascular disorders, respiratory disorders, gastrointestinal (GI) disorders, renal disease and other complications. Other complications included all complications except for those mentioned above.
Medical History (Other Than Lung Disorder or Malignant Tumor)   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 284 participants
Had Presence of Medical History
68
  23.9%
Had No Presence of Medical History
216
  76.1%
[1]
Measure Description: Medical history defined as a disease or a health condition for each participant before start of the study. Medical history was classified as congenital anomalies, hematologic disorders, psychiatric and nervous system disorders, cardiovascular disorders, respiratory disorders, GI disorders, hepatic and biliary disorders, renal disease and other medical history. Other medical history included all medical history except for those mentioned above.
Medical Complications (Other Than Lung Disorder or Malignant Tumor)   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 284 participants
Had Presence of Medical Complications
182
  64.1%
Had No Presence of Medical Complications
102
  35.9%
[1]
Measure Description: Complications defined as a disease or a health condition for each participant at the start of study. Complications were classified as congenital anomalies, endocrine disorders, hematologic disorders, psychiatric and nervous system disorders, cardiovascular disorders, respiratory disorders, gastrointestinal (GI) disorders, renal disease and other complications. Other complications included all complications except for those mentioned above.
Concomitant Hepatic Disorder  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 284 participants
Had Concomitant Hepatic Disorder
25
   8.8%
Had No Concomitant Hepatic Disorder
259
  91.2%
Concomitant Renal Disorder  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 284 participants
Had Concomitant Renal Disorder
20
   7.0%
Had No Concomitant Renal Disorder
264
  93.0%
Weight  
Mean (Standard Deviation)
Unit of measure:  Kilograms (kg)
Number Analyzed 284 participants
58.158  (13.0751)
BMI   [1] 
Mean (Standard Deviation)
Unit of measure:  Kg/meter (m)^2
Number Analyzed 284 participants
22.00  (3.991)
[1]
Measure Description: Body Mass Index = weight (kg)/[height (m)^2]
Smoking Classification  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 284 participants
Never Smoked
130
  45.8%
Current Smoker
16
   5.6%
Ex-Smoker
84
  29.6%
Unknown
54
  19.0%
Drug Therapy before Start of Brentuximab Vedotin Administration  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 284 participants
Had Drug Therapy
279
  98.2%
Had No Drug Therapy
5
   1.8%
Number of Regimens before Start of Brentuximab Vedotin Administration   [1] 
Mean (Standard Deviation)
Unit of measure:  Number of Regimens
Number Analyzed 279 participants
2.7  (1.57)
[1]
Measure Analysis Population Description: Population Analysis Description: This baseline characteristic was analyzed only in participants who had drug therapy before start of Brentuximab Vedotin administration.
Time in Days from Last Month of Previous Drug Therapy Regimen to First Cycle of Brentuximab Vendotin  
Mean (Standard Deviation)
Unit of measure:  Days
Number Analyzed 284 participants
299.1  (564.04)
Radiotherapy before Start of Brentuximab Vedotin Administration  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 284 participants
Had Radiotherapy
105
  37.0%
Had No Radiotherapy
179
  63.0%
Time in Days from Last Month of Most Recent Radiotherapy to First Cycle of Brentuximab Vendotin   [1] 
Mean (Standard Deviation)
Unit of measure:  Days
Number Analyzed 94 participants
703.4  (954.27)
[1]
Measure Analysis Population Description: Population Analysis Description: This baseline characteristic was analyzed only in participants who had radiotherapy before start of Brentuximab Vedotin administration. The number analyzed is the number of participants with data available for analysis.
Hematopoietic Stem Cell Transplantation before Start of Brentuximab Vedotin Administration  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 284 participants
Had No Hematopoietic Stem Cell Transplantation
219
  77.1%
Had Autologous Transplantation
43
  15.1%
Had Allogeneic Transplantation
9
   3.2%
Had Autologous and Allogeneic Transplantation
12
   4.2%
Unknown
1
   0.4%
Number of Participants Who Were Not Pregnant   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 100 participants
100
 100.0%
[1]
Measure Analysis Population Description: This baseline characteristic was analyzed only in female participants.
1.Primary Outcome
Title Number of Participants Who Had One or More Adverse Events (AE) and Serious Adverse Events (SAE)
Hide Description [Not Specified]
Time Frame Up to Week 48 or until discontinuation of treatment
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Analysis Set; The safety analysis set was defined as all participants who had all of the required safety data defined on the protocol.
Arm/Group Title Brentuximab Vedotin Infusion
Hide Arm/Group Description:
Intravenous infusion of 1.8 mg/kg (body weight) of brentuximab vedotin (recombinant) administered once every three weeks. Participants received interventions as part of routine medical care.
Overall Number of Participants Analyzed 284
Measure Type: Count of Participants
Unit of Measure: Participants
AE
238
  83.8%
SAE
97
  34.2%
2.Secondary Outcome
Title Percentage of Participants Who Achieve or Maintain Any Best Response
Hide Description Best response is defined as the cumulative numbers of participants who achieve each level of best response including partial response (PR), complete response uncertain (CRu) (when no positron emission tomography [PET] data are available), and complete response (CR) after each cycle of treatment. Reported data are divided into 4 populations; Hodgkin’s lymphoma (HL) participants with PET data, HL participants without PET data, anaplastic large cell lymphoma (ALCL) participants with PET data, and ALCL participants without PET data. PET is used in cancer diagnosis and treatment.
Time Frame Up to Week 48 or until discontinuation of treatment
Hide Outcome Measure Data
Hide Analysis Population Description
Efficacy assessment population; The efficacy assessment population was defined as participants who completed the study and had efficacy data at baseline and post-baseline time points available. The number analyzed is the number of participants with data available for analysis at the given time-point.
Arm/Group Title Brentuximab Vedotin Infusion
Hide Arm/Group Description:
Intravenous infusion of 1.8 mg/kg (body weight) of brentuximab vedotin (recombinant) administered once every three weeks. Participants received interventions as part of routine medical care.
Overall Number of Participants Analyzed 241
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
HL Participants with PET Data Number Analyzed 77 participants
64.9
(53.22 to 75.47)
HL Participants without PET Data Number Analyzed 85 participants
36.5
(26.29 to 47.62)
ALCL Participants with PET Data Number Analyzed 37 participants
67.6
(50.21 to 81.99)
ALCL Participants without PET Data Number Analyzed 42 participants
57.1
(40.96 to 72.28)
3.Secondary Outcome
Title Overall Survival (OS)
Hide Description OS is defined as the period from the start of therapy in standard medical care to the time when death (regardless of the cause of death) is confirmed. Reported data as OS was point estimates of 1 year survival rate for HL and ALCL participants.
Time Frame Up to 30 months
Hide Outcome Measure Data
Hide Analysis Population Description
Efficacy assessment population; The efficacy assessment population was defined as participants who completed the study and had efficacy data at baseline and post-baseline time points available.
Arm/Group Title Brentuximab Vedotin Infusion
Hide Arm/Group Description:
Intravenous infusion of 1.8 mg/kg (body weight) of brentuximab vedotin (recombinant) administered once every three weeks. Participants received interventions as part of routine medical care.
Overall Number of Participants Analyzed 280
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
HL Participants Number Analyzed 179 participants
82.7
(75.4 to 88.0)
ALCL Participants Number Analyzed 101 participants
79.3
(68.4 to 86.7)
Time Frame Up to Week 48 or until discontinuation of treatment
Adverse Event Reporting Description At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. For data of "Other Adverse Events", participants may be represented in more than 1 category.
 
Arm/Group Title Brentuximab Vedotin Infusion
Hide Arm/Group Description Intravenous infusion of 1.8 mg/kg (body weight) of brentuximab vedotin (recombinant) administered once every three weeks. Participants received interventions as part of routine medical care.
All-Cause Mortality
Brentuximab Vedotin Infusion
Affected / at Risk (%)
Total   51/284 (17.96%) 
Show Serious Adverse Events Hide Serious Adverse Events
Brentuximab Vedotin Infusion
Affected / at Risk (%)
Total   97/284 (34.15%) 
Blood and lymphatic system disorders   
Anaemia  1  3/284 (1.06%) 
Disseminated intravascular coagulation  1  2/284 (0.70%) 
Febrile neutropenia  1  4/284 (1.41%) 
Leukopenia  1  1/284 (0.35%) 
Lymphopenia  1  1/284 (0.35%) 
Neutropenia  1  15/284 (5.28%) 
Thrombocytopenia  1  3/284 (1.06%) 
Bone marrow failure  1  1/284 (0.35%) 
Cardiac disorders   
Cardiac failure  1  2/284 (0.70%) 
Cardiomegaly  1  1/284 (0.35%) 
Left ventricular dysfunction  1  1/284 (0.35%) 
Gastrointestinal disorders   
Diarrhoea  1  1/284 (0.35%) 
Gastrointestinal haemorrhage  1  1/284 (0.35%) 
Ileus  1  1/284 (0.35%) 
Ileus paralytic  1  1/284 (0.35%) 
Melaena  1  1/284 (0.35%) 
Pancreatitis acute  1  1/284 (0.35%) 
Small intestinal perforation  1  1/284 (0.35%) 
Lower gastrointestinal haemorrhage  1  1/284 (0.35%) 
General disorders   
Oedema peripheral  1  1/284 (0.35%) 
Pyrexia  1  1/284 (0.35%) 
Multiple organ dysfunction syndrome  1  2/284 (0.70%) 
Hepatobiliary disorders   
Cholecystitis  1  1/284 (0.35%) 
Liver disorder  1  1/284 (0.35%) 
Immune system disorders   
Graft versus host disease  1  1/284 (0.35%) 
Acute graft versus host disease  1  1/284 (0.35%) 
Infections and infestations   
Bacteraemia  1  1/284 (0.35%) 
Epstein-Barr virus infection  1  1/284 (0.35%) 
Cytomegalovirus infection  1  2/284 (0.70%) 
Herpes zoster  1  2/284 (0.70%) 
Meningitis aseptic  1  1/284 (0.35%) 
Fungal infection  1  1/284 (0.35%) 
Pneumonia  1  9/284 (3.17%) 
Pyelonephritis  1  1/284 (0.35%) 
Sepsis  1  5/284 (1.76%) 
Systemic candida  1  1/284 (0.35%) 
Anal abscess  1  1/284 (0.35%) 
Pneumonia fungal  1  1/284 (0.35%) 
Device related infection  1  1/284 (0.35%) 
Herpes zoster disseminated  1  1/284 (0.35%) 
Pneumocystis jirovecii pneumonia  1  3/284 (1.06%) 
Injury, poisoning and procedural complications   
Brain herniation  1  1/284 (0.35%) 
Fall  1  1/284 (0.35%) 
Femoral neck fracture  1  1/284 (0.35%) 
Patella fracture  1  1/284 (0.35%) 
Investigations   
Blood creatine phosphokinase increased  1  1/284 (0.35%) 
Blood lactate dehydrogenase increased  1  2/284 (0.70%) 
Alanine aminotransferase increased  1  1/284 (0.35%) 
Aspartate aminotransferase increased  1  1/284 (0.35%) 
Blood bilirubin increased  1  2/284 (0.70%) 
Transaminases increased  1  1/284 (0.35%) 
C-reactive protein increased  1  1/284 (0.35%) 
Blood urea increased  1  1/284 (0.35%) 
Weight increased  1  1/284 (0.35%) 
Metabolism and nutrition disorders   
Diabetes mellitus  1  1/284 (0.35%) 
Hyperglycaemia  1  1/284 (0.35%) 
Decreased appetite  1  1/284 (0.35%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
Hodgkin's disease  1  21/284 (7.39%) 
Peripheral T-cell lymphoma unspecified  1  1/284 (0.35%) 
Gingival cancer  1  1/284 (0.35%) 
Anaplastic large-cell lymphoma  1  13/284 (4.58%) 
Nervous system disorders   
Altered state of consciousness  1  2/284 (0.70%) 
Cerebral haemorrhage  1  1/284 (0.35%) 
Peripheral motor neuropathy  1  5/284 (1.76%) 
Peripheral sensory neuropathy  1  6/284 (2.11%) 
Clonic convulsion  1  1/284 (0.35%) 
Renal and urinary disorders   
Renal disorder  1  1/284 (0.35%) 
Chronic kidney disease  1  1/284 (0.35%) 
Respiratory, thoracic and mediastinal disorders   
Acute respiratory distress syndrome  1  1/284 (0.35%) 
Interstitial lung disease  1  13/284 (4.58%) 
Pneumonia aspiration  1  1/284 (0.35%) 
Pneumonitis  1  1/284 (0.35%) 
Respiratory disorder  1  1/284 (0.35%) 
Respiratory failure  1  2/284 (0.70%) 
Skin and subcutaneous tissue disorders   
Drug eruption  1  1/284 (0.35%) 
Erythema multiforme  1  1/284 (0.35%) 
Rash  1  1/284 (0.35%) 
Generalised erythema  1  1/284 (0.35%) 
1
Term from vocabulary, MedDRA 19.1
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Brentuximab Vedotin Infusion
Affected / at Risk (%)
Total   238/284 (83.80%) 
Blood and lymphatic system disorders   
Lymphopenia  1  22/284 (7.75%) 
Neutropenia  1  153/284 (53.87%) 
Thrombocytopenia  1  17/284 (5.99%) 
General disorders   
Pyrexia  1  15/284 (5.28%) 
Injury, poisoning and procedural complications   
Infusion related reaction  1  31/284 (10.92%) 
Nervous system disorders   
Peripheral sensory neuropathy  1  129/284 (45.42%) 
Skin and subcutaneous tissue disorders   
Rash  1  15/284 (5.28%) 
1
Term from vocabulary, MedDRA 19.1
Indicates events were collected by systematic assessment
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 first study related publication will be a multi-center publication submitted within 24 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 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.
Results Point of Contact
Name/Title: Medical Director
Organization: Takeda
Phone: +1-877-825-3327
Responsible Party: Takeda
ClinicalTrials.gov Identifier: NCT02139592     History of Changes
Other Study ID Numbers: 291-011
JapicCTI-142455 ( Registry Identifier: JapicCTI )
First Submitted: April 17, 2014
First Posted: May 15, 2014
Results First Submitted: June 25, 2018
Results First Posted: May 6, 2019
Last Update Posted: May 21, 2019