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Trial record 5 of 6 for:    PVS-RIPO

PVSRIPO for Recurrent Glioblastoma (GBM) (PVSRIPO)

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: NCT01491893
Recruitment Status : Active, not recruiting
First Posted : December 14, 2011
Results First Posted : September 28, 2018
Last Update Posted : November 27, 2018
Sponsor:
Collaborators:
National Cancer Institute (NCI)
Brain Tumor Research Charity Grant
Duke University
Information provided by (Responsible Party):
Istari Oncology, Inc.

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Sequential Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions GBM
Glioblastoma
Glioma
Malignant Glioma
Intervention Biological: Recombinant nonpathogenic polio-rhinovirus chimera (PVSRIPO)
Enrollment 61
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Dose Level 1 (Dose Escalation) Dose Level 2 (Dose Escalation) Dose Level 3 (Dose Escalation) Dose Level 4 (Dose Escalation) Dose Level 5 (Dose Escalation) Dose Level 4 (Dose De-escalation) Dose Level 2 (Dose Expansion) Dose Level -1 (Dose Expansion) Dose Level -2 (Dose Expansion) Dose Level -1 (Selected Dose Expansion)
Hide Arm/Group Description Participants received a single intratumoral infusion of 1.0 x 10^8 TCID50 of PVSRIPO, via convection-enhanced delivery to the brain tumor, with 4 weeks of monitoring for toxicities after infusion. Participants received a single intratumoral infusion of 3.3 x 10^8 TCID50 of PVSRIPO, via convection-enhanced delivery to the brain tumor, with 4 weeks of monitoring for toxicities after infusion. Participants received a single intratumoral infusion of 1.0 x 10^9 TCID50 of PVSRIPO, via convection-enhanced delivery to the brain tumor, with 4 weeks of monitoring for toxicities after infusion. Participants received a single intratumoral infusion of 3.3 x 10^9 TCID50 of PVSRIPO, via convection-enhanced delivery to the brain tumor, with 4 weeks of monitoring for toxicities after infusion. Participants received a single intratumoral infusion of 1.0 x 10^10 TCID50 of PVSRIPO, via convection-enhanced delivery to the brain tumor, with 4 weeks of monitoring for toxicities after infusion. Participants received a single intratumoral infusion of 3.3 x 10^9 TCID50 of PVSRIPO, via convection-enhanced delivery to the brain tumor, with 4 weeks of monitoring for toxicities after infusion. Participants received a single intratumoral infusion of 3.3 x 10^8 TCID50 of PVSRIPO, via convection-enhanced delivery to the brain tumor, with 4 weeks of monitoring for toxicities after infusion. Participants received a single intratumoral infusion of 5.0 x 10^7 TCID50 of PVSRIPO, via convection-enhanced delivery to the brain tumor, with 4 weeks of monitoring for toxicities after infusion. Participants received a single intratumoral infusion of 1.0 x 10^7 TCID50 of PVSRIPO, via convection-enhanced delivery to the brain tumor, with 4 weeks of monitoring for toxicities after infusion. Participants received a single intratumoral infusion of 5.0 x 10^7 TCID50 of PVSRIPO, via convection-enhanced delivery to the brain tumor, with 4 weeks of monitoring for toxicities after infusion.
Period Title: Overall Study
Started 1 1 1 1 4 1 6 24 15 7
Completed 1 1 1 1 4 1 6 24 15 7
Not Completed 0 0 0 0 0 0 0 0 0 0
Arm/Group Title Recombinant Nonpathogenic Polio–Rhinovirus Chimera (PVSRIPO)
Hide Arm/Group Description All participants who received a dose of PVSRIPO at any dose level
Overall Number of Baseline Participants 61
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 61 participants
52.9  (12.3)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 61 participants
Female
25
  41.0%
Male
36
  59.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 61 participants
Hispanic or Latino
2
   3.3%
Not Hispanic or Latino
57
  93.4%
Unknown or Not Reported
2
   3.3%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 61 participants
American Indian or Alaska Native
1
   1.6%
Asian
1
   1.6%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
1
   1.6%
White
57
  93.4%
More than one race
0
   0.0%
Unknown or Not Reported
1
   1.6%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 61 participants
61
 100.0%
1.Primary Outcome
Title Maximum Tolerated Dose (MTD)
Hide Description

The MTD will be the highest dose level for which the probability that a dose escalation patient experiences a dose-limiting toxicity (DLT) is estimated to be less than 20%. Any Grade 3 or 4 toxicity that is not reversible within 2 weeks, or any life-threatening event, or treatment-related death will be considered a DLT. Any grade 2 or higher serious autoimmune toxicities particularly those affecting vital organs (e.g. cardiac, renal, CNS) will be considered a DLT. 50% Tissue Culture Infective Dose (TCID50) is the unit of measure of infectious virus titer.

The MTD was determined based on the first 9 patients treated with PVSRIPO- 1 at dose level 1 (1.0 x 10e8 TCID50 (50% Tissue Culture Infectious Dose)), 1 at dose level 2 (3.3 x 10e8 TCID50), 1 at dose level 3 (1.0 x 10e9 TCID50), 2 at dose level 4 (3.3 x 10e9 TCID50), and 4 at dose level 5 (1.0 x 10e10 TCID50).

Time Frame 28 days after administration of PVSRIPO
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who received a dose of PVSRIPO at any dose level
Arm/Group Title Dose Escalation Patients
Hide Arm/Group Description:
Dose Escalation Patients
Overall Number of Participants Analyzed 9
Measure Type: Number
Unit of Measure: 50% Tissue Culture Infectious Dose
10,000,000,000
2.Primary Outcome
Title Number of Participants Who Experienced Dose-Limiting Toxicities (DLTs)
Hide Description The number of dose escalation patients experiencing a dose-limiting toxicity (DLT) will be reported. Any grade 3 or any Grade 4 toxicity that is not reversible within 2 weeks, or any life-threatening event, or treatment-related death will be considered a DLT. Any grade 2 or higher serious autoimmune toxicities particularly those affecting vital organs (e.g. cardiac, renal, CNS) will also be considered a DLT.
Time Frame 28 days after administration of PVSRIPO
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Dose Level 1 (Dose Escalation) Dose Level 2 (Dose Escalation) Dose Level 3 (Dose Escalation) Dose Level 4 (Dose Escalation) Dose Level 5 (Dose Escalation)
Hide Arm/Group Description:
Participants received a single intratumoral infusion of 1.0 x 10^8 TCID50 of PVSRIPO, via convection-enhanced delivery to the brain tumor, with 4 weeks of monitoring for toxicities after infusion.
Participants received a single intratumoral infusion of 3.3 x 10^8 TCID50 of PVSRIPO, via convection-enhanced delivery to the brain tumor, with 4 weeks of monitoring for toxicities after infusion.
Participants received a single intratumoral infusion of 1.0 x 10^9 TCID50 of PVSRIPO, via convection-enhanced delivery to the brain tumor, with 4 weeks of monitoring for toxicities after infusion.
Participants received a single intratumoral infusion of 3.3 x 10^9 TCID50 of PVSRIPO, via convection-enhanced delivery to the brain tumor, with 4 weeks of monitoring for toxicities after infusion.
Participants received a single intratumoral infusion of 1.0 x 10^10 TCID50 of PVSRIPO, via convection-enhanced delivery to the brain tumor, with 4 weeks of monitoring for toxicities after infusion.
Overall Number of Participants Analyzed 1 1 1 2 4
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1
  25.0%
3.Primary Outcome
Title Recommended Phase 2 Dose (RP2D)
Hide Description The RP2D of PVSRIPO is the safe, therapeutic dose where patients have not experienced undue side effects from PVSRIPO or from the management of cerebral inflammation secondary to PVSRIPO administration. 50% Tissue Culture Infective Dose (TCID50) is the unit of measure of infectious virus titer.
Time Frame 5 years
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title All Participants
Hide Arm/Group Description:
All Participants
Overall Number of Participants Analyzed 61
Measure Type: Number
Unit of Measure: 50% Tissue Culture Infectious Dose
50000000
4.Secondary Outcome
Title Median Overall Survival (OS)
Hide Description Time in months from the administration of PVSRIPO to the date of death from any cause. For patients alive as of the last follow-up, OS is censored at the last follow-up date. Median OS is estimated using Kaplan-Meier methods.
Time Frame 6 years
Outcome Measure Data Not Reported
5.Secondary Outcome
Title Median Progression-free Survival (PFS)
Hide Description PFS is defined as the time in months between the administration of PVSRIPO and the first occurrence of disease progression. PFS will be defined radiologically, if possible, or alternatively defined by a significant overall change (deterioration) in clinical status.
Time Frame 5 years
Outcome Measure Data Not Reported
Time Frame From PVSRIPO administration until a patient is taken off study for disease progression or the participant started a new treatment regimen (average of 10 months).
Adverse Event Reporting Description This includes all adverse events regardless of attribution to study treatment from the time of PVSRIPO administration until the patient is taken off study or is retreated with PVSRIPO. For the reporting of adverse events per dose level, all patients receiving a specific dose were combined.
 
Arm/Group Title Dose Level 1 Patients Dose Level 2 Patients Dose Level 3 Patients Dose Level 4 Patients Dose Level 5 Patients Dose Level -1 Patients Dose Level -2 Patients
Hide Arm/Group Description Participants received a single intratumoral infusion of 1.0 x 10^8 TCID50 of PVSRIPO, via convection-enhanced delivery to the brain tumor, with 4 weeks of monitoring for toxicities after infusion. Participants received a single intratumoral infusion of 3.3 x 10^8 TCID50 of PVSRIPO, via convection-enhanced delivery to the brain tumor, with 4 weeks of monitoring for toxicities after infusion. Participants received a single intratumoral infusion of 1.0 x 10^9 TCID50 of PVSRIPO, via convection-enhanced delivery to the brain tumor, with 4 weeks of monitoring for toxicities after infusion. Participants received a single intratumoral infusion of 3.3 x 10^9 TCID50 of PVSRIPO, via convection-enhanced delivery to the brain tumor, with 4 weeks of monitoring for toxicities after infusion. Participants received a single intratumoral infusion of 1.0 x 10^10 TCID50 of PVSRIPO, via convection-enhanced delivery to the brain tumor, with 4 weeks of monitoring for toxicities after infusion. Participants received a single intratumoral infusion of 5.0 x 10^7 TCID50 of PVSRIPO, via convection-enhanced delivery to the brain tumor, with 4 weeks of monitoring for toxicities after infusion. Participants received a single intratumoral infusion of 1.0 x 10^7 TCID50 of PVSRIPO, via convection-enhanced delivery to the brain tumor, with 4 weeks of monitoring for toxicities after infusion.
All-Cause Mortality
Dose Level 1 Patients Dose Level 2 Patients Dose Level 3 Patients Dose Level 4 Patients Dose Level 5 Patients Dose Level -1 Patients Dose Level -2 Patients
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/1 (0.00%)   6/7 (85.71%)   1/1 (100.00%)   2/2 (100.00%)   4/4 (100.00%)   24/31 (77.42%)   12/15 (80.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
Dose Level 1 Patients Dose Level 2 Patients Dose Level 3 Patients Dose Level 4 Patients Dose Level 5 Patients Dose Level -1 Patients Dose Level -2 Patients
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   1/1 (100.00%)   3/7 (42.86%)   1/1 (100.00%)   1/2 (50.00%)   3/4 (75.00%)   7/31 (22.58%)   5/15 (33.33%) 
Cardiac disorders               
Cardiac arrhythmia  1  0/1 (0.00%)  1/7 (14.29%)  0/1 (0.00%)  0/2 (0.00%)  0/4 (0.00%)  0/31 (0.00%)  0/15 (0.00%) 
Eye disorders               
Visual field cut - hemianopia  1  0/1 (0.00%)  0/7 (0.00%)  0/1 (0.00%)  0/2 (0.00%)  0/4 (0.00%)  1/31 (3.23%)  0/15 (0.00%) 
Gastrointestinal disorders               
Colitis  1  0/1 (0.00%)  0/7 (0.00%)  0/1 (0.00%)  0/2 (0.00%)  0/4 (0.00%)  1/31 (3.23%)  0/15 (0.00%) 
Diarrhea  1  0/1 (0.00%)  0/7 (0.00%)  0/1 (0.00%)  0/2 (0.00%)  0/4 (0.00%)  1/31 (3.23%)  0/15 (0.00%) 
Nausea  1  0/1 (0.00%)  0/7 (0.00%)  0/1 (0.00%)  0/2 (0.00%)  0/4 (0.00%)  1/31 (3.23%)  0/15 (0.00%) 
Pancreatic hemorrhage  1  0/1 (0.00%)  0/7 (0.00%)  0/1 (0.00%)  0/2 (0.00%)  1/4 (25.00%)  0/31 (0.00%)  0/15 (0.00%) 
Vomiting  1  0/1 (0.00%)  0/7 (0.00%)  0/1 (0.00%)  0/2 (0.00%)  0/4 (0.00%)  1/31 (3.23%)  0/15 (0.00%) 
General disorders               
Death NOS  1  0/1 (0.00%)  0/7 (0.00%)  0/1 (0.00%)  0/2 (0.00%)  0/4 (0.00%)  1/31 (3.23%)  0/15 (0.00%) 
Fatigue  1  0/1 (0.00%)  0/7 (0.00%)  0/1 (0.00%)  0/2 (0.00%)  0/4 (0.00%)  1/31 (3.23%)  0/15 (0.00%) 
Fever  1  0/1 (0.00%)  0/7 (0.00%)  0/1 (0.00%)  0/2 (0.00%)  0/4 (0.00%)  1/31 (3.23%)  0/15 (0.00%) 
Malaise  1  0/1 (0.00%)  0/7 (0.00%)  0/1 (0.00%)  0/2 (0.00%)  0/4 (0.00%)  1/31 (3.23%)  0/15 (0.00%) 
Steroid myopathy  1  0/1 (0.00%)  0/7 (0.00%)  0/1 (0.00%)  0/2 (0.00%)  0/4 (0.00%)  0/31 (0.00%)  1/15 (6.67%) 
Infections and infestations               
Enterocolitis infectious  1  0/1 (0.00%)  0/7 (0.00%)  0/1 (0.00%)  0/2 (0.00%)  0/4 (0.00%)  1/31 (3.23%)  1/15 (6.67%) 
Lung infection  1  0/1 (0.00%)  0/7 (0.00%)  0/1 (0.00%)  1/2 (50.00%)  0/4 (0.00%)  0/31 (0.00%)  0/15 (0.00%) 
Skin infection  1  0/1 (0.00%)  0/7 (0.00%)  0/1 (0.00%)  1/2 (50.00%)  0/4 (0.00%)  0/31 (0.00%)  0/15 (0.00%) 
Investigations               
Blood bilirubin increased  1  0/1 (0.00%)  0/7 (0.00%)  0/1 (0.00%)  1/2 (50.00%)  0/4 (0.00%)  0/31 (0.00%)  0/15 (0.00%) 
Platelet count decreased  1  0/1 (0.00%)  0/7 (0.00%)  0/1 (0.00%)  1/2 (50.00%)  0/4 (0.00%)  0/31 (0.00%)  0/15 (0.00%) 
Musculoskeletal and connective tissue disorders               
Generalized muscle weakness  1  0/1 (0.00%)  0/7 (0.00%)  0/1 (0.00%)  1/2 (50.00%)  0/4 (0.00%)  1/31 (3.23%)  0/15 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)               
Tumor pain  1  0/1 (0.00%)  0/7 (0.00%)  0/1 (0.00%)  0/2 (0.00%)  0/4 (0.00%)  0/31 (0.00%)  1/15 (6.67%) 
Nervous system disorders               
Cognitive disturbance  1  0/1 (0.00%)  0/7 (0.00%)  0/1 (0.00%)  0/2 (0.00%)  0/4 (0.00%)  0/31 (0.00%)  1/15 (6.67%) 
Dysphasia  1  0/1 (0.00%)  0/7 (0.00%)  0/1 (0.00%)  0/2 (0.00%)  0/4 (0.00%)  1/31 (3.23%)  0/15 (0.00%) 
Dystonia  1  0/1 (0.00%)  0/7 (0.00%)  0/1 (0.00%)  0/2 (0.00%)  0/4 (0.00%)  1/31 (3.23%)  0/15 (0.00%) 
Edema cerebral  1  0/1 (0.00%)  0/7 (0.00%)  0/1 (0.00%)  0/2 (0.00%)  0/4 (0.00%)  0/31 (0.00%)  1/15 (6.67%) 
Headache  1  0/1 (0.00%)  0/7 (0.00%)  0/1 (0.00%)  0/2 (0.00%)  0/4 (0.00%)  2/31 (6.45%)  0/15 (0.00%) 
Hydrocephalus  1  0/1 (0.00%)  0/7 (0.00%)  0/1 (0.00%)  0/2 (0.00%)  0/4 (0.00%)  0/31 (0.00%)  1/15 (6.67%) 
Intracranial hemorrhage  1  0/1 (0.00%)  0/7 (0.00%)  0/1 (0.00%)  0/2 (0.00%)  1/4 (25.00%)  3/31 (9.68%)  1/15 (6.67%) 
Pyramidal tract syndrome  1  0/1 (0.00%)  1/7 (14.29%)  0/1 (0.00%)  1/2 (50.00%)  1/4 (25.00%)  2/31 (6.45%)  3/15 (20.00%) 
Seizure  1  1/1 (100.00%)  2/7 (28.57%)  1/1 (100.00%)  0/2 (0.00%)  1/4 (25.00%)  4/31 (12.90%)  2/15 (13.33%) 
Psychiatric disorders               
Confusion  1  0/1 (0.00%)  0/7 (0.00%)  0/1 (0.00%)  0/2 (0.00%)  0/4 (0.00%)  3/31 (9.68%)  2/15 (13.33%) 
Delusions  1  0/1 (0.00%)  0/7 (0.00%)  0/1 (0.00%)  0/2 (0.00%)  0/4 (0.00%)  1/31 (3.23%)  0/15 (0.00%) 
Depression  1  0/1 (0.00%)  0/7 (0.00%)  0/1 (0.00%)  0/2 (0.00%)  0/4 (0.00%)  1/31 (3.23%)  0/15 (0.00%) 
Suicidal ideation  1  0/1 (0.00%)  0/7 (0.00%)  0/1 (0.00%)  0/2 (0.00%)  0/4 (0.00%)  1/31 (3.23%)  0/15 (0.00%) 
Vascular disorders               
Thromboembolic event  1  0/1 (0.00%)  1/7 (14.29%)  0/1 (0.00%)  0/2 (0.00%)  0/4 (0.00%)  3/31 (9.68%)  1/15 (6.67%) 
1
Term from vocabulary, CTCAE (4.0)
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 0%
Dose Level 1 Patients Dose Level 2 Patients Dose Level 3 Patients Dose Level 4 Patients Dose Level 5 Patients Dose Level -1 Patients Dose Level -2 Patients
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   1/1 (100.00%)   7/7 (100.00%)   1/1 (100.00%)   2/2 (100.00%)   4/4 (100.00%)   31/31 (100.00%)   15/15 (100.00%) 
Blood and lymphatic system disorders               
Anemia  1  1/1 (100.00%)  4/7 (57.14%)  1/1 (100.00%)  2/2 (100.00%)  3/4 (75.00%)  19/31 (61.29%)  11/15 (73.33%) 
Cardiac disorders               
Cardiac arrhythmia  1  0/1 (0.00%)  0/7 (0.00%)  0/1 (0.00%)  0/2 (0.00%)  0/4 (0.00%)  1/31 (3.23%)  0/15 (0.00%) 
Ear and labyrinth disorders               
Ear and labyrinth disorders  1  0/1 (0.00%)  0/7 (0.00%)  0/1 (0.00%)  0/2 (0.00%)  0/4 (0.00%)  2/31 (6.45%)  0/15 (0.00%) 
Hearing impaired  1  0/1 (0.00%)  0/7 (0.00%)  0/1 (0.00%)  0/2 (0.00%)  0/4 (0.00%)  0/31 (0.00%)  2/15 (13.33%) 
Tinnitus  1  0/1 (0.00%)  0/7 (0.00%)  0/1 (0.00%)  0/2 (0.00%)  0/4 (0.00%)  0/31 (0.00%)  1/15 (6.67%) 
Vertigo  1  0/1 (0.00%)  0/7 (0.00%)  0/1 (0.00%)  0/2 (0.00%)  0/4 (0.00%)  1/31 (3.23%)  2/15 (13.33%) 
Endocrine disorders               
Cushingoid  1  0/1 (0.00%)  2/7 (28.57%)  0/1 (0.00%)  1/2 (50.00%)  1/4 (25.00%)  1/31 (3.23%)  0/15 (0.00%) 
Diabetes  1  0/1 (0.00%)  1/7 (14.29%)  0/1 (0.00%)  0/2 (0.00%)  0/4 (0.00%)  0/31 (0.00%)  0/15 (0.00%) 
Eye disorders               
Blurred vision  1  0/1 (0.00%)  1/7 (14.29%)  0/1 (0.00%)  0/2 (0.00%)  1/4 (25.00%)  3/31 (9.68%)  1/15 (6.67%) 
Diplopia  1  0/1 (0.00%)  1/7 (14.29%)  0/1 (0.00%)  0/2 (0.00%)  0/4 (0.00%)  2/31 (6.45%)  0/15 (0.00%) 
Eye disorders - Other, specify  1  0/1 (0.00%)  0/7 (0.00%)  0/1 (0.00%)  0/2 (0.00%)  0/4 (0.00%)  2/31 (6.45%)  0/15 (0.00%) 
Farsighted  1  0/1 (0.00%)  0/7 (0.00%)  0/1 (0.00%)  0/2 (0.00%)  0/4 (0.00%)  1/31 (3.23%)  1/15 (6.67%) 
Focusing difficulty  1  0/1 (0.00%)  0/7 (0.00%)  0/1 (0.00%)  0/2 (0.00%)  0/4 (0.00%)  1/31 (3.23%)  0/15 (0.00%) 
Strabismus  1  0/1 (0.00%)  0/7 (0.00%)  0/1 (0.00%)  0/2 (0.00%)  0/4 (0.00%)  0/31 (0.00%)  1/15 (6.67%) 
Visual field cut - hemianopia  1  0/1 (0.00%)  1/7 (14.29%)  0/1 (0.00%)  0/2 (0.00%)  0/4 (0.00%)  9/31 (29.03%)  2/15 (13.33%) 
Gastrointestinal disorders               
Abdominal pain  1  0/1 (0.00%)  0/7 (0.00%)  0/1 (0.00%)  0/2 (0.00%)  0/4 (0.00%)  0/31 (0.00%)  1/15 (6.67%) 
Constipation  1  0/1 (0.00%)  2/7 (28.57%)  0/1 (0.00%)  0/2 (0.00%)  0/4 (0.00%)  7/31 (22.58%)  4/15 (26.67%) 
Diarrhea  1  0/1 (0.00%)  1/7 (14.29%)  1/1 (100.00%)  0/2 (0.00%)  0/4 (0.00%)  8/31 (25.81%)  0/15 (0.00%) 
Dry mouth  1  0/1 (0.00%)  1/7 (14.29%)  0/1 (0.00%)  1/2 (50.00%)  0/4 (0.00%)  0/31 (0.00%)  0/15 (0.00%) 
Dysphagia  1  0/1 (0.00%)  0/7 (0.00%)  0/1 (0.00%)  1/2 (50.00%)  0/4 (0.00%)  0/31 (0.00%)  0/15 (0.00%) 
Enterocolitis  1  0/1 (0.00%)  0/7 (0.00%)  0/1 (0.00%)  0/2 (0.00%)  0/4 (0.00%)  1/31 (3.23%)  2/15 (13.33%) 
Fecal incontinence  1  0/1 (0.00%)  0/7 (0.00%)  1/1 (100.00%)  0/2 (0.00%)  0/4 (0.00%)  1/31 (3.23%)  1/15 (6.67%) 
Gastroesophageal reflux disease  1  1/1 (100.00%)  1/7 (14.29%)  0/1 (0.00%)  0/2 (0.00%)  0/4 (0.00%)  1/31 (3.23%)  0/15 (0.00%) 
Gastrointestinal disorders - Other, specify  1  0/1 (0.00%)  0/7 (0.00%)  0/1 (0.00%)  0/2 (0.00%)  0/4 (0.00%)  1/31 (3.23%)  0/15 (0.00%) 
Gingivitis  1  0/1 (0.00%)  0/7 (0.00%)  0/1 (0.00%)  0/2 (0.00%)  0/4 (0.00%)  1/31 (3.23%)  1/15 (6.67%) 
Hemorrhoids  1  0/1 (0.00%)  0/7 (0.00%)  0/1 (0.00%)  0/2 (0.00%)  1/4 (25.00%)  1/31 (3.23%)  0/15 (0.00%) 
Lower gastrointestinal hemorrhage  1  0/1 (0.00%)  0/7 (0.00%)  0/1 (0.00%)  0/2 (0.00%)  0/4 (0.00%)  0/31 (0.00%)  2/15 (13.33%) 
Mucositis oral  1  0/1 (0.00%)  1/7 (14.29%)  0/1 (0.00%)  1/2 (50.00%)  0/4 (0.00%)  0/31 (0.00%)  2/15 (13.33%) 
Nausea  1  1/1 (100.00%)  3/7 (42.86%)  0/1 (0.00%)  1/2 (50.00%)  0/4 (0.00%)  13/31 (41.94%)  3/15 (20.00%) 
Taste disorder  1  0/1 (0.00%)  0/7 (0.00%)  0/1 (0.00%)  0/2 (0.00%)  0/4 (0.00%)  1/31 (3.23%)  0/15 (0.00%) 
Vomiting  1  1/1 (100.00%)  2/7 (28.57%)  1/1 (100.00%)  0/2 (0.00%)  0/4 (0.00%)  6/31 (19.35%)  2/15 (13.33%) 
General disorders               
Chills  1  0/1 (0.00%)  0/7 (0.00%)  0/1 (0.00%)  0/2 (0.00%)  0/4 (0.00%)  0/31 (0.00%)  1/15 (6.67%) 
Edema face  1  0/1 (0.00%)  0/7 (0.00%)  0/1 (0.00%)  0/2 (0.00%)  0/4 (0.00%)  0/31 (0.00%)  1/15 (6.67%) 
Fatigue  1  1/1 (100.00%)  3/7 (42.86%)  1/1 (100.00%)  2/2 (100.00%)  2/4 (50.00%)  11/31 (35.48%)  3/15 (20.00%) 
Fever  1  0/1 (0.00%)  0/7 (0.00%)  0/1 (0.00%)  0/2 (0.00%)  1/4 (25.00%)  0/31 (0.00%)  0/15 (0.00%) 
Gait disturbance  1  0/1 (0.00%)  1/7 (14.29%)  1/1 (100.00%)  0/2 (0.00%)  0/4 (0.00%)  4/31 (12.90%)  1/15 (6.67%) 
Infusion related reaction  1  0/1 (0.00%)  0/7 (0.00%)  0/1 (0.00%)  0/2 (0.00%)  0/4 (0.00%)  0/31 (0.00%)  1/15 (6.67%) 
Irritability  1  0/1 (0.00%)  0/7 (0.00%)  0/1 (0.00%)  0/2 (0.00%)  0/4 (0.00%)  3/31 (9.68%)  1/15 (6.67%) 
Non-cardiac chest pain  1  0/1 (0.00%)  0/7 (0.00%)  0/1 (0.00%)  0/2 (0.00%)  0/4 (0.00%)  1/31 (3.23%)  0/15 (0.00%) 
Pain  1  0/1 (0.00%)  3/7 (42.86%)  0/1 (0.00%)  0/2 (0.00%)  0/4 (0.00%)  14/31 (45.16%)  5/15 (33.33%) 
Steroid myopathy  1  0/1 (0.00%)  2/7 (28.57%)  1/1 (100.00%)  2/2 (100.00%)  0/4 (0.00%)  2/31 (6.45%)  1/15 (6.67%) 
Immune system disorders               
Allergic reaction  1  0/1 (0.00%)  0/7 (0.00%)  0/1 (0.00%)  0/2 (0.00%)  0/4 (0.00%)  2/31 (6.45%)  0/15 (0.00%) 
Infections and infestations               
Bronchial infection  1  0/1 (0.00%)  0/7 (0.00%)  0/1 (0.00%)  0/2 (0.00%)  0/4 (0.00%)  0/31 (0.00%)  1/15 (6.67%) 
Conjunctivitis infective  1  0/1 (0.00%)  0/7 (0.00%)  0/1 (0.00%)  1/2 (50.00%)  0/4 (0.00%)  0/31 (0.00%)  0/15 (0.00%) 
Infections and infestations - Other, specify  1  0/1 (0.00%)  1/7 (14.29%)  1/1 (100.00%)  0/2 (0.00%)  0/4 (0.00%)  2/31 (6.45%)  0/15 (0.00%) 
Lung infection  1  0/1 (0.00%)  0/7 (0.00%)  0/1 (0.00%)  0/2 (0.00%)  0/4 (0.00%)  0/31 (0.00%)  1/15 (6.67%) 
Mucosal infection  1  0/1 (0.00%)  0/7 (0.00%)  0/1 (0.00%)  0/2 (0.00%)  0/4 (0.00%)  2/31 (6.45%)  3/15 (20.00%) 
Phlebitis infective  1  0/1 (0.00%)  1/7 (14.29%)  0/1 (0.00%)  0/2 (0.00%)  0/4 (0.00%)  0/31 (0.00%)  0/15 (0.00%) 
Skin infection  1  0/1 (0.00%)  0/7 (0.00%)  0/1 (0.00%)  1/2 (50.00%)  0/4 (0.00%)  2/31 (6.45%)  1/15 (6.67%) 
Tooth infection  1  0/1 (0.00%)  0/7 (0.00%)  0/1 (0.00%)  0/2 (0.00%)  0/4 (0.00%)  2/31 (6.45%)  0/15 (0.00%) 
Upper respiratory infection  1  0/1 (0.00%)  1/7 (14.29%)  0/1 (0.00%)  1/2 (50.00%)  0/4 (0.00%)  9/31 (29.03%)  6/15 (40.00%) 
Urinary tract infection  1  0/1 (0.00%)  1/7 (14.29%)  0/1 (0.00%)  0/2 (0.00%)  0/4 (0.00%)  3/31 (9.68%)  2/15 (13.33%) 
Vaginal infection  1  0/1 (0.00%)  0/7 (0.00%)  0/1 (0.00%)  0/2 (0.00%)  0/4 (0.00%)  2/31 (6.45%)  0/15 (0.00%) 
Injury, poisoning and procedural complications               
Bruising  1  0/1 (0.00%)  1/7 (14.29%)  0/1 (0.00%)  1/2 (50.00%)  0/4 (0.00%)  1/31 (3.23%)  1/15 (6.67%) 
Burn  1  0/1 (0.00%)  0/7 (0.00%)  0/1 (0.00%)  0/2 (0.00%)  0/4 (0.00%)  1/31 (3.23%)  0/15 (0.00%) 
Fall  1  0/1 (0.00%)  1/7 (14.29%)  0/1 (0.00%)  1/2 (50.00%)  0/4 (0.00%)  4/31 (12.90%)  0/15 (0.00%) 
Vascular access complication  1  0/1 (0.00%)  0/7 (0.00%)  0/1 (0.00%)  0/2 (0.00%)  0/4 (0.00%)  1/31 (3.23%)  0/15 (0.00%) 
Investigations               
Alanine aminotransferase increased  1  0/1 (0.00%)  2/7 (28.57%)  0/1 (0.00%)  1/2 (50.00%)  0/4 (0.00%)  5/31 (16.13%)  4/15 (26.67%) 
Alkaline phosphatase increased  1  0/1 (0.00%)  0/7 (0.00%)  0/1 (0.00%)  1/2 (50.00%)  0/4 (0.00%)  3/31 (9.68%)  3/15 (20.00%) 
Aspartate aminotransferase increased  1  1/1 (100.00%)  2/7 (28.57%)  0/1 (0.00%)  2/2 (100.00%)  0/4 (0.00%)  9/31 (29.03%)  4/15 (26.67%) 
Blood bilirubin increased  1  0/1 (0.00%)  2/7 (28.57%)  0/1 (0.00%)  1/2 (50.00%)  0/4 (0.00%)  1/31 (3.23%)  2/15 (13.33%) 
Creatinine increased  1  0/1 (0.00%)  0/7 (0.00%)  0/1 (0.00%)  1/2 (50.00%)  0/4 (0.00%)  7/31 (22.58%)  2/15 (13.33%) 
Lymphocyte count decreased  1  0/1 (0.00%)  1/7 (14.29%)  1/1 (100.00%)  1/2 (50.00%)  2/4 (50.00%)  13/31 (41.94%)  7/15 (46.67%) 
Neutrophil count decreased  1  0/1 (0.00%)  2/7 (28.57%)  0/1 (0.00%)  0/2 (0.00%)  1/4 (25.00%)  5/31 (16.13%)  3/15 (20.00%) 
Platelet count decreased  1  0/1 (0.00%)  4/7 (57.14%)  1/1 (100.00%)  2/2 (100.00%)  1/4 (25.00%)  9/31 (29.03%)  6/15 (40.00%) 
White blood cell decreased  1  0/1 (0.00%)  1/7 (14.29%)  0/1 (0.00%)  0/2 (0.00%)  1/4 (25.00%)  7/31 (22.58%)  3/15 (20.00%) 
Metabolism and nutrition disorders               
Anorexia  1  0/1 (0.00%)  0/7 (0.00%)  0/1 (0.00%)  0/2 (0.00%)  0/4 (0.00%)  4/31 (12.90%)  0/15 (0.00%) 
Dehydration  1  0/1 (0.00%)  0/7 (0.00%)  0/1 (0.00%)  1/2 (50.00%)  0/4 (0.00%)  3/31 (9.68%)  0/15 (0.00%) 
Hyperglycemia  1  1/1 (100.00%)  6/7 (85.71%)  1/1 (100.00%)  1/2 (50.00%)  2/4 (50.00%)  22/31 (70.97%)  5/15 (33.33%) 
Hyperkalemia  1  0/1 (0.00%)  0/7 (0.00%)  0/1 (0.00%)  0/2 (0.00%)  0/4 (0.00%)  2/31 (6.45%)  0/15 (0.00%) 
Hypermagnesemia  1  0/1 (0.00%)  0/7 (0.00%)  0/1 (0.00%)  0/2 (0.00%)  0/4 (0.00%)  0/31 (0.00%)  1/15 (6.67%) 
Hypernatremia  1  0/1 (0.00%)  1/7 (14.29%)  0/1 (0.00%)  0/2 (0.00%)  0/4 (0.00%)  1/31 (3.23%)  0/15 (0.00%) 
Hypoalbuminemia  1  1/1 (100.00%)  4/7 (57.14%)  1/1 (100.00%)  1/2 (50.00%)  3/4 (75.00%)  18/31 (58.06%)  8/15 (53.33%) 
Hypocalcemia  1  1/1 (100.00%)  4/7 (57.14%)  1/1 (100.00%)  1/2 (50.00%)  2/4 (50.00%)  13/31 (41.94%)  7/15 (46.67%) 
Hypoglycemia  1  0/1 (0.00%)  1/7 (14.29%)  0/1 (0.00%)  0/2 (0.00%)  0/4 (0.00%)  7/31 (22.58%)  2/15 (13.33%) 
Hypokalemia  1  0/1 (0.00%)  2/7 (28.57%)  1/1 (100.00%)  2/2 (100.00%)  1/4 (25.00%)  9/31 (29.03%)  6/15 (40.00%) 
Hypomagnesemia  1  1/1 (100.00%)  0/7 (0.00%)  0/1 (0.00%)  1/2 (50.00%)  0/4 (0.00%)  3/31 (9.68%)  0/15 (0.00%) 
Hyponatremia  1  0/1 (0.00%)  2/7 (28.57%)  0/1 (0.00%)  0/2 (0.00%)  2/4 (50.00%)  10/31 (32.26%)  3/15 (20.00%) 
Hypophosphatemia  1  0/1 (0.00%)  0/7 (0.00%)  0/1 (0.00%)  0/2 (0.00%)  1/4 (25.00%)  1/31 (3.23%)  0/15 (0.00%) 
Musculoskeletal and connective tissue disorders               
Arthralgia  1  0/1 (0.00%)  0/7 (0.00%)  0/1 (0.00%)  0/2 (0.00%)  0/4 (0.00%)  6/31 (19.35%)  1/15 (6.67%) 
Arthritis  1  0/1 (0.00%)  2/7 (28.57%)  0/1 (0.00%)  0/2 (0.00%)  0/4 (0.00%)  2/31 (6.45%)  0/15 (0.00%) 
Buttock pain  1  0/1 (0.00%)  0/7 (0.00%)  0/1 (0.00%)  0/2 (0.00%)  0/4 (0.00%)  1/31 (3.23%)  0/15 (0.00%) 
Generalized muscle weakness  1  0/1 (0.00%)  0/7 (0.00%)  0/1 (0.00%)  0/2 (0.00%)  0/4 (0.00%)  1/31 (3.23%)  0/15 (0.00%) 
Joint range of motion decreased  1  0/1 (0.00%)  0/7 (0.00%)  0/1 (0.00%)  0/2 (0.00%)  0/4 (0.00%)  1/31 (3.23%)  0/15 (0.00%) 
Muscle cramp  1  0/1 (0.00%)  0/7 (0.00%)  0/1 (0.00%)  0/2 (0.00%)  0/4 (0.00%)  3/31 (9.68%)  0/15 (0.00%) 
Nervous system disorders               
Cognitive disturbance  1  1/1 (100.00%)  5/7 (71.43%)  1/1 (100.00%)  0/2 (0.00%)  0/4 (0.00%)  7/31 (22.58%)  3/15 (20.00%) 
Dysgeusia  1  0/1 (0.00%)  1/7 (14.29%)  0/1 (0.00%)  0/2 (0.00%)  0/4 (0.00%)  0/31 (0.00%)  0/15 (0.00%) 
Dysphasia  1  0/1 (0.00%)  2/7 (28.57%)  1/1 (100.00%)  0/2 (0.00%)  2/4 (50.00%)  13/31 (41.94%)  2/15 (13.33%) 
Dystonia  1  0/1 (0.00%)  0/7 (0.00%)  0/1 (0.00%)  0/2 (0.00%)  0/4 (0.00%)  1/31 (3.23%)  0/15 (0.00%) 
Facial muscle weakness  1  0/1 (0.00%)  0/7 (0.00%)  0/1 (0.00%)  0/2 (0.00%)  0/4 (0.00%)  1/31 (3.23%)  0/15 (0.00%) 
Headache  1  1/1 (100.00%)  5/7 (71.43%)  0/1 (0.00%)  2/2 (100.00%)  1/4 (25.00%)  23/31 (74.19%)  9/15 (60.00%) 
Intracranial hemorrhage  1  0/1 (0.00%)  0/7 (0.00%)  0/1 (0.00%)  0/2 (0.00%)  0/4 (0.00%)  2/31 (6.45%)  1/15 (6.67%) 
Myokymia  1  0/1 (0.00%)  0/7 (0.00%)  0/1 (0.00%)  0/2 (0.00%)  0/4 (0.00%)  0/31 (0.00%)  1/15 (6.67%) 
Nervous system disorders - Other, specify  1  0/1 (0.00%)  0/7 (0.00%)  0/1 (0.00%)  0/2 (0.00%)  0/4 (0.00%)  3/31 (9.68%)  0/15 (0.00%) 
Neuralgia  1  0/1 (0.00%)  1/7 (14.29%)  1/1 (100.00%)  0/2 (0.00%)  0/4 (0.00%)  1/31 (3.23%)  1/15 (6.67%) 
Paresthesia  1  0/1 (0.00%)  3/7 (42.86%)  0/1 (0.00%)  1/2 (50.00%)  1/4 (25.00%)  8/31 (25.81%)  2/15 (13.33%) 
Peripheral sensory neuropathy  1  0/1 (0.00%)  2/7 (28.57%)  0/1 (0.00%)  0/2 (0.00%)  0/4 (0.00%)  0/31 (0.00%)  0/15 (0.00%) 
Presyncope  1  0/1 (0.00%)  1/7 (14.29%)  0/1 (0.00%)  0/2 (0.00%)  0/4 (0.00%)  0/31 (0.00%)  0/15 (0.00%) 
Pyramidal tract syndrome  1  0/1 (0.00%)  2/7 (28.57%)  0/1 (0.00%)  1/2 (50.00%)  3/4 (75.00%)  18/31 (58.06%)  8/15 (53.33%) 
Restless leg syndrome  1  0/1 (0.00%)  0/7 (0.00%)  0/1 (0.00%)  0/2 (0.00%)  0/4 (0.00%)  1/31 (3.23%)  0/15 (0.00%) 
Seizure  1  1/1 (100.00%)  6/7 (85.71%)  1/1 (100.00%)  0/2 (0.00%)  3/4 (75.00%)  15/31 (48.39%)  10/15 (66.67%) 
Tremor  1  0/1 (0.00%)  1/7 (14.29%)  0/1 (0.00%)  0/2 (0.00%)  0/4 (0.00%)  1/31 (3.23%)  1/15 (6.67%) 
Psychiatric disorders               
Agitation  1  0/1 (0.00%)  0/7 (0.00%)  0/1 (0.00%)  0/2 (0.00%)  0/4 (0.00%)  1/31 (3.23%)  0/15 (0.00%) 
Anxiety  1  0/1 (0.00%)  1/7 (14.29%)  0/1 (0.00%)  0/2 (0.00%)  0/4 (0.00%)  5/31 (16.13%)  0/15 (0.00%) 
Confusion  1  0/1 (0.00%)  2/7 (28.57%)  0/1 (0.00%)  0/2 (0.00%)  1/4 (25.00%)  7/31 (22.58%)  1/15 (6.67%) 
Depression  1  0/1 (0.00%)  1/7 (14.29%)  0/1 (0.00%)  0/2 (0.00%)  0/4 (0.00%)  2/31 (6.45%)  1/15 (6.67%) 
Hallucinations  1  0/1 (0.00%)  0/7 (0.00%)  0/1 (0.00%)  0/2 (0.00%)  0/4 (0.00%)  1/31 (3.23%)  1/15 (6.67%) 
Insomnia  1  0/1 (0.00%)  4/7 (57.14%)  0/1 (0.00%)  0/2 (0.00%)  1/4 (25.00%)  8/31 (25.81%)  2/15 (13.33%) 
Suicidal ideation  1  0/1 (0.00%)  1/7 (14.29%)  0/1 (0.00%)  0/2 (0.00%)  0/4 (0.00%)  0/31 (0.00%)  0/15 (0.00%) 
Renal and urinary disorders               
Hematuria  1  0/1 (0.00%)  0/7 (0.00%)  0/1 (0.00%)  0/2 (0.00%)  0/4 (0.00%)  3/31 (9.68%)  1/15 (6.67%) 
Proteinuria  1  0/1 (0.00%)  0/7 (0.00%)  0/1 (0.00%)  1/2 (50.00%)  0/4 (0.00%)  5/31 (16.13%)  1/15 (6.67%) 
Renal and urinary disorders - Other, specify  1  0/1 (0.00%)  0/7 (0.00%)  0/1 (0.00%)  0/2 (0.00%)  0/4 (0.00%)  0/31 (0.00%)  1/15 (6.67%) 
Renal calculi  1  0/1 (0.00%)  0/7 (0.00%)  0/1 (0.00%)  0/2 (0.00%)  0/4 (0.00%)  0/31 (0.00%)  1/15 (6.67%) 
Urinary frequency  1  0/1 (0.00%)  1/7 (14.29%)  1/1 (100.00%)  0/2 (0.00%)  0/4 (0.00%)  0/31 (0.00%)  1/15 (6.67%) 
Urinary incontinence  1  0/1 (0.00%)  1/7 (14.29%)  1/1 (100.00%)  0/2 (0.00%)  0/4 (0.00%)  4/31 (12.90%)  1/15 (6.67%) 
Urinary retention  1  0/1 (0.00%)  0/7 (0.00%)  0/1 (0.00%)  0/2 (0.00%)  0/4 (0.00%)  1/31 (3.23%)  0/15 (0.00%) 
Reproductive system and breast disorders               
Irregular menstruation  1  0/1 (0.00%)  0/7 (0.00%)  0/1 (0.00%)  0/2 (0.00%)  0/4 (0.00%)  2/31 (6.45%)  0/15 (0.00%) 
Vaginal hemorrhage  1  0/1 (0.00%)  0/7 (0.00%)  0/1 (0.00%)  0/2 (0.00%)  0/4 (0.00%)  0/31 (0.00%)  1/15 (6.67%) 
Respiratory, thoracic and mediastinal disorders               
Allergic rhinitis  1  0/1 (0.00%)  0/7 (0.00%)  0/1 (0.00%)  0/2 (0.00%)  0/4 (0.00%)  4/31 (12.90%)  0/15 (0.00%) 
Cough  1  0/1 (0.00%)  0/7 (0.00%)  1/1 (100.00%)  1/2 (50.00%)  0/4 (0.00%)  1/31 (3.23%)  0/15 (0.00%) 
Dyspnea  1  0/1 (0.00%)  1/7 (14.29%)  1/1 (100.00%)  0/2 (0.00%)  0/4 (0.00%)  4/31 (12.90%)  1/15 (6.67%) 
Epistaxis  1  0/1 (0.00%)  0/7 (0.00%)  0/1 (0.00%)  0/2 (0.00%)  0/4 (0.00%)  3/31 (9.68%)  1/15 (6.67%) 
Hiccups  1  0/1 (0.00%)  0/7 (0.00%)  0/1 (0.00%)  0/2 (0.00%)  0/4 (0.00%)  1/31 (3.23%)  0/15 (0.00%) 
Hoarseness  1  0/1 (0.00%)  1/7 (14.29%)  0/1 (0.00%)  0/2 (0.00%)  1/4 (25.00%)  2/31 (6.45%)  0/15 (0.00%) 
Nasal congestion  1  1/1 (100.00%)  0/7 (0.00%)  1/1 (100.00%)  1/2 (50.00%)  0/4 (0.00%)  3/31 (9.68%)  1/15 (6.67%) 
Postnasal drip  1  0/1 (0.00%)  0/7 (0.00%)  0/1 (0.00%)  0/2 (0.00%)  0/4 (0.00%)  6/31 (19.35%)  0/15 (0.00%) 
Respiratory, thoracic and mediastinal disorders - Other, specify  1  0/1 (0.00%)  0/7 (0.00%)  1/1 (100.00%)  0/2 (0.00%)  0/4 (0.00%)  2/31 (6.45%)  0/15 (0.00%) 
Sleep apnea  1  0/1 (0.00%)  1/7 (14.29%)  0/1 (0.00%)  0/2 (0.00%)  0/4 (0.00%)  0/31 (0.00%)  1/15 (6.67%) 
Skin and subcutaneous tissue disorders               
Dry skin  1  0/1 (0.00%)  1/7 (14.29%)  0/1 (0.00%)  0/2 (0.00%)  0/4 (0.00%)  5/31 (16.13%)  1/15 (6.67%) 
Pruritus  1  0/1 (0.00%)  0/7 (0.00%)  0/1 (0.00%)  0/2 (0.00%)  0/4 (0.00%)  1/31 (3.23%)  0/15 (0.00%) 
Rash  1  0/1 (0.00%)  0/7 (0.00%)  0/1 (0.00%)  0/2 (0.00%)  1/4 (25.00%)  8/31 (25.81%)  3/15 (20.00%) 
Skin and subcutaneous tissue disorders - Other, specify  1  0/1 (0.00%)  0/7 (0.00%)  0/1 (0.00%)  0/2 (0.00%)  0/4 (0.00%)  1/31 (3.23%)  0/15 (0.00%) 
Skin trauma  1  0/1 (0.00%)  0/7 (0.00%)  0/1 (0.00%)  0/2 (0.00%)  0/4 (0.00%)  4/31 (12.90%)  2/15 (13.33%) 
Social circumstances               
Menopause  1  0/1 (0.00%)  0/7 (0.00%)  0/1 (0.00%)  0/2 (0.00%)  0/4 (0.00%)  1/31 (3.23%)  0/15 (0.00%) 
Surgical and medical procedures               
Surgical and medical procedures - Other, specify  1  0/1 (0.00%)  1/7 (14.29%)  0/1 (0.00%)  0/2 (0.00%)  0/4 (0.00%)  0/31 (0.00%)  0/15 (0.00%) 
Vascular disorders               
Hot flashes  1  0/1 (0.00%)  0/7 (0.00%)  0/1 (0.00%)  0/2 (0.00%)  0/4 (0.00%)  2/31 (6.45%)  0/15 (0.00%) 
Hypertension  1  0/1 (0.00%)  1/7 (14.29%)  0/1 (0.00%)  0/2 (0.00%)  1/4 (25.00%)  8/31 (25.81%)  3/15 (20.00%) 
Thromboembolic event  1  0/1 (0.00%)  0/7 (0.00%)  1/1 (100.00%)  0/2 (0.00%)  1/4 (25.00%)  0/31 (0.00%)  1/15 (6.67%) 
1
Term from vocabulary, CTCAE (4.0)
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT 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.
Results Point of Contact
Name/Title: Henry Friedman, MD
Organization: Duke University Medical Center
Phone: 9196845301
Responsible Party: Istari Oncology, Inc.
ClinicalTrials.gov Identifier: NCT01491893     History of Changes
Other Study ID Numbers: Pro00031169
NS20023 ( Other Grant/Funding Number: National Institute of Neurological Disorders and Stroke )
First Submitted: December 1, 2011
First Posted: December 14, 2011
Results First Submitted: June 27, 2018
Results First Posted: September 28, 2018
Last Update Posted: November 27, 2018