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Trial record 76 of 163 for:    ISOTRETINOIN

ch14.18 Pharmacokinetic Study in High-risk Neuroblastoma

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: NCT01592045
Recruitment Status : Completed
First Posted : May 4, 2012
Results First Posted : September 23, 2015
Last Update Posted : September 23, 2015
Sponsor:
Information provided by (Responsible Party):
United Therapeutics

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Neuroblastoma
Interventions Biological: ch14.18 -NCI
Biological: ch14.18-UTC
Biological: Granulocyte-Macrophage Colony-Stimulating Factor (GM-CSF)
Biological: Aldesleukin (IL-2)
Drug: Isotretinoin
Enrollment 28
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Sequence 1 Sequence 2
Hide Arm/Group Description

UTC ch14.18 for two courses followed by NCI ch14.18 for three courses

ch14.18 -NCI: 25 mg/m^2/day IV for four consecutive days

ch14.18-UTC: 17.5 mg/m^2/day IV for four consecutive days

Granulocyte-Macrophage Colony-Stimulating Factor (GM-CSF): GM-CSF will be administered SC at a dose of 250 mcg/m^2/day for 14 days during Courses 1, 3, and 5.

Aldesleukin (IL-2): Aldesleukin (IL-2) will be administered IV at a dose of 3 MIU/m^2/day for the first week and at a dose of 4.5 MIU/m^2/day for the second week during Courses 2 and 4.

Isotretinoin: Isotretinoin (13-cis-retinoic acid; ISOT) will be administered by mouth over six courses as follows:

If weight > 12 kg: 80 mg/m^2/dose twice daily (total daily dose is 160 mg/m^2/day, divided twice daily).

If weight ≤ 12 kg: 2.67 mg/kg/dose twice daily (total daily dose is 5.33 mg/kg/day, divided twice daily).

NCI ch14.18 for two courses followed by UTC ch14.18 for three courses

ch14.18 -NCI: 25 mg/m^2/day IV for four consecutive days

ch14.18-UTC: 17.5 mg/m^2/day IV for four consecutive days

Granulocyte-Macrophage Colony-Stimulating Factor (GM-CSF): GM-CSF will be administered SC at a dose of 250 mcg/m^2/day for 14 days during Courses 1, 3, and 5.

Aldesleukin (IL-2): Aldesleukin (IL-2) will be administered IV at a dose of 3 MIU/m^2/day for the first week and at a dose of 4.5 MIU/m^2/day for the second week during Courses 2 and 4.

Isotretinoin: Isotretinoin (13-cis-retinoic acid; ISOT) will be administered by mouth over six courses as follows:

If weight > 12 kg: 80 mg/m^2/dose twice daily (total daily dose is 160 mg/m^2/day, divided twice daily).

If weight ≤ 12 kg: 2.67 mg/kg/dose twice daily (total daily dose is 5.33 mg/kg/day, divided twice daily).

Period Title: Overall Study
Started 14 14
Completed Course 1 13 14
Completed Course 2 13 13
Completed Course 3 11 13
Completed Course 4 11 12
Completed Course 5 9 12
Completed 9 12
Not Completed 5 2
Reason Not Completed
Disease Progression             1             1
Adverse Event             1             1
Withdrawal by Subject             1             0
Moved out of country             2             0
Arm/Group Title Sequence 1 Sequence 2 Total
Hide Arm/Group Description

UTC ch14.18 for two courses followed by NCI ch14.18 for three courses

ch14.18 -NCI: 25 mg/m^2/day IV for four consecutive days

ch14.18-UTC: 17.5 mg/m^2/day IV for four consecutive days

Granulocyte-Macrophage Colony-Stimulating Factor (GM-CSF): GM-CSF will be administered SC at a dose of 250 mcg/m^2/day for 14 days during Courses 1, 3, and 5.

Aldesleukin (IL-2): Aldesleukin (IL-2) will be administered IV at a dose of 3 MIU/m^2/day for the first week and at a dose of 4.5 MIU/m^2/day for the second week during Courses 2 and 4.

Isotretinoin: Isotretinoin (13-cis-retinoic acid; ISOT) will be administered by mouth over six courses as follows:

If weight > 12 kg: 80 mg/m^2/dose twice daily (total daily dose is 160 mg/m^2/day, divided twice daily).

If weight ≤ 12 kg: 2.67 mg/kg/dose twice daily (total daily dose is 5.33 mg/kg/day, divided twice daily).

NCI ch14.18 for two courses followed by UTC ch14.18 for three courses

ch14.18 -NCI: 25 mg/m^2/day IV for four consecutive days

ch14.18-UTC: 17.5 mg/m^2/day IV for four consecutive days

Granulocyte-Macrophage Colony-Stimulating Factor (GM-CSF): GM-CSF will be administered SC at a dose of 250 mcg/m^2/day for 14 days during Courses 1, 3, and 5.

Aldesleukin (IL-2): Aldesleukin (IL-2) will be administered IV at a dose of 3 MIU/m^2/day for the first week and at a dose of 4.5 MIU/m^2/day for the second week during Courses 2 and 4.

Isotretinoin: Isotretinoin (13-cis-retinoic acid; ISOT) will be administered by mouth over six courses as follows:

If weight > 12 kg: 80 mg/m^2/dose twice daily (total daily dose is 160 mg/m^2/day, divided twice daily).

If weight ≤ 12 kg: 2.67 mg/kg/dose twice daily (total daily dose is 5.33 mg/kg/day, divided twice daily).

Total of all reporting groups
Overall Number of Baseline Participants 14 14 28
Hide Baseline Analysis Population Description
Twenty-eight subjects were enrolled in this study with all subjects receiving at least one dose of study therapy.
Age, Continuous  
Mean (Full Range)
Unit of measure:  Years
Number Analyzed 14 participants 14 participants 28 participants
4
(2 to 7)
4
(1 to 9)
4
(1 to 9)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 14 participants 14 participants 28 participants
Female
6
  42.9%
6
  42.9%
12
  42.9%
Male
8
  57.1%
8
  57.1%
16
  57.1%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 14 participants 14 participants 28 participants
Hispanic or Latino
4
  28.6%
2
  14.3%
6
  21.4%
Not Hispanic or Latino
10
  71.4%
12
  85.7%
22
  78.6%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 14 participants 14 participants 28 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
1
   7.1%
1
   3.6%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
2
  14.3%
1
   7.1%
3
  10.7%
White
12
  85.7%
11
  78.6%
23
  82.1%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
1
   7.1%
1
   3.6%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 14 participants 14 participants 28 participants
14 14 28
Pre-ASCT Response   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 14 participants 14 participants 28 participants
Complete Response (CR) 5 3 8
Very Good Partial Response (VGPR) 5 4 9
Partial Response (PR) 4 7 11
[1]
Measure Description: At pre-ASCT evaluation, subjects must have met the International Neuroblastoma Response Criteria (INRC) for complete response (CR), very good partial response (VGPR) or partial response (PR) for primary site, soft tissue metastases, and bone metastases. Subjects who met those criteria were also required to meet the protocol specified criteria for bone marrow response.
1.Primary Outcome
Title Area Under the Plasma Concentration Curve (AUC)
Hide Description

Twenty-two PK samples will be obtained at the following timepoints:

Courses 1 and 3:

Day: 0 Days: 3, 4, 5 and 6: post ch14.18 Days 7:10 to 14 hours post ch14.18 Days 9 to 11: Single sample Days 14 to 17: Single sample

Courses 2 and 4:

Day 0: Pre-IL-2 Day 7: Pre-ch14.18 Day 10 (Course 4 only): Post ch14.18 End of Treatment: Within 2 weeks post isotretinoin

Time Frame PK samples obtained during Courses 1 and 3: Days 0, 3, 4, 5, 6, 7, 9, 10, 11, 14, 15, 16, 17; PK samples obtained during Courses 2 and 4: Days 0, 7, 10; End of Treatment
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title UTC ch14.18 NCI ch14.18
Hide Arm/Group Description:
United Therapeutics Manufactured ch14.18
NCI Manufactured ch14.18
Overall Number of Participants Analyzed 27 27
Mean (Standard Deviation)
Unit of Measure: mcg*hr/mL
518  (418) 470  (376)
2.Primary Outcome
Title Peak Plasma Concentration (Cmax)
Hide Description

Twenty-two PK samples will be obtained at the following timepoints:

Courses 1 and 3:

Day: 0 Days: 3, 4, 5 and 6: post ch14.18 Days 7:10 to 14 hours post ch14.18 Days 9 to 11: Single sample Days 14 to 17: Single sample

Courses 2 and 4:

Day 0: Pre-IL-2 Day 7: Pre-ch14.18 Day 10 (Course 4 only): Post ch14.18 End of Treatment: Within 2 weeks post isotretinoin

Time Frame PK samples obtained during Courses 1 and 3: Days 0, 3, 4, 5, 6, 7, 9, 10, 11, 14, 15, 16, 17; PK samples obtained during Courses 2 and 4: Days 0, 7, 10; End of Treatment
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title UTC ch14.18 NCI ch14.18
Hide Arm/Group Description:
United Therapeutics Manufactured ch14.18
NCI Manufactured ch14.18
Overall Number of Participants Analyzed 27 27
Mean (Standard Deviation)
Unit of Measure: ng/mL
6468  (719) 6689  (853)
Time Frame Adverse events (AEs) and serious adverse events (SAEs) were reported at the time of informed consent through 30 days after the last dose of study therapy.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title UTC ch14.18 NCI ch14.18
Hide Arm/Group Description United Therapeutics Manufactured ch14.18 NCI Manufactured ch14.18
All-Cause Mortality
UTC ch14.18 NCI ch14.18
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
UTC ch14.18 NCI ch14.18
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   17/27 (62.96%)      12/27 (44.44%)    
Blood and lymphatic system disorders     
Anemia * 1  0/27 (0.00%)  0 2/27 (7.41%)  2
Cardiac disorders     
Palpitations * 1  0/27 (0.00%)  0 1/27 (3.70%)  1
Eye disorders     
Mydriasis * 1  1/27 (3.70%)  1 0/27 (0.00%)  0
Gastrointestinal disorders     
Diarrhea * 1  1/27 (3.70%)  1 1/27 (3.70%)  1
Abdominal Pain * 1  1/27 (3.70%)  1 0/27 (0.00%)  0
Constipation * 1  1/27 (3.70%)  1 0/27 (0.00%)  0
Ileus * 1  1/27 (3.70%)  1 0/27 (0.00%)  0
Nausea * 1  0/27 (0.00%)  0 1/27 (3.70%)  1
Vomiting * 1  0/27 (0.00%)  0 1/27 (3.70%)  1
General disorders     
Pyrexia * 1  5/27 (18.52%)  7 3/27 (11.11%)  7
Disease Progression * 1  1/27 (3.70%)  1 0/27 (0.00%)  0
Fatigue * 1  1/27 (3.70%)  1 0/27 (0.00%)  0
Malaise * 1  1/27 (3.70%)  1 0/27 (0.00%)  0
Hepatobiliary disorders     
Hyperbilirubinemia * 1  1/27 (3.70%)  1 0/27 (0.00%)  0
Immune system disorders     
Anaphylactic Reaction * 1  0/27 (0.00%)  0 1/27 (3.70%)  1
Serum Sickness * 1  0/27 (0.00%)  0 1/27 (3.70%)  1
Infections and infestations     
Device Related Infection * 1  3/27 (11.11%)  3 1/27 (3.70%)  1
Gastroenteritis Viral * 1  2/27 (7.41%)  2 1/27 (3.70%)  1
Sepsis * 1  1/27 (3.70%)  1 1/27 (3.70%)  1
Alpha Hemolytic Stretococcal Infection * 1  1/27 (3.70%)  1 0/27 (0.00%)  0
Bacteremia * 1  1/27 (3.70%)  1 1/27 (3.70%)  1
Bacterial Infection * 1  0/27 (0.00%)  0 1/27 (3.70%)  1
Enterobacter Sepsis * 1  1/27 (3.70%)  1 0/27 (0.00%)  0
Influenza * 1  0/27 (0.00%)  0 1/27 (3.70%)  1
Pneumonia * 1  0/27 (0.00%)  0 1/27 (3.70%)  1
Pneumonia Bacterial * 1  0/27 (0.00%)  0 1/27 (3.70%)  1
Streptococcal Bacteremia * 1  1/27 (3.70%)  1 0/27 (0.00%)  0
Investigations     
Blood Creatinine Increased * 1  1/27 (3.70%)  1 0/27 (0.00%)  0
Metabolism and nutrition disorders     
Hypokalemia * 1  3/27 (11.11%)  3 0/27 (0.00%)  0
Dehydration * 1  0/27 (0.00%)  0 1/27 (3.70%)  1
Hypercalcemia * 1  0/27 (0.00%)  0 1/27 (3.70%)  1
Hypoalbuminemia * 1  1/27 (3.70%)  1 0/27 (0.00%)  0
Hyponatremia * 1  1/27 (3.70%)  1 0/27 (0.00%)  0
Hypophosphatemia * 1  1/27 (3.70%)  1 0/27 (0.00%)  0
Nervous system disorders     
Convulsion * 1  1/27 (3.70%)  1 0/27 (0.00%)  0
Psychiatric disorders     
Agitation * 1  1/27 (3.70%)  1 0/27 (0.00%)  0
Renal and urinary disorders     
Renal Failure Acute * 1  1/27 (3.70%)  1 0/27 (0.00%)  0
Skin and subcutaneous tissue disorders     
Herpes Simplex * 1  0/27 (0.00%)  0 1/27 (3.70%)  1
Vascular disorders     
Capillary Leak Syndrome * 1  1/27 (3.70%)  1 0/27 (0.00%)  0
Hypertension * 1  0/27 (0.00%)  0 1/27 (3.70%)  1
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA (17.0)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
UTC ch14.18 NCI ch14.18
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   27/27 (100.00%)      27/27 (100.00%)    
Blood and lymphatic system disorders     
Anemia * 1  15/27 (55.56%)  22 13/27 (48.15%)  15
Neutropenia * 1  2/27 (7.41%)  5 1/27 (3.70%)  1
Cardiac disorders     
Tachycardia * 1  11/27 (40.74%)  18 10/27 (37.04%)  15
Sinus Tachycardia * 1  7/27 (25.93%)  14 7/27 (25.93%)  13
Endocrine disorders     
Hypothyroidism * 1  0/27 (0.00%)  0 2/27 (7.41%)  2
Eye disorders     
Periorbital Edema * 1  4/27 (14.81%)  4 0/27 (0.00%)  0
Photophobia * 1  0/27 (0.00%)  0 2/27 (7.41%)  2
Vision Blurred * 1  0/27 (0.00%)  0 2/27 (7.41%)  2
Gastrointestinal disorders     
Abdominal Pain * 1  13/27 (48.15%)  22 11/27 (40.74%)  21
Constipation * 1  4/27 (14.81%)  7 3/27 (11.11%)  4
Diarrhea * 1  10/27 (37.04%)  13 13/27 (48.15%)  17
Vomiting * 1  10/27 (37.04%)  11 12/27 (44.44%)  21
Nausea * 1  9/27 (33.33%)  11 6/27 (22.22%)  10
Cheilitis * 1  1/27 (3.70%)  2 3/27 (11.11%)  3
Abdominal Distension * 1  2/27 (7.41%)  2 2/27 (7.41%)  2
Gastritis * 1  2/27 (7.41%)  2 0/27 (0.00%)  0
Lip Dry * 1  0/27 (0.00%)  0 2/27 (7.41%)  2
Lip Swelling * 1  2/27 (7.41%)  2 0/27 (0.00%)  0
Oropharyngeal Pain * 1  2/27 (7.41%)  2 0/27 (0.00%)  0
General disorders     
Pyrexia * 1  27/27 (100.00%)  71 27/27 (100.00%)  64
Pain * 1  16/27 (59.26%)  28 12/27 (44.44%)  22
Face Odema * 1  10/27 (37.04%)  13 8/27 (29.63%)  9
Fatigue * 1  5/27 (18.52%)  6 5/27 (18.52%)  10
Malaise * 1  3/27 (11.11%)  5 3/27 (11.11%)  5
Chills * 1  3/27 (11.11%)  3 2/27 (7.41%)  2
Edema * 1  3/27 (11.11%)  4 3/27 (11.11%)  4
Edema Peripheral * 1  4/27 (14.81%)  5 3/27 (11.11%)  3
Injection Site Reaction * 1  3/27 (11.11%)  3 1/27 (3.70%)  1
Asthenia * 1  2/27 (7.41%)  2 1/27 (3.70%)  1
Generalized Edema * 1  2/27 (7.41%)  2 0/27 (0.00%)  0
Localized Edema * 1  1/27 (3.70%)  1 2/27 (7.41%)  2
Hepatobiliary disorders     
Hyperbilirubinemia * 1  3/27 (11.11%)  4 2/27 (7.41%)  3
Hypoalbuminemia * 1  3/27 (11.11%)  60 1/27 (3.70%)  59
Immune system disorders     
Hypersensitivity * 1  2/27 (7.41%)  3 3/27 (11.11%)  4
Infections and infestations     
Device Related Infection * 1  4/27 (14.81%)  5 2/27 (7.41%)  2
Gastroenteritis Viral * 1  2/27 (7.41%)  2 1/27 (3.70%)  1
Clostridium Difficile Infection * 1  2/27 (7.41%)  2 0/27 (0.00%)  0
Injury, poisoning and procedural complications     
Contusion * 1  4/27 (14.81%)  4 0/27 (0.00%)  0
Investigations     
Platelet Count Decreased * 1  12/27 (44.44%)  18 12/27 (44.44%)  17
Alanine Aminotransferase Increased * 1  18/27 (66.67%)  27 9/27 (33.33%)  15
Neutrophil Count Decreased * 1  11/27 (40.74%)  19 9/27 (33.33%)  11
Lymphocyte Count Decreased * 1  2/27 (7.41%)  3 4/27 (14.81%)  6
White Blood Cell Count Decreased * 1  6/27 (22.22%)  8 8/27 (29.63%)  12
Aspartate Aminotransferase Increased * 1  14/27 (51.85%)  27 14/27 (51.85%)  27
Urine Output Decreased * 1  5/27 (18.52%)  11 4/27 (14.81%)  5
Blood Creatinine Increased * 1  3/27 (11.11%)  8 6/27 (22.22%)  6
Blood Alkaline Phosphatase Increased * 1  2/27 (7.41%)  4 5/27 (18.52%)  5
Blood Bilirubin Increased * 1  6/27 (22.22%)  8 3/27 (11.11%)  6
International Normalized Ratio Increased * 1  4/27 (14.81%)  6 3/27 (11.11%)  4
Weight Decreased * 1  2/27 (7.41%)  2 3/27 (11.11%)  3
Weight Increased * 1  3/27 (11.11%)  5 4/27 (14.81%)  5
Activated Partial Thromboplastin Time Prolonged * 1  3/27 (11.11%)  4 3/27 (11.11%)  5
Electrocardiogram QT Prolonged * 1  2/27 (7.41%)  2 1/27 (3.70%)  1
Blood Chloride Increased * 1  1/27 (3.70%)  2 2/27 (7.41%)  3
Blood Triglycerides Increased * 1  2/27 (7.41%)  2 0/27 (0.00%)  0
Eosinophil Count Increased * 1  2/27 (7.41%)  3 2/27 (7.41%)  3
Gamma-Glutamyltransferase Increased * 1  2/27 (7.41%)  2 1/27 (3.70%)  2
Metabolism and nutrition disorders     
Hypokalemia * 1  25/27 (92.59%)  65 23/27 (85.19%)  55
Hyponatremia * 1  21/27 (77.78%)  48 20/27 (74.07%)  43
Hypocalcemia * 1  15/27 (55.56%)  30 15/27 (55.56%)  26
Hyperglycemia * 1  10/27 (37.04%)  15 8/27 (29.63%)  14
Hypophosphatemia * 1  5/27 (18.52%)  5 6/27 (22.22%)  6
Hypoalbuminemia * 1  23/27 (85.19%)  60 26/27 (96.30%)  59
Hypertriglyceridemia * 1  12/27 (44.44%)  14 10/27 (37.04%)  10
Decreased Appetite * 1  6/27 (22.22%)  9 7/27 (25.93%)  8
Hypercalcemia * 1  6/27 (22.22%)  8 4/27 (14.81%)  6
Hypoglycemia * 1  5/27 (18.52%)  5 8/27 (29.63%)  10
Hypomagnesemia * 1  8/27 (29.63%)  18 7/27 (25.93%)  15
Hyperkalemia * 1  4/27 (14.81%)  4 4/27 (14.81%)  7
Fluid Retention * 1  3/27 (11.11%)  3 2/27 (7.41%)  2
Hyperphosphatemia * 1  0/27 (0.00%)  0 2/27 (7.41%)  3
Musculoskeletal and connective tissue disorders     
Pain in Extremity * 1  9/27 (33.33%)  14 11/27 (40.74%)  18
Back Pain * 1  4/27 (14.81%)  5 2/27 (7.41%)  3
Neck Pain * 1  2/27 (7.41%)  2 1/27 (3.70%)  1
Musculoskeletal Pain * 1  2/27 (7.41%)  2 0/27 (0.00%)  0
Nervous system disorders     
Headache * 1  4/27 (14.81%)  5 1/27 (3.70%)  1
Lethargy * 1  1/27 (3.70%)  2 2/27 (7.41%)  2
Psychiatric disorders     
Irritability * 1  5/27 (18.52%)  8 4/27 (14.81%)  9
Agitation * 1  4/27 (14.81%)  7 4/27 (14.81%)  4
Anxiety * 1  2/27 (7.41%)  2 3/27 (11.11%)  4
Abnormal Behavior * 1  2/27 (7.41%)  2 1/27 (3.70%)  1
Insomnia * 1  1/27 (3.70%)  1 2/27 (7.41%)  2
Restlessness * 1  1/27 (3.70%)  1 2/27 (7.41%)  2
Renal and urinary disorders     
Urinary Retention * 1  7/27 (25.93%)  7 4/27 (14.81%)  7
Hematuria * 1  2/27 (7.41%)  3 4/27 (14.81%)  5
Proteinuria * 1  3/27 (11.11%)  5 5/27 (18.52%)  10
Dysuria * 1  2/27 (7.41%)  2 0/27 (0.00%)  0
Respiratory, thoracic and mediastinal disorders     
Hypoxia * 1  5/27 (18.52%)  7 5/27 (18.52%)  9
Cough * 1  13/27 (48.15%)  16 13/27 (48.15%)  21
Rhinorrea * 1  2/27 (7.41%)  3 3/27 (11.11%)  4
Nasal Congestion * 1  1/27 (3.70%)  1 3/27 (11.11%)  3
Tachypnea * 1  3/27 (11.11%)  3 1/27 (3.70%)  1
Sneezing * 1  0/27 (0.00%)  0 2/27 (7.41%)  2
Upper Respiratory Tract Infection * 1  0/27 (0.00%)  0 2/27 (7.41%)  3
Skin and subcutaneous tissue disorders     
Pruritus * 1  17/27 (62.96%)  21 14/27 (51.85%)  18
Dry Skin * 1  6/27 (22.22%)  6 6/27 (22.22%)  6
Rash * 1  7/27 (25.93%)  10 7/27 (25.93%)  7
Urticaria * 1  8/27 (29.63%)  9 6/27 (22.22%)  10
Rash Maculo-Papular * 1  3/27 (11.11%)  4 2/27 (7.41%)  3
Vascular disorders     
Hypotension * 1  12/27 (44.44%)  18 9/27 (33.33%)  13
Capillary Leak Syndrome * 1  6/27 (22.22%)  10 6/27 (22.22%)  9
Hypertension * 1  7/27 (25.93%)  15 7/27 (25.93%)  17
Flushing * 1  2/27 (7.41%)  2 3/27 (11.11%)  3
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA (17.0)
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Institution and/or Principal Investigator agree not to publish or publicly present any interim results of the Study without the prior written consent of Sponsor, not to be unreasonably withheld or delayed, except as provided below. Institution and/or Principal Investigator further agree to provide Sponsor with drafts of any such publication or presentation for review and approval no less than 30 days prior to submission for publication or the date of public presentation.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Allison Lim
Organization: United Therapeutics Corporation
Phone: 919-425-8799
EMail: alim@unither.com
Layout table for additonal information
Responsible Party: United Therapeutics
ClinicalTrials.gov Identifier: NCT01592045     History of Changes
Other Study ID Numbers: DIV-NB-201
First Submitted: April 30, 2012
First Posted: May 4, 2012
Results First Submitted: June 3, 2015
Results First Posted: September 23, 2015
Last Update Posted: September 23, 2015