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Selinexor in Treating Younger Patients With Recurrent or Refractory Solid Tumors or High-Grade Gliomas

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: NCT02323880
Recruitment Status : Active, not recruiting
First Posted : December 24, 2014
Results First Posted : January 2, 2024
Last Update Posted : January 2, 2024
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Children's Oncology Group

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Malignant Glioma
Recurrent Brain Neoplasm
Recurrent Childhood Central Nervous System Neoplasm
Recurrent Childhood Glioblastoma
Recurrent Lymphoma
Recurrent Malignant Solid Neoplasm
Refractory Lymphoma
Refractory Malignant Solid Neoplasm
Refractory Primary Central Nervous System Neoplasm
WHO Grade 3 Glioma
Interventions Other: Pharmacological Study
Drug: Selinexor
Enrollment 59
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Part A: Dose Level 1 Part A: Dose Level 1 (DL 1) Part A: Dose Level -1 (DL -1) Part A: Weekly Dose Level 1 (WDL 1) Part A: Weekly Dose Level -1 (WDL -1) Part B: Weekly Dose Level -1 (WDL -1) Part PK: Dose Level -1 (DL -1) Part PK: Weekly Dose Level -1 (WDL -1)
Hide Arm/Group Description 35 mg/m^2 of Selinexor PO twice weekly on a days 1 and 3 schedule (Mon/Wed, Tues/Thurs, or Wed/Fri) of a 28 day, or 8 dose course (Pre-amendment #1) 35 mg/m^2 of Selinexor PO twice weekly on a days 1 and 3 schedule (Mon/Wed, Tues/Thurs, or Wed/Fri) on Weeks 1-3, Week 4 rest, on a 28 day course (Amendment 1) 20 mg/m^2 of Selinexor PO twice weekly on a days 1 and 3 schedule (Mon/Wed, Tues/Thurs, or Wed/Fri) on Weeks 1-3, Week 4 rest, on a 28 day course 45 mg/m^2 Selinexor once weekly, on days 1, 8, 15, and 22 of a 28-day cycle 35 mg/m2 Selinexor once weekly, on days 1, 8, 15, and 22 of a 28-day cycle 35 mg/m^2 Selinexor once weekly, on days 1, 8, 15, and 22 of a 28-day cycle 20 mg/m2 of Selinexor PO twice weekly on a days 1 and 3 schedule (Mon/Wed, Tues/Thurs, or Wed/Fri) on Weeks 1-3, Week 4 rest, on a 28 day course 35 mg/m^2 Selinexor once weekly, on days 1, 8, 15, and 22 of a 28-day cycle
Period Title: Overall Study
Started 6 13 6 6 6 10 6 6
Completed 0 0 0 0 0 0 0 0
Not Completed 6 13 6 6 6 10 6 6
Reason Not Completed
Adverse Event             2             0             1             1             1             0             1             0
Death             0             0             0             0             0             1             0             0
Lack of Efficacy             4             11             5             5             4             8             4             6
Physician Decision             0             0             0             0             1             1             1             0
Withdrawal by Subject             0             2             0             0             0             0             0             0
Arm/Group Title Part A: Dose Level 1 Part A: Dose Level 1 (DL1) Part A: Dose Level -1 (DL -1) Part A: Weekly Dose Level 1 (WDL 1) Part A: Weekly Dose Level -1 (WDL -1) Part B: Weekly Dose Level -1 (WDL -1) Part PK: Dose Level -1 (DL -1) Part PK: Weekly Dose Level -1 (WDL -1) Total
Hide Arm/Group Description 35 mg/m^2 of Selinexor PO twice weekly on a days 1 and 3 schedule (Mon/Wed, Tues/Thurs, or Wed/Fri) of a 28 day, or 8 dose course (Pre-Amendment #1) 35 mg/m^2 of Selinexor PO twice weekly on a days 1 and 3 schedule (Mon/Wed, Tues/Thurs, or Wed/Fri) on Weeks 1-3, Week 4 rest, on a 28 day course (Amendment 1) 20 mg/m^2 of Selinexor PO twice weekly on a days 1 and 3 schedule (Mon/Wed, Tues/Thurs, or Wed/Fri) on Weeks 1-3, Week 4 rest, on a 28 day course 45 mg/m^2 Selinexor once weekly, on days 1, 8, 15, and 22 of a 28-day cycle 35 mg/m2 Selinexor once weekly, on days 1, 8, 15, and 22 of a 28-day cycle 35 mg/m^2 Selinexor once weekly, on days 1, 8, 15, and 22 of a 28-day cycle 20 mg/m2 of Selinexor PO twice weekly on a days 1 and 3 schedule (Mon/Wed, Tues/Thurs, or Wed/Fri) on Weeks 1-3, Week 4 rest, on a 28 day course 35 mg/m^2 Selinexor once weekly, on days 1, 8, 15, and 22 of a 28-day cycle Total of all reporting groups
Overall Number of Baseline Participants 6 13 6 6 6 10 6 6 59
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 6 participants 13 participants 6 participants 6 participants 6 participants 10 participants 6 participants 6 participants 59 participants
<=18 years
6
 100.0%
13
 100.0%
6
 100.0%
4
  66.7%
5
  83.3%
9
  90.0%
5
  83.3%
6
 100.0%
54
  91.5%
Between 18 and 65 years
0
   0.0%
0
   0.0%
0
   0.0%
2
  33.3%
1
  16.7%
1
  10.0%
1
  16.7%
0
   0.0%
5
   8.5%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 6 participants 13 participants 6 participants 6 participants 6 participants 10 participants 6 participants 6 participants 59 participants
13.5
(11.0 to 18.0)
16
(10.0 to 18.0)
15.5
(6.0 to 17.0)
16.5
(7.0 to 20.0)
14
(7.0 to 20.0)
15.5
(7.0 to 19.0)
10.5
(7.0 to 20.0)
11
(6.0 to 14.0)
15
(6.0 to 20.0)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 6 participants 13 participants 6 participants 6 participants 6 participants 10 participants 6 participants 6 participants 59 participants
Female
2
  33.3%
9
  69.2%
3
  50.0%
4
  66.7%
5
  83.3%
3
  30.0%
3
  50.0%
4
  66.7%
33
  55.9%
Male
4
  66.7%
4
  30.8%
3
  50.0%
2
  33.3%
1
  16.7%
7
  70.0%
3
  50.0%
2
  33.3%
26
  44.1%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 6 participants 13 participants 6 participants 6 participants 6 participants 10 participants 6 participants 6 participants 59 participants
Hispanic or Latino
2
  33.3%
2
  15.4%
0
   0.0%
1
  16.7%
1
  16.7%
1
  10.0%
0
   0.0%
1
  16.7%
8
  13.6%
Not Hispanic or Latino
4
  66.7%
10
  76.9%
6
 100.0%
4
  66.7%
4
  66.7%
8
  80.0%
6
 100.0%
5
  83.3%
47
  79.7%
Unknown or Not Reported
0
   0.0%
1
   7.7%
0
   0.0%
1
  16.7%
1
  16.7%
1
  10.0%
0
   0.0%
0
   0.0%
4
   6.8%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 6 participants 13 participants 6 participants 6 participants 6 participants 10 participants 6 participants 6 participants 59 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
0
   0.0%
1
  16.7%
0
   0.0%
1
  16.7%
2
  20.0%
0
   0.0%
0
   0.0%
4
   6.8%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
0
   0.0%
3
  23.1%
0
   0.0%
0
   0.0%
0
   0.0%
1
  10.0%
3
  50.0%
1
  16.7%
8
  13.6%
White
4
  66.7%
8
  61.5%
5
  83.3%
4
  66.7%
3
  50.0%
5
  50.0%
3
  50.0%
3
  50.0%
35
  59.3%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
1
  16.7%
0
   0.0%
1
  10.0%
0
   0.0%
0
   0.0%
2
   3.4%
Unknown or Not Reported
2
  33.3%
2
  15.4%
0
   0.0%
1
  16.7%
2
  33.3%
1
  10.0%
0
   0.0%
2
  33.3%
10
  16.9%
1.Primary Outcome
Title Number of Dose Limiting Toxicities of Selinexor
Hide Description The number of toxicity evaluable patients experiencing a dose limiting toxicity at least possibly attributable to selinexor by study part, schema, and dose level.
Time Frame Up to 28 days
Hide Outcome Measure Data
Hide Analysis Population Description
Toxicity evaluable patients
Arm/Group Title Part A: Dose Level 1 Part A: Dose Level 1 (DL 1) Part A: Dose Level -1 (DL -1) Part A: Weekly Dose Level 1 (WDL 1) Part A: Weekly Dose Level -1 (WDL -1) Part B: Weekly Dose Level -1 (WDL -1) Part PK: Dose Level -1 (DL -1) Part PK: Weekly Dose Level -1 (WDL -1)
Hide Arm/Group Description:
35 mg/m^2 of Selinexor PO twice weekly on a days 1 and 3 schedule (Mon/Wed, Tues/Thurs, or Wed/Fri) of a 28 day, or 8 dose course (Pre-amendment #1)
35 mg/m^2 of Selinexor PO twice weekly on a days 1 and 3 schedule (Mon/Wed, Tues/Thurs, or Wed/Fri) on Weeks 1-3, Week 4 rest, on a 28 day course (Amendment 1)
20 mg/m^2 of Selinexor PO twice weekly on a days 1 and 3 schedule (Mon/Wed, Tues/Thurs, or Wed/Fri) on Weeks 1-3, Week 4 rest, on a 28 day course
45 mg/m^2 Selinexor once weekly, on days 1, 8, 15, and 22 of a 28-day cycle
35 mg/m2 Selinexor once weekly, on days 1, 8, 15, and 22 of a 28-day cycle
35 mg/m^2 Selinexor once weekly, on days 1, 8, 15, and 22 of a 28-day cycle
20 mg/m2 of Selinexor PO twice weekly on a days 1 and 3 schedule (Mon/Wed, Tues/Thurs, or Wed/Fri) on Weeks 1-3, Week 4 rest, on a 28 day course
35 mg/m^2 Selinexor once weekly, on days 1, 8, 15, and 22 of a 28-day cycle
Overall Number of Participants Analyzed 6 12 6 6 6 7 6 6
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
4
  33.3%
1
  16.7%
2
  33.3%
1
  16.7%
0
   0.0%
2
  33.3%
0
   0.0%
2.Primary Outcome
Title Number of Adverse Events of Selinexor
Hide Description The number of patients experiencing adverse events at least possibly attributable to selinexor by study part, schema, and dose level.
Time Frame Up to 6 years 11 months
Hide Outcome Measure Data
Hide Analysis Population Description
Toxicity evaluable patients
Arm/Group Title Part A: Dose Level 1 Part A: Dose Level 1 (DL 1) Part A: Dose Level -1 (DL -1) Part A: Weekly Dose Level 1 (WDL 1) Part A: Weekly Dose Level -1 (WDL -1) Part B: Weekly Dose Level -1 (WDL -1) Part PK: Dose Level -1 (DL -1) Part PK: Weekly Dose Level -1 (WDL -1)
Hide Arm/Group Description:
35 mg/m^2 of Selinexor PO twice weekly on a days 1 and 3 schedule (Mon/Wed, Tues/Thurs, or Wed/Fri) of a 28 day, or 8 dose course (Pre-amendment #1)
35 mg/m^2 of Selinexor PO twice weekly on a days 1 and 3 schedule (Mon/Wed, Tues/Thurs, or Wed/Fri) on Weeks 1-3, Week 4 rest, on a 28 day course (Amendment 1)
20 mg/m^2 of Selinexor PO twice weekly on a days 1 and 3 schedule (Mon/Wed, Tues/Thurs, or Wed/Fri) on Weeks 1-3, Week 4 rest, on a 28 day course
45 mg/m^2 Selinexor once weekly, on days 1, 8, 15, and 22 of a 28-day cycle
35 mg/m2 Selinexor once weekly, on days 1, 8, 15, and 22 of a 28-day cycle
35 mg/m^2 Selinexor once weekly, on days 1, 8, 15, and 22 of a 28-day cycle
20 mg/m2 of Selinexor PO twice weekly on a days 1 and 3 schedule (Mon/Wed, Tues/Thurs, or Wed/Fri) on Weeks 1-3, Week 4 rest, on a 28 day course
35 mg/m^2 Selinexor once weekly, on days 1, 8, 15, and 22 of a 28-day cycle
Overall Number of Participants Analyzed 6 12 6 6 6 7 6 6
Measure Type: Count of Participants
Unit of Measure: Participants
6
 100.0%
12
 100.0%
6
 100.0%
6
 100.0%
6
 100.0%
7
 100.0%
6
 100.0%
6
 100.0%
3.Primary Outcome
Title Area Under the Drug Concentration Curve of Selinexor
Hide Description The median (min, max) of the area under the drug concentration curve evaluated at 0.5, 1, 2, 3, 4, 6, 8, and 24 hours post dose on day 1 for Selinexor by study part, schema, and dose level.
Time Frame Up to 2 days
Hide Outcome Measure Data
Hide Analysis Population Description
All eligible patients
Arm/Group Title Part A: Dose Level 1 Part A: Dose Level 1 (DL 1) Part A: Dose Level -1 (DL -1) Part A: Weekly Dose Level 1 (WDL 1) Part A: Weekly Dose Level -1 (WDL -1) Part B: Weekly Dose Level -1 (WDL -1) Part PK: Dose Level -1 (DL -1) Part PK: Weekly Dose Level -1 (WDL -1)
Hide Arm/Group Description:
35 mg/m^2 of Selinexor PO twice weekly on a days 1 and 3 schedule (Mon/Wed, Tues/Thurs, or Wed/Fri) of a 28 day, or 8 dose course (Pre-amendment #1)
35 mg/m^2 of Selinexor PO twice weekly on a days 1 and 3 schedule (Mon/Wed, Tues/Thurs, or Wed/Fri) on Weeks 1-3, Week 4 rest, on a 28 day course (Amendment 1)
20 mg/m^2 of Selinexor PO twice weekly on a days 1 and 3 schedule (Mon/Wed, Tues/Thurs, or Wed/Fri) on Weeks 1-3, Week 4 rest, on a 28 day course
45 mg/m^2 Selinexor once weekly, on days 1, 8, 15, and 22 of a 28-day cycle
35 mg/m2 Selinexor once weekly, on days 1, 8, 15, and 22 of a 28-day cycle
35 mg/m^2 Selinexor once weekly, on days 1, 8, 15, and 22 of a 28-day cycle
20 mg/m2 of Selinexor PO twice weekly on a days 1 and 3 schedule (Mon/Wed, Tues/Thurs, or Wed/Fri) on Weeks 1-3, Week 4 rest, on a 28 day course
35 mg/m^2 Selinexor once weekly, on days 1, 8, 15, and 22 of a 28-day cycle
Overall Number of Participants Analyzed 6 13 6 6 6 10 6 6
Median (Full Range)
Unit of Measure: h*ng/ml
5030
(3807.3 to 8789.4)
4656.8
(3660.5 to 7285.5)
2602.4
(2355.9 to 4889.3)
6173.2
(5401.1 to 9161.2)
7135.9
(4718.0 to 8665.6)
4666.9
(2154.7 to 10151.4)
3132.8
(2028.5 to 3377.1)
6505.5
(4739.7 to 8809.0)
4.Secondary Outcome
Title Antitumor Effect of Selinexor
Hide Description Number of patients with best response using RECIST 1.1 criteria of partial response (at least a 30% decrease in the sum of the diameters of target lesions) or complete response (disappearance of all target and non-target lesions and any pathological lymph nodes must have reduction in short axis to <10 mm).
Time Frame Up to 6 years 11 months
Hide Outcome Measure Data
Hide Analysis Population Description
Responsive patients
Arm/Group Title Part A: Dose Level 1 Part A: Dose Level 1 (DL 1) Part A: Dose Level -1 (DL -1) Part A: Weekly Dose Level 1 (WDL 1) Part A: Weekly Dose Level -1 (WDL -1) Part B: Weekly Dose Level -1 (WDL -1) Part PK: Dose Level -1 (DL -1) Part PK: Weekly Dose Level -1 (WDL -1)
Hide Arm/Group Description:
35 mg/m^2 of Selinexor PO twice weekly on a days 1 and 3 schedule (Mon/Wed, Tues/Thurs, or Wed/Fri) of a 28 day, or 8 dose course (Pre-amendment #1)
35 mg/m^2 of Selinexor PO twice weekly on a days 1 and 3 schedule (Mon/Wed, Tues/Thurs, or Wed/Fri) on Weeks 1-3, Week 4 rest, on a 28 day course (Amendment 1)
20 mg/m^2 of Selinexor PO twice weekly on a days 1 and 3 schedule (Mon/Wed, Tues/Thurs, or Wed/Fri) on Weeks 1-3, Week 4 rest, on a 28 day course
45 mg/m^2 Selinexor once weekly, on days 1, 8, 15, and 22 of a 28-day cycle
35 mg/m2 Selinexor once weekly, on days 1, 8, 15, and 22 of a 28-day cycle
35 mg/m^2 Selinexor once weekly, on days 1, 8, 15, and 22 of a 28-day cycle
20 mg/m2 of Selinexor PO twice weekly on a days 1 and 3 schedule (Mon/Wed, Tues/Thurs, or Wed/Fri) on Weeks 1-3, Week 4 rest, on a 28 day course
35 mg/m^2 Selinexor once weekly, on days 1, 8, 15, and 22 of a 28-day cycle
Overall Number of Participants Analyzed 6 13 6 6 6 10 6 6
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
5.Secondary Outcome
Title Pharmacodynamics of Selinexor
Hide Description Median (min,max) ratio of XPO1 mRNA expression after treatment to pre-treatment by study part, schema, and dose
Time Frame Up to 28 days
Hide Outcome Measure Data
Hide Analysis Population Description
There were 0 (zero) patients from Part A: Dose Level 1 (Pre-amendment #1). Participation in the PD studies was optional. The subjects who had matched pre- and post-treatment blood samples were analyzed; not all the subjects had samples collected for PD analysis.
Arm/Group Title Part A: Dose Level 1 (DL 1) Part A: Dose Level -1 (DL -1) Part A: Weekly Dose Level 1 (WDL 1) Part A: Weekly Dose Level -1 (WDL -1) Part B: Weekly Dose Level -1 (WDL -1) Part PK: Dose Level -1 (DL -1) Part PK: Weekly Dose Level -1 (WDL -1)
Hide Arm/Group Description:
35 mg/m^2 of Selinexor PO twice weekly on a days 1 and 3 schedule (Mon/Wed, Tues/Thurs, or Wed/Fri) on Weeks 1-3, Week 4 rest, on a 28 day course (Amendment 1)
20 mg/m^2 of Selinexor PO twice weekly on a days 1 and 3 schedule (Mon/Wed, Tues/Thurs, or Wed/Fri) on Weeks 1-3, Week 4 rest, on a 28 day course
45 mg/m^2 Selinexor once weekly, on days 1, 8, 15, and 22 of a 28-day cycle
35 mg/m2 Selinexor once weekly, on days 1, 8, 15, and 22 of a 28-day cycle
35 mg/m^2 Selinexor once weekly, on days 1, 8, 15, and 22 of a 28-day cycle
20 mg/m2 of Selinexor PO twice weekly on a days 1 and 3 schedule (Mon/Wed, Tues/Thurs, or Wed/Fri) on Weeks 1-3, Week 4 rest, on a 28 day course
35 mg/m^2 Selinexor once weekly, on days 1, 8, 15, and 22 of a 28-day cycle
Overall Number of Participants Analyzed 1 2 2 2 4 1 2
Median (Full Range)
Unit of Measure: Ratio of XPO1 mRNA expression
7.1
(7.1 to 7.1)
4
(3.5 to 4.5)
5.5
(4.2 to 6.7)
1.7
(0.2 to 3.2)
4.6
(1.2 to 5.3)
7.9
(7.9 to 7.9)
5.4
(5.0 to 5.9)
6.Secondary Outcome
Title Pharmacodynamics of Selinexor in High-grade Glioma (HGG) Patients
Hide Description Median (min,max) ratio of XPO1 mRNA expression after treatment to pre-treatment by study part, schema, and dose
Time Frame Up to 28 days
Hide Outcome Measure Data
Hide Analysis Population Description
high-grade glioma (HGG) patients with data available
Arm/Group Title Part A: Weekly Dose Level 1 (WDL 1) Part B: Weekly Dose Level -1 (WDL -1) Part PK: Weekly Dose Level -1 (WDL -1)
Hide Arm/Group Description:
45 mg/m^2 Selinexor once weekly, on days 1, 8, 15, and 22 of a 28-day cycle
35 mg/m^2 Selinexor once weekly, on days 1, 8, 15, and 22 of a 28-day cycle
35 mg/m^2 Selinexor once weekly, on days 1, 8, 15, and 22 of a 28-day cycle
Overall Number of Participants Analyzed 1 4 1
Median (Full Range)
Unit of Measure: Ratio of XPO1 mRNA expression
4.2
(4.2 to 4.2)
4.6
(1.2 to 5.3)
5.9
(5.9 to 5.9)
7.Secondary Outcome
Title Radiographic Response of Selinexor in High-grade Glioma (HGG) Patients
Hide Description Number of HGG patients with radiographic response by study part, schema, and dose level.
Time Frame Up to 6 years 11 months
Hide Outcome Measure Data
Hide Analysis Population Description
high-grade glioma (HGG) patients
Arm/Group Title Part A: Dose Level 1 Part A: Dose Level 1 (DL 1) Part A: Weekly Dose Level 1 (WDL 1) Part A: Weekly Dose Level -1 (WDL -1) Part B: Weekly Dose Level -1 (WDL -1) Part PK: Weekly Dose Level -1 (WDL -1)
Hide Arm/Group Description:
35 mg/m^2 of Selinexor PO twice weekly on a days 1 and 3 schedule (Mon/Wed, Tues/Thurs, or Wed/Fri) of a 28 day, or 8 dose course (Pre-amendment #1)
35 mg/m^2 of Selinexor PO twice weekly on a days 1 and 3 schedule (Mon/Wed, Tues/Thurs, or Wed/Fri) on Weeks 1-3, Week 4 rest, on a 28 day course (Amendment 1)
45 mg/m^2 Selinexor once weekly, on days 1, 8, 15, and 22 of a 28-day cycle
35 mg/m2 Selinexor once weekly, on days 1, 8, 15, and 22 of a 28-day cycle
35 mg/m^2 Selinexor once weekly, on days 1, 8, 15, and 22 of a 28-day cycle
35 mg/m^2 Selinexor once weekly, on days 1, 8, 15, and 22 of a 28-day cycle
Overall Number of Participants Analyzed 3 3 2 2 9 2
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
8.Secondary Outcome
Title Progression-free Survival of Selinexor in Surgical High-grade Glioma (HGG) Patients
Hide Description Number of surgical HGG patients with 6-month progression-free survival using the Response Evaluation Criteria in solid tumors criteria (RECIST v1.1) defining best response of progressive disease including at least 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study and no prior stable disease, partial response, or complete response.
Time Frame Up to 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
high-grade glioma (HGG) patients
Arm/Group Title Part A: Dose Level 1 Part A: Dose Level 1 (DL 1) Part A: Dose Level -1 (DL -1) Part A: Weekly Dose Level 1 (WDL 1) Part A: Weekly Dose Level -1 (WDL -1) Part B: Weekly Dose Level -1 (WDL -1) Part PK: Dose Level -1 (DL -1) Part PK: Weekly Dose Level -1 (WDL -1)
Hide Arm/Group Description:
35 mg/m^2 of Selinexor PO twice weekly on a days 1 and 3 schedule (Mon/Wed, Tues/Thurs, or Wed/Fri) of a 28 day, or 8 dose course (Pre-amendment #1)
35 mg/m^2 of Selinexor PO twice weekly on a days 1 and 3 schedule (Mon/Wed, Tues/Thurs, or Wed/Fri) on Weeks 1-3, Week 4 rest, on a 28 day course (Amendment 1)
20 mg/m^2 of Selinexor PO twice weekly on a days 1 and 3 schedule (Mon/Wed, Tues/Thurs, or Wed/Fri) on Weeks 1-3, Week 4 rest, on a 28 day course
45 mg/m^2 Selinexor once weekly, on days 1, 8, 15, and 22 of a 28-day cycle
35 mg/m2 Selinexor once weekly, on days 1, 8, 15, and 22 of a 28-day cycle
35 mg/m^2 Selinexor once weekly, on days 1, 8, 15, and 22 of a 28-day cycle
20 mg/m2 of Selinexor PO twice weekly on a days 1 and 3 schedule (Mon/Wed, Tues/Thurs, or Wed/Fri) on Weeks 1-3, Week 4 rest, on a 28 day course
35 mg/m^2 Selinexor once weekly, on days 1, 8, 15, and 22 of a 28-day cycle
Overall Number of Participants Analyzed 3 3 0 2 2 9 0 2
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
0
   0.0%
 0
0
   0.0%
0
   0.0%
0
   0.0%
 0
0
   0.0%
Time Frame Up to 7 years 8 months
Adverse Event Reporting Description Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. Ineligible patients are excluded from reporting of adverse events. All-Cause Mortality includes all deaths collected on the study.
 
Arm/Group Title Part A: Dose Level 1 Part A: Dose Level 1 (DL1)(Amendment 1) Part A: Dose Level -1 (DL-1) Part A: Weekly Dose Level 1 (WDL 1) Part A: Weekly Dose Level -1 (WDL -1) Part B: Weekly Dose Level -1 (WDL -1) Part PK: Dose Level -1 (DL -1) Part PK: Weekly Dose Level -1 (DL -1)
Hide Arm/Group Description 35 mg/m^2 of Selinexor PO twice weekly on a days 1 and 3 schedule (Mon/Wed, Tues/Thurs, or Wed/Fri) of a 28 day, or 8 dose course (pre-amendment #1) Amendment 1- 35 mg/m^2 of Selinexor PO twice weekly on a days 1 and 3 schedule (Mon/Wed, Tues/Thurs, or Wed/Fri) on Weeks 1-3, Week 4 rest, on a 28 day course (amendment #1) 20 mg/m^2 of Selinexor PO twice weekly on a days 1 and 3 schedule (Mon/Wed, Tues/Thurs, or Wed/Fri) on Weeks 1-3, Week 4 rest, on a 28 day course 45 mg/m^2 Selinexor once weekly, on days 1, 8, 15, and 22 of a 28-day cycle 35 mg/m2 Selinexor once weekly, on days 1, 8, 15, and 22 of a 28-day cycle 35 mg/m^2 Selinexor once weekly, on days 1, 8, 15, and 22 of a 28-day cycle 20 mg/m2 of Selinexor PO twice weekly on a days 1 and 3 schedule (Mon/Wed, Tues/Thurs, or Wed/Fri) on Weeks 1-3, Week 4 rest, on a 28 day course 35 mg/m^2 Selinexor once weekly, on days 1, 8, 15, and 22 of a 28-day cycle
All-Cause Mortality
Part A: Dose Level 1 Part A: Dose Level 1 (DL1)(Amendment 1) Part A: Dose Level -1 (DL-1) Part A: Weekly Dose Level 1 (WDL 1) Part A: Weekly Dose Level -1 (WDL -1) Part B: Weekly Dose Level -1 (WDL -1) Part PK: Dose Level -1 (DL -1) Part PK: Weekly Dose Level -1 (DL -1)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/6 (0.00%)   1/13 (7.69%)   0/6 (0.00%)   0/6 (0.00%)   0/6 (0.00%)   2/10 (20.00%)   0/6 (0.00%)   0/6 (0.00%) 
Hide Serious Adverse Events
Part A: Dose Level 1 Part A: Dose Level 1 (DL1)(Amendment 1) Part A: Dose Level -1 (DL-1) Part A: Weekly Dose Level 1 (WDL 1) Part A: Weekly Dose Level -1 (WDL -1) Part B: Weekly Dose Level -1 (WDL -1) Part PK: Dose Level -1 (DL -1) Part PK: Weekly Dose Level -1 (DL -1)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   1/6 (16.67%)   5/13 (38.46%)   3/6 (50.00%)   2/6 (33.33%)   3/6 (50.00%)   3/10 (30.00%)   0/6 (0.00%)   3/6 (50.00%) 
Eye disorders                 
Blurred vision †  0/6 (0.00%)  0/13 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  1/6 (16.67%)  0/10 (0.00%)  0/6 (0.00%)  0/6 (0.00%) 
Gastrointestinal disorders                 
Dysphagia †  0/6 (0.00%)  2/13 (15.38%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/10 (0.00%)  0/6 (0.00%)  0/6 (0.00%) 
Nausea †  1/6 (16.67%)  0/13 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/10 (0.00%)  0/6 (0.00%)  0/6 (0.00%) 
Vomiting †  1/6 (16.67%)  1/13 (7.69%)  1/6 (16.67%)  0/6 (0.00%)  0/6 (0.00%)  0/10 (0.00%)  0/6 (0.00%)  0/6 (0.00%) 
General disorders                 
Fatigue †  0/6 (0.00%)  2/13 (15.38%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/10 (0.00%)  0/6 (0.00%)  0/6 (0.00%) 
Fever †  0/6 (0.00%)  0/13 (0.00%)  1/6 (16.67%)  0/6 (0.00%)  0/6 (0.00%)  0/10 (0.00%)  0/6 (0.00%)  0/6 (0.00%) 
Pain †  0/6 (0.00%)  0/13 (0.00%)  0/6 (0.00%)  1/6 (16.67%)  1/6 (16.67%)  0/10 (0.00%)  0/6 (0.00%)  0/6 (0.00%) 
Infections and infestations                 
Lung infection †  0/6 (0.00%)  0/13 (0.00%)  1/6 (16.67%)  0/6 (0.00%)  0/6 (0.00%)  0/10 (0.00%)  0/6 (0.00%)  0/6 (0.00%) 
Urinary tract infection †  0/6 (0.00%)  0/13 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  1/10 (10.00%)  0/6 (0.00%)  0/6 (0.00%) 
Metabolism and nutrition disorders                 
Acidosis †  0/6 (0.00%)  0/13 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  1/10 (10.00%)  0/6 (0.00%)  0/6 (0.00%) 
Anorexia †  0/6 (0.00%)  0/13 (0.00%)  2/6 (33.33%)  0/6 (0.00%)  0/6 (0.00%)  0/10 (0.00%)  0/6 (0.00%)  0/6 (0.00%) 
Dehydration †  0/6 (0.00%)  1/13 (7.69%)  1/6 (16.67%)  0/6 (0.00%)  0/6 (0.00%)  0/10 (0.00%)  0/6 (0.00%)  0/6 (0.00%) 
Musculoskeletal and connective tissue disorders                 
Back pain †  0/6 (0.00%)  0/13 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  1/6 (16.67%)  0/10 (0.00%)  0/6 (0.00%)  0/6 (0.00%) 
Nervous system disorders                 
Cognitive disturbance †  0/6 (0.00%)  1/13 (7.69%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/10 (0.00%)  0/6 (0.00%)  0/6 (0.00%) 
Depressed level of consciousness †  0/6 (0.00%)  0/13 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  2/10 (20.00%)  0/6 (0.00%)  0/6 (0.00%) 
Dysarthria †  0/6 (0.00%)  1/13 (7.69%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/10 (0.00%)  0/6 (0.00%)  0/6 (0.00%) 
Edema cerebral †  0/6 (0.00%)  1/13 (7.69%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/10 (0.00%)  0/6 (0.00%)  0/6 (0.00%) 
Encephalopathy †  0/6 (0.00%)  0/13 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  1/10 (10.00%)  0/6 (0.00%)  1/6 (16.67%) 
Headache †  0/6 (0.00%)  0/13 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/10 (0.00%)  0/6 (0.00%)  1/6 (16.67%) 
Seizure †  0/6 (0.00%)  0/13 (0.00%)  0/6 (0.00%)  1/6 (16.67%)  0/6 (0.00%)  1/10 (10.00%)  0/6 (0.00%)  1/6 (16.67%) 
Somnolence †  0/6 (0.00%)  0/13 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  1/10 (10.00%)  0/6 (0.00%)  0/6 (0.00%) 
Respiratory, thoracic and mediastinal disorders                 
Aspiration †  0/6 (0.00%)  1/13 (7.69%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  1/10 (10.00%)  0/6 (0.00%)  0/6 (0.00%) 
Hypoxia †  0/6 (0.00%)  0/13 (0.00%)  1/6 (16.67%)  0/6 (0.00%)  0/6 (0.00%)  1/10 (10.00%)  0/6 (0.00%)  0/6 (0.00%) 
Pleural effusion †  0/6 (0.00%)  0/13 (0.00%)  1/6 (16.67%)  0/6 (0.00%)  0/6 (0.00%)  0/10 (0.00%)  0/6 (0.00%)  0/6 (0.00%) 
Pleuritic pain †  0/6 (0.00%)  0/13 (0.00%)  1/6 (16.67%)  0/6 (0.00%)  0/6 (0.00%)  0/10 (0.00%)  0/6 (0.00%)  0/6 (0.00%) 
†
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Part A: Dose Level 1 Part A: Dose Level 1 (DL1)(Amendment 1) Part A: Dose Level -1 (DL-1) Part A: Weekly Dose Level 1 (WDL 1) Part A: Weekly Dose Level -1 (WDL -1) Part B: Weekly Dose Level -1 (WDL -1) Part PK: Dose Level -1 (DL -1) Part PK: Weekly Dose Level -1 (DL -1)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   6/6 (100.00%)   13/13 (100.00%)   6/6 (100.00%)   6/6 (100.00%)   6/6 (100.00%)   10/10 (100.00%)   6/6 (100.00%)   6/6 (100.00%) 
Blood and lymphatic system disorders                 
Anemia †  4/6 (66.67%)  11/13 (84.62%)  3/6 (50.00%)  4/6 (66.67%)  3/6 (50.00%)  6/10 (60.00%)  3/6 (50.00%)  4/6 (66.67%) 
Cardiac disorders                 
Cardiac disorders - Other, ASYMPTOMATIC LV DSYFUNCTION †  0/6 (0.00%)  0/13 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/10 (0.00%)  1/6 (16.67%)  0/6 (0.00%) 
Chest pain - cardiac †  1/6 (16.67%)  0/13 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/10 (0.00%)  0/6 (0.00%)  0/6 (0.00%) 
Mitral valve disease †  0/6 (0.00%)  0/13 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  1/6 (16.67%)  0/10 (0.00%)  0/6 (0.00%)  0/6 (0.00%) 
Palpitations †  0/6 (0.00%)  0/13 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  1/6 (16.67%)  0/10 (0.00%)  0/6 (0.00%)  0/6 (0.00%) 
Pericardial effusion †  0/6 (0.00%)  0/13 (0.00%)  1/6 (16.67%)  0/6 (0.00%)  0/6 (0.00%)  0/10 (0.00%)  0/6 (0.00%)  0/6 (0.00%) 
Sinus bradycardia †  0/6 (0.00%)  1/13 (7.69%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/10 (0.00%)  0/6 (0.00%)  0/6 (0.00%) 
Sinus tachycardia †  2/6 (33.33%)  4/13 (30.77%)  3/6 (50.00%)  1/6 (16.67%)  3/6 (50.00%)  1/10 (10.00%)  1/6 (16.67%)  2/6 (33.33%) 
Ear and labyrinth disorders                 
Ear and labyrinth disorders - Other, EAR PRESSURE †  0/6 (0.00%)  1/13 (7.69%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/10 (0.00%)  0/6 (0.00%)  0/6 (0.00%) 
Ear and labyrinth disorders - Other, PHONOPHOBIA †  0/6 (0.00%)  0/13 (0.00%)  1/6 (16.67%)  0/6 (0.00%)  0/6 (0.00%)  0/10 (0.00%)  0/6 (0.00%)  0/6 (0.00%) 
Ear pain †  1/6 (16.67%)  1/13 (7.69%)  0/6 (0.00%)  1/6 (16.67%)  0/6 (0.00%)  0/10 (0.00%)  0/6 (0.00%)  0/6 (0.00%) 
Hearing impaired †  1/6 (16.67%)  1/13 (7.69%)  0/6 (0.00%)  0/6 (0.00%)  2/6 (33.33%)  1/10 (10.00%)  0/6 (0.00%)  1/6 (16.67%) 
Tinnitus †  0/6 (0.00%)  1/13 (7.69%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  1/10 (10.00%)  0/6 (0.00%)  0/6 (0.00%) 
Vertigo †  0/6 (0.00%)  1/13 (7.69%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/10 (0.00%)  0/6 (0.00%)  0/6 (0.00%) 
Endocrine disorders                 
Adrenal insufficiency †  0/6 (0.00%)  1/13 (7.69%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/10 (0.00%)  0/6 (0.00%)  1/6 (16.67%) 
Cushingoid †  1/6 (16.67%)  2/13 (15.38%)  1/6 (16.67%)  0/6 (0.00%)  1/6 (16.67%)  2/10 (20.00%)  0/6 (0.00%)  1/6 (16.67%) 
Hyperthyroidism †  0/6 (0.00%)  0/13 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/10 (0.00%)  1/6 (16.67%)  0/6 (0.00%) 
Hypothyroidism †  0/6 (0.00%)  2/13 (15.38%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  1/10 (10.00%)  1/6 (16.67%)  0/6 (0.00%) 
Eye disorders                 
Blurred vision †  2/6 (33.33%)  4/13 (30.77%)  1/6 (16.67%)  0/6 (0.00%)  4/6 (66.67%)  2/10 (20.00%)  1/6 (16.67%)  2/6 (33.33%) 
Conjunctivitis †  0/6 (0.00%)  1/13 (7.69%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/10 (0.00%)  0/6 (0.00%)  0/6 (0.00%) 
Dry eye †  0/6 (0.00%)  2/13 (15.38%)  1/6 (16.67%)  0/6 (0.00%)  1/6 (16.67%)  0/10 (0.00%)  0/6 (0.00%)  0/6 (0.00%) 
Extraocular muscle paresis †  0/6 (0.00%)  0/13 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  1/6 (16.67%)  0/10 (0.00%)  0/6 (0.00%)  0/6 (0.00%) 
Eye disorders - Other, †  0/6 (0.00%)  0/13 (0.00%)  0/6 (0.00%)  1/6 (16.67%)  1/6 (16.67%)  1/10 (10.00%)  0/6 (0.00%)  2/6 (33.33%) 
Eye disorders - Other, DECREASED VISION AND LIGHT PERCEPTION †  0/6 (0.00%)  1/13 (7.69%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/10 (0.00%)  0/6 (0.00%)  0/6 (0.00%) 
Eye disorders - Other, DECREASED VISUAL ACUITY †  0/6 (0.00%)  0/13 (0.00%)  1/6 (16.67%)  0/6 (0.00%)  0/6 (0.00%)  0/10 (0.00%)  0/6 (0.00%)  0/6 (0.00%) 
Eye disorders - Other, DIPLOPIA †  0/6 (0.00%)  0/13 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/10 (0.00%)  1/6 (16.67%)  0/6 (0.00%) 
Eye disorders - Other, DISCONJUGATE GAZE †  0/6 (0.00%)  1/13 (7.69%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/10 (0.00%)  0/6 (0.00%)  0/6 (0.00%) 
Eye disorders - Other, DOUBLE VISION †  0/6 (0.00%)  0/13 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/10 (0.00%)  1/6 (16.67%)  0/6 (0.00%) 
Eye disorders - Other, Double vision †  0/6 (0.00%)  0/13 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  1/10 (10.00%)  0/6 (0.00%)  0/6 (0.00%) 
Eye disorders - Other, FIELD DEFICIT †  0/6 (0.00%)  1/13 (7.69%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/10 (0.00%)  0/6 (0.00%)  0/6 (0.00%) 
Eye disorders - Other, MILD OPTIC ATROPHY †  1/6 (16.67%)  0/13 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/10 (0.00%)  0/6 (0.00%)  0/6 (0.00%) 
Eye disorders - Other, PARINAUD'S SYNDROME †  0/6 (0.00%)  0/13 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/10 (0.00%)  1/6 (16.67%)  0/6 (0.00%) 
Eye disorders - Other, PERIORBITAL PAIN †  0/6 (0.00%)  1/13 (7.69%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/10 (0.00%)  0/6 (0.00%)  0/6 (0.00%) 
Eye disorders - Other, PTOSIS †  0/6 (0.00%)  1/13 (7.69%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/10 (0.00%)  0/6 (0.00%)  0/6 (0.00%) 
Eye disorders - Other, Ptosis of left eye †  0/6 (0.00%)  0/13 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  1/10 (10.00%)  0/6 (0.00%)  0/6 (0.00%) 
Eye disorders - Other, R ESOTROPIA †  0/6 (0.00%)  0/13 (0.00%)  1/6 (16.67%)  0/6 (0.00%)  0/6 (0.00%)  0/10 (0.00%)  0/6 (0.00%)  0/6 (0.00%) 
Eye disorders - Other, RIGHT APD †  0/6 (0.00%)  1/13 (7.69%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/10 (0.00%)  0/6 (0.00%)  0/6 (0.00%) 
Eye disorders - Other, RIGHT EXTROPIA †  0/6 (0.00%)  1/13 (7.69%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/10 (0.00%)  0/6 (0.00%)  0/6 (0.00%) 
Eye disorders - Other, RIGHT EYE SWELLING/PTOSIS †  0/6 (0.00%)  1/13 (7.69%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/10 (0.00%)  0/6 (0.00%)  0/6 (0.00%) 
Eye disorders - Other, VISION LOSS †  0/6 (0.00%)  1/13 (7.69%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/10 (0.00%)  0/6 (0.00%)  0/6 (0.00%) 
Eye disorders - Other, VISUAL FIELD DEFICIT †  0/6 (0.00%)  1/13 (7.69%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/10 (0.00%)  2/6 (33.33%)  0/6 (0.00%) 
Eye pain †  0/6 (0.00%)  0/13 (0.00%)  0/6 (0.00%)  1/6 (16.67%)  1/6 (16.67%)  0/10 (0.00%)  0/6 (0.00%)  0/6 (0.00%) 
Floaters †  0/6 (0.00%)  0/13 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  1/10 (10.00%)  0/6 (0.00%)  0/6 (0.00%) 
Papilledema †  1/6 (16.67%)  0/13 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/10 (0.00%)  0/6 (0.00%)  0/6 (0.00%) 
Photophobia †  0/6 (0.00%)  0/13 (0.00%)  1/6 (16.67%)  0/6 (0.00%)  0/6 (0.00%)  0/10 (0.00%)  1/6 (16.67%)  1/6 (16.67%) 
Gastrointestinal disorders                 
Abdominal distension †  0/6 (0.00%)  0/13 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  1/6 (16.67%)  0/10 (0.00%)  0/6 (0.00%)  0/6 (0.00%) 
Abdominal pain †  1/6 (16.67%)  1/13 (7.69%)  3/6 (50.00%)  1/6 (16.67%)  4/6 (66.67%)  3/10 (30.00%)  2/6 (33.33%)  0/6 (0.00%) 
Anal hemorrhage †  0/6 (0.00%)  0/13 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/10 (0.00%)  1/6 (16.67%)  0/6 (0.00%) 
Bloating †  0/6 (0.00%)  0/13 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  1/6 (16.67%)  1/10 (10.00%)  0/6 (0.00%)  0/6 (0.00%) 
Constipation †  1/6 (16.67%)  5/13 (38.46%)  3/6 (50.00%)  3/6 (50.00%)  5/6 (83.33%)  3/10 (30.00%)  3/6 (50.00%)  2/6 (33.33%) 
Diarrhea †  3/6 (50.00%)  6/13 (46.15%)  3/6 (50.00%)  2/6 (33.33%)  4/6 (66.67%)  3/10 (30.00%)  1/6 (16.67%)  1/6 (16.67%) 
Dyspepsia †  2/6 (33.33%)  1/13 (7.69%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/10 (0.00%)  0/6 (0.00%)  0/6 (0.00%) 
Dysphagia †  0/6 (0.00%)  2/13 (15.38%)  0/6 (0.00%)  0/6 (0.00%)  3/6 (50.00%)  3/10 (30.00%)  0/6 (0.00%)  0/6 (0.00%) 
Fecal incontinence †  0/6 (0.00%)  1/13 (7.69%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/10 (0.00%)  0/6 (0.00%)  0/6 (0.00%) 
Flatulence †  0/6 (0.00%)  0/13 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  1/6 (16.67%)  0/10 (0.00%)  0/6 (0.00%)  0/6 (0.00%) 
Gastritis †  0/6 (0.00%)  0/13 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  1/6 (16.67%)  0/10 (0.00%)  0/6 (0.00%)  0/6 (0.00%) 
Gastroesophageal reflux disease †  0/6 (0.00%)  1/13 (7.69%)  1/6 (16.67%)  0/6 (0.00%)  1/6 (16.67%)  2/10 (20.00%)  0/6 (0.00%)  0/6 (0.00%) 
Gastrointestinal disorders - Other, ABDOMINAL CRAMPING †  0/6 (0.00%)  1/13 (7.69%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/10 (0.00%)  0/6 (0.00%)  0/6 (0.00%) 
Gastrointestinal disorders - Other, BRIGHT RED BLOOD PER RECTUM/POSSIBLE INTERNAL FISSURE †  0/6 (0.00%)  1/13 (7.69%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/10 (0.00%)  0/6 (0.00%)  0/6 (0.00%) 
Gastrointestinal disorders - Other, TOOTH SENSITIVITY †  0/6 (0.00%)  1/13 (7.69%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/10 (0.00%)  0/6 (0.00%)  0/6 (0.00%) 
Nausea †  5/6 (83.33%)  10/13 (76.92%)  6/6 (100.00%)  5/6 (83.33%)  5/6 (83.33%)  8/10 (80.00%)  3/6 (50.00%)  6/6 (100.00%) 
Rectal hemorrhage †  0/6 (0.00%)  0/13 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  1/6 (16.67%)  0/10 (0.00%)  0/6 (0.00%)  0/6 (0.00%) 
Stomach pain †  2/6 (33.33%)  3/13 (23.08%)  1/6 (16.67%)  0/6 (0.00%)  1/6 (16.67%)  0/10 (0.00%)  1/6 (16.67%)  1/6 (16.67%) 
Vomiting †  4/6 (66.67%)  10/13 (76.92%)  4/6 (66.67%)  4/6 (66.67%)  4/6 (66.67%)  6/10 (60.00%)  4/6 (66.67%)  6/6 (100.00%) 
General disorders                 
Chills †  0/6 (0.00%)  1/13 (7.69%)  0/6 (0.00%)  2/6 (33.33%)  0/6 (0.00%)  0/10 (0.00%)  0/6 (0.00%)  0/6 (0.00%) 
Edema face †  1/6 (16.67%)  1/13 (7.69%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  1/10 (10.00%)  0/6 (0.00%)  0/6 (0.00%) 
Edema limbs †  1/6 (16.67%)  1/13 (7.69%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/10 (0.00%)  1/6 (16.67%)  0/6 (0.00%) 
Fatigue †  6/6 (100.00%)  10/13 (76.92%)  5/6 (83.33%)  3/6 (50.00%)  5/6 (83.33%)  10/10 (100.00%)  5/6 (83.33%)  4/6 (66.67%) 
Fever †  1/6 (16.67%)  3/13 (23.08%)  1/6 (16.67%)  1/6 (16.67%)  0/6 (0.00%)  1/10 (10.00%)  0/6 (0.00%)  0/6 (0.00%) 
Gait disturbance †  0/6 (0.00%)  4/13 (30.77%)  2/6 (33.33%)  1/6 (16.67%)  1/6 (16.67%)  3/10 (30.00%)  1/6 (16.67%)  1/6 (16.67%) 
General disorders and administration site conditions - Other, ABDOMINAL CRAMPING †  0/6 (0.00%)  0/13 (0.00%)  1/6 (16.67%)  0/6 (0.00%)  0/6 (0.00%)  0/10 (0.00%)  0/6 (0.00%)  0/6 (0.00%) 
General disorders and administration site conditions - Other, COLD INTOLERANCE †  0/6 (0.00%)  1/13 (7.69%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/10 (0.00%)  0/6 (0.00%)  0/6 (0.00%) 
General disorders and administration site conditions - Other, NIGHT SWEATS †  0/6 (0.00%)  1/13 (7.69%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/10 (0.00%)  0/6 (0.00%)  0/6 (0.00%) 
General disorders and administration site conditions - Other, OSMOPHOBIA †  0/6 (0.00%)  1/13 (7.69%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/10 (0.00%)  0/6 (0.00%)  0/6 (0.00%) 
General disorders and administration site conditions - Other, POLYDIPSIA †  1/6 (16.67%)  0/13 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/10 (0.00%)  0/6 (0.00%)  0/6 (0.00%) 
General disorders and administration site conditions - Other, RHINORRHEA †  0/6 (0.00%)  1/13 (7.69%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/10 (0.00%)  0/6 (0.00%)  0/6 (0.00%) 
General disorders and administration site conditions - Other, surgical site pain †  0/6 (0.00%)  0/13 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  1/10 (10.00%)  0/6 (0.00%)  0/6 (0.00%) 
Localized edema †  0/6 (0.00%)  0/13 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/10 (0.00%)  1/6 (16.67%)  0/6 (0.00%) 
Malaise †  0/6 (0.00%)  0/13 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  1/6 (16.67%)  0/10 (0.00%)  0/6 (0.00%)  0/6 (0.00%) 
Neck edema †  0/6 (0.00%)  0/13 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/10 (0.00%)  0/6 (0.00%)  1/6 (16.67%) 
Non-cardiac chest pain †  0/6 (0.00%)  1/13 (7.69%)  1/6 (16.67%)  2/6 (33.33%)  3/6 (50.00%)  0/10 (0.00%)  0/6 (0.00%)  0/6 (0.00%) 
Pain †  0/6 (0.00%)  2/13 (15.38%)  0/6 (0.00%)  0/6 (0.00%)  1/6 (16.67%)  1/10 (10.00%)  0/6 (0.00%)  0/6 (0.00%) 
Hepatobiliary disorders                 
Hepatobiliary disorders - Other, NON-ALCOHOLIC STEATOHEPATITIS †  0/6 (0.00%)  0/13 (0.00%)  1/6 (16.67%)  0/6 (0.00%)  0/6 (0.00%)  0/10 (0.00%)  0/6 (0.00%)  0/6 (0.00%) 
Infections and infestations                 
Infections and infestations - Other, CLOSTRIDIUM DIFFICILE †  1/6 (16.67%)  0/13 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/10 (0.00%)  0/6 (0.00%)  0/6 (0.00%) 
Infections and infestations - Other, COVID-19 †  0/6 (0.00%)  0/13 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  1/10 (10.00%)  0/6 (0.00%)  0/6 (0.00%) 
Infections and infestations - Other, INFLUENZA †  0/6 (0.00%)  1/13 (7.69%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/10 (0.00%)  0/6 (0.00%)  0/6 (0.00%) 
Infections and infestations - Other, PARAINFLUENZA †  0/6 (0.00%)  1/13 (7.69%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/10 (0.00%)  0/6 (0.00%)  0/6 (0.00%) 
Infections and infestations - Other, STREP PHARYNGITIS †  0/6 (0.00%)  1/13 (7.69%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/10 (0.00%)  0/6 (0.00%)  0/6 (0.00%) 
Infections and infestations - Other, covid-19 †  0/6 (0.00%)  0/13 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/10 (0.00%)  0/6 (0.00%)  1/6 (16.67%) 
Infections and infestations - Other, salmonella †  0/6 (0.00%)  0/13 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  1/10 (10.00%)  0/6 (0.00%)  0/6 (0.00%) 
Mucosal infection †  0/6 (0.00%)  1/13 (7.69%)  1/6 (16.67%)  0/6 (0.00%)  0/6 (0.00%)  0/10 (0.00%)  0/6 (0.00%)  0/6 (0.00%) 
Paronychia †  0/6 (0.00%)  0/13 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/10 (0.00%)  1/6 (16.67%)  0/6 (0.00%) 
Sinusitis †  0/6 (0.00%)  1/13 (7.69%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/10 (0.00%)  0/6 (0.00%)  0/6 (0.00%) 
Skin infection †  0/6 (0.00%)  0/13 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  1/6 (16.67%)  1/10 (10.00%)  1/6 (16.67%)  0/6 (0.00%) 
Upper respiratory infection †  1/6 (16.67%)  2/13 (15.38%)  0/6 (0.00%)  1/6 (16.67%)  0/6 (0.00%)  1/10 (10.00%)  0/6 (0.00%)  0/6 (0.00%) 
Urinary tract infection †  0/6 (0.00%)  2/13 (15.38%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/10 (0.00%)  0/6 (0.00%)  0/6 (0.00%) 
Injury, poisoning and procedural complications                 
Bruising †  0/6 (0.00%)  1/13 (7.69%)  1/6 (16.67%)  0/6 (0.00%)  1/6 (16.67%)  0/10 (0.00%)  0/6 (0.00%)  0/6 (0.00%) 
Fall †  0/6 (0.00%)  0/13 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  1/6 (16.67%)  0/10 (0.00%)  2/6 (33.33%)  0/6 (0.00%) 
Fracture †  0/6 (0.00%)  0/13 (0.00%)  1/6 (16.67%)  0/6 (0.00%)  2/6 (33.33%)  0/10 (0.00%)  1/6 (16.67%)  0/6 (0.00%) 
Injury, poisoning and procedural complications - Other, PSEUDOMENINGOCELE †  0/6 (0.00%)  0/13 (0.00%)  1/6 (16.67%)  0/6 (0.00%)  0/6 (0.00%)  0/10 (0.00%)  0/6 (0.00%)  0/6 (0.00%) 
Investigations                 
Activated partial thromboplastin time prolonged †  0/6 (0.00%)  0/13 (0.00%)  2/6 (33.33%)  0/6 (0.00%)  1/6 (16.67%)  1/10 (10.00%)  0/6 (0.00%)  0/6 (0.00%) 
Alanine aminotransferase increased †  4/6 (66.67%)  8/13 (61.54%)  5/6 (83.33%)  1/6 (16.67%)  5/6 (83.33%)  5/10 (50.00%)  2/6 (33.33%)  1/6 (16.67%) 
Alkaline phosphatase increased †  0/6 (0.00%)  0/13 (0.00%)  1/6 (16.67%)  1/6 (16.67%)  2/6 (33.33%)  2/10 (20.00%)  1/6 (16.67%)  0/6 (0.00%) 
Aspartate aminotransferase increased †  2/6 (33.33%)  6/13 (46.15%)  5/6 (83.33%)  1/6 (16.67%)  3/6 (50.00%)  4/10 (40.00%)  2/6 (33.33%)  1/6 (16.67%) 
Blood bilirubin increased †  1/6 (16.67%)  1/13 (7.69%)  0/6 (0.00%)  0/6 (0.00%)  3/6 (50.00%)  0/10 (0.00%)  0/6 (0.00%)  1/6 (16.67%) 
Creatinine increased †  1/6 (16.67%)  3/13 (23.08%)  0/6 (0.00%)  1/6 (16.67%)  1/6 (16.67%)  3/10 (30.00%)  2/6 (33.33%)  0/6 (0.00%) 
Ejection fraction decreased †  0/6 (0.00%)  0/13 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/10 (0.00%)  0/6 (0.00%)  1/6 (16.67%) 
Electrocardiogram QT corrected interval prolonged †  0/6 (0.00%)  0/13 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  1/6 (16.67%)  1/10 (10.00%)  0/6 (0.00%)  0/6 (0.00%) 
Hemoglobin increased †  0/6 (0.00%)  1/13 (7.69%)  0/6 (0.00%)  1/6 (16.67%)  3/6 (50.00%)  0/10 (0.00%)  0/6 (0.00%)  0/6 (0.00%) 
INR increased †  0/6 (0.00%)  1/13 (7.69%)  0/6 (0.00%)  0/6 (0.00%)  1/6 (16.67%)  0/10 (0.00%)  0/6 (0.00%)  0/6 (0.00%) 
Investigations - Other, BICARBONATE < LLN †  0/6 (0.00%)  0/13 (0.00%)  1/6 (16.67%)  0/6 (0.00%)  0/6 (0.00%)  0/10 (0.00%)  0/6 (0.00%)  0/6 (0.00%) 
Investigations - Other, BICARBONATE DECREASED †  0/6 (0.00%)  0/13 (0.00%)  2/6 (33.33%)  0/6 (0.00%)  0/6 (0.00%)  0/10 (0.00%)  0/6 (0.00%)  0/6 (0.00%) 
Investigations - Other, BICARBONATE LOW †  0/6 (0.00%)  0/13 (0.00%)  1/6 (16.67%)  0/6 (0.00%)  0/6 (0.00%)  0/10 (0.00%)  0/6 (0.00%)  0/6 (0.00%) 
Investigations - Other, BICARBONATE SERUM LOW †  0/6 (0.00%)  2/13 (15.38%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/10 (0.00%)  0/6 (0.00%)  0/6 (0.00%) 
Investigations - Other, DECREASE CO2 †  0/6 (0.00%)  0/13 (0.00%)  1/6 (16.67%)  0/6 (0.00%)  0/6 (0.00%)  0/10 (0.00%)  0/6 (0.00%)  0/6 (0.00%) 
Investigations - Other, DECREASED CO2 †  0/6 (0.00%)  0/13 (0.00%)  1/6 (16.67%)  0/6 (0.00%)  0/6 (0.00%)  0/10 (0.00%)  0/6 (0.00%)  0/6 (0.00%) 
Investigations - Other, Decreased creatinine †  0/6 (0.00%)  0/13 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  1/6 (16.67%)  0/10 (0.00%)  0/6 (0.00%)  0/6 (0.00%) 
Investigations - Other, ELEVATED BUN †  0/6 (0.00%)  1/13 (7.69%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/10 (0.00%)  0/6 (0.00%)  0/6 (0.00%) 
Investigations - Other, ELEVATED LDH †  1/6 (16.67%)  1/13 (7.69%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/10 (0.00%)  0/6 (0.00%)  0/6 (0.00%) 
Investigations - Other, ELEVATED TSH †  0/6 (0.00%)  1/13 (7.69%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/10 (0.00%)  0/6 (0.00%)  0/6 (0.00%) 
Investigations - Other, Elevated Chloride †  0/6 (0.00%)  0/13 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  1/6 (16.67%)  0/10 (0.00%)  0/6 (0.00%)  0/6 (0.00%) 
Investigations - Other, Elevated chloride †  0/6 (0.00%)  0/13 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  1/6 (16.67%)  1/10 (10.00%)  0/6 (0.00%)  0/6 (0.00%) 
Investigations - Other, HYPOCHLOREMIA †  0/6 (0.00%)  2/13 (15.38%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/10 (0.00%)  0/6 (0.00%)  0/6 (0.00%) 
Investigations - Other, INCREASED CHLORIDE †  0/6 (0.00%)  0/13 (0.00%)  1/6 (16.67%)  0/6 (0.00%)  0/6 (0.00%)  0/10 (0.00%)  0/6 (0.00%)  0/6 (0.00%) 
Investigations - Other, LOW BICARB †  0/6 (0.00%)  0/13 (0.00%)  1/6 (16.67%)  0/6 (0.00%)  0/6 (0.00%)  0/10 (0.00%)  0/6 (0.00%)  0/6 (0.00%) 
Investigations - Other, LOW BICARBONATE †  0/6 (0.00%)  0/13 (0.00%)  1/6 (16.67%)  0/6 (0.00%)  0/6 (0.00%)  0/10 (0.00%)  0/6 (0.00%)  0/6 (0.00%) 
Investigations - Other, LOW CO2 †  0/6 (0.00%)  0/13 (0.00%)  1/6 (16.67%)  0/6 (0.00%)  0/6 (0.00%)  0/10 (0.00%)  0/6 (0.00%)  0/6 (0.00%) 
Investigations - Other, LOW TESTOSTERON †  0/6 (0.00%)  1/13 (7.69%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/10 (0.00%)  0/6 (0.00%)  0/6 (0.00%) 
Lipase increased †  1/6 (16.67%)  1/13 (7.69%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/10 (0.00%)  0/6 (0.00%)  1/6 (16.67%) 
Lymphocyte count decreased †  4/6 (66.67%)  7/13 (53.85%)  4/6 (66.67%)  3/6 (50.00%)  4/6 (66.67%)  10/10 (100.00%)  2/6 (33.33%)  4/6 (66.67%) 
Neutrophil count decreased †  5/6 (83.33%)  10/13 (76.92%)  6/6 (100.00%)  6/6 (100.00%)  5/6 (83.33%)  7/10 (70.00%)  5/6 (83.33%)  5/6 (83.33%) 
Platelet count decreased †  5/6 (83.33%)  11/13 (84.62%)  5/6 (83.33%)  4/6 (66.67%)  6/6 (100.00%)  6/10 (60.00%)  3/6 (50.00%)  2/6 (33.33%) 
Serum amylase increased †  0/6 (0.00%)  1/13 (7.69%)  0/6 (0.00%)  0/6 (0.00%)  1/6 (16.67%)  0/10 (0.00%)  1/6 (16.67%)  1/6 (16.67%) 
Weight gain †  0/6 (0.00%)  2/13 (15.38%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  2/10 (20.00%)  0/6 (0.00%)  0/6 (0.00%) 
Weight loss †  4/6 (66.67%)  3/13 (23.08%)  3/6 (50.00%)  2/6 (33.33%)  2/6 (33.33%)  2/10 (20.00%)  1/6 (16.67%)  3/6 (50.00%) 
White blood cell decreased †  6/6 (100.00%)  12/13 (92.31%)  6/6 (100.00%)  6/6 (100.00%)  5/6 (83.33%)  8/10 (80.00%)  5/6 (83.33%)  5/6 (83.33%) 
Metabolism and nutrition disorders                 
Anorexia †  2/6 (33.33%)  7/13 (53.85%)  5/6 (83.33%)  4/6 (66.67%)  4/6 (66.67%)  5/10 (50.00%)  4/6 (66.67%)  5/6 (83.33%) 
Dehydration †  0/6 (0.00%)  1/13 (7.69%)  1/6 (16.67%)  1/6 (16.67%)  1/6 (16.67%)  1/10 (10.00%)  0/6 (0.00%)  1/6 (16.67%) 
Glucose intolerance †  0/6 (0.00%)  2/13 (15.38%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/10 (0.00%)  0/6 (0.00%)  0/6 (0.00%) 
Hypercalcemia †  0/6 (0.00%)  0/13 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  2/6 (33.33%)  1/10 (10.00%)  1/6 (16.67%)  0/6 (0.00%) 
Hyperglycemia †  4/6 (66.67%)  7/13 (53.85%)  0/6 (0.00%)  2/6 (33.33%)  3/6 (50.00%)  3/10 (30.00%)  1/6 (16.67%)  5/6 (83.33%) 
Hyperkalemia †  0/6 (0.00%)  1/13 (7.69%)  3/6 (50.00%)  0/6 (0.00%)  0/6 (0.00%)  2/10 (20.00%)  0/6 (0.00%)  0/6 (0.00%) 
Hypermagnesemia †  3/6 (50.00%)  3/13 (23.08%)  0/6 (0.00%)  1/6 (16.67%)  1/6 (16.67%)  5/10 (50.00%)  0/6 (0.00%)  2/6 (33.33%) 
Hypernatremia †  1/6 (16.67%)  4/13 (30.77%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/10 (0.00%)  1/6 (16.67%)  1/6 (16.67%) 
Hypoalbuminemia †  1/6 (16.67%)  2/13 (15.38%)  1/6 (16.67%)  1/6 (16.67%)  1/6 (16.67%)  1/10 (10.00%)  0/6 (0.00%)  1/6 (16.67%) 
Hypocalcemia †  4/6 (66.67%)  6/13 (46.15%)  1/6 (16.67%)  2/6 (33.33%)  1/6 (16.67%)  2/10 (20.00%)  0/6 (0.00%)  3/6 (50.00%) 
Hypoglycemia †  0/6 (0.00%)  0/13 (0.00%)  1/6 (16.67%)  1/6 (16.67%)  1/6 (16.67%)  1/10 (10.00%)  0/6 (0.00%)  2/6 (33.33%) 
Hypokalemia †  4/6 (66.67%)  4/13 (30.77%)  3/6 (50.00%)  1/6 (16.67%)  3/6 (50.00%)  1/10 (10.00%)  0/6 (0.00%)  1/6 (16.67%) 
Hypomagnesemia †  1/6 (16.67%)  4/13 (30.77%)  0/6 (0.00%)  0/6 (0.00%)  1/6 (16.67%)  0/10 (0.00%)  1/6 (16.67%)  0/6 (0.00%) 
Hyponatremia †  1/6 (16.67%)  6/13 (46.15%)  2/6 (33.33%)  2/6 (33.33%)  3/6 (50.00%)  4/10 (40.00%)  1/6 (16.67%)  3/6 (50.00%) 
Hypophosphatemia †  3/6 (50.00%)  5/13 (38.46%)  3/6 (50.00%)  2/6 (33.33%)  4/6 (66.67%)  3/10 (30.00%)  2/6 (33.33%)  1/6 (16.67%) 
Metabolism and nutrition disorders - Other, †  0/6 (0.00%)  0/13 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  1/6 (16.67%)  0/10 (0.00%)  0/6 (0.00%)  0/6 (0.00%) 
Metabolism and nutrition disorders - Other, BICARBONATES †  0/6 (0.00%)  1/13 (7.69%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/10 (0.00%)  0/6 (0.00%)  0/6 (0.00%) 
Metabolism and nutrition disorders - Other, Bicarbonate, low †  0/6 (0.00%)  0/13 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  1/6 (16.67%)  0/10 (0.00%)  0/6 (0.00%)  0/6 (0.00%) 
Metabolism and nutrition disorders - Other, DIABETES INSIPIDUS †  0/6 (0.00%)  0/13 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/10 (0.00%)  1/6 (16.67%)  0/6 (0.00%) 
Metabolism and nutrition disorders - Other, HYPERPHOSPHATEMIA †  0/6 (0.00%)  1/13 (7.69%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/10 (0.00%)  0/6 (0.00%)  0/6 (0.00%) 
Metabolism and nutrition disorders - Other, INCREASED APPETITE †  0/6 (0.00%)  1/13 (7.69%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/10 (0.00%)  0/6 (0.00%)  0/6 (0.00%) 
Obesity †  1/6 (16.67%)  2/13 (15.38%)  0/6 (0.00%)  1/6 (16.67%)  1/6 (16.67%)  1/10 (10.00%)  0/6 (0.00%)  0/6 (0.00%) 
Musculoskeletal and connective tissue disorders                 
Arthralgia †  0/6 (0.00%)  2/13 (15.38%)  0/6 (0.00%)  2/6 (33.33%)  1/6 (16.67%)  1/10 (10.00%)  1/6 (16.67%)  2/6 (33.33%) 
Back pain †  0/6 (0.00%)  1/13 (7.69%)  2/6 (33.33%)  2/6 (33.33%)  2/6 (33.33%)  3/10 (30.00%)  1/6 (16.67%)  1/6 (16.67%) 
Bone pain †  0/6 (0.00%)  0/13 (0.00%)  1/6 (16.67%)  0/6 (0.00%)  0/6 (0.00%)  0/10 (0.00%)  0/6 (0.00%)  0/6 (0.00%) 
Buttock pain †  0/6 (0.00%)  0/13 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  1/6 (16.67%)  0/10 (0.00%)  0/6 (0.00%)  0/6 (0.00%) 
Chest wall pain †  0/6 (0.00%)  0/13 (0.00%)  1/6 (16.67%)  0/6 (0.00%)  0/6 (0.00%)  0/10 (0.00%)  0/6 (0.00%)  0/6 (0.00%) 
Flank pain †  0/6 (0.00%)  0/13 (0.00%)  2/6 (33.33%)  0/6 (0.00%)  1/6 (16.67%)  1/10 (10.00%)  0/6 (0.00%)  0/6 (0.00%) 
Generalized muscle weakness †  0/6 (0.00%)  4/13 (30.77%)  1/6 (16.67%)  1/6 (16.67%)  1/6 (16.67%)  1/10 (10.00%)  0/6 (0.00%)  0/6 (0.00%) 
Joint range of motion decreased †  1/6 (16.67%)  0/13 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  1/6 (16.67%)  1/10 (10.00%)  1/6 (16.67%)  1/6 (16.67%) 
Joint range of motion decreased cervical spine †  0/6 (0.00%)  0/13 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/10 (0.00%)  0/6 (0.00%)  1/6 (16.67%) 
Kyphosis †  0/6 (0.00%)  0/13 (0.00%)  1/6 (16.67%)  0/6 (0.00%)  0/6 (0.00%)  0/10 (0.00%)  0/6 (0.00%)  0/6 (0.00%) 
Muscle weakness lower limb †  0/6 (0.00%)  1/13 (7.69%)  1/6 (16.67%)  0/6 (0.00%)  0/6 (0.00%)  3/10 (30.00%)  0/6 (0.00%)  0/6 (0.00%) 
Muscle weakness trunk †  0/6 (0.00%)  0/13 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  1/6 (16.67%)  0/10 (0.00%)  0/6 (0.00%)  0/6 (0.00%) 
Muscle weakness upper limb †  1/6 (16.67%)  1/13 (7.69%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  1/10 (10.00%)  0/6 (0.00%)  1/6 (16.67%) 
Musculoskeletal and connective tissue disorder - Other, Achiness †  0/6 (0.00%)  0/13 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  1/6 (16.67%)  0/10 (0.00%)  0/6 (0.00%)  0/6 (0.00%) 
Musculoskeletal and connective tissue disorder - Other, LEFT KNEE TENDONITIS †  0/6 (0.00%)  0/13 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/10 (0.00%)  1/6 (16.67%)  0/6 (0.00%) 
Musculoskeletal and connective tissue disorder - Other, RIGHT ANKLE TENDONITIS †  0/6 (0.00%)  0/13 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/10 (0.00%)  1/6 (16.67%)  0/6 (0.00%) 
Musculoskeletal deformity †  0/6 (0.00%)  1/13 (7.69%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/10 (0.00%)  0/6 (0.00%)  0/6 (0.00%) 
Myalgia †  0/6 (0.00%)  2/13 (15.38%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  1/10 (10.00%)  1/6 (16.67%)  1/6 (16.67%) 
Neck pain †  0/6 (0.00%)  0/13 (0.00%)  0/6 (0.00%)  2/6 (33.33%)  0/6 (0.00%)  3/10 (30.00%)  0/6 (0.00%)  2/6 (33.33%) 
Pain in extremity †  1/6 (16.67%)  3/13 (23.08%)  2/6 (33.33%)  2/6 (33.33%)  1/6 (16.67%)  5/10 (50.00%)  4/6 (66.67%)  2/6 (33.33%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)                 
Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, PROGRESSIVE DISEASE †  0/6 (0.00%)  1/13 (7.69%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/10 (0.00%)  0/6 (0.00%)  0/6 (0.00%) 
Tumor pain †  1/6 (16.67%)  1/13 (7.69%)  0/6 (0.00%)  1/6 (16.67%)  0/6 (0.00%)  0/10 (0.00%)  0/6 (0.00%)  0/6 (0.00%) 
Nervous system disorders                 
Abducens nerve disorder †  0/6 (0.00%)  1/13 (7.69%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  1/10 (10.00%)  1/6 (16.67%)  0/6 (0.00%) 
Accessory nerve disorder †  0/6 (0.00%)  1/13 (7.69%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/10 (0.00%)  0/6 (0.00%)  0/6 (0.00%) 
Acoustic nerve disorder NOS †  0/6 (0.00%)  1/13 (7.69%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/10 (0.00%)  0/6 (0.00%)  0/6 (0.00%) 
Ataxia †  0/6 (0.00%)  4/13 (30.77%)  1/6 (16.67%)  1/6 (16.67%)  2/6 (33.33%)  2/10 (20.00%)  1/6 (16.67%)  2/6 (33.33%) 
Cognitive disturbance †  1/6 (16.67%)  2/13 (15.38%)  0/6 (0.00%)  0/6 (0.00%)  1/6 (16.67%)  1/10 (10.00%)  0/6 (0.00%)  0/6 (0.00%) 
Concentration impairment †  1/6 (16.67%)  0/13 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/10 (0.00%)  0/6 (0.00%)  1/6 (16.67%) 
Depressed level of consciousness †  0/6 (0.00%)  1/13 (7.69%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  1/10 (10.00%)  0/6 (0.00%)  0/6 (0.00%) 
Dizziness †  2/6 (33.33%)  5/13 (38.46%)  1/6 (16.67%)  1/6 (16.67%)  5/6 (83.33%)  1/10 (10.00%)  0/6 (0.00%)  1/6 (16.67%) 
Dysarthria †  0/6 (0.00%)  4/13 (30.77%)  0/6 (0.00%)  0/6 (0.00%)  1/6 (16.67%)  1/10 (10.00%)  1/6 (16.67%)  0/6 (0.00%) 
Dysesthesia †  0/6 (0.00%)  0/13 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/10 (0.00%)  2/6 (33.33%)  0/6 (0.00%) 
Dysgeusia †  2/6 (33.33%)  1/13 (7.69%)  1/6 (16.67%)  0/6 (0.00%)  0/6 (0.00%)  2/10 (20.00%)  0/6 (0.00%)  0/6 (0.00%) 
Dysphasia †  0/6 (0.00%)  1/13 (7.69%)  1/6 (16.67%)  0/6 (0.00%)  0/6 (0.00%)  0/10 (0.00%)  0/6 (0.00%)  0/6 (0.00%) 
Facial muscle weakness †  0/6 (0.00%)  1/13 (7.69%)  1/6 (16.67%)  0/6 (0.00%)  2/6 (33.33%)  3/10 (30.00%)  0/6 (0.00%)  0/6 (0.00%) 
Facial nerve disorder †  0/6 (0.00%)  4/13 (30.77%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  3/10 (30.00%)  1/6 (16.67%)  1/6 (16.67%) 
Headache †  2/6 (33.33%)  9/13 (69.23%)  2/6 (33.33%)  2/6 (33.33%)  2/6 (33.33%)  6/10 (60.00%)  3/6 (50.00%)  3/6 (50.00%) 
Hydrocephalus †  1/6 (16.67%)  0/13 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/10 (0.00%)  0/6 (0.00%)  0/6 (0.00%) 
Hypersomnia †  0/6 (0.00%)  0/13 (0.00%)  1/6 (16.67%)  0/6 (0.00%)  1/6 (16.67%)  0/10 (0.00%)  0/6 (0.00%)  1/6 (16.67%) 
Hypoglossal nerve disorder †  0/6 (0.00%)  1/13 (7.69%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/10 (0.00%)  0/6 (0.00%)  0/6 (0.00%) 
Intracranial hemorrhage †  2/6 (33.33%)  1/13 (7.69%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/10 (0.00%)  1/6 (16.67%)  0/6 (0.00%) 
Lethargy †  0/6 (0.00%)  0/13 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  1/6 (16.67%)  1/10 (10.00%)  0/6 (0.00%)  0/6 (0.00%) 
Memory impairment †  1/6 (16.67%)  0/13 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  1/10 (10.00%)  0/6 (0.00%)  0/6 (0.00%) 
Movements involuntary †  0/6 (0.00%)  1/13 (7.69%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/10 (0.00%)  0/6 (0.00%)  0/6 (0.00%) 
Muscle weakness left-sided †  0/6 (0.00%)  3/13 (23.08%)  0/6 (0.00%)  0/6 (0.00%)  2/6 (33.33%)  2/10 (20.00%)  1/6 (16.67%)  1/6 (16.67%) 
Muscle weakness right-sided †  0/6 (0.00%)  2/13 (15.38%)  0/6 (0.00%)  1/6 (16.67%)  0/6 (0.00%)  2/10 (20.00%)  0/6 (0.00%)  1/6 (16.67%) 
Nervous system disorders - Other, †  0/6 (0.00%)  0/13 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  2/10 (20.00%)  0/6 (0.00%)  1/6 (16.67%) 
Nervous system disorders - Other, ACUTE NEURO CHANGES †  0/6 (0.00%)  0/13 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/10 (0.00%)  1/6 (16.67%)  0/6 (0.00%) 
Nervous system disorders - Other, HYPERALGESIA †  0/6 (0.00%)  1/13 (7.69%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/10 (0.00%)  0/6 (0.00%)  0/6 (0.00%) 
Nervous system disorders - Other, LEFT SIDED DECREASED SENSORY AND PROPIOCEPTION †  0/6 (0.00%)  1/13 (7.69%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/10 (0.00%)  0/6 (0.00%)  0/6 (0.00%) 
Nervous system disorders - Other, Nystagmus †  0/6 (0.00%)  0/13 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/10 (0.00%)  1/6 (16.67%)  0/6 (0.00%) 
Nervous system disorders - Other, PSUEDOBALBAR AFFECT †  0/6 (0.00%)  1/13 (7.69%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/10 (0.00%)  0/6 (0.00%)  0/6 (0.00%) 
Nystagmus †  0/6 (0.00%)  0/13 (0.00%)  1/6 (16.67%)  1/6 (16.67%)  0/6 (0.00%)  0/10 (0.00%)  0/6 (0.00%)  0/6 (0.00%) 
Oculomotor nerve disorder †  0/6 (0.00%)  1/13 (7.69%)  1/6 (16.67%)  0/6 (0.00%)  0/6 (0.00%)  0/10 (0.00%)  1/6 (16.67%)  0/6 (0.00%) 
Paresthesia †  0/6 (0.00%)  4/13 (30.77%)  1/6 (16.67%)  2/6 (33.33%)  1/6 (16.67%)  2/10 (20.00%)  0/6 (0.00%)  0/6 (0.00%) 
Peripheral motor neuropathy †  0/6 (0.00%)  1/13 (7.69%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/10 (0.00%)  0/6 (0.00%)  0/6 (0.00%) 
Peripheral sensory neuropathy †  0/6 (0.00%)  1/13 (7.69%)  0/6 (0.00%)  2/6 (33.33%)  0/6 (0.00%)  1/10 (10.00%)  0/6 (0.00%)  0/6 (0.00%) 
Seizure †  4/6 (66.67%)  1/13 (7.69%)  1/6 (16.67%)  0/6 (0.00%)  1/6 (16.67%)  2/10 (20.00%)  0/6 (0.00%)  3/6 (50.00%) 
Somnolence †  0/6 (0.00%)  3/13 (23.08%)  0/6 (0.00%)  0/6 (0.00%)  1/6 (16.67%)  0/10 (0.00%)  0/6 (0.00%)  0/6 (0.00%) 
Spasticity †  0/6 (0.00%)  0/13 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/10 (0.00%)  1/6 (16.67%)  0/6 (0.00%) 
Stroke †  0/6 (0.00%)  0/13 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/10 (0.00%)  1/6 (16.67%)  0/6 (0.00%) 
Tremor †  0/6 (0.00%)  1/13 (7.69%)  1/6 (16.67%)  0/6 (0.00%)  0/6 (0.00%)  4/10 (40.00%)  1/6 (16.67%)  1/6 (16.67%) 
Trochlear nerve disorder †  0/6 (0.00%)  0/13 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  1/10 (10.00%)  0/6 (0.00%)  0/6 (0.00%) 
Psychiatric disorders                 
Agitation †  0/6 (0.00%)  0/13 (0.00%)  1/6 (16.67%)  0/6 (0.00%)  1/6 (16.67%)  1/10 (10.00%)  0/6 (0.00%)  0/6 (0.00%) 
Anxiety †  0/6 (0.00%)  0/13 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  3/6 (50.00%)  4/10 (40.00%)  1/6 (16.67%)  1/6 (16.67%) 
Confusion †  0/6 (0.00%)  1/13 (7.69%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  1/10 (10.00%)  0/6 (0.00%)  0/6 (0.00%) 
Delirium †  0/6 (0.00%)  1/13 (7.69%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/10 (0.00%)  0/6 (0.00%)  0/6 (0.00%) 
Delusions †  0/6 (0.00%)  0/13 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  1/10 (10.00%)  0/6 (0.00%)  0/6 (0.00%) 
Depression †  0/6 (0.00%)  1/13 (7.69%)  1/6 (16.67%)  0/6 (0.00%)  1/6 (16.67%)  1/10 (10.00%)  0/6 (0.00%)  0/6 (0.00%) 
Hallucinations †  0/6 (0.00%)  0/13 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  1/10 (10.00%)  1/6 (16.67%)  0/6 (0.00%) 
Insomnia †  0/6 (0.00%)  3/13 (23.08%)  3/6 (50.00%)  0/6 (0.00%)  2/6 (33.33%)  2/10 (20.00%)  2/6 (33.33%)  0/6 (0.00%) 
Irritability †  0/6 (0.00%)  0/13 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/10 (0.00%)  0/6 (0.00%)  1/6 (16.67%) 
Psychiatric disorders - Other, ADHD †  0/6 (0.00%)  0/13 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/10 (0.00%)  1/6 (16.67%)  0/6 (0.00%) 
Psychiatric disorders - Other, AUTISIM †  0/6 (0.00%)  1/13 (7.69%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/10 (0.00%)  0/6 (0.00%)  0/6 (0.00%) 
Psychiatric disorders - Other, EMOTIONAL †  1/6 (16.67%)  0/13 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/10 (0.00%)  0/6 (0.00%)  0/6 (0.00%) 
Psychiatric disorders - Other, HX OF ADHD †  1/6 (16.67%)  0/13 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/10 (0.00%)  0/6 (0.00%)  0/6 (0.00%) 
Psychiatric disorders - Other, Mood swings †  0/6 (0.00%)  0/13 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  1/6 (16.67%)  0/10 (0.00%)  0/6 (0.00%)  0/6 (0.00%) 
Renal and urinary disorders                 
Chronic kidney disease †  0/6 (0.00%)  1/13 (7.69%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/10 (0.00%)  1/6 (16.67%)  0/6 (0.00%) 
Cystitis noninfective †  0/6 (0.00%)  0/13 (0.00%)  0/6 (0.00%)  1/6 (16.67%)  0/6 (0.00%)  0/10 (0.00%)  0/6 (0.00%)  0/6 (0.00%) 
Hematuria †  0/6 (0.00%)  0/13 (0.00%)  0/6 (0.00%)  1/6 (16.67%)  0/6 (0.00%)  3/10 (30.00%)  1/6 (16.67%)  1/6 (16.67%) 
Hemoglobinuria †  0/6 (0.00%)  0/13 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  1/6 (16.67%)  0/10 (0.00%)  0/6 (0.00%)  0/6 (0.00%) 
Proteinuria †  0/6 (0.00%)  1/13 (7.69%)  1/6 (16.67%)  1/6 (16.67%)  2/6 (33.33%)  3/10 (30.00%)  1/6 (16.67%)  2/6 (33.33%) 
Urinary frequency †  1/6 (16.67%)  2/13 (15.38%)  0/6 (0.00%)  1/6 (16.67%)  2/6 (33.33%)  0/10 (0.00%)  0/6 (0.00%)  0/6 (0.00%) 
Urinary incontinence †  0/6 (0.00%)  2/13 (15.38%)  0/6 (0.00%)  1/6 (16.67%)  1/6 (16.67%)  0/10 (0.00%)  1/6 (16.67%)  0/6 (0.00%) 
Urinary retention †  0/6 (0.00%)  0/13 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  1/10 (10.00%)  0/6 (0.00%)  0/6 (0.00%) 
Urinary urgency †  0/6 (0.00%)  0/13 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  1/6 (16.67%)  1/10 (10.00%)  0/6 (0.00%)  0/6 (0.00%) 
Reproductive system and breast disorders                 
Irregular menstruation †  0/6 (0.00%)  3/13 (23.08%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/10 (0.00%)  0/6 (0.00%)  0/6 (0.00%) 
Pelvic pain †  0/6 (0.00%)  0/13 (0.00%)  0/6 (0.00%)  1/6 (16.67%)  0/6 (0.00%)  0/10 (0.00%)  0/6 (0.00%)  0/6 (0.00%) 
Premature menopause †  0/6 (0.00%)  0/13 (0.00%)  0/6 (0.00%)  1/6 (16.67%)  0/6 (0.00%)  0/10 (0.00%)  0/6 (0.00%)  0/6 (0.00%) 
Vaginal inflammation †  0/6 (0.00%)  0/13 (0.00%)  0/6 (0.00%)  1/6 (16.67%)  0/6 (0.00%)  0/10 (0.00%)  0/6 (0.00%)  0/6 (0.00%) 
Respiratory, thoracic and mediastinal disorders                 
Allergic rhinitis †  1/6 (16.67%)  2/13 (15.38%)  2/6 (33.33%)  0/6 (0.00%)  0/6 (0.00%)  2/10 (20.00%)  1/6 (16.67%)  1/6 (16.67%) 
Aspiration †  0/6 (0.00%)  0/13 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  1/6 (16.67%)  0/10 (0.00%)  0/6 (0.00%)  0/6 (0.00%) 
Atelectasis †  0/6 (0.00%)  1/13 (7.69%)  1/6 (16.67%)  0/6 (0.00%)  1/6 (16.67%)  0/10 (0.00%)  1/6 (16.67%)  0/6 (0.00%) 
Cough †  2/6 (33.33%)  3/13 (23.08%)  2/6 (33.33%)  2/6 (33.33%)  3/6 (50.00%)  1/10 (10.00%)  1/6 (16.67%)  2/6 (33.33%) 
Dyspnea †  0/6 (0.00%)  1/13 (7.69%)  1/6 (16.67%)  1/6 (16.67%)  2/6 (33.33%)  1/10 (10.00%)  0/6 (0.00%)  0/6 (0.00%) 
Epistaxis †  2/6 (33.33%)  0/13 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/10 (0.00%)  0/6 (0.00%)  0/6 (0.00%) 
Hiccups †  0/6 (0.00%)  1/13 (7.69%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/10 (0.00%)  0/6 (0.00%)  0/6 (0.00%) 
Hoarseness †  1/6 (16.67%)  0/13 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/10 (0.00%)  0/6 (0.00%)  0/6 (0.00%) 
Hypoxia †  0/6 (0.00%)  1/13 (7.69%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/10 (0.00%)  0/6 (0.00%)  0/6 (0.00%) 
Laryngeal hemorrhage †  0/6 (0.00%)  0/13 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  1/6 (16.67%)  0/10 (0.00%)  0/6 (0.00%)  0/6 (0.00%) 
Laryngeal inflammation †  0/6 (0.00%)  0/13 (0.00%)  1/6 (16.67%)  0/6 (0.00%)  0/6 (0.00%)  0/10 (0.00%)  0/6 (0.00%)  0/6 (0.00%) 
Nasal congestion †  2/6 (33.33%)  2/13 (15.38%)  2/6 (33.33%)  0/6 (0.00%)  0/6 (0.00%)  0/10 (0.00%)  1/6 (16.67%)  1/6 (16.67%) 
Pleural effusion †  0/6 (0.00%)  0/13 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  1/6 (16.67%)  0/10 (0.00%)  0/6 (0.00%)  0/6 (0.00%) 
Productive cough †  0/6 (0.00%)  1/13 (7.69%)  1/6 (16.67%)  0/6 (0.00%)  0/6 (0.00%)  0/10 (0.00%)  0/6 (0.00%)  0/6 (0.00%) 
Respiratory, thoracic and mediastinal disorders - Other, ASTHMA †  0/6 (0.00%)  1/13 (7.69%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/10 (0.00%)  0/6 (0.00%)  0/6 (0.00%) 
Respiratory, thoracic and mediastinal disorders - Other, HEMOPTYSIS †  0/6 (0.00%)  0/13 (0.00%)  1/6 (16.67%)  0/6 (0.00%)  0/6 (0.00%)  0/10 (0.00%)  0/6 (0.00%)  0/6 (0.00%) 
Respiratory, thoracic and mediastinal disorders - Other, RHINORRHEA †  0/6 (0.00%)  1/13 (7.69%)  1/6 (16.67%)  0/6 (0.00%)  0/6 (0.00%)  0/10 (0.00%)  0/6 (0.00%)  0/6 (0.00%) 
Respiratory, thoracic and mediastinal disorders - Other, TACHYPNEA †  0/6 (0.00%)  1/13 (7.69%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/10 (0.00%)  0/6 (0.00%)  0/6 (0.00%) 
Respiratory, thoracic and mediastinal disorders - Other, TONSILLITIS †  0/6 (0.00%)  0/13 (0.00%)  1/6 (16.67%)  0/6 (0.00%)  0/6 (0.00%)  0/10 (0.00%)  0/6 (0.00%)  0/6 (0.00%) 
Sleep apnea †  0/6 (0.00%)  1/13 (7.69%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/10 (0.00%)  0/6 (0.00%)  0/6 (0.00%) 
Sneezing †  0/6 (0.00%)  0/13 (0.00%)  1/6 (16.67%)  0/6 (0.00%)  0/6 (0.00%)  0/10 (0.00%)  0/6 (0.00%)  0/6 (0.00%) 
Sore throat †  0/6 (0.00%)  2/13 (15.38%)  1/6 (16.67%)  1/6 (16.67%)  0/6 (0.00%)  0/10 (0.00%)  0/6 (0.00%)  0/6 (0.00%) 
Wheezing †  0/6 (0.00%)  0/13 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  1/6 (16.67%)  0/10 (0.00%)  0/6 (0.00%)  0/6 (0.00%) 
Skin and subcutaneous tissue disorders                 
Alopecia †  1/6 (16.67%)  2/13 (15.38%)  0/6 (0.00%)  2/6 (33.33%)  2/6 (33.33%)  3/10 (30.00%)  1/6 (16.67%)  1/6 (16.67%) 
Bullous dermatitis †  0/6 (0.00%)  0/13 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  1/10 (10.00%)  0/6 (0.00%)  0/6 (0.00%) 
Dry skin †  1/6 (16.67%)  0/13 (0.00%)  3/6 (50.00%)  0/6 (0.00%)  1/6 (16.67%)  0/10 (0.00%)  0/6 (0.00%)  0/6 (0.00%) 
Nail discoloration †  0/6 (0.00%)  1/13 (7.69%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/10 (0.00%)  0/6 (0.00%)  0/6 (0.00%) 
Pruritus †  1/6 (16.67%)  1/13 (7.69%)  1/6 (16.67%)  1/6 (16.67%)  0/6 (0.00%)  1/10 (10.00%)  2/6 (33.33%)  1/6 (16.67%) 
Rash acneiform †  0/6 (0.00%)  2/13 (15.38%)  1/6 (16.67%)  0/6 (0.00%)  0/6 (0.00%)  3/10 (30.00%)  1/6 (16.67%)  0/6 (0.00%) 
Rash maculo-papular †  0/6 (0.00%)  1/13 (7.69%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/10 (0.00%)  0/6 (0.00%)  0/6 (0.00%) 
Skin and subcutaneous tissue disorders - Other, †  0/6 (0.00%)  0/13 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  2/6 (33.33%)  0/10 (0.00%)  0/6 (0.00%)  1/6 (16.67%) 
Skin and subcutaneous tissue disorders - Other, INCISION, LEFT OCCIPITAL REGION †  0/6 (0.00%)  0/13 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/10 (0.00%)  1/6 (16.67%)  0/6 (0.00%) 
Skin and subcutaneous tissue disorders - Other, INCISION, RIGHT PARIETAL REGION †  0/6 (0.00%)  0/13 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/10 (0.00%)  1/6 (16.67%)  0/6 (0.00%) 
Skin and subcutaneous tissue disorders - Other, NAIL BRITTLENESS †  0/6 (0.00%)  1/13 (7.69%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/10 (0.00%)  0/6 (0.00%)  0/6 (0.00%) 
Skin and subcutaneous tissue disorders - Other, NEVI †  0/6 (0.00%)  1/13 (7.69%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/10 (0.00%)  0/6 (0.00%)  0/6 (0.00%) 
Skin and subcutaneous tissue disorders - Other, PEELING SKIN †  0/6 (0.00%)  0/13 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/10 (0.00%)  1/6 (16.67%)  0/6 (0.00%) 
Skin and subcutaneous tissue disorders - Other, PLANTAR WART †  0/6 (0.00%)  0/13 (0.00%)  1/6 (16.67%)  0/6 (0.00%)  0/6 (0.00%)  0/10 (0.00%)  0/6 (0.00%)  0/6 (0.00%) 
Skin and subcutaneous tissue disorders - Other, SCARRING †  0/6 (0.00%)  1/13 (7.69%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/10 (0.00%)  0/6 (0.00%)  0/6 (0.00%) 
Skin and subcutaneous tissue disorders - Other, abrasions- bilateral lower extremity †  0/6 (0.00%)  0/13 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  1/10 (10.00%)  0/6 (0.00%)  0/6 (0.00%) 
Skin atrophy †  0/6 (0.00%)  0/13 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  3/10 (30.00%)  0/6 (0.00%)  0/6 (0.00%) 
Skin ulceration †  0/6 (0.00%)  0/13 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  1/10 (10.00%)  0/6 (0.00%)  0/6 (0.00%) 
Surgical and medical procedures                 
Surgical and medical procedures - Other, CRANIOTOMY †  0/6 (0.00%)  1/13 (7.69%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/10 (0.00%)  0/6 (0.00%)  0/6 (0.00%) 
Surgical and medical procedures - Other, Portacath placement †  0/6 (0.00%)  0/13 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  1/10 (10.00%)  0/6 (0.00%)  0/6 (0.00%) 
Vascular disorders                 
Flushing †  1/6 (16.67%)  0/13 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/10 (0.00%)  0/6 (0.00%)  0/6 (0.00%) 
Hot flashes †  0/6 (0.00%)  0/13 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  1/6 (16.67%)  0/10 (0.00%)  0/6 (0.00%)  0/6 (0.00%) 
Hypertension †  2/6 (33.33%)  5/13 (38.46%)  1/6 (16.67%)  1/6 (16.67%)  3/6 (50.00%)  6/10 (60.00%)  1/6 (16.67%)  2/6 (33.33%) 
Hypotension †  0/6 (0.00%)  0/13 (0.00%)  1/6 (16.67%)  0/6 (0.00%)  0/6 (0.00%)  1/10 (10.00%)  0/6 (0.00%)  1/6 (16.67%) 
Thromboembolic event †  1/6 (16.67%)  2/13 (15.38%)  0/6 (0.00%)  1/6 (16.67%)  0/6 (0.00%)  0/10 (0.00%)  0/6 (0.00%)  0/6 (0.00%) 
†
Indicates events were collected by systematic assessment
[Not Specified]
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.
Must obtain prior sponsor approval
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Results Reporting Coordinator
Organization: Children's Oncology Group
Phone: 16264470064
EMail: resultsreportingcoordinator@childrensoncologygroup.org
Layout table for additonal information
Responsible Party: Children's Oncology Group
ClinicalTrials.gov Identifier: NCT02323880    
Other Study ID Numbers: ADVL1414
NCI-2014-02410 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
ADVL1414
ADVL1414 ( Other Identifier: Pediatric Early Phase Clinical Trial Network )
ADVL1414 ( Other Identifier: CTEP )
UM1CA097452 ( U.S. NIH Grant/Contract )
First Submitted: December 16, 2014
First Posted: December 24, 2014
Results First Submitted: October 31, 2023
Results First Posted: January 2, 2024
Last Update Posted: January 2, 2024